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Immunization: It is Now Time to Make it Unclear: Reconciling Differences between Public Health Vaccine Recommendations and FDA Product Labeling-RECORDED WEBINAR

About this Course

This course is a recorded (home study version) of the CE Finale Encore Webinars.

 

Learning Objectives

Upon completion of this application based CE Activity, a pharmacist will be able to:

1. Compare and contrast the roles & activities of the Center for Biologics Evaluations and Research (CBER), US Food & Drug Administration (FDA), Centers for Disease Control & Prevention (CDC), and the Advisory Committee on Immunization Practices (ACIP) during the development and clinical use of vaccines in the United States.
2. Describe one specific example where the routine clinical use of a vaccine may differ from FDA-approved product prescribing information due to the following:

(a) costs, (b) disease epidemiology, (c) public acceptance, (d) vaccine supplies.

Release and Expiration Dates

Released:  December 15, 2023
Expires:  December 15, 2026

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-23-042-H06-P

Session Code

23RW42-KXV39

Accreditation Hours

1.0 hours of CE

Additional Information

 

How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

Accreditation Statement

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-23-042-H06-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

Grant Funding

There is no grant funding for this activity.

Faculty

Jeffery Aeschlimann, PharmD
Associate Clinical Professor-Infectious Disease Specialty
University of Connecticut 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.

  • Dr. Aeschlimann consults with F2G, Inc. but there is no crossover in the topics, so all issues have been mitigated.

Disclaimer

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.

Content

Handouts

Post Test

 

    Immunizations (Aeschlimann) – Post-Test Questions

     

     

    1. If asked, which of the following activities would the Food and Drug Administration decline to do and send to another agency?

     

    1. Verify appropriate vaccine manufacturing processes
    2. Approve advertising for vaccine products Reporting System (VAERS)
    3. Determine the strategy for public use of vaccines in the U.S.

     

     

    2.) Which of the following items would you expect to always/very-commonly see in the FDA-Approved product labeling for a vaccine product?

     

    1. Instructions for preparation of the product and route of administration
    2. Comparative effectiveness data for people taking chronic steroid therapy
    3. Recommendations for use of lower doses in case of product shortages

     

     

    3.) Which of the following is a correct example of a vaccination situation for which ACIP has issued “Shared Clinical Decision-making” (SCDM) guidance?

     

    1. Intranasal influenza vaccine administration in immunocompromised persons
    2. Respiratory syncytial virus vaccination for adults aged 60 years and older
    3. Human papillomavirus vaccination for persons aged 16-21 years

     

     

    4.) Which entity ultimately approves the content for FDA vaccine product labeling?

     

    1. The Vaccines and Related Biological Products Advisory Committee
    2. The Center for Biologic Evaluation & Research
    3. The Center for Drug Evaluation and Research

     

     

    5.) Which of the following people would be allowed to sit in the CDC’s Advisory Committee on Immunization Practices (ACIP)?

     

    1. A member of a vaccine manufacturer’s current Board of Directors
    2. A college professor whose expertise is mechanical engineering
    3. A practicing physician who is an expert in virology and vaccine safety

     

     

    6.) What does ACIP recommend after healthcare providers receive a full series of hepatitis B immunizations?

     

    1. Serologic testing for all healthcare providers at high risk for occupational percutaneous or mucosal exposure to blood or body fluids.
    2. Serologic testing for immunocomproised healthcare providers at high risk for occupational percutaneous of any type.
    3. Molecular testing for all healthcare providers at high risk for occupational percutaneous or mucosal exposure to blood or body fluids.

    VIDEO

    Antipsychotic Utilization in a Pediatric Population-RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the CE Finale Encore Webinars.

     

    Learning Objectives

    Upon completion of this application based CE Activity, a pharmacist will be able to:

    1. Describe current practice guidelines regarding the use of antipsychotic medications in a pediatric population.
    2.  Outline adverse effects associated with the use of antipsychotic medication in a pediatric population.
    3.  Discuss when to initiate an antipsychotic medication in a pediatric patient.

    Release and Expiration Dates

    Released:  December 15, 2023
    Expires:  December 15, 2026

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-23-043-H01-P

    Session Code

    23RW43-XYW84

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

    Accreditation Statement

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-23-043-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Megan J. Ehret PharmD, MS, BCPP
    Professor, Co-Director of Mental Health Program
    University of Maryland School of Pharmacy
    Baltimore, MD

    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.

    • Dr. Ehret is a consultant with Saladex Biomedical

    Disclaimer

    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.

    Content

    Post Test

    Post Test

    Antipsychotic Utilization in a Pediatric Population

    Megan Ehret, PharmD

     
    1. Which medication is a first-line treatment option for a 14-year-old patient with newly diagnosed schizophrenia?
    a. Divalproex Sodium
    b. Haloperidol
    C. Risperidone

    2. Which medication is a first-line treatment option for a 16-year-old patient with bipolar disorder, most recent episode depressed?
    A. Aripiprazole
    B. Divalproex Sodium
    C. Lurasidone

    3. Which medication can cause the most substantial weight gain?
    A. Cariprazine
    B. Lumateperone
    C. Olanzapine

    4. Which rating scale should be used to screen patients for tardive dyskinesia?

    A. Extrapyramidal Symptom Rating Scale
    B. Barnes Akathisia Rating Scale
    C. Abnormal Involuntary Movement Scale

    5. In which disease state would it be appropriate to initiate an antipsychotic medication in a pediatric patient?
    A. Autism
    B. Conduct Disorder
    C. Intellectual Disability

    Handouts

    VIDEO

    TOP 10 Cardiovascular Drugs Used Off Label!!!-RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the CE Finale Encore Webinars.

     

    Learning Objectives

    Upon completion of this application based CE Activity, a pharmacist will be able to:

    • Identify how an FDA approved and off label indication differ and the implications of that differential designation
    • Identify which 10 FDA approved cardiovascular drugs have the most promising off label uses for treating other cardiac or noncardiac disorders
    • Describe the mechanisms of action for the purported off label uses of these drugs
    • Identify which national guidelines or consensus statements recommend the off-label use of drugs

    Release and Expiration Dates

    Released:  December 15, 2023
    Expires:  December 15, 2026

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-23-039-H01-P

    Session Code

    23RW39-TXJ88

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

    Accreditation Statement

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-23-039-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    C. Michael White, PharmD, FCCP, FCP
    BOT Distinguished Professor and Chair of Pharmacy Practice
    University of Connecticut 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.

    • Dr. White has no relationships with ineligible companies

    Disclaimer

    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.

    Content

    Post Test

    Post Test “TOP 10 Cardiovascular Drugs Used Off Label!!!”

    1. Which of the following drugs has been used to enhance the chances of delivering a baby in patients with Factor 5 Leiden and what is the mechanism of benefit?
    a) Thiazide diuretics; reduced placental calcium that stops crystalline umbilical cord blockage
    b) LMWH; preventing placental thrombosis in patients who are hypercoagulable
    c) Disopyramide – decreasing the inotropic effect in hypertrophic cardiomyopathy that leads to placental detachment

    2. Which of the following drugs is effective for treating anal fissures and what is the mechanism of action?
    a) IV iron; iron deficiency anemia promotes fissure formation so treating it reverses fissure
    b) Amiodarone; overactive potassium channels in the anus lead to apoptosis of anal mucosal cells
    c) CCBs; Blood vessel dilation enhancing blood flow to targeted areas in the body

    3. Which of the following drugs is properly linked to the off-label indication it is commonly used for?
    a) Beta-blockers – Raynaud’s phenomenon
    b) Prazosin – Nightmares in PTSD patients
    c) Clonidine – Stage fright

    4. Which of the following drugs is used off label for the treatment of abnormal face and body hair growth in patients and what is the mechanism of action?
    a) Spironolactone – blocking the effects of testosterone in several ways
    b) Beta-blockers – blocking epinephrine induced follicular stimulation
    c) Clonidine – central outflow of norepinephrine causes abnormal hair growth

    5. Sally Sue has had atrial fibrillation for several months. Her cardiologist has prescribed several therapies that have been ineffective, and one that is on the drug shortage list and hard to find. Which of the following might the cardiologist use off-label according to the AHA/ACC Guideline?

    a) Calcium channel blockers
    b) Prazocin
    c) Amiodarone

    Handouts

    VIDEO

    The ABCD of Off-Label Medications for Weight Management-RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the CE Finale Encore Webinars.

     

    Learning Objectives

    Upon completion of this application based CE Activity, a pharmacist will be able to:

    1.     Discuss the main principles of management of adiposity-based chronic disease (ABCD)
    2.     Identify the efficacy of commonly prescribed medications that may be used off-label for weight reduction
    3.     List major safety considerations for medications prescribed off-label for weight reduction

    Release and Expiration Dates

    Released:  December 15, 2023
    Expires:  December 15, 2026

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-23-038-H01-P

    Session Code

    23RW38-CBA96

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

    Accreditation Statement

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-23-038-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Khanh Dang, PharmD, CDCES, FNAP
    Clinical Professor
    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.

    • Dr. Dang has no relationships with ineligible companies

    Disclaimer

    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.

    Content

    Post Test

    Post Test

    The ABCD of Off-Label Medications for Weight Management
    Post Test
    1. When working with a patient to manage ABCD, what is the first goal?

    A. prevent weight regain
    B. stop further weight gain
    C. achieve weight reduction

    2. Which of the following is the correct order of weight reduction efficacy (highest to lowest)?

    A. tirzepatide > semaglutide > phentermine
    B. semaglutide > SGLT2 inhibitors > phentermine
    C. metformin = semaglutide > topiramate

    3. What did the SELECT RCT report about patients 45 years and older with ABCD and existing cardiovascular disease who did not have diabetes?

    A. The placebo-subtracted weight reduction for weekly semaglutide 2.4 mg was 15% of baseline body weight.
    B. Subcutaneous semaglutide 2.4 mg once weekly reduced major adverse cardiovascular events in ABCD.
    C. Subcutaneous semaglutide 2.4 mg once weekly significantly reduced weight but did not prevent cardiovascular events.

    4. What is the most common adverse reaction for GLP-1 receptor agonist-based medications?

    A. nausea and other gastrointestinal adverse effects
    B. hypoglycemia
    C. sleep disturbance

    5. With which drug class can tirzepatide interact ?

    A. beta blockers
    B. ACE inhibitors
    C. oral hormonal contraceptives

    Handouts

    VIDEO

    LAW: Off-Label Drug Use and The Pharmacists Role-RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the CE Finale Encore Webinars.

     

    Learning Objectives

    Upon completion of this application based CE Activity, a pharmacist will be able to:

    1. Define the term "off-label" in terms of drug promotion, prescribing, and use.
    2. Distinguish between the use of unapproved drugs and unapproved uses of approved drugs.
    3. List at least two reasons why off-label drug promotion could be harmful to patients.
    4. Explain whether a pharmacist has an obligation to dispense (or not dispense) a drug prescribed for an off label
    use.
    5. Identify potential liabilities for pharmacists who recommend off-label use of a drug.

    Release and Expiration Dates

    Released:  December 15, 2023
    Expires:  December 15, 2026

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-23-037-H03-P

    Session Code

    23RW37-ABC28

     

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

    Accreditation Statement

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-23-037-H03-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Jennifer A. Osowiecki, RPh, JD
    Cox & Osowiecki, LLC
    Suffield, Connecticut  

    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.

    • Attorney Osowiecki has no relationships with ineligible companies

    Disclaimer

    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.

    Content

    Post Test (for viewing only)

    Post Test
    2023 CE Finale – LAW: Off-Label Drug Use and the Pharmacist’s Role

    1. Which of the following statements about off-label drug use is TRUE?
    a. Connecticut’s Pharmacy Practice Act prohibits a pharmacist from dispensing a drug for a use other than its FDA-approved indication.
    b. Drug companies have a First Amendment (“free speech”) right to promote FDA-approved drugs for unapproved indications.
    c. Pharmacists who have declined to fill a prescription for an unapproved use have been found liable for interfering with the prescriber-patient relationship.

    2. According to the FDA, which of the following statements about unapproved drugs and unapproved uses of approved drugs is FALSE?
    a. Unapproved drugs have not been cleared as safe and effective by the FDA.
    b. All drugs compounded pursuant to a prescription are unapproved drugs.
    c. The importation and use of an unapproved drug is prohibited in all circumstances.

    3. According to the Agency for Healthcare Research and Quality (AHRQ), off-label prescribing accounts for approximately what percentage of all prescriptions in the United States?
    a. 3%
    b. 20%
    c. 40%

    4. A patient asks the pharmacist to mix up some “Magic Mouthwash” consisting of two FDA-approved OTC medications (such as Benadryl liquid and Mylanta) to treat mouth sores. What should the pharmacist tell the patient?
    a. The pharmacist needs to do some research; if research indicates this product is effective, he can make it.
    b. A prescription is needed because the pharmacist is compounding two FDA-approved drugs for an unapproved use.
    c. The pharmacist can make Magic Mouthwash because both medications are OTC (not prescription-only).

    5. Which of the following statements about pharmacist responsibilities when dispensing FDA-approved drugs for an unapproved use is TRUE?
    a. Unless it’s a prescription for a compounded drug, a pharmacist is obligated to verify the intended use of each drug that is dispensed pursuant to a prescription.
    b. When a pharmacist recognizes that a prescription is for an off-label use, the pharmacist is obligated to inform the patient that the use is not approved by the FDA.
    c. If a pharmacist recommends an off-label use of a drug to a prescriber, the pharmacist should be aware of evidence-based support for the use.

    Handouts

    VIDEO

    Immunization: A Quick Refresher: Perfect Intramuscular Injection Technique

    Learning Objectives

     

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

    Review basic intramuscular technique for vaccine administration
    List changes in administration technique that increase safety and decrease patient pain
    Describe the "clean as you go" process that saves time and reduces error

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

    Review basic intramuscular technique for vaccine administration
    List changes in administration technique that increase safety and decrease patient pain
    Describe the "clean as you go" process that saves time and reduces error

       

      Release Date: January 9, 2024

      Expiration Date: January 9, 2027

      Course Fee

      FREE

      There is no funding for this CE.

