The use of ethanol in paediatric formulations in New Zealand.

Abstract

Children’s right to access safe and effective medicines is recognised globally. Ethanol, used in paediatric liquid formulations as a solvent and preservative, is associated with safety concerns with respect to both acute ingestion and chronic exposure. In addition, families may have cultural or religious values making ethanol use inappropriate when alternatives are available. International guidelines aim to reduce, and if possible eliminate, the use of ethanol in paediatric medicines. Guidelines on labelling vary globally, limiting the ability of health professionals and patients to make informed decisions on appropriate medicines. This study aimed to explore the availability of ethanol-containing medicines for use in the paediatric population in New Zealand and to discuss findings alongside international guidelines. Forty-seven paediatric liquid medicines were identified containing ethanol. The ethanol concentration could be determined in 35 of these medicines and ranged from 0.6 % v/v to an alarming 76 % v/v ethanol. If recommended dosing instructions are followed, the ethanol consumed per dose is not expected to cause acute toxic effects. The medicines identified are indicated for both acute and chronic use, including digoxin (10.1–11.4 % v/v ethanol) which is used in patients of all ages, including preterm neonates. Conclusion: Stronger guidance should be provided to reduce the use of ethanol in paediatric medicines, in New Zealand and globally. If ethanol is used, full disclosure of its presence and concentration on the product label is essential to enable prescribers and patients to make informed decisions on the most suitable pharmaceutical formulations.