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Transcript: Drug Safety Communications

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Captain Mary Kremzner: Whenever postmarking drug safety issues arise, healthcare professionals and the public need to know the latest information to protect their patients and to make good treatment decisions.  Drug Safety Communications get this message out.  Hi, I'm Captain Mary Kremzner, and this is Drug Info Rounds, brought to you by the pharmacists in the FDA's Division of Drug Information.  I'm joined today by two FDA pharmacists; Commander Catherine Chew and Lieutenant Commander Sam Skariah to talk about the role of Drug Safety Communications in healthcare today.  So Cat, what types of events warrant notification, and what is the typical content and distribution approach for these communications?

Commander Catherine Chew:  Well, there are basically two types of drug safety communications, or as we call them, DSCs.  The first alerts readers that the FDA is investigating a possible safety issue, which could alter a drug's risk benefit profile or usage.  The second announces whether the safety issue is in fact real, and if so, what steps should be taken.

Captain Mary Kremzner: What are some examples of recommended actions a healthcare professional should take?

Commander Catherine Chew:  Actions could include making a dosing restriction or monitoring the patients closely for a side effect like a possible cardiovascular event.  In more severe cases, when the FDA removes a drug from the market, healthcare professionals need to inform patients of this action and switch their patients to another drug.

Lt. Commander Sam Skariah:  There's an entire section on the FDA web site dedicated to these alerts.  The landing page features a chronological listing of all Drug Safety Communications.  DSCs are often picked up by and reported on other medical web sites and news outlets as well.  The FDA often writes press releases and hosts conference calls to proactively deliver messages contained in these communications.  We occasionally create supplemental materials like articles for journals, videos and podcasts and translate them into Spanish.  Our goal is to ensure that the right people get the right message at the right time.

Captain Mary Kremzner: I know the format of communications has changed in recent years.  Can you talk a little bit more about that evolution?

Lt. Commander Sam Skariah: Initially, each audience, physicians, pharmacists and consumers had its own DSC messaging.  In 2010, we merged them into one cohesive communication strategy.  Tiered messaging now helps different audiences easily find the information they want within one DSC.  This information includes specific recommendations for patients and healthcare professionals, the scientific basis for any FDA decisions, drug facts and links to related information.

Commander Catherine Chew: FDA staff comb through clinical data, reports and journal articles from outside investigators looking for signals that may warrant an investigation.  We rely heavily on MedWatch reports sent by healthcare professionals.  The more data we have on an adverse event, the better we can determine if it merits a safety signal.

Captain Mary Kremzner: It's clear that every bit of information really does count, and healthcare professionals can report adverse events easily on the MedWatch web site.  Additionally, FDAs Division of Drug Information tweets every single Drug Safety Communication.  You can follow us on Twitter.  We also podcast these DSCs.  Listen online or subscribe to us on iTunes.  If you have questions about Drug Safety Communications, call or email the FDA's Division of Drug Information.