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.

Department of Gastroenterology and Internal Diseases Medical University of Warsaw Banacha 1a 02 097 Warsaw Poland

MS Pharm s r o Praga Czech Republic

Zobrazit více v PubMed

European Medicines Agency. Heads of Medicines Agencies . Guideline on good pharmacovigilance practices (GVP): module IX—signal management (rev 1) 2017.

Pacurariu A, van Haren A, Berggren AL, Grundmark B, Zondag D, et al. SCOPE work package 5 signal management best practice guide. 2016.

European Commission . Commission implementing regulation (EU) no 520/2012 (4) on the performance of Pharmacovigilance activities provided for in regulation (EC) no 726/2004 and directive 2001/83/EC. Brussels: European Commission; 2012.

Ferreira GL, Shakir SS, Brown D. A systematic literature review of the determinants of signal detection in post-marketing surveillance systems. Drug Saf. 2008 doi: 10.2165/00002018-200831100-00038. DOI

Klose J, Frohling S, Kroth E, Dobmeyer T, Nolting A. Safety information from spontaneous and literature adverse reaction reports: a comparison. Ther Innov Regul Sci. 2013;47(2):248–255. doi: 10.1177/0092861512463920. PubMed DOI

Egberts TC. Signal detection: historical background. Drug Saf. 2007;30(7):607–609. doi: 10.2165/00002018-200730070-00006. PubMed DOI

Winnenburg R, Sorbello A, Ripple A, Harpaz R, Tonning J, Szarfman A, et al. Leveraging MEDLINE indexing for pharmacovigilance—Inherent limitations and mitigation strategies. J Biomed Inform. 2015;57:425–435. doi: 10.1016/j.jbi.2015.08.022. PubMed DOI PMC

European Medicines Agency. Heads of Medicines Agencies . Guideline on good pharmacovigilance practices (GVP): Module VI—Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) 2017.

Pontes H, Clement M, Rollason V. Safety signal detection: the relevance of literature review. Drug Saf. 2014;37(7):471–479. doi: 10.1007/s40264-014-0180-9. PubMed DOI

Avillach P, Dufour JC, Diallo G, Salvo F, Joubert M, Thiessard F, et al. Design and validation of an automated method to detect known adverse drug reactions in MEDLINE: a contribution from the EU-ADR project. J Am Med Inform Assoc. 2013;20(3):446–452. doi: 10.1136/amiajnl-2012-001083. PubMed DOI PMC

Stricker BH, Psaty BM. Detection, verification, and quantification of adverse drug reactions. BMJ. 2004;329(7456):44–47. doi: 10.1136/bmj.329.7456.44. PubMed DOI PMC

Garcelon N, Mougin F, Bousquet C, Burgun A. Evidence in pharmacovigilance: extracting adverse drug reactions articles from MEDLINE to link them to case databases. Stud Health Technol Inform. 2006;124:528–533. PubMed

Folks TM, Justement J, Kinter A, Dinarello CA, Fauci AS. Cytokine-induced expression of HIV-1 in a chronically infected promonocyte cell line. Science. 1987;238(4828):800–802. doi: 10.1126/science.3313729. PubMed DOI

Kitano K, Abboud CN, Ryan DH, Quan SG, Baldwin GC, Golde DW. Macrophage-active colony-stimulating factors enhance human immunodeficiency virus type 1 infection in bone marrow stem cells. Blood. 1991;77(8):1699–1705. doi: 10.1182/blood.V77.8.1699.1699. PubMed DOI

Shetty KD, Dalal SR. Using information mining of the medical literature to improve drug safety. J Am Med Inform Assoc. 2011;18(5):668–674. doi: 10.1136/amiajnl-2011-000096. PubMed DOI PMC