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NAPLEX Calculation Review LIVE Event-2025

Are you studying for the NAPLEX EXAM?

NAPLEX Pharmacy Calculations Review 2025

Live Event-THIS WILL BE A LIVE IN-PERSON Event (no streaming)

Date:  Friday, May 16, 2025
Where:  Pharmacy Biology Building (PBB) Room 131
Time:  8:30 am – 4:30 pm
Cost:  $0

You MUST Register (even though there is no fee)

There is a fee for parking in the North Garage

Typical Schedule:

Friday

8:30-9:00     Check in and Presentation of Program and Review
9:00- 10:00  Diagnostic Test Administration
10:00-10:45  Review Answers t0 Diagnostic Test
10:45-11:00   Break
11:00-12:00   Students work on problem sets
12:00-1:00     Lunch
1:00-4:30       NAPLEX Calculations workshop

Lunch will be provided, please contact Alicia Scolaro at alicia.scolaro@uconn.edu with any dietary restrictions

 

CT Law Review LIVE Event-2025

Are you new to Connecticut?

Do you need to take the Connecticut Law Exam for licensure?

MPJE CT Law Review 2025

THIS WILL BE both IN PERSON and LIVE STREAMED.

Thursday, May 15, 2025
Time:  8:00 am-5:00 pm
Location:  Pharmacy Biology Building Room 131
Cost:  $200
There is a fee for parking in the North Garage

REGISTER

Typical Schedule:

8:20-8:30 Check-In
8:30-5:00 Law Review with break for lunch

Lunch will be provided-Please contact Alicia Scolaro at alicia.scolaro@uconn.edu if you have any dietary restrictions.

Click to order 2024 Law Review Handouts

Study Guide/Handouts from the 2025 program will be available for $50.

Register and Order the 2025 Handouts-COMING JUNE 2025

Anticoagulation Traineeship – Certificate Program

The University of Connecticut School of Pharmacy and The UConn Health Center Outpatient Anticoagulation Clinic have developed 2-day practice-based ACPE certificate continuing education activity for registered pharmacists and nurses who are interested in the clinical management of patients on anticoagulant therapy and/or who are looking to expand their practice to involve patient management of outpatient anticoagulation therapy. This traineeship will provide you with both the clinical and administrative aspects of a pharmacist-managed outpatient anticoagulation clinic. The activity features ample time to individualize your learning experience. A “Certificate of Completion” will be awarded upon successful completion of the traineeship.

I had a very successful and wonderful learning experience that I will treasure and WILL apply to my practice ASAP” – LKD

….this is a great program and I do not have enough good things to say about Dr. Durman and Dr. Bui.  They have amalgamated the art of customer service and patient care and have integrated my traineeship into their routine without any issues. ” – LP

“.….very comprehensive 2 days. I was able to see a lot!” – MS

Target Audience

This certificate program is for registered pharmacists and nurses who are interested in the clinical management of patients on anticoagulant therapy and/or who are looking to expand their practice to involve patient management of outpatient anticoagulation therapy.

Traineeship Learning Objectives

At the conclusion of the 2 day traineeship, pharmacists will be able to:

  1. Conduct patients interviews
  2. Evaluate current medications as it relates to anticoagulation therapy
  3. Describe the proper technique for obtaining point-of- care INR testing
  4. Adjust anticoagulant therapy for a patient based on desired outcome
  5. Prepare a patient-specific monitoring plan
  6. Formulate a note for the patient’s chart outlining your assessment and plan
  7. Describe how to bill for services

Pre-Requisites

  1. All participants must successfully complete the 12-hour online training at pharmacy.uconn.edu/academics/ce/anticoagulation or an equivalent training as approved by the Director of CE and the faculty of the traineeship.
  2. All participants must have a valid pharmacist, MD or nursing license
  3. All participants must provide documentation of current professional liability insurance
  4. All participants must complete the application (below)
  5. A telephone interview will be conducted prior to day 1 to discuss goals and expectations of the A copy of clinic’s policy and procedures will also be forwarded to the participant prior to the visit. Participants are expected to be familiar with the clinic’s policy and point-of-care testing manual.

Location

UConn Health Outpatient Services Anticoagulation Clinic
11 SOUTH ROAD
FARMINGTON, CT 06030
Suite 230 MC 6237

Email your completed application and proof of liability insurance to joanne.nault@uconn.edu. Once received, UConn will contact you with the date of attendance.

Spring 2025 dates!
Tuesday and Wednesday – March 25-26, 2025
Tuesday and Wednesday – April 15-16, 2025
Monday and Tuesday – April 28-29, 2025
Wednesday and Thursday – May 14-15, 2025
Tuesday and Wednesday – June 3-4

 

Agenda for Traineeship

Day 1
8:30-9:00 am Orientation to the clinic and staff, HR forms, review clinic workflow
9:00 am-12:30 pm Observation of patient interview process, point-of-care testing, dose decision making, and documentation procedures.
12:30 pm-1:00 pm Lunch
1:00 pm-3:00 pm Observed patient interviews and documentation
3:00 pm-3:30 pm Observed telephone patient interviews, and documentation
3:30 pm-4:30 pm Day 1 review and evaluation
Day2
8:30 am-9:00 am Q/A in preparation for day’s work
9:00 am-12:30 pm Solo telephone patient interviews, and documentation.
12:30 pm -1:00 pm Lunch
1:00 pm-1:30 pm Review of morning’s work
1:30 pm-2:30 pm Solo patient interviews, and documentation.
2:30 pm-4:30 pm Wrap up Q/A, address individual needs and final evaluation.

Activity Faculty

Anuja Rizal, RPh, PharmD, CACP, John Dempsey Hospital Anticoagulation Clinic Coordinator, Farmington, CT

Elizabeth Biron, PharmD, John Dempsey Hospital Anticoagulation Clinic Pharmacist, Farmington, CT

Damian Green, Pharmacy Technician, John Dempsey Hospital Anticoagulation Clinic, Farmington, 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. Rizal does not have anything to disclose.

Dr. Biron does not have anything to disclose.

Activity Fees

Prerequisite Online content: can be found at www.pharmacy.uconn.edu/academics/ce/anticoagulation click on each of the listed activities to register.  If you register for the entire bundle, the pricing is discounted to $140 total rather than approximately $17/credit hour.

Live  content:  Please see above for available traineeship dates.  These dates are filled on a first come/first serve basis.

The Registration Fee of $500 includes all costs of the traineeship instruction and printed materials, but does not include the home study pre-requisites.

APPLICATION

Please call Joanne at 860-486-2084 with credit card information. Scan and email your completed application to the address below.

joanne.nault@uconn.edu

There is no reduced fee for UConn faculty, adjunct faculty,  preceptors or volunteers for this program

Refunds

The registration fee, less a $75 processing fee, is refundable for those that cancel their registration more than 14 days prior to your scheduled live program. After that time, no refund is available. Participant substitutions may be made at any time.

