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Effect of An Educational Intervention to Improve Adverse Drug Reaction Reporting in Physicians: A Cluster Randomized Controlled Trial

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Abstract

Background

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).

Objectives

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.

Methods

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.

Results

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).

Conclusions

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.

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Acknowledgments

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.

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Authors and Affiliations

  1. Dto. de Medicina Preventiva y Salud Pública, Facultad de Medicina, University of Santiago de Compostela, c/San Francisco s/n, 15786, Santiago de Compostela (A Coruña), Spain

    Elena Lopez-Gonzalez & Adolfo Figueiras

  2. CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Rua Central de Gandra, 1317, 4585-116, Gandra, PRD, Portugal

    Maria T. Herdeiro

  3. Northern Pharmacovigilance Unit, Faculty of Medicine, University of Porto, Porto, Portugal

    Maria T. Herdeiro

  4. Consortium for Biomedical Research in Epidemiology and Public Health (CIBER en Epidemiología y Salud Pública- CIBERESP), Santiago de Compostela, Spain

    María Piñeiro-Lamas & Adolfo Figueiras

Authors
  1. Elena Lopez-Gonzalez
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  2. Maria T. Herdeiro
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  3. María Piñeiro-Lamas
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  4. Adolfo Figueiras
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On behalf of the GREPHEPI group

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Correspondence to Adolfo Figueiras.

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Lopez-Gonzalez, E., Herdeiro, M.T., Piñeiro-Lamas, M. et al. Effect of An Educational Intervention to Improve Adverse Drug Reaction Reporting in Physicians: A Cluster Randomized Controlled Trial. Drug Saf 38, 189–196 (2015). https://doi.org/10.1007/s40264-014-0256-6

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