As more states legalize marijuana, more physicians have begun recommending cannabis to their patients for the management of pain, nausea, anxiety, and loss of appetite. Recent literature also suggests that cannabis may be effective in treating other conditions. For example, the Federal Food and Drug Administration (FDA) recently approved a drug whose active ingredient is an extract from the marijuana plant, cannabidiol (CBD), for the treatment of a rare form of epilepsy. Some physicians would like to prescribe marijuana or marijuana extracts for hospital patients and have asked that these substances be added to the hospital formulary, but strictly speaking it that would require the breaking (or bending) of federal regulations.
Here Greeley paints a picture of the current state and federal situation and suggests a few approaches hospitals might consider if they choose to support the use of marijuana in the hospital environment.
State of the States
- It remains illegal to possess or provide marijuana in some states. For example, it is still a felony to possess cannabis in Alabama.
- Currently, 31 states allow the use of marijuana and marijuana extracts for medical purposes. In these instances, marijuana extracts may be obtained from cannabis dispensaries, not pharmacies, with the authorization, not prescription, of a state-approved prescriber — typically a physician with a state-issued medical marijuana card.
- Nine states now allow recreational marijuana use.
The Federal View
The marijuana plant is classified as a Schedule I substance along with heroin, LSD, ecstasy, and peyote. Marijuana extracts too!
The Federal Drug Enforcement Agency (DEA) maintains five lists, or “schedules,” of the substances it controls. Schedule V lists the most benign medications and Schedule I lists those that are all but prohibited. The marijuana plant (drug code 7360) is classified as a Schedule I substance along with heroin, LSD, ecstasy, and peyote. Marijuana extracts (drug code 7350), including tetrahydrocannabinol (THC), cannabinol (CBN), and cannabidiol (CBD), are also listed as Schedule I substances.
- The DEA requires an individual or organization to possess a valid certificate to receive, store, dispense, provide or prescribe any “scheduled” medications in situations where interstate commerce is involved and by Medicare providers, including practitioners and hospitals.
- With rare exceptions, the DEA does not issue Schedule I certificates to physicians or hospitals. Such certificates are only issued for special situations, such as use in an approved clinical trial with a very narrow use case. With rare exceptions, the DEA does not issue Schedule I certificates to physicians or hospitals.
Physicians and hospitals have the option of prescribing, dispensing, and administering THC in the form Marinol (dronabinol). This drug is listed on the DEA’s Schedule III and has been approved by the FDA for many years for chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS.
Pressure from CBD advocates
There is growing pressure on the DEA to remove the marijuana extract CBD from Schedule I. CBD is reported to have most of the medical benefits of marijuana without the side effect of intoxication. CBD is commonly used by individuals undergoing chemotherapy for appetite stimulation, anxiety relief, and other benefits. Advocates argue that there is little risk of abuse. The DEA, however, has taken a strict interpretation of the definition of “marijuana” as used in the federal drug classification statute: since CBD can be extracted from the potent parts of the marijuana plant (flowers, etc.), the DEA continues to list it in Schedule I.
Stay tuned: On June 21, 2018 the FDA approved Epidiolex® (active ingredient CBD) to treat a rare form of epilepsy. This may trigger the removal of CBD from Schedule I. We’ll have to see. Keep in mind that dronabinol (Marinol — above) is a Schedule III medication even though its active ingredient, THC, remains on Schedule I.
Why can I buy it down the street, but I can’t use it in the hospital?
There are domains where the state rules apply, and domains where the federal rules apply, which are best explained by constitutional scholars. Put simply, the federal rules apply when 1) interstate commerce is involved, or 2) the federal government is paying.Federal rules apply when 1) interstate commerce is involved, or 2) the federal government is paying.
So, in some states an individual may buy marijuana, THC, CBN, or CBD at a local retailer, but (for now) the hospital can’t receive, store, dispense, order, or administer any of these substances while dealing with interstate suppliers and/or while accepting federal payments (from Medicare, Medicaid, among others.)
Confused? You are not alone.
Hospitals continue to struggle with the disconnect between state and federal requirements and there is no consensus approach. We, therefore, offer the following “thought stimulators” for hospitals attempting to navigate these murky waters.
