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Accommodating Disabilities in Experiential Education: Easier Than it Seems, Full of Reward

Learning Objectives

 

After completing this application-based continuing education activity, pharmacist preceptors will be able to

  • DEFINE types of learning disabilities that preceptors are likely to encounter
  • LIST the information the school of pharmacy should provide to preceptors
  • IDENTIFY accommodation that are appropriate for specific students
  • DESCRIBE reasonable accommodation in experiential education

    Education for disabled children. Handicapped kid on wheelchair in kindergarten. Equal opportunities, preschool program, special needs. Vector isolated concept metaphor illustration

     

    Release Date: December 10, 2023

    Expiration Date: December 10, 2026

    Course Fee

    Pharmacists: $5

    UConn Faculty & Adjuncts:  FREE

    There is no grant funding for this CE activity

    ACPE UANs

    Pharmacist: 0009-0000-23-059-H04-P

    Session Code

    Pharmacist:  23PC59-ACA37

    Accreditation Hours

    1.0 hours of CE

    Accreditation Statements

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-059-H04-P  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

     

    Disclosure of Discussions of Off-label and Investigational Drug Use

    The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

    Faculty

    Jennifer Luciano, PharmD
    Director, Office of Experiential Education; Associate Clinical Professor
    UConn School of Pharmacy
    Storrs, CT

    Neha Patel
    2025 PharmD Candidate
    UConn School of Pharmacy
    Storrs, CT

    Jeannette Y. Wick, RPh, MBA, FASCP
    Director, Office of Pharmacy Professional Development
    UConn School of Pharmacy
    Storrs, CT

     

     

     

     

     

     

    Faculty Disclosure

    In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

    Jeannette Wick, Neha Patel, and Jennifer Luciano do not have any relationships with ineligible companies

     

    ABSTRACT

    From time to time, preceptors need to address the needs of students who have disabilities, be they visible or invisible. Students’ disabilities may include chronic diseases, physical limitations, or difficulty with processing information. This continuing education activity introduces various types of disabilities that preceptors may encounter and suggests a stepwise process to develop accommodation plans. It discusses information that preceptors will need or want to have on hand, and potential sources to obtain the information. It also describes the various stakeholders and the accommodation process and the potential benefits for the entire workplace.

    CONTENT

    Content

    INTRODUCTION

    Some pharmacy students have visible or invisible disabilities that require accommodation (a change or adaptation to adjust a situation to meet the student’s unique needs). Anecdotally, faculty at the University of Connecticut School of Pharmacy report that between 5% and 12% of students in a typical class in the last 10 years need accommodation. In terms of physical disabilities, institutions of higher learning have almost always built or altered existing buildings to accommodate students with disabilities with ramps, elevators, wide doors, and similar structural changes. Preceptors who work in larger organizations may have support teams that address or have already addressed physical disabilities. Those who work in smaller organizations or older buildings may be intimidated by the need to accommodate but will find that the law requires “reasonable” accommodation.

     

    Pharmacy preceptors are more likely to encounter students who have chronic disease (e.g., asthma, autoimmune syndromes, diabetes, etc.) or learning disabilities, including those who are neurodivergent (the SIDEBAR explains the concept of neurodiversity). While taking classes, pharmacy schools often (and are legally required to) provide accommodation for students with learning disabilities (see Table 1). They may provide double time or access to a quiet room during exams, permission to take breaks during class, or notetakers to help them depending on the disability type. Students with learning disabilities acquire, organize, retain, comprehend, or use verbal or nonverbal information differently than others. They have impaired perception, thinking, remembering, or learning processes.1

    Table 1. Types of Learning Disabilities1-7

     

    Learning disability Description
    Anxiety disorder Anxiety that does not go away and can worsen over time. Symptoms can interfere with daily activities such as job performance, schoolwork, and relationships. Subtypes of anxiety disorders include generalized anxiety disorder, panic disorder, social anxiety disorder, and various phobia-related disorders.
    Attention deficit hyperactivity disorder Causes an ongoing pattern of inattention and/or hyperactivity that interferes with functioning and/or development.
    • Inattention may manifest as difficulty staying on task, sustaining focus, and staying organized; these problems are not due to insubordination or lack of comprehension.
    • Hyperactivity manifests as involuntary constant movement, even when it is inappropriate, or excessive fidgeting, tapping, or talking. Adults with ADHD are often extremely restless or talkative.
    • Impulsivity is acting without thinking or difficulty with self-control. It may include a desire for immediate reward or inability to delay gratification. It may manifest as interrupting others or making key decisions while ignoring long-term consequences.
    Autism spectrum disorder (ASD) A neurologic and developmental disorder that affects how people interact with others, communicate, learn, and behave. Autism is known as a “spectrum” disorder because its wide variation in presentation and symptom severity.

    People with ASD often have:

    ·       Difficulty with communication and interaction with other people

    ·       Restricted interests and repetitive behaviors

    ·       Symptoms that affect their ability to function in school, work, and other areas of life

    Dysgraphia A neurological disorder characterized by writing disabilities that appear as distorted or incorrect writing (inappropriately sized and spaced letters, or wrong or misspelled words despite focused instruction).
    Dyscalculia Causes consistent failure to achieve in mathematics marked by difficulties with counting, working memory, visualization; visuospatial, directional, and sequential perception and processing; retrieval of learned facts and procedures; quantitative reasoning speed; motor sequencing; perception of time; and the accurate interpretation and representation of numbers when reading, copying, writing, reasoning, speaking, and recalling.
    Dyslexia Impairs a person’s ability to read. Although varies by individual, common characteristics include difficulty with
    • Phonological processing (the manipulation of sounds)
    • Rapid visual-verbal responding
    • Spelling

     

    SIDEBAR: Emerging Terminology and Necessary Understanding: Neurodiversity8-11

     

    Neurodiversity refers to the diversity of all people, but is often used in the context of autism spectrum disorder (ASD), neurological or developmental conditions, and learning disabilities. It is neither a medical term nor a diagnosis; it’s a descriptor used to replace the tendency to think of behaviors as normal or abnormal or to marginalize certain people based on their behaviors. When thinking about neurodiversity, it’s critical to remember that there is no one right way of thinking, learning, and behaving, and all differences are not necessarily deficits. Neurodiversity is not preventable, treatable, or curable. It’s the result of normal variation in the human genome. The term is used to promote equity and social justice for people who are members of a neurologic minority.

     

    Students who are neurodivergent experience and interact with the world around them in many different ways. Common characteristics among students who are neurodivergent include eye contact, facial expressions, and body language that are different than many other people’s.

     

    Students may or may not disclose (or even know) they are neurodivergent. When students do, it is important for preceptors to acknowledge neurodiversity and ask directly about a person’s preferred communication style and accommodations, many of which are described in the text of this continuing education activity. Many of the accommodations for people who are neurodiverse also help other students and employees who do not fall into neurologic minority categories, including

    • Offering or allowing individuals to make small adjustments to the workspace
    • Avoiding sarcasm, idioms, euphemisms, and implications
    • Providing concise instructions
    • Posting information about due dates and meetings as far in advance as possible
    • Treating all people with respect

     

    Preceptors should foster environments that are conductive to neurodiversity, and to recognize and emphasize each person’s individual strengths and talents while also providing support for their differences and needs. It’s also helpful to know that many large companies are now adjusting their hiring processes to attract people who are neurodivergent. They’ve found that although some people have trouble navigating the hiring process, their unique abilities are valuable, increase the company’s productivity, and often lead to remarkable product and process improvements.

     

     

    This continuing education activity is designed to help preceptors who encounter pharmacy students with disabilities develop workable plans. Preceptors should start by acknowledging a critical fact: accommodation isn’t special treatment. Accommodation levels the playing field so student pharmacists (and employees) can learn and do their best work.

     

     

    PAUSE AND PONDER: You’re a preceptor for your state university. In April, the experiential education office notifies that you have one student per month from June through April. Shortly after, a staff member from the experiential education office calls and tells you that the student scheduled for August needs accommodation. What should you expect going forward, and what is the best time to plan?

     

    Providing Reasonable Accommodation

    Institutions of higher learning usually have entire departments that develop policies, document the student’s type and degree of disability, and develop student-specific accommodation plans. When students who have disabilities go on clinical rotations, rotation sites may have no processes or policies to provide the same accommodation. Preceptors may not know how to cater to their needs. Often, practice sites need only to make minor adjustments to their environments, policies, and procedures. Once the organization makes the changes, the policies will be ready for future students! A PRO TIP is that an astute student who has disabilities may be willing to help edit and adjust policies; this insight can be valuable. However, the student may not want to help as this can be an added burden that other students don’t have.

     

    Five basic principles help schools ensure that clinical rotation sites provide reasonable accommodation for students on clinical rotations1,11,12:

     

    • Before going on rotation, it is critical for the school to document the student’s disability with a reliable diagnosis. The school’s department for students with disabilities usually does this.
    • All parties will need to work together to identify elements of the student’s disability that would cloud the preceptor’s ability to assess the student’s competence. Any accommodation should mitigate those elements.
    • Preceptors should work with the school to develop accommodation tailored to the specific rotation site and tasks to be accomplished at that site.
    • Three hundred sixty-degree communication is essential. Preceptors, students, school and rotation site administration, and disability service staff must collaborate and communicate.
    • Throughout the whole process, all parties must protect the student’s privacy.

     

    Students with disabilities are subject to a great deal of stigma not only from the outside world but also from preceptors. Ideally, schools should match these students with rotation sites and preceptors with prior experience accommodating students with disabilities.13 However, this may not always be possible. In ideal situations, preceptors are sympathetic and the relationship between the student and preceptor is open, non-judgmental, friendly, and relaxed. These characteristics set the stage for students to disclose their learning needs without fear of discrimination.14

     

    The school, however, must identify sites and preceptors based on the student’s accommodation needs without disclosing student-specific accommodation descriptions. Open and honest communication between students, the experiential education team, and representative(s) of the school’s disabilities office before they develop the rotation schedule can prevent problems later.13 Once the school confirms the student’s sites, it can share very basic student-specific details with the preceptor but only the student can share specific health information.1 In other words, the school can communicate the accommodation the student needs, but not the underlying diagnosis; that is private and only the student may disclose it.

     

    A challenge for students with physical disabilities is needing accommodation through multiple sites, which requires significant coordination and planning. A solution is providing multiple rotations at a single site where accommodation is available. When this solution is available, students can acclimate once.13 This can provide the best possible experience for the student, providing a level of comfort in the environment; conversely, this solution may force disabled students to stay at one site while their peers rotate from site to site and experience different healthcare teams. In institutions without pre-existing policies, schools would benefit by working with preceptors and the sites to develop guidelines for accommodating students. For students with physical disabilities, guidelines should address different types of mobility devices, physical dimensions of hospital facilities, safety requirements of the pharmacies, and access to particular areas.13 The preceptor should do this before the student begins working at the site. It would be unfortunate if a student arrived at a site only to find it was inaccessible.

     

    Step-by-Step to Accommodation

    Using a stepwise approach on site helps preceptors ensure that they provide reasonable accommodation to students.

     

    1. Raising awareness among the clinical team regarding disabilities, accommodation, and inclusive learning environments is a prudent first step. The team is able to do this by reviewing the literature, laws, and regulations. The Americans with Disabilities Act (ADA) Titles I, II, and III and the Rehabilitation Act (see Table 2) are the constellation of laws that prohibit discrimination and govern accommodation in pharmacy experiential education.15 Individual states may also have additional laws that protect disabled students.

     

    Table 2. Federal Laws and Regulations that Protect Students with Disabilties15

    Law/regulation Description
    Americans with Disabilities Act (ADA)
    Title 1: Employment ·       Prohibits discrimination in recruitment, hiring, promotions, training, pay, social activities, and other privileges of employment.

    ·       Restricts questions that can be asked about an applicant’s disability before a job offer is made

    ·       Requires that employers make reasonable accommodation for known physical or mental limitations of otherwise qualified individuals with disabilities, unless it results in undue hardship.

     

    Title II: Public sector ·       Requires state and local governments to give people with disabilities an equal opportunity to benefit from their programs, services, and activities

    ·       Requires reasonable modifications to policies, practices, and procedures where necessary to avoid discrimination, unless doing so would fundamentally alter the nature of their service

    ·       Does not require actions that would result in undue financial and administrative burdens

    ·       Indicates governmental agencies must communicate effectively

    Title III: Private sector ·       Explains public accommodation in businesses and nonprofits must not discriminate, exclude, segregate, or provide unequal treatment

    ·       Requires businesses and nonprofits to make  reasonable modifications to polices, practices and procedures and communicate effectively with people with hearing, vision, or speech disabilities

    ·       Requires employers to remove barriers and meet other access requirements.

    Rehabilitation Act of 1973
    Section 504 Prohibits programs or activities that receive federal funding from discriminating against disabled people.

     

    One area that all employers and employees need to understand is that accommodation can include variations on the workspace or equipment needed to complete various tasks, how work is assigned and communicated, the specific tasks, and the time and place that the work is done.16

     

    1. Establishing essential learning activities and outcomes for students helps all students, not just those with learning or physical disabilities. This means specifying essential functions, minimum competencies, expectations, and procedures that all students must be able to perform by the end of the rotation.15 Preceptors should note that accommodating a student’s needs does not mean lowering expectations.1 A PRO TIP here is that sometimes a student can meet the expectation with only small changes in the preceptor’s style. For students who have information processing issues, asking questions and then pausing for five seconds to allow the student to answer is better than rapid fire questions.1 (This is actually an approach that all preceptors and teachers need to use more in all situations. Pausing benefits everyone, including people who are not native English speakers.)

     

    1. The rotation site should make reasonable accommodation based on a reliable diagnosis that the student has documented via the school’s office of student disabilities. The pharmacy school’s office will also provide documentation of the requested accommodation to preceptors; students who have disabilities should not make the requests to preceptors on their own; they may, however, provide the accommodation letter and any information they want to share with the preceptor and copy the school’s director of experiential education if that is the school’s policy. One area that can be difficult for preceptors is the student’s healthcare appointments.1 A PRO TIP is to ask the student at the beginning of the rotation if you need to be aware of any scheduled appointments. Preceptors should also be very clear that the student must notify them of unanticipated appointments as soon as possible (or even before they call to schedule the appointment). If students miss time at rotations, they are responsible for making up the time.

     

    Documenting and discussing reasonable accommodation with the individual student who has a disability may be an uncomfortable or unfamiliar task for preceptors but will avoid problems later. Preceptors should meet with students to discuss exactly what they need in relation to their experiential outcomes (using the aforementioned list of specifying essential functions, minimum competencies, expectations, and procedures), asking questions such as1,15

    • What limitations do you anticipate experiencing on the rotation?
    • What tasks will you find problematic?
    • What have you done in the past to reduce or eliminate these limitations?
    • Do you anticipate needing us to make any modifications while you are here?
    • What will you do if you encounter an unanticipated obstacle?

     

    Here’s another PRO TIP: Knowing a few ways to accommodate disabilities will help preceptors help the student. For example, a student who has severe anxiety will find many rotations difficult and threatening. A preceptor can suggest that the student observe or “preview” activities before requiring interaction, especially if the site is fast-paced or chaotic. Allowing the student to arrive early may also help. Students who are challenged organizationally may benefit from one (not multiple) outline of what to expect every day.1

     

    1. The student should self-assess and document how the disability affects each general competency and how accommodation could mitigate each concern.1 Figure 1 describes the process of preceptors choosing accommodation.

     

     

     

    The preceptor and student should develop an accommodation plan together and document it in writing. An ideal plan would list the intervention or accommodation and how it supports the student, those involved in creating the accommodation, and the parties responsible for any financial costs (discussed below). 11 For example, in a pharmacy setting where a great deal of business is conducted over the phone using headphones, a student who has difficulty hearing may need a phone amplifier. If the student wears hearing aids, headphones may interfere with her ability to hear. The plan should also include specific days/times for periodic check-ins so the student and preceptor can assess whether the intervention/accommodation meets the students’ needs and is still reasonable for the site.11

     

    A PRO TIP for preceptors is to stay abreast of technology changes.16 If students have difficulty reading or writing—these are students with dyslexia or dysgraphia—many programs now have read-aloud or voice-to-text programs that are remarkably accurate. Some calculators will talk. Encourage students to use them. Asking students to listen to their work using a read-aloud program will also help them catch errors.

     

    PAUSE AND PONDER: You meet with your new APPE student and learn that he has serious visual impairment. He indicates he needs to use assistive devices (supplemental lighting, a magnifier). How would you initiate a discussion about who will secure these devices?

     

    The last step, which overlaps with the previous steps to some extent, is providing reasonable accommodation. Readers may read the term “reasonable accommodation” and wonder what is considered reasonable. Accommodation should not pose an undue financial or administrative hardship to the practice site.15 The law would not consider an accommodation reasonable if it decreased quality or posed safety issues to patients or imposed undue financial or administrative burden on the institution. It would also be unreasonable to change curricular elements or alter course objectives substantially. Preceptors might reach out to the school’s experiential education office who can contact the university’s legal department to determine whether a specific accommodation is reasonable. Or, preceptors can contact their own legal representatives. Preceptors and students need to communicate openly and honestly to determine reasonable accommodation together. Table 3 describes some examples of reasonable accommodation.

     

    Table 3. Examples of Reasonable Accommodation in Clinical Experiential Learning8,15-17

     

    Student Limitation Accommodation
    Anxiety ·       Embrace the learning experience and don’t be too hard on students when they make an error. Provide feedback and guidance for them to improve.

    ·       Plan the days and weeks, setting achievable goals, and prioritizing tasks.

    ·       Offer counseling services and other resources to support the student.

    Concentration difficulties ·       Use organization techniques that help students manage time and stay on track.

    ·       Ask students if using a highlighter to emphasize assignments that are priorities will help.

    ·       Step away from busy workplaces to provide directions in a quieter location.

    ·       Develop or have the student develop checklists for common tasks.

    Distractibility ·       Provide or allow students to use their own noise-canceling headphones or give them a private room to work.

    ·       Provide a quiet space away from noise and busy office traffic and a “Do Not Disturb” sign so students can work without interruption.

    ·       Avoid allowing or encouraging multitasking. Have students complete one thing at a time.

    Dyslexia ·       Encourage use of appropriate read-aloud and voice-to-text software.

    ·       Explain and provide a list of common or site-specific acronyms and other jargon.

    Neurodiversity ·       Sound sensitivity: offer a quiet break space, communicate expected loud noises (like fire drills), offer noise-canceling headphones.

    ·       Tactile: allow modifications to the usual work uniform

    ·       Movement: allow the use of fidget toys, allow extra movement breaks, offer flexible seating

    ·       Use a clear communication style:

    o   Avoid sarcasm, euphemisms, and implied messages.

    o   Provide concise verbal and written instructions for tasks, and break tasks down into small steps.

    ·       Inform people about workplace etiquette, and don’t assume someone is deliberately breaking the rules or being rude.

    ·       Try to give advance notice if plans are changing and provide a reason for the change

    ·       Don’t make assumptions – ask a person’s individual preferences, needs, and goals.

    ·       Be kind, be patient

    Poor organization ·       Set aside 15 minutes at the end of the day to plan the next day’s work.

    ·       Have students and all employees return important shared items to the same place each time they use them.

    ·       Consider a color-coding system for assignments or shelving.

    ·       Keep things visible on shelves, bulletin boards, or other places; avoid storage in drawers or closets.

    ·       Attach important objects physically to the place they belong.

    Processing disorders ·       Provide both written and oral instructions.

    ·       Follow-up important conversations with a brief e-mail

    ·       Ask the student to make notes and provide them to you for review.

    ·       Use the teach-back method; ask the student to repeat the information back so you can be sure you covered everything (and they heard the key messages)

     

    Emphasis on Planning Ahead

     

    Before rotations start, students with disabilities and preceptors should complete a practice walk-through at the rotation site to identify, modify, and make necessary adjustments.13 The experiential team must also understand the student’s career aspirations. Frank discussion will help all involved with rotation planning. The experiential team and the preceptor can address the students’ and preceptors’ concerns, needs, and goals in advance. Also, the person coordinating this process should identify and discuss costs and financial resources for the accommodation plan with all parties involved and determine who is responsible for the costs. This creates clear expectations. 13

     

    If during the check-in or at any time a situation changes, the plan needs revision to find a more acceptable or effective reasonable accommodation or an urgent concern arises, the student or the preceptor should contact the school immediately.13

     

    CONCLUSION

    Preparing and executing accommodation can be challenging. Preceptors who develop skills in this area help student pharmacists develop communication, collaboration, and planning skills they will use and improve all during their careers. Preceptors also assess the actual barriers associated with the student’s disability in a controlled environment and help students learn how to mitigate the challenges associated with their disabilities in future employment. A PRO TIP is to keep in mind that many employees have disabilities or have slightly different learning styles. Learning how to accommodate them from students and schools of pharmacy will benefit your entire work force. It may even help you!

     

     

     

     

    Pharmacist Post Test (for viewing only)

    1. A student has been diagnosed with attention deficit hyperactivity disorder (ADHD), a type of learning disorder. Which of the following BEST describes ADHD?
    A. A disorder characterized by writing disabilities that appear as distorted or incorrect writing
    B. A disorder that affects how people interact with others, communicate, learn, and behave
    C. A disorder that causes ongoing patterns of inattention and/or hyperactivity that interferes with functioning and/or development

    2. You observe that a student has difficulties counting, putting documents in numerical order, and calculating doses when the order specifies a mg/kg dosing. What type of disability is this MOST LIKELY to be?
    A. Dyslexia
    B. Dyscalculia
    C. Dysgraphia

    3. Once the school confirms a student’s site, what information can the school share with the preceptor?
    A. The required accommodation
    B. The student’s diagnosis
    C. The student’s health information

    4. How can the school of pharmacy help students with disabilities to be comfortable and meet their needs at various clinical sites?
    A. Informing the site that the student will be doing all their clinical rotations at that site
    B. Providing policies and student-specific accommodation plans that can be adjusted
    C. Only using preceptors who have experience accommodating students with disabilities

    5. Mary, a preceptor, is preparing for Elwin to start a rotation at her site. Elwin told the preceptor that he struggles with organization. They are identifying accommodation and exploring if they need to make any changes to the site. Which of the following is the most appropriate accommodation to keep the site organized for the student?
    A. Color-code the shelving system in the pharmacy
    B. Provide both written and oral instructions
    C. Provide directions away from the workplace

    6. A pharmacy student, Sarah, has attention deficit hyperactivity disorder (ADHD) and will be going on her clinical rotation. She has been in communication with the school and the preceptor about accommodation, indicating her key limitation is distractibility. Which of the following is the is the BEST accommodation the preceptor can provide?
    A. Encourage use of appropriate read aloud and voice to text software
    B. Plan the days and weeks, setting achievable goals, and prioritizing tasks.
    C. Provide a quiet space away and a “Do Not Disturb” sign

    7. Which of the following factors would a preceptor consider when providing a reasonable accommodation?
    A. The accommodation’s feasibility and financial cost
    B. The student’s academic grade point average
    C. The student’s specific diagnosis

    8. Which answer correctly lists the steps when choosing an accommodation for a student?
    A. Lower your expectations, assess whether the accommodation is meeting the student’s needs, analyze the required tasks
    B. Maintain your expectations, analyze the required tasks, periodically assess whether the accommodation is meeting the student’s needs
    C. Meet with the student, ask about the specific diagnosis of neurodiversity, develop a plan you think is suitable for the student

    References

    Full List of References

    REFERENCES
    1. Vos S, Kooyman C, Feudo D, et al. When Experiential Education Intersects with Learning Disabilities. Am J Pharm Educ. 2019;83(8):7468.
    2. Anxiety Disorders. National Institutes of Mental Health. Accessed August 9, 2023. https://www.nimh.nih.gov/health/topics/anxiety-disorders
    3. Autism Spectrum Disorder. National Institutes of Mental Health. Accessed August 14, 2023. https://www.nimh.nih.gov/health/topics/autism-spectrum-disorders-asd
    4. Attention-Deficit/Hyperactivity Disorder. National Institute of Mental Health. Accessed August 5, 2023. https://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd
    5. Dysgraphia. National Institutes of Neurological Disorders and Stroke. Accessed August 5, 2023. https://www.ninds.nih.gov/health-information/disorders/dysgraphia
    6. Dyscalculia. Dycalculia.org. Accessed August 5, 2023. https://www.dyscalculia.org/
    7. Dyslexia. National Institutes of Neurological Disorders and Stroke. Accessed August 5, 2023. https://www.ninds.nih.gov/health-information/disorders/dyslexia
    8. Baumer N. What is Neurodiversity? Accessed August 14, 2023. https://www.health.harvard.edu/blog/what-is-neurodiversity-202111232645
    9. Neurodivergent. The Cleveland Clinic. Accessed August 15, 2023. https://my.clevelandclinic.org/health/symptoms/23154-neurodivergent
    10. Austin RD, Pisano GP. Neurodiversity as a Competitive Advantage. Harvard Business Review. May-June 2017. Accessed August 15, 2023. https://hbr.org/2017/05/neurodiversity-as-a-competitive-advantage
    11. Elliott HW, Arnold EM, Brenes GA, et al. Attention deficit hyperactivity disorder accommodations for psychiatry residents. Acad Psychiatry. 2007;31(4):290-296.
    12. Shrewsbury D. Dyslexia in general practice education considerations for recognition and support. Educ Prim Care. 2016;27(4):267-270.
    13. Kieser M, Feudo D, Legg J, et al. Accommodating Pharmacy Students with Physical Disabilities During the Experiential Learning Curricula. Amer J Pharm Ed. Published online April 2, 2021:8426.
    14. L’Ecuyer KM. Clinical education of nursing students with learning difficulties: An integrative review (part 1). Nurse Educ Pract. 2019;34:173-184.
    15. Vos SS, Sandler LA, Chavez R. Help! Accommodating learners with disabilities during practice‐based activities. 2021;4(6):730-737.
    16. Job Accommodation Ideas for People with Learning Disabilities. Learning Disabilities Association of American. Accessed August 5, 2023. https://ldaamerica.org/info/job-accommodation-ideas-for-people-with-learning-disabilities/
    17. Horesh A. Conquer Anxiety in Clinical Rotations: A Guide for Medical Students. Accessed August 9, 2023. https://futuredoctor.ai/anxiety-in-clinical-rotations/

    Patient Safety: Workplace Bullying

    Learning Objectives

     

    After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able

    1. Define workplace bullying in the healthcare setting
    1. Explain the impact of workplace bullying on individuals, organizations, and patient care
    1. Differentiate workplace bullying from harassment and workplace dysfunction
    1. Describe the necessary steps to address and counteract workplace bullying

      Individuals talking to each other behind another individual's back

       

      Release Date: November 20, 2023

      Expiration Date: November 20, 2026

      Course Fee

      Pharmacists: $7

      FREE FOR UConn Preceptors

      Pharmacy Technicians: $4

      There is no funding for this CE.

      ACPE UANs

      Pharmacist: 0009-0000-23-058-H05-P

      Pharmacy Technician:  0009-0000-23-058-H05-T

      Session Codes

      Pharmacist:  23YC58-ABC28

      Pharmacy Technician: 23YC58-BCA49

      Accreditation Hours

      2.0 hours of CE

      Accreditation Statements

      The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-058-H05-P/T will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

       

      Disclosure of Discussions of Off-label and Investigational Drug Use

      The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

      Faculty

      Giovanni Fretes, PharmD Candidate 2025
      UConn School of Pharmacy
      Storrs, CT

                                         

      Jeannette Y. Wick, RPh, MBA, FASCP
      Director OPPD, UConn School of Pharmacy
      Storrs, CT

      Faculty Disclosure

      In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

      Giovanni Fretes and Jeannette Wick have no relationships with ineligible companies.

       

      ABSTRACT

      Several healthcare professional organizations have identified workplace bullying as a problem. Workplace bullying can decrease morale, but additionally, it can also compromise patient safety. Some studies have found that physicians tend to be identified most often as workplace bullies, but additional studies indicate that bullying in pharmacy is present and under reported. The most likely type of workplace bullying in pharmacy is verbal bullying, which includes mocking, name-calling, teasing, or intimidating a target. In some instances, physical or nonverbal bullying may occur. Unaddressed bullying can lead to diminished morale, strained employee relations, loss of respect for management, and increased absenteeism or tarnished reputation of the workplace. Establishing a reasonable definition of bullying, differentiating it from harassment, and training employees in bystander intervention can help improve the workplace and decrease the likelihood of damage from bullying.

      CONTENT

      Content

      INTRODUCTION

      Bullying is a popular topic these days. Hardly a day goes by without a story in the media about school bullies, social media bullies, celebrity bullies, political bullies, and even chef bullies. In addition, lawsuits have found people and organizations liable for suicides when they bullied the victim (called the target) or failed to address bullying.1 And many times, serial killers or individuals who conduct mass shootings are later identified as having been bullied. Clearly, the United States (U.S.) has a bullying problem. Does healthcare and, on a smaller scale, pharmacy, have a bullying problem?

      This continuing education activity discusses bullying in the workplace because healthcare and on a smaller scale, pharmacy, do have bullying problems and students sometimes experience bullying as they are introduced to the profession on rotations or in residencies. Unlike harassment, bullying isn’t illegal in the U.S., but it has serious repercussions to individuals and organizations. Recognizing and addressing workplace bullying is essential to foster healthy and supportive work environments in healthcare settings, ultimately benefiting both staff and patients. Although the authors drafted this activity to address the bullying that students sometimes experience in experiential rotations, during extensive peer review, reviewers indicated this topic is of interest to all pharmacy personnel, not just preceptors.

      Mock, Taunt, Intimidate

      Workplace bullying is a widespread issue that affects various industries, including pharmacies and other healthcare settings. Most of the data in healthcare comes from studies of physicians’ interactions with other disciplines, and the American Medical Association (AMA) recognizes the problem. AMA defines workplace bullying as “repeated, emotionally or physically abusive, disrespectful, disruptive, inappropriate, insulting, intimidating or threatening behavior targeted at a specific individual.”2 Bullying’s purpose is to control, embarrass, undermine, threaten, or cause harm toward an individual. Various factors at the individual, organizational, and health system level can contribute to creation of an unprofessional workplace climate or culture.2

      Workplace bullying is important to address because it can impact patient care, resulting in preventable mistakes. In a 2021 survey, roughly 35% of healthcare providers had concerns about medication orders but chose to assume correctness to avoid engaging with specific providers. One pharmacist was shamed by a colleague after seeking an independent double check for a vancomycin order with incorrect timing. Multiple errors like this occur annually because of the culture of shaming.3 Some data about how bullying affects the medication prescribing and administration process demonstrates this subject’s importance.

      Every few years, the Institute for Safe Medication Practices (ISMP) surveys healthcare professionals about disrespectful behaviors and intimidation in the workplace.4,5 ISMP conducted its most recent survey in September 2021.3 Among the 1,047 respondents, 26% worked in the pharmacy, suggesting that bullying is a problem in pharmacies since a disproportionate number of pharmacy employees responded compared to more populous health care providers like physicians and nurses. A full 37% of respondents were pharmacists and 6% were pharmacy technicians.3

      Disrespectful behaviors were clearly linked to medication concerns3:

      • 40% of respondents said past disrespectful behaviors had altered the way they handled order clarifications or questions about medication orders.
      • Roughly half of respondents said that they had relied on colleagues to interpret or validate an order rather than contact the prescriber in the past year; the reason was to avoid contact with the disrespectful prescriber.
      • 11% of respondents indicated they avoided talking to a prescriber to interpret or validate an order’s safety more than ten times in the previous year.
      • 7% said that they had been pressured to accept an order, dispense a product, or administer a drug despite safety
      • Slightly more than one-third reported having concerns about a medication order but assumed it was correct rather than interact with a specific prescriber; roughly the same number of respondents said that a prescriber’s stellar clinical reputation often made them reluctant to question or clarify orders even if they had concerns.

      TYPES OF WORKPLACE BULLYING IN HEALTHCARE

      In the limited research that addresses workplace bullying in pharmacies and other health care settings, researchers frequently bemoan the fact that, the AMA’s definition aside, we have no consensus definition of bullying. It would be ideal if we could provide a concise definition of bullying or a checklist that would help managers, supervisors, coworkers, and preceptors ascertain when bullying is occurring. In fact, bullying occurs in many different forms.

       

      Verbal Bullying

      Verbal bullying encompasses various forms of harmful language and communication. Examples of verbal bullying include mocking, name-calling, teasing, or intimidating someone to belittle or demean them. Insults and derogatory comments can degrade a person's self-esteem, creating a hostile working environment. Fans of the television show NCIS may recall that the section supervisor, Leroy Jethro Gibbs, always dubbed the newest hire “Probie,” which appears to have been short for probationary employee. People watching this show who are familiar with human resources regulations often shuddered when Gibbs did this, as it could be perceived as a form of bullying. Especially in government organization where the rules are very clear, such behavior would be dangerous. In pharmacies, calling people by unwelcome nicknames could be perceived as bullying.

      Public humiliation is another form of verbal bullying that aims to embarrass the person who is being bullied in front of others. Trainees commonly report persistent attempts from their preceptors or trainers to humiliate them in front of colleagues. According to a study, “The abuse of students is ingrained in medical education and has shown little amelioration despite numerous publications and righteous declarations by the academic community over the past decade.”6

      PAUSE AND PONDER: A preceptor asked a student a question in front of the rounding team. The student, who was unable to answer, blushed and stuttered. The preceptor said, “What school of pharmacy did you go to again? I need to call them and ask them what they're teaching because you clearly should have known the answer to this question.” The student reddened even more, and the preceptor said, “Oh! So, you're a blusher are you?” Was this teasing, was this misplaced humor, or was it bullying?

      The term bullying does not appear in the Accreditation Council for Pharmacy Education (ACPE) standards. Researchers reviewed the professional literature and American Association of Colleges of Pharmacy (AACP) survey data collected from student evaluations of preceptors (N = 2087); students provided low evaluations for preceptors in at least one area in 119 evaluations.6 When the researchers scanned the comments for words or phrases closely associated with bullying, they found respondents reported 34 instances indicating bullying. Figure 1 shows the distribution of comments and includes examples of troublesome comments.6

      Comments related to workplace bullying involve offensive behavior, humiliation, intimidation, exclusion or denial to opportunities, and excessive criticisms.

      Figure 1. Comments Related to Bullying from Pharmacy Survey Data6

      This data came from one college of pharmacy, but the researchers compared their data to that of a national study.6 It was similar. Although the rates of bullying seemed low, the researchers believed that bullying is seriously underreported in pharmacy. Some reasons may include the small number of pharmacists compared to physicians and nurses, the use of assessment tools that are not intended to identify bullying (asking the wrong questions), and students’ reluctance to complain because it may be perceived as unprofessional. Students may also be afraid that reporting bullying may affect their grades. The researchers recommend ACPE place more emphasis on bullying and develop of a consensus definition.6

      Intimidation and threats instill fear and anxiety, leaving the target feeling vulnerable and powerless. Intimidating behaviors in the healthcare workplace are far from isolated incidents. A survey conducted with more than 2,000 healthcare providers revealed that subtle, yet effective forms of intimidation were more common than explicit forms.4 Respondents reported encountering behaviors such as condescending language, impatience with questions, and reluctance to answer or return calls. Physicians and prescribers were identified as the primary perpetrators of intimidation, exhibiting behaviors such as condescension, reluctance to answer questions, and verbal abuse more frequently than other healthcare providers.4

      Additionally, destructive criticism is another unjustified way in which someone can wear down the target emotionally and psychologically. Constructive criticism and destructive criticism differ based on their delivery and the ways in which they impact individuals and their work.7 Constructive criticism uplifts people by providing suggestions and potential solutions while highlighting both positive aspects of someone's work and identifying areas for improvement. Destructive criticism undermines confidence, belittles efforts, and focuses on ridicule, leading to decreased morale and performance. It creates a hostile atmosphere and restrains productivity.7

      Constructive feedback begins and ends with positive comments and present information in a supportive way, as this “compliment sandwich” exemplifies:

      “Jacob, I appreciate your dedication and commitment to our pharmacy team. However, I've observed a higher number of medication errors when you’re dispensing prescriptions, which is unusual based on your work history. I know how dedicated you are to the team, so if you're facing any challenges that may be impacting your performance, please don't hesitate to reach out to me or any team member. We are here to support you and provide the best patient care possible."

      Destructive feedback is replete with negativity:

      "Jacob, your work recently in the pharmacy has been extremely disappointing. Why are you making so many mistakes? It's causing a lot of problems for the team, and frankly, I don't have the time or patience to fix everything for you. You really need to step up and improve your performance because it's negatively impacting our overall productivity."

      It’s not always possible to use a compliment sandwich when addressing issues in the pharmacy. It is always possible to be kind.

      Verbal bullying is usually easy to spot if the bully conducts the browbeating in public. In one pharmacy, a seasoned technician seemed to have a bias against students who were accruing IPPE or APPE hours. She would frequently tell students loudly, “If you can’t work any faster, it would be lovely if you would just get out of the way.” Her colleagues would turn a blind eye, but the section supervisor eventually took action and referred her to employee assistance. However, many bullies are adept at mounting their campaigns of terror when no one is looking. (Remember that the most likely place for bullying is schools is in the most difficult place to supervise: the playground.8)

       

      Non-Verbal Bullying

      Non-verbal bullying in healthcare manifests through actions that undermine and harm the target without using explicit words.9 Bullies use exclusion and social isolation to insulate targets from their colleagues, fostering a sense of loneliness and alienation. Undermining and sabotage minimize the target's work and efforts, eliminating a culture of safety.9

       

      PAUSE AND PONDER: A preceptor assigned one pharmacy student to sort and file a large backload of paperwork. She also assigned a technician to explain what needed to be done and how. The technician was frustrated by the student’s questions, but two hours later, the student finished sorting. He asked the technician to check his work before he filed it. The technician riffled through the pile, said, “This is correct,” and then said, “Oops!” and intentionally dropped the entire pile on the floor. Was that bullying?

       

      Ignoring and dismissing ideas invalidates targets’ contributions and suggestions which diminishes their confidence and ability to perform well.10 Additionally, intentionally withholding information deprives targets of essential knowledge needed to perform their assigned tasks effectively.9 Individuals who use “the silent treatment” (refusing to engage in discussion and making no eye contact) are also bullies. Researchers have found that people in positions of power who use the silent treatment also frequently assign unreasonable or unnecessary tasks.11

       

      Finally, bullies may also use noise in subtle ways to intimidate or disturb targets. In one situation, students were assigned to work in an office across from a pharmacist who did not like to precept but did so because he was assigned the task. He kept his door closed most of the time but would slam it hard when coming and going. He’d watch to see if the students reacted.

       

      Physical Bullying

      While less common in healthcare, physical bullying involves direct aggression towards the target.12 This can include pushing or shoving, which poses a threat to the target’s safety and well-being. Damaging personal belongings is another form of physical bullying, violating the target's personal space and property. Also forcing physical exertion on the target, such as excessive workloads or tasks beyond their capacity, can cause physical harm and exhaustion.12

      Healthcare workers are already at risk for physical violence, and four times more likely to experience violence requiring an absence from work than people employed in other industries.12 According to 2013 Bureau of Labor Statistics (BLS) data, 80% of serious violent incidents were a result of interactions with patients. The remaining incidents were attributed to visitors, coworkers, or individuals outside of the healthcare facility with 3% of the incidents from coworkers.12

      BLS found one fact of particular note: Employees were significantly less likely to report bullying and other forms of verbal abuse. They cited three contributing reasons: (1) lack of a reporting policy, (2) lack of faith in the reporting system, and (3) fear of retaliation, which is discussed below.12 Although healthcare workers appear to be more likely to be bullied by patients than coworkers, concerns about reporting flaws and retaliation may skew the data.12

      SIGNS AND EFFECTS OF BULLYING

      Absent a clear definition, healthcare managers and workers may struggle to identify bullying or differentiate it from harassment. Signs may be obvious—as in the example of the technician who tells students to get out of the way—or subtle.

      Signs of Workplace Bullying

      Recognizing the signs of workplace bullying is crucial for early intervention. Behavioral changes in targets, such as increased irritability, anxiety, or withdrawal, may indicate they are experiencing bullying.13

      Effect on Workers and Patients

      Workplace bullying has detrimental effects on both healthcare professionals and the quality of patient care.9 The emotional and psychological impact on targets can lead to heightened levels of stress, anxiety, and depression. This affects their well-being and their ability to provide optimal care to patients. Bullying can contribute to higher rates of medication errors, increased infections, and other negative patient outcomes. This is partly due to staff members' fear of speaking up against physicians or prescribers who are bullies.14 Physician Alan Rosenstein, an expert in disruptive behavior, highlights the existence of a "hidden code of silence" that keeps coworkers or colleagues from reporting or appropriately addressing many incidents.14

      Rosenstein has collected anecdotes from his work. He doesn’t report any from situations involving pharmacists or technicians, some examples of disparaging remarks/actions may feel somewhat familiar to pharmacy workers who have had unfortunate interactions with prescribers14:

      • During a tense operation, a surgeon insulted a male nurse, who had a special needs son, by saying, "You're a [r-word] just like your boy." The nurse filed a written complaint because of the insulting, disrespectful remark.
      • At Vanderbilt University Medical Center in Nashville, a surgeon proceeded with an operation without washing his hands. Instead of openly addressing the issue, a nurse discreetly offered the surgeon gloves, but he simply discarded them into the trash.
      • An OB/GYN patient was experiencing excruciating pain while the doctor sutured without providing sufficient anesthetic. When questioned by a medical student, the doctor made a joke saying that the patient could be given memory-erasing ketamine to forget about the experience.

      It is essential for pharmacy owners to recognize the consequences of workplace bullying on their businesses. Table 1 lists negative consequences of unaddressed bullying and provides examples. Preceptors, supervisors, mentors, and organizations must address factors that promote bullying (like power imbalances, addressed below) and provide employees with support to maintain healthy, successful pharmacy settings.

      Table 1. Negative Consequent of Unaddressed Bullying15

      Consequences Examples
      Diminished morale A seasoned pharmacy technician (whose pronouns = they/them), who has been working diligently for years, consistently faces belittling comments and criticism from the pharmacist. As a result, their overall enthusiasm for their work decreases, affecting their productivity and leading to a sense of resignation or disengagement. The rest of the staff will also feel disengaged and resigned.
      Strained employee relations One pharmacist consistently questions another pharmacist’s decisions and recommendations in front of colleagues and patients leading to tension and hostility between them. This strained relationship might extend beyond work-related matters, making collaboration difficult and creating an uncomfortable atmosphere for other team members.
      Loss of respect for management Employees witness a manager ignoring complaints, failing to provide a safe and supportive environment. The affected employees lose respect for the management team as they perceive the lack of intervention as a sign of management’s incompetence, leading to a diminished view of their leadership abilities.
      Increased absenteeism/

      tarnished reputation

      Over time, employees are subjected to behaviors of bullying and begin to experience high levels of stress and anxiety due to the hostile environment. So, the employees start taking more sick days or even extended leaves of absence to cope with bullying’s emotional toll. The toxic work environment spreads through word of mouth among colleagues, potential hires, and even patients. The pharmacy’s reputation suffers as news of the toxic work environment and unaddressed bullying gets around.

      Ultimately, workplace bullying may reduce everyone’s job satisfaction and productivity resulting from the negative work environment created by workplace bullying.16 Extensive studies have confirmed the association between workplace bullying and perceptions of organizational settings, including job satisfaction and commitment. Job dissatisfaction, which leads to emotional distress, can be regarded as a factor that influences employees’ commitment to their work.16

       

      CAUSES AND RISK FACTORS

      To effectively address workplace bullying, preceptors—and all staff—need to understand the underlying causes and risk factors contributing to its occurrence in healthcare settings.

       

      Power Imbalances

      Power imbalances can contribute to disruptive behavior in healthcare settings, leading to a range of negative consequences. (Yes, this means the bully might be the boss!8) While some may associate disruptive behavior with overt bullying and intimidation, the broader definition preferred by experts includes any actions that undermines safety culture.14

      The issue of power imbalances in pharmacy is a growing concern, as evidenced by a 2015 report from the United Kingdom’s Advisory, Conciliation, and Arbitration Service (ACAS).15 Workplace bullying has been on the rise in the U.K., with a staggering 20,000 calls annually reporting bullying incidents to ACAS. Disturbingly, this problem extends to community pharmacies, where staff members face bullying from pharmacy owners, managers, supervisors, and colleagues.15 The level of labor stability also has a significant impact on vulnerability to bullying because lower-status employees often hold the most unstable and temporary jobs. An empirical study (a study that uses observation, measured phenomena, and participant’s experience rather than theory or belief) conducted among university employees in an academic center aimed to demonstrate that flexible working arrangements contribute to the prevalence of bullying.16 One reason for the increase in bullying within organizations is the restructuring processes and higher levels of outsourcing, which have widened the power gap between managers and employees.16

      High Stress Levels and Demanding Work Environment

      The demanding nature of healthcare work, coupled with high stress levels, can create an environment prone to workplace bullying.16 Healthcare professionals often face intense pressure, long working hours, and challenging situations that may increase tension and exacerbate conflicts. Stress can amplify negative behaviors and create a breeding ground for bullying. Bullying within a stressful environment can lead to burnout and cause talented, compassionate individuals to leave the healthcare profession.17,16

       

      Do pharmacy employees experience stress? In a recent survey, 61.2% of pharmacists reported experiencing significant burnout in their practices.17 This trend is prevalent among hospital pharmacists, with consistent rates across various practice settings and areas. The study reveals that those most affected by burnout were often unmarried, had no children, and worked extended hours, surpassing 40 hours per week. Pharmacists can be impacted by stress and burnout in all practice settings. Thus establishing support systems with family, friends, and coworkers is vital to enhancing morale and alleviating feelings of burnout.17

       

      High Expectations from Society

      Healthcare professionals are entrusted with caring for the health and well-being of individuals, and society places high expectations on them. The pressure to meet these expectations, combined with limited resources and time constraints, can contribute to stressful work environments that may foster workplace bullying.18 Most healthcare workers feel like they are held to higher standards than the general public. This feeling is rooted in centuries of traditions and most medical organizations emphasize respect in personal interactions.18

       

      Healthcare workers also believe that the general public’s expectations of them outside the healthcare setting are set too high.12 The demanding and high-stress nature of healthcare work can make it challenging for professionals to enjoy their personal lives. The constant feeling of being at work and the fear that their actions could be scrutinized even during off-hours creates additional stress and anxiety. This work-life imbalance can have a significant impact on well-being and overall quality of life.18

       

      Lack of Policies and Procedures to Address Bullying

      The absence of comprehensive policies and procedures specifically targeting workplace bullying in healthcare settings can perpetuate its occurrence.19 Without clear guidelines and protocols in place, both targets and bystanders may feel powerless and unsure of how to address and report bullying. Instances of bullying and verbal abuse are often under-reported for various reasons. As revealed by the 2022 National Pharmacy Workplace Survey by industry experts, the lack of robust policies and procedures to address bullying in the pharmacy profession is a pressing concern.19 The study highlights the absence of a formal mechanism for pharmacists and pharmacy personnel to discuss workplace issues with supervisors and management. This leads to an unwelcoming atmosphere, resulting in heightened stress and eventual burnout. Over 60% of respondents indicated that their employers did not actively seek their opinions, nor did employers respect or value employee input.19 Employers, insurers, lawmakers, and the public must come together to ensure ample resources, address patient safety concerns, and promote the well-being of pharmacy personnel.

       

      One topic also needs more attention: the bullying individual. The SIDEBAR provides information about people who tend to bully others.

