Abstract
Medicine counterfeiting and its impact on patient safety is an emerging healthcare problem with an estimated annual prevalence of 0,005% (1,5 million packs) in the European legal drug supply chain. The aim of the Falsified Medicines Directive 2011/62/EU (FMD) is to prevent the entry of illegitimate medicines into the legal supply chain. There is, however, a relative lack of in-depth assessments of cost implications for hospital pharmacies. This study aims to evaluate the financial burden of FMD on Hungarian hospitals. Based on literature review and interviews with hospital pharmacy experts, a 37-question data collection form was developed to evaluate the implementation process before February 2019 and for the following stabilization period. Institutional data, infrastructural and IT developments and procedures related to authentication (verification and decommissioning) were evaluated in 3 large hospitals (900-1500 beds). Data collection started from February 2019. Authentication was performed upon shipment receipt. The average number of medication packs processed by the pharmacies was approximately 50 000 packs/month, of which on average 9 864 packs (ranging from 3 930 to 15 442) were FMD-compliant. That ratio is expected to increase over time. As human resource requirement, the added workload required 1 FTE pharmacy technician, with an estimated 7 719,23 € annual cost (ranging from 4138,77 € to 12 640,35 €). Initial one-off infrastructure and IT development costs were 2526,73 € (ranging from 77,99 € to 1 434,93 €). Our results illustrate that FMD may have a significant financial impact on hospital pharmacies. The findings of this study might offer a better understanding of influencing factors of FMD implementation in hospitals contributing to an optimized cost estimation methodology.
Published Version
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