IOM calls for data tracking, technology to combat counterfeit drugs

Tracking and identification technology is one way to help curb the scourge of fake and sub-standard drugs, but access to data and resources is lacking, according to a new report from the Institute of Medicine.

The report was created at the request of the U.S. Food and Drug Administration, which has been working to create a national tracking system to prevent drug counterfeiting--but without success. The IOM report could give the effort new life, however. One of its recommendations is that the FDA establish a public database to share information on suspended or revoked wholesale licenses, for example.

Another recommendation: Increase access to technologies designed to identify counterfeit drugs.

Analysis techniques range from low-tech visual inspections to more advanced technologies such spectroscopic techniques and mass spectrometry. Some technologies can be used in the field, while others require sophisticated lab equipment and a high level of technical expertise, the report notes.

But not every country or region has access to the range of hardware and devices necessary to aid detection.

To help fix that, the IOM report recommends the National Institute of Standards and Technology fund the development of a central repository for existing and newly innovative detection, sampling and analytical technologies ranging from field and rapid screening technology to sophisticated laboratory based assessments to identify substandard and falsified medicines.

"Making detection technology more accessible in low- and middle-income countries would be invaluable to controlling the trade in falsified and substandard drugs," the report states.

"Technologies can protect consumers and are useful to surveillance staff working to generate accurate estimates of the magnitude of the problem of poor quality drugs. An understanding of the technological landscape, the range and gaps in available technologies, and the likely improvements in the near future, is essential for using technologies in developing countries."

Many states--most notably California--have begun their own drug tracking programs. And private enterprise is getting involved, as well. In fact, mobile product authentication solutions have been on the market since 2010. Newer versions include a text-based platform that authenticates drugs digitally.

Pharmaceutical anti-counterfeiting technology could be a $1.2 billion worldwide market by 2015--a national standard would help drive that growth.

To learn more:
- read the IOM report