      ACPE UANs

      Pharmacist: 0009-0000-24-005-H06-P

      Pharmacy Technician:  0009-0000-24-005-H06-T

      Session Codes

      Pharmacist:  21YC03-ABC28

      Pharmacy Technician: 21YC03-CBA24

      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 0009-0000-24-005-H06-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

      Jill M. Fitzgerald, PharmD
      Emeritus Associate Professor of Clinical Pharmacy
      University of Connecticut School of Pharmacy
      Storrs, CT

      Jeannette Y. Wick, RPh, MBA
      Director, Office of Pharmacy Professsional Development
      University of Connecticut School of Pharmacy
      Storrs, CT

      Gabriella Scala
      PharmD Candidate 2022
      University of Connecticut School of Pharmacy
      Storrs, CT

      Samuel Breiner
      PharmD Candidate 2021
      University of Connecticut 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.

      Jill Fitzgerald, Samuel Breiner,  Gabriela Scala and Jeannette Wick have no relationships with ineligible companies.

       

      ABSTRACT

      Over the next months, we expect that more people will receive intramuscular vaccines than ever before. Many pharmacists and in some cases, pharmacy technicians, will mobilize to help with the immunization efforts. Some will take training for the first time, and others will have been trained but rusty. This activity reviews the best practices associated with intramuscular injection. UConn School of Pharmacy is providing this continuing education activity free as a public service.

      CONTENT

      Content

      INTRODUCTION

      As the healthcare community mobilizes and begins vaccinating to prevent the spread of coronavirus-SARS-19, pharmacists and in many places pharmacy technicians will be called to assist. In an effort to engage Americans in the program and encourage vaccination, the media is full of stories and videos of people receiving vaccinations. We at the University of Connecticut School of Pharmacy have watched with great interest, reading national newspapers and watching television clips about vaccination. One comment posted in response to an article in the New York Times caught our attention. Someone who dubbed herself “Retired Nurse” wrote the following comments1:

      “As for sore arms, I am not surprised. The wide variation in injection techniques displayed on television have been horrendous: Slow, tentative needle insertions, not stabilizing the site, too high up in the shoulder, exceptionally large needle lengths in tiny arms, etc. make me cringe. Hilariously, they showed doctors ceremoniously giving some of them on television but let's be honest, most physicians do not routinely administer shots. That task is delegated to a nurse or even a medical assistant in doctors' offices in many states. A vaccination can be a lot less painful, if not virtually painless, with good injection training.”

      We could not agree more, and as we prepare to train people from a number of professions in our state, we decided to create this short continuing education homestudy to help you review injection technique and stay abreast of the most recent developments.

      Intramuscular Injections

      Vaccines administered in pharmacies are generally given by one of two routes: (1) intramuscularly, or (2) subcutaneously. Most (but not all) immunizations are given intramuscularly. Most inactivated vaccines are administered intramuscularly in the deltoid, whereas all live-attenuated injectable vaccines are administered subcutaneously in the anterior arm (midway between the elbow and armpit).2 An exception of a common inactivated vaccine given subcutaneously would be meningococcal vaccine. To date, the available COVID-19 vaccines are all given intramuscularly. Intramuscular (IM) injections are exactly what the name implies – they are injections given into a muscle using a syringe.

      Let’s review the parts of the syringe very quickly. A syringe has three primary parts. The needle, the barrel, and the plunger (see Figure 1). The needle is also called the “sharp,” and for vaccines, it’s a very fine needle. This is the distal part of the syringe that penetrates the skin. The barrel is the tube that holds the vaccine, and it has markings similar to that on a ruler. In most cases, the barrel measures milliliters (mL). The plunger is the plastic device used to pull the vaccine into and push the vaccine out of the syringe.

      Cartoon showing the sections of a syringe, including needle, hub, barrel, and plunger

      An important area of the syringe is called the hub or the hilt. This is the place where the needle meets the barrel. When penetrating the skin, you will push the needle all the way to the hub or the hilt. Before you inject, the entire needle will be in the skin and the muscle – you won’t be able to see any of the metal needle. Many people worry that they will hit the patient’s bone. It’s a comfort to know that if you hit the bone, you will feel it. The patient will not. This is a word-for-word explanation that our peer reviewer and authors like3:

      "Needle length should be chosen based on the body habitus and weight of the patient. A needle that is too long can penetrate the deltoid muscle, hitting the bone. Although patients will not feel their bones being hit, the vaccine might not fully absorb into the muscle, leading to a reduced immune response. Furthermore, if the needle is too short the vaccine might be administered subcutaneously, which might result in decreased immune response and the development of nodules or cellulitus."

      Good Technique

      Good technique starts with preparation. Before you start administering vaccines, it’s essential that you prepare and anticipate how many patients you’ll see and what their needs will be. A cornerstone of good technique is knowing exactly how you will document. Especially with the COVID-19 vaccine, knowing how to document will be essential. Our understanding is that a new Vaccine Administration Management System has been developed to capture that data. When you arrive at your site, and eventually when the vaccine is available in your pharmacy, someone should train you on how to use the Vaccine Administration Management System. As with all vaccines, you’ll need to document the patient’s name, the vaccine’s lot number and expiration date, and where you gave the vaccine (left deltoid, right deltoid, etc.).4 And here is a quick aside: Many pharmacies don’t do a good job of documenting vaccines they give in their medication systems. Be certain to know what documentation is necessary, either in addition to or instead of Vaccine Administration Management System. For instance, health systems will require documentation in their electronic medical records or pharmacy system.

      Before you start, survey your area and ensure that the station at which you vaccinate has a sufficient amount of supplies. Table 1 lists items that you need at your station at all times and items you have to have ready for each patient. One thing we wish to emphasize is a technique that one of our students taught us. When you have gloves on, it’s very difficult to open a Band-Aid and apply it. In anticipation of needing it, if you peel back the outer wrapper before you start, it will be much easier to use the Band-Aid should you need it after vaccination.  Some people even place the small opened section of the bandage on the patient’s skin right next to where they will inject, so it’s easy access. And note that often, if you have good technique, the patient will not bleed. But use a Band-aid in case they “spring a leak” later.

      Table 1. Necessary Supplies for Immunization4,5

      Always at Your Station Have Ready for Each Patient
      •        A sharps container

      •        A handy trash can

      •        Band-Aids

      •        Cleaning solution

      •        Your personal protective equipment (mask, face shield, gloves)

      •        A box of tissues

       

      •        One alcohol wipe

      •        One sterile 2 x 2 gauze pad

      •        A new needle and syringe that are the correct size

      •        A clean pair of disposable gloves (for you to wear) for each patient

      •        A Band-Aid, partially open

       

      Next, commit to cleaning as you go. Have you ever noticed that when you go to any fast food restaurant, it is always clean and organized? That’s because they teach their staff to clean as they go. This lesson, when employed in our homes and in our workplaces, is extremely useful. It’s especially useful when you are immunizing many people. You don’t accumulate trash that has to be picked up later. This process has three key points when it comes to immunization4,5:

      • Throw paper and miscellaneous trash away immediately. What this means is if you take the cap off the needle, throw it in the trash immediately. You won’t be using the cap because we don’t recap needles any longer. Throwing it in the trash ensures you won’t be tempted to recap the needle. Similarly, any paper trash generated from anything that you open should go into the trash can immediately.
      • After you inject and withdraw the needle from the muscle, activate the safety device on the needle using a hands-free method immediately.
      • Place used needles or sharps in the sharps container as soon as you finish with them. Do not place the used syringe on your work area even for a moment. Put it in the sharps container. (Yes, we are stressing this point!)

      Have a Seat, Please

      It’s critical for patients to be seated when you give injections. Ideally, you should be seated also and we will discuss why below. Ask patients to relax their arms. They can place their palms on their legs or dangle their arms at the sides. Completely expose the upper arm and find your upside-down triangle target area of the deltoid muscle. If administering more than one vaccine in the same arm, separate the injection sites by one inch so that any local reactions can be differentiated.6

      As we implied above, for most adults, we administer the COVID-19 and most other IM vaccines in the upper arm. This is the location of the deltoid muscle. You will give the injection in the center of an upside-down triangle. To give the vaccine, completely expose the patient’s upper arm, and feel for the bone that goes across the top of the upper arm. This is the acromion process. The bottom of the acromion process is the flat edge of the inverted triangle (see Figures 2 and 3).5 The triangle points down. It ends at about the level of the armpit. You will inject into the lower two thirds of the deltoid. Note that giving injections in the upper third of the deltoid can damage the muscle and cause inordinate pain.7-9

      Graphic showing the bones of the shoulder, including acromion

       

      Drawing of person showing the deltoid injection area, which is an upside-down triangle in the mid-shoulder

      Shoulder injury related to vaccine administration (SIRVA) is an emerging concern. 3,7-9 This occurs when immunizers inject vaccines into the subdeltoid bursa or within the joint space. SIRVA causes shoulder pain and limited range of motion within 48 hours after IM vaccine administration.10,11 Experts advise immunizers to avoid administering vaccines in the top one-third of the deltoid. Studies show that immunizers who sit and administer vaccines to seated patients, using needles of the appropriate length, reduce the risk of SIRVA.7,8,12

      Let’s get more specific. The correct area to give an injection is in the center of the triangle. You would inject one to two inches or two to three finger widths below the lower edge of the acromion process.5,14 Gently stretch the skin around the injection site with your non-dominant hand. This displaces the subcutaneous tissue, aids needle entry and reduces pain. Insert the needle at a 90 degree angle, all the way to the hub. Depress the plunger at a rate of 1 second for every 0.1 ml of fluid.13 Again, avoid injecting too close to the top of the arm. Don’t use this site if a person is very thin or the muscle is very small. In these cases, it’s better to inject into the anterolateral thigh.4 The SIDEBAR describes considerations when selecting needles size and length.

      A final word before we go to the actual injection process. Please don’t say, “This will not hurt a bit!” People have very different thresholds for pain and it’s impossible to predict whether it will hurt. Develop some language that you are comfortable with, and use it. A good response of people who ask if it will hurt is to say, “It may hurt or sting a little but just for a minute or two.”

      Prepare yourself before you give an injection by using personal protective equipment, and using it correctly.4 During the pandemic, we advise covering your nose and your eyes, keeping your hands away from your face, and washing your hands often. Practice good hygiene before and after immunizing each patient. Do not wear the same set of gloves for more than one patient. Change gloves between patients and wash your hands and sanitize (and let dry) before putting on a new pair of gloves.4,5

      SIDEBAR: Choosing the Right Needle4,5,14-17

      Immunizers will administer current COVID-19 vaccine from Pfizer and Moderna using needles that fall in the ranges of 22-25 gauge and 1-1.5 inches in length. Remember, the higher the gauge, the finer the needle! The Pfizer COVID vaccine is currently approved for ages 16 and older while the Moderna vaccination has approval for ages 18 and older. CDC vaccination recommendations on needle gauge and length are consistent with current Pfizer and Moderna recommendations. The table below summarizes CDC recommendations on general needle gauges and lengths for IM injections based on age.

      Chart showing CDC recommendations on needle gauge and length based on age and weight

      Although we may be injecting 1 to 1.5-inch needles into patients' deltoids now, our near future will consist of younger and frail patients. This may require use of shorter needles (i.e., 5/8 inch) and a different injection site - that being the vastus lateralis (a muscle on the outer thigh).

      Ready, Set, Go

      Let’s go through the process twice and review first the general procedure, then some specifics.

      Here are the steps4,14:

      • First, open the alcohol wipe. Wipe the area where you plan to give the injection.
      • Prepare the needle.
      • Hold (stretch) the skin around where you will give the injection.
      • Insert the needle into the muscle at a 90° angle, all the way to the hub.
      • Inject the vaccine at a rate of 0.1 ml per second.
      • Remove the needle at the same 90 degree angle.

      Now let’s review some nuances.4,5,14

      • First, open the alcohol wipe. Wipe the area where you plan to give the injection. Wiping in a circular motion from the center out sometimes increases circulation and desensitizes the area. However, there’s no need to scrub. Just wipe firmly and dispose of the used alcohol wipe and its wrapper. Let the area dry (approximately 30 seconds) and do not blow on or touch the area until you give the injection.
      • Prepare the needle. Hold the syringe with your dominant hand and pull the cover off with your other hand. Throw the cover in the trashcan immediately so you are not tempted to recap. Place the syringe between your thumb and first finger (like a dart). Let the barrel of the syringe rest on your finger.
      • Hold the skin around where you will give the injection. With your free hand, which is also your non-dominant hand, gently press on the skin and pull it so that it’s slightly tight. Experts recommend two different ways of doing this. One is to make a “C” with your nondominant hand and stretch the skin between your first finger in your thumb. The second is to use the outer edge of you hand below the pinkie finger and pull the patient’s skin taut by pushing toward the outer edge of the arm (toward your non-dominant hand).
      • Insert the needle into the muscle. Hold the syringe barrel tightly and inject the needle through the skin and into the muscle at a 90° angle.
      • Inject the vaccine. Push down on the plunger and inject the medicine using your index finger. Push firmly and steadily at a rate of about 0.1 mL per second. Note that the Pfizer COVID-19 vaccine is only 0.3 mL, so you can inject it in about three seconds. The Moderna COVID-19 vaccine is a 0.5 mL volume, so it will take five seconds to inject.
      • Remove the needle. Once you have injected the vaccine, remove the needle at exactly the same angle as you used for it to go in – that is, 90°. Activate the safety device and dispose of the entire syringe in your sharps container. You can place gauze over the area where you give the injection or cover the injection site with a Band-Aid (do not massage the area).

      SIDEBAR: Needle Safety4,18

      Now let's quickly discuss how we can keep ourselves safe while immunizing. The CDC estimates that 590,194 needlestick injuries occur annually in all healthcare settings. Immunizing exposes pharmacists to an increased risk of needlestick injury and transmission of bloodborne disease, with the most dangerous being hepatitis B, hepatitis C, and HIV. Therefore, if we are to know the perfect technique to immunize we must also know the perfect technique to keep ourselves safe.

