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患者为中心的阿片类药物处方指南和优化 FDA -compliant 术后住院过量药物处置:前瞻性临床试验。

Guidelines for Patient-CenteredOpioid Prescribing and Optimal FDA-Compliant Disposal of Excess Pills after Inpatient Operation: Prospective Clinical Trial.

机构信息

Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Dartmouth Geisel School of Medicine, Hanover, NH.

出版信息

J Am Coll Surg. 2021 Jun;232(6):823-835.e2. doi: 10.1016/j.jamcollsurg.2020.12.057. Epub 2021 Feb 25.

Abstract

BACKGROUND

To optimize responsible opioid prescribing after inpatient operation, we implemented a clinical trial with the following objectives: prospectively validate patient-centered opioid prescription guidelines and increase the FDA-compliant disposal rate of leftover opioid pills to higher than currently reported rates of 20% to 30%.

STUDY DESIGN

We prospectively enrolled 229 patients admitted for 48 hours or longer after elective general, colorectal, urologic, gynecologic, or thoracic operation. At discharge, patients received a prescription for both nonopioid analgesics and opioids based on their opioid usage the day before discharge: if 0 oral morphine milligram equivalents (MME) were used, then five 5-mg oxycodone pill-equivalents were prescribed; if 1 to 29 MME were used, then fifteen 5-mg oxycodone pill-equivalents were prescribed; if 30 or more MME were used, then thirty 5-mg oxycodone pill-equivalents were prescribed. We considered patients' opioid pain medication needs to be satisfied if no opioid refills were obtained. To improve FDA-compliant disposal of leftover pills, we implemented patient education, convenient drop-box, reminder phone call, and questionnaire.

RESULTS

Our opioid guideline satisfied 93% (213 of 229) of patients. Satisfaction was significantly higher in lower opioid usage groups (p = 0.001): 99% (99 of 100) in the 0 MME group, 90% (91 of 101) in the 1 to 29 MME group, and 82% (23 of 28) in the 30 or more MME group. Overall, 95% (217 of 229) of patients used nonopioid analgesics. Sixty percent (138 of 229) had leftover pills; 83% (114 of 138) disposed of them using an FDA-compliant method and 51% (58 of 114) used the convenient drop-box. Of 2,604 prescribed pills, only 187 (7%) were kept by patients.

CONCLUSIONS

This clinical trial prospectively validated a patient-centered opioid discharge prescription guideline that satisfied 93% of patients. FDA-compliant disposal of excess pills was achieved in 83% of patients with easily actionable interventions.

摘要

背景

为了优化住院手术后负责任的阿片类药物处方,我们开展了一项临床试验,旨在验证以患者为中心的阿片类药物处方指南,并将剩余阿片类药物药丸的符合 FDA 规定的处理率提高到高于目前报告的 20%至 30%的水平。

研究设计

我们前瞻性地招募了 229 名接受择期普通、结肠直肠、泌尿科、妇科或胸科手术的患者,住院时间为 48 小时或以上。出院时,根据患者出院前一天的阿片类药物使用情况,为其开具非阿片类镇痛药和阿片类药物的处方:如果使用 0 个口服吗啡毫克当量 (MME),则开 5 个 5 毫克羟考酮片等效物的处方;如果使用 1 至 29 MME,则开 15 个 5 毫克羟考酮片等效物的处方;如果使用 30 个或更多 MME,则开 30 个 5 毫克羟考酮片等效物的处方。如果患者没有获得阿片类药物的补充处方,我们认为他们的阿片类药物疼痛缓解需求得到了满足。为了提高剩余药丸符合 FDA 规定的处理率,我们实施了患者教育、方便的投药箱、提醒电话和问卷调查。

结果

我们的阿片类药物指南满足了 93%(213/229)的患者需求。在阿片类药物使用量较低的患者群体中,满意度明显更高(p=0.001):0 MME 组为 99%(99/100),1 至 29 MME 组为 90%(91/101),30 个或更多 MME 组为 82%(23/28)。总体而言,95%(217/229)的患者使用了非阿片类镇痛药。60%(229/229)的患者有剩余药丸;83%(138/138)的患者使用符合 FDA 规定的方法处理了这些药丸,其中 51%(58/138)使用了方便的投药箱。在开出的 2604 片药丸中,只有 187 片(7%)被患者保留。

结论

这项临床试验前瞻性地验证了以患者为中心的阿片类药物出院处方指南,满足了 93%的患者需求。通过易于实施的干预措施,有 83%的患者实现了剩余阿片类药物药丸符合 FDA 规定的处理。

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