Controlled Substances

受控物质
  • 文章类型: Journal Article
    关于通过远程医疗开具丁丙诺啡和兴奋剂等受控物质的处方正在进行政策辩论。联邦和州政策制定者的目标是确保获得医疗服务,同时限制转移风险。然而,关于临床医生如何看待和解决转移以及远程医疗在转移中的作用,几乎没有证据。从2023年12月到2024年1月,我们对21位从事混合(远程医疗和面对面)护理模式的精神科医生和初级保健医生进行了半结构化访谈,在这些访谈中,我们探索了对转移的看法和用于监测转移的策略。大多数医生报告监测转移,但是在如何进行监测方面几乎没有一致性,并且报告的策略在远程医疗和当面护理之间没有差异.当医生怀疑转移时,回应也存在很大差异:一些临床医生没有立即采取任何行动,而另一些医生对患者提出了更多要求(例如,更频繁的访问),不再规定受控物质,或终止病人的实践。很少有医生报告过涉嫌转移到执法部门的案件。我们的调查结果表明,缉毒局可以澄清报告要求,专业协会可以就如何应对涉嫌转移提供额外指导,鉴于目前不同临床医生的实践差异可能会被想要转移注意力的个人利用.
    There is ongoing policy debate on the prescribing of controlled substances such as buprenorphine and stimulants via telemedicine. The goal of federal and state policymakers is to ensure access to care while limiting diversion risk. However, there is little evidence on how clinicians view and address diversion and on telemedicine\'s role in diversion. From December 2023 to January 2024, we conducted semi-structured interviews with 21 psychiatrists and primary care physicians engaged in hybrid (telemedicine and in-person) care models in which we explored perceptions of diversion and strategies used to monitor for diversion. Most physicians reported monitoring for diversion, but there was little consistency on how monitoring was done and reported strategies did not differ between telemedicine vs in-person care. When physicians suspected diversion, there was also wide variation in responses: some clinicians did not immediately take any action while others imposed more requirements on patients (e.g., more frequent visits), no longer prescribed the controlled substance, or terminated the patient from their practice. Few physicians had ever reported a case of suspected diversion to law enforcement. Our findings suggest that the Drug Enforcement Administration could clarify reporting requirements and professional societies could provide additional guidance on how to respond to suspected diversion, given the current variation in practice across clinicians could be exploited by individuals who want to divert.
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  • 文章类型: Journal Article
    美国法律对所有制造和分销受控物质的实体都规定了严格的记录和报告要求。因此,处方阿片类药物危机在数据饱和的环境中展开。本文询问为什么阿片类药物交易的系统记录未能预防或缓解危机。利用最近披露的来自Mallinckrodt制药公司的140万条内部记录,领先的处方阿片类药物制造商,我们强调了一个我们建议称之为数据转移的现象,该行业将表面上为管制受控物质的分配而产生或收集的数据重新用于相反的目的,即不惜一切代价增加销售。系统数据转移,我们争论,对阿片类药物的药物转移规模做出了重大贡献,应成为政策干预的重点。
    U.S. law imposes strict recording and reporting requirements on all entities that manufacture and distribute controlled substances. As a result, the prescription opioid crisis has unfolded in a data-saturated environment. This article asks why the systematic documentation of opioid transactions failed to prevent or mitigate the crisis. Drawing on a recently disclosed trove of 1.4 million internal records from Mallinckrodt Pharmaceuticals, a leading manufacturer of prescription opioids, we highlight a phenomenon we propose to call data diversion, whereby data ostensibly generated or collected for the purpose of regulating the distribution of controlled substances were repurposed by the industry for the opposite aim of increasing sales at all costs. Systematic data diversion, we argue, contributed substantially to the scale of drug diversion seen with opioids and should become a focus of policy intervention.