      Prevention is key to avoiding needlestick injury. Prevention includes:

      • NEVER recapping needles by hand (if you absolutely must recap a syringe by hand, use a one-handed method and scoop the cap onto the needle. That is, place cap on a flat surface, remove your hand from the cap, insert the syringe needle tip deep into the cap, and press the tip of the cap against an inanimate object to secure it in place)
      • Disposing of used needles in sharps containers
      • Use needles with safety features, called "engineered injury protection"
      • NEVER handing a syringe with an uncapped needle to someone else

      If a needlestick injury should occur, you must be equipped with the knowledge of what to do next.

      • Needlestick/cut: wash with soap and water
      • Splashed on skin or in nose or mouth: flush with water (soap if possible)
      • Splashed in eyes: irrigate with clean water, saline, or sterile irrigants

      Be sure to report the incident to your supervisor and seek medical treatment to discuss possible risk of exposure or need for post-exposure treatment. Keeping ourselves safe is just as important as keeping our patients safe.

      Refining Technique

      So now we’ve reviewed the step-by-step process for giving an IM vaccine. Let’s talk about a few points that will refine your technique and make you a real pro.

      As we prepare to vaccinate an entire nation, pharmacists will be working side-by-side with people from many different healthcare disciplines. In fact, we may be working with people who are not healthcare providers but have simply been trained to administer immunizations. From our experience, we have learned that conflict sometimes arises because healthcare practitioners trained in different disciplines have different ways of doing things. Our intent is to follow the most recent expert advice and use best practices. For that reason, we want to point out a few things that are either so new that others may not be aware of them or different from what you may see or hear at immunization sites.

      First, some helpful observers may tell you that you need to aspirate before you inject. For many years, many healthcare professionals were trained to aspirate – meaning after the needle is in the muscle, the immunizer will pull back on the plunger and see if they draw up any blood. This is an outdated practice.14 The Centers for Disease Control and Prevention indicates that aspiration is unnecessary and unwarranted when administering vaccines. They indicate, “Aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion but before injection) is not necessary because no large blood vessels are present at the recommended injection sites, and a process that includes aspiration might be more painful for infants.”4,19  Should another provider approach you and criticize your technique, telling you that you need to aspirate, feel free to educate them about the proper way to give a vaccine!

      Second, while you are going through the immunization steps, you can help patients relax and build some confidence if you talk to the patient. A little chitchat will help patients feel comfortable. We probably don’t need to say this but we will: Stick with safe topics. Some good questions are things like, “Do you have a pet?” or “It’s really cold today, isn’t it?” Remember that it’s best to use open-ended questions once you get the conversation started, with open-ended questions being those that cannot be answered with a yes or a no. For example, if the patient responds affirmatively to your question about pets, keep the ball rolling by saying “What kind of pet do you have?” If you’re talking about the weather, you can ask the patient what his or her favorite season is, or what they like about rainy days. Asking, “What’s for dinner tonight?” is also of great conversation starter. It will also give you some ideas for your own supper!

      Next, let’s talk about skin that is not clear or is discolored. Ideally, we would want to inject into an area of the skin that is clear. You should never inject into broken skin, moles, or rashy areas. While you can inject into tattooed skin, we advise against it. The reason for this is the same as the reason that we inject into the clear areas of the skin: we want to be able to see a local reaction if it develops.4

      Finishing Up

      Finally, we are ready to finish the process. Once you’ve administer the vaccine, you’ll need to direct patients about their next steps and what they need to do. With the current COVID-19 vaccines at the current time, patients need to stay at the immunization site for 15 minutes for observation or as directed by your site’s specific policy.20 This may change as we administer significantly larger numbers of vaccinations. Older pharmacists were trained to provide a vaccine fact sheet to every patient they immunize. That practice seems to be site-specific at this point, so if your site requires a vaccine fact sheet be given to patients, do that.

      Review your documentation, and make sure that you have completed it entirely. This is critical for the COVID-19 vaccines because at some point, patients may need to prove that they were vaccinated to engage in certain activities. Take a few minutes to ensure that you have completed the documentation and submitted it appropriately.20

      A last PRO TIP is to take a minute to look at your station. Ensure that you have enough supplies to continue immunizing patients. Do not overfill your sharps containers. Know where the “FULL” line is. When they are close to full ask for or retrieve an empty container as a backup. Sanitize the area as directed by your site in preparation for the next patient.

      CONCLUSION

      Even the most proficient immunizer sometimes faces dilemmas in the immunization clinic. A final PRO TIP is indispensable: If at any time you encounter a problem and you are unsure or uncomfortable, find a more experienced immunizer and ask for help. We see all kinds of issues when we immunize—people who experience vasovagal syndrome (faint at the sight or thought of needles), people who are very thin or obese, people who have latex allergies and need to know if the vial’s stopper contains latex (neither the Pfizer or Moderna vaccine vials do). Finding someone with more expertise or simply collaborating with others to plan an approach is smart. It important to do your best to ensure the patient receives the vaccine; if you turn a patient away, he or she may not return.

       

       

       

       

       

       

      Pharmacist and Pharmacy Technician Post Test (for viewing only)

      Post Test

      Immunization: A Quick Refresher: Perfect Intramuscular Injection Technique

      1. When injecting a vaccine into the deltoid muscle, which area should you be certain to AVOID?
      A. The lower 1/3 of the upside-down triangle in which the acromion process is the top edge
      B. The middle 1/3 of the upside-down triangle in which the acromion process is the top edge
      C. The upper 1/3 of the upside-down triangle in which the acromion process is the top edge
      2. You have completed the steps necessary to prepare for injecting a vaccine. You are almost ready to insert the needle into the patient’s arm. What is the LAST STEP before inserting the needle?
      A. Pinch the skin on both sides so it makes a “mountain” and inject into the scrunched skin
      B. Use your non-dominant hand to pull the skin in one direction away from the injection site
      C. Tell the patient that it will not hurt and inject in whatever way is most comfortable for you

      3. After injecting the vaccine, removing the needle, activating the safety mechanism, and discarding the syringe in the sharps container, what should you do to ensure the medication is absorbed?
      A. Nothing. If you have used good injection technique, your job is done!
      B. Massage the area for approximately one or two minutes.
      C. Apply a hot compress and have the patient hold it there for 15 minutes.

      4. How quickly do most guidelines recommend to inject vaccines?
      A. 1 mL/second
      B. 0.1 mL/second
      C. 0.01 mL/second

      5. Why does the Advisory Committee for Immunization Practices recommend AGAINST aspiration when injecting vaccines?
      A. It increases risk of bleeding that will be difficult to stop
      B. It causes vaccine to leak from the muscle and decreases effectiveness
      C. No large blood vessels are present at the recommended injection sites

      6. Which of the following are the MOST COMMON bloodborne pathogens?
      A. Hepatitis B, hepatitis C, and HIV
      B. Influenza, coronavirus, and HIV
      C. Pneumonia, pinkeye, and staphylococcus

      7. Which of the following statements is TRUE?
      A. Always recap needles by hand
      B. Dispose of used needles in trash receptacles
      C. Use needles with safety features

      8. If you absolutely must recap a syringe by hand, how many hands should you use?
      A. One
      B. Two
      C. Three (get someone else to help)

      9. You are prepared to inject a vaccine and have uncapped the needle, and thrown away the cap. Your team leader enters the room and says she needs you immediately to answer some questions about your last patient. She has brought another immunizer to take over your station for 15 minutes. Which of the following is the BEST way to proceed?
      A. Hand the syringe with the uncapped needle to your replacement so he can finish this patient’s vaccination and leave with the team leader.
      B. Fish around in the trash can, find the cap, and recap the needle, and give the now-capped needle to your replacement to finish with this patient.
      C. Tell the team leader that you have discarded the cap, and suggest you finish with your current patient since it will only be a few seconds.

      10. You inadvertently squirt something from a used syringe into your eye. What do you do?
      A. Irrigate with clean water, saline, or sterile irrigants
      B. Wash with soap and water
      C. Flush with detergent and water

      11. Which of the following would be considered an “engineered injury protection”?
      A. Syringes with sliding sheath that shields the attached needle after use
      B. Using an open container in which to dispose used needles
      C. Asking employees for input on what needles they prefer

      12. Select the statement that is TRUE for the current Pfizer and Moderna vaccines:
      A. Both vaccines do not come with administration devices
      B. Both must be stored in the refrigerator until 15 minutes before use
      C. Both require needles that are 22-25 gauge and 1-1.5 inches in length

      13. You greet a patient and ask him to uncover his deltoid. As you assess him, you notice that he must weigh at least 350 pounds. Which factor needs to be adjusted before you administer the vaccine?
      A. The dose
      B. The needle gauge
      C. The needle length

      14. Your patient looks at the syringe, pales, and begins to shake. She tells you that she has a “vasovagal” reaction to needles. You do not know what this means. What is the BEST way to proceed?
      A. Distract her with idle chit-chat
      B. Find a more experienced immunizer
      C. Tell her she will have reschedule

      15. Patients can be quirky. Your current patient wants to stand to receive the vaccination. What is the BEST explanation for why both of you should sit?
      A. Immunizers who sit and administer vaccines to seated patients reduce the risk of injury to the patient’s shoulder.
      B. Immunizers who sit and administer vaccines to seated patients reduce the risk of needlestick injury to the immunizer.
      C. Immunizers who stand and administer vaccines to seated patients reduce the risk of the patient fainting.

      16. Your patient is heavily tattooed. In this training, we emphasized the importance of finding the area of clearest skin. Why?
      A. We want to be able to see a local reaction if it develops.
      B. Injecting into tattooed skin is more painful for the patient.
      C. Current COVID vaccines cannot be given in a tattooed area.

      17. What is the proper angle to give an IM injection?
      A. 45o
      B. 90o
      C. Inject at 45o, withdraw at 90o.

      18. Which of the following questions should you be prepared to answer in case a patient asks?
      A. Does the vaccine’s vial have plastic in the stopper?
      B. Does the vaccine’s vial have latex in the stopper?
      C. Does the vaccine come in a multidose vial?

      19. What is the BEST position for a patient’s arm while you are giving an IM injection?
      A. Relaxed with palms on legs or arm dangling at sides
      B. Taut with the patient squeezing a rubber ball
      C. Flexed as if they were showing you the size of their deltoid

      20. You’ve vaccinated a patient with a COVID vaccine, disposed of the sharp, and finished your task. What is the BEST thing to tell the patient?
      A. Thanks for doing this, your nation appreciates you.
      B. See you for the follow-up dose in six weeks!
      C. Please remain in the clinic for 15 minutes.

      References

      Full List of References

      References

         
        1. Harmon A. What the Vaccine Side Effects Feel Like, According to Those Who’ve Gotten It. Available at https://www.nytimes.com/2020/12/28/us/vaccine-first-patients-covid.html. Accessed December 30, 2020.
        2. Wick JY. Immunization: Tips, tools, and total success. Available at https://www.pharmacytimes.com/publications/issue/2016/August2016/Immunization-Tips-Tools-and-Total-Succes. Accessed January 2, 2020.
        3. Bancsi A, Houle SKD, Grindrod KA. Getting it in the right spot: Shoulder injury related to vaccine administration (SIRVA) and other injection site events. Can Pharm J (Ott). 2018;151(5):295-299.
        4. Centers for Disease Control and Prevention. Vaccine administration. Available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/administration.html. Accessed December 30, 2020.
        5. Centers for Disease Control and Prevention. Vaccine Administration: Intramuscular (IM) Injection Children 7 through 18 years of age. Available at https://www.cdc.gov/vaccines/hcp/admin/downloads/IM-Injection-children.pdf. Accessed December 30, 2020.
        6. Centers for Disease Control and Prevention. Adminster the vaccines. Available at https://www.cdc.gov/vaccines/hcp/admin/administer-vaccines.html. Accessed January 3, 2021.
        7. Bodor M, Montalvo E. Vaccination-related shoulder dysfunction. Vaccine. 2007;25(4):585-587.
        8. Atanasoff S, Ryan T. Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine administration (SIRVA). Vaccine. 2010;28(51):8049-8052. doi: 10.1016/j.vaccine.2010.10.005.
        9. Cook IF. Subdeltoid/subacromial bursitis associated with influenza vaccination. Hum Vaccin Immunother. 2014;10(3):605-606. doi:10.4161/hv.27232.
        10, National Vaccine Injury Compensation Program (VICP). Prevention of SIRVA. Health Resources and Services Administration website. Available at hrsa.gov/advisorycommittees/childhoodvaccines/meetings/20150604/sirva.pdf. Accessed December 30, 2020.
        11. Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don’t aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303-306.
        12. Kroger AT, Sumaya CV, Pickering LK, Atkinson WL. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2011;60(RR02):1-60.
        13. : Dougherty L, Lister S (2015) The Royal Marsden Hospital Manual of Clinical Nursing Procedures. Oxford: Wiley-Blackwell.
        14. Immunize.org. How to administer intramuscular and subcutaneous vaccine injections. Avaialble at https://www.immunize.org/catg.d/p2020.pdf. Accessed January 3, 2021.
        15. Centers for Disease Control and Prevention. Moderna COVID-19 vaccine. Available at https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/standing-orders.pdf. Accessed January 3, 2021.
        16. Centers for Disease Control and Prevention. Pfizer-BioNTech COVID-19 Vaccine. Available at https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/prep-and-admin-summary.pdf. Accessed January 3, 2021.
        17. Centers for Disease Control and Prevention. Vaccine administration: Needle gauge and length. Available at https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf. Accessed January 3, 2021.
        18. U.S. Government Printing Office. Needlestick Safety and Prevention Act. Available at http://www.gpo.gov/fdsys/pkg/PLAW-106publ430/html/PLAW-106publ430.htm. Accessed January 3, 2021.
        19. Ipp M, Taddio A, Sam J, Gladbach M, Parkin PC. Vaccine-related pain: randomised controlled trial of two injection techniques. Arch Dis Child. 2007;92(12):1105-1108. DOI: 10.1136/adc.2007.118695
        20. Centers for Disease Control and Prevention. Resource library. Available at https://www.cdc.gov/vaccines/hcp/admin/resource-library.html. Accessed January 3, 2021.

