Medical marijuana: A new business model for pharmacists

Article

If you enjoy working one-on-one with patients and have an entrepreneurial spirit, this might just be for you.

A new career path is opening up for pharmacists as a growing number of states pass laws to allow the use of medical marijuana. For decades the use of marijuana has been strictly prohibited in the United States, but the tide is turning, and more states now see the medicinal value the plant can offer patients in need. As a result, dispensaries are popping up across the country. 

See also: Should you establish a medical marijuana dispensary?

Sometimes pharmacists are at the helm. Nearly half of all states now have laws that legalize the use of medical marijuana, and several require that pharmacists be part of the distribution process.

Pharmacists paving the way in this emerging industry say it's a rewarding career path. They appreciate working one-on-one with patients and helping them find relief after they have exhausted more traditional treatment approaches.

"Here in this setting, with patients at the end of their rope who have failed all conventional therapy options, there is a very special level of reward in being able to help them live a more fulfilled life, free of pain or anxiety or many other symptoms that we treat," said Geri Ann Bradley, owner of The Healing Corner in Bristol, Connecticut.

But with little U.S-based research to dictate specific dosing and with continued federal treatment of medical marijuana as an illegal substance, pharmacists who decide to pursue this niche practice must be comfortable living with a certain level of risk and must understand, as well, that they will need to forge their own way in an industry just establishing its roots.

Regulatory landscape

The public perception of marijuana has changed drastically over the last  half-century as U.S. citizens have supported legalization of the drug in growing numbers.

According to a Gallup survey, in 1969 just 12% of U.S. adults were in favor of legalizing marijuana. That number grew to 25% in 1997 and jumped to 58% in 2013.

Not only does a public majority now favor legalizing marijuana, but a significant portion of the American public also sees the medical benefits of marijuana use. According to a 2013 survey from the Pew Research Center, 77% of Americans between the ages of 50 and 64 years old, along with 60% of those age 65 or older, agreed that marijuana has legitimate medical uses.

Currently, distribution of marijuana remains illegal at the federal level, and marijuana remains classified as a Schedule I substance under the Controlled Substance Act. However, in 2009 President Obama  sent a memo encouraging federal prosecutors to stop prosecuting people who were distributing marijuana for medical purposes, and in August of 2013 the U.S. Department of Justice announced that it would defer the right to challenge state legalization laws.

Increasing numbers of states are legalizing the medical use of marijuana and adopting comprehensive programs to facilitate its use. According to the National Conference of State Legislatures, 23 states, the District of Columbia, and Guam now have public medical marijuana and cannabis programs.

 

The pharmacist’s role

As public acceptance of medical marijuana grows, pharmacists are considering what role they might play in the emerging industry. Last month a Drug Topics survey of 715 pharmacists found that 48% of respondents were in favor of pharmacist oversight of state-approved medical marijuana dispensaries.

Not everyone agreed, however; 28% of respondents said they didn't believe pharmacists should be dispensing such medication until the FDA reschedules cannabis as a Schedule II Controlled Substance. An additional 18% said they didn't believe pharmacists should be dispensing cannabis because additional research is needed.

See also: Smoked marijuana is not good medicine

Joseph FriedmanBut several states require that a pharmacist be involved in the process. For instance, in Connecticut, in order to obtain proper licensure, dispensaries must be run by pharmacists; in Minnesota, state laws dictate that marijuana be distributed to qualified patients only by pharmacists working with manufacturers registered with the state.

Pharmacists already working in the industry say that as a group, pharmacists have a distinct skill set that makes them uniquely qualified to practice in medical marijuana dispensaries.

"We've got the basic skills; we've got the necessary training and education,'" said Joseph Friedman, RPh, MBA, chief operations officer at PDI Medical LLC in Illinois. "We've got practical experience in patient care, dealing with difficult suppliers, all of that. We've got a patient-focused mindset, and that's very important."

Getting started

Throughout the country, pharmacists are on the cutting edge of this new approach to patient care, and many are opening the doors of their own medical marijuana dispensaries. As one pharmacist put it, practitioners in these new dispensaries can be likened to modern apothecaries; they are able to tailor the therapy to the needs of each patient, using the best product, administration route, and dosage for each.

