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Dr. Joseph Rosado is clearly emotional when he discusses the patients that he has lost to cancer and other ailments prior to the completion of the 90 day relationship period required by Florida Statute. According to current Florida law, a physician must have a 90 day relationship with a patient before they are allowed to give a referral for low-thc Marijuana. This will be changed with the roll out of Constitutional Amendment 2 which received 71% of the vote on the November 8th, 2016 Ballot and expands the number of illness where Cannabis treatment is permitted. Dr. Rosado is a physician based in Orlando, FL and he is looking forward to the release of the rules related to Amendment 2. He is unclear as to why he is able to prescribe narcotics within five minutes of meeting a patient, but has to wait 90 days before a patient can benefit from the natural healing of the Cannabis plant. He is disturbed by the loss of 25% of his patients before he could offer them comfort and healing in the form of Cannabis. He is determined to spread the word to other physicians and encourages them to start educating themselves with books such as the "Handbook of Cannabis" by Roger G. Pertwee, seminars, and webinars. Similarly, Dr. Michelle Weiner is a strong advocate of the healing properties of Cannabis. She is a physician with five locations in South Florida. She emphasizes that doctors have the responsibility to educate themselves and not rely on dispensaries to tell them which illnesses respond to which variations of Cannabis. She is optimistic that we will begin to see Cannabis Medicine Education being added to the curriculum of medical schools around the country. Dr. Rudy Moise, who is based in Miami, Florida says that he does not like to prescribe narcotics and sees Medical Marijuana as an exit drug. He recognizes the addictive nature and devastating impacts of prescription narcotics. He is looking to reduce patient reliance on opiates, by giving his patients medical marijuana as an option, in appropriate doses. He agrees with Dr. Rosado and Dr. Weiner that it is unfortunate that terminal cancer patients have to wait 90 days for a referral for medical marijuana treatment.
Despite the increased paperwork and the 90 day restriction on their ability to refer, these doctors are committed to being advocates, giving patients the treatment that they deserve, and educating themselves on the dosages for their patients. Dr. Rosado encourages physicians to "start low and go slow" when determining the correct Medical Marijuana dose for patients. I got an opportunity to speak with patient, Heather Joy Russell in his office waiting area. She was looking forward to Amendment 2 Medical Marijuana and describes her experience as a disabled veteran with post traumatic stress disorder. She says that she has been self-medicating for years and without marijuana, she feels like "the Hulk, as if she is going to burst out of her skin". She is not able to eat, sleep, or work due to her rage and anxiety related to PTSD. She starts to cry when she talks about what this new treatment will mean for her life. She has been prescribed 40 narcotics over the years to treat her symptoms and none of them has worked. Medical Marijuana is a life changer for Heather. Dr. Rosado, Dr. Weiner, and Dr. Moise all agree that Medical Marijuana creates a new opportunity for physicians to heal people and change lives. The question that remains to be answered is, if we trust physicians to issue prescriptions for narcotics tied to overdosing fatalities, why don’t we trust them to refer patients for medical marijuana treatment, when there have not been any overdosing deaths? This question is being considered by our Florida Senate and House of Representatives Health Quality sub-committees. If a physician is seeking more information on treatment and dosing best practices, they can contact any of the mentioned physicians.
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In the aftermath of the elections, last November, proponents of legalizing marijuana scored a number of victories. For them, the goal of legalizing marijuana nationwide seems closer than ever. However, the elections have released counter-forces that may seriously upset their vision of the future of marijuana in the United States.
Background
In August 2013, the Department of Justice issued guidance to states indicating that this agency intended to devote fewer resources to investigating and prosecuting individuals who distribute and consume marijuana in a manner that is consistent with state law. Later, the so-called "Hinchey-Rohrabacher Medical Marijuana Amendment" to the Consolidated Appropriations Act of 2016, prohibited the expenditure of federal funds to prosecute individuals whose marijuana-related activities are permitted under the relevant state law (an analogous amendment is included in the proposed 2017 Consolidated Appropriations Act). There also have been signs that the federal government is considering reclassifying marijuana from a Schedule 1 to a Schedule 2 drug.
In Florida, the "Compassionate Medical Cannabis Act of 2014" permitted a limited number of patients to legitimately obtain marijuana for medical purposes. Last November voters overwhelmingly approved the adoption of "Amendment 2", which greatly expands the permissible uses of medical marijuana in the State. Under certain circumstances, this amendment to the Florida Constitution decriminalizes the production, distribution, prescription, and consumption of marijuana.
