By Rajkaran Singh Dhaliwal
Falsified medicines are medicines that claim to be authentic but contain ingredients of poor quality or in incorrect amounts. The European Union (EU) has classified the potential impact of such products as severe, since active ingredients may also be affected which can lead to a detrimental impact on patient health. This problem has been augmented by the presence of increasing quantities of falsified medicines within the illegal and legal supply chains, which has increased the potential for patients to be exposed to such harmful products. These issues were first outlined in 2011, when the European Commission published a directive which recommended steps to reduce the amount of falsified medicines in circulation. Among these was the use of “safety features”, which would allow accurate identification of the authenticity of individual packs and provide an indication of any tampering that has occurred. This directive also set the ball rolling for ensuring the quality of medicines that are provided through Internet pharmacies, by recommending the use of a common logo to be displayed on their website. This ensures that the consumer is easily able to identify the country of origin of the pharmacy, as well as see that it is genuine. This requirement is now being practiced across the EU. This directive set the foundation for the Falsified Medicines Directive (FMD) which is due to come into force on 9th February 2019.
Under the FMD, all Marketing Authorisation (MA) holders will be required to put two safety features on packs of all prescription-only medicines within the European market:
- A 2-D barcode: This encodes a summary of the individual packets unique identifier. This unique identifier consists of the serial number, product details such as name and strength, the expiry date and the batch number. This barcode will be scanned at various points throughout the medicines supply chain, including during the dispensing process and when handing prescription out to patients
- An anti-tamper device in the form of a seal
The FMD provides a systematic network of end-to-end verification of medicinal products across the EU, providing stakeholders such as wholesalers, pharmacists and patients with assurances that the medicines that they are handling are genuine.
Therefore, the verification of an individual packet’s authenticity will be two-fold. Firstly, there is the need to check that the anti-tamper device is intact, to ensure that the contents have not been accessed unnecessarily. Furthermore, there is the requirement that the 2-D barcode is scanned at various points in the supply chain. From a pharmacy perspective, this will occur as part of the dispensing process. Scanning will have 3 purposes:
- Verification- this can occur at any time in order to check if the particular pack is still within the supply chain and is not subject to any recalls
- Decommissioning – this changes the pack to being inactive and should occur when the pack is handed over to the patient. An inactive status will prevent the further supply of other packs which have the same unique identifier (i.e., potentially falsified packs cannot be supplied once this occurs)
- Recommissioning – this reverses the decommissioning scan, after the pack is made inactive. This scan can occur within 10 days of the decommissioning scan
Scanning an individual pack will cause a comparison of the pack’s unique identifier with a central database of unique identifiers that are uploaded by the MA holders. These databases will be managed on a national level, with the UK version being provided by SecurMed. These national systems will also hold information about which packs are subject to a recall, stolen packs and those that have been known to be tampered with. Each national database will be linked to a central European medicines verification system, which creates a linked network, allowing parallel importing to occur.
Since pharmacies are the public’s gateway for access to medications, they will be the final step within the medicines supply chain and so form an essential component of the FMD. Firstly, contractors will need to ensure that their systems are up to date, to enable communication with the UK’s national database, as well as to allow scanning of packs. This is thought to involve extensive software and hardware upgrades, including the purchase of scanners, which is likely to increase the financial cost for community pharmacy contractors. This is an aspect of the FMD guidance that is currently causing an issue for community pharmacy contractors, especially considering the recent funding cuts to the sector. This issue is of particular concern since community pharmacists are expected to foot the bill for a mandatory overhaul of their systems. This has led to substantial discussion, resulting in the chair of the UK FMD Working Group for Community Pharmacy to advise contractors to avoid implementing such changes for now. This is to allow time for groups such as the PSNC to negotiate with the government with regards to securing funding for pharmacists to update their systems. However, this situation is becoming more unlikely, as currently there is no guarantee of additional funding to pharmacy contractors.
Additionally, there is also the fact that the associated changes to the dispensing processes may be time-consuming. There will need to be a comprehensive change to standard operating procedures (SOPs), in order to integrate the components of FMD into pharmacy processes. However, with little information on the practical changes FMD will bring, it is unclear as to what impact it will have on the workflow within a busy dispensary. There is also the question of what happens for larger prescriptions which require multiple packs of medication. Would pharmacists be expected to scan every single pack, which would be time-consuming in an already busy environment? A solution to this has been suggested by using aggregated codes. An aggregated code would be a single label put on the outside of the medicines bag. During dispensing individual packs would be scanned, and a single label with a barcode pertaining to all of these packs would be printed. When the medicines are handed out, the aggregated code would be scanned, showing all of the packs as inactive. Since the use of aggregated codes is not mandatory under FMD, it is not fully known how widely this will be adopted.
Additionally, since the FMD is being introduced across the EU, the impact of a no-deal Brexit would mean that the FMD will be revoked in the UK. Since Brexit is planned for less than two months after FMD comes into force, it is unfair to expect community pharmacy contractors to pay for extensive system changes to accommodate FMD if it will end up being revoked. However, there are currently plans to introduce a UK version of the FMD after Brexit, which would need to make use of the existing FMD software that contractors would’ve already paid for. Furthermore, FMD is likely to remain in the UK since there is expected be a short transition period following Brexit.
To conclude, FMD is the culmination of concerted efforts to ensure a consistent, systematic network across the EU with the common goal of minimizing and preventing the circulation of falsified medicines and their impact on patient health. However, there are practical difficulties associated with its implementation in community pharmacies, with uncertainty over the financial aspect of accommodating changes associated with FMD, as well as the long-term future of FMD in a post-Brexit UK.
European Union Directive 2011/62/EU. Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf
PSNC – Falsified Medicines Directive. Available at: https://psnc.org.uk/contract-it/pharmacy-regulation/falsified-medicines-directive/
UK FMD Working Group for Community Pharmacy. Available at: https://fmdsource.co.uk/
Clews, G. (2018). FMD regulations won’t apply after ‘no-deal’ Brexit, says MHRA. Available at: https://www.pharmaceutical-journal.com/news-and-analysis/news/fmd-regulations-wont-apply-after-no-deal-brexit-says-mhra/20205559.article