Challenges and Solutions to Pharmacovigilance Literature Screenng

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CHALLENGES AND SOLUTIONS TO PHARMACOVIGILANCE
LITERATURE SCREENING
TAGS Pharmacovigilance Definition Good
Pharmacovigilance Practice Pharmacovigilance
certification Pharmacovigilance Consultant
Drug safety and pharmacovigilance Signal
detection in pharmacovigilance
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Background
Adverse drug reactions assume much significance
in terms of risk associated with safety of
patients and could make a major impact on costs
related to health systems. Owing to its
significant implications for public health and
safety of patients, regulatory authorities around
the world have enforced and put into practice
novel legislations related to pharmacovigilance
in recent times. Activities related to
pharmacovigilance largely hinges on undertakings
for signal detection, which is executed on data
assimilated from impulsive reporting
systems. Health professionals tend to
under-report any adverse drug reactions, the
focus of new legislations are largely on
pertinence of other safety information
sources. Scientific and medical literature could
prove to be a substantial source for valid
information in order to monitor the risk-benefit
balance and safety profile of medicinal products .
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Pharmocovigilance Regulations

• Regulations related to Pharmacovigilance have
  concentrated largely on Medical Literature
  Monitoring (MLM), which is a complex procedure,
  the scope of which continues to deepen and widen.
• Current regulations offer in-depth guidance on
  medical literature searches and review in order
  to facilitate reporting of individual Case
  Safety Reports (ICSRs) those that have not been
  directly reported to the sponsor, while helping
  signal detection .

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Literature screening is a key element of
pharmacovigilance.
Medical and scientific literature emerges as a
vital information source on cases of suspected
adverse drug reactions.
Pharmacovigilance and Literature Screening The
Link
Main objective of the screening is to recognize
ICSR and / or any substantially new information
from studies pertaining to safety and efficacy.
Such studies might not be covered through current
product labeling and / or any deviation from the
existing safety information pertaining to the
product label.
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Challenges
The continuous growth in the number of sources
for data or information, combined with the
regulatory requirements could render the
procedure to be a rather formidable
proposition. Teams functioning in the domain of
pharmacovigilance are under duress to come up
with strategies that are not only flexible but
extensive too as . Pharmaceutical organizations
are confronted by several challenges in terms of
scientific literature screening. Contd.
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Pharmaceutical organizations are faced with the
issue of amalgamating the continuously growing
data on safety from literature, within their
efforts towards pharmacovigilance .
This is done with the objective of being
compliant with regulations that are
applicable. Literature screening for product
citations emerges to be a humongous task. This
requires significant time (in excess) to be
invested, cost and effort of sifting through
large volumes of cross-disciplinary and
heterogeneous reports.
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The European Medicine Agencys (EMA) latest
initiative (September, 2015) is focused on
lowering the number of duplicates in terms of
monitoring medical literature and efforts at
review by the Marketing Authorization Holders
(MAHs).
Solution
This initiative has the potential to enhance
monitoring of drugs for safety by improving the
consistency and quality of information(EudraVigila
nce).
Monitoring medical literature and entering
pertinent data within EudraVigilance would be
executed by the EMA in order to improve adverse
drug reaction reporting efficiency. ICSRs found
within the literature would be rendered available
to MAHs, enabling them to incorporate it within
their safety databases while meeting their
obligations in terms of reporting .
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Conclusion
There is a gnawing need for the industry to adopt
novel, extensive, cost-effective and efficient
solutions for medical literature screening and
review with a view to match the continuously
evolving marketing, regulatory and strategic
requirements. In order to ensure regulatory
compliance, Pharmaceutical organizations should
adopt enhanced tools and procedures that allow
triage, monitor and review pertinent articles
from every literature source available. This has
to be rather rapid as well as accurate and at the
same time should also have the capability to
interrogate and incorporate new streams of
data. Such solutions need to facilitate incorpora
tion of safety data from diverse sources within a
single unified repository throughout the whole
lifecycle of the product.
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