Impact of Safety Warning on Domperidone Prescribing for Geriatric Patients in South Korea: Analysis of National Insurance Claim Data

Abstract

Domperidone is a dopamine antagonist used for the symptomatic management of nausea and vomiting. Many countries banned or add a black box warning due to an increased risk of serious adverse cardiac effects. In 2014, the Korea Ministry of Food and Drug Safety also released a safety warning to carefully consider adverse cardiac effects when prescribing domperidone. Therefore, we conducted this study to analyze the impact of the safety warning on domperidone prescribing. This study included patients 65 years or older who used national health insurance services in the years 2011 and 2016, using the national patient sample dataset in South Korea. We analyzed the characteristics of domperidone prescribing and compared on pre- and post-safety warning. Prescribing frequency of domperidone was significantly reduced from 603,962 cases in 2011 to 24,623 cases in 2016. In 2011, 53,272 (8.8%) prescriptions were for greater than 30 mg/day, whereas only 200 (0.8%) prescriptions were in 2016. The number of patients with one or more comorbidities and electrocardiogram monitoring showed positive changes after the safety warning. In conclusion, after the 2014 safety letter was issued, domperidone was more safely prescribed in various aspects in elderly patients, including frequency of prescribing, maximum daily dose, and duration of continuous prescription.

<p>Effects of a Safety Letter on Metoclopramide Use in Korea: An Interrupted Time-Series Analysis</p>

“…Many researchers have used ITSA methodologies to evaluate the effectiveness of healthcare policies. 8,[14][15][16][17][18][19] In recent years, several studies have suggested a scientific process and recommendations for ITSA including methodology and reporting. We performed an ITSA comparing the utilization pattern of metoclopramide before and after the publication of the safety letter with reference to these recommendations.…”

“…The safety letter included recommendations with regard to the indications, prescription, and dosage of metoclopramide However, the effects of a safety letter from the MFDS during post-marketing surveillance are mixed. Previous studies have shown that a safety letter from the MFDS can change the drug utilization pattern, 8 whereas other studies have reported that safety letter from the MFDS had a limited impact on treatment use in clinical practice. 9 A safety letter from the MFDS is an important national policy option in Korea for pharmacovigilance and risk management.…”

Perfil do uso do medicamento domperidona em pacientes idosos internados em um hospital universitário

“…corpo médico para as práticas de prescrição mais segura. Um estudo realizado porCarvalho et al, (2022) descreve a visão dos preceptores de residência médica, e afirma sobre a importância da atualização cientifica de forma contínua para atuarem com qualidade em suas preceptorias e assistência.O sexo feminino se destacou com 78% se corroborando com os resultados do estudo realizado porRhew, Han & Oh (2019) que demonstrou maior utilização do domperidona por mulheres idosas do serviço de seguro de saúde nacional nos anos de 2011 e 2016 na Coreia do Sul, representando respectivamente 66% e 63%. É importante citar que as mulheres apresentam maior risco no prolongamento do intervalo QT e desenvolver TdP como demonstram alguns estudos que o sexo feminino devido as mudanças hormonais que ocorrem com o envelhecimento podem contribuir com a indução/inibição da CYP3A influenciando assim no metabolismo dos fármacos(Cotreau et al, 2005), além de que pode apresentar fisiologicamente intervalo de QT em torno de 20 milisegundos (ms) a mais do que o sexo masculino(Prado et al, 2017).…”