Pharmaceutical Medicine

Int J Pharm Med 2007; 21 (4): 253-262CURRENT OPINION 1364-9027/07/0004-0253/$44.95/0

© 2007 Adis Data Information BV. All rights reserved.

Pharmaceutical MedicineHistory, Global Status, Evolution and Development

Peter D. Stonier,1 Honorio Silva2 and Herman Lahon3

1 Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK, London, UK2 Science & Medical Professional Development, Pfizer Inc., New York, New York, USA3 International Federation of Associations of Pharmaceutical Physicians, Brussels, Belgium

For over 30 years pharmaceutical medicine has developed as a medical scientific discipline for the discovery,Abstractdevelopment, evaluation, registration, monitoring and medical marketing of medicines for the benefit of patientsand community health. Pharmaceutical medicine occupies common ground between the clinical and healthcareprofessions, pharmaceutical industry and government. While the boundaries of pharmaceutical medicine areindistinct, at its centre is the clinical testing of medicines, translation of drugs into new medicines, safety andwell-being of research subjects in clinical trials, and understanding the safety profile of medicines and theirbenefit-risk balance. Pharmaceutical medicine is a discipline that takes its place alongside other medicalspecialties; it has developed its own professional ethos; it has established a distinct body of knowledge basedprimarily on clinical science; and its practitioners represent a cohesive group of specialists with common goalsand aspirations. Pharmaceutical physicians work in industry, drug regulatory authorities and clinical researchorganisations, but have a close affinity with their medical colleagues in primary and secondary healthcare and atuniversities.

As a postgraduate medical discipline, pharmaceutical medicine has a recognised international syllabus,training courses with examinations and qualifications, its own research methodologies, professional bodies andacademic societies, journals and texts, and embraces new technologies and regulations in pursuit of proof ofefficacy, safety and effectiveness of medicines. Pharmaceutical medicine is a listed medical specialty in the UK,Ireland, Switzerland and Mexico. This official recognition is underlined by the availability of accreditededucation and training of specialist pharmaceutical physicians and the establishment and maintenance ofstandards of practice and professionalism in the competency, care and conduct applied to their work and ofgrowing public recognition and accountability.

Pharmaceutical medicine is the medical scientific discipline The emergence of pharmaceutical medicine, as a discrete medi-cal discipline, has established channels for communication andconcerned with the discovery, development, evaluation, registra-opportunities for development and advancement for medical pro-tion, monitoring and medical aspects of marketing of medicinesfessionals in the pharmaceutical, biotechnology, clinical researchfor the benefit of patients and public health.[1,2] Implicit in thisand medical device industries, as well as those in academia,definition are vaccines, medicinal components of medical devices,regulatory or government agencies. Notwithstanding, most bi-diagnostics and all forms of available medicines. Overall theomedical professionals are not fully aware of the mission anddescription of pharmaceutical medicine depicts an ethical, medicalvision of the pharmaceutical industry, and the complexities andand scientific endeavour to provide effective and safe medicallyregulations associated with drug discovery, development and com-active agents for patients across the spectrum of diseases. Doctorsmercialisation.working in this medical discipline, while not dealing with individ-

ual patients, influence the health and well-being of populations, Pharmaceutical medicine is a broad medical specialty thatcohorts and groups of patients, and place the safety and interests of requires pharmaceutical physicians to have a wide range of experi-those patients uppermost in their activities and decisions. ence, including training and expertise in basic research, drug

254 Stonier et al.

development and evaluation, clinical trials and registration as well increased influence of payer-providers and of patients themselvesas a thorough understanding of pharmacoeconomics, medical as- in their treatment, the acceptance of the need to consider clinicalpects of the marketing of medicines, business administration and and cost-effectiveness in addition to the traditional proof of effica-the social impact of healthcare on patients and public health.[3] The cy, safety and quality in making medicines available to the public,basics of pharmaceutical medicine are founded on the knowledge have all increased the intimate involvement of the medical profes-and understanding of how drugs work, the limitations and variabil- sion in the development, introduction and maintenance ofity of response to therapies, and how therapies can be used medicines.[4,6]

optimally in clinical practice. Throughout this period the specialty of pharmaceuticalmedicine and its medical practitioners have developed hand-in-hand with regulations, in what must now be considered one of the1. Historical Aspectsmost regulated of industries.[7]

