Moving Toward a Standard of Care for Medical Marijuana
The Medical Board of California has recently issued updated guidelines for physicians to avoid disciplinary action related to the recommendation of cannabis to their patients for medical purposes. The board explicitly states that these guidelines are not intended to mandate the standard of care, and that the board “recognizes that deviations from these guidelines may occur and may be appropriate depending upon the unique needs of individual patients.” These guidelines, and similar guidelines by other states, however, serve as the foundation for an emerging standard of care for medical cannabis. In legal terms, the standard of care is how similarly qualified practitioners would have managed the patient's care under the same or similar circumstances. As medical cannabis becomes more widespread and accepted as a legitimate treatment by the medical community, a uniform standard is needed to ensure consistency of care and patient safety.
Along with close attention to medical documentation, essential components of the California guidelines include:
- An established physician-patient relationship
- Adequate medical evaluation
- Informed consent
- A treatment plan and ongoing monitoring.
The Physician-Patient Relationship and Patient Evaluation
The guidelines outline the key factors and considerations for assessing the appropriateness of a physician’s recommendation of medical cannabis and require the establishment of a physician-patient relationship prior to the recommendation of cannabis. It is expected that the physician shall not recommend medical cannabis unless the physician is the patient’s “attending physician,” meaning that he or she has taken responsibility for an aspect of the medical care, treatment, diagnosis, counseling or referral of a patient. The board requires documentation of a patient’s history and an initial medical examination that includes considerations such as the history of the patient’s present illness, social history, past medical and surgical history, alcohol/substance abuse history, family history on addiction, psychotic disorders, mental illness, therapies with inadequate response and the diagnosis supporting a cannabis recommendation.
Qualifying Medical Conditions
Though the California Compassionate Use Act of 1996 names certain medical conditions for which cannabis may be useful (including cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis and migraine), physicians are not limited to those specific conditions. The guidelines acknowledge that there is currently “a paucity of evidence for the efficacy of cannabis in treating certain medical conditions,” but that recommending cannabis for any medical condition is nevertheless “at the professional discretion of the physician acting within the standard of care.” The physician’s recommendation “should be evaluated in accordance with standards of practice as they evolve over time.” In an attempt to provide additional guidance on this issue to physicians, the board suggests that “the physician should base his or her determination on the results of clinical trials, if available, medical literature and reports, or on the experience of that physician or other physicians, or on credible patient reports,” and that in all cases, the physician must determine that the risk−benefit ratio of cannabis is as good or better than other treatment options.
An Informed and Shared Decision-Making Process
The California guidelines emphasize the importance of an informed and shared decision-making process between the doctor and patient, which requires the physician to advise the patient on the variability and lack of standardization with cannabis. A discussion is encouraged on the use of cannabis and the varying effects it may have on different individuals. Other considerations important to the informed decision-making process are the potential cognitive effects, risks of driving under the influence, unknown risks to pregnancy or breastfeeding, and parental consent for minors.
The Treatment Plan and Medical Monitoring
The guidelines further stress the importance of a written treatment agreement for each patient that outlines the patient’s individualized objectives, measurable goals and an exit strategy for discontinuing cannabis if necessary. This written treatment plan must document that the physician has advised the patient on options other than cannabis, reached a determination that the individual may benefit from cannabis, advised of the potential risks and provided an authorization for a period no greater than 12 months. The board also looks for an actual authorization, attestation or recommendation for cannabis; instructions to the patient regarding cannabis use; the results of the patient’s assessment and ongoing monitoring; and a signed treatment agreement with instructions on safekeeping and the federal and state legal implications of sharing the prescribed cannabis.
Specialized Assessment for Substance Abuse and Mental Health Disorders
For any patient with a history of substance abuse disorder or a co-occurring mental health disorder, specialized assessment and treatment may be necessary. The physician is encouraged to seek consultation, as needed, with pain management, mental health or addiction specialists. The guidelines emphasize that a determination should be made that cannabis use is not masking symptoms of another condition or that cannabis use will lead to the worsening of an underlying condition.
Physician Conflicts of Interest
California’s Business & Professions Code makes it unlawful for a physician who recommends cannabis for a medical purpose to accept, solicit or offer any form of remuneration from/to a facility if the physician or his/her immediate family has a financial interest in that facility. It is considered unprofessional conduct for the physician to be employed by or enter into any other agreement with any person or entity dispensing cannabis for medical purposes.
Risk Management Recommendations for Physicians
Any physician or medical group considering recommending medical cannabis to patients in California should ask several important questions, including whether there is a policy that:
- Requires a physician-patient relationship to have been established?
- Requires a medical examination of the patient?
- Requires discussion of the risks and benefits of the use of cannabis with the patient, or if the patient is a minor or without decision-making capacity, with the patient’s parent or guardian?
- Requires specialized assessment and treatment for any patient who has a history of substance abuse disorder or a co-occurring mental health disorder?
- Requires maintaining adequate and accurate medical records?
- Requires that a written treatment plan be established?
- Requires a regular assessment of the patient’s response to the use of cannabis and overall health and level of function?
- Prohibits the physician from recommending the medical cannabis for personal use or for use by family members?
- Prohibits the physician from being employed by, holding a financial interest in or having a professional office located at any entity or facility that dispenses cannabis for medical purposes?
Toward an Accepted Standard of Care
Other states have issued similar guidelines for physicians when determining that medical marijuana is an appropriate treatment. For example:
- Florida, New York, Washington and Ohio require physicians to complete continuing education training prior to obtaining certification to recommend cannabis.
- Oregon requires that the physician be a specialized attending physician for one of the enumerate debilitating mental conditions pursuant to Oregon Revised Statute 475B.410.
- Florida has comparable physician guidelines with regard to the written documentation requirements and specific documentation demonstrating that the medical use of marijuana likely outweighs potential health risks.
- Washington’s guidelines regarding treatment plans advise physicians to include a review of other measures attempted to treat the terminal or debilitating medical condition without the medical use of marijuana, the physician’s advice regarding other treatment options and a determination the patient may benefit from medical use of marijuana.
The many variations and inconsistencies among the states demonstrate the need for an accepted standard of care for physicians when considering the medical use of cannabis for patients to ensure consistency of care and patient safety. Although the various state guidelines are an important step in this process, greater uniformity is needed as medical cannabis becomes more widespread and accepted as a legitimate treatment by the medical community.