Post-Marketing Surveillance Efforts Expanded by FDA
The Food and Drug Administration is stepping up efforts to ensure drug safety through a partnership with the Centers for Medicare and Medicaid Services (CMS). The two will collaborate to create The Sentinel Initiative, as described by Health and Human Services Secretary Mike Leavitt.
Key components of the system include the deployment of a new electronic system that supports capture of adverse event information through a public-private partnership. The system will be populated with claims and medical records information available from CMS, particularly included information available from the Medicare Part D program. Other insurance companies will be encouraged to participate in this program to support patient safety.
This approach offers the FDA a much larger array of data to assess in considering safety of both drug and devices approved for the market. It is much more likely that potential problems will be detected earlier with this broader data set to monitor. It is further anticipated that both the Department of Veterans Affairs and the Department of Defense will participate.
This new system is more proactive than the existing strategies to monitor the side effects of drugs after they are approved by the FDA. Existing tools rely on providers and pharmaceutical companies to report information. This process can lag and is fraught with unreported effects. The FDA has commenced attaching post-marketing surveillance requirements to many drug and device approvals.
The Sentinel effort is made possible through a recent decision which allows for utilization of claims data from the Medicare Part D Program to support quality and safety initiatives. This type of programming was previously recommended by the Institute of Medicine.
May 28, 2008 Related topics: Legal & legislative, Trends, Partnerships & Consortia, Quality, Safety, Errors