These Include Crohn’s Disease

Even though only low THC oil is approved for use in the State of Georgia, several respondents use a product with greater than 5% THC oil or a non-oil form of cannabis. They were greatly concerned about the legality of MRPs and the ability to obtain them. They felt supported by their family members and other medical providers regarding their decision to use MRPs, and they relied on their doctor for information on the use of these products.

Cannabis sativa and Cannabis indica plants (often referred as marijuana) contain more than 60 cannabinoids. The two cannabinoids most often studied are delta-9-tetrahydrocannabinol (THC) and CBD.11 THC has been found to have analgesic, antiemetic, anti-inflammatory, and antioxidant properties. CBD has antipsychotic as well as anxiolytic and anticonvulsive properties.12,13 However, both THC and CBD have harmful effects.14 For example, THC can decrease muscle tone, which leads to increased risk of falls, can increase risk of psychosis, and can cause physical dependency. CBD is a CYP3A4 inhibitor that can cause multiple drug-drug interactions with, for example, blood thinners and immunosuppressant drugs often used in patients receiving transplants.12,13

Moderate-quality evidence currently exists supporting therapeutic marijuana for chronic pain, neuropathic pain, and spasticity resulting from multiple sclerosis.15,16 These findings seem to have little influence on the legal status of THC that would grant greater access to medical marijuana nationally. Investigators seeking to conduct cannabis-related research must secure Schedule I research registration. Must obtain cannabis through the National Institute on Drug Abuse. These requirements can be challenging, thus limiting research.5 However, states with medical marijuana programs sanction cannabis use for a variety of conditions for which there is little evidence of clinical benefit. For example, Georgia permits medical marijuana cards for 17 different medical conditions. These include Crohn’s disease, sickle cell disease, and epidermolysis bullosa.7 Advanced cancer was the most common reason (76%) in our sample of respondents for granting patients access to a low THC oil card.

In our study, a majority of the respondents were using nonapproved formulations of medical marijuana. This may be the result of a lack of safe access to the approved formulation (low THC oil). Furthermore, even if patients reported using low THC oil, there is no guarantee that the patient will get the same product each month, even if it is obtained from the same source. This is because there is a lack of nationwide quality control for THC oil production that results in variability in tested cannabis products.17

Given that medical cannabis is not covered by medical insurance, cost is an important factor for patients. More than a third of the patients spend $100 to $500 per month on cannabis-related products. If cannabis becomes a globally accepted therapy for symptom management, it is possible that access to and use of cannabis may be limited by the patient’s own socioeconomic status. Higher-income patients may be more likely to buy cannabis, whereas lower-income patients may elect to continue receiving opioids for pain control for economic reasons, despite the increased risk of harm. A recent article raised concern that access to non-opioid and nonpharmacologic therapies may be particularly challenging for patients with racial and socioeconomic disadvantages who already face significant barriers in receiving adequate pain care.18

Patients expressed considerable concerns about the legality of THC and their ability to obtain it. The US Drug Enforcement Agency (DEA) assigns Schedule status (I-V) on the basis of a drug’s acceptable medical use and the drug’s potential for abuse or dependency. Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence, whereas Schedule V drugs have the lowest potential. Marijuana and its derivatives are classified as Schedule I substances according to the DEA (same category as heroin). So far, only two derivatives of THC (dronabinol and nabilone) are approved by the US Food and Drug Administration (FDA) to treat nausea and vomiting associated with chemotherapy and to stimulate appetite in patients with AIDS. According to a Federal Register document (83 FR 48950) published by the DEA on September 28, 2018, FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1% tetrahydrocannabinols are placed in Schedule V.19 Currently Epidiolex is the only FDA-approved drug that meets these requirements. It is an oral solution of CBD approved in June 2018 for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.20

