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罗得岛州的处方药限制法是否有助于减少全关节置换术后的阿片类药物使用?

Has a Prescription-limiting Law in Rhode Island Helped to Reduce Opioid Use After Total Joint Arthroplasty?

机构信息

D.B.C. Reid, B. Shapiro, K.N. Shah, J.H. Ruddell, E.M. Cohen, E. Akelman, A.H. Daniels, Warren Alpert Medical School and the Department of Orthopaedic Surgery, Warren Alpert Medical School, Brown University, Providence, RI.

出版信息

Clin Orthop Relat Res. 2020 Feb;478(2):205-215. doi: 10.1097/CORR.0000000000000885.

Abstract

BACKGROUND

In the United States, since 2016, at least 28 of 50 state legislatures have passed laws regarding mandatory prescribing limits for opioid medications. One of the earliest state laws (which was passed in Rhode Island in 2016) restricted the maximum morphine milligram equivalents provided in the first postoperative prescription for patients defined as opioid-naïve to 30 morphine milligram equivalents per day, 150 total morphine milligram equivalents, or 20 total doses. While such regulations are increasingly common in the United States, their effects on opioid use after total joint arthroplasty are unclear.

QUESTIONS/PURPOSES: (1) Are legislative limitations to opioid prescriptions in Rhode Island associated with decreased opioid use in the immediate (first outpatient prescription postoperatively), 30-day, and 90-day periods after THA and TKA? (2) Is this law associated with similar changes in postoperative opioid use among patients who are opioid-naïve and those who are opioid-tolerant preoperatively?

METHODS

Patients undergoing primary THA or TKA between January 1, 2016 and June 28, 2016 (before the law was passed on June 28, 2016) were retrospectively compared with patients undergoing surgery between June 1, 2017 and December 31, 2017 (after the law's implementation on April 17, 2017). The lapse between the pre-law and post-law periods was designed to avoid confounding from potential voluntary practice changes by physicians after the law was passed but before its mandatory implementation. Demographic and surgical details were extracted from a large multi-specialty orthopaedic group's surgical billing database using Current Procedural Terminology codes 27130 and 27447. Any patients undergoing revision procedures, same-day bilateral arthroplasties, or a second primary THA or TKA in the 3-month followup period were excluded. Secondary data were confirmed by reviewing individual electronic medical records in the associated hospital system which included three major hospital sites. We evaluated 1125 patients. In accordance with the state's department of health guidelines, patients were defined as opioid-tolerant if they had filled any prescription for an opioid medication in the 30-day preoperative period. Data on age, gender, and the proportion of patients who were defined as opioid tolerant preoperatively were collected and found to be no different between the pre-law and post-law groups. The state's prescription drug monitoring program database was used to collect data on prescriptions for all controlled substances filled between 30 days preoperatively and 90 days postoperatively. The primary outcomes were the mean morphine milligram equivalents of the initial outpatient postoperative opioid prescription after discharge and the mean cumulative morphine milligram equivalents at the 30- and 90-day postoperative intervals. Secondary analyses included subgroup analyses by procedure and by preoperative opioid tolerance.

RESULTS

After the law was implemented, the first opioid prescriptions were smaller for patients who were opioid-naïve (mean 156 ± 106 morphine milligram equivalents after the law's passage versus 451 ± 296 before, mean difference 294 morphine milligram equivalents; p < 0.001) and those who were opioid-tolerant (263 ± 265 morphine milligram equivalents after the law's passage versus 534 ± 427 before, mean difference 271 morphine milligram equivalents; p < 0.001); however, for cumulative prescriptions in the first 30 days postoperatively, this was only true among patients who were previously opioid-naïve (501 ± 416 morphine milligram equivalents after the law's passage versus 796 ± 597 before, mean difference 295 morphine milligram equivalents; p < 0.001). Those who were opioid-tolerant did not have a decrease in the cumulative number of 30-day morphine milligram equivalents (1288 ± 1632 morphine milligram equivalents after the law's passage versus 1398 ± 1274 before, mean difference 110 morphine milligram equivalents; p = 0.066).

