PP-22 Adherence to labelling guidelines, the case of fluoroquinolones. results of a retrospective multicenter drug utilisation study

Abstract

IntroductionLabeledpediatric indications for prescription of fluoroquinolones (FQ) are limited. Furthermore, the safety of systemic FQ for growing children has been debated for a long time.1,2 Nevertheless, prescribing FQ for children can be advantageous. First, FQ cover a broad spectrum of bacteriae.3 Second, pharmacokinetic (PK) characteristics of systemic FQ are favourable. The bioavailability of common FQ agents is usually high and FQ typically penetrate in deep compartments.4,5 In this retrospective multicenter drug utilisation study, we aimed to investigate indications for FQ prescription in a population of children hospitalised in two Belgian university children’s hospitals. Additionally, another goal was to assess the adequacy of prescribed doses, and risk factors for incorrectly dosed FQ prescriptions within our population.MethodsUsing data obtained from electronic medical files, the study included all children who received a sys-temic FQ prescription in two Belgian university children’s hospitals between 2010–2013. Two authors reviewed pre-scribed daily doses. Univariate and multivariate logistic regression models were used to analyse risk factors for inadequately dosing.ResultsA total of 262 FQ prescriptions for unique pa-tients were identified. Most children (57.6%) had signifi-cant chronic comorbidity such as any type of cancer, a neurologic disease, or congenital anomalies of the kid-neys and urinary tract. Ciprofloxacin was by far the most frequently prescribed FQ, representing 253 prescriptions (96.6%). Overall, the number of on-label FQ prescriptions was 43 (16.4%), and prescription was guided by a micro-bial culture in 62 cases (35.1%). 79 prescriptions (30.2%), of which 78 ciprofloxacin prescriptions, were considered to be inaccurately dosed. Underdosing was the most common type, as 57.1% of all inaccurately dosed pre-scriptions were underdosed. In the univariate logistic regression analysis, children younger than 6 years of age were at particular risk of receiving an inadequately dosed prescription. In the final multivariate logistic regression model, when controlled for the sort of FQ prescribed, Odds Ratios for infants and preschool children remained statistically significant.ConclusionFQ were often prescribed off-label and not guided by bacteriological findings in our study popula-tion. Dosing errors were common, particularly in infants and preschool children. FQ prescriptions for children should be improved by specific paediatric antimicrobial stewardship teams.