FDA begins active monitoring of drug safetyBMJ 2008; 336 doi: https://doi.org/10.1136/bmj.a211 (Published 29 May 2008) Cite this as: BMJ 2008;336:1211
- Bob Roehr
- 1Washington, DC
After growing fears in recent years over the safety of drugs, the US Food and Drug Administration has announced the start of a surveillance programme to actively monitor drugs for problems.
The first phase of the Sentinel Initiative will tap into Medicare’s Part D prescription claims database, which serves 25 million Americans aged 65 years or older. Its participants have, on average, 28 prescriptions a year, while those in poor health have about 45. This compares with the US average of about 13 prescriptions a year.
Under the initiative FDA computers will be able to ask questions of the database and seek out associations between drug …