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On the road > AAPS 2010 in New Orleans

Partnerships needed to beat public health counterfeit threat

By Mike Stones , 17-Nov-2010

Combatting counterfeit drugs through forging stronger partnerships is beyond profit, it is about saving lives, AstraZeneca principal scientist Dr Michael Claybourn told a workshop on global drug quality at the AAPS annual meeting in New Orleans.

Speaking after the workshop, Dr Claybourn told InPharmaTechnologist.com: "People are dying - a lot; mainly from the counterfeiting of anti-malarials. Anti-counterfeiting is a public health concern."

Counterfeiting can be found across all categories of drugs in all locations. High margin drugs - particularly oncology medications - can prove tempting targets, he added. Hotspots for counterfeiting include South and Central America, India and Africa.

It is difficult too to be precise about the size of the global counterfeiting problem. "We should treat cautiously suggestions that about 1 per cent of drugs worldwide are counterfeit: Particularly (bearing in mind) that in the UK alone, 400m prescriptions are given to patients."

In developed countries, he suggested, most progress could be made against the counterfeiters by stepping up partnerships between regulators, law enforcers and industry, while in other pharmaceutical markets greater cooperation between bodies like Interpol is needed.

Enforcement agencies

In economically evolving countries, the challenges of combatting counterfeiting are more complex. Part of the problem is that there are insufficient disincentives to discourage counterfeiting and, in some areas, apparent tolerance of counterfeiting activities according to Claybourn who suggested that: "In some countries, counterfeiters are pretty much let off with a slap on the hand."

As a first step, there needs to be greater discussion and definition of what the authorities need to put in place to make the supply chain more secure.

Also, conducting market surveys in high-risk parts of the world targeting high-risk problems is a defensive strategy that is paying off in some areas.

China, Indonesia and Egypt are deploying particularly innovative solutions to detect counterfeit drugs, said Claybourn. "China is really ahead and having a major impact on this problem. Both China and Indonesia are using mobile labs to test the authenticity of drugs in remote, inaccessible locations."

Technical back-up in the field is helping to make rapid authentication decisions about suspect products sometimes under difficult and sometimes dangerous circumstances. Equipment such as the Ahura Truscan can deliver portable Raman spectroscopy with a pass/fail decision in seconds.

In the past, samples had to be sent back for analysis in the United States, Sweden or UK. While lab analysis to reverse engineer the chemical construction of counterfeit products remains important, tough battery-powered field tests are making a big impact.

Not just drugs but delivery systems too are counterfeited. This includes tablets, capsules, vials, ampoules, injectables and inhalables.

Claybourn also predicted that high-tech solutions such as forensic markers and nanotechnology will become important to AstraZeneca and other Big Pharma companies in the fight against fakes in years to come.

Forensic markers

But low-cost solutions such as tamper-evident packaging could also make an important contribution.

Dr Anthony Moffat, professor of pharmaceutical analysis at the School of Pharmacy, University of London, highlighted draft guidance from the US Food and Drug Administration (FDA) which suggested the greater use of inks, pigments, flavours and other physical identifiers (PCIDs) to help fight counterfeiting.

But PCIDs used in drugs should be pharmacologically inactive. "Food additives, colourants or excipients with established safety profiles would be ideal candidates," according to FDA guidelines.

Dr Mofat also warned that some drugs may not be counterfeit but different from normal production runs. The reasons for this could be normal variability in global manufacturing processes at different sites, changes in API and/or excipients and modified formulations and manufacturing processes

Meanwhile, earlier this month the Medicines Quality Monitoring Programme (MQMP) reported the discovery of counterfeit and sub-standard anti-malarials in several Ghanaian hospitals.

MQMP is part of a collaborative initiative supported by the US Pharmacopeia (USP) which staged the workshop at the AAPS trade event in New Orleans.

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