Principles And Practice Of Pharmaceutical Medicine
Principles and Practice
of Pharmaceutical Medicine
Principles and Practice
of Pharmaceutical Medicine
Lionel D. Edwards
Novartis and Pharma Pro Plus Inc. New Jersey, USA
Andrew J. Fletcher
Temple University School of Pharmacy, Philadelphia, USA
Anthony W. Fox
EBD Group Inc., California, USA and Munich, Germany
and Skaggs SPPS, University of California, San Diego
Peter D. Stonier
Consultant in Pharmaceutical Medicine, Richmond, Surrey, UK
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Library of Congress Cataloging-in-Publication Data
Principles and practice of pharmaceutical medicine/edited by Lionel D. Edwards ... [et al.]. – 2nd ed.
Includes bibliographical references and index.
ISBN 978-0-470-09313-9 (cloth: alk. paper)
1. Drug development. 2. Drugs–Research. 3. Pharmacology. I. Edwards, Lionel D.
[DNLM: 1. Drug Evaluation. 2. Drug Industry–organization & administration. QV 736 P9567 2007]
British Library Cataloguing in Publication Data
A catalogue record for this book is available from the British Library
Typeset in 10.5/12.5 pt Times by Thomson Digital, India
Printed and bound in Great Britain by Antony Rowe Ltd., Chippenham, Wilts
This book is printed on acid-free paper responsibly manufactured from sustainable forestry
in which at least two trees are planted for each one used for paper production.
Preface to the First Edition ix
Preface to the Second Edition xi
About the Editors xiii
SECTION I: OVERVIEW OF PHARMACEUTICAL MEDICINE 1
1 The Practice and Practitioners of Pharmaceutical Medicine 3
Anthony W. Fox
2 Pharmaceutical Medicine as a Medical Specialty 7
Michael D. Young and Peter D. Stonier
3 Clinical Research Education and Training for Biopharmaceutical Staff 25
SECTION II: DRUG DISCOVERY AND DEVELOPMENT 41
4 Drug Discovery: Design and Serendipity 43
Ronald R. Cobb and Leslie J. Molony
5 Pharmaceutics 51
Anthony W. Fox
6 Nonclinical Toxicology 63
7 Informed Consent 75
Anthony W. Fox
8 Phase I: The First Opportunity for Extrapolation from Animal
Data to Human Exposure 79
Stephen H. Curry, Dennis McCarthy, Helen H. DeCory, Matthew Marler
and Johan Gabrielsson
9 Phase II and Phase III Clinical Studies 101
Anthony W. Fox
10 Phase IV Drug Development: Post-Marketing Studies 119
Lisa R. Johnson-Pratt
11 Site Management 127
12 Good Clinical Practices 139
Wendy Bohaychuk and Graham Ball
13 Quality Assurance, Quality Control and Audit 159
14 The Unique Role of Over-the-Counter Medicine 179
SECTION III: SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES 191
15 Drug Research in Older Patients 193
Lionel D. Edwards
16 Drug Development Research in Women 203
Lionel D. Edwards
17 Clinical Research in Children 223
Lionel D. Edwards
18 Racial and Ethnic Issues in Drug Registration 231
Lionel D. Edwards, J.M. Husson, E. Labbe, C. Naito, M. Papaluca Amati,
S. Walker, R. Williams and H. Yasurhara
19 Hepatic and Renal Failure 249
Anthony W. Fox
20 Drug Interactions 255
Anthony W. Fox and Anne-Ruth van Troostenburg de Bruyn
21 Orphan Drugs 265
SECTION IV: APPLIED ASPECTS OF DRUG DEVELOPMENT 277
22 Biotechnology Products and Development 279
David A. Shapiro and Anthony W. Fox
23 Pharmacoeconomics: Economic and Humanistic Outcomes 291
Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer
24 Pharmacoepidemiology and the Pharmaceutical Physician 303
Hugh H. Tilson
25 Statistical Principles and Application in Biopharmaceutical Research 313
26 Data Management 345
T.Y. Lee and Michael Minor
27 Patient Compliance: Pharmionics, a New Discipline 355
