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Marijuana in Missouri- What Pharmacists Should Know

16 Sep 2018 9:54 PM | Anonymous

Marijuana in Missouri-What Missouri Pharmacists Should Know
Authors: Sierra Richard, PharmD Candidate, Sarah Cox, PharmD, MS and Mary Durham, PharmD, MS, BCPS

Epidiolex
On June 25, 2018, the Food and Drug Administration (FDA) approved the first drug containing a “purified drug substance derived from marijuana”, Epidiolex. This new medication differs from medications such as dronabinol and nabilone that are synthetic derivatives of marijuana based on how the medication is manufactured.1 Epidiolex is a cannabidiol oral solution approved for the treatment of two forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two year of age and older. Both syndromes occur early in childhood and pediatric pharmacists and community pharmacists may start seeing prescriptions for Epidiolex in this population soon. At the time of approval, Epidiolex is the only FDA approved medication for Dravet syndrome giving this population a proven treatment option for the first time.2 However, another medication for the treatment of Dravet Syndrome, Diacomit (stiripentol) was approved by the FDA on August 20, 2018 which may influence the use of Epidiolex in practice.3

Legal Challenges
Dispensing this medication may come with legal questions. First, cannabidiol (CBD) is a schedule I substance under the Controlled Substances Act. Since Epidiolex was approved, the Drug Enforcement Agency (DEA) has ninety days from the time of FDA approval to reconsider the schedule of CBD to legally allow Epidolex to be administered.2 The ninety-day deadline is September 23, 2018. At the time of writing, no statements regarding the marijuana rescheduling process have been published. Additionally, Missouri state law restricts the use of CBD oil. Under current state regulations, patients who have an intractable epilepsy may be approved for a Missouri Hemp Extract Registration Card after receiving a signed statement from a licensed Missouri neurologist indicating that the patient may benefit from the hemp extract treatment. This waver allows patients who are 18 year or older, or the parent or legal guardian of a minor to legally possess more than twenty ounces of CBD oil containing less than 0.3% tetrahydrocannabinol [THC] (the psychoactive component of cannabis). There are two licensed facilities in Missouri that can dispense CBD oil. The Missouri Hemp Extract Registration card is valid for one year and may be renewed by the neurologist annually. Since the program’s inauguration in 2014, 331 cards have been issued and 148 remain active. Of the currently active cards, 125 are for the treatment of minors.4

In December of 2016 the DEA established a new drug code for marijuana extract which would improve tracking of these products. However, in their statement, they reinforced that extracts of marijuana were still classified as a schedule I controlled substance.5 Prior to this, the part of the marijuana plant that hemp was extracted from (the stalk) was excluded from the Controlled Substance Act definition of marijuana.6 Despite these regulations, many stores in Missouri cities, including Columbia, have started selling cannabis extract without a Missouri Hemp Extract Registration Card or any medical oversight.7

Legal challenges surrounding possession of Epidiolex2 or other CBD4 oil products may bring new complexities in the care of institutionalized patients. Current regulatory status should be considered when assessing the addition of a CBD oil product to the pharmacy formulary, or developing a protocol to accommodate dispensation of a patient’s home therapy. Every step in the medication use process should be assessed, taking into account high risk points for diversion including procurement and storage, unit dose dispensation of an oral liquid controlled substance, administration, documentation, and waste. Understanding the legality of CBD possession by specific patients4 is paramount to maintaining compliance with current state and federal regulations; this may dictate the fine line between whether a patient has a product lawfully or illicitly, and the role of the pharmacist to facilitate access to safe and appropriate therapy.

Pros and Cons of Medical Marijuana
Research conducted regarding medical marijuana has shown that it can help reduce pain and nausea for patients suffering from cancer and other illnesses in addition to reducing the number of seizures in patients who are refractory to other treatment options.8 Additionally, a study published in the August 2014 edition of JAMA Internal Medicine found that states with legalized medical marijuana had decreased opioid related deaths compared to states where it was not legal between 1999 and 2010.9

However, concerns arise on the long-term effects of marijuana. Reduced regulations likely would lead to increased access to minors. Current research has shown that chronic marijuana use by pre-adolescents and those in their early 20s can lead to a diminished IQ, increased risk of dropping out of school, and increased risk of respiratory problems. Furthermore, there is mixed evidence on the safety of operating a motor vehicle after using marijuana. This becomes increasingly difficult to determine as the metabolites of marijuana remain in the body for days to weeks after use. 8


What does this mean for Missouri pharmacists?
Currently, Missouri pharmacies can legally dispense synthetic THC derivatives such as dronabinol and nabilone given that they are classified as schedule III and schedule II medications, respectively. However, with the FDA approval of Epidiolex it is possible that the DEA schedule of marijuana could change. In addition, there are will be three initiatives supporting medical marijuana legalization on the Missouri ballots in November10. If legislative changes occur, institutions may need to consider updating policies regarding the handling of CBD oil.


Resources:

1. marinol.com [Internet]. North Chicago (IL): AbbVie Inc.; c2017 [cited 2018 Sep 2]. Available from: http://www.marinol.com/hcp/differences-from-medical-marijuana

2. fda.gov [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2018 [cited 2018 Sep 2]. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm

3. fda.gov [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2018 [cited 2018 Sep 2]. Available from: https://www.fda.gov/Drugs/InformationOnDrugs/ucm618455.htm

4. health.mo.gov [Internet]. Jefferson City (MO): Missouri Department of Health & Senior Services; c2014 [updated 2018 June 30; cited 2018 Sep 2]. Available from: https://health.mo.gov/about/proposedrules/hempextract.php

5. gpo.gov [Internet]. Springfield (VA): U.S. Department of Justice Drug Enforcement Administration; c2016 [cited 2018 Sep 2]. Available from: https://www.gpo.gov/fdsys/pkg/FR-2016-12-14/pdf/2016-29941.pdf?utm_campaign=subscription%20mailing%20list&utm_source=federalregister.gov&utm_medium=email

6. deadivision.usdoj.gov [Internet]. Springfield (VA): U.S. Department of Justice Drug Enforcement Administration; c1990 [cited 2018 Sep 2]. Available from: https://www.deadiversion.usdoj.gov/21cfr/21usc/802.htm

7. columbiatribune.com [Internet]. Columbia (MO): Columbia Tribune; c2017 [cited 2018 Sep 2]. Available from: http://www.columbiatribune.com/news/20171223/stores-sell-cannabis-extract-despite-state-regulations

8. health.usnews.com [Internet]. Washington, D.C.: U.S. News & World Report; [cited 2018 Sep 2]. Available from: https://health.usnews.com/health-news/patient-advice/articles/2016-10-12/marijuanas-public-health-pros-and-cons

9. Bachhuber M. Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010. JAMA Intern Med [Internet]. 2014 [cited 2018 Sep 2]; 174(10): 1668-1673. Available from: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1898878

10. www.sos.mo.gov [internet]. Jefferson City (MO): Missouri Secretary of State; [cited 2018 Sep 9]. Available from: https://www.sos.mo.gov/default.aspx?PageId=9456


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