Pharmacovigilance network as an additional tool for the surveillance of antimicrobial resistance.

Background The WHO Programme for International Drug Monitoring (PIDM) is a large Pharmacovigilance network of countries sharing Adverse Drug Reaction (ADR) reports. Pharmacovigilance Experts have suggested that antimicrobial resistance (AMR) is an overlooked adverse event. We undertook this study to investigate the potential role of Pharmacovigilance databases in the surveillance of antimicrobial resistance. Methods Using the AWaRe (Access, Watch and Reserve) list and the WHO Priority Pathogens List, we established a list of antimicrobials and carried out a VigiBase search via VigiAccess, looking for ADR reports with Preferred Terms (PTs) that contained AMR-relevant information. Identified Terms were matched with codes from the Medical Dictionary for Regulatory Activities (MedDRA Version 21.1). Results Records on 86 drugs were retrieved with a total of 1 170 751 ADR reports submitted between 1968 and 2018. 17 PTs suggesting suspected resistance, ineffectiveness, inappropriate use, or medication error were used to code 15250 reports. The most frequently used PTs were "Drug Ineffective" (45.6%), "Off label use" (9.5%) and "Pathogen Resistance" (8.9%). A group of 6 agents (Amoxicillin, Cefalotin, Ciprofloxacin, Clarithromycin, Levofloxacin and Daptomycin) accounted for 38% (n = 5806) of all 15.250 AMR-relevant ADR reports. The PTs most frequently used in 5806 reports were grouped in 4 categories: drug ineffectiveness (62.5%), resistance (19.2%), off-label use (12.1%) and prescription errors (6.2%). Conclusion Our findings suggest that Pharmacovigilance databases could serve as a tool in tracking antimicrobial use and resistance especially in settings where laboratory capacity is still in its development stages. National Pharmacovigilance centers could play a proactive role in stimulating the reporting of AMR-relevant ADRs which can serve as a basis for resistance suspicion alerts. Further studies focusing on the narrative and other clinical pharmacology details in ADR reports are required. This article is protected by copyright. All rights reserved.