Review of Drug Safety Data: How to Analyze, Summarize, and Interpret to Determine Risk
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Review of Drug Safety Data: How to Analyze, Summarize, and Inteqwet to Determine Risk Alan Hochberg F. Hoffmann-La Roche Ltd. Basel. Switzerland
Correspondence Address Alan Hochberg. F. Hoffmann-LaRoche Ltd. Bldg/Room 663/2010. Grenzacherstrasse 124, 4070 Basel. Switzerland (email: alan-mark. [email protected]).
DRUG SAFElYDATA: HOWTOANALYZE, SUMMARIZE, AND INTERPRET TO DETERMINE RlSK by Michael J. Klepper and Barton Cobert. Sudbury, MA: Jones & Bartlett Learning; 2010. Drug Safety Data fills an unmet need for a practical, industry-oriented how-to guide for anyone involved in drug safety. The book begins with a plain-language introduction to what safety is all about: benefit/risk assessment, coding and building a database, determining causality, weighing evidence, and incorporating this work into the proper documents. The authors have a great deal of experience in the safety field, and they make sure that the reader gets the big picture before diving into the details. The middle section of the book contains a rather unique synopsis of safety-oriented clinical information. There is a chapter on laboratory tests, followed by one on electrocardiography, followed by a third chapter that goes through what the authors call “adverse events that should be on everyone’s radar screen,” roughly equivalent to designated medical events. This chapter covers events such as pancreatitis and anaphylaxis, devoting a column or so to each. The medicine-made-simple approach in this book does not provide sufficient detail as a stand-alone reference to really teach the reader how to, say, code cases or assess clinical data. The chapter on coding is rightly titled “Coding Basics‘‘and does not, for instance, discuss the
rules for how one might code a verbatim report that says, “Myocardial infarction was ruled out, and pulmonary embolism was suspected.” Under the data assessment topic, the very important Naranjo criteria are not mentioned. On the whole, however, this clinical overview is a useful introduction and compilation for the newcomer to drug safety. As a clear and concise synopsis, it can be useful reference material for the more experienced safety professional as well, particularly for communicating with those outside the field. Later sections cover the analysis of adverse event reports, laboratory results, vital signs, physical findings, and electrocardiographic data. The goal here is to teach the reader how to contribute to the major types of safety-oriented documents, such as issue workups, the integrated analysis of safety, the company core safety information sheet, and the periodic safety update report (PSUR). There is a chapter on estimation of postmarketing exposure, which is a practical topic sometimes overlooked in safety handbooks. The final section includes all of the above documents for a fictitious anti-inflammatory drug “MEPRO,” in full detail, so that the reader can get a look at some real-world company internal safety documentation. Again, nobody is going to read this book and go out and write a PSUR-there
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