Background and aim Paediatric patients are widely exposed to a range of excipients which may cause harm to this vulnerable patient group. Legal requirement to disclose quantitative information on excipients changed in 2010,2 however, since most formulations were licensed prior to this date, there is a lack of potentially critical information available to currently practising pharmacists and clinicians. The aim of this study was to quantify excipient exposure to children in a secondary care setting.
Method A cohort study was conducted within Altnagelvin Area Hospital Paediatric Ward (Northern Ireland, Western Health and Social Care Trust) in January 2017. Medicines prescribed to patients throughout the study were recorded and exposure to ethanol, sodium benzoate and propylparaben was quantified.
Exposure was then compared to proposed safe limits. Off-label and unlicensed use of medicines was assessed as a secondary aim. This study was classified as a service evaluation and ethical approval was not required.
Results A total of 91 patients were enrolled in the study. Patient age ranged from 5 days to 15 years. The mean number of items prescribed per patient was 3.0. Analysis revealed that 75.8% of patients were exposed to ≥1 excipient of interest including ethanol, sodium benzoate and propylparabens. Excipient safety levels as proposed by the European Medicines Agency or World Health Organisation (where available) were not exceeded.
Quantitative excipient information were not available for two products. There was both off-label and unlicensed use ofmedicines, with off-label prescribing (9.6%) being more common than the use of unlicensed medicines (0.4%).
Conclusion The paediatric population is exposed to potentially harmful excipients contained in commonly prescribed medicines. Although exposure within this study falls within existing safety limits, further research into paediatric specific safe exposure limits are required. It is notable that despite contacting themanufacturer, quantitative excipient information were not available for two products. Safety limits when considered together with quantitative excipient information will allow clinicians to complete an informed risk-benefit analysis for paediatric patients.
Tulec C. Paediatric formulations in practice. In Costello I, Long PF, Wong IK, Tulec C, Yeung V (Ed.), Paediatric drug handling 2007:pp. 43–74. London: Pharmaceutical Press.
European Commission. A guideline on summary of product characteristics [Online]2009;2:1–29. http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf [Accessed: 14th April 2017].
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