- Email: [email protected]
Cannabis & ENT: State certification—An expanding yet unregulated system
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Cannabis & ENT: State certification—An expanding yet unregulated system☆ William L. Valentinoa, Brian J. McKinnonb, a b
⁎
Department of Surgery, Temple University Hospital, United States of America Department of Otolaryngology - Head and Neck Surgery, UTMB Health, United States of America
A R T I C LE I N FO
A B S T R A C T
Keywords: Cannabis Certification Qualifying conditions State laws Approval process
Objectives: 1) Ascertain the status of cannabis legalization by state, 2) Explore the process required to obtain cannabis credentials for both the patient and the physician, 3) Determine the level of interest of otolaryngologists in the medicinal cannabis, and 4) Explore possible research directions into efficacy and potential complications. Study design: Descriptive study. Methods: Internet searches were conducted to identify each state's Medical Cannabis Program website. The qualifying conditions, list of approved-practitioners, process required for both practitioners and patients for approval were noted. Lists of approved practitioners were analyzed to determine the prevalence of board-certified otolaryngologists. Results: Of the 33 states that authorize medicinal cannabis, eight provide lists of approved-practitioners, six of which provide specialty information. A total of 24 Otolaryngologists can be found of the 5944 physicians on these six lists. All otolaryngologists were located in highly-populated metropolitan areas with a mean number of 29.9 years in practice. Significant variations exist between each state including legal definitions and qualifying conditions. Conclusions: Lack of consistent regulation across the country drives uncertainty regarding the adoption of medicinal cannabis. Very few otolaryngologists in the country are registered to certify patients for medical cannabis. While the medicinal use of cannabis may currently have limited applications within otolaryngology, many areas that have yet to be explored.
1. Introduction Cannabis (marijuana) is the most commonly used illicit drug in the world and its use continues to increase while the use of most other illegal substances (such as cocaine, methamphetamine, and benzodiazepines) have plateaued [1]. In the last decade, cannabis has seen increases in popularity due to its perceived potential as a therapy. Numerous legislative efforts at decriminalizing its use have succeeded. Many preclinical and clinical studies have published potential benefits cannabis may have on ailments including, but not limited to, nausea and vomiting secondary to chemotherapy [2], chronic pain [3], appetite stimulation [4], glaucoma [5], the multiple sequelae of multiple sclerosis [6], and even the antineoplastic activity of cannabinoids on gliomas [7]. There are also reports linking cannabis to increased risk of addiction [8], motor vehicle accidents (with short and long term use) [9], anxiety and depression [10], neuropsychological decline when
used in childhood [11], and mounting evidence for the increased risk of later psychotic disorders [12]. Is there sufficient evidence to have a consensus on cannabis' therapeutic potential? The National Academies of Sciences, Engineering, and Medicine (NASEM) published a book in 2017 reviewing the current evidence on the health effects of cannabis and cannabinoids. They concluded only three conditions with conclusive or substantial evidence that cannabis or cannabinoids are effective for. These conditions are 1) cannabis for the treatment of chronic pain in adults, 2) oral cannabinoids as antiemetics in the treatment of chemotherapy-induced nausea and vomiting, and 3) oral cannabinoids for the improvement of patientreported multiple sclerosis spasticity symptoms. All other conditions evaluated either have limited evidence for effectiveness or insufficient evidence to support or refute effectiveness [13]. It is important to recognize that cannabis is not a single drug in the pharmacologic sense of the word. Over one thousand distinct molecules
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Presented at the Triological Combined Sections Meeting, January 23–25, 2020. Corresponding author at: Department of Otolaryngology-Head and Neck Surgery, UTMB Health, 301 University Blvd., Galveston, TX 77555-0521, United States of America. E-mail address: [email protected] (B.J. McKinnon). ⁎
https://doi.org/10.1016/j.amjoto.2020.102459 Received 8 March 2020 0196-0709/ © 2020 Elsevier Inc. All rights reserved.
Please cite this article as: William L. Valentino and Brian J. McKinnon, Am J Otolaryngol, https://doi.org/10.1016/j.amjoto.2020.102459
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that also noted each of their specialties were then used to determine the total number physician-providers and the number of Otolaryngologists that were approved to certify patients for medical cannabis use. State websites with a list of providers without each provider's medical specialty were contacted via email to have this information provided. All Otolaryngologists were verified by the American Board of Otolaryngology (ABO) online credential verification system or by their respective state's medical licensure verification system. Both verification systems provide the year of primary certification which was used to determine each Otolaryngologists' number of years in practice. After verification, the name and location of every Otolaryngologist was put into an internet search to determine if they were affiliated with an academic practice. Using the addresses provided on the state's list of approved providers, the location of these Otolaryngologists was determined to be either rural or urban areas. This was accomplished by utilizing the United States Department of Agriculture – Economic Research Service (USFDAERS) definitions of urban and rural using Rural-Urban Commuting Area Codes (RUCAs). RUCAs classify U.S. Census Tracts utilizing measures of population density, urbanization, and daily commuting. It is often used in various types of health related research and program development and implementation [19]. First, the provided address of each Otolaryngologist was entered into the FFIEC Geocoding System in order to obtain its associated census tract [20]. The census tract was then searched for using the Microsoft Excel sheet provided by the USFDAERS to find the corresponding RUCA [21]. The data herein corresponds to the most recently available RUCA data (year 2010), which is updated every decade. The USFDA-ERS defines RUCA-1 as a metropolitan area core and a RUCA-2 as a metropolitan area with high commuting; RUCA10 is used as the definition of rural [22]. Furthermore, all census tracts were cross-referenced through the Rural Health Grants Eligibility Analyzer (maintained by the Health and Resources Administration, an agency of the U.S. Department of Health and Human Services) [23]. This tool that can be used by healthcare providers to determine if they are located in a geographic area defined as rural and, thus, eligible to apply for Rural Health Grants.
