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Managing Medical Marijuana in the Health-System Pharmacy
November 2011 - Vol. 8 No. 11 - Page #10

Marijuana, a drug derived from the Cannabis sativa plant, has been cultivated for thousands of years for agricultural, medicinal, and recreational use throughout the world. In the United States marijuana has a storied past, transforming from an essential crop to a demonized evil; in recent years, interest in its various medicinal properties has undergone an important rebirth as a possible medical panacea. In Colonial America, marijuana was so valued that “must-grow” orders for farmers were implemented. Thomas Jefferson wrote drafts of the Declaration of Independence on hemp paper, derived from the cannabis plant. However, in the early 1900s, marijuana use was denounced through a series of political and journalistic campaigns and was eventually taxed out of use in 1937. In 1970, the Controlled Substances Act formally outlawed marijuana, and it was not until California legalized its use for medical purposes in 1996 that its resurgence became a national issue. Today physicians and pharmacists stand at a crossroads, trying to balance the science versus the myth.  

The use of marijuana for medical purposes has become a hot button topic in the US, as 16 states, plus the District of Columbia, have now passed laws supporting its use to treat certain conditions (for states where medical marijuana is legal, see Table 1). Although the scientific community has not yet reached consensus on its safety and efficacy, facilities operating in states where patients might be using medical marijuana must develop a clear understanding of the drug and the complicated medical and legal issues surrounding its use. 



Background
A complex drug, marijuana is comprised of hundreds of active chemicals, including approximately 60 classified as cannabinoids, which exert a number of  physiological effects through an endocannabinoid system in the body. The primary psychoactive cannabinoid of marijuana is believed to be delta-9-tetrahydrocannabinol, or THC (see Figure 1). This component has been isolated, synthetically manufactured, and marketed for sale in the US as Marinol (dronabinol), which is FDA-approved for treatment of anorexia associated with weight loss in patients with AIDS, as well as nausea and vomiting related to cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Keep in mind that it is not an FDA-approved form of marijuana; rather it is a single cannabinoid, whereas marijuana is a much more complex drug and its myriad active substituents are believed to be responsible for its widespread utility and varying effectiveness. 

As a medicine, marijuana is most often administered by smoking a rolled cigarette (joint) or through a vaporizer, or eating, usually in baked goods, although a multitude of other products also are available. The use of a vaporizer minimizes the harmful toxins associated with smoking marijuana and is considered the preferred smoked route of administration. Marijuana can also be distilled down to make oil and butter, which is then used in a variety of recipes. Recently, marijuana-containing beverages, including soda, also have become available. 

Legal Framework
Currently, marijuana is regulated federally as a schedule I controlled substance in the US, meaning the drug has been deemed to have a high potential for abuse, no currently accepted medical use, and a lack of accepted safety. This is the most restrictive schedule the Drug Enforcement Administration (DEA) maintains. Simply put, it is illegal to possess, grow, or distribute marijuana in the US. Meanwhile, the 16 states and the District of Columbia, which have legalized marijuana for certain medical purposes under state and local law, created a perceived conflict of law, as well as definite confusion among many physicians, pharmacists, and patients. 

However, a closer look at the situation provides a clear understanding and appreciation of the risks. Most marijuana arrests—99% in fact—are local, meaning they involve town or state police rather than federal agents, who usually target the most prominent violators1; only 1% of arrests involve the DEA or federal marshals. Accordingly, if a state chooses to legalize marijuana for medical purposes, the risk of arrest is extremely low if patients are in compliance with the applicable state law. Federal police are unlikely to investigate or arrest individuals for simple marijuana possession for medical purposes; their objective is to catch major offenders and spend their resources accordingly.  

Recent Developments
The federal government issued important guidance on October 19, 2009, concerning its “enforcement discretion” of prosecution for medical marijuana use. The Ogden Memo, as it has become known because it was signed by David Ogden, a department of justice deputy attorney general, simply stated that the federal government does not intend to use “Federal resources in states on individuals whose actions are in clear and unambiguous compliance with existing state laws providing for the medical use of marijuana.”2 This was a welcome notice for states that have enacted medical marijuana laws and the patients properly registered in these states. The guidance further states that the federal government maintains its rights to investigate and criminalize violations of the Controlled Substances Act, especially when state law is used as a pretext to circumvent the federal law. 

