FDA joins e-mail counterfeit drug alert service

By Gregory Roumeliotis

- Last updated on GMT

Related tags Pharmacology Drugs Fda

The US Food and Drug Administration (FDA) has linked its
Counterfeit Alert Network (CAN) to SafeMeds Alert System, an
electronic mailing list backed by pharmaceutical manufacturers that
sends warnings about fake drugs to anyone who signs up,
significantly increasing public awareness and cracking down on

Previously the CAN was only available to key stakeholders, like health care providers and big pharma, so this partnership will make an important difference in the dissemination of information on counterfeit drugs.

Around 10 per cent of all prescription drugs are forgeries according to the World Health Organisation (WHO), and the FDA estimates that 1 per cent of the drugs in the US are counterfeit, leading to 35 million prescriptions filled with something else other than the supposed drug.

Liability issues, consumer confidence, and brand erosion costs are driving pharmaceutical manufacturers to seek new approaches to combat this growing global problem.

To tackle the issue, which not just jeopardises the health of patients but also damages manufacturers financially, many US pharma and biotech companies are supporting, through their trade organisations, the Partnership for Safe Medicines, a coalition of patient, physician, pharmacist, university, industry and other professional agencies determined to consumers against unapproved, counterfeit, substandard, mishandled or otherwise unsafe medicines.

The Partnership has now secured the FDA's collaboration to its electronic alert service so that anyone who signs up with just their name and e-mail address will receive alerts as soon as the FDA or other health agencies announce them.

It is hoped that the SafeMeds Alert System will become a key component of the new anti-counterfeiting IMPACT task force led by the WHO.

"We have over 1,000 enrollers in our counterfeit alert system, but with our new affiliation with FDA we predict that this number will have tremendous growth in the coming months,"​ Marv Shepherd, director of the Center for pharmacoeconomic studies at the College of Pharmacy at the University of Texas-Austin, told In-PharmaTechnologist.com​.

"It is a great way to warn people, the alert goes out instantly, and we are hoping to expand the system worldwide."

Of about 6,000 licensed drug distributors in the United States, three major ones, Pennsylvania's AmerisourceBergen, California's McKesson and Ohio's Cardinal Health, handle 90 per cent of the supply.

Although most drugs follow a relatively safe route from manufacturer to wholesale distributor to retailer, a minority, particularly prescription drugs, is sold to small distributors by hospitals or wholesalers looking to get rid of overstocked product.

As a result, these drugs are often sold again to big distributors who are after a bargain, making it impossible to identify who has handled them all the way through.

Furthermore, many patients fall prey to counterfeit drugs as they try to buy medicines cheaper on the internet from unreliable sources.

The free counterfeit electronic alert service is available at >http://www.safemedicines.org​.

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