Abstract. Making drugs is messy. Take heparin.You raise pigs and then slaughter them. You isolate the pig intestines and cook them. Then you scrape the intestinal insides, dry them, and get them to a factory to undergo more processing (Harris, 2008).

Making drugs is also expensive. Outsourcing this messy activity to countries such as China is convenient and cheap. The hassles of oversight are vastly reduced, as are the details of getting the raw materials. So costs are minimized and profits enhanced.

Earlier this year, the case of tainted heparin from China demonstrated the vulnerability of the drug production and supply chain. Tainting the drug with undetectable deadly material that was 1/100th the cost of the legitimate active ingredient was ludicrously simple. It even came on the heels of known faulty products from China—from toys to toothpaste to pet food. With at least 81 deaths and hundreds of allergic reactions, the heparin case showed that lifesaving drugs can quickly become life-threatening weapons due to loose oversight (Harris, 2008).

This is a policy problem that encompasses the globalization of drug production and distribution. But more deeply, it is a problem of how this system can be exploited to do great harm and represents a very different kind of patient safety issue.

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