ASHP Risk Evaluation and Mitigation Strategies Resource Center

April 2, 2010 by admin

In 2007, the Food and Drug Administration Amendments Act (FDAAA) was passed as a means to enhance the post-marketing authorities of the FDA in regard to drug safety. The FDA now has the authority to require post-marketing studies or clinical trials for medications that they deem necessary. The Risk Evaluation and Mitigation Strategies, REMS, were created by the FDA to serve as a post-marketing surveillance process that ensures medication safety. Previous risk management programs were classified as Risk Minimization Action Plans (RiskMAPs) and Restricted Drug Distribution Systems (RDDS), and while some of these programs remain active today, it seems that the number of medications with REMS grows each day. Whether these risk management programs are required by law or simply created by manufacturers, there goal is universal, to ensure a medication's benefits outweigh its risks. This resource center also includes medications that are managed through other medication risk management programs or RDDS outside of the REMS processes.

http://www.ashp.org/Import/MEMBERCENTER/Sections/SectionofPharmacyPracti...

Permalink