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RFID and ePedigree Won't Help these Twists in the Pharmaceutical Supply Chain

Contributed by Joanne Kelleher

On February 28, 2008, the New York Times published an article called Twists in Chain of Supplies for Blood Drug which describes how U.S. regulators are investigating why over 400 patients in the United States have suffered serious complications after receiving the blood-thinner drug heparin.

This article points to the issues in regulating and sourcing the raw materials used to manufacture heparin in China. The heparin manufacturer states that they receive their raw materials from two wholesalers and they in-turn purchase from 10-12 audited suppliers.

But interviews with dozens of heparin producers and traders in several Chinese provinces, as well as a visit to a village near here dominated by tiny family workshops that process crude heparin from pig intestines, show the difficulties confronting investigators as they seek to trace the supply chain.

Some experts say as much as 70 percent of China’s crude heparin for domestic use and for export comes from small factories in poor villages.

In a village called Xinwangzhuang, nearly every house along a narrow street doubles as a tiny heparin operation, where teams of four to eight women wearing aprons and white boots wash, splice, separate and process pig intestines into sausage casings and crude heparin.

I was aware that pharmaceuticals can travel through 8-12 organizations on their path from manufacturer through distributors and various wholesalers to the dispenser at a pharmacy, hospital or clinic.* The implementation of an e-Pedigree process and RFID tags is often discussed as a way to protect the pharmaceuticals as they move from the manufacturer through this supply chain.

Unfortunately, implementing an e-Pedigree solution will not address the issues that U.S. and Chinese regulators face related to uncontrolled sources and the desire to purchase raw materials for the lowest price.

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* By the way, if you are unfamiliar with the black market industry that complicates the U.S. pharmaceutical supply chain and the FDA’s fight against it, I would highly recommend that you read the book Dangerous Doses: A True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply by Katherine Eban.