have been described to be found in the plant species Cannabis sativa, including terpenes, phenolic compounds, and nearly one hundred distinct cannabinoids [14]. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the most well-known cannabinoids. Cannabis is, at the time of this writing, classified as a Schedule I illegal substance according to the federal government; however, individual states have created laws for the limited medicinal and recreational use of cannabis, resulting in a patchwork of laws across the country. Two studies (both published in 2017) could be found which presented the legal differences across states including the qualifying diseases, patient protections against privacy and discrimination, product safety testing, package/label regulations, and the regulation of dispensaries [15,16]. Although one study has revealed patients' general experiences while obtaining medical cannabis [17], no studies could be found on the actual process required for patients and providers and the variations of this that exists across the country. There are distinct medical specialties adopting the use of medical cannabis (including pain specialists, palliative care physicians, and neurologists), though for other specialties it is unclear. The authors have previously written a literature review of the use of medical cannabis within the field of Otolaryngology. The majority were published in the last decade and pertain to the subspecialty of Head and Neck; specifically, its association with incident cancers [18]. There were no studies found on the prevalence of cannabis-approved Otolaryngologists and thus the level of interest the field has on its use. The objectives of this study are to 1) determine the state of cannabis legalization in order to further elucidate how physicians across the country perceive its use, 2) explore the process required to obtain cannabis credentials for both the patient and the physician, 3) determine the level interest Otolaryngologists may have in the medical use of cannabis, and 4) explore research directions the field can take in order to gain more insight into efficacy and potential complications. 2. Materials and methods The Drexel University Institutional Review Board concluded this research endeavor to not require approval involve human subjects plus the data utilized was not protected and publicly available. All online information presented herein was accessed between March 17, 2019 and April 5, 2019. Using each state's official government websites, it was first determined which states had legalized the use of cannabis for medicinal purposes (see Appendix A for a list of each state's Medical Marijuana Program website). When available, both the approval process for patients and providers was reviewed for these states. The list of qualifying conditions and a list of providers was identified on each website and documented. Those with a list of providers
3. Results As of March 2019, thirty-three states and the District of Columbia had comprehensively legalized cannabis for medicinal purposes. Fourteen states only permit cannabis with very low THC:CBD ratios for medical use. Three states (Idaho, Nebraska, South Dakota) prohibit any use of any form of cannabis. See Fig. 1 for the trend over legalization over time in the U.S. The typical process for a patient to receive cannabis for a medical
Fig. 1. Number of states with medical or recreational cannabis laws over time. Shaded circle = number of states with medical laws. Unshaded triangle = number of states with recreational laws. 2
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departments for this information. The authors received no response from two but were referred to the Cincinnati Enquirer by the Ohio Medical Marijuana Control Program. The Cincinnati Enquirer merged the approved provider list with the active state license roster to create a database that allows users to search by specialty as well as use an interactive map to find the nearest physician [28]. This merged list was first published in December 2018 and it is updated monthly. Therefore, of the six states with specialty information, there are 5944 physicians. A total of 24 Otolaryngologists, verified through either the ABO or state licensure system, are among these six lists. Therefore, ENTs make up approximately 0.4% of the total approved physicians. All but one of these Otolaryngologists is in private practice. The number of years since primary board certification ranged from 6 to 44 years with a mean and median of 29.875 and 31.5, respectively. All but two of the 24 ENT physicians are in a RUCA-1 area; the former two are in RUCA-2 areas. As none of the hospitals or practices for the identified ENT physicians was listed in a rural setting, none were eligible for Rural Health Grants. The patient certification process by the practitioner has the same concept with slight variations among states. Firstly, a “bona-fide” relationship must exist between the patient and practitioner with some states even requiring a minimum number of visits over a minimum course of time (months to years). Once a relationship has been established, the practitioner must perform a formal, in-person exam within a specified time frame of the patient's application for state registration (often six months). All 33 states require a patient to have a qualifying condition, except for Oklahoma and the District of Columbia. The state of Oklahoma requires that “the physician has determined the presence of a medical condition(s) for which the patient/applicant is likely to receive therapeutic or palliative benefit from use of medical marijuana” [29]. The form physicians fill out has an optional section to list the patient's conditions as ICD-10 Codes [30]. The District of Columbia passed an emergency amendment on Jul 29, 2014 to expand the definition of a qualifying medical condition to be “any condition for which treatment with medical marijuana would be beneficial, as determined by the patient's physician” [31]. Table 1 details the number of conditions accepted by state, Table 2 details a list of conditions approved in the majority of states, and Table 3 details a list of conditions approved in five states of less. Many states have avenues available to add conditions to their state's list; some allow the public to submit petitions, others only allow providers. All states require patients to renew their certification, with their provider, either every year or every two years.
Table 1 Number of approved conditions, by state. State
Total number of approved conditions a
Washington D.C. Oklahoma Illinois New Mexico Connecticut Michigana Minnesota New Hampshire Ohio Missouri Pennsylvania New Jersey Arkansas Louisiana New York Utah North Dakota Rhode Island Delaware West Virginia Montana Arizona Hawaii Mainea Vermonta Washingtona Californiaa Florida Maryland Massachusettsa Oregona Coloradoa Nevadaa Alaskaa a
Any Any 40 31 30 29 25 25 23 22 22 20 19 19 18 17 16 16 15 15 14 13 13 13 13 12 11 11 11 11 10 9 9 8
State also has legalized recreational cannabis.