In April 2011, a number of US attorneys issued guidance to their respective state government officials, reminding them that marijuana remains illegal under federal law and that many state distribution channels violate the Ogden Memo and are susceptible to criminalization. In June 2011, the US attorney general’s office issued another memo to US attorneys, advising them that large cultivators and distributors of medical marijuana remain at risk of criminalization and should not be considered protected under state law. Consistent with the Ogden Memo, it reiterated that individual patients and caregivers in compliance with state law will not be targeted; however, industrial cultivation centers and commercial marijuana clubs may be. 

In sum, the terrain surrounding medical marijuana use remains rocky and unsettled at this time. The drug is illegal under federal law, despite a number of states that have passed medical marijuana legislation. In states that have approved such laws, patients use marijuana at risk of federal enforcement discretion and subject to a myriad of risks. 



Clinical Practice
Marijuana is generally used to treat five conditions: pain, nausea and vomiting associated with chemotherapy and surgery, weight loss associated with debilitating diseases such as HIV and cancer, neurological and movement disorders such as multiple sclerosis/Parkinson’s disease/seizures, and other miscellaneous diseases such as glaucoma, Crohn’s disease, and mood disorders. 

State programs typically require a physician’s recommendation and participants are issued a state registry card to prove their eligibility. Doctors do not prescribe marijuana and pharmacies do not stock or fill prescriptions for it, as physicians, hospitals, clinics, and pharmacies are registered with the DEA and marijuana is a schedule I controlled substance within their jurisdiction. Thus, patients are left in a complicated legal labyrinth wherein they often must obtain product from an illegal source or cultivate it on their own without the protection of pharmacies and pharmacists. Additionally, as the potency of marijuana varies greatly, patients are left trying to dose themselves to maximize benefit while minimizing the central nervous system effects, with little data on the long-term health consequences. Also, although state laws may allow for medical marijuana use, the courts have been slow to provide security. Employment drug testing, family law custody battles, eviction notices, and driving under the influence likely have little or no protection under state medical marijuana law. 

As a result of this maze, a number of marijuana clubs and cooperatives have sprouted up to offer patients a wide selection of products at competitive prices, often providing delivery services and access to advice from individuals experienced in marijuana use. Denver currently has more marijuana dispensaries than liquor stores, Starbuck’s coffee shops, or public schools.3 However, adding fuel to this complicated debate, these locations have sometimes been found to be fronts for money-laundering activities and often operate outside of the protection of the medical marijuana laws of the states. 

Efficacy
The clinical evidence in support of the effectiveness of marijuana to treat medical conditions is sparse, which further complicates the issue. The legal, ethical, and practical challenges involved in studying the drug pose significant barriers to researching its effectiveness. Because the drug is a schedule I controlled substance and is deemed to have no medical benefit, the available clinical evidence generally involves small populations, short study durations, mixed methods, and shows varying outcomes. Nevertheless, the efficacy of marijuana has been documented in a number of esteemed journals; in 2010, the Canadian Medical Association Journal published a quality report that marijuana use caused a statistically significant improvement in chronic neuropathic pain compared with placebo, although the clinical significance was marginal. Additionally, the study found a dose-related response in adverse effects.4 However, more research is necessary before any conclusions regarding marijuana’s safety and efficacy can be considered definitive. 

Health and Economic Risks
The health risks of marijuana are many and varied. A true assessment of the dangers, however, remains challenging, because given the drug’s illegal status, many do not disclose their use and no widespread vigilance program exists to assess risk. Complicating these issues, users oftentimes concomitantly use other drugs and alcohol illicitly with marijuana, making a true evaluation of marijuana risk difficult. 

Nevertheless, some risks effecting the cardiovascular, respiratory, and central nervous systems have been well documented. Marijuana increases heart rate, alters blood pressure, and increases myocardial stress. Smoking marijuana is associated with chronic bronchitis and wheezing, and may increase the risk of lung cancer. It also can cause dizziness, memory and learning deficits, sleep disturbances, bone loss, decreased male fertility, periodontal disease, and immune suppression. Additionally, the drug can cause addiction, dependence, and withdrawal symptoms. 

Marijuana may be involved in a number of important drug-drug interactions, including warfarin, surgical anesthetics, and protease inhibitors, all which can pose significant health risks. Additionally, marijuana use can complicate the treatment of psychiatric illnesses, including depression, bipolar disorder, psychoses, and schizophrenia.  

