Statutes that allow the recommendation of medical marijuana present a real malpractice risk to physicians and medical providers. Despite a rapidly growing medical and recreational marijuana industry, there has been no definition of a standard of care for the use and recommendation of marijuana for medicinal purposes. This issue has been essentially ignored Federal regulators and legislatures. Most of the medical opposition to medical marijuana is borne from concern over serious medical and social consequences in patients resulting from marijuana use.
When considering what constitutes the “standard of care,” it is important to embrace practices that reduce the risk to patients as well as reducing the risk of potential malpractice litigation of providers. In legal terms, the “Standard of Care” is the level at which the average, prudent provider in a given community would practice. It is how similarly qualified practitioners would have managed the patient’s care under the same or similar circumstances. (1).
Pure Cannabis-based medicines such as Marinol, Cesamet, Epidiolex, and Sativex are already FDA approved and on the market as medications that may be prescribed. Providers “recommending” state-approved cannabis are clearly recommending a non-FDA approved substance. The recommendation of marijuana as a medicine generally has malpractice risk because “recommendations” for the use of marijuana are lacking the standard safe practices required of modern-day medicine. Research demonstrates that the use of marijuana even for pain has fallen into question (2). Extensive literature review and several international organizations have concluded that the use of cannabinoids for chronic non-cancer pain is not yet supported nor proven by research and its use for pain is considered limited (3,4).
Questions must also be answered as to what form of the drug is to be provided (smoked, vaped, gummies, oils etc.), what doses are safe and effective, what side effects should be expected, and what long-term side effects might be experienced. Patients must also be notified and cautioned of these side effects and the problem that such delivery vehicles present unreliable doses to the patient.
Several of the elements necessary for the standard of care to be met are listed below.
Medical Evaluation- As with any medical disorder, a thorough and complete medical evaluation must be performed, documented, and updated regularly by a licensed medical provider. This is a central and essential part of any medical evaluation. This process should also include specific documentation of other medical treatments and other successful or failed medications. The documentation of these elements must be entered into the patient’s medical record which is appropriately retained, stored, and made readily available for other providers also treating the patient. The patient’s mental health history must be explored as cannabis use can damage mental health. (5) The few Cannabinoid products that have been approved for use by the FDA, including Epidiolex (a CBD product) and Marinol and Cesamet (synthetic THC) have extensive warnings of the many risks of use. The FDA drug label for Marinol issues a warning that the drug “may cause psychiatric and cognitive effects and impair mental and/or physical abilities. Avoid use in patients with psychiatric history.” (Table 1)
Concentration/Dose- Research is now suggesting that THC concentrations should not exceed 10% (4), and that higher concentrations have been associated with psychosis and other psychiatric disorders. It is worth also noting that state statutes allowing “medical” applications of marijuana include smoking, oils, vaping for example that can have 70-90% THC concentrations, and generally do not have specific dose restrictions.
Failure to warn – The question of side effects and whether a less problematic and less toxic medication might be available, must be made available to the patient, and there must also be a rationale provided if the practitioner proceeds in recommending marijuana over a less toxic medication. The patient must be warned on any drug interaction which may harm them or render a medically necessary drug for the patient (such as coumadin) dangerous or ineffective. This rationale and patient notification must be clearly documented in the medical record.
Failure to monitor– Ongoing monitoring of symptoms, toxicity, need for dosage change, need for additional medication are all elements of good medical care.
REMS- Risk Evaluation and Mitigation Strategies are widely used for high-risk therapies such as opiates. While REMS for marijuana administration are not widely used, as they become available it is strongly recommended to be a requirement for prescribing/recommending providers.
These elements are generally not required in existing statutes.
Bibliography
- Moffett P, Moore G. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med. 2011;12(1):109-112.
- Why Marijuana Will Not Fix the Opioid Epidemic, by Kenneth Finn, MD. https://www.msma.org/uploads/6/2/5/3/62530417/why_marijuana_will_not_fix_the_opioid_epidemic_mayjune_2018_momed.pdf
- Boland EG,Bennett MI, Allgar V, et al. BMJ Supportive & Palliative Care 2020;10:14–24.
- Pratt et al. Systematic Reviews (2019) 8:320 https://doi.org/10.1186/s13643-019-1243-x
- Di Forti et al Lancet Psychiatry 2019; 6: 427–36 Published Online
March 19, 2019. http://dx.doi.org/10.1016/ S2215-0366(19)30048-3 - Lieblich LM. N Engl J Med. 2004 Apr 22;350(17):1798. PMID: 15106274
Authors
The International Academy on the Science and Impact of Cannabis-IASIC-https://iasic1.org
From the Board of Directors of IASIC:
Eric A. Voth, M.D., FACP
Ken Finn, M.D.
Catherine Antley, M.D.
Elizabeth Stuyt, M.D.
Roneet Lev, M.D.
