Tracking troubles stalled recall

Although noncompliance with good manufacturing practices led to the contamination of heparin injections from late 2007 to early 2008, an inability to cope with supply chain complexities is to blame for the time required to track the problem and issue a recall. CDC investigators ultimately traced outbreaks of Serratia marcescens bloodstream infections to heparin syringes produced by just one company.

"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," according to a Centers for Disease Control and Prevention report, as detailed in Medpage Today. In addition, the authors write in the October 12, 2009, report published in the Archives of Internal Medicine, investigations of possible adverse drug events should include both epidemiologic and laboratory components.

"Close collaboration among federal agencies, public health authorities, and clinicians was critical to the identification of the cause of this outbreak," says the report. Using information from facilities in Texas and Illinois, investigators determined the infections were cause by syringes prefilled with heparin and saline.

- here's the article


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.