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阿片类药物过量预防与治疗中纳洛酮法律地位调查

Survey of naloxone legal status in opioid overdose prevention and treatment.

作者信息

Hewlett Leanne, Wermeling Daniel P

机构信息

Department of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, Kentucky.

Professor, Department of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, Kentucky.

出版信息

J Opioid Manag. 2013 Sep-Oct;9(5):369-77. doi: 10.5055/jom.2013.0179.

Abstract

OBJECTIVE

To survey the federal and state-by-state legal status for prescribing, dispensing, and administering naloxone injection.

DESIGN

The survey was a review of legislation, which encompassed analyzing current and proposed laws regarding naloxone's role in opioid overdose prevention and treatment.

MAIN OUTCOME MEASURE(S): The primary study outcome was to evaluate the legal aspects of current naloxone overdose prevention and treatment. Aspects of the legislation studied included Food and Drug Administration (FDA) regulatory status, prescriber authorization, prescription requirements, defining the patient, authority to administer naloxone, status of lay person administration, and provisions for Good Samaritan protections from criminal and civil liability.

RESULTS

To date, 10 states have legislation implementing opioid overdose prevention programs including naloxone. Several states with high opioid overdose burdens are in the legislative process. Reasons for hesitation to initiate such programs include fear of liability, a proxy endorsement for drug abuse, and apprehension of increasing drug usage.

CONCLUSIONS

A number of state legislatures have passed legislation permitting lay administration of naloxone to individuals in an attempt to revive a person with an apparent opioid overdose. These emerging state policy initiatives parallel similar laws and regulations governing lay person epinephrine administration for anaphylaxis and applying automated electric defibrillators for sudden cardiac arrest. Public health initiatives increasing access to naloxone will likely continue in states with high opioid overdose burdens. FDA approval of a new needle-free naloxone delivery system would facilitate greater public access.

摘要

目的

调查纳洛酮注射液处方开具、配药及给药的联邦及各州法律状况。

设计

该调查为一项立法审查,包括分析有关纳洛酮在阿片类药物过量预防和治疗中作用的现行及拟议法律。

主要观察指标

主要研究结果是评估当前纳洛酮过量预防和治疗的法律方面。所研究的立法方面包括食品药品监督管理局(FDA)监管状况、开处方者授权、处方要求、患者界定、纳洛酮给药权限、非专业人员给药状况以及对见义勇为者免受刑事和民事责任的保护规定。

结果

迄今为止,已有10个州制定了实施包括纳洛酮在内的阿片类药物过量预防项目的立法。一些阿片类药物过量负担较重的州正在立法过程中。对启动此类项目犹豫不决的原因包括担心责任问题、被视为对药物滥用的认可以及对药物使用增加的担忧。

结论

一些州立法机构已通过立法,允许非专业人员对疑似阿片类药物过量的个人进行纳洛酮给药,以试图救活该人。这些新出现的州政策举措与管理非专业人员使用肾上腺素治疗过敏反应以及使用自动体外除颤器治疗心脏骤停的类似法律法规并行。在阿片类药物过量负担较重的州,增加纳洛酮可及性的公共卫生举措可能会持续下去。FDA批准一种新的无针纳洛酮给药系统将有助于公众更广泛地获取。

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