       

      SIDEBAR: Some People are Simply Bullies20,8,21,22

       

      Bullies Unveiled: Bullies are individuals who employ intimidation and control tactics to further their own objectives. While they might appear cooperative when their goals align with the team’s or the employer’s, their methods are unfair and dishonest. In the workplace, bullies often target coworkers in lateral or lower responsibility positions, resorting to manipulation and terrorizing behaviors. They may even intimidate superiors, using tactics like threats of resignation during crises.

       

      The Hidden Shame: Some psychologists attribute bullying to ingrained shame, although others cite insecurities, disparate socioeconomic backgrounds, personality traits that make them outliers, and basic insecurities. Some theories indicate that targets of bullying are more likely to become bullies. Contrary to common belief, bullies don't necessarily suffer from low self-esteem. Instead, their behavior can stem from internalized shame. While some individuals who harbor shame may have low self-esteem, those who engage in bullying tend to have high self-esteem, and hubristic (overbearing or presumptuous) pride. Bullies may also be quite clever. Their attacks on others are defense mechanisms to alleviate their own feelings and ignore their real emotions.

       

      Shame's Impact on Coping: Early in life, people develop various responses to shame, which solidify into personality traits by adulthood. These coping mechanisms can be categorized by attacking others, self-attacking, avoidance, and withdrawal. For those who bully, the fear of shame, such as being perceived as inadequate at work, drives them to target others. Bullies exploit others' vulnerabilities—and especially others’ insecurities—and redirect their own shame onto their targets. The bully’s ultimate feeling is power.

       

      Narcissism and Withdrawal: Some bullies ultimately develop narcissistic traits, continually attacking others as a means to cope with deeply rooted shame. Conversely, targets are often sensitive individuals who respond to shame by self-blame. This response might maintain a connection with the bully and perpetuates a victim or target mentality. Withdrawal, another reaction to shame, involves concealing one's emotions and can lead to depression. Prolonged exposure to workplace bullying often triggers this response, proving just as harmful as self-attacking.

       

      Seeking Solutions: Bullying deflects a bully's shame and also provides a sense of power. However, many bullies remain unaware of their own inadequacies. The key to dealing with workplace bullies is solidarity among coworkers. Banding together against a bully offers support, as targets of bullying often face isolation and by confronting the bully's behavior collectively, coworkers can neutralize their power. Banding together does not mean ganging up on the bully. It means using the principles of bystander intervention (discussed below) and firmly calling out bullying when one sees it in a respectful but direct manner. Documenting repeated episodes of bullying is also critical.

       

      Readers should note, however, that when the bully’s target is someone that others tend to dislike or find little sympathy for, the team may not coalesce to support the target. Supervisors, managers, or observers who are leaders need to jump in and remind staff that bullying is unacceptable, and if the target leaves, who knows who will be next. Further, some research indicates that bullies may eventually become targets; backlash is not an ideal solution.

       

      A Path Forward: Ultimately, bullies can change their behavior by developing better coping mechanisms and learning to process their feelings constructively. Recognizing that bullies are driven by a response to shame or other factors, rather than consciously acknowledging it, is essential for devising effective strategies to address this issue. Supervisors and managers should refer employees with bullying tendencies to their employee assistance programs or similar programs.

       

      DIFFERENTIATING WORKPLACE BULLYING, HARASSMENT, AND DYSFUNCTION

      To address workplace bullying effectively, healthcare workers and managers must differentiate it from harassment and dysfunction within the healthcare setting.

       

      Key Differences in Behaviors and Intent

      While workplace bullying and harassment share similarities, such as the creation of a hostile work environment, they differ in terms of intent and behaviors. Again, bullying is often described as offensive, intimidating, malicious, or insulting behavior intended to undermine, humiliate, denigrate, or injure the recipient, and it may involve individuals or groups.23 It can take various forms, including spreading rumors, excluding someone, giving unachievable tasks, and more.

       

      Harassment, as defined by U.S. employment discrimination laws, involves unwelcome conduct based on various protected characteristics including race, color, religion, sex, national origin, age, disability, or genetic information. Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act of 1967 (ADEA), and the Americans with Disabilities Act of 1990 (ADA) all prohibit harassment as a form of employment discrimination.24 The difference between bullying and harassment is subtle. For example, calling a coworker or a student a skinny witch is bullying. Calling a coworker or a student a skinny Catholic witch introduces the element of religion. While neither is acceptable, the introduction of religion crosses the line to harassment. While bullying is not necessarily illegal, harassment based on protected characteristics is unlawful.

       

      PAUSE AND PONDER: Consider a technician who announces to all who are on duty that the new student smells terrible. Is that bullying or harassment? If he follows it up with, “It’s because people from his culture cook all that stinky food!” Is that bullying or harassment?

       

      Laws and Regulations against Workplace Harassment

      Various laws and regulations protect employees against workplace harassment. Title VII, ADEA, and ADA prohibit harassment on a federal level, while individual states also have laws that require employers to enact anti-harassment policies.24,25  Harassment is illegal and someone—meaning anyone who is harassed or observes harassment—should report it when it creates a work environment that a reasonable person would find intimidating, hostile, or abusive. It is crucial to prevent harassment, and employers should establish clear anti-harassment policies, provide training, and address complaints appropriately.

       

      Supervisors, co-workers, or non-employees may harass others, and the employer may be liable for harassment by supervisors resulting in disciplinary actions.24,25 For non-supervisory harassment, employers can be liable if they knew or should have known about the harassment and failed to take corrective action. The Equal Employment Opportunity Commission (EEOC) assesses each case of harassment individually by considering the nature and context of the conduct. Overall, addressing harassment requires proactive measures and a commitment to maintaining a respectful work environment. 24,25

       

      Protection of Whistleblowers

      Whistleblowers are protected under OSHA’s Whistleblower Protection Program, which enforces provisions from more than 20 whistleblower statutes safeguarding employees from retaliation for reporting violations.26 Retaliation is strictly prohibited under these laws and encompasses actions such as firing, demoting, denying benefits, intimidation, harassment, and other adverse actions. Retaliative actions may dissuade an employee from raising concerns about potential violations. Subtle actions like exclusion from important meetings or false accusations of poor performance can be considered retaliation. Temporary workers supplied by staffing agencies are also protected from retaliation. OSHA's program not only safeguards whistleblowers reporting violations, but also shows some similarities between retaliation and workplace bullying. Exclusion and intimidation are shared tactics in both retaliation and bullying, mainly differing in the employer's intent.26 Many experts in bullying indicate that given these parallels, employees who are targets of bullying should be protected in the same manner that whistleblowers are safeguarded. This approach would foster a work environment where all individuals can voice concerns and engage in their roles without fear of adverse consequences.

       

      PREVENTION AND INTERVENTION STRATEGIES

      Although the U.S. hadn’t yet addressed workplace bullying formally, Australia has.27 Its Fair Work Act 2009 (Cth), allows its Fair Work Commission to hear bullying claims and order any corrective action other than monetary compensation) to stop bullying from continuing. In 2019, the Fair Work Commission heard a claim from a pharmacist. The SIDEBAR summarized the case, which ended in a ruling in favor of the employer but raised many questions. It highlights the complexities of these kinds of cases and the fact that some people have little insight into their behaviors.

       

      SIDEBAR: Who’s Bullying Who?27

      A pharmacist alleged the pharmacy’s management was bullying him by scheduling him to work on Saturdays without adequate assistance. The employer had replaced a dispensing technician with an intern pharmacist who he considered incompetent. The pharmacist claimed it created unnecessary stress, doubling his work. He alleged that the pharmacy’s Saturday workload was similar to weekday workloads and required more staff.

       

      The employer demonstrated successfully that its Saturday workflow was significantly lower than weekdays. CCTV footage revealed that the pharmacist spent considerable time on Saturdays looking at his phone rather than working. The employer also indicated the pharmacist engaged in aggressive and intimidating conduct, even reducing the intern to tears on one occasion. His hostile behavior extended to other employees, leading two of them to seek counseling. The employer stated that the pharmacist's inability to work cooperatively with colleagues was the root of the problem, not the intern's competence.

      The deciding official ruled no one acted unreasonably towards the pharmacist. He acknowledged the pharmacist's unacceptable behavior that involved mistreating several other employees. Some readers are no doubt reading this and nodding their heads, having seen, been subject to, or accused of bullying rightly or wrongly. Others are thinking, “Why is this guy still employed?”

      To combat workplace bullying effectively in healthcare, a multi-faceted approach involving various strategies is necessary.

       

      Policy Development and Enforcement

      It is essential to develop policies to combat workplace bullying in all pharmacy settings. Drawing from the AMA's report, pharmacy management can adopt key steps to create an effective anti-bullying policy and cultivate a positive work environment.2 Everyone involved needs to realize that developing a policy takes time, and implementing it requires an endless, consistent effort on the part of managers, supervisors, and staff. People from every level of the organization should have input into the draft and the review process. Putting the issue on the department’s staff meeting agenda will ensure that it doesn’t fall through the cracks.8

       

      First, management must ensure that the administration is fully aware of the impact of unprofessional behavior. The team can create strategies proactively to address and prevent bullying by recognizing the problem. One strategy might be to identify when and where the bullying occurs. Changes to the workflow, the schedule, or the supervision can improve the situations.8

       

      Second, management can arrange to educate the entire pharmacy staff about the harmful consequences of unprofessional or hostile conduct. When employees perceive that their leaders are committed to addressing bullying, they are more likely to report incidents or even intervene when witnessing inappropriate behavior among colleagues. Two types of education can help28:

      • Federal law requires certain organizations to provide compliance training on harassment and discrimination. The U.S. Equal Employment Opportunity Commission also recommends (but does not require) workplace civility training. Workplace civility training promotes workplace respect and civility. Good training would include workplace norms, appropriate and inappropriate behaviors in the workplace, and possibly interpersonal skills, conflict resolution, and effective supervisory techniques.
      • Bystander intervention training, usually associated with sexual harassment in schools, is increasingly recognized as a critical element of efforts to decrease harassment and inappropriate behaviors. Its goal is to refine employees’ sensitivity to harassment or bullying and empower them act. This training would need to identify offensive behaviors, describe employment non-discrimination laws, and explain how bystanders should respond upon witnessing a harassment incident.

       

      These crucial management steps and well-structured anti-bullying policies can foster a respectful and supportive workplace, promoting the well-being of all employees and enhancing overall patient care.

       

      Promoting a Supportive and Respectful Workplace Culture

      Healthy working relationships are crucial to promoting a supportive and respectful workplace culture in the pharmacy. The most important characteristics that build good working relationships include29

      • mutual respect
      • open communication
      • empathy
      • building rapport with every member of the team.

      Table 2 defines these terms. Practicing mindfulness (awareness of one’s feelings and the impact they have on themselves and others) can further improve relationships by reducing stress and anxiety, increasing emotional intelligence, and improving communication. It is essential to address inappropriate behavior promptly to prevent escalation, with support and guidance available to deal with bullying or harassment.

       

      Table 2. Key Characteristics of Healthy Working Relationships29

      Characteristic Definition
      Mutual respect The foundation of a healthy workplace where all members of the pharmacy team are valued and their views are acknowledged.
      Open communication Free expression of ideas without fear of criticism, fostering trust and understanding
      Empathy Compassionate comprehension of others’ states when connecting with colleagues and patients so effective communication, negotiation, problem-solving, and assertiveness to enhance collaboration and conflict resolution is possible.
      Building rapport Fostering a positive dynamic with every team member to enhance workplace happiness

       

      PAUSE AND PONDER: Janine supervises three employees, Mary, Alice, and Siobhan. Mary and Alice are very close and tend to gossip. They dislike Siobhan, speak badly of her to others, and often fail to provide the information Siobhan needs to complete her work. They criticize her work cruelly in the weekly staff meeting. Siobhan’s name is pronounced shi-VON, but Mary and Alice consistently mispronounce it and misspell it. What should Janine do, and how can she support Siobhan?

       

      Encouraging Reporting and Providing Confidential Channels

      Managers, supervisors, and preceptors should encourage healthcare workers to report incidents of bullying without fear of retaliation.14 They should establish confidential reporting channels to protect the identities of those who come forward.14

       

      When addressing bullying within the pharmacy setting, it is essential to establish a comprehensive reporting system that includes confidential channels for employees to voice their concerns.14 Vanderbilt University uses a slowly escalating corrective approach, where trained professionals engage in open discussions with alleged offenders, fostering an environment of respect and mutual understanding. Second offenses are met with warnings, followed by formal letters outlining the issues and potential interventions such as mental and physical screening (in case a health condition is causing symptoms of anger, frustration, and lack of patience). Repeat offenders may face the consequence of losing staff privileges.14

       

      Apart from corrective measures, effective strategies can also focus on providing help and support to offenders, such as anger management classes, counseling, or assistance with medical or addiction issues.14 Creating a reporting system that ensures confidentiality empowers pharmacy staff to come forward with their concerns, enabling prompt intervention.

       

      CONCLUSION

      Workplace bullying in healthcare is a pressing issue that requires attention and action. It negatively impacts healthcare professionals’ well-being and compromises patient care. It is crucial to define and emphasize workplace bullying so we can shed light on the significance of addressing this problem. To reiterate

      • Understanding the types, signs, and effects of workplace bullying allows us to recognize its presence and take appropriate measures.
      • Identifying the causes and risk factors helps us understand the underlying factors contributing to its persistence in healthcare settings.
      • Differentiating workplace bullying from harassment and dysfunction clarifies the specific behaviors and intent involved, leading to more effective interventions.
      • Upholding laws and ethical obligations, along with whistleblower protection, ensures legal and ethical accountability.
      • Creating prevention and intervention strategies, such as developing policy and promoting a supportive culture, provide a framework for addressing workplace bullying.
      • Reporting incidences through mechanisms and confidential channels empower individuals to seek help and create a safer environment.

      In conclusion, by recognizing, preventing, and intervening in cases of workplace bullying, healthcare organizations can create a better work environment that supports their employees and promotes optimal patient outcomes.

      Pharmacist Post Test (for viewing only)

      Patient Safety: Workplace Bullying
      Post-test
      Learning objectives
      After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
      1. Define workplace bullying in the healthcare setting
      2. Explain the impact of workplace bullying on individuals, organizations, and patient care
      3. Differentiate workplace bullying from harassment and workplace dysfunction
      4. Describe the necessary steps to address and counteract workplace bullying
      1. Which of the following statements correctly describes findings about bullying in pharmacies?
      A. Researchers have a consistent definition to identify bullying in pharmacy and it includes behaviors that are mocking, taunting, or intimidating.
      B. Leading pharmacy organizations have embraced the AMA's definition of workplace bullying and apply it consistently.
      C. One study found several comments related to bullying, but the study wasn't designed to identify bullying and rates are probably higher.

      2. What is the focus of the Institute for Safe Medication Practices periodic survey of health care professionals?
      A. Disrespectful behaviors and intimidation
      B. Causes of medication errors
      C. Harassment as defined by the US government

      3. Which of the following did approximately half of ISMP survey respondents report?
      A. Respondents said that they had been pressured to accept an order or administer a drug despite safety concerns.
      B. Respondents said they had avoided talking to a prescriber to validate an order about a safety concern more than ten times in the previous year.
      C. Respondents said they relied on colleagues to interpret or validate an order rather than contact the prescriber.

      4. A competent floating pharmacist is occasionally assigned to a store where a technician consistently calls out, “How many times do I have to tell you this? You've worked here before! You should know where these things are!” every time he asks her a question. Which of the following might the staff experience when observing this behavior?
      A. Decreased absenteeism
      B. Diminished morale
      C. Relief that they are not targets

      5. A prescriber who works in a hospital is notorious for his disrespectful treatment of nurses and pharmacists. He frequently scolds nurses if they call to clarify orders, and he often hangs up by slamming the phone in pharmacists’ ears. Which of the following potential negative patient outcomes have studies associated with this type of behavior?
      A. Higher medication error rates and increased infections
      B. Increased rates of falls and hip fracture
      C. Strained employee relations reducing collaboration

      6. Aadhil is a practicing Muslim who steps away from the work site to pray a couple of times a day. He's also a new father and has been up all night. He mentions this fact to his coworkers during the morning huddle, and asks for their support during the day. The pharmacist on duty finds that Aadhil has made two mistakes in filling a physician's order within the first three hours of work. He calls out, “Hey Aadhil, maybe next time you go to pray you could pray for better accuracy!” Aahil laughs uncomfortably. How would you classify this behavior?
      A. The pharmacist is bullying Aadhil but it's OK because Aadhil laughed.
      B. The pharmacist is bullying Aadhil and this behavior is never OK.
      C. The pharmacist is harassing Aadhil and the pharmacist’s behavior is illegal.

      7. Two technicians, Maria and Dolores don't get along. Maria develops a sinus infection and presents a prescription to be filled late in the day when Dolores is the only technician on duty. Maria is unable to come to work for a week because of her illness, and Delores whispers to anyone who will listen that Maria had a prescription filled to treat a sexually transmitted disease. In addition to the fact that Dolores has violated HIPAA rules, what kind of behavior is this?
      A. Harassment; Maria is a member of a protected class
      B. Bullying; Spreading false rumors is unacceptable behavior
      C. Neither harassment nor bullying; it's just gossip

      8. What is the best way to combat workplace bullying effectively in healthcare?
      A. Use a multifaceted approach that employs different strategies concurrently
      B. Have management and supervisors develop and enforce a policy against bullying
      C. Advise everyone in the workplace including the target to ignore the bully

      9. It's a busy day in the pharmacy and the pharmacy’s resident bully is in great form this morning. She has called several technicians names including Dumbo, Idiot, and Sweet Cheeks. She has also made fun of one of the pharmacist’s pants, remarking on how poorly they fit him. How can the seven people who were on duty and have witnessed these attacks best address this issue?
      A. Ignore it, because giving her any attention will increase her attacks
      B. Use bystander intervention and ask the bully to stop the name calling
      C. Make a note to ask the manager to refer the targets to the employee assistance program (EAP)

      10. Janine supervises Mary, Alice, and Siobhan. Janine witnesses Mary and Alice treating Siobhan very badly at a staff meeting. They consistently mispronounce Siobhan’s name. How should Janine approach this situation after she has corrected them several times in previous meetings and also corrected the spelling of Siobhan’s name on several documents that Mary and Alice have prepared? HINT: What process has Vanderbilt university used?

      A. Janine should meet with Mary and Alice privately and warn them that their behavior constitutes bullying and it needs to stop. She should say that she will pursue corrective and disciplinary action if the bullying behavior continues.
      B. Janine should continue to correct Mary and Alice each and every time that they mispronounce Siobhan’s name and send any documents with misspellings back to Mary and Alice for correction. Reinforcement is the key to success!
      C. Janine should meet with Mary, Alice, and Siobhan and try to get to the bottom of the problem. It's clear that Siobhan has done something to irritate Mary and Alice and correcting Siobhan’s behavior will fix the entire problem.

      Pharmacy Technician Post Test (for viewing only)

      Patient Safety: Workplace Bullying
      Post-test
      Learning objectives
      After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
      1. Define workplace bullying in the healthcare setting
      2. Explain the impact of workplace bullying on individuals, organizations, and patient care
      3. Differentiate workplace bullying from harassment and workplace dysfunction
      4. Describe the necessary steps to address and counteract workplace bullying
      1. Which of the following statements correctly describes findings about bullying in pharmacies?
      A. Researchers have a consistent definition to identify bullying in pharmacy and it includes behaviors that are mocking, taunting, or intimidating.
      B. Leading pharmacy organizations have embraced the AMA's definition of workplace bullying and apply it consistently.
      C. One study found several comments related to bullying, but the study wasn't designed to identify bullying and rates are probably higher.

      2. What is the focus of the Institute for Safe Medication Practices periodic survey of health care professionals?
      A. Disrespectful behaviors and intimidation
      B. Causes of medication errors
      C. Harassment as defined by the US government

      3. Which of the following did approximately half of ISMP survey respondents report?
      A. Respondents said that they had been pressured to accept an order or administer a drug despite safety concerns.
      B. Respondents said they had avoided talking to a prescriber to validate an order about a safety concern more than ten times in the previous year.
      C. Respondents said they relied on colleagues to interpret or validate an order rather than contact the prescriber.

      4. A competent floating pharmacist is occasionally assigned to a store where a technician consistently calls out, “How many times do I have to tell you this? You've worked here before! You should know where these things are!” every time he asks her a question. Which of the following might the staff experience when observing this behavior?
      A. Decreased absenteeism
      B. Diminished morale
      C. Relief that they are not targets

      5. A prescriber who works in a hospital is notorious for his disrespectful treatment of nurses and pharmacists. He frequently scolds nurses if they call to clarify orders, and he often hangs up by slamming the phone in pharmacists’ ears. Which of the following potential negative patient outcomes have studies associated with this type of behavior?
      A. Higher medication error rates and increased infections
      B. Increased rates of falls and hip fracture
      C. Strained employee relations reducing collaboration

      6. Aadhil is a practicing Muslim who steps away from the work site to pray a couple of times a day. He's also a new father and has been up all night. He mentions this fact to his coworkers during the morning huddle, and asks for their support during the day. The pharmacist on duty finds that Aadhil has made two mistakes in filling a physician's order within the first three hours of work. He calls out, “Hey Aadhil, maybe next time you go to pray you could pray for better accuracy!” Aahil laughs uncomfortably. How would you classify this behavior?
      A. The pharmacist is bullying Aadhil but it's OK because Aadhil laughed.
      B. The pharmacist is bullying Aadhil and this behavior is never OK.
      C. The pharmacist is harassing Aadhil and the pharmacist’s behavior is illegal.

      7. Two technicians, Maria and Dolores don't get along. Maria develops a sinus infection and presents a prescription to be filled late in the day when Dolores is the only technician on duty. Maria is unable to come to work for a week because of her illness, and Delores whispers to anyone who will listen that Maria had a prescription filled to treat a sexually transmitted disease. In addition to the fact that Dolores has violated HIPAA rules, what kind of behavior is this?
      A. Harassment; Maria is a member of a protected class
      B. Bullying; Spreading false rumors is unacceptable behavior
      C. Neither harassment nor bullying; it's just gossip

      8. What is the best way to combat workplace bullying effectively in healthcare?
      A. Use a multifaceted approach that employs different strategies concurrently
      B. Have management and supervisors develop and enforce a policy against bullying
      C. Advise everyone in the workplace including the target to ignore the bully

      9. It's a busy day in the pharmacy and the pharmacy’s resident bully is in great form this morning. She has called several technicians names including Dumbo, Idiot, and Sweet Cheeks. She has also made fun of one of the pharmacist’s pants, remarking on how poorly they fit him. How can the seven people who were on duty and have witnessed these attacks best address this issue?
      A. Ignore it, because giving her any attention will increase her attacks
      B. Use bystander intervention and ask the bully to stop the name calling
      C. Make a note to ask the manager to refer the targets to the employee assistance program (EAP)

      10. Janine supervises Mary, Alice, and Siobhan. Janine witnesses Mary and Alice treating Siobhan very badly at a staff meeting. They consistently mispronounce Siobhan’s name. How should Janine approach this situation after she has corrected them several times in previous meetings and also corrected the spelling of Siobhan’s name on several documents that Mary and Alice have prepared? HINT: What process has Vanderbilt university used?

      A. Janine should meet with Mary and Alice privately and warn them that their behavior constitutes bullying and it needs to stop. She should say that she will pursue corrective and disciplinary action if the bullying behavior continues.
      B. Janine should continue to correct Mary and Alice each and every time that they mispronounce Siobhan’s name and send any documents with misspellings back to Mary and Alice for correction. Reinforcement is the key to success!
      C. Janine should meet with Mary, Alice, and Siobhan and try to get to the bottom of the problem. It's clear that Siobhan has done something to irritate Mary and Alice and correcting Siobhan’s behavior will fix the entire problem.

      References

      Full List of References

      References

         
        1. Meko H. School Will Pay $9.1 Million to Settle Lawsuit Over a Student’s Suicide. The New York Times. July 29, 2023. Accessed August 20, 2023. https://www.nytimes.com/2023/07/29/nyregion/new-jersey-student-suicide-settlement.html?searchResultPosition=1
        2. Murphy B. Why bullying happens in health care and how to stop it. American Medical Association. Published April 2, 2021. Accessed August 4, 2023. https://www.ama-assn.org/practice-management/physician-health/why-bullying-happens-health-care-and-how-stop-it
        3. Survey Suggests Disrespectful Behaviors Persist in Healthcare: Practitioners Speak Up (Yet Again) – Part I. Institute for Safe Medication Practices. February 24, 2022. https://www.ismp.org/resources/survey-suggests-disrespectful-behaviors-persist-healthcare-practitioners-speak-yet-again
        4. Intimidation: Practitioners Speak Up About This Unresolved Problem (Part I). Institute For Safe Medication Practices. Published March 11, 2004. https://www.ismp.org/resources/intimidation-practitioners-speak-about-unresolved-problem-part-i
        5. Disrespectful Behaviors: Their Impact, Why They Arise and Persist, and How to Address Them (Part II). Institute for Safe Medication Practices. April 14, 2024. Accessed August 4, 2022. https://www.ismp.org/resources/disrespectful-behaviors-their-impact-why-they-arise-and-persist-and-how-address-them-part
        6. Knapp K, Shane P, Sasaki-Hill D, Yoshizuka K, Chan P, Vo T. Bullying in the clinical training of pharmacy students. Am J Pharm Educ. 2014;78(6):117. doi:10.5688/ajpe786117
        7. Calvello M. Constructive vs. Destructive Feedback: Examples + Template | Fellow. Fellow.app. Published April 25, 2023. https://fellow.app/blog/feedback/constructive-vs-destructive-feedback-examples-template/
        8. Ryan M. Besting the Workplace Bully. Reference & User Services Quarterly. 2016;55(4):267-269.
        9. The Joint Commission. Bullying has no place in health care. www.jointcommission.org. Published June 2021. https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-24-bullying-has-no-place-in-health-care/bullying-has-no-place-in-health-care/
        10. Manzoni JF, Barsoux JL. The Set-Up-To-Fail Syndrome. Harvard Business Review. Published March 1998. https://hbr.org/1998/03/the-set-up-to-fail-syndrome
        11. Stein M, Vincent-Höper S, Schümann M, Gregersen S. Beyond Mistreatment at the Relationship Level: Abusive Supervision and Illegitimate Tasks. Int J Environ Res Public Health. 2020;17(8):2722. doi:10.3390/ijerph17082722
        12. Caring for Our Caregivers Caring for Our Caregivers Workplace Violence in Healthcare. https://www.osha.gov/sites/default/files/OSHA3826.pdf
        13. Infrontadmin. The 6 Stages of Bullying. https://truesport.org/bullying-prevention/stages-of-bullying/
        14. “Disruptive” doctors rattle nurses, increase safety risks. USA TODAY. Accessed August 3, 2023. https://www.usatoday.com/story/news/2015/09/20/disruptive-doctors-rattle-nurses-increase-safety-risks/71706858/
        15. Bullying in the workplace. www.independentpharmacist.co.uk. Accessed August 3, 2023. https://www.independentpharmacist.co.uk/services/bullying-in-the-workplace
        16. Ariza-Montes A, Muniz N, Montero-Simó M, Araque-Padilla R. Workplace Bullying among Healthcare Workers. International Journal of Environmental Research and Public Health. 2013;10(8):3121-3139. doi:https://doi.org/10.3390/ijerph10083121
        17. Glenn R. Grantner, PharmD, BCPS Clinical Pharmacist Sacred Heart Hospital Pensacola. Pharmacist Burnout and Stress. www.uspharmacist.com. Published May 15, 2020. https://www.uspharmacist.com/article/pharmacist-burnout-and-stress
        18. Medscape: Medscape Access. Medscape.com. Published 2023. Accessed August 9, 2023. https://www.medscape.com/slideshow/2022-physicians-misbehaving-6015583?icd=login_success_email_match_norm#13
        19. Staff B. Customer Harassment, Bullying Affecting Pharmacists’ Ability to Do Their Jobs. www.uspharmacist.com. https://www.uspharmacist.com/article/customer-harassment-bullying-affecting-pharmacists-ability-to-do-their-jobs
        20. Lamia M. The psychology of a workplace bully. the Guardian. Published March 28, 2017. https://www.theguardian.com/careers/2017/mar/28/the-psychology-of-a-workplace-bully
        21. Smith PK. Commentary III: Bullying in Life‐Span Perspective: What Can Studies of School Bullying and Workplace Bullying Learn from Each Other? J Community Appl Soc Psychol. 1997;7:249-255.
        22. Vramjes I, Elst TV. Griep Y, De Witte H, Baillen E. What Goes Around Comes Around: How Perpetrators of Workplace Bullying Become Targets Themselves. Group Organ Manag. 2023;48(4):1135-1172.
        23. Bullying and harassment. Pharmacist Support. Accessed August 3, 2023. https://pharmacistsupport.org/i-need-help-managing-my/work-life/bullyin-fact-sheet/
        24. Harassment | U.S. Equal Employment Opportunity Commission. www.eeoc.gov. https://www.eeoc.gov/harassment#:~:text=Harassment%20becomes%20unlawful%20where%201
        25. Anti-Harassment Policy Requirements By State. getimpactly.com. Accessed August 9, 2023. https://www.getimpactly.com/resources/anti-harassment-policy-requirements-by-state
        26. United States Department of Labor. The Whistleblower Protection Programs | Whistleblower Protection Program. Whistleblowers.gov. Published 2019. https://www.whistleblowers.gov/
        27. Koelmeyer S. An elbow in the waist: What is and isn’t bullying in the workplace. SmartCompany. Published May 20, 2019. Accessed August 3, 2023. https://www.smartcompany.com.au/business-advice/legal/bullying-workplace/
        28. Harassment Training Requirements by State. Project WHEN (Workplace Harassment Ends Now). Accessed August 4, 2023.
        29. Building positive workplace relationships. Pharmacist Support. https://pharmacistsupport.org/i-need-help-managing-my/work-life/building-positive-workplace-relationships/

        Beyond Medication Management: A Multi-Disciplinary Approach to Pain Management and Fall Risk Reduction

        Learning Objectives

         

        After completing this application-based continuing education activity, pharmacists will be able to:

        1.     Recognize opportunities to reduce pain medication and mitigate risk of falls
        2.     Identify appropriate patients for referral to physical therapy for non-pharmacologic pain management
        3.     Discuss deprescribing of "fall risk increasing pain medication" (FRIDs) with prescribers
        4.     Review the types of OTC assistive and adaptive devices available at the pharmacy to support pain relief, safety, or mobility

        After completing this application-based continuing education activity, pharmacy technicians will be able to:

        1. Identify classes of FRIDs that contribute to fall risk
        2. Complete fall risk screening to identify at-risk patients
        3. Recognize patients to refer to the pharmacist or other healthcare providers (HCPs) for further consultation
        4. List OTC assistive and adaptive devices to support pain relief and safer mobility

          Older adult fallen on the floor

           

          Release Date: November 15, 2023

          Expiration Date: November 15, 2026

          Course Fee

          Pharmacists: $7

          Pharmacy Technicians: $4

          There is no funding for this CE.

          ACPE UANs

          Pharmacist: 0009-0000-23-056-H08-P

          Pharmacy Technician: 0009-0000-23-056-H08-T

          Session Codes

          Pharmacist:  23YC56-TKF43

          Pharmacy Technician:  23YC56-FTX83

          Accreditation Hours

          2.0 hours of CE

          Accreditation Statements

          The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-056-H08-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

           

          Disclosure of Discussions of Off-label and Investigational Drug Use

          The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

          Faculty

          Carolyn J. Graziano, DPT, MSPT, MBA
          Senior Manager
          Global Strategic Marketing
          Health Economics & Reimbursement
          Avanos Medical
          Alpharetta, GA

          Faculty Disclosure

          In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

          Carolyn Graziano works for Avanos Medical and any potential conflicts of interest have been mitigated.

           

          ABSTRACT

          Pharmacists and pharmacy technicians often come in contact with older adults who have had or are at risk for falls. Often they are treated with opioid analgesics or non-steroidal anti-inflammatory drugs. Unfortunately, using medication alone to treat pain and discomfort can often increase risk for falls. If members of the multidisciplinary team work together, they can use a combination of non-pharmacologic approaches and medication management to improve the patient’s functioning and reduce risks of falls. Knowing which drugs are associated with falls is a first step to identifying patients who need additional attention. Pharmacies can provide screening for fall risk and help ensure that patients get the help they need to find appropriate assistive devices. Including a physical therapist on the team is one way to ensure that patients take advantage of the many services they provide.

          CONTENT

          Content

          INTRODUCTION

          Dotty is an 84-year-old widow suffering from osteoarthritis of the knees. Most days, she manages her pain with acetaminophen and has remained active in her community. Some days however, her painful knees make her unsteady on her feet and she has come close to falling, especially during the long walk from the parking lot through the senior center to get to BINGO.

          Managing chronic pain—pain lasting three months or more—in older community dwellers is a challenge due to the link between pain and increased risk of falls. Over-the-counter (OTC) and prescribed pain medication further compound fall risk through adverse effects. More than 100 million adults in the United States (U.S.) suffer from chronic pain.1 Common types of chronic pain include neuropathic, musculoskeletal, inflammatory, and mechanical pain. Between 30% and 40% of community-dwelling people older than 65 and 50% older than 80 fall each year.2

          Despite the use of fall prevention programs, the rate of falls resulting in injury has not declined. Researchers conducted a pragmatic, cluster-randomized trial (N = 5451) at 86 primary care practices across 10 U.S. health care systems. The trial evaluated the effectiveness of a multifactorial intervention including fall risk assessment and individual fall reduction plans compared to a control group receiving usual care. The results of the study found intervention did not significantly lower fall rates.3

          Many factors contribute to falls, but compelling evidence suggests that chronic musculoskeletal pain increases fall risk and people living with chronic pain show poorer executive function (mental skills that include working memory, flexible thinking, and self-control). Signs of poor executive function such as impaired impulse control, reduced ability to pay attention or focus, and problems starting, organizing or planning tasks can all contribute to fall risk. Treatment options for chronic pain include physical and behavioral medicine, neuromodulation, and surgical intervention. Despite a variety of treatment options, providers most frequently use pharmacologic approaches.

          Integrated, patient-centric, multi-disciplinary management of chronic pain offers a practical solution to reducing pain, over-medication, and risk of falls. Practitioners from several disciplines can help:

          • Pharmacists understand how medications work individually and in combination and provide medication management that is more informed than other professionals’ medication management.
          • Pharmacists and pharmacy technicians interact routinely with the community and can provide risk screening, patient education, and referrals to other HCPs.
          • Primary care physicians provide medication management including medication review and reconciliation and oversight for changes from multiple providers. Providers correctly prescribe but may not evaluate medications regularly for appropriateness.
          • Physical therapists can reduce pain and improve functional mobility through exercise, modalities (i.e., ultrasound, electric stimulation, iontophoresis), manual techniques, and prescription and training on assistive and adaptive devices.
          • Physical or occupational therapists may provide in-home safety evaluation and recommend modifications and equipment to reduce the risk of falls.
          • Collaborative relationships between community rehabilitation therapists and local pharmacies can support patient decisions and pathways for obtaining needed devices and aids to reduce pain and fall risk.

          THE CLINICAL PROBLEM

          Scope of Chronic Pain and Fall Risk

          Falls are the leading cause of death and injury in people 65 years of age and older. Pain often contributes to fall-risk. According to a recent Helsinki Aging Study, 61% of community-dwelling people 74 years and older reported they suffer from musculoskeletal pain that interferes with activities of daily living.4

          Because pain contributes to falls that result in further painful injuries, a cyclical pattern occurs. More than 50% of older Americans report pain at multiple sites.5 The most prevalent painful conditions affecting older adults include arthritis, chronic disease complications (i.e., diabetes, cancer) and post-stroke pain).6

          In Dotty’s case, her painfully arthritic knees prompted her to purchase a three-wheeled folding walker with a seat from an infomercial she saw on daytime television. Unfortunately, it folded while in use, collapsing to the ground along with Dotty. She ended up with a severely bruised and painful hip as a result of the fall.

          While environmental accidents and age-related changes can contribute to falls, chronic pain with medication use is a significant fall risk factor. In addition to polypharmacy, studies have shown both opioid use and exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) contribute to fall risk. A retrospective, observational, multicenter cohort study of registry data in Canada (N = 67,929) concluded that recent opioid use is associated with an increased risk of falls in older adults and an increased likelihood of death from fall-related injuries.7 A systematic review also found an increased risk of falls is probable when elderly individuals are exposed to NSAIDs.8

          A pharmacologic approach to pain may be necessary when pain is significant, unremitting, and affects physical function or quality of life. However, health care professionals should not overlook the importance of nonpharmacologic pain management. Non-pharmacologic pain management and the reduction of falls is an important health topic for consideration by pharmacists and pharmacy technicians.9

          Economic and Socioeconomic Burden of Pain Related Falls

          Serious injuries from falls can lead to permanent injury, functional and cognitive decline, reduced quality of life and the need for institutional care resulting in significant cost.10 The American College of Rheumatology, a leading authority and partner of rheumatology professionals, considers pain chronic when it lasts more than three months, the normal time for tissue healing. Chronic pain is a major cause of disability and linked to mental health deterioration including depression and anxiety.11

          Professionals use many evidence-based fall prevention programs, such as those listed on the National Council on Aging website (Evidence-Based Falls Prevention for Older Adults (ncoa.org) to reduce falls in the community. These interventions vary in length such as 2-hour workshops, in-home interviews, or 8 week to 5-month programs that focus on aging in place, exercise, balance, removal of home hazards, adaptive equipment, task modification, education, and self-management.

          Even with fall prevention programs, the number of falls among older community dwellers is increasing. The reason for the rising number of elderly falls is multifaceted12,13:

          • The population of older adults is growing with more people living longer and remaining in their homes.
          • Access to and participation in fall prevention programs varies among community elderly.
          • In an aging population, musculoskeletal disability and resulting pain increases.
          • As musculoskeletal disability increases, the number of invasive joint surgeries such as hip and knee replacements rises. The projected volume of primary total knee replacements alone will increase by more than 400% over the next 20 years.
          • 7% to 23% of patients after hip and 10% to 34% after knee replacement have long-term post-operative pain.

          When surgeries such as joint replacement result in chronic pain, providers primarily use medication to address pain due to limited treatment options. The combination of aging, more joint replacement surgeries, and concomitant medication use requires more attention to pharmaceutical services in the role of fall prevention. Furthermore, age-related changes in pharmacokinetics and pharmacodynamics may increase the risk and incidence of adverse drug events related to falls.6

          IMPACT OF PAIN MEDICATION ON FALLS

          Risk of Opioid Use in the Elderly

          After her fall, an ambulance whisked Dotty to the hospital. Luckily, she did not sustain any fractures and the emergency department physician sent her home with a prescription for opioids, advised follow up with her primary care doctor, and gave her a flyer for a local fall prevention program.

          The use of opioids for pain management is a significant public health concern particularly among older community dwellers at risk for falls. Prescribed opioid use among middle-aged and older adults is more prevalent than among younger adults.14 Moreover, one-fourth (25.4%) of adults aged 65 years and older who take opioids report being long-time opioid users for a period of 90 days or longer (see Figure 1).15

          Age 40-59 have the highest opioid use, followed by age 60+

          An average of 8.6 million non-institutionalized older adults filled at least one opioid prescription between 2018 and 2019, while 2.7 million older people filled five or more opioid prescriptions or refills. Older women were more likely than men to fill one or more opioid prescriptions.16 In addition to age, socioeconomic factors and patient demographics impact opioid use. According to the statistical brief published by the Agency for Healthcare Research and Quality (AHRQ), elderly adults who were poor filled five or more opioid prescriptions compared to low- and middle-income adults (see Figure 2).16

          Poor and low income elderly adults have the highest amounts of individuals filling 5 or more opioid prescriptions

          A large retrospective, observational, multicenter cohort study of registry data of 67,929 Canadian patients with a mean age of 80.9 (±8.0) evaluated the link between recent opioid use and fall-related injuries. The study identified patients who had filled an opioid prescription in the two weeks preceding an injury were 2.4 times more likely to have a fall than any other type of injury. Patients who had a fall-related injury who used opioids were also at increased risk of in-hospital death.7

          A systematic review and meta-analysis of 30 studies evaluated the impact of opioid use on falls, fall injuries, and factures among adults at least 65 years old. The study found that opioid use was associated with falls, fall injuries, and fractures.17

          Sedation is a common adverse effect of opioids. Medication with sedative effects can lead to daytime drowsiness, reduced alertness, and impaired motor function. Older adults experience these adverse effects more frequently, particularly during the first few days of taking a new pain medication.18 Anticholinergic burden is one of the opioids’, such as oxycodone, lesser-known effects. Anticholinergic drugs impact central nervous system functions and can result in cognitive impairment, confusion, and blurred vision compounding the risks of sedation.19

          Because opioids cause drowsiness, orthostatic hypotension (dizziness or lightheadedness when standing up or otherwise changing position), and hyponatremia (low sodium levels leading to nausea, vomiting, loss of energy and confusion), they can increase fall risk. Risk is more prominent in older adults already prone to falls. Active drug half-life and metabolites are prolonged in older adults with renal impairment because most drugs, particularly water-soluble drugs, are eliminated by the kidneys.20 Understanding renal function is therefore important when assessing dosing risks in the older population. Reviewing for combination opioid use is also important in all patients, and particularly older patients. For example, physicians and pharmacists must take caution with patients using codeine and oxycodone together.21

          Risk of OTC Pain Medication

          Physicians often prescribe acetaminophen as a first-line or preferred OTC pain medication for older adults with nociceptive pain, which is pain caused by physical trauma, burns or surgery, because of potential adverse effects of NSAID (diclofenac, etodolac, fenoprofen, ibuprofen, ketorolac, meloxicam , naproxen) use. Long-term NSAID use is associated with adverse gastrointestinal, renal, and cardiovascular effects. An observed decrease in prescription NSAID and acetaminophen use may be due in part to the increased availability and variety of OTC NSAIDs over time, a phenomenon reported for other medications after becoming available OTC.22

          NSAIDs are among the 5% to 10% most commonly prescribed medications for pain and inflammation. The prevalence of NSAID use in the over-65 population is as high as 96%.23 Physicians and other healthcare providers often prescribe NSAIDs for acute or chronic arthritic pain because of their anti-inflammatory results over just the analgesic effect of acetaminophen.22

          Problems may arise related to NSAID-related toxicity in the elderly. Similar to opioids, age-related changes in pharmacokinetics may affect how the elderly metabolize NSAIDs. Dose reduction is appropriate for naproxen, ketoprofen, and salicylates in healthy older patients. Additionally, prescribers may need to reduce the dosage of diflunisal, indomethacin, sulindac, and mefenamic acid for the elderly in the presence of renal disease.24

          Table 1 lists the adverse effects of long-term use of NSAIDs that can impact fall risk.

          Table 1. NSAIDs Adverse Effects23

          System Adverse Effects
          Kidney Increased risk of nephrotoxicity

          Promotes renal vasoconstriction and reduced renal perfusion

          Electrolyte imbalance such as hyperkalemia

          Reduced glomerular filtration rate

          Nephrotic syndrome

          Chronic kidney disease

          Acute interstitial nephritis

          Sodium retention

          Edema

          Renal papillary necrosis

          Gastrointestinal Increased risk of GI bleeding
          Cardiovascular Edema

          Myocardial infarction

          Thrombotic events

          Stroke

          Hypertension

           

          Study data has been inconsistent but overall trends support an association of falls with NSAIDs use in the elderly. A systematic review of 13 studies published between 1966 and 2008 specifically reviewed fall risk associated with NSAIDs in the elderly population. The overall mean age of study participants was high, preventing generalizability to a larger population. However, all studies showed an increased risk of falling associated with NSAIDs.8 A similar systematic review identified 22 studies that enrolled patients older than 60 years to assess the association between medication use and falling. These analysts reviewed nine different drug classes (antidepressants, antihypertensives, benzodiazepines, beta-blockers, diuretics, narcotics, neuroleptics and antipsychotics, NSAIDs, and sedatives and hypnotics) encompassing 79,081 participants. The use of sedatives and hypnotics, neuroleptics and antipsychotics, antidepressants, benzodiazepines and NSAIDS resulted in an increased likelihood of falling. The unadjusted odds ratio estimate for likelihood of falls related to NSAIDs was 1.21 (95% CI, 1.01-1.44) compared to 0.96 (95%CI, 0.78-1.18) for narcotics.25

          The Case for Non-Pharmacologic Pain Management

          The evidence supporting the need for nonpharmacologic pain management treatment is compelling. The population is aging, the prevalence and incidence of musculoskeletal disability is on the rise, and use of pain medication is associated with known risks. While all adverse effects of taking pain medication are important, falls can be among the most debilitating and costly for the elderly.

           

          Pharmacists and pharmacy technicians are front line community healthcare providers in pivotal positions to positively impact fall reduction. By moving beyond medication management, pharmacists and pharmacy technicians can proactively participate in a multi-disciplinary approach to reduce reliance on pain medication and facilitate non-pharmacologic treatment including physical therapy.

          DEVELOPING AN INTEGRATED PATIENT-CENTRIC TEAM-BASED APPROACH TO FALL PREVENTION

          Pharmacists’ Role in Medication Management

          Pharmacists play a key role in fall prevention by recognizing “fall risk-increasing drugs” (FRIDs), identifying at-risk patients, and collaborating with other healthcare professionals including physicians, home care nurses, and physical therapists by making appropriate referrals.

           

          A traditional first step for pharmacists and pharmacy technicians is medication management. Knowing FRIDs is important (see Table 2).

          Table 2. FRIDs at-a-glance

          Classes of Fall Risk-Increasing Drug
          Antidepressants Antihypertensives Opioids NSAIDs
          Anticonvulsants Antipsychotics Sedative hypnotics Antispasmodics
          Anticholinergics Benzodiazepines Antihistamines Antispastics

           

          Polypharmacy, exposure to FRIDs, or the combination of polypharmacy including FRIDs can be associated with fall risk. Pharmacists should also consider exposure to potentially inappropriate medications (PIMs) as described in prescribing guidance tools such as the American Geriatric Society (AGS) Beers Criteria.26

          The Beers Criteria considers five broad categories of potentially inappropriate medications used in the elderly27:

          1. Medications considered potentially inappropriate
          2. Medications potentially inappropriate in patients with certain diseases or syndromes
          3. Medications to be used with caution
          4. Potentially inappropriate drug-drug interactions
          5. Medications whose dosages should be adjusted based on renal function.

          Additionally, the National Council on Aging (NCOA) advocates for a thorough medication review for older adults at risk of falling, noting that OTC medications can cause harmful interactions and increase falls.

          The five important problem areas identified by pharmacists in conjunction with the program’s algorithms include28

          1. Unnecessary therapeutic duplication
          2. Use of medications that can cause falls and confusion
          3. Use of medications that can cause cardiovascular problems
          4. Inappropriate use of non-steroidal anti-inflammatory drugs
          5. Review for effectiveness of opioid prescriptions and alternate options

          An example of unnecessary therapeutic duplication occurs when patients take a muscle relaxer such as meloxicam with an OTC for inflammation like naproxen. Many patients are also unaware of medications that can cause falls and confusion such as OTC antihistamines. Patient education directly from pharmacists or pharmacy technicians can be beneficial in preventing falls related to these types of OTC drugs.

          After her fall, Dotty filled her opioid prescription and continued taking acetaminophen due to the pain in her knees and hip from the fall. Since her providers or pharmacist had not “prescribed” acetaminophen, they were unaware of the unnecessary analgesic duplication.

