Testimony for new Cannabis Regulations January 2017
The new regulations put forward by DPH for consideration presently are generally a good step forward. There are a few items which deserve additional thought, however: Access to care, Testing Labs, and Sales Limits and Treatment Plans
Access to care, the role of mid-level providers, and continuing medical education
Access to Cannabis care in Massachusetts is not limited by physician availability, but rather by a system that assumed that any and all physicians, in particular primary care physicians, would simply add Cannabis to their repertoire.
Physicians are a conservative group of people and, for the most part, this is a good thing. Many of us have seen promising therapies come and go, and occasionally go down in flames after harming patients. We are slow to adopt new methods and demand ample evidence to support claims. This protects patients.
As a Cannabis specialist, I know that despite political tropes to the contrary, there is an astounding amount of research on Cannabis and studies worthy of consideration are published daily. I spend about two hours each day reviewing the literature to stay current.
As a Harvard physician, I am well trained to specifically read, analyze, dissect, and interpret scientific studies. This is a core skill for physicians. Not only must you understand the methods and the data acquired, but also the biases introduced by the design and by the authors themselves. This is not easy to do, despite years of training and experience.
Given the vast amount there is to know about Cannabis medicine, the time it takes to keep up with new data, and the already over-taxed schedule of PCPs, it is just not a reasonable assumption that any physician would take this on.
High quality Cannabis care has become a specialty unto itself; to whom other physicians refer.
Adding mid-level practitioners to the certification process is unlikely to increase quality care. The role of mid-levels is generally to increase access in fields where physicians are overwhelmed by volume. This works very well in fields with established data, clear practice protocols, and established standards of care. Primary care and Cardiology are good examples.
If we are to have mid-level practitioners involved in providing Cannabis care, and if we wish to elevate the standard of Cannabis care overall for all patients, then we must assure that practitioners maintain their knowledge. The field has moved beyond just certifying “Cannabis is likely better for you than it might be bad” into dose-specific, delivery system specific treatment for specific illnesses.
I propose that all practitioners, regardless of degree, be required to maintain their education through logged professional reading and/or other CME activities totaling a minimum of 16 hours per year. This is significantly below my own nearly 400 hours per year, but well above the current 4 hours once requirement.
Testing Labs
The currently proposed language for independent Cannabis testing laboratories needs clarification. As written, the proposed language implies, perhaps unintentionally, that registered labs would only be able to provide testing to RMDs, but not to individual people who have grown their own Cannabis. This creates two major problems.
First, as a matter of public safety, we should be encouraging all growers of Cannabis for individual medical use to test their Cannabis for potency and contamination. We expect government regulation to advocate for better assurance of safety and dosing for all medicines. Cannabis should be no exception.
Second, to maintain the transparency and accuracy of lab testing, the concept of an independent lab must be maintained. If labs, however, are restricted to serving only RMDs, then they are no longer truly independent. They become, in fact, completely dependent on the good will and business relationship they have with the RMDs. This is not good for patients who rely upon independent testing for their safety.
It is my belief that the current wording is just an oversight, but nonetheless must be addressed to clarify that labs can continue to test individuals’ samples in order to maintain safety for everyone.
Cannabis Sales Limits and Treatment Plans
Current regulation allows medical patients to possess and purchase up to 10 ounces in a 60 day period. 10 ounces of Cannabis for medical use is an astounding amount. For the sake of comparison, the majority of my many hundred patients use one eighth to one half ounce per month. I have occasional patients who have not been able to regulate their use and who have needed guidance to use Cannabis in the most helpful and appropriate manner. Further, I have occasional patients who come to me already using Cannabis for good reasons but using far more than is healthful for them or necessary for their condition. They come to me for help moderating their use,as well as to get the best benefit. Under these circumstances, I would welcome the ability to limit the amount of Cannabis these patients can be sold.
The current system encourages overuse, and in particular aligns the RMD’s financial incentives with encouraging patients to overuse. I have had numerous patients report being asked, “are you sure you don’t want to buy more than that? You can buy up to 10 oz.” This pressure is inappropriate in a medical context. Cannabis patients, like any other patient population, are a vulnerable group, open to the potentially harmful influence of sales tactics. I’ve even heard from patients that they’ve been told, “oh, don’t listen to your doctor, I’ll tell you want you need.”
In discussion with many of my patient advocate colleagues, I have come to understand that the 10 oz. limit was instituted to prevent patients who were growing their own medicine from being arrested for having too much. This makes some sense. Growing Cannabis is an agricultural process and, as such, is somewhat unpredictable. Allowing people to grow a relatively large amount would account for this unpredictability and prevent shortfalls of needed medicine.
It is not clear, however, why the limit set forth for growing Cannabis should apply to selling Cannabis. Particularly now that adult use has been legalized and people who want to use unlimited amounts will be able to just buy it, people who participate in the medical system are doing so because they wish for the guidance and supervision of the knowledgeable Cannabis specialist.
Setting a limit must not be an opportunity re-criminalize possession. The onus must not be on the patient to possess the correct amount. We do not raid homes to see if someone has finished or discarded the Percocet they were prescribed after their surgery. We do, however, limit the ability of pharmacies to sell Percocet. This is the model we need to apply to RMDs as well. The amount allowed should be set by the physician in discussion with the patient based on what is best for the patient and their illness.
Advocates have voiced their objection to limit-setting primarily by offering examples of when the 10 oz. limit might be appropriate or even not enough. This really doesn’t address the fact that sometimes patients would benefit from a lower limit. I am not suggesting changing the default limit, only allowing physicians to actively change the limit to suit a patient’s needs.
In fact, I think we need to go further and develop a system of “treatment plans” wherein the physician can specify the products or type of products the RMD can sell to a patient. In the pharmacy model if Percocet is prescribed, the pharmacy cannot sell the patient Fentanyl. Similarly, most of my patients need flower, but not edibles, keef, or concentrates. I should be able to prevent the RMD from “upselling” unsuspecting patients more potent, higher margin products that an not appropriate for the patient’s needs.
Patient care in Cannabis medicine, as in any other field of medicine, is a dialogue between the knowledgeable care provider and the patient. It is inconceivable that other players with less knowledge, no credentials, and significant financial motivations are allowed to “advise” patients. Moving to a system that provides treatment plans from physicians to which the RMD is bound to comply would be a tremendous step toward improved patient care and safety.
Thank you for your attention and allowing me to participate in this public comment period.