Today we are going to talk about REMS and CME. REMS stands for Risk Evaluation and Mitigation Strategy. REMS was approved by the FDA in the FDA Amendments Act of 2007, and this law gave the FDA the authority to require REMS from a drug manufacturer to ensure that the benefits of a drug outweigh its risks. While each REMS is unique, its components can include three main things. The first is a medication guide that’s developed by industry and approved by the FDA. The second is a patient package insert for patient education information, and the third are elements to assure safe use, and those elements can include CME.

Issues Facing REMS based CME

There are two key hurdles on the path to REMs based CME. The first of those hurdles is drug specific education. Due to the FDA mandate and the unique risks of each drug, some of the REMS may need to focus on just one drug, and CME usually deals with class wide issues when it talks about drugs, not a specific or particular drug. The second hurdle deals with collaboration on REMS content. In a discussion with the ACCME last week, we learned that the ACCME is specifically saying that any content developed by industry, even if FDA approved, cannot be incorporated into accredited CME. However, it appears that there may be an opportunity to develop a CME activity on REMS that is class wide and that doesn’t deal with a particular drug, but deals with the entire class. Separately, there could be allowed voluntary access to REMS information on specific drugs, of course this second type of information would not be CME Certified.

As you can see, there are several opportunities and obstacles when it comes to REMS and CME. After communication with the ACCME this week, we now understand that the ACCME is compiling specific REMS information and a possible Q & A on REMS and CME to address these issues. Of course as we learn more we will be providing updates on these developments, and as a free resource we will update this blog as well as send out and email CME news update to our partners and other interested groups.

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