Pharmacovigilance Techniques - Ikya Global Education

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Pharmacovigilance Techniques
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Introduction
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
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Case-Control Studies

• 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.

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Case Reports

• 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.

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Cohort Studies

• 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.

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Meta-Analysis

• 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.

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Secular Trend Analysis

• 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.

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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.ph
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For More Information Please visit
http//www.ikyaglobaledu.net