Piotr Merks, Mariola Drozd, Urszula Relgioni

Introduction of Good Practices of Drug Verification (DPWL) in hospital practice in Poland in order to protect against counterfeit drugs and improve patient safety
2020-09-28

The phenomenon of counterfeit medicines is common in healthcare systems around the world, making it a global problem. The number of recorded cases of falsified drugs available on the market is increasing every year. The World Health Organization indicates that up to 10% of the drugs in the global market are falsified. In Internet trading, this percentage reaches even 50%. Counterfeit medicines pose a serious threat to human health and life. The Delegated Regulation, which started the implementation of the Falsified Medicines Directive (FMD) published in 2016, was an essential step in the field of patient safety in Europe. Hospital pharmacies in Europe had three years to prepare to start the drug authentication process (the deadline for compliance with the requirements of the European Directive was February 2019).

Although the Falsified Medicines Directive affects many groups of healthcare stakeholders, some of them still do not comply with the introduced rules. As a result of FMD, the vast majority of prescription drugs, as well as some over-the-counter (OTC) drugs, will require authentication. The Directive stipulates that each legal medicinal product must have a unique code and a tamper-evident label, which protects the drug against an unauthorized opening, which will enable the authentication of each drug package at the time of its release. The Falsified Medicines Directive offers a real opportunity to reduce this risk and optimize healthcare services, also by optimizing the workflow of pharmacies and supporting patients to comply with medical recommendations. A necessary step to ensure these benefits and achieve compliance with the FMD is the development and regular review of Good Authentication Practice guidelines.

The article aims to present the impact of the Falsified Medicines Directive on the operation of a hospital pharmacy, including the additional obligations imposed by this Directive on pharmacists. The main goal of the article is also to present Good Medicine Authentication Practice (GMAP), which will be a practical guide for pharmacy employees in the field of drug authentication.

Keywords: hospital pharmacy, patient safety, Falsified Medicines Directive.

© Farm Pol, 2020, 76 (8): 467–472