An update on the Falsified Medicines Directive from Sultan “SID” Dajani, Chairman of the Falsified Medicines Directive at the Royal Pharmaceutical Society and UK Representative for the Pharmacy Group of the European Union (PGEU).
“With the Falsified Medicines Directive coming (slowly) to fruition, it will be pharmacies and wholesalers bearing the brunt of the changes in the continual pursuit of patient safety.
With over half of UK legislation emanating from within Europe, it is vital for our profession to monitor and engage with European public policy that involves pharmacy. The RPS is a member of a European representative body that presents a Europe-wide professional viewpoint to legislators.
The PGEU presents the pharmacy view on the many different relevant directives passing through the European Parliament, providing a voice for every pharmacist in Great Britain.
We are working on over 30 Directives, and the Falsified Medicines Directive and its associated Delegate Acts are by far the most complex piece of legislation that the RPS has been involved in.
The FMD aims to substantially reduce the potential for falsified/counterfeit medicines to enter the legitimate medicine chain in both hospital and community pharmacies.
It also sets out to introduce a reporting and recall process to every pack suspected of being either falsified/counterfeit or being subject to a substandard manufacturing process.
It sets the standard for ensuring that every aspect of the raw ingredients that form a medicine, are monitored and that the highest of clinical standards are adhered to. The Directive also focuses on the production of a unique random identifier on every pack (most likely 2D or Matrix), which can be authenticated at the point of dispensing and verified as a legitimate medicine.
This is supplemented by a tamper-proof seal that demonstrates the integrity of any particular pack is maintained until it is handed to a patient.
What starts with a simple principle – reducing the incidence of falsified/counterfeit medicines in Europe – soon becomes more complex. To ensure the system excludes as much of the rising number of falsified medicines imposed upon the legitimate medicine supply chain, the Westminster Government would be required to make some bold decisions.
Scanning equipment will be needed that reads both the 2D or Matrix barcode as well as the standard linear so the same equipment will carry out the verification process and continue to use EPOS if available.
Pharmacists should have additional functionality added to the system, that allows an accuracy check at the point of dispensing in addition to displaying information on the expiry date of dispensed medicines and provides information on any change in appearance or dosage of individual medicines.
The Government has commenced the scoping work to determine how the Directive will be implemented in the UK. As a profession, we would like to see the introduction of a system that provides an addition safety check, reducing dispensing errors and increasing patient safety. Patient safety will also be enhanced when we can confidently say that every pack of medicine authenticated by this system is part of the legitimate medicine chain. The Directive was to be transposed into national legislation by Member States by January 2013, it was published in November 2015 and adopted in February 2016. Whilst different timelines will apply to EU Member States as regards the final adoption of the provisions of the Delegated Acts: the UK must implement the FMD by February 9th 2019.
Clearly this Directive has huge implications for many stakeholders including the pharmaceutical industry, wholesalers, our patients, the Department of Health and especially us, hence no system should be designed without the cooperation and advice of our profession.
Similarly no verification system could function unless we develop a system which: – is not unnecessarily expensive or bureaucratic, – is seamless and consistent with current pharmacy practice, – does not add unnecessarily to our workload – protects pharmacy data – is relevant to community, prison and hospital pharmacies – the extra workload is outweighed by the advantages the systems will bring in the wider perspective.
Clearly while this system is being sold to everyone as a sugar plum fairy, many iron maidens are lurking in the shadows and currently there are many controversial discussions ongoing.
The main ones include those around:
– The use of data for the greater good e.g. for understanding medicines shortages, parallel importing and exporting, illness epidemiology and so on however others argue that data use of this sort falls foul of the FMD.
– There are also issues around ‘gold-plating’ the system. This is where the use of the software can be expanded to beyond the realms of verification and authentication and into expiry date and accuracy checking.
Whilst many agree this would be a great idea, the arguments lie in who pays as this again falls outside the remit of FMD.
Some argue as a patient benefit the government should pay, the government says the software suppliers pay and they say the pharmacy contractors should pay as it’s a business tool.
Contractor representatives argue they already have to stump up around £1m for installation and because FMD is an imposition and a patient protection issue, it’s the government who should pay.
Negotiations are ongoing.
– There’s a major headache around how the UK will implement this and the hub and spoke model the UK government is proposing.
– Finally there are major disagreements on what the consultation should include and how it will be carried out.
With these and many issues, some subjective that need to be resolved very soon to meet the implementation deadline, the MHRA and the Department of Health have recently set up an Implementation Board with at least six working groups covering subjects such as communications, the consultation and so on.
Of course the RPS does not have a magic wand but it is central to key discussions and is in a position to influence outcomes. It has set-up a Virtual Pharmacy Network (VPN) to hear your views, engage with others and update you with any developments.
Technology can seduce, but eventually it comes down to real benefit and that’s why you need to be part of the process through the RPS and use this rare opportunity to make real improvements to the standard of care provided to patients and the public.
The potential benefits from the Falsified Medicines Directive offer visible results for patients, enhance the standing of pharmacists within the communities they serve, and reduce the potential for harm to befall patients whilst they are in our care.”
Thanks to Sid Dajani for the guest blog post, and update on the Falsified Medicines Directive.
If you are a wholesaler and aren’t up to speed on the FMD then read and digest the above.
Remember that there is an expectation that you are well trained and knowledgeable about GDP, the FMD and other emerging regulations.