condition is to register with the state, get certified by an approved practitioner, pay for an ID card, then go to a state-run dispensary where a Dispensary Technician (also known as a “budtender”) [24] will recommend the strain, dose, and formulation. Budtenders complete online modules from various companies like the Cannabis Training Institute [25], Green CulturED [26], or Trichome Institute [27] to learn their operational and medicinal responsibilities. Patients are then required to follow their state's laws of the maximum amount they can possess at one time, if public use is allowed, if and how much they are allowed to grow, and to never distribute or sell the cannabis to anyone else. Many states define a practitioner as a physician with either a M.D. or D.O. degree; however, there are several states that include physician assistants and advanced practice nurses. There are also a few states that list various other healthcare providers such as dentists, podiatrists, naturopaths, and chiropractors. In order to qualify as an approved practitioner, one must register with the state which may require a two to eight-hour course. There are a few states that do not even require practitioners to be approved; these states' certifications have physicians merely “verify” the patient has a condition that is on the qualifying list rather than having physicians “recommend” cannabis for medical use. Of the 33 states that have legalized the use of cannabis for medicinal purposes, eight have a list of approved practitioners on their respective government websites and two more states express lists to be posted soon. All other state websites either do not mention a list, recommend patients find a physician on their own, or instruct patients to speak with their current physician. It is important to note, though, that many states only list provider information with their permission. A total of 6498 physician-providers can be found on the eight lists available, ranging from 43 to 2114 for each state. Five of the eight lists provide the physicians' specialty. The authors reached out to the other three state
4. Discussion This study provides indirect evidence that Otolaryngologists have not embraced the medicinal use of cannabis, with 0.4% of physicians approved indicated as Otolaryngologists. Based on the available information [32], the authors can conservatively estimate that less than 2% of Otolaryngologists are approved to recommend the medicinal use of cannabis. Table 2 Conditions approved in majority of states. Cancer HIV/AIDS Seizuresa Glaucoma Cachexia or wasting syndrome Post-traumatic stress disorder Amyotrophic lateral sclerosis Crohn's disease Severe and persistent muscle spasmsb Severe nausea a b
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Including those characteristic of, but not limited to, epilepsy. Including those characteristic of, but not limited to, multiple sclerosis.
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better defined. However, there is there danger of anecdotal experience being considered evidence of benefit. More alarming is the dissemination of unsupported claims made by some to vulnerable patients who have exhausted conventional. Since September 2017, the FDA has issued warning letters for nearly 500 websites. The most recent websites to come under scrutiny markets CBD oils for pets and for conditions such as age-related dementia [41]. The mislabeling of cannabis and its extracts in both retail stores and state dispensaries is an emerging concern. Vandrey et al. analyzed 75 edible products sold in three different West Coast cities and determined 17% were accurately labeled, 23% were under-labeled, and 60% were over-labeled with respect to THC content [42]. This variation may reflect the different boiling points of THC and CBD (157 °C and 170 °C, respectively) [43]. Undercooking or overcooking edibles may result in decreased or increased levels of the compounds. Some states have laboratory regulations ensure the biochemical contents of products. However, Jikomes et al. found the inter-laboratory differences within the state of Washington varied significantly, underscoring the need for standardized laboratory methodologies across the industry [44]. Finally, those that recommend the strain, dosage, and formulation to patients at dispensaries (budtenders) were surveyed and found that only 55% received formal training for their position and only 20% had medical/scientific training. Furthermore, while many dispensary staff made recommendations consistent with current evidence, some recommended cannabis that has either not been shown effective for, or could even exacerbate, a patient's condition [45].
Table 3 Conditions approved in five states or less. Fibromyalgia Nail-Patella syndrome Migraine Severe arthritisa Lupus Obstructive sleep apnea Cerebral palsy Severe psoriasis Complex regional pain syndromeb Cystic fibrosis Osteogenesis imperfecta Interstitial cystitis Post-concussion syndrome Sjogren's syndrome Obsessive compulsive disorder Chronic pancreatitis Chronic traumatic encephalopathy a b
Including, but not limited to, rheumatoid arthritis. Previously known as reflex sympathetic dystrophy.
Physicians may choose not to embrace medical cannabis for numerous reasons, including the lack of further research, the unregulated market patients must use, and the simple fact that cannabis remains illegal under federal law. The authors found the available Otolaryngologists that are approved for patient certification of medical cannabis are in metropolitan areas. Access to medical cannabis varies considerably across the country. Patients must register with the state and provide a recommendation from a provider, which is defined differently depending on the state. This recommendation could be as simple as verifying a patient has a condition on the list of qualifying conditions or attesting that the patient has essentially run out of conventional treatment options and medical cannabis could provide benefit. The approved conditions vary substantially around the country as well. Some remain highly regulated and list ten or fewer conditions while others have dozens. All this evidence points to a need for broad regulation that is based on the evidence. For example, there are three states that have Obstructive Sleep Apnea on the list of approved conditions, yet the American Academy of Sleep Medicine has publicly announced that states should exclude this condition from their lists due to unreliable delivery methods and insufficient evidence of effectiveness [33]. To demonstrate how quickly the landscape can change, in 2017, the National Academies of Sciences, Engineering, and Medicine (NASEM) concluded that “there is insufficient evidence to support or refute the conclusion that cannabinoids are an effective treatment for epilepsy” [13]. In June 2018, the FDA approved Epidiolex®, a synthetic cannabinoid for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years and older [34] after randomized controlled trials demonstrated its efficacy [35,36]. In contradistinction to the evidence for a narrow role for medical cannabis, social acceptance of cannabis is increasing. Canada became the second entire nation to legalize cannabis (October 2018) [37], second to Uruguay (December 2013) [38]. Ramo et al. revealed hundreds of mobile apps for Apple and Android devices after searching the stores using the terms “cannabis” or “marijuana”; the most common content was informational (facts, strain classification) [39]. Even large companies can't ignore the increasing hype. Coca-Cola® stated on September 17, 2018 “We have no interest in marijuana or cannabis. Along with many others in the beverage industry, we are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world. The space is evolving quickly. No decisions have been made at this time” [40]. As evidence continues to evolve, the medical effects will become