    Grant Funding

    There is no grant funding for this activity.

      ACPE logo

      The University of Connecticut, School of Pharmacy, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Sixteen contact hours (1.6 CEU’s)  of practice-based certificate continuing education credit for pharmacists who participate in the traineeship and pass the competency evaluation with at least a “3” in all of the assessment categories. Credit will be automatically uploaded to the CPE Monitor system, and a certificate of completion will be mailed within 4 weeks of traineeship completion. UAN#0009-0000-23-003-L01-P

      Initial release date:  March 16, 2023
      Planned expiration date:  March 16, 2026

      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.

      A Review of Introductory Statistical Concepts (Optional)

      Learning Objectives:

      1. Define a framework for the application of evidence-based medicine to clinical practice List the criteria that contribute to the quality of a trial
      2. Distinguish between categorical and continuous variables and how this impacts outcome assessment in a trial
      3. Interpret descriptive statistics in a given trial
      4. Define, interpret, and calculate a relative risk, odds ratio, relative and absolute risk, and number need to treat
      5. Use a 95% confidence interval to determine clinical and statistical significance
      6. Define type I and type II error and their impact on trial results

      Activity Faculty

      Diana Sobieraj, PharmD
      Assistant Professor, Senior Research Scientist and Program Manager
      University of Connecticut School of Pharmacy/Hartford Hospital Evidence-based Practice Center, Hartford, 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. Sobieraj has no relationship with an ineligible company.

      Activity Fees

      The fee for this activity is $20

      Grant Funding

      There is no grant funding for this activity.

      Requirements for Successful Completion

      ACPE LogoThe University of Connecticut, School of Pharmacy, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Two contact hours (0.2 CEU’s) will be awarded to pharmacists who view the presentation, pass the post test with a 70% or higher, and complete the evaluation. Statement of credit for 0009-0000-21-036-H04-P will be sent to CPE Monitor and can be printed from your CPE Monitor Profile.

      Initial release date:  July 15, 2021
      Planned expiration date:  July 15, 2024

      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.

      Teaching Philosophy and Portfolios (Optional)

      Learning Objectives:

      1. Explain the purpose of a teaching philosophy
      2. Describe the components of a philosophy
      3. Discuss the fundamental element of a teaching portfolio
      4. Describe the material from oneself and from others that are contained in a teaching portfolio
        Create a draft teaching portfolio

      Activity Faculty

      Nathaniel Rickles, PharmD, PhD, BCPP
      Associate Professor 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. Rickles does not have any relationship with an ineligible company.

      Activity Fees

      This activity costs $15

      Grant Funding

      There is no grant funding for this activity.

      Requirements for Successful Completion

      ACPE LogoThe University of Connecticut, School of Pharmacy, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. One and one half contact hours (0.15 CEU’s) will be awarded to pharmacists who view the presentation, and pass a post test with a 70% or better.  Statements of credit for 0009-0000-21-035-H04-P, will be sent to CPE Monitor and can be printed from your CPE Monitor Profile.

      Initial release date:  July 15, 2021
      Planned expiration date:  July 15, 2024

      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.

      UConn Medical Writing Certificate

      Emblem saying one of the best writing classes in Reedsy's 2023 class

       

      In this comprehensive 30.5 hour CPE credit activity, pharmacists, and pharmacy technicians (and any other interested healthcare providers) will learn the concepts and mechanics of medical writing from continuing education activities to policy writing to medical marketing.  A Practice-based Certificate of Achievement will be awarded to those who have completed the pre-requisites and all phases of this practice-based certificate program 0009-0000-20-076-B04-P and 0009-0000-20-076-B04-T.

      Learning Objectives for Pharmacists and Technicians:
      At the completion of this activity, the participant will be able to:

      • Demonstrate the ability to apply the principles of good writing to common documents used in pharmacy, medicine, regulatory writing

      • List specific approaches needed for various types of medical writing

      • Write a variety of documents pertaining to medicine and pharmacy, including continuing education activities, slide kits, and scholarly works

      • Assemble a portfolio of writing pieces that demonstrate the learner’s areas of expertise

      See below to see all of the activities and their  learning objectives

      To Register Click on Orange Registration Button above

      Activity Learning Objectives Number of Credit Hours
       Introduction to Medical Writing 0
      1. Fundamentals of Writing -List the principles of good writing
      -Recognize common errors in one’s own and others’ writing
      -Apply Plain Language Guidelines
      -Analyze writing samples for error, readability, and flow
      3
      2. References and Libraries -Compare and contrast reference types
      -Select appropriate references
      -Identify copyright infringement pitfalls and how to avoid them
      -Compose AMA citations for common reference types
      2
      3.  Working with Clients -Describe clients’ typical expectations from medical writers
      -List the necessary components in an LOA or contract
      -Contrast clients expectations with one’s own strengths and limitations
      -Complete an analysis of one’s readiness to pursue medical writing
      0.75
      4.  Developing Visuals

      -Discuss when it may be appropriate to add visual aids into your writing
      -List the basic components needed for constructing tables and figures
      -Given information, construct a suitable table or figure
      1
      5. Scholarly Works -Outline the various types of scholarly publications
      -Recall the key sections of scholarly manuscripts
      -Identify and consult journal specific “Authors’ Guide” throughout the writing process
      -Demonstrate ability to effectively peer review a manuscript
       

      2

      6. Continuing Pharmacy & Medical Education -Discuss the purpose of quality continuing education
      -Describe the elements of a good needs assessment proposal to obtain funding for continuing education
      -Recognize the medical writer’s role in continuing education development
      -Produce a 1200 word document with two learning objectives and three post-test questions that incorporates the principles taught here
       

      2

      7.  Short Pieces & Educational Materials

      -Recall available  educational media platforms
      -Select a media platform tailored towards a specific audience
      -Describe the essential components of patient education brochures and professional posters
      -Evaluate the effectiveness of circulating patient education brochures and professional posters
      2
      8. Powerful Presentations -Identify the techniques necessary to create engaging presentations
      -Demonstrate the ability to construct slide decks and graph inserts properly
      -Differentiate high quality presentations from low quality presentations
       

      2

      9. Communication -Describe informative, succinct, and professional correspondence with attention to protected health information
      -Format professional documents of all types
      -Recall the elements of a concise invoice
      -Dissect customer complaints
       

      0.75

      10. Research Documents -Identify  the purpose  of the various research documents
      -List the different  types of writing styles
      -Demonstrate the ability  to reference relevant resources
       

      2

      11. Regulatory Writing -Describe  the purpose  of regulatory writing and its importance
      -Identify regulatory documents  required for target products  at various development stages
      -Use regulatory guidance to format and create proper documents
      -Define the internal review process
      1
      12. Medical Marketing of Healthcare Products -List the ways in which writing for medical marketing projects differs from other types of writing
      -Recall regulations that govern medical marketing
      -Identify requirements that most pharmaceutical companies insist upon
       

