Summary Background Signal 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. Methods The 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 Abstracts, IPA and the Allied and the Complementary Medicine Database, AMED) was performed. Results A 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%). Conclusion This 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.

Medical literature is an important source of drug safety information relevant for signal detection, safety profile analysis and risk-benefit assessment. The main goal of our study was to assess the utility of domestic medical literature as a source of drug safety information. All safety information identified for active substances published between 1.01.2018-31.12.2019 in domestic medical journals published in Poland were analyzed. Four thousand seven hundred eighty-nine drug safety information was reported for 500 active substances. Two thousand and forty-four submissions dealing with drug safety (48.28%) were identified in the 10 journals from the list of analyzed journals (3 of these were identified in the 2019 JCR and 5 of these were indexed in the main scientific databases and 9 of these had an affiliation to scientific society). There was a correlation between journal impact factor and scientific database indexation with the number of published individual literature reports and type of safety information. Journals publishing in Polish constituted source for about 40% of all safety information published in the examined period. Journals indexed in Medline were the source of about 37% of all safety information while 42% was published in Embase. Local medical literature is a source of valuable safety information but the list of journals for monitoring should be carefully selected with particular attention to journals with impact factor.

INTRODUCTION. Collecting information about drugs in clinical practice is essential for ongoing risk-benefit analysis of the drug use. Medical literature is an important source of new information on drug safety, in particular for the signal assessment. A signal is an information about a new potentially causal association, or a new aspect of a known association (e.g. change in frequency or severity of the reaction) between a drug and an adverse event (AE). AIM OF THE STUDY. To verify the effectiveness of the identification of adverse drug reaction (ADR) reports published in the local medical literature using MEDLINE and Embase, versus manual full text review of journals. MATERIAL AND METHODS. The study was performed for 20 randomly selected drugs and 84 Polish medical journals and covers a review of 1,576 individual journal issues with 20,146 articles. Retrospective analysis of literature reports collected during manual full text review was performed and compared to the outcome of database search. RESULTS. ADRs for analyzed drugs were identified only in 17 out of 84 journals, as a result of which 66 reports were analyzed. The majority of reports (55%) were found in local non-indexed journals. Three reports originated from journals indexed in MEDLINE and 9 reports from journals indexed in Embase were not found in these databases because databases do not fully cover conference abstracts and journal supplements. Moreover, while using databases for ADR report search there is a risk of missing up to 30% of ADR reports. The average gap between article publication date and database entry was 119 days. CONCLUSIONS. We verified that the effectiveness of the identification of ADR reports published in the local medical literature is more accurate based on manual full text review than by searching in bibliographic databases.

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