        Treating Gout without Doubt

        Learning Objectives

         

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

        1. Describe gout's pathogenesis, relationship to hyperuricemia, and complications of untreated gout
        2. Describe the diagnosis and goals of therapy for gout
        3. Recall nonpharmacologic therapy for the management of gout and medications that can increase serum uric acid level
        4. Discuss the appropriate approach to gout therapy (acute attack treatment, prevention of future gout attacks, "medication-in-pocket," and "treat-to-target") and its timing

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

        1. Describe gout's pathogenesis, relationship to hyperuricemia, and complications of untreated gout
        2. Recall nonpharmacologic therapy for the management of gout and medications that can increase serum uric acid level
        3. Recognize different pharmacological classes and regimens for urate-lowering therapy (ULT) and target serum uric acid level
        4. Define the "treat-to-target" and "medication-in-pocket" approaches in gout therapy

           

          Release Date: January 10, 2024

          Expiration Date: January 10, 2027

          Course Fee

          Pharmacists:  $7

          Pharmacy Technicians: $4

          There is no funding for this CE.

          ACPE UANs

          Pharmacist: 0009-0000-24-006-H01-P

          Pharmacy Technician:  0009-0000-24-006-H01-T

          Session Codes

          Pharmacist:  24YC06-JBX39

          Pharmacy Technician: 24YC06-XJB44

          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 0009-0000-24-006-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

          Samar Nicolas, RPh, PharmD, CPPS
          Assistant Professor of Pharmacy Practice
          MCPHS University
          Worcester/Manchester, MA

          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.

          Samar Nicolas has no relationships with ineligible companies.

           

          ABSTRACT

          Gout is the most common form of inflammatory arthritis affecting about 9.2 million adults in the United States (US) and is the result of hyperurice-mia. Gout results from the chronic deposition and crystallization of urate in the joints and tissues. Although gout can affect any joint, initial attacks usually in-volve the big toe joint. The most recent guideline for the management of gout recommends colchicine, nonsteroidal anti-inflammatory drugs, or glucocorticoids (oral, intraarticular, intramuscular) as first-line agents for the treatment of gout flares. Patient-specific factors guide the drug choice among the first-line agents. Interleukin-1 inhibitors or adrenocorticotropic hormone are alternative agents. Pharmacists are well-positioned to assess adherence to ULT and educate patients about the importance of urate lowering therapy. Pharmacy technicians can ensure that patients have refills on their medication-in-pocket prescription to facilitate early initiation.

          CONTENT

          Content

          INTRODUCTION

          “I’ve been shot, and I’ve been stabbed; nothing compares to gout pain.”

          This is how Jim, a 77 year old man, describes his pain as he hobbles into the pharmacy to refill his prescription for colchicine. Jim complains that colchicine is not controlling his gout. He is wearing slippers that show his red swollen joint around his right big toe that is warm and painful to touch. Jim says his physician explained that these symptoms are due to podagra, uric acid crystallization and settling in the joint between his foot and big toe.1 As Jim speaks, his breath projects a strong alcohol smell.

          Gout is the most common form of inflammatory arthritis affecting about 9.2 million adults in the United States (US) and is the result of hyperuricemia.2,3 Men are at higher risk of developing gout than women.4 Other risk factors include post-menopause, genetics, end-stage renal disease, and major organ transplant.

          Uric acid overproduction, under-excretion, or both, elevate serum uric acid levels.5 Underexcretion of uric acid accounts for about 90% of gout cases.6 Human bodies produce uric acid as they break down dying tissues.4 Other sources of uric acid are foods high in purines, such as meats, seafood, and alcoholic beverages.7, 8 Ancient Greek history states that only rich people, who could afford these expensive foods, experience gout.9 Therefore, in the 5th century before Christmas (B.C.), people referred to gout as “the disease of kings.”10

          PATHOGENESIS

          Uric acid circulates in the blood as monosodium urate.11 In the kidneys, uric acid and urate undergo filtration and secretion into the filtrate followed by about 90% reabsorption into the blood.12 The American College of Rheumatology (ACR) guideline defines hyperuricemia as serum uric acid of 6.8 mg/dL or greater, the level above which urate becomes insoluble in the blood.4

          Gout results from the chronic deposition and crystallization of urate in the joints and tissues.4,13 Insoluble monosodium urate crystals form stone-like deposits, known as tophi, in soft tissues, synovial tissues, or bones.14,15 Tophi trigger an inflammatory response, which presents as an acute gout attack.15,16 However, hyperuricemia does not always result in gout.4

          Although gout can affect any joint, initial attacks usually involve the big toe joint. Gout attacks are sudden and very painful.17 Acute gout attacks reach maximum pain level in 12 to 24 hours and may last 3 to 14 days if patients do not seek therapy.18 For this reason, all healthcare providers including those on pharmacy teams need to educate patients to seek medical care. Effective gout management reduces the risk of long-term complications like degenerative arthritis, urate nephropathy, infections, renal stones, joint fractures, and nerve or spinal cord impingement.19

           

          DIAGNOSIS OF GOUT

          Clinicians diagnose gout by collecting patient history, examining the patient, laboratory workup, and imaging.19 Uric acid crystals in the synovial fluid or tophi in tissues and/or bones confirm gout diagnosis regardless of the uric acid level.4

          TREATMENT OF GOUT

          The ACR guideline describes 3 treatment goals for patients with gout20:

          1. Terminating the acute gout attack
          2. Preventing future attacks
          3. Lowering the serum uric acid level

          Terminating the Acute Gout Attack

          The ACR published the most recent guideline for the management of gout in 2020. The ACR guideline recommends colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), or glucocorticoids (oral, intraarticular, intramuscular) as first-line agents for the treatment of gout flares.20  Patient-specific factors guide the drug choice among the first-line agents. Interleukin-1 (IL-1) inhibitors or adrenocorticotropic hormone (ACTH) are alternative agents.20  If a first-line agent is ineffective, intolerable, or contraindicated, the ACR guideline recommends switching to another first-line agent before trying alternative agents. Topical ice is an adjunct to pharmacologic therapy. The severity of the gout flare guides the treatment duration.

           

          Colchicine

          Colchicine exerts its anti-inflammatory effects by binding to free tubulin dimers leading to microtubule polymerization inhibition, which affects cellular function.21, 22 Colchine has had an interesting history, as the SIDEBAR explains. Common side effects of colchicine are dose-dependent and include diarrhea, nausea, and vomiting.  Because of its mechanism of action, toxic levels of colchicine inhibit cellular division leading to failure of multiple organs .22 Colchicine doses of 0.8 mg/kg are lethal.23 Colchicine undergoes extensive tissue distribution and therefore, a lower dose can be toxic in patients with liver or renal failure. Some unchanged colchicine undergoes renal excretion through glomerular filtration and therefore, requires dosage adjustment for renal dysfunction.21, 24  Cytochrome P450 3A4 hepatic enzymes metabolize colchicine.21, 25 P-glycoprotein facilitates colchicine removal from the body.26 Co-administration of medications that inhibit CYP3A4 enzyme activity (example: grapefruit juice, azole antifungals, erythromycin, verapamil) increase the risk of colchicine toxicity.21, 25 In addition, co-administration of colchicine with P-glycoprotein inhibitors (example: digoxin) increases the risk of colchicine toxicity.26 Toxic symptoms are dose-dependent with increasing severity.27 Patients with toxicity may present with gastrointestinal symptoms (nausea, vomiting, diarrhea), hypotension, lactic acidosis, or acute kidney injury.22, 27 To decrease the risk of toxicity, colchicine’s prescribing information recommends avoiding its co-administration with P-glycoprotein inhibitors or CYP3A4 inhibitors in patients with renal or hepatic impairment.28 For other patients, the prescribing information recommends weighing risks versus benefits before co-administering colchicine with medications that pose a significant drug interaction.

           

          SIDEBAR: HISTORY OF COLCHICINE

          Colchicine is derived from a plant, Colchicum automnale.29 Other names for this plant include Autumn Crocus, meadow saffron, naked lady, and colchicum.30 Ebers Papyrus, an Egyptian medical document on herbs dating back to 1500 BC, indicates the use of C. automnale for joint pain.31 In 1833, a German pharmacist analyzed the substance and gave it the name colchicine.29 In France, in 1819, a chemist and a pharmacist isolated colchicine from the plant. In 1884, a French pharmacist produced and sold colchicine as 1 mg granules, which is still available in some countries.29,32 Colchicine accounts for about 0.1-0.6% of the plant content.33 Non-surprisingly, the C. automnale plant is poisonous. Humans should not ingest the plant. Symptoms of C. automnale toxicity resemble the side effects or toxicity of colchicine.34 These symptoms range from diarrhea, nausea, and vomiting to organ failure and death.

          Colchicine was available for decades in the US without a U.S. Food and Drug Administration (FDA) approved labeling.35 Despite the Food, Drug, and Cosmetics Act requiring the FDA to approve medications based on efficacy and safety data, colchicine was grandfathered in. Grandfathered drugs were medications available on market before the Food, Drug, and Cosmetics Act of 1938 or its amendments in 1962.

          In 2006, the FDA initiated the unapproved drug initiative (UDI).36 The goal of the UDI program was to decrease the number of medications in the United States that do not carry FDA approval. Under the UDI program, the FDA allowed exclusive marketing to manufacturers who obtain FDA approval. Some pharmacists and pharmacy technicians may recall colchicine shortage as manufacturers of colchicine received warning letters from the FDA to stop selling colchicine.37 Mutual Pharmaceutical Company submitted a new drug application (NDA) for colchicine in November 2008.38 The UDI did not require manufacturers to conduct new clinical trials to obtain FDA approval. Mutual Pharmaceutical Company’s NDA included data from randomized controlled trials in 1974 and 2004 that proved the safety and efficacy of colchicine. As a result, in July 2009 the FDA approved colchicine for the treatment of gout and familial Mediterranean fever. Colchicine came back to the US market under brand name Colcrys.39

           

          Colchicine is light sensitive. Pharmacies should protect colchicine from light and dispense it in a light-resistant container.28 The FDA requires pharmacies to distribute a medication guide to patients when dispensing colchicine.40 Medication guides inform patients of potential serious adverse reactions and harm mitigation strategies. The Institute for Safe Medical Practices (ISMP) lists colchicine on the look-alike sound-alike (LASA) list due to potential for confusion with Cortrosyn, which is the brand name for cosyntropin.41  Of note, cosyntropin is a synthetic adrenocorticotropin hormone that has anti-inflammatory properties and is an alternative agent for gout attacks.42 In patients with a history of gout, the ACR guideline recommends a “medication-in-pocket” (discussed below) approach to allow early initiation of an anti-inflammatory drug at the onset of a gout flare.20 Since colchicine has anti-inflammatory properties, it is an option for the “medication-in-pocket” approach.

          The pharmacist takes a close look at Jim’s prescription refill history to figure out why colchicine is not working for Jim. The pharmacist explores several possibilities:

          • Is Jim adhering to his urate-lowering therapy (ULT)?
          • Is Jim refilling his colchicine as part of a gout flare prophylactic therapy upon initiating ULT?
          • Is Jim asking for colchicine as a “medication-in-pocket” approach?
          • Is Jim consuming excessive alcohol?
          • Is Jim eating foods rich in purines?
          • Is Jim taking any prescription or over-the-counter medications that may increase his uric acid level?

          NSAIDs

          The FDA has approved indomethacin, naproxen, and sulindac for the treatment of acute gout flare.43,44, 45 However, the guideline does not recommend a specific NSAID.20 Choice of agent depends on patient-specific factors including cardiovascular (CV) risk, gastrointestinal (GI) risk, cost, and availability without a prescription.46 Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor and therefore carries a low GI risk but is associated with a dose-dependent increase in CV risk.47, 48 Ibuprofen carries a low GI risk. Indomethacin, naproxen, diclofenac, and sulindac carry a moderate GI risk.49, 50 Among the nonselective NSAIDs, CV risk is highest with diclofenac and lowest with naproxen.51 Despite differences in CV risk among nonselective NSAIDs, the FDA mandates a boxed warning for all NSAIDs about increased  risk of thrombosis, myocardial infarction (MI), and stroke.52, 53 In addition, the FDA requires pharmacies to distribute a medication guide to patients when dispensing a prescription for NSAIDs.54 Any NSAID is an option for the “medication-in-pocket” approach.20

          Glucocorticoids

          The ACR guideline does not recommend a specific oral glucocorticoid.20 Parenteral glucocorticoids (intramuscular, intravenous, or intraarticular) are alternative options for patients who cannot tolerate oral therapy. Glucocorticoids (example: prednisone, methylprednisolone) are an attractive option for patients with chronic kidney disease (CKD) or those who cannot tolerate colchicine or NSAIDs.1,55 Short-term glucocorticoids do not cause significant side effects.56, 57 Glucocorticoids are an additional option for the “medication-in-pocket” approach, including injectable formulations for patients who cannot take oral medications.20 Methylprednisolone is available in different dosage forms such as oral, intramuscular (as acetate or succinate), intravenous (as acetate), and intraarticular (as acetate).58

          Anakinra

          Anakinra is an IL-1 receptor antagonist.59 It blocks the activity of the inflammatory mediatory IL-1. Anakinra has an off-label indication for gout attacks at a dose of 100 mg subcutaneously daily for 3 to 5 days.60, 61 The ACR guideline classifies anakinra as an alternative agent, particularly due to cost.20 The manufacturer recommends storing anakinra in the refrigerator and protecting from light until ready for administration.62 Patients can self-administer anakinra after demonstrating proper administration technique.59

          ACTH

          Adrenocorticotropic hormone (ACTH) binds to melanocortin receptors, which triggers the release of endogenous steroids, thus decreasing inflammation.63 The ACR guideline recommends ACTH as an alternative agent.20,63 ACTH is available as an intramuscular or subcutaneous injection.64 The purified cortrophin formulation carries an indication for acute gouty arthritis.65 The manufacturer does not provide a dosing recommendation specific for gout and recommends caution in patients with renal insufficiency.64-66 The manufacturer recommends storing ACTH in the refrigerator until ready for administration and warming to room temperature before injecting.67

          Table 1 summarizes the first-line agents for the treatment of gout flares.

