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出自识林

2014-03-09 Lachman CONSULTANTS

氢可酮复方产品向II类管制药品更近一步

2014年2月27日发布的联邦公报通告 中，缉毒局(Drug Enforcement Administration, DEA)宣布，拟制定的规定将所有含氢可酮的复方产品(Hydrocodone combination products, HCP)从《管制药物法案》的III类管制药品列入限制更严的II类管制药品。这一进程已历时多年，现在看来将迅速得以实现。这一行动曾在消费者群体、医疗人员、药物滥用专家及相关人士当中进行过激烈的争论。为满足的2012年《FDA安全与创新法案》（FDASIA）中相关条款的要求，FDA于2013年1月召开公开咨询会。咨询委员会会议是在FDASIA中达成的妥协，原因在于改变这类药品的管制类别正是该法案的立法者一直考虑的。负责的委员会以19票赞成10票反对的投票结果，通过了赞成重新分类的建议。

会议之后，（FDA就该会议收到了近800份意见），FDA及卫生与人类服务部（Division of Health and Human Services ,DHHS）向美国缉毒局(DEA)提交了他们对氢可酮组合产品重分类的建议。DEA基于以下因素做出最终决定：

a) 使用足够剂量HCP的个体，将对自身健康、他人及社区安全产生风险。

b)根据国家法医实验室系统报告的法医实验室数据，HCP类药品与合法药品渠道存在显著偏离。

c) 个人使用HCP类药品更多是出于主动而非根据医疗建议。

d) HCP类药品在作用上与有已被列为具有滥用可能性的某一药品或其它成分有关联，使之也很可能具有具有与这类物质类似的滥用可能性，因此，与合法渠道存在显著偏离，明显违反或未经医嘱使用，或确实会对使用者健康和社区稳定造成风险的假定都是合理的。

基于从整体上对资料的评估，DEA作出以下决定：

• HCP类药品具有与II类管制药品相似的高滥用可能性；
• HCP类药品在美国具有目前公认的医疗用途。根据HHS的资料，FDA已批准几种包含氢可酮与对乙酰氨基酚、非甾体类抗炎药及后马托品的复方药品，作为用于缓解疼痛的止痛药、咳嗽以及与过敏和感冒有关的上呼吸道症状的症状缓解，并且
• 滥用HCP类药品可能导致与II类管制药品相似的严重心理与生理依赖

基于上述认定结果，DEA署长做出结论，将HCP列入《管制药物法案》21 U.S.C. 812(b)(2)中的II类管制药品管理

药品生产商应在最终规定出台之前开始有所准备，确保适当的库存和行政程序均到位。

Lachman CONSULTANTS - Bob Pollock先生 2014-02-27
校译：识林-Kapok 2014-03-08

Hydrocodone Combination Products a Step Closer to Schedule II
Written by Bob Pollock • February 27, 2014

In a Federal Register Notice that published on February 27, 2014, the Drug Enforcement Administration (DEA) announced the proposed Rulemaking to place all hydrocodone-containing combination products into the more restrictive Schedule II category from Schedule III of the Controlled Substances Act. This process has been going on for several years and now looks like it will swiftly move towards becoming reality. This move has been hotly debated among consumer groups, healthcare providers, drug abuse experts and the like. FDA held a public advisory meeting in January 2013 to meet the requirement established by one of the provisions of Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). The Advisory Committee meeting was a compromise reached in FDASIA, as changing the schedule of these products was one thing that the Act's sponsors had considered. The Committee that was charged with making a recommendation voted 19-10 in favor of the rescheduling effort.

Subsequent to the meeting, (to which the FDA received almost 800 comments), FDA and the Division of Health and Human Services (DHHS) provided their recommendation on rescheduling of Hydrocodone combination products (HCP) to the DEA. The DEA considered the following factors in reaching a final decision:

a) Individuals are using HCPs in amounts sufficient to create a hazard to their health, to the safety of other individuals, or to the community.

b) There is a significant diversion of HCPs from legitimate drug channels,according to forensic laboratory data as reported by the National Forensic Laboratory System.

c) Individuals are using HCPs on their own initiative rather than on the basis of medical advice.

d) HCPs are so related in their action to a drug or other substance already listed as having a potential for abuse to make it likely that they will have the same potential for abuse as such substance, thus making it reasonable to assume that there may be significant diversion from legitimate channels, significant use contrary to or without medical advice, or that they have a substantial capability of creating hazards to the health of the user or to the safety of the community.

Based on the DEA's evaluation of the information in totality they have determined that:

• HCPs have a high potential for abuse similar to that of Schedule II substances;
• HCPs have a currently accepted medical use in treatment in the United States. According to the HHS, several pharmaceutical products containing hydrocodone in combination with acetaminophen, aspirin, NSAIDS, and homatropine are approved by FDA for use as analgesics for pain relief and for the symptomatic relief of cough and upper respiratory symptoms associated with allergies and colds; and
• Abuse of HCPs may lead to severe psychological or physical dependence similar to that of schedule II substances.

Based on these findings, the Administrator of the DEA concludes that HCPs warrant control in schedule II of the CSA. 21 U.S.C. 812(b)(2).

Drug manufacturers should begin preparations for assuring they have all of the proper storage and administrative procedures in place in anticipation of a final ruling.