New European regulations mean that all prescription medicines will need to carry a barcode on their packaging to reduce the risk of counterfeit and unsafe drugs entering the healthcare system.
Earlier this month, the European Commission formally adopted the delegated act on safety features for medicinal products for human use, which implements some of the requirements of the Falsified Medicines Directive – legislation that came into force in January 2013 to ensure the safety of medicines.
One of the measures of the Falsified Medicines Directive when it was passed was an “obligatory authenticity feature on the outer packaging of the medicines” that would be decided at a later stage via a delegated act.
This delegated act was published in August and has now been adopted by the EC. It includes several features, such as a requirement for prescription medicines and some over-the-counter drugs to carry a 2D barcode as a unique product identifier containing the product code, a serial number, the national reimbursement number (if requested), the batch number and the expiry date of the drug.
There should also be an “end-to-end verification system supplemented by risk-based verifications by wholesalers” in order to verify the unique identifier of the medicine when it is dispensed.
The rule means that all NHS and other healthcare sites in the UK that dispense medicines will have to install an identification system to scan the barcodes by the time the act comes into force. This is likely to be late 2018 or early 2019, three years after it is published in the Official Journal of the European Union.
Mark De Simone is chief executive of Aegate, which markets authentication technology for medicines across Europe.
He told Digital Health News that these new rules were “probably the most important change to the medicine supply chain in the past 30 to 40 years”.
Regarding the frontline of healthcare, De Simone said the impact of the regulation will be relatively simple for community pharmacies in the UK as the new software needed could be integrated into existing patient medication record software already installed to record prescriptions.
Instead, the main issue for these community pharmacies is the scanners needed to authenticate medicines and who will pay for them, said De Simone.
He added that the new regulations mean that big chains will no longer be able to use centralised dispensaries to manage medications, meaning that all dispensing processes will have to be localised.
“You cannot dispense some place and ship it some other place to give it to customer because there could be tampering.”
The biggest challenge will be in hospitals where the dispensing of medicines is more complicated, said De Simone.
Issues that need to be considered include the larger number of software packages that any system will need to integrate with; the variation in how automated each hospital pharmacy is; the different types of people medicines are dispensed to (patients, doctors, nurses etc); and the cost of the more expensive medicines.
De Simone said that Aegate has done some work in this area at Oxford University Hospitals NHS Trust and has been able to develop a document for good authentication practice.
Aegate also has experience using its technology in healthcare systems in Belgium, Greece and Italy where there are existing rules in place to verify medicines.
De Simone said that Aegate had helped prevent counterfeit and other illicit medicines reaching patients.
He gave the example of a medicine that had been recalled for safety reasons being picked up by a scanner in a pharmacy just ten minutes after it the information had been entered into the central system
The delegate act comes includes a transition period that means medicines without a barcode that are produced before the act comes into force can be used until they expire.