Exploring sociodemographic and economic factors that promote adverse drug reactions reporting by patients

Health Policy. 2018 Mar;122(3):263-268. doi: 10.1016/j.healthpol.2017.10.004. Epub 2017 Nov 8.


Background: Adverse drug reactions (ADRs) are recognized as a leading cause of morbidity and mortality, and an important cost factor to health systems. Patient reporting of ADRs has emerged as an important topic in recent years but reporting rates are still low in many countries.

Objective: To explore different countries' sociodemographic and economic features as explanatory factors for population ADRs reporting, including the propensity of patients' reporting to pharmacovigilance authorities.

Methods: Cross-sectional observational design. A data set of 42 global sociodemographic and economic factors for 44 countries were retrieved, as to analyse statistical associations between these factors and the patient reporting rate of ADRs. Multivariate logistic regression models were designed to identify the predictive covariables.

Results: Health investment indicators, such as per capita public health expenditure, hospital bed density and under five mortality rate were the relevant factors responsible to discriminate between countries that have higher patient reporting rates.

Conclusions: This study shows that healthcare investment-related factors help explain the propensity of patients to report suspected ADRs, while pharmacovigilance features were not directly associated with higher patient participation in drug safety mechanisms. Although general, these results point a direction in further policy making to improve resources allocation concerning the promotion of patients' participation.

Keywords: Adverse drug reactions; Adverse drug reactions reporting systems; Health policy; Patient reported outcome measures; Pharmacovigilance; Quality of health care.

Publication types

  • Observational Study

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Cross-Sectional Studies
  • Demography*
  • Humans
  • Internationality
  • Patient Participation / statistics & numerical data*
  • Pharmacovigilance*
  • Socioeconomic Factors*