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双膦酸盐相关颌骨坏死的法律责任

Legal liability in bisphosphonate-related osteonecrosis of the jaw.

作者信息

Lo Russo L, Ciavarella D, Buccelli C, Di Fede O, Campisi G, Lo Muzio L, Pellegrino G, Di Lorenzo P

机构信息

Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy.

Department of Advanced Biomedical Sciences, University "Federico II", Naples, Italy.

出版信息

Br Dent J. 2014 Sep;217(6):273-8. doi: 10.1038/sj.bdj.2014.806.

Abstract

Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is an adverse reaction that may occur in patients administered with bisphosphonates (BP). This condition can cause high morbidity and hinder quality of life. Its treatment is complex and often unsatisfactory, and prevention strategies may have limited effectiveness, if any. Thus, managing patients treated with BP may result in exposure of the practitioner to legal liability or malpractice claims: legal actions pursuant to BRONJ are reported to be underway on three continents. Nonetheless, the attribution of liability, if any, is a complex process requiring, on the basis of current knowledge, a robust and pragmatic approach to the facts, which must be identified from the point of view of the time, place and individuals involved. This means a comprehensive consideration of the sequence of actions from bisphosphonates prescription to BRONJ occurrence (as well as immediately after, and any action potentially related to its causation or worsening) is required in order to determine if a breach in informing, diagnosing, managing or referring the patient took place, as well as determining if the patient was compliant in attending to prescriptions and follow-up programmes.

摘要

双膦酸盐相关颌骨坏死(BRONJ)是接受双膦酸盐(BP)治疗的患者可能发生的一种不良反应。这种情况可导致高发病率并影响生活质量。其治疗复杂且往往不尽人意,预防策略即便有效果也可能有限。因此,管理接受BP治疗的患者可能会使从业者面临法律责任或医疗事故索赔:据报道,三大洲都有针对BRONJ的法律诉讼正在进行。尽管如此,确定责任归属(若有)是一个复杂的过程,根据目前的知识,需要对事实采取稳健且务实的方法,这必须从所涉时间、地点和个人的角度来确定。这意味着需要全面考虑从双膦酸盐处方到BRONJ发生(以及之后立即发生的情况,以及任何可能与其病因或病情恶化相关的行为)的一系列行为,以便确定在告知、诊断、管理或转诊患者方面是否存在疏忽,以及确定患者是否遵守处方和后续治疗方案。

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