The Problem With Counterfeit Drugs

Editor's Choice
Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health;  Alcohol / Addiction / Illegal Drugs;  Infectious Diseases / Bacteria / Viruses
Article Date: 09 May 2008 - 11:00 PDT

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An editorial published this week in The Lancet calls attention to the growing crisis concerning counterfeit drugs. Currently, America is dealing with a potential case of counterfeiting in the drug heparin. It is possible that a contaminant found in batches of heparin has led to the death of at least 81 patients.

Between 2000 and 2006, according to the Editorial, the US Food and Drug Administration (FDA) has witnessed an 800% increase in the number of new counterfeit cases. It is thought that in developing countries, with weak or non-existing regulatory systems, about 10 - 30% of drugs are counterfeit. Due to their high demand, antimalarials are a popular choice for counterfeiters - fake medicines have been introduced into the markets in several countries in Asia.

The Editorial calls for a multi-lateral approach in order to combat counterfeiters, and states the necessary involvement of WHO, countries and the pharmaceutical industry.

"According to WHO, only 20% of its member states have well-developed drug regulatory systems, and around 30% have no or weak drug regulation... Drug authorities also need to work effectively with customs, the police, scientists, health workers, WHO, and INTERPOL. This type of collaborative approach has proved successful in tackling counterfeit antimalarials in southeast Asia. The pharmaceutical industry should be legally required to report suspected cases of counterfeiting to the relevant national drug authority - a practice which is currently voluntary. Companies must also be encouraged to lower the prices of their products in developing countries to reduce the economic incentive for counterfeiters," writes the Editorial.

It concludes that, "There is no magic bullet to deal with counterfeit medicines. Countries need to adopt multipronged, multidisciplinary approaches to combat the problem. WHO and donor countries should provide support to developing nations to strengthen their drug regulatory systems. But individual governmental commitment to this goal is essential. Without it, public safety will continue to be compromised."

Combating counterfeit drugs
Editorial
The Lancet (2008): 371[9624]. p. 1551.
Click Here to View Journal Website

Written by: Peter M Crosta
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