Naltrexone Injection for Opioid Use Disorder: FDA's Efforts to Reduce Medication Errors

In this FDA Drug Topics Continuing Education webinar, CDR Jessica Voqui and Sofanit Getahun discuss the opioid crisis and the importance of medications used to treat opioid use disorder.

Chapters
00:00 - Lecture Introduction
03:42 - Presentation, CDR Jessica Voqui
20:36 - Presentation, Sonfanit Geathun
34:50 - Presentation, CDR Jessica Voqui
41:20 - Question and Answer Session
47:20 Lecture Wrap Up

References:
U.S. Department of Health and Human Services, Overdose Prevention Strategy, accessed August 29, 2023: [ Ссылка ].
Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (May 2022), [ Ссылка ].
Guidance for Industry: REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary (April 2019), [ Ссылка ].
Guidance for Industry: Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (July 2013), [ Ссылка ].
Guidance for Industry: Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (October 2019), [ Ссылка ].


Healthcare Provider Resources
Vivitrol, (Full Prescribing Information) Labeling – Package Insert, 2022, [ Ссылка ].
MedWatch: [ Ссылка ]
U.S. Food and Drug Administration, 2018, Questions and Answers on FDA’s Adverse Event Reporting System (FAERS), accessed August 29, 2023, [ Ссылка ].
U.S. Food and Drug Administration, 2023, Postmarket Drug Safety Information for Patients and Providers, accessed August 29, 2023: [ Ссылка ].

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