Abstract
Pharmacovigilance is a scientific discipline concerned with the safety of drugs as used in clinical practice and whose main purpose is to balance the risk–benefit ratio to the public. This chapter discusses the progression of pharmacovigilance as a discipline from its start in the early 1960s during the thalidomide tragedy to its current status as a visible and pervasive part of the health care delivery and research. It provides an overview of the recent activities and science supporting pharmacovigilance and their informatics dependencies and implications, as well as the settings in which pharmacovigilance activities are undertaken. Major informatics themes related to pharmacovigilance include the design and support of drug safety data collection systems, identification of alternative data sources, methodological development to support new analyses and discovery, methods to support the use of patient-specific genetic profile data as mitigating factors, and communication of complex information to physicians, policy makers, and patients. This chapter also reviews the various methods of detecting new adverse drug reactions, including pre- and postmarketing studies, spontaneous reporting, intensive monitoring, and database studies, as well as the pros and cons of each. Both pharmacovigilance and drug safety monitoring impact the activities and workflows of clinical research, and the knowledge generated from these activities will lead to safer use of drugs in the future.
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van Grootheest, A.C.(., Richesson, R.L. (2012). Pharmacovigilance. In: Richesson, R., Andrews, J. (eds) Clinical Research Informatics. Health Informatics. Springer, London. https://doi.org/10.1007/978-1-84882-448-5_19
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