Synopsis

Completely Revised And Updated, The Manual Of Drug Safety And Pharmacovigilance, Second Edition Is A How-To Manual For Those Working In The Fields Of Drug Safety, Clinical Research, Pharmacology, Regulatory Affairs, Government And Legal Professions. This Comprehensive And Practical Guide Discusses The Theory And The Practicalities Of Drug Safety (Also Known As Pharmacovigilance) And Side Effects, As Well As Providing Essential Information On Drug Safety And Regulations, Including: Recognizing, Monitoring, Reporting And Cataloging Serious Adverse Drug Reactions.

The Manual Of Drug Safety And Pharmacovigilance, Second Edition Teaches The Ins And Outs Of Drug Safety In The Industry, Hospitals, FDA, And Other Health Agencies Both In The US And Around The World, And Presents Critical Information About What Is Done When Confronted With A Drug Safety Problem.

Reviewer: Barbara L 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.