Aims This study aimed to establish the ethanol content in commonly prescribed formulations in the Neonatal Intensive Care Unit (NICU) and determine resulting daily exposure levels for patients. Data was then compared to recommended maximum alcohol intake levels for adults and recommendations from the American Academy of Paediatrics for maximum alcohol blood concentration after single dose administration. Finally it was assessed whether through use of alternative preparations the alcohol exposure could be reduced.
Methods Data was collected from patient drugs charts with the aid of a data collection form over a week on a level 3 NICU. Extrapolating recommended daily adult consumption values, a hypothetical limit was proposed in units/kg/day. Specific alcohol concentrations were identified from product labels or SPC's. Using the dosage regimes and patient weight, the administration volume was calculated to establish exposure levels in units/kg/day. Further calculations were conducted, using the parameters described on ethanol pharmacokinetics, to establish the volume of ethanol containing formulations required to produce a 25 mg/100 ml blood ethanol concentration. The local neonatal formulary and BNFc were consulted to identify plausible alternatives to reduce ethanol exposure and respective exposure was calculated.
Results Forty-six patients drug charts were evaluated. Two were not receiving any medications and were excluded. Seventeen patients, both pre-term and term infants, were prescribed ethanol containing formulations with exposure ranging from 0.002 to 0.0062 units/kg/day; none exceeded the equivalent adult ethanol limits. Fourteen of the formulations available in NICU contain ethanol; only 7 were encountered during the data collection period with the highest proportion being oral preparations (9/14). Two preparations very frequently used on NICU, Ranitidine and Furosemide, had the highest alcohol concentration, 9.51% v/v and 10% v/v respectively. Viable alternative preparations were found for only 2 of the drugs, ranitidine and clarithromycin. Switching to these would have reduced alcohol exposure significantly for 6/17 patients and completely eliminated it in 4/17 patients.
Each formulation was evaluated to determine what volumes would produce a BEC of 2 mg/100 ml. It was determined these volumes would not be encountered based on drug doses used in neonates.
Conclusion No patient was identified to be receiving abnormal volumes of ethanol compared to adults and no single dose was producing a BEC of 25 mg/100 ml. Only 2 possible non-alcoholic alternative formulations were identified. However, as alcohol metabolism in the neonate is immature and as adverse effects related to ethanol intake in neonates and paediatrics are well documented, it begs the question why formulations still contain ethanol today.