Drug Safety
Problems, Pitfalls and Solutions in Identifying and Evaluating Risk
by Nigel S. B. Rawson

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With “Big Pharma” garnering an increasing number of negative headlines due to reports of adverse drug reactions and a surge in prescription drug addiction and overdose deaths, many people are increasingly skeptical about the safety of modern pharmaceutics and the moral integrity of the pharmaceutical industry. This book was written to provide a balanced perspective on drug safety risks. No therapeutic prescription drug is entirely risk-free. Before receiving marketing approval, new drugs go through arduous and expensive testing processes that can take up to a decade and cost over two billion dollars. While not perfect, the process is far from a “Wild West” environment where big pharmaceutical companies ride roughshod over government regulators. However, author and pharmacoepidemiologist Nigel Rawson argues, the antipathy that is common between governments, pharmaceutical industry and academic experts in Canada needs to change to an environment of collaboration and partnership to enhance our ability to respond in a timely fashion to future pharmaceutical crises. While directed mainly at students in the health sciences and pharmaceutical professionals, this book will be of interest to anyone, including lay people and policy makers, who would like to know more about the evolution of the prescription drug evaluation and risk assessment process. Although the book focuses primarily on Canada, it makes comparisons with the United States and Europe, and several of the author’s recommendations for how to improve the prescription drug evaluation process are applicable worldwide.

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A “must read” if your work involves pharmaceuticals. Dr. Rawson brings his considerable experience as an epidemiologist, an academic, as well as a pharmaceutical and health insurance industry researcher, in the United Kingdom, the United States and Canada to bear on an important issue ... Drug Safety. His monograph is well structured and very accessible to both novice and experienced researchers, clinicians and policy makers. He has done an admirable job of providing a brief history of medicinal use, the development of drug use and tracking of drug related events, pharmacovigilance, the use of administrative databases and pharmacoepidemiology. He nicely highlights some of the key drug safety challenges as well as offering a way forward in an effort to improve event reporting to ultimately mitigate avoidable drug related events in the near term. A concise text that both clinicians and researchers will find illuminating. Christopher J. Longo, Ph.D. Associate Professor, Health Policy and Management, McMaster University, Hamilton, ON Dr. Rawson’s monograph provides the necessary excellent background for the teaching of health science students, health professionals and those involved in government and industry in making decisions regarding the safe and effective use of therapeutic drugs in the real world. A monograph of this nature is long overdue in Canada. His work will serve well to increase appreciation of how decisions on the safety of drug therapy should be made in Canada. Roy West, Ph.D. Professor Emeritus of Epidemiology Memorial University of Newfoundland, St. John’s, NL, Canada Dr. Rawson has studied and published extensively on drug safety issues. In this monograph, he explains the concepts, methods and challenges in the monitoring and evaluation of drug risks and how results from these assessments can be over-simplified or interpreted out of context. I highly recommend this monograph to scientists in healthcare industries, healthcare professionals, reporters and other interested individuals who want to better evaluate and understand the myriad of risk-related drug safety findings reported in the public and scientific media. John H. Stewart, M.Sc. Retired President and Chief Executive Officer, Purdue Pharma, Stamford, CT, USA Former Chair, Innovative Medicines Canada

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Dr. Nigel Rawson is pharmacoepidemiologist, pharmaceutical policy researcher, President of Eastlake Research Group in Oakville, Ontario, an affiliated scholar with the Canadian Health Policy Institute in Toronto, and a senior fellow with the Fraser Institute in Vancouver, British Columbia. He has a BSc with first class honours, an MSc in statistics, and a PhD in pharmacoepidemiology. Dr. Rawson has held academic positions at the University of London and the University of Southampton in the United Kingdom and at the University of Saskatchewan and Memorial University in Newfoundland in Canada. In the private sector, he has served as a senior researcher at the Center for Health Care Policy and Evaluation, an independent research group at one of the United States’ largest health insurers, where he collaborated with the Food and Drug Administration on drug safety studies. He was also GlaxoSmithKline’s only epidemiologist in Canada, providing advice and analysis for the company’s current and developing products. Dr. Rawson has performed epidemiological studies on the use of drugs and their outcomes for over thirty-five years and has published more than one hundred book chapters and articles in peer-reviewed journals.

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Contributors

Author

Nigel S. B. Rawson

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