On December 18, President Trump signed an Executive Order instructing the Attorney General and DEA to reschedule cannabis from schedule I to schedule III.
So, does this mean will we start seeing commercials for pharmaceutical grade cannabis? Not quite yet, but sooner than you might think.
First, the Executive Order does not make it a done deal. The DEA still must go through the process. When President Biden tried to reschedule cannabis, the DEA put up a lot of roadblocks. It is possible they will try to do the same again. But in making this order, and doing it so publicly, I think Trump is signaling he will not tolerate the DEA creating any delays. So, I believe estimates that say rescheduling will happen in a few months.
And, of course, every drug needs FDA approval. Many people think it will take many years to see a cannabis drug on the market. But I don’t think it will take that long. There are existing pharmaceutical companies already poised to enter the US market. They have done phase 3 trials in Europe or have been applying to do studies in the US. Honestly, I think it will take less than 2 years for a THC cannabis product to enter the US market.
So, by 2028 prescription grade cannabis could be a thing. My hospice patients might be able to get it sooner.
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Now, rescheduling doesn’t make cannabis from dispensaries legal. The state programs for recreational and medical cannabis are still federally illegal. But, as of now, they will still be operational in states where they are legal. So, patients will still be accessing cannabis from dispensaries until FDA approved products are available. And depending on the insurance coverage and cost of prescription cannabis, some patient might be going to dispensaries even afterwards. Also, it is unlikely that there will be an FDA approved whole flower product, so patients who insist on an inhaled product, will still go to dispensaries.
Schedule III means cannabis is be acknowledged as a medication. So, we must change our mindset about cannabis. It is no longer just a drug of abuse. It is a medication that has some potential for dependence and abuse. But it is a medication.
Also, as a schedule III medication, we need to understand cannabis from a liability perspective. If a patient tells us they are using it for a medical indication, and they have a drug interaction, we could be legally liable, even if they get it from a recreational dispensary.
We should ask about with other medications and put in the medication section of the chart. EMR are going to have to catch up to this. And if it is a medication, if daily use causes tolerance and withdrawal, but without other criteria, is still considered mild cannabis use disorder?
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We need to be non-judgmental when we talk about it. We now know thiazides lower the blood pressure by affecting the endocannabinoid system. But no one judges people for needing blood pressure medications.
Yes, like other medications, people may be using it inappropriately. But like we do with other medications, we address those issues. People can get addicted. Teens, and even young adults under 25, are at increased of psychosis, schizophrenia, and other issues if they use cannabis. Cannabis hyperemesis syndrome is real and need more research. And there are still unanswered questions about its effect on the heart. We must be vigilant about those issues.
There is more research about cannabis that most doctors think there is. It is true that many studies are poor quality. Large RCTs are expensive, though a few drug companies from Europe and Southa America are doing some. Treatment of spasticity in Multiple Sclerosis and Chronic Pain are approved uses for cannabis in multiple countries. And once companies start moving toward FDA approval, we will see even more studies. Until then, doctors need to learn about the current research so we better guide patients about cannabis using shared decision making.
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In my informal discussions with physicians, most doctors admit they know little to nothing about cannabis. Most know about joints, gummies, and creams, but very few know about formulations, dosage, strength, drug interactions, side effects, risks, and benefits. And it is not their fault. We are not trained in this.
As a palliative doctor, I saw patients benefit from cannabis and was a believer in its medical use. Among my peers, I was probably the most knowledgeable and comfortable about cannabis, but I’m embarrassed to say, that for the longest time I though people smoked the leaves, like tobacco.
When I admitted this story to a group of colleagues about a half a dozen other doctors responded with, “People don’t smoke the leaves? Then what do they smoke?” (FYI, the flower of the female cannabis plant is the only part that make THC.) Doctors do not get this education in school.
Medical schools don’t even teach about the endocannabinoids system. The endocannabinoid system is a major system that keeps our body in homeostasis. It regulates brain development and function, cardiovascular function, inflammation, metabolism, immunity and pain (to name just a few functions) and ubiquitous in our body. Yet, since it was discovered while researching cannabis (hence the name), it is often neglected.
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That will have to change with rescheduling. Medical schools will need to teach the mechanism of action of prescription cannabis, just like they do with ace inhibitors. But in the meantime, doctors need to catch up and learn.
With rescheduling, patients are going to be asking about it more, even before there is an FDA product and commercial. Currently, studies show that people are not telling their doctors about their cannabis use, even for medical use. But with the federal government rescheduling cannabis, patients who are currently using may be less scared to tell their doctors. And patients who are considering use may finally be more comfortable asking doctors, instead of budtenders, for advice. And we need to be ready to have those discussions.
The rescheduling of cannabis fundamentally changes the nature of the relationship between doctors and cannabis. No longer a drug, cannabis is now a medicine, and we need to be ready to help our patients navigate this new reality.
We need to be non-judgmental when we talk about cannabis. We now know thiazides lower the blood pressure by affecting the endocannabinoid system. But no one judges people for needing blood pressure medications.
