Abuse-Deterrent Formulations and the Prescription Opioid Abuse Epidemic in the United States Lessons Learned From OxyContin
Abuse-Deterrent Formulations and the Prescription Opioid Abuse Epidemic in the United States Lessons Learned From OxyContin
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DOI：
10.1001/jamapsychiatry.2014.3043
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发表时间：
2015-05-01
期刊：
影响因子：
25.8
通讯作者：
Ellis, Matthew S.
中科院分区：
文献类型：
--
作者：
Cicero, Theodore J.;Ellis, Matthew S.
重要性 为了减少盐酸羟考酮专有制剂奥施康定的大规模滥用，2010 年推出了一种防滥用制剂 (ADF)。虽然重新制剂使滥用率立即下降，但随着时间的推移，出现了明确的上限效应，超过该上限就没有看到进一步的下降。 目的 研究导致奥施康定滥用最初急剧下降以及自该药物滥用以来一直保持相对稳定的大量残留滥用的因素。 2012.设计、设置和参与者我们使用了正在进行的关键信息提供者患者调查计划的数据，该计划是研究滥用、转移和成瘾相关监测系统的一部分，该系统收集和分析有关处方阿片类镇痛药和海洛因的滥用和转移的上市后数据。在我们的调查研究中，DSM-V 诊断为阿片类药物使用障碍且主要滥用药物包括处方阿片类药物或海洛因的患者 (N = 10 784) 在参加 48 个州 150 个药物治疗项目中的一个时完成了一项阿片类药物滥用模式的匿名结构化调查（调查于 2009 年 1 月 1 日至 2014 年 6 月 30 日完成）。对这些患者的一个子集（n = 244）进行了访谈，以添加背景信息并扩展结构化调查。 主要结果和措施 除了关键的人口统计指标外，过去一个月的阿片类药物滥用情况是结构化调查的主要指标。在访谈中，研究了引入 ADF 对寻求药物行为的影响。 结果 重新配制的奥施康定与引入后过去一个月的滥用率显着减少相关（2009 年 1 月至 6 月为 45.1% [95% CI, 41.2%-49.1%]，2012 年 7 月至 12 月为 26.0% [95% CI, 23.6%-28.4%]； P < .001；x(2) = 230.83)，显然是由于迁移到其他阿片类药物，特别是海洛因。然而，这种减少趋于平稳，2012 年至 2014 年期间，25% 至 30% 的样本持续支持过去一个月的滥用行为（在研究结束时[2014 年 1 月至 6 月]，26.7%[95% CI，23.7%-29.6%]）。在 88 名表示有使用 ADF 前和 ADF 奥施康定经验的参与者中，残留的滥用水平反映了以下 3 个现象：(1) 从非口服给药途径过渡到口服使用（38 名参与者 [43%]）； (2) 成功克服 ADF 机制，导致继续吸入或注射使用（30 名参与者 [34%]）； (3) 单独使用口服途径，与制剂类型无关（20 名参与者 [23%]）。 结论和相关性 防滥用制剂可以达到减少滥用的预期目的，但其有效性程度有明显的限制，导致严重程度的残留滥用。因此，尽管药物滥用政策应侧重于限制滥用处方镇痛药（包括 ADF 技术）的供应，但仅靠减少供应的努力并不能缓解该国的阿片类药物滥用问题。
IMPORTANCE In an effort to reduce wide-scale abuse of the proprietary oxycodone hydrochloride formulation OxyContin, an abuse-deterrent formulation (ADF) was introduced in 2010. Although the reformulation produced an immediate drop in abuse rates, a definite ceiling effect appeared over time, beyond which no further decrease was seen.OBJECTIVE To examine the factors that led to the initial steep decline in OxyContin abuse and the substantial levels of residual abuse that have remained relatively stable since 2012.DESIGN, SETTING, AND PARTICIPANTS We used data from the ongoing Survey of Key Informants' Patients program, part of the Researched Abuse, Diversion and Addiction-Related Surveillance system that collects and analyzes postmarketing data on misuse and diversion of prescription opioid analgesics and heroin. For our survey study, patients with a DSM-V diagnosis of opioid use disorder and primary drug of abuse consisting of a prescription opioid or heroin (N = 10 784) at entry to 1 of 150 drug treatment programs in 48 states completed an anonymous structured survey of opioid abuse patterns (surveys completed from January 1, 2009, through June 30, 2014). A subset of these patients (n = 244) was interviewed to add context and expand on the structured survey.MAIN OUTCOMES AND MEASURES In addition to key demographic measures, past-month abuse of opioids was the primary measure in the structured surveys. In the interviews, the effect of the introduction of the ADF on drug-seeking behavior was examined.RESULTS Reformulated OxyContin was associated with a significant reduction of past-month abuse after its introduction (45.1% [95% CI, 41.2%-49.1%] in January to June 2009 to 26.0% [95% CI, 23.6%-28.4%] in July to December 2012; P < .001; x(2) = 230.83), apparently owing to a migration to other opioids, particularly heroin. However, this reduction leveled off, such that 25% to 30% of the sample persisted in endorsing past-month abuse from 2012 to 2014 (at study end [January to June 2014], 26.7%[95% CI, 23.7%-29.6%]). Among the 88 participants who indicated experience using pre-ADF and ADF OxyContin, this residual level of abuse reflects the following 3 phenomena: (1) a transition from nonoral routes of administration to oral use (38 participants [43%]); (2) successful efforts to defeat the ADF mechanism leading to a continuation of inhaled or injected use (30 participants [34%]); and (3) exclusive use of the oral route independent of formulation type (20 participants [23%]).CONCLUSIONS AND RELEVANCE Abuse-deterrent formulations can have the intended purpose of curtailing abuse, but the extent of their effectiveness has clear limits, resulting in a significant level of residual abuse. Consequently, although drug abuse policy should focus on limiting supplies of prescription analgesics for abuse, including ADF technology, efforts to reduce supply alone will not mitigate the opioid abuse problem in this country.