Marek Bielski, Business Development Manager,MS Pharm
As per GVP, Marketing Authorisation Holders are expected to collect the information for the monitoring of the safety profile and of the risk-benefit balance of their medicinal products from the medical literature. The awareness of possible publications should be realized through a systematic literature review of widely used reference databases. In addition to that, the MAHs should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorization. In addition means these two modes of reviewing the medical literature are not replaceable by each other, they need to be considered complementary. Surprisingly, there are MAHs that tend to exclude local journals which are indexed in Medline/Embase – just because they are included in the database reviews. The most common background of this approach is the fear of duplicates reporting. However, there exist several drawbacks of this approach which outweigh the apparent benefits of just avoiding duplicates.
Based on the recent MS Pharm research run in late 2020, excluding the local journals indexed in Embase/Medline from the local monitoring may lead to omitting the information required by GVP, including foremost the ICSRs presented in the published articles.
The key reasons why ICSRs may not be captured by Embase/Medline searches may fall under the following groups:
- the English abstracts are available for the articles published in the local journals, whereas the full-texts are published in the local language (non-English) only
- the publisher issues Supplements including conference abstracts, they are published in the local language (non-English), though
- the medicinal products concerned are not referred to directly in the article but included in the treatment regimen used (e.g. the regimen acronym is referred to only).
Given that, as per GVP, reports of suspected adverse reactions from the medical literature, including relevant published abstracts from meetings, should be reviewed and assessed by MAHs to identify and record ICSRs, at least one of the GVP conditions cannot be met if the local journals indexed in Embase/Medline are not reviewed in full-text mode but the review is limited to database abstract review only. Noteworthy, GVP recognizes that abstracts from major scientific meetings may be indexed and available in some databases but e.g. posters and communications are rarely available from this source.
What might be expected then is the stakeholders should make the efforts aiming at modifying the MAH’s literature review procedures to include the local journals indexed in the databases in the local reviews rather than to maintain the current approach of excluding them from the local searches, as well as aiming at being able to capture the duplicates (whichever the primary report comes from first, the database or the local review) early enough to prevent them from being submitted again. That seems to be challenging as will require the change of mindsets and, perhaps, the use of additional resources but will certainly result in enhancing the MAHs’ GVP-compliance and, last but not least, will foster the safety of the medicinal products.