Langley Paul C
Adjunct Professor, College of Pharmacy, University of Minnesota.
Innov Pharm. 2018 Nov 30;9(4). doi: 10.24926/iip.v9i4.1527. eCollection 2018.
The acceptance by a large number of state governments of medical marijuana dispensaries and the regulatory framework to support their licensing has put to one side the issue of monitoring and reporting outcomes. This is a major oversight. It is an untenable situation given the limited evidence base for the clinical benefits and risks associated with dispensed botanical marijuana. The purpose of this commentary is to propose that, as a condition of licensing, marijuana dispensaries should be required to establish a registry to support ongoing monitoring of patient response associated with botanical cannabis formulations. Patients should be monitored over the course of their treatment to assess, in the case of severe non-cancer pain as an example, pain intensity and functional status by pain location. The dispensary, in meeting required audit standards, should be in a position to report on patient response over baseline to the provider who has recommended botanical cannabis. As well, registries should be in a position to report to state licensing agencies response to therapy by target patient groups. Establishing site-specific registries should go some way to meeting the present evidence deficit for botanical marijuana, reducing barriers to its acceptance by providers, patients and health agencies.
许多州政府对医用大麻药房的认可以及支持其许可的监管框架,将监测和报告结果的问题搁置在了一边。这是一个重大疏忽。鉴于与分发的植物性大麻相关的临床益处和风险的证据基础有限,这种情况是站不住脚的。本评论的目的是提议,作为许可条件,应要求大麻药房建立一个登记系统,以支持对与植物性大麻制剂相关的患者反应进行持续监测。应以重度非癌性疼痛为例,在患者治疗过程中对其进行监测,以按疼痛部位评估疼痛强度和功能状态。药房在符合所需的审计标准时,应能够向推荐植物性大麻的医疗服务提供者报告患者相对于基线的反应情况。此外,登记系统应能够向州许可机构报告目标患者群体对治疗的反应。建立特定地点的登记系统应在一定程度上弥补目前植物性大麻的证据不足,减少医疗服务提供者、患者和卫生机构接受它的障碍。