PHARMACOEPIDEMIOLOGY By: Dr. Aqeel Nasim (M.Phil Pharmacy Practice) Introduction Pharmacoepidemiology is the study of interactions b...
PHARMACOEPIDEMIOLOGY
By:
Dr. Aqeel Nasim (M.Phil Pharmacy Practice)
Introduction
Pharmacoepidemiology
is the study of interactions between drugs and human populations,
investigating, in real conditions of life, benefits, risks and use of drugs.
Pharmacoepidemiology applies to drugs the methods and/or reasoning of both
pharmacology and epidemiology. The development of pharmacoepidemiology should
improve the “rational drug use” (Montastruc et
al., 2019).
The
study of illness and health in human communities is known as epidemiology.
One of the things that influences such a distribution is drugs (Porta &
Hartzema, 1987).
The
application of epidemiologic information, techniques, and reasoning to the
study of drug effects and usage in human populations is known as
pharmacoepidemiology. Pharmacoepidemiology encompasses both descriptive and
etiologic techniques (e.g., characterising a phenomenon or calculating a risk
in real-world situations) (e.g., determining the extent to which a health
product is likely to increase a risk under real conditions of use) (Garbe &
Suissa, 2005).
The
objective of this field is to characterise, control, and anticipate the effects
and applications of pharmacological treatments. The economic impact and health
benefits of unexpected pharmacological effects are also addressed in
pharmacoepidemiology. The need to generate a more realistic image of how
medicines are used in the general population has fueled the growth of
pharmacoepidemiology (Wertheimer
& Andrews, 1995).
Clinical
evaluation of drugs before approval is based on the experimental design of
clinical trial with randomization of drug exposure. Unfortunately, conclusions
of clinical trials are necessarily limited to patients included into the
trials. It is thus necessary to compare these experimental data coming from
clinical trials with the real use of drugs in clinical practice (Montastruc et
al., 2019).
Brief
History of Pharmacoepidemiology
Pharmacoepidemiology
as a field is probably just a few decades old. The term was coined only a
little more than 25 years ago, and prior to that, Jan Venulet coined the phrase
"pharmaceutical epidemiology." It may be simply defined as the use of
epidemiological methodologies to study the impact of medications, such as
vaccinations and cell-based or biological therapies (Venulet, 1974). The founding of the
International Society of Pharmacoepidemiology and the development of particular
scientific techniques and huge databases marked the beginning of the modern era
in 1985. Pharmacoepidemiology emerged as a result of a lengthy time in which
the true aim of medications, i.e., patients in real-life situations, was
ignored, with the truth supplied exclusively by pre-approval or peri-approval
clinical studies (Bégaud, 2019).
Principles
of pharmacoepidemiology
In
clinical and pharmacy practise, pharmacoepidemiology has made a significant
contribution to better prescription and understanding drug safety. Prescription
patterns, medication mistakes, and nonadherence to drugs have all been found
via studies, which have aided in the improvement of postmarket surveillance of
medicines and medical devices and offered evidence for bettering drug usage and
health outcomes (Nishtala
& Narayan, 2019).
Some
pharmacoepidemiology concepts are utilised to obtain further insight into the
efficacy, and notably the safety, of new medicines after they have transitioned
from restricted exposure in controlled therapeutic pre-registration studies to
the more open circumstances of community usage (Tulunay &
Orme, 2012).
Role
of Pharmacoepidemiology in the Healthcare System and Academia
As
regulators move toward adaptive drug approval processes, which are designed to
provide patients with earlier and more progressive access to new drugs, and as
learning healthcare systems emerge, the perspective of pharmacoepidemiology is
expected to become increasingly important. In the healthcare delivery system
and academic medical institutes, pharmacoepidemiology has become a major
discipline. Pharmacoepidemiology has become a major tool for converting
real-world data into evidence that can be used to influence clinical,
regulatory, and policy choices as records of healthcare interactions and
transactions are increasingly collected digitally. Data is examined using
ever-more sophisticated software and technology, as well as ever-more complex
epidemiologic and analytic approaches (Gagne &
Avorn, 2019).
Applications
of pharmacoepidemiology
·
studies of drug utilization;
·
evaluating and improving physician prescribing;
·
special methodological issues in
pharmacoepidemiology of vaccine safety;
·
pharmacoepidemiologic studies of devices.
·
Studies of drug-induced birth defects;
·
pharmacoepidemiology and risk management; the
use of pharmacoepidemiology to study medication errors;
·
Food and Drug Administration (FDA) Sentinel
Initiative; and comparative effectiveness research are the other studies (chapter: et
al., 2013)
References
Bégaud,
B. (2019). A history of pharmacoepidemiology. Therapies, 74(2), 175-179.
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