But the road to this alternative practice environment differs for each pharmacist, depending on individual state rules and regulations.

Connecticut authorized the establishment of six dispensary facilities across the state. The first opened in August 2014.

A pool of 27 applicants vied for the licenses before six pharmacists were chosen. Bradley thinks the biggest deciding factor for the state was the pharmacist's own background and the proposed location of the dispensary.

"I think it was that simple," she said. "I was an established pharmacist that they could trust, in the state of Connecticut, and my location was key."

 

“Who will step up?”

For many already in the industry, operating a medical marijuana dispensary was a career step they never imagined taking until discussions began at the state level to legalize the drug.

"After being a pharmacist for so long in Connecticut, I thought, who's going to do this?" Bradley said. "Who's going to step up and actually make this happen? Because Connecticut was depending on this completed pharmaceutical model, and I thought, if they are not pharmacists, if they are owners that aren't pharmacists, will it be what the state was envisioning?"

Bradley CarlsonIn Minnesota, Bradley Carlson, PharmD, RPh, vice president of pharmacy operations and chief pharmacist at LeafLine Labs, said he made the decision to form LeafLine Labs with his business partner, a physician, after seeing patients come into the ER who couldn’t get the help they needed and realizing that his background in medications and medication reconciliation would be a valuable asset in a dispensary.

"When we started talking about medical cannabis a little bit more, it seemed like a good opportunity to take a chance at something that could be beneficial for that group of people, who have tried so many other things to no avail," he said.

Mutual aid

Those who have established medical marijuana dispensaries say that being at the forefront of the movement has meant there were few models or roadmaps to guide their creation and development of such facilities. Pharmacists instead have turned to one another for support. They also have conducted extensive research into the medical properties of cannabis, sought support and information from the state agencies leading their programs, and attended conferences and other educational events.

Nick TamborrinoNick Tamborrino, PharmD, founder  and dispensary director at Bluepoint Wellness in Branford,  Conn., opened his dispensary just over a year ago. It is structured somewhat like a medical office, he said, where patients make appointments for a detailed initial consultation with a pharmacist, during which they discuss their medical history, disease state, and treatment goals.

In the course of a year, the number of physicians with whom the dispensary works has quadrupled, and acceptance continues to grow, Tamborrino said.

"More doctors are becoming more comfortable prescribing medical marijuana for patients, which I think is a great sign," he said.

Pharmacists say the biggest obstacle they faced when they decided to seek dispensary licensure was often the application process itself, which in some cases required more than 100 hours to complete or required submission of more than 400 pages of information.

Approved uses

When it comes to using medical marijuana to treat patients, pharmacists are entering territory that is somewhat uncharted. Up to this point, much of the U.S. research has been conducted with mice, leaving pharmacists to base many of their treatment decisions on the drug's profile and studies conducted outside the United States.

"There are a lot of unknowns in terms of the mechanisms of action of how the cannabinoids work and why they work, so that was a little nerve-wracking, but it quickly changed once I started seeing first-hand the positive results from some of these patients," said Tamborrino.

While the indications approved by each state differ, Bradley said, at this point she believes the greatest acceptance of medical marijuana occurs in connection with treatment of cancer and other life-threatening or chronic conditions.

"I think the closer that the condition is to end of life or absence of other solutions, the more apt the community is to be on board and not worried about the consequences, because the benefits outweigh the risks," she said.

Aside from cancer treatment, some of the uses for medical marijuana more commonly accepted by the medical community include treatment of diseases such as multiple sclerosis, Parkinson's disease, rheumatoid arthritis, glaucoma, Crohn's disease, epilepsy, and spinal injuries; at this point, psychiatric conditions such post-traumatic stress disorder are less accepted.

 

Administration

Medical marijuana can be administered in several different ways, including by inhalation, sublingual, or oral methods. Selection of the best administration route often depends on the patient's indicated disease state, symptoms, and previous experience with the drug.

At the Healing Corner, Bradley recommends that patients start with inhalation, although she usually prefers that they use vaporized marijuana rather than smoke the drug, she said.

"The benefits of inhalation are the quick onset and short duration, allowing patients to self-titrate their doses easily," she said, adding that it works well as an appetite stimulant for patients with cancer, cachexia, or HIV/AIDs.

