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Medical Marijuana Goes Mainstream

The University of Mississippi’s 12-acre farm has been the sole domestic source of cannabis for government-funded and approved research.

Pharmacy schools are beginning to offer programs to study medical marijuana as its use expands across the country.

By Joseph A. Cantlupe

Ninety years ago, marijuana was widely known as the “evil weed,” prompting the 1936 propaganda film “Reefer Madness” about its dangers. In the ensuing decades, study after study gradually backed off the hyperbole about marijuana, though it is still under a spotlight of continued research. In today’s world, marijuana is sometimes used to treat what ails us. Pharmacy is keeping pace as medical marijuana goes mainstream.

Pharmacy schools are offering programs to study medical marijuana not only for student pharmacists but others seeking to learn more about it for myriad reasons, including regulatory or business purposes as well as for improved patient care. As the industry expands, more colleges are adding cannabis or marijuana courses to their portfolio. Medical marijuana is gaining traction in America with more states legalizing its use and more dispensaries opening across the country. Some educators point to the increasing need for medical professionals—including physicians, nurses and pharmacists—to properly advise patients about medical marijuana.

At last count, 33 states as well as the District of Columbia, Guam and Puerto Rico have legalized medical marijuana. Three states are already requiring that pharmacists be part of the dispensing process, according to the National Community Pharmacists Association. For instance, New York State requires a pharmacist to be on the premises and supervising the activities within a marijuana dispensing facility.

The legalization movement is expected to broaden to more states. “The number is only expected to increase in the future, fueling a demand for an educated workforce that is well-trained in both the science and therapeutic effects associated with this medicinal plant,” said Dr. Natalie D. Eddington, dean and professor at the University of Maryland School of Pharmacy.

A 2019 study from the University of Pittsburgh School of Pharmacy found that 62 percent of U.S. pharmacy schools surveyed incorporated medical cannabis into their doctor of pharmacy programs and another 23 percent planned to include courses in their programs in the next 12 months.

New Horizon

The University of Maryland School of Pharmacy has launched a new master of science in medical cannabis science and therapeutics, one of the first in the country to do so. The two-year program is designed for an array of healthcare professionals, scientists, regulators, dispensary owners and staff and anyone interested in the field. The program was developed “because of a knowledge gap (in medical cannabis), particularly for healthcare professionals,” said Dr. Leah Sera, assistant professor in the Department of Pharmacy Practice and Science, director of the school’s new master’s program and a clinical pharmacist.

University of the Sciences in Philadelphia has launched a medical cannabis MBA program, specifically targeting the business of cannabis, said Dr. Andrew Peterson, John Wyeth Dean Emeritus and professor of clinical pharmacy and health policy at USciences. Peterson said that the “combination of healthcare, pharmaceutical and cannabis business knowledge and expertise will be incredibly valuable as graduates move forward in their careers.” The USciences courses are provided through the business department in conjunction with the Substance Disorders Institute at USciences and include partnerships with Philadelphia-area cannabis organizations, Peterson said.

Researching the Risks and Benefits

While much of the academic community is focusing on medical marijuana, many questions remain about the impact of the drug and where it fits into pharmaceutical treatment regimens. That’s where the University of Florida College of Pharmacy is jumping in. The university is leading a statewide consortium studying health outcomes related to medical marijuana by evaluating its benefits and risks.

The consortium will tackle safety and effectiveness outcomes but also specific intricacies of medical marijuana inherent in its dosing routes of administration and the effects of smoking versus other methods of consumption, according to Dr. Almut Winterstein, a professor and chair in pharmaceutical outcomes and policy at the University of Florida College of Pharmacy and director of the University of Florida Center for Drug Evaluation and Safety. As the demand grows in the emerging marijuana and cannabis market in Florida, she said there is an “urgent need” for evidence-based studies revolving around medical marijuana. Under the program, the consortium of academic institutions will create a statewide resource for health outcomes research related to medical marijuana, said Winterstein, who was appointed director of the consortium.

As Winterstein sees it, marijuana would be put to the test in the same way as any other drug in development. “As with any other medical treatment, providers, patients and regulators need the necessary information to evaluate its benefits and risks,” she said. “At the time of drug approval, we really don’t know much about side effects and how the new drug works in populations with multiple comorbidities” because that’s not the focus of clinical trials. That’s why post-marketing safety and effectiveness studies are pivotal, and the same applies to medical marijuana. “Really we know very little about what medical marijuana actually does, and for me this requires basically the same systematic evaluation as is in place for any other drug that is on the market.”

While there are similarities with other drugs in studying the impacts of medical marijuana, there is a major difference: for the most part, medical marijuana lacks Food and Drug Administration approval, she noted. As a result, the Florida research “is probably more important because we don’t have approval process on the front end. We really don’t know much about efficacy. And it’s being used by patients who have really serious problems.” If patients who have Parkinson’s disease or multiple sclerosis take medical marijuana, “we don’t know the degree medical cannabis interacts with other drugs necessary to control the disease,” she continued.