The majority of patients stated that they had the drug shipped from a state in which medical and/or recreational cannabis is legal. Shipping marijuana (medical or otherwise) is prohibited by the US Postal Service (USPS).21 Regulations are provided in Publication 52, Hazardous, Restricted, and Perishable Mail on the USPS Web site.22 Texas and Mississippi are the only states with low THC-CBD programs, which have in-state production methods or dispensaries. Texas has authorized medical marijuana dispensaries licensed by the Department of Public Safety and permits CBD oil for compassionate use. The Department of Pharmacy Services at the University of Mississippi dispenses CBD oil to qualified individuals. Unfortunately, most of the states with low THC-CBD programs (Alabama, Georgia, Idaho, Indiana, Iowa, Kentucky, Oklahoma, Virginia, Wisconsin, and Wyoming) do not have in-state production methods or dispensaries to dispense low THC-CBD products and do not define the source of the product. This puts patients at risk for obtaining unsafe products that may cause harm, and it places medical providers in a precarious position in which they are unable to counsel patients on safe cannabis practices when they are unclear about the contents of the cannabis products that their patients are using. Although, the Georgia House of Representatives recently passed a bill to permit growing, manufacturing, testing, and distribution of medical marijuana, this bill is yet to be passed by the Senate and approved by the Governor.23

Cancer is considered a qualifying condition for using medical marijuana in most states. A mail-in survey was conducted in 2016 in a random sample of 400 nationally representative oncologists, regarding their beliefs, knowledge, and practices regarding medical marijuana.24 It found that even though 70% of oncologists do not feel equipped to make clinical recommendations regarding medical marijuana, 80% conducted discussions regarding medical marijuana with their patients, and 46% recommended it clinically. The majority (67%) felt that medical marijuana was a helpful adjunct to standard pain management strategies.24 These findings correlate well with what we found in our patient population, the majority of whom had cancer as the qualifying condition. Patient depend on their medical providers for information regarding therapeutic cannabis use. Therefore, there is a need for medical providers to be educated about the status of cannabis in the United States and in their respective states.

It should be noted that although data were de-identified and patients had the option of not participating in the survey, questions related to illegal use of cannabis may not have been answered honestly because of fear of reprisal or other consequences. These concerns may have skewed the results of the study.

The 100% agreement with the verbal invitation to participate in the survey is somewhat higher than is generally found in the literature, possibly because the survey was offered during the patients’ regular clinic visit with supportive care. Because of the thoroughness of this visit and the variety of questionnaires filled out during a regular clinic visit, patients know that these visits can take a long time and may not mind filling out a research survey that takes only 10 minutes. In addition, as noted earlier, patients find cannabis products very useful for pain and are concerned about access to them. Patients may have wanted to share their views. Thus might have seen the research survey as a way to express their opinions. It should be noted that not all of the patients with a low THC oil card who visited this Supportive Care Clinic were offered the survey. Because most of the patients who were offered the low THC card in this clinic had advanced cancer, it is possible that many were deceased by the time the survey was conducted. The survey was offered during a limited time period to the patients with already scheduled clinic visits. Thus, this limitation on the sample may have introduced significant bias into the study findings.

Because marijuana use is a very sensitive topic, patients were given the option to skip questions if they did not feel comfortable answering them. Even though some of the questions were likely skipped on purpose, it is possible that some questions were skipped in error. If a similar survey were to be repeated in the future, the option of “choose not to answer” should be added to all the questions, which might prevent the respondents from skipping that question and continuing on to the next one.

Respondents were able to select multiple answers to the question pertaining to type of cannabis product used, which means the total percentage is more than 100. Instructions directed the respondents to “check all that apply.” A nonresponse was coded as a negative response. This is a limitation of the survey design; the reason for why a respondent skipped the question or desired to enter a negative response was not given. To avoid this limitation in future surveys, options such as “none apply” or “not applicable” could be added to the questions along with instructions to “check all that apply.” Ten respondents who did not check “any” were included in the denominator for percentage calculation.

Among our sample of patients who used cannabis as part of a state-approved low THC oil program, the majority had advanced cancer. They were more concerned about the economic and legal aspects of obtaining marijuana products than the potential adverse effects and health hazards of using it. A majority of the patients obtained information regarding MRPs from their doctor. Furthermore, they believed that their health care providers and family members were supportive of their cannabis use.

Given the patients’ concerns regarding the legality of and ability to obtain cannabis products, distribution and retail need to be better defined in states with approved medical cannabis programs. Addressing this public health issue is of utmost importance for safety. Consistency in MRPs consumed by the patients. Furthermore, physicians should be aware that patients rely on them for information regarding medical marijuana. Given the complexities of medical cannabis laws, irregular access to cannabis products, and their variable costs, we believe that physicians should be educated on the status of cannabis in the United States, particularly in states with restricted access laws.