Global Drug Safety

Abstract

Due to collaborative agreements between health authorities, prescription drugs are now essentially approved on a global basis. Many serious side effects of drugs are not found among the relatively small number of patients exposed in the pre-approval clinical trials. When suspicion of serious side effects emerges, researchers use crude epidemiological methods in retrospective studies—the results of which are open to debate. This article explores the high tech future of drug safety surveillance driven by market forces and allowing real-time reporting of adverse events to pharmaceutical companies, regulators, patients, and wiki communities. This system is seen to be a consequence of the marriage of Big Medicine and Big Data, and competition between medical providers and insurance companies. The benefits and risks of this 2030 reality and four possible scenarios are presented.