Background Many medications used in PICU contain excipients which are classed as non-pharmaceutically active ingredients. There is increasing reports of adverse effects attributed to these agents. This study looks for recommendations of maximum levels and actual excipient intake in 5 PICU patients.
Methods EmBASe, Medline, UK and International guidelines were searched for adverse effects, pharmacokinetics, maximum doses for non-pharmaceutically active ingredients. The medication intake for 5 PICU patients was recorded and excipient content calculated where available.
Results There were 49 medications administered, no excipient information could be found for 8. There was 235 excipients listed in the remaining 42 medicines, complete excipient information was available for 11/49 medicines. Maximum upper limits were found for sorbitol (0.5g/kg), Propylene glycol (25mg/kg) and hydroxybenzoates (10mg/kg). Only a lethal dose was found for ethanol (3.8ml/kg), there was a recommendation that no ethanol should be contained in medicines for under 6 year olds.
Whilst excipient intake calculation was not complete due to lack of response or availability of information from the manufacturer, each patient received a medicine containing ethanol. Patient 3 and 5 had above the sorbitol level (0.9g and 2.1 gram/kg respectively). Three patients received above the propylene glycol limit (52.6mg, 30mg and 190mg/kg), and at least one patient was getting 14.4mg/kg of hydroxybenzoates.
Conclusion When the information regarding quantities of excipients in medicines are available and calculated PICU patients are receiving significant amounts of excipients, some above the recommended safe limits.