      1

      13. Finding Employment -List three ways to begin a search for medical writing jobs
      -Identify companies (or types of companies) that hire medical writers
      -Match your interests and abilities to suitable medical writing jobs
       

      0.5

      14. Policy Writing

      -Define Standard Operating Procedure
      -Describe the components of the SCP document
      -Discuss the format and writing style
      0.5
      Submission of Writing Example (Final Project) To complete the UConn Medical Writing Certificate Program, participants must produce a final project of approximately 5500 to 6000 word. Each participant will select a final project in collaboration with a UConn Medical Writing Certificate Program faculty member. The participant and the faculty members will select the type of assignment (e.g., needs assessment, continuing education activity homestudy, manuscript for submission to a journal), agree on a formal outline, and establish deadlines for draft and revision submissions. 10

       

      Activity Faculty

      Kelsey Giara, PharmD
      Medical Writer
      Pelham, NH

      Kelsey Fontneau Maytas, PharmD
      CVS Pharmacy Manager
      Shelton, CT

      Sara Miller, PharmD
      CVS Pharmacist
      Franklin, MA

      Bisni Narayanan, PharmD
      Specialty Clinical Pharmacist
      Yale New Haven Health
      Hamden, CT

      Stefanie Nigro, PharmD, BCACP, BC-ADM
      Associate Clinical Professor
      UConn School of Pharmacy
      Storrs, CT

      Paul Staffieri, PharmD
      Clinical Manager
      The Mount Sinai Hospital
      New York, NY

      Angela Su
      PharmD Candidate 2024
      University of Connecticut School of Pharmacy
      Storrs, CT

      Conner Walker, PharmD
      Medical Writer
      WriteAngle, Inc.
      Torrington, CT

      Jeannette Y. Wick, RPh, MBA
      Director, Office of Pharmacy Professional Development and Visiting Instructor,
      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.

      None of the above listed faculty have a relationship with ineligible companies.

       

      Acitivity Fees

      General Registration– $1999.00

      • Register above using the Orange Registration Button.  Once registered a confirmation email with further details will be sent

      Grant Funding

      There is no grant funding for this activity.

      Requirements for Successful Completion

      For those wishing to receive CE Credit and ACPE Certificate of Achievement:

      • Complete all of the required online modules and participate in the activities, including an evaluation of each activity within the HuskyCT system.
      • Prepare and submit a “writing example”
      • Complete and send in the Verification of Participation form found on the HuskyCT site, and submit to Joanne Nault
      • Once all of the activities are complete, visit our online CE Center at https://pharmacyce.uconn.edu/login.php and complete the course evaluation to have your CE credits uploaded to the CPE Monitor system

        ACPE logoThe University of Connecticut, School of Pharmacy, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Thirty and one half contact hours (3.05 CEU’s) will be awarded to pharmacists and pharmacy technicians who view the presentations, participate in the activities and complete the assignments and evaluations, and deliver their final submission. Statements of credit for ACPE UAN 0009-0000-23-057-B04-P/T will be automatically sent to CPE Monitor and can be printed from your CPE Monitor Profile. A Certificate of Achievement will be sent to those who complete all activities, evaluations and submit a complete Verification of Participation Form.

        Initial release date:  December 1, 2023
        Planned expiration date:  November 30, 2026

        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.

        Teaching and Learning Certificate Program 2024-2027

        In this comprehensive 28.5 CPE credit activity (with an additional 3.5 hours of optional CE credit), pharmacists, preceptors and residents will learn the concepts of teaching and learning as it relates to classroom, discussion group and experiential learning. Participants may participate at any level they choose, however, a Practice-based Certificate of Achievement will be awarded to those who have completed all phases of the education.

        “I learned so much and the materials learned have greatly help to improve the APPE and PGY-1 Rotations that I managed. Thank you for providing a well-informed, self-paced program that can accommodate working professionals!”           Lauren C.

        University of Connecticut Faculty and Adjunct Faculty

        • For registration without CE credit:  Contact Joanne Nault (joanne.nault@uconn.edu) and provide your NetID for access to the learning management system.  For those without a NetID, please contact Judy Vigneau at  860-486-9576 and  complete the Adjunct Faculty Appointment Form and email to  Judith.vigneau@uconn.edu 
        • .You must be actively (within the last 3 years and willing to take new students) taking UConn students to register for FREE.
        • For registration with CE credit:  Visit our registration site.  After you register successfully, UCONN will send a confirmation e-mail with details concerning how to proceed.  You must be actively (within the last 3 years and willing to take new students) taking UConn students to register for half price CE.

        Target Audience

        Pharmacists, pharmacy preceptors and pharmacy residents who are interested in enhancing their skills in the area of teaching and learning.

        This activity is not accredited for technicians

        Learning Objectives

        Module 1-Teaching Basics

        Topic Faculty strong>Learning Objectives:
        Blooms taxonomy-1.5 hour Wick 1. Differentiate between higher and lower order thinking
        2. Compare and contrast old and new Bloom’s taxonomy
        3. Describe the different levels of the taxonomy
        4. Apply the taxonomy for planning lecture/activities
        Learning objectives: Beginning with the end in mind-1 hour Wick 1. Compare and contrast learning objectives and learning goals
        2. List the 3 parts of a learning objective
        3. Write learning objectives that contain a measurable verb
        4. Develop learning objectives that demonstrate higher order learning
        Understanding learning styles-1 hour Wick 1. Discuss the concept of learning style
        2. Evaluate the effectiveness of learning styles tool(s)
        3. Formulate a view on the role of learning styles
        Teaching philosophy and portfolios-1.5 hours-OPTIONAL Rickles-OPTIONAL 1. Explain the purpose of a teaching philosophy
        2. Describe the components of a philosophy
        3. Discuss the fundamental element of a teaching portfolio
        4. Describe the material from oneself and from others that are contained in a teaching portfolio
        5. Create a draft teaching portfolio
        Syllabus Creation-1 hour Salvo 1. Describe the purpose of a comprehensive syllabus
        2. List and explain the components of a syllabus
        3.  Compare and contrast the elements included in various syllabi
        4. Create or modify a course/rotation syllabus
        Writing Exam Questions-1 hour Ehret 1. Compare and contrast the difference between true/false and one-best answer type questions
        2. Construct effective stems and options for multiple choice exam questions
        3. Detect problems with poorly written test questions
        Assessments Beyond Examinations- 1.5 hour Wick 1. Explain the difference between criterion and norm-based grading
        2. Weigh pros and cons of various assessment techniques
        3. Discuss best practices for developing a rubric
        4. Develop a rubric for evaluating an active learning activity
        Designing inter-professional Education Activities-1 hour Dang 1.  List general principles, goals,and competencies of inter-professional education (IPE)
        2.  Describe opportunities and challenges in developing and implementing IPE activities
        3.  List strategies for incorporating IPE activities in the didactic or experiential environment
        Explicit Instruction-1 hour Kleven 1.  Identify the main elements of explicit instruction
        2.  Analyze a lesson plan outline using explicit instruction functions
        3.  Explore strategies for processing content

