As the state prepares to launch its medical marijuana program, pharmacists are planning for how to approach the entirely new experience of working with a drug without federal approval. (Getty Images / August 29, 2010)
By WILLIAM WEIR, [email protected] The Hartford Courant
December 2, 2013
East Lyme pharmacist Laurie Zrenda sees the state’s medical marijuana program as a possible way to take her career in a promising direction.
“I’ve been a retail pharmacist for 26 years and it gets a little old after a while,” she said. “The chain stores have taken over.”
With little opportunity to work for an independent pharmacy, or own one herself, she is one of 21 people applying for a state license to run a medical marijuana dispensary.
“This is the chance to live the dream and own my own business,” she said, “and it will be good for people, too, I think.”
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It would be more than a new career opportunity for Zrenda. She would become one of the state’s medical pioneers, part of a network of doctors and pharmacists devising a protocol for working with a drug for which there is no federal approval.
State law requires that every dispensary be run by a state-certified pharmacist. The state expects to award a license to anywhere from three to five applicants in early 2014.
Without FDA approval for marijuana, pharmacists will have to rely on themselves to some extent, said John Gadea, director of drug control for the state Department of Consumer Protection.
“It’s critical to have a person in that position to gather the data that’s lacking and do something with it,” said Gadea, who is also a pharmacist. “Once you start getting and collecting that data, they’re getting a more medical side to it. Those studies aren’t there, so there’s a void, and the pharmacists feel that they can help fill it.”
“There’s very little federal oversight; in fact, there’s practically none,” said Gadea. “Oversight then falls to the state.”
Marijuana As Medicine
Margherita Giuliano, a pharmacist and the executive vice president of the Connecticut Pharmacists Association, said she wants to work with the state Department of Consumer Protection, which runs the medical marijuana program, to develop a system that would guide pharmacists, physicians and patients in the use of medical marijuana.
“As the umbrella statewide organization for pharmacists, we do see ourselves playing a critical role in all of this,” she said. “We want to collaborate with growers and dispensers and with the Department of Consumer Protection and other stakeholders to design the research plan.”
She said the state’s medical marijuana program is set up to create a database for information regarding patients’ experiences with medical marijuana.
Gadea and Giuliano say that Connecticut is the only state that has legalized medical marijuana to require that dispensaries be run by a certified pharmacist.
“We’re the only state that has brought pharmacists into the process,” Giuliano said. “We’re thrilled that the state of Connecticut is following this pathway — it opens a host of ways to study medicinal marijuana.”
Giuliano said it’s hard to plan for what kind system the state would put in place because “everything is still up in the air.”
“Until you have all stakeholders at the table, there’s so many unknowns about this,” she said.
One possibility, Giuliano said, is that physicians would collect information from patients who use medical marijuana.
“I think that the hope is that the information would help identify what strains of medical marijuana would be best for patients based on their disabilities,” she said.
Zrenda, who currently works at Rite-Aid, is applying for the license with her niece, who is also a pharmacist. She said they don’t have the financial backing that some of other applicants might have. They hope to open in Uncasville in a relatively small space to be renovated by her niece’s contractor husband. It’s important that the state requires that dispensaries be run by a state-certified pharmacist, she said.
“It builds the public’s trust to have a pharmacist, so they know it’s not just some kid running it,” she said.
Gadea said he expects that his department will treat medical marijuana as it does any other Schedule II drug — those deemed to have medical value but also a potential for abuse. That said, Gadea acknowledges that marijuana presents a different situation.
“Most pharmacists, they have six years of college and they have heavy-duty biology and chemistry and they look at things a certain way,” said Gadea. “A lot of people have concerns about where the studies are. They don’t exist in the traditional sense because the FDA doesn’t have those studies.”
The FDA-approved drug Marinol contains the chemical THC, derived from marijuana. Dr. Richard Alper, an associate professor in the department of pharmaceutical sciences at the University of St. Joseph in West Hartford, said this gives the medical community some limited insight about the use of marijuana as a medicine. Although Marinol has isolated one active ingredient from marijuana, he said, the plant itself has 400 or more biologically active chemicals.
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“The concern that I have is that most of what we know about medical marijuana is through 4,000 years of anecdotal information,” he said. “Medical marijuana has not undergone the rigorous testing that FDA requires for other products.”
He has given a few talks about medical marijuana to pharmacology students at St. Joseph.
“When I teach [about] medical marijuana. I simply have to point out that there are unknowns about medical marijuana,” he said. “One of the things that needs to be watched out for are serious contraindications or serious side effects.”
He added that his concerns are “tempered” because there appear to be few serious contraindications with marijuana.
Dr. Andrew Salner, chief of the department of radiation oncology at Hartford Hospital and a supporter of medical marijuana, said that initial forays with the drug will be “trial and error.”
Before certifying a patient for marijuana, Salner said, he will first try conventional medications. If those don’t work out, he said, the patient might be a good candidate for marijuana. At first, he said, he will start out certifying the patient for a small amount, “particularly for older folks, who might be more sensitive to the sedating effects.