          While medication management and identification of FRIDs is important to reducing risk of falls, it is not a substitute for a comprehensive multi-disciplinary approach. A recently published systematic review of the use of fall risk-increasing drugs looked at 14 observational or intervention studies that assessed FRID use in participants 60 years or older. Participants had experienced a fall resulting in a hospitalization or emergency department (ED) visit. The studies reported the prevalence of FRID use was 65% to 93% at the time of hospitalization or ED admission among older adults with a fall-related injury. Further, studies within the review found FRID use did not decrease at one and six months following a fall. Intervention trials included in the review demonstrated that interventions to reduce FRIDs did not result in a significant reduction in falls. The authors conclude that medication review with suggestions to the primary care provider as a stand-alone intervention was ineffective in preventing falls. Interventions to reduce FRID use are only one part of a more comprehensive strategy.29

          Dosing and Deprescribing to Reduce Falls

          When making decisions to deprescribe opioids, prescribers and pharmacists should consider whether the opioid use matches an appropriate indication. Since opioids are strong analgesics, their indications should be for moderate to severe acute pain, post-operative pain, or palliative care. Prescribers and pharmacists should always consider deprescribing when there are no indications for prescribing an opioid and safer alternatives are available.6

          Opioid dosing should always be specific to the individual with lower doses for older adults. Reducing the dose or switching to a less potent analgesic to maintain effective pain management is a viable strategy while implementing other nonpharmacologic techniques such as physical therapy.6

          Pharmacists are skilled in identifying medications for discontinuation based on known risks. A careful plan for tapering and discontinuing drugs at an appropriate pace is critical to avoid increasing patients’ pain, stress, and discouragement. Various tools are available to pharmacists to collaborate with patients to create a deprescribing plan.30 Examples of resources to assist healthcare providers optimize medications while minimizing adverse events include the Medication Appropriateness Index Calculator ( https://globalrph.com/medcalcs/medication-appropriateness-index-calculator/) and the AGS Beers Criteria available from the American Geriatrics Society (https://agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.18372). No one tool is the gold standard and inconsistencies exist among the various resources.31

          For example, the STOPPFall tool provides deprescribing in a stepwise manner.18 STOPPFall recommends reducing the opioid dose by 5% to 25% of the daily dose every one to four weeks. If adverse effects occur during deprescribing, prescribers can reduce the dose more slowly. If the patient dose is high or he or she has been using the opioid for a longer period, deprescribing should proceed very slowly.

          Conversely another tool, MedStopper, indicates when a patient has been taking an opioid daily for more than four weeks, prescribers should reduce the dose by 25% every three to four days. Upon any symptoms of withdrawal, they should increase the dose back to 75% of the previous tolerated dose. Once at 25% of the original dose with no withdrawal symptoms, they can discontinue the drug.32 Prescribers and pharmacists should monitor patients during and after deprescribing for symptoms of withdrawal such as musculoskeletal or gastrointestinal symptoms, restlessness, anxiety, insomnia, diaphoresis (excessive sweating), anger, and chills.

          Pharmacy Fall Risk Prevention Service

          To be an integral part of a more comprehensive fall prevention intervention, pharmacies should consider offering a fall prevention service. Establishing a community fall prevention service consists of fall risk screening, consultation to assess modifiable fall risk factors with referral to appropriate non-pharmacological intervention, medication check, and comprehensive medication review and adjustment by the pharmacy and primary prescriber.

          Use of an appropriate screening tool by pharmacists or pharmacy technicians is a major step to reducing risk of falls. To assist healthcare professionals in reducing fall risk, the Centers for Disease Control and Prevention (CDC) developed the STEADI (Stopping Elderly Accidents, Deaths, and Injuries) initiative. This initiative includes three steps for providers to address their patient’s fall risk.31,33

          • Screening for fall risk by asking patients if they have experienced past falls, feel unsteady, or are afraid of falling
          • Reviewing and managing their medications to determine if they impact fall risk and stopping, switching, or reducing them
          • Studies shows recommending vitamin D supplements to improve bone, muscle, and nerve can reduce risk of falls in the elderly

          The CDC and the University of North Carolina Eshelman School of Pharmacy and School of Medicine developed an algorithm called STEADI-RX to improve collaboration between healthcare providers and pharmacists based on the CDC’s STEADI initiative. STEADI-RX incorporates the Joint Commission of Pharmacy Practitioners (JCPP) Pharmacists’ Patient Care Process and an algorithm for integrating fall screening and prevention into pharmaceutical care. It also includes a tool kit for use by healthcare providers to help reduce risk of falls.34 Figure 3 shows the STEADI-Rx’s key steps.

          Steadi-Rx steps: 1 (screen), 2 (assess), 3 (coordinate care), 4 (response)                                                                     

          The STEADI-RX Community Fall Risk Checklist35 (https://www.cdc.gov/steadi/pdf/provider/steadi-rx/STEADIRx_pharmacy_fallrisk_checklist-508.pdf) is available to help the pharmacy staff quickly identify risk factors including fall history, postural hypotension episodes, and review medication classes associated with fall risk.

          Getting Started with A Fall Risk Service

          The STEADI-Rx Older Adult Fall Prevention Guide for Community Pharmacists, available from the CDC at https://www.cdc.gov/steadi/steadi-rx.html,36 provides a framework for how to start a fall prevention service, identifies best practices, and provides tools and references for implementing a successful program.

          To start an in-pharmacy fall reduction program, a key recommendation is to first identify a program champion. This is either a pharmacist or trained pharmacy technician who will serve as the lead role and ensure proper design and implementation of the program. Next, an environmental scan may help identify the patient population that will benefit from the service and how it fits into existing workflow. A fundamental aspect of conducting an environmental scan may include an analysis of strengths, weaknesses, opportunities, and threats (SWOT) to identify any internal or external obstacles to implementation, described in Sample Fall Prevention SWOT Analysis.

           

          SIDEBAR: SAMPLE FALL PREVENTION SERVICE SWOT ANALYSIS

          STRENGTHS - Internal factors include available resources and staff

          WEAKNESSES - Internal obstacles may be poor workflow or documentation procedures

          OPPORTUNITIES - External factors to support a successful service include an age-appropriate population, supportive providers, and state physical therapy direct access provisions to facilitate referrals

          THREATS - External factors that may hinder a successful service such as nearby pharmacies with strong prevention services, reimbursement or other financial factors inhibiting patient participation

           

          The guide also recommends conducting a readiness assessment to determine the steps needed to implement the service and to develop an action plan. The readiness assessment addresses staffing, resources, and training needed and assure there is appropriate support from leadership before moving forward. Depending upon existing pharmacy workflow, a pharmacy technician can lead a fall prevention service with pharmacist support when they need clinical judgement and expertise.

           

          Coordinating Care: Physical Therapy and Physician Support

          Dotty eventually came into the pharmacy looking for a “better” assistive device. She seemed confused about what device to choose and reported she recently had a fall. With her permission, a fall risk screening revealed she was taking both NSAIDs and opioids and had not been referred to physical therapy. She stated the ED gave her a flyer for a fall prevention program, but she didn’t go because it conflicted with BINGO at the senior center.

           

          Pharmacists and prescribers should consider practice guideline recommendations to determine when to make referrals to physical therapy for the nonpharmacologic treatment of pain. It is important to consider reducing reliance on opioids and inappropriate use of NSAIDs.

           

          Data from the National Ambulatory Medical Care Survey identified 11,994 visits representing a cross-section of all age patients between 2007-2015 where ICD-9 (diagnosis) codes indicated new chronic musculoskeletal pain. The survey found that healthcare providers prescribed patients opioids 21.5% of the time when they presented with new symptoms of chronic musculoskeletal pain but prescribed physical therapy just 10% of the time.37

          Numerous studies have examined the relationship between early physical therapy and opioid use for chronic musculoskeletal pain including back neck, shoulder, and knee. Due to its incidence, prevalence and associated costs, a preponderance of studies focused on low back pain (LBP). A retrospective analysis using commercial health insurance claims data from 2009-2013 observed 148,866 patients aged 18 to 64 years with a new primary diagnosis of LBP over a 1-year period. Compared to patients who received late or no physical therapy, patients who saw a PT first had an 89.4% lower probability of obtaining an opioid prescription.38

          Another cross-sectional observational study using the National Ambulatory and National Hospital Ambulatory Medical Care Surveys between 1997 and 2010 also identified lower PT referral rates among LBP patients aged 16 to 90 years old insured by Medicare and Medicaid. The study estimated 170 million visits for LBP led to 17.1 million PT visits. Further, visits not associated with PT referrals were more likely to be associated with opioid prescriptions.39

          Healthcare providers do not always prescribe nor do patients use physical therapy as a frontline treatment for chronic pain. Patients may use physical therapy along with other nonpharmacologic treatments, such as behavior health interventions or medication. Physical therapy is an integral part of multidisciplinary care, particularly to support success with opioid taper or cessation. Physical therapy treatments to reduce pain include exercise, manual therapy, electrical nerve stimulation, and other physical agents.

          When conducting a pharmacy fall risk service, pharmacy staff may encounter patients with chronic pain who have not received physical therapy prior to treatment with pain medication. The screening process will be the first step in assessing true risk.

          Pharmacy staff can use the STEADI-RX Provider Consult Form(s) for Medication or Fall Screening to share medication therapy problems with the patient’s provider or to refer the patient to a physical therapist for a full fall risk assessment.40,41 A physical therapist’s formal fall risk assessment is more in-depth than the screening tool used at the pharmacy and includes an evaluation of gait, balance, and strength. When using these forms or any other type of communication, states have different physical therapy direct access provisions and limitations. Pharmacies can verify the levels of patient access to physical therapist services in the U.S. through the American Physical Therapy Association (https://www.apta.org/contentassets/4daf765978464a948505c2f115c90f55/direct-access-by-state-map.pdf). After referral, physical therapists should respond within seven days. If they don’t, the patients or pharmacy should contact the PT again.

          Pharmacists and pharmacy technicians identifying at-risk patients during an initial fall risk screening performed at the pharmacy should refer patients to physical therapy for a full fall risk assessment. Physical therapists use a variety of objective assessment tools to address gait and balance such as the Tinetti Balance and Gait Assessment, Berg Balance Scale, or Timed Up and Go test to determine fall risk and areas for intervention. Therefore, when implementing a pharmacy fall reduction service, it is important for pharmacists to develop relationships with local outpatient physical therapy clinics able to accept referrals for fall risk evaluations.

          Because musculoskeletal pain is highly prevalent and a leading cause of disability, physical therapists are crucial members of the interdisciplinary pain management team. Physical therapists work effectively by providing nonpharmacologic treatment of pain incorporating various pain-relieving modalities such as transcutaneous electrical stimulation, heat or cold therapy, joint or soft tissue mobilizations or the use of braces or splints. In addition to physical therapy treatment to address pain, physical therapists also recommend various assistive and adaptive devices. Patients may use these devices to reduce pain through off-loading a painful limb or making mobility including ambulation and transfers (i.e., moving from one position to another such as from sitting to standing, or getting in or out of bed) easier and safer.

          Improperly selected or poorly fitted devices can result in further injury, pain or falls. Receiving instructions and training on proper use of assistive devices and compliance with instructions has not been strongly correlated. A small (N=17) observational cross-sectional study and focus group investigated older adults’ use of walkers in the home setting compared to current guidance in an attempt to identify circumstances leading to deviation from instructions for use. This study observed incorrect use of walkers 16% to 29% of the time associated with reduced stability.42 Another study found comparable results from a questionnaire of 94 patients using a cane for hip pathology.;47% of these patients were using the aid in the incorrect hand and of this group, 64% used their dominant hand. Furthermore, 66% of respondents reported they never received instruction on the correct hand to use. The study concluded that a significant percentage of patients are using canes incorrectly which may be due to lack of education.43

          A patient-appropriate assistive device, when fitted and used correctly, can reduce pain and increase physical activity in patients with chronic pain, painful or impaired gait and other mobility issues. Selection and fitting of an assistive device should always be conducted through a PT evaluation. PTs use a multi-factorial assessment of the patient’s physical and cognitive abilities of and consider the environment in which the patient will use the device (see 5 Factors of Device Prescription). PTs will also ensure devices match a patient’s height, weight, and size when selecting the best assistive device.

           

          SIDEBAR: 5 FACTORS OF DEVICE PRESCRIPTION

          1. Cognitive Function
          2. Coordination
          3. Upper-body, hand and grip strength
          4. Physical endurance
          5. Walking environment

           

          Upon competition of their evaluation, it is important for the therapists to know what types of OTC assistive and adaptive devices are available for purchase at local pharmacies to support patient needs. Although assistive devices are often available at physical therapy clinics, a patient’s health insurance plan may not include reimbursement for devices. Often OTC devices and aids are priced lower at retail locations and purchased directly by patients or family members.

          Rather than have Dotty guess and purchase a “better” assistive device, the pharmacy referred her to a physical therapist who determined that at least initially, a 4-point walker with front wheels would provide her the most stability and allow her to walk safely in both her home and the community.

          Table 3 describes items often recommended by therapists to reduce pain, fall risk, and improve home safety. See Fun Facts to learn about the history of walkers.

          Table 3. Assistive & Adaptive Devices

          Item Description Purpose
          Bed Rails Railing inserted between mattress and box spring or physically attached to bedframe Assist with transfer out of bed by allowing people to pull their body to change position using arms/upper body
          Cane, Walker Ambulation assist devices. Canes can be single point, multi point (quad) and walkers with or without wheels Provides additional point of contact to improve balance, alleviate weakness, or offload a painful joint
          Commode, Raised Toilet Seat, Toilet Seat Rails Portable toilet, elevated seat or arm rails Assist with safe transfer on and off toilet
          Grab Bars Bars and railings permanently affixed to walls near showers, toilets, entry ways, steps, stairs Promotes safe transfers from sit to stand, up and down stairs, in and out of shower
          Grabbers or Reachers Reaching aid with grab assist Allows items to be safely grabbed if out of reach or if mobility, pain, or strength impairs reaching and grabbing
          Neoprene braces and wraps Supportive and compressive wraps and braces for ankles, knees, wrists Provide joint protection, stability, and pain relief
          Shoe wedges or inserts Partial or full inserts used inside of shoes Cushion or improve postural alignment to offload painful foot
          Shower Chairs Waterproof, quick dry, slip resistant stool or chair Allows safe seating in shower to reduce slipping or falling and fatigue with standing

           

           

          SIDEBAR: FUN FACTS43,44,45,46

          A walker, walking frame, or rollator is a mobility device used by people suffering from leg or back pain, weakness, impaired balance, amputation, or poor stamina.

          • Walkers first appeared in the 1950s.
          • The first US Patent was awarded in 1953 to William Cribbes Robb of the United Kingdom for device called a “walking aid” filed with the British patent office in 1949.
          • Two US patents in 1957 are for variants with wheels.
          • The first non-wheeled designed walker was patented in 1965 by Elmer F. Ries of Ohio. In 1970, Alfred Smith of California patented the first walker resembling modern day walkers.

           

          Establishing Effective Team Communications

          Communication between pharmacists, prescribers, and therapists is important to monitor progress and avoid symptoms of medication withdrawal. As patients progress with their therapy plan of care, medication dosing may be easier to adjust. Ongoing patient education from pharmacists and pharmacy technicians can help avoid unnecessary patient self-medication with OTC pain relievers during the transition period.

           

          The physician or primary care provider receives regular updates from the physical therapy team and can provide the pharmacy with necessary progress to help coordinate dose reduction or deprescribing. When designing the workflow for a pharmacy fall prevention service, the program champion should be sure to include a schedule for giving and receiving team updates.

           

          With ongoing treatment, the physical therapist reported Dotty was making progress toward her therapy plan of care goals. Upon completion of therapy Dotty would be stronger, have less pain, and reduce or eliminate pain medication, and graduate to using a single point cane as needed. Since Dotty’s Medicare insurance plan only covered the cost of the 4-point wheeled walker, she would have to purchase the cane out-of-pocket and would be returning to the pharmacy with the PT’s recommendation so that the PT could fit and train Dotty on its proper use during her therapy sessions.

          Closing the Treatment Gap

          The benefits of a pharmacy fall reduction service are multi-fold. Moving beyond medication management closes the current treatment gap in the delivery of consistent and effective fall prevention. By working collaboratively with other HCPs, pharmacists help achieve better fall prevention outcomes by reducing or eliminating pain medications while facilitating non-pharmacologic pain management and improved functional mobility improvement.

          Contact Joanne Nault to describe this figure

          Pharmacist Post Test (for viewing only)

          Beyond Medication Management: A Multi-Disciplinary Approach to Pain Management & Fall Risk Reduction

          Pharmacists Post-test
          After completing this continuing education activity, pharmacists will be able to
          1. Recognize opportunities to reduce pain medication and mitigate risk of falls
          2. Identify appropriate patients for referral to physical therapy for non-pharmacological pain management
          3. Discuss deprescribing of fall risk increasing pain medication with physician prescribers
          4. Review the types of OTC assistive and adaptive devices available at the pharmacy to support pain relief, safety, or mobility

          1. Which of the following patients presents with an opportunity to reduce pain medication and fall risk?
          a. 53-year-old male tennis coach taking methocarbamol and hydrocodone/acetaminophen for recent back surgery
          b. 84-year-old frail widow taking ibuprofen, diazepam, lisinopril and gabapentin
          c. 62-year-old male with a transtibial amputation taking metformin and acetaminophen
          d. 74-year-old female with early onset Alzheimer’s taking meloxicam, alendronic acid, and vitamin D

          2. Which of the following patients should be referred to physical therapy for fall risk assessment?
          A. 92-year-old male who plays tennis daily but fell trying to jump over the net after a victory and is now taking ibuprofen for pain
          B. 85-year-old female active in her community who takes gabapentin for nerve pain
          C. 82-year-old female who lives alone, has a history of advanced cancer and has “tripped” several times at home without injury and takes lisinopril, bupropion, and pilocarpine

          3. Betty is 84 years old, suffers from osteoarthritis of the spine and has fallen twice in the past year. Which of the following is an example of unnecessary therapeutic duplication?
          A. Metformin and Valium
          B. Meloxicam and Aleve
          C. Lisinopril and Lipitor
          4. What class of medication is among the top 5-10% of drugs prescribed for pain and inflammation?
          A. Muscle relaxers
          B. Opioids
          C. NSAIDs

          5. Which of the 5 broad categories of the Beers Criteria is particularly important when performing pain medication management for fall risk prevention?
          A. Use of cardiovascular medications
          B. Medications whose dosages should be adjusted based on renal function
          C. Medications considered as potentially inappropriate

          6. Which of the following items are adaptive devices used for safety commonly sold in pharmacies?
          A. Reachers
          B. Cordless telephones
          C. Canes
          D. Crutches

          7. A template for starting a pharmacy fall service can be found through which CDC initiative?
          A. STEADI-Rx
          B. MedStopper
          C. STOPPFall

          8. Which of the following are ambulation assistive devices a patient may request to purchase at a pharmacy?
          A. Canes and walkers
          B. Shower chairs
          C. Raised toilet seats
          9. In addition to antidepressants, anticonvulsants and antihypertensives, which category of drugs is often overlooked as a contributor to falls?
          A. NSAIDs
          B. Antivirals
          C. Antibiotics

          10. 84-year-old Dotty is nearing the completion of physical therapy and her PT reports a significant reduction in her bilateral arthritis knee pain but is still currently being prescribed opioids since a recent fall what should you do?
          A. Nothing. Opioids were correctly prescribed by the ED physician and continued by her primary care doctor
          B. Have a discussion with the primary care about deprescribing the opioids
          C. Just tell her to wean off the opioids herself in a step-wise fashion

          Pharmacy Technician Post Test (for viewing only)

          Beyond Medication Management: A Multi-Disciplinary Approach to Pain Management and Fall Risk Reduction

          Pharmacy Technician Post-test

          After completing this continuing education activity, pharmacy technicians will be able to
          1. Identify classes of fall-risk increasing drugs (FRIDs) that contribute to fall risk
          2. Complete fall risk screening to identify at-risk patients
          3. Recognize patients to refer to the pharmacist or other healthcare providers (HCPs) for further consultation
          4. List OTC assistive and adaptive devices to support pain relief and safer mobility
          1. What percentage of people over the age of 65 fall each year?
          A. Between 5 and 10%
          B. Between 30 and 40%
          C. Over 50%

          2. Which of the following patients should be referred to the pharmacist for consultation?
          A. An 88-year-old female reporting new onset of dizziness after beginning a new pain medication
          B. A 68-year-old male purchasing acetaminophen while picking up a prescription for oxycodone
          C. A 90-year-old male asking where he can find canes to replace the one he is using
          3. Which of the following is a common adverse effect of taking opioids?
          A. Increased energy
          B. Improved vision
          C. Drowsiness

          4. Which one of the 5 important problem areas that the National Council on Aging (NCOA) identified can be corrected through medication review to reduce fall risk?
          A. Low vitamin D levels
          B. Unnecessary therapeutic duplication
          C. Past history of falling

          5. Which of the following are Fall-Risk Increasing Drugs?
          A. Opioids, NSAIDs, Antidepressants
          B. Antihistamines, Antibiotics, Statins
          C. Antihypertensives, Antivirals, Proton Pump Inhibitors

          6. What is the first step of the STEADI-RX program?
          A. Eliminate all fall-risk increasing medications
          B. Screen patients for fall risk in the pharmacy
          C. Assess modifiable risk factors

          7. Which of the following assistive devices may make mobility safer and reduce pain?
          A. Reacher
          B. Cane or walker
          C. Shower chair

          8. Which initiative recommends reducing an opioid dose by 25% if patients have been taking opioids daily for four or more weeks?
          A. STEADI-Rx
          B. MedStopper
          C. STOPPFall

          9. In addition to antidepressants, anticonvulsants and antihypertensives, which category of drug is often overlooked as a contributor to falls?
          A. NSAIDs
          B. Antivirals
          C. Antibiotics

          10. What class of medication is among the top 5-10% of drugs prescribed for pain and inflammation?
          A. Muscle relaxers
          B. Opioids
          C. NSAIDs

          References

          Full List of References

          References

             
            1. Nahin RL. Estimates of pain prevalence and severity in adults: United States, 2012. J Pain. 2015;16(8):769. Epub 2015 May 29.
            2. Moreland B, Kakara R, Henry A. Trends in Nonfatal Falls and Fall-Related Injuries Among Adults Aged ≥65 Years - United States, 2012-2018. MMWR Morb Mortal Wkly Rep. 2020;69(27):875-881. doi:10.15585/mmwr.mm6927a5
            3. Bhasin S, Gill TM, Reuben DB, et al. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med. 2020;383(2):129-140. doi:10.1056/NEJMoa2002183
            4. Lehti TE, Rinkinen MO, Aalto U, et al. Prevalence of musculoskeletal pain and analgesic treatment among community dwelling older adults: changes from 1999 to 2019. Drugs Aging. 2021;38(10):931-937. doi:10.1007/s40266-021-00888-w
            5. Patel KV, Guralnik JM, Dansie EJ, et al. Prevalence and impact of pain among older adults in the United States: findings from the 2011 national health and aging trends study. Pain. 2013;154:2649-2657.
            6. Virnes RE, Tiihonen M, Karttunen N, van Poelgeest EP, van der Velde N, Hartikainen S. Opioids and Falls Risk in Older Adults: A Narrative Review. Drugs Aging. 2022;39(3):199-207. doi: 10.1007/s40266-022-00929-y.
            7. Daoust R, Paquet JM, Moore L, Emond M, Gosselin S, Lavigne G, et al. Recent opioid use and fall related-injury among older patients with trauma. CMAJ 2018; 190:E500-6. Doi:10.1503/cmaj.171286
            8. Hegeman, J., van den Bemt, B.J.F., Duysens, J. et al. NSAIDs and the Risk of Accidental Falls in the Elderly. Drug-Safety 2009;32;489-498.. https://doi.org/10.2165/00002018-200932060-00005
            9. Gemmeke M, Koster ES, van der Velde N, Taxis K, Bouvy ML. Establishing a community pharmacy-based fall prevention service - An implementation study. Res Social Adm Pharm. 2023;19(1):155-166. doi:10.1016/j.sapharm.2022.07.044
            10. Woo AK. Depression and anxiety in pain. Rev Pain. 2010; 4(1):8-12.
            11. Burns E, Kakara R. Deaths from falls among persons aged ≥ 65 years—United States, 2007–2016. Morb Mortal Wkly Rep. 2018;67:509–514.
            12. Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020-2040 Using the National Inpatient Sample. J Rheumatol. 2019;46(9):1134-1140. doi:10.3899/jrheum.170990
            13. Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What portion of patients report long-term pain after total hip or knee replacement for osteoarthritis. A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2(1):e000435.
            14. Frenk SM, Porter KS, Paulozzi LJ. Prescription opioid analgesic use among adults: United States, 1999–2012. NCHS Data Brief. Hyattsville, MD: National Center for Health Statistics;2015:89.
            15. Mojtabai R. National trends in long-term use of prescription opioids. Pharmacoepidemiol Drug Saf. 2018;27:526–534. doi: 10.1002/pds.4278
            16. Moriya AS, Fang Z. Any Use and “Frequent Use” of Opioids among Elderly Adults in 2018–2019, by Socioeconomic Characteristics. 2022 Mar. In: Statistical Brief (Medical Expenditure Panel Survey (US)) [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2001-. STATISTICAL BRIEF #541. Accessed July 13, 2023. https://www.ncbi.nlm.nih.gov/books/NBK581184/
            17. Yoshikawa A, Ramirez G, Smith ML, et al. Opioid Use and the Risk of Falls, Fall Injuries and Fractures among Older Adults: A Systematic Review and Meta-Analysis. J Gerontol A Biol Sci Med Sci. 2020;75(10):1989-1995. doi:10.1093/gerona/glaa038
            18. Seppala LJ, Petrovic M, Ryg J, et al. STOPPFall (Screening Tool of Older Persons Prescriptions in older adults with high fall risk): a Delphi study by the EuGMS Task and Finish Group on Fall-Risk-Increasing Drugs. Age Ageing. 2021;50(4):1189-1199. doi:10.1093/ageing/afaa249
            19. Staskin DR, Zoltan E. Anticholinergics and central nervous system effects: are we confused?. Rev Urol. 2007;9(4):191-196
            20. Merck Manual, Le J. Drug Elimination. Sep 2022. Accessed July 6, 2023. https://merckmanuals.com/professional/clinical-pharmacology/pharmacokinetics/drug-excretion
            21. Niscola P, Scaramucci L, Vischini G, Giovannini M, Ferrannini M, Massa P, Palumbo R. The use of major analgesics in patients with renal dysfunction. Curr Drug Targets. 2010;11:752-758.
            22. Davis JS, Lee HY, Kim J, et al. Use of non-steroidal anti-inflammatory drugs in US adults: changes over time and by demographic. Open Heart 2017;4:e000550. doi: 10.1136/openhrt-2016-000550
            23. Wongrakpanich S, Wongrakpanich A, Melhado K, Rangaswami J. A Comprehensive Review of Non-Steroidal Anti-Inflammatory Drug Use in The Elderly. Aging Dis. 2018;9(1):143-150. Published 2018 Feb 1. doi:10.14336/AD.2017.0306
            24. Johnson AG, Day RO. The problems and pitfalls of NSAID therapy in the elderly (Part I). Drugs Aging. 1991;1(2):130-143. doi:10.2165/00002512-199101020-00005
            25. Woolcott JC, Richardson KJ, Wiens MO, Patel B, Marin J, Khan KM, et al. Meta-analysis of the impact of 9 medication classes on falls in elderly persons. Arch Intern Med. 2009;169:1952-1960.
            26. Fick DM, Semla TP, Steinman M, et al. American Geriatrics Society 2019 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019;67(4):674–694. doi: 10.1111/jgs.15767
            27. By the 2023 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;1- 30. doi:10.1111/jgs.18372
            28. National Council on Aging. How Can Medication-Related Falls Be Prevented in Older Adults? Accessed June 20, 2023. https://ncoa.org. How Can Medication-Related Falls Be Prevented in Older Adults? (ncoa.org)
            29. Hart LA, Phelan EA, Yi JY, Marcum ZA, Gray SL. Use of Fall Risk-Increasing Drugs Around a Fall-Related Injury in Older Adults: A Systematic Review. J Am Geriatr Soc. 2020;68(6):1334-1343. doi:10.1111/jgs.16369
            30. Murphy L, Ng K, Isaac P, Swidrovich J, Zhang M, Sproule BA. The Role of the Pharmacist in the Care of Patients with Chronic Pain. Integr Pharm Res Pract. 2021;10:33-41. doi:10.2147/IPRP.S248699
            31. Karani MV, Haddad Y, Lee R. The Role of Pharmacists in Preventing Falls among America's Older Adults. Front Public Health. 2016;4:250. doi:10.3389/fpubh.2016.00250
            32. MedStopper: MedStopper. Accessed 21 Jun 2023. https://medstopper.com/
            33. Murad MH, Elamin KB, Abu Elnour NO, et al. Clinical review: The effect of vitamin D on falls: a systematic review and meta-analysis [published correction appears in J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1495]. J Clin Endocrinol Metab. 2011;96(10):2997-3006. doi:10.1210/jc.2011-1193
            34. Pharmacy Care (STEADI-Rx) | STEADI - Older Adult Fall Prevention | CDC Injury Center https://www.cdc.gov/steadi/steadi-rx.html. Accessed Jun 22, 2023.
            35. Steadi-Rx Community Pharmacy Fall Risk Checklist (cdc.gov) https://www.cdc.gov/steadi/pdf/provider/steadi-rx/STEADIRx_pharmacy_fallrisk_checklist-508.pdf. Accessed Jun 27, 2023.
            36. Steadi-rx Older Adult Fall Prevention Guide for Community Pharmacists (cdc.gov) https://www.cdc.gov/steadi/pdf/Steadi-Implementation-Plan-508.pdf. Accessed Jun 22, 2023.
            37. George SZ, Goode AP. Physical therapy and opioid use for musculoskeletal pain management: competitors or companions? Pain Rep. 2020;5(5):e827. Published 2020 Sep 24. doi:10.1097/PR9.0000000000000827
            38. Frogner BK, Harwood K, Andrilla CHA, Schwartz M, Pines JM. Physical therapy as the first point of care to treat low back pain: an instrumental variables approach to estimate impact on opioid prescription, health care utilization, and costs. Health Serv Res. 2018;53:4629-4646
            39. Zheng P, Kao MC, Karayannis NV, Smuck M. Stagnant Physical Therapy Referral Rates Alongside Rising Opioid Prescription Rates in Patients with Low Back Pain in the United States 1997-2010. Spine (Phila Pa 1976). 2017;42(9):670-674. doi:10.1097/BRS.0000000000001875
            40. Provider Consult - Medication (cdc.gov) https://www.cdc.gov/steadi/pdf/provider/steadi-rx/STEADIRx_provider_consult_medication_form-508.pdf. Accessed Jun 27, 2023.
            41. Provider Consult - Fall Screening (cdc.gov). https://www.cdc.gov/steadi/pdf/provider/steadi-rx/STEADIRx_provider_consult_fallscreening_form-508.pdf. Accessed Jun 27, 2023.
            42. Thies SB, Bates A, Costamagna E, et al. Are older people putting themselves at risk when using their walking frames?. BMC Geriatr. 2020;20(1):90. Published 2020 Mar 4. doi:10.1186/s12877-020-1450-253. Shepherd AJ. Incorrect use of walking aids in patients with hip pathology. Hip Int. 2005;15(1):52–4.
            43. Walking Aid. U.S. Patent US2656874. Accessed August 31, 2023. https://patents.google.com/patent/US2656874
            44. Invalid walker and transfer device. U.S. Patent US2792052. Accessed August 31, 2023. https://patents.google.com/patent/US2792052
            45. Orthopedic walker. U.S. Patent US2792874. Accessed August 31, 2023. https://patents.google.com/patent/US2792874
            46. Invalid walker. U.S. Patent US3517677. Accessed August 31, 2023. https://patents.google.com/patent/US3517677

            The Path to Time Management: Time to Hit the Road!

            Learning Objectives

            After completing this knowledge-based continuing education activity, pharmacy technicians will be able to

              • Describe how an individual technician’s time management impacts the whole pharmacy’s efficiency
              • List three time management techniques that could improve a technician's function
              • Recognize time management techniques to apply in specific settings and situations

               

              Re-Release Date: September 24, 2023

              Expiration Date: September 24, 2026

              Course Fee

              Pharmacy Technicians: $4

              There is no funding for this CE.

              ACPE UAN

              Pharmacy Technician: 0009-0000-23-027-H04-T

              Session Codes

              Pharmacy Technician:  20YC65-TJX49

              Accreditation Hours

              1.0 hours of CE

              Accreditation Statements

              The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-027-H04-T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

               

              Disclosure of Discussions of Off-label and Investigational Drug Use

              The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

              Faculty

               

              Isabella Bean
              PharmD Candidate 2022
              UConn School of Pharmacy
              Storrs, CT

              Sara Miller, PharmD, RPh
              CVS
              Foxboro, MA

              May Zhang
              PharmD Candidate 2022
              UConn School of Pharmacy
              Storrs, CT

              Faculty Disclosure

              In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

              Isabella Bean, Sarah Miller and May Zang do not have any relationships with ineligible companies.

               

              VIDEO

              html

              Pharmacy Technician Post Test (for viewing only)

              The Path to Time Management: Time to Hit the Road!

              LEARNING OBJECTIVES
              After completing this continuing education activity, the pharmacy technician should be able to
              1. Describe how an individual technicians' time management impacts the whole pharmacy’s efficiency
              2. List three time management techniques that could improve a technician's function
              3. Recognize time management techniques to apply in specific settings and situations

              1. Barbara and Linda are great multitaskers. They are able to work and talk while getting everything done effectively. While ringing out a customer, Barbara continues her conversation with Linda. What should Barbara have done instead?
              a. Paused the conversation, because it makes the customer feel unimportant
              b. Done nothing different—in situations like this, she never makes errors
              c. Asked someone else to ring the customer so she can go on her 15 minute break

              2. Lilly makes it to work within the 7 minute grace period every day. Technically she is on time, but she’s not ready and at her station at her 7:30 shift time. How does this disturb workflow when she takes advantage of the grace period every day?
              a. It doesn’t disturb workflow because she is not late. The grace period is in effect so that she doesn’t have to be in right when her shift starts.
              b. Exploiting the grace period means the other technicians who arrive before the official start time have to cover her station until she comes in.
              c. Employers know how often employees are late and why, and communicate problems like traffic congestion to local governments, so the effect on the workplace is positive.

              3. You’re heading to work and you know it takes exactly 11 minutes to travel there. Your shift starts at 9 am. What time do you leave?
              a. I leave by 8:40 am at the latest so that I have time to park and walk in.
              b. I leave at 8:49 am because I know it takes 11 minutes to get there.
              c. I leave at 9:00 am because I know they can handle me being a little late.

              4. You are entering in an insurance card that you haven’t seen before. You’ve been struggling with it for five minutes and can’t figure it out. You are unsure of how to proceed, but the pharmacist is busy. What do you do?
              a. Politely interrupt the pharmacist to ask your question
              b. Ask a more senior technician if they have seen it before
              c. Go to a different station to avoid this insurance card

              5. Laura is a new pharmacy technician. The customers will ask her where to find an OTC or grocery item frequently, but she doesn’t know yet. She asks you how she can become more familiar with where everything is. What do you say?
              a. Suggest that she ask the manager for front store training so that she can become more familiar with the store
              b. Tell Laura that it takes time to learn the store, and to keep asking the other techs and pharmacists
              c. Tell Laura she that she should identify this problem’s quadrant and decide whether to ask or act

              6. You are working in the pharmacy and a huge order arrives. You know you have to finish putting away the order before your shift ends, but prescriptions and patients keep popping up. What do you do?
              a. Prioritize the customers and prescriptions that are here now and do as much of the order as possible
              b. The other technicians are busy too, but leave it for them because you’ve had to put the order away on three recent days
              c. Multitask by putting the order away as you ring customers and retrieve and count controlled substances

              7. The phone is ringing! When you answer it, a provider is on the line. She’s very frustrated because she’s been on hold for 10 minutes, and she “doesn’t have the time for this kind of thing” and “needs an answer ASAP.” She has a clinical question about a medication you fill very frequently. What is the most appropriate response?
              a. ACT—you’ve been a tech for four years; you’ve seen this medication dozens of times. You know enough to answer the provider’s question.
              b. ASK—you’re in the middle of something else right now. Ask another tech to handle this provider.
              c. ASK—the pharmacist should take the call, since it involves a clinical question and you may not know all the details.

              8. The phone is ringing! When you answer it, a provider is on the line. She’s very frustrated because she’s been on hold for 10 minutes, and she “doesn’t have the time for this kind of thing” and “needs an answer ASAP.” She has a clinical question about a medication you fill very frequently. What quadrant of workplace activity best describes this situation?
              a. Quadrant 1: important and urgent
              b. Quadrant 2: important but not urgent
              c. Quadrant 4: not important and not urgent

              9. Flu season is coming. Martha, an experienced pharmacy technician, knows that the store serves a very elderly population. She decides to ask the pharmacist to order more high potency flu vaccines, in anticipation of a higher customer demand. This best describes which time management technique?
              a. Good organization
              b. Planning ahead
              c. Multitasking effectively

              10. You’ve just transferred pharmacies, and you’re trying to figure out the lay of the land. It’s really hard to find things in your new pharmacy. Some meds are ordered by brand name, some by generic. Topicals, inhalers, and DME are all combined on the same shelf. When you bring this up to other techs, they sympathize but say you’ll figure it out eventually, like they had to. Which time management technique would best solve this issue?
              a. Acting instead of asking
              b. Multitasking effectively
              c. Good organization

              References

              Full List of References

              References

                 

                Motivation to be the Best Drug Information Station

                Learning Objectives

                 

                After completing this application-based continuing education activity, pharmacists will be able to

                • Recognize key elements of a drug information request
                • Describe a typical process for researching drug information requests
                • Prioritize information in the final written response
                • Identify the best language to use based on the inquiring party’s needs

                After completing this application-based continuing education activity, pharmacy technicians will be able to

                • Identify questions that are within the pharmacy technician’s scope of practice
                • Recognize tools and resources to use when attempting to answer a drug information question
                • Complete the steps to completing a drug information request that is within the pharmacy technician’s scope of practice

                  Cartoon person standing in front of gigantic question mark

                   

                  Release Date: September 15, 2023

                  Expiration Date: September 15, 2026

                  Course Fee

                  Pharmacists: $7

                  Pharmacy Technicians: $4

                  There is no funding for this CE.

                  ACPE UANs

                  Pharmacist: 0009-0000-23-035-H01-P

                  Pharmacy Technician: 0009-0000-23-035-H01-T

                  Session Codes

                  Pharmacist:  23YC35-PXK63

                  Pharmacy Technician:  23YC35-KPX44

                  Accreditation Hours

                  2.0 hours of CE

                  Accreditation Statements

                  The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-035-H01-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                   

                  Disclosure of Discussions of Off-label and Investigational Drug Use

                  The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                  Faculty

                  Sumoda Achar
                  PharmD and MBA Candidate 2024
                  UConn School of Pharmacy
                  Storrs, CT

                  Shelly Evia
                  PharmD Candidate 2024
                  UConn School of Pharmacy
                  Storrs, CT

                  Stefanie Nigro, PharmD, BCACP, CDCES
                  Associate Clinical Professor
                  UConn School of Pharmacy
                  Storrs, CT

                  Jeannette Y. Wick, RPh, MBA
                  Director Office of Pharmacy Professional Development
                  UConn School of Pharmacy
                  Storrs, CT

                  Faculty Disclosure

                  In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                  Samoda Achar, Shelly Evia, Jeannette Wick, and Stefanie Nigro do not have any relationships with ineligible companies.

                   

                  ABSTRACT

                  Pharmacists and pharmacy technicians often field questions from patients or other healthcare providers. Pharmacists may be more accustomed to answering questions than pharmacy technicians are, but that doesn't mean that pharmacy technicians can't answer appropriate questions. Pharmacy staff members should know their scope of practice and be willing and able to answer questions that fall within the scope of practice. Using an organized approach can help pharmacy staff members answer questions efficiently and effectively. Documentation is also an important aspect of drug information questions, as is saving the information in case it is needed later.

                  CONTENT

                  Content

                  INTRODUCTION

                  A drug information (DI) request is a medication-related question posed by any interested party, but usually a healthcare professional or a patient. As the healthcare team’s drug expert, one of a pharmacist’s main duties is answering these queries effectively and providing an answer that is appropriate for the inquirer’s level of expertise. Pharmacy technicians and pharmacy interns also answer some drug information questions (see TECH TALK SIDEBAR). This continuing education activity outlines various drug information questions that pharmacy staff field most often and describes a methodical approach to ensure pharmacy staff answer requests effectively and accurately.1

                   

                   

                  TECH TALK SIDEBAR: Questions within the Pharmacy Technician’s Scope of Practice?2,3

                  Pharmacy technicians and interns can answer general questions that are within the bounds of their education and training. That vague statement requires some interpretation. If the answer is common knowledge (not specialized pharmaceutical knowledge), technicians can answer. In addition to working with supervising pharmacists to interpret the statement, pharmacy technicians and interns need to know state law governing their scope of practice.

                   

                  Pharmacy technicians and interns are often the first point of contact for customers who want over-the-counter (OTC) medications. Technicians can answer general questions about ingredients if the information is on the label. Some examples include

                  • Does this product contain acetaminophen? What brands of acetaminophen do you stock?
                  • Where are the medicines for pain?
                  • Is there a less expensive generic or store brand for this product?
                  • Do you have any [insert name of prescription medication] in stock?
                  • Do I need to refrigerate this liquid antibiotic?
                  • What does “analgesic” mean?
                  • What does “sustained release” mean?
                  • Is this prescription for a controlled substance?
                  • Why can’t I refill this prescription today?

                   

                  Pharmacy technicians and interns can also convey information from the pharmacist but should be careful. A PRO TIP is that if technicians or interns don’t understand what the pharmacist says, they should ask the pharmacist to make the information clearer. And if the answer is long or complicated, they should write it down and recite it back to the pharmacist before transmitting it to the person with the question.

                   

                  Helping customers find specific medications or classes of medications is within the technician’s scope of practice. When patients have questions about their medications, doses, and how best to administer them, technicians may hesitate to answer. If the information is clearly printed on the prescription label, on the auxiliary labels, or contained in an FDA-approved Medication Guide, the technician or intern can answer.

                   

                  Technicians and interns need to work with the supervising pharmacist to determine if they can answer other questions. When in doubt, technicians should consult with or refer the question to the pharmacist. Technicians and interns must refer questions about potential adverse effects, administration problems, possible alternative medications, and clinical issues to the pharmacist. Before referring the patient, they can collect some baseline information. They cannot counsel or give advice, even if the medication is OTC.

                   

                   

                  Depending on the practice setting, the nature and complexity of DI requests can vary. Being able to answer DI requests is every pharmacy employee’s responsibility (although the type of information varies and at a certain level, the response is the pharmacist’s primary responsibility). Having an organized approach to answering DI questions is highly relevant when working within the community and hospital settings.4

                   

                  Pharmacy employees who work primarily within a community setting can expect to receive DI requests from patients and from practitioners. These requests can range from asking about drug storage requirements (which a technician can usually answer) to consequences of taking an OTC medication in combination with prescription drugs, to requests regarding the safety of a medication for an uncommon or off-label indication. Pharmacists who work in hospital settings can expect to receive most DI requests from colleagues within the care team. For instance, a DI request could come from a prescriber asking about medication absorption and distribution in a patient with comorbid conditions, or from a nurse asking if a medication can be crushed. Pharmacists who work in industry settings, however, may receive medication information requests that vary greatly from those received in clinical settings.4

                   

                  All DI requests require referencing reliable materials and sometimes, various internal policy or research documents. While DI requests are diverse, they all require similar analysis of sources and communication to provide a quality answer. Because pharmacy employees at different levels of responsibility can answer DI questions, this continuing education activity will call the person asking the question the requestor and the person finding the answer the respondent.

                   

                  SCREENING THE REQUEST

                  One of the most confounding situations in the pharmacy occurs when someone asks a question, the respondent spends times finding an answer, and then the requestor says, “Oh, that’s not what I needed to know!” Sometimes, requestors don’t really know how to ask questions effectively. This is a problem that all customer service fields encounter, and answering DI requests is both a clinical function and a customer service. It’s why when you call many customer service lines, the customer service representative will say, “OK, what I hear you asking is….” and then rephrase the question.5

                   

                  To answer DI requests effectively, the respondent must thoroughly understand the question.5 Very specific questions tend to be easily answerable, while others are more general or vague. In both instances, respondents need to ensure they understand the question. They can rephrase the question in their own words and say, “Let me make sure I understand. Do you mean….”, or they can use open ended questions (questions that cannot be answered with a yes or a no) to ask the requestor to provide more information. This avoids answering a question that wasn’t asked or intended or was poorly formulated.

                   

                  Often, requestors don’t know how to ask a question that will provide the information they need. The hallmark of this type of question is that the requestor may use jargon inappropriately or words that don’t seem to make sense. Respondents can say, “Excuse me, I’m not sure I understood entirely. Can you rephrase the question?” or “Pardon me, but I didn’t quite understand the question. Can you tell me a little more about what you want to know and why?” That final word—WHY—provides the impetus for the requestor to provide necessary information.

                   

                  Once the question has coalesced and both parties agree on its intent, the respondent can solicit important details from the requester and, if applicable, the patient, before delving into a search. At this point, the respondent needs to spend time actively listening to the requestor’s explanations.

                   

                  This can be difficult if the requestor is long-winded, difficult to understand, or cognitively impaired, so it requires patience. Here’s a PRO TIP for listening: it’s called the traffic-light-rule.6 During the first 30 seconds (which seems like a short period of time, but is actually relatively long), the requestor’s “talking light” is green. Pharmacy staff should let them talk. In the next 30 seconds, the requestor’s light is yellow: pharmacy staff probably have enough information and should make note of comments or questions. After one minute, the requestor’s talking light is red: pharmacy staff should be comfortable stopping the requestor politely or asking questions.6

                   

                  Before continuing, review the following DI requests. How would you proceed? Later  in this activity, we’ll provide a description of the ideal process.

                   

                  Pharmacist DI request #1: TN, 35-year-old obese female (BMI = 32.4 kg/m2) with uncontrolled type 2 diabetes will start on an atypical antipsychotic today to manage schizophrenia. TN’s psychiatric nurse practitioner (NP) calls with questions about drug selection. The NP mentions that TN’s drug formulary lists aripiprazole, haloperidol, olanzapine, and quetiapine as tier 1 preferred options. The NP wants your opinion as to which atypical antipsychotic may be most appropriate to prescribe for TN. What do you suggest?

                   

                  Pharmacist DI Request #2: You work at a tertiary care internal medicine center. MS, an 80-year-old female, was recently admitted to the medicine floor. She had fallen when she was trying to use the restroom at her nursing home and presented to the emergency department with a wrist fracture. She suffers from insomnia and other comorbidities. Her medication list includes lisinopril 20 mg daily, metformin 500 mg twice daily, rosuvastatin 20 mg daily, and lorazepam 0.5 mg PRN anxiety and sleep. The nursing home staff states that MS received more doses of lorazepam in recent weeks. The medical resident believes that the increased lorazepam use could have contributed to the fall and wants to know if trazodone would be a safer replacement for MS’s insomnia. How do you respond?

                   

                  Technician DI Request #1: I left this medication in my bathroom for four days, and then I noticed it says, “Keep in the refrigerator.” My house is cold, and the bottle didn’t feel warm. Is this still good, and if it isn’t, what should I do?

                   

                  Technician DI Request #2: My child is having trouble swallowing her medication and refuses to take it. Are there any easier ways I could give it to her?

