Why America Must Do More To Track And Trace Counterfeit Medication

A new study released Wednesday by the Institute of Medicine concludes with a dire warning: start effectively tracking and monitoring medication, or face the devastating worldwide public health consequences of a market littered with counterfeit products.

According to the Associated Press, researchers and global health advocates are deeply concerned about the effects that diluted — and even poisonous — drugs can have on patient health. Particularly troubling is the fact that, superficially, imitation drugs appear to be indistinguishable from real ones, making step-by-step tracking procedures of utmost importance:

“There can be nothing worse than for a patient to take a medication that either doesn’t work or poisons the patient,” said Lawrence O. Gostin, a professor of health law at Georgetown University who led the IOM committee that studied how to combat the growing problem.

A mandatory drug-tracking system could use some form of barcodes or electronic tags to verify that a medication and the ingredients used to make it are authentic at every step, from the manufacturing of the active ingredient all the way to the pharmacy, he said. His committee examined fakes so sophisticated that health experts couldn’t tell the difference between the packaging of the FDA-approved product and the look-alike.

“It’s unreliable unless you know where it’s been and can secure each point in the supply chain,” Gostin said.

Patient safety advocates have pushed for that kind of tracking system for years, but attempts to include it in FDA drug-safety legislation last summer failed.

The report goes on to suggest various approaches to combating the scourge of counterfeit drugs, including “licensing requirements for the wholesalers and distributors who get a drug from its manufacturer to the pharmacy, hospital or doctor’s office,” and “wider promotion of the National Association of Boards of Pharmacy’s online accreditation program” aimed at helping consumers locate legitimate drugs from online vendors — one of the biggest sources of counterfeit medicine today.


The real world effects of counterfeit drugs are already rampant, with tuberculosis gaining resistance to antibiotics largely due to watered-down versions of the drugs peddled to patients in developing nations and a fake Adderall scandal right here in America.

A federal tracking system was in the pipeline for a landmark food and drug safety overhaul passed last summer with bipartisan support — but the amendment did not make it into the final bill despite support from both the FDA and the pharmaceutical industry due to Congress’ inability to sketch out an effective digital tracking regime.