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Mahmuda Khatun

Falsified Medicines Directive – What you need to know

The safety of medicines is important. Every time we purchase over-the-counter painkillers or receive a prescription from a pharmacy, we place a huge amount of trust in the supply chain, trusting that the medicine we’ve just received is legitimate and safe to take.

Falsified or fake medication puts this at risk. In the UK supply chain, there were 11 cases of fake medication detected between 2001 and 2011. Retailers and consumers can be misled by this, and the result is unsafe medication being unwittingly supplied by well-meaning pharmacists and taken by unsuspecting patients.

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What is the Falsified Medicines Directive?

The Falsified Medicines Directive (FMD) is a framework introduced by the European Commission. It is designed to increase the safety and protection of those who need to take medication. Designed to come into force by February 2019, there are a range of features being implemented in order to safeguard patients against fake or counterfeit medication.

What will change?

All medication must now have a unique randomised serial number and barcode. This means that the medication can be scanned when it is delivered to and dispensed from a pharmacy. When it has been scanned after dispensing, a notification is sent to the central verification organisation, SecurMed, decommissioning the pack, ensuring it can’t be used again.

For example, if a counterfeiter got hold of the box, they would be unable to use it to supply fake medication to another pharmacy, as when that pharmacy scanned the box, it would alert them that this medication had previously been dispensed. If this happens, the MHRA will also be informed.

Manufacturers must also introduce a tamper-proof seal to the medication. This will visually tell the customer whether the medication has been opened or tampered with after it has left the manufacturer. It will very quickly identify counterfeit medication that has found its way into the supply chain, or instances where products or packaging have been stolen for re-use or re-sale.

What happens to existing medication?

The Falsified Medicines Directive comes into place in February 2019, and it’s expected that all manufacturers and pharmacies will be compliant after this date. However, it’s estimated that it will take between 12-18 months before previously manufactured non-compliant medication works its way through the supply chain.

Which medication does this apply to?

Generally speaking, the Falsified Medicines Directive applies to all medicines within the UK supply chain. Prescription and high-risk medicines will need to receive verification and decommissioning scans every time they enter or leave a pharmacy. However, in practice, over the counter medicines will not generally need to be scanned every time they’re sold. They will only be scanned if there is evidence of that particular medicine being subject to counterfeiting.

Will Brexit affect the Falsified Medicines Directive?

Yes and No. Should the UK leave the EU with a deal, the Falsified Medicines Directive will continue to apply and UK manufacturers of medication will be expected to comply with the rules and regulations. However, should the UK leave without a deal, theoretically the FMD will not apply. However, it is likely that the UK government will replace it with a similar scheme designed to safeguard patients from counterfeit medication.

How will I know a pharmacy is compliant?

After February 2019 all pharmacies are expected to be compliant with the FMD. However, in practice, this is unlikely to happen. The MHRA is working with pharmacies to work towards compliance, but it’s estimated that less than half of UK pharmacies will be ready before the deadline.

Instant eCare met the February 9th deadline to implement the Falsified Medicines Directive, and is fully compliant. Other online pharmacies may not be, so you should check with their superintendent pharmacist or visit their terms and conditions page. The FMD also applies to community pharmacies, so you should speak to the pharmacist on duty for more information about whether a community pharmacy is compliant or not.

If you’re concerned a pharmacy is not compliant, you can report them to the MHRA or GPhC, the pharmacy regulatory bodies in the United Kingdom.

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How will this affect me as a patient?

If everything goes right, it shouldn’t affect you at all. You should be able to continue receiving the medication you receive now, safe in the knowledge that the process to identify counterfeit medication is that much more stringent and controlled.

However, it’s important to be vigilant. If you buy online, make sure you fully vet the pharmacy you’re buying from. Offshore pharmacies that sell medication illegally without a prescription are unlikely to be compliant with the FMD, and you may be purchasing medication that is dangerous, counterfeit or unsuitable for you. Whilst it might be tempting to save a little money, always put your health first and ensure you only use reputable online pharmacies that are registered with the GPhC or MHRA, or your local community pharmacy.

If you have any more questions about the FMD, or how we’ve implemented it, get in touch with us at support@instantecare.com and we’ll be happy to help you.

References

Harrogate and Rural District., (2019). Falsified Medicines Directive (FMD). [Online] [Accessed 6 Mar. 2019]. Available at: http://www.harrogateandruraldistrictccg.nhs.uk/data/uploads/medicines-management/guidelines/falsified-medicines-directive.pdf.

Pharmaceutical Journal., (2016). What is the Falsified Medicines Directive? [Online] [Accessed 6 Mar. 2019.]. Available at: https://www.pharmaceutical-journal.com/your-rps/what-is-the-falsified-medicines-directive/20201820.article.

University of Oxford., (2017). Detecting counterfeit medicines. [Online] [Accessed 6 Mar. 2019]. Available at: http://www.ox.ac.uk/news/science-blog/detecting-counterfeit-medicines.

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