The Case for Medical Marijuana Registries: Practice Risk Management and Outcomes Claims
Guest Contributor: Paul C. Langley, Ph.D., Adjunct Professor, College of Pharmacy, University of Minnesota
In a previous blog the case was put forward that medical marijuana dispensaries need to be able to demonstrate that botanical cannabis has a beneficial role in the delivery of care. If dispensaries recognize that they have a duty of care then there are a number of questions dispensary owners need to address, and which legislators in licensing dispensaries need to ask. These questions, which are detailed in a recent commentary and are summarized below, focus on the ability of the dispensary to risk manage their patient base by demonstrating a commitment to the monitoring of and reporting on response to botanical marijuana in the process of care.
Understandably, dispensaries would wish to avoid more regulation and restrictions on licensing. If this is to be avoided, one option is for the dispensary owner to be proactive and commit to establishing a registry framework for monitoring and reporting client outcomes. There are a number of reasons for advocating a registry framework: (i) the adoption of a registry commits the dispensary to an evidence-based approach to the dispensing of botanical cannabis; (ii) the registry framework allows reports to be generated that can support links to a client’s provider, establishing botanical cannabis as potentially integral to the process of care; (iii) the commitment to a registry reinforces the argument that a dispensary recognizes it has a duty of care to its clients and that this duty of care can be exercised without additional government regulation; and (iv) the commitment to a registry has the potential to add significantly to the dispensary revenue flows.
Medical marijuana dispensaries have a potentially important role to play in the treatment of a number of conditions and symptoms. A failure to achieve this potential stems from a number of factors: (i) the limited evidence base for botanical cannabis outcomes , particular for the medium and long-term benefits; (ii) the reluctance of physicians, due in large part to the lack of evidence, to consider botanical cannabis; (iii) the lack of physician training in prescribing cannabis; (iv) the reluctance of state legislators to support medical marijuana dispensing; and (v) obstacles placed by insurers and others for access to botanical cannabis.
Unless the evidence base, particularly through registry structures that can support observational studies and claims, is enhanced, dispensary owners are in a catch-22 situation. This can be illustrated in the case of severe or chronic non-cancer pain. Evidence from states where there are dispensaries points to the dominant position of severe and chronic pain in conditions reported. Overall, some 75 to 85% of patients treated with botanical cannabis report pain. This translates, broadly, to a situation where some four out of every five dollars of dispensary revenue is from pain. Yet we have little if any evidence, outside of that from a handful of well-conducted, randomized clinical trials and even fewer well-conducted observational studies, of the impact of cannabis. These suggest, and we can say no more, that botanical cannabis is potentially effective in both neuropathic and nociceptive pain. The emphasis is on the word ‘potentially’ because dispensaries simply fail to collect the data that would allow them to make claims for cannabis effectiveness. Pain is the most prevalent condition or disease in the US population. It is a vast yet underserviced market due, in large part, to concerns regarding abuse of pain medication where opioids dominate, and the lack of long-term evidence for surgical interventions. Dispensaries have a role to play, yet they fail to meet expectations.
The pressing need for more evidence from both clinical trials and observational studies including registries is emphasized in a report issued on 4 December by the European Monitoring Centre for Drugs and Drug Addiction. The Center points to the limited and fragmented evidence gaps for the medicinal properties of cannabis and the need for ‘additional research and clinical studies, including larger and better-designed trials, studies looking at dosage and interactions between medicines and studies with longer-term follow-up of participants’.
The paradox is that we have the tools at our disposal to monitor and report the contribution of botanical cannabis in the treatment of pain within a registry framework. Any assessment of nociceptive pain, for example, must take account of pain intensity by pain location and the impact of treatment interventions on functional status. Fibromyalgia presents challenges yet there is little evidence for cannabis in treatment practice. Validated patient-reported outcomes (PROs) instruments can address these issues. Patients can be monitored over successive visits to a dispensary to evaluate clinical improvement with other PRO instruments to capture the quality of life and comorbid status for high prevalence associated conditions such as fatigue, anxiety, depression, constipation, and sleep. Neuropathic pain issues can be addressed in exactly the same way.
So, what are the questions a dispensary owner should ask? The most critical are:
- Has the dispensary adopted a registry design that allows patients with specific conditions to be monitored over the course of treatment?
- Has this registry design and its data collection and reporting protocols been validated in other dispensaries?
- Does the registry identify all disease and conditions for which medical marijuana has been approved in the state reported by the patient?
- Does the registry design require inputs from health care providers, patients, and dispensary staff or only the patient and dispensary staff?
- Does the registry have guidelines for the dosing and administration of botanical cannabis which meet standards proposed for initial dosing, dose titration and the avoidance of psychoactive response?
- Are the registry clinical staffs equipped to assess response to therapy by pain type and location and advice on adjustments to the dosing and administration regimen?
- Does the registry capture both clinical responses to therapy as well as the patient’s perception of the response over baseline?
- Does the registry utilize validated instruments to measure response to therapy? Is it possible to determine from the instruments minimum clinical improvement?
- Are summary reports provided to the patient and, with permission, the provider following each dispensary visit?
- Does the registry generate dispensary level reports for outcomes by target patient group?
Establishing a registry generates a structured, real-time environment that tracks patients over the course of treatment. This accumulation of data provides a robust evidence base for the individual dispensary to make claims for the services it offers. The registry can be interrogated for reports on individual patients, recognizing the personalized medicine focus of cannabis therapy, linking the dispensary to the provider a part of a continuum of care. In addition, the registry can report on target cannabinoid dosing populations with management reports on therapy options, costs, and effectiveness and even the provision of de-identified data to third parties for research purposes. A dispensary that is prepared to make clear its commitment to its duty of care and can demonstrate how that is exercised will stand aside from its competitors.
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.