Option 1: Just say no
Even though it may be legal for the patient to possess and use marijuana in your state, the hospital may choose not to allow possession on hospital property. Hospitals adopting this approach treat any recognizable marijuana as it would any other “contraband” like firearms: legal, but not allowed on hospital property. Policies typically ask the family to take disallowed items home. Otherwise, illegal items are usually turned over to authorities by security according to local protocol. It is important that pharmacy and pharmacy personnel not be involved in the holding of marijuana in any form not approved by the FDA. It is incompatible with their overall responsibility for compliance with DEA and FDA requirements.
This “just say no” approach would not necessarily apply to discharge instructions, which are not orders. Discharge instructions are the physician’s recommendations for post-hospital care. Although we urge you to involve your legal counsel and risk manager in the discussion, we see no regulatory vulnerability should the hospital include any otherwise legal product or activity in the discharge instruction process.
Also, the patient’s medication history recorded upon admission should include herbal preparations, including marijuana or its extracts.
Option 2: Allow recreational use
Hospitals may simply ignore the legal use of marijuana by an individual patient as long as it is not in conflict with his or her treatment plan or other hospital policies. There are a number of speed bumps down this road, so consider the following:
- Pills, liquids, or oils containing marijuana extracts are similar to medications, except that they are not FDA approved. They cannot be “administered” by hospital staff and most hospitals do not allow the self-administration by inpatients of non-FDA-approved (e.g. herbal) preparations. If they are legal in the state, the family should be asked to take these products home when possible. If that’s not an option, security (or another department other than pharmacy) should hold the material until discharge following standard procedures.
- Smoking marijuana, like smoking tobacco, is typically prohibited in hospital buildings and, in most cases, anywhere on hospital property. The Joint Commission allows patient-specific exemptions, but most hospital policies do not.
- “Vaping” is lumped in with smoking by the Joint Commission, but hospitals may make patient-focused exemptions for vaping if they desire.
- Brownies or other edibles brought in from the outside would be handled according to hospital policy.
- Outpatients can typically eat whatever they want (unless they are NPO.)
- Inpatients on a regular diet may or may not be allowed consume food from home, depending on hospital policy.
- Food from the outside is usually prohibited for patients on a therapeutic diet.
Again, Option 2 is not for the faint of heart and should be explored only with very careful consideration by individuals with a comprehensive and in-depth knowledge of applicable external requirements (state marijuana laws, accreditation rules, CMS regulations, etc.)
Option 3: Allow use upon a physician’s order (not an option)
We cannot see any way for a hospital to allow a prescriber to order the administration of marijuana or marijuana extracts that are not approved by the FDA.
We would also advise against the hospital allowing physicians to issue orders authorizing the recreational use of marijuana during the patient’s stay … it cuts too close to the line of prescribing. As it says along the borders of ancient world maps, “There be dragons here.”
Conclusion (for now)
This is a rapidly-changing subject. Momentum is currently on the “legalize” side of the tug of war. But we see few options (other than plausible deniability) for hospitals wishing to acknowledge the use of an otherwise legal substance in the hospital setting.
The Greeley Company would like to thank D Ross Consulting and Ken Rohde for their consultation in the preparation of this post.
- Borgelt, L., Franson, K: Considerations for Hospital Policies Regarding Medical Cannabis Use; Hospital Pharmacy, 2017 Feb; 52(2): 89–90.
- Wikipedia, Legality of cannabis by U.S. jurisdiction
- American Pharmacists Association. 2014–2015 APhA Policy Committee Report: Role of the pharmacist in the care of patients using cannabis.
- U.S. Department of Justice, Drug Enforcement Information, Diversion Control Division: Practitioner’s Manual – Section II.
- newcannabisventures.com, How FDA Approved Cannabis Products Could Affect CBD Distribution Channels. April 23, 2018
- FDA News Release. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. June 25, 2018
The Greeley Company works with hospitals and health systems to identify and evaluate options when state and federal regulations and accreditor requirements make decisions more complex than they need to be. Let’s start the conversation about your most challenging policy and compliance decisions.