Navigating the Changing Landscape of Medical Marijuana


November 2014 - Vol. 11 No. 11 - Page #10

Few issues inspire such spirited debate as the use of marijuana for medical purposes. Proponents cite its use for thousands of years to treat a variety of diseases and conditions, as well as the lack of any documented deaths from overdose throughout this time, while opponents note that marijuana is classified as a Schedule I drug, meaning it has no currently accepted medical use and has a high potential for abuse, and that the risks of using marijuana are still unclear, as only a small number of randomized, controlled clinical trials have been conducted to evaluate its safety and efficacy. 

With the legalization of recreational marijuana in Colorado and Washington State and the legalization of medical marijuana in almost two dozen states and the District of Columbia, the debate is likely to intensify. However, despite the recent growth of medical marijuana, the medical and pharmacy establishments have been reluctant to address it. Pharmacists and other health care professionals are in a position to step out in front of the issues and lead the educational effort surrounding new research and legislation that will undoubtedly impact patient care. As marijuana becomes increasingly available to patients through authorized dispensaries, pharmacists likely will find themselves in a position of needing to counsel patients on its use. (See SIDEBAR for a brief history of medical marijuana.)

The Current State of Law and Opinion
Medical marijuana remains illegal under federal law, and state laws that permit its use are valid only to the extent that federal police powers use enforcement discretion to not arrest or convict users. This conundrum has left health care professionals in a quandary; institutions are reluctant to embrace it, thus reducing utilization, which makes research that could provide valuable information about the risks and benefits of the substance more difficult to conduct. And without such data, laws will be slower to change. 

In addition, pharmacists remain at a crossroads with regard to dispensing marijuana in their institutions. Dispensing remains in clear violation of federal law concerning controlled substances, but the individual states may lend some legal protection for pharmacists. For example, Connecticut requires that a pharmacist dispense the drug,1 and Michigan2 and Oregon3 have attempted to reclassify marijuana as a Schedule II controlled substance, permitting pharmacists to dispense pharmaceutical-grade product. Nevertheless, state law is subject to preemption by federal law if the state law is less stringent; thus, these laws really provide only a guise of protection. Further, ASHP opposes the procurement, storage, preparation, or distribution of marijuana by licensed pharmacies or health care facilities for purposes other than research.4

The number of people in favor of legalizing marijuana has increased dramatically over the years, from 12% in 1969 to 58% in 2013 (see FIGURE 1),5 and nearly half the nation has legalized the use of marijuana for multiple medical purposes (Click Here to see ONLINE-ONLY TABLE 1 ,6 TABLE 2, and FIGURE 26).6 Moreover, the federal government has stated it will not pursue criminal arrest of users who follow state law or pursue financial institutions who bankroll legitimate businesses. In August 2013, the department of justice issued a trust but verify policy, stating that the federal government will not prevent the implementation of marijuana laws in the states and will respect the will of the states where its residents voted to legalize small amounts of marijuana for both personal and medical use.7 The Justice Department also issued a list of priorities on which federal prosecutors who enforce laws pertaining to marijuana will focus (see TABLE 3).7 These priorities target certain offenses for prosecution, such as distribution to minors, use of violence or firearms in the distribution of marijuana, and the sale of marijuana to fund gangs or cartels. 

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Policymakers and advocacy groups are working to address confusion, empower researchers to determine marijuana’s safety and efficacy in alleviating symptoms and treating diseases, and improve access to medical marijuana. In February 2014, New York’s Governor, Andrew Cuomo, proposed a plan that would allow selected hospitals to administer marijuana to patients with approved illnesses, citing the Antonio G. Olivieri Controlled Substance Therapeutic Research Program (also known as the Olivieri law).8 This law, however, does not explicitly allow hospitals to purchase the substance or sell it to patients; it only allows for the use of marijuana that comes from the federal government (grown at the University of Mississippi, containing low concentrations of cannabidiol [CBD], or from selected dispensaries). New York became the 23rd state to legalize medical marijuana utilizing the Compassionate Care Act, which avoids limiting patient access to medical marijuana to within hospitals (as would be required by the Olivieri law).9

Implications for Hospitals
Numerous clinical, legal, and financial questions remain regarding the availability of marijuana in hospital and institutional settings. One of the most significant challenges is that current laws do not require government or private health insurance companies to reimburse patients for costs associated with medical marijuana. Even if they did, the substance demonstrates considerable variability in terms of potency, complicating physician dosing recommendations. Moreover, under its current Schedule I status, the federal government deems marijuana to have a high potential for abuse, no accepted medical use, and to lack a proven safety record for use. Thus, institutions participating in federal programs (eg, Medicaid, Medicare, 340B drug pricing, etc) presently may be ill-advised to involve themselves with marijuana because the likelihood of ramifications (eg, ineligibility for federal funding, arrest or imprisonment, pharmacy license revocation, etc) is completely unknown. Additionally, individual practitioners risk consequences with administrative agencies and civil and criminal liability, and malpractice insurance carriers will almost certainly refuse to provide protection from claims. For these reasons, medical marijuana is unlikely to be available in the hospital setting until it is legalized at the federal level.

