Principles and Practice of Pharmaceutical Medicine

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
speciality of pharmaceutical medicine.
Pharmaceutical medicine can be defined as ‘the
discipline of medicine that is devoted to the dis-
covery, research, development, and support of ethi-
cal promotion and safe use of pharmaceuticals,
vaccines, medical devices, and diagnostics’ (by-
laws of the Academy of Pharmaceutical Physicians
and Investigators, APPI). Pharmaceutical medi-
cine covers all medically active agents from neu-
traceuticals, through cosmeceuticals and over-the-
counter (OTC) pharmaceuticals, to prescription
drugs. Furthermore, the speciality is not confined
to those physicians working within what is classi-
cally considered the pharmaceutical industry but
includes those involved in the clinical management
or regulation of all healthcare products. It is the
basic speciality for physicians within the cosmetics
and nutrition industry for those in the device indus-
try and for those in ‘not-for-profit’ companies, such
as those responsible for the national blood supplies
and/or for specialized blood products. Further-
more, it is the fundamental discipline for physi-
cians who are in government health ministries,
insurance companies, National Health Trusts or
HMO management, drug regulatory agencies or
any other oversight or regulatory function for
healthcare.
In the early part of this quarter-century, for a
medicine to be adopted and to sell, it was sufficient
that science could conceive of a new treatment, that
technology could deliver that treatment, and that
clinical research could prove it effective and safe
for the physician to use. This is no longer the case.
Over the past three decades, we have seen the
emergence of two major influences in decisions
about new advances in healthcare. These are the
payer–providers and the patient–consumers. Their
role in the decision-making process has increased
rapidly in the last 25 years, as can be seen in
Figure 2.1.
With an increasing proportion of society’s
healthcare budget spent on pharmaceuticals, even
a growth in the percentage of the gross national
product that governments are willing to allocate to

healthcare has been unable to meet the demands of

unbridled development. This has made the payer/

provider a major determiner of the use of pharma-

ceuticals. All possible treatments cannot be freely

available to all and a cost-to-benefit consideration

has to be introduced. This, in turn, has ensured that

pharmaceutical medicine involves pharmacoeco-

nomics training and even media training to deal

with what, for some, may be seen as the rationing

and/or the means-testing of access to the totality of

healthcare options. These are significant ethical

and social issues, and physicians within the phar-

maceutical industry or the health regulatory agen-

cies will inevitably be required to provide a

perspective, both internally and to those outside.

The second new decision maker in the provision

of healthcare has arrived even more recently as a

crucial component. These are the end-user or

patient groups. The rising status of the physician

since the nineteenth century has encouraged a

paternalistic doctor–patient relationship, with the

physician clearly in the lead. In recent times, the

natureof thisrelationship hascome underquestion.

The advent of holistic medical concepts focused on

the whole patient, and taking into account the

entirety of an individual patient’s life has forced

changes in the focusing of any therapeutic interac-

tion. The general increase in educational standards

within the developed world and the massive

increase in available information culminating

today with the electronic media and the Internet

has inevitably produced a more informed patient.

This has empowered the patient and led to the

formation of all kinds of public interest and patient

groups. Furthermore, the ability in this century to

think in terms of the maintenance of good health

and even of the abolition of disease (e.g. smallpox

and polio) has changed the patient’s and society’s

Relative influences (%)1970s 1980s 1990s 2000s

Science

Providers

Patients

Figure 2.1 The influencers of healthcare provision

8 CH2 PHARMACEUTICAL MEDICINE AS A MEDICAL SPECIALTY