degree as well as at least one year of structured
training or ‘practicum’. Again, European equiva-
lents exist. A four to five-year program following
graduation in medicine can accomplish all of
these. Additionally, those interested in pharma-
ceutical matters which involve epidemiology, but
who do not aspire to board certification, can often
attend specialized courses, and use case studies
in this area to fulfill their academic requirements,
or, of course, at least enroll in a MPH degree
program. Many of these now exist as ‘off-
campus’ (so-called executive) degree programs,
particularly for physicians.
Complicating the training challenge for the phy-
sician pharmacoepidemiologist has been the rela-
tive paucity of academic centers of excellence
specializing in this field. Thus, as part of the FDA
ModernizationAct of 1997 in the United States,the
Congress created, and the agencies working
together have jointly developed, a network of Cen-
ters for Education and Research on Therapeutics,
with particular emphasis on outcomes research and
the capacity in pharmacoepidemiology. For further
details, the reader should consult the CERTs web-
site. The International Society for Pharmacoepide-
miology maintains a registry of academic centers
currently training and conducting research in
Pharmacoepidemiolgy (website: pharmacoepide-
miology.org).
More commonly, if not the ‘high road’, a phar-
maceutical physician will stumble into this area by
lateral transfer within a company, or due to the
chance happening of being assigned a development
project that requires extensive pharmacoepidemio-
logical support. Such physicians can supplement
their training withad hocprograms in statistics and
epidemiology that are commonly offered on a
short-term or part-time nondegree basis by many
universities and training groups, or an executive
MPH.
All physicians seeking to be ‘credentialed’ in
Pharmaceutical Medicine will have, as part of the
required core competencies for the field, extensive
and substantial orientation to the broad field and
approaches of pharmacoepidemiology, so that they
may be effective demanders and intelligent users
of the fruits of pharmacoepidemiology and part-
ners with their physician pharmaceopidemiologist
colleagues.24.11 The future
Pharmacoepidemiology has proved itself over the
last 25 years, and will only grow during this new
century. It is unlikely that society as a whole will
understand the subtle but vital nuances of the
concepts of risk and uncertainty any better in 25
years time than it does now. Governments and the
general public will require the pharmacoepide-
miologist to protect their interests, and to accu-
rately assess the hazards that today’s powerful
drugs will also bring. And tomorrow’s drugs, dri-
ven by the genomics revolution, will only further
underscore the need for epidemiology, to help us
map the genome to the ‘phenome’, that is, the
population manifestations of our genomic make-
up. Although it is by no means clear where our
earliest experiences with genetic alteration will
lead, it is clear thatanyefforts in this arena will
require long-term population-based follow-up.
Cost containment will become increasingly a con-
straint on pharmaceutical medicine, and we must
ensure that it does not bring its own hazard. And
risk management, with its accompanying account-
ability, is emerging as a classic epidemiological
challenge. The future for the pharmacoepidemiol-
ogist trained in both epidemiology and medicine
is bright indeed. The lucky men and women
who choose pharmaceopidemiology will be
highly fulfilled in this subspecialty of pharmaceu-
tical medicine.References
American College of Epidemiology (ACE). 2000.Data
Privacy Protections(www.aceepidemiology.org).
EMEA. 2005.Guideline on Risk Management Systems
for Medicinal Products for Human Use. CHMP,
December (www.emea).
Hartzema A, Porta M, Tilson H (eds). 1998.Pharma-
coepidemiology, an Introduction, 3rd edn. Harvey
Whitney Books: Cincinnati, USA.REFERENCES 311