Despite potential consequences, it is imperative that hospitals and health care professionals prepare to manage patient, provider, state, and federal expectations for the use of medical marijuana in the inpatient setting. To this end, initiating open discussions on the benefits and risks of medical marijuana and identifying how it fits with the institution’s mission and values will become important moving forward. Serious consideration should be given to developing state- and hospital-specific policies and procedures (P&Ps) regarding whether medical marijuana use is supported. Representatives from each department that would be involved with the prescribing, dispensing, handling, and administration of medical marijuana should be represented when drafting these P&Ps. Topics covered should include safety, efficacy, cost, and legality, with intentional avoidance of personal biases and anecdotal commentary. Specifics should include:

  • Type(s) of marijuana to use
  • Formulation(s)
  • Dosing and/or titration strategies 
  • Logistics of administration
  • The illnesses and/or symptoms for which it will be approved 
  • Patient monitoring parameters and counseling
  • Comparative therapeutic options 
  • Authorized prescribers (restricted versus unrestricted)
  • The level of additional education required for those handling the substance (including training for staff delivering marijuana to patients) 
  • Safeguards that should be in place for patients 

Once comprehensive P&Ps have been developed and agreed upon, refer to your institution’s policy review procedures and follow them accordingly. Permitting patients taking medical marijuana to bring their own supply of the drug to a hospital may appear reasonable. Patients are gaining access to numerous cannabis-infused products, such as carbonated beverages, gummy bears, cupcakes, butter, etc, as these products are becoming increasingly commonplace and standardized in state-approved marketplaces. However, this practice poses significant risks and may be imprudent until further experience is gained. For example, driving under the influence of marijuana is illegal in all states and jurisdictions, so transportation to and from the hospital may be a source of legal exposure for patients. Moreover, the source of the product is not widely regulated, so patients may be prone to under- or over-dosing. In addition, marijuana is most often smoked—a delivery system that is less than ideal within hospital confines. 

Oral administration of medical marijuana has several benefits over smoking, and oral products are widely available, but oral ingestion of marijuana also has the potential to alter the perceived effect compared with smoking, as over 2000 compounds may be produced by pyrolysis.10 Other routes investigated have been sublingual, vaporization, transdermal, and rectal administration via suppository.10 Vaporization is widely touted as a safer alternative to smoking because of the decreased by-products, but long-term safety and effectiveness data are lacking and dosing issues remain problematic. The optimal route of administration has not been determined and will probably be an individual choice.

Medical marijuana must be stored securely, as clearly it is at risk for diversion. If it is stored in the hospital, it should be stored with other controlled substances, properly inventoried, and repackaged into individual doses. Other storage concerns include protection from light, heat, and humidity, as all three have been shown to degrade the active constituents.11

Some hospital pharmacies may utilize a “meds from home” program to avoid having the hospital incur the cost of specialty or investigational drugs or drugs that may be difficult to acquire. However, with such programs, typically the pharmacy must identify the product to ensure patient safety—ie, monitoring for drug interactions, verifying strengths, and ensuring medications are not expired. Some marijuana dosage forms may be easier to verify than others (oral extracts or foods vs dry plant products for smoking), but this could raise concern about adulteration if the medication has been altered or laced with potentially harmful substances, which may not be recognized. Hospital pharmacies may consider instituting a meds from home program, but with certain restrictions to allow the pharmacist to properly identify the product. 

Educating Health Care Professionals
As medication experts, pharmacists are best suited to manage patients using marijuana for medicinal purposes and to develop materials to help patients, caregivers, and prescribers understand the risks and benefits associated with use of the drug. Thoroughly evaluating available clinical studies and new research as it becomes available, keeping abreast of new legislation on state and federal levels, and availing continuing education opportunities will help pharmacists respond to patient and clinician questions about the therapeutic and legal issues surrounding medical marijuana use.4

It is interesting to note that in the US no widely accepted published guidelines on medical marijuana exist.12 Health Canada, on the other hand, has published an online document compiled and maintained by the Controlled Substances and Tobacco Directorate that provides comprehensive, detailed information for health care professionals on cannabis and cannabinoids.13 This document is an excellent starting point to learn about the chemistry, clinical pharmacology, dosing, potential therapeutic uses, warnings, precautions, and side effects of marijuana and other cannabinoids. Similarly, a systematic review published by the American Academy of Neurology (AAN) includes efficacy and safety information on medical marijuana in treating select neurological disorders.14 The AAN also supplies physician and patient tools and materials, including case examples and a slide presentation. Attending conferences and educational webinars also can yield important information for health care professionals. 

Pharmacists may ultimately counsel patients concerning the use of medical marijuana. As health care professionals, it is our duty to provide patients with unbiased and scientifically accurate information. See Table 415 for tips to avoid liability when counseling patients receiving medical marijuana. 

Anticipating Future Trends
Until the federal government approves marijuana for medical use, the patchwork regulations that exist in individual states will continue to befuddle patients and health care professionals alike and allow both private and public insurers to continue to avoid coverage. But with public opinion now tipping in favor of marijuana legalization, it appears the tide is turning. The pressing question is no longer whether patients will have access to medical marijuana, but rather how will it be regulated? Will it be treated like tobacco, subject to federal oversight and state taxation? Or will it be regulated as an FDA-approved drug product, requiring compliance with good manufacturing practices and proof of safety and efficacy? 