While the FDA has not approved marijuana as a safe and effective drug for any indication, it has approved a drug that contains purified cannabidiol, one of the more than 80 active chemicals in marijuana, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years or older. The FDA also has approved drugs containing a synthetic version of a substance in marijuana.

At least 20 marijuana research studies have been initiated in the past five years in Florida, where as many as 200,000 people have been registered to receive medical marijuana, including people suffering from severe and life-threatening health conditions. Researchers have been examining the health benefits and risks of medical marijuana from different perspectives and include outcomes research related to HIV infection, chronic pain in older adults and cannabinol treatment for children with drug-resistant epilepsy.

The university has been involved in a medical marijuana program since 2014. It has extensive research infrastructure and a broad faculty, Winterstein said, and is well positioned to lead the Consortium for Medical Marijuana Clinical Outcomes Research, which comprises public and private universities engaged in research on clinical outcomes of medical marijuana. It will receive $1.5 million in annual recurrent funding from the state to support the research. The university proposes to:

Build a repository known as the Medical Marijuana Clinical Outcomes Repository or MEMORY that can track patient outcomes over time.
Develop a Clinical Research Core that will provide infrastructure support for studies and establish a competitive grants program offering $600,000 annually from the state appropriation to participating institutions.

The core will assemble a group of physicians and clinical partners to recruit patients for medical marijuana research studies. In addition, the core plans to conduct a survey of medical marijuana providers in Florida, engage a scientific expert group and provide opportunities for the public and industry to help inform the most urgent clinical research priorities, according to the university. The repository will be available to researchers within the consortium and create a statewide resource for real-world health outcomes research related to medical marijuana.

While pharmacy schools are beginning to tap into coursework for medical marijuana, the University of Mississippi School of Pharmacy has been involved in researching the plant for more than 50 years. A 12-acre farm run by the university has been the sole domestic source of cannabis for government-funded and approved research. Through the National Institute on Drug Abuse (NIDA), the University of Mississippi provides marijuana to researchers across the U.S. under NIDA’s Drug Supply Program. After an open competition among institutions around the country, the University of Mississippi won the first contract in spring 1968 to be the government’s provider for marijuana for research purposes.

“During our 50 years of cannabis research we have been involved in a multitude of projects involving the botanical and chemical properties of the plant as well as ongoing development of candidates for new cannabis-based drugs and novel drug delivery systems,” said Don Stanford, assistant director, Research Institute of Pharmaceutical Sciences, which is part of the school of pharmacy. After some legal challenges, the government has now opened the door for more than 30 other organizations to grow cannabis for research, although the process has yet to begin, officials said.

A Complicated Substance

While medical marijuana presents many possibilities, the plant itself is extremely controversial with questions over its legality, overall addictiveness and effectiveness. Marijuana use is legal in some states but it’s still illegal from the federal government’s perspective. About 85 percent of Americans support legalizing medical marijuana.

Because the marijuana plant contains chemicals that scientists say could help a range of illnesses and symptoms, many people argue it should be legal for medical purposes. The major thrust of medical marijuana has been for pain control. Chronic pain impacts millions of Americans.

Marijuana has more than 100 active components. THC, which stands for tetrahyrocannabiniol, is the chemical that ignites the “high” that is linked to marijuana use. CBD, which stands for cannabidiol, is derived from the hemp plant, a “cousin” of the marijuana plant, according to Harvard Medical School. CBD has been used by patients for a variety of conditions, such as pain relief, or to combat anxiety or insomnia. CBD does not have intoxicating properties (although it is also present in the marijuana variety of Cannabis sativa).

The medical cannabis MBA program at University of the Sciences in Philadelphia offers a “combination of healthcare, pharmaceutical and cannabis business knowledge and expertise [that] will be incredibly valuable as graduates move forward in their careers.

Dr. Andrew Peterson

The marijuana plant remains classified as a Schedule I substance under the federal Controlled Substances Act. Schedule I substances are considered to have a high potential for dependency and no accepted medical use, making distribution of marijuana a federal offense. The law, however, is generally applied only when people possess, cultivate or distribute large quantities of cannabis, according to Americans for Safe Access, an organization that advances legal medical marijuana therapeutics and research. The Obama administration encouraged federal officials not to prosecute people who distribute marijuana for medical purposes. The Trump administration differs; it has allowed federal prosecutors to decide how to prioritize enforcement of federal marijuana laws.

Marijuana dispensaries have grown because federal law prohibits cannabis from being prescribed and filled at pharmacies for medical or recreational purposes. State-regulated dispensaries are designated under regulations for the growth and consumption of cannabis, noted Americans for Safe Access.

In Maryland, Strategic Advantage

As the marijuana industry began expanding, University of Maryland officials believed they needed to initiate a program to give students a “competitive advantage” in pursuing a career in the medical cannabis industry, whether working in healthcare or not. Indeed, the program is specifically designed for students with or without a background in science or medicine, said Sera.

The Maryland curriculum includes coursework in “policy and direct patient care,” with a “grounding in the basic science of pharmacology and the development of the formulation and chemistry of different cannabinoids and how we can treat different conditions,” Sera said. For students, the courses also provide a “grounding in the history of cannabis regulation in our country in order to participate in the development of well-informed medical cannabis policy moving forward.”

