Drug Utilization Studies in Latin America: A Scoping Review and Survey of Ethical Requirements

Abstract

Drug utilization studies (DUSs) are increasingly being conducted in Latin America, especially in countries with a universal healthcare coverage, to inform policies and decision making. The need for an ethical framework specific to DUSs in Latin America has been recognized. To describe the ethical and/or legal requirements applicable to DUSs in Latin American countries with universal healthcare coverage. We conducted a nonsystematic scoping review on DUSs in this region, covering the period from January 1, 2012, to July 1, 2017, and reviewed legislations and data protection requirements in each country. We also surveyed 45 ethics committees and 22 key informants to determine specific ethical requirements for various types of DUSs differing in data collection methods, study populations, and settings. Local legislations on DUSs are highly heterogeneous across Latin America. In Chile and Guatemala, authorization from the national health authority must be obtained for accessing clinical records, whereas in Argentina, no authorization is required for the secondary use of existing data. In Argentina, Brazil, Costa Rica, Guatemala, and Peru, a national ethics committee approval is required in addition to a site-specific approval. Requirements for patient informed consent also vary across countries and depend on the type of DUS and study population. The lack of consensus in the legislative and ethical frameworks applicable to DUSs across Latin America leads to operational challenges for the implementation of multinational studies. In many countries, absence of a framework leads to precautionary stringent requirements, which restricts the feasibility of DUSs.