                   

                  Identify Critical Information

                  Although it may seem counterintuitive, beginning with the end in mind is critical and the person gathering information must determine the requestor’s preferred response format. This means asking how the requester wants to receive the response. The respondent will need to adjust the answer according to the requestor’s preferences. Some requestors will want to wait for an answer. If the information is to be communicated through email or an electronic medical record, respondents may use their organization’s required format (a SOAP note or similar formats; see Table 1), but formats used in medical records may not be the most efficient approach in person or over phone. In person or on the phone, respondents need to use a more conversational tone. Furthermore, the respondent will need to determine the requestor’s level of medical competency and tailor the response accordingly. If the requestor is a patient, it is more appropriate to use simple language than if a provider asked the same or  similar question. Respondents will have to evaluate these factors critically to provide a sound and comprehensive answer.7

                  Table 1. Formats for Communicating Critical Information8,9

                  Communication Format Parts of the format Uses
                  SOAP S: Subjective information

                  This section includes descriptive information about a patient’s symptoms, feelings and experiences.

                   

                  O: Objective information

                  This section includes pertinent lab values, imaging, or diagnostic tests.

                   

                  A: Assessment

                  In this section the subjective and objective information are taken into consideration to make an assessment regarding the patient's disease states.

                   

                  P: Plan/ Follow Up

                  This section outlines a detailed plan regarding the patient's treatment and the follow-up and monitoring required.

                  This format is a widely-used written format in healthcare. It helps organize pertinent patient information and efficiently present an answer. This format is especially useful when the respondent must consider multiple pieces of information.
                  ISBAR I: Introduction

                  Introduction of the pharmacist and the respondent, and the pharmacist’s role and location.

                   

                  S: Situation

                  What are the current events regarding the patient?

                   

                  B: Background

                  What has happened in the past with the patient?

                   

                  A: Assessment

                  Identify the problem at hand and make assessments regarding the patient's disease state.

                   

                  R: Recommendation

                  Outline the next steps and your plan.

                  This format is beneficial for verbal communication. It helps the presenter explain the problem at hand and the solution in a time efficient way.
                  TITRS T: Title

                  Introduction of who you are and your purpose in helping the patient.

                   

                  I: Introduction

                  Present the patient and the problems that the patient needs help with.

                   

                  T: Text

                  State subjective and objective information that is necessary to support any recommendations.

                   

                  R: Recommendation

                  Outline the treatment plan in a clear, complete, and concise manner.

                   

                  S: Signature

                  Include name, title, and phone number.

                  This format is beneficial when a brief and concise formal consult is needed to communicate a progress note towards a medical team.

                   

                  Assess the Urgency of the Response

                  While it is critical to provide an appropriate response for the question, doing so in a timely manner is just as critical. Asking the requestor is the simplest way to determine the expected response time. However, many times the requestor isn’t present or cannot be reached, and it is up to the respondent to determine which questions require immediate responses and which may not. Clinically critical topics include

                  • Medication safety: does the DI request ask if a certain therapy could cause or have caused harm to the patient?
                  • Time sensitivity of the treatment: how important is timeliness to the treatment and disease progression?
                  • How much of a concern is the problem to the requestor: does it seem that the requestor needs an immediate response?

                   

                  Sometimes, respondents don’t know the answer to the question immediately.10,11 Pharmacy staff will never be able to answer every question, but they can handle every question gracefully and provide a complete, accurate answer within a reasonable time. When they don’t know the whole answer, they should answer what they can immediately and tell the respondent that they need to do a little more research to answer the remainder. A PRO TIP is to tell the requestor when to expect an answer (and to be sure to follow through).10-12

                   

                  Obtain Sufficient Background Information

                  In simple words, this step is about getting to know the patient or problem or establishing a strong understanding of the patient’s relevant characteristics by obtaining background information. Since some patients have low health literacy, obtaining this information can be a challenge. However, narrowing the search to only include relevant information and filtering unnecessary information can make the process more efficient. This could be achieved by7

                  • Asking targeted questions to patients. For example, instead of asking patients if they take their medication regularly (a closed-ended question that can be answered with yes or no), asking when they last took their medications provides a more precise answer.
                  • Identifying avenues that can provide accurate information. For example, instead of asking patients what other medications they take, checking the local profile and/or contacting their community or specialty pharmacist to receive a medication list can be more accurate.
                  • Reviewing any available records like medical charts or dispensing records.

                   

                  Identify Extraneous Information

                  Obtaining complete information is important but ensuring that the information is pertinent to the question being asked is just as important.

                   

                  Many times, DI requests are in-depth and require researching two or more sources before arriving at an answer. While conducting this search, ensure that the sources are relevant to the problem at hand. For example, if a study suggests that a medication is contraindicated in a patient, determine if the patient’s characteristics are similar to the study’s population. Furthermore, extraneous information could come from data gathering as well. For example, a patient may have multiple diseases, but they may not all impact the problem at hand. Making this distinction is important to provide a thorough and accurate answer.7

                   

                  Answers to Pause and Ponder

                  Pharmacist DI request #1: Haloperidol is not an atypical antipsychotic; therefore, it would be eliminated immediately and the remaining atypical antipsychotics would be reviewed as outlined below:

                  Screen Request Pertinent patient information: past medical conditions (uncontrolled diabetes, schizophrenia). Medications on tier 1 of patient's formulary: quetiapine, olanzapine, haloperidol, aripiprazole.
                  Reformulate Request This is a therapeutics drug information request because the provider is looking for the best medication to treat the patient's schizophrenia without adding any contraindications to the patient's current medication list or concomitant medical conditions.
                  Formulate Response The provider made the request in writing, so a written response is most appropriate. The SBAR format would succinctly and effectively convey the message. First, we conducted a Google search and a tertiary source search (PubMed) including the pertinent patient information and request. Our search read "effects of antipsychotics on obesity and diabetes." Through this, we determined that some antipsychotics lead to changes in metabolic activity. Because the patient has diabetes that is exacerbated by weight gain, the best choice is an antipsychotic that does not have a significant effect on the metabolism. After conducting a more thorough primary source search on the metabolic effects of antipsychotics, we found that the best drug would be aripiprazole. Additionally, monitoring the BMI and efficacy would be appropriate.
                  Assess Understanding Provide the response in a professional and timely manner. Document the request to display accountability and in case there is a similar question in the future. Follow up with the requestor to access the outcomes and ensure that there are no lingering questions or concerns.

                   

                  Pharmacist DI request #2:  Off-label use of low-dose (25 to 100 mg) trazodone, a decades-old antidepressant with drowsiness as a side effect, is common.13 In fact, off-label usage for insomnia has surpassed its use for depression.14 The American Academy of Sleep Medicine does not recommend trazodone because of limited supporting data. A 2018 Cochrane review found equivocal evidence supporting its short-term use for insomnia, but little data on long‐term safety and efficacy exists.15 The Beers Criteria doesn’t highlight trazodone as a potentially inappropriate medication in older adults, not because of evidence demonstrating safety, but because of lack of studies demonstrating harm. However, a retrospective cohort study found low-dose trazodone was no safer with respect to fall-related injury risk than benzodiazepines among 15,582 nursing home residents aged 66 years and older. Future studies need to confirm trazodone’s safety with respect to other risks such as dependence, withdrawal, and cognitive impairment.16

                   

                  Technician DI request #1:

                  It would depend on the medication. Some medications, like amoxicillin, are refrigerated to preserve the taste while most others, such as insulin, are refrigerated to preserve the compound. The technician should ask what medication the patient is referring to and then look up the specific storage requirements for that medication. Some places where this information is available include Drugs.com (https://www.drugs.com/medical-answers/drugs-that-require-cold-storage-166784/) and (https://www.iehp.org/en/members/helpful-information-and-resources?target=emergency-safety). If the medication is not listed in these resources or the medication’s stability has possibly been compromised (such as exposure to extreme heat), the technician should consult the pharmacist.

                   

                  Technician DI request #2:

                  It would vary depending on the medication. Some medications have specific coating that needs to stay intact to ensure proper drug delivery, and such medications should not be crushed. Other medications do not have such restrictions and can be crushed, split in half, sprinkled in foods like applesauce, or have a liquid formulation that can be considered as an alternative with a doctor’s approval. The technicians should ask, “What medication is your child taking so that I can look it up?” Information regarding which medications can be crushed can be found in the following website https://pharmacist.therapeuticresearch.com/Content/Segments/PRL/2014/Aug/Meds-That-Should-Not-Be-Crushed-7309. If the medication or the specific dosage form is not available on the list, the technician should ask the pharmacist to review the medication.

                   

                  Recognize when to ask for additional support or information. While drug information requests can be challenging, involving other healthcare professionals to hear about their experiences with similar clinical situations can offer a new perspective. Some benefits of consulting with experts include formulating a patient-specific answer to the question whereas a study may be irrelevant. When the request requires analysis beyond the scope of a drug information search, it is appropriate to reach out to a professional. While this may take additional time, arriving at the correct answer is more important than to harm the patient unknowingly. And a PRO TIP is that if reaching out will mean you cannot answer the question in the time frame promised, contact the requestor and say you need more time and why.

                   

                  REFORMULATING THE REQUEST 

                  To ensure the core request is clear, the respondent will need to ask many questions, especially if requesters don’t know what question they need to ask. Before starting to research the answer, respondents need to gather information needed from the requestor. In addition, it’s prudent to identify resources the requestor has already consulted (and their reliability in case information needs to be corrected).

                   

                  Categorize the Request

                  Requests can be based on complex patient specific cases, for educational purposes, or geared towards a decision-making process in medication therapy for a specific patient demographic. To fully optimize patient care and provide evidence-based recommendations, it is helpful to ask specific questions and consider all factors pertinent to the specific DI request. Categorizing the request can help stay on track, address all concerns, and point the respondent to the appropriate resources. Table 2 lists common categories and the questions that can clarify the request.

                   

                  Table 2. Common DI Categories and Related Questions1

                  DI Category Related Questions
                  Allergy/Cross-reactivity

                   

                  Does the patient have any documented allergies?

                  What caused or is suspected to have caused the allergic reaction?

                  When did the patient take the medication, and when did the reaction occur?

                  What type of allergic reaction occurred?

                  Is this a class or drug specific effect?

                  Alternative, or Complementary Medicine

                   

                  Where did the patient obtain the medication?

                  Why is the requestor taking or interested in taking the medication?

                  What other medications or treatments are available?

                  ADR/Safety

                   

                  What are the possible side effects?

                  What monitoring parameters need to be considered?

                  Compatibility (Y-site, syringe, IV)

                   

                  What solution will medication be used in?

                  If applicable, how will the medications be administered?

                  Dosage/Route/Administration

                   

                  What is the route of administration?

                  What is the recommended therapeutic dose for pediatrics, adults, and geriatrics?

                  How should the medication be taken (with/without food, with water, etc)

                  Drug Identification

                   

                  What was the source of the medication (e.g., domestic or foreign)?

                  What is the generic and brand name?

                  Where did the medication come from?

                  Ingredients/Stability

                   

                  What physical conditions exist? (Temperature, light protectant, storage duration, diluents)

                  Are there IV admixture compatibility/non-admixture stability data available?

                  Interactions

                   

                  What are the possible interactions between:

                  ●      Drug-drug

                  ●      Drug-food

                  ●      Drug-lab

                  ●      Drug allergy

                  Kinetics

                   

                  What is the onset/half-life/duration?

                  What are the serum levels?

                  Is dialysis a consideration?

                  What is the medication’s bioavailability?

                  Pharmacoeconomics

                   

                  Are there other competitors on the market?

                  Are there cheaper alternatives with the same therapeutic effects?

                  What is the AWP pricing?

                  Pharmaceutics

                   

                  What is the drug route of administration and drug dosage?

                  What patient factors will affect the drug?

                  Age, weight, gender, organ function, current medications

                  Pharmacology What factors will affect drug metabolism and bioavailability?
                  Pregnancy/Lactation What health conditions does the mother have?

                  What medications is the mother currently taking?

                  What is the current trimester?

                  How long has the mother been taking the medication or expected to take this medication?

                  Will the drug be present in breast milk?

                  How will the drug affect the infant?

                  What is the infant's age?

                  What health conditions do the mother and infant have?

                  Was the infant a full term or premature delivery?

                  Vaccinations

                   

                  Is the vaccination appropriate for the patient?

                  What are some side effects to monitor?

                  When should the patient get the vaccination?

                  Therapeutics

                   

                  What is the desired effect?

                  Is the goal cure or prophylaxis?

                  What previous medications and doses has the patient used?

                  Is this medication being used for an FDA approved or off-label use?

                  Toxicity

                   

                  What are possible sequelae?

                  What management strategies are available?

                  Abbreviations: ADR = adverse drug reaction; AWP = Average Wholesale Price; FDA = Food Drug Administration; IV = Intravenous

                   

                  Finding Reliable Sources

                  Being able to locate sources efficiently and correctly for a DI request is very important. Three main types of sources are available: primary, secondary, and tertiary.

                  • A primary source is any original research found in journals. Examples of primary sources are trial results found in the New England Journal of Medicine (NEJM) or similar journals in which researchers use a trial design to answer a specific question. (Note that NEJM and similar journals also publish secondary source materials, too.) This is the strongest Limitations of using this evidence include lack of access to journals that require paid subscriptions and lack of good search skills to find relevant papers.
                  • Secondary sources analyze, interpret, present, or restate information from primary sources. Textbooks, books and review articles, commentaries, guidelines, and Medline are examples of secondary sources.
                  • Tertiary sources compile information from other sources and organize it. Lexicomp , Micromedex, and DynaMed are common tertiary sources for DI requests as they use information from Food and Drug Administration-approved complete prescribing information (package inserts) and clinical studies. One limitation to be aware of is these sources are not updated rapidly therefore the information could be old and outdated.

                   

                  Determine the Best Source

                  When evaluating DI requests, in most cases the best course of action is to start with tertiary sources, such as textbooks or DI databases, when possible.1 These platforms provide a starting point and often suggest a basic idea for the answer. For many DI requests such as dosage, half-life, or adverse effects, the tertiary resource may provide a sound answer. Requests asking to compare two medications’ efficacy or assess the appropriateness of an uncommon or off-label medication use may require further research. Databases that identify off-label use include Micromedex.  In such cases, a primary source is the best resource. References sections of databases like DynaMed and Micromedex can be a great start for finding appropriate primary sources. Using search engines such as MEDLINE, PubMed or Google Scholar (scholargoogle.com) can provide access to relevant primary literature as well.1 Reviewing two to three sources is good practice for most drug information requests. Respondents must determine the relevance of the studies by evaluating if the trial size was large enough to be statistically reliable, if its findings were clinically significant, and if the patient population is similar to the patient.

                   

                  Use General Search Engines Appropriately

                  Using general search engines like Google, and Microsoft Edge can be an acceptable starting point for a search. A metasearch engine is usually better. A metasearch engine is a platform that aggregates the results from multiple search engines and organizes them based on their relevance. Examples of metasearch engines include Dogpile, ixquick, and Metacrawler which aggregate information from sources like Google and Yahoo as well as videos posted on various platforms.

                  Researchers must consider the following factors when determining a source’s credibility17:

                  • Is the information’s original source listed and reliable?
                  • Does the funding for the site come from a sound source such as a university (.edu), an established patient advocacy organization or a professional society (.org), or a government-funded organization (.gov)?
                  • How is the information presented and how is it supported?
                  • Who wrote the article on the webpage? Is the author a credible healthcare provider or a journalist writing about a medical topic?
                  • Is the information updated and verifiable with other sources?

                   

                  Table 3 matches types of information and reliable sources to find information.

                   

                  Table 3. Finding Reliable Sources for Drug Information Requests

                  Type of Request Source
                  Alternative or Complementary medicine Natural Medicine Comprehensive Database
                  ADR/Safety Lexicomp*, UpToDate*, Micromedex*, Package Inserts
                  Compatibility FDA-approved prescribing information, Trissel’s Stability of Compounded Formulations*
                  Dosage/Route/Administration Complete prescribing information, Lexicomp*, Micromedex*, etc.
                  Drug Identification Lexicomp* (Drug I.D) Drugs.com, WebMD Pill identifier, RxResouce.org (pill identification tool)
                  Ingredients/Stability Complete prescribing information, Lexicomp*
                  Interactions

                   

                  CYP Complete prescribing information, Lexicomp*
                  HIV HIV Drug Interactions

                  Clinicalinfo Drug Database

                  Kinetics Complete prescribing information, Lexicomp*
                  Pharmacoeconomics Studies published in pharmacoeconomics journals
                  Pharmaceutics PubMed* and primary sources
                  Pharmacology Lexicomp*, Micromedex* and could require further research with primary sources
                  Pregnancy/Lactation LactMed
                  Regulatory The Pharmacy Practice Act, Pharmacist's Manual
                  Therapeutics Dynamed*, UpToDate*, DiPiro’s textbook
                  Toxicity MSDS, PubChem, Micromedex*
                  Vaccinations CDC vaccine and immunization schedule, Lexicomp
                  Veterinary Information Plumb’s Veterinary Drug Handbook

                  *=sources requiring a subscription or payment

                  Abbreviations: ADR = Adverse Drug Reactions; CDC = Center for Disease Control and Prevention; CYP = Cytochrome P450; FDA = Food and Drug Administration; MSDS = Material Safety Data Sheet;  HIV = Human immunodeficiency virus

                   

                  Another relevant option that many healthcare professionals are considering for answering drug information requests is artificial intelligence (AI) platforms such as ChatGPT. While these seem to be able to provide responses that are based on data and research, the issue that users run into is the AI is not able to approach/appraise situations critically. While AI can provide information that may be or seem accurate, it is cannot assess the data that it uses to ensure that it is relevant to the situation or specific patient. Additionally, AI doesn’t cite its sources, meaning that it can be difficult to assess the appropriateness of the source. Last, it is important to realize that AI has sometimes provided wrong answers that could lead to patient harm and therefore need to be checked against reliable sources.

                   

                  Figure 2 summarizes a typical drug information process.

                  Figure 2. The Drug Information Process


                  FORMULATE THE RESPONSE 

                  Verbal responses tend to be easier for most people than written responses, but respondents should document every request. One simple rule should guide the response: Use principles of clear communication. Clear communication reduces risks of misinterpretation and increases the requestor’s understanding. It optimizes patient care. Clear, concise sentences that are short (fewer than 25 to 32 words) and straightforward create an ideal response.18 It is best to be comprehensive with adequate information and complete sentences that leave no confusion. Each statement should have a clear purpose with no extraneous information or unnecessary words. Respondents must paraphrase important information from accumulated data taken from reliable sources, while avoiding copying and pasting from other outside sources. The response must focus on the audience (the requestor) and the requestor’s background, remembering that different types of professionals have different education and focus.18

                   

                  Organize and Evaluate Information 

                  Organizing information makes research and presentation straightforward and simple for the audience to understand quickly. Templates are available to help keep information organized and formulated, but they have advantages and disadvantages.

                   

                  • Pros: Templates provide consistency that makes it easier for requesters to follow. (Saving your responses to DI requests is a PRO TIP, discussed in the SIDEBAR) Templates also provide an idea about how the completed presentation will look and reduce the time associated with creating the response. Some organizations provide templates for their employees. Lacking an approved template, respondents can find customizable templates from their workplace or university. Example templates found in the appendices show how useful templates can be. Templates can act as checklists to remember what should be included in a drug information response.
                  • Cons: Many templates limit the amount of allowable customization or text, and respondents must be knowledgeable about editing templates. Templates may also limit the approach to the topic and limit the information to standard or predictable fields; this is a problem when the question is unique or unusual. It is important to understand that templates are guides in answering requests and are not restrictions.

                   

                  Templates that can be used while answering drug information questions have different strengths and limitations. The choice of template can be dependent on the pharmacist’s preference as well as the type of drug information request. We reviewed the templates in the addendum and assessed their utility. Take a minute to look at them. How do your assessments compare to ours?

                   

                  Template 1 located in Appendix 1:

                  Pros: Extensive prompts for what should be included in a drug information response. This format is very detailed which could be useful for less experienced users.

                  Cons: Could be too detailed to be used for a wide range of requests. It lacks space, so users will have to use it against a document that they have already created.

                   

                  Template 2 located in Appendix 2:

                  Pros: This format displays the drug information request topic quickly, organizes patient information and the response, and includes references to use for evidence-based literature support. It is broad enough to be used for multiple types of requests. It could be especially helpful for pharmacists who receive a wide variety of requests as it allows them to focus and tailor responses appropriately.

                  Cons: Insufficient prompts or guidance responders, making it more suitable for experienced pharmacy staff. This would too broad for beginners or pharmacy students because it does not outline various aspects of drug information responses.

                   

                  SIDEBAR: Saving FAQs for Future Use: The FAQ File19,20

                  Pharmacy staff often notice that they receive the same or similar questions repeatedly. Each time a requestor asks the question, the respondent must answer again. When employees in the pharmacy discuss questions they receive, they may find that although each of them has only answered a specific question once or twice, collectively they are answering the same question often. A frequently asked question (FAQ) file has numerous advantages. It can

                  • Save time for everyone including the requestor
                  • Standardize the answer so that it is consistent each time staff answer the specific question
                  • Provide the answer in clear language
                  • Create an answer that technicians and students can give to requestors without asking the pharmacist to intervene
                  • Refer requestors to web sites or documents for additional information

                   

                  To develop a reliable FAQ file, pharmacy staff should take several steps:

                  • Identify the questions that are asked frequently.
                  • Develop a simple format for all FAQs. Usually, the actual question appears at the top of the documents, with the answer below.
                  • Start small and ask one employee to draft the FAQ.
                  • Have two or three people review the FAQ, including a pharmacist and at least one or two support personnel. Encourage reviewers to provide constructive criticism. If the FAQ usually comes from a colleague or patient, involve colleagues and patients in the review.
                  • A good process for reviewing FAQs is to ask a reviewer to read to a certain point and then stop. The project coordinator should ask, “Can you tell me in your own words what you just read?” If the reviewer explains and the information is incorrect, the project coordinator should not correct the reviewer; rather, the project coordinator should make a note that the section needs work and why.
                  • The project reviewer should ask additional, open-ended questions including
                    • What’s your general reaction to this draft FAQ?
                    • What did you like about this draft FAQ?
                    • What did you dislike about this draft FAQ?
                    • Is anything in this draft FAQ confusing?
                    • What would you do if you got this document?
                    • What do you think the writer was trying to do with this document?
                    • And here’s a PRO TIP: Often, people will not answer directly because they do not want to appear uneducated or picky. A way to circumvent this issue is to ask, “Thinking of other people you know who might get this document…”
                      • What about the document might work well for them?
                      • What about the document might cause them problems?
                    • Once the FAQ completes the process and is ready for “prime time,” save it in a format that cannot be edited (i.e. a PDF that is locked for editing) and upload it to a shared file or drive where all employees can access the document and print or clip it to an email when needed.

                   

                  Finally, drugs and drug information change over time. Organizations that use FAQ files must schedule routine review (at least annually and more often if necessary) to ensure that the content in FAQ files remains current and correct.

                   

                  Proofing and Editing Drafts 

                  Proofing and editing written drafts entails first fact-checking the narrative and the sources used, and then reviewing the text to ensure it is clear and professional. The respondent must re-assess and re-evaluate each source and the information gathered. Asking other healthcare professionals who have expertise to contribute to or proofread the draft is smart. Collaborating with colleagues can be beneficial, especially in healthcare. The recent emphasis on interdisciplinary approaches reminds us that healthcare professionals from multiple backgrounds need to collaborate and exchange information more often than not. Colleagues can also help confirm or modify any information, while also giving feedback to learn how to better future drug information requests.

                  Once the data is confirmed as accurate, the last step is to double check for spelling and grammar errors and ensure the response is clear and concise. A skilled pharmacy technician is often an exceptional collaborator in this step.

                   

                  Document, Document, Document

                  Documentation is helpful when pharmacy employees have to refer back to that specific topic on a similar drug information question or when colleagues have a similar request in the future. Documenting the response will aid as a reference point and could help clinicians in the future make decisions regarding patient care.21 Documentation will also display accountability and the respondent’s value to the organization and the interdisciplinary team. Many healthcare organizations have policies and procedures for documenting DI requests, and all staff should follow them if they exist.

                   

                  ASSESS REQUESTOR’S UNDERSTANDING AND SATISFACTION 

                  Following up after responding to a DI request is a professional action. The respondent should follow up with the requestor in a timely manner and assess the outcomes. If the requestor is not completely satisfied, the respondent can adjust the answer and recommendations appropriately.7 Follow-up will also reveal if the requestor has implemented the recommendation (and if it worked), provide feedback for potential modifications in future DI requests, and show professionalism and dedication to patient care. A PRO TIP is to document the follow-up and outcomes.

                   

                  CONCLUSION

                  Pharmacy teams have serious responsibilities related to DI requests, which can cover a broad spectrum of topics and specialties. Pharmacists, pharmacy technicians, and pharmacy students should use a methodical approach, followed by documentation. As the ever-changing landscape of healthcare, medicine, and technology continues to advance, the providing drug information will remain an integral part of the pharmacist’s responsibilities.

                   

                  Table 4 provides additional resources.

                   

                  Table 4. Additional Resources

                  Systematic Approach to Answering Drug Information Requests

                   

                  This resource helps characterize the various types of drug information requests

                  https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/preceptor-toolkit/sicp-busy-day-systematic-approach-answering-drug-info-requests.ashx?la=en&hash=7C8B36648FAB999DE761D3AE37BFE48A847B8551
                  7 Tips on Improving Communication in Your Pharmacy

                   

                  This resource provides guidance on how best to speak with patients

                  https://www.pbahealth.com/elements/7-tips-on-improving-communication-in-your-pharmacy/
                  Formulating an Effective Response: A Structured Approach

                   

                  This resource provides strategies to answer formulated drug information requests.

                  https://accesspharmacy.mhmedical.com/content.aspx?bookid=2275&sectionid=177197497 :
                  ASHP Guidelines on the Pharmacist’s Role in Providing Drug Information

                   

                  This resource provides suggestions on how to answer a formulated drug information request.

                  https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/pharmacists-role-providing-drug-information.pdf
                  How To Evaluate Health Information on the Internet: Questions and Answers

                   

                  This resource provides approaches on how to find credible sources to answer drug information requests.

                  https://ods.od.nih.gov/HealthInformation/How_To_Evaluate_Health_Information_on_the_Internet_Questions_and_Answers.aspx

                   

                   

                  Templates:

                  Requirements checklist for drug information Response1 - UBC Blogs. Accessed July 3, 2023. https://blogs.ubc.ca/oeetoolbox/files/2019/01/Requirements-Checklist-for-Drug-Information-Response.pdf.

                  Drug Information Request and Response Form.; 2017. Accessed July 3, 2023.

                  https://blogs.ubc.ca/oeetoolbox/files/2019/01/DIR-Example.pdf

                  PHRM Handbook. Accessed July 3, 2023.

                  https://blogs.ubc.ca/oeetoolbox/files/2019/01/Drug-Information-Request-and-Response-Fillable-Form-.pdf

                  Pharmacist Post Test (for viewing only)

                  Pharmacy: Motivation to be the Best Drug Information Station

                  Pharmacists Post-test

                  After completing this education activity, pharmacists will be able to
                  1) Recognize key elements of a drug information request
                  2) Describe a typical process for researching drug information requests
                  3) Prioritize information in the final written response
                  4) Identify the best language to use based on the inquiring party’s needs

                  1. Which of the following describes a good practice in answering complicated drug information requests?
                  A. Reviewing at least two sources when looking for answers
                  B. Using a couple of metasearch engines (e.g., Dogplie)
                  C. Using tertiary sources (e.g., Micromedex, Lexicomp)

                  2. A patient approaches the community pharmacy counter asking about experiencing GI upset when taking his daily medications. His medications include metformin, prednisone and lisinopril. Which of the following is an appropriate targeted question to obtain key information?
                  A. Are you taking your medications at the correct times?
                  B. How are you taking your medications?
                  C. Are you taking your medications with food?

                  3. Which of the following are elements of screening a response to correctly identify the key elements in a drug information request?
                  A. Setting aside extraneous information to focus on pertinent information
                  B. Relying solely on the patient’s recollection of medical information
                  C. Asking closed-ended questions to extract targeted information

                  4. Which of the following correctly identifies the process of answering a drug information request?
                  A. Screen request for pertinent information, reformulate request, formulate response, assess understanding
                  B. Assess understanding, reformulate request, screen request for pertinent information, formulate response
                  C. Formulate response, reformulate request, access understanding, screen request for pertinent information

                  5. A doctor asks how many hours prior to dialysis medication X should be administered to ensure an optimal response. Which category would the question fall under?
                  A. ADR inquiry
                  B. Therapeutics
                  C. Kinetics

                  6. If asked a question about the dosing for atorvastatin for a 40-year-old patient recently diagnosed with dyslipidemia, which of the following sources would be the most appropriate place to look for the answer?
                  A. Natural medicine comprehensive database
                  B. LactMed
                  C. Lexicomp

                  7. Which of the following correctly pairs the appropriate language and the type of requestor who is asking for information?
                  A. Patient: “Possible adverse events include gastrointestinal upset and an increase frequency of bowel movements.”
                  B. Provider: “The patient may have a tummy ache and have to go to the bathroom to poop a lot.”
                  C. Nurse: “Patients who take this medication may develop some side effects including nausea and diarrhea”

                  8. Which of the following statements identifies the purpose of the “assess understanding” step
                  A. To gauge requestors’ satisfaction and determine if they implemented the recommendation or need further assistance
                  B. To test the requesters health literacy and attempt to match the language you use to the language they understand
                  C. To provide new information to requestors so that they have multiple options in case the first answer didn’t resolve their problem

                  9. You have been tasked with creating a general drug information template. Which of the following are important aspects to include in your template
                  A. Prior medical history; lab values; current medications
                  B. Patient’s education; reference authors; siblings’ ages
                  C. Patient’s age, financial status, current medications

                  10. A patient approaches the pharmacy stating that she left a refrigerated medication on her front porch for more than 24 hours. She asks if it is still safe to use the medication. Which of the following is the most efficient way to answer?
                  A. Google the name of the drug and look for a patient or nurse blog site
                  B. Look at the package insert for the medication in the pharmacy database
                  C. Find two the primary sources for the stability in various temperatures

                  Pharmacy Technician Post Test (for viewing only)

                  Pharmacy: Motivation to be the Best Drug Information Station

                  Pharmacy Technician Post-test

                  After completing this education activity, pharmacy technician’s will be able to
                  1) Identify questions that are within the pharmacy technician’s scope of practice
                  2) Recognize tools and resources to use when attempting to answer a drug information question
                  3) Complete the steps to completing a drug information request that is within the pharmacy technician’s scope of practice

                  1. Which of the following questions would require counseling from a licensed pharmacist?
                  A. Do I store this liquid antibiotic at room temperature or refrigerate it?
                  B. Is there a less expensive generic or store brand for this product?
                  C. What other medications should I avoid taking with this prescription?

                  2. A patient approaches the community pharmacy counter asking about experiencing GI upset when taking his daily medications. His medications include metformin, prednisone, and lisinopril. Which of the following is an appropriate targeted question to obtain key information?
                  A. Are you taking your medications at the correct times?
                  B. How are you taking your medications?
                  C. Are you taking your medications with food?

                  3. When can pharmacy technicians answer questions and help customers find specific medications or classes of medications while staying within their scope of practice?
                  A. If information is clearly printed on the prescription label, on auxiliary labels, or in an FDA-approved Medication Guide.
                  B. If the supervising pharmacist is busy and will not have time to help a customer for at least 15 minutes to an hour.
                  C. When the technician does not like the specific customer and would like to see the customer leave as soon as possible

                  4. Which of the following correctly identifies the process of answering a drug information request?
                  A. Screen request for pertinent information, reformulate request, formulate response, assess understanding
                  B. Assess understanding, reformulate request, screen request for pertinent information response, formulate response
                  C. Formulate response, reformulate request, access understanding, screen request for pertinent information

                  5. A 58-year-old woman comes to the pharmacy counter and tells you she received her Shingrix vaccine two weeks ago and does not remember when she needs to come back for her next Shingrix dose. Where would a pharmacy technician be able to find information about vaccine scheduling to answer the patient’s question?
                  A. Trissel’s Stability Compendium
                  B. LactMed and lexicomp
                  C. CDC Vaccine and Immunization Schedule

                  6. According to the traffic-light-rule, what should the pharmacy staff member do after one minute of listening?
                  A. Pharmacy staff should let patients continue to talk because it’s unlikely they have disclosed enough information.
                  B. Pharmacy staff probably has enough information and should make note of comments or questions.
                  C. Pharmacy staff should be comfortable stopping the requestor politely or asking additional questions.

                  7. A mother is picking up her son’s antibiotic prescription and asks if there is a specific way that her son should take the medication. Where would you find this information about the route of administration for antibiotics?
                  a) PubMed
                  b) Pharmacists Manual
                  c) Lexicomp

                  8. Which of the following statements identifies the purpose of the “assess understanding” step
                  A. To gauge requestors’ satisfaction and determine if they implemented the recommendation or need further assistance
                  B. To test the requesters health literacy and attempt to match the language you use to the language they understand
                  C. To provide new information to requestors so that they have multiple options in case the first answer didn’t resolve their problem

                  9. You have been tasked with creating a general drug information template. Which of the following are important aspects to include in your template
                  A. Prior medical history; lab values; current medications
                  B. Patient’s education; reference authors; siblings’ ages
                  C. Patient’s age, financial status, current medications

                  10. A patient approaches the pharmacy stating that she left a refrigerated medication on her front porch for more than 24 hours. She asks if it is still safe to use the medication. Which of the following is most efficient way to answer?
                  A. Google the name of the drug and look for a patient or nurse blog site
                  B. Look at the package insert for the medication in the pharmacy database
                  C. Find two the primary sources for the stability in various temperatures

                  References

                  Full List of References

                  References

                     
                    1. Systematic Approach to Answering Drug Information Requests Systematic Approach to Answering Drug Information Requests Step 1: Obtain Background Information. Accessed August 8, 2023. https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/preceptor-toolkit/sicp-busy-day-systematic-approach-answering-drug-info-requests.ashx?la=en&hash=7C8B36648FAB999DE761D3AE37BFE48A847B8551
                    2. Understanding Your Scope of Practice as a Pharmacy Technician. Career Advice. Accessed March 25, 2023. https://www.careerstep.com/blog/news/understanding-your-scope-of-practice-as-a-pharmacy-technician/
                    3. Foster P. What You Can and Can’t Say to Customers as a Pharmacy Technician. October 28, 2016. Accessed March 25, 2023. https://www.pennfoster.edu/blog/2016/october/what-you-can-and-can-not-you-say-to-customers-as-a-pharmacy-technician
                    4. ASHP Guidelines on the Pharmacist’s Role in Providing Drug Information Background and Rationale. Accessed August 8, 2023. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/pharmacists-role-providing-drug-information.pdf
                    5. Martin SW. Strategies for Answering Your Customers’ Toughest Questions. Harvard Business Review. June 28, 2012. Accessed March 25, 2023. https://hbr.org/2012/06/handling-customers-toughest-qu
                    6. Nemko M. How to handle difficult clients. Psychology Today. February 25, 2021. Accessed March 25, 2023. https://www.psychologytoday.com/us/blog/how-do-life/202102/how-handle-difficult-clients
                    7. Malone PM, Witt BA, Malone MJ, Peterson DM. Formulating an Effective Response: A Structured Approach | Drug Information: A Guide for Pharmacists, 6e | AccessPharmacy | McGraw Hill Medical. Accessed August 8, 2023. https://accesspharmacy.mhmedical.com/content.aspx?bookid=2275§ionid=177197497
                    8. Podder V, Lew V, Ghassemzadeh S. SOAP Notes. Published 2022. Accessed August 8, 2023. https://www.ncbi.nlm.nih.gov/books/NBK482263
                    9. Burgess A, van Diggele C, Roberts C, Mellis C. Teaching clinical handover with ISBAR. BMC Medical Education. 2020;20(2):1-8. doi:https://doi.org/10.1186/s12909-020-02285-0
                    https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-020-02285-0
                    10. Compassionate Geek. IT Customer Service Skills: What To Do When You Don’t Know The Answer To A Customer Question. Accessed March 25, 2023. https://compassionategeek.com/customer-service-skills-when-you-dont-know-the-answer/
                    11. Expert Panel Forbes Councils Member. Leaders: Nine Good Ways To Handle A Business Question You Don't Know The Answer To. June 7, 2021. Accessed March 25, 2023. https://www.forbes.com/sites/theyec/2021/06/07/leaders-nine-good-ways-to-handle-a-business-question-you-dont-know-the-answer-to/?sh=39d2b40823ba
                    12. Csizmadia A. Oops, I don’t know: How to respond to a customer’s question when you don’t know the answer. September 25, 2018. Accessed March 25, 2023. https://www.liveagent.com/blog/oops-i-don’t-know-how-to-respond-to-a-customers-question-when-you-don’t-know-the-answer/
                    13. Gill LL. Consumer Reports. Should You Take Trazodone for Insomnia? Accessed January 26, 2022. https://www.consumerreports.org/insomnia/trazodone-for-insomnia-should-you-take-a9455377183/
                    14. Jaffer KY, Chang T, Vanle B et al. Trazodone for insomnia: a systematic review. Innov Clin Neurosci 2017;14:24-34.
                    15. Everitt H, Baldwin DS, Stuart B et al. Antidepressants for insomnia in adults. Cochrane Database of Systematic Reviews 2018;5:CD010753.
                    16. Bronskill SE, Campitelli MA, Iaboni A et al. Low-dose trazodone, benzodiazepines, and fall-related injuries in nursing homes: a matched-cohort study. J Am Geriatr Soc 2018;66:1963-71.
                    17. How To Evaluate Health Information on the Internet: Questions and Answers. ods.od.nih.gov. National Institutes of Health. Published June 24, 2011. Accessed August 8, 2023. https://ods.od.nih.gov/HealthInformation/How_To_Evaluate_Health_Information_on_the_Internet_Questions_and_Answers.aspx
                    19. U.S. Department of Health & Human Services. National Institutes of Health Naional Cancer Institute. Making Health Communications Programs Work. Accessed March 25, 2023. https://www.cancer.gov/publications/health-communication/pink-book.pdf
                    18. Clear Writing Assessment. Centers for Disease Control and Prevention. Accessed match 25, 2023. https://www.cdc.gov/nceh/clearwriting/docs/Clear_Writing_Assessment-508.pdf
                    20. JIMDO. How to Write an FAQ Page–with Example. October 21, 2021. Accessed March 25, 2023. https://www.jimdo.com/blog/how-to-write-an-faq-page-with-examples/
                    21. 7 Steps to Respond to Drug Information Requests. Pharmacy Times. Accessed August 8, 2023. https://www.pharmacytimes.com/view/7-steps-to-respond-to-drug-information-requests

                    Considerations in Veterinary Compounding

                    Learning Objectives

                     

                    After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to

                    1.     List food items which may be harmful to certain pets
                    2.     Identify additives which should not be used in veterinary compounding
                    3.     Discover when veterinary compounding is acceptable
                    4.     Recognize federal laws pertaining to veterinary compounding
                    5.     Investigate labeling requirements for veterinary compounds

                     

                      Watercolor cat veterinarian treating smaller cat.

                       

                      Release Date: October 15, 2023

                      Expiration Date: October 15, 2026

                      Course Fee

                      Pharmacists: $7

                      Pharmacy Technicians: $4

                      There is no funding for this CE.

                      ACPE UANs

                      Pharmacist: 0009-0000-23-046-H07-P

                      Pharmacy Technician: 0009-0000-23-046-H07-T

                      Session Codes

                      Pharmacist:  23YC46-BMX34

                      Pharmacy Technician:  23YC46-XBM78

                      Accreditation Hours

                      2.0 hours of CE

                      Accreditation Statements

                      The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-047-H07-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                       

                      Disclosure of Discussions of Off-label and Investigational Drug Use

                      The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                      Faculty

                      Laura Nolan, CPhT, CSPT
                      Academic Assistant
                      UConn School of Pharmacy
                      Storrs, CT

                      Faculty Disclosure

                      In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                      Laura Nolan does not have any relationships with ineligible companies.

                       

                      ABSTRACT

                      With an estimated 65.1 million households with dogs and another 46.5 million households with cats in the U.S., veterinary practices are booming with business. Knowing what to feed them and how to keep them well is becoming increasingly important in compounding pharmacies.

                      CONTENT

                      Content

                      Introduction:

                      For many people, pets are a major part of everyday life. They become part of their households and are like family, but like children, none of them come with true owner’s manuals. Sure, there are many books on the subject, but who do you trust? And who has the time to read all that stuff? What happens if or when they become sick or injured and need medication?

                      As a somewhat reticent parent of a very large Weimaraner (OK, my husband and daughter bought him without my knowledge), I was forced to learn rather quickly about the ins and outs of pet ownership. Still, he arrived, and we needed to determine what’s best for this 99-pound dufus, who amazingly survived eating an entire box of oatmeal raisin cookies. It wasn’t pretty, but that story is reserved for an antidote CE.

                      At the University of Connecticut School of Pharmacy, advanced compounding students are trained in some veterinary compounding, but most pharmacy schools do not teach it. This is a bit upsetting since people spend millions of dollars on pets every year. An estimated 65.1 million households are home to dogs and another 46.5 million households have cats in the U.S. With pet ownership comes the responsibility of caring for them. The average cost of veterinary care for a dog is $730 per year, with cats averaging $253 per year. In 2022, Americans spent $136.8 billion dollars on their pets.1

                      Increasingly, pharmacy staff need to know some basics about companion animals and their health issues. Pet owners can request a paper prescription from the veterinarian and fill it at community pharmacies. The American Veterinary Medical Association (AVMA) incorporated prescription guidelines into their 1991 bylaws. It states that “a veterinarian shall honor a client's request for a prescription or veterinary feed directive in lieu of dispensing but may charge a fee for this service.”2 What do you do when a pet owner brings a prescription to your pharmacy?

                      People’s perceptions about feeding human food to dogs and cats are surprising. An old wives’ tale, passed from generation to generation, tells us that dogs can eat just about anything, including bones. Most of us now know that sharp bone shards can penetrate the soft tissues at the back of the throat, they can lodge in the esophagus, or they can pierce the intestines. It is also possible for a piece of bone to lodge in the trachea (windpipe), interfering with a dog’s ability to breathe.3 The controversy still continues today, but no pet owner wants their pet to have broken teeth, mouth injuries, or intestinal blockages if they can avoid it. If cooked bones are out, what else is bad for them? Certain foods create a risk for most pets, so compounders must not use these items as ingredients in their compounds. Table 1 contains a list of some human foods that should be avoided in pets.

                      Table 1. Human Foods That Should Not Be Given to Pets4

                       

                      Food Item Type of Pet Toxicity/Reasoning
                      Alcohol Dogs, cats, chickens, rabbits Alcohol poisoning
                      Tobacco Dogs, cats Nicotine
                      Onions, chives, garlic (Allium family) Dogs, cats, chickens,  rabbits Sulfates, disulfides
                      Avocado Dogs, cats, chickens, horses, cows, pet birds Persin
                      Salt Dogs, cats, chickens Fluid imbalance
                      Spicy foods Dogs G.I. upset
                      Grapes, raisins Dogs, cats, rabbits Kidney failure
                      Caffeine Dogs, cats, rabbits Methylxanthines
                      Chocolate Dogs, cats, horses, rabbits Theobromine and caffeine
                      Citrus fruits Cats, chickens Citric Acid, essential oils
                      Cinnamon Dogs, cats Mouth and throat irritant
                      Nutmeg Dogs, cats Myristicin
                      Macadamia nuts Dogs, cats Toxicity unknown
                      Mushrooms Dogs, cats Mycotoxins
                      Green tomatoes, raw potatoes Dogs, cats, chickens, horses, rabbits Solanine
                      Raw bread dough, raw yeast, bread Dogs, cats, horses, rabbits G.I. upset, bloating, empty calories
                      Rhubarb Chickens, rabbits
                      Dairy items, ice cream Dogs, cats, chickens, horses, rabbits High sugar, high fat, lactose intolerance. Adult cats become lactose intolerant
                      Sugar free gum and sugar free candy Dogs, cats Xylitol
                      Seeds and Pits Dogs, cats, chickens, horses, rabbits Cyanide
                      Turkey skin, chicken skin, ham Dogs, cats, rabbits High fat content, can cause acute pancreatitis
                      Marijuana Dogs, cats, horses, rabbits Tetrahydrocannabinol (THC)

                       

                      Items like alcohol, tobacco, caffeine, and chocolate make sense. Alcohol and tobacco affect dogs and cats as they do humans, but our pets are much smaller, so it takes significantly less alcohol or tobacco to cause catastrophic events such as breathing problems, vomiting, diarrhea, coma, or even death. Dogs are curious, and a tobacco or marijuana “cigarette” on the ground might be pretty tasty. The average tobacco cigarette contains 10 to 12 milligrams of nicotine. A toxic dose of nicotine for a pet is 0.5 to 1 milligram per pound, and a 4-milligram dose per pound can be lethal.5 Doing some quick math, consuming as little as three or four cigarettes could be fatal to a 10-pound dog.

                      Vaping has become extremely popular, which has caused an increase in nicotine poisonings. An average 6 mL, 5% nicotine e-cigarette can contain up to 300 mg of nicotine. Pets can be subjected to nicotine poisoning by secondhand smoke, through spillage on skin, and by drinking the vaping liquid. Consider this: a 40-pound dog would only need to be exposed to a 1 mL dose for it to become poisoned.5 Nicotine is not the only toxin in e-cigarettes. They also contain volatile organic compounds, heavy metals (e.g., cadmium, copper, lead, nickel, tin) and they contain propylene glycol. All of these components are harmful to pets.

                      Those other “cigarettes” can be pretty tasty too. Marijuana use is on the rise in the U.S. since it is now legal in more than 21 states, and for the first time, it has now made its way onto the list of the top 10 items that cause pet poisonings. The two major components of marijuana are cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). CBD is nontoxic to animals, whereas THC is the psychoactive ingredient that is extremely toxic. CBD is widely advertised for human and pet use, but consumers must read labels carefully. Most CBD products are not entirely pure. They contain small amounts of THC.6

                      Although secondhand smoke and consuming raw marijuana leaves can be toxic, the most reported intoxications come from pets eating infused edibles. Edibles like brownies, cookies or gummies are made with concentrated THC infused oils or THC-infused butter. They tend to be a more significant threat since most edibles also contain chocolate or xylitol.7  If pets exhibit any symptoms, they should be taken to a veterinarian. THC poisoning closely mimics the signs of antifreeze poisoning which is fatal and an antidote needs to be given as quickly as possible.6,7

                      Symptoms of marijuana intoxication can become visible within 30 to 60 minutes after ingestion. Pets may stumble and cross their feet, walking as if they were drunk, they may have enlarged pupils, become lethargic and flinch in reaction to sudden movements. Pets with severe cases of intoxication may vomit, have tremors, shake uncontrollably and in extreme cases become comatose. Roughly 50% of dogs develop urinary incontinence and dribble urine uncontrollably (which might make the drug less popular if this happened in humans).7

                      Some medications contain significant amounts of alcohol. If unsecured, a dog or cat could consume them. Certain formulations of diphenhydramine (Benadryl, Sominex), guaifenesin with codeine (Cheracol Plus), dextromethorphan, guaifenesin, pseudoephedrine combinations (Dimetane, Robitussin, Triaminic, Vicks), hydrocodone and pseudoephedrine combinations (Novahistine), and certain multivitamin liquids (Geritol) contain alcohol. Some remedies can contain up to 25% alcohol, which can harm pets (and children).8  Alcohol is sweet tasting to dogs, so they will not stop drinking it until it is all gone.