         

        Module 2-Taking Teaching into the Pharmacy

        Topic Faculty Learning Objectives
        Empowering Preceptors to Teach: Defining Roles & Responsibilities-1 hour Seo 1. Explain the importance of precepting and mentoring in professional development
        2. Define each of the 4 preceptor roles in teaching clinical problem solving (instructing, modeling, coaching, and facilitating)
        3. Determine which preceptor role would be appropriate to use to help a resident progress, given specific case examples
        Assessing your Student Pharmacists or Residents Performance Through Feedback- 1.5 hour Hritcko/Wick 1. Explain the role of the preceptor’s assessment in the overall evaluation of a student pharmacist by the school of pharmacy
        2.  Develop strategies to collect student performance data throughout the rotational experience
        3.  Identify methods to ensure that the evaluation of student pharmacists are fair, objective, and accurate
        4.  List strategies to provide constructive feedback to students who are not achieving rotational goals and objectives
        5.  Explain the for providing positive feedback to students
        6.  Demonstrate effective feedback to students
        Professional Identity-2 hour Wick/Luciano/Yazdanpanah 1.  Describe the professional identity formation process
        2.  Apply the steps to help student and pharmacists at points in their careers develop a professional identity
        3.  Identify activities that contribute to Professional Identity develop appropriately
        Conflict Management & Communication in Pharmacy Practice Experiences- 1.5 hour White 1.  Differentiate between the various types of conflict that pharmacists and/or residents confront at their practice sites
        2.  Identify common emotional and physical reactions to conflict and possible strategies to defuse the situation
        3.  Explain how to use communication skills to resolve conflicts between preceptors and students while on their pharmacy practice experiences

         

        Module 3: Stepping Up Your Game

        Topic Faculty Learning Objectives
        Active learning, tools of the trade-1 hour Kleven
        1. Define active learning.
        2. List and describe various active learning strategies
        3. Determine the best active learning strategy for a given situation.
        4. Visualize concerns about active learning.
        Effective Online Teaching & Learning- 1.25 hours Wick/Nolan 1. Recognize best practices in developing online courses
        2. Describe 5 basic elements of course development
        3. Differentiate between topics that are amenable to online teaching and those that are not
        4. List some tricks and tips for making online learning more engaging
        Integrating Pharmacy students into practice-0.75 hours Hritcko/Wick 1. Describe benefits and potential barriers to successful integration of students into pharmacy practice
        2. Recognize opportunities to integrate students that will be valuable to students, preceptors, and practice institutions
        3. Identify strategies and resources available to support pharmacy preceptors
        Patient Cases:  Discussion, Construction and Assessment-1 hour  Wheeler 1.  Discuss theory behind case-based teaching
        2.  Identify a strategy for discussing patient cases with students
        3.  List some tools that could assist students with preparation for case discussion
        4.  Explain the relationship between patient case design/discussions to Bloom’s taxonomy of learning
        5.  Identify strategies for assessing student performance

         

        Module 4: Playing with the Big Dogs (Go Huskies!)

        Topic Faculty Learning Objectives
        A Review of Introductory Statistical Concepts(OPTIONAL)-2 hours Sobieraj 1. Define a framework for the application of evidence-based medicine to clinical practice
        2. List the criteria that contribute to the quality of a trial
        3. Distinguish between categorical and continuous variables and how this impacts outcome assessment in a trial
        4. Interpret descriptive statistics in a given trial
        5. Define, interpret, and calculate a relative risk, odds ratio, relative and absolute risk, and number need to treat
        6. Use a 95% confidence interval to determine clinical and statistical significance
        7. Define type I and type II error and their impact on trial results
        Incorporating Scholarship into your Day- 1 hour Sobieraj 1. Identify research tips for various steps involved including formulation of a research question, biostatistics for researchers, working with the IRB, obtaining grant funding, and writing a manuscript
        2. Provide examples of scholarship of teaching from the classroom setting
        3. Provide examples of scholarship from the preceptor’s perspective
        Ethical issues in Authorship and Scholarship-1 hour Wick 1. Identify the ICMJE criteria for authorship
        2.  Discuss issues related to authorship criteria, student-faculty publications, and duplicate publications
        3. Develop personal approaches for handling authorship criteria, author order, student-faculty publications, and duplicate publication cases
        Clinical Teaching Venues:
        Applying Pedagogy in a Big Wide World- 1.5 hours
        White 1. Compare and contrast the roles and responsibilities of full time tenure track and non-tenure track faculty
        2. Describe the advantages of being an adjunctive instructor of students and residents
        3. Describe how to apply teaching skills to various settings
        4. Describe how to gauge feedback aside from student evaluations of teaching
        Continuing Professional Development-1 hour Nault 1. Explain the concept of Continuing Professional Development (CPD)
        2. Outline the steps involved in the CPD process
        3. Prepare an individualized CPD plan
        ACPE Continuing Education Standards:  How to plan and deliver an exceptional activity- 1 hour Fitzgerald 1. Describe the ACPE standards for continuing pharmacy education
        2. Explain the components of a needs assessment
        3. Identify ways to measure outcomes from continuing education
         Teaching Example-1 hour  CE Participant 1. Prepare a presentation using teaching and learning concepts
        2. Deliver a presentation using teaching and learning concepts

         

        Activity Faculty

        Devra Dang, PharmD, BCPS, CDE
        Associate Clinical Professor, University of Connecticut, School of Pharmacy, Storrs, CT

        Megan Ehret , PharmD, MS, BCPP
        Associate Professor, University of Maryland, School of Pharmacy
        Baltimore, MD

        Jill Fitzgerald, PharmD
        Director, Experiential Learning and Continuing Professional Development and Associate Clinical Professor
        University of Connecticut, School of Pharmacy, Storrs, CT

        Philip Hritcko, PharmD, CACP
        Dean, School of Pharmacy
        University of Connecticut School of Pharmacy, Storrs, CT

        Nathaniel Rickles, PharmD, PhD, BCPP
        Associate Professor of Pharmacy Practice
        University of Connecticut School of Pharmacy, Storrs, CT

        Marissa Salvo, PharmD, BCACP
        Associate Clinical Professor Pharmacy Practice,
        University of Connecticut School of Pharmacy, Storrs, CT

        Teresa Seo, PharmD, BCPS, FASHP
        Department of Pharmacy Services
        UConn Health – John Dempsey Hospital
        Farmington, CT

        Diana Sobieraj, PharmD
        Assistant Professor, Senior Research Scientist and Program Manager
        University of Connecticut School of Pharmacy/Hartford Hospital Evidence-based Practice Center, Hartford, CT

        Kathryn Wheeler, PharmD, BCPS
        Associate Dean of Academic Affairs
        Associate Clinical Professor of Pharmacy Practice
        University of Connecticut School of Pharmacy, Storrs, CT   

        C. Michael White, PharmD, FCCP, FCP
        Department Head and Professor
        University of Connecticut School of Pharmacy, Storrs, CT

        Jeannette Y. Wick, RPh, MBA
        Assistant Director, Office of Pharmacy Professional Development and Visiting Instructor,
        University of Connecticut School of Pharmacy, Storrs, CT

        Heather Kleven

        Joanne Nault

        Laura Nolan

         

        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.

