Display options
Cite
Merks P, Swieczkowski D, Byliniak M, et al. The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists. Eur J Hosp Pharm. 2016;25(1):10-15doi: 10.1136/ejhpharm-2016-000970.
Merks, P., Swieczkowski, D., Byliniak, M., Drozd, M., Krupa, K., Jaguszewski, M., Brindley, D. A., & Naughton, B. D. (2018). The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists. European journal of hospital pharmacy : science and practice, 25(1), 10-15. https://doi.org/10.1136/ejhpharm-2016-000970
Merks, Piotr, et al. "The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists." European journal of hospital pharmacy : science and practice vol. 25,1 (2018): 10-15. doi: https://doi.org/10.1136/ejhpharm-2016-000970
Merks P, Swieczkowski D, Byliniak M, Drozd M, Krupa K, Jaguszewski M, Brindley DA, Naughton BD. The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists. Eur J Hosp Pharm. 2018 Jan;25(1):10-15. doi: 10.1136/ejhpharm-2016-000970. Epub 2016 Jul 27. PMID: 29445453; PMCID: PMC5750370.
Copy Download .nbib Format: NLM
Share it on

Eur J Hosp Pharm. 2018 Jan;25(1):10-15. doi: 10.1136/ejhpharm-2016-000970. Epub 2016 Jul 27.

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists.

European journal of hospital pharmacy : science and practice

Piotr Merks, Damian Swieczkowski, Michal Byliniak, Mariola Drozd, Katarzyna Krupa, Milosz Jaguszewski, David A Brindley, Bernard D Naughton

Affiliations

  1. Department of Pharmaceutical Technology, Faculty of Pharmacy, Ludwig Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toru?, Toru?, Poland.
  2. First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.
  3. Regional Pharmaceutical Chamber, Warsaw, Poland.
  4. Department of Applied Pharmacy, Medical University of Lublin, Lublin, Poland.
  5. Tokarski-Olszewski Law Firm, Warsaw, Poland.
  6. Said Business School, University of Oxford, Oxford, UK.
  7. Department of Paediatrics, The University of Oxford, Oxford, UK.
  8. The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), The University of Oxford, Oxford, UK.
  9. Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, UK.
  10. Harvard Stem Cell Institute, Cambridge, Massachusetts, USA.
  11. USCF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), USA.
  12. Oxford University Hospitals NHS Trust, Oxford, UK.
  13. Institute of Science and Technology in Medicine, Keele University, Stoke-on-Trent, UK.

PMID: 29445453 PMCID: PMC5750370 DOI: 10.1136/ejhpharm-2016-000970

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.

Keywords: Counterfeit Drugs; PUBLIC HEALTH; Pharmaceutical care; Pharmacy Legislation; Pharmacy Service

Conflict of interest statement

Competing interests: It must be emphasised that this publication was created purely for practice and academic interest and must not be construed in any way as an investment recommendation. PM is a res

References

  1. BMJ. 2012 Dec 20;345:e8356 - PubMed
  2. J Generic Med. 2014 Sep;11(3-4):169-172 - PubMed
  3. J Clin Nurs. 2013 Feb;22(3-4):559-68 - PubMed
  4. Bull World Health Organ. 2010 Apr;88(4):247-8 - PubMed
  5. Cent Eur J Public Health. 2012 Dec;20(4):276-81 - PubMed
  6. Eur J Hosp Pharm Sci Pract. 2016 Mar;23(2):118-120 - PubMed
  7. Int J Risk Saf Med. 2015;27 Suppl 1:S37-40 - PubMed
  8. Rocz Panstw Zakl Hig. 2010;61(3):227-35 - PubMed

Publication Types