Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognised adverse drug reactions, thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use.
As a discipline, pharmacovigilance impacts on many specialist areas such as pharmacoepidemiology, medical practice, public health, but is most intimately linked to clinical research, development and drug licensing. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities.
The Dictionary of Pharmacovigilance contains a comprehensive list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms.
Examples include: Absolute Risk Increase (ARI), Bayesian Confidence Propagation Neural Network (BCPNN), Confounding Factor, Case narrative, Causality Assessment, Company Core Safety Information (CCSI), Data mining, 15-day report, Rechallenge, Directive 2001/83/EC, EU Birth Date, Expert report, FDA Form 1639, Historical control, Number Needed to Harm, Toxikinetics, Post-Marketing Surveillance, Qualified Person, Source Data Verification (SDV), Spontaneous Reporting, Vaccine Adverse Event Reporting System (VAERS), Warning Letter, Product Withdrawal.
Written by someone with excellent knowledge of pharmacovigilance gained from working in industry and a regulatory authority. This book will be essential reference for pharmacovigilance and regulatory affairs professionals worldwide.
Reviews:
01-Aug-04, Doody, 'This certainly will serve as a useful reference for anyone who desire such a book for their work in the field of pharmacovigilance.'; Patrick J McDonnell, PharmD (Temple University, School of Pharmacy)
01-Jan-05, Drug Development and Industrial Pharmacy, 'This text if the first of its kind in the English language and provides a comprehensive list of over 3100 abbreviations, terms, and phrases with definitions for each one.' ''a good reference providing brief summaries of key pharmacovigilance terminology in the English language.' 'This book would be a recommended resource for anyone involved in the research, regulatory, or drug development functions for drugs, biologics, vaccines, blood products, and herbal therapies.'; Kathleen M. Swanson, M.S. R.Ph., Regulatory Affairs/Adverse Event Specialist, Cooperative Studies Program, Clinical Research Pharmacy, Albuquerque, New Mexico, USA
