U.S. Food & Drug Administration

Activity Outline
FDA Drug Topics: How to Avoid Medication Errors with Pen Injectors
May 23, 2023
FDA

Activity Coordinators:

Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov), Kara Burke (Kara.Burke@fda.hhs.gov), Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov)

Description

There has been an increasing number of ready-to-use or ready-to-administer injectable medications reaching the market as auto-injectors, pen injectors, or otherwise requiring syringe/needle use at home. This webinar will provide participants with important safety information to help patients and caregivers avoid medication errors with these products, whether intended for use institutionally or at home. The presenters will share information derived from a review of medication error reports submitted by practitioners and patients to the FDA Adverse Event Reporting System (FAERS) and the Institute for Safe Medication Practices National Medication Errors Reporting Program (ISMP MERP). These reports, as well as other observations by the presenters will help identify safety issues and prevention measures that health care professionals should consider for incorporation into their patient safety education programs, including when prescribing or dispensing these products for patients at home.

References

FDA advises health care professionals and patients about insulin pen packaging and dispensing (https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-health-care-professionals-and-patients-about-insulin-pen-packaging-and-dispensing)
Grissinger M. “Wrong Patient” Insulin Pen Injections Alarmingly Frequent Even With Barcode Scanning. P&T: A Peer-Reviewed Journal for Managed Care and Hospital Formulary Management. 2017;42(9):550-552. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5565125/)
FDA Adverse Event Reporting System (FAERS) (https://www.fda.gov/drugs/drug-approvals-and-databases/fda-adverse-event-reporting-system-faers)
National Action Plan for Adverse Drug Event Prevention. U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. Published November 28, 2022. (https://health.gov/about-odphp/previous-initiatives/national-ade-action-plan)
Shah A, Sullivan MM, Rushakoff RJ. A New “Twist” on Insulin Pen Administration Errors. Endocr Pract 2014;20:617. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425423/)

Learning Objectives

Identify at least 3 drugs that are available in pen injectors.
Describe at least 3 medication error types that have been reported to FDA or ISMP that involve insulin pens.
Discuss how to identify opportunities that can minimize safety risks for drugs available in pen injectors.

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.

Agenda
Day 1 May 23, 2023

Time	Topic	Speaker
1:00 - 2:00 PM EDT	FDA Drug Topics: How to Avoid Medication Errors with Pen Injectors	Zachary Oleszczuk, PharmD, MSPharm; BCGP Michael Cohen, R. Ph

Continuing Education Accreditation

In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME

FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)^™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CPE

This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-040-L05-P , and ACPE Universal Activity Number JA0002895-0000-23-040-L05-T for 1.00 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).

AAPA

This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation.

CPH

Up to 1.00 CPH Recertification Credits may be earned at this event.

Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

Cohen, Michael, R. Ph, President Emeritus, ISMP - nothing to disclose
Oleszczuk, Zachary, PharmD, MSPharm; BCGP, Deputy Division Director, FDA - nothing to disclose

Planning Committee

Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team

Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.

Registration Information
Registration is complimentary; therefore refunds are not applicable.

Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

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