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Pharmacovigilance: Basic Concepts and Applications of Pharmacoinformatics
Abstract
Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. It is important to understand the basic concepts related to Adverse Drug Reactions (ADRs): epidemiology, classification, predisposing factors, evaluation parameters, and surveillance methods. Pharmacovigilance is defined as the science and activities relating to the detection, evaluation, understanding, and prevention of ADRs or any other drug-related problems. It involves patients, medical professionals, the pharmaceutical industry, drug regulatory agencies, and academic scientists. Pharmacoinformatics, the application of information technology with regard to the drug design, development, and drug use has played a major role in the appropriate implementation of pharmacovigilance at industry, regulatory, and hospital levels. The functioning of international regulatory agencies and drug safety departments of pharmaceutical industries has been greatly influenced by pharmacoinformatics. Pharmacoinformatics has changed the way in which health care is practiced. Modern information technology can be used by health care professionals for various purposes and, thereby, make a substantial contribution to optimize the quality of medication use in institutions with due importance of safety. Pharmacoinformatics has a major influence in the development of pharmacogenetics and its individual applications including improving drug safety. Pharmacoinformatics will play a major role in the future development and practice of pharmacovigilance. The present chapter is aimed at providing the readers an insight into the importance and basic concepts of pharmacovigilance, and the process involved in it. Application of pharmacoinformatics in improving drug safety at various levels from an industry, regulatory and hospital perspective is discussed.
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