173 - Balancing Access and Safety: The FDA's Prescription Drug Risk Mitigation Strategy (REMS)

HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

コンテンツは Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャストコンテンツは、Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel またはそのポッドキャストプラットフォームパートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal。

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In this episode, we will discuss the definition of REMS (Risk Evaluation and Mitigation Strategies), why they exist, the role of FDA in administering REMS, types and examples of REMS, and how they impact pharmacy practice.

Key Concepts

The REMS (Risk Evaluation and Mitigation Strategies) program was developed in 2007 as part of the FDA’s drug risk management strategies designed to balance risk and benefits of certain drugs.
Elements of REMS vary depending on the drug, but commonly include medication guides, communication plans, and other elements to assure safe use.
REMS can require patients, providers, and pharmacies to take certain actions including training, registration, enrollment, safety monitoring, documentation of safety concerns, and follow prescribing and dispensing regulations.
The FDA captures and assesses data on a regular basis to make changes in the REMS program. It also has authority to enforce compliance and take punitive actions against non-compliant parties.

References

Risk Evaluation and Mitigation Strategies. Food and Drug Administration. May 16, 2023. Accessed October 17, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

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