The medical literature monitoring (MLM) is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Hence, it is important to review suspected adverse reaction gathered from scientific journals, medical researcher, relevant published abstract and draft manuscripts.
Need for medical literature monitoring (MLM)
Marketing authorization holders (MAH) are therefore expected to maintain awareness of possible publications through a systematic literature monitoring review of widely used reference databases (e.g. Pubmed, Medline, Excerpta Medica or Embase) no less frequently than once a week. In addition, MAH should have SOPs in place to monitor scientific and medical publications in local/international journals in countries where medicinal products have a marketing authorization, and to bring them to the attention of the company safety department as appropriate.
Targeting literature ICSRs
Reports of suspected adverse reactions from the medical literature, including relevant published abstracts from meetings and draft manuscripts, should be reviewed and assessed by marketing authorisation holders to identify and record ICSRs. If multiple medicinal products are mentioned in the publication, only those which are identified by the publication’s author(s) as having at least a possible causal relationship with the suspected adverse reaction should be considered for literature review by the concerned marketing authorisation holder(s).
Need of an automated solution for MLM
The expenses and efforts required to obtain important safety information from the vast amount of published literature in many languages and countries of the world is a rather challenging task.
Much of the manual efforts were required in MLM for the activities like
- Extracting the literature articles from the database sources like Pubmed, Medline and Embase by implying specific search strings specific for a medicinal product to find out the valid ICSRS.
- Analysis of articles for identifying duplicates
- Selection of article of interest (AOI) which will be prone for a valid ICSR
- Rejection of articles which were not useful for creation of ICSRs
- Primary and secondary evaluations for the segregated literature articles for an efficient ICSR screening
- Identification of exact no. of literature articles for which valid ICSRs to be created
- Record management for full text requisitions
Hence, there is an immense need of an efficient solution which can automate all the processes of medical literature monitoring (MLM).
Sarjen’s literature monitoring automation module (LAM)
Sarjen’s PvEdge-Literature automation module (LAM) is the NextGen solution which offers many features like,
- Auto collection of all product specific literature articles, abstracts from meetings and draft manuscripts
- Scrutinization of duplicates
- Management and monitoring full-text requisitions
- Classification MAH/Non-MAH articles
- Documentation of all selections and rejections electronically
- Auto filtration of safety publications into selected, non-selected, article of interests (AOI) for PSURs and signal detection
- Inbuilt integrated workflow wherein Medics can review all the selections made by preliminary assessors for the final evaluation for validity of ICSRs
- Complete audit trail along with assigned justifications
- Any status can be searched, and articles filtered
- Transfer of full text articles directly into the case and can be archived
All the above features are highly useful in avoiding much of the manual efforts and expenses behind the complex tasks of medical literature team in any of PV operation, which will ultimately helpful in proper resource utilization in any PV team.
