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Adverse reactions to antimicrobials in pediatric patients admitted to a tertiary hospital: a cohort study
Luísa Rodrigues Furtado Leitzke1, Gabriele Lenhart2, Allan Lemos Rocha3
1Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil luisarfurtado@gmail.com.
Insights
Adverse drug reactions (ADRs) from antimicrobials affected 18.2% of pediatric patients, with diarrhea being common. Causality and severity varied, with clindamycin and increased hospital days posing higher risks.
Area of Science:
- Clinical Pharmacology
- Infectious Diseases
- Pediatric Medicine
Background:
- Antimicrobials are crucial in hospitals but frequently linked to adverse drug reactions (ADRs).
- Understanding the incidence and characteristics of antimicrobial-induced ADRs is vital for patient safety.
Purpose of the Study:
- To determine the incidence of ADRs caused by antimicrobials in pediatric patients.
- To classify these ADRs by reaction type, antimicrobial class, causality, severity, and avoidability.
Main Methods:
- A prospective cohort study involving 303 pediatric patients over six months.
- Causality assessed using Naranjo and Liverpool algorithms; severity by Hartwig scale; avoidability by Liverpool Avoidability Assessment Tool.
Main Results:
- 18.2% of patients experienced ADRs, with diarrhea being the most frequent (28/55).
- Beta-lactams and cephalosporins were most used; cefepime was most implicated in ADRs.
- Clindamycin use (RR 3.0), longer hospital stays (OR 1.022), and multiple antimicrobial prescriptions (OR 1.649) increased ADR risk.
Conclusions:
- ADRs occurred in approximately one-fifth of pediatric patients, primarily gastrointestinal and moderate.
- Causality assessment varied by algorithm, with many reactions deemed unavoidable.
Background:
Antimicrobials are widely used in hospitals and are often associated with adverse drug reactions (ADRs). The objective of this study was to determine the incidence of ADRs caused by antimicrobials and classify them according to the type of reaction, the class of antimicrobials used, causality, severity and avoidability.
Methods:
A prospective cohort study was carried out with paediatric patients for 6 months. Causality was verified using the Naranjo and Liverpool algorithms, the severity was verified with the adapted scale of Hartwig and the avoidability was verified with the Liverpool Avoidability Assessment Tool.
Results:
A total of 303 patients were followed, and 18.2% (55/303) of them had one or more ADRs during the hospital stay. Just over half of the patients (28/55) had diarrhea. The most used antimicrobials were beta-lactams and second-generation cephalosporins. Suspicions were classified mainly as possible 78.6% (55/70) according to the Naranjo algorithm, and as probable 48.6% (34/70) according to the Liverpool algorithm. The antimicrobial most involved with ADRs was cefepime. The risk of manifesting ADR was greater with the use of some antimicrobials such as clindamycin (relative risk (RR) 3.0, CI 1.67 to 5.4), as well as with the increase in hospitalisation days (OR 1.022, CI 1.008 to 1.036) and in the number of antimicrobials prescribed (OR 1.649, CI 1.360 to 2.001).
Conclusion:
ADRs were observed in approximately one-fifth of patients and were mostly gastrointestinal, moderate, unavoidable and with variable causality, depending on the algorithm used.
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