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Stat Methods Med Res. 2019 Dec;28(12):3697-3711. doi: 10.1177/0962280218814570. Epub 2018 Nov 25.
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N Engl J Med. 2018 Aug 9;379(6):504-506. doi: 10.1056/NEJMp1803661.
6
Opioid Prescriptions in Older Medicare Beneficiaries After the 2014 Federal Rescheduling of Hydrocodone Products.2014 年联邦政府调整氢可酮类药物分类后,老年 Medicare 受益人群中的阿片类药物处方情况。
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9
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Pharmacoepidemiol Drug Saf. 2018 May;27(5):513-519. doi: 10.1002/pds.4376. Epub 2017 Dec 21.
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药品执法署 2014 年羟考酮调整管理规则与术后阿片类药物配给

Drug Enforcement Agency 2014 Hydrocodone Rescheduling Rule and Opioid Dispensing after Surgery.

机构信息

From the Department of Anesthesiology and Critical Care (M.D.N., L.G.) Center for Perioperative Outcomes Research and Transformation (M.D.N., L.G.) Center for Pharmacoepidemiology Research and Training (M.D.N., S.H., D.S.S.) Department of Biostatistics, Epidemiology, and Informatics (S.H.) Center for Clinical Epidemiology and Biostatistics (S.H., D.S.S.,C.N., C.M.B.), Perelman School of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania (M.D.N., S.H., D.S.S.) Department of Statistics, The Wharton School, University of Pennsylvania, Philadelphia, Pennsylvania (D.S.S.) Department of Anesthesia, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada (D.N.W.) Department of Anesthesia, Perioperative, and Pain Medicine and Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (B.T.B.) Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (H.W.) Department of Anesthesia and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada (H.W.).

出版信息

Anesthesiology. 2020 May;132(5):1151-1164. doi: 10.1097/ALN.0000000000003188.

DOI:10.1097/ALN.0000000000003188
PMID:32101973
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7160003/
Abstract

BACKGROUND

In 2014, the U.S. Drug Enforcement Agency reclassified hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, resulting in new restrictions on refills. The authors hypothesized that hydrocodone rescheduling led to decreases in total opioid dispensing within 30 days of surgery and reduced new long-term opioid dispensing among surgical patients.

METHODS

The authors studied privately insured, opioid-naïve adults undergoing 10 general or orthopedic surgeries between 2011 and 2015. The authors conducted a differences-in-differences analysis that compared overall opioid dispensing before versus after the rescheduling rule for patients treated by surgeons who frequently prescribed hydrocodone before rescheduling (i.e., patients who were functionally exposed to rescheduling's impact) while adjusting for secular trends via a comparison group of patients treated by surgeons who rarely prescribed hydrocodone (i.e., unexposed patients). The primary outcome was any filled opioid prescription between 90 and 180 days after surgery; secondary outcomes included the 30-day refill rate and the amount of opioids dispensed initially and at 30 days postoperatively.

RESULTS

The sample included 65,136 patients. The percentage of patients filling a prescription beyond 90 days was similar after versus before rescheduling (absolute risk difference, -1.1%; 95% CI, -2.3% to 0.1%; P = 0.084). The authors estimated the rescheduling rule to be associated with a 45.4-mg oral morphine equivalent increase (difference-in-differences estimate; 95% CI, 34.2-56.7 mg; P < 0.001) in initial opioid dispensing, a 4.1% absolute decrease (95% CI, -5.5% to -2.7%; P < 0.001) in refills within 30 days, and a 37.7-mg oral morphine equivalent increase (95% CI, 20.6-54.8 mg; P = 0.008) in opioids dispensed within 30 days.

CONCLUSIONS

Among patients treated by surgeons who frequently prescribed hydrocodone before the Drug Enforcement Agency 2014 hydrocodone rescheduling rule, rescheduling did not impact long-term opioid receipt, although it was associated with an increase in opioid dispensing within 30 days of surgery.

摘要

背景

2014 年,美国缉毒局将氢可酮从《管制物质法》附表 III 重新分类到附表 II,从而对其续方做出了新的限制。作者假设氢可酮重新分类导致手术 30 天内总阿片类药物配给量减少,并减少了手术患者中新的长期阿片类药物配给。

方法

作者研究了 2011 年至 2015 年间接受 10 种普通或骨科手术的私人保险、无阿片类药物使用史的成年人。作者进行了差异-差异分析,比较了重新分类规则前后接受经常开氢可酮处方的外科医生治疗的患者(即功能上受重新分类影响的患者)的总体阿片类药物配给量,同时通过比较很少开氢可酮处方的外科医生治疗的患者(即未暴露患者)的对照组来调整季节性趋势。主要结果是手术后 90 至 180 天内任何已填阿片类药物处方;次要结果包括 30 天内的续方率和最初及术后 30 天内的阿片类药物配给量。

结果

样本包括 65136 名患者。手术后 90 天以上患者填写处方的比例在重新分类前后相似(绝对风险差异,-1.1%;95%CI,-2.3%至 0.1%;P=0.084)。作者估计重新分类规则与初始阿片类药物配给量增加 45.4mg 口服吗啡当量(差异-差异估计值;95%CI,34.2-56.7mg;P<0.001)、30 天内续方绝对减少 4.1%(95%CI,-5.5%至-2.7%;P<0.001)和 30 天内阿片类药物配给量增加 37.7mg 口服吗啡当量(95%CI,20.6-54.8mg;P=0.008)有关。

结论

在接受经常开氢可酮处方的外科医生治疗的患者中,2014 年缉毒局氢可酮重新分类规则并未影响长期阿片类药物的使用,尽管与手术后 30 天内阿片类药物配给量的增加有关。