spontaneous reports

Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports

Objective. To analyze spontaneous reports (SRs) from the Russian database of adverse reactions (Automated information system «Pharmacovigilance» of Roszdravnadzor), containing information on fatal outcomes during ceftriaxone treatment, and to identify factors associated with an increased risk of death with ceftriaxone use. Materials and Methods. The study included 122 SRs concerning fatal cases during ceftriaxone therapy. All SRs were submitted to the Russian pharmacovigilance database from 06 May 2019 to 23 November 2022.

Adverse drug reactions of macrolide therapy: analysis of spontaneous reports according to the Pharmacovigilance system

Objective. To perform pharmacoepidemiological analysis of spontaneous reports of adverse drug reactions (ADRs) occurred during macrolide group antibiotics prescription and registered in the “Pharmacovigilance 2.0” subsystem of the Federal Service for Surveillance in Healthcare. Materials and Methods. A retrospective pharmacoepidemiological analysis of spontaneous reports of ADRs arising from the use of all macrolide and azalide antibiotics registered in Russia and registered in the electronic database of the “Pharmacovigilance 2.0” subsystem of the Federal Service for Surveillance in Healthcare for the period from 01.

Medication Errors Associated with the Use of Penicillins

Objective. To determine the prevalence of medication errors associated with the use of penicillin-group antibiotics through analysis of national spontaneous reporting database. Materials and Methods. The study involved examination of 1123 spontaneous reports about adverse drug reactions related to penicillin-group antibiotics. All these reports were sent to Russian safety database in the period from 01.01.2012 till 01.08.2014. To identify cases of medication errors we used Russian drug labels, standards of medical care and practical guidelines for certain diseases.