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Determinants of Under-Reporting of Adverse Drug Reactions

A Systematic Review

Drug Safety volume 32, pages 19–31 (2009)Cite this article

Abstract

A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation. This bibliographic review sought to assess the influence of personal and professional characteristics on ADR reporting and to identify knowledge and attitudes associated with ADR reporting.

A systematic review was conducted using the MEDLINE and EMBASE databases. We included papers that were published in English, French and Spanish, and covered a study population made up of health professionals. In each case, the following data were extracted: study population; workplace; study type; sample size; type of questionnaire; type of scale for measuring knowledge; response rate; personal and professional factors; and knowledge and attitudes (based on Inman’s ‘seven deadly sins’) associated with reporting.

Based on a search of computerized databases, we identified a total of 657 papers in MEDLINE and 973 in EMBASE. In all, the review covered 45 papers that fulfilled the inclusion criteria. Medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Other factors associated with under-reporting were ignorance (only severe ADRs need to be reported) in 95%; diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 72%; lethargy (an amalgam of procrastination, lack of interest or time to find a report card, and other excuses) in 77%; indifference (the one case that an individual doctor might see could not contribute to medical knowledge) and insecurity (it is nearly impossible to determine whether or not a drug is responsible for a particular adverse reaction) in 67%; and complacency (only safe drugs are allowed on the market) in 47% of studies.

While personal and professional factors display a weak influence, the knowledge and attitudes of health professionals appear to be strongly related with reporting in a high proportion of studies. This result may have important implications in terms of public health, if knowledge and attitudes are viewed as potentially modifiable factors.

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Acknowledgements

The authors wish to express their sincere thanks to Angel Salgado for his invaluable comments on the previous versions of this manuscript and to Michael Benedict for his help in reviewing and revising the English version. Dr Adolfo Figueiras’ work on this project was funded by CIBERESP (AC08_008). Professor Dr Maria Teresa Herdeiro’s work on this project was in part funded by Science and Technology Fundo (Fundação para a Ciência e a Tecnologia) grants SFRH/BPD/35746/2007 from the Portuguese Ministry of Science, Technology and Superior Education.

The authors have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

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

    Elena Lopez-Gonzalez, Maria T. Herdeiro &  Adolfo Figueiras

  2. Centro de Investigação em Tecnologias da Saúde (CITS), IPSN-CESPU, Gandra, Portugal

    Maria T. Herdeiro

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

    Adolfo Figueiras

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  1. Elena Lopez-Gonzalez
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  2. Maria T. Herdeiro
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Lopez-Gonzalez, E., Herdeiro, M.T. & Figueiras, A. Determinants of Under-Reporting of Adverse Drug Reactions. Drug-Safety 32, 19–31 (2009). https://doi.org/10.2165/00002018-200932010-00002

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Keywords

  • Medical Specialty
  • Spontaneous Reporting
  • Report Card
  • Professional Characteristic
  • Yellow Card