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The Falsified Medicines Directive (FMD) pilot: Medicine authentication technology in a hospital setting

From 19 February 2019, the vast majority of prescription-only medicines supplied to the public throughout Europe will require authentication, largely at the point of supply to the patient. For the unprepared, this will be of major concern. But what is authentication? How does it work and how will hospitals manage?

Authentication technologies work through the scanning of a two-dimensional barcode printed onto a medicine packet. The data from this barcode is then cross checked against a national database to establish if this is a genuine medicine which is not expired, recalled, stolen, substandard or potentially counterfeit.

The authentication of medicine has been occurring in community pharmacies in Greece, Italy and Belgium for the past number of years with apparent success. But what will happen in a hospital environment? Medicines authentication technology has been piloted in a UK hospital to further understand this scenario.

This pilot revealed that medicines authentication technology was capable of an average response rate (the time it takes to read a code send it to a national database and return relevant information) confidently below the FMD limit of 300ms and a technical detection rate of 100%.

The major issues associated with this technological approach appear to be the management of staff compliance with medicine authentication and the interpretation of prompts from the technology.

Introducing a new technology and process such as medicines authentication into a busy hospital dispensary may not be straightforward.

A recent hospital pilot conducted in Oxfordshire and published in BMJ Open observed that just 66% of medicines which required authentication were authenticated and as a result the detection of expired, recalled and potentially counterfeit medicines was low.

Of the medicines entered into the study with a 2D code generating an alert, 31.8% of counterfeit medicines, 58% of recalled medicines and 64% of expired medicines were detected.

The lower rate of counterfeit medicines detected appears to be an issue which relates to the similarity of two pop-ups, one of which required quarantine and one of which did not.

The companies developing authentication technology solutions will not have an in-depth knowledge of how hospital dispensaries operate, so there will inevitably be alterations necessary to fit these technologies into the hospital setting.

The biggest issue is likely to be staff education and training and therefore staff buy-in and compliance. When staff are over-stretched, they often prioritise what they deem to be most important, if medicine authentication is not rated highly on staff priorities it is likely to result in expired, recalled, substandard and potentially counterfeit medicines reaching patients via legitimate hospital dispensaries.

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