Earlier this year, Europe’s largest haul of counterfeit medicine was discovered at the port of Le Havre, France, with fake aspirin – containing sugar in place of the API – contributing to over half the 2.4 million tablets and sachets found.
Whilst the sale of falsified ‘playboy’ drugs such as Viagra and Cialis in the EU and US has been well documented, the extent of how lower-cost, OTC drugs have infiltrated the supply chain is still unknown as local manufacturing and the reluctance of consumers to come forward stifle the prevention of counterfeit drugs, according to Samuel Louis, an ex-Deputy Criminal Chief for the US Department of Justice.
“Counterfeiters are becoming more sophisticated, setting up their own manufacturing lines in the US,” he told in-Pharmatechnologist.com. Louis – who served as Assistant US Attorney in Houston, Texas, until last November – added this has coincided with the first investigations into OTC drug fraud after hundreds of cases involving falsified prescription drugs.
“In the last six months there have been two instances of counterfeit OTC sites being investigated, one in New York and one in Texas,” he said. “We hadn’t seen this before but it seems to be on the rise.”
One case Louis spoke to us about was an individual in Texas with links to China who was manufacturing a large quantity of medicines including OTCs in an upscale neighbourhood.
With local production of prescription pills, counterfeiters just require some API in order for the drug to have some affect and therefore to ensure repeat business, he continued.
However, for OTCs, if a product does not work “it would be very unlikely to be reported either due to the placebo affect or the less serious nature of an OTC drug not working,” and therefore the active ingredient could be replaced with sugar for example, as was the case in the French haul.
OTC detection and warnings
The US Food and Drug Administration (FDA) have in the past issued warnings against counterfeit forms of GSK’s weight-loss OTC alli, but in those cases the pills contained the controlled substance sibutramine in place of the API orlistat.
Spokesman Stephen King told this publication: “Because the safety and effectiveness of the ingredients included in fake drugs are unknown, fake versions of both OTC and prescription drugs raise significant public health concerns.”
However, neither the FDA nor the European Medicines Agency (EMA) have specific information that distinguishes the difficulties in detecting fake OTC versus prescription drugs, but King warned that “even a fake drug with no active ingredient could prove harmful to patients who think they are taking a lifesaving or life-sustaining medication.
“Because fake drugs are often difficult to detect, investigate, and quantify, it is hard to know the true extent of the problem.”