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滥用威慑型阿片类药物用于慢性疼痛治疗的法律责任视角

Legal liability perspectives on abuse-deterrent opioids in the treatment of chronic pain.

作者信息

Brushwood David B, Rich Ben A, Coleman John J, Bolen Jennifer, Wong Winston

机构信息

College of Pharmacy, University of Florida, Gainesville, Florida 32610-0496, USA.

出版信息

J Pain Palliat Care Pharmacother. 2010 Dec;24(4):333-48. doi: 10.3109/15360288.2010.524979.

DOI:10.3109/15360288.2010.524979
PMID:21133741
Abstract

Abuse-deterrent opioid analgesic formulations can help reduce the risk of opioid diversion and abuse. Not all opioid analgesics are available as both extended- and immediate-release dosage forms in abuse-deterrent formulations. Clinicians may have to balance the clinical benefit of a product that does not use abuse-deterrent technology versus the regulatory benefit of using a product with this technology. There is the possibility that a health care professional may be held legally liable when a product without abuse-deterrent qualities is used and a person suffers harm that would not have occurred had an abuse-deterrent formulation been provided. This article reviews legal precedents that inform an understanding of the need to reduce malpractice exposure by identifying patients who are at high risk of opioid diversion and/or abuse and considering the use of an abuse-deterrent formulation for these patients.

摘要

具有滥用威慑作用的阿片类镇痛药制剂有助于降低阿片类药物转移和滥用的风险。并非所有阿片类镇痛药都有滥用威慑制剂的缓释和速释剂型。临床医生可能需要权衡不采用滥用威慑技术的产品的临床益处与采用该技术的产品的监管益处。当使用没有滥用威慑特性的产品且有人遭受伤害时,如果提供了具有滥用威慑作用的制剂则该伤害本不会发生,那么医疗保健专业人员有可能承担法律责任。本文回顾了一些法律先例,这些先例有助于理解通过识别阿片类药物转移和/或滥用高风险患者并考虑为这些患者使用具有滥用威慑作用的制剂来降低医疗事故风险的必要性。

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引用本文的文献

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Pain Med. 2016 Nov;17(11):2047-2060. doi: 10.1093/pm/pnw033. Epub 2016 Apr 20.
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The health insurance industry: perpetuating the opioid crisis through policies of cost-containment and profitability.医疗保险行业:通过成本控制和盈利政策使阿片类药物危机持续存在。
J Pain Res. 2015 Mar 18;8:153-8. doi: 10.2147/JPR.S83368. eCollection 2015.
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A practical and ethical solution to the opioid scheduling conundrum.
解决阿片类药物管制难题的一个切实可行且符合伦理的方案。
J Pain Res. 2013 Dec 6;7:1-3. doi: 10.2147/JPR.S58148. eCollection 2013.
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Long-term opioid treatment of chronic nonmalignant pain: unproven efficacy and neglected safety?长期阿片类药物治疗慢性非恶性疼痛:疗效未经证实且安全性被忽视?
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