28 Monitoring Drug Concentrations in Clinical Practice 375
Anthony W. Fox
29 Generics 381
J.D. Gabriel Lopez and J.D. Thomas Hoxie
30 Complementary Medicines 387
Anthony W. Fox
SECTION V: DRUG REGULATION 393
31 United States Regulations 395
32 Special US Regulatory Procedures: Emergency and Compassionate INDs
and Accelerated Product Approvals 407
Anthony W. Fox
33 The Development of Human Medicines Control in Europe from Classical
Times to the Year 2000 415
John P. Grifﬁn
34 Medicines Regulation in the European Union 443
Anne-Ruth van Troostenburg de Bruyn and Giuliana Tabusso
35 Japanese Regulations 487
36 Drug Registration and Pricing in the Middle East 509
SECTION VI: MEDICAL SERVICES 517
37 Medical Affairs 519
Gregory P. Geba
38 Drug Labeling 529
Anthony W. Fox
39 Drug Surveillance 535
Howard J. Dreskin and Win M. Castle
40 Data Mining 545
Mirza I. Rahman and Omar H. Dabbous
41 Risk Management in Product Approval and Marketing 557
Anthony W. Fox
42 Publishing Clinical Studies 565
Anthony W. Fox
43 Organizing and Planning Local, Regional, National and International Meetings
and Conferences 575
Zoﬁa Dziewanowska and Linda Packard
44 Drug Withdrawals from the Market – Causes and Consequences 579
Ronald D. Mann
SECTION VII: LEGAL AND ETHICAL ASPECTS OF PHARMACEUTICAL MEDICINE 585
45 Introduction to Bioethics for Pharmaceutical Professionals 587
Andrew J. Fletcher
46 Pharmaceutical Medicine and the Law 595
Sarah Croft and Timothy Pratt
47 Pharmaceutical Product Liability 605
Han W. Choi and Howard B. Yeon
48 Patents 619
49 Fraud and Misconduct in Clinical Research 631
SECTION VIII: BUSINESS ASPECTS 643
50 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory
Framework and the Medico-commercial Environment 645
R. Drucker and R. Graham Hughes
51 Advertising and Marketing 653
52 Middle East, India, China and the Far East: Pharmaceutical Medicine in the East 665
53 Financial Aspects of Clinical Trials 689
R.G. Hughes and N. Turner
54 Outsourcing Clinical Drug Development Activities to Contract Research
Organizations (CROs): Critical Success Factors 701
John R. Vogel
55 The Impact of Managed Care on the US Pharmaceutical Industry 725
Robert J. Chaponis, Christine Hanson-Divers, and Marilyn J. Wells
Appendix: Useful Internet Links 745
Preface to the First Edition
Pharmaceutical medicine is a relatively new, but rapidly growing, academic discipline. As these trends
continue into the 21st century, pharmaceutical physicians are increasingly 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.
Preface to the Second Edition
Since the ﬁrst edition of this book, 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.
About the Editors
LIONEL D. EDWARDS, MB, BS, LRCP, MRCS, DipRCOG, FFPM, is Senior Director of Medical Affairs
for Novartis USA, and President of Pharma Pro Plus Inc., a drug development consulting company. Dr.
Edwards has been involved in all aspects of clinical trials for over 33 years on many different research drug
and devices in 10 therapeutic areas. Previously, he was Vice President of Clinical Research at Bio-
Technology Pharmaceutical Corporation, a small biotechnology ﬁrm operating both in the United States
and internationally. Prior to this, he worked at Noven Inc., a small Skin Patch Technology ﬁrm with large
internationally licensed partners – CIBA and Rhone Poulenc Rorer. He was Assistant Vice President,
International Clinical Research at Hoffman-La Roche, Senior Director of Schering-Plough International
Research, and Director of US Domestic Gastrointestinal, Hormonal, and OTC Research Departments.
