Pharmacovigilance necessitates the comprehensive collection and analysis of data from diverse sources to evaluate pharmaceutical products effectively. Medical literature monitoring, in particular, is a pivotal information source that often identifies information from other sources, such as case reports, clinical trial reports and regulatory reports.
Understanding the distinct requirements of regulatory authorities, such as the EMA and FDA, regarding medical literature monitoring is imperative for marketing authorization holders (MAHs) to ensure compliance and enhance pharmacovigilance practices.
FDA and EMA Regulatory Requirements for Medical Literature Monitoring
In the European Union, the European Medicines Agency (EMA) sets out guidance in GVP Module VI (Collection, management and submission or reports of suspected adverse reaction to medicinal products) as follows:
"Marketing authorisation holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used refence databases no less frequency than one a week. The marketing authorisation holder should ensure that the literature review included the use of reference database that contain the largest reference of articles in relation to the medicinal product properties"
In the US, the US Food and Drug Administration (FDA) guidance on medical literature monitoring is outlined in various documents provided by the agency. An important source of information is in Guidance for Industry – Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. This guidance outlines that:
"spontaneous case reports of adverse events submitted to the sponsor and FDA, and reports from other sources, such as the medical literature or clinical studies, may generate signals of adverse effects of drugs"
📖Learn more: In our guide to FDA compliant literature monitoring
Case Study: Literature Monitoring for Olutasidenib
Olutasidenib is a selective and potent isocitrate dehydrogenase-1 (IDH1) inhibitor. Olutasidenib was recently approved by the FDA and is indicated for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in patients with a susceptible IDH1 mutation.
IDH1 mutations are common in a variety of cancers such as gliomas, AML, intrahepatic cholangiocarcinoma and they lean to an increase in the metabolite, 20hydroxyglutatre (2-HG) which participates in tumorigenesis.
Effective and comprehensive literature searches are the cornerstone of patient safety data. Databases must be comprehensive and meet the minimum standards to ensure safety information is not missed. MAHs must ensure that their searches gather the pertinent data that will adhere to their regulatory commitments and contribute to the safety profile of their products.
📖Learn More: In our guide of Literature Databases for Regulatory Searches
biologit MLM-AI is a complete scientific literature monitoring platform, including an integrated literature database covering PubMed and a range of global and regional sources including Crossref, the Directory of Open Access Journals (DOAJ) and many more.
To investigate the value of broad data sources in literature monitoring, this case study reports results of literature searches using the biologit Database against PubMed alone:
A search for Olutasidenib was run on both PubMed and the biologit Database covering the period 01 Jan 2023 to 31 December 2023.
The biologit Database retrieved 12 additional articles not present in PubMed, while capturing all articles from the PubMed search (two PubMed hits were excluded as falling outside the selected date range).
Duplicate detection automatically excluded 2 articles from the result set, and out of the remaining 10 articles, 8 were identified as having pertinent safety information while the remaining 2 articles outlined authorisation information.
Conclusion: Find More Safety Events with the biologit Database
Safe and effective use of pharmaceuticals is a key objective of pharmacovigilance. Medical literature monitoring is key in ensuring the safety profile of a product. The systematic monitoring and review of medical literature must also ensure screening is performed in comprehensive database.
This case study reveals pertinent articles containing safety information outside of the realm of PubMed. The can however be retrieved from a single search by leveraging the broader reach of the biologit Database.
About biologit MLM-AI
biologit MLM-AI is a complete literature screening platform built for pharmacovigilance, medical device and veterinary vigilance teams. Its flexible workflow, unified global scientific database, which includes local journals and unique AI productivity features deliver fast, inexpensive, and fully traceable results for any screening needs. Teams can save up to 70% of their time and work collaboratively across departments.
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