Dispensing Cannabis

US Pharm. 2016;41(4):49-52.

Imagine a time when professional, licensed pharmacists would be dispensing marijuana products to patients. Seems a little far-fetched? That day is happening now. In at least three states, regulations and legislation have been adopted that allow such practices. In those states, pharmacists are entitled to make a profit from the sale of cannabis products. For some, this is enough incentive to risk violating federal government regulations.

It should be noted from the onset that medical marijuana is still classified as a Schedule 1 controlled substance under federal law. Thus, possession is a criminal offense. This has not stopped 23 states and the District of Columbia from enacting provisions that to one degree or another allow the use of marijuana by individuals. It is estimated that 1.4 million Americans are current cardholders of medical marijuana registrations.¹

New York

In New York, the Compassionate Care Act of 2014 puts pharmacists in charge of dispensing marijuana at up to 20 licensed facilities located throughout the state.² The law provides that a New York–licensed pharmacist must be on the premises where marijuana is sold or dispensed. As of January 2016, eight dispensaries (not pharmacies) were open and selling a variety of liquids, capsules, tinctures, concentrates, sprays, vapor pens, and other smokeless forms of cannabis products.³ New York law bans smokable and edible forms of marijuana products from being dispensed in the authorized facilities. The amount dispensed is not to exceed a 30-day supply. Interestingly, the law provides that there are only two New York State–mandated products for medical marijuana—one with an equal ratio of tetrahydrocannabinol (THC) to cannabidiol (CBD)—that must be offered by each dispensary. However, each facility will also offer other products that have varying ratios of THC to CBD.

Only about 200 patients were certified by the first of the year under the strict guidelines for the program’s eligibility, which requires certification by physicians registered by the state to authorize access to marijuana. The potential patient population in all of New York State has been estimated at between 100,000 and 400,000 patients.

The 220 or so physicians who signed up as willing to prescribe marijuana will be listed in the state’s Medical Marijuana Data Management System. The database is located online so that primary care or other treating doctors can make appropriate referrals to the registered prescribers.⁴

The medical criteria for a patient’s ability to use marijuana in New York are limited. Cancer, HIV/AIDS, amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), Parkinson’s disease, multiple sclerosis, intractable spasticity caused by damage to the nervous tissue of the spinal cord, epilepsy, inflammatory bowel disease, neuropathies, and Huntington’s disease are the qualifying conditions. The associated or complicating conditions are cachexia or wasting syndrome, severe or chronic pain, severe nausea, seizures, or severe or persistent muscle spasms. The law indicates that the condition must be specific, severe, or life-threatening. The state is able to add other qualifying diagnoses to the list at a later date if the medical literature supports findings that marijuana could be helpful in moderating or eliminating symptoms. According to state documentation, “To date, scientists and physicians at the Department of Health have already analyzed more than 2 dozen scientific studies on Alzheimer’s, muscular dystrophy, dystonia, posttraumatic stress disorder, and rheumatoid arthritis. They also sought input from medical professionals and associations. Despite these comprehensive reviews, there is not enough scientific evidence at this time to support the inclusion of additional conditions to the Medical Marijuana Program. However, the [state] has not stopped its review, and will evaluate new scientific evidence as soon as it becomes available.”⁴

While New York does not set the pricing of marijuana per se, the regulations do require dispensaries to submit their costs to manufacture, market, and distribute products and certify that the information is accurate. The state then determines the reasonableness of proposed charges. Approved prices stay in effect until July 30, 2017, or until the state approves a price change. New products will be similarly regulated as they become available.

Nothing comes cheap. Each applicant for one of the initial five licenses had to submit a nonrefundable $10,000 fee. Approved licenses cost $200,000. Start-up costs were estimated to be around $2 million for each facility.⁵ Forty-three companies submitted applications; five winners were chosen, with each allowed to open up to four dispensaries.

