Abstract
SummaryBackgroundSignal management is considered an important activity in pharmacovigilance and should be performed using any available source of data, including scientific literature. The main aim of this study was to assess the role of scientific literature in both indexed and unindexed journals and compare the relevance of both in the signal management process.MethodsThe study was a retrospective analysis of safety data. For the purposes of the study, drugs for which safety signals were evaluated by European Medicine Agency (EMA) were chosen. A match analysis of data collected in the EudraVigilance (EV) database with data from bibliographic databases such as MEDLINE, Embase or EBSCO (International Pharmaceutical s, IPA and the Allied and the Complementary Medicine Database, AMED) was performed.ResultsA total of 73 drug event associations (DEA) and 4160 individual case safety reports (ICSRs) were analyzed. About 33% of ICSRs were created based on scientific literature. A total of 1196 ICSRs were submitted to the EV database based on journals indexed in global bibliographic databases Embase (86.00%) or MEDLINE (81.96%) or EBSCO (IPA or AMED, 0.66%).ConclusionThis study underlines the importance of scientific literature for the signal management process in addition to other data sources. Most literature ICSRs from this analysis were created based on scientific journals indexed in bibliographic databases; therefore, it can be concluded that a systematic review of bibliographic databases, such as Embase or MEDLINE is highly relevant for the signal management process.
Highlights
Signal management is considered as an important activity in pharmacovigilance [1, 2]
Szewczyk MS Pharm s.r.o., Praga, Czech Republic it can be concluded that a systematic review of bibliographic databases, such as Embase or MEDLINE is highly relevant for the signal management process
Their study demonstrated the importance of literature individual case safety reports (ICSRs) in addition to other spontaneous ICSRs for a sufficient risk-benefit assessment of medicinal products, and confirmed that none of these sources could be used as a stand-alone system in signal detection [5]
Summary
Signal management is considered as an important activity in pharmacovigilance [1, 2]. Referring to Regulation (EU) No 520/2012 of 19 June 2012 the signal management process shall include the following activities: signal detection, signal validation, signal confirmation, signal analysis and prioritization, signal assessment, and recommendations for action [3]. Drug safety is assessed during both premarketing and postmarketing phases. Signal detection is a key step of the process, and a fundamental part of the postmarketing drug surveillance system [4]. A new aspect of a known risk (including known ADR) may change in severity, frequency, ADR outcome, duration, distribution (e.g. gender, age and country) and clinical nature [1]
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