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International Journal of Clinical Pharmacy

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01-10-2014 | Commentary

Pharmacovigilance: empowering healthcare professionals and patients

Authors: Stephane Steurbaut, Yolande Hanssens

Published in: International Journal of Clinical Pharmacy | Issue 5/2014

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.

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.

Hazell L, Shakir SA. Under-reporting of adverse drug reactions : a systematic review. Drug Saf. 2006;29(5):385–96.PubMedCrossRef

Williams D, Feely J. Underreporting of adverse drug reactions: attitudes of Irish doctors. Ir J Med Sci. 1999;168(4):257–61.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMed

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.PubMedCrossRef

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.PubMedCrossRef

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.

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.PubMedCrossRef

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.PubMedCrossRef

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.

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRefPubMedCentral

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.

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.PubMedCrossRef

Title: Pharmacovigilance: empowering healthcare professionals and patients
Authors: Stephane Steurbaut
Yolande Hanssens
Publication date: 01-10-2014
Publisher: Springer Netherlands
Published in: International Journal of Clinical Pharmacy / Issue 5/2014
Print ISSN: 2210-7703
Electronic ISSN: 2210-7711
DOI: https://doi.org/10.1007/s11096-014-0004-0

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