Faculty for the medical cannabis program include instructors from the pharmacy school immersed in the basic sciences, teaching pharmacology and chemistry, as well as clinicians. Besides those working in the medical field, adjunct professors who are knowledgeable in the study of cannabis will be engaged. Sera herself is a specialist in pain medicine and palliative care.

At least half of the 150 students who were accepted into the program’s first class, which began in August, have a background in science, chemistry, medicine or microbiology. Others include attorneys, educators and patient advocates, and even an art student. The classes are primarily online with an in-person symposium held once each semester.

Neil Leikach, president of a Catonsville-based pharmacy and a BSP graduate of the University of Maryland, is a student in the master’s program and is particularly interested in learning about evolving regulations around cannabis that are impacting pharmacies.

“This has been a Schedule I drug, and states are looking at this differently. There are many opportunities to help patients,” Leikach said. “States are really catching up on how to help patients with different disease states.” Leikach said he’s attended classes that have focused on regulations and drug interactions with cannabis. He’s pleased with the course offerings. “As pharmacists we need more information, and there is not enough good information out there.”

A Matter of Business in Philadelphia

As USciences officials began looking into the academic program for cannabis instruction, they believed that it should examine not only the science of the plants but also something that has not received enough focus: the business of medical marijuana, its marketing and sales. “There are many unique aspects to the medical cannabis and hemp industry,” noted Peterson.

As he examined the program and worked with experts in the field, Peterson said he was surprised by the complexity involved in the underlying business of marijuana and the horticulture process. “I learned so much about the science of growing plants,” he said. “The humidity, pest control, so many things.”

The legal aspect will also be explored. Students will be asked questions such as “what is the status of cannabis as a controlled substance in the U.S. under federal law as well as state to state?” Peterson said. USciences sought assistance in developing its program through a memorandum of understanding agreement with Franklin BioScience, a Colorado-based cannabis grower and retailer. Franklin BioScience assisted in developing educational programs about the cannabis plant and its medicinal value.

Four separate courses are being offered online as part of the Cannabis Industry Masters of Business Administration option under the pharmaceutical and healthcare business curriculum. While any student can take the courses, priority is given to MBA students, and there is no certificate for taking cannabis-related electives, school officials said.

The courses include introduction to the medical cannabis industry; finance and regulation in the medical cannabis industry; cannabis marketing and sales; and a project-based course where students will work to write a business plan or bring a product to market. Currently 14 people are enrolled; officials are still recruiting for the next cohort, all of them MBA students (some of whom are pharmacists). Like Maryland, USciences does not have an on-site cannabis lab.

Symposium attendees in discussion at round tables. — *Attendees at the University of Maryland 2019 fall symposium for the MS in Medical Cannabis Science and Therapeutics Program. Photo credit: Matthew Di’Agostino*

Symposium attendees gathered for a group photo. — *Attendees at the University of Maryland 2019 fall symposium for the MS in Medical Cannabis Science and Therapeutics Program. Photo credit: Matthew Di’Agostino*

Mississippi: Ahead of the Field

The University of Mississippi has not offered an advanced degree in medical marijuana despite its research on the substance, officials said. “We could not consider doing so due to our long-standing efforts to develop new cannabis-based therapies as (Food and Drug Administration) approved products, but we are now exploring the possibilities of a cannabis program here,” said Stanford.

From 2005 to 2015, the University of Mississippi was involved in discovering 43 new cannabinoids, which are generally considered the most pharmacologically active compounds in the plant, according to the university. “Our contributions to the understanding of the chemical makeup and biological properties of the Cannabis sativa plant has spanned several decades,” Stanford said. “The longtime use of cannabis for the treatment of glaucoma is another example of how we have been involved in the search for new cannabis therapies.”

The University of Maryland’s program provides a “grounding in the history of cannabis regulation in our country in order to participate in the development of well-informed medical cannabis policy moving forward.

Dr. Leah Sera

In the early 1970s, studies in both humans and animals indicated that smoking marijuana might provide relief for the intraocular pressure in the eyes, according to Stanford. Taking that a step further, the University of Mississippi conducted studies and provided the standardized cigarettes used in the studies conducted in the U.S. This evidence “led to one of the earliest expanded access programs by the FDA that allow patients access to unapproved treatments,” he said. The university’s research efforts also explored cannabis-based therapies for dry eye, macular degeneration and diabetic retinopathy.

Although the University of Mississippi was the sole contractor with the government for all these years, other researchers are seeking to grow marijuana for contracts now that the process is going to open to more than 30 other organizations and academic institutions. “The University of Mississippi applies for the contract just like everyone else,” said Dr. Mahmoud ElSohly, director of the university’s Marijuana Project and professor of pharmaceutics. “Our research capability, our expertise, our knowledge in the areas of cannabis chemistry and production our personnel and facilities—everything is in place to make us very competitive.” The Drug Enforcement Administration said it “anticipates that registering additional qualified marijuana growers will increase the variety of marijuana available for these purposes.”

Joseph A. Cantlupe is a freelance writer based in Washington, D.C.