          Table 1. First-line Agents for the Treatment of Gout Flares20, 24, 44-46, 56, 68-71 
          Therapy Dose Comment Monitoring parameters
          Colchicine ·        Day 1 of therapy: Use treatment dose of 1.2 mg by mouth (PO) as soon as possible then 0.6 mg after one hour. Maximum dose 1.8 mg/day.

          ·        Day 2 and until flare resolves, use prophylactic dose of 0.6 mg PO once or twice daily.

          If creatinine clearance (CrCl) < 30 mL/min:

           

          ·        Use 1.2 mg PO as soon as possible then single dose of 0.6 mg after one hour. Avoid repeating therapy within a 14-day period.

          ·        Alternatively, use 0.3 mg PO as soon as possible as a single dose. Avoid repeating therapy within 3-7 days.

           

          If patient is on dialysis:

          ·        Use 0.6 mg PO as a single dose. Avoid repeating therapy within a 14-day period.

          Monitor patients with CrCl ≤ 80 mL/min closely for adverse effects.
          NSAIDs

           

          ·        Indomethacin: 50 mg three time daily until pain is tolerable (usually, 3 to 5 days).

          ·        Sulindac: 200 mg twice daily until attack resolves (usually, 7 days).

          ·        Naproxen: 750 mg x 1 dose then 250 mg every 8 hours until attack resolves (usually, 2 days).

          ·        The manufacturer does not provide recommendations for renal dosage adjustment.

          ·        The Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommends avoiding use of NSAIDs If CrCl < 30 mL/minute.

          Monitor GI, renal, and CV toxicity in elderly patients.

          Prescribe lowest effective dose for the shortest duration possible.

          Glucocorticoids ·        Follow specific glucocorticoid dosing recommendation. Safest option in patients with CKD. Monitor serum glucose, blood pressure, electrolytes, mood changes, and recurrent infections.

           

          Interestingly, a panel consisting of eight patients with gout participated in the development of the 2020 ACR guidelines.20 The patient panel provided valuable input from a patient perspective regarding therapy preference for patients with an established gout diagnosis. The patient panel strongly favored a medication-in-pocket approach for the treatment of acute gout flares. With this approach, the clinician prescribes an anti-inflammatory medication that the patient keeps on hand for use as needed.72 Moreover, the patient panel favored an injectable dosage form for the medication-in-pocket to control the pain faster in patients who can take nothing by mouth. The medication-in-pocket approach ensures that patients have quick access to an anti-inflammatory medication at the first onset of gout attack symptoms.20

          Jim’s colchicine regimen is consistent with the “medication-in-pocket” to treat an acute gout flare.

          MANAGEMENT OF CHRONIC GOUT

          The goal of chronic gout management is to lower the serum uric acid level with ULT, if indicated, and to prevent future attacks.20 ULT includes medications that decrease uric acid production or promote uric acid excretion.73 The ACR 2020 guideline recommends a “treat-to-target” approach that guides ULT dose titration and maintenance to achieve serum uric acid of less than 6 mg/dL.20 Lower ULT initial dosing with subsequent titration decreases the risk of gout flare associated with ULT initiation.20

          Pause and Ponder: What patient factors determine eligibility for urate lowering therapy (ULT)?

          Table 2 provides recommendation on initiation of ULT based on patient-specific factors.

          Table 2 - Indication for ULT 20
          Patient factors 2020 ACR guideline recommendation Comment
          ≥1 subcutaneous tophi ACR guideline strongly recommends initiating ULT Moderate or high certainty of evidence that benefits of ULT consistently outweigh the risks
          Gout-attributable radiographic damage
          ≥2 gout flares per year
          > 1 flare but < 2 flares per year ACR guideline conditionally recommends initiating ULT Low certainty of evidence or no data available and/or benefits and risks closely balanced
          First flare and any of the following:

          ·        Chronic kidney disease (CKD) stage ≥ 3

          ·        Serum uric acid > 9 mg/dL

          ·        Urolithiasis

          First gout flare ACR guideline conditionally recommends against initiating ULT
          Asymptomatic hyperuricemia*

          *Serum uric acid > 6.8 mg/dL

          Pause and Ponder: Which urate-lowering agent is first-line therapy?

          Table 3 summarizes urate-lowering medications.

          Table 3 - Urate Lowering Medications 20,74-76
          Pharmacological class Mechanism of action Medication Comments
          Xanthine Oxidase Inhibitors Inhibition of xanthine oxidase resulting in decreased conversion of hypoxanthine to xanthine and xanthine to uric acid. Allopurinol

          Febuxostat

          ·        Allopurinol is first-line agent.

          ·        Start allopurinol at ≤ 100 mg/day in normal kidney function and ≤ 50 mg/day in CKD stage ≥ 3 then titrate.

          ·        Start febuxostat at ≤ 40 mg/day then titrate.

           

          Uricosuric Agents Inhibition of urate reabsorption in the renal tubules resulting in increased excretion of uric acid in the urine. Probenecid ·        ACR guideline strongly recommends XOI over probenecid for patients with CKD stage ≥ 3

          ·        Start probenecid at 500 mg PO once or twice daily then titrate.

          Urate Oxidase Enzyme Catalysis of uric acid oxidation to water-soluble allantoin resulting in increased excretion of the allantoin in the urine. Pegloticase ·        ACR guideline strongly recommends against use of pegloticase as a first-line agent

          ·        Administer pegloticase 8 mg IV infusion every 2 weeks along with methotrexate 15 mg PO once a week with a folic acid supplement.

          ·        Start weekly methotrexate and folic acid supplementation 4 weeks before initiating pegloticase and continue while on pegloticase.

           

          Clinicians usually determine eligibility for ULT when patients present with an acute gout attack.20 Some experts favor initiating ULT two to four weeks after the resolution of a gout attack.77 One reason for this practice stems from the fear of gout attack worsening with ULT initiation. The other reason is the perception that during a gout attack, patients are in too much pain to process information regarding chronic therapy. However, the ACR guideline favors initiating ULT during a gout flare as patients may not return for a follow-up visit to initiate ULT after the flare resolves.20

          XANTHINE OXIDASE INHIBITORS (XOIs)

          XOI include allopurinol and febuxostat.20 XOI are first-line among urate-lowering agents, and the guideline recommends allopurinol as a first-line agent for all patients with gout, unless contraindicated.

          Allopurinol

          Allopurinol is associated with an increased risk of allopurinol hypersensitivity syndrome (AHS), a rare but severe, and potentially life-threatening adverse reaction.78 AHS presents as fever, severe rash, eosinophilia, hepatitis, and acute kidney injury.79 AHS is more common in patients who are African Americans or of Southeast Asian descent.78 Pharmacogenetic studies show that these patients have a gene on their human leukocyte antigen (HLA) system that increases the risk of developing AHS. This gene is the HLA-B*5801 allele.80 The interaction of allopurinol with the HLA-B*5801 allele triggers an immune reaction characterized by T-cell activation.81 Not all patients who are positive for HLA-B*5801 allele develop AHS.82 Risk of AHS increases in HLA-B*5801 allele positive patients who have elevated allopurinol serum level due to dose increase or renal dysfunction.81

          In the US, testing for HLA-B*5801 in Caucasians or Hispanics is not cost-effective.83 The 2020 ACR guideline recommends genetic testing for the HLA-B*5801 allele before starting allopurinol for patients who are African Americans or of Southeast Asian descent.20 The guideline recommends starting allopurinol at a low dose of 100 mg daily for normal renal function and a lower dose in case of renal dysfunction.

          The prescribing information recommends protecting allopurinol from light.74 ISMP lists the brand name of allopurinol, Zyloprim, on the look-alike sound-alike (LASA) list due to potential for confusion with zolpidem.42

           

          SIDEBAR: DID YOU KNOW THAT THE DISCOVERY OF ALLOPURINOL LED TO A NOBEL PRIZE AWARD?

          Gertrude Elion, who earned a master’s degree in chemistry from New York University in 1941, worked as a lab assistant for George Hitchings. Up until the 1950s, scientists produced medications by screening and modifying naturally existing substances.84 However, Elion and Hitchings’ contribution to medicine was groundbreaking to drug development as they introduced drug therapy that was targeted to specific cells. In 1963, Elion and Hutchings discovered that allopurinol blocked the synthesis of uric acid. In 1988, the Nobel Prize Committee awarded Gertrude Elion and George Hitchings the Nobel Prize in Physiology or Medicine for the discovery of allopurinol and other medications.85

           

          Febuxostat

          Febuxostat carries a boxed warning for increased risk of CV death in patients with cardiovascular disease (CVD), when compared to allopurinol.86 Therefore, the 2020 ACR guideline recommends selecting another ULT medication in patients with established CVD.20 For patients who experience a CV event while on febuxostat, the ACR guideline recommends switching to a different ULT medication.20 The FDA requires pharmacies to distribute a medication guide when dispensing febuxostat to patients.86

          URICOSURICS

          Probenecid

          Probenecid is the only uricosuric drug approved in the United States.87,88 Probenecid may cause nephrolithiasis (uric acid stones in the kidneys).89 These uric acid stones form as the uric acid crystallizes in an acidic urine. The prescribing information for probenecid recommends adequate hydration and adjunct urine alkalinizing agents (example: sodium bicarbonate or potassium citrate).89 However, the 2020 ACR guideline determined insufficient evidence to recommend the routine use of alkalinizing agents with probenecid.20 Probenecid is usually an add-on therapy in patients with partial response to an XOI. Remember to counsel patients on adequate hydration to decrease the risk of nephrolithiasis.

          ISMP lists probenecid on the LASA list due to potential for confusion with Procanbid, the brand name for procainamide, an antiarrhythmic drug.42 Probenecid also has some interesting abuse potential (see the SIDEBAR).

           

          SIDEBAR: CAN PROBENECID HELP ATHLETES IMPROVE PERFORMANCE?

          Random drug testing in sports led athletes to misuse probenecid to mask the unlawful use of performance-enhancing drugs such as anabolic-androgenic steroids.90 Probenecid inhibits the tubular secretion of anabolic-androgenic steroids in the kidneys, thus inhibiting their excretion in the urine. As a result, urine drug testing will not detect the use of these illegal substance, and athletes can pass the random drug testing successfully. In 1986, a doping control officer traveled from Norway and collected 6 urine samples from 6 Norwegian athletes who were training in the US. The athletes showed up at least 1.5 hours late probably to allow time for onset of action of the masking agent. Five of the samples showed an unusually dilute urine with low specific gravity. In addition, the concentration of endogenous androgenic-anabolic steroids in the urine samples was at least 100 times below normal.90 These unusual findings along with suspicious behaviors projected by the athletes during the testing process, triggered further analysis of the urine samples. The lab identified a “new masking agent”, probenecid and its metabolite, in these urine samples. Today, probenecid appears on the World Anti Doping Agency (WADA) prohibited list.91 The WADA list serves as a standard for identifying substances that athletes may illegally use to enhance performance in sports.91

           

          URATE OXIDASE ENZYME

          Pegloticase

          The FDA approved pegloticase for adults with chronic gout refractory to conventional therapy.92 The 2020 ACR guidelines recommends switching to pegloticase when XOIs, probenecid, and other interventions fail.20 In clinical trials, administering methotrexate with pegloticase increased the chance of tophi resolution by 22.8% compared to pegloticase monotherapy.76 Therefore, pegloticase’s prescribing information recommends co-administration with methotrexate, unless contraindicated. Folic acid supplementation decreases the risk of hepatotoxicity and GI side effects associated with methotrexate.93 Pharmacists should counsel patients about the importance of adherence to folic acid while on methotrexate.

          The manufacturer recommends storing pegloticase in the refrigerator and protecting it from light before dispensing.76 After diluting pegloticase for IV infusion in an institutional setting, healthcare workers should protect the solution from light.

           

          Pause and Ponder: When does the guideline recommend switching urate-lowering agents?

          The 2020 ACR guideline recommends using the maximum tolerated or recommended dose of a ULT.20  Figure 1 outlines the management of patients taking a XOI requiring adjustment to therapy:

          Figure 1. Switching ULT

          Jim’s medication profile reveals that he has been taking allopurinol for little over a year now.

           

          DURATION OF THERAPY

          For patients tolerating ULT, the 2020 ACR guideline recommends indefinite therapy to avoid worsening gout and its associated complications.20 Patients may not adhere to therapy due to cost, pill burden, and low health literacy.94 Remember to counsel patient on adherence and goals of ULT as patients may think they do not need to take ULT if they have no symptoms.

          PREVENTING GOUT FLARE UPON INITIATION OF ULT

          Initiation of ULT may trigger a gout flare due to activation of crystals precipitated in joints.95, 96 The risk of gout flare increases with higher reduction in serum uric acid levels. Studies suggest that gout attacks associated with ULT may decrease patient adherence to ULT.97 Prophylaxis with anti-inflammatory medications decreases the risk of gout flare upon ULT initiation. The 2020 ACR guideline recommends prophylactic therapy upon initiating ULT and for at least three to six months. Patients who continue to experience flares may require a longer duration of prophylactic therapy.20 Experts recommend colchicine or NSAIDs as first-line prophylactic therapy.98 Table 4 summarizes prophylactic medications and recommendations.

          Table 4 – Medications that Prevent Gout Attack with ULT Initiation
          Medication Recommendation
          Low-dose colchicine Use 0.6 mg once or twice daily
          Low-dose NSAIDs Use naproxen 250 mg or equivalent dose of different NSAID

          Add proton pump inhibitor if indicated

          Low-dose prednisone or prednisolone Use less than or equal to 10 mg per day

          Reserve corticosteroids for patients who cannot tolerate colchicine and NSAIDs

           

          NONPHARMACOLOGIC THERAPY AND LIFESTYLE MODIFICATIONS

          Serum uric acid levels decrease only slightly with dietary modifications.20 In addition, certain diets may trigger a gout flare. To decrease the risk of flares, the 2020 ACR guideline conditionally recommends the following approaches:

          • Limiting alcohol intake
          • Limiting purine intake. Some examples of high-purine foods include seafood like sardines, tuna, haddock, and meats like bacon, turkey, veal, and liver.99, 100
          • Limiting high-fructose corn syrup intake
          • Following a weight loss program if the patient is overweight or obese

          Jim projected an alcohol breath when speaking. Jim may be consuming excessive amounts of alcohol. He may be consuming a non-gout friendly diet.

