FDA Drug Topics: Naltrexone Injection for Opioid Use Disorder - FDA’s Efforts to Reduce Medication Errors
October 24, 2023
virtual
This presentation will focus on the importance of medications used for opioid use disorder and provide an overview of FDA's postmarket surveillance process related to medication errors. The presenters will discuss medication errors identified for naltrexone injectable suspension, actions to mitigate those errors, and will highlight the importance of the healthcare provider's role in drug safety.
- U.S. Department of Health and Human Services, Overdose Prevention Strategy, accessed August 29, 2023: https://www.hhs.gov/overdose-prevention/.
- Vivitrol, Labeling – Package Insert, 2022, https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021897s057lbl.pdf.
- Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (May 2022), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-container-labels-and-carton-labeling-design-minimize-medication-errors.
- U.S. Food and Drug Administration, 2018, Questions and Answers on FDA’s Adverse Event Reporting System (FAERS), accessed August 29, 2023, https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers.
- U.S. Food and Drug Administration, 2023, Postmarket Drug Safety Information for Patients and Providers, accessed August 29, 2023: https://www.fda.gov/drugs/drug-safety-and-availability/postmarket-drug-safety-information-patients-and-providers.
- Discuss the opioid crisis and importance of medications used to treat opioid use disorder.
- Describe postmarket drug safety authorities and postmarket medication error surveillance.
- Illustrate how FDA’s process for identifying and evaluating postmarket safety issues was applied for medication errors.
- Recognize how postmarket safety information can be used to change product labeling.
- Summarize how healthcare providers can contribute to drug safety within their practice.
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Other - Certified Public Health (CPH), and physician assistants.
Day 1 October 24, 2023
Time | Topic | Speaker |
---|---|---|
1:00 - 2:00 PM EDT | FDA Drug Topics: Naltrexone Injection for Opioid Use Disorder - FDA’s Efforts to Reduce Medication Errors |
Jessica Voqui, PharmD Sofanit Getahun, PharmD |
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.
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.
Faculty
- Getahun, Sofanit, PharmD, Safety Evaluator, CDER - nothing to disclose
- Liberatore, Mark, PharmD, RAC, Deputy Director for Safety, HHS/FDA/CDER/OND/ON/DAAP - nothing to disclose
- Rychlik, Idalia, PharmD, General Health Scientist, FDA - nothing to disclose
- Vaughan, Valerie, PharmD, Pharmacist, FDA - nothing to disclose
- Voqui, Jessica, PharmD, Associate Director for Postmarket Regulatory Science, 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
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.
Must attend 100% of the activity.