                      Caffeine and chocolate ingestion should also be taken seriously. Caffeine contains methylxanthines, which can cause bronchodilatory and stimulatory effects in humans. In animals, they can also cause vomiting, diarrhea, hyperactivity, seizures, and cardiac arrhythmias. Chocolate, derived from the roasted seeds of Theobroma cacao, contains methylxanthine, theobromine, and caffeine. The theobromine content in chocolate is three to ten times that of caffeine. Cats do not have taste buds that can detect sweetness, but dogs do have a sweet tooth and love the taste of chocolate. One ounce (28 grams) of chocolate could be a lethal dose in a small dog. Theobromine has a half-life of two to three hours in humans, but it is longer in dogs. The half-life of theobromine in dogs is 17.5 hours.9,10 The SIDEBAR provides more information about chocolate toxicity in dogs.

                       

                      How Much Chocolate is Too Much?10,11

                      Different cocoa beans and chocolate products contain various amounts of methylxanthines. Compounders and veterinary care providers must consider the dog or cat’s weight and the amount of chocolate consumed.

                      Methylxanthine doses of 15 mg/kg (7.5 mg per pound) or less should not harm a dog. This is equivalent to one square of dark chocolate for a 3 kg (6 lb.) dog or seven squares of chocolate for a 15 kg (33lb.) dog. One square of chocolate is approximately 6 grams (0.21 oz). This formula calculates the dose consumed:

                      Theobromine dose = concentration in type of chocolate x amount eaten/weight

                      Caffeine dose = concentration in type of chocolate x amount eaten/weight

                      Theobromine + caffeine = Total methylxanthines

                      The caffeine and theobromine amounts in the specific type of chocolate may be on the label, and the Table10 below provides some information about common products. However, in emergencies, healthcare providers can use calculators on the Internet that performs this calculation quickly and efficiently. This is not to say that cats never get into chocolate and get sick. There are also cat chocolate toxicity calculators online in case of emergency.

                      Methylxanthines in Chocolate 10

                      Product Methylxanthines per 1 gram chocolate mg methylxanthines /ounce of chocolate
                      Dry cocoa powder 28.5 mg 800 mg
                      Unsweetened bakers chocolate 16 mg 450 mg
                      Milk Chocolate bar 2.3 mg 64 mg
                      Dark Chocolate bar 5.7 mg 150- 160 mg
                      Cocoa bean hulls (mulch) 9.1 mg 225 mg
                      White chocolate Negligible

                       

                      Excess salt (sodium chloride) can cause fluid imbalances which could lead to seizures and spicy foods can cause painful vomiting, diarrhea, or stomach ulcers. Dogs, cats, and even birds are very sensitive to salt, so pet owners and compounders should be aware of common items that contain large amounts of salt. For example, sea water, baking soda, homemade play dough, and driveway deicer all contain high concentrations of salt. Sodium chloride poisonings in dogs are most often caused by pet owners who use salt to induce vomiting after the dog has ingested a different toxin. It is important to consult with a veterinarian or pet helpline before administering any type of antidote.12

                      Even seemingly harmless spices can be harmful. Cinnamon can cause mouth irritations and nutmeg, which contains myristicin, can cause hallucinations in smaller animals. Mushrooms contain mycotoxins which can also cause hallucinations, diarrhea, vomiting, or kidney failure and in extreme cases, liver failure.4

                      Although more toxic to cats than dogs, onions, chives, garlic,  and all members of the allium family of herbs contain sulfoxides and disulfides, and an oxidant called n-propyl disulfide. These can cause a fatal anemia, called oxidative hemolysis, which affects dogs, cats, rabbits and chicken. Signs of anemia may take several days to appear.4,17,18  If a dog is fed a little garlic once in a while it should not be a problem but avoid giving pets garlic supplements. It was once believed that garlic supplements given to dogs could help to repel fleas and ticks, but this has now been proven to be ineffective.13

                      Other problematic vegetables include green tomatoes, raw potatoes, and avocado. The tomato plant’s green parts, its stems and leaves, and raw potatoes contain solanine. Solanine is poisonous, even to humans. It has pesticide-like properties and is part of the plant’s natural defenses. Solanine can be found in green potatoes and potato tubers (eyes).14 It is also found in other members of the nightshade family (e.g., eggplant skin).

                      Avocado is only slightly dangerous to dogs and cats, but extremely dangerous to birds and large animals such as cows, goats, sheep and horses. The bark, leaves, skin, pits and fruit of the avocado contain persin, which is a fungicidal toxin. Persin is an oil soluble compound that seeps into the fruit from the large seed inside. It is similar in structure to a fatty acid, and is harmless to humans, but toxic to most animals. Symptoms of persin toxicity range from edema and mastitis to respiratory distress and heart failure.15,16

                      Chickens, which are increasingly popular in back yards, are sensitive to many food items. They should not be fed most human foods, but especially avoid feeding them citrus fruits, uncooked rice and uncooked dried beans, fruit seeds and pits, tomato leaves, green potatoes, and rhubarb.17 Rhubarb’s high oxalic acid content binds to minerals and can form kidney stones. Although high in calcium and phosphorus, certain dried beans are acidic and contain hemagglutinin. Hemagglutinins bind to receptors on red blood cells to initiate viral attachment and infection.

                      Rabbits, guinea pigs, and most herbivores have similar dietary restrictions. Fruit seeds and pits contain small amounts of cyanide, which can be a concern to smaller animals. Cabbage, cauliflower, other gassy vegetables and iceberg lettuce must be avoided. Iceberg lettuce contains lactucarium. Lactucarium (also called lettuce opium), a milky fluid excreted near the base of the lettuce plant, has sedative properties. Rabbits and other herbivores should stick to darker greens.18

                      Factors That Influence Toxicity

                      Each species of animal reacts to toxins differently due to variations in absorption, metabolism, or elimination. The dose of toxin per body weight is a major concern. Other factors include the animal’s age, size, nutritional status, stress level, and overall health. For example, most young animals do not have a fully developed system of metabolism, which may cause a toxin to remain in their system longer, causing more harm. Horses, rabbits, and small rodents do not have the ability to vomit, which means that they may be poisoned at a lower dose.19

                      One must also consider the chemical nature of a food, drug or poison that is consumed. If the drug or toxin dissolves in water easily, it will spread throughout the body easier. If there are substances added to an active ingredient, such as a binding agent or outer coating, or if it is a sustained release product, it will affect absorption.19 Overall, pharmacists should become familiar with species specific toxins and the factors that affect the risk of toxicity. Animals absorb, distribute, metabolize, and eliminate medications and toxins differently from humans, and the interspecies differences are also notable. See the SIDEBAR for a list of the top ten toxic items.

                       

                      ASPCA: The Official Top 10 Toxins of 202220

                      Each year, the Animal Poison Control Center of America (ASPCA) compiles a yearly list of toxic items. They received 335,136 pet poisoning calls in 2022 and have tabulated the results as follows:

                      1. Over the Counter Medications. Ibuprofen and acetaminophen are the most common.
                      2. Food items. Protein bars, xylitol, grapes and raisins top the list.
                      3. Human prescription medications
                      4. ASPCA received approximately five calls per hour regarding chocolate.
                      5. Plants
                      6. Household chemicals. Disinfecting wipes top the list.
                      7. Veterinary products
                      8. Rodenticides
                      9. Insecticides. Ant baits are an example.
                      10. Recreational drugs. Edible THC products are the most common.

                       

                      Evolution has influenced species-specific diets. Dogs have evolved to become opportunistic gorgers, while cats are very picky. A dog will eat every bit of chocolate once he starts, which is the reason why dog poisonings are more common. Cat poisonings are less common and are usually the result of intentional harm by human beings.

                      Pause and Ponder: Have you tried to give a dog a tablet or capsule? Did you wrap it in some meat or cheese? How did you get a cat to take his dose?

                      When to Compound

                      Pharmacists should consider compounding veterinary products under three conditions:

                      1. When a commercial product is unavailable. This could be due to drug recalls, drug shortages, or because a commercial product has yet to be developed. In some cases, rapid changes in disease state management create an urgent need for medication.
                      2. When an approved drug needs to be modified. This would include an increase or decrease in dosage due to a lack of appropriate dosage size, or a lack of formulation for a desired route, for example, making a dilution, adding flavoring, or changing the form of the drug. A popular compounding task is changing a tablet into a suspension.
                      3. When the likelihood of nonadherence is high. Owners’ adherence is greater when they can administer one combination product instead of two or three. For example, combining two injectable vaccines or allergy medications into one syringe for ease of use would be helpful to the pet owner. Of course, it is also more beneficial to the animal, since it will minimize harm and stress, which will lead to a better prognosis. Our students have recently formulated a compound of ketoconazole, gentamicin sulfate, and mometasone furoate all in one for a dog with an external ear bacterial yeast infection.

                      Dogs and cats can be very particular, and their sense of smell will give that medication away every time. This means that compounding must be creative. The most popular forms of medications for veterinary consideration include capsules, transdermal medications, flavored liquids, tablets, chews, or treats. Oral formulations can be difficult to give, but devices such as droppers, mechanical pill injectors, oral syringes, and oral pastes and gels can mask medications. Pill pockets—soft, flexible treats—can be molded around a tablet or capsule. Medicated oral pastes and gels, when placed on a cat’s paw, are an ingenious way for the cat to lick his medicine up. Compounders make a variety of products from hairball pastes and pectin gels, used for diarrhea, to dental licks and probiotic powders which are placed on a cat’s fur.

                      Human compounding caters to the customer, and the same is true for pets. Tuna or salmon flavoring attracts cats; beef or chicken flavoring may fool dogs; and birds love seeds. Other ingredients can be rather generic. Compounders can choose from a myriad of thickeners, sweeteners, and preservatives. Choosing the correct excipient could be crucial.

                      Pause and Ponder: Take another look at the list of forbidden foods. Which items on your pharmacy compounding shelf could be harmful to pets?

                      Ingredients for veterinary compounding

                      In human compounding we tend to lean toward avocado or grapeseed oil to soothe and treat the skin, which are lighter than other oils. We use alcohol, propylene glycol, polysorbate 80 (Tween 80), and essential oils in compounds and peanut butter quite often for dog treats. These may not be the best choices in some veterinary situations. Let’s look at what is safe and what should not be used for pets.

                      Sweeteners

                      Sugar substitutes are game changers for people who have diabetes or are on low calorie diets. Xylitol is a current human favorite, occuring naturally in small amounts in berries, cauliflower, corn, mushrooms, oats, plums, and pumpkins. In industrial production, the purest form is extracted from raw biomass materials such as hard and soft wood, and especially from the birch tree. More economical processing uses hydrolyzed, purified agricultural corn, wheat, and rice waste. Economists expect xylitol production to become a $1.4 billion industry by 2025.21 Why the increase in popularity? Xylitol contains two-thirds of the calories of sucrose and has a mild increased saliva effect. Unfortunately, xylitol is extremely toxic to dogs.

                      When dogs consume xylitol, it is quickly released into the bloodstream, causing an immediate and potent release of insulin from the pancreas. This leads to severe hypoglycemia, with onset that can occur anywhere from 10 to 60 minutes after ingestion. Without treatment, the dog may develop liver failure, have seizures, or become comatose.22

                      Products that contain xylitol are ubiquitous. It’s found in foods such as barbeque sauce, candy, gum, jam, ketchup, low calorie maple syrup, and peanut butter (meaning that compounders who use peanut butter need to check labels carefully; xylitol may be listed as 1,4-anhydro-d-xylitol, anhydroxylitol, birch bark extract, birch sugar, D-xylitol, Xylite, xylitylglucoside, or zylatol). In fact, sugar-free gum is the most common source of xylitol poisoning in dogs. For example, one piece of gum or one breath mint can be fatal to a 10-pound dog. The Pet Poison Helpline responded to 5,846 xylitol poisoning cases in 2020.22

                      Xylitol can also be found in many pharmaceuticals and personal care products: cough syrup, deodorant, digestive aids, gummy vitamins, laxatives, mouthwash, nasal sprays, shampoo, skin care products, sleep supplements, toothpaste, and especially orally dissolving tablets. Small traces of xylitol can even be found in prescription medications.22 Gabapentin tablets and capsules do not contain xylitol, but gabapentin oral solution contains xylitol. The side bar discusses one xylitol poisoning case.

                       

                      SIDE BAR: POOR MIMI23

                      In 2020, Mimi, a pet poodle passed away after receiving gabapentin. The veterinarian prescribed gabapentin oral solution, for ease of use and medication adherence for Mimi’s seizures. The owner administered the dose and Mimi’s seizures increased, so the owner called the veterinarian, who increased the dose of medication to be given. Within 24 hours Mimi was gone.

                      How could this happen?

                      Many veterinarians are unfamiliar with the added ingredients in human formulations. Also, drug manufacturers may change sweeteners without notice. A retail pharmacist filled her prescription for gabapentin oral solution with the commercially available product, which contained xylitol.  When the dogs owners went to the pharmacy to investigate, they found several factors which caused the problem.

                      • They were told that the pharmacist did not know that the solution contained xylitol and he was also unaware that xylitol was harmful to dogs.
                      • The pharmacy had no drug utilization reviews processes in place for veterinary drugs.
                      • The existing built-in computer software was not programmed to issue alerts for xylitol or other veterinary toxins.
                      • The pharmacy did not have a veterinary drug reference book, for example, Plumbs Veterinary Medicine, or a veterinary drug formulary. Unfortunately, the majority of state boards of pharmacy do not require pharmacies to carry a veterinary drug reference book.

                      Pharmacists and pharmacy technicians need to be aware of additives in human drug formulations that can be harmful to pets. Mimi’s death could have been avoided.23

                       

                      Many other sugar substitutes are considered safe to use in veterinary compounding. Erythritol, a sugar used mainly in keto desserts and baked goods, is safe in small amounts. Stevia and aspartame are also considered safe to use, although pets may experience stomach aches or slight diarrhea. Saccharin (Sweet-n-Low), sucralose (Splenda), or monk fruit, a newer sweetener, are all considered safe in pets.24 Dogs have more of a sweet tooth than cats, but in general, sweeteners should be kept to a minimum.

                      Flavors

                      Using an optimal flavor profile helps mask the active ingredient’s taste and will promote animal adherence. Compounders should use only flavorings that are intended for compounding use. They shouldn’t use meat-flavored bouillon cubes or bouillon powders for compounding since they contain high amounts of salt, onion powder, and other harmful spices. Table 2 lists common flavorings and the species that find them enjoyable.

                       

                      Table 2. Common Flavorings for Pets25

                      Animal Flavor Reasoning
                      Birds Banana, grape, orange, raspberry, tangerine, tutti-fruiti, piña colada Birds prefer sweet and fruity flavors
                      Dogs Bacon, beef, liver, chicken, turkey, cheese, peanut butter, molasses, caramel, anise, marshmallow, raspberry, strawberry, honey Dogs prefer meats and sweets
                      Cats Fish, liver, tuna, cod liver oil, sardines, mackerel, salmon, beef, chicken, cheese, bacon, molasses, peanut butter, butterscotch, marshmallow Cats do not like very much sweetness but hate bitterness
                      Gerbil Banana cream, orange, peach, tangerine, tutti-fruiti Gerbils like sweet and fruity flavors
                      Iguana Banana, cantaloupe, kiwi, orange, tangerine, watermelon, other melons Iguanas and most reptiles rely on their sense of smell more than taste, so it must smell good
                      Rabbits Banana cream, carrot, celery, lettuce, parsley, pineapple, vanilla, butternut Find their favorite vegetable or fruit and use it
                      Poultry Cantaloupe, corn, meal, milk, vanilla, butternut, watermelon Research is ongoing to determine the sense of taste in chickens.

                       

                      Preservatives and Additives

                      The Food and Drug Administration (FDA) maintains a list of additives generally recognized as safe (GRAS) for use in pet foods. Manufacturers must submit food additives used in their pet foods for FDA review, which if approved, are added to the GRAS list.26

                      Still, many excipients should not be used for veterinary compounding 27,28,31

                      • Butylated hydroxyanisole (BHA)
                      • Butylated hydroxytoluene (BHT)
                      • Ethoxyquin
                      • Propylene glycol
                      • Polysorbate 80 (Tween 80)

                      BHA and BHT are preservatives that are added to oils and rendered fats in certain pet foods and treats. They have been found to be carcinogens and can cause liver and kidney damage in rats, but the FDA has cleared them for use in small amounts in pet foods and treats. Ethoxyquin, a preservative, is used as a hardening agent. It is also used in pesticides and rubber and is illegal for human use, yet the FDA has ruled the additive “may be safely used in animal feeds” when used according to regulations.27 Which is the best preservative to use? The answer is to stick to more natural preservatives. Vitamin C and E are great choices, as are lemon, except for use in cats and chickens, and honey. Honey is packed with vitamins A, B, C, D, E, and K and also contains potassium, calcium, magnesium, copper, and antioxidants. Giving a pet a small amount of honey can even help to build immunity from some allergens, such as pollen.29

                      Propylene glycol is a controversial excipient used as a humectant, or moisturizing agent, in many pharmaceutical formulations. Propylene glycol is derived from ethylene glycol, which is antifreeze’s main component. Small amounts may be used in dog formulations, but it is extremely toxic to cats. Extended exposure to propylene glycol over several years has been shown to cause seizures and possible blood disorders in both dogs and cats.28 Cats may develop Heinz body hemolytic anemia, which can lead to death.

                      Cats and dogs are also extremely reactive to essential oils. Popular essential oils (e.g., eucalyptus oil, peppermint oil, tea tree oil) can be found in some natural flea repellents, perfumes, and aromatherapy products. These are safe to use in humans and can be found in many topical preparations; using these oils in topical preparations for dogs or especially cats (since they are continual groomers), can be harmful. Signs of toxicity are lethargy, depression, ataxia, tremors, seizures, or death.30

                      Polysorbate 80 (Tween 80) is a surfactant used in soaps and as a lubricant in eye drops. It is also used as an excipient quite often to stabilize aqueous formulations of lipophilic drugs for vaccines and for parenteral administration. Many Chinese herbal injectable medications contain high amounts of polysorbate 80. When dogs are given intravenous (IV) medications that contain high levels of polysorbate 80, for example vitamin K, it causes systemic histamine release, which causes allergic reactions and tachycardia and may lead to an anaphylactic reaction.31

                      Corn syrup is a cheap humectant, sweetener, and flavoring agent all-in-one, but it can be addictive to dogs and can increase blood sugar significantly. A vegetable-based glycerin, such as coconut glycerin is a better choice.32

                      Food dyes and colorants should be used sparingly when compounding. Blue dye #2, red #40, yellow #5 and #6 can cause hypersensitivity or allergic reactions in some pets. Also, caramel color 4-methylimidazole (4-MIE) is under investigation as a possible carcinogen in pets.32 In actuality, pets do not care about the color of the compound. Artificial coloring only appeals to the pet owner.

                       

                      When to Call a Professional

                      When should pet owners or concerned pharmacy staff call a professional for a suspected pet poisoning? The sooner the better. The first call should be to the pet’s veterinarian, but national hotlines are also available for emergencies 24/7 for a fee.

                      • ASPCA Animal Poison Control

                      https://www.aspca.org/pet-care/animal-poison-control

                      888-426-4435

                      Free access to website

                      $95.00 fee for hotline service

                      *90% of the fee is covered with ASPCA insurance

                       

                      • Pet Poison Helpline

                      http://www.petpoisonhelpline.com

                      855-746-7661

                      Free access to website. $85.00 fee for hotline service

                       

                      General Recommendations for Compounding

                      Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA permits compounding of animal drugs when the source of the active ingredient is a finished FDA-approved drug, and not a bulk drug substance (BDS), unless certain exceptions, described below, are followed. A “bulk drug substance” is a substance used to make a drug that becomes an active ingredient in the drug’s finished dosage form.33 Most pharmacists would recognize that as an active pharmaceutical ingredient (API).

                      A commercially available drug may not always be available or appropriate for veterinary use. For example, an FDA-approved drug may have excipients or preservatives that are unsuitable for pets, the dose may be too large, or the flavoring may be unacceptable. In this case, the FDA has acknowledged the need for certain bulk drug substances. On April 14, 2022, the FDA released the Guidance for Industry (GFI #256), entitled “Compounding Animal Drugs from Bulk Drug Substances” which became effective in April 2023.The FDA has also created approved BDS lists for use in veterinary preparations.35  Separate BDS lists exist for non-food producing animals, for food producing animals, for veterinary office stock drugs, and certain wildlife species.36 GFI #256 allows pharmacies to purchase and use bulk drug substances from FDA-registered suppliers if a certificate of analysis (COA) is included with the compounding record. The FDA also requires compounders to report any adverse reactions to the FDA within 15 days. Veterinarians must also provide more patient specific detailed clinical information explaining why a pet cannot use an FDA approved manufactured product.

                      The FDA has composed a check list for pharmacists regarding veterinary compounding.34

                      1. Confirm whether patient(s) is a nonfood-producing animal or a food-producing animal. Make sure that chicken is just a pet! Food-production animals (cattle, chickens, etc.) have an additional set of rules (not discussed here). Check the FDA guidelines for more information.33
                      2. Follow all state laws and regulations that apply to compounding animal drugs. Compounders need to check their state regulations. It appears that most states tend to merely restate FDA animal compounding guidance.
                      3. Meet USP standards and FD&C Act requirements. Use FDA-approved drugs or FDA-approved BDS, follow USP guidelines and monographs, if they exist, and follow FD&C act requirements.
                      4. Include all labeling information. See below.
                      5. Dispense the compounded drug(s) to the patient’s owner or caretaker or the veterinarian who prescribed or ordered it. A valid veterinarian-client relationship must exist, and a veterinarian must provide a valid prescription.
                      6. Report adverse events and product defects associated with the compounded drug to the FDA on Form FDA 1932a.
                      7. Consider other FDA-approved options first. Check to see if alternative options are available. Compounding is permitted if the active ingredient is a different salt, ester, or other derivative.
                      8. Determine if you are compounding a copy of an FDA-approved product. If the exact form of medication is commercially available, it cannot be compounded.
                      9. Obtain a medical rationale and retain it in your records if a copy is needed. The rationale for the compound must be documented on the prescription.

                      Other considerations include determining the physical and chemical compatibility of the drugs, the drugs’ solubility and stability, and the active ingredients’ pharmacodynamics.

                      Labeling

                      In addition to including the client's name on the label, the American Veterinary Medical Association (AVMA) recommends veterinarians and compounders in veterinary offices convey the following information to animal owners when prescribing all compounded preparations37:

                      • Name, address, and telephone number of veterinarian
                      • Identification of animal(s) treated, species, and number of animals treated, when possible
                      • Date of treatment, prescribing, or dispensing of drug
                      • Name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed
                      • Drug strength (if more than one strength available)
                      • Dosage and duration
                      • Route of administration
                      • Number of refills
                      • Cautionary statements, as needed
                      • Beyond-use date (BUD)
                      • Slaughter withdrawal and/or milk withholding times, if applicable

                      Per FDA regulations, pharmacies must include the following on the compounded drug’s labeling: name and strength or concentration of drug; species and name or identifier of patient(s); name, address, and contact information for the compounding pharmacy and name of the prescribing veterinarian; a beyond use date; the withdrawal time as determined by the prescribing veterinarian; and the following statements must be included33:

                      • “Report suspected adverse reactions to the pharmacist who compounded the drug and to FDA using online Form FDA 1932a.”
                      • “This is a compounded drug. Not an FDA approved or indexed drug.”
                      • “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

                      CONCLUSION

                      On June 10, 2021, the FDA finalized Guidance for Industry (GFI) # 263, (not to be confused with GFI #256 which was mentioned previously) requesting that participating animal drug companies voluntarily transition certain antimicrobials from over-the-counter availability to veterinary prescription within two years. The aim of this guidance is to decrease antibiotic resistance in animals, and the target date to introduce new prescription labels onto the market was June 11, 2023.38 These include well known antibiotics such as erythromycin, gentamicin, penicillin, sulfamethoxazole, and tetracycline. This FDA requirement is now in effect for food-production animals and pets, and it may be one reason why many pharmacies have seen an increase in pet prescriptions. Another reason may be that more pet owners trust their local pharmacy to prepare the correct formula for their furry family members.

                      The field of veterinary medicine is expanding seemingly daily, and it is a field where compounding pharmacies can be instrumental. Veterinary compounding has its challenges, but when collaborating with a veterinarian, the compounder can impart professional judgment to ensure that the compound is safe, effective, and therapeutic. That’s a rewarding practice in the end.

                       

                       

                       

                      Pharmacist Post Test (for viewing only)

                      Considerations in Veterinary Compounding
                      Post-test
                      Learning Objectives: After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
                      1. List food items which may be harmful to certain pets
                      2. Identify additives which should not be used in veterinary compounding
                      3. Discover when veterinary compounding is acceptable
                      4. Recognize federal laws pertaining to veterinary compounding
                      5. Investigate labeling requirements for veterinary compounds

                      1. Which of the following is a major source of poisoning in dogs?
                      a. Turkey skin
                      b. Chocolate
                      c. Bones

                      2. A client asks if she can feed her chickens dried corn, table scraps, or dried beans. Which of those foods would be inappropriate?
                      a. Dried corn
                      b. Table scraps
                      c. Dried beans

                      3. Which is not considered a factor when evaluating the toxicity of a drug or food item?
                      a. The age or maturity of an animal
                      b. The weight and size of an animal
                      c. Whether it is a food-producing animal

                      4. A compounder receives a prescription for a feline. This cat is picky, and the final product needs a humectant and flavoring. Which ingredient is contraindicated?
                      a. Propylene glycol
                      b. Glycerin
                      c. Salmon flavoring

                      5. When a sweetener is required, what is a good choice for veterinary compounding?
                      a. Xylitol
                      b. Sucralose
                      c. Corn syrup

                      6. Select the safe preservative to use when compounding for dogs.
                      a. Vitamin C and E
                      b. Ethoxyquin
                      c. Propylene glycol

                      7. Which of the following is an appropriate flavoring agent for dogs?
                      a. Chicken bouillon cubes
                      b. Bacon flavoring
                      c. Grape flavoring

                      8. Mrs. MacDonald, wife of Old MacDonald, brings you a prescription for her favorite chicken. She confirms that all of the following facts (answers a, b, and c) are true. Which fact forces you to tell her you cannot compound the medication?
                      a. The chicken needs a small dose of medication
                      b. The owner has a valid prescription from a veterinarian
                      c. The chicken is food producing

                      9. Under what condition can a pharmacist compound a veterinary prescription?
                      a. The drug is on the FDA list of approved drugs
                      b. The drug is cheaper to make than the available product
                      c. There is no USP monograph for this drug

                      10. According to GFI 256, a compounder must not
                      a. Use a product on the FDA bulk drug substance list
                      b. Attach the COA to the compounding record
                      c. Purchase BDS from a non-FDA approved supplier

                      11. What should a compounder do before mixing a prescription?
                      a. Confirm that the patient is a pet
                      b. Inform the FDA
                      c. Call the veterinarian

                      12. How soon should compounders report adverse events in veterinary compounding to the FDA?
                      a. Within 7 days
                      b. Within 15 days
                      c. Within 30 days

                      13. As you prepare a prescription label for a compounded product for a pet hamster, what must you include on the label?
                      a. Not for use in food producing animals
                      b. For office use only, not for resale
                      c. This is a compounded drug. Not an FDA approved or indexed drug

                      14. The compounding technician has prepared a label for a compounded veterinary product. The label is terribly crowded and hard to read. Which of the following can you tell the technician to remove?
                      a. Species of pet
                      b. Name of active ingredient
                      c. Veterinary phone number

                      15. Which FDA Guidance for Industry mandates the transition of certain antibiotics from OTC to prescription?
                      a. 256
                      b. 263
                      c. 265

                      Pharmacy Technician Post Test (for viewing only)

                      Considerations in Veterinary Compounding
                      Post-test
                      Learning Objectives: After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
                      1. List food items which may be harmful to certain pets
                      2. Identify additives which should not be used in veterinary compounding
                      3. Discover when veterinary compounding is acceptable
                      4. Recognize federal laws pertaining to veterinary compounding
                      5. Investigate labeling requirements for veterinary compounds

                      1. Which of the following is a major source of poisoning in dogs?
                      a. Turkey skin
                      b. Chocolate
                      c. Bones

                      2. A client asks if she can feed her chickens dried corn, table scraps, or dried beans. Which of those foods would be inappropriate?
                      a. Dried corn
                      b. Table scraps
                      c. Dried beans

                      3. Which is not considered a factor when evaluating the toxicity of a drug or food item?
                      a. The age or maturity of an animal
                      b. The weight and size of an animal
                      c. Whether it is a food-producing animal

                      4. A compounder receives a prescription for a feline. This cat is picky, and the final product needs a humectant and flavoring. Which ingredient is contraindicated?
                      a. Propylene glycol
                      b. Glycerin
                      c. Salmon flavoring

                      5. When a sweetener is required, what is a good choice for veterinary compounding?
                      a. Xylitol
                      b. Sucralose
                      c. Corn syrup

                      6. Select the safe preservative to use when compounding for dogs.
                      a. Vitamin C and E
                      b. Ethoxyquin
                      c. Propylene glycol

                      7. Which of the following is an appropriate flavoring agent for dogs?
                      a. Chicken bouillon cubes
                      b. Bacon flavoring
                      c. Grape flavoring

                      8. Mrs. MacDonald, wife of Old MacDonald, brings you a prescription for her favorite chicken. She confirms that all of the following facts (answers a, b, and c) are true. Which fact forces you to tell her you cannot compound the medication?
                      a. The chicken needs a small dose of medication
                      b. The owner has a valid prescription from a veterinarian
                      c. The chicken is food producing

                      9. Under what condition can a pharmacist compound a veterinary prescription?
                      a. The drug is on the FDA list of approved drugs
                      b. The drug is cheaper to make than the available product
                      c. There is no USP monograph for this drug

                      10. According to GFI 256, a compounder must not
                      a. Use a product on the FDA bulk drug substance list
                      b. Attach the COA to the compounding record
                      c. Purchase BDS from a non-FDA approved supplier

                      11. What should a compounder do before mixing a prescription?
                      a. Confirm that the patient is a pet
                      b. Inform the FDA
                      c. Call the veterinarian

                      12. How soon should compounders report adverse events in veterinary compounding to the FDA?
                      a. Within 7 days
                      b. Within 15 days
                      c. Within 30 days

                      13. As you prepare a prescription label for a compounded product for a pet hamster, what must you include on the label?
                      a. Not for use in food producing animals
                      b. For office use only, not for resale
                      c. This is a compounded drug. Not an FDA approved or indexed drug

                      14. The compounding technician has prepared a label for a compounded veterinary product. The label is terribly crowded and hard to read. Which of the following can you tell the technician to remove?
                      a. Species of pet
                      b. Name of active ingredient
                      c. Veterinary phone number

                      15. Which FDA Guidance for Industry mandates the transition of certain antibiotics from OTC to prescription?
                      a. 256
                      b. 263
                      c. 265

                      References

                      Full List of References

                      References

                         
                        REFERENCES
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                        2.Principles of Veterinary Medical Ethics of the AVMA. American Veterinary Association. August 2019. Accessed July 6, 2023 https://www.avma.org/resources-tools/avma-policies/principles-veterinary-medical-ethics-avma
                        3.Veterinary Centers of America (VCA) Animal Hospitals: Why Bones are not Safe for dogs. By Ryan Llera, BSc, DVM; Robin Downing, DVM, CVPP, CCRP, DAAPM. Accessed 07/04/2023. https://vcahospitals.com/know-your-pet/why-bones-are-not-safe-for-dogs#:~:text=Dogs%20can%20choke.,your%20dog's%20ability%2
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                        6. Chapin. Pets On Pot, Just High or Highly Dangerous? Michigan State College of Veterinary Medicine, Decenber 4, 2018. Accessed August 5, 2023. https://cvm.msu.edu/vetschool-tails/pets-on-pot-just-high-or-highly-dangerous#
                        7. Johnstone, Gemma, American Kennel Club. Marijuana Poisoning in Dogs. April 10, 2023. Accessed August 5, 2023. https://www.akc.org/expert-advice/health/marijuana-poisoning-in-dogs/.
                        8. Liquid medicine may contain a high level of alcohol. Use with caution when administering to a child. Consumer Med Safety.org. Accessed August 5, 2023. https://www.consumermedsafety.org/safety-articles/liquid-medicine-may-contain-a-high-level-of-alcohol-use-with-caution-when#:~
                        9. Myers J. Chocolate toxicosis (Methylxanthine Toxicosis) in Dogs. September 9, 2022. Accessed August 5, 2023. https://vetster.com/en/conditions/dog/chocolate-toxicosis-methylxanthine-toxicosis-in-dogs
                        10. Gwaltney-Brant SM. Chocolate Toxicosis in Animals. Accessed August 5, 2023. https://www.merckvetmanual.com/toxicology/food-hazards/chocolate-toxicosis-in-animals#:~:text=DVM%2C%20PhD%2C%20DABVT,Modified%20Nov%202022
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                        13. Burle A. Can Dogs Eat Garlic? August 4,2022. Accessed August 5, 2023.. https://www.akc.org/expert-advice/nutrition/can-dogs-eat-garlic/
                        14. Medline plus, National Library of Medicine. Potato plant poisoning. Accessed August 5, 2023. https://medlineplus.gov/ency/article/002875.htm
                        15. Oelrichs PB, Ng JC, Seawright AA, Ward A, Schäffeler L, MacLeod JK. Isolation and identification of a compound from avocado (Persea americana) leaves which causes necrosis of the acinar epithelium of the lactating mammary gland and the myocardium. Nat Toxins. 1995;3(5):344-349. doi:10.1002/nt.2620030504
                        16. Avocado. Pet Poison Helpline. Accessed August 5, 2023. https://www.petpoisonhelpline.com/poison/avocado/#
                        Reviewed/Revised Jun 2021 | Modified Nov 20
                        17. What not to feed chickens, 33 Foods to Avoid. Backyard chicken project.com. Accessed August 5, 2023. https://backyardchickenproject.com/what-not-to-feed-chickens/
                        18. Foods Rabbits should never eat. February 15, 2021. Oxbow Animal Health. Accessed August 5, 2023. https://oxbowanimalhealth.com/blog/foods-rabbits-should-never-eat/
                        19. Factors Affecting the Activity of Poisons. Merck Veterinary Manual. Accessed August 5, 2023.https://www.merckvetmanual.com/special-pet-topics/poisoning/factors-affecting-the-activity-of-poisons#
                        20. The Official Top 10 Toxins of 2022. March 23,2023. ASPCA. Accessed August 5, 2023. https://www.aspca.org/news/official-top-10-pet-toxins-2022
                        21. Xylitol, Drugs.com. Accessed August 5, 2023. https://www.drugs.com/npp/xylitol.html
                        22. Xylitol Poisoning in Dogs. VCA. Accessed August 5, 2023. https://vcahospitals.com/know-your-pet/xylitol-toxicity-in dogs#:~:text=What%20is%20xylitol%3F,corn%20fiber%20or%20birch%20trees.
                        23. Dog Dies After Being Treated with Gabapentin Exposing Flaws in the Divide Between Human and Animal Drugs. Pet Food Safety News and Information. Accessed August 5, 2023. https://www.poisonedpets.com/dog-dies-after-being-treated-with-gabapentin-exposing-flaws-in-the-divide-between-human-and-animal-drugs/.
                        24. Brahlek A. Not-So Sweet Toxic Sweeteners for Dogs: Xylitol and Others. November 21, 2022, Accessed August 5, 2023. https://grubblyfarms.com/blogs/the-flyer/toxic-for-dogs-xylitol
                        25. Allen, LV Chapter 29, Veterinary Pharmaceuticals. The Art, Science, and Technology of Pharmacy Compounding. 6th edition, American Pharmacists Association, 2020.
                        26. Current Animal Food GRAS Notices Inventory. U.S. Food and Drug Administration. Accessed August 5, 2023. https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-program/current-animal-food-gras-notices-inventory
                        27. Mahaney P. Pet Food: The Good, the Bad, and the Healthy. Accessed August 5, 2023. https://www.petsafe.net/learn/pet-food-the-good-the-bad-and-the-healthy
                        28. Dog Food Advisor. These 6 Dog Food Preservatives Could Be Toxic to Your Pet. Accessed August 5, 2023. https://www.dogfoodadvisor.com/red-flag-ingredients/dog-food-preservatives/
                        29. People Foods Dogs Can and Can’t Eat. AKC staff. April 3, 2022. Accessed August 5, 2023. https://www.akc.org/expert-advice/nutrition/human-foods-dogs-can-and-cant-eat/
                        30. Schmid R, Brutlag A. Flint C. DVM Essential Oil and Liquid Potpourri Poisoning in Cats. Accessed August 5, 2023. https://vcahospitals.com/know-your-pet/essential-oil-and-liquid-potpourri-poisoning-in-cats#
                        31. Qiu S, Liu Z, Hou L, et al. Complement activation associated with polysorbate 80 in beagle dogs. Int Immunopharmacol. 2013;15(1):144-149. doi:10.1016/j.intimp.2012.10.021
                        32. 10 Ingredients to avoid in dog food. TPLO info. November 12, 2021. Accessed August 5, 2023. https://tploinfo.com/blog/10-ingredients-to-avoid-in-dog-food/
                        33. Animal Drug Compounding. U.S. Food and Drug Administration. Accessed August 5, 2023. https://www.fda.gov/animal-veterinary/unapproved-animal-drugs/animal-drug-compounding
                        34. Check List for Pharmacists: Compounding Animal Drugs. U.S. Food and Drug Administration. Accessed August 5, 2023. https://www.fda.gov/media/157331/download
                        35. GFI # 256- Compounding Animal Drugs from Bulk Drug Substances. August 2022. U.S. Food and Drug Administration Center for Veterinary Medicine. Accessed August 5, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances
                        36. FDA list of Bulk Drug Substances for compounding office stock drugs for Non-food producing animals. Accessed August 5, 2023. https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office-stock-drugs-use-nonfood-producing-animals
                        37. Compounding: Facts for Veterinarians. American Veterinary Medicine Association. Accessed August 5, 2023. https://www.avma.org/resources-tools/animal-health-and-welfare/animal-health/compounding/compounding-faq-veterinarians
                        38. Over-the-counter antimicrobials changing to prescription-only . American Veterinary Medicine Association. Accessed August 5, 2023. https://www.avma.org/resources-tools/one-health/antimicrobial-use-and-antimicrobial-resistance/over-counter-antimicrobials-changin

                        The upcoming USP changes and its impact on immediate use medications

                        Learning Objectives

                         

                        After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to

                          1. Point out an immediate use medication
                          2. Recognize locations where immediate use medications may be compounded
                          3. Investigate the designated person’s responsibilities
                          4. Identify core competencies required for immediate use compounding

                          Image of person with syringe between their teeth.

                           

                          Release Date: September 1, 2023

                          Expiration Date: September 1, 2026

                          Course Fee

                          Pharmacists: $5

                          Pharmacy Technicians: $2

                          There is no grant funding for this CE activity

                          ACPE UANs

                          Pharmacist: 0009-0000-23-031-H07-P

                          Pharmacy Technician: 0009-0000-23-031-H07-T

                          Session Codes

                          Pharmacist:  23YC31-ABC28

                          Pharmacy Technician:  23YC31-BCA82

                          Accreditation Hours

                          1.5 hours of CE

                          Accreditation Statements

                          The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-031-H07-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                           

                          Disclosure of Discussions of Off-label and Investigational Drug Use

                          The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                          Faculty

                          Laura Nolan, CPhT, CSPT
                          Pharmacy Lab Coordinator
                          UConn School of Pharmacy
                          Storrs, CT

                           

                                     

                          Faculty Disclosure

                          In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                          Laura Nolan does not have any financial relationships with ineligibile companies.

                           

                          ABSTRACT

                          The United States Pharmacopeia (USP) recently published updated guidelines on sterile compounding that become effective on November 1, 2023. These guidelines affect not only sterile medications compounded in pharmacy clean rooms, but also injectable medications that may be compounded in healthcare institutions, medical and surgical treatment sites, infusion facilities, pharmacies, and physician and veterinarian practice sites. This affects personnel such as chiropractors, dentists, naturopaths, nurses, pharmacists, pharmacy technicians, physicians, veterinarians, and any other medical professional who compounds sterile products. The USP made these changes to minimize harm, including death, to human and animal patients. By reviewing these updates, and by making changes, medical professionals will be able to comply with state and federal regulations and prevent harm to their patients.

                          CONTENT

                          Content

                          INTRODUCTION

                          In 1905, a person in excruciating pain in a dentist’s office would have been thrilled to receive an injection of procaine (Novocain) delivered in a reusable glass hypodermic syringe. Besides the dentist’s white coat, it’s likely nothing else used in the procedure was clean or remotely sterile. Today, given what we know about sterile products, an educated patient would have turned and run in the opposite direction.

                          Yet, according to the U.S. Food and Drug Administration (FDA), the number of trendy med spas and intravenous (IV) hydration clinics, some mobile, that treat patients with medications such as injectable vitamin infusions, have exploded. Many operate under the FDA’s radar. The FDA may not be aware of which compounders are making such drugs, and some states may have insufficient resources to adequately oversee them. The FDA has recently documented varying offenses from personnel  wearing street clothing and not wearing gloves while preparing injections to using toaster ovens for sterilization.2

                           

                          Human drug compounding is a practice in which ingredients are combined, mixed, or altered to create a medication tailored to an individual patient’s medical needs. The Federal Food, Drug and Cosmetic Act (FD&C Act) governs human compounding. Section 503A describes the conditions under which compounded human drug products are exempt from its regulations2:

                          • Section 505 concerning approval prior to marketing
                          • Section 501(a)(2)(B) concerning current good manufacturing practice (CGMP) requirements
                          • Section 502(f)(1) concerning labeling with adequate directions for use

                          The FDA act exempts one condition—compounds are exempt when a licensed pharmacist or physician prepares the medication in a licensed facility based on a valid patient specific prescription. An explosion of naturopathic clinics, which often use unapproved nutritional, herbal, and homeopathic products and administer them by injection, have become a growing concern for the FDA. A brief Internet search revealed that nurses run many clinics with a physician consulting offsite. The FDA has become increasingly aware of drug products compounded at medical offices and clinics that may be prepared under unsanitary conditions. The FDA has also become aware of business models, such as IV hydration clinics, medical spas, and mobile IV infusion services, that are compounding drugs that may not meet the conditions of the FD&C Act’s section 503A or comply with state regulations.2

                          Unsanitary conditions are more common than one would think. The FDA cites a recent example (February 2021) wherein a 50-year-old patient was hospitalized and treated for suspected septic shock with multi-organ failure after receiving an IV vitamin infusion in her home.2 The patient’s blood cultures grew Pseudomonas fluorescens, which is a gram-negative bacterium of emerging concern.3 A California medical clinic that specialized in services including IV therapies and vitamin injectables, sexual health products, hormone replacement therapy, weight loss/management products, and diagnostic laboratory assays prepared and dispensed the contaminated bag.2 When state and federal agents inspected the facility, they observed several deficiencies2:

                          • Lack of an International Organization for Standardization (ISO) air quality classification of ISO-5; in other words, a clean room which is certified to contain a particle count of less than 3,520 particles per cubic meter in the air, required for sterile compounding
                          • Contamination in compounding areas including peeling paint, stained work surfaces, visibly dirty equipment, and air vents with dust and grime
                          • Difficult-to-clean equipment and surfaces (e.g., carpeting in the IV storage and mixing room)
                          • Standing water in a refrigerated storage area used to store sterile vials
                          • Use of expired active pharmaceutical ingredients to prepare drug products intended to be sterile

                          The full extent of this nationwide problem is unknown since many practitioners operating in medical offices or clinics do not register with the FDA. The FDA encourages all patients who experience adverse effects to report them to the FDA MedWatch Adverse Event Reporting program (www.fda.gov/medwatch/report.htm).2 

                          Defining Immediate Use Medication

                          According to the proposed USP<797> Pharmaceutical Compounding-Sterile Preparations, sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation. Compounding personnel must follow aseptic techniques, processes, and procedures for preparing any sterile medication.1

                          Within a hospital setting, urgent situations may arise where compounding cannot occur in a USP<797> compliant area. Often, acute care situations require STAT (meaning with no delay; at once) doses for critical patients, or medication for an unanticipated procedure.4 Compounders do not necessarily need to comply with all requirements detailed in USP<797> to make these immediate use medications. These frequently asked questions can help clarify when an immediate use medication may be needed and who can compound it.1,4

                          • Can nurses mix compounded sterile preparations (CSPs) for immediate use? Any qualified health professional can prepare an immediate use preparation as long as (1) it is within their scope of practice, (2) the facility’s policies allow it, and (3) the designated person (defined and discussed below) has documented the health care professional’s competency.
                          • Is docking a vial onto a proprietary bag system considered an immediate use medication? Yes and no. Docking a vial onto a proprietary bag for future activation and use is considered compounding and must be performed in an ISO class 5 environment. However, docking a vial onto a proprietary bag according to manufacturer's instructions for immediate administration to a single patient is considered an immediate use medication and is not considered compounding.
                          • Can a nurse prepare an immunoglobulin (IGG) solution in a home care setting, by reconstituting the powder vial with the sterile water supplied by the manufacturer in a kit? This is an example of preparation that is compliant with FDA-approved labeling. Preparing a sterile product in accordance with the manufacturer's approved labeling is not considered compounding as long as
                            • the product is prepared as a single dose for a single patient
                            • the approved labeling includes the following information: the diluent, the final strength, the container closure system, and storage time
                          • If a nurse reconstitutes an antibiotic vial and adds it to a piggyback bag, is this considered immediate use? If the pharmacy is open, this should be done in a sterile clean room. If it is a STAT dose or the pharmacy is closed, then this could be considered immediate use. The nurse mixing the medication needs to have documented competency and the compound should not involve more than three products. One vial of drug, one vial of diluent, and one piggyback bag are three products, which is allowed.

                          In 2020, the American Society of Health Systems Pharmacists conducted a study among professionals who compounded outside of the pharmacy setting. Of the 444 respondents, 77% were nurses, and the rest were primarily anesthesia providers and decentralized pharmacists. Eighty-one percent performed compounding in a acute care settings; other locations included ambulatory surgery centers, infusion centers, physicians’ practices, and long-term care.5

                          The most frequently prepared items were5

                          • IV pushes drawn directly from vials into syringes. (i.e., antibiotics, antiemetics, opioids, proton pump inhibitors)
                          • Intermittent infusions, all of which were proprietary vial and bag systems.
                          • Intramuscular injections including vaccines, antipsychotics, and antibiotics

                           

                          Personnel and Settings Affected by USP<797>

                          All personnel who prepare CSPs are required to comply with USP<797> guidelines. This includes but is not limited to chiropractors, dentists, naturopaths, nurses, pharmacists, technicians, physicians, and veterinarians.1

                          All sites including but not limited to hospitals, infusion facilities, medical and surgical patient treatment sites, pharmacies, physician or veterinarian sites, and other healthcare institutions must meet at least the minimum requirements in USP<797>.1

                          The compounding facility must designate one or more individuals to be responsible and accountable for the facility’s performance, operation, and personnel in the preparation of CSPs and for performing other functions described in USP<797>.1 The facility’s standard operating procedures (SOPs) must identify the person deemed “the designated person.” All designated persons now have immense jobs; failure to meet the USP’s expectations  comes with considerable consequences.

                          The Designated Person

                          The USP mentions the designated person more than 50 times in section <797> alone and several other chapters also refer to the designated person. Below is a list of some, but not all tasks required of a designated person, which will become effective on November 1, 2023. Many states, such as Connecticut and Texas, have already embraced the designated person. The designated person or persons must be identified in the facilities SOPs and registered with the state. In Texas and Connecticut, pharmacists must also complete 30 hours of sterile compounding training to become a designated person. Duties include1

                          • Overseeing a training program to ensure competency of personnel involved in compounding, handling, and preparing CNSPs
                          • Selecting components
                          • Monitoring and observing compounding activities and taking immediate corrective action if deficient practices are observed
                          • Ensuring that SOPs are fully implemented. The designated person(s) must ensure that follow-up is carried out if problems, deviations, or errors are identified
                          • Establishing, monitoring, and documenting procedures for the handling and storage of CNSPs and/or components of CNSPs.

