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The Directives are coming


07 Oct 2011

And, for better or for worse, pharmacy has to take notice. The EU has what the lawyers call ‘competence’ in pharmaceuticals – that is, it is allowed to make laws in this area (the EU is fairly limited in what it can do, although you might have missed that in the British press). Recently, it has been rather active.
Four new Directives relevant to pharmacy have come before the European parliament in the last two years. We have had a proposed new law aimed at making it easier for the pharmaceutical industry to provide information on medicines directly to patients; a Directive overhauling the EU rules on pharmacovigilance (recognising the role of pharmacists for the first time); a new law adopting a series of measures aimed at removing the threat of counterfeit medicines; and if that wasn’t enough, the long awaited Directive on cross border health care includes a section on the recognition of prescriptions.

Prescription recognition
Prescription recognition It is now obligatory for pharmacists to recognise prescriptions from other EU states (the change in the UK requiring recognition preceded the Directive). But there is something inherently problematic about recognising foreign prescriptions, and not just that the prescriptions might look very different from what you are accustomed to (PGEU has studied prescriptions from all 27 EU members, and I can assure you no two are alike). What if you think that there is, for example, a prescribing error? Most pharmacists will pick up the phone and check with the doctor. Try doing that if the prescriber is in Greece.
PGEU argued that pharmacists’ normal professional discretion should be protected in relation to foreign prescriptions – a principle thankfully written into the Directive. Pharmacists will not be forced to dispense foreign prescriptions if there are sound professional reasons for not doing so. In addition, national rules on dispensing apply, so things like generic dispensing are unaffected. More radically, the Directive mandates the European Commission to develop a list of elements for EU prescriptions to try and address some of the wide ranging differences – an opportunity perhaps for pharmacy to press the case for the inclusion of information such as indication in the prescription, a move many believe would facilitate better pharmaceutical care.
In reality the number of prescriptions being used across borders is small, and the impact of the new rules limited. The same cannot be said for the Directive on Falsified Medicines, finally passed into law on July 1.

The Falsified Medicines Directive
The Falsified Medicines Directive has been adopted on the assumption, probably justified, that although the actual incidence of fake medicines in the legal supply chain is low, the threat is growing, and it is therefore better to act now than to wait until people start getting hurt or, heaven forbid, killed as a direct or indirect result of counterfeits.
The Directive has two elements of significance for pharmacy. First, it addresses the issue of internet sales. Among other things, it requires legal internet pharmacies to display a common EU logo with the intention of helping patients recognise authorised online pharmacies. Such a scheme has of course been up and running in the UK for some time. The UK scheme will need to be overhauled in line with a new system designed by the European Commission. It will be interesting to see how the Commission deals with the possibility that such logos can themselves be faked.
Second, the Directive requires the application of ‘safety features’ on medicines packs that will allow them to be individually ‘verified’. For ‘safety features’, read ‘bar codes with an individual serial number’. The idea is that pharmacists, and perhaps to a lesser extent wholesalers, will verify the medicine by scanning the bar code at point of dispensing, although the Directive is very vague about who must do what, and does not explicitly say that pharmacists must be involved.
The serial number will be sent to a database where the original code for the scanned medicine will be stored. If the numbers match, the product is genuine. The Directive mandates the European Commission to establish a technical framework for the system, including deciding which supply chain actors do what, and which medicines must carry the safety feature – most people assume it will be the majority of prescription medicines.

The thorny issues
That simple description hides a whole series of decidedly thorny issues:

  • Who pays for all this? The manufacturers will pay for the databases and putting on the codes, but pharmacies will probably have to stump up for scanners and software.
  • How will it affect the pharmacy workflow? In theory, the process of matching the codes should be instantaneous. Pharmacists will not accept anything less.
  • What happens to the data generated, since pharmacy transactions will effectively be recorded by the system? The data belongs to pharmacists. The industry would love to have it. PGEU managed to get the Directive to recognise that the verification systems have to take ownership and confidentiality of data into account.

The Commission is now sitting down with stakeholders – industry, pharmacists and wholesalers – to try to work out how all this is going to work. In has been suggested that the UK authorities are in no hurry to have a verification system in place, although note that the government signed on the dotted line when the Directive was passed. It is worth remembering that most counterfeits found in the legal supply chain in the EU have turned up in the UK.
But why would pharmacists want an expensive new technological scheme (remember E-prescription?), when most of us have never come across a counterfeit in our professional lives? Especially since pharmacists, virtually without exception in the EU, are already doing more work for less money these days.
Well, I think for three reasons:

  • This is about patient safety. That is our mission, historically, professionally, morally, and of course economically. Given that the Directive has been adopted, and that verification is near certain to go ahead in some form in the future (although it is difficult to say when), it would in my view damage the standing of the profession if we are left on the sidelines.
  • We constantly read these days of some new threat to pharmacy’s place in the supply chain, be it internet, home care services, direct supply and so on. Here is a chance to show that the community pharmacy interface is really the only way properly to ensure patient safety.
  • Although some investment will be required, once the infrastructure is in place new possibilities open up. In Belgium, for example, which already has a verification system in pharmacies, the system is being used to provide pharmacists with up to date information at the point when the medicine is dispensed.

Perhaps electronic verification should be seen as one aspect of pharmacy using technology to improve the effectiveness of our professional services. E-prescription is slowly gaining ground (Finland is the latest member of the e-prescription club). But it is electronic medication records that hold real promise for a profession that has historically lacked sufficient technical tools to augment its skills and knowledge. Here once again the EU has a role – it is investing millions of euros in standards development for e-prescription and electronic health records.
It is essential that we ensure that the benefits of pharmacy access to the records are fully taken into account when systems are designed and standards established. These benefits are real: in France the pharmacist professional body has itself developed a pharmacy based medication record, now rolling out to every pharmacy in the country. The system (called the ‘Dossier Pharmaceutique’) is accessible from any pharmacy and holds records for the last four months on both prescribed and non-prescribed medicines – the latter is possible because there are no general sales in France. A study of 160 pharmacies found that using the record led to prescription adjustments in 10 per cent of cases.
In the Netherlands, where doctor/pharmacist collaboration on the basis of access to records is well established, a common patient record for health professionals has been up and running for nearly two decades. In Spain, the government has just passed a law establishing a pharmaceutical record on the back of existing e-prescription and electronic dispensing support tools. Similar systems are either in place or being developed in Denmark, Czech Republic, Belgium and Portugal.
If we are going to fully realise the value of our contribution, particularly with the anticipated surge in polypharmacy as the population ages, I think we have to grab the opportunity technology represents and run with it. The pilots in Wigan in relation to summary records are showing the way. I think there is plenty to learn from experiences in other EU countries.
By the time you read this, Greece may have defaulted, and Italy and Spain may be standing on the precipice. But don’t rule out the importance of Europe for pharmacy just yet!

John Chave
is Secretary general of the Pharmaceutical Group
of the European Union


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