Hospital pharmacies: a weak link in EU falsified medicine plans?

A pilot study has found low compliance rates in hospital pharmacies on the verification of product codes on medicine packs.

The study was carried out in a large UK-based National Health Service teaching trust. Over a two-week period, pharmacists and dispensing technicians were asked to scan codes on around 4,200 test medicine packs, 4 per cent (180) of which were pre-programmed with a message to indicate they were expired, recalled or counterfeit, were dispensed to patients.

The pharmacists and technicians scanned around 80 per cent of the coded packs, meaning that one out of every five was not checked. Moreover, in some cases they failed to quarantine packs marked as being expired, recalled or counterfeit, even when faced with a pop-up message indicating action needed to be taken.

Overall, that gave an operational authentication rate (OAR) of 66 per cent, with only 32 per cent of counterfeit medicines, 58 per cent of recalled drugs and 64 per cent of expired medicines detected as a proportion of those entered into the study. The authors note the finding "poses significant quality and safety issues with this detection approach."

"In terms of medicines verification systems I believe this study is a bit of a wake-up call for policy makers and hospital managers," lead author Bernard Naughton of Keele University told SecuringIndustry.com.

To comply with the EU Falsified Medicines Directive, hospital and other pharmacies as well as public pharmacies will have to authenticate prescription drugs by means of an individual serial number from February 9, 2019.

This approach may be technically accurate but alterations to practice will be required, suggested Naughton. "The deadline for compliance is short and some NHS trusts may struggle to effectively implement this change if action is not taken well in advance of the February 2019 deadline," said Naughton.

The study investigated the effectiveness of medicines authentication technology, but did not provide any indication of the likely causes for why the dispensers/checkers failed to identify recalled, expired and potentially falsified medicines.

"Further studies are required to identify the reasons for less than absolute authentication and detection rates," said Naughton. Nevertheless, he suggested possible reasons could include staff compliance, which could have been influenced by the effectiveness of pop up alerts, technology management of change issues, organisational behavioural issues and human factors.

"My recommendations are for studies to be conducted which engage with healthcare professionals in an effort to understand their opinions and suggestions relating to the advancement of this technological approach," said Naughton.

It will also be important to engage with management of change experts, to promote effective and timely implementation of the new procedures.

The study has been published in the British Medical Journal.