The discipline of pharmaceutical medicine has evolved over a2. The Role of the Physician in the Discipline ofperiod of two millennia, developing from the use of herbs andPharmaceutical Medicinenatural medicaments to relieve pain and aid the sick in coping with

their ailments. The scientific basis of medicine, developed over theFifty years ago, the life of physicians in the pharmaceuticallast 100–150 years, resulted in an exponential growth of knowl-

industry was not particularly enviable because there were notedge and a shift in society’s approach to pharmaceuticals, movingmany doctors employed in each company and jobs in the industryfrom unregulated sale and use to government intervention andcame to be regarded as having a low status by others in theprofessional regulation, and the requirements to demonstrate safe-profession.[6] It was possible for pharmaceutical physicians toty and, later, efficacy before medicines were marketed. These legalbecome quite isolated from the mainstream of the medical profes-requirements reflected changes in social attitudes and expectationssion and recognising this, they joined together in 1957 to form theof medicines based around questions posed by biological and basicAssociation of Medical Advisers in the Pharmaceutical Industrysciences.[4]

(AMAPI; later called the British Association of PharmaceuticalThe medical profession has always been concerned about thePhysicians [BrAPP]) as a vehicle for mutual support.quality and safety of medicines, because drugs are so central to the

Decades later, the pharmaceutical industry has become anpractice of medicine and treatment of the sick, with surgery andinteresting employment opportunity for physicians since an in-advice being the other treatment interventions by doctors. Thecreasing number of professionals with medical degrees are neededemergence of pharmaceutical medicine as a medical scientificby the pharmaceutical industry to support many tasks requiringdiscipline and the role of doctors within it have been described,medical training and expertise. These physicians and professionalsand the history traced, by a number of authors who have used thereport satisfaction with the pharmaceutical industry because:milestones along this path to fix turning points, accelerated devel-

• the work is never repetitive, dull or boring;opment or increased recognition of pharmaceutical medicine as a

• they encounter a new set of challenges and problems everymedical discipline.[4-6]

working day;Examples of pivotal events from which pharmaceutical

• there is a strong sense of accomplishment, team work andmedicine has sprung include: the foundation of the Royal Collegecollaboration in their job environment.[8]of Physicians (England) in 1518; the appointment of inspectors to

search apothecaries’ shops and destroy defective medicines; the However, the opportunity for advancement in pharmaceutical,introduction of the London Pharmacopoeia in 1618; the arrival of biotechnology and medical device companies may be limited duescientific medicine and, at the turn of the 20th century, the emer- to an incomplete understanding of, or insufficient skills in, phar-gence of drug manufacturers as the forerunners of the modern maceutical medicine.pharmaceutical industry; the introduction of anaesthetics, antipy- Pharmaceutical medicine was initially considered outside theretics and hypnotics; the emergence of statistical methodology and conventionally respected medical and scientific professions. Thisthe development of randomised controlled clinical trials; and the was despite the ultimate responsibility of pharmaceutical physi-tragedy of thalidomide and growth of drug regulation. cians for interpreting clinical data to determine whether or not

In the modern era of the last 50 years, the employment, in drugs should be, or should continue to be, marketed. These consid-increasing numbers, of physicians by companies and the growth of erable responsibilities extended nationally, and for some regulato-medical departments and research and development operations, ry and pharmaceutical physicians, internationally. The responsi-the need to be involved in the ethical marketing of medicines, the bility could be likened to signing prescriptions for whole coun-

© 2007 Adis Data Information BV. All rights reserved. Int J Pharm Med 2007; 21 (4)

Global Status of Pharmaceutical Medicine 255

tries, with some pharmaceutical physicians responsible for the 2. To assess the benefits and risks of medicines; to manage thoseactual signing, many for providing information to ensure the risks and arrive at a benefit-harm balance that supports, or not, theprescription was correct, and others, through government regulato- continued availability of a medicine on the market. To strive in thery departments and committees, for scrutinising the prescription interests of patients’ safety and well-being to provide access toonce it was written.[5] effective and appropriate medicines for their condition.

3. To maintain the viability of the medicines industry so that itPharmaceutical medicine is a multidisciplinary and globalcontinues to produce innovative medicines for unmet medicalfield, involving scientists and a wide range of professional andneeds. Pharmaceutical physicians must be able to temper thetechnical groups, both medical and nonmedical, in its work togeth-natural desire of commercial companies to make profit with theer with support from legal, financial and administrative profes-need to ensure that medicines are of a high standard so thatsions. As a medical specialty, it is also very broad, encompassing:patients’ interests are safeguarded. Similarly, regulatory physi-physicians working in basic research to identify targets for drugcians need to be able to temper the natural desire of governmentsaction; experimental medicine to identify potentially useful bi-to avoid all risk of injury due to drugs with the need to makeomarkers; clinical development, running and managing phase I, IIavailable new medicines for patients in the fight against disease.and III clinical trials; pharmacoeconomics; and supporting

medicines in the healthcare marketplace.[9] In their work, these 4. To operate in a professional manner, adopting values,doctors undertake an enormously wide range of jobs in the fields behaviours and relationships that underpin the trust the public hasof drug development, medical affairs, drug safety, regulatory in doctors; to abide by the ethical codes for pharmaceutical physi-affairs, and information, education and communication. cians;[11-13] to set and maintain standards of practice and of compe-

