Teeling M, MacAvin M J, Bennett K
Department of Pharmacology and Therapeutics, Trinity College Dublin, Dublin, Ireland.
Population Health Sciences Division, Royal College of Surgeons in Ireland, Dublin, Ireland.
Ir J Med Sci. 2018 May;187(2):281-285. doi: 10.1007/s11845-017-1657-1. Epub 2017 Jul 20.
This study aimed to investigate the impact of the 2014 safety warnings on use of domperidone, on subsequent prescribing patterns in Ireland.
The Irish HSE-PCRS pharmacy claims database was used to identify the study cohort (aged 18+), prescribed domperidone from Jan 2014 to Oct 2015. Dosage was available for each claim; concomitant prescription with the following drug classes was identified and calculated as a percentage of the total number of claims: anti-arrhythmics, macrolide antimicrobials and the selective serotonin receptor inhibitors (SSRIs) citalopram and escitalopram. Segmented regression analysis was used to examine the changes in prescribing before and after the issue of safety warnings in May 2014.
A total of 397,572 claims for domperidone were identified from Jan 2014 to Oct 2015. Overall, there was a significant decline in numbers receiving domperidone during the study period (from 22,226 to 15,691 claims, p = 0.012), with no significant change over time. In addition, no significant change in co-prescribed SSRIs or anti-arrhythmic agents was observed over time; co-prescribed macrolide antimicrobials significantly increased after the safety advisory compared to trends before (p = 0.031). In those aged 60+ years, 10% of claims (n = 1332) were for doses >30 mg/day at the start of the study with no significant change in dose after the May advisory.
Safety warnings concerning domperidone appeared to have had little effect on prescribing patterns in Ireland. Of concern is the continuing co-prescription with drugs known to increase the risk of QT prolongation, in all ages, including the 60+ year age group.
本研究旨在调查2014年多潘立酮安全警告对爱尔兰后续处方模式的影响。
利用爱尔兰健康服务执行局-药房索赔记录系统(HSE-PCRS)数据库确定研究队列(年龄18岁及以上),这些患者在2014年1月至2015年10月期间开具了多潘立酮处方。每次索赔都有剂量信息;确定与以下药物类别同时开具的处方,并计算其占索赔总数的百分比:抗心律失常药、大环内酯类抗菌药以及选择性5-羟色胺再摄取抑制剂(SSRI)西酞普兰和艾司西酞普兰。采用分段回归分析来研究2014年5月发布安全警告前后处方的变化情况。
2014年1月至2015年10月期间共确定了397,572例多潘立酮索赔。总体而言,研究期间接受多潘立酮治疗的人数显著下降(从22,226例降至15,691例,p = 0.012),且随时间无显著变化。此外,随时间推移,同时开具的SSRI或抗心律失常药物无显著变化;与之前的趋势相比,安全建议发布后同时开具的大环内酯类抗菌药显著增加(p = 0.031)。在60岁及以上人群中,研究开始时10%的索赔(n = 1332)为每日剂量>30mg,5月建议发布后剂量无显著变化。
关于多潘立酮的安全警告似乎对爱尔兰的处方模式影响不大。令人担忧的是,在所有年龄段,包括60岁及以上年龄组,仍持续存在与已知会增加QT间期延长风险的药物同时开具处方的情况。