Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional

J Eval Clin Pract. 2004 Nov;10(4):483-9. doi: 10.1111/j.1365-2753.2003.00456.x.


Rationale, aims and objectives: The spontaneous reporting of adverse drug reactions (ADRs) through the yellow card and made concrete by the knowledge and attitudes of doctors, has been rousing a great deal of bibliographical interest in recent years. However, there does not seem to be any actual revision in the theme on which the theoretical models that explain the process of decision in reporting are proposed. In this work an explanatory model of the factors that condition reporting is proposed and a revision of the literature on the subject has also been carried out.

Methods: The proposed model is centralized in the medical professional and it considers the habit of reporting as the result of the doctor's formation and his interaction with the environment. The combination of knowledge-attitudes-practices and the theory of the satisfaction of needs seemed very adequate for ADR systematization.

Results and conclusions: The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Attitude of Health Personnel*
  • Decision Making
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Physicians / psychology*
  • Portugal
  • Product Surveillance, Postmarketing*
  • Risk Management / statistics & numerical data*
  • Spain