Taken together, the Justice Department’s guidance, the Hinchey-Rohrabacher Amendment, and Amendment 2 seemed to clear the way for the development of a medical marijuana industry in Florida. Indeed, over half the states have enacted legislation that permit the use of marijuana for medical and/or recreational use. The rapid manner in which these states, which contain more than half the population of the United States, have liberalized their laws regarding marijuana dispensing, possession, and use indicate that this should be an issue that is no longer controversial and well on its way to national acceptance (at least with respect to medicinal uses of marijuana).
The November Elections
The national election results, however, cast doubt on these efforts to legalize the prescription, production, distribution, prescription, possession, or use of marijuana in the United States, at least in the near future. Neither President-elect Trump, nor Secretary-designate Price appears to have announced their view regarding the legalization of marijuana. However, there are Members of the House of Representatives, primarily political conservatives, who do not view this development favorably. They may have the ability to block adoption of the 2017 version of the "Hinchey-Rohrabacher Medical Marijuana Amendment." Also, congressional opposition may be sufficient to thwart any attempt to reclassify marijuana as a Schedule 2 Drug.
From the perspective of federal law enforcement, support for legalizing marijuana (in any form or for any purpose) also seems unlikely. Attorney General–designate Jeff Sessions, who built his reputation on being a strong law enforcement advocate, does not seem to be a likely candidate for supporting the legalization of marijuana. As such, there is a very distinct possibility that DOJ will significantly shift its view away from current flexible enforcement policy in this area.
Caveat Emptor
While a majority of states have adopted laws legitimizing the production, prescription, distribution and use of marijuana (some states only for medical purposes, other states have included recreational uses), in light of uncertainty regarding the federal government’s future position "buyer beware" may never be more relevant than for those physicians, healthcare providers and vendors who venture into the medical marijuana industry.
Physicians in the United States of America take the Hippocratic Oath which is often erroneously credited with containing the phrase “Do No Harm”, however this phrase is accepted as a foundational principle of the medical profession. The legalization of Medical Marijuana is an extremely controversial topic as to whether it is harmful and addictive or is it a natural healer and comforter.
The Supporters
Three of the most well-known organizations in the advocacy of the health benefits of Cannabis and byproducts are Patients Out of Time which was the first organization in the United States to offer CME’s to doctors and nurses on medical cannabis, Marijuana Policy Project, and NORML. NORML has chapters across the country, partners with other organizations, and hosts gatherings with like-minded supporters. I serve as General Counsel for two Advocacy organizations which are also in support of legalization. First, Patience with Patients is led by Melanie Grant a long time Sickle Cell disease educator. Patience with Patients supports people with debilitating and chronic diseases battling stigma as they try to navigate the complex hospital systems in their attempts to get care for their illness. Next, Minorities 4 Medical Marijuana is an organization that promotes equal access to careers and business opportunities in the Cannabis industry for geographic, ethnic, and business size diverse professionals. Minorites 4 Medical Marijuana is lead by Chair Erik Range and Rosalind McCarthy. These organizations provide helpful resources on the benefits of legalizing Medical Marijuana and how you can get involved in promoting legalization.
Medical Marijuana Industry Careers and Business Opportunities
When people think about the Medical Marijuana Industry, they automatically think about the dispensaries. Marijuana dispensaries are extremely lucrative business opportunities, however, they are also extremely costly to get started and require expertise in governmental compliance. The average person does not have the resources needed to file the zoning applications, renovate the business space, hire attorneys and consultants to submit the application to the State and hire staff, security, and scientists. However, there are other “ancillary” business opportunities in the Cannabis Industry. In my Cannabis Law Practice, my clients tend to be vendors to dispensaries or medical practitioners. Here is a summary of some business opportunities for individuals that lack the capital to invest in a dispensary:
• Physicians (M.D.’s and D.O.’s)
• Chemists
• Security
• Tracking services
• E-Wallet solution providers
• Independent testing labs
• Secure Transportation companies
• Creators of Salves and Lotions
• Creators of Pet products containing CBD’s
• Creators of Edible products
• Membership Organizations
• Journalists covering industry growth
• Compliance Consultants
• Attorneys
• Local Government Consultants on Ordinances
• Curriculum design experts for CME’s and CLE’s
• Inventors of delivery devices
• Architects and General Contractors
It is important to note that this is not a comprehensive list. I work with my clients and determine how they can best match their existing skillset to the needs of the industry and build a business model from there.