        None of the above listed faculty have actual or potential conflicts of interest associated with this presentation.

        Acitivity Fees

        General Registration–  $359.00

        University of Connecticut Faculty and Adjunct Faculty – Free of charge without continuing education credit; or for $179.50 (50% group discount) continuing education credit.

        • For registration without CE credit:  Contact Joanne Nault  (joanne.nault@uconn.edu) and provide your net ID for access to the learning management system.  For those without a NetID, please contact Judith Vigneau (judith.vigneau@uconn.edu) complete the Adjunct Faculty Appointment Form.pdf and email to Judith Vigneau (judith.vigneau@uconn.edu)
        • For registration with CE credit:  Register using Registration Button above. Once registered a confirmation email with further details will be sent.

        Grant Funding

        There is no grant funding for this activity.

        Requirements for Successful Completion

        For those wishing to receive CE Credit and ACPE Teaching Certificate of Achievement:

        •  Complete all of the required online modules and participate in the activities, including an evaluation of each activity within the huskyct system.
        • Prepare and deliver a “teaching experience”
        • Complete and send in the Verification of Participation form found on the HuskyCT site, and submit to Joanne Nault
        • Once all of the activities have been completed, Visit our online CE Center at https://pharmacyce.uconn.edu/login.php and complete the course evaluation to have your CE credits uploaded to the CPE Monitor system

        For those wishing to receive UConn School of Pharmacy Teaching Certificate of Completion (no CE Credit):

        • Complete all of the required online modules and participate in the activities
        • Complete the evaluation forms found under each activity on the HuskyCT site
        • Prepare and deliver a “teaching experience”
        • Complete and send in to Joanne Nault the Verification of Participation form found on the HuskyCT site

        ACPE logo

        The University of Connecticut, School of Pharmacy, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Twenty-eight and one half contact hours (2.85 CEU’s) will be awarded to pharmacists who view the presentations, participate in the activities and complete the evaluations, and deliver their teaching example. Statements of credit for 0009-0000-24-030-H04-P, will be sent to CPE Monitor and can be printed from your CPE Monitor Profile. A Certificate of Achievement will be sent to those who complete all activities, evaluations and submit a complete Verification of Participation Form. Upon successful completion of the optional activities  ACPE UAN 0009-0000-21-035-H04-P,  and ACPE UAN 0009-0000-21-036-H04-P we will award 1.5 contact hours (0.15 CEU’s) and 2.0 contact hours (0.20 CEU’s), respectively.

        Initial release date:  July 15, 2024
        Planned expiration date:  July 15, 2027

        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.

        NDMA Contamination Drives Recent Drug Recalls: What Do We Need to know?

        Learning Objectives

        At the end of this continuing education activity, the pharmacist will be able to:

        1. Describe details of recent ranitidine and metformin drug recalls
        2. Differentiate between categories of drug recalls
        3. Identify appropriate patient education regarding recalled medications

         

        At the end of this continuing education activity, the pharmacy technician will be able to:

        1. Describe details of recent ranitidine and metformin drug recalls
        2. Differentiate between categories of drug recalls
        3. Identify when referral to a pharmacist is appropriate

        Session Offered

        Release Date: February 22, 2024

        Expiration Date:  February 22, 2027

        Course Fee

        $4 Pharmacist

        $2 Technician

        Session Codes

        Pharmacist: 21YC05-XTR58

        Pharmacy Technician :  21YC05-RXT82

        ACPE UANs

        Pharmacist: 0009-0000-24-010-H05-P

        Pharmacy Technician :  0009-0000-24-010-H05-T

        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.

        Pharmacists and pharmacy technicians are eligible to participate in this application-based activity and will receive up to 0.1 CEU (1 contact hours) for completing the activity ACPE UAN 0009-0000-24-010-H05-P/T, 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

        None

         

        Disclosure of Discussions of Off-label and Investigational Drug Use

        This activity may contain discussion of off label/unapproved use of drugs. The content and views presented in this educational program are those of the faculty and do not necessarily represent those of the University of Connecticut School of Pharmacy. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

        Faculty

        Ariana Hawkins is a 2021 PharmD candidate

        Jeannette Y. Wick, R.Ph., MBA, FASCP, is the Assistant Director, Office of Pharmacy Professional Development, at the University of 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.

        Ariana Hawkins and Jeannette Wick do not have any financial relationships with ineligible companies.

        Abstract

        The unexpected presence of N-nitrosodimethylamine (NDMA) in prescription and over-the-counter drug products precipitated several drug recalls in the last few years. Its presence has been troubling for the pharmaceutical industry and patients alike. With many questions unanswered, pharmacists and pharmacy technicians need to know the basics about this recall: the affected products, how NDMA may have contaminated various products, and appropriate actions and the timeframe in which to take them. This continuing education activity explains the recent recalls and provide current information.

         

         

        Content

        CONTENT

        A drug recall is a public notification of a product removed from the market due to a defective or harmful ingredient or label.1 Recalls are voluntary if initiated by the company or manufacturer. The United States (U.S.) Food and Drug Administration (FDA) initiates an involuntary recall when it finds a drug (or device) defective or harmful to consumers and the drug company does not issue a recall voluntarily.

        Recalls happen every year, as the FDA has measures in place to ensure consumer safety.1 The most common reasons for drug recalls are contamination, mislabeling, defective drug products, adverse reactions, newly published clinical studies, and incorrect drug potency.2 A classification system is in place to determine the level of harm the recalled product may cause (see the Technician Talk: Classifying Recalls2).1 The FDA also posts weekly enforcement reports containing pertinent information to inform the public about recalls.

        TECH TALK SIDEBAR: Classifying Recalls2

        The FDA classifies recalls into three categories that range in level of severity:

        1. Class I recalls are most severe, and product use might lead to serious health problems or death.
        2. Class II recalls are most common and can cause non-life-threatening adverse events or a slight threat of a serious event.
        3. Class III recalls are least severe and less likely to cause harm; often these are related to a labeling concern or a manufacturing citation.

        Sometimes, a recall is “unclassified,” meaning the FDA has not classified the recall yet but wants to inform stakeholders as soon as possible.

        This continuing education activity discusses the most recent recalls involving ranitidine/nizatidine and metformin.