Wegmans School of Pharmacy at St. John Fisher College in Rochester held a day of medical marijuana training sessions for local pharmacists in January 2016. Approximately 80 pharmacists attended and showed interest in preparing for the role of dispensing marijuana. “We want to ensure that patients know how to take their medication effectively and how to manage any side effects that might occur, and how to prevent medication errors associated with medical marijuana therapy,” said Karl Williams, JD, associate dean of academic affairs at Wegmans School of Pharmacy.⁶

Connecticut

With one of the most restrictive medical marijuana programs in the country, Connecticut requires pharmacists to own and operate dispensaries. Pharmacists have been dispensing cannabis in that state since 2015. Six medical marijuana dispensaries were originally licensed in the state to sell marijuana under the control of a board-certified pharmacist.⁷ An additional three licenses were authorized in the middle of this year because of “significant growth” in patient registration.⁸ Patients are required to obtain an authorization from a Connecticut-licensed physician to register for the medical marijuana program. As part of the registration process, patients must also indicate their preferred dispensary and have to reregister if they want to change dispensaries. Patients can receive up to 2.5 ounces of marijuana in a 30-day period, which is tracked by the dispensary.

The conditions for which marijuana can be prescribed are similar to those previously listed for New York State. Unlike those in New York, patients in Connecticut may purchase products for smoking and edibles as well as other forms of marijuana. Connecticut pharmacists have asked the Department of Consumer Protection (DCP) to mandate standards for dosing, labeling, conversion, and equivalency factors when converting from inhaled to ingestible products, as well as for consistency of the medical marijuana product and supply. Although these products are mandated to have labels stating CBD/THC percentages and expiration dates, there are no standards regarding how the information has to appear. Along with the DCP, growers test and examine every cannabis strain in the products that Connecticut dispensaries are authorized to sell. The goal of this quality control measure for medical cannabis is the same as it would be for pharmaceutical testing, and it is also helping to standardize medical cannabis. Information from growers about dosing on the packaging is also meant to help pharmacists more accurately dose cannabis to patients.

Connecticut law classifies marijuana as a Schedule II controlled substance. Medical cannabis goes through the same process as other controlled substances in Connecticut, meaning it is tracked through the state’s Prescription Monitoring and Reporting System, a database updated weekly with patients’ prescription data. The DCP knows who is prescribing and dispensing and to which patient. The database also allows a participant to include notes about the effect cannabis has on a patient’s symptoms and conditions and how it interacts with other drugs the patient might be taking. Of the state’s 10,000 physicians, about 230 are authorized to certify the approximately 8,200 registered users of marijuana.⁹ An estimated population of 20,000 people in the state may be eligible to use marijuana.

Originally, only one entity was licensed to grow and distribute marijuana to the dispensaries. Now there are four growers, and prices for marijuana have come down due to the competition.⁸

Minnesota

Since July 2015, pharmacists may only dispense marijuana in one of the three up and running dispensaries in Minnesota.¹⁰ The law will allow up to eight dispensaries.¹¹ State-licensed medical doctors, physician assistants, and advance practice registered nurses can certify patients for medical marijuana use. They do not actually “prescribe” marijuana. Two entities are licensed to grow marijuana in Minnesota. Medical cannabis that is sold in Minnesota will consist of THC and CBD with an emphasis on higher concentrations of CBDs. The law also only allows the product to be produced in tablet, liquid, and vaporized forms, not in a smokable form. Patients who are enrolled in the medical cannabis program are automatically enrolled in a medical cannabis trial, which means researchers will be able to study its use.

The medical conditions that qualify under Minnesota’s law include glaucoma, HIV/AIDS, Tourette syndrome, ALS, seizures, Crohn’s disease, and severe and persistent muscle spasms. Patients with cancer or a life expectancy under 1 year also qualify if they suffer from severe or chronic pain, nausea or vomiting, or severe wasting.¹²

The Board of Pharmacy is not involved in the regulation of marijuana in Minnesota; that is left to the Department of Health.¹³

Importance of Federal Law

As noted above, marijuana remains a Schedule I drug under federal law. Schedule I drugs are deemed to have no legitimate medical use and have a high potential for abuse. The U.S. Constitution provides that federal law is supreme to state law.¹⁴ Generally, states may enact laws that are more stringent than federal laws, but not more lenient. A state has no power to lower this classification. So how do states get away with enacting laws legalizing the possession and dispensing of marijuana? The answer is a concept called selective enforcement. This occurs when an agency responsible for the enforcement of a law decides to not enforce that particular law.

