Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
In this definitive new text, the major medicines, devices and vaccines used by women worldwide are brought together for the first time in a single volume. Written and edited by international experts with an evidence-based approach, the book offers a comprehensive summary of all the key areas of women’s medicines. In the first part, issues relating to female drug exposure and considerations for prescribing for subgroups of women - for example during pregnancy and lactation - are presented in the context of contemporary clinical practice. In the second part, specific groups of pharmaceutical products are reviewed, including oral contraceptives, emergency contraception, treatment of chronic pelvic pain, hormone replacement therapy, bisphosphonates, herbal medicines for women, contraceptive devices and human papilloma virus (HPV) vaccines. Every chapter reviews and summarises the efficacy and safety of each group of products and concludes with a useful set of clinical take home messages. In the third part, broader perspectives are presented - from a primary care overview of prescribing for women, through to regulatory, political and religious aspects, including issues with women’s medicines in developing countries. The final two chapters focus on risk communication and conclude that women themselves should be placed at the centre of all discussions about their medicines. The book is aimed at prescribers, other healthcare professionals and students in the field of women’s health throughout the world. It is an extremely valuable resource for all in clinical practice, for students of medicine, nursing, pharmacy and related sciences, and also for those in medicines regulation, pharmacovigilance and the pharmaceutical industry.
Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.