        The FDA classifies recalls into three categories that range in level of severity:

        1. Class I recalls are most severe, and product use might lead to serious health problems or death.
        2. Class II recalls are most common and can cause non-life-threatening adverse events or a slight threat of a serious event.
        3. Class III recalls are least severe and less likely to cause harm; often these are related to a labeling concern or a manufacturing citation.

        Sometimes, a recall is “unclassified,” meaning the FDA has not classified the recall yet but wants to inform stakeholders as soon as possible.

        Not all recalls are announced on fda.gov, published in the media, or released to the public.1 The FDA notifies the public when a recall poses a serious health hazard or involves a widely distributed product.1 Otherwise, patients learn of recall information from drug manufacturers, their primary care physicians, or their local pharmacy.1 When the recall is widespread—meaning it affects many Americans—the media also announces it.

        Some of the most significant drug recalls from the past include3-5

        • Terfenadine (Seldane) in 1997: a non-sedating antihistamine formerly used to treat allergic rhinitis caused severe heart complications and potentially fatal drug interactions with certain antibiotics and antifungal medications
        • Astemizole (Hismanal) in 1999: a second-generation antihistamine used for treating allergy symptoms led to rare but potentially fatal cardiac side effects
        • Fenfluramine/phentermine (Fen-Phen) in 1997: a prescription weight loss medication that was associated with cases of pulmonary hypertension and many lawsuits
        • Rofecoxib (Bextra) in 2004: an anti-inflammatory drug used to treat arthritis linked to increased heart attack and stroke risk
        • Valdecoxib (Vioxx) in 2005: an anti-inflammatory drug linked to heart, stomach, and severe skin reactions, such as Stevens-Johnson Syndrome

        Drug recalls can leave patients feeling vulnerable and create or deepen mistrust between some patients and the healthcare profession if handled poorly.6 As patients hear news of a drug recall, healthcare professionals can help them understand what to do. Healthcare providers must rely on trusted resources that are updated often for guidance. Interested individuals can go to fda.gov/safety/recalls-market-withdrawals-safety-alerts to register for emails, safety alerts, and notifications pertaining to drug recalls.7 Safety alerts and drug recall information is available for three years on the FDA’s website before being archived. Patients and healthcare professionals can search the FDA’s archived content for older recalls on fda.gov/about-fda/about-website/fdagov-archive.8

        NDMA is an N-nitrosamine with cancer-causing potential that is ubiquitous in the environment; it is present in water, soil, and the air in small amounts.15 Humans are primarily exposed to NDMA orally.16 Most everyone is exposed to low levels of NDMA because dairy products, meats, and vegetables often contain it in trace amounts.17 The average daily NDMA intake from food sources is about 1 microgram.15

        NDMA can end up in water, food, and medication we consume daily. It can be generated from chemicals used to disinfect plants and therefore contaminate the public drinking water supply.16 Plants and animals subsequently use the water and the animals eat the plants. Additionally, when treatment plants chlorinate and disinfect waste- and drinking-water using chloramines, NDMA is an unintended byproduct.16  NDMA was historically used in the production of rocket fuel, antioxidants, softeners for copolymers, and lubricants which could contaminate the water and soil.16,18 Today, people only produce NDMA in its pure form for research purposes.

        NDMA’s cancer-causing potential stems from structural mutations that arise through its metabolic activation and covalent interaction with deoxyribonucleic acid (DNA).15 If these mutations persist throughout DNA’s replication cycle, permanent damage in critical sites may result.15

        NDMA may have contaminated medications in various ways. The first is cross-contamination from merging solvents and catalysts from factories in different industries. Solvents and catalysts that convert precursor chemicals into active ingredients become less effective over time. They should be segregated from other solvents to avoid cross contamination. ARBs are believed to have fallen victim to this phenomenon. Multiple manufacturers of finished pharmaceutical products acquired contaminated active ingredients because the solvents and/or catalysts used to produce them were tainted.16,17

        NDMA contamination of ranitidine and nizatidine is through one or both of the following16,18:

        • a direct byproduct of chemical reactions needed to produce the active ingredients
        • breakdown of the active ingredient itself

        The ranitidine molecule contains both a nitroso group and dimethylamine (DMA) group on either end of the molecule. NDMA is formed when the nitroso group and DMA group are near one another and a chemical reaction occurs.6

        It is currently unclear to what extent the aforementioned mechanisms drove the NDMA contamination of metformin ER products. Researchers examining drug products to detect their NDMA levels sometimes find either an nitroso group or a DMA group, but not both. They suggest the breakdown of unstable byproducts, side reactions during drug synthesis, and recycled solvents used in manufacturing could have led to NDMA formation and contamination of medications.6

        Different manufacturers’ drug processing methods and extreme medication storage temperature conditions may account for the varying NDMA levels found within drug products. Extreme temperature conditions can liberate the nitroso or the DMA and galvanize formation of NDMA in medications. It is unclear whether its formation stems from extreme temperature exposure by the manufacturer or from patients doing the same during their daily activities.18 Researchers detected increasing NDMA levels over an extended period and temperature conditions in some ranitidine products, posing a health concern for patients. 15,18

        Discovering a Discrepancy

        The interest in NDMA as a possible carcinogen arose from experimental animal studies.15 Several studies found that NDMA caused cancer, cirrhosis, and hyperplastic nodules in monkeys, classifying it as possibly carcinogenic to humans.15 Following these studies, additional research led to the discovery of this possible carcinogen in the drugs discussed here.

        A research associate at Valisure—an analytical pharmacy—discovered NDMA contamination in ranitidine prescribed to the company’s cofounder’s daughter.6 Using mass spectrometry and gas chromatography, the associate noted giant peaks on the test printout that indicated the presence of NDMA in ranitidine oral solution.6 The peaks’ intensity was so high that the research associate ran several tests to ensure the validity of the results. This discovery was not an isolated incident, as researchers from other companies have detected the presence of NDMA in medications taken by millions of people each year.6 It was, however, the instigator of the most recent recalls.

        Too much of any one ingredient or item can be toxic. The FDA indicates that a safe daily ingestion NDMA found in medications is 96 nanograms.15 The lowest amount of NDMA found by Valisure in ranitidine was 4 nanograms and the highest was 860 nanograms.6,15 Recalled metformin ER formulations also exceeded the allowable daily limit for products containing NDMA or N-nitrosamine-related compounds.19 A flaw in the FDA’s acceptable limit of NDMA per tablet or capsule is that some drugs are dosed multiple times per day, increasing daily exposure. Additionally, patients taking multiple drugs with NDMA concentrations just under the acceptable limit could have extensive aggregated exposure each day.

        Pause & Ponder: How do you counsel patients on protecting their medications from extreme temperatures over extended periods of time?

        Healthcare providers are vital in addressing patients’ questions and concerns about medication recalls. Ranitidine is no longer on the market, and prescribers are switching their patients to alternative medications.20,21 FDA testing of famotidine, cimetidine, lansoprazole, omeprazole, pantoprazole, and esomeprazole have not revealed NDMA contamination, so these are viable options to recommend.11 Patients taking metformin ER should continue to take their medication until they are able to speak to their provider or pharmacist.19 They should also contact their provider or go to the hospital if they experience severe or unusual side effects from their current therapy.

