Vranken Marjolein J M, Mantel-Teeuwisse Aukje K, Jünger Saskia, Radbruch Lukas, Scholten Willem, Lisman John A, Subataite Marija, Schutjens Marie-Hélène D B
Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
Institute of General Practice, Hannover Medical School, Hannover, Germany.
Addiction. 2017 Jun;112(6):1069-1076. doi: 10.1111/add.13755. Epub 2017 Feb 8.
Barriers linked to drug control systems are considered to contribute to inequitable access to controlled medicines, leaving millions of people in pain and suffering. Most studies focus on access to opioids for the treatment of severe (cancer) pain. This study aims to identify specific access barriers for patients with opioid dependence in legislation and regulations of 11 central and eastern European countries.
This study builds on a previous analysis of legislation and regulations as part of the EU 7th Framework Access To Opioid Medication in Europe (ATOME) project. An in-depth analysis was undertaken to determine specific barriers for patients with opioid dependence in need of opioid analgesics or opioid agonist therapy (OAT). For each country, the number and nature of specific potential barriers for these patients were assessed according to eight categories: prescribing; dispensing; manufacturing; usage; trade and distribution; affordability; penalties; and other. An additional keyword search was conducted to minimize the omission of barriers. Barriers in an additional category, language, were recorded qualitatively. Countries included Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia and Turkey.
Ten of the 11 countries (all except Estonia) showed specific potential barriers in their legislation and regulations. The total number of barriers varied from two (Slovenia) to 46 (Lithuania); the number of categories varied from one (Slovenia) to five (Lithuania). Most specific potential barriers were shown in the categories 'prescribing', 'usage' and 'other'. The total number in a single category varied from one to 18 (Lithuania, prescribing). Individual differences between countries in the same specific potential barrier were shown; for example, variation in minimum age criteria for admission to OAT ranging from 15 (Lithuania, in special cases) to 20 years (Greece). All countries had stigmatizing language in their legislation.
Patients with opioid dependence are likely to experience specific barriers to accessing opioids in addition to those experienced by other non-dependent patients.
与药品管制系统相关的障碍被认为是导致获得管制药品机会不平等的原因，致使数百万人遭受疼痛和痛苦。大多数研究聚焦于获取阿片类药物用于治疗重度（癌症）疼痛。本研究旨在确定中东欧11个国家的法律法规中，阿片类药物依赖患者在获取药物方面的具体障碍。
本研究基于先前对法律法规的分析，该分析是欧盟第七框架“欧洲阿片类药物获取”（ATOME）项目的一部分。进行了深入分析，以确定需要阿片类镇痛药或阿片类激动剂疗法（OAT）的阿片类药物依赖患者的具体障碍。针对每个国家，根据八个类别评估这些患者的具体潜在障碍的数量和性质：处方；配药；生产；使用；贸易与分销；可负担性；处罚；以及其他。进行了额外的关键词搜索，以尽量减少障碍的遗漏。对“语言”这一额外类别的障碍进行了定性记录。这些国家包括保加利亚、塞浦路斯、爱沙尼亚、希腊、匈牙利、拉脱维亚、立陶宛、塞尔维亚、斯洛伐克、斯洛文尼亚和土耳其。
11个国家中的10个（除爱沙尼亚外）在其法律法规中显示出具体的潜在障碍。障碍总数从2个（斯洛文尼亚）到46个（立陶宛）不等；类别数量从1个（斯洛文尼亚）到5个（立陶宛）不等。大多数具体潜在障碍出现在“处方”“使用”和“其他”类别中。单个类别中的总数从1个到18个（立陶宛，处方）不等。显示了同一具体潜在障碍在不同国家之间的个体差异；例如，接受OAT的最低年龄标准各不相同，从15岁（立陶宛，特殊情况）到20岁（希腊）。所有国家的法律法规中都存在污名化语言。
除了其他非依赖患者所面临的障碍外，阿片类药物依赖患者在获取阿片类药物方面可能还会遇到特定障碍。