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  • 文章类型: News
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  • 文章类型: Journal Article
    临床医生使用处方药监测计划(PDMPs)与更好的患者预后有关,但是州对使用PDMP的要求执行不均。我们评估了明尼苏达州的PDMP使用情况,这要求阿片类药物处方者持有账户,在大多数情况下,在处方前搜索PDMP,但在执法权有限的地方。使用2023PDMP数据,我们发现,十分之四的阿片类药物处方者没有进行搜索,十分之二的患者没有账户.PDMP使用与处方量密切相关,但即使在阿片类药物处方的前十位中,8%的人从未搜索过PDMP。32%的阿片类药物填充来自没有搜索PDMP的临床医生。无法使用PDMP可能是由于缺乏有关状态要求的信息,认为这些要求没有得到执行,以及与收益相关的访问PDMP的成本。这些结果凸显了决策者通过解决迄今为止限制PDMP使用的力量,促进更安全,更知情的阿片类药物和其他药物处方的潜力。
    Clinician use of prescription drug monitoring programs (PDMPs) has been linked to better patient outcomes, but state requirements to use PDMPs are unevenly enforced. We assessed PDMP use in Minnesota, which requires opioid prescribers to hold accounts and, in most cases, search the PDMP before prescribing, but where enforcement authority is limited. Using 2023 PDMP data, we found that 4 in 10 opioid prescribers did not search and 2 in 10 did not hold an account. PDMP use was strongly associated with prescribing volume, but even among the top decile of opioid prescribers, 8% never searched the PDMP. Thirty-two percent of opioid fills came from clinicians who did not search the PDMP. Failures to use the PDMP may be driven by a lack of information about state requirements, beliefs that these requirements are not enforced, and the costs of accessing the PDMP relative to the benefits. These results highlight the potential for policy makers to promote safer and better-informed prescribing of opioids and other drugs by addressing the forces that have limited PDMP use so far.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:对于生活在撒哈拉以南非洲的人们来说,获得麻醉和手术护理是一个主要问题。在这个地区,氯胺酮对于提供麻醉护理至关重要。然而,在国际上控制氯胺酮作为受控物质的努力可能会极大地影响其可得性。因此,这项研究旨在评估氯胺酮在撒哈拉以南非洲的麻醉和手术护理中的重要性,并评估如果计划使用氯胺酮对获得氯胺酮的潜在影响。
    方法:这项研究是一项混合方法研究,包括卢旺达医院层面的横断面调查,以及与撒哈拉以南非洲麻醉护理专家的关键线人访谈。从卢旺达的医院(n=54)收集了四种麻醉剂的可用性数据。对10名主要举报人进行了半结构化访谈,收集有关氯胺酮重要性的信息,在国际上安排氯胺酮的潜在影响,以及关于滥用氯胺酮的意见。访谈被逐字转录,并使用专题分析方法进行分析。
    结果:在卢旺达进行的调查发现,氯胺酮和异丙酚的可利用性约为80%,而硫喷妥钠和吸入剂只有大约一半的医院可用。确定了阻碍获得麻醉护理的重大障碍,包括政府普遍缺乏对专业的关注,麻醉师的短缺和训练有素的麻醉师的迁移,以及药品和设备的匮乏。由于这些障碍,氯胺酮被描述为对提供麻醉护理至关重要。线人认为滥用氯胺酮不是问题。
    结论:氯胺酮对于在撒哈拉以南非洲提供麻醉护理至关重要,并且其时间安排将对其用于麻醉护理的可用性产生重大负面影响。
    BACKGROUND: Access to anaesthesia and surgical care is a major problem for people living in Sub-Saharan Africa. In this region, ketamine is critical for the provision of anaesthesia care. However, efforts to control ketamine internationally as a controlled substance may significantly impact its accessibility. This research therefore aims to estimate the importance of ketamine for anaesthesia and surgical care in Sub-Saharan Africa and assess the potential impact on access to ketamine if it were to be scheduled.
    METHODS: This research is a mixed-methods study, comprising of a cross-sectional survey at the hospital level in Rwanda, and key informant interviews with experts on anaesthesia care in Sub-Saharan Africa. Data on availability of four anaesthetic agents were collected from hospitals (n = 54) in Rwanda. Semi-structured interviews with 10 key informants were conducted, collecting information on the importance of ketamine, the potential impact of scheduling ketamine internationally, and opinions on misuse of ketamine. Interviews were transcribed verbatim and analysed using a thematic analysis approach.
