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

HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

Sean P. Kane, PharmD, BCPS

Health & Fitness, Medications, Rosalindfranklin, Rfums, Pharmacy, Pharmd, Pharmacist, Medicine, Drugs

5 • 644 Ratings

🗓️ 31 October 2023

⏱️ 42 minutes

🔗️ Recording | iTunes | RSS

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Summary

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

Transcript

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0:00.0	Welcome to Helix Talk, an educational podcast for healthcare students and providers covering real-life clinical pearls, professional pharmacy topics, and drug therapy discussions.
0:11.0	This podcast is provided by pharmacists and faculty members at Rosal Franklin University College of Pharmacy.
0:17.0	This podcast contains general information for educational purposes only. This is not professional
0:22.4	advice and should not be used in lieu of obtaining advice from a qualified health care provider.
0:27.2	And now on to the show.
0:31.2	Welcome to Helix Talk, episode 173. I'm your co-host, Dr. Kane. And I'm Dr. Patel. And the title of today's episode is
0:39.2	balancing access and safety, the FDA's prescription drug risk mitigation strategy. We shortly
0:45.9	know this as REMs. We're going to hope to cover in this episode, just definition of what
0:51.6	REMS is, why do they exist, some history exist? Some history and the role of FDA in developing this program,
0:58.7	administering this program, and some examples of REMs.
1:02.3	And at the end of the day, how does it impact us, pharmacist,
1:06.1	and when we are practicing out there?
1:08.2	So, Dr. Patel, as you mentioned, RIMS stands for risk evaluation and mitigation strategy
1:12.9	or strategies.
1:14.1	So this is a core part of the role of really any health care provider to understand that
1:19.4	medications have risks associated with them and then to mitigate or reduce the chances of those
1:24.6	risks from happening.
1:25.6	This is a formal program from the FDA to make
1:28.4	sure that we're being good stewards of that risk for our patients. Right. And it's part of their
1:33.9	risk mitigation strategies. And if we kind of do a time travel of when FDA started this, one example
1:41.3	is package insert. Package inserts are part of their risk mitigation strategy.
1:46.0	Formally, the REMS program was established in 2007, but we have examples of how FDA used to do risk mitigation.
	...

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