The Anticipated Future
It is estimated that the Cannabis industry will be a Fifty (50) billion dollar industry in 20 years. States such as Colorado have generated so much revenue that they are able to use this money to eradicate its homeless problem. Florida is expected to be one of the largest Cannabis markets in upcoming years. As far as the medical profession, we are seeing Physicians open “Medical Marijuana Treatment Centers” across the State . Under current law, patients are required to have a medical relationship with a physician for at least 90 days before receiving a referral for Marijuana. Regulate Florida, an advocacy organization run by Attorney Michael Minardi, Esq. and activist Karen Goldstein, has a petition being circulated that would require Marijuana to be regulated like alcohol. Also, many advocates believe that the ability to refer should be expanded beyond physicians to Nurse Practitioners in order to give more access to patients in need across economic backgrounds. We can expect to see CBD’s and Cannabinoids in more of our household products, lotions, dog food, and even vitamins in the future depending on what happens with Federal and State Laws.
In closing, we can all agree that Medical Marijuana is a very lucrative prospect for citizens as well as the government. Regardless of where you stand on the controversy around the health benefits and potential harms, there is definitely a need for further research on how Medical Marijuana can help patients with Epilepsy, Multiple Sclerosis, and other disorders.
Established and Evolving Science
A growing body of evidence exists for the use of cannabis as medicine for certain medical conditions.(1,2) The Endocannabinoid System (ECS) is an independent, endogenous system of cannabinoid receptors and ligands found throughout the body that is involved in many physiologic processes and was first described in the 1990’s.(3,4) It is comprised of: (a) at least two G-protein coupled receptors (CB1 and CB2), (b) endocannabinoids (anandamide and 2-AG) and (c) regulatory enzymes. CB1 receptors are in presynaptic terminals in the brain and regulate neurotransmitter release. They are also found in adipose, liver, pancreatic, skeletal and immune cells. They mediate numerous physiological processes, including cardiovascular function, energy homeostasis, and reproduction. The activation of CB1 receptors also affects cognition and memory, reward sensation and emotional behavior, sensory perception, motor control, pain modulation, and other functions. CB2 receptors are found primarily on B cells, T cells, and macrophages and signaling results in inhibition of immune cell activation and pro-inflammatory cytokine production. (5,6,7)
Phytocannabinoids are the naturally occurring chemical compounds found within the flowers of the cannabis plant. Most of the biological properties attributed to phytocannabinoids are dependent on their interactions with the ECS in humans. Currently, more than 70 different phytocannabinoids have been discovered, but only a few of the major ones have been characterized in depth, primarily delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). (8)
THC is a main bioactive component of cannabis and is the main psychoactive ingredient in the plant. THC appears to possess anti-inflammatory, analgesic, muscle relaxant, neuro-antioxidative, and anti-spasmodic activities. THC has demonstrated efficacy in treating neuropathic pain and in reducing muscle spasms. THC may also act as a neuroprotectant via various mechanisms, potentially playing a beneficial role in several neurodegenerative disorders such as ALS and Alzheimer’s. Forms of synthetic THC have been approved for treatment of chemotherapy induced nausea and vomiting and for AIDS related anorexia. (3,7)
CBD is the major non-psychotropic cannabinoid found in cannabis. CBD has been shown to antagonize the undesirable effects of THC, such as intoxication, sedation, and tachycardia, while enhancing the analgesic and anti-emetic properties of THC. CBD has been proposed to possess anticonvulsant, anti-inflammatory, anti-cancer and neuroprotective properties. 9,10 Clinical studies have demonstrated very promising results in various epilepsy syndromes. (11,12)
The efficacy of cannabis in pain syndromes, including cancer related pain and neuropathic pain, makes it a promising alternative or adjunct to opioids. A lethal overdose from cannabis and cannabinoids has not been documented, primarily because cannabinoid receptors, unlike opioid receptors, are not located in the brainstem areas controlling respiration. (13,14,15,16) The addictive potential of cannabinoids is considerably lower than that of other prescribed agents or substances of abuse. (14,15,16) In states that have legalized medical cannabis, opioid overdose mortality rates have decreased by about 25% in one year and by about 33% after 3-5 years. (17)
Federal Stance
The federal government allows states to regulate the use of cannabis within their territories. The U.S. Department of Justice (DOJ) has issued guidance to state level District Attorneys not to prosecute those who follow state law. Additionally, in August 2016, the 9th Circuit Court of Appeals ruled that the DOJ cannot expend funds to prosecute people who violate federal drug laws but are in compliance with state medical marijuana laws.
