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Child Psychiatrist /Adult Psychiatrist

Medical Marijuana May be Sold in Pharmacies, But It Is Not a Medicine

COMMENTARY


Georgia will soon be the first state in the nation to allow independent pharmacies to sell medical marijuana products, with more than 100 pharmacies already applying to participate. This raises serious health concerns. The public should be aware that medical marijuana is not a medicine and that it differs from US Food and Drug Administration (FDA)-approved medications in several key ways.


Medical Marijuana

Since the 1990s, the use of medical marijuana has received significant attention and has been subject to intense debate.

The use of medical marijuana was initially approved for palliative and compassionate care, primarily driven by empathy for those suffering from debilitating or terminal medical illnesses. However, the landscape has rapidly evolved, and medical marijuana now includes a wide range of claims and promoted uses.


With so much circulating information available to the public, it is important to emphasize the facts about medical marijuana, especially the distinction between qualifying conditions and FDA-approved indications, its limited evidence, and the poorly regulated products available in marijuana dispensaries.


The origins of medical marijuana can be traced back to the compassionate care movement of the late 20th century. It was initially promoted for individuals dealing with terminal illnesses such as cancer and AIDS and those with debilitating conditions such as late-stage multiple sclerosis.


The compassionate use of medical marijuana aimed to provide relief and comfort, although not necessarily medical benefit. Compassionate care was approved for severely ill patients whose illnesses did not respond to conventional treatments as well as those who were at risk of legal jeopardy if found in possession of cannabis.


One of the critical distinctions between medical marijuana and FDA-approved medications is how qualifying conditions and indications are determined. Prior to approving a new medication for treatment of a specific condition, the FDA requires rigorous research, including safety studies in both animals and humans, as well as randomized controlled clinical trials to establish that the benefits outweigh potential harms in individuals with a specific medical condition.


In contrast, qualifying conditions are determined by state laws and allow patients to access medical marijuana if they have approved medical conditions. Evidence for medical marijuana use for each condition varies widely, but no state laws require the same level of rigorous research for qualifying conditions as the FDA. This explains variations in laws from one state to another, as approving or adding a qualifying condition is often a political decision rather than a scientific one.


State approval of a qualifying condition does not necessarily mean that there are proven benefits for the condition, that benefits outweigh potential harms, or that a specific dose is established for each medical condition. For a list of states that have approved medical marijuana, see the Sidebar.


Posttraumatic stress disorder (PTSD) is an example of a qualifying medical condition for medical marijuana in many states. Although there is some pre-clinical and anecdotal evidence that medical marijuana may have benefits for PTSD, there was no evidence of benefit in 1 randomized controlled clinical trial.


Conversely, there are many reports of harmful consequences when marijuana is used to treat PTSD, including impaired attention, worsening cognition, impaired ability to operate a motor vehicle even hours after last use, development of a cannabis use disorder, psychosis, depression, anxiety, and suicide.


Given these aforementioned harms and lack of evidence, the Veterans Health Administration and Department of Defense Clinical Practice Guideline on the Management of PTSD recommends against the use of cannabis products for the treatment of this disorder.3 Nonetheless, Georgia and other states have included PTSD in the growing list of medical conditions that can qualify an individual to obtain a medical marijuana card.


Another difference between medical marijuana products and FDA-approved medications is the way they are prescribed/recommended and consumed. When prescribing FDA-approved medications, clinicians prescribe a specific dose and duration of treatment according to the package insert, which is established by randomized controlled clinical trials. However, there have been no randomized controlled clinical trials to establish the safety and efficacy of commercial marijuana products, nor the optimal dose ranges.

And dose matters. For example, frequent use of high-potency cannabis can cause severe intractable vomiting known as cannabis hyperemesis syndrome, which is only relieved by stopping cannabis use. For medical marijuana, the specific cannabis product and amount are often determined by consumers or at the discretion of the marijuana retailer.