                          The SIDEBAR discusses an issue of emerging importance.

                          SIDEBAR: Who Inspects Physicians’ Offices? 6

                          In 2016, the Pew Charitable Trust conducted a study and asked boards of pharmacy in all 50 states and the District of Columbia to respond to several compounding questions. Of the 51 states, 43 responded to the questionnaire. Although the survey consisted of pages of questions, three of them were forward thinking.

                          1. Does your state have a mechanism to track which in-state physicians’ offices or clinics perform sterile compounding? The answer: 2 % yes, 74% no, 24% don’t know.
                          2. Does the state require physicians’ offices or clinics to be held to the same quality standards as pharmacies? The answer: 17% yes, 38% no, 45% don’t know.
                          3. How do states provide oversight of physician’s offices or clinics that perform sterile compounding to ensure compliance with applicable standards? The answer: 7 by the state board of medicine, 1 by the board of pharmacy (way to go, IDAHO!), 24 reported no oversight system to ensure compliance and 11 states chose not to respond to this question.

                          Who knew Idaho would be so revolutionary? Keep in mind that this study took place in 2016, four years after the New England Compounding mishap of 2012. The Pew study reported, “The Drug Quality and Security Act of 2013, among other reforms, added a new category of compounders called outsourcing facilities that can compound supplies of drugs without obtaining prescriptions.”

                          The new category—outsourcing facilities—was intended to reduce the number of medications made in offices. However, it is obvious that state policies are not uniform. Some states are still working to advance change, and others have yet to act. The Pew report concluded that we are still in a state of transition and that “The variations in sterile compounding policy across states suggest that an opportunity exists to review state oversight systems for potential weaknesses, and consequently to advance regulatory practices to better protect patients.”

                           

                          Gap Analysis

                          In some states, as in the state of Connecticut, the designated person must be a pharmacist. That means that the designated person or persons are responsible for the oversight of all compounding within an institution including the operating room, emergency room, clinics, and nursing station medication rooms.

                          PAUSE AND PONDER: In what areas of your facility could people possibly be compounding without your designated person’s knowledge?

                          A gap analysis compares the current situation with a future state. Creating a gap analysis could help identify areas where compounding is done without the designated person’s knowledge. A gap analysis is performed in three steps7:

                          1. Identify objectives and goals. Most designated persons will create a sheet with three columns: current state, future state, and actions. They will need to identify who, what, where and when immediate use compounding occurs. Using a team approach and including nurses and physicians is a good place to start.
                          2. Analyze the current state. Gather data. One critical area to examine is medications in short supply or backordered. (Aren’t there always a few of these lately!?!) Checking purchasing records and delivery slips to see where medications are being used can be eye-opening. Facilities that substitute vials because the premixed bag is backordered will find that this is a target area.
                          3. Determine how to bridge the gap. Collaborating with the team to create policies and procedures for compounding and writing them into standard operating procedures is critical. Facilities should create a designated compounding area in each unit and establish a cleaning routine. They should also create a training document for nurses and other professionals who compound and set date that each person should complete training as a goal.

                          Immediate Use Gap Analysis

                          All facilities that compound need to compare the current (2008) USP<797> Pharmaceutical Compounding-Sterile Preparations guidelines with the proposed (2022) USP<797> guidelines. In short, the proposed changes are few in number but may cause significant impact throughout the facility.8 Table 1 compares a few minor changes.

                          Table 1.  Less Strict Changes to USP<797> 1,8,9

                          Subject Current Proposed
                          Compounding Process

                          and number of components

                          Only low risk level

                          NMT 3 sterile packages

                          NMT 3 sterile products
                          Situation Emergency use or immediate

                          administration

                          No emergency stipulation
                          Number of manipulations NMT 2 entries into any container/bag Not defined
                          Maximum BUD 1 Hour 4 hours
                          Aseptic technique Aseptic technique is followed Aseptic technique, processes, and procedures followed per written SOPs
                          Risk Level Medium and high risk not prepared as immediate use Category 1, 2, and 3 requirements do not apply
                          Hazardous Drugs Only non-hazardous drugs may be used Must follow USP<800>

                          BUD = beyond use date; NMT = Not More Than

                          A quick glance at the table shows that compounders can now assign a beyond use date (BUD) of four hours for immediate use products. Hurray! This prompts the question, “Is that all I need to implement, and can I do it right now?” Not so fast! These are changes to existing subjects within <797> guidelines, but the proposed guidelines also include many new stipulations, so let’s dig deeper. The following requirements have now been added which pertain to immediate use medications1,8:

                          • Written SOPs must be in place and compounding personnel must follow aseptic technique, processes, and procedures.
                          • Personnel must be trained and demonstrate competency according to the facility SOPs.
                          • SOPs must include methods to minimize contamination and decrease mix-up errors.
                          • The product must be compounded in accordance with evidence-based information for physical and chemical compatibility, per labeling or stability studies.
                          • Any unused starting component from a single use container must be discarded.
                          • Single dose containers must not be used for more than one patient.
                          • A compounding record is required when preparing immediate use medications for more than one patient.

                           

                          Training and Evaluation

                          Training is the elephant in the room. Many nurses and other health professionals have mixed or prepared single use medications for ages, so it might be difficult to teach an old dog new tricks. Demonstration of competency can be difficult and perhaps this is where the nursing team can shine. Luckily, immediate use compounders need not perform fingertip and thumb sampling, or media fill tests as is required for sterile clean room staff.

                          All personnel who compound must now be initially trained and qualified by demonstrating their knowledge and competency of sterile compounding before they can perform their job independently. The designated person(s) is responsible for creating and implementing a training program but may assign training to other qualified personnel. The training procedure for immediate use CSPs must be written into the facilities SOPs.1 One interesting note, the proposed USP<797> states that personnel who are compounding in a clean room, or who have direct oversight of those personnel, must complete training initially, and at least every 12 months. However, immediate use compounders only need to complete training as required by the facilities SOPs.1 A best practice would be to evaluate yearly.

                          Skills may vary from one location to another, but at a minimum, healthcare professionals who will perform immediate use compounding must demonstrate the following core skills8:

                          • Hand hygiene and proper gloving
                          • Calculations, measuring and mixing
                          • Aseptic technique and compounding procedures

                          Required skills will depend on the clinic’s location; for example, an oncology clinic will need to follow USP<800> Standards for Hazardous Drugs, along with USP<797>. Other skills may include cleaning, garbing, documentation, and labeling and should align with the immediate use procedures in the facilities SOPs.

                          Competency assessment must be based on the aseptic processes that are related to the tasks being performed, which can be difficult to recreate. Demonstration of a simulated manipulation may be acceptable in most cases. A simulated aseptic manipulation using empty vials, syringes, sterile water, or saline could consist of the three maximum products allowed, with no need to incubate the sample.7 Using a convenient checklist, like the one in Table 2, helps trainers evaluate staff and document consistently.

                          The SIDEBAR highlights one practice that needs to end immediately.

                          Normal Saline Flush Prefilled Syringes7,10

                          The Institute for Safe Medical Practices (ISMP) released the results of a 2018 immediate use compounding survey. Of the 977 practitioners who responded to the survey, almost all were nurses. ISMP discovered that 81% of the respondents used premixed 5 mL and 10 mL normal saline flushes to dilute medications. The FDA considers a premixed normal saline flush as a medical device and they are “not approved for dilution and administration of IV push medications.”

                          Some clever (but forbidden) uses of prefilled syringes include

                          • Using prefilled syringes as vials: withdrawing and or adding part of a prefilled syringe into another prefilled syringe for administration (Example: adding 5 mL from one syringe to another 5 mL syringe to make a 10 mL syringe).
                          • Using a prefilled syringe to reconstitute a powder vial, then drawing the dose back into the same syringe. (Example, using a 10 mL flush, adding 5 mL from the flush, reconstituting, and withdrawing the 5 mL back into the syringe to create a 10 mL dose.)

                          Using prefilled syringes in these ways is dangerous, since most of the time the health care professional conducting these “procedures” fail to relabel these syringes, so the syringes still have a bright yellow or white label and can be easily picked up by another person and administered in error.

                          Why would prefilled flushes be used for compounding? First, among the many recent drug shortages, normal saline topped the list for a very long time. Second, they are quick and easy to use, and third, healthcare professionals cling to many misconceptions. Some professionals believe that a syringe does not need to be labeled. There is also a myth that a 10 mL syringe must be used to administer IV push medications. Perhaps it is due to “telephone tag” teaching, where one procedure is passed from one to another.

                          So, how do we fix this? Clear procedures need to be established for compounding each medication. Staff training is a must, and a simple roll of blank labels in the compounding area can go a long way to avoiding errors.

                           

                          Table 2. Sample Immediate Use Compounding Evaluation

                          Name of person assessed: Jonathan the Husky Dog  Location:

                           

                          Husky Clinic

                           Evaluation of Handwashing, Garbing, Gloving and Aseptic technique:

                          In left-hand boxes, indicate for each activity

                           P = acceptable completion of the described activity in the correct order,

                          X = the order is incorrect or the activity is performed incorrectly or

                          N/O = the activity was not observed.

                          Notes/

                          Comments on any of the activities.

                          Removes all jewelry and outer garments
                          Uses nail pick under running water
                          Washes hands with soap and water for 30 seconds
                          Dries hands with approved wipe
                          Dons required garb
                          Applies alcohol-based hand sanitizer, allows to air dry
                          Selects the correct pair of gloves
                          Correctly dons sterile gloves
                          Applies sterile alcohol to gloves, allows to air dry
                          Disinfects compounding area with facility approved agent
                          Selects proper components
                          Disinfects critical sites with 70% alcohol wipe

                           

                          Punctures vial at a 45-degree angle to avoid coring
                          Withdraws the correct amount of fluid from vial
                          Disposes waste in proper container
                          Visually inspects final product
                          Demonstrates proper labeling
                          Applies correct 4-hour BUD
                          Name of evaluator________________________Date:_____ Pass   /   Fail

                           

                          CONCLUSION

                          Whether you are the designated pharmacist or just a team member, it is important for you to recognize immediate use medications and locations where they may be compounded. With the implementation of USP<797> commencing on November 1, 2023, now is the time to look at the pharmacy clean room and all areas in your facility where compounding may be occurring. Huge changes in workflow as well and policies and procedures may need to be adopted. Create a well-balanced team of professionals and get to work!

                           

                          Pharmacist Post Test (for viewing only)

                          The Upcoming USP<797> Changes: Impact on Immediate Use Medications
                          Post-test Pharmacists and Technicians
                          After completing this continuing education activity, pharmacists and pharmacy technicians will be able to:
                          1. Point out an immediate use medication
                          2. Recognize locations where immediate use medications may be compounded
                          3. Investigate the designated person’s responsibilities
                          4. Identify core competencies required for immediate use compounding

                          1. Jerry is the designated person for a large health system. He is preparing to implement the new USP<797> changes. Today, he is making a list of potential immediate use situations. Which of the following situations should he add to his list?
                          a. A technician docking ten vials onto proprietary bags
                          b. A pharmacist reconstituting TPA in the emergency department
                          c. An anesthesiologist using a premade fentanyl syringe

                          2. Abdul and Allyssa are having coffee at break. Abdul says that he receives e-mail notifications from the FDA’s automated system. Alyssa asks, “have they reported anything interesting lately about compounding?” What does Abdul report?
                          a. The FDA has seen an uptick in community-based clinics compounding under unsanitary conditions
                          b. The MedWatch Adverse Event Reporting reports more errors caused by choosing the wrong syringe
                          c. The FDA indicates that they are having trouble tracking problems when patients pay cash for infusions

                          3. A veterinarian works in a veterinary practice that employs a certified veterinary technician and has taken all necessary steps to be USP<797> compliant. She needs to prepare and administer an injection of an analgesic immediately for a dog that was hit by a car. Can she do this?
                          a. Yes, because veterinary medications do not need to comply with USP <797>
                          b. Yes, if the certified veterinary technician prepares the dose in the medication room
                          c. Yes, because the practice has taken steps to comply completely with USP<797>

                          4. Clara applies for a job as a “designated person” at a naturopathic clinic. The person interviewing indicates that the facility’s staff seems to prepare immediate use medications in many different (and USP<797> noncompliant) ways. She asks Clara how she would solve this problem. What is the BEST answer?
                          a. Training all staff personally and documenting the training in the facility’s SOPs
                          b. Purchasing medications from a wholesaler that is licensed by the federal government
                          c. Establishing, monitoring, and documenting procedures for CSP handling and storage

                          5. It’s October 31, 2023, at 10:22 PM and Andy needs to prepare an immediate use medication that will probably be given in the emergency department shortly after midnight. The facility’s SOPs are compliant with the revised USP<797> chapter that becomes effective on November 1, 2023. He determines that he can prepare the medication now for its administration after midnight. What do you think?
                          a. Since the USP <797> is not effective until tomorrow, the facility needs to use the maximum BUD allowed in the previous version (2 hours)
                          b. Since the facility is already USP <797> compliant and its SOPs have been updated, 4 hours is the maximum BUD
                          c. Andy needs to wait until midnight and prepare the immediate use medication closer to the time it will be administered.

                          6. Sally’s supervisor is checking her competencies as required by the USP<797>. She asks, “Which of the following represents an appropriate situation that would be considered an immediate use medication?”
                          a. Using a premixed normal saline syringe for reconstituting vial contents
                          b. Completing a compounding record for more than one patient
                          c. Using a single dose vial for two patients within four hours

                          7. Maria considers herself a responsible healthcare professional. She hasn’t needed to prepare an immediate use medication in several months, but today, she needs to compound an antibiotic on site. What should she do before compounding this medication?
                          a. Ensure the designated pharmacist has evaluated the facility’s training procedures
                          b. Complete a standard USP form that is a declaration that she knows how to compound.
                          c. Schedule a media fill test and thumb and fingertip test using an agar plate

                          8. What information is the designated person responsible for updating in the SOPs?
                          a. Training and competency procedures
                          b. Names of personnel who have been trained
                          c. The cost of training to the hospital

                          9. When must immediate use compounders have their training completed?
                          a. Initially and then annually
                          b. Initially and every 6 months
                          c. As required by the facilities SOPs

                          10. Which core competencies apply to immediate use compounding?
                          a. Hand hygiene and sterile filtration
                          b. Hand hygiene, measuring and mixing
                          c. Measuring, mixing and principles of high-efficiency filters

                          Pharmacy Technician Post Test (for viewing only)

                          The Upcoming USP<797> Changes: Impact on Immediate Use Medications
                          Post-test Pharmacists and Technicians
                          After completing this continuing education activity, pharmacists and pharmacy technicians will be able to:
                          1. Point out an immediate use medication
                          2. Recognize locations where immediate use medications may be compounded
                          3. Investigate the designated person’s responsibilities
                          4. Identify core competencies required for immediate use compounding

                          1. Jerry is the designated person for a large health system. He is preparing to implement the new USP<797> changes. Today, he is making a list of potential immediate use situations. Which of the following situations should he add to his list?
                          a. A technician docking ten vials onto proprietary bags
                          b. A pharmacist reconstituting TPA in the emergency department
                          c. An anesthesiologist using a premade fentanyl syringe

                          2. Abdul and Allyssa are having coffee at break. Abdul says that he receives e-mail notifications from the FDA’s automated system. Alyssa asks, “have they reported anything interesting lately about compounding?” What does Abdul report?
                          a. The FDA has seen an uptick in community-based clinics compounding under unsanitary conditions
                          b. The MedWatch Adverse Event Reporting reports more errors caused by choosing the wrong syringe
                          c. The FDA indicates that they are having trouble tracking problems when patients pay cash for infusions

                          3. A veterinarian works in a veterinary practice that employs a certified veterinary technician and has taken all necessary steps to be USP<797> compliant. She needs to prepare and administer an injection of an analgesic immediately for a dog that was hit by a car. Can she do this?
                          a. Yes, because veterinary medications do not need to comply with USP <797>
                          b. Yes, if the certified veterinary technician prepares the dose in the medication room
                          c. Yes, because the practice has taken steps to comply completely with USP<797>

                          4. Clara applies for a job as a “designated person” at a naturopathic clinic. The person interviewing indicates that the facility’s staff seems to prepare immediate use medications in many different (and USP<797> noncompliant) ways. She asks Clara how she would solve this problem. What is the BEST answer?
                          a. Training all staff personally and documenting the training in the facility’s SOPs
                          b. Purchasing medications from a wholesaler that is licensed by the federal government
                          c. Establishing, monitoring, and documenting procedures for CSP handling and storage

                          5. It’s October 31, 2023, at 10:22 PM and Andy needs to prepare an immediate use medication that will probably be given in the emergency department shortly after midnight. The facility’s SOPs are compliant with the revised USP<797> chapter that becomes effective on November 1, 2023. He determines that he can prepare the medication now for its administration after midnight. What do you think?
                          a. Since the USP <797> is not effective until tomorrow, the facility needs to use the maximum BUD allowed in the previous version (2 hours)
                          b. Since the facility is already USP <797> compliant and its SOPs have been updated, 4 hours is the maximum BUD
                          c. Andy needs to wait until midnight and prepare the immediate use medication closer to the time it will be administered.

                          6. Sally’s supervisor is checking her competencies as required by the USP<797>. She asks, “Which of the following represents an appropriate situation that would be considered an immediate use medication?”
                          a. Using a premixed normal saline syringe for reconstituting vial contents
                          b. Completing a compounding record for more than one patient
                          c. Using a single dose vial for two patients within four hours

                          7. Maria considers herself a responsible healthcare professional. She hasn’t needed to prepare an immediate use medication in several months, but today, she needs to compound an antibiotic on site. What should she do before compounding this medication?
                          a. Ensure the designated pharmacist has evaluated the facility’s training procedures
                          b. Complete a standard USP form that is a declaration that she knows how to compound.
                          c. Schedule a media fill test and thumb and fingertip test using an agar plate

                          8. What information is the designated person responsible for updating in the SOPs?
                          a. Training and competency procedures
                          b. Names of personnel who have been trained
                          c. The cost of training to the hospital

                          9. When must immediate use compounders have their training completed?
                          a. Initially and then annually
                          b. Initially and every 6 months
                          c. As required by the facilities SOPs

                          10. Which core competencies apply to immediate use compounding?
                          a. Hand hygiene and sterile filtration
                          b. Hand hygiene, measuring and mixing
                          c. Measuring, mixing and principles of high-efficiency filters

                          References

                          Full List of References

                          References

                             
                            REFERENCES:
                            1. United States Pharmacopeia (USP). General Chapter, <797> Pharmaceutical Compounding—Sterile Preparations. (2023) USP-NF. Rockville, MD: United States Pharmacopeia. Accessed June 19, 2023.
                            2. FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions. Oct. 25,2021. https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-compounding-drug-products-medical-offices-and-clinics-under-insanitary
                            3. Scales BS, Dickson RP, LiPuma JJ, Huffnagle GB. Microbiology, genomics, and clinical significance of the Pseudomonas fluorescens species complex, an unappreciated colonizer of humans. Clin Microbiol Rev. 2014 Oct;27(4):927-48. doi: 10.1128/CMR.00044-14. PMID: 25278578; PMCID: PMC4187640.
                            4. ASHP, The sterile compounding answer book. Chapter 8, Immediate use and preparation for administration. page 33-34
                            5. Pedersen CA, Schneider PJ, Ganio MC, Scheckelhoff DJ. ASHP National survey of pharmacy practice in hospital settings: Dispensing and administration- 2020. Am J Health Syst Pharm. 2021;78(12):1074–93.
                            6. National Assessment of State Oversight of Sterile Drug Compounding. The Pew Charitable Trust. February 2016. Accessed August 7, 2023. https://www.pewtrusts.org/~/media/assets/2016/02/national_assessment_of_state_oversight_of_sterile_drug_compounding.pdf
                            7. Mind Tools, Gap Analysis. Accessed Jun18,2023. https://www.mindtools.com/afv9hac/gap-analysis

                            8. Pharmacy Purchasing & Products Magazine, USP <797> Immediate-Use CSPs: Small Changes, Big Impact. Feb.2023 Vol.20 No.2, page 10. Kevin N. Hansen, PharmD, MS, BCPS, BCSCP Amanda M. Choi, PharmD, MBA Annie Lambert, PharmD, BCSCP February 2023 - Vol.20 No. 2

                            9. United States Pharmacopeia (USP). General Chapter, <797> Pharmaceutical Compounding—Sterile Preparations. (2008) USP-NF. Rockville, MD: United States Pharmacopeia. Accessed June 20, 2023.

                            10. Institute of Safe Medical Practices. Part II Survey results suggest action is needed to improve safety with adult IV push medications. Dec. 2018, Vol.16, Issue 12. Accessed June 22, 2023.https://www.ismp.org/sites/default/files/attachments/201812/NurseAdviseERR201812.pdf

                            Prepping Pharmacist Preceptors on the Pharmacists’ Patient Care Process (PPCP)

                            Learning Objectives

                             

                            After completing this application-based continuing education activity, pharmacists will be able to

                              • Describe the PPCP model and its uses
                              • Apply the PPCP when students address clinical problems in the workplace
                              • Identify areas where pharmacy students need the most guidance when using the PPCP

                              Two healthcare professionals talking while looking at a vial filled with medication capsules

                               

                              Release Date: July 21, 2023

                              Expiration Date: July 21, 2026

                              Course Fee

                              Pharmacists: $7

                              UConn Faculty & Adjuncts:  FREE

                              There is no grant funding for this CE activity

                              ACPE UANs

                              Pharmacist: 0009-0000-23-028-H04-P

                              Session Code

                              Pharmacist:  23PC28-XPK68

                              Accreditation Hours

                              2.0 hours of CE

                              Accreditation Statements

                              The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-028-H04-P  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                               

                              Disclosure of Discussions of Off-label and Investigational Drug Use

                              The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                              Faculty

                              Kimberly Ma
                              PharmD Candidate 2024
                              UConn School of Pharmacy
                              Storrs, CT

                              Jeannette Y. Wick, RPh, MBA, FASCP
                              Director, Office of Pharmacy Professional Development
                              UConn School of Pharmacy
                              Storrs, CT

                              Faculty Disclosure

                              In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                              Kimberly Ma and Jeannette Wick do not have any relationships with ineligible companies

                               

                              ABSTRACT

                              Preceptors often work with students to review patient cases in an organized way. Experts developed the Pharmacists’ Patient Care Process (PPCP) in 2014 to provide a template that is consistent and concise, but also comprehensive. Using this process, students and licensed pharmacists develop SOAP notes to document the subjective and objective data they need to complete an assessment, and ultimately make a plan. PPCP stresses an important point: follow-up is critical and a well-written SOAP note can be extremely helpful in the follow-up process. This continuing education activity uses a case study to demonstrate how the PPCP process should work and emphasize areas where preceptors can provide tangential learning. It includes PRO TIPS for preceptors when they supervise students who are attempting to complete PPCP. It highlights the most common errors and suggest ways that preceptors can work with students to improve their experiential education.

                              CONTENT

                              Content

                              INTRODUCTION: A PATIENT CASE

                              JM, an 8-year-old white male presents to your clinic. It’s a pediatric care clinic located in an area where many financially challenged families live. After talking with his parents, you learn he was recently diagnosed with central precocious puberty (CPP). His endocrinologist recommends initiating therapy and would like to know what treatment you recommend. His parents also have questions.

                              Your spry pharmacy student jumps at the opportunity to write a SOAP note using the “PPCP.” To you, PPCP sounds like an illegal drug that was abused in the 1980s. She explains that the Pharmacists’ Patient Care Process (PPCP) is a standardized model for collaborative medication management. She clarifies what it entails and how to apply the process in a clinical setting.

                              PPCP’s Importance

                              Schools of pharmacy have taught the PPCP for the past few years. Preceptors who are unfamiliar with the process may find it helpful to review the PPCP as many students will take this approach when addressing clinical problems in the workplace.

                              PPCP: THE DETAILS

                              Teamwork in healthcare has achieved major goals for many patients (although we have room for improvement): accessible, affordable, and high-quality care. In addition to the many healthcare team members, pharmacists are critical contributors to care plans. Medication expertise equips pharmacists with the knowledge to reduce drug adverse events, prevent medication errors, and provide invaluable input for decision-making.1

                              In 2014, the Joint Commission of Pharmacy Practitioners (JCPP) developed a standardized process for medication management that could be used across interdisciplinary teams and dubbed it PPCP. JCPP’s members developed the approach using principles of evidence-based practice. The five steps—collect, assess, plan, implement, and follow-up—are tied together with careful communication and documentation.2 Pharmacists can remember the steps as the pneumonic “CAP-IF.”

                              SOAP Notes

                              The subjective, objective, assessment, and plan (SOAP) note provides a method of documentation for the collect, assess, and plan steps of the PPCP. SOAP notes are probably familiar to most preceptors, as clinicians have used them for roughly 50 years.3 Table 1 highlights the key components of SOAP notes.

                              Table 1. Components of a SOAP Note1

                               

                              Objective Information Subjective Information
                              ·       Current medication list (prescription and nonprescription)

                              ·       Medical history

                              ·       Physical assessments (i.e., blood pressure, heart rate, weight, height, respiratory rate, etc.)

                              ·       Laboratory results

                              ·       Chief complaint

                              ·       Symptoms

                              ·       Patient lifestyle habits, preferences, and beliefs

                              ·       Patient goals for care

                              ·       Socioeconomic factors

                              Assessment
                              ·       Problem: statement highlighting the chief complaint or main medication-related problem

                              ·       Rationale: the reasoning for the intervention cited from guidelines and supporting evidence from the collected information

                              ·       Goals of care: possible barriers to adherence, socioeconomic considerations, and desired outcome of intervention

                              Plan
                              ·       Specific recommendation or intervention based on practice guidelines (i.e., initiation of drug therapy, referral to another provider, or non-pharmacologic lifestyle modifications)

                              ·       Plan for upcoming sessions, specific monitoring parameters, and progress indicators

                               

                              Collect

                              Thorough collection of the right information supplies pharmacists with tools to make safe, effective decisions. A combination of objective and subjective information paints a more complete picture of a patient’s clinical status. If possible, pharmacists should obtain and verify their information across multiple sources. Past medical records, active medication lists, and laboratory results are great places to start.

                              When soliciting subjective information, pharmacists should use open-ended questions. Prompting patients with questions formatted to avoid “yes” or “no” answers allow providers to obtain more information in less time, prioritize chief complaints better, and minimize implicit assumptions.4

                              Back to the Case

                              Your head is spinning trying to sort all the “P’s” in PPCP, CPP, and JCPP, but your student assures you that she will start with collecting relevant clinical information. First, you and your student perform a physical assessment of JM including taking his height and weight. JM takes no medication except an occasional antihistamine, but if he took other chronic medications, this would be the time to direct your student to perform a medication reconciliation. Next, you prompt JM’s parents with open ended questions, and they recall JM’s past medical history. You should ask your student if JM needs to be involved in the discussion (see SIDEBAR). After meeting with JM and his parents, here is the relevant information your student jots down:

                              Subjective information

                              • At age 5, JM frequently soaked through his underarm clothing with pungent perspiration, so since then, he uses a strong deodorant
                              • He is starting to develop pubic and underarm hair
                              • He has some acne on his face and upper back
                              • JM occasionally tells his parents he feels “different” than his classmates because he is so much bigger and taller
                              • He has no past surgeries or hospitalizations
                              • Takes OTC multivitamins daily and loratadine for allergies in the spring

                              Objective Information

                              • Height = 4’8” inches
                              • Weight = 102 pounds
                              • DHEA Sulfate = Tanner stage III - 60 ug/dL (N = < 28 ug/dL)
                              • Clinical exam findings = testicle size indicates puberty
                              • X-ray bone age hand and wrist = greater than 2 standard deviations, 156 months (expected = 108.9 months)
                              • Luteinizing hormone (LH) = 0.4 units/L (N = < 0.3 units/L)

                              SIDEBAR: Pediatric Involvement in Healthcare Decisions5,6

                              In pediatric cases, clinicians may choose to consult only parents when making decisions regarding their child’s medical care. However, this practice, which is rooted in legal precedence, should shift to involve affected children to some extent. The American Academy of Pediatrics advocates that adolescents actively participate in decisions based on their ability and maturity. 5 While research is lacking on how exactly to assess a child’s aptitude to participate in decision making, some studies show that children can participate as young as age 5.6 Regardless, it doesn’t hurt to ask children if they have questions or concerns. In the case, JM is 8 and has voiced his concern previously about his height and size. Therefore, including him in the conversation is a possibility if his parents agree.

                              Preceptors can and should provide tangential learning when working with special populations. Reminding students that adolescents, older adults, people who have cognitive decline or dementia, and people for whom English is a second language will need careful counseling. Pharmacists and pharmacy staff will also need to select their words carefully and accommodate these patients’ needs. Assigning students to do some research on the various needs in these populations is an excellent way to help them develop skills and a professional identity.

                              Upon looking at your student’s notes so far, you assure her she has done well. However, you still have some questions. You remind her that sometimes information like height and weight requires additional evaluation and ask her to calculate JM’s BMI; she finds that it’s 22.9. You ask your student, “How does JM’s height and weight compare to the expected height and weight of boys his age?” To which she replies, “Pediatric growth charts will give us a better idea!” After consulting the growth charts, she determined and documented that JM falls within the 112th percentile for both measurements.

                              To make learning comprehensive, you could ask the student if the only kind of precocious puberty is central in nature. This will help your student learn to differentiate among different forms of similar diagnoses.

                              Assessment

                              An assessment of comprehensive patient information helps prioritize the problems that require attention. Pharmacists should consider all information when identifying the problem, the rationale, and the goals of therapy. Some example questions pharmacists can consider include1

                              Medication appropriateness

                              • What is the indication for each medication?
                              • What is the correct dosing?
                              • What are the common adverse effects?
                              • What are the possible drug interactions?

                              Factors that impact access to care

                              • What cultural factors create barriers to care?
                              • What socioeconomic factors impact the patient?
                              • What is the patient’s level of healthcare literacy?
                              • What goals does the patient or his parents have?
                              • What barriers impact patient adherence?

                              Additional services

                              • What preventive care measures does the patient qualify for?
                              • Which immunizations has the patient received?
                              • What other concerns does the patient have?

                              THE CASE RESUMED...

                              After compiling the objective and subjective information on JM, the student finds guidelines in the Journal of Clinical Endocrinology for the management of CPP.7 Due to JM’s symptoms and lab values showing consistencies with CPP, the guidelines recommend initiating a gonadotropin releasing hormone (GnRH) analog. Depending on JM’s and his parents' preferences, the endocrinologist can choose either an injectable (leuprolide) or long-acting implantable device (histrelin) provided the insurance covers it or the cost is manageable.

                              Once again, you should have some questions for your student. For example, asking the student to list the search terms and search engines she employed can shed light on her process. Another question might be, “Are these the only guidelines available?” You can show her that you used PubMed, as she did, but when you used Google Scholar, you found an excellent review article that lists five other publications. You suggest she look at them since expert recommendations can vary. She might also contact the endocrinologist and ask if he plans to follow the guidelines she identified, and if not, why not.

                              The endocrinologist messages back saying he agrees leuprolide and histrelin are both reasonable options to consider for first-line therapy. However, he also cites a 2019 update published on Hormone Research in Paediatrics. These guidelines recommend a third U.S. Food and Drug Administration (FDA)-approved option for the treatment of CPP, triptorelin.8 He says the student should consider this choice as a potential treatment for JM as well.

                              After reading the endocrinologist’s note, you emphasize to your student the importance of citing multiple guidelines when drafting an assessment. In this case, the FDA approved an additional treatment, triptorelin, in 2022. You walk through your student’s process of finding clinical information to identify more ways she can improve next time. Furthermore, you point out how the endocrinologist’s insight exemplifies the importance of interdisciplinary care.

                              Simultaneously, you and your student read through all three monographs and discuss the major differences you’d like to share with his parents. You ask the student to practice her delivery of the information, and she says, “Leuprolide is a long acting injectable administered intramuscularly (IM) or subcutaneously. Your doctor will administer the IM formulation every month, three months, or six months. “Triptorelin is similar to leuprolide, but is only available as a six month IM formulation. The other option is for your doctor to administer the subcutaneous formulation every six-months.9 On the other hand, histrelin comes as a long-acting 1¼ inch implant surgically placed into the upper arm every 12 to 24 months. For the first 24 hours after the surgery, JM should avoid swimming or bathing. As long as JM avoids heavy play or exercise for the first week, he will not have to worry about any further restrictions after that. The implant also requires surgical removal.”10

                              Now, you prompt the student to recall that JM’s parents expressed concern about what would happen if JM experienced an adverse reaction to the long-acting implantable device. They asked, “What is the procedure like?” and “If JM has a reaction to the implant, must he continue to wear it for 12 months or can the doctor remove it easily before then?”

                              The student does more research and says she will assure JM’s parents that this outpatient procedure lasts only 10 minutes, though the appointment may last 60 to 90 minutes. Most surgeons will just numb the area; however, children may undergo sedation if necessary. The surgeon will insert the narrow implant into a small approximately 5 mm opening made in the skin on the inner surface of the arm. With this option, JM can return to school the same day. The student plans to mention that complications don’t commonly occur, but minor discomfort and bruising may.11 The student plans to continue, “The implant may be removed immediately if JM presents at any time a severe allergic reaction or adverse effect. However, this is not common.”

                              Before you and the student document the assessment section of your SOAP note, the student indicates she will ask JM if he has questions. He shares that he “HATES needles” but is also scared of the surgery hurting.” The student plans to tell him not to worry because he won’t feel any pain during the operation. He can also choose to sleep during the surgery if he prefers.

                              Here, the preceptor should step in with gentle corrections about patient-appropriate language. First, most Americans have no idea what a 5 mm incision will look like. You ask her to calculate its length in inches and explain it by comparing it to something the child will recognize, like the size of small dice or a stack of 20 playing cards. Next, it’s critical to remind the student that we must never tell patients that something won’t hurt. This is a lesson students should learn during immunization training and creates an opportunity for cross training (applying this principle to other areas of pharmacy) that applies regardless of patient age. Healthcare professionals should never say, “This will not hurt a bit!” or anything similar. People have different pain thresholds making it impossible to predict whether it will hurt. Student pharmacists need to develop language they are comfortable with and use it. A good response if people ask if it will hurt is, “It may hurt or sting a little but just for a minute or two.” In this case, the preceptor suggests saying, “The doctor will numb the area.”

                              Finally, the preceptor may point out that “operation” can be a scary word for children. The student needs to use a word like “procedure” or find a way to avoid either of those words.

                              The preceptor should also point out that JM’s parents had also said they were worried about two things: (1) potential side effects and (2) the cost of care. They heard on the news that expenses associated with these medications can add up quickly. The cost of care and determining what the patient’s insurance will cover is probably foremost in the endocrinologist’s mind, too.

                              In terms of potential side effects, your student says that both GnRH analogs have similar side effect profiles. From the pediatric studies she read on GnRH adverse effects, she shares that signs of puberty may increase transiently with therapy before growth velocity eventually slows down. Some children experience weight gain, changes in appetite, body aches, headaches, gastrointestinal (GI) symptoms, or signs of a common cold. Parameters like physical growth and bone mass density may decrease during treatment but usually return to normal one year after treatment discontinuation.9, 10

                              Before selecting JM’s treatment option, it’s critical to evaluate insurance coverage since it’s on the forefront of everyone’s concerns. The student needs to determine if they have insurance and what the plan covers. She starts by finding information on ballpark cost. She reports a histrelin implant costs around $40,000. If the patient requires mild sedation when the doctor inserts the implant, the cost may increase. However, in some cases, the implant may be used for up to two years. Leuprolide’s median annual cost ranges from $20,000-$40,000 depending on the formulation.12 A single injection of triptorelin costs roughly $19,000, making the annual cost nearly $40,000 as well. Then says she will remind JM’s parents that while this may give them an idea, the cost may vary outside of that range.

                              Plan

                              Following the assessment, pharmacists work to develop a personalized patient care plan in collaboration with other healthcare professionals. The plan should reflect recommendations from the most recent evidence-based clinical practice guidelines. Pharmacists should focus on optimization of care in a safe, effective, and cost-effective manner.

                              1. Address medication-related problems and optimize medication therapy
                              2. Set specific, measurable, achievable, realistic, and timed (SMART) goals in the context of the patient’s healthcare goals and access to care
                              3. Involve patients to engage in education, empowerment, and self-management
                              4. Support non-pharmacologic interventions as appropriate

                              SMART Goals. When creating an action plan for patients, pharmacists should aim to set goals that are SMART.

                              • Specific instructions provide other clinicians with accurate information about the patient.
                              • Measurable outcomes provide clinicians the ability to evaluate the patient’s progress and whether the plan requires adjustments
                              • Achievable and realistic goals
                              • A timeline for the plan ensures healthcare providers routinely follow up with their patient

                              A PLAN FOR JM

                              After you document JM’s main problem, rationale, and goals for care in the assessment section, you move on to create his plan. Following careful consideration of the assessment, you and your student decide to recommend starting histrelin to treat his CPP since his insurance will cover it once the endocrinologist completes prior authorization forms. (Here, you suggest that the student find the prior authorization forms and volunteer to complete as many sections as she can for the endocrinologist. You explain that she can expedite the process and this is a skill she can apply to many different pharmacy practice locations.) Choosing histrelin is also a needle-free option, which may make JM happy. You remind your student that the plan should also include scheduling necessary appointments and follow-ups with JM’s other providers in addition to counseling on the specific adverse effects of the medication detailed in Table 2.

                              Table 2. Example SOAP note for JM 7

                              Name: JM

                              Age: 8    

                              DOB: 10/02/14

                              Allergies: Seasonal allergies, NKDA

                              Chief Complaint: Patient referred to clinic by endocrinologist for medication therapy; patient was recently diagnosed with central precocious puberty (CPP)
                              Subjective Information

                              JM is an 8-year old white male presenting to the clinic. He recently met with his endocrinologist on 6/28/23 and has been referred to the clinic for drug therapy to treat CPP. His parents confirm JM’s use of deodorant to combat excessive perspiration and body odor since the age of 5. He has also developed pubic and underarm hair in addition to acne on his face and upper back. His parents are concerned regarding JM’s reported insecurities at school due to his larger size.

                              PMH: no surgeries or hospitalizations Medications: daily multivitamin, OTC loratadine (prn for allergies)
                              Objective Information

                              Clinical exam findings = testicle size indicates puberty

                              112th percentile for weight and height

                              Relevant Labs: Bone age of 13, LH 0.4 units/L, DHEA sulfate 60 ug/dL

                              Height: 55 in Weight: 102 lbs BMI: 22.9 BP: 110/61 mmHg HR: 75 bpm Temp: 98.6 ℉ RR: 15
                              Assessment

                              Problem: Patient requires medication therapy for untreated indication.

                              Rationale: According to the Journal of Clinical Endocrinology Practice Guidelines for Central Precocious Puberty, JM requires hormone suppression therapy. Symptoms of rapid linear growth, advanced skeletal maturation, and basal LH levels > 0.3 units/L require treatment with GnRH analogs until the normal age of puberty.

                              Goals of Care: The goal of treatment is to reduce signs of premature pubertal progression while ensuring therapy is well tolerated and medication side effects are minimized. Patient’s parents would like to choose an option that is cost effective and safe.

                              Plan

                              Initiate histrelin 50mg SQ implant to be administered by JM’s surgeon every 12-24 months depending on safety and efficacy parameters evaluated at follow up appointments

                              Schedule surgery appointment with JM’s surgeon at earliest convenience

                              Schedule follow up in 3 months to evaluate pubertal progression, growth velocity, skeletal maturation, and tolerability

                              Counsel JM/JM’s parents on possible adverse effects including weight gain, changes in appetite, initial flare of puberty symptoms, GI symptoms, body aches/pains, and signs of common cold

                              Counsel JM’s parents on providing support to make JM feel good about himself. Children who are undergoing rapid development at this age may feel different when comparing themselves to other children their age.

                              Implement

                              During the implementation phase, pharmacists set the action plan into motion. This may include the administration of vaccines, initiating or discontinuing a medication, or scheduling the next follow-up appointment. Pharmacists, primary care physicians, or caregivers work together to provide care based on the goals made in the planning step.1

                              Follow-up and Monitor

                              The pharmacist in collaboration with other health care providers should follow-up with the patient as recommended in practice guidelines and referring back to the SOAP note. Continuous monitoring of medication appropriateness, adherence, safety, laboratory results, and patient concerns will indicate if the plan requires revision. Routine medication reconciliations, check-ups, or conversations with patients improve outcomes and help to achieve goals of therapy.

                              Putting it All Together

                              Upon completion of the SOAP note, you send the endocrinologist your recommendations. You contact JM’s parents to discuss scheduling a follow-up appointment in three months with the endocrinologist and counsel on histrelin.

                              IMPLICATIONS FOR PRECEPTORS

                              The Benefits. The PPCP model creates a reproducible framework that demonstrates clinical pharmacists’ contributions to medication-related outcomes.13 In addition to improving the quality and completeness of patient medical records, SOAP notes give pharmacists a place to start when working up a new patient. As students practice developing SOAP notes, preceptors should emphasize how the lessons they learn in one case can apply to future cases.

                              The Drawbacks. As more pharmacy programs integrate PPCP into their curriculum, new students will have access to courses that teach the model. But because the PPCP model is relatively new, many licensed pharmacists have not yet familiarized themselves with the process. Extracting the necessary information to write quality SOAP notes can also be time consuming. Depending on the setting, pharmacists may not have enough time to walk through every step with students. Finally, the PPCP method does not encompass all clinical situations. The framework relies on pharmacists to exercise clinical judgment and reasoning to modify the model as needed.

                              Uncomfortable Topics. Students often have little exposure to difficult topics. These may include end-of-life issues, psychiatric diagnoses, cultural or ethnic differences, drug abuse/misuse, and gender-related topics. In this case, students may feel strong discomfort in discussing matters related to sex and sexual development. Preceptors need to help students reduce their hesitancy when communicating with you and the patient because improper communication can lead to poor collection of relevant information. Keep in mind strong note-writing skills facilitate good care. Two things help: (1) practice, and (2) finding resources designed to help with difficult topics. The Conversation Project (https://theconversationproject.org/resources/healthcare/) is one such resource that can help students become more comfortable with difficult topics.

                              In addition, students may have implicit and explicit biases for uncomfortable topics such as the use of hormone blockers, which may bring to mind their use in transgender children. Creating a safe place for your student to share opinions provides a great opportunity for you to teach students how to avoid these biases. Preceptors need to remember that learning—especially if it changes a student's perspective or points out a student's mistake—can be threatening, and students can feel vulnerable while learning. It’s an emotional experience.6

                              To help guide students through these experiences, the SIDEBAR provides 10 additional tips preceptors can use when supervising the PPCP.

                              SIDEBAR: PRO TIPS for Preceptors Who Supervise the PPCP

                              (1) Don't let the acronym scare you! This is a new name for a process you've probably used knowingly or unknowingly for years.

                              (2) Encourage independence. Hand over the problem to the student once you've described the problem and fielded the student's questions. Establish a time for the student to be prepared to discuss it but check in periodically to see if the student is having trouble.

                              (3) Rescue when necessary. Some students will need more support than others. If a student is clearly flummoxed, spend more time and provide more direction.

                              (4) Promote interdisciplinary communication. Having students discuss a clinical problem with another clinician, either with you or on their own, fosters interdisciplinary care. Students will also learn from the other clinicians, which will lighten your load!

                              (5) When students present findings, always ask them to describe things like the search terms and search engines they used or the obstacles they encountered. Help them refine their processes to reduce barriers or find more appropriate resources.

                              (6) Consistently prompt students to determine if the case is typical or unusual. Asking questions based on a modification of the case can help students learn more globally.

                              (7) Don't "stay in your lane"! In this CE, the practice site is an ambulatory care location specific to pediatrics. The lessons a student learns in this rotation, if they go beyond pediatrics, will be invaluable. Helping students develop communication skills or analyze how disease states present or are treated in adults or other special populations will increase their clinical acumen in future rotations.

                              (8) Address implicit biases or misconceptions. Students may not know that an attitude or opinion is biased, incorrect, or simply rude.

                              (9) Debrief. After the PPCP is done, provide feedback, ask others who may have been involved to provide feedback, and ask the student to perform a self-assessment.

                              (10) Appreciate reverse mentoring. Remember that students often teach us new things!

                               

                              Common Sources of Error

                              Collecting too little information. Not all the information pharmacists need to collect will be obvious. In the patient case, the student collected important objective information like height and weight. However, without something like growth charts to evaluate JM’s height/weight compared to other kids his age, the information does not help in the assessment. Preceptors can aid students who are new to documenting SOAP notes when they are required to dive deeper into collected information. Students should not make assumptions as to what other clinicians know off the top of their heads. In this case, other areas where the preceptor helped the student included directing her to seek other expert opinions like the endocrinologist. That puts the “inter” in “interdisciplinary” care!

                              Collecting too much information. Pharmacists and students should collect information worthy of appraisal. In other words, only collect the necessary information that will contribute to the identification, prevention, and resolution of either the chief complaint or medication-related problems. If pharmacists/students do not actively use collected information to make the assessment or plan, they should omit it in the note. Documenting more information does not equate to better information. This leads to overly lengthy or confusing SOAP notes. Here, as in the previous error, preceptors should ask students to examine and explain their processes.

                              Not verifying information. All information should be verified across multiple sources like when performing traditional medication reconciliations. This prevents possible errors in note-taking that may arise from outdated documentation.

                              Sourcing one guideline. Depending on the disease state, the frequency in which guidelines are updated can vary. Preceptors should emphasize the importance of looking for multiple guidelines and paying attention to their publication dates. Occasionally, the FDA may approve new treatment options after the release of clinical guidelines or updates. In this case, the student completely missed an additional treatment option as a result of sourcing a single guideline from 2013. Similar to how preceptors should encourage students to verify collected information across multiple sources, preceptors should also encourage students to cross-check sources that aid in their assessment.

                              The assessment lacks evidence. As mentioned above, the assessment should communicate the assessor’s thought process. The information collected by the pharmacist/student should justify why the problem is a problem. If there is no subjective or objective information to back up the assessment, the assessment has no basis.

                              Forgetting recommendations on current medications. Pharmacists/students should not forget to include instructions for the patient’s current medications, not just the newly prescribed medications.

                              Forgetting non-pharmacologic recommendations. The plan section also encompasses non-pharmacologic interventions such as referral to another provider, ordering additional laboratory tests, education, or counseling on lifestyle interventions. Pharmacists/students should remember that not all patients require initiation of a new medication.

                              Being vague. When initiating new therapy appropriately, pharmacists/students should always provide specific recommendations with the drug name, dose, and frequency. Vague instructions such as “Initiate hormone blocker therapy” are unhelpful. Similarly, instead of “monitor for side effects,” pharmacists/students can list the specific symptoms that present most commonly.

                              Poor communication. Errors due to poor communication directly hinder the PPCP. Furthermore, clinicians with experience are not necessarily better communicators. Therefore, pharmacists should engage in education/training to constantly improve communication skills. SOAP notes should effectively communicate the pertinent information used to create a plan and document important details for the patient’s medical record.

                              Setting it and forgetting it. The PPCP is not a linear process. While this framework provides clinicians a place to start and a checklist of sections to complete in order, pharmacists should remember to review and revise all sections at any given time. For example, pharmacists may identify new information they should go back to collect as they work on their assessments. Preceptors should encourage their students to occasionally step back and evaluate the completeness and coherence of the SOAP note. Sometimes patient cases will require students to revise sections of the SOAP note they already completed.

