Quality & Compliance
Safety & Vigilance
10 january 2022
As the Good pharmacovigilance practices (GVP) module VI states “medical literature is a significant source of information” for marketing authorization holders and has to be taken into consideration. Marketing authorization holders are expected to perform international and local literature searches to identify pharmacovigilance (PV) cases and to detect safety signals to establish a product’s benefit-risk profile. ProductLife Group can help with all these activities.
With a background in literature searches and training in PV, the information and documentation officers (IDOs) of the literature Line of Business (LoB) are best qualified to perform international searches. In order to answer the GVP recommendations, searches are performed weekly in one or two widely used reference databases: AdisInsight Safety, and PubMed. Databases are selected in collaboration with the client, based on the product portfolio and whether the international nonproprietary name (INN), in other words the generic name for a pharmaceutical substance, is followed in the medical literature monitoring service provided by the European Medicines Agency (EMA).
Searches are performed based only on the INN and the searched period, unless the client specifically asks for a search strategy that includes pharmacovigilance keywords. All potential PV cases are identified, as well as special situations according to the GVP definitions. Abstracts are recorded and sent to the client once the search is finalized. Based on the contract and technical agreement, IDOs can also pre-analyze the abstracts according to the GVP inclusion/exclusion criteria. Results are sent on a weekly basis, whether abstracts were identified or not.
Regular interaction with the client is the key to meeting PV requirements and the IDOs are fully aware of the importance of being responsive and reachable. The IDOs also work in collaboration with the case management team and, if PLG is in charge of this activity, all information flows seamlessly between the two lines of business.
Local literature monitoring is carried out on a range of journals and websites suggested by our teams, then chosen by mutual agreement with the client according to the therapeutic areas of the client’s portfolio. Journals followed are not indexed in the international literature databases such as Embase and PubMed. The list of journals is updated regularly, depending on portfolio changes.
Monitoring is carried out in France by IDOs, and in other countries by local safety officers (LSOs) or local PLG staff native speakers of the relevant language. The central team of the literature LoB coordinates the activity so each article identified is sent to the IDOs who either forward search results to the client or, where relevant, to the PLG case management team.
Depending on what is agreed with the client, the selection of articles can be limited to PV cases and special situations, any article with safety information, or any article mentioning a client’s products. The central team of the literature LoB also ensures weekly or monthly reporting to the client.
Our teams are in constant communication across all countries in Europe to provide a comprehensive and multilingual local literature offering.
Literature for safety reports
The literature search for the safety reports is an important task within medical writing. While the writing of the safety reports is managed by the medical writing LoB, a dedicated central team is responsible for performing the literature searches.
The IDOs interact with the experts of the medical writing Lob to agree on the research period, search strings based on the type of reports and a list of keywords to ensure the search encompasses any relevant areas, as well as deadlines.
International searches are caried out either in the AdisInsight database and/or PUBMED to find any article related to safety, benefits-risks, efficacy, as well as other relevant vigilance searches depending on the type of report.
Most searches are performed with the molecule name and the relevant period using specific keywords. The more accurate and detailed the keywords, the more targeted and relevant the search will be.
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