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IT and detecting fakes - an eye on europe

IT and detecting fakes - an eye on europe

Sid Dajani, the Royal Pharmaceutical Society's elected representative on the Pharmaceutical Group of the European Union, explains how the Falsified Medicines directive will use IT to root out counterfeit medicines

Bogus medicines are a growing market - and, according to the WHO and Interpol, they are more lucrative than heroin. No wonder then that the largest hauls captured by the regulatory authorities over recent years have been counterfeit medicines. Not just those expensive lifestyle drugs you'd expect, like Viagra and Levitra, but now we are seeing fake insulins and Herceptin along with the high turnover cheaper generics like aspirin, omeprazole, digoxin and levothyroxine. Nothing is sacred.

We may think we are immune in the UK because the incidence of illegal medicines entering the supply chain is small. But the risk is high and, because 'pharmacrime' is on the increase and because we import over £2bn of medicines from the Common Market, it is also growing. While most fake medicines are bought over the internet, the chances of them entering the supply chain is a big concern for all of us. This is a global problem, and the RPS, NPA and PSNI are playing a major role in tackling this as a priority.

Big problems require equally big solutions, and it's going to take the biggest EU-wide patient safety initiative and the largest IT project ever to address this problem and ensure Britain remains the safest place to take medicine. Under the Falsified Medicines directive the introduction of an EU-wide harmonised verification system will become a requirement for all pharmacies and dispensing doctors.

Development of the IT systems for both EU and member states will be paid for by the pharmaceutical industry. However, the chosen system should be endorsed by the end users €“ that's you and me €“ and be fit-for-purpose. This may sound like a 'sugar plum fairy' proposal but there are plenty of iron maidens lurking in the shadows. The definition of 'fit-for-purpose' is open to interpretation, as is the wording in the delegated act, and every stakeholder will have an opinion. We have already had fun trying to marry different versions.

Fundamentally, the directive is only about the authentication of medicines, but its introduction could be either a positive step for UK pharmacy stakeholders or it could become another Connecting for Health fiasco. The NHS does not have a good track record in this area and we will have to work with the chosen system for the foreseeable future.

What we end up with needs to be both useable and useful and, with the UK being in a unique position in relation to prescribing, the electronic prescription service (EPS), national clinical services and advanced PMR software, we need the right system.

To this end, and for the first time in any member state, the RPS is inviting the three key software suppliers to present at our next meeting, on July 14. We expect to hear about the differences between each system and to seek assurances on reliability, interoperability, efficiency, security and support.

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