Eric A. Voth, MD, FACP is the President and Chairman of the Board of IASIC. He is a specialist in Internal Medicine, Pain management, and Addiction Medicine., is recognized as an international authority on drug use, and lectures on drug policy-related issues, pain management, and appropriate prescribing practices. He has been quoted by numerous international news media. Dr. Voth is a former member of the National Advisory Committee for the Center for Substance Abuse Treatment of HHS and has advised Reagan, Clinton, both Bush, and Obama administrations. He also advises on alcohol and drug abuse issues to the Kansas State Board of Healing Arts
Catherine Antley, M.D. is Treasurer of IASIC. She is board certified in Anatomic and Clinical Pathology and in Dermatopathology and was elected a Fellow of the American Society of Dermatopathology in December 2001. For 20 years she has served as laboratory director of Vermont Dermatopathology, the only independent dermatopathology lab in Vermont serving VT, NH and NY. She has a strong interest in public health and effective prevention as well as exploring the impact of policy on the prevention of use disorder and resulting health care costs. Dr. Antley has co-authored several Vermont Medical Society resolutions on cannabis. She recently contributed a chapter “Cannabis in Dermatology” to the textbook “Cannabis in Medicine, an Evidence Based Approach” edited by Dr. Ken Finn and published by Springer Nature.
Ken Finn, M.D., Pain Medicine and Drug Policy- is Vice-President of IASIC
Practicing medicine in Colorado Springs since 1994, serves on the American Board of Pain Medicine Exam Council (’01) and is the President of the American Board of Pain Medicine (’20)., serves on the Appeals Committee (’14), and Executive Board (’14). Finn served on the Colorado Governor’s Task Force on Amendment 64, Consumer Safety and Social Issues Work Group (’12) and served 4 years on the Colorado Medical Marijuana Scientific Advisory Council (’14-’18). He was an Executive Board member of El Paso County Medical Society (’14-’18) and helped Colorado Medical Society and Colorado Pain Society develop their position statement on cannabis (’18) as well as the El Paso County Board of Health (’14) and Medical Society (’14) on their statements. Finn is a voluntary clinical instructor for the University of Colorado Medical School-Colorado Springs Branch (‘17-’20).
Roneet Lev, MD FACEP is Vice-President of IASIC and was the first Chief Medical Officer of
the White House Office of National Drug Control Policy, ONDCP, 2018-2020. She brought refreshing frontline medical experience to national health policy. She is a nationally acclaimed medical expert and speaker who continues to treat patients in the emergency department and hosts a podcast titled High Truths on Drugs and Addiction. As a mother of four she relates to families who struggle. Lev uses data to drive change and is frequently quoted in print and television media. Lev is dually board certified in emergency and addiction medicine, bringing over 25 years of experience treating the frontline cases of addiction. She came to the White House as chief of the emergency department at Scripps Mercy Hospital in
San Diego. In 2012, she established and chaired the San Diego Prescription Drug Abuse Medical Task Force, the first of its kind in California that integrated physicians of various specialties along with hospitals, law enforcement, hospital administration, treatment programs and public health for the purpose of decreasing deaths and mortality from prescription drugs. Lev’s medical publications known as the “Death Diaries” studied the details of prescription patterns of people who died from accidental medication drug overdoses, giving insight to the causes of overdose and directing prevention efforts. Lev graduated from the University of Texas Medical School in San Antonio and completed her emergency medicine residency training at the University of California San Diego. Dr. Lev served as President of the California Chapter of the American College of Emergency Physicians in 2000. She is Founder and President of IEPC, Independent Emergency Physicians Consortium, an organization providing collaboration to independent emergency departments in California. Her program on Safe Prescribing in the emergency department won the 2014 National Association of Counties award. The California US Attorney’s office nominated her for the White House Champion of Change Award. Lev is an energetic leader with a passion to assist communities in preventing and treating addiction. She continues to practice medicine on the front lines and consults on clinical medicine and health policy. Visit: Hightruths.com
Elizabeth Stuyt, M.D., Addiction Psychiatry is Secretary of IASIC
Dr. Stuyt is a board-certified Addiction Psychiatrist and has worked in the addiction/behavioral health field since 1990. She was the Medical Director for the Circle Program, a 90-day inpatient treatment program, funded by the state of Colorado, for persons with co-occurring mental illness and substance abuse who have failed other levels of treatment from June 1999 to May 2020. She was instrumental in helping the Circle Program to become tobacco free in January 2000 and has been a strong advocate of the need to address all addictions at the same time, including tobacco, to improve outcomes. She has been actively incorporating complementary treatments into treatment programs, including the 5-point ear acupuncture NADA (National Acupuncture Detoxification Association) protocol and BST (Brain Synchronization Therapy), to help patients
recover from addiction as well as trauma which often underlie addiction and chronic pain issues. Her current mission is to educate as many people as possible on the un-intended consequences of the commercialization of marijuana in Colorado, focusing primarily on the deleterious effects of high potency THC on the developing brain.