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 AMR.


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. Seventeen PTs suggesting suspected resistance, ineffectiveness, inappropriate use, or medication error were used to code 15 250 reports. The most frequently used PTs were "Drug Ineffective" (45.6%), "Off label use" (9.5%) and "Pathogen Resistance" (8.9%). A group of six 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.
['Habarugira|Jean Marie Vianney|JMV|0000-0003-1267-5972', 'Figueras|Albert|A|0000-0002-2740-2013']
D016907:Adverse Drug Reaction Reporting Systems D000900:Anti-Bacterial Agents D016208:Databases, Factual D024881:Drug Resistance, Bacterial D064420:Drug-Related Side Effects and Adverse Reactions D006801:Humans D060735:Pharmacovigilance
Pharmacovigilance antimicrobial resistance adverse drug reaction AWaRe VigiBase VigiAccess MedDRA antimicrobial use