INOPP Forum
Monitoring of Medical Literature
Quote from VigiServe Admin on February 7, 2021, 1:07 PMhttps://www.youtube.com/watch?v=L7nTs92paUU&t=1049s
The medical literature 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. Marketing authorisation holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week. The marketing authorisation holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties.
In addition, marketing authorisation holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation, and to bring them to the attention of the company safety department as appropriate.
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).
One case should be created for each single identifiable patient. Relevant medical information should be recorded and the first publication author (or the corresponding author, if designated) should be considered as the primary source of information. Details about the co-authors do not need to be documented among the primary sources of information.
The medical literature 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. Marketing authorisation holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week. The marketing authorisation holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties.
In addition, marketing authorisation holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation, and to bring them to the attention of the company safety department as appropriate.
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).
One case should be created for each single identifiable patient. Relevant medical information should be recorded and the first publication author (or the corresponding author, if designated) should be considered as the primary source of information. Details about the co-authors do not need to be documented among the primary sources of information.
Quote from VigiServe Admin on February 7, 2021, 1:11 PMFor ICSRs described in the medical literature, the clock starts (day zero) with the awareness of a publication containing the minimum criteria. Where contractual arrangements are made with a person/organisation to perform literature searches and/or submit valid ICSRs, detailed agreements should exist to ensure that the marketing authorisation holder can comply with its regulatory submission obligations.
When additional significant information is received for a previously submitted case, the clock for the submission of a follow-up report starts again from the date of receipt of the relevant follow-up information. For the purpose of submission of ICSRs, significant follow-up information corresponds to new medical or administrative information that could impact on the assessment or management of a case, or could change its seriousness criteria; non-significant information includes updated comments on the case assessment or corrections of typographical errors in the previous case version. S
For ICSRs described in the medical literature, the clock starts (day zero) with the awareness of a publication containing the minimum criteria. Where contractual arrangements are made with a person/organisation to perform literature searches and/or submit valid ICSRs, detailed agreements should exist to ensure that the marketing authorisation holder can comply with its regulatory submission obligations.
When additional significant information is received for a previously submitted case, the clock for the submission of a follow-up report starts again from the date of receipt of the relevant follow-up information. For the purpose of submission of ICSRs, significant follow-up information corresponds to new medical or administrative information that could impact on the assessment or management of a case, or could change its seriousness criteria; non-significant information includes updated comments on the case assessment or corrections of typographical errors in the previous case version. S
Quote from VigiServe Admin on February 7, 2021, 1:15 PMWhen to start and stop searching in the medical literature?
In addition to the submission of serious and non-serious ICSRs or their presentation in periodic safety update reports, the marketing authorisation holder has an obligation to review the worldwide experience with the medicinal product in the period between the submission of the marketing authorisation application and the granting of the marketing authorisation. The worldwide experience includes published medical literature.
For the period between submission and granting of marketing authorisation, literature searching should be conducted to identify published articles that provide information that could impact on the risk-benefit assessment of the product under evaluation. For the purpose of the preparation of periodic safety update reports, the requirement for literature searching is not dependent on a product being marketed. Literature searches should be conducted for all products with a marketing authorisation, irrespective of commercial status. It would therefore be expected that literature searching would start on submission of a marketing authorisation application and continue while the authorisation is active.
When to start and stop searching in the medical literature?
In addition to the submission of serious and non-serious ICSRs or their presentation in periodic safety update reports, the marketing authorisation holder has an obligation to review the worldwide experience with the medicinal product in the period between the submission of the marketing authorisation application and the granting of the marketing authorisation. The worldwide experience includes published medical literature.
For the period between submission and granting of marketing authorisation, literature searching should be conducted to identify published articles that provide information that could impact on the risk-benefit assessment of the product under evaluation. For the purpose of the preparation of periodic safety update reports, the requirement for literature searching is not dependent on a product being marketed. Literature searches should be conducted for all products with a marketing authorisation, irrespective of commercial status. It would therefore be expected that literature searching would start on submission of a marketing authorisation application and continue while the authorisation is active.
Quote from VigiServe Admin on February 7, 2021, 1:19 PMDetailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency
Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency
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