5. Conclusions In addition to the concepts that Bryant et al. [46] offers in the realms of pain, inflammation, and cancer for the Otolaryngologic patients we would like to propose additional discussions for the field. Considering the evidence for the potential cannabis has on spastic conditions, as Otolaryngologists, we wonder of its efficacy in spasmodic dysphonia or other movement disorders like hemifacial spasm, oromandibular dystonia, and spasmodic torticollis. Also, while there currently may not be enough sufficient evidence for the use of cannabis for neuropathies, potentially there is a place for cannabis in the treatment of trigeminal neuralgia, vestibular/auditory neuropathy, Bell's Palsy, Frey's syndrome and Eagle syndrome. The rapidly changing landscape makes it difficult for physicians to keep up. Furthermore, the lack of broad regulation across the country adds to the uncertainty of a substance that has become so popular among the public. Every state has its own set of definitions for qualified patients, providers, and conditions. The level of interest physicians have across the country varies by specialty, particularly due to the potential conditions it could be used for. Our study has shown that very few Otolaryngologists in the country are registered to certify patients for medical cannabis; however, not all states list providers nor require providers to be registered. While the medicinal use of cannabis, on its surface, may not seem to apply to the field of Otolaryngology, there are many areas that have yet to be explored. Physicians are more commonly being asked about cannabis in the office. No matter what your opinion is on cannabis, for its recreational or medicinal use, we are still vital intermediaries for patients' access to evidence-based medicine. Funding and conflicts of interest There is no funding or conflicts of interest to report. Level of evidence Not applicable; not human research.
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Appendix A
State
Website
Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Hawaii Illinois Louisiana Maine Maryland Massachusetts Michigan Minnesota Missouri Montana Nevada New Hampshire New Jersey New Mexico New York North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island Utah Vermont Washington West Virginia Washington D.C.
http://dhss.alaska.gov/dph/vitalstats/pages/marijuana.aspx https://www.azdhs.gov/licensing/medical-marijuana/index.php https://www.healthy.arkansas.gov/programs-services/topics/medical-marijuana https://www.cdph.ca.gov/Programs/CHSI/Pages/MMICP.aspx https://www.colorado.gov/pacific/cdphe/medicalmarijuana https://portal.ct.gov/DCP/Medical-Marijuana-Program/Medical-Marijuana-Program https://dhss.delaware.gov/dph/hsp/medmarhome.html http://knowthefactsmmj.com/ http://health.hawaii.gov/medicalcannabisregistry/ http://www.dph.illinois.gov/topics-services/prevention-wellness/medical-cannabis http://www.legis.la.gov/legis/law.aspx?d=96986 https://www.maine.gov/dafs/bbm/mmmp/home https://mmcc.maryland.gov/Pages/home.aspx https://www.mass.gov/orgs/medical-use-of-marijuana-program https://www.michigan.gov/lara/0,4601,7-154-89334_79571—,00.html https://www.health.state.mn.us/people/cannabis/index.html https://health.mo.gov/safety/medical-marijuana/ https://dphhs.mt.gov/marijuana http://dpbh.nv.gov/Reg/MM-Patient-Cardholder-Registry/MM_Patient_Cardholder_Registry_-_Home/ https://www.dhhs.nh.gov/oos/tcp/ https://www.nj.gov/health/medicalmarijuana/ https://nmhealth.org/about/mcp/svcs/ https://www.health.ny.gov/regulations/medical_marijuana/ https://www.ndhealth.gov/mm/ https://www.medicalmarijuana.ohio.gov/ http://omma.ok.gov/ https://www.oregon.gov/oha/PH/DiseasesConditions/ChronicDisease/MedicalMarijuanaProgram/Pages/index.aspx https://www.health.pa.gov/topics/programs/Medical%20Marijuana/Pages/Medical%20Marijuana.aspx http://www.health.ri.gov/programs/detail.php?pgm_id=150 https://health.utah.gov/medical-cannabis https://medicalmarijuana.vermont.gov/ https://www.doh.wa.gov/YouandYourFamily/Marijuana/MedicalMarijuana https://dhhr.wv.gov/bph/Pages/Medical-Cannabis-Program.aspx https://dchealth.dc.gov/service/medical-marijuana-and-integrative-therapy
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[24] The Cannabis Reporter. What you need to know about becoming a budtender. https://www.thecannabisreporter.com/want-budtender/. Accessed March 31, 2019. [25] Cannabis Training Institute. Dispensary technician certification course. https:// cannabistraininginstitute.com/course-catalog/medical-cannabis-education/ dispensary-course-product/. Accessed March 31, 2019. [26] Green CulturED. Cannabis College. https://www.greencultured.co/ cannabiscollege/152/. Accessed March 31, 2019. [27] Trichome Institute. Cannabis Products and Sales Training. https:// trichomeinstitute.com/cpst. Accessed March 31, 2019. [28] Borchardt J, Pilcher J. Where to find an Ohio doctor who can recommend medical marijuana. Cincinnati Enquirer. https://www.cincinnati.com/story/news/2018/12/ 11/where-ohios-medical-marijuana-doctors-heres-map/2271076002/. Published March 14, 2019. Accessed March 28, 2019. [29] Oklahoma State Dept. of Health - Title 310, Chapter 681: medical marijuana control program. https://www.ok.gov/health2/documents/310-681%20Permanent %20Medical%20Marijuana%20Packet.pdf. Accessed March 25, 2019. [30] Oklahoma Medical Marijuana Authority. Physician recommendation form. http:// omma.ok.gov/Websites/ddeer/images/Application%20Information/OMMA%20-% 20Adult%20Patient_Physician%20Recommendation%20Form.pdf. [31] Code of the District of Columbia - Title 7, Chapter 16B: use of marijuana for medical treatment (§ 7–1671.01.). https://code.dccouncil.us/dc/council/code/titles/7/ chapters/16B/. Accessed March 25, 2019. [32] Hughes CA, McMenamin P, Mehta V, Pillsbury H, Kennedy D. Otolaryngology workforce analysis. Laryngoscope. 2016;126(Suppl. 9):S5–11. https://doi.org/10. 1002/lary.26238. [33] Ramar K, Rosen IM, Kirsch DB, et al. Medical cannabis and the treatment of obstructive sleep apnea: an American Academy of Sleep Medicine position statement. J Clin Sleep Med 2018;14(4):679–81. https://doi.org/10.5664/jcsm.7070. [34] FDA News & Events. https://www.fda.gov/newsevents/newsroom/ pressannouncements/ucm611046.htm. Published June 25, 2018. Accessed April 4, 2019. [35] Thiele EA, Marsh ED, French JA, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391(10125):1085–96. https://doi.
