Hospital Audit as a Useful Tool in the Process of Introducing Falsified Medicines Directive (FMD) into Hospital Pharmacy Settings—A Pilot Study

Abstract

Background: Recently, the European Union has introduced the Falsified Medicines Directive (FMD). Additionally, in early 2016, a Delegated Act (DA) related to the FMD was published. The main objective of this study was to evaluate the usefulness of external audits in the context of implementing new regulations provided by the FMD in the secondary care environment. Methods: The external, in-person workflow audits were performed by an authentication company in three Polish hospital pharmacies. Each audit consisted of a combination of supervision (non-participant observation), secondary data analysis, and expert interviews with the use of an independently designed authorial Diagnostic Questionnaire. The questionnaire included information about hospital drug distribution procedures, data concerning drug usage, IT systems, medication order systems, the processes of medication dispensing, and the preparation and administration of hazardous drugs. Data analysis included a thorough examination of hospital documentation in regard to drug management. All data were subjected to qualitative analysis, with the aim of generating meaningful information through inductive inference. Results: Only one dispensing location in the Polish hospitals studied has the potential to be a primary authentication area. In the audited hospitals, an Automated Drug Dispensing System and unit dose were not identified during the study. Hospital wards contained an enclosed place within the department dedicated to drug storage under the direct supervision of senior nursing staff. An electronic order system was not available. In the largest center, unused medications are re-dispensed to different hospital departments, or may be sold to various institutions. Additionally, in one hospital pharmacy, pharmacists prepared parenteral nutrition and chemotherapeutic drugs for patients admitted to the hospital. Conclusions: External audits might prove beneficial in the course of introducing new regulations into everyday settings. However, such action should be provided before the final implementation of authentication services. To sum up, FMD can impact several hospital departments.

Implementation and Evaluation of a Medicines Authentication System in a German Secondary Care Environment

“…The study was based on real-life dispensing scenarios identified in hospital pharmacies before the implementation of FMD. Methods (questionnaire and direct assessment) and the results of some of these assessments were published previously (12)(13)(14). All possible workflows were mapped and the implementation of the FMD requirements was studied to offer the best utilization of benefits of the FMD compliance.…”

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“…The hospital pharmacy supplies all regional hospitals in the Austrian Tirol, 16 hospitals, so it works as a centralized hub for the region. The hospitals that are supplied do not have a hospital pharmacy [ 19 ].…”

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“…Human resources need to deal with the possible costs of hiring new staff and the necessary training if they are not qualified to dispense medication. Other studies refer to the possibility of increasing the number of staff because of the implementation of the FMD [ 19 ].…”

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