Pharma R&D Today
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Easing the Pain in Monitoring Literature for Adverse Drug Events
Posted on September 20th, 2016 by Neal Katz in Pharmacovigilance
Over the past year, we have heard about the various challenges associated with the cumbersome task of monitoring scientific literature for adverse drug events (AE) from thought leaders on this blog. Pharmacovigilance professionals have written about the literature monitoring and review process, the recent EMA Medical Literature Monitoring initiative, and the importance of literature search strategies.
Between difference in regulations, monitoring literature in local languages, inspection readiness, and the rising sea of literature that must be monitored, there is no shortage of challenges in performing this task in an efficient manner. The number of literature articles that have to be handled continues to rise, and subsequently more AEs are identified. This facilitates the need to ensure all AEs are recognized and assessed, requiring an efficient resource to manage the increasing articles.
To help pharmacovigilance professionals to better organize, centralize, and automate this process, as well as seamlessly support initiatives like EMA MLM, Elsevier has worked with PV experts to deliver QUOSA PV. This browser-based solution allows pharmacovigilance teams to integrate their database literature searches, de-duplicate articles, quickly review articles for case reports, and capture audit trails that can be exported for inspections. In addition, supervisors can monitor backlogs and track team performance in case workloads need to be re-allocated.
The new solution will reduce valuable time currently taken up wading through large amounts of content, and ensuring all relevant information is identified and analyzed. With this in mind PV groups can focus their efforts on their primary role – safeguarding patient safety!
All opinions shared in this post are the author’s own.
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