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Contents lists available at ScienceDirect
Am J Otolaryngol journal homepage: www.elsevier.com/locate/amjoto
Cannabis & ENT: State certification—An expanding yet unregulated system☆ William L. Valentinoa, Brian J. McKinnonb, a b
⁎
Department of Surgery, Temple University Hospital, United States of America Department of Otolaryngology - Head and Neck Surgery, UTMB Health, United States of America
A R T I C LE I N FO
A B S T R A C T
Keywords: Cannabis Certification Qualifying conditions State laws Approval process
Objectives: 1) Ascertain the status of cannabis legalization by state, 2) Explore the process required to obtain cannabis credentials for both the patient and the physician, 3) Determine the level of interest of otolaryngologists in the medicinal cannabis, and 4) Explore possible research directions into efficacy and potential complications. Study design: Descriptive study. Methods: Internet searches were conducted to identify each state's Medical Cannabis Program website. The qualifying conditions, list of approved-practitioners, process required for both practitioners and patients for approval were noted. Lists of approved practitioners were analyzed to determine the prevalence of board-certified otolaryngologists. Results: Of the 33 states that authorize medicinal cannabis, eight provide lists of approved-practitioners, six of which provide specialty information. A total of 24 Otolaryngologists can be found of the 5944 physicians on these six lists. All otolaryngologists were located in highly-populated metropolitan areas with a mean number of 29.9 years in practice. Significant variations exist between each state including legal definitions and qualifying conditions. Conclusions: Lack of consistent regulation across the country drives uncertainty regarding the adoption of medicinal cannabis. Very few otolaryngologists in the country are registered to certify patients for medical cannabis. While the medicinal use of cannabis may currently have limited applications within otolaryngology, many areas that have yet to be explored.
1. Introduction Cannabis (marijuana) is the most commonly used illicit drug in the world and its use continues to increase while the use of most other illegal substances (such as cocaine, methamphetamine, and benzodiazepines) have plateaued [1]. In the last decade, cannabis has seen increases in popularity due to its perceived potential as a therapy. Numerous legislative efforts at decriminalizing its use have succeeded. Many preclinical and clinical studies have published potential benefits cannabis may have on ailments including, but not limited to, nausea and vomiting secondary to chemotherapy [2], chronic pain [3], appetite stimulation [4], glaucoma [5], the multiple sequelae of multiple sclerosis [6], and even the antineoplastic activity of cannabinoids on gliomas [7]. There are also reports linking cannabis to increased risk of addiction [8], motor vehicle accidents (with short and long term use) [9], anxiety and depression [10], neuropsychological decline when
used in childhood [11], and mounting evidence for the increased risk of later psychotic disorders [12]. Is there sufficient evidence to have a consensus on cannabis' therapeutic potential? The National Academies of Sciences, Engineering, and Medicine (NASEM) published a book in 2017 reviewing the current evidence on the health effects of cannabis and cannabinoids. They concluded only three conditions with conclusive or substantial evidence that cannabis or cannabinoids are effective for. These conditions are 1) cannabis for the treatment of chronic pain in adults, 2) oral cannabinoids as antiemetics in the treatment of chemotherapy-induced nausea and vomiting, and 3) oral cannabinoids for the improvement of patientreported multiple sclerosis spasticity symptoms. All other conditions evaluated either have limited evidence for effectiveness or insufficient evidence to support or refute effectiveness [13]. It is important to recognize that cannabis is not a single drug in the pharmacologic sense of the word. Over one thousand distinct molecules
☆
Presented at the Triological Combined Sections Meeting, January 23–25, 2020. Corresponding author at: Department of Otolaryngology-Head and Neck Surgery, UTMB Health, 301 University Blvd., Galveston, TX 77555-0521, United States of America. E-mail address: [email protected] (B.J. McKinnon). ⁎
https://doi.org/10.1016/j.amjoto.2020.102459 Received 8 March 2020 0196-0709/ © 2020 Elsevier Inc. All rights reserved.
