Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Stopford Building, Oxford Road, Manchester, M13 9PT, United Kingdom.
Health Data Research Center, National Taiwan University, Taipei, Taiwan.
J Formos Med Assoc. 2021 Feb;120(2):810-818. doi: 10.1016/j.jfma.2020.09.011. Epub 2020 Sep 30.
BACKGROUND/PURPOSE: Prescribing of opioids to patients with non-cancer pain is strictly regulated in Taiwan, but tramadol is not included in the regulation on chronic opioid prescribing. This study aims to identify the utilization trend of prescribing tramadol and other opioid analgesics and investigate the influence of government regulation on opioid prescribing in Taiwan.
This cross-sectional study used the Taiwan National Health Insurance claims database and the cancer registry from 2001 through 2016. The annual number of adult opioid users, opioid utilization (Defined Daily Doses [DDDs]/1000 registrants) and the number of supply days were enumerated for each calendar year and stratified by cancer or non-cancer patients. Descriptive statistics were used to report the trends in utilization for each calendar year.
The regulation strictly limited persistent use of opioids for patients with non-cancer pain, of which only a small proportion of fentanyl (20%) and morphine (<2%) users were prescribed with an annual number of supply days greater than 28 days. The annual utilization of morphine (6.4-53.5 vs. 1.1 to 9.6 DDD/1000 registrants) and fentanyl (8.3-37.0 vs. 0.16 to 1.8 DDD/1000 registrants) to patients with cancer was consistently higher than patients without cancer. In contrast to morphine and fentanyl, the utilization of tramadol prescribed to patients without cancer increased 92.2-fold (3.7-341.2 DDD/1000 registrants) from 2002 to 2016.
The regulation in Taiwan limited the prescribing of selective opioids for patients with non-cancer pain and the substitution of tramadol for other opioids may have safety implications.
背景/目的：台湾对非癌痛患者开具阿片类药物处方有严格规定，但曲马多未被纳入慢性阿片类药物处方规定。本研究旨在确定曲马多和其他阿片类镇痛药的使用趋势，并调查政府对台湾阿片类药物处方的监管影响。
本横断面研究使用了 2001 年至 2016 年的台湾全民健康保险理赔数据库和癌症登记处。每年列出每个日历年度的成年阿片类药物使用者人数、阿片类药物使用量（定义日剂量[DDD]/1000 名登记患者）和供应天数，并按癌症或非癌症患者进行分层。使用描述性统计报告每个日历年度的使用趋势。
该规定严格限制了非癌痛患者持续使用阿片类药物，其中只有小部分芬太尼（20%）和吗啡（<2%）使用者的年度供应天数超过 28 天。吗啡（6.4-53.5 与 1.1-9.6 DDD/1000 名登记患者）和芬太尼（8.3-37.0 与 0.16-1.8 DDD/1000 名登记患者）在癌症患者中的年使用率始终高于非癌症患者。与吗啡和芬太尼不同，2002 年至 2016 年，非癌症患者开具的曲马多处方使用率增加了 92.2 倍（3.7-341.2 DDD/1000 名登记患者）。
台湾的规定限制了非癌痛患者选择性阿片类药物的处方，曲马多替代其他阿片类药物可能存在安全隐患。
