Pharmacoepidemiology Introduction
INTRODUCTION, DEFINITION &SCOPE
Epidemiology is the study of the distribution and
determinants of diseases in populations
Epidemics is the study of chronic/ infectious diseases in
large populations
Pharmacoepidemiology is the application of the principles
of epidemiology to drug effects and drug use. Hence,
Pharmacoepidemiology is the study of the use of and the
effects of drugs in larger population
+It involves the examination of a single individual or large
groups of people followed for many years
It involves gathering & analysis of information in order to identifyy
possible causation & related factors, that can be applied in clinical
practice to group of people & also to individuals undergoing
treatment
ORIGIN& EVOLUTION.
ADRs to drugs were as old as modern
which
pharmacotherapy
was developed in 20" century.
Drug resistance, drugabuse & variations in rates of clinical
effectiveness were the other therapeutic
problems which
emerged.
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Pharmacoepidemiology Introduction
I n 1961, the case reports of maternal use ofthalidomide with
malformations in offspring results in awareness of the
potential for drugs to cause ADRs.
Since then, a greater attention was focused on the detection,
prevention & management of ADRs & the era of
Pharmacoepidemiology has began
The important ADRs detected through these systems
include,
Grey baby syndrome due to Chloramphenicol
Vaginal cancer in springs
off of women who took
diethylstilbestrol during pregnancy
Isotretinoin induced birth defects
Triazolam induced CNS disturbances
Suicidal ideation with Fluoxetine
Deaths with Fenoterol
Venous thromboembolism with OCs.
of
ISPE was formed,to obtain more data on risk & benefits
& disseminate
drugs in population and to discuss, develop
methods
information about Pharmacoepidemiological
related field of drug utilization was
In early 1960, the
the study of ADRs
developed along with
Previously, DU studies were conducted mostly for marketing
for use by health
data were not available
purposes and
authorities
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Pharmacoepidemiology Introduction
As a result of wide variations in the pattern & extent of drug
prescribing. growing concern about ADRs &cost of the
drugs, the Pharmacoepidemiological methods were
developed
According to WHO, DU is the marketing, distribution,
prescription & use of drugs in a society with special
emphasis on the resulting medical, social & economic
Consequences
I n Europe, DU research developed at the national &
international level with a common methodology for
comparative DU studies using a
relatively economic&
readily available drug
statistical sources
In NA, DU research was developed
on a smaller s ale & was
most emphasized on the qualitative aspects of prescribing
(antibiotics)
DUR is an authorized, structured & contnuing program that
reviews, analyses & interprets patterns of drug use against
predetermined standards
I n Europe, the medical audit concept was implemented &
was defined as a searching examination of the way in which
drugs are used in clinical practice carried out at intervals
frequent enough to maintain generally accepted standard of
prescribing
I t was mainly focused on medical practitioners with aim of
improving the Rational Drug Usage(RDU)
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Introduction
PharmacoepidemiologY
NEED OF PHARMACOEPIDEMIOLOGY
some drug events
models to investigate
Lack ofalternative
evaluate teratogenic effects of a new
E.g.: to
medicine
inadequate to answer questions
Trials (CTs) are
Clinical
statistical power
about drug safety, as they lack adequate
effectiveness, the sample
all adequate for establishing
If at detect less c o m m o n
ADRs
size are inadequate to
selected patients without any
C T s are conducted on highly
medications.
no other
co-morbidities & who taking
patients
CTs does not involve elderly, pediatric or pregnant
indication
CTs investigate the single
information related to
Hence, CTs fail to provide adequate in
conditions&
drug under non-trial
safety & efficacy of a
other indications
Pharmacoepidemiological
models provide
In contrast,
evaluate drug effects.
alternative approaches to
AIMS OF PHARMACOEPIDEMIOLOGY
1. Signal generation:
serious ADRs
Identification of new, sometimes
Also helps to detect new applications of a drug
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Pharmacoepidemiology Introduction
Ex: Minoxidil is used as Antihypertensive and Hirsutism
2. Risk quantification:
PEY models can be applied for risk quantification which
make use of "The rule of three" indicates if an event occurs in 1 of
every 5000 exposed persons, 3 x 5000, People would be needed
in a sample to be 95.
3. Hypothesis testing
It requires the use of comparison groups to determine whether
there are differences in variables of interest
APPLICATIONS OF PEY
1. Estimation of the risks of drug use:
The risk involved in drug use can be quantified
.The benefits & risks of use of a drug may be
weighed
.Risk estimation also helps to
identify risk situation
Ex: Case reports of triazolam induced psychiatric disturbances
appeared soon after its introduction to market
The drug withdrawn in some countries . The reaction was
was
likely due to dose related, hence the problem was abated
recommending a lower dose
by
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Pharmacoepidemiology Introduction
2. Use in patient counseling:
Collection& analysis of observational data from other studies
may help to address certain issues through counseling the
patients
Ex: A pregnant patient may wish to terminate pregnancy if there
is a substantial risk for producing a seriously malformed child, but
would also wish to proceed with the pregnancy if the risk is low.
3. Formulation of public health policy decisions:
Qualitative as well as quantitative information from PEY studies
helps to address many issues
Ex: If an inappropriate prescribing is observed among
prescribers, regulatory agencies may require educational
intervention or may impose restrictions on specific drugs or on
practitioners
PEY studies also helps the policy makers to assess whether
a drug should be withdrawn from the market or allowed to remain
4. Facilitation of pharmacoeconomic evaluations:
Data from PEY studies can be used to measure the effects
of drugs on overall health care costs & resource consumption
Ex: Hospitalization due to serious adverse effects of a drug
leads to more expenses as well as resource consumption, which
could be avoidable
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