Effect of An Educational Intervention to Improve Adverse Drug Reaction Reporting in Physicians: A Cluster Randomized Controlled Trial
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The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs).
To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system.
A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches—one active (group sessions), the other passive (educational material, reporting form)—implemented from November 2007 to December 2008, with a follow-up period of 8 months.
Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2–153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46–3.68) and 1.04 (95 % CI: 0.61–1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19–3.55).
Pharmacovigilance educational interventions that have proved effective can be successfully applied in different geographical areas. A high baseline notification rate could account for the educational program having a moderate effect.
KeywordsEducational Intervention Reporting Rate Conditional Logistic Regression Model Primary Healthcare Center High Reporting Rate
The authors would like to thank the Northern Pharmacovigilance Centre, in Portugal, for supplying the data for the year 2003; all the medical practitioners who took part in the intervention; and Michael Benedict for his help with the English version of this paper. Prof. Dr. Adolfo Figueiras’ work on this project was in part funded by the Health Research Fund (Fondo de Investigación Sanitaria) grants PI 081239, PI09/90609 from the Spanish Ministry of Health.
Elena Lopez-Gonzalez, Maria T. Herdeiro, María Piñeiro-Lamas, and Adolfo Figueiras have no conflicts of interest that are directly relevant to the content of this study.
- 1.Bahri P, Arlett P. Regulatory pharmacovigilance in the European Union. In: Andrews EB, Moore N, editors. Mann’s pharmacovigilance, p. 173. London: Wiley; 2014.Google Scholar
- 3.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. Off J Eur Union. 2010; L 348:74–99.Google Scholar
- 8.Lindquist M. The WHO Global ICSR database system: basic facts. Drug Inf J. 2008;42:409–19.Google Scholar
- 9.The Uppsala Monitoring Centre: reporting trends. http://www.who-umc.org/DynPage.aspx?id=108476&mn1=7347&mn2=7252&mn3=7322&mn4=7558. Accessed 1st Feb 2013.
- 14.StataCorp. Stata statistical software: release 13.1. College Station: StataCorp LP; 2013.Google Scholar
- 15.Thomson O’Brien MA, Freemantle N, Oxman AD, Wolf F, Davis DA, Herrin J. Continuing education meetings and workshops: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2001;2:CD003030. doi: 10.1002/14651858.CD003030.
- 21.Bracchi RC, Houghton J, Woods FJ, Thomas S, Smail SA, Routledge PA. A distance-learning programme in pharmacovigilance linked to educational credits is associated with improved reporting of suspected adverse drug reactions via the UK yellow card scheme. Br J Clin Pharmacol. 2005;60(2):221–3. doi: 10.1111/j.1365-2125.2005.02419.x.CrossRefPubMedCentralPubMedGoogle Scholar
- 23.Gony M, Badie K, Sommet A, Jacquot J, Baudrin D, Gauthier P, et al. Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrenees region (PharmacoMIP) network 2-year pilot study. Drug Saf. 2010;33(5):409–16. doi: 10.2165/11319170-000000000-00000.CrossRefPubMedGoogle Scholar
- 25.Consellería de Sanidade. Sistema Sanitario de Galicia. Memoria 2006. Santiago de Compostela (Spain): Xunta de Galicia, 2008. www.sergas.es. Accessed 26 June 2014.
- 27.Forsetlund L, Bjorndal A, Rashidian A, Jamtvedt G, O’Brien MA, Wolf F et al. Continuing education meetings and workshops: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2009;2:CD003030. doi: 10.1002/14651858.CD003030.pub2.