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| Date post: | 11-Jan-2021 |
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CHALLENGES AND
SOLUTIONS TO
PHARMACOVIGILANCE
LITERATURE SCREENING
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
TAGS:
Pharmacovigilance Definition | Good Pharmacovigilance Practice | Pharmacovigilance
certification | Pharmacovigilance Consultant| Drug safety and pharmacovigilance | Signal
detection in pharmacovigilance |
Copyright © 2019 pepgra. All rights reserved
Background
Adverse drug reactions assume much significance in terms of risk associated with safety of patients andcould 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 theworld 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 isexecuted on data assimilated from impulsive reporting systems.
Health professionals tend to under-report any adverse drug reactions, the focus of new legislations arelargely on pertinence of other safety information sources.
Scientific and medical literature could prove to be a substantial source for valid information in order tomonitor 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 ofindividual Case Safety Reports (ICSRs) those that have not been directly reported to the sponsor, while helpingsignal detection .
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Pharmacovigilanceand LiteratureScreening: The Link
Literature screening is a key element of pharmacovigilance.
Medical and scientific literature emerges as a vital informationsource on cases of suspected adverse drug reactions.
Main objective of the screening is to recognize ICSR and / or anysubstantially new information from studies pertaining to safety andefficacy.
Such studies might not be covered through current productlabeling and / or any deviation from the existing safety informationpertaining to the product label.
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Challenges
The continuous growth in the number of sources for data orinformation, combined with the regulatory requirements could renderthe procedure to be a rather formidable proposition.
Teams functioning in the domain of pharmacovigilance are underduress to come up with strategies that are not only flexible butextensive too as .
Pharmaceutical organizations are confronted by several challengesin terms of scientific literature screening.
Contd.
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved
Pharmaceutical organizations are faced with the issue of amalgamating thecontinuously growing data on safety from literature, within their efforts towardspharmacovigilance .
This is done with the objective of being compliant with regulations that areapplicable.
Literature screening for product citations emerges to be a humongous task.
This requires significant time (in excess) to be invested, cost and effort ofsifting through large volumes of cross-disciplinary and heterogeneousreports.
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
Copyright © 2019 pepgra. All rights reservedCopyright © 2019 pepgra. All rights reserved
Solution
The European Medicine Agency’s (EMA) latest initiative (September, 2015) isfocused on lowering the number of duplicates in terms of monitoring medicalliterature and efforts at review by the Marketing Authorization Holders(MAHs).
This initiative has the potential to enhance monitoring of drugs for safety byimproving the consistency and quality of information(EudraVigilance).
Monitoring medical literature and entering pertinent data within EudraVigilancewould be executed by the EMA in order to improve adverse drug reactionreporting efficiency.
ICSRs found within the literature would be rendered available to MAHs, enablingthem to incorporate it within their safety databases while meeting theirobligations in terms of reporting .
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
Conclusion
There is a gnawing need for the industry to adopt novel, extensive, cost-effective and efficient solutions formedical literature screening and review with a view to match the continuously evolving marketing, regulatoryand strategic requirements.
In order to ensure regulatory compliance, Pharmaceutical organizations should adopt enhanced tools andprocedures 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 tointerrogate and incorporate new streams of data.
Such solutions need to facilitate incorporation of safety data from diverse sources within a single unifiedrepository throughout the whole lifecycle of the product.
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
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