    RESULTS: The survey conducted in Rwanda found that availability of ketamine and propofol was comparable at around 80%, while thiopental and inhalational agents were available at only about half of the hospitals. Significant barriers impeding access to anaesthesia care were identified, including a general lack of attention given to the specialty by governments, a shortage of anaesthesiologists and migration of trained anaesthesiologists, and a scarcity of medicines and equipment. Ketamine was described as critical for the provision of anaesthesia care as a consequence of these barriers. Misuse of ketamine was not believed to be an issue by the informants.
    CONCLUSIONS: Ketamine is critical for the provision of anaesthesia care in Sub-Saharan Africa, and its scheduling would have a significantly negative impact on its availability for anaesthesia care.
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  • 文章类型: Journal Article
    背景:美国与毒品有关的危害危机继续恶化。虽然与处方相关的药物过量大幅下降,他们仍然远远高于2010年之前的水平。医生可以通过改善阿片类药物处方实践并确保患者能够轻松获得药物治疗的药物来减少过量和其他药物相关危害的风险。大多数医生在医学院接受过很少或根本没有接受过这些科目的培训。继续医学教育可能会提高医师对适当处方和物质使用障碍治疗以及患者预后的了解。
    方法:描述性法律审查。搜索了所有50个州和哥伦比亚特区的法律,以寻找要求所有或大多数医生接受有关受控物质处方的一次性或持续医学教育的规定,疼痛管理,或物质使用障碍治疗。
    结果:具有相关要求的州数量迅速增加,从2010年底的3个州到2021年底的42个州。各州所需教育的频率和持续时间差异很大。在所有州,相关主题所需的小时数仅占所需继续教育的一小部分,平均每年1小时。尽管最近导致药物过量的物质发生了变化,大多数要求仍然集中在阿片类药物上。
    结论:尽管大多数州现在都采用了有关受控物质处方的继续教育要求,疼痛管理,或物质使用障碍治疗,这些要求包括所需的培训后教育要求的一小部分。需要进行研究以确定这种培训是否可以减少与毒品有关的伤害。
    BACKGROUND: The crisis of drug-related harm in the United States continues to worsen. While prescription-related overdoses have fallen dramatically, they are still far above pre-2010 levels. Physicians can reduce the risk of overdose and other drug-related harms by improving opioid prescribing practices and ensuring that patients are able to easily access medications for substance use disorder treatment. Most physicians received little or no training in those subjects in medical school. It is possible that continuing medical education can improve physician knowledge of appropriate prescribing and substance use disorder treatment and patient outcomes.
    METHODS: Descriptive legal review. Laws in all 50 states and the District of Columbia were searched for provisions that require all or most physicians to receive either one-time or continuing medical education regarding controlled substance prescribing, pain management, or substance use disorder treatment.
    RESULTS: There has been a rapid increase in the number of states with relevant requirements, from three states at the end of 2010 to 42 at the end of 2020. The frequency and duration of required education varied substantially across states. In all states, the number of hours required in relevant topics is a small fraction of overall required continuing education, an average of 1 h per year. Despite recent shifts in the substances driving overdose, most requirements remain focused on opioids.
    CONCLUSIONS: While most states have now adopted continuing education requirements regarding controlled substance prescribing, pain management, or substance use disorder treatment, these requirements comprise a small component of the required post-training education requirements. Research is needed to determine whether this training translates into reductions in drug-related harm.