Dr. Edwards chaired the PMA Special Population Committee, and also sat on the Institute of Medicine
Committee for Research in Women, sponsored by the US National Instutes of Health. He also served on the
efﬁcacy subcommittee Topic 5 (Acceptability of Foreign Clinical Data) for the International Committee on
Dr. Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple
University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research
Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He is a
founder member of the American Academy of Pharmaceutical Physicians. Dr. Edwards has homes in New
Jersey and Florida.
ANDREW J. FLETCHER, MB, BChir, (Cantab), MS (Columbia), DipPharmMedRCP, FFPM was
formerly the Senior Assistant Editor of The Merck Manual, and is Adjunct Professor of Pharmaceutical
Health Care at Temple University School of Pharmacy. He graduated from Cambridge University and
St. Bartholomew’s Hospital, London, brieﬂy trained in Neurosurgery, joined CIBA-Geigy in the UK as
Medical Advisor, then European Medical Director for Syntex, and joined Merck, ﬁrst in the international
division after graduating in business studies from Columbia University, New York City, then as Assistant
Editor of The Merck Manual. He teaches pharmaceutical medicine, bioethics and medical and scientiﬁc
writing at Temple University’s School of Pharmacy. He is a founder member and former trustee of the
Academy of Pharmaceutical Physicians and Investigators (formerly the American Academy of Pharma-
ceutical Physicians). Dr. Fletcher resides in Ohio.
ANTHONY (‘Tony’) W. FOX, BSc, MBBS, FFPM, FRCP, MD(Lond), DipPharmMedRCP, CBiol, FIBiol,
is President of EBD Group, a consultancy with ofﬁces in San Diego and Munich. From the Royal London
Hospital, after general clinical training, he was Rotary International Fellow at Emory University (Atlanta)
and CIBA-Geigy Fellow at Harvard. Industrial positions at Procter & Gamble and (then) Glaxo Inc. came
next. He has also been a clinical and regulatory Vice President within a small pharmaceutical company.
Among many societies, Tony was a Charter Member, Trustee, and Education VP of the American Academy
of Pharmaceutical Physicians, and is a liveryman guardant of the Worshipful Society of Apothecaries of
London. He is an Adjunct (i.e. honorary) Associate Clinical Professor in the Skaggs School of Pharmacy and
xiv ABOUT THE EDITORS
Pharmaceutical Sciences, at the University of California, San Diego. His publications span several areas of
pharmaceutical medicine, for example, regulation, pharmacology, clinical trials, pharmacovigilance,
analgesics, migraine, genotoxicology, and metabolism, and he is named as inventor on several patents.
He is on the editorial boards of several journals, and serves in a more senior capacity for two of them. Tony is
proud to be an Essex man, researches the history of that County, and has been elected as a fellow of the Royal
Geographical and the Royal Numismatic Societies.
PETER D. STONIER, BA, BSc, PhD, MBChB, MRCPsych, FRCP, FRCPE, FFPM has 29 years
experience in pharmaceutical medicine. He is a graduate of Manchester Medical School, qualifying in
1974, following a BSc degree in physiology (University of Birmingham) and a PhD in protein chemistry
(University of Shefﬁeld). He is a pharmaceutical physician and was Medical Adviser with the UK Hoechst
Group of companies from 1977, serving as Medical Director and Board Director until 2000. Currently, he is
Director of Education and Training of the Faculty of Pharmaceutical Medicine, Royal Colleges of
Physicians of the UK. He is Medical Director of Amdipharm Plc, and of Medical Resource Provider
Axess Ltd. Formerly, he was President of the International Federation of Associations of Pharmaceutical
Physicians (IFAPP) and Chairman of the British Association of Pharmaceutical Physicians. He is a past-
President of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians, UK. He is Visiting
Professor in pharmaceutical medicine at the University of Surrey, which under his direction introduced the
ﬁrst MSc degree in Pharmaceutical Medicine in 1993, which is now part of the Postgraduate Medical School
of the University. His publications include edited works in human psychopharmacology, pharmaceutical
medicine, clinical research, medical marketing, and careers in the pharmaceutical industry. He is a member
of the Association of Pharmaceutical Physicans and Investigators (APPI). Professor Stonier has been elected
a Fellow of the Royal Society for the encouragement of Arts, Manufactures and Commerce.
