Principles and Practice of Pharmaceutical Medicine

(Elle) #1

24 Pharmacoepidemiology


and the Pharmaceutical


Physician


Hugh H. Tilson


The specialty practice of preventive medicine
extends into the realm of pharmaceutical medicine
just as deeply as better-recognized disciplines such
as clinical pharmacology or toxicology. Pharma-
ceutical physicians may often be found practicing
preventive medicine under the guise of clinical
research or regulatory affairs, or in separate depart-
ments of pharmacoepidemiology, health econom-
ics or outcomes research, as well as the perhaps
more predictable aegis of drug safety and pharma-
covigilance.
Preventive Medicine/Public Health physicians,
alias pharmacoeconomists and pharmacoepide-
miologists, are trained in the core sciences of pub-
lic health – epidemiology and statistics along with
their nonphysician pharmacoepidemiology collea-
gues. But, being physicians, they are also steeped
in pathophysiology, diagnostics, therapeutics and
behavioral sciences. Additionally, specialization in
preventive medicine requires detailed education in
environmental health and general management and
behavioral science skills. Many of these areas of
expertise are shared with other types of pharma-
ceutical physicians, for example clinical trialists. It
is not uncommon to find professionals moving (or
oscillating) between pharmacoepidemiology and
other departments within the same company or
regulatory agency.


Public health physicians use all these tools to
identify, and control, public health hazards. In the
pharmaceutical sector, these skills extend to such
hazards associated with pharmacotherapy. Phar-
macoepidemiologists have an additional dimen-
sion to their work, in that they may study drugs
not only as a potential hazard to the public health
(perhaps through drug surveillance programs) but
also as a potential benefit to the public health (e.g.
in large-scale interventional, clinical outcomes or
economics studies). Identifying the types of
patients who are most likely to benefit (or be
harmed) by a therapeutic intervention is merely
an extension of the orthodox world in which the
public health physician practices. Thus, preventive
medicine physicians may be found in pharmaceu-
tical companies, CROs, academic, governmental
and international political environments.

24.1 Epidemiology


The word has three components, from the Greek
epi, upon;demos, the people; andlogos, the study.
These elements describe the fundamentals of what
epidemiology is all about, the application of scien-
tific principles to the understanding of health issues
which are ‘upon the people’.Allpharmaceutical

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

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