Inpharma 1441 - 12 Jun 2004

Highlights of US CDER drug safetyactivity in 2003

The US Center for Drug Evaluation and Research(CDER) has published its 2003 Report to the Nation, inwhich a number of highlights relating to drug safety andquality are discussed.

CDER, which monitors the "quality of marketed drugsand their promotional materials though product testingand surveillance", processed and evaluated370 887 reports of adverse events in 2003. Of thesereports, 29 955 were submitted directly fromindividuals, with the number of direct reports up 51%from 1998, 144 310 were expedited (15-day)manufacturer reports, 58 998 were seriousmanufacturer periodic reports and 144 624 werenonserious manufacturer periodic reports. Of note is thefact that 21% of the expedited reports received in 2003were submitted electronically.

In addition, CDER reviewed approximately3000 reports of medication errors in 2003, about half ofwhich were due to error-prone labelling. A furtherhighlight in the CDER’s drug safety and quality activity in2003 was the proposal of a regulation, which becamefinal in 2004, calling for OTC medications commonlyused in hospitals and all prescription medicines to havea bar code.Food and Drug Administration. Center for Drug Evaluation and Research 2003.Report to the Nation: Improving Public Health Through Human Drugs. InternetDocument : [58 pages], 24 May 2004. Available from: URL: http://www.fda.gov 800967201

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Inpharma 12 Jun 2004 No. 14411173-8324/10/1441-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved