By Eric Dick, MNAAP Lobbyist, and Pamela Gonzalez, MD, FAAP, Addiction Medicine Specialist at Abound Health and Member of AAP’s Committee on Substance Abuse
Few issues garnered more attention during the 2014 legislative session than the effort to authorize the use of marijuana for medicinal purposes. The legislation was the subject of much debate by patient advocates, health care professionals, and law enforcement interests. With the launch of the program set for this summer, it’s timely to review what the law does and not entail.
Under the new law, patients with one of nine specified conditions are eligible to participate. Those conditions include seizures (including those associated with epilepsy), muscle spasms such as those characteristic of multiple sclerosis, Tourette’s Syndrome, and terminal illnesses with a life expectancy of less than a year if the treatment produces severe/chronic pain, nausea, or wasting. Importantly, physicians will not be “prescribing” medical cannabis but rather certifying that a patient has one of the conditions defined in law.
Before issuing a written certification of a qualifying condition, a health practitioner must conduct a full assessment of the patient’s medical history and current medical condition, including an in-person physical exam, diagnosis and development of a treatment plan.
Once certified, the patient applies to the Office of Medical Cannabis and pays a registration fee. After the certification is complete, the patient (or a patient’s designated caregiver) may obtain medical cannabis from one of two manufacturers at one of a total of eight distribution sites located around the state.
At the distribution facility, patients or their caregivers will consult with on-site pharmacists that will work to determine the appropriate dosage and type of medical cannabis for each patient. The product will only be provided to patients as a liquid, pill, or via vaporized delivery; no plant material may be distributed nor is smoking allowed. There are no additional guidelines in the law or rules that govern pediatric use.
In an effort to monitor the effectiveness of the program, MDH is in the process of establishing a research protocol. As a condition of participation, patients must agree to continue to receive treatment for their condition. Participating physicians must also agree to provide ongoing reports about the patient’s health status/condition to MDH via a process that will be announced.
The distribution sites may begin operations on July 1, 2015, though physicians began certifying patients on June 1, 2015.
The Minnesota Medical Cannabis Program (“Program”), a form of marijuana decriminalization, can complicate patient-physician relationships. As a fellow pediatrician and addiction medicine specialist serving on the Governor’s Task Force on Medical Cannabis, I offer the following as you consider program participation:
Professional liability
The law protects physicians from civil or disciplinary penalties “solely for participation in the registry program.” Although dissociated from prescribing, as participants we provide continuing care for a patient’s qualifying condition. Commissioner approval is weighted toward certification, effectively making practitioners gatekeepers for medical cannabis.
Certification can be reasonably viewed as at least tacit approval. With approval comes a professional expectation to discuss benefits and risks, and ensure adequate informed consent. Cannabinoid analogs such as Nabilone have FDA-approved (adult chemotherapy-related nausea/vomiting), and off-label (neuropathic pain) indications. In contrast, cannabis has no FDA approval. Are we liable if a patient is harmed by medical cannabis, a non-approved treatment? Maybe. Will liability carriers cover medical cannabis-related claims? Maybe.
You may conclude medical cannabis is appropriate for a child’s condition. If you participate in the program, consider how you will document benefits/risks and informed consent, and consult with your liability carrier about coverage. Those employed by health care systems may need to consult with relevant leadership about institutional policy and risk management.
Financial burden
Anticipated fees include: $15 for caregiver background check; $200 annual registration fee ($50 for eligible patients), and $200-500 estimated monthly product cost. Yearly $2400-$6000 drug cost could limit program accessibility for families living in poverty/low income.
Informal discussions of vendor-driven sliding fees have occurred, but no publicized plans exist yet. In states with retail, medical, and illegal markets, illicit cannabis is reliably the cheapest. An individual can also illegally cultivate cannabis. If more affordable, some could be driven to such illicit sources, leading to legal and other consequences. Pediatricians can help advocate for licit medical cannabis accessibility.
AAP stance
Efficacy is reviewed in the Technical Report accompanying the AAP Policy Statement on Impact of Marijuana Policies.
Briefly, data are insufficient to recommend cannabis for medicinal use in children, and AAP “opposes ‘medical marijuana’ outside the regulatory process of the US Food and Drug Administration,” while noting, “marijuana may currently be an option for cannabinoid administration for children with life-limiting or severely debilitating conditions and for whom current therapies are inadequate.” The latter supports decriminalizing caregiver administration in limited cases.
AAP “strongly supports research and development of pharmaceutical cannabinoids”, and where cannabis is sold legally, “it should be contained in child-proof packaging to prevent accidental ingestion.”
“It’s just marijuana”
Youth cannabis use is linked to access, perceived harm and parental disapproval, and other drug use. Cannabis has detrimental effects on developing brains, and is an addictive substance. The younger age at exposure, the more likely the development of substance use disorder.
The relationship between cannabis use and exacerbation/onset of psychosis and mania is complex. Toxic pediatric exposures have occurred, involving retail and medical cannabis. Pediatricians have the expertise to help develop monitoring and prevention strategies. Please become involved in shaping the Program in the best interests of children.
For more information, visit www.health.state.mn.us/topics/cannabis/practitioners/index.html
