Problems With Tracing Contaminated Drugs Identified

Jamie Sheller

Attorney
(866) 735-1102 Ext 475

0 CommentsPrint ArticleSubscribe

A new report published in the Archives of Internal Medicine discussed the investigation of recent outbreaks of heparin contamination, and raises concerns about drug safety. The report was done by the Centers for Disease Control and Prevention. According to the CDC, the recent outbreaks were caused by lax compliance with federal regulations. Contaminated heparin syringes caused bacterial bloodstream infections. Outbreaks of bloodstream infections between October 2007 and February 2008 were traced to prefilled heparin syringes produced by a single company. According to the report, the unnamed company violated FDA Good Manufacturing Practices, in its manufacturing facility. After the CDC inspection of its facility, the company recalled its prefilled heparin syringes and stopped producing medical products.

The investigation highlights difficulties with tracing the sources of drug contamination, due in part to the fact that products move through multiple distributors before reaching patients. The CDC investigation also identified several other problems with tracing medical products. These problems should be promptly addressed to enable more efficient handling of contaminated medications. "Drug manufacturers must ensure that they are in full compliance with the FDA requirements, ..., and distributors, healthcare facilities, and pharmacies should keep track of the lot numbers of products they distribute, so contaminated products can be traced to their origins more rapidly."