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Dramatic decrease in fluoroquinolones in the pediatric population in Korea
Ju-Young Shin1, Mi Hee Kim, Sun Mi Shin
1Korea Institute of Drug Safety and Risk Management (KIDS), Seoul, Korea.
Insights
Korean regulatory actions significantly reduced fluoroquinolone prescribing in pediatric patients. This study highlights the impact of regulatory measures on antibiotic use in children, decreasing fluoroquinolone prescriptions by over 94%.
Area of Science:
- Pharmacovigilance and Drug Safety
- Pediatric Pharmacology
- Public Health Policy
Background:
- Fluoroquinolones are potent antibiotics with potential risks, particularly in pediatric populations.
- Regulatory actions are often implemented to mitigate adverse drug events and optimize antibiotic stewardship.
- Understanding prescribing pattern shifts is crucial for evaluating the effectiveness of regulatory interventions.
Purpose of the Study:
- To evaluate the impact of regulatory actions on fluoroquinolone prescribing patterns in pediatric patients.
- To quantify the change in fluoroquinolone use before and after the implementation of regulatory measures.
Main Methods:
- A time series analysis was conducted using the Korea Health Insurance Review and Assessment Service National Patients Sample database.
- Pediatric patients (under 18 years) prescribed antibiotics between January 2009-December 2011 were included.
- Fluoroquinolone use was defined by the prescription of specific fluoroquinolone agents; monthly user numbers and proportions were calculated pre- and post-regulation.
Main Results:
- A total of 4,945,169 antibiotic prescriptions in 484,914 pediatric patients were analyzed.
- Fluoroquinolone use decreased from 4.81% pre-regulation to 0.26% in the year following regulatory action.
- This represents a significant 94.55% relative reduction in pediatric fluoroquinolone prescribing.
Conclusions:
- Korean regulatory actions effectively reduced the use of fluoroquinolones in the pediatric population.
- The findings demonstrate the successful implementation of policy to improve antibiotic stewardship in children.
- This study underscores the importance of regulatory oversight in managing the use of potentially high-risk medications.
Purpose:
This study was performed to evaluate the change of prescribing patterns after the regulatory action regarding fluoroquinolones in pediatric patients.
Methods:
We conducted a time series analysis using the Korea Health Insurance Review and Assessment Service National Patients Sample database. Study subjects consisted of pediatric patients under 18 years of age who were prescribed antibiotics at least once (ATC code, J01) before (January 2009-December 2009) and after implementation (January 2010-December 2011) of the regulation. The use of fluoroquinolones was defined as the use of the following antibiotics for at least once in pediatric patients: ofloxacin, ciprofloxacin, norfloxacin, lomefloxacin, levofloxacin, and gemifloxacin. We calculated the number of pediatric fluoroquinolone users for each month. The difference between proportions before and after the regulation was estimated as relative and absolute reduction of fluoroquinolone use. We calculated 95% confidence intervals (CI).
Results:
We identified 4, 945, 169 antibiotic prescriptions in 484, 914 pediatric patients. During the 12-month period before implementation, percentage of fluoroquinolone use was 4.81% (95% CI: 4.70-4.91%, N = 8001). We observed a rapid decrease in the monthly number of fluoroquinolone users in pediatric population after the implementation of regulatory action. In the year after regulatory action, the percentage of fluoroquinolone use was only 0.26% (95% CI: 0.24-0.28%, N = 834). Overall, there was a 94.55% relative reduction (95% CI: 88.02-101.56%) in the use of fluoroquinolones.
Conclusion:
Korean regulatory actions regarding fluoroquinolones had an effect of reducing use in pediatric population.
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