ABSTRACT
OBJECTIVES, SETTING AND PARTICIPANTS: In July 2011, the EU adopted the Falsified Medicines Directive (FMD) primarily aiming to prevent the infiltration of falsified medicines into the legitimate supply chain. Our aim was to measure the cost elements of FMD implementation and operation using an internationally adaptable tool among Hungarian hospital pharmacies. DESIGN: A 41-item questionnaire was developed to evaluate the implementation process and associated cost consequences leading up to February 2019, and the stabilisation period. RESULTS: Our representative data are supported by the high response rate, as 44.8% of the Hungarian hospital pharmacies have completed the survey. Human resource requirements related to decommissioning activities were measured as working hours and were expressed in full time equivalent (FTE). We have found an increased workload with extra 0.25 pharmacist and 0.75 technician FTE/institution at the end of the stabilisation period. The entire infrastructural and IT implementation costs were determined as 2173, on average (SD: 3366) and the median was 1506 (range: 0-20 723). The total IT investment cost per institution was valued at 1410 (SD: 335). We identified a positive correlation (R=0.663) in consideration of the costs, the number of beds and the number of hospital locations with a multivariate linear regression model. At the time of our survey, 76.7% of the respondents experienced drug shortages, 58.1% reported suspected increase in drug costs regarding serialised medications, and 53.5% noticed an increase in packaging size. CONCLUSIONS: Notably, our research is the first complex study depicting FMD cost implications in the hospital pharmacy sector in Central Europe, indicating decommissioning significantly impacted workflow referencing human resources and IT.