Anbar, Dan ClinPro Inc., 1661 Route 22 West, Round Brook, NJ 08805, USA.
Ball, Graham Good Clinical Research Practices Consultants, Lakehurst, Ontario, Canada, and Oxford,
Barrett, Jane 2 Falcon Way, Wokingham, Berkshire RG41 3HD, UK.
Belsey, Jonathan JB Medical, The Old Brickworks, Chapel Lane, Little Cornard, Sudbury, Suffolk CO10
0PB, UK. Email: firstname.lastname@example.org
Bohaychuk, Wendy Good Clinical Research Practices Consultants, Lakehurst, Ontario, Canada, and
Boyer, J. Gregory Accreditation Council for Pharmacy Education, Chicago, IL, USA
Castle, Win M. Formerly of GlaxoSmithKline, Philadelphia, PA, USA.
Chaponis, Robert J. US Medical Operations, Pﬁzer Inc., 235 East 42nd Street, New York, NY 10017,
Choi, Han W. Oracle Investment Management Inc., 200 Greenwich Ave 3rd Fl., Greenwich, CT 06830,
Cobb, Ronald R. RiverWood BioConsulting Inc., 8909 SW 75th Street,
Gainesville, FL 32608, USA.
Croft, Sara Shook, Hardy and Bacon International LLP, London, UK and Shook, Hardy and Bacon LLP,
Kansas City, MO, USA
Curry, Stephen H. Department of Pharmacology and Physiology, University of Rochester, Rochester, NY
Dabbous, Omar H. Health Economics & Clinical Outcomes Research, Medical Affairs, Centocor Inc.,
800 Ridgeview Drive, Horsham, PA 19044, USA.
DeCory, Heleen H. UCB, 755 Jefferson Road, Rochester, NY, USA
Dreskin, Howard J. 7809 Via Optuntia, Carlsbad, CA 92009, USA. Formerly of GlaxoSmithKline,
Philadelphia, PA, USA.
Drucker, R. Technomark Consulting Services Ltd, King House, 11 Westbourne Grove, London W2 4UA, UK.
Dziewanowska, Zoﬁa Ligand Pharmaceuticals Inc., 10275 Science Center Drive, San Diego, CA 92121,
Edwards, Lionel D. Novartis Pharmaceuticals Corporation, US CD&MA, Building 501/Room 216, One
Health Plaza, East Hanover, NJ 07936-1080, USA.
Fletcher, Andrew J. Temple University School of Pharmacy, PHARM-QA/RA, 3307 North Broad Street,
Philadelphia, PA 19140, USA.
Fox, Anthony W. EBD Group Inc., 2032 Corte del Nogal #120, Carlsbad, CA 92011, USA and Neuhauser
Straße 3, Munich, D-80331, Germany.
Freidank-Muschenborn, Edda International Regulatory Affairs, Engelhard Arzneimittel GmbH,
Herzbergstrasse 3, 61138 Niederdorfelden, Germany.
Gabrielsson, Johan AstraZeneca R&D, Wilmington, DE, USA
Geba, Gregory P. Novartis Pharmaceuticals Corporation, One Health Plaza, Building 701, East Hanover,
NJ 07936-1080, USA.
Grifﬁn, John P. John Grifﬁn Associates Ltd, Quartermans, Digswell Lane, Digswell, Welwyn, Hertfordshire
AL7 1SP, UK.
Hammad, Gamal 24 Cassiobury Park Avenue, Watford, Hertfordshire WD18 7LB, UK.
Hanson-Divers, Christine Cary, NC, USA
Hattemer-Apostel, Rita Verdandi AG, Wieslergasse 2, 8049 Zurich, Switzerland.
