The Falsified Medicines Directive

This article looks at the practical implications that hospital pharmacists across Europe will need to address as we near the implementation date on 2018 for the Falsified Medicines Directive.

In 2011, the EU passed Directive 2011/62/EU. This is often referred to as the Falsified Medicines Directive, or more colloquially, the ‘FMD’. The directive became European law in 2013, and should be incorporated into each EU member country’s legislation and implemented by 2018.

To support national implementation, the European Medication Verification Organisation (EMVO) was created. This organisation already has selected software suppliers to support the national implementation groups for each country, and to ensure there is sufficient communication functionality between local and national databases to be able to exchange information across a Europe-wide system. EMVO are currently working with pharmaceutical industry and major wholesalers with regard to sorting out implementation issues, but not the smaller wholesalers, or hospitals with a wholesaler dealers licence.

The concept these databases are expected to record is the unique pack number on each packet, as detailed in the FMD. At the point of use, a pharmacist should be able to scan the product, and the database should confirm if the product is a genuine product or not.

This however, throws up a series of problems operationally for this aspect of the implementation, and principally for the hospital sector. If we consider for a moment the community pharmacy setting, it is envisaged that the pharmacist receives the prescription, and dispenses a product against it. The product with its unique product number will be sitting in the national database as ‘active’.

On dispensing to a patient, the product will be scanned as it will then be ‘used’ and should therefore be taken off the active list on the national database, and then also classified as inactive on the European-wide database. The re-emergence of that product with the same number subsequently would trigger an alert, as this should not be able to re-appear again. So far so good. But in the hospital situation, things are not so straightforward. The future falls into what Donald Rumsfeld called ‘known knowns, known unknowns, and unknown unknowns’.

Once a product is delivered to a hospital, several things can happen to that product. Products can be dispensed as ward stock, which in theory means they should at that point be scanned to de-activate that particular brand of product on the national and European databases.

However, most hospitals encourage return and re-use of products, so it follows there should be a means of being able to re-activate the unique product number. This may or may not be possible in the software. However, the whole purpose is to detect fraudulent medicines using the system, so having a mechanism that could thwart the process would be against the whole concept of the FMD.

Some hospitals have wholesaler dealers licences, which mean products can move on to other locations before they are de-activated. How would this be addressed in the EMVO system?

Many hospitals have MS licences, and undertake over-labelling and pre-packing. If the hospital follows the Coding for Success principles, their own products should have a unique number for each carton of product. Is it envisaged these are added as ‘live’ products on the national and European databases? Will there be a means of deleting these once issued to the final user? The other point to consider, is, who is the final user? If over-labelled items are supplied to a walk-in clinic, the final user will be a patient, and not the clinic itself.

From an operational viewpoint, if products were pre-packed into the hospitals own boxes, then the removal of the unique pack number from the database would be final, and the product would be transformed with the hospitals own unique number. This would mean any supplier of over-labelled or pre-packed products would have to comply with the regulations, which may make matters more expensive as a consequence.

Then there is also the fragility of the supply system to consider. Hospital pharmacists will be well aware of the growth of suppliers who are able to import medicines into the UK. The growth of these companies in size and number could be regarded as a proxy measure of the fragility of the supply system. In our own hospital, our hierarchy of preference if we have to import is firstly, from an English speaking country; secondly, from an EU country, thirdly some other country, with a proviso to avoid some countries.

Products from an English speaking country most likely would not have a unique pack number, (because they might come from Canada, USA or Australia where the Directive does not apply) and may not register on the national database, so nothing could be done about that. Imports from the EU could pose a problem if say a Czech product was used. The unique product number would be registered in Czech republic, but scanning the product to de-activate it in UK would only happen if there was good cohesion with the software across the national-EU central-national database matrices.

Given that national systems will reflect national practices, the product may not be recognised. This will trigger as an alert somewhere in the UK national system, leaving the pharmacists with the problem of deciding if the product is genuine, or a clever fraudulent medicine.

They will almost certainly need the medicine quickly (why else import), so it will trigger a professional dilemma, to risk using the product or not. The new systems to be implemented should have some means of checking the authenticity of the product if such an alert message is triggered.

Bearing in mind all of the above factors, it would seem logical that the best way for hospitals to implement the FMD is to regard hospitals as end users. This means any part of the hospital ‘microsystem’ would be of no relevance to EMVO so long as stock did not re-enter the supply chain. Hospitals could return ward stock and re-issue to other wards without disrupting the European registration system. Supplies to clinics would similarly not impact on the EMVO system.

The exception would be where hospitals have a wholesaler dealer’s licence, and stock is re-entering the supply chain system. If the wholesaling hospital de-activated the unique number then sold on the product, the recipient hospital would have an alert or error when scanning the number. An over-labelled pack would identify the origin, and the pharmacist would be able to make an informed decision on the suitability of the pack for supply to a patient.

Whilst this is one seemingly practical way forward, the potential work is significant. Hospitals receive hundreds if not thousands of packs per day, and the task of de-activating the numbers of each and every individual pack before use will be enormous. In effect, there would have to be a quarantine area equivalent in size to the existing floor area for deliveries whilst the individual pack numbers were de-activated.

Stock would have to be received in the usual way, but then quarantined until scanned, ready to be put on the shelf for use. For those pharmacies with limited space already, this could be a significant challenge. There would also be more staff required to do the scanning. When NHS hospitals are currently experiencing one of the toughest financial periods in a long time, obtaining the necessary resources may not be easy.

In conclusion, there is certainly a range of problems to grapple with, and probably more as details of how the software can work become apparent within the constraints of the normal working systems. The advantage for hospitals will be each uniquely numbered pack provides an opportunity to map exactly what happens to that pack, and can shed light into the potential issues of diversion of stock. Raising the issue now for pharmacists can focus thoughts on any procurement specifications.

For example, 2D scanners on robots would provide a means to upload all the product information including the unique pack number, but the software needs to have the capability to capture and store it. This means we as a hospital pharmacy service need to be approaching suppliers of robots to tell them this is something we need. The suppliers of pharmacy systems will also have to be consulted, as we need to record this data on file.

There is a very tight time frame to think through the European and national systems and how they will work operationally. Hospitals are not yet geared to looking at how they might incorporate this new legal requirement into their working practices by 2018.

Each and every hospital across Europe will have to look at this. Arrangements for smaller EU countries such as Malta and Cyprus may need to be creative within the system. Malta uses packs predominantly from the UK, so there may be an option to ‘piggy back’ onto the UK system.

Although not usually a problem in UK, ‘prescription tourism’ may be another consideration for countries where there is easy cross-border dispensing of prescriptions. Intriguing times are ahead for hospital pharmacy!

Key points

Implementation of the falsified medicines directive is only two years away.
It is still unclear how countries will roll out national plans.
There is significant work to be done regarding how the systems will work.
The falsified medicines directive has potentially significant workload implications for hospital pharmacy.

Authors

Rod Beard BPharm MSc MBA MProf MRPharmS
Sunderland Royal Hospital, UK
Email: [email protected]

Karen Shield BPharm MSc MRPharmS
Sunderland Royal Hospital, UK

The Falsified Medicines Directive

Key points

Authors

References

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