1 Clinical Pharmacy Services, University of Massachusetts Medical School, Shrewsbury.
2 Center for Health Policy and Research, University of Massachusetts Medical School, Shrewsbury.
J Manag Care Spec Pharm. 2017 May;23(5):532-539. doi: 10.18553/jmcp.2017.23.5.532.
In 2012, hydrocodone combination products (HCPs) were the most prescribed medications in the United States. Under the Controlled Substance Act of 1970, hydrocodone alone was classified as a Schedule II drug, while HCPs were classified as Schedule III, indicating a lower risk for abuse and misuse. However, according to a Drug Enforcement Agency analysis, the addition of nonopioids has not been shown to diminish abuse potential of hydrocodone. In response to concerns for drug abuse and overdose, the Drug Enforcement Agency rescheduled HCPs to Schedule II in October 2014, with the intent of limiting overprescribing and increasing awareness of their abuse potential. However, it is unknown whether this has affected the overall claims for HCPs in a Medicaid population.
To (a) compare the trend in HCP prescription claims with select non-HCP (opioid and nonopioid) analgesic claims before and after the HCP schedule change in the Massachusetts Medicaid fee-for-service/Primary Care Clinician plan population and (b) identify if there was a change in HCP new start member and claim characteristics before and after the HCP schedule change.
This quasi-experimental, retrospective study used enrollment and pharmacy claims data to evaluate all members in the study population 1 year before and after the HCP schedule change. The number of claims for HCPs and select non-HCP analgesics was reported as the monthly rate per total population, and an interrupted time series analysis compared the change in the monthly rate of claims across groups. Members with 1 or more pharmacy claims for a new HCP prescription during a 5-month period before or after the HCP schedule change were analyzed to determine member demographics (age, gender, and number of claims) and claim characteristics (average daily dose, average quantity per claim, and days supply).
The rate of HCP claims increased before and decreased after the HCP schedule change. Controlling for the trend during the period before the HCP schedule change, the rate of HCP claims per 1,000 members per month decreased at a greater rate than non-HCP analgesics in the period after the HCP schedule change (P < 0.001). The percentage of HCP claims for new start members decreased after the HCP schedule change (44.9% vs. 34.1% of all HCP claims pre- to post-schedule change; P < 0.001). In the group of new starts, there was not a significant difference in the average daily dose (26.3 mg vs. 26.4 mg; P = 0.69), while there was a decrease in average number of tablets dispensed per claim (from 37.1 to 20.3 tablets; P < 0.001) and an increase in the percentage of claims for a shorter days supply (from 57.7% to 81.6%; P < 0.001).
The findings of this study suggest that the HCP schedule change may have contributed to the decrease in claims for HCPs in a Medicaid population. After the HCP schedule change, there was a trend towards decreased HCP use among new starts.
No outside funding supported this study. The authors have nothing to disclose. Study concept and design were contributed by all authors except for Arnold and Clements. Tran, Arnold, and Clements took the lead in data collection, along with Peristere, and data interpretation was performed by all the authors, except Arnold. The manuscript was written primarily by Tran, along with Lavitas, Stevens, and Greenwood, and revised by all the authors except Arnold and Peristere. A poster of this research project was presented at the Academy of Managed Care Pharmacy's 2016 Annual Meeting in San Francisco, California, April 2016.
2012 年，氢可酮复方制剂（HCPs）是美国使用最多的处方药物。根据 1970 年《管制物质法案》，氢可酮单独被列为附表 II 药物，而 HCPs 则被列为附表 III，表明滥用和误用的风险较低。然而，根据美国缉毒署的分析，添加非阿片类药物并没有显示出降低氢可酮的滥用潜力。为了应对对药物滥用和过量用药的担忧，美国缉毒署于 2014 年 10 月将 HCPs 重新归类为附表 II，目的是限制过度处方和提高对其滥用潜力的认识。然而，目前尚不清楚这是否会影响医疗补助人群中 HCPs 的总体索赔。
（a）比较 HCP 处方索赔与马萨诸塞州医疗补助按服务付费/初级保健医生计划人群中 HCP 计划变更前后选择的非 HCP（阿片类和非阿片类）镇痛药的索赔趋势，（b）确定 HCP 计划变更前后 HCP 新开始成员和索赔特征是否发生变化。
这项准实验、回顾性研究使用了参保和药房理赔数据来评估 HCP 计划变更前后一年研究人群中的所有成员。HCP 和选择的非阿片类镇痛药的索赔数量以总人群的每月费率报告，中断时间序列分析比较了各组之间索赔月度费率的变化。分析了在 HCP 计划变更前后的 5 个月内有 1 次或更多次新 HCP 处方药房理赔的成员的人口统计学特征（年龄、性别和理赔次数）和理赔特征（平均日剂量、平均每次理赔数量和用药天数）。
HCP 索赔的比率在 HCP 计划变更之前增加，在 HCP 计划变更之后减少。在 HCP 计划变更之前的时期内控制趋势，HCP 索赔的比率在 HCP 计划变更之后的时期内以比非阿片类镇痛药更快的速度下降（P < 0.001）。HCP 新开始成员的索赔比例在 HCP 计划变更后下降（44.9%与 HCP 计划变更前后所有 HCP 索赔的 34.1%；P < 0.001）。在新开始成员组中，平均日剂量没有显著差异（26.3 毫克与 26.4 毫克；P = 0.69），但平均每张处方分发的片剂数量减少（从 37.1 片减少到 20.3 片；P < 0.001），较短用药天数的索赔比例增加（从 57.7%增加到 81.6%；P < 0.001）。
这项研究的结果表明，HCP 计划变更可能导致医疗补助人群中 HCP 索赔的减少。HCP 计划变更后，新开始成员中 HCP 的使用呈下降趋势。
本研究没有外部资金支持。作者没有任何披露。研究概念和设计由除 Arnold 和 Clements 以外的所有作者做出贡献。Tran、Arnold 和 Clements 带头进行数据收集，Peristere 也参与了数据收集，所有作者都参与了数据解释，除了 Arnold。手稿主要由 Tran 与 Lavitas、Stevens 和 Greenwood 共同撰写，除了 Arnold 和 Peristere 以外的所有作者都对其进行了修订。本研究项目的海报在 2016 年 4 月于加利福尼亚州旧金山举行的美国管理式医疗药师协会 2016 年年会展示。