Please cite this article as: William L. Valentino and Brian J. McKinnon, Am J Otolaryngol, https://doi.org/10.1016/j.amjoto.2020.102459
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that also noted each of their specialties were then used to determine the total number physician-providers and the number of Otolaryngologists that were approved to certify patients for medical cannabis use. State websites with a list of providers without each provider's medical specialty were contacted via email to have this information provided. All Otolaryngologists were verified by the American Board of Otolaryngology (ABO) online credential verification system or by their respective state's medical licensure verification system. Both verification systems provide the year of primary certification which was used to determine each Otolaryngologists' number of years in practice. After verification, the name and location of every Otolaryngologist was put into an internet search to determine if they were affiliated with an academic practice. Using the addresses provided on the state's list of approved providers, the location of these Otolaryngologists was determined to be either rural or urban areas. This was accomplished by utilizing the United States Department of Agriculture – Economic Research Service (USFDAERS) definitions of urban and rural using Rural-Urban Commuting Area Codes (RUCAs). RUCAs classify U.S. Census Tracts utilizing measures of population density, urbanization, and daily commuting. It is often used in various types of health related research and program development and implementation [19]. First, the provided address of each Otolaryngologist was entered into the FFIEC Geocoding System in order to obtain its associated census tract [20]. The census tract was then searched for using the Microsoft Excel sheet provided by the USFDAERS to find the corresponding RUCA [21]. The data herein corresponds to the most recently available RUCA data (year 2010), which is updated every decade. The USFDA-ERS defines RUCA-1 as a metropolitan area core and a RUCA-2 as a metropolitan area with high commuting; RUCA10 is used as the definition of rural [22]. Furthermore, all census tracts were cross-referenced through the Rural Health Grants Eligibility Analyzer (maintained by the Health and Resources Administration, an agency of the U.S. Department of Health and Human Services) [23]. This tool that can be used by healthcare providers to determine if they are located in a geographic area defined as rural and, thus, eligible to apply for Rural Health Grants.
have been described to be found in the plant species Cannabis sativa, including terpenes, phenolic compounds, and nearly one hundred distinct cannabinoids [14]. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the most well-known cannabinoids. Cannabis is, at the time of this writing, classified as a Schedule I illegal substance according to the federal government; however, individual states have created laws for the limited medicinal and recreational use of cannabis, resulting in a patchwork of laws across the country. Two studies (both published in 2017) could be found which presented the legal differences across states including the qualifying diseases, patient protections against privacy and discrimination, product safety testing, package/label regulations, and the regulation of dispensaries [15,16]. Although one study has revealed patients' general experiences while obtaining medical cannabis [17], no studies could be found on the actual process required for patients and providers and the variations of this that exists across the country. There are distinct medical specialties adopting the use of medical cannabis (including pain specialists, palliative care physicians, and neurologists), though for other specialties it is unclear. The authors have previously written a literature review of the use of medical cannabis within the field of Otolaryngology. The majority were published in the last decade and pertain to the subspecialty of Head and Neck; specifically, its association with incident cancers [18]. There were no studies found on the prevalence of cannabis-approved Otolaryngologists and thus the level of interest the field has on its use. The objectives of this study are to 1) determine the state of cannabis legalization in order to further elucidate how physicians across the country perceive its use, 2) explore the process required to obtain cannabis credentials for both the patient and the physician, 3) determine the level interest Otolaryngologists may have in the medical use of cannabis, and 4) explore research directions the field can take in order to gain more insight into efficacy and potential complications. 2. Materials and methods The Drexel University Institutional Review Board concluded this research endeavor to not require approval involve human subjects plus the data utilized was not protected and publicly available. All online information presented herein was accessed between March 17, 2019 and April 5, 2019. Using each state's official government websites, it was first determined which states had legalized the use of cannabis for medicinal purposes (see Appendix A for a list of each state's Medical Marijuana Program website). When available, both the approval process for patients and providers was reviewed for these states. The list of qualifying conditions and a list of providers was identified on each website and documented. Those with a list of providers
3. Results As of March 2019, thirty-three states and the District of Columbia had comprehensively legalized cannabis for medicinal purposes. Fourteen states only permit cannabis with very low THC:CBD ratios for medical use. Three states (Idaho, Nebraska, South Dakota) prohibit any use of any form of cannabis. See Fig. 1 for the trend over legalization over time in the U.S. The typical process for a patient to receive cannabis for a medical
Fig. 1. Number of states with medical or recreational cannabis laws over time. Shaded circle = number of states with medical laws. Unshaded triangle = number of states with recreational laws. 2
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departments for this information. The authors received no response from two but were referred to the Cincinnati Enquirer by the Ohio Medical Marijuana Control Program. The Cincinnati Enquirer merged the approved provider list with the active state license roster to create a database that allows users to search by specialty as well as use an interactive map to find the nearest physician [28]. This merged list was first published in December 2018 and it is updated monthly. Therefore, of the six states with specialty information, there are 5944 physicians. A total of 24 Otolaryngologists, verified through either the ABO or state licensure system, are among these six lists. Therefore, ENTs make up approximately 0.4% of the total approved physicians. All but one of these Otolaryngologists is in private practice. The number of years since primary board certification ranged from 6 to 44 years with a mean and median of 29.875 and 31.5, respectively. All but two of the 24 ENT physicians are in a RUCA-1 area; the former two are in RUCA-2 areas. As none of the hospitals or practices for the identified ENT physicians was listed in a rural setting, none were eligible for Rural Health Grants. The patient certification process by the practitioner has the same concept with slight variations among states. Firstly, a “bona-fide” relationship must exist between the patient and practitioner with some states even requiring a minimum number of visits over a minimum course of time (months to years). Once a relationship has been established, the practitioner must perform a formal, in-person exam within a specified time frame of the patient's application for state registration (often six months). All 33 states require a patient to have a qualifying condition, except for Oklahoma and the District of Columbia. The state of Oklahoma requires that “the physician has determined the presence of a medical condition(s) for which the patient/applicant is likely to receive therapeutic or palliative benefit from use of medical marijuana” [29]. The form physicians fill out has an optional section to list the patient's conditions as ICD-10 Codes [30]. The District of Columbia passed an emergency amendment on Jul 29, 2014 to expand the definition of a qualifying medical condition to be “any condition for which treatment with medical marijuana would be beneficial, as determined by the patient's physician” [31]. Table 1 details the number of conditions accepted by state, Table 2 details a list of conditions approved in the majority of states, and Table 3 details a list of conditions approved in five states of less. Many states have avenues available to add conditions to their state's list; some allow the public to submit petitions, others only allow providers. All states require patients to renew their certification, with their provider, either every year or every two years.
