IOM Report Calls for International Cooperation to Improve Drug Safety

An international agreement could help eliminate falsified, substandard and counterfeit pharmaceuticals, according to an Institute of Medicine report.

At the request of the Food and Drug Administration, an IOM committee examined the global effects of falsified, substandard and counterfeit drugs in a report, "Countering the Problem of Falsified and Substandard Drugs." The committee made several recommendations to address the public health risk of these drugs, including a voluntary international agreement to curb unsafe drugs. "The World Health Assembly should adopt a global code of practice to build national regulatory capacities and promote inter¬national cooperation among public health and criminal justice authorities," the authors wrote.

Other recommendations include the following:

•    Strengthen regulatory systems
•    Add inspectors to police wholesalers, distributors and manufacturers
•    Enforce quality standards
•    License only manufacturers that meet international standards
•    Restrict the U.S. wholesale market to firms approved by the National Association of Boards of Pharmacy
•    In the U.S., create a public database for reporting violations and license suspensions and cancellations

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