An earlier example of this concept was the importation of prescription drugs from Canada. The FDA stated that all drug importation was illegal, but it exercised discretion and would not prosecute individuals bringing in prescription drugs for their own use. In essence, the activity is still illegal, but the current administration chooses to do nothing about it. The caveat here is that the agencies always have the ability to change their minds.¹⁵

The current position of the Drug Enforcement Administration (DEA) is that it has enforcement priorities for marijuana, including: “1) prevent distribution to minors; 2) prevent revenue from the sale from going to criminal enterprises; 3) prevent diversion from states where it is legal under state law to those states where it is not legal; 4) prevent state-authorized marijuana activity from being used as a pretext for trafficking other illegal drugs or other illegal activity; 5) prevent violence and the use of firearms in the cultivation and distribution; 6) prevent drugged driving and the exacerbation of other adverse public health effects; 7) prevent the growth on public lands; and 8) prevent possession or use on federal property.”¹⁵

Currently, the DEA will not take any action in states that have legalized marijuana if the states agree to help with these priorities. Therefore, individuals who possess marijuana for personal use on private property in those states will not face DEA prosecution at this time. Because they do not possess it for personal use, in the opinion of some attorneys, a pharmacist dispensing marijuana is not covered by this exception.¹⁵ Pharmacists must be diligent in making sure their dispensing does not violate one of these enforcement priorities. The DEA has made it clear that it will change its stance if it believes a state is too lax in assisting with enforcement priorities.

In 2009, the U.S. attorney general stated that it was not a priority for the Department of Justice to prosecute people who used marijuana for medical purposes, but people using it illicitly would be prosecuted.¹⁶ A different administration might choose to enforce the current laws. In 2011, a petition was raised to the DEA to reschedule cannabis, but it was denied with the statement that marijuana still has no scientific or medical evidence for its use.¹⁶

In June 2014, the FDA announced that it intends to conduct an eight-factor test to determine whether cannabis should be rescheduled.¹⁶ In July 2014, the Charlotte’s Web Medical Hemp Act of 2014 (HR 5226) was introduced to amend the definition of marijuana in the Controlled Substances Act (CSA) and to exclude medical marijuana from federal controlled substance lists,¹⁶ but it apparently died in committee.¹⁷

In March 2015, several U.S. senators introduced the Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 (S 683), which would transfer medical marijuana from Schedule I to Schedule II of the CSA.¹⁸ The CARERS Act, called the “most comprehensive piece of federal medical marijuana legislation ever introduced,” would remedy the state-federal conflict over medical cannabis law.¹⁹ It would also allow veterans to have access to medical marijuana within the Veterans Affairs (VA) healthcare system, eliminate current barriers to research, permit marijuana dispensaries to access banking services, and deschedule CBD entirely.

Conclusion

Conflicting federal and state law creates a scenario in which pharmacists can be acting lawfully under state law while simultaneously being at risk of federal prosecution.¹⁶ For this reason, pharmacists have been reluctant to be involved with medical marijuana. Federal prosecution could result in severe consequences such as fines and imprisonment. Another concern is that the pharmacy could lose its DEA registration, leading to the inability to dispense controlled substances.

REFERENCES

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2. Compassionate Care Act. Bill no. A06357E. New York State Assembly. March 26, 2013. http://assembly.state.ny.us/leg/?bn=A06357E&term=2013&Summary=Y&Actions=Y&Votes=Y&Memo=Y&Text=Y. Accessed February 27, 2016.
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13. Minnesota Board of Pharmacy. General FAQs. https://mn.gov/boards/pharmacy/resourcesfaqs/faqs/generalfaqs.jsp. Accessed February 28, 2016.
14. U.S. Constitution. Article VI. “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, anything in the Constitution or Laws of any State to the Contrary notwithstanding.”
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17. HR 5226—Charlotte’s Web Medical Hemp Act of 2014. Introduced July 28, 2014. www.congress.gov/bill/113th-congress/house-bill/5226. Accessed March 15, 2016.
18. S 683—The Compassionate Access, Research Expansion, and Respect States Act of 2015. Introduced March 10, 2015. www.congress.gov/bill/114th-congress/senate-bill/683. Accessed March 15, 2016.
19. Momentum builds for the CARERS Act as patients prepare to come to D.C. Huffington Post. March 15, 2016. www.huffingtonpost.com/steph-sherer/momentum-builds-for-the-c_b_9470034.html. Accessed March 15, 2016.

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