Paediatric clonidine medication errors: Findings from a multicentre French study

AIMS: This study aimed to describe the characteristics of medication errors involving clonidine in paediatric patients and reported to French Network of Pharmacovigilance and Poison Control Centres. METHODS: This retrospective observational study analysed clonidine-related medication errors reported between 1985 and June 2024 in patients under 12 years. Data were extracted from both the French Pharmacovigilance and Poison Control Centres databases. Descriptive statistics were applied to identify common patterns and risk factors. RESULTS: A total of 91 cases were analysed. Most errors occurred during the administration stage in hospital settings (73%). Overexposure exceeding 10 times the prescribed dose was the most frequent (52%), often resulting from the erroneous adaptation of adult formulations for paediatric use. Among 87 cases of overexposure, 41 children (47%) received preventive interventions (e.g., activated charcoal) and 63 (72%) experienced clinical manifestations such as bradycardia, hypotension or somnolence. Among them, 20 (32%) received curative treatment such as fluid support (n = 10; 50%), atropine (n = 6; 30%) and naloxone (n = 6; 30%) administration. Challenges in weight-based dosing and the lack of paediatric-specific formulations were identified as significant contributors to errors. CONCLUSIONS: Medication errors involving clonidine in paediatric patients are predominantly linked to challenges during hospital administration, exacerbated by the absence of paediatric formulations. Addressing these risks requires regulatory changes, including the development of ready-to-use paediatric formulations and standardized dosing protocols, to enhance clonidine safety in clinical practice.