        Many patients will consult with a pharmacist—their accessible, local drug experts—for guidance. The pharmacy team should be ready to answer patients’ inventory-related questions pertaining to ranitidine and metformin ER. It is important to note that not all manufacturers of these medications are included in the recall. Patients often contact pharmacies to inquire if their medication has been recalled. Pharmacies with unrecalled metformin ER in stock should provide that specific manufacturer to patients to prevent lapses in therapy.

        Pharmacists can contact prescribers to discuss concerns and alternative treatment options. They can suggest alternatives to ranitidine, such as famotidine, cimetidine, or proton pump inhibitors (e.g., lansoprazole, omeprazole, pantoprazole, esomeprazole). Pharmacists can also assist in finding an appropriate dose of unrecalled metformin ER for patients before straying from their original therapy. Unrecalled metformin ER is preferred before requesting a medication change, as most patients are accustomed to the long-acting formulation and drastic changes in blood glucose levels can be hazardous. If an appropriate formulation is unavailable, pharmacists can assist physicians in converting metformin ER to immediate release dosing for patients with type 2 diabetes.

        PAUSE & PONDER:  Have you, a family member, or friend ever been affected by a drug recall? If so, how were you informed of the recall and what steps did you take next?

        Common Drugs with a Common Contaminant

        In November 2018, chemists had the first inkling that N-nitrosodimethylamine (NDMA) might be a medication contaminantChemists found NDMA impurities in the angiotensin receptor blocker (ARB) class of medications, otherwise known as the “sartans”.9 Several pharmaceutical companies recalled valsartan, losartan, and irbesartan because they contained NDMA and a related compound, N-nitrosodiethylamine (NDEA).10

        The FDA published a Class II recall for ranitidine due to potentially cancer-causing NDMA found in certain formulations in September 2019.11,12 Ranitidine is a histamine 2 receptor antagonist (H2RA) indicated for gastroesophageal reflux disease, heartburn, stomach ulcers, and other related conditions that cause stomach acid overproduction. Pharmacists and pharmacy technicians should advise patients that this recall affects prescription and over-the-counter (OTC) versions of ranitidine, one of which is the popular brand Zantac.14 The FDA has also found NDMA in another H2RA, nizatidine (Axid), which shares a similar chemical structure to ranitidine. It is also indicated to treat conditions caused by overproduction of stomach acid. As of April 2020, Amneal and Mylan voluntarily recalled nizatidine oral solution (15 mg/mL) and oral capsules, respectively, as each contained NDMA levels exceeding the acceptable daily intake limit of 96 nanograms.11

        The FDA also announced an unclassified metformin recall in June 2020.13 This recall does not apply to metformin immediate release formulations; it only pertains to certain extended release (ER) versions of the drug.13 Metformin ER is an antihyperglycemic medication indicated for patients with type 2 diabetes. Patients should confer with their pharmacist or other healthcare provider to determine an appropriate switch to a safer alternative. More guidance on appropriate counseling appears below.

        These recalls have affected millions of patients because those with common health conditions—acid reflux and diabetes—take ranitidine and metformin ER routinely and chronically. Many companies, including Apotex, Aurobindo, Dr. Reddy’s, Mylan, Lupin, Sandoz, Sanofi, Teva, and others, have recalled their drug products containing unacceptable NDMA levels.13 Data collection for both recalls is ongoing as the FDA continually posts updates on fda.gov/safety/recalls-market-withdrawals-safety-alerts.7

        Table 1 compares drug information of metformin ER and immediate-release metformin.19,22-24

        Table 1. Comparison of Metformin ER and IR19,22-24
          Metformin ER Metformin IR
        Doses 500 mg, 750 mg, 1000 mg 500 mg, 850 mg, 1000 mg
        ER to IR dosing Once daily ER = twice daily IR

        Twice daily ER = three times daily IR

        Twice daily IR = once daily ER

        Three times daily IR = twice daily ER

        Frequency Once or twice daily Twice or three times daily
        Patient Adherence Better than IR Worse than ER
        Pharmacokinetics Peaks slower, but lasts longer in the body (4 to 8 hours) Peaks faster, but has a shorter duration within the body (2 to 3 hours)
        Side Effects Fewer gastrointestinal side effects (e.g., diarrhea, nausea, vomiting) More gastrointestinal side effects (e.g., diarrhea, nausea, vomiting)

        ER=extended release; IR=immediate release

         

        Pause & Ponder: What strategies you have tried in the past to reassure patients amid a drug recall?

        Conclusion

        Medication recalls can be confusing and scary for patients, and pharmacy teams should be prepared to help them navigate next steps. Reassure patients that manufacturers are being more stringent in testing for NDMA. In light of the widespread recall, companies producing metformin-containing ER products are evaluating their medications cautiously for the presence of NDMA. If any tested batch is unacceptable, companies will not release it.13 Other companies producing NDMA-containing medications, including ranitidine, nizatidine, and antihypertensives, are also continually testing their products for NDMA to ensure the safety of products stocked within pharmacies.

        Discovery of NDMA impurities within several common medications for chronic conditions has highlighted its potential as a possible human carcinogen. Clinical literature to suggest NDMA’s clear correlation with cancer in humans is scant at this time. Future research and pharmacoepidemiologic studies are needed to establish a distinctive link between patients taking ranitidine and/or metformin and their exposure to NDMA.

        Post Test for Pharmacist

        Pharmacist Post-test Questions

        Question 1:  Mr. Taylor takes over-the-counter ranitidine for acid reflux. He heard news of a recent recall online pertaining to ranitidine products. He approaches the consultation counter to ask you for guidance. He has tried antacids without any relief. What do you advise Mr. Taylor to do?

        1. Continue taking the ranitidine he has at home because it was backordered, not recalled
        2. Contact his doctor because you are unsure of the right medication to recommend
        3. Take over-the-counter famotidine since it is safe and therapeutically equivalent

        Question 2:  The FDA has classified ranitidine as a class two recall. Which description below appropriately classifies a Class II recall?

        1. Can cause non-life-threatening adverse events or a slight threat of a serious event
        2. Most severe and use of the product might lead to serious health problems or death
        3. Least severe and less likely to cause harm; often related to a labeling concern

        Question 3: Mrs. Banks hears about a metformin recall through a friend and calls your pharmacy to ask if her metformin ER has been recalled. You check the lot numbers, realize that the manufacturer she received is on the recall list, and inform Mrs. Banks of this news. She is frantic and no longer wants to take her medication. What is the best advice for Mrs. Banks?

