Domperidone prescribing patterns in pediatric patients before and after safety warning in South Korea
Insights
Korean pediatric domperidone prescriptions decreased significantly after a 2014 safety warning on cardiac risks. Prescribing patterns improved, reducing dosage, duration, and interacting drug co-prescriptions, enhancing child safety.
Area of Science:
- Pediatric Pharmacology
- Drug Safety and Pharmacovigilance
- Public Health Policy
Background:
- A 2014 safety warning was issued by the Korean Ministry of Food and Drug Safety (MFDS) regarding potential adverse cardiac effects of domperidone in children.
- Domperidone is a medication commonly prescribed for gastrointestinal issues in pediatric populations.
Purpose of the Study:
- To evaluate the impact of the 2014 MFDS safety warning on domperidone prescribing trends in pediatric patients.
- To compare domperidone prescription patterns before and after the safety warning.
Main Methods:
- Analysis of national health insurance data for patients under 18 years old in 2011 and 2016.
- Assessment of prescribing patterns including dosage, duration, and co-prescribed medications.
Main Results:
- Domperidone prescriptions in pediatrics decreased by 30% from 2011 to 2016.
- Significant reductions were observed in prescriptions with high daily dosages (>30 mg) and long continuous use (>7 days).
- Co-prescriptions of interacting medications with domperidone also significantly decreased.
Conclusions:
- The 2014 MFDS safety warning led to improved pediatric domperidone prescribing practices.
- Enhanced drug safety for children was achieved through reduced prescription frequency, shorter treatment durations, and fewer interacting drug co-prescriptions.
Objective:
In 2014, the Korean Ministry of Food and Drug Safety (MFDS) issued a safety warning to carefully consider adverse cardiac effects when prescribing domperidone for children. We conducted this study to compare the trends of domperidone prescription in pediatrics before and after the MFDS safety warning.
Materials:
This study included patients < 18 years old who used national health insurance services within the year 2011 and the year 2016, sampled from Health Insurance Review Agency data.
Methods:
We analyzed domperidone prescribing patterns including prescribed daily dosage, maximum period of continuous prescription, and number and types of co-prescribed medications and compared two different years pre and post safety warning.
Results:
A total of 16,614 pediatric patients (1.74%) received domperidone prescriptions in 2011, and 11,317 patients (1.23%) in 2016. The probability of receiving at least one prescription in 2016 has been reduced by 30% compared to 2011. Gastritis was the most common indication in both years. The number of prescriptions containing a maximum daily dosage of over 30 mg was significantly lower in 2016. In the same time period, the number of cases with a maximum continuous prescription period of more than 7 days significantly decreased (p < 0.001). In addition, from 2011 to 2016, comorbid diseases of domperidone-treated patients were similar, but the number of co-prescriptions of interacting medication to domperidone decreased (p < 0.001).
Conclusion:
After the 2014 safety letter was released, the pattern of prescribing domperidone in pediatrics has enhanced drug safety for children in terms of frequency of prescriptions, maximum duration of domperidone use, and the prescription of drugs interacting with domperidone.
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