Reviewer: Michael R Jacobs, BS, PharmD (Temple University School of Pharmacy)
Description: This is a guide to establishing and performing good pharmacovigilance practices as defined by volume 9A of The Rules Governing Medicinal Products in the European Union.
Purpose: The book, compiled by the Medicines and Healthcare Products Regulatory Agency (MHRA), "addresses practical issues" related to good pharmacovigilance practices. Guidance documents and books are commonly used to facilitate adherence to complex regulatory issues. This book provides valuable insight to the agency's expectations.
Audience: The target audience is identified as those individuals and organizations involved in pharmacovigilance activities, excluding those who work for regulatory authorities. The Qualified Person for Pharmacovigilance (QPPV) of an organization will likely possess much of the working knowledge offered in this book. The authors correctly point out that pharmacovigilance is not restricted to individuals or departments. The book will be most useful to those working in the pharmaceutical industry whose duties lie outside the area of pharmacovigilance, as well as outside providers and consultants. Of course, MHRA is the most credible source in discussing its own activities.
Features: The book interprets the regulations with the goal of facilitating organization compliance. Most chapters include a section describing inspection findings for areas of concern, which should be useful in avoiding mistakes made by others. Reference is made to specific U.K. requirements when appropriate. A glossary defines important regulatory terms and several useful appendixes (annexes) include an overview to prepare for and respond to the findings of pharmacovigilance inspections, a listing of relevant legislative and guidance documents, and a description of common U.K. pharmacovigilance offenses.
Assessment: Although the book is written with the very narrow focus of providing guidance to meet the pharmacovigilance requirements of volume 9A of the European Union, it should be quite useful in promoting a culture of product safety across the spectrum of departments in companies that market medicinal and herbal products. Those whose primary role lies outside the area of pharmacovigilance are very likely to benefit from the book because it should help them to better understand the commitments the organization is making to maximize product safety.