The identification of signals of drug reactions is a complex and daunting task, especially since some reactions mimic common illnesses and may therefore be difficult to identify. Constant awareness is needed if signals are to be detected. The diagnosis and reporting of suspected ADRs are needed to protect both individual patients and the community. Present methods are indispensable but inadequate.
The pharmacovigilance professional is best able to place potential safety signals into appropriate context with a full appreciation of methods for surveillance, epidemiology and critical appraisal. This book intends to present the regulatory and ethical framework for drug safety evaluation, some of the key clinical outcomes of frequent interest, and a variety of approaches that have been used over time. This book is intended as a prompt for further development in this important field. Physicians and patients will be better served with richer information on appropriate medication use. More comprehensive and accurate definition of medication safety can help regulators and industry take appropriate action to improve safety—from removal of unsafe products to protection of useful products from unwarranted removal.
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