Advertisement

International Journal of Clinical Pharmacy

, Volume 36, Issue 5, pp 859–862 | Cite as

Pharmacovigilance: empowering healthcare professionals and patients

  • Stephane Steurbaut
  • Yolande Hanssens
Commentary
First Online:

Abstract

The European Union has thoroughly reformed its pharmacovigilance legislation in July 2012. Despite the changes, underreporting of adverse drug reactions remains a concern. This underreporting seems to be partially associated with incorrect customs and beliefs by healthcare professionals. Therefore, strengthening teaching and training in drug safety monitoring and reporting are essential. Sustained campaigns and education on pharmacovigilance are key elements to enhance its performance and effectiveness. In general, all healthcare professionals as well as patients should be more sensitized and empowered to contribute to pharmacovigilance programmes in order to improve drug safety.

Keywords

Adverse drug reaction Drug safety Health care professional Patient Pharmacovigilance Spontaneous reporting 
This is a preview of subscription content, log in to check access.

Notes

Acknowledgments

We thank the European Society of Clinical Pharmacy (ESCP) for having supported the workshop “Adverse Drug Reactions—Applying Theory to Practice” at the 41st ESCP Symposium in October 2012. We are also grateful to the participants of the workshop for completing the survey.

Funding

None.

Conflicts of interest

None.

References

  1. 1.
    Anonymous. European medicines agency. New EU pharmacovigilance legislation—key concepts. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/07/WC500129593.pdf Accessed 16 Aug 2013.
  2. 2.
    Hazell L, Shakir SA. Under-reporting of adverse drug reactions : a systematic review. Drug Saf. 2006;29(5):385–96.PubMedCrossRefGoogle Scholar
  3. 3.
    Williams D, Feely J. Underreporting of adverse drug reactions: attitudes of Irish doctors. Ir J Med Sci. 1999;168(4):257–61.PubMedCrossRefGoogle Scholar
  4. 4.
    Irujo M, Beitia G, Bes-Rastrollo M, Figueiras A, Hernández-Díaz S, Lasheras B. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf. 2007;30(11):1073–82.PubMedCrossRefGoogle Scholar
  5. 5.
    Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Influence of pharmacists’ attitudes on adverse drug reaction reporting : a case-control study in Portugal. Drug Saf. 2006;29(4):331–40.PubMedCrossRefGoogle Scholar
  6. 6.
    Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19–31. doi: 10.2165/00002018-200932010-00002.PubMedCrossRefGoogle Scholar
  7. 7.
    González-Rubio F, Calderón-Larrañaga A, Poblador-Plou B, Navarro-Pemán C, López-Cabañas A, Prados-Torres A. Underreporting of recognized adverse drug reactions by primary care physicians: an exploratory study. Pharmacoepidemiol Drug Saf. 2011;20(12):1287–94. doi: 10.1002/pds.2172.PubMedCrossRefGoogle Scholar
  8. 8.
    Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, et al. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1–234. doi: 10.3310/hta15200.PubMedGoogle Scholar
  9. 9.
    van Hunsel F, Härmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35(1):45–60. doi: 10.2165/11594320-000000000-00000.PubMedCrossRefGoogle Scholar
  10. 10.
    Inch J, Watson MC, Anakwe-Umeh S. Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf. 2012;35(10):807–18. doi: 10.2165/11631650-000000000-00000.PubMedCrossRefGoogle Scholar
  11. 11.
    Rolfes L, Wilkes S, van Hunsel F, van Puijenbroek E, van Grootheest K. Important information regarding reporting of adverse drug reactions: a qualitative study. Int J Pharm Pract. 2013. doi: 10.1111/ijpp.12056.
  12. 12.
    Durrieu G, Palmaro A, Pourcel L, Caillet C, Faucher A, Jacquet A, et al. First French experience of ADR reporting by patients after a mass immunization campaign with Influenza A (H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals. Drug Saf. 2012;35(10):845–54. doi: 10.2165/11631800-000000000-00000.PubMedCrossRefGoogle Scholar
  13. 13.
    Leone R, Moretti U, D’Incau P, Conforti A, Magro L, Lora R, et al. Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study. Drug Saf. 2013;36(4):267–76. doi: 10.1007/s40264-013-0028-8.PubMedCrossRefGoogle Scholar
  14. 14.
    Marques J, Ribeiro-Vaz I, Pereira AC, Polónia J. A survey of spontaneous reporting of adverse drug reactions in 10 years of activity in a pharmacovigilance centre in Portugal. Int J Pharm Pract. 2014;22(4):275–82. doi: 10.1111/ijpp.12078.
  15. 15.
    Moore N. The past, present and perhaps future of pharmacovigilance: homage to Folke Sjoqvist. Eur J Clin Pharmacol. 2013;69(Suppl 1):33–41. doi: 10.1007/s00228-013-1486-8.PubMedCrossRefGoogle Scholar
  16. 16.
    Biagi C, Montanaro N, Buccellato E, Roberto G, Vaccheri A, Motola D. Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region). Eur J Clin Pharmacol. 2013;69(2):237–44. doi: 10.1007/s00228-012-1321-7.PubMedCrossRefGoogle Scholar
  17. 17.
    Gonzalez-Gonzalez C, Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Strategies to improve adverse drug reaction reporting: a critical and systematic review. Drug Saf. 2013;36(5):317–28. doi: 10.1007/s40264-013-0058-2.PubMedCrossRefGoogle Scholar
  18. 18.
    Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013;36(2):75–81. doi: 10.1007/s40264-012-0014-6.PubMedCrossRefPubMedCentralGoogle Scholar
  19. 19.
    White RW, Harpaz R, Shah NH, DuMouchel W, Horvitz E. Toward enhanced pharmacovigilance using patient-generated data on the internet. Clin Pharmacol Ther. 2014;96(2):239–46. doi: 10.1038/clpt.2014.77.
  20. 20.
    Pontes H, Clément M, Rollason V. Safety signal detection: the relevance of literature review. Drug Saf. 2014;37(7):471–9. doi: 10.1007/s40264-014-0180-9.PubMedCrossRefGoogle Scholar

Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014

Authors and Affiliations

  • Stephane Steurbaut
    • 1
  • Yolande Hanssens
    • 2
  1. 1.Department of Clinical Pharmacology and Pharmacotherapy, UZ Brussel and Faculty of Medicine and PharmacyVrije Universiteit BrusselJette, BrusselsBelgium
  2. 2.Department of PharmacyHamad General HospitalDohaQatar

Personalised recommendations

Cite article

Buy options