ER/LA Opioid Analgesics REMS: Overview of Ongoing Assessments of Its Progress and Its Impact on Health Outcomes.
ER/LA Opioid Analgesics REMS: Overview of Ongoing Assessments of Its Progress and Its Impact on Health Outcomes.
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DOI：
10.1093/pm/pnw129
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发表时间：
2017-01-01
期刊：
影响因子：
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通讯作者：
Wallace LE
中科院分区：
文献类型：
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作者：
Cepeda MS;Coplan PM;Kopper NW;Maziere JY;Wedin GP;Wallace LE
Objective.阿片类药物滥用是一个严重的公共卫生问题。作为回应，美国食品药品监督管理局（FDA）确定，有必要对缓释和长效（ER/LA）阿片类药物进行风险评估和缓解策略（REMS），以确保这些镇痛剂的益处继续超过风险。REMS的关键组成部分是通过认证的继续教育（CE）对处方医生进行培训，并提供患者教育材料。方法.已使用多种指标评估了该REMS的影响，包括评价处方者和患者对阿片类药物相关风险的理解;患者对用药指南和患者咨询文件的接收和理解;患者对阿片类药物获取的满意度;药物利用和处方模式的变化;以及对ER/LA阿片类药物误用、滥用、过量、成瘾和死亡的监测。结果和结论。这些评估的结果表明，在实施REMS之前观察到的阿片类药物滥用、成瘾、过量和死亡率的增加已经趋于平稳或开始下降。然而，这些获益不能仅归因于ER/LA阿片类镇痛剂REMS，因为同时发生了许多其他预防滥用的措施。这些改善是在保留患者获得阿片类药物的同时发生的，因为绝大多数接受调查的患者对其获得阿片类药物表示满意。
Objective. Opioid abuse is a serious public health concern. In response, the Food and Drug Administration (FDA) determined that a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids was necessary to ensure that the benefits of these analgesics continue to outweigh the risks. Key components of the REMS are training for prescribers through accredited continuing education (CE), and providing patient educational materials. Methods. The impact of this REMS has been assessed using diverse metrics including evaluation of prescriber and patient understanding of the risks associated with opioids; patient receipt and comprehension of the medication guide and patient counseling document; patient satisfaction with access to opioids; drug utilization and changes in prescribing patterns; and surveillance of ER/LA opioid misuse, abuse, overdose, addiction, and death. Results and Conclusions. The results of these assessments indicate that the increasing rates of opioid abuse, addiction, overdose, and death observed prior to implementation of the REMS have since leveled off or started to decline. However, these benefits cannot be attributed solely to the ER/LA opioid analgesics REMS since many other initiatives to prevent abuse occurred contemporaneously. These improvements occurred while preserving patient access to opioids as a large majority of patients surveyed expressed satisfaction with their access to opioids.