IOM Recommends Track-and-Trace System to Combat Fake Drugs

A recent report from the Institute of Medicine on combating the problem of fake and substandard drugs recommends implementing a mandatory drug tracking system. The report, titled “Countering the Problem of Falsified and Substandard Drugs,” was released on February 13, 2013.

The tracking system would use technology such as bar codes or electronic tags to ensure that medications and the ingredients used to make them are genuine and unadulterated at each step in the manufacturing process, from the production of raw materials to the pharmacy shelf. Attempts to include a similar tracking system in the 2012 FDA Safety and Innovation Act were unsuccessful.

The report emphasizes that the problem of fake drugs is an international one requiring an international response, as medications and their ingredients can change hands multiple times in multiple countries. It points out that people in developing nations are particularly harmed by phony medications. For example, drug-resistant tuberculosis has flourished in part due to weak medications sold in many poor countries.

The report also recommends that state regulators require drug wholesalers and distributors to have accreditation from the National Association of Boards of Pharmacy as a prerequisite for licensing and that oversight of Internet pharmacies, which play an important role in distributing fake drugs, be increased.