The second problem, however, seems a bit more daunting. It is the authors' apparent confusion about the book's target audience.
Throughout the text, the authors assume that the reader has a great understanding of the purposes, goals, and reporting structures
for a pharmacovigilance professional. Yet this background information is included in Annex One, which would strike experienced
readers as superfluous. A solution might have been to include the basic principles early in the book to ensure that all of
readers are on the same level.
The authors' confusion is also manifest in the relative depth of the book's chapters. The basic chapters occasionally include
a wealth of information, but others are somewhat sketchy. For example, the "Reference Safety Information" chapter does not
include enough discussion to elucidate this complex concept. Yet the section about data management, which is largely irrelevant
to new pharmacovigilance professionals, is complete and extensive. Nevertheless, new professionals would still benefit from
the book because even where the information is sketchy, the text indicates areas that require investigation.
This book is highly recommended to new qualified persons for pharmacovigilance and to those who aspire to fill this important
role. The value of the core material that simply and completely lays out the responsibilities for the pharmacovigilance system
should not be underestimated because it can have a significant effect upon a drug company. The annexes provide information
in a concise manner that will make this a valuable reference for both new and experienced pharmacovigilance professionals.
Todd L. Cecil is vice-president for compendial sciences at the US Pharmacopeia, 12601 Twinbrook Pkwy, Rockville, MD 20852-1790, tel. 301.816.8234,
. He is also a member of Pharmaceutical Technology's editorial advisory board.