Marijuana is considered the most widely available and widely used illicit drug in the US. In 2001, there were more than 5,000 hospital discharges where marijuana dependence or abuse was the primary diagnosis, although this number is significantly lower than those for alcohol (168,000), heroin (56,000), or cocaine (21,000). Interestingly, the mean length of stay was much higher with marijuana dependence—three times longer than alcohol or heroin dependence, and the mean cost associated with hospitalization was twice as high as the others.5

Institutional Concerns
Based on the numerous legal, practical, clinical, social, economic, and philosophical concerns surrounding marijuana, institutional pharmacy administrators are left in a challenging predicament. Hospital pharmacy practice is charged with offering patients the best medical care available, including drugs, which may at times involve marijuana. However, as the legal landscape involving marijuana is unsettled, offering such resources involves risk—potentially dire risk. Additionally, the published clinical benefit of marijuana is unconvincing at this time. 

In states where medical marijuana use is illegal, there is not much of a role for institutional practitioners beyond vigilance and awareness. However, in states where medical marijuana is legal, one should recognize that the government of that jurisdiction has demonstrated its acceptance of this treatment and its desire to make it available to authorized patients; in these states, pharmacy should consider ways to integrate marijuana into patients’ pharmaceutical care program, if its use has been recommended by physicians and patients are willing to accept it.

TJC has not drafted any policies addressing marijuana use in the institutional practice setting and is currently evaluating the situation. Clearly, smoking marijuana in the hospital is impractical and illegal, but other possibilities exist, and a number of questions still need to be answered.

  • Consumption of marijuana in public is generally prohibited in states that have programs. However, is a patient’s hospital room considered a public place or a private place for that purpose?
  • Should the consumption of marijuana-containing foods be permissible? 
  • Should patients be screened for marijuana use and counseled/advised by pharmacists? Should this screening be performed during routine medication reconciliation or during a drug screen? Do pharmacists have sufficient knowledge and training to perform counseling involving marijuana? 
  • If patients use medical marijuana compliant with state law, should they be allowed a temporary discharge from the hospital to go outside and smoke? 
  • Who should answer these questions, general counsel or physician specialists? 

These are complex questions without obvious answers. Therefore, a stepwise approach to medical marijuana in the institutional pharmacy practice setting is a rational approach to adopt (see Table 2).

Adopting a Facility-wide Policy
Each individual institution should consider implementing and adopting a policy on the use or avoidance of medical marijuana. A good starting point is a needs assessment to determine the potential role and acceptance. Each hospital should carefully consider its jurisdiction and community standards. All relevant health care professionals and institutional administrators must be educated on the role of medical marijuana and asked to provide input on their experiences and beliefs. 

Knowledge of any physicians in-network who recommend or support medical marijuana should be shared and these doctors consulted for insight and experience. Staunch opponents to medical marijuana also should be consulted, and a discussion on the risks and merits should be held with patience and understanding. Ultimately, a consensus must be established like any decision made in the institution, relying on various key stakeholders.  

Institutional legal counsel and local and federal law enforcement should then be consulted and a risk assessment determined. If a decision is made to integrate medical marijuana into care, preparation should occur to minimize liability and risk. This includes not providing any particular source of product to patients and identifying appropriate patients and indications. Pharmacists should be involved in medical marijuana reconciliation with attention to frequency and route of administration, and patients should be permitted to use their own medication.  Acceptable indications should be established through an evidence-based approach, relying on the best clinical evidence available. Monitoring and follow-up are necessary, thus appropriate duration and testing must be determined. Patients should be provided with a safe location to administer the drug and educated on the risks associated with medical marijuana. There should be safeguards in place, such as required registration in state medical marijuana programs, which should be verified and confirmed continuously. Other safeguards include a signed release and waiver of liability and an assumption of risk. All policies and documentation should be routinely audited, for example, on a bi-yearly schedule, as this area is actively changing. Medication use evaluations should be conducted to compare actual use against established standards of care in the institution, and the findings reported and discussed.  

Conclusion
Medical marijuana continues to be a hot topic. The drug may well have a proper clinical place; however, until the controversial political embers surrounding its use burn out, patients will be at risk and the scientific evidence will lag. Institutional pharmacy administrators are in a unique position to advocate for the best clinical resources, including marijuana; however, they clearly must work within the narrowest confines of the law. Removing any layer of obstruction will likely bring patients closer to using medical marijuana, just as adding any impediment will hinder their access to this unusual product. In the meantime, hospital pharmacy leaders must maintain increased vigilance when practicing in this rapidly changing arena. 

