Background The Falsified Medicines Directive (FMD) and the Delegated Regulation (DR) 2016/161 will require, from 9 February 2019, hospital pharmacies to check the authenticity of each medicinal product they receive. Our hospital participates in a test with the National Medicines Verification Organisation to evaluate possible strategies, compatible with legislation, for the implementation of serialisation.
Purpose The aim of the first test is to evaluate the feasibility of decommissioning of each unique identifier at the reception of medicinal products in the pharmacy.
Material and methods During 14 days (summer 2018), the pharmacy technician scanned the data-matrix of each box received with an Optel certa tabletop (possibility of switching between vertical and handheld scanner). Quantitative indicators (number of boxes received, number of serialised drugs in circulation, products with a non-compliant data matrix) were recorded. The scanning time of each carton was measured and the equipment’s ergonomics evaluated.
Results During the study, the pharmacy received an average of 822 boxes/day (min: 273; max: 1737), of which 90% were in the scope of the FMD and the RD. The average scanning time per pack was 5 s, totalling an average of 56 minutes/day to scan all boxes. Only 3/530 medications displayed a serial number, while three of them (nicardipine, pemetrexed, midazolam) had a non-readable data-matrix (colour inversion) on their packaging and thus could not be scanned. The Optel certa tabletop and its software are considered easy to use. But the manoeuverability and malfunctions of the handheld scanner contributed to inflate the scanning time.
Conclusion This first test demonstrated the technical feasibility of decommissioning boxes on their reception in real working conditions. The connection to the National Medicines Verification System was not effective during the test, so the upload time between interfaces could not be evaluated. The imposing equipment leads to opting for mobile and compact scanning devices. Decommissioning at reception confronts us with repeated interruptions of tasks (deliveries, phone calls …) but avoids the storage of non-authentic and non-conforming boxes. A second decommissioning test just before dispensing to patients is planned to assess the feasibility of this scenario.
References and/or acknowledgements Falsified Medicines Directive.
Delegated Regulation 2016/161.
No conflict of interest.
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