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FMD: We Are Ready, Are You?

FMD: We Are Ready, Are You?

Counterfeit medicines are bad news. From a pharmacists perspective, falsified medicines can affect bottom lines and breed scepticism from consumers prompting a breakdown of trust. Much more important than that though are the very real dangers of fake drugs to those that take them.

Counterfeit medicines can look exactly like legitimate ones. Products and packaging can be so well made that even experts can easily be fooled. But a quick test of the medicines themselves would prove that they’re really quite different indeed. Many falsified medicines will still contain the active ingredient(s), but often in reduced doses. While some won’t contain them at all, merely similar components (or, in extreme cases, no ingredients of use whatsoever).

Despite appearances, the quality of the manufacturing is almost always significantly poorer and, in some instances, these forgeries can actually contain dangerous or even toxic ingredients. At the very least they pose very real risks of setting off allergies or reactions with their cheaper and often undocumented components. 

What can be done?

Lots of things can and are being done to cut back on the number of falsified medicines that get out there into people’s hands, but nothing has completely eradicated them.

In order to completely strangle the fake medicine ‘industry’ or at least severely cut back the amount of counterfeit drugs that make their way onto the market, a new ‘Track and Trace’ initiative is to be introduced. It will be European wide and is due to be introduced in February 2019. Known as the ‘Falsified Medicines Directive’ or ‘FMD’, the solution aims to eradicate fake drugs via a computerised tracking system that can be followed from initial manufacturing of the drug right through to the point where a customer leaves a pharmacy with the medicine.

How will it work?

In a word: Barcodes. All drugs from February 2019 are to have two-dimensional barcodes printed on their packaging; barcodes which can be scanned at any point of their journey from manufacture to customer. Scanning will give a full breakdown of the point of creation, the whereabouts, the logistics (from factory, to wholesalers, to distributors and to pharmacies...), all the relevant details.

A simple scan will verify the medicine’s authenticity in seconds because it will have its own unique - and entirely random - number. For added security, every single packet will feature a tamper-proof security seal. 

This identification information is to be stored in a database which will be managed by the European Medicines Verification Organisation (EMVO), with assistance from the UK Medicines Verification Organisation (UKMVO), aka SecurMedUk Ltd.

What does it mean for pharmacies?
First of all, it means that you will have to read and fully digest the new legislation that applies to FMD. You will also need to alter your basic processes a little to incorporate barcode scanning for validating and decommissioning medicines. Aside from this, most of the work is going to be made by us, your PMR provider. We’ll make sure your system is fully prepared for the introduction of the Falsified Medicines Directive.

Just be mindful that a few tweaks to your Standard Operating Procedure may be needed and there may be a requirement for a little staff training on it. The worst case scenario is that you may have to think about altering your pharmacy’s layout or invest in an additional terminal (an outlay that will soon pay for itself, no doubt). This latter option is only really required if you are currently operating at capacity and anticipate that even the slightest FMD-based delays could cause bottlenecking.

Anything else to bear in mind?
Implementing FMD should be relatively easy, however, a few creases may need to be ironed out along the way. One thing that is worth noting and implementing into your SOP alteration is that FMD will require a new ten-day window to come into place for   adding medication back into stock when not supplied to the patient. So we would recommend that you decommission the pack as the customer picks up their prescription, rather than as you prepare their medication. Otherwise, should you prepare it and they not collect it within the ten day time period, the medicine(s) will no longer be able to re-entered into the system and used for another customer.

This scheme has been well thought out and should be a vital step to drastically cutting down on fake medicines, so it will be well worth any minor inconveniences. If anything, we’re looking forward to FMD’s implementation.

In the coming months we will be sending out further information and updates to enable you to be ready for the new Directive - so keep an eye on your inbox or ask our sales team. In the meantime, register for our FMD Webinar on 25th July where we will be sharing details of our FMD solution.

Visit our FMD Resources page 

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