Principles and Practice of Pharmaceutical Medicine 

Principles and Practice of Pharmaceutical Medicine 2nd Edition 2007 (www.webofpharma.com)

Pharmaceutical medicine is a relatively new, but rapidly growing, academic discipline. As these trends continue into the 21st century, pharmaceutical physicians are increasing regarding consultancy work and contract research organization (CRO) affiliation as good career opportunities, and now recognize the need for continuing education and training in this broad-spectrum discipline.
As editors, we would like to thank our contributors for their expertise, their dedication, and their vision. We would like to thank and acknowledge the work and counsel of our colleague Robert Bell, MD, MRPharmS, who helped us greatly during the early part of this project. We would also like to thank and acknowledge the enormous help, encouragement, and patience of the team at John Wiley & Sons, Inc., UK, with whom we have worked closely over these past few years, among whom we have particularly stressed (!) Michael Davis, Deborah Reece, Hannah Bradley, Lewis Derrick, and Hilary Rowe.
Lastly, we would like to thank our families, and friends, who have withstood the frequent telephone calls, e-mails, and meetings, often late into the night. Indeed, to all who made this project possible, both authors and non-authors, we thank you. We are certain that this specialty, and our patients, even though we may help them vicariously, will benefit because of your contributions.

Pharmaceutical medicine has only become more diverse and has also become widely accepted as a recognized medical specialty, for example, with its first graduates of specialist training in the United Kingdom, to add to those of Switzerland, and Mexico. This has been accompanied by pharmaceutical medicine’s rapid progress toward specialty recognition within the European Community, and many changes in the pharmaceutical environment. So, we have taken this book further with this second edition. There are new chapters on European regulations, risk management, the Middle East, Asia, and other topical subjects in pharmaceutical medicine. Those chapters that did appear in the first edition have all been brought up to date.
But this book is for all those working in pharmaceutical medicine, regardless of their degrees, titles, or affiliations. Although it comprehensively covers the internationally harmonized syllabus for the Diplomas in Pharmaceutical Medicine that are awarded in Belgium, Switzerland, and the United Kingdom, this book will also usefully serve those teaching other types of certificates and (usually Master’s) degrees in this field, as well as being a vade mecum for those who are not undertaking academic courses.
We would again like to thank the team at John Wiley and Sons, Inc., Chichester (UK). Hannah Bradley got this second edition started, but then went off on a tour around the world; the editors strenuously deny that they are the reason why. Lucy Sayer and Juliet Booker have since piloted the ship to the dock-side, successfully cajoling us into getting this edition done before its second decade. Not least, we would like to thank you, the reader, for your continued support and suggestions. So here is our second edition, it is more than a simple update, and it is even less US-centric than before.

Overview of Pharmaceutical Medicine

Pharmaceutical medicine is unquestionably a young medical specialty. The first university chair in pharmaceutical medicine is less than 10 years old, and there are no great buildings or institutions dedicated to it, unlike venerable medical specialties such as chest medicine, neurology, physiology, pharmacology, and so on. Possibly because of its youth, this is a specialty that can be misunderstood by those outside it. Even among practitioners of pharmaceutical medicine, there can be surprised when they consider their own diversity.
Nonetheless, elements of what we recognize today as the practice of pharmaceutical medicine have existed for a long time. Withering’s identifi-cation of Digitalis purpurea as a treatment for what was then called ‘dropsy’ and the clinical trial of citrus fruit conducted by Lind are examples of drug discovery and investigation. Sequential clinical trial designs have been borrowed from as far a-field as the discipline of engineering and date from the mid-twentieth century. The techniques shared with the fields of epidemiology and public health are obvious and also well established. Every prescription written in ordinary clinical practice is a clinical trial of some sort, where n ¼ 1 because human beings are angiogenetic; this even applies to identical twins as they age or are exposed to different environments. Ever since the need to demonstrate efficacy, tolerability and purity in drug products (and their equivalents in diagnostics and devices), pharmaceutical medicine has become evidence-based; it is interesting to note that the more venerable medical specialties are now imitating the supposed ‘new kids on the block’ with the recent emphasis on evidence-based approaches to the patient.
It is therefore not surprising that the diverse and overlapping discipline of pharmaceutical medicine is populated by practitioners with varied educational backgrounds. There can be no doubt that clinical experience is always a good prelude to a career in pharmaceutical medicine. But dental sur-geons, medical practitioners, nurses, pharmacists, physiotherapists, psychologists, and many other members of the allied health professions have all found satisfying careers in this specialty.
Few medical specialties involve working in teams with as large a number of other professions as pharmaceutical medicine. For example, general practitioners regularly work with nurses, health visitors, administrators, hospital colleagues, and social workers; radiologists might add radiographers and physicists to this list and delete the health visitors and social workers. But, by way of comparison, the following list of nouns, all of which have their own professions, comprise pharmaceutical


