Two recent headlines highlight the need for a federal electronic track-and-trace system for prescription drugs.

Last week, a Baltimore pharmacist was sentenced to 57 months in prison for making fraudulent claims and misbranding hundreds of thousands of bottles of drugs from an unlicensed supplier. According to the FDA Office of Criminal Investigations, an inspection in 2008 revealed more than 200,000 bottles of misbranded drugs in Pamela Arrey’s Medicine Shoppe, as well as drugs that had expired, or had altered labels. Arrey’s rebranding schemes included metformin, a diabetes medication, and gabapentin, an anti-seizure medication.  (See the FDA press release here.)

And FiercePharma has just released its Top Ten list of pharma cargo thefts by value in 2009-2010. Atop the list was March’s headline-making $76 million heist of antidepressants and other drugs through the roof of an Eli Lilly plant in Connecticut. But it is only the most high-profile case in a growing trend: Pharmaceutical cargo theft has quadrupled in the last four years, according to Freightwatch International, which tracks cargo theft issues.

FiercePharma’s list and Arrey’s conviction are reminders of the risks posed to patients when improperly sold or stolen pharmaceuticals end up back on pharmacy shelves.

Cargo theft and misbranding schemes like Arrey’s highlight the need for a federal electronic track-and-trace system, which would establish a unique electronic ID tag for each medicine bottle so that drugs can be traced back to their original source and verified at each transaction point along the supply chain, from the factory to the pharmacy shelf.  Congresswoman Rosa Delauro (D-CT), who chairs the House subcommittee on FDA appropriations, emphasized the importance of such a system in her Chairman’s Mark last week, and federal track and trace legislation has been introduced in previous sessions of Congress.

For more on drug safety and the importance of developing a prescription drug tracking system, visit the Pew Prescription Project’s Securing a Safe Drug Supply.

–Kate Petersen, PostScript blogger