tency and care in work that is in the interests of patients and publicA group of pharmaceutical physicians and their teams deserv-health.ing of special recognition are clinical pharmacologists, whose task

embraces the critical bridge between preclinical and clinical stud-ies and the close evaluation of pharmacokinetics and pharmacody- 3. International Pharmaceutical Medicinenamics, tolerability and dosage in phase I studies, often earlyclinical studies in the patient population with the target disease and In 1970, three British ‘medical advisers’ (as pharmaceuticalalso in special populations such as the elderly and children. It is physicians were known at the time) conceived the idea of holdingthrough the work of these pharmaceutical physicians that drugs an international meeting of global pharmaceutical physicians.reach humans for the first time, and with that comes the attendant While drafting a constitution for the international federation, med-responsibilities to safeguard the well-being of their volunteer ical advisers became aware that their function and responsibilitiessubjects. were quite different from those practised by their colleagues in the

However, the roles of physicians practising pharmaceutical clinic. The need for specific professional national associationsmedicine must be distinguished from the day-to-day jobs they do, became obvious and by 1975 national associations had beenand it is these roles that define the relationship of pharmaceutical formed in 12 countries: Argentina, Belgium, Brazil, France, Ger-physicians to their specialty, whether they are clinical pharmacolo- many, India, Italy, Japan, South Africa, Sweden, The Netherlandsgists, clinical toxicologists, clinical research physicians, medical and the UK.advisers, regulatory physicians, pharmacoepidemiologists or drug The federation was formed and named the International Federa-safety specialists, not only in the pharmaceutical industry but also tion of Associations of Pharmaceutical Physicians (IFAPP) toin regulatory authorities and academia. reflect its global perspective and the movement to no-longer refer

to industry physicians as medical advisers but as specialists.In contributing to the field of drug development and mainte-Today, the IFAPP continues to grow steadily in size and scope,nance, doctors bring to bear an extensive education and clinicaland to fulfil its objective to support the development of associa-training that in itself is sufficient for some commentators to justifytions at a national level (table I).their place at the table.[10] However, to be more explicit, the roles

and responsibilities of all practising pharmaceutical physicians in The IFAPP is a nonprofit organisation with the mission tothe specialty of pharmaceutical medicine are 4-fold. “promote Pharmaceutical Medicine by enhancing the knowledge,

expertise, and skills of pharmaceutical physicians worldwide, thus1. To be involved in the development, introduction and mainte-leading to the availability and appropriate use of medicines for thenance of medicines for the treatment and benefit of patients. Inbenefit of patients and society.”[2] The aims and objectives of theshort, to work throughout their careers towards ensuring that theIFAPP are to:right patient receives the right medicine by the right route in the

right dose at the right time. 1. act as an international forum;


256 Stonier et al.

Table I. National member associations of the International Federation of Associations of Pharmaceutical Physicians in 2007

Organisation Member name Country

American APPI Academy of Pharmaceutical Physicians and Investigators USA

AMEIFAC Mexican Pharmaceutical Physicians Associations Mexico

AMIFE Asociacion de Medicina de la Industria Farmaceutica Espanola Spain

AMIPS Association of Physicians from the Health Products Industry France

AMPIF Associacao dos Medicos Portugueses da Industria Farmaceutica Portugal

APPA Australian Pharmaceutical Physicians Association Australia

APPI Association of Pharmaceutical Physicians of Ireland Ireland

APPS Association of Pharmaceutical Physicians of Singapore Singapore

BeAPP Belgian Association of Pharmaceutical Physicians Belgium

BrAPP British Association of Pharmaceutical Physicians UK

DAPP Danish Association of Pharmaceutical Physicians Denmark

DGPharMed Deutsche Gesellschaft fur Pharmazeutische Medizin Germany

ELEFI Hellenic Society of Pharmaceutical Medicine Greece

FiAPP Finnish Association of Pharmaceutical Physicians Finland

GPMed Gesellschaft fur Pharmazeutische Medizin Austria

HCTMS Hungarian Clinical Trial Management Society Hungary

IPPA Indonesian Pharmaceutical Physicians Association Indonesia

ISMED Turkish Association of Medical Profession Members in the Pharmaceutical Industry Turkey

JAPhMed Japanese Association of Pharmaceutical Medicine Japan

KSPM Korean Society of Pharmaceutical Medicine South Korea

NAPP Netherlands Association of Pharmaceutical Physicians Holland

PAPP Pakistan Association of Pharmaceutical Physicians Pakistan

SAAPP South African Association of Pharmaceutical Physicians South Africa

SAMEFA Argentinean Society of Pharmaceutical Medicine Argentina

SBMF Sociedade Brasileira de Medicina Farmaceutica Brazil

SFM Serbian Association of Pharmaceutical Physicians Serbia

SGPM Swiss Society of Pharmaceutical Medicine Switzerland

SOMFAR Romanian Society of Pharmaceutical Medicine Romania

SSFA Society for Applied Pharmaceutical Sciences Italy

SSPM Swedish Society of Pharmaceutical Medicine Sweden

2. foster the development and international recognition of phar- 3.1 Pharmaceutical Medicine in the USAmaceutical medicine as a separate medical specialty;

