Related Experiment Videos
Adverse drug reactions and off-label drug use in paediatric outpatients
Benjamin Horen1, Jean-Louis Montastruc, Maryse Lapeyre-Mestre
1Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et dInformations sur le médicament, Faculté de Médecine.
Aims:
To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients.
Methods:
A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France).
Results:
The study involved a sample of 1419 children under 16 years old. Forty-two percent of patients were exposed to at least one off-label prescription. The incidence of adverse drug reactions was 1.41% (95% CI 0.79, 2.11). Off-label drug use was significantly associated with adverse drug reactions (relative risk 3.44; 95% CI 1.26, 9.38), particularly when it was due to an indication different than that defined in the Summary Product Characteristics (relative risk 4.42; 95% CI 1.60, 12.25).
Conclusions:
Our data suggest an increasing risk of adverse drug reactions related to off-label drug use. This risk would be acceptable if further studies prove the potential benefit of such a drug use.
Related Concept Videos
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Pharmacokinetics in Pediatric Patients: Drug Excretion
Drug Dosing: Infants and Children
Factors Affecting Drug Response: Overview
Pharmacokinetics in Pediatric Patients: Drug Distribution
Drug Toxicity: Risk factors