Background The Directive 2011/62/EU (Falsified medicines directive, FMD) provides for measures to prevent the entry into the legal supply chain of falsified medicinal products and has been supplemented by the commission delegated regulation (EU) 2016/161. From February 2019 onwards prescription medicines are required to bear individual safety features that need to be verified and decommissioned by pharmacies before being supplied to the public. While this process has already been tested in some community pharmacies, little is known on the implications the FMD has on healthcare institutions.
Purpose Aim of the present study was to assess the impact of the implementation of the FMD in a university-based hospital pharmacy that currently provides medicines for approximately 2000 beds and prepares more than 55 000 chemotherapies per year.
Material and methods In order to simulate the ‘end-to-end’ verification as outlined by the directive, packs of prescription medicines were scanned at goods in and at several points of dispense within the pharmacy. The time required to process the respective number of drugs was measured and clustered for the individual product type.
Results A total of 1546 packs of 59 different medicinal products were assessed at goods in, which took a median of 2.1 s (0.6–6. 5 s) to process each single pack. However, some drugs such as iv-anaesthetics, iv-antibiotics and iv-painkillers, all of which were stored on pallets, required a significantly higher amount of time to verify. The simulation was repeated at four different points of dispense where 2056 packs of 811 different drugs were scanned. Here the amount of time required was not significantly different (median 2 s) from goods in but with a higher variation between the different products. Based on these data we extrapolated that the amount of time needed to process the 2.8 million packs of prescription drugs supplied by our pharmacy is more than 1,500 hours per year.
Conclusion Our study demonstrates that the implementation of the FMD in the hospital pharmacy is a major challenge. Compared with the community pharmacy, a much greater degree of planning, organisation and technical support is needed to cope with the decommissioning of large numbers of drugs.
References and/or Acknowledgements 1. FMD:https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf
2. Commission Delegated Regulation (EU) 2016/161: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf
No conflict of interest
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