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在欧洲,癌症疼痛阿片类药物的处方供应和可及性的监管障碍:来自 ESMO/EAPC 阿片类药物政策倡议的报告。

Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative.

机构信息

Cancer Pain and Palliative Medicine Unit, Department of Oncology, Shaare Zedek Medical Center, Jerusalem, Israel; European Society for Medical Oncology; Palliative Care Working Group.

Medical Oncology Service, Vall d'Hebron University Hospital, Barcelona, Spain; European Society for Medical Oncology.

出版信息

Ann Oncol. 2010 Mar;21(3):615-626. doi: 10.1093/annonc/mdp581.

Abstract

BACKGROUND

Many patients in Europe do not receive adequate relief of pain because of excessive regulatory restrictions on the availability and accessibility of opioids. This is a major public health problem. The aim of the study is to evaluate and report on opioid availability and the legal and regulatory barriers to accessibility across the countries of Europe.

METHODS

European Society for Medical Oncology and European Association for Palliative Care national representatives reported data regarding survey of opioid availability and accessibility. Formulary adequacy is evaluated relative to the World Health Organization (WHO) essential drugs list and the International Association for Hospice and Palliative Care list of essential medicines for palliative care. Overregulation is evaluated according to the guidelines for assessment of national opioid regulations of the WHO.

RESULTS

Data were reported on the availability and accessibility of opioids for the management of cancer pain in 21 Eastern European countries and 20 Western European countries. Results are presented describing the availability and cost of opioids for cancer pain in each surveyed country and nine forms of regulatory restrictions.

CONCLUSIONS

Using standards derived from the WHO and International Narcotics Control Board, this survey has exposed formulary deficiencies and excessive regulatory barriers that interfere with appropriate patient care in many European countries. There is an ethical and public health imperative to address these issues.

摘要

背景

由于对阿片类药物的可及性和可获得性存在过多的监管限制,许多欧洲患者的疼痛无法得到充分缓解。这是一个重大的公共卫生问题。本研究旨在评估并报告整个欧洲国家阿片类药物的可获得性以及获取方面的法律和监管障碍。

方法

欧洲肿瘤内科学会和欧洲姑息治疗协会的国家代表报告了有关阿片类药物可获得性和可及性调查的数据。通过与世界卫生组织(WHO)基本药物清单和国际姑息治疗协会姑息治疗基本药物清单进行比较,评估了处方的充分性。根据世界卫生组织国家阿片类药物监管评估指南,对过度监管进行了评估。

结果

报告了 21 个东欧国家和 20 个西欧国家在管理癌症疼痛方面阿片类药物的可获得性和可及性数据。结果描述了每个调查国家的阿片类药物的可获得性和成本以及 9 种形式的监管限制。

结论

本调查使用世界卫生组织和国际麻醉品管制局的标准,揭示了许多欧洲国家在处方药物和过度监管方面的缺陷,这些缺陷干扰了对患者的适当治疗。解决这些问题具有伦理和公共卫生方面的紧迫性。

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