In the early 1990s, a formal pharmaceutical medicine society3. foster development of training and continuing educationaldid not exist in the US. Although the idea had been explored forprogramme;many years, it had only been the subject of debate and not of

4. promote a closer relationship and understanding between na-implementation.[14] In the early stages, the Pharmaceutical Manu-

tional member associations and medical and allied professions,facturers Association (PMA) was involved in many of the over-

regulatory authorities and international organisations;arching concerns in pharmaceutical medicine and had a specialist

5. disseminate information on developments in pharmaceutical group termed the ‘Medical section’, which was responsible formedicine to health professionals worldwide; and human ethics and regulatory affairs. In 1981 the PMA Medical6. organise international conferences on pharmaceutical section and the IFAPP fostered the concept of an independentmedicine. association of American pharmaceutical physicians. In 1989, the

Membership of the IFAPP is open to all national organisations core founders lobbied PMA members and the American Academyof pharmaceutical physicians. of Pharmaceutical Physicians (AAPP) was finally formed in 1993.



By 1995, the PMA had evolved into the Pharmaceutical Research year that the UK Medicines Control Agency was established toand Manufacturers of America (PhRMA) and became concerned streamline the regulation of drug development and approval ofprimarily with governmental affairs.[15,16] medicines. [20]

The AAPP was modelled after the European organisations with Further developments to advance the specialty included thethe membership restricted to physicians only. In 1995 the bylaws establishment of the multidisciplinary Society of Pharmaceuticalwere changed to allow membership of physicians outside the Medicine in 1987, with the aim of challenging standards, stimulat-pharmaceutical industry and, subsequently, the membership grew ing research and helping to solve problems at the interfaces ofrapidly to over 1000 members with diverse places of employment academia, industry and regulatory bodies. Together with theincluding: pharmaceutical companies, biotechnology companies, BrAPP (communicating standards and education) and the Facultyregulatory authorities, universities, consultant firms and contract (standard-setting), these three bodies represented the professionalresearch organisations. In 2005, a new entity with a broad mem- infrastructure for the specialty. [21]

bership was formed as the Academy of Pharmaceutical Physiciansand Investigators (APPI). Clearly the role of the Physician Investi- 5. Recognising the Specialty ofgator (PI) overlaps with that of the pharmaceutical physician, and Pharmaceutical Medicinethis was recognised as an important factor leading to the creationof the APPI. The mission of the APPI is “to enhance proficiency of Although there are physicians working for pharmaceuticalall physicians engaged whether directly or indirectly, in the dis- companies worldwide, there is limited awareness of the disciplinecovery and development of ethical new drugs or products and to at the level of the academic and national medical associations,vigorously protect the welfare of all subjects participating in which has contributed to a slow uptake in achieving recognition asclinical research”.[16]

a medical specialty. Pharmaceutical medicine is currently accept-In 2005, the APPI applied to the American Medical Association ed as a medical specialty in the UK, Ireland, Switzerland and

for a certificate of added qualification in clinical pharmacology Mexico. This limited recognition substantiates the need for furtherand pharmaceutical medicine. However, they were unsuccessful in awareness and education.achieving recognition as a subspecialty. In pursuing its aim to achieve formal specialty recognition for

pharmaceutical medicine, the Faculty within the Royal Colleges of4. The Specialty of Pharmaceutical Medicine Physicians of the UK embraced the European legislation establish-

ing pan-European postgraduate medical training. The EuropeanOrganised pharmaceutical medicine is a relatively young spe- Medical Directive (93/16/EEC) established the free movement of

cialty, and whilst physicians have worked with pharmaceutical doctors across Europe, recognition of medical qualifications andcompanies for many years, it was in 1975 that the first structured the issue of Certificates of Completion of Specialist Trainingtraining programme in pharmaceutical medicine was introduced (CCSTs) to those who had completed a prescribed programme offor physicians employed in the pharmaceutical industry; from postgraduate training in medical specialties. Working with the1978 the course, the Postgraduate Course in Pharmaceutical Joint Committee on Higher Medical Training of the Royal Col-Medicine, was jointly organised by the University of Wales (Car- leges of Physicians from 1995, the Faculty developed a postgradu-diff) and the AMAPI.[17] These initiatives paralleled the creation of ate training programme leading to a CCST, which was submitteda diploma examination in the discipline in 1976, with the aim of with an application for listing of the specialty to the Specialistadvancing the specialty, and this was adopted by the Royal Col- Training Authority (1999) and then to the Department of Healthleges of Physicians of the UK as a means of establishing standards (2000). It received the signature of the Secretary of State forin the discipline.[18-20] These developments in the UK are consid- Health in April 2002 and the assent of the UK Parliament, whenered to be the start of organised pharmaceutical medicine. pharmaceutical medicine was listed as a specialty in Schedule 2 of