References

  1. Okie S. Medical marijuana and the Supreme Court. N Engl J Med. 2005;353(7):648-651.
  2. US Department of Justice, Office of the Deputy Attorney General David W. Ogden. Memorandum for selected United States attorneys: Investigations and Prosecutions in States Authorizing the Medical Use of Marijuana, October 19, 2009. www.justice.gov/opa/documents/medical-marijuana.pdf Accessed August 23, 2011.
  3. The Denver Post. As Dispensaries Pop Up, Denver May Be Pot Capital, U.S.A. Christopher N. Osher. www.denverpost.com/ci_14112792. Accessed August 23, 2011.
  4. Ware MA, Wang T, Shapiro S, et al. Smoked cannabis for chronic neuropathic pain: A randomized controlled trial. CMAJ. 2010;182(14):E694-E701.
  5. Pacula, RL. Marijuana Use and Policy: What We Know and Have Yet to Learn. The National Bureau of Economic Research. http://www.nber.org/reporter/winter05/pacula.html Accessed September 23, 2011.

 


Matthew J. Seamon, PharmD, Esq, is currently an associate professor of pharmacy practice at Nova Southeastern University (NSU) College of Pharmacy in Fort Lauderdale, Florida, where he focuses on pharmacy law. Matthew earned his PharmD from the University of Michigan and completed a drug information specialized residency at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania. He then returned to school, earning his law degree from NSU while working full-time on faculty. In addition to working in academia, Matthew has practiced in clinical research, hospital pharmacy, community pharmacy, and the pharmaceutical industry.

 


Click here to view a larger version of this Table

Alaska 1998
Cachexia, cancer, chronic pain, epilepsy and other disorders characterized by seizures, glaucoma, HIV or AIDS, multiple sclerosis and other disorders characterized by muscle spasticity, and nausea. Other conditions are subject to approval by the Alaska Department of Health and Social Services.

Arizona 2010
Cancer, glaucoma, HIV/AIDS, Hepatitis C, ALS, Crohn’s disease, Alzheimer’s disease, cachexia or wasting syndrome, severe and chronic pain, severe nausea, seizures (including epilepsy), severe or persistent muscle spasms (including multiple sclerosis).

California 1996
AIDS, anorexia, arthritis, cachexia, cancer, chronic pain, glaucoma, migraine, persistent muscle spasms, including spasms associated with multiple sclerosis, seizures, including seizures associated with epilepsy, severe nausea; Other chronic or persistent medical symptoms.

Colorado 2000
Cancer, glaucoma, HIV/AIDS positive, cachexia, severe pain, severe nausea,seizures (including those that are characteristic of epilepsy), persistent muscle spasms (including those that are characteristic of multiple sclerosis). Other conditions are subject to approval by the Colorado Board of Health.

Delaware 2011
Debilitating medical conditions, defined as cancer, HIV/AIDS, decompensated cirrhosis, ALS, Alzheimer’s disease, PTSD; or a medical condition that produces wasting syndrome, severe debilitating pain that has not responded to other treatments for more than three months or for which other treatments produced serious side effects, severe nausea, seizures, or severe and persistent muscle spasms.

Hawaii 2000
Cancer, glaucoma, positive status for HIV/AIDS, chronic or debilitating disease or medical condition or its treatment that produces cachexia or wasting syndrome, severe pain, severe nausea, seizures, including those characteristic of epilepsy, or severe and persistent muscle spasms, including those characteristic of multiple sclerosis or Crohn’s disease. Other conditions are subject to approval by the Hawaii Department of Health.

Maine 1999
Epilepsy and other disorders characterized by seizures, glaucoma, multiple sclerosis and other disorders characterized by muscle spasticity, nausea or vomiting as a result of AIDS or cancer chemotherapy.

Michigan 2008
Debilitating medical conditions, defined as cancer, glaucoma, HIV, AIDS, hepatitis C, amyotrophic lateral sclerosis, Crohn’s disease, agitation of Alzheimer’s disease, nail patella, cachexia or wasting syndrome, severe and chronic pain, severe nausea, seizures, epilepsy, muscle spasms, and multiple sclerosis.