          DIGITAL HEALTH AND GOUT MANAGEMENT

          Digitalization of health care is rapidly evolving and involves the use of technology to manage health conditions, ameliorate modifiable risk factors, and promote health and wellness.101 Wearable devices such as fitness trackers, patient portals, and mobile apps are only few examples of digital health tools. Investigators suggest that gout mobile health apps may improve patient perception of the disease, clarify beliefs, and benefit self-care.102 However, further studies are essential to prove these mobile applications beneficial. As of this writing, several gout-related mobile health applications are available. Target users for these applications can be clinicians or patients. For example, a physician developed a mobile application called Gout Diagnosis. The application includes an evidence-based algorithm to facilitate an accurate diagnosis of gout.103 On the other hand, patients can download from a variety of existing gout mobile applications at little or no cost.104 The National Kidney Foundation developed a mobile application called Gout Central. This application comes from a reputable foundation and provides patient education on symptoms and risk factors for gout, nonpharmacologic recommendations such as diet and lifestyle modifications, and medications to treat gout and prevent flares.104 The FDA does not regulate mobile medical applications.105 Therefore, the choice of mobile health application depends on patient preference such as cost, ease of use, compatibility, security, and type of content.106

          A mobile application may help Jim learn about foods and drinks that may trigger gout attacks.

          PHARMACY TEAM IMPACT ON GOUT MANAGEMENT

          Pharmacists are the most accessible healthcare professionals. Patients with a gout flare may seek pharmacists for recommendations on pain management. When patients without a previous gout diagnosis present to the pharmacy, pharmacists may recognize signs of gout and refer them to their primary care clinician. Pharmacists can educate patients who have a diagnosis for gout about the phases and goals of gout therapy, including the likelihood that ULT will be a lifelong therapy.

          Pharmacists are well-positioned to assess adherence to ULT and educate patients about the importance of ULT.107 Pharmacists can assess patient understanding of various therapies and remind them that anti-inflammatory medications treat acute gout attack or prevent gout flare upon initiating ULT. Pharmacists should empower patients to request from their clinician a medication-in-pocket prescription. Pharmacists should counsel patients on the proper use of medication-in-pocket by reminding them to take the anti-inflammatory medication as soon as possible, ideally within 12 hours of onset of a gout attack.108 In addition, patients may need a reminder about continuing their ULT while taking the medication-in-pocket for acute flares.109

          Pharmacy technicians can ensure that patients have refills on their medication-in-pocket prescription to facilitate early initiation. Updating the patient’s records in the pharmacy software with the gout diagnosis can facilitate this continuity of care. The pharmacy team should encourage patients to fill all their prescriptions at the same pharmacy. Through access to all the patient’s medications, pharmacists and pharmacy technicians can play a crucial role in optimizing gout management by identifying medications that increase serum uric acid levels.110

          In addition, the pharmacy team can identify potential drug-drug interactions. This is particularly important with colchicine as it is a substrate for CYP3A4 and P-gp and has a narrow therapeutic window.111 In addition, some medications are known to increase serum uric acid levels.20 Advising patients to check with the pharmacy team before purchasing an over-the-counter (OTC) medication can decrease the use of inappropriate medications. When completing transactions at the register, pharmacy technicians are well positioned to identify OTC products that can worsen gout, such as vitamin A or niacin.112 On the other hand, frequent purchase of OTC anti-inflammatory medications like naproxen or ibuprofen may imply uncontrolled gout.

          Patients can find educational videos on YouTube to learn more about gout therapy and appropriate diet.113 Additional resources are available to patients on goutalliance.org. These include videos, podcasts, guides, and awareness events.114 Some patients may like to learn about their condition using gout-related mobile applications.

          Pharmacy interns may benefit in hearing from patients about their experience with gout, especially the debilitating pain. This may help future pharmacists empathize and develop better relationships with patients, which can improve patient outcomes.115

          The entire pharmacy team could engage in alleviating misconceptions about gout. Some patients with gout have reported stigma regarding their condition from friends, family members, and healthcare workers.116 Some patients with gout have even reported an internalized stigma. Stigmatization may be due to the misbelief that gout is benign, preventable, or self-inflicted.

          Did you know that May 22 is National Gout Awareness Day?

          Jim states that he feels embarrassed about wearing slippers that expose his swollen toe. The pain is so intense that he is unable to tolerate a close-toe shoe.

          Table 5 summarizes some medications that may increase serum uric acid level.

          Table 5 – Managing Medications that Increase Serum Uric Acid Level and Risk of Gout Attack20,110,117-119
          Medication Mechanism Recommendation
          Loop and thiazide diuretics

          Use: hypertension, edema

           

          Decrease urate excretion The guideline recommends switching to a different antihypertensive and suggests losartan when feasible.

           

          Aspirin (low-dose, 81 mg)

          Use: prevention of CVD

          Increases uric acid renal reabsorption and decreases secretion The guideline conditionally recommends against discontinuing low-dose aspirin with appropriate indication.
          Niacin

          Use: dietary supplement

          Inhibits the enzyme uricase, thus inhibiting the oxidation of uric acid, or decreases uric acid excretion The guideline does not provide a specific recommendation for niacin-induced hyperuricemia. Experts recommend adequate hydration.

           

          After looking into Jim’s medication profile and inquiring about his OTC products, the pharmacist does not identify any medication that may be increasing his serum uric acid level.

          CONCLUSION

          Gout is the most common type of inflammatory arthritis. Untreated gout can lead to complications such as degenerative arthritis, urate nephropathy, infections, renal stones, joint fractures, and nerve or spinal cord impingement. ULT is indicated for chronic gout management. Allopurinol is the first-line urate-lowering agent. Colchicine, NSAIDs, and corticosteroids are indicated for acute flares, and, in lower doses, for gout flare prophylaxis upon initiating ULT. Diet and lifestyle modifications complement the pharmacologic therapy. The pharmacy team plays a crucial role in identifying drug-induced hyperuricemia and educating patients about the importance of adherence to ULT. Gout flares are painful and debilitating. Pharmacists can recommend initiation of anti-inflammatory therapy for acute gout flares. Pharmacy technicians can ensure patients have refills for their anti-inflammatory medication to facilitate the medication-in-pocket approach.

          Jim’s uncontrolled gout may be due to various reasons that pharmacy team can investigate. Inquiring about Jim’s drinking habits and educating him about the negative impact of alcohol on gout management is a necessary first step in his therapy. If an adequate trial of dietary changes does not control his symptoms, then switching to a different XOI or adding probenecid, depending on what he has tried so far, would be appropriate.

           

           

          Pharmacist Post Test (for viewing only)

          Treating Gout without Doubt

          Pharmacist POST-TEST
          1. Which of the following patient factors accounts for about 90% of gout cases?
          a) Overproduction of uric acid
          b) Underexcretion of uric acid
          c) Liver dysfunction

          2. Why does the American College of Rheumatology (ACR) define hyperuricemia as serum uric acid level greater than or equal to 6.8 mg/dL?

          a) All patients with serum uric acid level ≥ 6.8 mg/dL experience gout
          b) Serum uric acid level ≥ 6.8 mg/dL is insoluble in the blood
          c) Patients with serum uric acid level ≥ 6.8 mg/dL experience urate kidney stones

          3. Which of the following is involved in the pathogenesis of gout?

          a) Chronic deposition and crystallization of urate in the joints and tissues
          b) Chronic deposition and crystallization of calcium in the joints and tissues
          c) Increased glomerular filtration rate of uric acid due to caffeine intake

          4. Which of the following is a complication of untreated gout?

          a) Renal stones
          b) Congestive heart failure
          c) Visual changes

          5. Which of the following findings confirms a diagnosis of gout?
          a) Elevated uric acid
          b) Tophi in tissues and/or bones
          c) Burning upon urination

          6. According to the American College of Rheumatology (ACR) guideline, which one of the following is a goal of chronic gout therapy?
          a) Limiting gout attacks to a maximum of 2 attacks per year
          b) Preventing future gout attacks
          c) Decreasing the renal excretion of uric acid

          7. A 55 year-old-man presents with his first acute gout attack. In the absence of contraindications, which of the following medications is an appropriate first-line therapy for this patient?

          a) Colchicine
          b) Intramuscular methylprednisolone
          c) Anakinra

          8. Which one of the following statements is accurate about colchicine drug interactions?
          a) Co-administration of colchicine with P-glycoprotein inhibitors increases the risk of colchicine toxicity
          b) Co-administration of colchicine with P-glycoprotein inhibitors decreases colchicine efficacy
          c) Co-administration of colchicine with CYP 450 3A4 inhibitors decreases colchicine efficacy

          9. In the absence of contraindications, which one of the following medications is the first-line urate-lowering therapy?
          a) Allopurinol
          b) Febuxostat
          c) Probenecid

          10. A patient presents to fill his first prescription for allopurinol. Which one of the following is an appropriate counseling point for this patient?
          a) Start taking allopurinol today and continue indefinitely
          b) Discontinue allopurinol once you achieve uric acid level of < 6 mg/dL c) Keep allopurinol on hand and start taking at the first sign of a gout attack 11. A patient experiences an acute attack of gout. You review his medication profile. Which of the following medications may be aggravating his gout? a. atorvastatin b. niacin c. losartan 12. Which of the following is an appropriate nonpharmacologic intervention for gout? a. Increasing intake of purine-containing foods b. Switching from beer or wine to hard alcohol c. Applying ice to sore joints if tolerable

          Pharmacy Technician Post Test (for viewing only)

          Treating Gout without Doubt
          Technician POST TEST question

          1. According to the American College of Rheumatology (ACR), what is the definition of hyperuricemia?

          a) uric acid level > 6 mg/dL
          b) uric acid level ≥ 6.5 mg/dL
          c) uric acid level ≥ 6.8 mg/dL

          2. Which of the following statements is accurate about gout attacks?

          a) Gout attacks happen only in the big toe joint
          b) Gout attacks happen only in the morning
          c) Gout attacks happen in any joint

          3. When should patients with a first gout attack seek medical care?
          a) Only if the pain is unbearable
          b) Only if the pain lasts more than 10 days
          c) Anytime patients experience their first gout attack

          4. A patient calls the pharmacy saying that he is starting to experience a gout attack. The patient asks the pharmacy technician to refill his medication-in-pocket prescription. Which one of the following medications can the patient use for medication-in pocket approach?
          a) Allopurinol
          b) Naproxen
          c) Probenecid

          5. A pharmacy technician is refilling a patient’s medication-in pocket prescription for colchicine. The technician notices that after this fill, the prescription has no more refills. The patient’s next appointment is in eight months. What is the best next step?

          a) Send a refill request to the clinician’s office
          b) Inactivate the prescription
          c) Tell the patient to request a prescription during their next visit

          6. What is the goal of therapy for a patient taking allopurinol as part of a gout regimen?
          a) Achieving a serum uric acid level < 6 mg/dL b) Terminating an acute gout attack c) Decreasing the intensity of pain during an acute gout attack 7. Which one of the following nonpharmacologic therapy is beneficial for patients with gout? a) Decreasing the intake of foods high in purines b) Increasing alcoholic beverages consumption c) Decreasing the intake of caffeine 8. A patient visits the pharmacy counter frequently to check-out some OTC products. In the past three months, the patient has purchased the same product four times. Which one of the following OTC products may imply uncontrolled gout? a) Vitamin C b) Ibuprofen c) Dextromethorphan 9. A medication guide should accompany which of the following medications? a) NSAIDs b) Allopurinol c) Probenecid 10. Which one of the following medications Is a urate oxidase enzyme? a) Pegloticase b) Colchicine c) Probenecid 11. A patient experiences an acute attack of gout. You review his medication profile. Which of the following medications may be aggravating his gout? a. atorvastatin b. niacin c. losartan 12. Which of the following is an appropriate nonpharmacologic intervention for gout? a. Increasing intake of purine-containing foods b. Switching from beer or wine to hard alcohol c. Applying ice to sore joints if tolerable

          References

          Full List of References

          References

             

            1. Gout: Disease basics, symptoms and treatment options. Gout Treatment : Medications and Lifestyle Adjustments to Lower Uric Acid. Johns Hopkins Arthritis Center. Published 2016. https://www.hopkinsarthritis.org/arthritis-info/gout/gout-treatment/

