Cobert's Manual of Drug Safety and Pharmacovigilance, 2nd Edition

ISBN: 9780763791599
ISBN-10: 0763791598
Copyright: 2012
Edition: 2nd
Editor: Cobert, Barton
Doody's Expert Review    Score: 91
Reviewer: Barbara Giacomelli,  PharmD, MBA, FASHP  (McKesson Provider Technologies)
Description
This manual defines and outlines regulatory agencies, regulations, and reporting requirements for pharmacovigilance in the United States and other key countries.
Purpose
A goal of the book is to improve medication safety, and it provides a broad overview of how adverse events are handled from discovery through investigation and outcome.
Audience
Written for both practitioners and students, the book is relevant for those in pharmacy, quality assurance, and nursing. The author is hoping to increase practitioners' knowledge and motivate them to improve drug safety.
Features
The book is very detailed. It defines drug safety and adverse drug events, and it is an excellent guide to the different regulatory agencies that oversee medication therapy in the United States and other countries. It provides information on medications from research and approval to post-marketing surveillance and ongoing monitoring.
Assessment
This manual is useful as a tool for education in pharmacy schools and as a resource for pharmacy quality management. It is the most comprehensive reference I have seen on pharmacovigilance.
Review Questionnaire
Range Question Score
1-10 Are the author's objectives met? 10
1-10 Rate the worthiness of those objectives. 10
1-5 Is this written at an appropriate level? 5
1-5 Is there significant duplication? (1=significant, 5=insignificant) 3
1-5 Are there significant omissions? (1=significant, 5=insignificant) 5
1-5 Rate the authority of the authors. 5
1-5 Are there sufficient illustrations? 3
1-5 Rate the pedagogic value of the illustrations. N/A
1-5 Rate the print quality of the illustrations. N/A
1-5 Are there sufficient references? 5
1-5 Rate the currency of the references. 5
1-5 Rate the pertinence of the references. 5
1-5 Rate the helpfulness of the index. 5
1-5 If important in this specialty, rate the physical appearance of the book N/A
1-10 Is this a worthwhile contribution to the field? 10
1-10 If this is a 2nd or later edition, is this new edition needed? 6