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.
Pharmacovigilance
and Literature
Screening: The Link
Medical and scientific literature emerges as a vital information
source on cases of suspected adverse drug reactions.
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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Copyright © 2019 pepgra. All rights reserved
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
The European Medicine Agency’s (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).
This initiative has the potential to enhance monitoring of drugs for safety by
improving the consistency and quality of information(EudraVigilance).
Solution
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 incorporation of safety data from diverse sources within a single unified
repository throughout the whole lifecycle of the product.
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