OBJECTIVES: The Ministry of Food and Drug Safety (MFDS) in Korea released a safety notice recommending the changes of metoclopramide administration to minimize the adverse effect in serious nervous system. We aimed to estimate the impact of this Government notice on the use of metoclopramide.

METHODS: We performed a retrospective analysis using the Korean Health Insurance Review & Assessment Service claims database from 2011 to 2015 covering the entire population in Korea. The interrupted time series analysis was conducted to evaluate the impact of safety notice by comparing the metoclopramide utilization patterns per month before and after the release of safety notice in October 2013. We assessed the number of prescriptions, dose and administration period per prescription as the utilization patterns, stratified by age (<1, 1-18, 19-64 and ≥65) and disease (with or without cancer) group, because the safety notice restricted the dose and duration of metoclopramide by age and recommended for limited use in controlling nausea and vomiting for patients with radiotherapy and surgery.

RESULTS: We included 40,730,545 prescription claims for metoclopramide during 2011-2015. For total age-group, the safety notice did not affect the metoclopramide utilization patterns except the duration. The trend of duration shifted downward after the safety notice and subgroup analysis showed that this result was more pronounced in older age groups. The number of prescriptions, dose and duration significantly decreased following the safety notice and similar results were shown in the subgroup analysis.

CONCLUSIONS: To our knowledge, this is the first study to estimate the impact of regulatory announcement related to the drug safety of metoclopramide. Our results indicated that the changes in the number of prescriptions, dose, and duration per prescription might have occurred by the restrictions and recommendations in the safety notice.