Family Medicine & Primary Care Review

Full text

3/2026 vol. 28
Review paper
CONTINUOUS MEDICAL EDUCATION (CME)

Drug safety monitoring. Adverse events reporting in Poland – role of general practitioners

Michał Chrzanowski 1
,
Iwona Rościszewska-Żukowska 2, 3
,
Dagmara Mirowska-Guzel 4

  1. Polish Society of Pharmacovigilance, Warsaw, Poland

  2. Collegium Medicum, University of Rzeszow, Rzeszow, Poland

  3. Department of Neurology with Stroke Unit, St. Jadwiga Queen Clinical Hospital, Rzeszow, Poland

  4. Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland

Family Medicine & Primary Care Review 2026; 28(3): 343–347

DOI: https://doi.org/10.5114/fmpcr.2026.164667
Data publikacji online: 2026/09/29
Article file
16 FM&PCR 3 26 - CME - Chrzanowski - 1875 - Drug safety monitoring.pdf
  1. European Medicine Agency. Amsterdam (NL): EMA; c2025. EudraVigilance system overview; 2025. Available from URL: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-system-overview.
  2. Food and Drug Administration. Silver Spring (US): FDA; c2025.FDA’s Adverse Event Reporting System (FAERS); 2024 Aug 11. Available from URL: https://www.fda.gov/drugs/surveillance/fdas-adverse-event-reporting-system-faers.
  3. Uppsala Monitoring Centre. Uppsala (SE): UMC; c2025. About VigiBase; 2025. Available from URL: https://who-umc.org/vigibase.
  4. Ustawa z dnia 6 września 2001 r. – Prawo farmaceutyczne (Dz.U. z 2001 r. nr 126, poz. 1381 z późn. zm.) (in Polish).
  5. Ustawa z dnia 5 grudnia 1996 r. o zawodach lekarza i lekarza dentysty (Dz.U. z 1997 r. nr 28, poz. 152 z późn. zm.) (in Polish).
  6. Ustawa z dnia 15 lipca 2011 r. o zawodach pielęgniarki i położnej (Dz.U. z 2011 r. nr 174, poz. 1039 z późn. zm.) (in Polish).
  7. Ustawa z dnia 10 grudnia 2020 r. o zawodzie farmaceuty (Dz.U. z 2021 r. poz. 97 z późn. zm.) (in Polish).
  8. Ustawa z dnia 1 grudnia 2022 r. o zawodzie ratownika medycznego oraz samorządzie ratowników medycznych (Dz. U. z 2022 r. poz. 2705 z późn. zm.) (in Polish).
  9. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29(5): 385–396, doi: 10.2165/00002018-200629050-00003.
  10. Supreme Audit Office. Information on audit outcomes: Adverse drug reactions monitoring. Warsaw: SAO; 2020 Nov. Report No.: P/19/097. Available from URL: https://www.nik.gov.pl/kontrole/P/19/097/.
  11. Ustawa z dnia 5 grudnia 2008 r. o zapobieganiu oraz zwalczaniu zakażeń i chorób zakaźnych u ludzi (Dz.U. z 2008 r. nr 234 poz. 1570 z późn. zm.) (in Polish).
  12. European Parliament, Council of the European Union. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance. Directive 2001/83/EC on the Community code relating to medicinal products for human use. Brussel: European Parliament, Council of the European Union; 2011.
  13. European Parliament, Council of the European Union. Regulation No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use. Brussel: European Parliament, Council of the European Union; 2014.
  14. European Medicine Agency. Guideline on good pharmacovigilance practices (GVP) Annex I – Definitions. EMA/876333/2011 Rev 5. Amsterdam: European Medicines Agency; 2024.
  15. European Medicine Agency. Metoclopramide-containing medicines – referral. EMA/13239/2014 Corr. 1, London: European Medicines Agency; 2013.
  16. European Medicines Agency. European Medicines Agency confirms positive benefit-risk balance of topical formulations of ketoprofen. EMA/CHMP/465633/2010. London: European Medicines Agency; 2010.
  17. European Medicine Agency. Tetrazepam-containing medicines – referral. EMA/402567/2013 – Rev 1; London: European Medicines Agency; 2013.
  18. European Medicine Agency. Metamizole – direct healthcare professional communication (DHPC). Amsterdam: European Medicines Agency; 2020.
  19. European Medicine Agency. Pseudoephedrine – direct healthcare professional communication (DHPC). Amsterdam: European Medicines Agency; 2024.
  20. European Medicine Agency. Ozempic – direct healthcare professional communication (DHPC). Amsterdam: European Medicines Agency; 2023.
  21. European Medicine Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev 1. London: European Medicines Agency; 2017.
  22. European Medicine Agency. PRAC recommendations on signals. EMA/PRAC/222449/2024. Amsterdam: European Medicines Agency; 2024.
Copyright: © 2026 Family Medicine & Primary Care Review. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License (http://creativecommons.org/licenses/by-nc-sa/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
SUBMIT YOUR PAPER
Share
without publication fees
Coverage in
Integrated with
Editorial Policies
Sarajevo Declaration on Integrity and Visibility of Scholarly Publications