Elsewhere many countries followed this lead, with professional the European Specialist Medical Qualifications Order (1995).associations, courses of study, and diplomas in pharmaceutical In September 2005, under new legislation The General andmedicine. The large number of national associations are coordinat- Specialist Medical Practice (Education, Training and Qualifica-ed through the IFAPP. tions) Order, 2003,[22] the Postgraduate Medical Education and

In the mid 1980s, in recognition of the growing acceptance of Training Board (PMETB) took over the work of the Specialistthe specialty within medicine, the BrAPP proposed that the Royal Training Authority and Joint Committee for Postgraduate TrainingColleges of Physicians set up a Faculty of Pharmaceutical in General Practice. The Certificate of Completion of TrainingMedicine (FPM), and this was inaugurated in 1989, in the same (CCT) replaced the CCST.


258 Stonier et al.

Specialist recognition and formal listing in the UK followed Since 2003, the CEPM has accredited postgraduate courses atthat in Mexico and Switzerland (which occurred in 1999), and was universities in Barcelona, Basel, Belgrade, Brussels, Cardiff, Dub-followed by similar moves in Ireland, a second Member State of lin, Madrid, Mexico, Stockholm and Surrey (Guildford, UK), withthe European Union, in 2005. Sydney and Latin American universities in Buenos Aires and Sao

Paulo, scheduled for accreditation in 2007.

Through this major harmonisation effort, the CEPM will con-6. Education and Certification intinue to foster the mutual recognition of diplomas in pharmaceuti-Pharmaceutical Medicinecal medicine as well as worldwide recognition of pharmaceuticalmedicine as a medical specialty.Informal educational programmes were developed as physi-

cians met to share experiences, define best practices and stay The CEPM has recently issued Guidance Notes for the Estab-abreast of changes as the pharmaceutical industry experienced lishment of Structured National CME/CPD Programmes for Phar-growth.[23] Originally through the efforts of professional societies maceutical Physicians.[25] Today, such structured programmesand clinical pharmacology meetings, these nonstructured forums only exist in Belgium, Switzerland, the Netherlands and the UK,were important first steps in the educational process for medical but it is hoped that the initiative by the CEPM will assist anddoctors entering the pharmaceutical industry. stimulate other national member associations to organise a similar

system. This will contribute to the evolution of pharmaceuticalAs mentioned previously, the first postgraduate course in phar-medicine as a specific medical specialty. Furthermore, a workingmaceutical medicine was established in 1975 and transferred to thegroup of the CEPM has developed an international computerisedUniversity of Wales at Cardiff in 1978 (now called Cardiff Univer-training course for investigators.sity). This programme was introduced to advance graduate educa-

tion and the status of medical advisors in the pharmaceutical Currently, ten European countries offer postgraduate educa-industry. By 1976, the Royal Colleges of Physicians of the UK had tional programmes in pharmaceutical medicine (table II) with adeveloped the first Diploma in Pharmaceutical Medicine. The range of levels of accreditation from the IFAPP and other academ-Diploma examination was conducted by examiners who were ic institutions. These programmes include a varied approach insenior physicians working in pharmaceutical companies, regulato- course delivery including distance learning, in class lectures andry authorities, universities and hospitals with experience in phar- interactive online learning.maceutical medicine and related specialties such as clinical phar- Most programmes require 2 years of study with course contentmacology and toxicology.[24]

delivered by lecturers from industry, academia, clinical researchIn 1994, the Diploma examination was transferred from the organisations and regulatory authorities. Postgraduate courses in

parent Royal Colleges of Physicians of the UK to their FPM, pharmaceutical medicine are taught under the auspices of thewhich had been inaugurated in 1989. The need to spearhead the CEPM with a mandate to:development of the Faculty evolved as a result of a transition of 1. assist IFAPP’s national member associations to establish ap-clinical pharmacologists and specialist physicians to industry and propriate educational and training programmes in pharmaceuticalregulatory positions. From its inception, the FPM has had a strong medicine;association with clinical pharmacology that forms a fundamental

2. support the development of structured CME and CPDpillar of the Faculty, based on the premise that clinical pharmacol-

programmes in pharmaceutical medicine;ogy and therapeutics are crucial to the pharmaceutical business of

3. contribute to the harmonisation of existing postgraduatethe discovery, development and registration of medicines.[3] The

courses in pharmaceutical medicine;Faculty has overarching responsibility for maintaining and raising