                              And a New Case

                              Just before the end of the month, the endocrinologist sends yet another patient with precocious puberty to you. The patient LD is a 9-year old Hispanic female. Her endocrinologist recently diagnosed her with idiopathic precocious puberty and wants to know which treatment you recommend. Her parents also want to know why this is happening to their daughter. Before taking LD’s family from the clinic waiting room, you decide to let your student take charge of this case while you supervise. You ask your student “Now that you have practiced writing SOAP notes and know a little about this disease state, how will you approach the PPCP this time?”

                              The student says to you...

                              “I stored all my notes from the last case on precocious puberty from earlier this month. I have a document containing the guidelines from the Journal of Clinical Endocrinology along with several updated publications that cite all additional first-line medications approved after the original guideline’s release. I will start with the collection of subjective information such as LD’s symptoms and medical history followed by objective information, specifically pertaining to her growth statistics. I should calculate BMI and her height/weight percentiles since precocious puberty is usually associated with accelerated growth. Next, I will examine her relevant lab values. Since the patient is female, I will be looking out for progesterone levels this time. If possible, I shall cross-reference all of the information I collect across multiple sources.”

                              “Before I move onto making an assessment, I understand LD’s parents may feel very concerned about their daughter's condition. I don’t want to forget to address their question. I will explain that idiopathic precocious puberty does not have a definitive cause. To help them better understand, I’ll mention that idiopathic cases may result from anything ranging from a head injury in childhood to exposure to certain chemicals. Regardless of the cause, I will assure them there are several treatment options that may be appropriate for LD at this time. I can walk them through the pros and cons of all the available options.”

                              “Next, I would prompt LD’s parents with open-ended questions to learn more about their major concerns, potential barriers to medication therapy, and insurance eligibility. I know these are important considerations for my assessment. It would also be appropriate for me to engage with LD using appropriate language for a 9-year-old girl. I realize the topic may be uncomfortable to discuss, but without taking initiative of the discussion I may forget to include pertinent details in my SOAP note.”

                              “Finally, using the information I collected about the family’s preferences and LD’s medical history, I will draft the chief complaint, rationale for treatment, goals of therapy, and eventually a completed plan. The plan will include which treatment I recommend along with the dose, frequency, and which adverse effects are most common. I will write when I recommend a follow-up with her endocrinologist and make note of which lifestyle modifications may support her specific treatment. If the endocrinologist is on board, then we can collaboratively implement and follow-up with the patient as appropriate.”

                              You are overjoyed to hear that your student has taken what she learned from the previous case and applied it to this case as well. Although some of the parameters were different, such as the patient’s sex, she was able to anticipate how the changes may impact her SOAP note this time. While you identify a few areas in which she can improve, you are happy that she is continuing to expand her clinical pharmacy knowledge.

                              Conclusion

                              The PPCP model can be applied to any healthcare setting in which pharmacists practice. This comprehensive approach to patient-centered care has established a streamlined method of documenting patient information to be shared among healthcare teams. As the PPCP continues to grow in clinical settings, practicing pharmacists should become familiar with its methods and applications.

                              Pharmacist Post Test (for viewing only)

                              Prepping Pharmacist Preceptors on the Pharmacists’ Patient Care Process (PPCP)
                              Post-test
                              Learning Objectives
                              After completing this continuing education activity, preceptor-pharmacist will be able to
                              • Describe the PPCP model and its uses
                              • Apply the PPCP when students address clinical problems in the workplace
                              • Identify areas where pharmacy students need the most guidance when using the PPCP
                              POST TEST
                              1. Which of the following correctly lists the steps of the PPCP process in order?
                              A. Collect, plan, assess, follow-up, implement
                              B. Collect, assess, plan, implement, follow-up
                              C. Plan, collect, assess, follow-up, implement
                              2. Which of the following best describes the JCPP’s reason for developing the PPCP?
                              A. To establish a more efficient method of medical documentation
                              B. To provide an opportunity for pharmacists to expand their clinical role
                              C. To create a reproducible method of managing patient medications

                              3. Which of the following examples is a common error pharmacy students make when using the PPCP?
                              A. Avoiding discussion involving uncomfortable topics such as those sexual in nature
                              B. Spending too long counseling the patient as opposed to documenting the SOAP note
                              C. Omitting recommendations to follow up with the patient’s primary care provider
                              4. Which of the following is a common source of error with the PPCP?
                              A. Using a single clinical guideline for recommendations
                              B. Spending the most time documenting the assessment section
                              C. Cross-referencing medication lists against too many sources
                              5. A nurse practitioner calls your clinic and would like you and your student to work up a patient with stage II hypertension. The patient is a 64-year-old African American male who is currently taking amlodipine 2.5 mg and chlorthalidone 6.25 mg. His blood pressure was 150/90 mmHg at his last doctors appointment. Which of the following would be an appropriate first step?
                              A. Increase the dose of his medications. The SOAP note does not need to be performed as his blood pressure remains elevated due to subtherapeutic dosing.
                              B. Ask the patient about his/her medication adherence recently. This information will dictate how you decide to approach the patient.
                              C. Contact the patient’s local pharmacy for a complete list of active medications. This will be valuable information to collect prior to assessing the patient.
                              6. A student working on a SOAP note cites a 2012 guideline from Europe. The preceptor notices the student forgets to consider a first-line treatment option that was approved in 2022. What should the preceptor do at this point?
                              A. Call the physician to get his/her opinion on the newly approved medication
                              B. Discuss the importance of citing multiple sources with the student
                              C. When the student finishes the note, add in the missing information
                              7. Laboratory values belong under which of the following sections of the PPCP?
                              A. Assessment
                              B. Objective information
                              C. Subjective information
                              8. Your student is counseling a patient who has dementia. When you ask him to practice how he would counsel the patient, he looks puzzled and asks “What for? He has dementia and he won’t understand anyway.” How do you proceed?
                              A. Ask the student to find guidelines on how to determine when and how dementia patients should be counseled.
                              B. Tell him it was a trick question and that he is correct that dementia patients should never be counseled.
                              C. Explain pharmacists are legally required to offer counseling and he should be prepared if the patient requests it.
                              9. A preceptor and student are working in an ambulatory care clinic. A patient presents to the counter and says she has been experiencing terrible adverse effects from one of her medications. The patient places a bottle of sertraline on the counter. She believes this is the medication causing her persistent insomnia. After talking with the doctor, she has switched to taking it in the morning, but she claims it does not help. How should the preceptor advise the student to continue?
                              A. Advise the student to counsel the patient on ways to manage this adverse effect of sertraline. The student may consult the monograph or other recent guidelines.
                              B. Remind the student that persistent insomnia is a flag to contact the provider. The psychiatrist can handle this as it isn’t in the scope of the preceptor’s practice.
                              C. Advise the student to start by evaluating the patient’s past medical history and evaluating her medications before sending her back to see her doctor.
                              10. A general practitioner refers a patient with mild asthma to your clinic. He has recommended the patient to start SMART therapy and would like you to supply your recommendations through a SOAP note. Under your supervision, the student finishes collecting the necessary objective and subjective information and has begun a draft of the assessment as follows:
                              “The patient needs medication therapy for an untreated indication. According to the GINA guidelines, the patient should initiate a low dose inhaled corticosteroid plus a long-acting beta agonist combination in low doses as needed.”
                              Which of the following best describes the feedback the preceptor should give the student when applying the PPCP model?
                              A. The student has done a good job so far. However, the assessment should also consider patient concerns such as insurance coverage.
                              B. The student has done a good job so far. The student should provide specific doses and monitoring parameters for completeness.
                              C. The student has done a good job so far. The student should call the provider to check if they follow the GINA guidelines, and if not, why.

                              References

                              Full List of References

                              References

                                 
                                REFERENCES
                                1. Joint Commission of Pharmacy Practitioners. Pharmacists’ Patient Care Process. Published May 29, 2014. Accessed June 21, 2023. https://jcpp.net/patient-care-process/
                                2. Cooley J, Lee J. Implementing the Pharmacists' Patient Care Process at a Public Pharmacy School. Am J Pharm Educ. 2018;82(2):6301. doi:10.5688/ajpe6301
                                3. Podder V, Lew V, Ghassemzadeh S. SOAP Notes. [Updated 2022 Aug 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 January. https://www.ncbi.nlm.nih.gov/books/NBK482263/
                                4. Takemura Y, Sakurai Y, Yokoya S, et al. Open-ended questions: are they really beneficial for gathering medical information from patients?. Tohoku J Exp Med. 2005;206(2):151-154. doi:10.1620/tjem.206.151
                                5. Taub S. Learning to Decide: Involving Children in their Health Care Decisions. Virtual Mentor. 2003;5(8): virtualmentor.2003.5.8. pfor3-0308. Published 2003 Aug 1. doi: 10.1001/virtualmentor.2003.5.8.pfor3-0308
                                6. Elnicki DM. Learning with emotion: which emotions and learning what?. Acad Med. 2010;85(7):1111. doi:10.1097/ACM.0b013e3181e20205
                                7. Fuqua JS. Treatment and outcomes of precocious puberty: an update. J Clin Endocrinol Metab. 2013;98(6):2198-2207. doi:10.1210/jc.2013-1024
                                8. Bangalore Krishna K, Fuqua JS, Rogol AD, et al. Use of Gonadotropin-Releasing Hormone Analogs in Children: Update by an International Consortium. Horm Res Paediatr. 2019;91(6):357-372. doi:10.1159/000501336
                                9. Lexicomp. Wolters Kluwer Health, Inc. Updated June 20, 2023. Accessed June 21, 2023. https://online-lexi-com.ezproxy.lib.uconn.edu/lco/action/doc/retrieve/docid/pdh_f/129683?cesid=afdPrd0aazi&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dleuprolide%26t%3Dname%26acs%3Dfalse%26acq%3Dleuprolide#rfs
                                10. Lexicomp. Wolters Kluwer Health, Inc. Updated June 6, 2023. Accessed June 21, 2023. https://online-lexi-com.ezproxy.lib.uconn.edu/lco/action/doc/retrieve/docid/pdh_f/128793?cesid=4Ds6TlNfgKm&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dhistrelin%26t%3Dname%26acs%3Dfalse%26acq%3Dhistrelin
                                11. Supprelin LA (Histrelin) Subcutaneous Implant Procedure. Children’s Hospital of Philidelphia. Published May 4, 2021. Accessed June 21, 2023. https://www.chop.edu/treatments/supprelin-la-histrelin-subcutaneous-implant-procedure
                                12. Kaplowitz P, Hoffman, R. Precocious Puberty Medication. Medscape. Updated January 24, 2022. Accessed June 21, 2023. https://emedicine.medscape.com/article/924002-medication
                                13. Harris IM, Phillips B, Boyce E, et al. Clinical pharmacy should adopt a consistent process of direct patient care. Pharmacotherapy. 2014;34(8):e133-e148. doi:10.1002/phar.1459
                                14. Silverman LA, Han X, Huang H, Near AM, Hu Y. Clinical characteristics and treatment patterns with histrelin acetate subcutaneous implants vs. leuprolide injections in children with precocious puberty: a real-world study using a US claims database. J Pediatr Endocrinol Metab. 2021;34(8):961-969. Published 2021 Jun 21. doi:10.1515/jpem-2020-0721

                                Patient Safety: Fad Diets: Do They Deserve the Hype?

                                Learning Objectives

                                 

                                After completing this application-based continuing education activity, pharmacists will be able to

                                1. Describe the prevalence of fad diets in society
                                2. Outline the components of different types of fad diets
                                3. Explain the effect different fad diets can have on the body
                                4. Recognize situations in which fad diets present safety concerns for patients

                                  After completing this application-based continuing education activity, pharmacy technicians will be able to

                                  1. Describe the prevalence of fad diets in society
                                  2. Outline the components of different types of fad diets
                                  3. Explain the effect different fad diets can have on the body
                                  4. Recognize situations in which fad diets present safety concerns for patients

                                  Obese individual standing in front of words relating to food.

                                   

                                  Release Date: July 15, 2023

                                  Expiration Date: July 15, 2026

                                  Course Fee

                                  Pharmacists: $7

                                  Pharmacy Technicians: $4

                                  There is no grant funding for this CE activity

                                  ACPE UANs

                                  Pharmacist: 0009-0000-23-022-H05-P

                                  Pharmacy Technician: 0009-0000-23-022-H05-T

                                  Session Codes

                                  Pharmacist:  23YC22-XPK68

                                  Pharmacy Technician:  23YC22-KPX83

                                  Accreditation Hours

                                  2.0 hours of CE

                                  Accreditation Statements

                                  The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-022-H05-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                                   

                                  Disclosure of Discussions of Off-label and Investigational Drug Use

                                  The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                                  Faculty

                                  Abigail R. Johnson, BS
                                  Senior US FDA Regulatory Affairs/Medical Writing Intern
                                  Arciel LLC, Stratford, CT

                                             

                                  Faculty Disclosure

                                  In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                                  Ms. Johnson has no financial relationships with ineligibile companies.

                                   

                                  ABSTRACT

                                  In the United States, being overweight or having obesity are two leading causes of health issues, and these rates have increased in recent years. Enter the concept of fad diets. People often turn to diets or tools advertised as promoting quick weight loss without considering the diet’s sustainability and their bodies’ reaction. Fad diets’ one-size-fits-all approach is usually not the cure-all solution people hope it will be. Overall healthy nutrition and lifestyle choices are more beneficial. Due to fad diets’ popularity, it is essential to understand their components and their affect within the body to reduce health risks. This continuing education activity discusses intermittent fasting, ketogenic (“keto”) diets, pay-for-food systems, paleolithic (“paleo”) diets, and the Atkins diet. It identifies patients for whom fad dieting can be dangerous.

                                  CONTENT

                                  Content

                                  INTRODUCTION

                                  Fad diets have always existed but have been on the rise in recent years due to the explosion of social media in the 21st Century. A fad diet is a popular diet followed to achieve fast results or fix long-term problems associated with eating, specifically weight.1 Fad diets are labeled as fads for a reason. These short-lived trends with wide popularity disregard for the rationale behind or quality of the approach itself.3,4

                                  People who choose fad diets are often trying to fix ongoing problems including overweight or obesity, inadequate nutrition, sedentary behaviors, and failure to maintain overall healthy habits.2 Individuals who follow fad diets adhere to a mainstream concept of dieting without acknowledging individual health needs and restrictions. Health consequences may arise as a result of adhering to a diet ill-suited to an individual's nutritional needs and ability to sustain the associated effort. In addition, certain diets may influence medication interactions and disease outcomes. For this reason, fad diets can undermine patient safety.

                                   

                                  This continuing education activity summarizes popular fad diets to inform pharmacy teams of their benefits and risks. It will allow teams to make recommendations for patients, understand how medications interact with the diets, and help prevent health complications.

                                   

                                  The History of Fad Diets

                                  Fad diets have existed throughout history in different forms. For example, in the 1920s, the Cigarette Diet was popular. Lucky Strike, a cigarette company, promoted the cigarette diet. They claimed that cigarettes would suppress appetite to boost sales using the tagline “Reach for a Lucky instead of a sweet.” Promoters advertised that people would lose weight successfully while following the diet.6 The 1940s saw the rise of the Master Cleanse. This juice cleanse consisted of a meal replacement drink consisting of hot water, lemon juice, maple syrup, and cayenne pepper. Its popularity stemmed from promises of cleansing the body of toxins while providing very few calories. It reached new levels of popularity in 2006, when superstar Beyoncé claimed to lose 20 pounds in two weeks using this method 6 In the 1960s, The Drinking Man’s Diet made an appearance. The recommendation was to consume high-protein and low-carbohydrate foods while drinking as much alcohol as desired. An example meal may have included a large serving of steak, salad or vegetables, and several alcoholic beverages. The Drinking Man’s Diet’s supporters considered alcohol a good carbohydrate and allowed indulgence. This diet was marketed toward the male population.6

                                   

                                  People have always been interested in quick fixes for weight loss and appearance without considering how they will feel or how to keep the weight off indefinitely.1 This approach to choosing a diet or making nutrition decisions ignores tactics that sustain weight loss. Fad diets are inherently unsustainable options that often lead to weight regain. These outcomes prove many fad diets are unreliable (if not dangerous).

                                   

                                  With the creation and explosion of modern social media in the early 2000s, fad diets surged in popularity. Social media often fosters a community of misinformation regarding fad diet composition, how to follow the specific diet, and the diet’s benefits.5 Much of the information on social media regarding fad diets lacks reputable, verifiable sources. Fad diet promoters use scientific jargon loosely and inappropriately to make information convincing when describing seemingly miraculous diets. However, the information could just be the opinion of an individual or a promotional company sponsorship.5 Unless diet information is published by a credible source, it should be regarded as untrustworthy.

                                   

                                  Pause and Ponder: How many times a week do you see diet-related content on social media?

                                   

                                  Fad Diet Prevalence

                                  Approximately 45 million Americans (about 14% of the total population) go on a diet each year.7 Of these diets, 50% are fad diets.7 According to the United States (U.S.) Weight Loss & Diet Control Market, the weight loss industry is one of the most advertised with investors spending $66 billion annually.7 More people than ever are overweight or obese and using diets as a solution. Table 1 summarizes obesity’s prevalence, which is rising each year in the U.S.

                                   

                                  Table 1. Obesity Prevalence in the U.S. Population8

                                  Age (years) % of Population
                                  Adults aged 20 and up 41.9%
                                  Adolescents aged 12-19 22.9%
                                  Children aged 6-11 20.7%
                                  Children aged 2-5 12.7%

                                   

                                  According to the Centers for Disease Control and Prevention (CDC), individuals who are overweight or have obesity are at elevated risk for many health issues. These include elevated cholesterol, stroke, heart disease, hypertension, cancer, type 2 diabetes, mental illness, low quality of life, and mortality, among others.9 While many factors can influence weight, individuals can adapt their diets to meet nutritional needs and make long-term differences to improve health outcomes.

                                   

                                  TYPES OF FAD DIETS

                                  As the definition implies, fad diets’ popularity increases and decreases with current trends. This section discusses some of the most popular current fad diets.

                                   

                                  Intermittent Fasting

                                  Individuals following an intermittent fasting diet alternate eating and fasting (not eating or drinking anything) on a cyclic schedule. This diet focuses more on eating during specific periods of time than restricting meal components. Various intermittent fasting schedules exist, but popular versions include alternate-day and time-restricted fasting.10,11 Alternate-day fasting means fasting every other day, while time-restricted fasting involves eating within set time windows during the day. Individuals should consult a doctor and choose the type of intermittent fasting that best fits their health needs (but most do not). Studies show following intermittent fasting schedules leads to decreased body weight, body mass index (BMI), and waist circumference.11 Studies also show improved blood glucose and triglyceride levels following this diet.10

                                   

                                  The body uses ingested calories—specifically carbohydrates, sugars, and nutrients—as fuel.10 If people eat continuously throughout the day, the body uses ingested calories as fuel to perform necessary bodily functions. The body stores unused ingested calories in the form of fat where they become an energy reserve.10,12

                                   

                                  When the period between meals lengthens and the body lacks a constant supply of calories for fuel, it turns to the fat reserve to burn fat stored in the body. The theory is that the longer a person goes without eating, the more the body will use its fuel reserve. The more reserve is used, the more fat is burned.10 As more of the reserve is used for energy while intermittent fasting, more weight is lost through fat burn.

                                   

                                  Intermittent fasting regulates eating times without restricting foods or food groups. Dieters must make conscious choices to include foods beneficial to health. This includes fruits, vegetables, plant proteins or lean meats, whole grains, superfoods (see Sidebar: Superfoods), and low-fat dairy options.12 Healthy choices also include limiting processed foods and sugars.

                                   

                                  Sidebar: Superfoods13

                                  Superfoods are nutrient-rich and high in important dietary components including antioxidants, vitamins, minerals, fiber, and healthy fats. These help keep the body functioning, reduce disease risk, and improve well-being. Some examples of superfoods are

                                  • Avocados → These include potassium and healthy fats to lower the risk of heart disease.
                                  • Chia seeds → These include fiber, protein, antioxidants, vitamins, and minerals. They are also easy to add to recipes.
                                  • Dark and leafy greens → All greens are good greens, but these are especially nutrient dense, including vitamins A, C, and E. They also contain vitamin K, which promotes bone health.
                                  • Ginger → This includes vitamin C, magnesium, and potassium. It also helps reduce pain and aid nausea.
                                  • Salmon → Fish is high in omega-3 fatty acids, which can help reduce heart disease.
                                  • Yogurt → This includes calcium and protein to help with bone health, cancer prevention, and immune health. It is also a good source of probiotics to support gut health.

                                   

                                  Pause and Ponder: Do patients ask about superfoods when discussing dietary information or supplements? Do you know which to recommend?

                                   

                                  Pros and Cons

                                  Like most diets, intermittent fasting has benefits and drawbacks. Following intermittent fasting correctly boosts memory, improves blood pressure, induces fat loss while maintaining muscle mass, helps prevent obesity, improves type 2 diabetes by reducing insulin resistance, and improves tissue health.12,14 Intermittent fasting also regulates the body’s 24-hour cycle to improve physiological functioning and metabolic health. As a result, gastrointestinal (GI) microbiomes, energy levels, and sleep may improve.15

                                   

                                  Drawbacks of this diet include issues with long-term maintenance/adherence, leading to regaining weight.10 It is difficult and tiring for individuals to maintain fasting for extended periods. In addition, until the body is accustomed to fasting periods, symptoms such as headaches, nausea, or dizziness may occur. Some individuals may feel an initial decrease in energy levels when starting this diet.10

                                   

                                  Keto Diet

                                  The keto diet, also known as the ketogenic diet, is centered around depriving the body of carbohydrates.16 Researchers originally developed the ketogenic or keto diet in the 1920s as an epilepsy treatment, especially for resistant pediatric cases.17 The rise of effective antiepileptic drugs and treatments decreased use of the ketogenic diet for this purpose. As originally designed, total daily calories were composed of high fat intake (70% to 80%), moderate amounts of protein (10% to 20%), and low carbohydrate intake (5% to 10%).16 An iteration of this diet has gained more traction since the 1990s, as people realized its effectiveness for quick weight loss.16

                                   

                                  The keto diet helps with weight loss through the processes of gluconeogenesis and ketogenesis. Under normal circumstances, carbohydrates produce energy for the body.16 When insufficient carbohydrates are available, insulin secretion is reduced and glucose is less available. The body then exploits gluconeogenesis, using lactic acid, glycerol, and amino acids to produce glucose as an energy source.16

                                   

                                  If carbohydrate levels drop further, the body enters ketogenesis and secretes ketone bodies as an alternative energy source.16 As insulin secretion levels remain low and ketone bodies are used for energy, fat and glucose storage falls significantly. This can cause other fats to break down, leading to bodily fat loss.16

                                   

                                  To remain in ketogenesis, the body needs constant carbohydrate deprivation.16 The longer it is deprived of carbohydrates, the more fat is burned in the ketotic state. This is known as nutritional ketosis and is considered safe, as opposed to the metabolic state of ketoacidosis (an accumulation of ketones that increases the blood’s acidity), which can be life-threatening.16

                                   

                                  During ketoacidosis, ketone bodies are produced in large amounts and can acidify the blood pH.16 Acidic blood pH reduces the amount of oxygen blood delivers to cells leading to cell death and life-threatening complications. Insulin keeps the production of ketone bodies at bay, so sometimes people with type 1 diabetes develop ketoacidosis due to decreased insulin production. Taking diabetes-related medication correctly reduces the risk of ketoacidosis in people with diabetes. Following a low carbohydrate diet for a prolonged amount of time can also lead to ketoacidosis.17 To reiterate, ketogenesis is the production of ketone bodies in response to carbohydrate and glucose depletion. Low concentrations of ketone bodies are generally regarded as a safe, as opposed to high concentrations caused by ketoacidosis (which is a medical emergency).16

                                   

                                  What to Eat and Avoid

                                  Given the strong emphasis on high-fat foods, healthy fats comprise the largest part of this diet.16 Foods such as seeds and nuts, coconut, avocados, poultry fat, and plant fats (e.g., olive or coconut oils) are encouraged. In addition, some dairy products—including butter, hard cheese, and yogurt—are allowed, but people on a ketogenic diet should avoid cream, ice cream, and full-fat milk given their natural sugar content.17 Individuals following this diet should consume a moderate amount of protein, ideally meats high in omega-3 fats.16 This includes grass-fed beef, free-range poultry, wild-caught fish, and pork. Nuts, seeds, tofu, and eggs are also acceptable protein sources.17

                                   

                                  Adhering to a diet with less than 10% of calories from carbohydrates can be challenging, especially since this diet requires individuals to calculate “net carbs” (See Sidebar: What are “Net Carbs”?).16 Vegetables lacking high starch contents (e.g., cauliflower, broccoli, onions, leafy greens, bell peppers, garlic, mushrooms, cucumber, summer squash) are encouraged. Small portions of fruit are also allowed, and fruits with a lower net carb content (e.g., berries) are preferred. Other acceptable carbohydrates include dark chocolate, herbs, spices, unsweetened tea, coffee, vinegars, and mustards.17

                                   

                                   

                                  Sidebar: What are “Net Carbs”? 17

                                  The body cannot digest or metabolize some carbohydrates because of their molecular structures. For example, fruits, vegetables, whole grains, and sugar alcohols contain insoluble fibers that are indigestible. Insoluble carbs have no energy value or blood sugar impact, so they are allowed when following the keto diet. The keto diet requires dieters to calculate “net carbs,” the amount of carbohydrates taken in by the body that are digested and metabolized and thus contribute to calories. However, it is important to note that the total calorie level does not change even when “net carbs” are calculated.

                                   

                                  Individuals calculate net carbs by subtracting the number of ingestible carbohydrates from the food’s total amount of carbohydrates. For example, food containing 24 total carbohydrates and 21 ingestible carbohydrates equals 3 net carbs. Ingestible carbohydrates can typically be found by subtracting the amount of fiber from the amount of carbohydrates in the food item, but it can be more complicated. A number on online net carb calculators are available to help.

                                   

                                  Net carbs are also known as “impact carbs.” Food manufacturers use both terms as marketing strategies, but governing bodies do not regulate use of these phrases.

                                   

                                  Foods containing added sugar, whole or refined grains, and flour products are restricted.17 Starchy foods are also not allowed, including some high-starch vegetables such as corn, potatoes, and winter squash. Fruits with a high net carb content and fruit juices are restricted. Most keto programs also advise against alcoholic beverages due to their carbohydrate content and added sweeteners.17

                                   

                                  Pros and Cons

                                  The keto diet may be beneficial for weight loss, as it uses ketone bodies for energy to deplete glucose and fat storage abilities. Decreasing sugar intake lowers the risk of developing diabetes, obesity, and metabolic syndrome.16 Following this diet may reduce cholesterol, blood sugar, and blood pressure, and decrease insulin resistance.17

                                   

                                  Diet restrictions may cause short-term adverse effects such as nausea and vomiting, fatigue, headaches, dizziness, and insomnia.16 This is known as the “keto flu.” Symptoms usually resolve once the body adjusts to the diet after a few weeks. Fluids and electrolyte replenishment can help alleviate discomfort during this period.16

                                   

                                  Documented long-term adverse effects include increased uric acid levels in the blood, increased risk of kidney stones, and osteoporosis.17 This is due to the diet’s restrictive nature and omission of necessary components to sustain a healthy diet. Nutrient deficiencies can occur as a result of following this diet.17

                                   

                                  People struggle to adhere to the ketogenic diet due to strict regulation of fat, protein, and carbohydrates.17 Dieters must carefully monitor their adherence to intake limits and meet target levels. This can be difficult for individuals to maintain long-term and lead to low adherence to the diet.17

                                   

                                  Pay-for-Food Systems

                                  Pay-for-food diets are meal prep services or meal delivery services with pre-portioned ingredients, pre-cooked meals, or meal replacement options. Diets focus on weight loss and are designed for convenience. These options take the guesswork out of planning meals and make it easier to track eating.

                                   

                                  Nutrisystem

                                  The Nutrisystem meal service claims its diets help with weight loss through a high-protein and low glycemic approach.18 Nutrisystem expects users to lose one to two pounds a week by managing blood sugar and controlling hunger to avoid overindulgence. Dietitians design meals to include healthy options and relieve the stress of planning.18

                                   

                                  Meals are pre-portioned to fit an individual’s needs and tastes.18 The meals’ composition of lean protein, healthy fat, and smart carbohydrate ingredients is supposed to curb hunger. Protein shakes and bars are options to supplement plans. Nutrisystem claims deprivation is too restrictive and allows for some deviation from the plan or healthy alternatives to “bad foods.” In addition, dieters can track their progress and calories using Nutrisystem’s app. This system promotes prizes and special offers to keep individuals motivated.18

                                   

                                  Prices vary by plan type but can range from $9.99 to $15.18 a day. Nutrisystem has plans designed specifically for men, women, partners, and people with diabetes.18

                                   

                                  SlimFast

                                  When SlimFast originated, the system promoted meal replacement shakes to lose weight.19 The company has since expanded to include drink mixes, snacks, and meal replacement bars. The products are grouped into categories such as calorie control, high protein, keto, and intermittent fasting. The website also contains a recipe section for dieters to use in their meal planning.19

                                   

                                  SlimFast plans are based on individuals’ goals and preferences, including the Favorite Foods Plan, Keto Plan, High Protein/Low Carb Plan, Original Plan, and Intermittent Fasting.19 Dieters purchase SlimFast products to supplement or replace parts of their current diet. Plans themselves are not priced because individuals buy their own groceries and supplement with SlimFast products associated with the plan of their choice. The company also has an app to use for weight management tracking and a private Facebook group to communicate with other individuals on the diet to offer support or guidance.19 SlimFast claims their plans and products promote and maintain weight loss and encourage people to make better food choices.19

                                   

                                  Jenny Craig

                                  The Jenny Craig company has recently gone out of business after 40 years in the industry. Some experts indicates that one reason has been the availability of weight loss medications and increased competition in this market space. This system emphasized one-on-one coaching mixed with healthy foods to lose weight quickly.20 The company claimed dieters could lose up to 18 pounds in the first four weeks. Coaches designed meal plans to be unrestrictive and included an individual’s favorite foods. Meals focused on low-fat foods with high fiber and protein. This program also emphasized physical activity and occasional intermittent fasting to aid the weight loss process.20

                                   

                                  Plans consisted of meals from the program, two snacks, and supplemental grocery items daily to promote weight loss and increase metabolism.20 One snack included Jenny Craig’s Recharge Bar, used when intermittent fasting. The program claimed the Recharge Bar helped dieters lose weight faster, feel less hungry, and maintain fasting. Jenny Craig coaches designed plans and provided guidance for the duration of the program.20

                                   

                                  Food was delivered weekly or biweekly. Depending on the type of plan, individuals paid $13.99 to $21.99 per day. Prices were based on the number of meals, membership length, and amount of coaching support included. Promotional offers and meal bundles were available.20

                                   

                                  Pros and Cons

                                  Pay-for-food diets can be intriguing as they promote healthy choices, weight loss, and convenience.18-20  They reduce mental load and stress surrounding dieting by making the choices easier or eliminating the need to choose altogether. Some services also provide support groups or coaches for accountability and guidance. In addition, if dieters can adhere to these plans, meal kits promote portion control and reduce overeating.18-20

                                   

                                  A major con associated with these diets and meal kits is adherence. As people lose weight on these diets, they may stop using them, gain weight back, and become discouraged about trying again. This can reverse improved health outcomes.18-20 Another con is cost. Individuals may be discouraged by the prices associated with pay-for-food systems. The cost may not be viable or sustainable options for all individuals.18-20  

                                   

                                  Studies have shown these diets to be ineffective. Attrition rates (percentages of people leaving a program) are 30% or greater, and 37% of dieters who complete programs lose less than 5% of their initial body weight.21 Other studies failed to produce significant results for how these pay-for-food diets affect weight loss when compared to educating or counseling individuals on weight.22 High attrition rates and insignificant weight loss results suggest these diets are unsustainable and unreliable.21

                                   

                                  Paleo Diet

                                  The paleo diet goes by many names, including the Paleolithic, caveman, or Stone-Age diet. It consists of (allegedly) eating like humans of the Paleolithic era did, mixed with modern components to supplement the diet. The Paleolithic era occurred from roughly 2.5 million years ago to 1,200 B.C. Diet supporters believe current body function is similar to how it functioned during this era and eating foods available or comparable to this time will improve health.23 Introduced in 2002 by Dr. Loren Cordain, a scientist specializing in nutrition, this diet has surged in popularity in recent years due to weight loss claims.24

                                   

                                  Due to disagreements about which foods were available in the Paleolithic era compared with today, many diet plans are dubbed “paleo.” They differ in specific foods allowed. All plans emphasize high protein, healthy fats, low or moderate carbohydrates, low sugar and sodium, and high fiber to meet weight loss goals.23 The term “paleo” will be used to describe this model. The paleo diet consists of consuming mostly lean meats, fruits, vegetables, nuts, seeds, and fish, in line with what researchers believe was consumed during the Paleolithic age.23 It also emphasizes reducing intake of dairy, grains, and carbohydrates.25

                                   

                                  Weight loss can occur through several pathways using the paleo diet. 23 Like the keto diet, ingesting fewer carbohydrates forces the body to use fat for fuel. In addition, replacing highly processed foods, added sugars, and large amounts of carbohydrates with healthier options can aid weight loss. Eating more protein and less calorically dense food (i.e., few calories in a large volume of food) also helps curb hunger and leave individuals more satisfied.23

                                   

                                  Less calorically dense foods—including vegetables, fruits, low-fat or fat-free dairy, and egg whites—can be eaten in larger quantities. These foods help with weight loss as they allow individuals to eat a larger volume and feel full, without ingesting large numbers of calories.26 This reduces snacking and overall food intake.23

                                   

                                  Conversely, calorically dense foods are high in calories and eaten in small amounts. These contribute weight gain as individuals who eat a small volume consume high numbers of calories.27 Examples of calorically dense foods include27

                                  • Proteins: fish, beans, eggs, cheese, yogurt, fats including nuts, avocados, nut butters
                                  • Carbohydrates: potatoes, brown rice, whole grains

                                   

                                  Overall, the paleo diet works by breaking down the diet into basic components and making healthier choices. Cutting out foods leading to high glucose or carbohydrate storage also aids in eating healthier and inducing weight loss.28

                                   

                                  What to Eat and Avoid

                                  Allowed foods emphasize fresh and healthy choices to remain consistent with foods found in the Paleolithic age.23 This includes lean meats, fish or shellfish, fruit, vegetables, honey, nuts or seeds, and olive or coconut oils. Frozen fruits and vegetables are allowed as they contain the same nutrients as the fresh variety and may be more convenient. Omega-3 fats are important for the body and can be found in fish, grass-fed beef, avocado, olive oil, some nuts (e.g., walnuts, almonds, pistachios), and seeds. Root vegetables such as cassava and sweet potatoes are highly nutritious and are allowed in moderation.23

                                   

                                  Restricted foods have little nutritional value or a high glycemic index unsuitable for the paleo diet.23 For example, white potatoes and processed foods are off limits. Other restricted foods include whole or refined grains, cereals, refined sugar, refined vegetable oil, legumes, dairy products, alcohol, coffee, and salt. Canola is a refined vegetable oil and is not allowed. Restricted legumes include peanuts, beans, and lentils.23

                                   

                                  This diet emphasizes eating healthy and portioning fats, proteins, and carbohydrates to enhance health.23 Calorie counting and general portion control are deemphasized in this diet. Some plans also allow for “cheat meals” (those consisting of food not beneficial to health) in the early stages of the diet to increase adherence.23

                                   

                                  Pros and Cons

                                  Components of this diet including fiber, potassium, and antioxidants aid bodily functions and reduce disease risk. Reducing the intake of highly processed foods with little nutritional value also helps improve overall health.25 Short-term benefits may include weight loss, improved blood pressure and cholesterol levels, and increased insulin sensitivity.23 One study documented improvements in metabolic levels, specifically glucose control and lipids, in people with diabetes.28

                                   

                                  Unfortunately, restricting or excluding foods altogether for long periods of time can lead to nutritional deficiencies and health complications. For example, limiting dairy intake leads to deficiencies of calcium, vitamin D, and B vitamins.23 These deficiencies can increase risk of osteoporosis and bone injuries.24 Dairy-related nutrient deficiencies are not specific to the paleo diet, but can occur due to its food restrictions. Restricting grains in the diet also deprives the body of nutrients, which increases risks of diabetes and heart disease. In addition, increased meat consumption (especially red meat) contributes to saturated fat intake and increases risks of cardiovascular problems and diabetes.23 It may also be difficult for people to adhere to a diet that restricts certain categories of foods.

                                   

                                  Atkins Diet

                                  The Atkins diet promotes low carbohydrate intake while allowing as much protein and fat as desired. Robert C. Atkins, a heart specialist, developed this diet in the 1960s as a method for weight loss and maintenance.30 Although it is a low-carb diet, the Atkins program acknowledges that eating right is always better than eating less.31 This diet is ever evolving to be current with updated nutritional expertise.30

                                   

                                  Like the keto diet, Atkins emphasizes low carbohydrate intake of less than 20 g per day to start.30 Unlike the keto diet, consumption of fat and protein is less restricted. Carbohydrates are claimed as the problem without regulating the intake of other food groups. Diet supporters believe the sugars found in carbohydrates cause health issues such as blood sugar imbalances and weight gain.30

                                   

                                  Hypothetically, eating fewer carbohydrates lowers dietary sugar leading to greater satiety, increased energy, less stored fat, and higher metabolism.31 When the body lacks glucose and carbohydrates to use as energy, it turns to fat to keep the body functioning through ketogenesis. The more fat a person burns, the more weight they lose.

                                   

                                  Fat and protein comprise the remainder of the diet. As carbohydrates are viewed as the source of health issues, intake levels of fat and protein are less restricted. Calorie counting and portion control are unnecessary, besides keeping track of carbohydrate intake to stay below the allowable limit.30

                                   

                                  The Atkins diet is split into phases with specific allowable limits of carbohydrates (see Table 2). The diet’s phases adjust to reflect changes in body function and weight. As carbohydrate levels fluctuate in each phase, protein and fat levels change to achieve satiety.

                                   

                                   

                                  Table 2. Atkins Diet Phases31

                                  Phase Instructions
                                  Phase 1:

                                  Induction

                                  3 regular sized meals or 4-5 small meals, vitamins/supplements, 8 oz. glasses of water, 20 g net carbs per day
                                  Phase 2:

                                  Ongoing weight loss

                                  Can add net carbs in 5 g increments weekly, vitamins/supplements, 8 oz. glasses of water, no more than 40 g a day after adding extra carbs, introduce Atkins food products
                                  Phase 3:

                                  Pre-Maintenance

                                  Maintaining previous stages, can add net carbs in 10 g increments weekly to find the perfect balance until the goal weight is reached, maintain carb intake of goal weight
                                  Phase 4:

                                  Maintenance

                                  Maintaining Phase 3 carb level, reducing fat intake as carb intake increases, managing cravings and weight

                                   

                                   

                                  While phases differ in carbohydrate intake levels, they include similar food groups overall.30 Allowed foods include vegetables, oils, fats, and protein (e.g., eggs, cheese, fish, meat and poultry). Dieters can introduce berries, nuts, seeds, starchy vegetables, and whole grains in the third phase, provided they are still losing weight. Dieters can also eat Atkins’ commercial selection of products during and after phase two. Most fruits, alcohol, baked goods high in sugar, bread, pasta, and nuts are restricted in phase one. Some fruits and grains are added by phase three.30

                                   

                                  Pros and Cons

                                  Benefits of the Atkins diet include weight loss; decreased blood pressure; and lower incidence of heart disease, metabolic syndrome, and diabetes.30 This diet can also improve blood sugar and cholesterol levels. These benefits are attributed to low carbohydrate intake and subsequent weight loss.30

                                   

                                  Reducing carbohydrate intake may initially cause symptoms such as headache, weakness, fatigue, and dizziness.30 Unrestricted fat intake can be unhealthy. In addition, using fat as the body’s energy source for too long may lead to ketoacidosis if dieters misuse the plan.29 Nutrient deficiency can also occur on this diet as a result of restrictions.30

                                   

                                  Weight loss pursuant to this diet is difficult to maintain due to its deficiencies and restrictive nature. Following the carbohydrate limit for long periods of time is difficult and unsustainable for some people.30 Cardiologists warn this diet puts oxidative stress (disproportionate levels of oxygen reactive species overwhelming the ability of body systems to detoxify them) on organs and can cause serious heart problems or fatal complications.29 Some long-term studies have shown the Atkins diet is no more effective than other fad diets. In addition, these studies show that most people who lost weight while following the Atkins diet regained it.30

                                   

                                  IMPLICATIONS FOR PHARMACY TEAM

                                  Fad dieting can compromise patient safety, and certain patients are at elevated risk for problems. Pharmacy teams are responsible for advising patients about drug-diet interactions and concerns. Table 3 describes conditions and their associated medications that impact the use of fad diets.

                                   

                                  Table 3. Implications for Pharmacy Teams10,16,23,30,32-40

                                  Diet Patient Conditions and Associated Medications That Can Be Contraindications with Diets
                                  Intermittent Fasting ·       Age younger than 18 years

                                  ·       Pregnancy or breastfeeding

                                  ·       Type 1 diabetes

                                  o   Insulin, blood pressure medication, cholesterol-lowering medication

                                  ·       History of eating disorder

                                  Keto ·       Diabetes

                                  o   Insulin, blood pressure medication, cholesterol-lowering medication

                                  ·       Hypoglycemia

                                  o   Glucagon or other forms of glucose

                                  ·       Pancreatitis

                                  o   Pain medication

                                  ·       Liver failure

                                  ·       Fat metabolism disorders

                                  o   Cholesterol-lowering medication

                                  ·       Primary carnitine deficiency

                                  o   L-carnitine supplements

                                  ·       Carnitine palmitoyltransferase deficiency

                                  ·       Carnitine translocase deficiency

                                  ·       Porphyrias

                                  o   Hemin

                                  ·       Pyruvate kinase deficiency

                                  o   Mitapivat (Pyrukynd), folic acid supplements, iron chelators

                                  Pay-For-Food Systems ·       Contraindications and associated medication will depend if it is an individually designed plan or the service’s version of intermittent fasting, keto, etc.
                                  Paleo ·       Cardiovascular related issues

                                  o   Anticoagulants, ACE inhibitors, cholesterol-lowering medications, diuretics, etc.

                                  ·       Diabetes

                                  o   Insulin, blood pressure medication, cholesterol-lowering medication

                                  ·       Nutrient deficiency disorders

                                  Atkins ·       Diabetes

                                  o   Insulin, blood pressure medication, cholesterol-lowering medication

                                  ·       Taking diuretics

                                  o   Thiazide, loop, potassium-sparing diuretics or a mix of types

                                  ·       Severe kidney disease

                                  o   Blood pressure medication, anemia medication, cholesterol-lowering medication, supplements

                                  ·       Pregnancy or breastfeeding

                                   

                                  Nutritional Myths

                                  As mentioned, misinformation surrounding diets has always existed, and social media has magnified the problem. Some myths are more harmful than others, but knowing the facts is essential to correctly informing others.32 Examples of nutritional myths that pharmacy teams can debunk for their patients are found in Figure 1.

                                   

                                   

                                  Dieting is not a one-size-fits-all solution. When pharmacy teams advise patients, they must work with patients to consider health factors . Factors to consider include a patient’s medications, lifestyle choices, and known health issues.33 Pharmacy teams should advise individuals that fad diets are not necessary and following a generally healthy diet is usually sufficient to lose weight. They should make healthy swaps and find strategies that work best for them as individuals. For example, they can cut back on processed foods, consume more fruits and vegetables, and be conscious of fat or carbohydrate intake to ensure healthy sources. These choices are effective ways to achieve the long-term goals without employing fad diets that promote quick fixes.33

                                   

                                  CONCLUSION

                                  Fad diets are undeserving of the positive hype they receive. They are short-term solutions that sometimes work for people looking to lose weight or make changes quickly. However, benefits are outweighed by their unsustainability and poor post-diet maintenance planning. Fad dieting also starts a cycle of yoyo dieting (see Sidebar: Yoyo Dieting). The best option for health is to find strategies that work individually and stick with them. Ditch the fad diets and make long-term healthy choices for better, lasting results.33

                                   

                                  Sidebar: Yoyo Dieting

                                  Yoyo dieting, or weight cycling, occurs when people achieve their goal weight through dieting, stop dieting and return to unhealthy habits, gain the weight back, diet again for a period, gain the weight back, and repeat the cycle. Yoyo dieting is not only a conscious choice. Physiological mechanisms related to energy intake and expenditure, genetics affecting weight control processes, and the interaction between genes and the environment also affect the cycle.34

                                   

                                  Yoyo dieting lacks substantial or sustainable changes to lifestyle or nutrition to keep weight off and instead focuses on quick fixes.34 These quick fixes ultimately fail when weight is regained, and the cycle continues. Most weight lost is gained back within the first two to three years after dieting ceases. However, if dieters keep weight off for two years, the likelihood of gaining it back decreases.35

                                   

                                  Pause and Ponder: Do you think fad diets are helpful or harmful?

                                  Resources for Pharmacists and Pharmacy Technicians

                                   

                                  Pharmacist Post Test (for viewing only)

                                  Fad Diets: Do They Deserve the Hype?

                                  Pharmacist Post-test

                                  After completing this continuing education activity, pharmacists will be able to

                                  ● Describe the prevalence of fad diets in society
                                  ● Outline the components of different types of fad diets
                                  ● Explain the effect different fad diets can have on the body
                                  ● Recognize the value of the pharmacist/pharmacist technician’s role in understanding this information

                                  1. Of the 45 million Americans who go on a diet each year, what percentage are fad diets?
                                  A. 66%
                                  B. 50%
                                  C. 14%

                                  2. What makes fad diets appealing to millions of dieters?
                                  A. They are a good way to stop the cycle of yoyo dieting
                                  B. They are considered safe for individuals with health complications
                                  C. They promote quick weight loss results

                                  3. Which of the following fad diets mainly focus on low carbohydrate intake?
                                  A. Keto and Atkins
                                  B. Keto and intermittent fasting
                                  C. SlimFast and Atkins

                                  4. Which types of fad diets claim to improve blood pressure?
                                  A. Intermittent fasting, pay-for-food diets, and Atkins
                                  B. Intermittent fasting, keto, paleo, and Atkins
                                  C. Paleo and Atkins

                                  5. What causes ketoacidosis?
                                  A. Prolonged extreme carbohydrate restriction***
                                  B. Prolonged extremely high carbohydrate intake
                                  C. Low-level ketone body production

                                  6. Why should individuals taking cardiovascular-related medications such as ACE inhibitors or cholesterol-lowering drugs avoid the Paleo diet?
                                  A. Nutrient deficiencies caused by the composition of the diet lead to increased risk of cardiovascular issues.
                                  B. Reduced grain intake and high meat or fat consumption leads to increased risk of cardiovascular issues.
                                  C. These medications cause sensitivity to foods included in the Paleo diet.