Table 1 Number of approved conditions, by state. State
Total number of approved conditions a
Washington D.C. Oklahoma Illinois New Mexico Connecticut Michigana Minnesota New Hampshire Ohio Missouri Pennsylvania New Jersey Arkansas Louisiana New York Utah North Dakota Rhode Island Delaware West Virginia Montana Arizona Hawaii Mainea Vermonta Washingtona Californiaa Florida Maryland Massachusettsa Oregona Coloradoa Nevadaa Alaskaa a
Any Any 40 31 30 29 25 25 23 22 22 20 19 19 18 17 16 16 15 15 14 13 13 13 13 12 11 11 11 11 10 9 9 8
State also has legalized recreational cannabis.
condition is to register with the state, get certified by an approved practitioner, pay for an ID card, then go to a state-run dispensary where a Dispensary Technician (also known as a “budtender”) [24] will recommend the strain, dose, and formulation. Budtenders complete online modules from various companies like the Cannabis Training Institute [25], Green CulturED [26], or Trichome Institute [27] to learn their operational and medicinal responsibilities. Patients are then required to follow their state's laws of the maximum amount they can possess at one time, if public use is allowed, if and how much they are allowed to grow, and to never distribute or sell the cannabis to anyone else. Many states define a practitioner as a physician with either a M.D. or D.O. degree; however, there are several states that include physician assistants and advanced practice nurses. There are also a few states that list various other healthcare providers such as dentists, podiatrists, naturopaths, and chiropractors. In order to qualify as an approved practitioner, one must register with the state which may require a two to eight-hour course. There are a few states that do not even require practitioners to be approved; these states' certifications have physicians merely “verify” the patient has a condition that is on the qualifying list rather than having physicians “recommend” cannabis for medical use. Of the 33 states that have legalized the use of cannabis for medicinal purposes, eight have a list of approved practitioners on their respective government websites and two more states express lists to be posted soon. All other state websites either do not mention a list, recommend patients find a physician on their own, or instruct patients to speak with their current physician. It is important to note, though, that many states only list provider information with their permission. A total of 6498 physician-providers can be found on the eight lists available, ranging from 43 to 2114 for each state. Five of the eight lists provide the physicians' specialty. The authors reached out to the other three state
4. Discussion This study provides indirect evidence that Otolaryngologists have not embraced the medicinal use of cannabis, with 0.4% of physicians approved indicated as Otolaryngologists. Based on the available information [32], the authors can conservatively estimate that less than 2% of Otolaryngologists are approved to recommend the medicinal use of cannabis. Table 2 Conditions approved in majority of states. Cancer HIV/AIDS Seizuresa Glaucoma Cachexia or wasting syndrome Post-traumatic stress disorder Amyotrophic lateral sclerosis Crohn's disease Severe and persistent muscle spasmsb Severe nausea a b
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Including those characteristic of, but not limited to, epilepsy. Including those characteristic of, but not limited to, multiple sclerosis.
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better defined. However, there is there danger of anecdotal experience being considered evidence of benefit. More alarming is the dissemination of unsupported claims made by some to vulnerable patients who have exhausted conventional. Since September 2017, the FDA has issued warning letters for nearly 500 websites. The most recent websites to come under scrutiny markets CBD oils for pets and for conditions such as age-related dementia [41]. The mislabeling of cannabis and its extracts in both retail stores and state dispensaries is an emerging concern. Vandrey et al. analyzed 75 edible products sold in three different West Coast cities and determined 17% were accurately labeled, 23% were under-labeled, and 60% were over-labeled with respect to THC content [42]. This variation may reflect the different boiling points of THC and CBD (157 °C and 170 °C, respectively) [43]. Undercooking or overcooking edibles may result in decreased or increased levels of the compounds. Some states have laboratory regulations ensure the biochemical contents of products. However, Jikomes et al. found the inter-laboratory differences within the state of Washington varied significantly, underscoring the need for standardized laboratory methodologies across the industry [44]. Finally, those that recommend the strain, dosage, and formulation to patients at dispensaries (budtenders) were surveyed and found that only 55% received formal training for their position and only 20% had medical/scientific training. Furthermore, while many dispensary staff made recommendations consistent with current evidence, some recommended cannabis that has either not been shown effective for, or could even exacerbate, a patient's condition [45].
Table 3 Conditions approved in five states or less. Fibromyalgia Nail-Patella syndrome Migraine Severe arthritisa Lupus Obstructive sleep apnea Cerebral palsy Severe psoriasis Complex regional pain syndromeb Cystic fibrosis Osteogenesis imperfecta Interstitial cystitis Post-concussion syndrome Sjogren's syndrome Obsessive compulsive disorder Chronic pancreatitis Chronic traumatic encephalopathy a b
Including, but not limited to, rheumatoid arthritis. Previously known as reflex sympathetic dystrophy.
