Against the backdrop of an opioid crisis that many believe caught health-care providers by surprise, a panel representing physicians, marijuana operators and lawyers spent hours Monday arguing about the maximum amount of medical marijuana doctors should be able to order for sick Floridians.
The daylong debate came as a rare “negotiated rulemaking” panel struggled to reach consensus about how much marijuana patients should be able to inhale, rub into their skin or ingest in other ways each day.
The Legislature ordered the Department of Health to craft the guidelines as part of a 2017 law aimed at implementing a voter-approved constitutional amendment broadly legalizing medical marijuana.
While doctors are already ordering medical marijuana for more than 100,000 patients registered in a statewide database, the state currently does not have caps for how much pot patients are allowed to consume or how much their physicians are allowed to prescribe.
Much of Monday’s meeting centered on disputes between doctors who advocated for a more-restrictive approach to medical marijuana consumption and other members of the panel --- including a physician affiliated with a medical marijuana operator, a patient who works for a different operator and a caregiver who’s also a lawyer who represents a nursery that sued the state in an attempt to get a highly sought-after medical marijuana license.
Under the 2017 law, health officials must come up with dosage levels to limit how much medical marijuana doctors, who are allowed to order up to 70-day supplies, can prescribe for their patients.
Marc Kaprow, a physician representing the Florida Osteopathic Medical Association on the eight-member panel, repeatedly warned that the state should use caution when setting the caps for both euphoria-inducing tetrahydrocannabinol, or THC, and non-euphoric cannabadiol, or CBD.
Decades ago, doctors were told they could treat patients with high levels of opioids without the risk of addiction, said Kaprow, who treats hospice patients.
“Here we are 20 years later, saying if we could have put the fire out in the beginning, we would probably be a lot better off,” he said, advising the panel to “err on the side of caution.”
But Kenneth Brummel-Smith, a doctor who serves as medical director of medical-marijuana treatment center Trulieve, said that equating opioids with marijuana is “problematic” for a variety of reasons.
“It’s a different subject completely to talk about the risks of opioids and the risks of cannabis,” he said, adding that patients using marijuana “would be asleep before they died.”
Unlike opioids, proponents of medical marijuana maintain that studies have shown cannabis is not addictive or deadly and is used as a treatment for opioid addiction in other states, Brummel-Smith said.
“We need to set a limit that allows physicians to treat those rare patients who require very high doses without having to go through a lot of bureaucratic rigmarole,” he said.
But Kaprow wasn’t satisfied.
“Just because something is not lethal doesn’t make it a good idea,” he said. Ten percent of patients who use cannabis end up dependent on it, he said.
Doctors also are allowed to request exceptions to the limits from the health department, Kaprow noted.
But Ari Gerstin, a lawyer who is also a registered caregiver, argued that the state has more control over medical marijuana than it did with opioids, including a database replete with information about patients, their doctors and how much the patients are allowed to consume. The database was established at the same time the state first legalized medical marijuana, beginning with non-euphoric cannabis --- also known as “CBD” --- in 2014.
The health department should not have to be “jumping in constantly to override recommendations” because the recommended levels are set “arbitrarily low,” Gerstin said.
But Kaprow advocated for starting with lower limits and increasing them if doctors later decide such action is necessary. He pointed to a dearth of studies about the efficacy of medical marijuana, which is still illegal under federal law. That makes it difficult for doctors to predict the quantities of cannabis their patients might need, compared to prescription drugs.
“What we are lacking here is the pharmaceutical data that usually helps drive those decisions,” Kaprow said. “We don’t have a large, clinically controlled trial to say this is what a normal amount is. … It is our job, though, to ensure the safety of the patients and the citizens of Florida.”
Kaprow pointed out Florida lawmakers this year placed limits on prescriptions that doctors can write for treatment of acute pain. Doctors in many cases are now limited to writing prescriptions for three-day supplies, though they can prescribe up to seven-day supplies of controlled substances if “medically necessary.”
“If we started with a low limit, that simply means that …you have to try them on a lower dose to begin with,” Kaprow said. “Start low and go slow.”
He said doctors “have a moral, ethical and legal obligation to direct the care of our patients” and to ensure that their treatment is safe.
In the end, the panel agreed to set daily limits at a total of 3,450 milligrams for THC and 5,250 for CBD, or about five to six times the average recommended dosages for medical marijuana patients.
Patients may receive medical marijuana in more than one route of administration. Within the overall limits, the panel also set caps on each route of administration.
Those caps would be 550 milligrams of THC or 750 of CBD for inhaling; 1,000 milligrams of THC or 1,500 of CBD for oral consumption, such as in pills or capsules; 300 mg of THC or 500 mg of CBD applied topically; and 1,000 mg of THC or 1,500 of CBD, absorbed sublingually.
“Where we ended up was pretty good,” Brummel-Smith said.