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Pharmacovigilance Techniques

Introduction

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Pharmacovigilance, for the most part, employs study designs

and techniques that are commonly used in epidemiology. This is

because pharmacovigilance is primarily associated with

detecting and responding to adverse drug reactions (ADRs),

which can be studied only through studies such as case-control

studies that rely on epidemiological techniques.

Pharmacovigilance training thus teaches epidemiological study

designs and techniques described as follows:

These are retrospective studies in pharmacovigilance in which a

group of patients with a specific disease are compared with

another group without that disease. Patient histories of previous

exposure to identified risk factors are then compared. This

technique, as will be clear after pharmacovigilance training, is

easy, cheap and fast for collection of data, can help study

uncommon diseases and multiple drug exposures. However, it

may suffer from recall bias and some information could be missed

out.

Case-Control Studies

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Pharmacovigilance courses train students in creating and

studying case reports and series. Case reports are records of

single patients who are administered with a drug. Any

observations including adverse drug reactions are noted. Records

of a group of patients with the same outcome are known as case

series. Case reports and series are helpful in generating drug

safety signals but cannot determine whether an adverse outcome

was the result of the tested drug. The incidence of ADRs also

cannot be quantified. Therefore, these are followed up with more

rigorous studies to confirm their findings.

Case Reports

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This pharmacovigilance technique compares the results of drug

exposure, especially with respect to ADRs,in a group of people

with that of another group that has not been exposed to the same

drug. These could be either retrospective or prospective studies.

Pharmacovigilance training incorporates these studies because

they enable the calculation of precise risks and incidence rates,

offer unbiased data for drug exposure, are applicable to the

analysis of multiple outcomes, and have a relatively low selection

bias. However, they are slightly more expensive, could yield

biased outcome data and may be difficult to conduct because of

the need for a large number of subjects.

Cohort Studies

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Another technique that students will come across in

pharmacovigilance training is meta-analysis. This is a very

important part of pharmacovigilance study which helps in the

systematic review of data obtained from clinical trials. Meta-

analytical studies enhance the statistical power of comparing

two different treatments. However, the detection of rare ADRs is

difficult.

Meta-Analysis

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This method analyses trends in exposure to drug which is

presumed to have caused an adverse reaction. This method often

utilizes mortality rates and other such vital statistics. It is helpful

in proving or disproving a hypothesis. The results are however

prone to misinterpretation, which is one of its drawbacks.

Pharmacovigilance courses train students in epidemiological

research techniques that are applied for the detection of ADRs.

Pharmacovigilance officers gain insights into the benefits and

ADRs of marketed drugs in the general public, which helps them

take necessary steps in light of emergencies.

Secular Trend Analysis

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Ikya Global is one of the few best pharmacovigilance training institutes in Hyderabad that offer training at affordable prices along with placement

assistance and certification.

For More Information Please visit http://www.ikyaglobaledu.net/pharmacovigilance.php

For More Information Please visit

http://www.ikyaglobaledu.net