Hoxie, Thomas Hoxie & Tso LLP, 374 Millburn Avenue, Suite 300E, Millburn,
NJ 07041, USA
Hughes, R. Graham Technomark Consulting Services Ltd, King House, 11 Westbourne Grove, London
W2 4UA, UK. Email: email@example.com
Husson, J.M. Paris, France
Johnson-Pratt, Lisa R. Wynnewood, PA, USA. Email: firstname.lastname@example.org
Kennedy, William Consultant, Delaware, USA; formerly V.P. Regulation Affairs.
Konig, Anja International Regulatory Affairs, Engelhard Arzneimittel GmbH, Herzbergstrasse 3, 61138
Labbe, Etienne UCB S.A., Allee de la Recherche, 60, 1070 Brussels, Belgium.
Lee, T.Y. ACER/EXCEL Inc., USA.
Lopez, Gabriel 6 Pleasantville Road, New Vernon, NJ 07976, USA.
Marler, Matthew Department of Psychiatry, University of California, San Diego, CA, USA
McCarthy, Dennis AstraZeneca R&D, Wilmington, DE, USA
Mann, Ronald D. 42 Hazleton Way, Waterlooville, Hampshire PO8 9BT, UK.
Marks, Peter Pﬁzer Inc., 50 Pequot Avenue, MS 6025-C4247, New London, CT 06320, USA.
Metry, Jean-Michel AARDEX Ltd, Untermueli 6, Postfach 2026, 6302 Zug, Switzerland.
Minor, Michael ACER/EXCEL Inc., USA
Miskin, Barry University of Florida, College of Medicine, PO Box 8068, Jupiter, FL 33468, USA.
Molony, Leslie J. RiverWood BioConsulting Inc., 8909 SW 75th Street, Gainesville, FL 32608, USA.
Naito, C. Teikyo University, Japan
Osterhaus, Jane T. Wasatch Health Outcomes, Park City, UT and Carlsbad, CA, USA.
Packard, Linda Formerly American Academy of Pharmaceutical Physicians, Research Triangle Park,
Papaluca Amati, M. EMEA, London, UK
Pratt, Timothy Shook, Hardy and Bacon International LLP, London, UK and Shook, Hardy and Bacon
LLP, Kansas City, MO, USA
Rahman, Mirza I. Health Economics & Clinical Outcomes Research, Medical Affairs, Centocor Inc., 800
Ridgeview Drive, Horsham, PA 19044, USA.
Reno, Frederick Merritt Island, FL, USA. Email: email@example.com
Shapiro, David A. Integrated Quality Resources, PO Box 8530, Rancho Santa Fe, CA 92067, USA.
Spilker, Bert Bert Spilker Associates, 8004 Overhill Road, Bethesda, MD 20814-1145, USA.
Starkey, Paul Formerly SmithKline Beecham Healthcare, Parsippany, NJ, USA.
Stonier, Peter D. 5 Branstone Road, Kew, Richmond, Surrey TW9 3LB, UK.
Tabusso, Giuliana Via Melchiorre Gioia 47, 20124 Milan, Italy.
Tilson, Hugh H. Ofﬁce of the Dean, School of Public Health, University of North Carolina, Chapel Hill,
NC 27599-7400, USA.
Townsend, Raymond J. Elan Pharmaceuticals, 7475 Lusk Boulevard, San Diego, CA 9212, USA.
Turner, Nadia Astra-Zeneca Pharmaceuticals, Macclesﬁeld, UK
van Troostenburg de Bruyn, Anne-Ruth Takeda Global R&D Centre (Europe), Arundel Great Court,
2 Arundel Street, London WC2R 3DA, UK.
Vogel, John R. John R. Vogel Associates Inc., 328 Pualoa Nani Place, Kihei, HI 96753, USA.
Email: firstname.lastname@example.org; email@example.com
Walker, S. Centre of Medicine Research, Carlshalton, UK
Wells, Marilyn J. Hampton University, Hampton, VA 23668, USA
Williams, R. US Pharmacopia, Rockville, MD, USA
Yasurhara, H. Teikyo University, Japan
Yeon, Howard B. Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.
