Falsified Medicines Directive (FMD): How will pharmacies make sure your medicine is genuine?

The Falsified Medicines Directive (FMD) is to be implemented in all member states of the European Union (including the UK) and the European Free Trade Area on 9th February 2019. This is a response to the growing number of falsified medicines entering the pharmaceutical supply chain, which can have serious consequences for patient health and safety. But how will it work? (1)

What is FMD?

FMD stands for Falsified Medicines Directive, a term used both to describe the process by which pharmacies will identify the medicines they receive from wholesalers as legitimate or falsified, and to refer to the European Directive on Falsified Medicinal Products, the piece of legislation concerning this process. (2)

What are falsified medicines?

Falsified medicines are illegitimate copies of legitimate medicines, from unlicensed manufacturers. Despite tight controls, some find their way into the supply chain, allowing them to reach patients. They have not been produced in the same highly regulated way in which legitimate medicines are produced by licensed pharmaceutical companies, but are often passed off as coming from such companies due to identical or stolen packaging. Falsified medicines can contain too much or too little of the active ingredient(s), no active ingredients at all, different active ingredients to what is stated on the packaging, and potentially harmful, banned or dangerously concentrated excipients (excipients are all ingredients of a medicine other than active ingredients). Clearly, there is a risk posed to patients, with overdose, drug interactions, poisoning or a condition being left untreated all possible outcomes of taking falsified medicines. (1)

How can you tell if you are buying falsified medicines?

Legitimate online pharmacies such as Webmed are approved and accredited by official regulatory bodies including the  MHRA, GPhC and CQC. The independence and unbiased nature of these bodies provide regulation, monitoring and inspection to ensure we and our peers are held to the highest standards.

You can rest assured that when you purchase treatments from Webmed (from erectile dysfunction medication all the way to Hair Loss Treatments) you are purchasing legitimate, official medicines.

How will FMD be implemented in pharmacies?

From 9th February 2019, two new features will be present on all prescription medicines supplied to pharmacies (bar a handful of specialist medications):

• A unique identifier (UI) – a 2D data matrix, or barcode, unique to each pack of medication

• An anti-tampering device (ATD) – an addition to the packaging that will make it evident whether or not it has been tampered with, such as adhesive seals, shrink wrap, or perforated sections of boxes that must be broken to open the pack. (2)

It is expected that electronic patient medication record (PMR) systems in pharmacies will be updated to incorporate a medicines verification feature that can be used to scan the UIs on packs and identify the medicine as genuine or falsified. By law, stock will not need to be verified until it is being prepared for a patient, but optional verification will most likely be performed when stock is received into the pharmacy, allowing suppliers to be alerted as soon as possible when a suspected falsified medicine is found. (2)

The safest way to verify medicines before supply to patients will be using aggregated codes, if PMR systems allow. During the dispensing process, each pack of medicine will be scanned and codes for all packs to be bagged up for the patient will be ‘aggregated’ and printed on a label to attach to the outside of the bag. Then, when the patient comes in to collect the bagged prescription items (or before handover to delivery drivers), the aggregated codes will be scanned and, if verified as legitimate, all packs inside the bag will be decommissioned, meaning that their UI codes become inactive. Since UIs will be unique by name and nature, the same UI showing up on a further pack will be flagged, highlighting the pack as potentially falsified and unsuitable for supply to the patient. Aggregated codes will be preferable to scanning each item individually as it will mean that the bag does not need to be reopened on handing over to the patient or delivery driver, which will uphold patient confidentiality, save time and lower the risk of a dispensing error. (2)

Once packs are decommissioned, they can be recommissioned (the UI reactivated and the pack put back to stock as long as it hasn’t left the pharmacy) within 10 days. This may happen if a patient no longer requires the item(s) or if a pack is decommissioned in error. (2)

Scanning will also flag up any recalled, discontinued or out of date medicines, further minimising the impact of human error on patient safety. It is hoped that eventually it will even be used to ensure the correct medicine has been picked against the prescription! (2)

Will Brexit have an impact on FMD?

Since FMD is part of EU law, there has been confusion over whether FMD in the UK will be continued after the UK leaves the EU on 29th March 2019. The Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have assured “high regulatory alignment” with the EU, meaning FMD will be here to stay. It is also believed that the UK will still be considered part of the EU for the purposes of FMD after Brexit, so the process should remain unchanged – this is the best outcome for ease of operation in pharmacies and for patient safety. (2)

References

1. UKFMD Working Group for Community Pharmacy. FMD (1): What is the Falsified Medicines Directive? [cited 31 October 2018].

2. UKFMD Working Group for Community Pharmacy. The way forward for FMD in community pharmacy [cited 31 October 2018]. Available at: https://www.communitypharmacyni.co.uk/wp-content/uploads/2018/02/fmd-cp-working-group-way-forward-paper-jan-18-public-v1-0-final.pdf

Author: Gabby Gallagher MPharm