            2. Gout. Centers for Disease Control and Prevention. Updated April 28, 2022. Accessed December 25, 2022. https://www.cdc.gov/arthritis/types/gout.html
            3. Chen-Xu M, Yokose C, Rai SK, Pillinger MH, Choi HK. Contemporary Prevalence of Gout and Hyperuricemia in the United States and Decadal Trends: The National Health and Nutrition Examination Survey, 2007-2016. Arthritis Rheumatol. 2019;71(6):991-999. doi:10.1002/art.40807
            4. Smith RG. The diagnosis and treatment of gout. Medscape. Published May 1, 2009. Accessed December 25, 2022. https://www.medscape.com/viewarticle/704970_1
            5. de Oliveira EP, Burini RC. High plasma uric acid concentration: causes and consequences. Diabetol Metab Syndr. 2012;4:12. doi:10.1186/1758-5996-4-12
            6. Choi HK, Mount DB, Reginato AM; American College of Physicians; American Physiological Society. Pathogenesis of gout. Ann Intern Med. 2005;143(7):499-516. doi:10.7326/0003-4819-143-7-200510040-00009
            7. Gout diet: what’s allowed, what’s not. Mayo clinic. Updated June 25, 2022. Accessed January 1, 2023. https://www.mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/gout-diet/art-20048524
            8. Gout: Disease of the Kings | The Hand Society. www.assh.org. Accessed January 25, 2023. https://www.assh.org/handcare/blog/gout-disease-of-the-kings
            9. Gout: Disease of Kings now a 21st Century Epidemic. News-Medical.net. Published September 28, 2022. Accessed July 13, 2023. https://www.news-medical.net/health/Gout-Disease-of-Kings-now-a-21st-Century-Epidemic.aspx
            10. Tang SCW. Gout: A Disease of Kings. Contrib Nephrol. 2018;192:77-81. doi:10.1159/000484281
            11. Liebman SE, Taylor JG, Bushinsky DA. Uric acid nephrolithiasis. Curr Rheumatol Rep. 2007;9(3):251-257. doi:10.1007/s11926-007-0040-z
            12. Álvarez-Lario B, Macarrón-Vicente J. Uric acid and evolution. Rheumatology (Oxford). 2010;49(11):2010-2015. doi:10.1093/rheumatology/keq204
            13. Mikuls TR. Gout. N Engl J Med. 2022;387(20):1877-1887. doi:10.1056/NEJMcp2203385
            14. Ragab G, Elshahaly M, Bardin T. Gout: An old disease in new perspective - A review. J Adv Res. 2017;8(5):495-511. doi:10.1016/j.jare.2017.04.008
            15. Salama A, Alweis R. Images in clinical medicine: Tophi. J Community Hosp Intern Med Perspect. 2017;7(2):136-137. doi:10.1080/20009666.2017.1328967
            16. Cronstein BN, Terkeltaub R. The inflammatory process of gout and its treatment. Arthritis Res Ther. 2006;8 Suppl 1(Suppl 1):S3. doi:10.1186/ar1908
            17. Burns CM, Wortmann RL. Latest evidence on gout management: what the clinician needs to know. Ther Adv Chronic Dis. 2012;3(6):271-286. doi:10.1177/2040622312462056
            18. Engel B, Just J, Bleckwenn M, Weckbecker K. Treatment Options for Gout. Dtsch Arztebl Int. 2017;114(13):215-222. doi:10.3238/arztebl.2017.0215
            19. Rothschild BM, Diamond HS. Gout and Pseudogout. Medscape. Updated January 11, 2023. Accessed January 25, 2023. https://emedicine.medscape.com/article/329958-overview#a1
            20. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology Guideline for the Management of Gout [published correction appears in Arthritis Care Res (Hoboken). 2020 Aug;72(8):1187] [published correction appears in Arthritis Care Res (Hoboken). 2021 Mar;73(3):458]. Arthritis Care Res (Hoboken). 2020;72(6):744-760. doi:10.1002/acr.24180
            21. Slobodnick A, Shah B, Krasnokutsky S, Pillinger MH. Update on colchicine, 2017. Rheumatology (Oxford). 2018;57(suppl_1):i4-i11. doi:10.1093/rheumatology/kex453
            22. Finkelstein Y, Aks SE, Hutson JR, et al. Colchicine poisoning: the dark side of an ancient drug. Clin Toxicol (Phila). 2010;48(5):407-414. doi:10.3109/15563650.2010.495348
            23. Fu M, Zhao J, Li Z, Zhao H, Lu A. Clinical outcomes after colchicine overdose: A case report. Medicine (Baltimore). 2019;98(30):e16580. doi:10.1097/MD.0000000000016580
            24. Colcrys. Prescribing information. AR Scientific, Inc.; 2009. Accessed December 26, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022353lbl.pdf
            25. Center for Drug Evaluation and Research. Table of Substrates, Inhibitors and Inducers. U.S. Food and Drug Administration. Published 2019. https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers
            26. Colchicine: Beware of toxicity and interactions. medsafe.govt.nz. https://medsafe.govt.nz/profs/puarticles/colchicine.htm
            27. Long N. Colchicine toxicity. Life in the Fast Lane • LITFL. Published March 5, 2019. https://litfl.com/colchicine-toxicity/
            28. Colchicine (HIGHLIGHTS of PRESCRIBING INFORMATION). Accessed August 14, 2023. https://content.takeda.com/?contenttype=PI&product=COL&language=ENG&country=GBL&documentnumber=1
            29. Karamanou M, Tsoucalas G, Pantos K, Androutsos G. Isolating Colchicine in 19th Century: An Old Drug Revisited. Curr Pharm Des. 2018;24(6):654-658. doi:10.2174/1381612824666180115105850
            30. Autumn Crocus, Colchicum spp. Wisconsin Horticulture. https://hort.extension.wisc.edu/articles/autumn-crocus-colchicum-spp/
            31. Dasgeb B, Kornreich D, McGuinn K, Okon L, Brownell I, Sackett DL. Colchicine: an ancient drug with novel applications. Br J Dermatol. 2018;178(2):350-356. doi:10.1111/bjd.15896
            32. Colchicine, 1 mg tablets. Accessed August 8, 2023. https://arpimed.am/colchicine-1-mg-tablets/
            33. Danel VC, Wiart JF, Hardy GA, Vincent FH, Houdret NM. Self-poisoning with Colchicum autumnale L. flowers. J Toxicol Clin Toxicol. 2001;39(4):409-411. doi:10.1081/clt-100105163
            34. Brvar M, Ploj T, Kozelj G, Mozina M, Noc M, Bunc M. Case report: fatal poisoning with Colchicum autumnale. Crit Care. 2004;8(1):R56-R59. doi:10.1186/cc2427
            35. Guglielmo BJ. The Colchicine Debacle. JAMA Internal Medicine. 2013;173(3):184. doi:https://doi.org/10.1001/jamainternmed.2013.1405
            36. Gunter SJ, Kesselheim AS, Rome BN. Market Exclusivity and Changes in Competition and Prices Associated With the US Food and Drug Administration Unapproved Drug Initiative. JAMA Intern Med. 2021;181(8):1124-1126. doi:10.1001/jamainternmed.2021.1989
            37. Gout Disease Control Suffered After FDA-Driven Price Hike: Study. BioSpace. Accessed August 8, 2023. https://www.biospace.com/article/gout-drug-colchicine-spikes-for-a-decade-after-2010-fda-policy-change/
            38. The Unapproved-Drugs Initiative Is Coming to an End. The Rheumatologist. Accessed August 8, 2023. https://www.the-rheumatologist.org/article/the-unapproved-drugs-initiative-is-coming-to-an-end/
            39. Generic Colcrys Availability. Drugs.com. Updated September 6, 2023. Accessed August 8, 2023. https://www.drugs.com/availability/generic-colcrys.html
            40. Research C for DE and. Patient Labeling Resources. FDA. Published online July 24, 2023. https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labeling-resources#medication-guides
            41. List of Confused Drug Names | Institute For Safe Medication Practices. www.ismp.org. Published February 16, 2015. https://www.ismp.org/recommendations/confused-drug-names-list?check_logged_in=1
            42. Cosyntropin - an overview | ScienceDirect Topics. www.sciencedirect.com. Accessed August 14, 2023. https://www.sciencedirect.com/topics/veterinary-science-and-veterinary-medicine/cosyntropin
            43. Indomethacin. Prescribing information. Qualitest Pharmaceuticals; 2016. Accessed February 6, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf
            44. Naproxen. Prescribing information. Roche Pharmaceuticals; 2007. Accessed February 6, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf
            45. Clinoril. Prescribing information. Merck & Co., Inc.; 2010. Accessed February 6, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s074lbl.pdf
            46. Laubscher T, Dumont Z, Regier L, Jensen B. Taking the stress out of managing gout. Can Fam Physician. 2009;55(12):1209-1212
            47. Celebrex. Prescribing information. Pfizer; 2008. Accessed February 6, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s027lbl.pdf
            48. Solomon SD, Pfeffer MA, McMurray JJ, et al. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006;114(10):1028-1035. doi:10.1161/CIRCULATIONAHA.106.636746.
            49. Henry D, Lim LL, Garcia Rodriguez LA, et al. Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis. BMJ. 1996;312(7046):1563-1566. doi:10.1136/bmj.312.7046.1563
            50. Safety Comparison of NSAIDs. pharmacist.therapeuticresearch.com. Accessed February 6, 2023. https://pharmacist.therapeuticresearch.com/Content/Segments/PRL/2017/Jan/Safety-Comparison-of-NSAIDs-10556
            51. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA. 2006;296(13):1633-1644. doi:10.1001/jama.296.13.jrv60011
            52. Antman EM, Bennett JS, Daugherty A, et al. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation. 2007;115(12):1634-1642. doi:10.1161/CIRCULATIONAHA.106.181424
            53. U.S. Food and Drug Administration. Analysis and recommendations for agency action regarding nonsteroidal antiinflammatory drugs and cardiovascular risk. J Pain Palliat Care Pharmacother. 2005;19(4):83-97.
            54. Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the End of This Medication Guide for a List of Prescription NSAID Medicines.). https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015MedGuide.pdf
            55. Cronstein BN, Sunkureddi P. Mechanistic aspects of inflammation and clinical management of inflammation in acute gouty arthritis. J Clin Rheumatol. 2013;19(1):19-29. doi:10.1097/RHU.0b013e31827d8790
            56. Gotzsche PC, Johansen HK. Short-term low-dose corticosteroids vs placebo and nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Cochrane Database Syst Rev. 2004;2005(3):CD000189. doi:10.1002/14651858.CD000189.pub2
            57. Rowe BH, Spooner C, Ducharme FM, Bretzlaff JA, Bota GW. Early emergency department treatment of acute asthma with systemic corticosteroids. Cochrane Database Syst Rev. 2001;(1):CD002178. doi:10.1002/14651858.CD002178
            58. Methylprednisolone: Generic, Uses, Side Effects, Dosages, Interactions & Warnings. RxList. Accessed August 22, 2023. https://www.rxlist.com/methylprednisolone/generic-drug.htm
            59. Kineret. Prescribing information. Swedish Orphan Biovitrum AB; 2020. Accessed 02/25/2023. https://kineretrxhcp.com/pdf/Full-Prescribing-Information-English.pdf
            60. Sharma E, Pedersen B, Terkeltaub R. Patients Prescribed Anakinra for Acute Gout Have Baseline Increased Burden of Hyperuricemia, Tophi, and Comorbidities, and Ultimate All-Cause Mortality. Clin Med Insights Arthritis Musculoskelet Disord. 2019;12:1179544119890853. doi:10.1177/1179544119890853
            61. Ghosh P, Cho M, Rawat G, Simkin PA, Gardner GC. Treatment of acute gouty arthritis in complex hospitalized patients with anakinra. Arthritis Care Res (Hoboken). 2013;65(8):1381-1384. doi:10.1002/acr.21989
            62. HIGHLIGHTS of PRESCRIBING INFORMATION. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf
            63. Daoussis, D., Bogdanos, D.P., Dimitroulas, T. et al. Adrenocorticotropic hormone: an effective “natural” biologic therapy for acute gout? Rheumatol Int 40, 1941–1947 (2020). https://doi.org/10.1007/s00296-020-04659-5
            64. Acthar. Prescribing information. Questcor Pharmaceuticals; 2010. Accessed February 26, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf
            65. PURIFIED CORTROPHIN® GEL (Repository Corticotropin Injection USP) Rx only. dailymed.nlm.nih.gov. Accessed September 20, 2023. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f27544ee-a0e2-4d84-b193-1c9efdf9e34c&type=display
            66. Vargas-Santos AB, Neogi T. Management of Gout and Hyperuricemia in CKD. Am J Kidney Dis. 2017;70(3):422-439. doi:10.1053/j.ajkd.2017.01.055
            67. HIGHLIGHTS of PRESCRIBING INFORMATION. Accessed August 14, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf
            68. Pisaniello HL, Fisher MC, Farquhar H, et al. Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review. Arthritis Res Ther. 2021;23(1):130. doi:10.1186/s13075-021-02416-y
            69. Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013;158(11):825-830. doi:10.7326/0003-4819-158-11-201306040-00007
            70. 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. doi:10.14336/AD.2017.0306
            71. Duru N, van der Goes MC, Jacobs JW, et al. EULAR evidence-based and consensus-based recommendations on the management of medium to high-dose glucocorticoid therapy in rheumatic diseases. Ann Rheum Dis. 2013;72(12):1905-1913. doi:10.1136/annrheumdis-2013-203249
            72. Pill in the pocket. Wiktionary. Published October 15, 2021. Accessed August 9, 2023. https://en.wiktionary.org/wiki/pill_in_the_pocket
            73. Stamp LK, Chapman PT. Urate-lowering therapy: current options and future prospects for elderly patients with gout. Drugs Aging. 2014;31(11):777-786. doi:10.1007/s40266-014-0214-0
            74. Zyloprim. Prescribing information. Casper Pharma; 2018. Accessed December 25, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016084s044lbl.pdf
            75. Pro-Cid. Prescribing information. Phebra; 2018. Accessed December 26, 2022. https://www.phebra.com/wp-content/uploads/2013/10/Procid-PI-V02.pdf
            76. Krystexxa. Prescribing information. Horizon Therapeutics; 2022. Accessed December 26, 2022. https://www.hzndocs.com/KRYSTEXXA-Prescribing-Information.pdf
            77. Evidence reviews for timing of urate-lowering therapy in relation to a flare in people with gout: Gout: diagnosis and management: Evidence review F. London: National Institute for Health and Care Excellence (NICE); 2022 Jun. (NICE Guideline, No. 219.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK583523/
            78. Stamp LK, Barclay ML. How to prevent allopurinol hypersensitivity reactions?. Rheumatology (Oxford). 2018;57(suppl_1):i35-i41. doi:10.1093/rheumatology/kex422
            79. Lupton GP, Odom RB. The allopurinol hypersensitivity syndrome. J Am Acad Dermatol. 1979;1(4):365-374. doi:10.1016/s0190-9622(79)70031-4
            80. Delves, PJ. Human Leukocyte Antigen (HLA) system. Merck Manual. Updated September 2022. Accessed January 7, 2023. https://www.merckmanuals.com/professional/immunology-allergic-disorders/biology-of-the-immune-system/human-leukocyte-antigen-hla-system
            81. Yun J, Adam J, Yerly D, Pichler WJ. Human leukocyte antigens (HLA) associated drug hypersensitivity: consequences of drug binding to HLA. Allergy. 2012;67(11):1338-1346. doi:10.1111/all.12008
            82. Jung JW, Kim DK, Park HW, et al. An effective strategy to prevent allopurinol-induced hypersensitivity by HLA typing. Genet Med. 2015;17(10):807-814. doi:10.1038/gim.2014.195
            83. Jutkowitz E, Dubreuil M, Lu N, Kuntz KM, Choi HK. The cost-effectiveness of HLA-B*5801 screening to guide initial urate-lowering therapy for gout in the United States. Semin Arthritis Rheum. 2017;46(5):594-600. doi:10.1016/j.semarthrit.2016.10.009
            84. Kent R, Huber B. Gertrude Belle Elion (1918-99). Nature. 1999;398(6726):380-380. doi:https://doi.org/10.1038/18790
            85. The Nobel Prize in Physiology or Medicine 1988. NobelPrize.org. https://www.nobelprize.org/prizes/medicine/1988/press-release/
            86. FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat). FDA drug safety communication. U.S. Food and Drug Administration. Published February 21, 2019. Accessed January 7, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat
            87. Bisht M, Bist SS. Febuxostat: a novel agent for management of hyperuricemia in gout. Indian J Pharm Sci. 2011;73(6):597-600. doi:10.4103/0250-474X.100231
            88. Sulfinpyrazone. MedlinePlus. National Library of Medicine. Updated June 15, 2017. Accessed January 7, 2023. https://medlineplus.gov/druginfo/meds/a682339.html
            89. Probenecid. Prescribing information. Lannett Company, Inc. 2021. Accessed January 7, 2023. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ab497fd8-00c3-4364-b003-b39d21fbdf38&type=display
            90. Hemmersbach P. The Probenecid-story - A success in the fight against doping through out-of-competition testing. Drug Test Anal. 2020;12(5):589-594. doi:10.1002/dta.2727
            91. Perishable. World Anti-Doping Agency (WADA) Prohibited List | USADA. Published May 1, 2019. Accessed August 8, 2023. https://www.usada.org/athletes/substances/prohibited-list/?gad=1&gclid=Cj0KCQjwz8emBhDrARIsANNJjS71Rf_P0EymCM5xDAwg2sS74_4kS9tb-fkv4arj4ldkMRbBEIpNSyMaApdDEALw_wcB
            92. Waknine Y. FDA Approves pegloticase for refractory gout. Medscape. Published September 15, 2010. Accessed January 7, 2023. https://www.medscape.com/viewarticle/728557
            93. Liu L, Liu S, Wang C, et al. Folate Supplementation for Methotrexate Therapy in Patients With Rheumatoid Arthritis: A Systematic Review. J Clin Rheumatol. 2019;25(5):197-202. doi:10.1097/RHU.0000000000000810
            94. Huang IJ, Liew JW, Morcos MB, Zuo S, Crawford C, Bays AM. Pharmacist-managed titration of urate-lowering therapy to streamline gout management. Rheumatol Int. 2019;39(9):1637-1641. doi:10.1007/s00296-019-04333-5
            95. Feng X, Li Y, Gao W. Prophylaxis on gout flares after the initiation of urate-lowering therapy: a retrospective research. Int J Clin Exp Med. 2015;8(11):21460-21465
            96. Jat N, DeSimone EM, McAuliffe R. Urate-Lowering Therapy for the Prevention and Treatment of Gout Flare. www.uspharmacist.com. https://www.uspharmacist.com/article/uratelowering-therapy-for-the-prevention-and-treatment-of-gout-flare
            97. Briesacher BA, Andrade SE, Fouayzi H, Chan KA. Comparison of drug adherence rates among patients with seven different medical conditions. Pharmacotherapy. 2008;28(4):437-443. doi:10.1592/phco.28.4.437
            98. Khanna D, Khanna PP, Fitzgerald JD, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012;64(10):1447-1461. doi:10.1002/acr.21773
            99. Low Purine Diet Explained with List of Foods to Eat or Avoid. Drugs.com. Updated April 2, 2023. Accessed April 16, 2023. https://www.drugs.com/cg/low-purine-diet.html
            100. Arthritis.org. Published 2020. https://www.arthritis.org/health-wellness/healthy-living/nutrition/healthy-eating/which-foods-are-safe-for-gout
            101. Ronquillo Y, Meyers A, Korvek SJ. Digital Health. [Updated 2023 May 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470260/
            102. Serlachius A, Schache K, Kieser A, Arroll B, Petrie K, Dalbeth N. Association Between User Engagement of a Mobile Health App for Gout and Improvements in Self-Care Behaviors: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019;7(8):e15021. doi:10.2196/15021
            103. Gout Diagnosis app: diagnosing and treating Gout with evidence based medicine. iMedicalApps. Published June 14, 2016. Accessed August 10, 2023. https://www.imedicalapps.com/2016/06/gout-diagnosis-app-evidence-based-medicine/#
            104. https://www.healthgrades.com/contributors/lorna-collier. Mobile Apps For Gout. Healthgrades. Published February 13, 2014. Accessed August 10, 2023. https://www.healthgrades.com/right-care/gout/mobile-apps-can-help-you-manage-gout
            105. Health C for D and R. Device Software Functions Including Mobile Medical Applications. FDA. Published September 9, 2020. https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications
            106. 10 keys to mHealth apps that are easier to use. American Medical Association. https://www.ama-assn.org/practice-management/digital/10-keys-mhealth-apps-are-easier-use
            107. Dickson A. Treatment and management of gout: the role of pharmacy. The Pharmaceutical Journal. Accessed April 18, 2023. https://pharmaceutical-journal.com/article/ld/treatment-and-management-of-gout-the-role-of-pharmacy
            108. Managing gout in primary care: Part 1 – bpacnz. bpac.org.nz. https://bpac.org.nz/2021/gout-part1.aspx
            109. Golenbiewski J, Keenan RT. Moving the Needle: Improving the Care of the Gout Patient. Rheumatology and Therapy. Published online March 2, 2019. doi:https://doi.org/10.1007/s40744-019-0147-5
            110. Haines A, Bolt J, Dumont Z, Semchuk W. Pharmacists' assessment and management of acute and chronic gout. Can Pharm J (Ott). 2018;151(2):107-113. doi:10.1177/1715163518754916
            111. Hansten PD, Tan MS, Horn JR, et al. Colchicine Drug Interaction Errors and Misunderstandings: Recommendations for Improved Evidence-Based Management. Drug Saf. 2023;46(3):223-242. doi:10.1007/s40264-022-01265-1
            112. Ford ES, Choi HK. Associations between concentrations of uric acid with concentrations of vitamin A and beta-carotene among adults in the United States. Nutr Res. 2013;33(12):995-1002. doi:10.1016/j.nutres.2013.08.008
            113. Onder, M.E., Zengin, O. YouTube as a source of information on gout: a quality analysis. Rheumatol Int 41, 1321–1328 (2021). https://doi.org/10.1007/s00296-021-04813-7
            114. Alliance for Gout Awareness. goutalliance.org. Published November 14, 2022. Accessed August 10, 2023. https://goutalliance.org/
            115. 5 Ways Pharmacists Can Show Empathy. Pharmacy Times. https://www.pharmacytimes.com/view/5-ways-pharmacists-can-show-empathy
            116. Kleinstäuber M, Wolf L, Jones ASK, Dalbeth N, Petrie KJ. Internalized and Anticipated Stigmatization in Patients With Gout. ACR Open Rheumatol. 2020;2(1):11-17. doi:10.1002/acr2.11095
            117. UpToDate. www.uptodate.com. https://www.uptodate.com/contents/diuretic-induced-hyperuricemia-and-gout. Updated March 2023. Accessed April 16, 2023.
            118. Song WL, FitzGerald GA. Niacin, an old drug with a new twist. J Lipid Res. 2013;54(10):2586-2594. doi:10.1194/jlr.R040592
            119. Ben Salem C, Slim R, Fathallah N, Hmouda H. Drug-induced hyperuricaemia and gout. Rheumatology. 2016;56(5):kew293. doi:https://doi.org/10.1093/rheumatology/kew293

