Consumer Narratives in ADR Reporting: An Important Aspect of Public Health? Experiences from Reports to a Swedish Consumer Organization.

Abstract

Harms of drugs are an important cause of mortality and morbidity. The use of pharmaceuticals always entails a risk of adverse events, often to an unknown extent, and increased drug utilization has made drug-related problems a common occurrence (1). It is, for instance, estimated that adverse drug reactions (ADRs) cause the European Union almost 200,000 deaths annually (2) and cost approximately €79 billion (3). The World Health Organization (WHO) clearly recognizes the need for prescribed medicines to be of good quality, safe, effective, and used by the right patient in the right dose at the right time in order to minimize the risk of harm (4). The thalidomide disaster around 1960 underscored the necessity of systems to monitor medicines safety after marketing. As a consequence, governments developed systems in order to affirm that drug products are safe and efficacious enough to be permitted on the market and that the pharmaceutical industry needed to be regulated since these companies have a responsibility to protect public health (5). This concern with patient safety and the rational usage of drugs is often referred to as pharmacovigilance (PV) (6), which can be defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any other possible drug-related problems” (7). It is however well established that knowledge about medicines safety is limited at the time of licensing of a new product and spontaneous reporting of ADRs to regulatory authorities and drug manufactures is perhaps the most important way of monitoring the post-market safety of medicines (8). National databases to collect signals of ADRs from health care professionals (HCPs) were established already from the late 1960s and a WHO international collaboration started in 1968. With their Drug Monitoring Program, WHO supports the reporting of potential ADRs by HCPs (9), but it is a well-recognized problem by the Organization, that this group under-report serious and fatal reactions (4). Unexpected ADRs are, for instance, seldom reported.