Young, Michael D. MDY-Associates, Philadelphia, PA, USA.
Anthony W. Fox
Pharmaceutical medicine is unquestionably a strate efﬁcacy, tolerability and purity in drug
young medical specialty. The ﬁrst university chair products (and their equivalents in diagnostics and
in pharmaceutical medicine is less than 10 years old, devices), pharmaceutical medicine has become
and there are no great buildings or institutions evidence based; it is interesting to note that the
dedicated to it, unlike venerable medical specialties more venerable medical specialties are now imitat-
such as chest medicine, neurology, physiology, ing the supposed ‘new kids on the block’ with the
pharmacology and so on. Possibly because of its recent emphasis on evidence-based approaches to
youth, this is a specialty that can be misunderstood the patient.
by those outside it. Even among practitioners of It is therefore not surprising that the diverse and
pharmaceutical medicine, there can be surprise overlapping discipline of pharmaceutical medicine
when they consider their own diversity. is populated by practitioners with varied educa-
Nonetheless, elements of what we recognize tional backgrounds. There can be no doubt that
today as the practice of pharmaceutical medicine clinical experience is always a good prelude to a
have existed for a long time. Withering’s identiﬁ- career in pharmaceutical medicine. But dental sur-
cation of Digitalis purpurea as a treatment for what geons, medical practitioners, nurses, pharmacists,
was then called ‘dropsy’ and the clinical trial of physiotherapists, psychologists and many other
citrus fruit conducted by Lind are examples of drug members of the allied health professions have all
discovery and investigation. Sequential clinical found satisfying careers in this specialty.
trial designs have been borrowed from as far Few medical specialties involve working in
a-ﬁeld as the discipline of engineering and date teams with as large a number of other professions
from the mid-twentieth century. The techniques as of pharmaceutical medicine. For example, gen-
shared with the ﬁelds of epidemiology and public eral practitioners regularly work with nurses, health
health are obvious and also well established. Every visitors, administrators, hospital colleagues and
prescription written in ordinary clinical practice is social workers; radiologists might add radiogra-
a clinical trial of some sort, where n ¼ 1, because phers and physicists to this list and delete the health
human beings are anisogenetic; this even applies to visitors and social workers. But, by way of compar-
identical twins as they age or are exposed to dif- ison, the following list of nouns, all of which have
ferent environments. Ever since the need to demon- their own professions, comprise pharmaceutical
Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
# 2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9
4 CH1 THE PRACTICE AND PRACTITIONERS OF PHARMACEUTICAL MEDICINE
medicine (in no particular order): ethics, chemis- oneself and what one does not like to do at work!
try, pharmacology, computational modeling, phar- But, nonetheless, there will usually be an opportu-
maceutics, project planning, toxicology, regulatory nity to gain some management experience and
affairs, logistics, quality control engineering, skills and to look at the therapeutic enterprise
biostatistics, pharmacogenomics, clinical trials, from a different angle: Appropriate scepticism
politics, economics, public relations, teaching, with regard to the wanted and unwanted effects
pharmacovigilance, marketing, ﬁnance, technical of drugs, and the ways they may be properly and
writing, data automation, actuarial analysis, infor- improperly promoted, is best learned inside the
mation science, publishing, public health, interna- industry and applied outside it. ‘Clinical re-entry’
tional aid and development, intellectual property after two or three years of pharmaceutical medicine
and other types of laws. However, this is not an will not be associated with being out of date in
exhaustive list. Surely, there can be no other indus- terms of knowledge and skills base, although re-
try with as many diverse professionals as this one entry after 10 years almost certainly will. Those
where all have the welfare of other human beings as attempting the latter should anticipate the need for
their ultimate concern? And for those with a life- re-training.
long thirst to learn on a cross-disciplinary basis,
this breadth of intellectual interaction is a magnet.
