Pharmacoepidemiology 9

PHARMACOEPIDEMIOLOGY
Define
• Pharmacoepidemiology is the study of drug
efficacy, toxicity and patterns of use in large
populations.
• The joining of the fields of clinical
pharmacology and epidemiology has resulted
in the development of a new field:
pharmacoepidemiology.
• This field involves the following disciplines;
- Epidemiologists.
- Pharmacologists.
- Medicine.
- Biostatics
- Computer programming
- Administrative data
. It studies the relationships between patients, diseases,
and medicines.
Some examples of applications of pharmacoepidemiology
are to:
• monitor the use and effects of medicines in populations,
• measure the occurrence of diseases,
• study the natural history of diseases,
• measure the characteristics of patients with and without
specific diseases,
Basic Concepts of Pharmacoepidemiology
Some basic concepts of pharmacoepidemiology

include:
• Cause-consequence
• Risk estimates
• Study Design
• Data sources
• Methods
Cause-Consequence
• Diseases can be caused by viruses, bacteria,
congenital, or acquired alterations of our
metabolism due to ageing, genetic factors,
and bad lifestyle habits.
• The mechanism by which an isolated factor
leads to a medical condition can sometimes be
very simple. A skateboard fall can result in a
broken arm!
• It can also be complex. Taking aspirin with
naproxen while being genetically susceptible,
smoking, being overweight,
having hypercholesterolemia and being
sedentary may result in an increased risk of
ischemic myocardial infarction.
Points to consider
• Everyone is different.
• Everyone might have a different, personal
definition of health.
• Pharmacoepidemiology helps in
understanding the different weight of these
factors, considered as potential causes, with
regards to consequences (benefit or harm).
Risk Estimates
• Risk, also known as cumulative incidence, has a
similar meaning in epidemiology as it does in
everyday usage – it is about chance.
• Risk is the probability that a negative event will
occur.
• In epidemiology, risk is the observed or
calculated probability that a health event will
occur in a known population - within a specified
time frame after exposure to a specific hazard
Risk Rate
• The risk rate (or incidence rate) introduces
the notion of time.
• Risk rates also measure the frequency of new
cases of a health event in a population, but
they take into account the sum of time that
each participant remained under observation
and at risk of developing the health event
under investigation.
• The risk rate is the frequency with which new
health events occur in a particular time frame
- the number of new cases in a time period
• Relative risk measures the strength of an

association between exposure and disease
and whether an observed association is likely
to be causal.
Reasons to perform pharmacoepidemiology
studies
(1) Regulatory purposes;
• It is required to obtain earlier approval for
marketing.
• As a response to question by regulatory
agency.
• To assist application for approval for marketing
elsewhere.
2. Marketing;
• To assist market penetration by documenting
the safety of the drug.
• To increase the name recognition.
• To assist in re- positioning the drug by;
-Different outcomes e.g. quality of life and
economic.
-Different types of patients e.g. the elderly.
-New indications
- Less restrictive labeling.
• To protect the drug from accusation about
adverse effects. Post marketing surveillance
studies can theoretically be useful as legal
prophylaxis in anticipation of eventually
having to defend against product liability suits.
3. In anticipation of future products.
4.Clinical practice;
• Hypothesis testing.
-Problem hypothesized on the basis of drug
structure.
-Problem suspected on the basis of pre clinical
or pre marketing human data.
-Problem suspected on the basis of spontaneous
reports.
-Need to better quantitate the frequency of
adverse reactions.
• Hypothesis generate need which depends on
whether;-
- It’s a new chemical entity.
- The safety profile of the class.
- The relative safety of the drug within its class.
-The disease to treated include;
• Its duration
• Its prevalence
• Its severity
• Whether alternative therapies are available.
Study designs utilized in pharmaco
epidemiology
• Case- control studies
• Cross- sectional studies
• Case – cross over study
• Case - Cohort studies
• Case report
• Analyses of secular trends.
Safety of drug versus Risk
• Drugs are said to be safe for use but still have
some risks, so consider the degree of safety of a
drug. The drug is safe if its risks are judged to be
acceptable. Assessing the drug requires to
measure the risk and judge the acceptability of
that risk which is the core business in pharmaco
epidemiology. Post marketing surveillance in
pharmaco epidemiological study depends on
ones willingness to tolerate the risk.
• Note; whether looking at it from
Manufacturing, regulator, academician or
clinical point of view, one needs to consider
the risk of adverse reactions which one
considers tolerable.
Factors that affect acceptability of risks
1.Features of the adverse outcome;

• Severity
• Reversibility
• Frequency
• Spread of disease
• Immediate versus delay
• Occurs in all people versus just in sensitive
people.
• The disease is known with certainty or not.
2. Characteristics of the exposure;-
• Essential versus optional.
• Present versus absent.
• Alternatives available
• Risk assumed voluntary
• Drug use will be as intended versus misuse is
likely.
3. Perceptions of the evaluation.
Threats to the integrity and mission of
Pharmaco epidemiology.
• Increasing secret work and non sharing of data
due to contractual obligations with the private
sector.
• Diversion of resources to fringe medicine where
no basis for rational study investigation has been
presented.
• In the desire to obtain funding, conducting studies
where a predetermined outcome is desired and
engineered as a service to the funding agency.
• Neglect by pharmaco epidemiologist of the
plight of the third world consumers, where
drug markets are often unregulated and drug
advertising grossly and dangerously
misleading.
• Increase control and setting of research
priorities in pharmacoepidemiology by private
sector to further its needs which are not
always congruent with public health goals.
• Poly pharmacy prescriptions.
• Publication of poorly conducted research
studies.
• Misinterpretation of results by consumers.
Benefits of pharmacoepidemiology
• Development and Marketing of safe and
effective pharmaceutical products worldwide.
• Facilitate the regulatory process
• To provide a rational basis for drug safety
surveillance.
Reference
European Network of Centres for
Pharmacoepidemiology and Pharmacovigilance
(2015).ENCePP Guide on methodological
standards in pharmacoepidemiology. Revision 4.
Retrieved 14 September, 2015, from
http://www.encepp.eu/standards_and_guidanc
es/methodologicalGuide.shtml
Lazarus J. Popmeranz BH Corey PN. Incidence of
adverse drug reactions in hospitalized patients a
meta- analysis of prospective studied. J. AM
Med. Association 998, 279, 1200-5.
Rawlins MD, Thompson JW. Pathogenesis of
adverse drug reactions Davies DM, ed. Textbook
of adverse drug Reactions. Oxford University
press 1985, 45.

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PHARMACOEPIDEMIOLOGY

Some basic concepts of pharmacoepidemiology

• Relative risk measures the strength of an

1.Features of the adverse outcome;

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