Pharmacists' views on the impact of the Falsified Medicines Directive on community pharmacies: A cross-sectional survey

BACKGROUND: The Falsified Medicines Directive (FMD) was implemented to minimise the circulation of falsified medicines in the legal pharmaceutical supply chain. Whilst pharmacists are involved in the final step of the FMD requirements with the decommissioning of medicines at the point of supply to patients, limited research has been conducted to investigate the impact of fulfilling these requirements on the relevant stakeholders. OBJECTIVE: To examine community pharmacists' views on how the FMD has affected their practice. METHODS: An online survey was disseminated via email in June 2020 to pharmacists in Ireland (n = 4727), who were invited to participate if practising full time or part time in community pharmacies. Quantitative data were captured through multiple option and Likert-scale questions, and analysed using descriptive and inferential statistics. Qualitative data were captured by use of a free-text box, with the open comments analysed thematically. RESULTS: In total, 618 valid responses were received (13.1% response rate). Most perceived that FMD requirements increased waiting times for patients (82%) and reduced time interacting with patients (65%). Only 28% agreed/strongly agreed that the introduction of the FMD legislation improves patient safety. In the open comments, the need for medicine authentication was acknowledged, but it was believed that this should be the wholesalers' responsibility, not pharmacists' responsibility. The additional step of medicines decommissioning was viewed as a time-consuming distraction to clinical checks that increased the risk for error. Pharmacists complained that they were not remunerated for the lost staff productivity or the additional software and equipment costs. Many pharmacists felt that the increased workload was disproportionate to the small risk of patients receiving falsified medicines. CONCLUSIONS: Key stakeholder engagement is required to optimise the implementation and integration of the FMD procedures into community pharmacy practice with minimal impact on dispensing and without compromising patient care.