Falsified Medicines Directive

 In Medicines Management Processes, Pharmacy Information, Regulations and Standards, Uncategorised

Falsified medicines include counterfeit and unauthorised medicines and these can pose a health risk for patients. They are often disguised as authentic medicines and may be impossible to detect by a visual inspection.

More than half the medical products bought online are fake or unlicensed according to the Medicines & Healthcare products Regulatory Agency (MHRA). In 2015, INTERPOL coordinated an investigation across 115 countries over one week and 20.7 million fake and illicit medicines were seized which had a value of 81 million US dollars (Operation Pangea VIII).

The most common falsified medicines include psychotropic drugs, such as antipsychotics, antidepressants, anxiolytics and sleeping tablets, and high-value medicines, such as those used for HIV treatment and erectile dysfunction.

What is the Falsified Medicines Directive?

In Europe, online pharmacies must be registered in order to supply medicines via the internet and these licensed pharmacies can be identified by the display of the EU-wide logo. This logo can be found on the Ashtons Hospital Pharmacy website. It provides some reassurance for consumers, but additional safeguards to improve the safety and security of medicines will be introduced by the Falsified Medicines Directive (FMD), which will become incorporated into UK legalisation in February 2019.

Measures to protect patients include:

  • Medicines will have safety features, including a unique identifier and anti-tampering device
  • Additional responsibilities and requirements for manufacturers and wholesale distributors
  • Increased regulation in importing medicines

In order to fulfil the Falsified Medicines Directive requirements, hospitals and other healthcare organisations will need to ensure that they only obtain stock medicines directly from the licensed manufacturer or via a licensed wholesaler. The MHRA is responsible for licensing in the UK, and they publish a register of licensed wholesalers online, which can be found on their website.

Ashtons has an MHRA Wholesale Dealer’s Licence and can, therefore, supply stock medicines, providing customers with the reassurance of the new safeguards of the Falsified Medicines Directive.

One of the main features of the MD regulations is the unique identifier, which consists of a 2D barcode, which will be printed on all medicines produced after February 2019. Each individual pack of medicine will have its own identification code, which means that it will be traceable from the original manufacturer, through the supply chain to the hospital, if stock, or to the patient if it was dispensed by a pharmacy.

Pharmacies are also subject to the Falsified Medicines Directive regulations, and they too can only obtain their supplies from the licensed manufacturer or via a licensed wholesaler.

The unique identifier for every single pack of medicine will be recorded on a database by the manufacturer. As the products are distributed by wholesalers and dispensed by pharmacies, the packs will be verified to check they are authentic. At the point of dispensing, the pack of medicine will be ‘decommissioned”’which means that it cannot be dispensed to anyone else.

Healthcare staff should be vigilant about the threat of falsified medicines and be aware of the measures to prevent their use.


 

References

https://ec.europa.eu/health/human-use/falsified_medicines_en

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