Models of implementation of the falsified medicines directive in different dispensing scenarios

Abstract

To minimize the burden and maximize the benefits of the Falsified Medicines Directive implementation in the setting of hospital pharmacy, an assessment of European hospital pharmacies aiming to map workflows of medicines dispensation was used. Different dispensation models were analyzed, aiming for the best implementation of the directive requirements. The location of verification and decommissioning steps in different scenarios were defined. Reference models were designed, and possible variances were discussed. Workflow analysis was carried out and eight different dispensing scenarios have been identified: manual, unitdose, compounding, robotic, electronic cabinet, robotic compounding and unit-dose, and conveyor belt. Minimum one verification and decommissioning steps were necessary to maintain up-to-date information about identified packages of medicines. The use of automated systems increases the number of verifications. Models proposed support stakeholder compliance with the directive and increased patient safety by providing up-todate information about product dispensed in basic and advanced models of hospital pharmacy operations.