4. promote the mutual recognition of equivalent educationalthe standards of practice in pharmaceutical medicine and hasqualifications and CME/CPD requirements between countries;grown to encompass aspects of an international specialty.andEducation is also a major focus of the IFAPP and in 2001 the5. stimulate the recognition of pharmaceutical medicine as afederation formed the Council for Education in Pharmaceuticaldistinct medical specialty.[2]

Medicine (CEPM). The mandate of the CEPM is to harmoniseTo address these objectives, the CEPM established a coreprogrammes of postgraduate courses in pharmaceutical medicine

curriculum of essential lectures that allows for accreditation byestablished by various universities, internationally, in collabora-IFAPP.tion with the local associations of pharmaceutical physicians, as

well as the continuing medical education (CME) and continuing Taking advantage of the acceptance and success of e-learning,professional development (CPD) programmes for this specialty. internet technologies and distance education[26] a partnership was




Tab

le I

I. P

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ate

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in p

harm

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Eur

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Cou

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obta

ined

Leve

lLo

catio

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each

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time

Lang

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Acc

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Bel

gium

1992

Pos

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lom

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of

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ssel

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and

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ssel

sye

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(PH

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nce

1999

Eur

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iplo

ma

in M

aste

rsU

nive

rsity

of

Lyon

s, L

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325h

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Eng

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Pha

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man

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ters

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ssen

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man

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and

2005

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Spa

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IFA

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eutic

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edic

ine

de M

adrid

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adrid

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eden

2001

Cou

rse

in P

harm

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tical

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lom

aK

arol

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lish

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icin

eU

nive

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lm,

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itzer

land

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Eur

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urse

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ity o

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e U

pper

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neU

nive

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es o

f B

asle

,F

reib

urg,

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asbo

urg

UK

1976

Pos

tgra

duat

e C

ours

e in

Dip

lom

aC

ardi

ff U

nive

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, W

ales

200h

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ears

Eng

lish

IFA

PP

Pha

rmac

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(Dip

Pha

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ed)

UK

1996

MS

c in

Pha

rmac

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alM

aste

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nive

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of

Sur

rey,

288h

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hysi

cian

s.

260 Stonier et al.

formed in 2004 between Hibernia College (Dublin, Ireland) and programme for registered doctors who have completed a period ofPfizer Inc., with academic support from Harvard University and clinical training and secured a position in pharmaceutical medicinethe Royal College of Surgeons (Ireland) that resulted in an interna- within a pharmaceutical company, clinical research organisationtional, online Masters of Science degree in Pharmaceutical or drug regulatory authority. This indicative 4-year programmeMedicine.[27] This web-based Masters programme in pharmaceuti- comprises a specialty knowledge base, leading to the Diploma incal medicine offers a standardised core curriculum as well as Pharmaceutical Medicine and six practical modules in operationaltraining in a broad range of nontraditional disciplines including: areas of pharmaceutical medicine: medicines regulation, clinicalleadership skills, fundamentals of information technology, pharmacology, statistics and data management, clinical develop-eMedicine, business ethics, health economics and finance. Two ment, healthcare marketplace and drug safety surveillance. Agroups of 40 Pfizer employees representing 25 countries were seventh, generic, module requires doctors to practise pharmaceuti-enrolled consecutively in 2005 and 2006. Interim results show cal medicine according to the principles and standards of ‘goodhigh metrics for academic performance and student satisfaction. medical practice’ laid down by the General Medical Council andFurthermore, the programme became available to all pharmaceuti- in the Good Pharmaceutical Medical Practice Guidelines[29]

cal companies in 2007. This innovation in pharmaceutical adopted by the FPM, and to acquire and demonstrate interpersonalmedicine education is the initial step in the integration of critical and management skills for the practice of pharmaceuticalknowledge management and performance improvement in a cost- medicine to the highest expected levels of competency and profes-effective, global manner.[27] sionalism.

Additionally, a novel approach has been created for pharma- The training programme is conducted within a framework ofceutical physicians and physician investigators in the form of the assessment of competencies, appraisal and annual review. TheCertified Physician Investigator examination. Accredited by the outcome for success is the CCT and a place on the GeneralAmerican APPI, this examination is offered to qualified physician Medical Council’s specialist register – in pharmaceuticalinvestigators (PIs) worldwide. It is a written examination that medicine.[30]

certifies that the physician possesses a basic knowledge sufficient In the UK today there are 70 specialist pharmaceutical physi-for the safe and ethical conduct of a clinical trial in accordance cians who have completed specialty training and gained theirwith the appropriate ethical, medical, scientific, legal and regulato- CCST/CCT. There are currently 180 physicians enrolled in thery standards.[28] A PI is defined as a physician who serves as a programme in over 80 establishments approved for training.principal investigator that monitors, supervises or designs clinicaltrials. PIs are responsible for the safe and ethical conduct of 6.2 Country Initiativesclinical trials, including systematic experimentation designed toevaluate pharmacokinetics, pharmacodynamics, pharmacoeco- The IFAPP has 30 national member associations (table I)nomics, safety, efficacy and effectiveness of a drug, biologic, representing over 6600 pharmaceutical physicians. A major objec-medical device, procedure or intervention involving human par- tive of IFAPP’s membership is to obtain formal recognition ofticipants. pharmaceutical medicine from the national body responsible for

