Pharmacovigilance Literature Screening Challenges and Solution

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During recent times, regulations related to pharmacovigilance services  have concentrated largely on medical literature monitoring (MLM), which is a complex procedure, the scope of which continues to deepen and widen. 

  • Background

Adverse drug reactions assume much significance in terms of risk associated with safety of patients and will make a serious impact on costs related to health systems. due to its significant implications for public health and safety of patients, regulatory authorities round the world have enforced and put into practice novel legislations associated with pharmacovigilance in recent times.



From a historical standpoint, activities associated with pharmacovigilance largely hinges on undertakings for detection , which is executed on data assimilated from impulsive reporting systems. But since health professionals tend to under-report any adverse drug reactions, the main target of latest legislations are largely on pertinence of other safety information sources.

Such sources would comprise of scientific literature for tracking the benefit-risk profile of medicinal products, also as signal detection[2]. Simply said, scientific and medical literature could convince be a considerable source for valid information so as to watch the risk-benefit balance and safety profile of medicinal products[3]. this is often specifically in regard to detecting emerging issues in safety or new safety signals.

  • Pharmacovigilance and Literature Screening: The Link

For the uninitiated, literature screening may be a key element of pharmacovigilance. Medical and scientific literature emerges as an important information source on cases of suspected adverse drug reactions (these also are commonly termed as individual case safety reports – ICSRs).

  • Challenges

The continuous growth within the number of sources for data or information, combined with the regulatory requirements could render the procedure to be a rather formidable proposition. Considering that the sources for information has increased multifold as compared to earlier, and therefore the continuous shift in global regulations, teams functioning within the domain of pharmacovigilance are under duress to return up with strategies that aren't only flexible but extensive too 

  • Solution

The European Medicine Agency’s (EMA) latest initiative (September, 2015) is concentrated on lowering the amount of duplicates in terms of monitoring medical literature and efforts at review by the Marketing Authorization Holders (MAHs). This initiative has the potential to reinforce monitoring of medicine for safety by improving the consistency and quality of data as reported within EudraVigilance.

  • Conclusion

In the present day, there's definitely 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.

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