        1. “You’re right, Mrs. Banks. It is not safe to continue taking metformin ER because it has been recalled. You should schedule an appointment with your doctor as soon as possible to discuss other medications you can take instead.”
        2. “I understand why you want to stop taking your medication, but it is best to continue taking it to control your blood sugar until you are able to speak with your doctor. If you’d like, I can reach out to your doctor to discuss alternative medications to manage your diabetes. How does that option sound to you?”
        3. “I understand your concerns, Mrs. Banks, but it is not safe to completely stop taking your medication. You wean off the medication slowly from once daily to one tablet every other day until you are able to see your doctor about switching your therapy regimen.”

        Pharmacy Technician Post-test Questions

        Pharmacy Technician Post-test Questions

        Question 1: Mr. Taylor approaches the pharmacy counter looking for a medication to treat his acid reflux. He has been taking over-the-counter ranitidine for many years, but due to the recent recall, he feels it is unsafe continuing to take it. He has also tried antacids without relief. What do you recommend to Mr. Taylor?

        1. Tell Mr. Taylor to continue taking the ranitidine he has at home because it was not recalled and is only on backorder
        2. Instruct Mr. Taylor to contact his prescriber because you are unsure of the right medication to recommend
        3. Refer Mr. Taylor to the pharmacist who can recommend a therapeutically-equivalent medication to treat his acid reflux

        Question 2: The FDA has classified ranitidine as a Class II recall. Which description below appropriately classifies a Class II recall?

        1. Can cause non-life-threatening adverse events, or a slight threat of a serious event
        2. Most severe and use of the product might lead to serious health problems or death
        3. Least severe and less likely to cause harm; often related to a labeling concern

        Question 3: Mrs. Banks is picking up her prescription for metformin ER at the pharmacy, and she is concerned about a recent metformin recall she heard about from a friend. You check the lot numbers and confirm that the manufacturer Mrs. Banks takes was not recalled. She asks you if she should continue taking her metformin or to stop taking the medication. What is the best response to tell Mrs. Banks?

        1. “I am not sure if you should continue or stop taking your medication, but I can let the pharmacist know you would like to speak to him/her. Do you mind waiting a few moments for the pharmacist to answer your question?”
        2. “You’re right, Mrs. Banks. There has been a recall on metformin medications, but not all the manufacturers were affected. You should still continue to take your medication. Would you like to speak to the pharmacist about the different options available to you?”
        3. “You’re right, there has been a recall on all metformin medications. You should not pick up this medication and speak to your doctor right away about switching to an alternative medication."

        References

        Full List of References

        1. U.S. Food & Drug Administration. FDA’s role in drug recalls. Updated July 3, 2018. Accessed at https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls, July, 21, 2020.
        2. Hall K, Stewart T, Chang J, Freeman MK. Characteristics of FDA drug recalls: A 30-month analysis. Am J Health Syst Pharm. 2016;73(4):235-240.
        3. U.S. Food & Drug Administration. Safety: market withdrawals/recalls. Updated September 15, 2009. Accessed at https://wayback.archive-it.org/7993/20170405031504/https://www.fda.gov/Safety/SafetyofSpecificProducts/ucm180605.htm, July 24, 2020.
        4. Gottlieb S. Antihistamine drug withdrawn by manufacturer. BMJ. 1999;319(7201):7.
        5. Handler Henning & Rosenberg, LLP. 5 Significant drug recalls in U.S. history & why they happened. October 7, 2019. Accessed at https://www.hhrlaw.com/blog/2019/october/5-significant-drug-recalls-in-us-history-why-the/, July 21, 2020.
        6. Boerner LK. NDMA, a contaminant found in multiple drugs, has industry seeking sources and solutions. Chemical & Engineering News. April 20, 2020. Accessed at https://cen.acs.org/pharmaceuticals/pharmaceutical-chemicals/NDMA-contaminant-found-multiple-drugs/98/i15, July 22, 2020.
        7. U.S. Food & Drug Administration. Recalls, market withdrawals, and safety alerts. Updated July 20, 2020. Accessed at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts, July 21, 2020.
        8. U.S. Food & Drug Administration. FDA.gov archive. Updated April 21, 2019. Accessed at https://www.fda.gov/about-fda/about-website/fdagov-archive, July 21, 2020.
        9. Charoo NA, Ali AA, Buha SK, Rahman Z. Lesson learnt from recall of valsartan and other angiotensin II receptor blocker drugs containing NDMA and NDEA impurities. AAPS PharmSciTech. 2019;20(5):166.
        10. Byrd JB, Chertow GM, Bhalla V. Hypertension hot potato - anatomy of the angiotensin-receptor blocker recalls. N Engl J Med. 2019;380(17):1589-1591.
        11. U.S. Food & Drug Administration. FDA updates and press announcements on NDMA in Zantac (ranitidine). April 16, 2020. Accessed at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine, July 21, 2020.
        12. Blue Cross Blue Shield Blue Care Network of Michigan. Drug recall list. Updated June 2020. Accessed at https://www.bcbsm.com/content/dam/microsites/medicare/documents/drug-recall-list.pdf, July 21, 2020.
        13. American Academy of Family Physicians. FDA issues recall alert for metformin ER products. June 1, 2020. Accessed at https://www.aafp.org/news/health-of-the-public/20200601metforminrecall.html, July 22, 2020.
        14. U.S. Food & Drug Administration. Question and answers: NDMA impurities in ranitidine (commonly known as Zantac). Updated April 01, 2020. Accessed at https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac, July 21, 2020.
        15. Adamson RH, Chabner BA. The finding of N-nitrosodimethylamine in common medicines. Oncologist. 2020;25(6):460-462.
        16. United States Environmental Protection Agency. Technical fact sheet–N-nitroso-dimethylamine (NDMA). January 2014. Accessed at https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf, July 21, 2020.
        17. U.S. Food & Drug Administration. Information about nitrosamine impurities in medications. Accessed at https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications, July 21, 2020.
        18. White CM. Understanding and preventing (N-Nitrosodimethylamine) NDMA contamination of medications. Ann Pharmacother. 2020;54(6):611-614.
        19. U.S. Food & Drug Administration. FDA updates and press announcements on NDMA in metformin. Accessed at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin, July 21, 2020.
        20. American Society of Health-System Pharmacists. Current drug shortages: ranitidine injection. April 2, 2020. Accessed at https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=426, July 21, 2020.
        21. U.S. Food & Drug Administration. FDA requests removal of all ranitidine products (Zantac) from the market. April 1, 2020. Accessed at https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market, July 21, 2020.
        22. Metformin [prescribing information]. Raleigh, NC: Indicus Pharma LLC;2020. Accessed at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56d13a1c-b289-4528-b23c-60f5427b4552, July 21, 2020.
        23. Pala L, Rotella CM. The "slower" the better. J Endocrinol Invest. 2014;37(5):497-498.
        24. Metformin ER [prescribing information]. Parsippany, NJ: Granules USA, Inc;2019. Accessed at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b857eccf-b9ff-45ba-8241-f47f5caada2a, July 21,2020.
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