An examination for investigators and scientific personnel for granting credit to new medical specialties. To reach this objective,good clinical practice exists in the UK and is accredited by the several prerequisites must be fulfilled, including the existence of aFPM. national association of pharmaceutical physicians, a specific sylla-

bus, a university teaching a postgraduate programme according tothis syllabus and awarding a Diploma or Masters in pharmaceuti-6.1 Specialty Training for Pharmaceutical Physicianscal medicine, a standard-setting body establishing and maintaining

The purpose of training in pharmaceutical medicine is to pro- standards and monitoring the educational programme, and a struc-duce accredited pharmaceutical physicians who are equipped with tured CME/CPD system.specialist knowledge and comprehensive skills and competencies In Japan the concept of pharmaceutical medicine is relativelyto practise to the highest ethical and professional standards, for the new with just over 100 physicians working in clinical develop-benefit and safety of patients and the public, in the development ment, clinical pharmacology, pharmacovigilance, regulatory af-and maintenance of medicines. fairs and marketing within the pharmaceutical industry. Since

The specialty training programme for pharmaceutical physi- implementation of the International Conference on Harmonisationcians was introduced in the UK in November 2002. This is a of Technical Requirements for Registration of Pharmaceuticals forworkplace-centred, competency-based, education and training Human Use (ICH) guidelines in Japan in 1998, the role for



physicians in clinical development have been evolving.[31] The thorities. Experts in pharmaceutical medicine recognise that theplace of pharmaceutical medicine is becoming increasingly impor- next hurdle in harmonisation will be the ‘common technical docu-tant as talented Japanese physicians are recruited to the pharma- ment’ to accelerate registration without sacrificing quality, safetyceutical industry and the quality of clinical trials sponsored by and efficacy.[36] Future discussions should focus on the paradigmpharmaceutical companies is leveraged. shift of genome-driven drug discovery and the rising pressures of

high throughput drug development as insurmountable tasks inIn Switzerland, the European Center of Pharmaceuticallight of the changing face of drug development with the addition ofMedicine (ECPM) was the first and leading university institute forthe biotechnology industry to the milieu.pharmaceutical medicine and drug development. In 1990, the

ECPM course was founded with 80 participants, of whom 66% Importantly, the need for multidisciplinary, harmonised educa-were physicians and 33% nonphysicians; the course has been tional programmes will address the need to strive for betteraccredited by the IFAPP.[32-34] medicines in an integrated drug development environment that

demands better training and education in pharmaceuticalIn 1993, the University of Surrey in the UK was the firstmedicine. Specialists in pharmaceutical medicine, as global physi-University to offer a MSc (Masters) programme in Pharmaceuticalcian managers, are expected to accelerate clinical developmentMedicine, which, as an academic degree, is open to all profession-and the approval cycle by conducting worldwide clinical researchal and graduate groups in addition to pharmaceutical physicians.programmes with effective navigation of the regulatory process. InIn Latin America the Pharmaceutical Medicine Associationsaddition to these responsibilities, there are critical challenges thatfrom Argentina, Brazil and Mexico have developed various CPDface the pharmaceutical industry over the next several years in-activities for their members and maintain close relationships withcluding:the respective government authorities and academic institutions.

• intellectual property and patent protection;In the US, the Drug Information Association (DIA) has taken a

• industry convergence and globalisation; andlead role in providing education pertaining to methodologicalknowledge required for the postgraduate education of pharmaceu- • technology transformation.tical medicine specialists. Ongoing courses include: design, con- Therefore to be effective in today’s employment landscape,duct, monitoring and analysis of clinical trials, pharmacoepidemi- specialists in pharmaceutical medicine must function as globalology, health economic studies, outcomes research, managers.[37]

pharmacokinetics, pharmacodynamics, as well as drug safety and Enhanced and improved education through undergraduate,surveillance, regulatory, approval, marketing and legal issues. [34] graduate and postgraduate programmes will continue to be a

significant contributing factor to the acceleration of and improve-ments to the drug development process by pharmaceutical7. Future of Pharmaceutical Medicinemedicine specialists. Improving the profile of publications inpharmaceutical medicine will also significantly contribute to thePharmaceutical medicine has grown to encompass globaldevelopment of the discipline. The expectations of pharmaceuticaldimensions. The principles of pharmaceutical medicine, whenmedicine in emerging markets will be fulfilled with e-learning andimplemented on a global scale, will enhance the timely introduc-accreditation.tion of novel, high quality medicines to patients anywhere in the