CONCLUSIONS

The prescription-limiting law was associated with a decline in cumulative opioid prescriptions at 30 days postoperatively filled by patients who were opioid-naïve before total joint arthroplasty. This may substantially impact public health, and these policies should be considered an important tool for healthcare providers, communities, and policymakers who wish to combat the current opioid epidemic. However, given the lack of a discernible effect on cumulative opioids filled from 30 to 90 days postoperatively, further investigations are needed to evaluate more effective policies to prevent prolonged opioid use after total joint arthroplasty, particularly in patients who are opioid-tolerant preoperatively.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

自 2016 年以来,美国 50 个州中至少有 28 个州通过了有关阿片类药物强制性处方限制的法律。最早的州法律之一(2016 年在罗得岛通过)限制了术后第一天首次开给被定义为阿片类药物无耐受史的患者的最大吗啡毫克当量为 30 毫克吗啡当量/天,总量 150 毫克吗啡当量或 20 剂。虽然此类法规在美国越来越普遍,但它们对全膝关节置换术后阿片类药物使用的影响尚不清楚。

问题/目的:(1)罗德岛州的阿片类药物处方限制是否与全髋关节置换术和全膝关节置换术后即刻(术后第一次门诊处方)、30 天和 90 天的阿片类药物使用减少有关?(2)该法律是否与术前阿片类药物无耐受史和术前阿片类药物耐受的患者术后阿片类药物使用的类似变化相关?

方法

回顾性比较了 2016 年 1 月 1 日至 2016 年 6 月 28 日(法律于 2016 年 6 月 28 日通过之前)期间接受初次全髋关节置换术或全膝关节置换术的患者和 2017 年 6 月 1 日至 2017 年 12 月 31 日(法律于 2017 年 4 月 17 日实施后)期间接受手术的患者。在法律生效之前和强制实施之后,设计这段时间的间隔是为了避免医生在法律通过后但在其强制实施之前自愿改变实践时产生混杂因素。使用当前程序术语代码 27130 和 27447 从大型多专业骨科组的手术计费数据库中提取人口统计学和手术细节。排除了在 3 个月随访期间接受翻修手术、同日双侧关节置换术或第二次初次全髋关节置换术或全膝关节置换术的患者。通过在相关医院系统中查看每个电子病历,对次要数据进行了确认,该系统包括三个主要医院站点。我们评估了 1125 名患者。根据州卫生部门的指导方针,如果患者在术前 30 天内服用了任何阿片类药物处方,则定义为阿片类药物耐受。收集了年龄、性别以及术前被定义为阿片类药物耐受的患者比例的数据,发现两组之间没有差异。使用州的处方药物监测计划数据库收集了在术前 30 天至术后 90 天期间填写的所有受控物质处方的数据。主要结局是出院后初始门诊术后阿片类药物处方的平均吗啡毫克当量和术后 30 天和 90 天的平均累积吗啡毫克当量。次要分析包括按程序和术前阿片类药物耐受性进行的亚组分析。

结果

该法律实施后,对于术前阿片类药物无耐受史的患者(法律通过后首次开阿片类药物处方的平均吗啡毫克当量为 156 ± 106,而法律通过前为 451 ± 296,平均差异为 294 毫克吗啡当量;p < 0.001)和术前阿片类药物耐受的患者(法律通过后首次开阿片类药物处方的平均吗啡毫克当量为 263 ± 265,而法律通过前为 534 ± 427,平均差异为 271 毫克吗啡当量;p < 0.001),第一剂阿片类药物处方较小;然而,对于术后 30 天内的累积处方,这仅适用于术前无阿片类药物耐受史的患者(法律通过后首次开阿片类药物处方的平均吗啡毫克当量为 501 ± 416,而法律通过前为 796 ± 597,平均差异为 295 毫克吗啡当量;p < 0.001)。对于术前阿片类药物耐受的患者,累积 30 天内的吗啡毫克当量无减少(法律通过后首次开阿片类药物处方的平均吗啡毫克当量为 1288 ± 1632,而法律通过前为 1398 ± 1274,平均差异为 110 毫克吗啡当量;p = 0.066)。

结论

限制处方阿片类药物的法律与全关节置换术后 30 天内术后首次门诊处方的累积阿片类药物处方数量减少有关,对于术前无阿片类药物耐受史的患者。这可能会对公共卫生产生重大影响,这些政策应被视为医疗保健提供者、社区和政策制定者的重要工具,他们希望对抗当前的阿片类药物流行。然而,鉴于从术后 30 天到 90 天之间的累积阿片类药物使用量没有明显变化,需要进一步调查以评估更有效的政策,以防止全关节置换术后阿片类药物的长期使用,特别是对于术前阿片类药物耐受的患者。

证据水平

III 级,治疗性研究。

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