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The Drug Safety Project works to ensure a safe, reliable pharmaceutical manufacturing and distribution system.
The drug supply chain has become increasingly complex in recent years. Today’s prescription and over-the-counter remedies originate in factories all over the world, moving into American homes through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers, and distributors. This increases the risk that substandard or counterfeit medicines could reach patients and contributes to shortages of essential medicines.
In 2007 and 2008, dozens of patients in the U.S. suffered adverse effects, and some died, after receiving heparin, a widely used blood-thinner that had been adulterated during its manufacture in China. The U.S. Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the U.S. pharmaceutical supply chain. According to FDA estimates, the number of drug products made outside of the United States doubled from 2001 to 2008, with up to 80 percent of active ingredients and 40 percent of finished drugs used by U.S. patients being manufactured abroad. Increasingly, the United States imports pharmaceutical materials from emerging economies such as India and China. Other recent examples illustrate threats to pharmaceutical distribution in the United States. For example, a shipment of 129,000 vials of insulin, stolen in 2009, was stored under unknown conditions before being resold to pharmacies and, ultimately, to patients. In 2002, counterfeit vials of an anemia drug were purchased by U.S. wholesalers and pharmacies and sold to patients. Supply chain weaknesses have also resulted in numerous high-profile drug shortages. In 2011, more than 200 drugs went through periods of limited or no availability in the United States, many of them crucial medicines for use in cancer, surgery, and intensive care. Pew works with diverse stakeholders to develop support for measures to address these risks and ensure the safety and security of the U.S. pharmaceutical supply chain.
May 09, 2013 - On May 9, 2013, The U.S. Senate Committee on Health, Education, Labor and Pensions held a hearing, entitled "Pharmaceutical Compounding: Proposed Legislative Solution." Allan Coukell, a pharmacist and drug safety expert, testified on the need to strengthen oversight of the compounding industry.
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