Background and importance To prevent the introduction of falsified medical products into the supply chain, on 9 February 2019, the directive 2011/62/EU was applied. This legislation has allowed the implementation of measures to ensure authenticity and a high level of traceability, providing greater patient safety.
Aim and objectives To assess the impact of the implementation of the falsified medicines directive 6 months after introducing the new legislation.
Material and methods Elaboration of a form (MS-Excel) with the purpose of systematising the data was performed. Of all products prescribed between 18 and 27 September 2019, products not covered by the requirement of a unique identifier code were excluded. The following parameters were analysed: presence of the unique identifier code, start time and end of code scan, and appearance of problems with the scanning procedure.
Results A total of 201 products were analysed. About 69% of the products had a unique identifier code. Of the products intended to be dispensed for outpatients, only 70% had a unique identifier. After reading 10 935 packages, it was found that, on average, reading of 12.9% of the products with a unique identifier code had at least one scanning issue. The average time for reading a unique identifier code was 9.5 s (includes connecting the software, verifying the safety device, positioning the packaging for the scan read and waiting for scan read confirmation).
Conclusion and relevance Six months after introducing the counterfeit medicines directive, about 31% of the products received in the hospital pharmacy did not have a unique identifier code. This includes products for outpatients where scanning at dispensing could be a relevant added value. Reading time of the unique identifier code represents around 29 working hours in 8 working days, or 0.5 ETC (7 hour working day). Implementation of this directive required investments in software, material and human resources, and the internal work procedures were also reorganised. Direct advantages for patient care are not yet evident as the unique identifier is still not fully implemented.
References and/or acknowledgements Directive2011/61/EU of the European Parliament and of the Council from June 8, 2011, Official Journal of The EU.
No conflict of interest.
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