Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre
Abstract
:1. Introduction
1.1. Antimicrobial Resistance (AMR) and Antimicrobial Stewardship
1.2. The Access, Watch and Reserve (AWaRe) Classification for Availability and Appropriate Use
1.3. Pharmacovigilance and Antimicrobial Resistance
1.4. Pharmacovigilance in The Netherlands
1.5. Study Objective
2. Material and Methods
Data Source and Search Strategy
- (a)
- Reports on Antibiotics classified under the Anatomical Therapeutic Chemical (ATC) Classification ATC J01 or ATC J04.
- (b)
- Reports coded with at least one of the following MedDRA (version 21.1) Preferred terms and codes included the following: pathogen resistance (10034133); drug ineffective (10013709); treatment failure (10066901); drug resistance (10059866); therapeutic product ineffective (10060769); therapy non-responder (10051082); decreased activity (10011953); drug ineffective for unapproved indication (10051118); therapeutic response decreased (10043414); multiple drug resistance (10048723); off label use (10053762); medication error (10027091); product use in unapproved indication (10076476); contraindicated product administered (10078504)
3. Results
3.1. ADR Reports with AMR-Relevant Codes
3.2. Most Frequently Used PTs in Cases of Suspected Resistance or Use-Related Issues
3.3. Applying the AWaRe Classification to the Reports
3.4. The 2015 Peak in Numbers of AMR-Relevant ADR Reports to Lareb
4. Discussion and Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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RIOLE Categories (Number of Reports; %) | PTs in the RIOLE Category (Number of Reports; %) | Most Reported Antibiotics per PT (Number of Reports; %) |
---|---|---|
Suggesting AMR (98; 39%) | drug ineffective (71; 72%), | aztreonam (9; 13%) |
amoxicillin + Beta-lactamase inhibitor (6; 8%) | ||
doxycycline (6; 8%) | ||
pathogen resistance (14; 14%) | ceftazidime (5; 36%) | |
ciprofloxacin (2; 14%) | ||
linezolid (2; 14%) | ||
drug resistance (13; 13%) | tobramycin (3; 23%) | |
ciprofloxacin (2; 15%) | ||
Suggesting use-related issues (119; 47%) | off-label use (91; 76%) | tobramycin (53; 58%) |
colistin (24; 26%) | ||
doxycycline (6; 7%) | ||
product use in unapproved indication (28; 15%) | tobramycin (27; 96%) | |
Suggesting both AMR and use-related issues (35; 14%) | Combinations of PTs Suggesting both AMR and use-related issues (35; 14%) | ciprofloxacin (7; 20%) azithromycin (3; 9%) |
TOTAL = 252; 100% | - | - |
AWaRe Categories (Number of Reports; %) | Most Reported Antibiotics in the AWaRe Category (Number of Reports; %) | Most Used PTs in the AWaRE Category (Number of Reports; %) * |
---|---|---|
Access (40; 16%) | doxycycline (14; 35%) | drug ineffective (25; 63%) off label use (6; 15%) |
amoxicillin + Beta-lactamase inhibitor (7; 18%) | ||
sulfamethoxazole + trimethoprim (4; 10%) | ||
Watch (137; 54%) | tobramycin (89; 78%) | Off label use (57; 42%) Product use in unapproved indication (27; 20%) drug ineffective (20; 15%) pathogen resistance (8; 6%) |
ciprofloxacin (16; 33%) | ||
azithromycin (8; 17%) | ||
moxifloxacin (7; 15%) | ||
Reserve (45; 19%) | colistin (30; 91%) | off label use (25; 76%) |
aztreonam (12; 11%) | ||
Combination of different classes (17; 6%) | concomitant from different classes | drug ineffective (7; 41%) drug resistance (3; 18%) |
Other or not classified (13; 5%) | drug ineffective (8; 61%) | |
TOTAL (252; 100%) | - | - |
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Habarugira, J.M.V.; Härmark, L.; Figueras, A. Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre. Antibiotics 2021, 10, 1512. https://doi.org/10.3390/antibiotics10121512
Habarugira JMV, Härmark L, Figueras A. Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre. Antibiotics. 2021; 10(12):1512. https://doi.org/10.3390/antibiotics10121512
Chicago/Turabian StyleHabarugira, Jean Marie Vianney, Linda Härmark, and Albert Figueras. 2021. "Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre" Antibiotics 10, no. 12: 1512. https://doi.org/10.3390/antibiotics10121512