PT Inquest is an online journal club. Hosted by Jason Tuori, Megan Graham, and Chris Juneau, the show looks at an article every week and discusses how it applies to current physical therapy practice.
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内容由Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel提供。所有播客内容(包括剧集、图形和播客描述)均由 Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品,您可以按照此处概述的流程进行操作https://zh.player.fm/legal。
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173 - Balancing Access and Safety: The FDA's Prescription Drug Risk Mitigation Strategy (REMS)
Manage episode 381482071 series 70056
内容由Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel提供。所有播客内容(包括剧集、图形和播客描述)均由 Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品,您可以按照此处概述的流程进行操作https://zh.player.fm/legal。
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
198集单集
173 - Balancing Access and Safety: The FDA's Prescription Drug Risk Mitigation Strategy (REMS)
HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast
Manage episode 381482071 series 70056
内容由Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel提供。所有播客内容(包括剧集、图形和播客描述)均由 Sean P. Kane, PharmD, BCPS, Sean P. Kane, and PharmD; Khyati Patel 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品,您可以按照此处概述的流程进行操作https://zh.player.fm/legal。
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
198集单集
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