State Regulations
Starting January 3, 2017, medical cannabis may be ordered for individuals with any of the following conditions: cancer, epilepsy, glaucoma, HIV, AIDS, PTSD, ALS, Crohn’s disease, Parkinson’s disease, multiple sclerosis, or other debilitating medical conditions for which a physician believes that the medical use of marijuana would likely outweigh the potential health risks for a patient.
Physicians must complete an 8 hour CME course presented by the FMA and FOMA, maintain an active physician–patient relationship for three months preceding the order, and provide written consent. The order must include dosage, route of administration and cannot exceed a 45-day supply. Additionally, the ordering physician must submit a patient treatment plan to the University of Florida College of Pharmacy. Smoking is not allowed and there are restrictions on use in public places. (For more information visit http://flhealthsource.gov/ocu/).
Summary
The passage of medical cannabis legislation across the country has garnered a great deal of attention. It’s imperative for physicians to remain up to date on the latest clinical data and regulatory requirements to ensure patients receive accurate and helpful information and to implement best practices when incorporating cannabis into patient care.
On November 8, 2016, Florida voters approved the Florida Medical Marijuana Legalization Initiative, known as Amendment 2. Amendment 2 amends the Florida Constitution allowing those with a “debilitating medical condition,” which includes, among other diseases, cancer, epilepsy, glaucoma, HIV/AIDS, multiple sclerosis, and “other debilitating medical conditions of the same kind or class as or comparable to those enumerated” to use medical marijuana (cannabis) for medical purposes if recommended by their physician.
While cannabis now has an accepted and expanded medical use in Florida, physicians should keep in mind that marijuana remains listed as a Schedule I drug and has no accepted medical use under federal law.
Despite the efforts of a majority of states to legalize medical marijuana, the federal Drug Enforcement Administration recently reaffirmed its position by refusing to reclassify marijuana as a Schedule I substance under the Controlled Substances Act (“CSA”). Nevertheless, the current Administration’s enforcement policy limits the prosecution of CSA violations, provided an individual has complied with state law and the state has implemented a strong and effective regulatory system to address threats that would undermine federal enforcement priorities. Although Amendment 2 does not shield physicians from any federal violations for prescribing a controlled substance, careful compliance with the requirements for recommending medical cannabis will provide immunity under Florida law. While compliance with the law will not trigger civil or criminal sanctions, the laws relating to professional negligence and malpractice still apply.
With the approval of Amendment 2, Florida continues to expand the lawful use of medical cannabis. Amendment 2 authorizes the legislature and Department of Health’s Office of Compassionate Use (“OCU”) to create a system for manufacturing, dispensing, and possessing medical cannabis. The OCU will have six months after the effective date of January 3, 2017 to pass certain regulations governing medical cannabis, and within nine months must begin issuing identification cards to qualifying patients and caregivers and registering “Medical Marijuana Treatment Centers.” In preparation for the implementation of Amendment 2 and the expansion of Florida’s medical marijuana industry, Florida physicians should begin preparing for the upcoming changes that will undoubtedly affect their practice. As a basis, physicians should read the OCU’s bi-weekly updates on implementations and independently educate themselves on the therapeutic benefits and health risks associated with the medical use of cannabis.
In 2014, the legislature enacted the Compassionate Medical Cannabis Act, which authorizes approved dispensing organizations to manufacture and sell “low-THC cannabis” for medical use by qualifying patients. The legislature expanded this law earlier this year to allow terminally ill patients to access medical cannabis without limitations on THC concentration. Under the current law, qualifying physicians recommending low-THC cannabis or medical cannabis must, among other requirements, (i) complete an eight-hour CME course and pass an examination (ii) add his or her qualifying patient to the state’s compassionate use registry, (iii) order the specified amount of low-THC cannabis or medical cannabis from an authorized dispensing organization, and (iv) maintain and submit a treatment plan for each patient to the University of Florida College of Pharmacy. Since the Florida legislature and OCU spent over one year developing this regulatory scheme, it is expected that the physician certification procedures under Amendment 2 will be relatively consistent with the current model, although they are subject to alterations.
Physicians who chose to participate in Florida’s expanding medical marijuana industry by incorporating cannabis into their patients’ treatment regimens must navigate through an emerging area of medicine and law that requires careful attention to how cannabis impacts the standard of care. Recommending medical marijuana to patients will open up compliance and liability considerations, so it is beneficial to consult with competent regulatory compliance counsel to advise on the laws and regulatory requirements, so that you, as Florida physicians, can fulfill your Hippocratic Oath by focusing your attention on how to best treat and care for your patients.