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Workshop- and Telephone-Based Interventions to Improve Adverse Drug Reaction Reporting

A Cluster-Randomized Trial in Portugal

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Abstract

Background: Spontaneous reporting of adverse drug reactions (ADRs) is the method most widely used by pharmacovigilance systems, with the principal limitation being the physician’s underreporting.

Objective: This study sought to evaluate the results of workshop and telephone-interview interventions designed to improve the quantity and relevance of ADR reporting by physicians.

Methods: A cluster-randomized controlled trial was conducted on 6579 physicians in northern Portugal in 2008. Following randomization, we allocated 1034 physicians to a telephone-interview intervention, 438 to a workshop intervention and the remaining 5107 to the control group. At the workshop, a real clinical case was presented and participants were then asked to report on it by completing the relevant form. In the telephone intervention, participants were asked (i) whether they had ever had any suspicion of ADRs; (ii) whether they had experienced any difficulties in reporting; (iii) whether they remembered the different methods that could be used for reporting purposes; and (iv) whether they attached importance to the individual physician’s role in reporting. We followed up physicians to assess ADR reporting rates to the Northern Pharmacovigilance Centre. In terms of relevance, adverse reactions were classified as serious or unexpected. Statistical analysis was performed on an intention-to-treat basis, and generalized linear mixed models were applied using the penalized quasi-likelihood method. The physicians studied were followed up over a period of 20 months.

Results: Two hundred physicians underwent the educational intervention. Comparison with the control group showed that the workshop intervention increased the spontaneous ADR reporting rate by an average of 4-fold (relative risk [RR] 3.97; 95% CI 3.86, 4.08; p < 0.001) across the 20 months post-intervention. Telephone interviews, in contrast, proved less efficient since they led to no significant difference (p = 0.052) vis-à-vis the control group in ADR reporting (RR 1.02; 95% CI 1.00, 1.04). The effects of the interventions on the reporting rate of serious and high-causality ADRs indicated that the RRs associated with workshops were 6.84 (95% CI 6.69, 6.98; p<0.001) for serious ADRs and 3.58 (95% CI 3.51, 3.66; p<0.001) for high-causality ADRs.

Conclusions: Whereas telephone interventions only increased spontaneous reporting in the first 4 months of follow-up, workshops significantly increased both the quantity and relevance of spontaneous ADR reporting for more than 1 year.

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Acknowledgements

The authors wish to express their sincere thanks to the following: Professor Altamiro da Costa Pereira for his invaluable help in developing this study; Professor Adolfo Figueiras, whose work on this project was funded by the Consortium for Biomedical Research in Epidemiology and Public Health (CIBER en Epidemiología y Salud Pública [CIBERESP]).[AC08_008]; María Piñeiro (CIBERESP), who contributed greatly to the statistical analysis; and Professor Maria Teresa Herdeiro, whose work on this project was funded, in part, by Science and Technology Fund (Fundação para a Ciência e Tecnologia) grant SFRH/BPD/35746/2007 from the Portuguese Ministry of Science, Technology and Higher Education.

The authors declare that they have no conflicts of interest directly relevant to the contents of this study.

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Authors and Affiliations

  1. Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto, Porto, Portugal

    Maria Teresa Herdeiro, Inês Ribeiro-Vaz & Jorge Polónia

  2. Centre for Health Technology and Information Systems Research (Centro de Investigação em Tecnologias e Sistemas de Informação em Saúde — CINTESIS), Porto, Portugal

    Maria Teresa Herdeiro & Inês Ribeiro-Vaz

  3. Health Technology Research Centre (Centro de Investigação em Tecnologias da Saúde — CITS), IPSN-CESPU, Gandra, Portugal

    Maria Teresa Herdeiro

  4. Centre for Cell Biology, University of Aveiro, Aveiro, Portugal

    Maria Teresa Herdeiro & Mónica Ferreira

  5. Centre for Neuroscience and Cell Biology — CNC, University of Coimbra, Coimbra, Portugal

    Amílcar Falcão

  6. Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal

    Amílcar Falcão

  7. Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain

    Adolfo Figueiras

  8. Consortium for Biomedical Research in Epidemiology and Public Health (CIBER en Epidemiología y Salud Pública — CIBERESP), Barcelona, Spain

    Adolfo Figueiras

Authors
  1. Maria Teresa Herdeiro
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  2. Inês Ribeiro-Vaz
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  3. Mónica Ferreira
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  4. Jorge Polónia
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  5. Amílcar Falcão
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  6. Adolfo Figueiras
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Corresponding author

Correspondence to Maria Teresa Herdeiro.

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Herdeiro, M.T., Ribeiro-Vaz, I., Ferreira, M. et al. Workshop- and Telephone-Based Interventions to Improve Adverse Drug Reaction Reporting. Drug Saf 35, 655–665 (2012). https://doi.org/10.1007/BF03261962

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  • DOI: https://doi.org/10.1007/BF03261962

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