This webinar described the role of the FDA Division of Medication Error Prevention and Analysis (DMEPA) in preventing and addressing medication errors through pre-market and post-market activities. DMEPA collaborates with the nonprofit Institute for Safe Medication Practices (ISMP), to share information from the ISMP National Medication Errors Reporting Program in a way that benefits overall drug safety. Actions taken to address recent medication error reports were explored, and the role of health care practitioners in identifying, preventing, and mitigating medication errors were discussed.

• Draft Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-developing-proprietary-names-drugs.
• Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-container-labels-and-carton-labeling-design-minimize-medication-errors.
• Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-product-design-minimize-medication-errors-guidance-industry.
• Guidance for Industry: Applying Human Factors and Usability Engineering to Medical Devices: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-andusability-engineering-medical-devices.
• A Lot Happens When You Report a Hazard or Error to ISMP – There’s No “Black Hole” Here! https://www.ismp.org/acute-care/medication-safety-alert-november-7-2019.
• Pump Up the Volume: Tips for Increasing Error Reporting and Decreasing Patient Harm https://www.ismp.org/resources/pump-volume-tips-increasing-error-reporting-and-decreasing-patient-harm.

• Explain FDA’s role in pre-marketing and post-marketing activities to prevent and address medication errors.
• Summarize how HCPs can help identify, prevent, and mitigate medication errors through adverse event reporting.
• Describe how FDA, ISMP utilize medication error reports to address reported safety issues.
• Outline strategies aimed to increase the safe use of drug products by minimizing user error related to the design, naming, labeling, and/or packaging of drug products.
• Review examples of actions taken to address recently reported medication error reports.

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.

• Cohen, Michael, R. Ph, President Emeritus, ISMP - nothing to disclose
• Vaughan, Valerie, PharmD, Pharmacist, FDA - nothing to disclose

• 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

• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Initial Release Date
February 11, 2022

Expiration Date
December 31, 2024