Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Finland.
Department of Statistics and Operational Research, Faculty of Sciences, University of Lisbon, Portugal.
Health Policy. 2018 Mar;122(3):263-268. doi: 10.1016/j.healthpol.2017.10.004. Epub 2017 Nov 8.
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.
To explore different countries' sociodemographic and economic features as explanatory factors for population ADRs reporting, including the propensity of patients' reporting to pharmacovigilance authorities.
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.
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.
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.
药物不良反应(ADRs)被认为是发病率和死亡率的主要原因,也是卫生系统的一个重要成本因素。近年来,患者报告药物不良反应已成为一个重要议题,但在许多国家,报告率仍然很低。
探讨不同国家的社会人口学和经济特征作为人群药物不良反应报告的解释因素,包括患者向药物警戒机构报告的倾向。
采用横断面观察性设计。检索了 44 个国家的 42 个全球社会人口学和经济因素数据集,以分析这些因素与药物不良反应患者报告率之间的统计关联。设计了多变量逻辑回归模型来确定预测变量。
卫生投入指标,如人均公共卫生支出、病床密度和五岁以下儿童死亡率,是区分报告率较高的国家的相关因素。
本研究表明,与医疗保健投资相关的因素有助于解释患者报告疑似药物不良反应的倾向,而药物警戒特征与患者更多参与药物安全机制之间没有直接关系。尽管具有普遍性,但这些结果为进一步制定政策以改善资源分配、促进患者参与指明了方向。