Pharmacovigilance: An Overview.

PURPOSE: Pharmacovigilance (PV) is a relatively new discipline in the pharmaceutical industry. Having undergone rapid growth over the past 2 decades, PV now touches many other disciplines in the research and development enterprise. With its growth has come a heightened awareness and interest in the medical community about the roles that PV plays. This article provides insights into the background and inner workings of PV.

METHODS: This narrative review covers the core PV activities and other major areas of the pharmaceutical enterprise in which PV makes significant contributions.

FINDINGS: Drug safety monitoring activities were organized by the US Food and Drug Administration and academic medical centers in the early 1950s in response to growing concern over the occurrence of aplastic anemia and other blood dyscrasias associated with the use of chloramphenicol. This experience was codified in the 1962 Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act as adverse event evaluation and reporting requirements. The ensuing decades have seen the development of core PV functions for pharmaceutical companies: case management, signal management, and benefit-risk management. A broader scope of PV has developed to include the following major activities: support of patient safety during the conduct of clinical trials through assuring proper use of informed consent and institutional review boards (ethics committees); selection of the first safe dose for use in humans, based on pharmacologic data obtained in animal studies; development of the safety profile for proper use of a new molecular entity and appropriate communication of that information to the range of relevant stakeholders; attendance to surveillance activities through a set of signal management processes; monitoring the manufactured product itself through collaborative activities with manufacturing professionals; management of benefit-risk to assure appropriate use in medical care after marketing; and maintenance of inspection readiness as a corporate cultural process.

IMPLICATIONS: The extent and pace of change promise to accelerate with the integration of biomedical informatics, analytics, artificial intelligence, and machine learning. This progress has implications for the development of the next generation of PV professionals who will need to be trained in entirely new skill sets to lead continued improvements in the safe use of pharmaceuticals. (Clin Ther. 2018;40:XXX-XXX) © 2018 Elsevier HS Journals, Inc.