Temporal profile of adverse drug reactions and associated clinical factors: a prospective observational study in a neonatal intensive care unit

Although adverse drug reactions (ADRs) are quite common in hospitalised neonates, pharmacovigilance activities in this public are still incipient. This study aims to characterise ADRs in neonates in a neonatal intensive care unit (NICU), identifying causative drugs, temporal profile and associated f...

Full description

Saved in:
Bibliographic Details
Published in:BMJ open 2023-08, Vol.13 (8), p.e073304-e073304
Main Authors: Leopoldino, Ramon Weyler Duarte, Marques, Daniel Paiva, Rocha, Luan Carvalho, Fernandes, Flavia Evelyn Medeiros, Oliveira, Antonio Gouveia, Martins, Rand Randall
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems
Birth weight
Caffeine
Data collection
Drug-Related Side Effects and Adverse Reactions - epidemiology
Drugs
Electronic health records
Female
Gestational age
Hospitalization
Humans
Hypertension
Hypokalemia
Infant, Newborn
Intensive care
Intensive Care Units, Neonatal
Length of stay
Medical records
Neonatal care
Newborn babies
Observational studies
Paediatrics
Patients
Pharmacovigilance
Polyuria
Pregnancy
Regression analysis
Statistical analysis
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Although adverse drug reactions (ADRs) are quite common in hospitalised neonates, pharmacovigilance activities in this public are still incipient. This study aims to characterise ADRs in neonates in a neonatal intensive care unit (NICU), identifying causative drugs, temporal profile and associated factors. Prospective observational study. NICU of a public maternity hospital in Natal/Brazil. All neonates admitted to the NICU for more than 24 hours and using at least one medication were followed up during the time of hospitalisation. Incidence rate and risk factors for ADRs. The ADRs were detected by an active search in electronic medical records and analysis of spontaneous reports in the hospital pharmacovigilance system. Six hundred neonates were included in the study, where 118 neonates had a total of 186 ADRs. The prevalence of ADRs at the NICU was 19.7% (95% CI 16.7% to 23.0%). The most common ADRs were tachycardia (30.6%), polyuria (9.1%) and hypokalaemia (8.6%). Tachycardia (peak incidence rate: 57.1 ADR/1000 neonates) and hyperthermia (19.1 ADR/1000 neonates) predominated during the first 5 days of hospitalisation. The incidence rate of polyuria and hypokalaemia increased markedly after the 20th day, with both reaching a peak of 120.0 ADR/1000 neonates. Longer hospitalisation time (OR 0.018, 95% CI 0.007 to 0.029; p
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-073304