                                  7. A patient with type 1 diabetes mentions that she plans to start following the keto diet because she knows that carbohydrates spike her blood sugar. Which of the following is the BEST response?
                                  A. It is the best way for people with diabetes to lose weight quickly and keep it off long-term
                                  B. It will be difficult for you to follow long-term, so the Atkins diet is more appropriate
                                  C. It is not a safe option for you because you are at increased risk of ketoacidosis

                                  8. Why is it important for pharmacy teams to understand contraindications and health implications of fad diets?
                                  A. To identify signs of diabetes based on how the body reacts to certain fad diets
                                  B. To advise patients about drug-diet interactions and how fad diets can impact their health
                                  C. To direct patients to an appropriate fad diet based on their current medications

                                  9. What general nutrition information should people follow instead of fad diets?
                                  A. Cut all dairy, gluten, and fat from the diet and eat only protein and carbohydrates
                                  B. Decrease fats and carbohydrates in the diet and increase red meat intake
                                  C. Limit processed foods and make overall healthy choices like eating more superfoods

                                  10. A patient comes to the pharmacy to pick up medication and you advise him to avoid diets involving fasting and calorie restrictions. His condition and associated medication indicate fasting and restricting calories would be harmful to his health. Which fad diets does this warning pertain to?
                                  A. Intermittent Fasting, Keto, Atkins
                                  B. Keto, Paleo, Atkins,
                                  C. Intermittent Fasting, Paleo, Atkins

                                  Pharmacy Technician Post Test (for viewing only)

                                  Fad Diets: Do They Deserve the Hype?

                                  Pharmacy Technician Post-test

                                  After completing this continuing education activity, pharmacy technicians will be able to

                                  ● Describe the prevalence of fad diets in society
                                  ● Outline the components of different types of fad diets
                                  ● Explain the effect different fad diets can have on the body
                                  ● Recognize the value of the pharmacist/pharmacist technician’s role in understanding this information

                                  1. Of the 45 million Americans who go on a diet each year, what percentage are fad diets?
                                  A. 66%
                                  B. 50%
                                  C. 14%

                                  2. What makes fad diets appealing to millions of dieters?
                                  A. They are a good way to stop the cycle of yoyo dieting
                                  B. They are considered safe for individuals with health complications
                                  C. They promote quick weight loss results

                                  3. Which of the following fad diets mainly focus on low carbohydrate intake?
                                  A. Keto and Atkins
                                  B. Keto and intermittent fasting
                                  C. SlimFast and Atkins

                                  4. Which types of fad diets claim to improve blood pressure?
                                  A. Intermittent fasting, pay-for-food diets, and Atkins
                                  B. Intermittent fasting, keto, paleo, and Atkins
                                  C. Paleo and Atkins

                                  5. What causes ketoacidosis?
                                  A. Prolonged extreme carbohydrate restriction
                                  B. Prolonged extremely high carbohydrate intake
                                  C. Low-level ketone body production

                                  6. Why should individuals taking cardiovascular-related medications such as ACE inhibitors or cholesterol-lowering drugs not follow the Paleo diet?
                                  A. Nutrient deficiencies caused by the composition of the diet lead to increased risk of cardiovascular issues.
                                  B. Reduced grain intake and high meat or fat consumption leads to increased risk of cardiovascular issues.
                                  C. These medications cause sensitivity to foods included in the Paleo diet.

                                  7. A patient with type 1 diabetes mentions that she plans to start following the keto diet because she knows that carbohydrates spike her blood sugar. Which of the following is the BEST response?
                                  A. It is the best way for people with diabetes to lose weight quickly and keep it off long-term
                                  B. It will be difficult for you to follow long-term, so the Atkins diet is more appropriate
                                  C. It is not a safe option for you because you are at increased risk of ketoacidosis

                                  8. Why is it important for pharmacy teams to understand contraindications and health implications of fad diets?
                                  A. To identify signs of diabetes based on how the body reacts to certain fad diets
                                  B. To advise patients about drug-diet interactions and how fad diets can impact their health
                                  C. To direct patients to an appropriate fad diet based on their current medications

                                  9. What general nutrition information should people follow instead of fad diets?
                                  A. Cut all dairy, gluten, and fat from the diet and eat only protein and carbohydrates
                                  B. Decrease fats and carbohydrates in the diet and increase red meat intake
                                  C. Limit processed foods and make overall healthy choices like eating more superfoods

                                  10. You are checking out a customer at the pharmacy counter and notice she is picking up some over-the-counter items along with her prescriptions. Which of the following groups of items would prompt you to refer an individual to the pharmacist?
                                  A. Metformin (for diabetes), Atkins snack bars, and Dramamine (for dizziness)
                                  B. Sertraline (for depression), SlimFast shakes, and a bottle of water
                                  C. Lisinopril (for blood pressure), a gallon of ice cream, and a bottle of soda

                                  References

                                  Full List of References

                                  References

                                     
                                    REFERENCES
                                    1. Wdowik M. The long, strange history of dieting fads. Colorado State University. November 13, 2017. Accessed January 14, 2023. https://source.colostate.edu/the-long-strange-history-of-dieting-fads/
                                    2. Tahreem A, Rakha A, Rabail R, et al. Fad Diets: Facts and Fiction. Front Nutr. 2022;9:960922. Published 2022 Jul 5. doi:10.3389/fnut.2022.960922
                                    3. Foxcroft L. Introduction: 'The Price of a Boyish Form'. In: Calories and Corsets: A History of Dieting over Two Thousand Years. Profile Books; 2011:1-8.
                                    4. British Dietetic Association (BDA). Fad diets: Food fact sheet. September 2021. Accessed January 16, 2023. https://www.bda.uk.com/resource/fad-diets.html
                                    5. British Dietetic Association (BDA). Fad diets and Instagram – friend or Foe? March 2019. Accessed January 16, 2023. https://www.bda.uk.com/resource/fad-diets-and-instagram-friend-or-foe.html
                                    6. Gans, K. Fad diets through the decades. U.S. News. December 23, 2019. Accessed January 17, 2023. https://health.usnews.com/health-news/blogs/eat-run/articles/fad-diets
                                    7. Johnson J. Fad diets are bad diets. American Council on Science and Health. July 2, 2018. Accessed January 20, 2023. https://www.acsh.org/news/2018/07/02/fad-diets-are-bad-diets-13134
                                    8. Centers for Disease Control and Prevention. Obesity and overweight. Updated January 5, 2023. Accessed January 20, 2023. https://www.cdc.gov/nchs/fastats/obesity-overweight.htm
                                    9. Centers for Disease Control and Prevention. Health effects of overweight and obesity. Updated September 24, 2022. Accessed January 20, 2023. https://www.cdc.gov/healthyweight/effects/index.html
                                    10. Johns Hopkins Medicine. Intermittent fasting: What is it, and how does it work? Accessed January 23, 2023. https://www.hopkinsmedicine.org/health/wellness-and-prevention/intermittent-fasting-what-is-it-and-how-does-it-work
                                    11. Chair SY, Cai H, Cao X, Qin Y, Cheng HY, Ng MT. Intermittent fasting in weight loss and cardiometabolic risk reduction: A randomized controlled trial. J Nurs Res. 2022;30(1):e185. doi:10.1097/jnr.0000000000000469
                                    12. UC Davis Health. Intermittent fasting: Benefits, how it works, and is it right for you? February 4, 2022. Accessed January 23, 2023. https://health.ucdavis.edu/blog/good-food/intermittent-fasting-benefits-how-it-works-and-is-it-right-for-you/2022/02
                                    13. Cleveland Clinic. What is a superfood, anyway? November 10, 2021. Accessed January 23, 2023. https://health.clevelandclinic.org/what-is-a-superfood/
                                    14. de Cabo R, Mattson MP. Effects of intermittent fasting on health, aging, and disease [published correction appears in N Engl J Med. 2020 Jan 16;382(3):298] [published correction appears in N Engl J Med. 2020 Mar 5;382(10):978]. N Engl J Med. 2019;381(26):2541-2551. doi:10.1056/NEJMra1905136
                                    15. Patterson RE, Laughlin GA, LaCroix AZ, et al. Intermittent fasting and human metabolic health. J Acad Nutr Diet. 2015;115(8):1203-1212. doi:10.1016/j.jand.2015.02.018
                                    16. Masood W, Annamaraju P, Uppaluri KR. Ketogenic Diet. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 11, 2022. Updated June 11, 2022. Accessed January 24, 2023. https://www.ncbi.nlm.nih.gov/books/NBK499830/
                                    17. Harvard T.H. Chan School of Public Health. Diet Review: Ketogenic diet for weight loss. May 22, 2019. Accessed January 24, 2023. https://www.hsph.harvard.edu/nutritionsource/healthy-weight/diet-reviews/ketogenic-diet/
                                    18. Nutrisystem. Accessed January 25, 2023. https://www.nutrisystem.com
                                    19. SlimFast. Accessed March 9, 2023. https://slimfast.com
                                    20. Jenny Craig. Accessed January 25, 2023. https://www-prd.jennycraig.com/how-it-works
                                    21. McEvedy SM, Sullivan-Mort G, McLean SA, Pascoe MC, Paxton SJ. Ineffectiveness of commercial weight-loss programs for achieving modest but meaningful weight loss: Systematic review and meta-analysis. J Health Psychol. 2017;22(12):1614-1627. doi:10.1177/1359105317705983
                                    22. Chaudhry ZW, Doshi RS, Mehta AK, et al. A systematic review of commercial weight loss programmes' effect on glycemic outcomes among overweight and obese adults with and without type 2 diabetes mellitus. Obes Rev. 2016;17(8):758-769. doi:10.1111/obr.12423
                                    23. Harvard T.H. Chan School of Public Health. Diet Review: Paleo diet for weight loss. October 28, 2019. Accessed January 26, 2023. https://www.hsph.harvard.edu/nutritionsource/healthy-weight/diet-reviews/paleo-diet/
                                    24. The Paleo Diet. Accessed January 26, 2023. https://thepaleodiet.com/
                                    25. UC Davis Health. Paleo diet: What it is and why it's not for everyone. April 27, 2022. Accessed January 26, 2023. https://health.ucdavis.edu/blog/good-food/paleo-diet-what-it-is-and-why-its-not-for-everyone/2022/04
                                    26. Weight loss: Feel full on fewer calories. Mayo Clinic. March 22, 2022. Accessed January 26, 2023. https://www.mayoclinic.org/healthy-lifestyle/weight-loss/in-depth/weight-loss/art-20044318
                                    27. Cleveland Clinic. High calorie foods and snack ideas to gain weight. September 15, 2020. Accessed January 26, 2023. https://my.clevelandclinic.org/health/articles/16555-snack-ideas-for-weight-gain
                                    28. Masharani, U., Sherchan, P., Schloetter, M. et al. Metabolic and physiologic effects from consuming a hunter-gatherer (Paleolithic)-type diet in type 2 diabetes. Eur J Clin Nutr 69, 944–948 (2015). https://doi.org/10.1038/ejcn.2015.39
                                    29. Parmar RM, Can AS. Dietary Approaches To Obesity Treatment. In: StatPearls. Treasure Island (FL): StatPearls Publishing; October 3, 2022. Accessed January 27, 2023. https://www.ncbi.nlm.nih.gov/books/NBK574576/
                                    30. Atkins diet: What's behind the claims? Mayo Clinic. May 12, 2022. Accessed January 27, 2023. https://www.mayoclinic.org/healthy-lifestyle/weight-loss/in-depth/atkins-diet/art-20048485
                                    31. Atkins. Accessed January 27, 2023. https://www.atkins.com/how-it-works
                                    32. Type 1 diabetes. Mayo Clinic. Accessed March 10, 2023. https://www.mayoclinic.org/diseases-conditions/type-1-diabetes/diagnosis-treatment/drc-20353017
                                    33. American Diabetes Association. Hypoglycemia (low blood glucose). Accessed March 10, 2023. https://diabetes.org/healthy-living/medication-treatments/blood-glucose-testing-and-control/hypoglycemia
                                    34. Natesan V, Kim SJ. Lipid Metabolism, Disorders and Therapeutic Drugs - Review. Biomol Ther (Seoul). 2021;29(6):596-604. doi:10.4062/biomolther.2021.122
                                    35. Health Resources & Services Administration. Primary carnitine deficiency. Accessed March 10, 2023. https://newbornscreening.hrsa.gov/conditions/primary-carnitine-deficiency
                                    36. Porphyria. Mayo Clinic. Accessed March 10, 2023. https://www.mayoclinic.org/diseases-conditions/porphyria/diagnosis-treatment/drc-20356072
                                    37. Cleveland Clinic. Pyruvate kinase deficiency. Cleveland Clinic. Accessed March 10, 2023. https://my.clevelandclinic.org/health/diseases/23419-pyruvate-kinase-deficiency
                                    38. American Heart Association. Types of heart medications. Accessed March 10, 2023. https://www.heart.org/en/health-topics/heart-attack/treatment-of-a-heart-attack/cardiac-medications
                                    39. Cleveland Clinic. Diuretics. Accessed March 10, 2023. https://my.clevelandclinic.org/health/treatments/21826-diuretics
                                    40. Mayo Clinic. Chronic Kidney Disease. Accessed March 10, 2023. https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/diagnosis-treatment/drc-20354527
                                    41. Egan S. 10 Nutrition myths experts wish would die. The New York Times. January 19, 2023. Accessed February 3, 2023. https://www.nytimes.com/2023/01/19/well/eat/nutrition-myths.html
                                    42. Haspel T. Weight-loss diets boil down to one thing, and it's not science jargon. The Washington Post. January 23, 2023. Accessed February 4, 2023. https://www.washingtonpost.com/food/2023/01/23/weight-loss-diets-fasting-keto/
                                    43. Contreras RE, Schriever SC, Pfluger PT. Physiological and epigenetic features of yoyo dieting and weight control. Front Genet. 2019;10:1015. Published 2019 Dec 11. doi:10.3389/fgene.2019.01015
                                    44. Johns Hopkins Medicine. Maintaining Weight Loss. August 8, 2021. Accessed February 6, 2023. https://www.hopkinsmedicine.org/health/wellness-and-prevention/maintaining-weight-loss
                                    45. Centers for Disease Control and Prevention. Weight Loss and Management. March 19, 2021. Accessed February 6, 2023. https://www.cdc.gov/healthyweight/tools/index.html
                                    46. USDA. Healthy Living and Weight. U.S Department of Agriculture. Accessed February 6, 2023. https://www.nutrition.gov/topics/healthy-living-and-weight

                                    The revised USP 795 becomes official in November 2023. What’s new?

                                    Learning Objectives

                                     

                                    After completing this application-based continuing education activity, pharmacists and pharmacy technicians will:

                                    1. Describe recent changes to USP <795>
                                    2. Identify the designated person’s responsibility
                                    3. Recognize areas of nonsterile compounding that could be improved

                                    Image of brown vial with pink liquid splattered around it.

                                     

                                    Release Date: July 1, 2023

                                    Expiration Date: July 1, 2026

                                    Course Fee

                                    Pharmacists: $7

                                    Pharmacy Technicians: $4

                                    There is no grant funding for this CE activity

                                    ACPE UANs

                                    Pharmacist: 0009-0000-23-021-H07-P

                                    Pharmacy Technician: 0009-0000-23-021-H07-T

                                    Session Codes

                                    Pharmacist:  23YC21-MBV42

                                    Pharmacy Technician:  23YC21-VBM24

                                    Accreditation Hours

                                    2.0 hours of CE

                                    Accreditation Statements

                                    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-021-H07-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                                     

                                    Disclosure of Discussions of Off-label and Investigational Drug Use

                                    The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                                    Faculty

                                    Christina Aglieco
                                    PharmD Candidate 2025
                                    UConn School of Pharmacy
                                    Storrs, CT

                                    Robin Bogner, PhD
                                    Professor of Pharmaceutics
                                    UConn School of Pharmacy
                                    Storrs, CT

                                    Laura Nolan, CSPT, CPhT
                                    Pharmacy Compounding Lab Coordinator
                                    Instructor Specialist in Sterile and Non-sterile Compounding
                                    UConn School of Pharmacy
                                    Storrs, CT

                                    Faculty Disclosure

                                    In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                                    Christina Anglieco and Laura Nolan do not have any financial relationships with ineligible companies and therefore have nothing to disclose.

                                    Robin Bogner acts as a consultant for Biontech.  There is no conflict of interest.

                                     

                                    ABSTRACT

                                    Compounding of drug preparations requires training and knowledge in the science underlying pharmaceutical compounding. Altering the original drug product can change the drug’s stability and clinical efficacy. The United States Pharmacopeia (USP) is an independent non-profit organization of knowledgeable volunteers who set the standards for pharmaceutical compounding to ensure patient safety. State regulating bodies oversee and enforce these standards at compounding pharmacies to ensure compounded preparations are up to quality and purity standards. Since the field of pharmaceutical compounding is constantly changing, USP revises its standards regularly. The USP recently revised General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations with revisions enforceable on November 1, 2023. To make this transition easier, this continuing education activity outlines the most significant changes made to USP <795>. USP changed General Chapter <795> Pharmaceutical Compounding - Nonsterile preparations to mimic those of USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. Overall, the revision elevates nonsterile compounding’s quality and sanitary standards to improve patient safety by reducing common safety errors seen across the United States.

                                    CONTENT

                                    Content

                                    Introduction

                                    The original “little blue pill” was created in the 1860s and was a popular cure for everything from toothache to tuberculosis.1 Pharmacists compounded “blue mass syrup” and “blue pills” based on their own recipes or on one of several widespread recipes. Its name probably derives from the use of blue dye or blue chalk (used as a buffer) in some formulations. Blue mass’s ingredients varied, as each pharmacist prepared it himself, but they all included elemental mercury. One recipe for blue mass syrup consisted of1

                                    • 33% mercury (measured by weight)
                                    • 5% licorice
                                    • 25% Althaea (a root extract, possibly from hollyhock or marshmallow)
                                    • 3% glycerol
                                    • 34% rose honey

                                     

                                    Pharmacist-compounders produced blue pills by substituting milk sugar or chalk for the glycerol and rose oil for the rose honey. Each pill contained one grain (64.8 milligrams) of mercury and was prescribed two to three times a day, which today we know causes heavy metal poisoning, since the dose is more than 100 times more than the limit set by the Environmental Protection Agency.1 Products were made without fancy definitions or regard to cleanliness. Times have changed.

                                     

                                    Pharmaceutical compounding is the act of manipulating a drug product to create a new drug formulation.2 Pharmacists and pharmacy technicians still compound drug preparations for a specific patient or group of patients when no drug product exists on the market, or as seen more recently, when the drug product is backordered with no therapeutic alternative(s). It is also interesting to note what the United States Pharmacopeia (USP; described below) does NOT consider to be compounding. Preparing a powdered antibiotic bottle with distilled water per manufacturer’s directions is not considered compounding. Splitting tablets and repackaging is also not considered compounding, nor is preparing a single dose for a single patient to be used within four hours. In other words, making one dose of blue mass syrup and giving it directly to a patient is not compounding. (OK, maybe no one makes blue mass syrup anymore, but crushing a tablet and placing it in a liquid for immediate use is still not a compounded preparation.)

                                     

                                    Pharmaceutical compounding has two categories: sterile compounding and nonsterile compounding.2

                                    • Sterile compounding is creating a new drug preparation that must be sterile (completely free of pathologic microorganisms) and includes preparations that are primarily infusions, injections, eye drops, and many irrigations.
                                    • Nonsterile compounding is creating a new drug product that is not required to be sterile (although these products should be as “clean” as possible) and are mostly used for oral or topical administration. Nonsterile compounding is often employed for pediatric and veterinary preparations where patients need very small or very large doses. Some examples are medicated creams for neuropathic pain, and anesthetic mouthwashes for oral sores and pains.

                                     

                                    The USP is an independent non-profit organization of knowledgeable volunteers who set the standards for pharmaceutical compounding to ensure patient safety.3 The USP also distinguishes guidelines for hazardous and non-hazardous compounding. Both sterile and nonsterile compounding can involve manipulation of hazardous drugs. This continuing education activity focuses on non-hazardous nonsterile compounding. More information on hazardous compounding can be found in General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. Access to the USP Compounding Compendium costs $250.00 for a 12-month membership. There are also various plans for multiple users. Many institutions have a contract with USP. (Readers should check with their designated person or supervisor, as they may already have access to this service.)

                                     

                                    The origin of nonsterile pharmaceutical compounding in the U.S. cannot be pinned down to one exact date, but historically, the 1800s saw immense growth in not only population but also in disease states as people traveled and settled to new areas. Between 1840 and 1850, it is estimated that more than 1.5 million persons immigrated to the United States. Backyard herbalists became highly regarded apothecaries seemingly overnight.4

                                     

                                    Unfortunately, there were no established compounding standards until 1820 when a small group of physicians raised concerns about the high prevalence of poor-quality medicine across America and the USP was formed. By 1863, during the height of the Civil War, the USP had become the most trusted source for information about medicines.3.

                                     

                                    The USP continuously strives to improve the quality of drugs, including compounded preparations. Today we know that the quality of a compounded preparation depends as much on handwashing, gloving and cleaning, as checking the pH of the product itself. These steps are necessary to safeguard the preparation that a pharmacist or pharmacy technician compounds, and ultimately, safeguard the patient.

                                     

                                    The USP sets standards for pharmaceutical compounding but has no regulatory authority, so it does not enforce the standards it sets. Each state is responsible for regulating pharmaceutical compounding, but the Food and Drug Administration (FDA) is also authorized to regulate all aspects of drugs, including compounding. Both state regulating bodies and the FDA can inspect compounding in pharmacies and take legal action and can amass fines if compounders do not uphold USP standards. However, this action only applies to states that write USP standards into their laws. Depending on the situation’s severity, legal action could result in a loss of license for the pharmacy or pharmacist.

                                     

                                    The USP sets standards for sterile and nonsterile compounding through General Chapter <797> and General Chapter <795>, respectively. (Here’s a PRO TIP: chapters numbered from 1 to 1000 are enforceable by state and federal agencies). More recently, the FDA has been inspecting compounding pharmacies to ensure they meet General Chapter <797> standards, but it is only a matter of time before these agencies turn their attention to General Chapter <795>.

                                     

                                    In November 2022, the USP published a revised General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations. Going forward, we will call these standards the newly revised standards. This revision now includes a designated person (the individual assigned to be accountable and responsible for the compounding facility’s operation, performance, and personnel) requirement to mimic General Chapter <797>. With the implementation of a designated person for nonsterile compounding under proposed General Chapter <795>, when the facility is not up to code, State boards of Pharmacy and the FDA hold the designated person responsible, creating a risk of loss of license. The revised standards will be official in November 2023. Major changes include

                                    • garbing
                                    • cleaning
                                    • training
                                    • beyond-use dating and
                                    • a designated person requirement

                                     

                                    The focus here is on how to implement the major changes made to the currently enforceable General Chapter <795>, which was revised and reissued in 2020. Going forward, we will call these standards the current standards. Once readers are familiar with this summary of the major changes in the newly revised standards, they are encouraged to review the full text of the proposed chapter <795> to address additional minor changes.

                                     

                                    So, to repeat, the standards that were revised and reissued in 2020 and are currently enforceable will be called the current standards. The revision that will be adopted in November 2023 will be called the newly revised standards.

                                     

                                    Garbing

                                    The newly revised standards put greater emphasis on garbing procedures for nonsterile compounding than the current standards do. Pharmacy personnel who compound sterile preparations are well acquainted with garbing, however, garbing is a foreign concept to many who prepare nonsterile preparations. Think back to the past. How often did you go to the back of the store, push some items on the counter aside, and start mixing a magic mouthwash? You probably made it wearing a shirt and tie or more formal dress, while possibly wearing a lab coat, unless it was a really hot day. You might even have washed your hands if you just came back from lunch. Conversely, many hospital pharmacies mix magic mouthwash in so much garb, that you might think that it is a toxic preparation. The SIDEBAR explores this topic in greater detail.

                                     

                                     

                                    TECH TALK SIDE BAR5

                                    Have you noticed that many pharmacists and pharmacy technicians no longer wear white lab coats? Physicians began to wear white coats in the late 1800s as doctors started to recognize the color white’s effectiveness. It is easier to see dirt and soil that prompts the wearer to launder it, and frequent laundering helps reduce pathogens. Soon all medical professionals adopted the practice. White coats were worn not only to protect one’s clothing, but they were seen as a sign of prestige and respect.

                                     

                                    Today, white coats are rarely used, because according to Dennis Miller, “White coats cause white coat syndrome” (hypertension) and they “increase the distance between the pharmacist and the customer.” Few states regulate pharmacy technician attire. Many institutions and most large retail chains require pharmacy technicians to wear uniform “scrubs.” Restricting white coats to professional staff may reduce some customer confusion, but in certain situations, scrubs might imply the wearer is a nurse or other hospital professional, which is also confusing. One of this CE’s authors says, “I can’t even tell you how many patients and families would ask if I was a nurse.”

                                     

                                    Recently, some hospitals have banned pharmacy technicians from wearing scrubs, forcing them to wear civilian clothing. Unfortunately, that makes technicians look like pharmacists again. Of course, some pharmacists like to wear scrubs to work; are they secretly wishing they were technicians? Doubtful. Business attire has certainly gone downhill lately. So, if we can’t wear a white coat and we can’t wear scrubs, what are we to wear?

                                     

                                    THE ANSWER (which is required by law in many states): A name tag that indicates your position!

                                     

                                     

                                    The current standards state that personnel involved in compounding should garb “as needed for personal protection and to prevent contamination” of the compounded nonsterile product (CNSP) prior to preparation.6 For example, compounding staff don two pairs of gloves for personal protection when preparing cytotoxic CNSPs for their own safety. More information on hazardous compounding can be found in General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. The current standards also state compounding personnel are responsible for maintaining good hand hygiene and wearing appropriate clothing to prevent contamination of the CNSP.6 These statements give compounding personnel some latitude when they make decisions. For example, currently, some compounders don gloves to make magic mouthwash, while many others prepare it with ungloved hands in their practice. Nonsterile gloves will become mandatory on November first.

                                     

                                    The newly revised standards now specify hand washing and garbing procedures and provide guidance on personnel who should NOT prepare a CNSP. Compounding personnel are to remove all “garments that cannot be easily cleaned” before entering the designated compounding area. So compounding personnel must now remove personal outer garments (such as jackets, sweaters, hats, and scarves), hand and wrist jewelry, anything that might hinder the use of gloves, and headphones must be removed before compounding something as simple as magic mouthwash. Compounding personnel must wash their hands for at least 30 seconds and dry with one-time use paper towels before compounding as well. After handwashing, personnel must don nonsterile gloves and inspect the gloves for holes, rips, or tears. Compounding personnel should wipe or replace gloves in between different preparations and must remove these gloves before leaving the designated compounding area.6 These proposed standards are analogous to the procedures required for sterile compounding. In fact, the format of and definitions within the revised <795> aligns with the revised <797> for sterile products much more closely than in the past.

                                     

                                    The current standards still require personnel to be in good health and fit for compounding, but the revisions are considerably more specific. Personnel who have new tattoos, oozing sores, open wounds, conjunctivitis, rashes, or active respiratory infections are not considered fit to compound due to risk of contamination of the CNSP. The newly revised standards hold the designated person responsible for deciding if personnel are fit for compounding or not.6

                                     

                                    Cleaning the Designated Compounding Area

                                    Do I need to create an area for compounding? Yes. The newly revised standards describe a designated compounding area in detail. Some readers are thinking, “My pharmacy is small. Can I use the area for tasks other than compounding?” The designated compounding area is a space with a marked perimeter that is required to be clean, orderly, sanitary, well-lit, and have low foot traffic, and no other activities can occur in this space simultaneously. You may perform other duties there if there is no compounding going on as long as someone cleans the area before compounding again. The newly revised standards suggest the designated compounding area be uncarpeted for easier cleaning, which in one of this CE’s author’s opinion should be changed to a must, since carpets tend to harbor dust and dander, and can be very difficult to clean. (Have you ever dropped and broken a bottle on the carpet in your pharmacy? It’s not pretty.)

                                     

                                    The compounding area must be used in a manner that prevents cross contamination of CNSPs from other areas of the pharmacy. For compounding to be completed in the most efficient manner possible, all equipment in the designated compounding area must be arranged in a way that prevents errors. Last, the facility’s standard operating procedures (SOPs) must always include this information and be available to staff.

                                     

                                    The current standards simply state that compounding equipment “shall be clean, properly maintained and used appropriately.”6 This statement allowed compounding personnel to decide on their own standard of clean when preparing a CNSP and their own definition of when or if they should clean. The newly revised guidelines strengthen the minimum requirements for cleaning the designated CNSP compounding area. The USP dedicates an entire section to cleaning procedures, representing a major change in the standards. The new standards indicate that personnel must clean the perimeters—walls and ceilings—when visibly soiled, after spills, and when surface contamination occurs.6 Readers will see that visible soil, spills, and surface contamination form a frequent theme in the newly revised standards!

                                     

                                    The new standards also establish a routine cleaning schedule. The section, “Cleaning and Sanitizing” states pharmacy personnel must clean work surfaces at the beginning and end of each shift at a minimum, between each CNSP, and again if spills or surface contamination occurs. The standards add that personnel must clean floors daily on days when compounding occurs, and again if spills or surface contamination occurs.6. Personnel must clean storage shelves every three months, after spills, and when surface contamination occurs. Personnel qualified to clean can be defined as any staff member who has been properly trained and observed in a facilities cleaning procedures. That means that pharmacy staff can train housekeeping staff to complete the cleaning.

                                     

                                    Personnel need to clean and sanitize, and if two separate products are used—one to clean and one to sanitize—cleaning is done first, followed by sanitizing second. Selecting appropriate cleaning products requires careful attention. They should be (1) compatible, (2) effective, and (3) leave minimal residue. Finally, daily documentation is essential on days when compounding occurs.6 An old adage applies here: cleaning is not truly done unless it is documented. High tech organizations commonly complete this documentation using an online platform integrated with other daily documentation requirements such as daily temperature monitoring, but a simple sign off sheet is also acceptable. A best practice is to include any cleaning and its documentation into the compounder’s daily workflow, so it is not forgotten. Daily and or weekly task charts can be created to include all activities that need to be performed.

                                     

                                    PAUSE AND PONDER: How were you originally trained to compound? Were you told to watch how it was done and then you were on your own?

                                     

                                    Training

                                    Another major area of change is the training of compounding personnel. The current standards state that compounders must be “proficient in compounding” and suggest that compounders should pursue knowledge by attending seminars or studying literature related to compounding. It also states that compounders must be conversant on General Chapter <795> and familiar with General Chapter <797>. With standards this vague, and no required number of CE credits on this subject, how often do you think compounding personnel previously searched for compounding topics? Also, the current standards simply require at a minimum compounding personnel to be trained and capable of the compounding duties assigned to them, and for someone to document the training. Compounding duties include verifying critical processes like weighing and mixing that occur frequently during compounding.

                                     

                                    The newly revised standards will require a more structured training program for compounding personnel. All compounding personnel must complete this training program initially before being allowed to compound and every 12 months thereafter. The newly revised standards require compounding personnel to repeat compounding procedures “independently while under the supervision of the designated person or assigned trainer for completion of the training program.”6 The organization’s designated person will be responsible for designing the training program, which must include

                                    • the required training, meaning a detailed description of the training
                                    • the frequency of training, and
                                    • the process used to evaluate competency.

                                     

                                    Table 1 lists the training program’s required topics. It is interesting to note that pharmacists who do not compound but complete in-process checks, verification, or dispensing also must complete the CNSP training program before completing checks, verification, or dispensing. A training program may include an online portion of reading or videos teaching concepts with quizzes to evaluate understanding, and a physical portion to evaluate measuring, mixing, and overall compounding. The designated person or assigned trainers can train personnel, and of course, they must document the completion of the training program.6

                                     

                                    Table 1. Proposed General Chapter <795> Required Topics for Training6

                                    Training programs must teach compounding personnel the following:
                                    ·       cleaning and sanitizing
                                    ·       documentation such as Master Formulation Records and Compounding Records
                                    ·       hand hygiene and garbing
                                    ·       handling and transporting CNSPs and their components
                                    ·       measuring and mixing
                                    ·       proper use of compounding equipment and devices
                                    ·       understanding General Chapter <795>
                                    ·       understanding safety data sheets
                                    ·       understanding procedures to complete compounding duties

                                     

                                    It is important to note this table only lists the minimum requirements, additional requirements may be necessary according to each facility’s needs.

                                     

                                    The Designated Person

                                    The necessity to designate a person who has oversight and full responsibility for compounding practices now in General Chapter <800> is included in proposed General Chapter <795> and <797>. The current standards again broadly describe the requirements. The chapter states that compounding personnel are responsible for adhering to the general principles of compounding outlined in the current standards. It specifies several responsibilities, which include training, selecting ingredients for compounding, labeling, and cleaning. However, since the compounding process may include many people, the ultimate accountability is unclear.

                                     

                                    To clarify accountability, the proposed General Chapter <795> requires each organization to designate one or more persons to be responsible and accountable for nonsterile compounding. The designated person’s responsibilities include ensuring the organization develops written formal quality control and quality assurance procedures and reviews them annually. The designated person must monitor and observe compounding, identify areas of error, and take corrective action if needed. The designated person has several other responsibilities. These include6

                                     

                                    • establishing, documenting, and monitoring SOPs within the CNSP compounding area to include component handling and storage
                                    • ensuring that all staff members follow all SOPs
                                    • reviewing complaints
                                    • determining if potential issues are likely with CNSPs
                                    • selecting components to be used in compounding

                                     

                                    Beyond Use Dates

                                    The final major difference is the establishment of beyond-use dates (BUD) for CNSPs. The current standards hold compounders responsible for establishing BUDs based on their observation of the drug during compounding. Compounders (not a designated person) are held responsible for noticing signs of instability and using their education and experience to assign a BUD to the final preparation.6 The current standards also recommend assigning BUDs based on three categories: non-aqueous, water-containing oral, or water-containing topical. The new guidelines are based on the activity of water (aw) in each product.

                                     

                                    Table 2 compares the current and proposed BUD recommendations.6

                                     

                                     

                                    Table 2. A Comparison of BUD Requirements6,7       

                                    Description Minimum BUD requirement
                                    Current USP <795> Proposed USP <795>
                                    Aqueous non-preserved 14 days in refrigerator 14 days in refrigerator

                                     

                                    Aqueous preserved 14 days in refrigerator 35 days controlled room temp or refrigerator
                                    Aqueous topical

                                    (Cream, lotion, shampoo, nasal spray, gel, rinse, foam, etc.)

                                    30 days 35 days if preserved

                                    14 days if non-preserved

                                    See activity of water chart

                                    Nonaqueous oral

                                    (Oil or powder filled capsule, glycol or oil based oral solution, compressed tablet, powder for inhalation, troche, lollipop, etc.)

                                    6 months 90 days
                                    Nonaqueous

                                    (Medicated stick, ointment, suppository, etc.)

                                    6 months 180 days (6 months)

                                     

                                    Proposed General Chapter <795> determines BUDs based on a preparation’s water activity (aw, see SIDEBAR), which is more clearly defined as aqueous and non-aqueous by the following distinction:

                                     

                                    • CNSPs with an aw ≥0.6, considered aqueous dosage forms
                                    • CNSPs with an aw <0.6, considered non-aqueous dosage forms

                                     

                                     

                                    SIDEBAR: Activity of Water7-10

                                    The water in a preparation can “participate in chemical, biochemical, or physicochemical reactions.” However, it is not the water content (such as % water in the CNSP), but rather the activity of water that determines the water’s availability to participate in degradation reactions and allow microbial growth. Therefore, compounders must determine a BUD by considering the preparation’s water activity and not the preparation’s water content.

                                     

                                    Water activity is roughly equivalent to relative humidity, except that relative humidity is expressed in terms of percent and water activity is expressed as a fraction. So, a water activity of 0.6 is roughly equivalent to 60% relative humidity. If the dosage form with a water activity of 0.6 were to be sealed in a package, any surrounding space would eventually have a relative humidity of 60%. Compounders can measure water activity for a specific preparation by the procedures outlined in General Chapter <922> Water Activity. However, the proposed General Chapter <795> provides an easy classification system (see Table 3).

                                     

                                    The aw cut-off of 0.6 established in USP comes from various studies showing no microbial growth of any kind in foods below this value. Although the water activity determination was constructed using food, it is also the basis of USP <1112> Water Activity Determination and is the foundation for the BUD rationale in the proposed <795>. A product with an aw greater than or equal to 0.6 has been shown to have increased bacterial, fungal, and other microbial growth. However, in products with an aw below the threshold of 0.6, no microbial growth was found.

                                     

                                     

                                    The newly revised standards recommend adding antimicrobial agents to any CNSP with an aw at or exceeding 0.6 when assigning a BUD of 35 days. Even components as simple as ascorbic acid can help extend the BUD. As always, careful research must be done to determine suitable preservatives for each product and if an extended BUD date is assigned, the preparation must be tested for antimicrobial effectiveness. Consider one formula for magic mouthwash, which might have an aw of 0.73 and contains no preservatives. With no USP monograph, one would refer to Table 3 to determine that the BUD should be limited to 14 days when stored in the refrigerator. We are sure that pharmacists compounding blue mass syrup could have cared less about the activity of water in their concoctions. We wonder if they would have viewed mercury as a preservative.

                                     

                                    Compounders can assign non-aqueous dosage forms with an aw less than 0.6 a maximum BUD of 90 days for an oral liquid and 180 days for alternative routes.

                                     

                                    While the newly revised standards provide strong guidance on determining a CNSP’s BUD, compounders should only use its tables if no other stability information is available. The designated person is responsible for searching for stability information for each CNSP and determining if a CNSP can have a BUD beyond that specified in Table 2. If the designated person finds an extended BUD appropriate, compounding staff must test it for antimicrobial effectiveness. However, if compounding staff is following a United States Pharmacopeia- National Formulary (USP-NF) monograph for CNSP preparations, the BUD must not exceed that which is indicated in the monograph. Last, the CNSP’s components should drive the overall expiration date, which is not a change from the current standards.

                                     

                                    Table 3. Proposed General Chapter <795> classification of commonly compounded dosage forms as non-aqueous or aqueous partial list.

                                    Nonaqueous Dosage Forms aw <0.6

                                     

                                    Aqueous Dosage Forms aw ≥0.6

                                     

                                    -       ­Animal treat, oil based

                                    -       Capsule: oil filled or powder filled

                                    -       Oral solution: glycol based or oil based.

                                    -       Glycol based gel

                                    -       Stick or lip balm

                                    -       Tablet compressed or triturate

                                    -       Sorbitol based lollipop

                                    -       Ointment: hydrophilic petrolatum polyethylene and mineral oil based

                                    -       Oral suspension: fixed oil

                                    -       Powder for inhalation

                                    -       Suppository: polyethylene glycol base or fatty acid base

                                    -       Troche or lozenge: gelatin based or glycol based

                                    -       Animal treat

                                    -       Foam

                                    -       Shampoo

                                    -       Cream: oil in water emulsion, emollient cream, petrolatum, and mineral oil gel: alcohol free aqueous or hydroxypropyl methylcellulose gel

                                    -       Lotion

                                    -       Nasal spray

                                    -       Rinse

                                    -       Oral solution: water based, low sucrose syrup vehicle

                                    -       Oral suspension

                                     

                                     

                                    CONCLUSION

                                    Compounders face many of the same challenges today as they did in the 1800s. They were faced with a limited drug list, similar to a closed formulary in today’s world. They searched for alternative therapies, and they did, as we still do, face many drug shortages. The main difference is that we have advanced knowledge to make better products to keep patients safer.

                                     

                                    The time has come to designate your area, designate your person, and train your staff, including pharmacists who may not actually be compounding! Keep the designated area clear for compounding use only, if possible, and remove any unnecessary items before entering. Set up a cleaning routine for the entire space, including floors, walls, and shelving, and incorporate the routine into the daily workflow so it is never forgotten. Train your staff well to the new standards and reevaluate every 12 months. Look into the literature to determine the best BUD for each CNSP and when information is not available, use USP guidance for assigning a BUD date. Choose a designated person wisely, as they need to be responsible and organized with taking responsibility and accountability for all nonsterile compounding occurring in the facility.

                                     

                                    Remember, improvements in non-sterile compounding standards will make for higher quality and safer compounded non-sterile products for our patients and are enforceable come November 1, 2023.

                                    Pharmacist Post Test (for viewing only)

                                    After completing this continuing education activity, pharmacists and pharmacy technicians will be able to

                                    1. Describe recent changes to USP <795>
                                    2. Identify the designated person’s responsibilities
                                    3. Recognize areas of nonsterile compounding that could be improved

                                    1. The USP made major revisions to General Chapter <795> in the newly revised standards. What topics are affected?
                                    a. Cleaning, training, purchasing, designated person, and verification processes.
                                    b. Garbing, training, sanitizing, designated person, purchasing.
                                    c. Garbing, cleaning, training, designated person, and BUDs.

                                    2. When will the proposed General Chapter <795> become enforceable?
                                    a. It is already enforceable
                                    b. July 1, 2023
                                    c. November 1, 2023

                                    3. Which of the following conditions would make compounding personnel unfit for compounding at the discretion of the designated person?
                                    a. Recent placement of a temporary (water-removable) tattoo
                                    b. Cough, runny nose, and upper respiratory congestion
                                    c. All of the above.

                                    4. Who must create and enforce a new training program under the newly revised standards?
                                    a. Only staff who will perform compounding
                                    b. All personnel involved in compounding verification and dispensing
                                    c. The designated person or the designated person’s designee

                                    5. How often must the training program and reevaluation of competency be completed?
                                    a. Once prior to compounding, and then every 12 months
                                    b. Once after November 1, 2023, and then biannually
                                    c. Once only, since compounding never changes

                                    6. Sally is about to enter the compounding area. She is wearing makeup, a set of bangle bracelets, and sterile gloves. Which item is not allowed when compounding a CNSP?
                                    a. Makeup
                                    b. Wrist jewelry
                                    c. Gloves

                                    7. Which of the following must the designated person complete personally (that is, not train or delegate to others)?
                                    a. Cleaning the compounding area twice daily
                                    b. Identifying BUDs for all compounded products
                                    c. Ensuring staff follow all operating procedures

                                    8. The FDA visits your pharmacy after several patients develop infections related to a CNSP compounded in your facility. They find that the BUD was incorrect and the product was contaminated. Who will ultimately “take the fall” for this issue?
                                    a. The designated person.
                                    b. The entire pharmacy department.
                                    c. The compounder who prepared the CNSP.

                                    9. Which of the following CNSP properties now restricts the maximum BUD?
                                    a. Activity of water
                                    b. Time till it reaches the patient
                                    c. Duration of treatment

                                    10. Your supervisor tells you it’s time to improve your organization’s compounding. You need to find the best area for compounding. Which of the following is the best option for a designated compounding area?
                                    a. The farthest corner of the pharmacy provided that customers cannot see it and housekeeping staff indicates it is clean
                                    b. A carpeted section of the pharmacy next to the employee refrigerator that has easily cleanable countertops and shelving.
                                    c. A well-lit, uncarpeted area with easily cleanable countertops that is segregated from countertop space used for daily activities

                                    Pharmacy Technician Post Test (for viewing only)

                                    After completing this continuing education activity, pharmacists and pharmacy technicians will be able to

                                    1. Describe recent changes to USP <795>
                                    2. Identify the designated person’s responsibilities
                                    3. Recognize areas of nonsterile compounding that could be improved

                                    1. The USP made major revisions to General Chapter <795> in the newly revised standards. What topics are affected?
                                    a. Cleaning, training, purchasing, designated person, and verification processes.
                                    b. Garbing, training, sanitizing, designated person, purchasing.
                                    c. Garbing, cleaning, training, designated person, and BUDs.

                                    2. When will the proposed General Chapter <795> become enforceable?
                                    a. It is already enforceable
                                    b. July 1, 2023
                                    c. November 1, 2023

                                    3. Which of the following conditions would make compounding personnel unfit for compounding at the discretion of the designated person?
                                    a. Recent placement of a temporary (water-removable) tattoo
                                    b. Cough, runny nose, and upper respiratory congestion
                                    c. All of the above.

                                    4. Who must create and enforce a new training program under the newly revised standards?
                                    a. Only staff who will perform compounding
                                    b. All personnel involved in compounding verification and dispensing
                                    c. The designated person or the designated person’s designee

                                    5. How often must the training program and reevaluation of competency be completed?
                                    a. Once prior to compounding, and then every 12 months
                                    b. Once after November 1, 2023, and then biannually
                                    c. Once only, since compounding never changes

                                    6. Sally is about to enter the compounding area. She is wearing makeup, a set of bangle bracelets, and sterile gloves. Which item is not allowed when compounding a CNSP?
                                    a. Makeup
                                    b. Wrist jewelry
                                    c. Gloves

                                    7. Which of the following must the designated person complete personally (that is, not train or delegate to others)?
                                    a. Cleaning the compounding area twice daily
                                    b. Identifying BUDs for all compounded products
                                    c. Ensuring staff follow all operating procedures

                                    8. The FDA visits your pharmacy after several patients develop infections related to a CNSP compounded in your facility. They find that the BUD was incorrect and the product was contaminated. Who will ultimately “take the fall” for this issue?
                                    a. The designated person.
                                    b. The entire pharmacy department.
                                    c. The compounder who prepared the CNSP.

                                    9. Which of the following CNSP properties now restricts the maximum BUD?
                                    a. Activity of water
                                    b. Time till it reaches the patient
                                    c. Duration of treatment

                                    10. Your supervisor tells you it’s time to improve your organization’s compounding. You need to find the best area for compounding. Which of the following is the best option for a designated compounding area?
                                    a. The farthest corner of the pharmacy provided that customers cannot see it and housekeeping staff indicates it is clean
                                    b. A carpeted section of the pharmacy next to the employee refrigerator that has easily cleanable countertops and shelving.
                                    c. A well-lit, uncarpeted area with easily cleanable countertops that is segregated from countertop space used for daily activities

                                    References

                                    Full List of References

                                    References

                                    1. Massae Pilularum—pill masses, Henriette’s Herbal Homepage. Accessed June 2, 2023. https://www.henriettes-herb.com/eclectic/kings/massae-pilu.html
                                    2. Watson, C.J., Whitledge, J.D., Siani, A.M. et al. Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors. J. Med. Toxicol. 17, 197–217 (2021). https://doi.org/10.1007/s13181-020-00814-3
                                    3. USP Timeline. www.usp.org. Accessed March 21, 2023. https://www.usp.org/200-anniversary/usp-timeline#:~:text=1820&text=Concerned%20about%20the%20dangers%20of
                                    4. Sprowls, Joseph Barnett, Lewis W. Dittert, and Rufus Ashley Lyman. Sprowls' American Pharmacy: An Introduction to Pharmaceutical Techniques and Dosage Forms. Lippincott Williams & Wilkins, 1974. page 3.
                                    5. Miller D. Are those white coats really necessary? Accessed June 3, 2023. https://www.drugtopics.com/view/dear-pharmacists-are-those-white-coats-really-necessary
                                    6. USP. Pharmaceutical Compounding - Nonsterile Preparations <795>. In: USP-NF. Rockville, MD: USP; May 1, 2020.

                                    DOI: https://doi.org/10.31003/USPNF_M99595_05_01

                                    1. USP. Pharmaceutical Compounding - Nonsterile Preparations <795>. In: USP-NF. Rockville, MD: USP; November 1, 2023.

                                    DOI: https://doi.org/10.31003/USPNF_M99595_06_01

                                    1. USP. Applications of Water Activity Determination to Non-sterile Pharmaceutical Dosage Products <1112>. In: USP-NF. Rockville, MD: USP; 2013

                                    DOI: https://doi.org/10.31003/USPNF_M402_01_01

                                    1. USP. Water Activity <922>. In: USP-NF. Rockville, MD: USP; May 1, 2021.

                                    DOI: https://doi.org/10.31003/USPNF_M12475_02_01

                                     

                                    1. Sikorski ZE. Fennema's food chemistry (fifth edition) edited by SrinivasanDamodaranKirk L.parkin CRC press, Boca Raton, Florida, 2017. 1107 pp. ISBN 9781482208122. J Food Biochem. 2018;42(2):e12483-n/a. doi: 10.1111/jfbc.12483.