In this post, I am going to share with you a drug safety book called An Introduction to Pharmacovigilance Patrick Waller PDF free. Pharmacovigilance is also known as drug safety. You can download this book with a direct download link. Everyone knows safety is important, but with the exception of a few people whose job it is to monitor safety, this is probably what most people have in mind. There are two reasons for this – first, safety is about something that is not happening (and we are more concerned about things that are happening) and second, that is how people think. It is natural that this should not happen to me, perhaps to deal with the potential danger of something catastrophic.
This book Introduction to Pharmacovigilance PDF Free may not help newcomers with the detailed aspects of their day to day job but I hope it will help them see where they fit into the bigger picture. I assume that readers will at least have a science degree, but they do not necessarily have more specific knowledge of medicine. Newcomers need to know where we are today.
The most important historical drug safety issues have shaped the development of pharmacovigilance and that is why I have used them as a starting point. I hope this book will also help newcomers appreciate that they are now working in an interesting and important field that is likely to grow significantly in the near future. I have deliberately not included any references in the text, at the beginning, I hope the reader will want to read instead of going elsewhere.
Table of Contents
What is pharmacovigilance and how has it developed let’s discuss it before moving ahead. In the beginning, there was thalidomide. It can be argued that the history of pharmacovigilance goes further back but for practical purposes, the story of modern pharmacovigilance starts from there. In the late 1950s, drug regulation outside the United States was minimal (where thalidomide was not marketed), and testing and development was largely in the hands of pharmaceutical companies.
In the case of thalidomide, unwarranted safety claims were made during pregnancy and its use targeted pregnant women. The drug turned out to be a teratogen, which causes a variety of birth defects, but especially organ defects called phocomelia.
Worldwide, about 10,000 embryos were affected, especially in Germany, where the drug was first marketed. Because Fukumilia was otherwise a very rare congenital abnormality, the large increase in its incidence was not noticed in Germany but was initially thought to be due to environmental factors. In 1961, The Lancet reported a series of just three cases involving thalidomide, eventually acknowledging the problem and withdrawing the drug from sale. In the early 1960s, the publication of potential drug side effects in the medical literature was the only way to effectively draw attention to them. Thalidomide has a non-lethal but visible and startling side effect, leading people to ask why so many bad babies were born before anything happened.
It is unlikely that we will ever be able to predict and prevent all the harms which may be caused by medicines but limiting the damage to much smaller numbers is now achievable. Today we would expect to be able to identify an association between drug and outcome analogous to thalidomide and phocomelia after the occurrence of less than 10 cases, i.e. at least three orders of magnitude more effectively than five decades ago. The overriding lesson learnt from thalidomide was that we cannot just wait until a drug safety problem, quite literally in this case, hits us between the eyes. So thalidomide led directly to the initial development of the systems we now have, although it is only quite recently (i.e. since the early 1990s) that the term pharmacovigilance has become widely accepted.
Pharmacovigilance has been defined by the WHO as ‘The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. There are other definitions but this very broad one seems to be the most appropriate since there is a clear implication that the process is one of ‘risk management.
|Book Name||An Introduction to Pharmacovigilance|
|Author of Book||Patrick Waller|
Newcomers need to know where we are today. The most important historical drug safety issues have shaped the development of pharmacovigilance and that is why I have used them as a starting point. I hope this book will also help newcomers understand that they are now working in an interesting and important field that is likely to grow significantly in the near future.
I have deliberately not included any references in the text, I hope the reader will want to read instead of going elsewhere. Larger references can be found in larger texts that readers should follow. In the previous chapter, I have selectively cited some key sources that may be helpful for further reading. A dictionary explaining the key terms is provided at the end for reference.
Topics of this Edition:
Chapter 1 What is pharmacovigilance and how has it
Origins and definition of pharmacovigilance, 1
Scope and purposes of pharmacovigilance, 3
Development of pharmacovigilance since the 1960s, 5
Chapter 2 Basic concepts, 15
Adverse drug reactions, 15
The concept of safety, 21
Causation – was the drug responsible?, 25
Chapter 3 Types and sources of data, 30
Pre-clinical studies, 30
Human volunteer studies, 31
Clinical trials, 31
Post-marketing surveillance, 33
Systematic reviews and meta-analysis, 42
Chapter 4 The process of pharmacovigilance, 44
Overview – a risk management process, 44
Signal detection, 44
Evaluation and investigation, 50
Taking action, 52
Crisis management, 59
Chapter 5 Regulatory aspects of pharmacovigilance, 61
Legislation and guidelines, 62
Regulatory pharmacovigilance systems, 64
Obligations of pharmaceutical companies, 65
Risk management planning, 69
Chapter 6 International collaboration, 74
World Health Organisation, 75
Council for the Organisation of Medical Sciences, 75
International Conference on Harmonisation, 78
Chapter 7 Ethical and societal considerations, 80
Stakeholders and their perspectives, 80
Ethical principles, 83
Ethical safeguards in relation to safety, 84
Conflicts of interest, 86
Chapter 8 Future directions, 89
Introduction—current limitations, 89
Meeting the challenges, 90
Chapter 9 Learning more about pharmacovigilance, 94
Useful websites, 95
International societies, 96