VI.App.2.6. Review and selection of articles

It is recognised that literature search results are a surrogate for the actual article. Therefore, it is expected that the person reviewing the results of a search is trained to identify the articles of relevance. This may be an information professional trained in pharmacovigilance or a pharmacovigilance professional with knowledge of the database used. Recorded confirmation that the search results have been reviewed will assist in demonstrating that there is a systematic approach to collecting information about suspected adverse reactions from literature sources. It is recommended that quality control checks are performed on a sample of literature reviews / selection of articles to check the primary reviewer is identifying the relevant articles.

A common issue in selecting relevant articles from the results of a search is that often this process is conducted for the purposes of identification of ICSRs only. Whereas the review should also be used as the basis for collating articles for the periodic safety update report production, therefore relevant studies with no ICSRs should also be identified, as well as those reports of events that do not qualify for submission as ICSR (see VI.C.2.2.3.2. for the exclusion criteria in the submission of ICSRs published in the medical literature).

Outputs from searches may contain enough information to be a valid ICSR, in which case the article should be ordered. All articles for search results that are likely to be relevant to pharmacovigilance requirements should be obtained, as they may contain valid ICSRs or relevant safety information. The urgency with which this occurs should be proportionate to the content of the material reviewed and the resulting requirement for action as applicable for the marketing authorisation holder.

Articles can be excluded for the submission of valid ICSRs by the marketing authorisation holder if another company’s branded medicinal product is the suspected medicinal product. In the absence of a specified medicinal product source and/or invented name, ownership of the medicinal product should be assumed for articles about an active substance. Alternative reasons for the exclusion of a published article for the submission of ICSRs are detailed in VI.C.2.2.3.2.