Dataset Information

Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study.

ABSTRACT: Though the pediatric use of fluoroquinolones (FQs) is limited for musculoskeletal safety concerns, the clinical usefulness still exists. This study examined the association between FQs and musculoskeletal adverse events (AEs) as well as the possible risk factors associated with the pediatric FQs uses. This population-based, longitudinal, retrospective study was conducted using Korean National Sample Cohort database originating between 2002 and 2015. An FQ-treated pediatric cohort (<18 years old) was compared to a control treated with amoxicillin. Propensity score matching (PSM) and a Cox proportional hazard model was used to estimate the hazard ratio (HR) for a diagnosis of musculoskeletal AEs within 60 days of the first prescription. Among one million participants, total of 15,706 and 147,840 children were eligible for the FQ and amoxicillin cohorts, respectively. The PSM cohorts showed a slightly increased risk of musculoskeletal AEs after FQ treatment (HR, 1.19; 95% confidence interval, 1.01-1.40; p?=?0.042). This association was stronger in males, older patients, and some FQs users. This study indicates that pediatric FQ use is associated with a risk of musculoskeletal AEs and that FQ use should be carefully monitored in groups with certain risk factors. Well-designed pragmatic trials could be expected to clarify these issues.

SUBMITTER: Kim Y

PROVIDER: S-EPMC6934562 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study.

Kim Yoonhye Y Paik Minwoo M Khan Chanjoo C Kim Yae-Jean YJ Kim EunYoung E

Scientific reports 20191227 1

Though the pediatric use of fluoroquinolones (FQs) is limited for musculoskeletal safety concerns, the clinical usefulness still exists. This study examined the association between FQs and musculoskeletal adverse events (AEs) as well as the possible risk factors associated with the pediatric FQs uses. This population-based, longitudinal, retrospective study was conducted using Korean National Sample Cohort database originating between 2002 and 2015. An FQ-treated pediatric cohort (<18 years old) ...[more]

PMID: 31882917

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Project description:Purpose:The aim of the present study was to describe the purchasing patterns of a set of antibiotics used exclusively in an out-patient pediatric setting in Italy using the Farma360 wholesale drug database (IQVIA Solutions Italy), identifying the proportion of medications which are not captured by Italian National Health Service (NHS) pharmacy claims databases and examining the implications of such findings from a public health and pharmaceutical policy perspective. Methods:Using a systematic approach, sixty-six antibiotic pediatric formulations were selected for the 5 most commonly used antibiotics in Italy in children and adolescents: amoxicillin in combination with clavulanic acid, amoxicillin, azithromycin, clarithromycin and cefixime. The Farma360 wholesale drug purchasing database was used to identify the yearly proportion of antibiotics not purchased based on NHS reimbursement in primary care from 2015-2017 at the national level. The relationship between product cost and purchase outside the NHS was assessed by a scatterplot. All analyses were stratified by geographic area: Northwest, Northeast, Central and Southern Italy. Results:The proportion of antibiotics not reimbursed by the NHS increased nationally from 24% in 2015 to 29% in 2017. The antibiotic with the highest proportion of purchases outside the NHS was amoxicillin, with almost two-thirds of all amoxicillin purchases in Southern Italy being made in this way in 2017. The relationship between antibiotic price and antibiotic purchase outside the NHS was almost linear for many geographic areas. Conclusions:This study showed that a large proportion of antibiotics with a pediatric formulation is purchased outside the NHS drug purchasing pathway, especially in Southern Italy, indicating that it is not possible to fully monitor drug utilization, including appropriateness, for these antibiotics. A better strategy is needed to improve drug utilization monitoring, such as better data collection or data linkage.

Dataset Information

Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study.

Publications

Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study.

Similar Datasets

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