Establishing Outcomes Standards for Medical Marijuana Dispensaries: The Role of Cannabis Registries
Guest Contributor: Paul C. Langley, Ph.D., Adjunct Professor, College of Pharmacy, University of Minnesota
One of the more puzzling features of the embrace by many state governments in the US of medical marijuana programs is the apparent lack of interest in establishing dispensary standards for monitoring the use and impact of botanical marijuana formulations on therapy outcomes. Rather, the focus is on establishing a regulatory basis for licensing and production. Outcomes of therapy associated with the choice of marijuana formulations either alone or in combination with prescription medications are essentially ignored. The net result is that while there is mandatory reporting to state agencies of some limited characteristics of dispensary cannabis users, we have little idea on whether or not the ability to access marijuana through dispensaries has a clinically significant impact on the course of a disease or symptoms reported. We have no idea of the distribution of outcomes associated with botanical marijuana within target patient groups together with the incidence of adverse events and the direct medical and social costs of treatment.
The limited and often contradictory evidence base for botanical cannabis means decisions on dosing and formulations by clinical pharmacists and other dispensary staff occurs in what is appropriately described as an information vacuum. This is untenable. If botanical cannabis is to meet its assumed potential as an integral part of therapy, notably for the management of chronic and severe pain which is reported by over 75% of patients treated by dispensaries, then an evidence base should be a priority. Add to this the situation in respect of opioids. Although opioids are the mainstay of pain therapy, evidence for their impact outside of short-term randomized clinical trials is lacking. The latest CDC Guidelines for Prescribing Opioids for Chronic Pain point out that evidence on long-term opioid therapy for chronic pain outside of end-of-life care remains limited, with insufficient evidence to determine long-term benefits versus alternative options or the absence of opioids altogether. The same criticism applies to botanical cannabis (and to the FDA approved cannabis-based pharmaceuticals). We are in a situation where attempts to reduce opioid utilization, often with claims for switching to botanical cannabis as an opioid-sparing policy, occurs in a situation where we have no idea of the clinical merits of switching or of the medium and long-term impact in pain management.
If dispensaries are to make claims for their services in ameliorating conditions such as severe pain, persistent severe muscle spasms, and seizures, then it is incumbent on dispensary managers and groups which control multiple dispensaries to commit to a program of outcomes assessment. State dispensary registration authorities should consider whether licensing and the renewal of licenses by responsible agencies should be dependent upon those dispensaries meeting standards for monitoring and reporting cannabis therapy outcomes. This does not mean a cursory reporting of patient satisfaction but the application of validated patient-reported outcomes (PRO) instruments together with clinical markers to track patients ongoing response to therapy at each dispensary visit. This is best accomplished by a commitment to build dispensary specific registries with inputs from both the patient and registry staff.
It is not, however, only the standard of reporting to state dispensary licensing agencies that is at issue. Dispensaries should also be required to act as intermediaries between providers and patients in reporting on cannabis interventions. Well managed dispensaries could provide an ideal reference point for developing provider-mediated marijuana medication management and reporting systems. Providers should receive regular reports on their patient’s response to therapy, recognizing that in the area of severe pain, which is all too often a chronic condition, access to cannabis is only one element in an overall pain management strategy.
At the same time, from the perspective of severe pain (and the same case can be made in other therapy areas) we know very little regarding the clinical profile of patients dispensed botanical marijuana, the type, intensity and location of pain reported prior to treatment, the prevalence of neuropathic pain and mixed nociceptive and neuropathic conditions. To this, we would add the potential for drug-drug interactions, prior response to therapy and risk for cannabis abuse, possibly in association with opioids. Unless a baseline standard for severe pain assessment and monitoring is established then it is impossible to judge whether the introduction of dispensary mediated botanical marijuana is not only clinically meaningful with an acceptable adverse event profile but, in more general terms, contributes to a beneficial impact on parameters such as quality of life over the timeframe of therapy.
The importance of monitoring therapy response and, for target patient groups, estimating the independent contribution of specific cannabis formulations to clinical outcomes are necessary steps in developing a needed evidence base for botanical marijuana. Such evidence would not only provide a justification for legislating approval for dispensaries but would also support physicians in their advice to patients that specific cannabis formulations, appropriately managed, may help to play a more central role in their duty of care.
A key question registration authorities should ask, therefore, is what monitoring and reporting systems should be in place that allow the dispensary to assess the impact of a prescribed cannabis formulation on the process and outcomes of care? Could a failure to meet such standards be an element for refusing an initial dispensary license or refusing to review a license? Should we recognize that dispensaries have a duty of care; a duty that is no different from that asked of other health care providers? In the absence of such requirements by legislative authorities, the result could be a ‘two-tier’ dispensary market with ‘duty of care’ dispensaries promoting a comprehensive initial assessment of patients by qualified clinical staff, monitoring patients over the course of their treatment and reporting response to therapy to the patient’s provider. Against this would be ‘shop front’ dispensaries that meet legislative requirements but lack not only clinical staff to support and monitor initial therapy decisions but also the infrastructure to report response to therapy in real time.
Failure to establish standards for the assessment by dispensary staff of therapy options together with standards for monitoring and reporting is unacceptable. If we are concerned to establish a robust evidence base to support claims for cannabis in therapy, then dispensaries should, ideally, be required to meet minimum standards for reporting response to therapy. If not, there Is the risk that will be a reluctance or outright refusal by providers to consider cannabis as an acceptable therapy option in pain management or other conditions such as severe nausea and persistent muscle spasms.
Want to learn more?
Dr. Paul Langley wrote an abstract paper entitled “Outcomes, Registries, and Medical Marijuana: Towards Establishing Dispensary Monitoring and Reporting Standards.” Click here to download his paper. And learn more about our unique approach to data hubs for therapeutic development here.