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  • 文章类型: Journal Article
    目标:评估严格的药物福利计划(PBS)即时释放(IR)和控释(CR)阿片类药物处方规则的影响(2020年6月1日),它还取消了未经授权重复分配可待因/扑热息痛和曲马多IR,并引入了IR配方的半包装尺寸项目代码。
    方法:对PBS配药数据的基于人群的中断时间序列分析,对符合PBS资格的居民和IQVIA国家阿片类药物销售数据的10%样本进行索赔(PBS补贴和私人处方),2018年5月28日-2021年6月6日。
    方法:每天分配的PBS补贴阿片类药物的平均量和每天销售的平均总量-每种以口服吗啡当量毫克(OME)表示-总体,按配方类型(IR,CR),并通过具体的表述。
    结果:在PBS变化后的十二个月内,PBS补贴的阿片类药物每日配药量比2018-20年的每日平均水平低81565OME(95%CI,-106146~-56984OME),在调整干预前趋势后下降3.8%;IR(8.4%)的相对降低幅度大于CR制剂(2.6%).所有的每日总销售额,IR配方,PBS改变后,CR制剂阿片类药物没有明显变化。在2020年6月1日之前,重复配药的处方占PBS补贴阿片类药物配药的7.4%,变化后占1.3%。在PBS更换后的十二个月内,半包装尺寸占PBS补贴的IR阿片类药物分配量的8.4%,占所有阿片类药物的2.8%。
    结论:新的PBS补贴阿片类药物规则的引入之后,PBS补贴的配药量下降。有些人可能通过改用私人处方来绕过新的限制,但我们的研究结果表明,由于新的限制措施,澳大利亚的阿片类药物使用量有所下降。
    OBJECTIVE: To evaluate the impact of the tightened Pharmaceutical Benefits Scheme (PBS) prescribing rules for immediate release (IR) and controlled release (CR) opioid medicines (1 June 2020), which also eliminated repeat dispensing without authorisation for codeine/paracetamol and tramadol IR and introduced half-pack size item codes for IR formulations.
    METHODS: Population-based interrupted time series analysis of PBS dispensing data claims for a 10% sample of PBS-eligible residents and IQVIA national opioid medicine sales data (PBS-subsidised and private prescriptions), 28 May 2018 - 6 June 2021.
    METHODS: Mean amount of PBS-subsidised opioid medicines dispensed per day and mean overall amount sold per day - each expressed as oral morphine equivalent milligrams (OME) - overall, by formulation type (IR, CR), and by specific formulation.
    RESULTS: During the twelve months following the PBS changes, daily PBS-subsidised opioid medicine dispensing was 81 565 OME lower (95% CI, -106 146 to -56 984 OME) than the mean daily level for 2018-20, a decline of 3.8% after adjusting for the pre-intervention trend; the relative reduction was greater for IR (8.4%) than CR formulations (2.6%). Total daily sales of all, IR formulation, and CR formulation opioid medicines did not change significantly after the PBS changes. Repeat dispensing of prescriptions comprised 7.4% of PBS-subsidised opioid dispensing before 1 June 2020, and 1.3% after the changes. Half-pack sizes comprised 8.4% of PBS-subsidised IR opioid medicine dispensing and 2.8% of all opioid medicines sold in the twelve months after the PBS changes.
    CONCLUSIONS: The introduction of new PBS rules for subsidised opioid medicines was followed by a decline in PBS-subsidised dispensing. Some people may have bypassed the new restrictions by switching to private prescriptions, but our findings suggest that opioid medicine use in Australia declined as a result of the new restrictions.