Conversance with, if not advanced capability in,
these specialties should therefore be an early goal 1.1 Organizations and
of any career in pharmaceutical medicine. Those educational systems
who remain in the industry thereafter usually value
their initial generalist experience. But eventually, Most countries in the developed world have one or
for most practitioners, the opportunity will exist more national societies or academies devoted to the
either to remain as a generalist in pharmaceutical specialty of pharmaceutical medicine. All hold
medicine or to sub-specialize within one or more education and training as central to their mission,
areas in the list shown above. whereas some societies will engage in regulatory
But, perhaps the greatest difference between this or political debates when particular issues arise.
specialty and all other specialties is the value The ﬁrst formal post-graduate qualiﬁcation to
placed on versatility, adaptability, communication acquire in pharmaceutical medicine is a Diploma
skills and teamwork. Physicians and pharmacists in Pharmaceutical Medicine (DipPharmMed). It
must learn that in pharmaceutical medicine, they requires two years of part-time study and tests the
are unlikely to be as predominant as decision knowledge basis for the specialty. This diploma has
makers as they were in clinical practice. Those been examined by the Royal Colleges of Physi-
who can become an expert in some subject and cians (RCP) in the United Kingdom for more than
be respected for it by people both inside and outside 30 years, and its possession qualiﬁes the holder for
the company, even though they may never have membership in the Faculty of Pharmaceutical
heard of that particular disease or drug before three Medicine (MFPM). The Belgian Academy has
months ago, will do well if they can match such more recently introduced a diploma which is
knowledge with superior inter-personal skills. recognized reciprocally with that in the United
Knowing when to lead, when to follow and when Kingdom, and accordingly, there is periodic
to get out of the way, rather than presuming a exchange of examiners. Switzerland is likely to
leadership role in all situations, will always be be the next, and progress toward an analogous
valued in this specialty. goal (‘Board certiﬁcation’) is being made in
Finally, what about those who do not stay in the North America. At least two years’ experience in
speciality? Any clinician who spends just two or clinical medicine and prescribing is a matriculating
three years in pharmaceutical medicine but then qualiﬁcation for these diplomas; in countries where
returns to his or her clinical calling, will have the roles of pharmacists, physician’s assistants and
beneﬁted, if only having learned something about nurses include prescribing responsibility, these
FURTHER READING 5
professionals should enquire from the relevant have to be well informed about the diversity of
Academy or Royal College whether they may formal recognitions that may be held by those
also sit this examination. who can contribute to the industry and its regula-
Beyond the diploma, the European Economic tion.
Area (the European Union plus Iceland, Norway Lastly, is there any evidence for all this opti-
and Liechtenstein) will probably soon recognize mism? In the year 2000, the American Academy of
pharmaceutical medicine as a medical specialty on Pharmaceutical Physicians (AAPP) polled its
the ofﬁcial list and national medical registers. members on their career choices and factors asso-
Achieving the Certiﬁcate of Specialized Training ciated with satisfaction. More than 90% of the
(CSST) will require completion of a modular, part- members indicated overall satisfaction with their
time program of Higher Medical Training (HMT) choice of pharmaceutical medicine. This propor-
for which the diploma will be the matriculating tion was higher than any other that has been
qualiﬁcation. Whether or not holding the CSST, it reported by learned societies from similar surveys
will also become possible to revalidate speciﬁcally in other medical sub-specialties in the United
as a pharmaceutical physician. States.
International compatibility and recognition of
these qualiﬁcations would seem essential in a pro-
fession whose activities are being increasingly
globalized. Many employment opportunities in Further reading
pharmaceutical medicine are with companies that
have become international conglomerates. Intra- Fox AW. 2001. What is pharmaceutical medicine? Clin.
Res. 1: 28–30.
company transfers and international job applica-
Smethurst D. 2004. Pharmaceutical medicine: making
tions can only be facilitated by universally
the leap. Student BMJ 12: 45–58 (see also http://
recognized and accredited qualiﬁcations. www.studentbmj.com/issues/04/02/careers/66.php,
Many other qualiﬁcations are also of beneﬁt in accessed 28 July 2005).
pharmaceutical medicine, even if the holder was Stonier PD (ed.). 2003. Careers with the Pharmaceu-