Pharmaceutical Medicine as a Medical Specialty

Medicine is an art that has been practiced since time immemorial. The use of herbs and natural medicaments to relieve pain or to aid the sick in coping with their afflictions has been a part of all societies. In the Western world, medicine has developed at least since the time of the Greeks and Romans – the Hippocratic oath reminds us of this nearly 2500-year history. However, the progress of medicine has been very different from that of many other arts within society. It has come of age after an incredibly long maturation period. As a function capable of offering a successful treatment for a human ailment, medicine is very much a development of the last 100–150 years. Indeed, the major advances have come in the last 50–75 years.
The role of physicians in society has changed over the centuries. It may have reached its nadir during the early renaissance, when the general attitude was, as Shakespeare said, ‘Trust not the physician; His antidotes are poison’. From the nineteenth century onwards, with their growing diagnostic understanding and their therapeutic agents becoming increasingly effective, physicians have come to be increasingly valued. Today, much of the practice of medicine in all of its subspecialties is based on a physician’s diagnosis and treatment with drugs, devices, or surgery. This radical change to an era of focused treatments, after eons of using homespun remedies and then watching hopefully for the crisis or the fever to pass, has accompanied the recent revolutions in the understanding of biological processes and in technical and biotechnical capabilities. These developments have allowed us to produce pure therapeutic agents and establish their safe and effective use.
The exponential growth in scientific knowledge, particularly over the last 100 years, has brought about a paradigm shift in our approach to pharmaceuticals. Until the twentieth century, the sale and use of medicines and medical devices were almost entirely unregulated by governments. It was a case of caveat emptor, with only the drug taker’s com-mon sense to protect against the dangers of the so-called patent medicines and ‘snake oils’. The obvious abuses in these situations eventually led to government intervention, professional regulation and requirements that drugs be pure and unadulterated. With advances in science and in the ability to define and establish drug efficacy came a requirement to demonstrate that drugs were also safe. Finally, as late as the second half of the twentieth century came the legal requirement to establish that pharmaceuticals were effective before they were marketed. These legal requirements reflected changes in social attitudes and expectations grounded in the questions that the development of biological and basic sciences had made it possible to ask and to answer. The response to these changes has led to the development of the specialty of pharmaceutical medicine.


Clinical Research Education and Training for Biopharmaceutical Staff


The biopharmaceutical industry is a highly regulated industry where many of the activities and tasks performed by company staff are defined by regulations and guidelines issued by international regulatory authorities. The training requirements for the clinical staff of pharmaceutical companies or sponsors can be relatively well defined.
The International Conference on Harmonization (ICH) Guideline for Good Clinical Practices (GCP), for example, describes a minimum standard for the ethical and scientific standards for designing, conducting, and reporting clinical research. The ICH GCP Guideline is the unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data. The ICH GCP Guideline, together with other ICH Guidelines, provides operational definitions of the core competencies needed by clinical staff to conduct world-class clinical research.
One of the principles of ICH GCP is that ‘each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s)’. Specifically, regarding the selection and qualifications of monitors, the ICH GCP Guideline states that ‘monitors should be appropriately trained and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. Most major pharmaceutical firms have always had varying degrees of in-house education and training for staff, supplemented (as appropriate) by external workshops, courses and training meetings. The ICH GCP Guidelines help formalize the desired elements of education programs to comply with current GCP requirements.

Drug Discovery and Development

How does a chemical become a medicine? A better question, given the huge attrition rates in drug development, might be: What governs whether a chemical becomes a medicine? This section of the book covers all those disciplines and processes that are needed for this putative transmogrification.
This can also be called the ‘pre-marketing phase of the drug life cycle. It should be noted that although all this is necessary, it is certainly not sufficient for commercial success.
Importantly, these chapters have had to be designed to present the general case. Two major limitations then automatically arise. The larger limitation is that whole disciplines can be essentially product specific; hence, there is little about preclinical pharmacology in this section because a general case cannot be extensively presented. The smaller limitation is well illustrated by the discipline of toxicology. In this case, the general principles are fairly easy to enunciate and have beencodified by the International Conference on Harmonization. However, the toxicology program for almost every new chemical entity deviates from these general principles because special studies are needed in pursuit of product-specific issues that are uncovered while doing the ‘standard’ tests. Neither can such custom-designed studies be generalized here.
Regulatory affairs are so fundamental to preclinical and clinical development that it deserves a section of this book to itself. However, this is a purely artificial distinction that must not be allowed to obscure the crucial, intimate, and interactive relationship between regulation and the other disciplines that are described in this section.
Lastly, there is some cross-referencing and overlaps between some of the chapters in this section. Much in this section would also apply to late phase III and phase IV drug development. This is intentional and again reinforces how an integrated approach must be taken in drug development for there to be any chance at all of the eventual success.

Drug Discovery: Design and Serendipity

How is it that medicines are discovered? In ancient times, and even today, tribal people knew the healing or hallucinogenic properties of indigenous plants and animals. The knowledge was accumulated through generations, recorded by chant and living memory, and was derived largely from human experience. Although many of the drugs in use today were discovered by chance, most drug discovery scientists engage in directed research, based on a series of steps, each requiring substantial scientific input. Although available facilities, resources, technology focus, or even corporate culture can define the procedures followed by researchers at particular institutions, there are some obvious, generally applicable milestones in this process that facilitate the discovery of therapeutics.

  


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