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Falsified medicines directive: A great opportunity for improving patient safety

Glen Hodgson, head of healthcare at GS1 UK, explains how the implementation of the Falsified Medicines Directive (FMD) will mean enormous changes to pharmacy practices.

The World Health Organisation (WHO) estimates that 1% of all medicines in the developed world are counterfeit. That percentage goes even higher on a global scale – reaching 10%. 

The Association of the British Pharmaceutical Industry (ABPI) reported that in about 2,500 cases, EU customs seized 27.4 million doses of falsified medicines at EU borders – and that was just in 2011. This is an almost seven-fold increase compared to 2007. 

Also, in May 2014 in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) had seized £8.6m worth of counterfeit and unlicensed medicines from illegal drug traders, and discovered fraudsters are infiltrating the NHS drugs supply chain and are diverting medicines to street drug dealers and illegal websites. 

These numbers show just how big the problem of falsified medicines is. 

But many chief pharmacists don’t really think that falsified medicines is a problem that directly affects them, even though recent EU legislation, including the FMD and statistics, suggest otherwise. The number of defective medicines reported by the MHRA increased 10-fold from five in 2001 to 50 in 2011. 

What exactly is the FMD? 

FMD legislation is a way of tackling the falsified medicines problem. It’s part of the bigger picture of bringing standards to healthcare, in the NHS and across the globe. 

FMD is supplemented by the Delegated Regulation (EU2016/161) from the European Parliament and Council. It introduces two mandatory safety features that allow all medicines to be verified and authenticated. It will need to be on the packaging of all medicines by 9 February 2019. 

The two mandatory safety features are:

1. A unique identifier, which must be placed on all medical products that can be verified and authenticated at any point in the supply chain, by scanning it using a barcode reader 

The legislation requires the unique identifier to: 

• Be applied to every pack of medicine at point of manufacture by the marketing authorisation holder
• Be coded into a 2D data matrix using GS1 or IFA/PPN standards – sometimes known as a 2D barcode – and also as human-readable information
• Relate to the product type and other specific information, such as batch number and expiry date
• Be uploaded to a data repository by the marketing authorisation holder (including distributors who repackage goods) – then before the medicine is dispensed, the pharmacy or hospital must verify medicine’s authenticity by checking it against the data repository 

2. An anti-tampering device (security seal), which must be on the pack 

How will FMD affect hospital pharmacy practice? 

FMD will mean the introduction of new processes for hospital pharmacies. When the manufacturer produces a product, they will assign unique identifiers to every pack of medicine and these identifiers will be uploaded to a central data repository. They then sell them via the distribution network through to the pharmacy. The wholesaler can check the identifiers against the central database, while, at point of dispensing, the pharmacist decommissions the pack. 

All this checking and verification of products, at various stages of the supply chain, mean that nobody else can reuse or falsify that product. This gives us the assurance that FMD aims at and brings great benefits to pharmacies. These checks improve safety for the patients. Simply put, when a nurse needs to administer any kind of medication, they can check and be confident that the one they’re giving the patient is indeed the right one. 

It’s an enormous change. FMD will help prevent the entry of falsified medicines into the legal supply chain. The way that pharmacies manage and dispense medicines will change and they’ll be required to scan and check each and every product package against a central database. 

But it also provides a great opportunity – an opportunity to not only improve patient safety, but also service efficiency and cost. 

It impacts every stage of the supply chain and administration, but this means that they will all become more efficient and, therefore, more cost effective.

The opportunity beyond patient safety 

Whether you’re a pharmaceutical manufacturer, distributer or pharmacy, there are significant benefits to your business in uniquely identifying every product pack, and then capturing and sharing this along its pathway – all the way to the patient. 

These benefits go beyond simply complying with FMD. There are the benefits and cost savings in operational efficiencies. Think about being able to automatically validate expiry dates – preventing the use or sale of out-of-date medicines. Or being able to easily identify and locate every product when a safety recall is issued, even when the product has reached the patient. 

This is all part of the standardisation process that is happening in healthcare. The 2014 eProcurement strategy includes a mandate that means any service or product procured by an NHS acute trust in England must be compliant with GS1 standards. 

GS1 standards can give every trust control over their supply chain, saving money and helping eliminate wastage. Trusts can uniquely identify every patient, every prescription and every dispensing. This allows for complete traceability and true interoperability between people and systems. The recent Carter Report clearly states that investment in digital platforms, improved staff organisation and a better approach to purchasing can make a significant difference to the way the NHS in England operates and could result in savings of up to £5bn per year. 

Medical devices are an integral part of this standardisation process, and it’s not just a UK or EU change in legislation that’s underway. In the US, the Food and Drug Administration (FDA) has established a Unique Device Identification (UDI) system for medical devices, which means that all devices entering the US healthcare supply chain must be identified with a UDI. GS1 standards conform to all US FDA requirements and can be used across the EU too. 

Going forward, all pharmaceutical companies will need to introduce new standards if they want to trade in the UK, EU and in the US. But they will do so knowing they will increase operational efficiencies and, more importantly, patient safety.

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