Marijuana can be vaporized in its natural flower form or as an oil. 

Although smoked marijuana may be the first form of delivery that comes to mind, pharmacists say that other administration routes are usually preferable.

"Smoking is just naturally irritating to the lungs, so that's not a good idea. Plus, when you have combustion of any kind of plant material, there's potential for carcinogens," Friedman said.

Sublingual slips or alcohol-based tinctures are another option. They have an onset of about 15 to 30 minutes, with a duration of between three to five hours.

Finally, oral routes such as pills or edible forms of cannabis can also be used. While patients who are naive to the drug may request this option, Bradley said, it isn't for everyone.

"Patients tend to have a unique oral absorption or metabolism of marijuana, so effective doses can radically differ from patient to patient," she said. "So we always start a patient low and slow to determine the effective oral dose, and then go from there, titrating upwards to the desired effect."

A patient's previous experience with cannabis often helps determine the best route of administration, said Tamborrino. For instance, depending on their symptoms, patients new to marijuana may start with either an ingestible or inhalation form, while solid concentrates of the drug may work better for patients with a high tolerance.

Finding the right dose

In an industry without any clearly defined dosing standards, the mantra for many pharmacists is “Start low and go slow.” Pharmacists can then slowly titrate up to the most effective dose for the  individual patient.

"There's   no consistency in this industry for dosing," said Friedman, who plans to open a dispensary in Illinois in late 2015. "What I am looking at and what I am counting on is the experience of others in the industry who have healthcare backgrounds."

When they make dosing decisions, pharmacists rely on the drug profile, its relatively low toxicity, patients’ previous experience with cannabis, and the existing literature.

Carlson, whose company, LeafLine Labs, not only distributes the medication but manufacturers it as well, said that a pharmacists' job isn't just about selecting the right dose for a patient; it also includes determining the best product to use. 

Much of the research available to help guide dosing decisions is based on the use of Marinol, a man-made form of cannabis, which varies greatly from the natural whole plant extract used in dispensaries, said Carlson.

For instance, LeafLine Labs grows numerous products featuring differing active cannabinoids, such as tetrahydrocannabinol (THC), cannabidiol (CBD), cannabiverol (CBV), cannabinol (CBN), or cannabigerol (CBG).

"It's like whole-plant science versus the one single synthetic cannabinoid," he said.

He said the initial patient counseling session is critical to determining which product and dose is best for each patient.

Drug interactions

Although there is little confirmed data about drug interactions, assumptions can be made based on how THC and CBD are metabolized. THC is metabolized by CYP2C9 and CYP3A4 inhibitors. Other drugs such as amiodarone, cimetidine, cotrimoxazole, metronidazole, fluoxetine, fluvoxamine, fluconazole, and voriconazole could inhibit THC elimination.

"With these kind of drugs, there could be competitive inhibition of the enzyme system, so you could have higher levels of these drugs or higher levels of cannabis based on taking these drugs," Friedman said.

Ketoconazole, an inhibitor of CYP3A4, has also been reported to increase peak concentration of THC, and other CYP3A4 inhibitors could also be expected to have similar increases in THC concentration.

 

The future

Pharmacists working with medical marijuana believe they are at the forefront of an industry that will soon grow in both numbers and available research. As more dispensaries open their doors across the country, more opportunities for U.S.-based research are also created. For instance, pharmacists in Connecticut are already working to partner with Yale University on future medical marijuana studies, which will increase the knowledge base for others.  

They also have formed a new organization, the Academy of Medical Marijuana Dispensaries, through the Connecticut Pharmacists Association, which provides all licensed Connecticut dispensaries a place to discuss issues and best practices with one another.

Pharmacists who want to learn more about the industry will also soon be able to visit The Cannabis Training Institute, an online training and education program.

"We are not there yet; we hope to be there by the end of this year, as far as having one or two or three modules for continuing education is concerned," said Friedman, who is working to help construct a training module.

Overall, pharmacists in the industry say they see working in medical marijuana dispensaries as an alternative career option for pharmacists who enjoy working closely with patients.

"To see them have an increased quality of life and be able to participate in that process is very, very gratifying," Carlson said.

Jill Sederstrom is a freelance writer based in Kansas City.

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