BMJ 2008;336:1211 (31 May), doi:10.1136/bmj.a211
News
FDA begins active monitoring of drug safety
Bob Roehr
1 Washington, DC
| The first 150 words of the full text of this article appear below. |
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 use and problems that might not otherwise be apparent. State health agencies and academic researchers will also have access to the system to analyse the data. All personal identifiers are stripped from the records to protect the privacy of individuals.
Other databases will be
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