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Medical News and Perspectives
August 24/31, 2011

As Production Goes Global, Drug Supply Faces Greater Risks to Safety, Quality

JAMA. 2011;306(8):811-813. doi:10.1001/jama.2011.1194

A sudden spike in adverse events among patients receiving dialysis in 2007 led public health authorities on an international chase to find the cause. The culprit, it turned out, was adulterated heparin that contained oversulfated chondroitin sulfate, a substance added to the drug at some point during its production in China.

The adulteration, estimated to have netted the individuals responsible for adding the chemical between $1 million and $3 million, led to hundreds of adverse events, including at least 3 deaths, according to a recent report (http://tinyurl.com/3nhypp7) from the Pew Health Group about the growing risks of substandard and counterfeit medications resulting from the increasing overseas production of pharmaceuticals and their ingredients. The Pew Health Group unveiled the report during a press briefing in July at which some stakeholders shared their views of the risks to drugs and offered support for many of the report's recommendations.

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