QIPP, Efficiency & Savings


GS1 standards: a weapon against counterfeit drugs

Source: NHE Jul/Aug 2017

Glen Hodgson, head of healthcare at GS1 UK, explores the rising problem of counterfeit drugs and the legislation being introduced to tackle it.

Counterfeit drugs are a global problem. World Health Organization data puts the sales of counterfeit drugs at over $75bn every year, with more than 50% of drugs sold online being falsified. And, in case you think this doesn’t affect us in the UK, the nation’s medicines regulator, the MHRA, seized over 12,000,000 fake or unlicensed products in the first half of last year and they’ve shut down more than 2,000 online pharmacies. You also probably know someone who is vulnerable – one in eight British people, aged between 18-30, have said they’re likely to buy diet pills online in the next 12 months. 

As you’d expect, countries all over the world are doing their best to combat this and legislation around labelling requirements for medicines is establishing how best to win the battle. The key focus for regulators is the need to identify and trace pharmaceutical products, so that we know the medicine is what it says it is and can see exactly where it has come from. More specifically in Europe, this has taken the form of the Falsified Medicines Directive (FMD), which requires a unique identifier to be placed on all medical products. And if you’re wondering about Brexit, the legislation comes into effect in February 2019 so we’ll need to be compliant at that point. But realistically, similar legislation is being brought in around the world so there’s no reason to think an independent UK wouldn’t need to keep up. 

How standards make a difference 

The FMD asks for all manufacturers of pharmaceuticals to put a two-dimensional barcode on the packaging of all products. This identifies the product, expiry date, batch number and serial number, and must appear in ‘human readable format’ too. It’s here that GS1 standards make the difference – the GS1 2D DataMatrix was chosen by the European Federation of Pharmaceutical Industries and Associations as its data carrier of choice, because of the need for globally unique codes to identify and authenticate these products. 

GS1 standards bring the interoperability and means that manufacturers, suppliers, pharmacies and hospitals are all speaking the same language, using the same standards, and ensuring that they can work across markets, stakeholders and sectors. It’s why the Department of Health has mandated the use of our standards in all acute trusts in England – to uniquely identify every person, product and place. And it’s another reason for suppliers to the NHS to become GS1-compliant as it will be written into their NHS contracts that they need to be so.

These changes represent an enormous change for pharmacy practice – but they also provide a fantastic opportunity for improving safety. They guarantee that every pack of medicine can be checked and verified at every stage of the supply chain. And in the case of a product recall, a product can be identified down to the individual packet, so healthcare professionals can know where drugs have come from, who has administered them and who they’ve come into contact with. The standards are a weapon against counterfeiting because they stop falsified medicines from even getting that far – they’re checked and verified at every point along the way.

These standards are already embedded in the retail sector, they’ve been using them for over 40 years. And the accurate data this brings benefits everyone, making for a more efficient and effective supply chain. The level of traceability we find in retail is what we’re now aiming for in healthcare, giving the healthcare system a common foundation for enhancing care delivery and ensuring patient safety.


W: www.gs1uk.org/healthcare


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