A Proposed Registry Design for Medical Marijuana Dispensaries
Guest Contributor: Paul C. Langley, Ph.D., Adjunct Professor, College of Pharmacy, University of Minnesota
Previous blogs in this series have pointed to the limited and fragmented evidence for the effectiveness of botanical cannabis in the treatment, not only of chronic non-cancer pain but is other conditions that are commonly presented by dispensary clients: severe nausea, persistent muscle spasms, and seizures. The argument was put forward that dispensaries are providing their clients with cannabis products for which the evidence base is lacking but that little effort appears to be to monitor and evaluate the effectiveness of botanical cannabis. The emphasis is, rather, on retailing cannabis products, a situation where registered medical marijuana dispensaries are effectively little different from recreational marijuana shop fronts.
The solution proposed in these two previous blogs is for the dispensary to commit to creating a registry that provides the framework for monitoring and reporting response to therapy. This would make public the recognition by the dispensary that it has a duty of care to its patients. A proposed framework for a Prometheus dispensary registry, utilizing its on-line RexRegistry platform, has been detailed in a recent commentary. The purpose of this blog is to provide an overview of the structure and content of the registry design.
The proposed registry design monitors patients through online reporting to sets of structured questions in real time. These responses capture the major conditions and symptoms reported by patients at dispensaries, providing feedback on response to therapy. Responses are cumulative, collected at each dispensary visit with online input from clinical staff complementing patient responses. Following baseline assessment at the initial visit, the registry outcomes capture:
- Severe pain: reduction in overall pain intensity and improvement in (i) location specific pain intensity and functionality scores; (ii) fibromyalgia and (iii) neuropathic pain
- Persistent Muscle Spasms: reduction in frequency, severity, and timing of spasms and cramps
- Severe nausea (chemotherapy): reduction in frequency and severity of nausea and vomiting prior to, during and following a chemotherapy episode
- Severe nausea (other): reduction in frequency and severity of nausea and vomiting
- Seizures (epilepsy): assessment of potential improvement in the quality of life
A registry offers the opportunity to define and standardize response to therapy over baseline through the adoption of validated patient-reported outcome (PRO) instruments. Two types of instrument are included: (i) PRO instruments, where available, that are specific to the symptom or condition being treated and (ii) PRO instruments that are more general in capturing high prevalence co-morbidities for the conditions being treated. These include fatigue, anxiety, depression and sleep experience.
The registry structure requires inputs from both the dispensary staff and the patient over the course of treatment. The proposed data entry on-line ‘screens’ are:
- initial data input by registry staff;
- subsequent or follow-up visit data entry by dispensary staff;
- initial data entry by the patient for single condition/symptom reported;
- subsequent or follow-up data entry by the patient for single condition/symptom reported;
- initial data entry by the patient for two conditions/symptoms reported;
- subsequent or follow-up data entry by the patient for two conditions/symptoms reported
In order to limit the operational complexity of data entry to the registry where multiple conditions may be reported by the patient, the registry restricts monitoring to a maximum of two conditions. In addition, as well over 90% of patients will report one or more of four conditions (severe pain, severe nausea or vomiting, severe muscle spasms or cramps and seizures), the number of possible specific ‘high prevalence’ target groups would be:
- Severe pain
- Persistent muscle spasms
- Severe nausea
- Severe pain + persistent muscle spasms
- Severe pain + severe nausea
- Severe pain + seizures
- Persistent muscle spasms + severe nausea
- Persistent muscle spasms + seizures
- Severe nausea + seizures
- General (none of the above)
The registry adopts a modular design. The registry could be configured in the first instance only for severe pain (75% to 85% of conditions reported) . This could be enhanced by then integrating responses for patients also reporting one or more of severe nausea, persistent muscle spasms or seizures. As familiarity with the registry grows, further conditions can be captured through customizing the registry structure.
Reports can be created within the registry for individual patients as case studies of therapy response as well as reports for target patient groups to support overall dispensary management and reporting to outside agencies.
At each dispensary visit, it is proposed that patients receive a report on their current status by condition(s) reported over baseline. This report would be reviewed with the clinical staff the dispensary with, if required, recommended changes to either the dosing regimen and/or delivery option. This review of the response to therapy would include both assessed clinical benefits from condition specific PRO instruments but also the core PROs for fatigue, anxiety, depression, sleep together with the PGIC for the patients’ own assessment of their cannabis experience.
If agreed with the patient, a copy of this visit report would be sent to the provider or caregiver together with recommended regimen changes. With annual re-certification of patients for medical marijuana, regular reports to providers on dosing, administration, and response to therapy with validated instruments specific to the condition(s) being treated provide a potentially robust base for therapy decisions. The provider is then in a position to recommend or deny recertification.
Understandably, dispensary staff and management might consider these reporting requirements to be onerous. In fact, they would be little different from reports provided to primary care physicians by specialists. The registry system would automatically generate these reports with the option of further notation by dispensary clinical staff. Given the requirements for recertification of patients for access to a dispensary, there would appear to be little option for the dispensary to monitor patients, reporting on response to therapy using validated instruments and linking the response to cannabis dosing, titration and administration.
In some cases, state agencies may require a formal audit trail capability. Just as an electronic medical record provides an audit trail, the Prometheus registry would provide a framework that can be used by dispensary management in cases of dispute resolution with third parties, demonstrating a commitment to their duty of care for the patient.
Will there be an acceptance by medical marijuana dispensaries to adopt a registry model? If the focus by investors and owners is on cannabis sales with an expected increase in the price of licenses then this is unlikely. Against this is the acceptance, to include investors and owners, that they have a duty of care for patients presenting with conditions for which cannabis is an option. Such a commitment would recognize the importance of evidence-based claims for outcomes potential, to recognize they have a place in the continuum of care and that feedback with providers to justify cannabis is not only clinically desirable but may encourage greater cannabis use. If those holding licenses that are subject to a competitive renewal and those competing for new licenses recognize this responsibility, then it may put them in a preferred position with competitive bidding.
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.