2SPD-008 Five years of the falsified medicines directive: a comparative analysis of compliance and impact in hospital pharmacy
Year: 2025
Type: conference-paper
Abstract: Background and Importance The Falsified Medicines Directive (2011/62/EU) (FMD), effective since 9 February 2019, establishes regulations to prevent falsified medicines from entering the legal supply chain. It ensures authenticity and traceability, providing greater patient safety. While the FMD provides valuable monitoring data, incomplete implementation impairs its full effectiveness. Aim and Objectives To verify compliance with the FMD 5 years after its implementation and to compare the impacts in hospital pharmacy 6 months after the initial implementation. Material and Methods Products received between 21 to 30 August 2024, were analysed using MS-Excel and compared with products received from 18 to 27 September 2019. Products not requiring a Unique Identifier Code (UIC) were excluded. The parameters analysed included the presence of a UIC, existence of an anti-tampering device (ATD), the timing of code scans, the quantity received, and any issues encountered with reading/scanning. Results A comparative analysis of 163 products in 2024 (10611 packages) versus 201 products in 2019 (10935 packages) revealed that in 2024, 100% of products had a UIC, a significant improvement from 69% in 2019. Reading issues decreased to 1.9% in 2024 compared to 12.9% in 2019. The average UIC reading time reduced from 9.5 seconds in 2019 to 8.57 seconds in 2024 (including connecting software, verifying safety devices, positioning the package for scanning, and waiting for confirmation). In 2024, 99.5% of products had an ATD. Conclusion and Relevance The analysis reveals a substantial improvement in compliance with the FMD, as evidenced by the increase in UIC implementation and the high rate of ATD presence, reflecting progress in enhancing patient safety. This includes outpatient products, where scanning at the point of dispensing could provide additional benefits, such as improved pharmacovigilance and pharmacoepidemiology. The reduction in scan issues and faster reading times are likely due to technological advancements and improved operational processes. However, challenges remain, including the time required for verifying safety features, which totals 25 hours over 8 working days (0.45 ETC), and ensuring the directive’s full benefits for patient care, particularly in a limited number of countries, low level of connection of hospital pharmacies. Addressing these issues will be crucial in realising the FMD’s potential for improved patient care. References and/or Acknowledgements Directive 2011/61/EU Report, Brussels, 4.7.2024 Conflict of Interest No conflict of interest
Authors: AC Franco, R Marques
Institution: Instituto Português de Oncologia Francisco Gentil
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408376309