            Vaccine Hesitancy: Management Strategies for Pharmacy Teams

            Learning Objectives

             

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

            ·       Describe vaccine hesitancy and barriers to vaccination
            ·       Recognize the how determinants of vaccine hesitancy contribute to behavioral outcomes
            ·       Recall anti-vaccine claims and rebuttals
            ·       Discuss situation-appropriate intervention strategies

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

            ·       Recall the benefits of vaccination
            ·       Recognize the various determinants of vaccine hesitancy
            ·       List ways to promote vaccine acceptance

               

              Release Date: August 21, 2023

              Expiration Date: August 21, 2026

              Course Fee

              Pharmacists: $4

              Pharmacy Technicians: $2

              There is no funding for this CE.

              ACPE UANs

              Pharmacist: 0009-0000-23-025-H06-P

              Pharmacy Technician:  0009-0000-23-025-H06-T

              Session Codes

              Pharmacist:  20YC61-VXK39

              Pharmacy Technician: 20YC61-KVT93

              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 0009-0000-23-025-H06-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

              Katharine E. MacDonald, PharmD Candidate 2021
              University of Connecticut School of Pharmacy
              Storrs, CT                                  

              Jeannette Y. Wick, RPh, MBA, FASCP
              Assistant Director, Office of Pharmacy Professional Development
              University of Connecticut 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.

              Katherine McDonald and Jeannette Wick have no relationships with ineligible companies.

               

              ABSTRACT

              Vaccines are responsible for reducing the incidence of vaccine-preventable diseases. While most people receive routine recommended vaccinations, a small portion of the population does not. Vaccine hesitancy and refusal are complex behaviors and the consequences of choosing not to vaccinate jeopardize both individual and societal health and safety. Pharmacists and pharmacy technicians must know the determinants and factors that contribute to vaccine hesitancy before they address and manage it appropriately. A comprehensive understanding of such influences can help pharmacists and pharmacy technicians identify and communicate with hesitant individuals better. Pharmacists and technicians are also able to screen patients for missing immunizations, provide patient education and support, and offer guidance.

              CONTENT

              Content

              INTRODUCTION

               

              Pharmacist Post Test (for viewing only)

              Pharmacist Post-test

              Pharmacist Learning Objectives:
              1. Describe vaccine hesitancy and barriers to vaccination
              2. Recognize the how determinants of vaccine hesitancy contribute to behavioral outcomes
              3. Recall anti-vaccine claims and rebuttals
              4. Discuss situation-appropriate intervention strategies

              1. Which of the following MOST CLOSELY corresponds to the WHO definition of vaccine hesitancy?
              A. Simple vaccine refusal in any context including lack of available vaccination services
              B. Acceptance of any vaccine if the ability to access vaccination is convenient
              C. Delay in acceptance or refusal of vaccines despite availability of vaccinations services

              2. Select the influence category, source of influence, and determinants that are paired correctly.
              A. Contextual influence—peer environment--costs
              B. Vaccine-specific issues—specific vaccine—mode of administration
              C. Group influences—political factors—reliability of vaccine supply

              3. A mother indicates she does not and will not vaccinate her children. You use motivational interviewing and learn that she believes natural immunity is safer than vaccine-induced immunity. What is an appropriate rebuttal if she consents to listen?
              A. Infection-induced immunity may elicit a superior immune response. However, the risks and complications associated with infection are significantly greater than those of vaccines.
              B. A panel of experts from the Institute of Medicine reviewed more than 12,000 published reports and several high-quality studies; none indicate natural immunity is stronger.
              C. The CDC’s system to track natural immunity vs. vaccine-induced immunity is called VAERS; you can examine the data in VAERS and see that your assumptions are wrong.

              4. Susan comes to the pharmacy and your technician reminds her she is due for her second HPV vaccination. Susan glances to the pharmacist’s workstation and quickly says, “Ummm, not today.” The technician gently says, “You’re here, and we’re not busy. Why don’t we get it done?” Susan replies, “No, not today. That guy gave me the last one and left a huge bruise. Not today.” What type of barrier is keeping Susan from her second shot?
              A. Vaccine accessibility
              B. Distrust of provider
              C. Gaps in knowledge

              5. Dave arrives at the pharmacy to pick up his “sugar meds” and you notice that he hasn’t received his flu shot yet. After providing him with a clinical recommendation for the vaccine, Dave replies, “Why do I need to? I work from home and have never gotten the flu before. What’s the point?!” Which barrier is preventing Dave from getting the flu shot?
              A. Distrust of vaccine
              B. Misinformation
              C. Perceived need for vaccine

              6. Manny is a regular customer who appears to be up to date on all of his vaccines except for the shingles vaccination. When you ask him why, he states that it’s for religious reasons, but says “I’d give it a try if there’s a shot without any pork in it.” Which intervention strategy would be most appropriate for Manny’s situation?
              A. Motivational interviewing about worldview
              B. Debiasing techniques to address overkill
              C. Offering Shingrix as an alternative

              Pharmacy Technician Post Test (for viewing only)

              Pharmacy Technician Post-test

              Pharmacy Technician Objectives:
              1. Recall the benefits of vaccination
              2. Recognize the various determinants of vaccine hesitancy
              3. List ways to promote vaccine acceptance

              1. Which of the following is a benefit of vaccination?
              A. Vaccines reduce the incidence of some diseases
              B. Vaccines completely eradicate vaccine-preventable diseases
              C. Vaccines only benefit vaccinated infants and children

              2. Which of the following types of vaccine coverage ensure the success of a vaccination program?
              A. Only high-risk people receive recommended vaccines
              B. Most people receive recommended vaccines on schedule
              C. Most infants and children receive some vaccines

              3. Mary tells you that she has not been vaccinated because the only place that is covered by her insurance requires a subway ride and then a taxi ride. Which of the following is the most likely determinant of Mary’s vaccine hesitancy?
              A. Geographic restrictions imposed by insurance
              B. Poor communication with her healthcare provider
              C. A bad attitude about necessary health care

              4. Joe lives in a rural area, and your pharmacist suggests he receive a flu shot. Joe says that his own doctor said that flu shots are fine, but not necessary for healthy folks. (The doctor said he hasn’t gotten one, and isn’t worried about it.) Which of the following is the most likely influence category to explain Joe’s vaccine hesitancy?
              A. Vaccine/ vaccination-specific issues
              B. Individual and group influences
              C. Contextual influences

              5. Which of the following is a way to promote vaccination in hesitant individuals?
              A. Ask the pharmacist to increase motivation using pressure
              B. Debunk any misinformation an individual may reference
              C. Listen to the individual’s concerns before taking action

              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/

                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/