world regardless of economic status. Change has been attributed to Expansion of pharmaceutical medicine throughout the world isgrowing economies with the increased potential to produce and required with a focus on naive populations and those without readydeliver products locally; as well as an increased reach of commu- access to medical school facilities. The fundamentals of the disci-nications and science across national and cultural borders.[35] pline should be included in the medical curriculum at the under-Additionally, unforeseen incremental development in basic phar- graduate and postgraduate levels. However, the education of phar-maceutical research (genetics and stem cell research) has contrib- maceutical medicine specialists requires innovative educationaluted to escalating development of pharmaceuticals.[35] partnerships between academia and the pharmaceutical industry,

achieved through incorporation of the fundamentals of experimen-The pharmaceutical industry and regulatory authorities fromtal and clinical pharmacology and enhanced with trainingthe European Union, US, Canada and Japan have achieved muchprogrammes including drug discovery and development, clinicalin the short history of harmonisation of the interpretation andtrials and regulatory matters.application of technical guidelines and requirements for product

registration. In Latin America, regulatory harmonisation and As a medical specialty, pharmaceutical medicine is dependentstandardisation has contributed to a better relationship and trans- on the progress of medicine and therapeutics and the diverseparency between the pharmaceutical industry and regulatory au- complexity of public health in countries worldwide. Pharmaceuti-


262 Stonier et al.

14. Fox AW. AAPP 1993–2003: the first decade. American Academy of Pharmaceuti-cal physicians are key to this process as they insure the protectioncal Physicians: 2003 report [online]. Available from URL: http://appinet.org/

of patients and the respect of ethics as pharmaceutical companies pdf/History_Booklet.pdf [Accessed 2007 Jun 21]

are driven by scientific and public health priorities and, most 15. Pharmaceutical Research and Manufacturers of America [online]. Available fromURL: http://www.phrma.org/news_room/ [Accessed 2006 Feb 23]importantly, public demand.[38] The future of pharmaceutical

16. Academy of Pharmaceutical Physicians and Investigators [online]. Available atmedicine is dependent on the accelerated development and educa- URL: http://www.appinet.org/ [Accessed 2007 Jun 24]tion of a new generation of innovative, international, multidiscipli- 17. Luscombe DK, Salek MS. An international postgraduate course in pharmaceutical

medicine: a 25-year review. Int J Pharm Med 2001; 15 (6): 261-3nary pharmaceutical physicians.18. Binns TB. A diploma in pharmaceutical medicine. Scot Med J 1976; 21: 163

19. Smith RN. A short history of the Board of Examiners. Int J Pharm Med 2000; 14(5): 283-9Acknowledgements

20. Goldberg A, Smith RN. Pharmaceutical medicine. Lancet 1985; I: 447-8

21. Gabbay FJ, Stonier PD. Pharmaceutical medicine: a recognized medical disci-Dr Chris Allen (Past President, International Federation of Associations of

pline? Have we got the message across? In: Ruiz Ferran J, editor. Communica-Pharmaceutical Physicians) and the Late Dr Louis Sherwood (Immediate Past tion in pharmaceutical medicine: a challenge for 1992. Seventh InternationalPresident, Academy of Pharmaceutical Physicians and Investigators) made Conference on Pharmaceutical Medicine; 1990 Sep 23-26; Madrid, Spain.

Barcelona: Prous Science Publishers, 1991: 369-74important contributions to the manuscript. The authors wish to thank Sandra22. The General and Specialist Medical Practice (Education, Training and Qualifica-Kleinstiver for her contributions to and editorial support for this manuscript.

tions) Order, 2003 [online]. Available from URL: http://www.opsi.gov.uk/SI/The opinions expressed in this article are those of the authors and do notsi2003/20031250.htm [Accessed 2007 Jun 21]necessarily reflect those of the Faculty of Pharmaceutical Medicine or its

23. Stonier P. Development of an educational programme in pharmaceutical medicine.parent colleges or their policies.Int J Pharm Med 2002; 16 (1): 37

The authors have no conflicts of interest relevant to the content of this24. Goldberg A, Shelley J, Smith R. Examination for the diploma in pharmaceutical

review. No sources of funding were used to assist in the preparation of this medicine: a review of 25 years. Int J Pharm Med 2001; 15 (6): 265-9review. 25. Council for Education in Pharmaceutical Medicine. CEPM Guidance Notes for the

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13. Faculty of Pharmaceutical Medicine. Guiding principles for pharmaceutical physi-Correspondence: Professor Peter D. Stonier, Faculty of Pharmaceuticalcians from the Ethical Issues Committee of the Faculty of PharmaceuticalMedicine, 1 St Andrew’s Place, Regent’s Park, London, NW1 4LB, UK.Medicine of the Royal Colleges of Physicians of the UK. Int J Clin Pract 2006;

60 (2): 238-41 E-mail: [email protected]


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