Abstract
According to the U.S. Food and Drug Administration (FDA), scientific and medical literature is among the four largest sources of adverse drug reactions (ADR) reporting. The aim of this work was to highlight the growing potential of medical literature search in conducting pharmacovigilance (PV) activities, summing up the most common challenges facing pharmaceutical industry in this field. A special emphasis was given to examination of Individual Case Safety Reports (ICSRs) publication frequency in medical literature over the past 15 years in the Republic of Serbia. A comprehensive review of published scientific papers, national and international PV guidance’s, and screening of websites of the relevant Contract Research Organizations experienced in medical literature monitoring for PV purposes has been carried out. Individual cases of ADRs published by Serbian authors in relevant medical journals have been identified by conducting a global Embase search. A significant overall increase in the number of case reports was identified. This showed a positive correlation with the number of ADR reports. Systematic review of medical literature appears to be an important tool especially for signal detection (1). In Serbia, a significant increase of ICSR literature reports has been recorded since 2010, mostly as the result of improvements in applying a good PV practice and the increasing development and availability of modern communication channels and global database use (2). However, adequate selection of local, non-indexed medical literature still appears to be one of the biggest challenges for pharmaceutical industry given the lack of clear regulatory guidance’s.
References
Ochyra B, Szewczyk M, Przybylkowski A. Impact of literature reports on drug safety signals. Wien Klin Wochenschr 2021; 133:188–193.
ALIMS. Godišnji izveštaji rezultata spontanog prijavljivanja neželjenih reakcija na lekove. Available at: https://www.alims.gov.rs/farmakovigilanca/godisnji-izvestaji/ (Last time accessed on 06-Jun-2022)
- Autori zadržavaju autorska prava i pružaju časopisu pravo prvog objavljivanja rada i licenciraju ga "Creative Commons Attribution licencom" koja omogućava drugima da dele rad, uz uslov navođenja autorstva i izvornog objavljivanja u ovom časopisu.
- Autori mogu izraditi zasebne, ugovorne aranžmane za neekskluzivnu distribuciju članka objavljenog u časopisu (npr. postavljanje u institucionalni repozitorijum ili objavljivanje u knjizi), uz navođenje da je članak izvorno objavljen u ovom časopisu.
- Autorima je dozvoljeno i podstiču se da postave objavljeni članak onlajn (npr. u institucionalni repozitorijum ili na svoju internet stranicu) pre ili tokom postupka prijave rukopisa, s obzirom da takav postupak može voditi produktivnoj razmeni ideja i ranijoj i većoj citiranosti objavljenog članka (Vidi Efekti otvorenog pristupa).