Medicine shortages make supply chains vulnerable to fake drugs

Ongoing shortages of a number of key medicines in the USA are leading to a rise in the grey market, with more and more secondary suppliers making unsolicited offers to hospitals and other healthcare facilities, according to new research.

The rise in the grey market is also raising the risk that counterfeit, stolen, ineffective or unsafe medicines will enter the supply chain, says the report by Premier Healthcare Alliance, an organisation which represents 2,500 hospitals and 75,000-plus other healthcare sites in the USA.

The US Food and Drug Administration notes that older sterile injectable products are in short supply, with cancer drugs featuring prominently among current drug shortages. All told there are more than 70 medicine types - and 180 individual products - on the FDA's shortage list, which can be viewed here . Estimates are the tally could double by the end of the year.

The Premier research showed that the average mark-up for shortage drugs was 650 per cent. One case involving a drug for high blood pressure called labetalol involved a massive 4,533 per cent hike, raising the price from $25.90 to $1,200.

Little wonder then that there are fears unscrupulous individuals may try to tap into that profit vein by infiltrating fake, expired or otherwise illegal products into the supply chain.

Mike Alkire, Premier’s chief operating officer, notes that it is often impossible to confirm the source and authenticity of grey market drugs, and questions are being asked about how these suppliers are able to get hold of drugs when official distributors cannot.

In June, the FDA asked US drugmakers to give advance warning of production problems which could lead to scarcity in available medicines, noting that shortages of essential medicines are "continuing to increase at a rapid pace after reaching a record high in 2010."

There is currently no legal requirement for companies to tell the FDA if one of their medicines could become scarce. However, in February, a bill aimed at addressing that issue was introduced in the Senate by Senators Amy Klobuchar and Bob Casey. This would make it mandatory for pharmaceutical companies to notify the FDA whenever a factor arises that may result in a drug shortage.

Premier collected 1,745 unsolicited grey market sales offers in April-May 2011 in order to generate its report. Among those offers, 636 that contained both price and proper drug identification information were analysed.