Pharmacovigilance data as a trigger to identify antimicrobial resistance and inappropriate use of antibiotics : A study using reports from the netherlands pharmacovigilance centre
Habarugira, Jean Marie Vianney (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Härmark, Linda (Netherlands Pharmacovigilance Centre Lareb)
Figueras, Albert 1961- (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)

Data:	2021
Resum:	(1) Background: Antimicrobial resistance (AMR) requires urgent multidisciplinary so-lutions, and pharmacovigilance has the potential to strengthen current antimicrobial stewardship strategies. This study aimed to characterize AMR-relevant adverse drug reaction (ADR) reports submitted to The Netherlands Pharmacovigilance Centre; (2) Methods: We carried out a descriptive analysis of ADR reports submitted to Lareb, coded with AMR-relevant MedDRA Preferred Terms (PTs); (3) Results: Between 1998 and January 2019, 252 AMR-relevant ADR reports were submitted to Lareb. The most frequent antibiotics were tobramycin (n = 89; 35%), colistin (n = 30; 11. 9%), cipro-floxacin (n = 16; 6. 3%), doxycycline (n = 14; 5. 5%), and aztreonam (n = 12; 4. 8%). The PTs used included off label use (n = 91; 36. 1%), drug ineffective (n = 71; 28. 2%), product use in unapproved indication (n = 28; 11. 1%), pathogen resistance (n = 14; 5. 6%), and drug resistance (n = 13; 5. 2%). 54% of the reports were on Watch antibiotics and 19% were involved in the Reserve group. In the Watch group, "off label use" and "product use in unapproved indication" were the most frequent PTs and the majority of reports on Reserve antibiotics were coded as "Off label". A sharp increase in the number of reports was observed in the three consecutive years with 21 in 2013, 54 in 2014, and 83 in 2015; (4) Conclusions: In addition to existing AMR monitoring strategies, pharmacovigilance databases can serve as a source of data on suspected resistance and inappropriate use. Future research should explore how these AMR-relevant MedDRA Terms are used in resource-limited settings with less capacity to generate laboratory-confirmed resistance data.
Nota:	Funding: J.M.V.H. was partially funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) for this research; grant number: not applicable.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	Antibiotics, Vol. 10 Núm. 12 (december 2021) , p. 1512, ISSN 2079-6382

DOI: 10.3390/antibiotics10121512
PMID: 34943724

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