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The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists
  1. Piotr Merks1,
  2. Damian Swieczkowski1,2,
  3. Michal Byliniak3,
  4. Mariola Drozd4,
  5. Katarzyna Krupa5,
  6. Milosz Jaguszewski2,
  7. David A Brindley6,7,8,9,10,11,
  8. Bernard D Naughton6,12,13
  1. 1Department of Pharmaceutical Technology, Faculty of Pharmacy, Ludwig Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń, Toruń, Poland
  2. 2First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
  3. 3Regional Pharmaceutical Chamber, Warsaw, Poland
  4. 4Department of Applied Pharmacy, Medical University of Lublin, Lublin, Poland
  5. 5Tokarski-Olszewski Law Firm, Warsaw, Poland
  6. 6Said Business School, University of Oxford, Oxford, UK
  7. 7Department of Paediatrics, The University of Oxford, Oxford, UK
  8. 8The Oxford—UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), The University of Oxford, Oxford, UK
  9. 9Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, UK
  10. 10Harvard Stem Cell Institute, Cambridge, Massachusetts, USA
  11. 11USCF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), USA
  12. 12Oxford University Hospitals NHS Trust, Oxford, UK
  13. 13Institute of Science and Technology in Medicine, Keele University, Stoke-on-Trent, UK
  1. Correspondence to Damian Świeczkowski, Department of Pharmaceutical Technology, Faculty of Pharmacy, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun with its registered office in Bydgoszcz, at Jagiellonska 13–15 Street, Bydgoszcz 85-067, Poland; d.swieczkowski{at}o2.pl

Abstract

By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD.

  • PUBLIC HEALTH
  • Counterfeit Drugs
  • Pharmacy Legislation
  • Pharmaceutical care
  • Pharmacy Service

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