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Physicians’ Attitudes and Adverse Drug Reaction Reporting

A Case-Control Study in Portugal

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Abstract

Objectives: Voluntary adverse drug reaction (ADR) reporting is fundamental to medical drug safety surveillance; however, substantial under-reporting exists and is the main limitation of the system. This study sought to identify the knowledge-and attitude-related factors associated with ADR reporting by physicians in Northern Portugal.

Methods: Case-control study covering a population of National Health Service medical practitioners. The 88 cases comprised physicians who had reported at least one ADR to the drug surveillance unit from the year 2000 to the date of enrolment in the study. The 771 controls were randomly selected from among the remaining physicians. All interviews were conducted using a self-administered questionnaire. Knowledge and attitudes regarding spontaneous ADR reporting were based on Inman’s ‘seven deadly sins’. Agreement with the questions included in the questionnaire was measured using a horizontal, continuous visual analogue scale, which was unnumbered. Recorded answers were read in a range from zero (total disagreement) to ten (total agreement). We used logistic regression to determine the ADR reporting adjusted odds ratio (ORadj) for a change in exposure corresponding to the interquartile range for each attitude.

Results: A total of 397 questionnaires were received from 731 eligible practitioners (54.3%). Physicians who worked in primary versus hospital care (ORadj 7.74 [95% CI 1.85, 32.30]) and in general medicine (ORadj 1.05 [95% CI 0.30, 3.69]) versus medical specialities were more likely to report ADRs. In contrast, physicians working in the medical-surgical/surgical fields were significantly less likely to report ADRs compared with medical specialists (ORadj 0.10 [95% CI 0.02, 0.46]). Attitudes to ADRs were strongly associated with reporting probability. Hence, an interquartile decrease in any of the following attitudes increased the probability of reporting by: (i) 87% (p < 0.05) for complacency (the belief that really serious ADRs are well documented by the time a drug is marketed); (ii) 109% (p < 0.01) for insecurity (the belief that it is nearly impossible to determine whether a drug is responsible for a particular adverse reaction); (iii) 143% (p < 0.001) for diffidence (the belief that one would only report an ADR if one were sure that it was related to the use of a particular drug); (iv) 220% (p < 0.001) for indifference (the belief that the one case an individual doctor might see could not contribute to medical knowledge); and (v) 71% (p < 0.05) for ignorance (the belief that it is only necessary to report serious or unexpected ADRs).

Conclusion: This study shows that there are attitudes strongly associated with under-reporting. The implementation of purpose-designed educational interventions based on the attitudes identified in this study may serve to improve reporting substantially.

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Acknowledgements

The authors wish to express their sincere thanks to the PRODEP (Program for the Educational Development in Portugal) for funding the study, the Northern Region Health Authority and all the medical practitioners who responded to the questionnaire. Dr Adolfo Figueiras’ work on this project was in part funded by Health Research Fund (Fondo de Investigación Sanitaria) grants 99/1189 from the Spanish Ministry of Health.

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

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Authors and Affiliations

  1. Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Santiago de Compostela, c/ San Francisco s/n, 15705, Santiago de Compostela, Spain

    Maria T. Herdeiro,  Adolfo Figueiras & Juan Jesus Gestal-Otero

  2. Northern Polytechnic Health Institute (Cooperativa de Ensino Superior Politécnico e Universitário — CESPU), Gandra, Porto, Portugal

    Maria T. Herdeiro

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

    Jorge Polónia

  4. Preventive Medicine Service, University Hospital of Santiago de Compostela, Spain

    Juan Jesus Gestal-Otero

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  1. Maria T. Herdeiro
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  2. Adolfo Figueiras
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  3. Jorge Polónia
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  4. Juan Jesus Gestal-Otero
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Correspondence to Adolfo Figueiras.

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Herdeiro, M.T., Figueiras, A., Polónia, J. et al. Physicians’ Attitudes and Adverse Drug Reaction Reporting. Drug-Safety 28, 825–833 (2005). https://doi.org/10.2165/00002018-200528090-00007

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