Medical/dental insurance databases and drug safety surveillance

Recent failures of the Drug Safety Surveillance system in the United States and abroad, as evidenced by market withdrawals of commonly used medications, call attention to the many limitations to the monitoring of long-term drug safety. Although drug safety evaluation is primarily performed during clinical development, clinical trials are not efficient in identifying rare adverse effects. Similarly, the post-market system suffers from inherent limitations, including the under-reporting of voluntary reports of adverse effects.

As a source of healthcare utilization data, administrative insurance databases present a viable and efficient alternative for pro-active safety surveillance. Several serious adverse effects have now been identified from the analysis of medical claims, and successful surveillance programs have been put in place in the medical field.

Today, in a symposium being held as part of the 35th Annual Meeting of the American Association for Dental Research, scientists and speakers from the National Association of Dental Plans, Columbia University, Ingenix-United Health Care, and Harvard University will discuss dental plans in the US today, working with dental claims data, and medical claims-based drug safety surveillance, and a case study in bisphosphonates (a family of drugs used to prevent and treat osteoporosis) and osteonecrosis (a condition where part of the bone is no longer alive and cannot regenerate itself due to a lack of blood supply) will be presented.

This is a summary of a symposium, Sequence #117, entitled "Medical/Dental Insurance Databases and Drug Safety Surveillance", being presented at 10:45 a.m. on Friday, March 20, 2006, in Asia 3 of the Walt Disney World Dolphin Hotel, during the 35th Annual Meeting of the American Association for Dental Research.

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