Medical marijuana lacks strong scientific evidence to support many of its purported benefits. Much of the evidence comes from anecdotal reports, small-scale uncontrolled studies, and patient accounts. These sources do not meet the standards of rigorous randomized placebo-controlled trials, which is the gold standard for medical evidence.


Although more quality research is needed, there are several barriers to achieving this. First, despite state laws allowing for its sale, marijuana remains a Schedule I controlled substance under federal law in the United States, which some argue hinders research efforts.


Additionally, conducting rigorous controlled clinical trials on raw marijuana plants is nearly impossible due to the inherent variability in the concentration of active ingredients and the composition of other chemical compounds.


Manufacturing and quality control standards for FDA-approved medications and medical marijuana products also differ greatly. FDA-approved medications are manufactured with rigorous standards for dose and purity. For example, the FDA requires that each tablet contains the same dose of medication that was shown to be effective in the research studies that led to its approval and that no other toxic chemicals were introduced in the manufacturing process.


Medical marijuana products, on the other hand, lack such quality control. Thus, there are considerable variations in the composition and potency of medical marijuana products. Often, the content on the product label does not match the actual tetrahydrocannabinol (THC) or cannabidiol (CBD) content on the label, making it difficult to determine appropriate dosages and assess potential risks versus benefits.


Furthermore, the manufacturing process can introduce toxic chemical compounds including pesticides and organic solvents such as butane. Allowing medical marijuana products to be sold in pharmacies will lead to false beliefs in their benefit and create more confusion for consumers.


Currently, there are only 4 FDA-approved cannabis-derived medications: Epidiolex® (cannabidiol) for 2 rare forms of epilepsy, Marinol® and Syndros® (both dronabinol) for nausea and vomiting caused by HIV or chemotherapy, and Cesamet® (nabilone) for nausea and vomiting from chemotherapy.


These FDA-approved medications are legal and available nationwide by prescription from a medical provider, but they are not sold through state medical marijuana programs. In contrast, cannabis products available in dispensaries (and soon in Georgia pharmacies) have not met the FDA’s stringent standards for safety and efficacy upheld for prescribed medications.


For FDA-approved, cannabis-based medications, the package inserts also warn of potential risks even when the medications are used at recommended doses and durations. Clinicians are advised to prescribe the medications at the lowest effective dose for the shortest possible duration to mitigate the risk of adverse effects.


These package inserts advise patients against driving a motor vehicle while using the product due to impairments in coordination and cognition that may last hours after they are taken. In contrast, most cannabis products sold in dispensaries lack any warnings about potential adverse effects, but not because these products are safer than FDA-approved medications.


Studies suggest that frequent use of cannabis—either recreational or medicinal—may lead to the development of a cannabis use disorder, which can negatively impact health. This is of particular concern, as the THC content of cannabis products and the frequency of use has increased in recent years.


Whereas 10 years ago, the risk of developing a cannabis use disorder among those who used cannabis was about 1 in 10, more recent data finds the risk to be about 1 in 3.4 This risk is even higher for individuals with a history of another substance use disorder or a predisposition to addiction due to family history or the presence of another mental illness.

Studies also show that cannabis use can cause or exacerbate mental health conditions such as depression, bipolar disorder, suicide, and psychosis.2 For individuals who already have or are predisposed to these conditions, the use of medical marijuana should be approached with even more caution, if at all.


In summary, as we start to see state laws allow marijuana to be sold in pharmacies, we need to take a step back and question a decision that will have a major impact on public health. Taking into account the historical context, differences between qualifying conditions and FDA-approved indications, limited research evidence, and the unregulated nature of products in dispensaries, it is important to educate the public about the distinction between medical marijuana and medicine.


There is an urgent need to emphasize quality research to assess the potential benefits and risks associated with marijuana use. In the absence of randomized placebo-controlled clinical trials, health care providers and patients must approach medical marijuana with caution, weighing the potential benefits against the limited evidence and regulatory uncertainties.


Note: This article originally appeared on Psychiatric Times

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