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  • 文章类型: Journal Article
    背景:在线药房市场正在增长,合法的网上药店提供便利和可访问性等优势。然而,这种增加的需求吸引了恶意行为者进入这个领域,导致非法供应商的扩散,这些供应商使用欺骗性技术在搜索结果中排名更高,并通过分发不合格或伪造的药物构成严重的公共卫生风险。搜索引擎提供商已经开始将生成式人工智能(AI)集成到搜索引擎界面中,它可以通过用户友好的体验提供更个性化的结果来彻底改变搜索。然而,这些新技术的不当整合会带来潜在风险,并可能会无意中将用户引向非法供应商,从而进一步加剧非法在线药房带来的风险。
    目标:生成AI集成在重塑搜索引擎结果中的作用,特别是与网上药店有关的,尚未研究。我们的目标是确定,确定患病率,并在AI生成的搜索结果和建议中描述非法的在线药房建议。
    方法:我们从Google的搜索生成体验(SGE)和MicrosoftBing的聊天中对AI生成的建议进行了比较评估,专注于代表多种治疗类别的流行和知名药物,包括受控物质。网站被单独检查以确定合法性,通过与全国药房委员会协会和LegitScript数据库的交叉引用,确定了已知的非法供应商。
    结果:在AI生成的搜索结果中推荐的262个网站中,47.33%(124/262)属于活跃的网上药店,31.29%(82/262)导致合法。然而,19.04%(24/126)的BingChat和13.23%(18/136)的GoogleSGE建议将用户引向非法供应商,包括受控物质。非法药房的比例因药物和搜索引擎而异。搜索引擎之间非法网站的分布存在显着差异。与GoogleSGE(6/92,6%)相比,BingChat(21/86,24%)中导致非法在线药店销售处方药的链接患病率明显更高(P=.001)。关于受控物质的建议,Google提出的建议导致流氓卖家的数量(12/44,27%;P=0.02)明显高于必应(3/40,7%)。
    结论:虽然将生成AI集成到搜索引擎中具有很好的潜力,这也带来了巨大的风险。这是第一项研究,揭示了这些平台中的漏洞,同时强调了与无意中推广非法药房相关的潜在公共卫生影响。我们发现AI生成的建议中有一个令人担忧的比例导致了非法的网上药店,这不仅可能会增加他们的交通,还会进一步加剧现有的公共卫生风险。在生成搜索中迫切需要严格的监督和适当的保障措施,以减轻消费者风险。确保积极引导用户到经过验证的药房,并优先考虑合法来源,同时将非法供应商排除在推荐之外。
    BACKGROUND: The online pharmacy market is growing, with legitimate online pharmacies offering advantages such as convenience and accessibility. However, this increased demand has attracted malicious actors into this space, leading to the proliferation of illegal vendors that use deceptive techniques to rank higher in search results and pose serious public health risks by dispensing substandard or falsified medicines. Search engine providers have started integrating generative artificial intelligence (AI) into search engine interfaces, which could revolutionize search by delivering more personalized results through a user-friendly experience. However, improper integration of these new technologies carries potential risks and could further exacerbate the risks posed by illicit online pharmacies by inadvertently directing users to illegal vendors.
    OBJECTIVE: The role of generative AI integration in reshaping search engine results, particularly related to online pharmacies, has not yet been studied. Our objective was to identify, determine the prevalence of, and characterize illegal online pharmacy recommendations within the AI-generated search results and recommendations.
    METHODS: We conducted a comparative assessment of AI-generated recommendations from Google\'s Search Generative Experience (SGE) and Microsoft Bing\'s Chat, focusing on popular and well-known medicines representing multiple therapeutic categories including controlled substances. Websites were individually examined to determine legitimacy, and known illegal vendors were identified by cross-referencing with the National Association of Boards of Pharmacy and LegitScript databases.
    RESULTS: Of the 262 websites recommended in the AI-generated search results, 47.33% (124/262) belonged to active online pharmacies, with 31.29% (82/262) leading to legitimate ones. However, 19.04% (24/126) of Bing Chat\'s and 13.23% (18/136) of Google SGE\'s recommendations directed users to illegal vendors, including for controlled substances. The proportion of illegal pharmacies varied by drug and search engine. A significant difference was observed in the distribution of illegal websites between search engines. The prevalence of links leading to illegal online pharmacies selling prescription medications was significantly higher (P=.001) in Bing Chat (21/86, 24%) compared to Google SGE (6/92, 6%). Regarding the suggestions for controlled substances, suggestions generated by Google led to a significantly higher number of rogue sellers (12/44, 27%; P=.02) compared to Bing (3/40, 7%).
    CONCLUSIONS: While the integration of generative AI into search engines offers promising potential, it also poses significant risks. This is the first study to shed light on the vulnerabilities within these platforms while highlighting the potential public health implications associated with their inadvertent promotion of illegal pharmacies. We found a concerning proportion of AI-generated recommendations that led to illegal online pharmacies, which could not only potentially increase their traffic but also further exacerbate existing public health risks. Rigorous oversight and proper safeguards are urgently needed in generative search to mitigate consumer risks, making sure to actively guide users to verified pharmacies and prioritize legitimate sources while excluding illegal vendors from recommendations.
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