Medicare Claims To Be Used To Monitor Drugs For Post-Market Adverse Events

Main Category: Medicare / Medicaid / SCHIP
Also Included In: Pharma Industry / Biotech Industry
Article Date: 04 Jun 2008 - 1:00 PDT

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The Food and Drug Administration (FDA) recently launched an initiative to use information from Medicare Part D claims to investigate the performance of drugs on the market and rapidly identify potential adverse events.

The program, termed the Sentinel Initiative, will allow the FDA to detect post-market problems with drugs as they arise. In the past, the agency relied on voluntary reporting of safety concerns and sometimes had to wait years to find out how a drug affected the health of millions of patients.

ASHP supports FDA's efforts to improve drug safety, and the Society worked with Congress to achieve passage of the Prescription Drug User Fee Act in 2007, which includes provision that calls for the development of Risk Evaluation and Mitigation Strategies (REMS). The REMS approach attempts to identify drugs with known risks and ensure that they are dispensed safely.

The FDA will monitor the use of medications and other medical products by querying a new electronic system containing Medicare claims information. The FDA also plans to include medical records data from private entities such as healthcare organizations in the system.

In a related action, the Centers for Medicare & Medicaid Services (CMS) recently issued a final regulation that permits government agencies and academic researchers to use Part D claims data for public health and safety research and other projects. CMS says the personal information of Medicare beneficiaries is subject to strict privacy protections.

American Society of Health-System Pharmacists