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Summer 2013 Vol. 13 Number 1

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A Weak Link in the Drug Supply Chain

Combating Flawed and Falsified Drugs

In 2011 and 2012 fake versions of the cancer drug Avastin reached the U.S. market, only one instance of a problem that is global in scope: falsified and substandard medications. Some of these drugs contain little or no active ingredient -- the case with the falsified Avastin -- and fail to heal patients, prolonging suffering and driving up the cost of care. Others contain toxic ingredients that actively sicken and kill; in 2008 and 2009, for example, 84 Nigerian children died from kidney failure caused by an industrial solvent, diethylene glycol, in teething syrup. Often the effects of inactive or toxic drugs can go unnoticed or be mistaken for the underlying disease, especially in parts of the world with weak oversight systems and generally high mortality rates.

The Institute of Medicine was asked by the U.S. Food and Drug Administration to examine the problem and recommend ways to help solve it. Falsified and substandard drugs are a difficult problem in part because medications make their way through complex channels of primary and secondary wholesalers and retailers. Every step affords opportunities for fake or poor-quality products to enter the market.

Secondary wholesalers -- who buy medications from other wholesalers rather than directly from manufacturers -- are the weakest link in the chain, the report says. These firms may trade in many products besides pharmaceuticals, and their staff are not required to show skill in managing or warehousing pharmaceuticals. All state licensing boards should license only wholesalers and distributors that meet the accreditation standards of the National Association of Boards of Pharmacy (NABP). States should collaborate with FDA to create a public database where states should report violations and license suspensions. And Congress should authorize and provide funds for FDA to establish a mandatory track-and-trace system that gives each package of medication a unique identifier, allowing it to be followed through every transaction.

The problem of falsified and substandard drugs will not be solved solely by countries acting individually, however. The report recommends that the World Health Organization lead an effort to develop a code of practice that includes guidelines on surveillance, regulation, and law enforcement. Similar codes on the marketing of breast milk substitutes have been effective.

One area of the industry -- online pharmacies -- will be difficult to regulate, the report says. It praises NABP's Verified Internet Pharmacy Practice Sites, an accreditation program for online pharmacies, as a useful program to help consumers identify legitimate pharmacies. -- Sara Frueh & Christine Stencel

Countering the Problem of Falsified and Substandard Drugs. Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products; Board on Global Health; Institute of Medicine (2013, 351 pp.; ISBN 978-0-309-26939-1; available from National Academies Press, tel. 1-800-624-6242; $74.00 plus $5.00 shipping for single copies).

The study committee was chaired by Lawrence O. Gostin, Linda and Timothy O'Neill Professor of Global Health Law, and director, WHO Collaborating Center on Public Health Law and Human Rights, Georgetown University Law Center, Washington, D.C. The study was funded by the U.S. Food and Drug Administration.

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Copyright 2013 by the National Academy of Sciences