Booster needed for security of drugs supply chain

18 April 2011

19 April 2011 | Naouel Zenaidi

Industry experts have welcomed legislation that tightens security around pharmaceutical supplies but warned more needs to be done.

The calls from pharmaceutical companies follow what has been described as the most serious known breach of counterfeit medicines in the UK regulated supply chain.

Earlier this month a British national was sentenced to eight years in prison for his part in a crime that saw more than two million doses of fake drugs infiltrating the UK supply chain between January and April 2007.

Despite most of the drugs being seized or recalled at the time, 700,000 unaccounted-for doses of Zyprexa (used in the treatment of psychosis), Plavix (used to prevent blood clots) and Casodex (used in the treatment of prostate cancer) reached high-street pharmacies, hospitals and care homes across the country, penetrating the NHS system.

Mick Deats, head of enforcement at the Medicines and Healthcare productsRegulatory Agency (MHRA) told SM that this type of case is extremely rare, and should be seen in the context of a massive national supply chain. It has, however, influenced legislation at both European and UK levels.

The Falsified Medicines Directive was announced this February by the European Union (EU), with measures including the introduction of security features designed to provide evidence of tampering, as well as tougher record-keeping requirements for wholesale distributors.

Colin Frost, head of trade at Pfizer UK, is hopeful that if pharmacists, generic manufacturers, wholesalers and governments work together it “should result in dramatically improved systems for security and consequent improvements in patient safety”.

He believes, however, that some important details still need to be worked through at both European and national levels to further secure the supply chain. “Specifics examples of areas still to be finalised include coding and verification before packets reach patients and which medicines should have safety features. In summary, this is a major step, we are hopeful, but it’s not there yet.”

Fredrick Moen, director of European government affairs at AstraZeneca, said full cooperation of pharmacies and hospitals is vital in the fight against counterfeit medicines.

We now have basic legal framework in place. However, more detailed provisions are needed and we are working closely together with other stakeholders and the European Commission to get the system in place.

“We need to ensure the integrity of the legal supply chain from originator to patient and close the door for criminals.”

He added that the initiative was not a “silver bullet” and people needed to be aware that the majority of counterfeits are sold through illegal websites.

Meanwhile, the MHRA has formulated separate proposals, including the introduction of a specific offence for manufacturing, supplying and handling counterfeit medicines. These proposals were developed out of the organisation’s commitment to review the supply chain as outlined in its Anti-Counterfeiting Strategy published in November 2007.

In 2006, the MHRA had rejected calls from pharmaceutical firm Pfizer to increase supply chain security and ban the repacking of drugs by third parties.

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