Pharmacovigilance

• Published in: The Textbook of Pharmaceutical Medicine pp. 235 - 253
• Main Authors: Hobbiger, Stephen F, Patel, Bina, Swain, Elizabeth
• Format: Book Chapter
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 18.04.2013
• Subjects: adverse reaction; expedite; periodic report; pharmacovigilance; risk management; safety signal
• ISBN: 9780470659878; 0470659874
• DOI: 10.1002/9781118532331.ch11

The science associated with monitoring and responding to safety issues throughout the life cycle of a medicine is termed pharmacovigilance. It must be remembered that no medicine is free of risk. All medicines are associated with adverse drug reactions and those taking a medicine will have both the potential for benefit as well as the risk of harm. Pharmacovigilance is tightly controlled and must rightly concern itself with meeting regulatory obligations for individual and periodic case reporting. In the process it will identify and react to new safety issues. Recent developments have seen the emergence of a more proactive approach to pharmacovigilance facilitated by the development of new analytical and methodological approaches to the interrogation of large volumes of aggregate safety data. Signal detection and signal evaluation are now mainstream activities linked to risk management. The intention is to reduce both the number and the extent of possible harms, known respectively as risk minimisation and risk mitigation. This chapter summarises the broad range of pharmacovigilance activities and will describe the key elements in more detail.