By Naveen Basar, Biologit Product Manager
Literature Surveillance: An Essential Component of Pharmacovigilance
In the world of pharmacovigilance, staying ahead of potential drug safety risk is paramount. Regulatory bodies rely on Individual Case Safety Reports (ICSRs) to identify and address adverse drug reactions (ADRs).
The scientific literature provides a vital source of data to allow for the identification of ICSRs and new safety information. Large global databases are often referenced as the primary source of high-quality scientific publications, but valuable data could be missing from the picture. This is where the biologit Database comes in.
Per the EMA GVP Module VI.B.1.2.2 (Literature Reports), marketing authorisation holders (MAHs) should have procedures to monitor local scientific and medical publications in countries where their medicinal products are authorised. Relevant safety findings from local journals should be promptly reported to the company's safety department as appropriate. The selection of local journals to be monitored varies by company and may be product or therapy area-dependent.
Local Literature: A Vital Source for ICSR identification
Local biomedical literature sources or websites represent a vital source of information for identifying ICSRs, that may be otherwise missed in the popular global databases:
Comprehensive Safety Data: Local biomedical journals often contain reports from healthcare professionals on the ground, providing insights that might not be captured elsewhere. These reports can reveal more nuanced understanding of a drug's safety profile in the context of the local healthcare system.
Early Warning Signs: ICSRs in local publications can shed light on emerging safety issues sooner, allowing for faster intervention and potentially preventing wider problems. This early detection can lead to improved patient safety and informed regulatory decisions.
Culturally Specific Reactions: Local populations may experience ADRs differently due to genetics or environmental factors. Local literature can unveil these variations, ensuring a more comprehensive understanding of a drug's safety profile for diverse populations.
Local Literature: Unique Challenges
Whilst the importance of local monitoring of journals is evident, it brings with it a unique set of challenges:
Inefficient workflow: Manually searching individual local journal websites for each screening cycle is a time-consuming and cumbersome process. In addition, many local journal websites lack user-friendly search capabilities, making it difficult to efficiently identify relevant articles. Finally, maintaining an up-to-date list of relevant local journals is challenging due to the emergence of new publications and the potential exclusion of others.
Language barriers: The need to search for keywords in both English and the local language significantly increases screening time and effort. Articles published in different local languages require translation by staff with language proficiency, adding an extra layer of complexity and cost.
Reporting and Quality: The process of documenting and reporting local literature screening results can be burdensome and prone to errors. The time-consuming nature of weekly local literature screening can lead to delays in meeting regulatory reporting deadlines. The quality review process may involve repeating the same laborious steps as the initial screening, leading to workflow inefficiencies.
Case Study: Pharmacovigilance Local Literature Screening for Methimazole
Introduction
In this case study we have conducted a global and local search to identify valid ICSRs related to Methimazole. We have demonstrated how our approach using the biologit MLM-AI platform allows users to overcome most challenges of local literature monitoring, and highlights the importance of searching local sources for the identification of ICSRs and safety information.
Methimazole is a thionamide antithyroid agent used to treat hyperthyroidism. We have chosen this drug for a case study as it has been authorised in many countries around the world.
The biologit Database: Global and Local Reach
To screen local literature for methimazole, we leveraged the biologit Database, a comprehensive and continuously updated repository of scientific literature with truly global reach.
The database is fully integrated into the biologit MLM-AI platform for literature monitoring, providing access to multiple databases covering both global and local sources, along with advanced search capabilities.
Methodology
We employed a broad search string encompassing compound and product synonyms for methimazole in English and local languages, and ran a search for 6 months duration.
This approach enabled our platform to scan a massive dataset of 110,000+ journals across 165+ countries.
The search retrieved relevant articles for methimazole from 81128 journals representing 31 countries.
Results
The biologit MLM-AI platform retrieved 189 articles from 31 countries. After automatic removal of 47 duplicates, 142 unique articles were identified. From these results our assessment identified 19 valid ICSRs from 10 countries.
Table 1: Journals retrieved for Methimazole
Table 2: Search results for Methimazole
Figure 1. Journals retrieved from biologit MLM-AI database for methimazole, by country (top 10 countries)
Figure 2: Distribution of Valid ICSRs for methimazole, by country
This search identified some significant Methimazole-associated adverse events:
Aplastic anemia
Hepatitis
Hypersensitivity
Pituitary Hyperplasia
Acute pancreatitis
Agranulocytosis
Glomerulonephritis
In particular, one of the important ICSRs were identified using MLM-AI platform from sources where only non-English version was published. Automatic translation from the platform helped reviewers to make informed decisions on the validity of this ICSR.
As an example, below is a case of a 43-year-old woman who developed ''metimazol-induced agranulocytosis.'' This case was retrieved from the journal Acta Médica Peruana, not published or indexed in PubMed, and therefore could have been missed from a global literature search.
Figure 3: Article Translation using biologit
Conclusion
This case study of methimazole illustrates local literature provides a valuable source of safety information for the monitoring of drug safety. This case study identified a total of 19 significant ICSRs from various countries by monitoring a large number of global and local journals.
By incorporating local sources and leveraging AI-assisted analysis, the biologit MLM-AI platform provides a comprehensive solution for pharmacovigilance. Amongst its advantages:
The biologit MLM-AI platform serves as a comprehensive and continously updated repository of both global and local journals, saving users time and effort of searching individual local journals websites.
Users can easily configure multi language search strings at once and run weekly searches seamlessly and automatically, eliminating the need to search each key term (both English and non-English) on every journal website.
The biologit MLM-AI platform filters assist users in identifying potential ICSRs and safety information, prioritising their workflow, and expediting the ICSR review process.
Auto translation and auto-deduplication features also save a significant amount of time.
This approach achieved approximately 50% time saving for local literature monitoring process compared to conducting the process outside the biologit MLM-AI platform.
* methimazole and metimazol are both used reflecting language differences
Learn More
Other case studies revealing the value of global + local literature searches from a single platform:
About the Biologit MLM-AI Platform
Biologit MLM-AI is a complete literature screening platform built for pharmacovigilance teams. Its flexible workflow, unified scientific database, and unique AI productivity features deliver fast, inexpensive, and fully traceable results for any screening needs.
Get in touch today to discuss your literature requirements and see a demo!
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