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Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine. 2025 May 22. doi: 10.5664/jcsm.11770 Q22.92024

Prescribing controlled substances in sleep medicine clinics: an overview of legal issues and best safety practices

睡眠医学诊所中受控物质的开具:法律问题与最佳安全实践概述 翻译改进

Bhanu Prakash Kolla  1  2, Michael H Silber  2  3, David R Rushlow  4, Kannan Ramar  2, Meghna P Mansukhani  2  3

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作者单位

  • 1 Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.
  • 2 Center for Sleep Medicine, Mayo Clinic, Rochester, MN.
  • 3 Department of Neurology, Mayo Clinic, Rochester, MN.
  • 4 Department of Family Medicine, Mayo Clinic, Rochester, MN.
  • DOI: 10.5664/jcsm.11770 PMID: 40400277

    摘要 中英对照阅读

    Study objectives: This review describes the legal and regulatory landscape surrounding controlled substance prescribing in sleep medicine, focusing on the Controlled Substance Act (CSA), Drug Enforcement Agency (DEA), and best practices. It explores abuse and dependence risks associated with these medications and addresses telemedicine and e-prescribing considerations.

    Methods: We synthesized information from the CSA, DEA, Centers for Disease Control and Prevention, Federation of State Medical Boards, peer-reviewed medical literature, and professional organizational position statements regarding controlled substances in sleep medicine.

    Results: Managing controlled substances in sleep medicine necessitates careful consideration of DEA scheduling, regulatory requirements, and potential risks. Opioids pose a risk of dependence or abuse, but the lower doses used in sleep medicine may mitigate this risk. There is less evidence available regarding the abuse potential of stimulants. Hypnotics and benzodiazepines require cautious prescribing due to the potential for long-term use by patients and possibility of dose escalation. Oxybates are subject to strict Risk Evaluation and Mitigation Strategy programs. Best practices include comprehensive patient evaluations, thorough risk assessments, Prescription Drug Monitoring Program checks, and transparent patient communication. Telemedicine prescribing is governed by strict regulatory statutes, with temporary exceptions currently in place.

    Conclusions: Controlled substances are vital for managing various sleep disorders. Balancing patient access to effective medications while minimizing abuse and diversion is crucial. Further research is needed to refine risk assessment tools and develop standardized protocols, particularly for non-opioids. The evolving role of telemedicine and e-prescriptions requires ongoing evaluation and adaptation of practices to ensure patient safety and regulatory compliance.

    Keywords: abuse; addiction; controlled substances; misuse; sleep medicine.

    Keywords:controlled substances; sleep medicine; legal issues

    研究目的: 本文综述了睡眠医学中管制物质处方的法律和监管环境,重点介绍了《管制物质法》(Controlled Substances Act, CSA)、美国缉毒局(Drug Enforcement Agency, DEA)以及最佳实践。文章探讨了这些药物相关的滥用和依赖风险,并讨论了远程医疗和电子处方方面的考虑因素。

    方法: 我们综合分析了CSA、DEA、疾病控制与预防中心、各州医学委员会联合会、同行评审的医学文献以及有关睡眠医学中管制物质的专业组织立场声明中的信息。

    结果: 在睡眠医学中管理管制物质需要仔细考虑DEA分类、监管要求和潜在风险。阿片类药物存在依赖或滥用的风险,但在睡眠医学中小剂量使用可能会减轻这种风险。关于兴奋剂的滥用潜力证据较少。镇静催眠药和苯二氮卓类药物需谨慎开处方,因为患者可能会长期使用,并且有剂量增加的可能性。奥沙布特(oxybates)受严格的评估与缓解策略计划监管。最佳实践包括对患者的全面评估、详细的危险性评估、处方药监控程序检查以及透明的患者沟通。远程医疗处方受到严格的法规约束,目前有一些临时例外规定。

    结论: 管制物质对于管理各种睡眠障碍至关重要。平衡患者获得有效药物的机会与减少滥用和转售的风险是至关重要的。需要进一步研究以完善风险评估工具并制定标准化流程,特别是针对非阿片类药物。远程医疗和电子处方的不断演变角色要求持续评价和调整实践,确保患者的用药安全和遵守监管规定。

    关键词: 滥用;成瘾;管制物质;误用;睡眠医学。

    关键词:管制物质; 睡眠医学; 法律问题

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    期刊名:Journal of clinical sleep medicine

    缩写:J CLIN SLEEP MED

    ISSN:1550-9389

    e-ISSN:1550-9397

    IF/分区:2.9/Q2

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    Prescribing controlled substances in sleep medicine clinics: an overview of legal issues and best safety practices