Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory

      Introductions

      

Introduction to the First Edition

      This manual is a practical instruction book on drug safety. It is aimed at newcomers, old-timers, and out-siders to the field who would like a demystification and explanation of what adverse events are and how drug safety departments work. Hopefully, readers, especially those not in the field, will understand that drug safety, like all other areas of medicine, is as much an art as it is a science.

      For newcomers, this is a “Drug Safety 101” course giving a broad overview of how adverse events are handled from start to finish. For old-timers, this book will fill in gaps in knowledge on drug safety. For outsiders not working directly in this field, this book will explain how “side effects” are handled by the industry and by health authorities.

      This book is not meant to be an encyclopedia. There are other such books already available. Rather, it is my hope that this will be an approachable book that will give a global overview of the field.

      It is expected that, after carefully reading and absorbing the contents, the reader will be able to begin work in a drug safety department, or, if an outsider, understand what happens in such a department and where listings or adverse events come from.

      I have attempted to avoid excess jargon (“This spontaneous SAE is expeditable since it is unlisted”) and make the book approachable for those with limited or no knowledge of medicine or pharmacology.

      Housekeeping: In this age of high technology, the references in the text are primarily websites rather than published citations. After much discussion, it was felt that putting URLs directly in the text would be distracting and of little use. Thus, they are noted in an appendix at the back of the book. In addition, accompanying this text is a CD-ROM with the entire contents of the book. This allows for rapid and easy searching for any topics the reader wishes. The URLs are “active” so that with a click or two the reader will be able to jump to that website when using the CD-ROM. All of the links were active and correct when this book was prepared but they cannot be guaranteed to be so in the future. Also, copying and pasting links into your browser may solve errors that you encounter.

      I wish you well in the world of drug safety.

      

Introduction to the Second Edition

      The first edition of this book was written several years ago and since that time, much has changed in the world of drug safety. The use of technology, which exploded in other areas of medicine over the past 30 or 40 years, has now hit drug safety (EDC, E2B, CDISC, HL-7, DSUR, PPR, ICSR—if you don’t know what these mean, read the rest of this book). This is and will be a “game changer.” It is likely that our current systems will look prehistoric or at best medieval in 10, 20, or 30 years, as everyone’s medical life (if not entire life) is digitalized and readily available for review, study, analysis, correlation, tweeting, social media, and so on. Whether one likes this or not, it is necessary to keep up to date to remain employable and to conduct quality drug safety work. This book attempts to help the reader wade through the theory and methodology of drug safety and pharmacovigilance to high quality work.

      Many changes in the field are heartening, but many are disheartening. On the heartening side, we are starting to understand pharmacology better. We are starting to develop methodology that will allow us to hopefully predict potential and likely drug toxicity in an individual. Perhaps genomics will allow us to truly tailor