Unraveling tenfold administration errors of oral risperidone solution in children

In early 2023, the Israeli National Poison Information Center received reports of children exposed to tenfold dosing errors of oral risperidone solution. To assess the scope of this issue, we systematically searched for all similar cases reported to the Israeli National Poison Information Center. Our aims were to describe the occurrence and causes of such errors and explore potential preventive measures.

Using the Israeli National Poison Information Center database, we retrospectively identified and reviewed cases of unintentional tenfold oral risperidone solution overdoses in children under 13 years of age between 1 January 2020, and 31 December 2023. We collected information about demographics, the circumstances of the administration error, and patient disposition and outcomes.

We identified 60 children (median age 7 years; IQR: 5.5-9 years; 73% boys) who were exposed to a tenfold error in the administration of oral risperidone solution. In 48% of cases, the error occurred upon the first administration. The main contributing factor to this dosing error appeared to be the discrepancy between the small dosing volume of the doses prescribed (approximately 0.25 mL) and the comparatively large syringe size provided by the manufacturer in the package (3 mL). We reported this issue to the Israeli Ministry of Health, which published a safety alert warning health care professional about such administration errors.

Oral medication solutions need to be measured individually and are therefore associated with a higher likelihood of dosing errors compared to tablets.

Health care workers and caregivers need to be aware of the risk of dosing errors when administrating oral risperidone solution to children. Supplying appropriate dosing syringes with the medication bottle may mitigate the risks of such administration errors.