Montana 2004
Cancer, glaucoma, or positive status for HIV/AIDS when the condition or disease results in symptoms that seriously and adversely affect the patient’s health status; cachexia or wasting syndrome; severe, chronic pain that is persistent pain of severe intensity that significantly interferes with daily activities as documented by the patient’s treating physician; intractable nausea or vomiting;epilepsy or intractable seizure disorder; multiple sclerosis; Crohn’s disease; painful peripheral neuropathy; a central nervous system disorder resulting in chronic, painful spasticity or muscle spasms; admittance into hospice care.

Nevada 2000
AIDS, cancer, glaucoma, and any medical condition or treatment to a medical condition that produces cachexia, persistent muscle spasms or seizures, severe nausea, or pain. Other conditions are subject to approval by the health division of the state Department of Human Resources.

New Jersey 2010
Seizure disorder (including epilepsy), intractable skeletal muscular spasticity, glaucoma, severe or chronic pain, severe nausea or vomiting, cachexia, wasting syndrome resulting from HIV/AIDS or cancer, ALS, multiple sclerosis, terminalcancer, muscular dystrophy, inflammatory bowel disease, Crohn’s disease, terminal illness (if the physician has determined a prognosis of less than 12 months of life), or any other medical condition or its treatment that is approved by the Department of Health and Senior Services.

New Mexico 2007
Severe chronic pain, painful peripheral neuropathy, intractable nausea/vomiting, severe anorexia/cachexia, hepatitis C infection, Crohn’s disease, PTSD, ALS, cancer, glaucoma, multiple sclerosis, damage to the nervous tissue of the spinal cord with intractable spasticity, epilepsy, HIV/AIDS, and hospice patients.

Oregon 1998
Cancer, glaucoma, positive status for HIV/AIDS or treatment for these conditions, a medical condition or treatment for a medical condition that produces cachexia, severe pain, or severe nausea; seizures, including seizures caused by epilepsy; persistent muscle spasms, including spasms caused bymultiple sclerosis. Other conditions are subject to approval by the Health Division of the Oregon Department of Human Resources.

Rhode Island 2006
Cancer, glaucoma, positive status for HIV/AIDS, hepatitis C, or the treatment of these conditions; a chronic or debilitating disease or medical condition or its treatment that produces cachexia or wasting syndrome; severe, debilitating, chronic pain; severe nausea; seizures, including but not limited to those characteristic of epilepsy; severe and persistent muscle spasms, including but not limited to those characteristic of multiple sclerosis or Crohn’s disease; agitation of Alzheimer’s disease; or any other medical condition or its treatment approved by the state Department of Health.

Vermont 2004
Cancer, AIDS, positive status for HIV, multiple sclerosis, or the treatment of these conditions if the disease or the treatment results in severe, persistent, and intractable symptoms; a disease, medical condition, or its treatment that is chronic, debilitating, and produces severe, persistent, and one or more of the following intractable symptoms: cachexia or wasting syndrome, severe pain, nausea, or seizures.

Washington 1998
Cachexia, cancer, HIV or AIDS, epilepsy, glaucoma, intractable pain (defined as pain unrelieved by standard treatment or medications), multiple sclerosis. Other conditions are subject to approval by the Washington Board of Health.

Washington, DC 2010
HIV, AIDS, glaucoma, multiple sclerosis, cancer, other conditions that are chronic, long-lasting, debilitating, or that interfere with the basic functions of life, serious medical conditions for which the use of medical marijuana is beneficial, patients undergoing treatments such as chemotherapy and radiotherapy. 

 

 

 

 

 

 


Table 2. Stepwise Approach to Medical Marijuana in the Institutional Pharmacy Practice Setting

 

 

 

 

  • Understand federal law and the role of enforcement discretion as it relates to medical marijuana
  • Be familiar with your state laws regarding medical marijuana
  • Considering the local community standards and practices, create a policy for medical marijuana use for your institution. Policy development should include insight from legal, medical, pharmacy, community, patient, and law enforcement personnel 
  • Have the P&T committee offer their perspective on medical marijuana 
  • Inquire of all patients if they use marijuana medically or recreationally, and treat accordingly 
  • Train the necessary staff on the clinical and legal issues surrounding medical marijuana 
  • Do not recommend or stock any source of marijuana 
  • Follow the published literature and sociopolitical trends involving marijuana, and update relevant policies regularly 
  • Respect patients’ right to privacy, law enforcement’s right to investigate, and work to balance these as necessary

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