Physicians may choose not to embrace medical cannabis for numerous reasons, including the lack of further research, the unregulated market patients must use, and the simple fact that cannabis remains illegal under federal law. The authors found the available Otolaryngologists that are approved for patient certification of medical cannabis are in metropolitan areas. Access to medical cannabis varies considerably across the country. Patients must register with the state and provide a recommendation from a provider, which is defined differently depending on the state. This recommendation could be as simple as verifying a patient has a condition on the list of qualifying conditions or attesting that the patient has essentially run out of conventional treatment options and medical cannabis could provide benefit. The approved conditions vary substantially around the country as well. Some remain highly regulated and list ten or fewer conditions while others have dozens. All this evidence points to a need for broad regulation that is based on the evidence. For example, there are three states that have Obstructive Sleep Apnea on the list of approved conditions, yet the American Academy of Sleep Medicine has publicly announced that states should exclude this condition from their lists due to unreliable delivery methods and insufficient evidence of effectiveness [33]. To demonstrate how quickly the landscape can change, in 2017, the National Academies of Sciences, Engineering, and Medicine (NASEM) concluded that “there is insufficient evidence to support or refute the conclusion that cannabinoids are an effective treatment for epilepsy” [13]. In June 2018, the FDA approved Epidiolex®, a synthetic cannabinoid for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years and older [34] after randomized controlled trials demonstrated its efficacy [35,36]. In contradistinction to the evidence for a narrow role for medical cannabis, social acceptance of cannabis is increasing. Canada became the second entire nation to legalize cannabis (October 2018) [37], second to Uruguay (December 2013) [38]. Ramo et al. revealed hundreds of mobile apps for Apple and Android devices after searching the stores using the terms “cannabis” or “marijuana”; the most common content was informational (facts, strain classification) [39]. Even large companies can't ignore the increasing hype. Coca-Cola® stated on September 17, 2018 “We have no interest in marijuana or cannabis. Along with many others in the beverage industry, we are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world. The space is evolving quickly. No decisions have been made at this time” [40]. As evidence continues to evolve, the medical effects will become
5. Conclusions In addition to the concepts that Bryant et al. [46] offers in the realms of pain, inflammation, and cancer for the Otolaryngologic patients we would like to propose additional discussions for the field. Considering the evidence for the potential cannabis has on spastic conditions, as Otolaryngologists, we wonder of its efficacy in spasmodic dysphonia or other movement disorders like hemifacial spasm, oromandibular dystonia, and spasmodic torticollis. Also, while there currently may not be enough sufficient evidence for the use of cannabis for neuropathies, potentially there is a place for cannabis in the treatment of trigeminal neuralgia, vestibular/auditory neuropathy, Bell's Palsy, Frey's syndrome and Eagle syndrome. The rapidly changing landscape makes it difficult for physicians to keep up. Furthermore, the lack of broad regulation across the country adds to the uncertainty of a substance that has become so popular among the public. Every state has its own set of definitions for qualified patients, providers, and conditions. The level of interest physicians have across the country varies by specialty, particularly due to the potential conditions it could be used for. Our study has shown that very few Otolaryngologists in the country are registered to certify patients for medical cannabis; however, not all states list providers nor require providers to be registered. While the medicinal use of cannabis, on its surface, may not seem to apply to the field of Otolaryngology, there are many areas that have yet to be explored. Physicians are more commonly being asked about cannabis in the office. No matter what your opinion is on cannabis, for its recreational or medicinal use, we are still vital intermediaries for patients' access to evidence-based medicine. Funding and conflicts of interest There is no funding or conflicts of interest to report. Level of evidence Not applicable; not human research.
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Appendix A
State
Website
Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Hawaii Illinois Louisiana Maine Maryland Massachusetts Michigan Minnesota Missouri Montana Nevada New Hampshire New Jersey New Mexico New York North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island Utah Vermont Washington West Virginia Washington D.C.
http://dhss.alaska.gov/dph/vitalstats/pages/marijuana.aspx https://www.azdhs.gov/licensing/medical-marijuana/index.php https://www.healthy.arkansas.gov/programs-services/topics/medical-marijuana https://www.cdph.ca.gov/Programs/CHSI/Pages/MMICP.aspx https://www.colorado.gov/pacific/cdphe/medicalmarijuana https://portal.ct.gov/DCP/Medical-Marijuana-Program/Medical-Marijuana-Program https://dhss.delaware.gov/dph/hsp/medmarhome.html http://knowthefactsmmj.com/ http://health.hawaii.gov/medicalcannabisregistry/ http://www.dph.illinois.gov/topics-services/prevention-wellness/medical-cannabis http://www.legis.la.gov/legis/law.aspx?d=96986 https://www.maine.gov/dafs/bbm/mmmp/home https://mmcc.maryland.gov/Pages/home.aspx https://www.mass.gov/orgs/medical-use-of-marijuana-program https://www.michigan.gov/lara/0,4601,7-154-89334_79571—,00.html https://www.health.state.mn.us/people/cannabis/index.html https://health.mo.gov/safety/medical-marijuana/ https://dphhs.mt.gov/marijuana http://dpbh.nv.gov/Reg/MM-Patient-Cardholder-Registry/MM_Patient_Cardholder_Registry_-_Home/ https://www.dhhs.nh.gov/oos/tcp/ https://www.nj.gov/health/medicalmarijuana/ https://nmhealth.org/about/mcp/svcs/ https://www.health.ny.gov/regulations/medical_marijuana/ https://www.ndhealth.gov/mm/ https://www.medicalmarijuana.ohio.gov/ http://omma.ok.gov/ https://www.oregon.gov/oha/PH/DiseasesConditions/ChronicDisease/MedicalMarijuanaProgram/Pages/index.aspx https://www.health.pa.gov/topics/programs/Medical%20Marijuana/Pages/Medical%20Marijuana.aspx http://www.health.ri.gov/programs/detail.php?pgm_id=150 https://health.utah.gov/medical-cannabis https://medicalmarijuana.vermont.gov/ https://www.doh.wa.gov/YouandYourFamily/Marijuana/MedicalMarijuana https://dhhr.wv.gov/bph/Pages/Medical-Cannabis-Program.aspx https://dchealth.dc.gov/service/medical-marijuana-and-integrative-therapy
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