As more states allow medical marijuana use, business will continue to expand, common misconceptions about the drug will be debunked, health care practitioners will gain more experience, and patients will pursue greater access. Ongoing clinical studies and research will ultimately become the oracle of judgment: if data show effectiveness, treatment pathways will evolve, acceptance will grow, and products will be developed for patient use; if the data show ineffectiveness, the medical establishment will lose interest and pursue more meaningful interventions. 

Many believe that an honest appraisal of the benefits and risks of medical marijuana suggests that patients—especially those for whom conventional therapies have failed—should have this agent available as part of their treatment armamentarium. Researchers must continue to publish valid, reproducible findings, and health care professionals should approach the matter with patience, intellect, and impartiality. Moreover, state health insurance plans should begin providing coverage and access to medical marijuana; insurers also should consider contracting with a single product source to ensure consistency. Institutional Review Boards should become more confident and comfortable supporting research in the field, and federal access should be expanded to support such research. 

It is clear that interest is increasing in medical marijuana as an alternative treatment; however, significant barriers to incorporating the drug into hospital treatment protocols persist. As the medication experts, pharmacists have an opportunity to take the lead in educating health care professionals and patients about marijuana and its medical uses. Ultimately, as health care professionals, while we are required to abide by the law, we also are charged with providing patients with the knowledge and resources they need to make informed health decisions. 

References

  1. State of Connecticut General Assembly. February Session, 2012. Raised Bill No. 5389, LCO No. 1762. An Act Concerning the Palliative Use of Marijuana. http://cga.ct.gov/2012/TOB/H/2012HB-05389-R00-HB.htm?utm_source=BenchmarkEmail&utm_campaign=e_News_05_16_12&utm_medium=email. Accessed September 9, 2014.
  2. State of Michigan Senate Bill 660. Public Act 268 of 2013 (Effective 12/30/2013). http://legislature.mi.gov/doc.aspx?2013-SB-0660. Accessed September 9, 2014.
  3. Oregon Board of Pharmacy. News Release: State Board of Pharmacy Reclassifies Marijuana.http://www.oregon.gov/pharmacy/Imports/News/June2010PressReleaseMarijuana.pdf.Accessed September 9, 2014. 
  4. American Society of Health-System Pharmacists. Summer Meeting 2011. Official Language of Professional Policies Approved by the 2011 ASHP House of Delegates: Medical Marijuana.http://www.ashp.org/DocLibrary/Policy/HOD/OfficialLang2011Policies.aspx. Accessed September 10, 2014.
  5. Gallup Politics. For First Time, Americans Favor Legalizing Marijuana. http://www.gallup.com/poll/165539/first-time-americans-favor-legalizing-marijuana.aspx. Accessed September 5, 2014.
  6. Medical Marijuana Pros and Cons Web site. 23 legal medical marijuana states and DC. Updated July 31, 2014. http://medicalmarijuana.procon.org/view.resource.php?resourceID=000881#summary. Accessed September 10, 2014.
  7. US Department of Justice. Office of the Attorney General. Memorandum for all United States Attorneys. Guidance Regarding Marijuana Enforcement. August 29, 2013. http://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf. Accessed September 10, 2014. 
  8. New York City Bar. Report by the Drugs and the Law Committee and the Health Law Committee: Governor Cuomo’s Proposal to Restart the Antonio G. Olivieri Controlled Sub-stances Therapeutic Research Program. February 2014. http://www2.nycbar.org/pdf/report/uploads/20072660-GovernorsMedicalMarijuanaProposal.pdf. Accessed September 10, 2014. 
  9. New York City Bar. Report in Support of Legislation Permitting the Production, Distribution and Use of Medical Marijuana in New York State, A.6357-A/S.4406-A (with recommendations), reissued June 2013. http://www2.nycbar.org/pdf/report/uploads/20072485-UpdatedReportPermittingMedicalMarijuana.pdf. Accessed September 10, 2014. 
  10. Huestis MA. Human cannabinoid pharmacokinetics. Chem Biodivers. 2007;4(8):1770-1804.
  11. Fairbairn JW, Liebmann JA, Rowan MG. The stability of cannabis and its preparations on storage. J Pharm Pharmacol. 1976:28;1-7.  
  12. Winstock A. Cannabis regulation: the need to develop guidelines on use. Brit Med J. 2014;348:g3940.
  13. Federal Department of Health, Canada. Information for Healthcare Professionals: Cannabis (marihuana, marijuana) and the cannabinoids. February 2013. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/marihuana/med/infoprof-eng.pdf. Accessed August 18, 2014.
  14. American Academy of Neurology Web site. Systematic Review: Efficacy and Safety of Medical Marijuana in Selected Neurological Disorders. Current Systematic Review. http://www.neurology.org/content/82/17/1556.full. Accessed September 8, 2014. 
  15. Seamon MJ, Fass JA, Maniscalco-Feichtl M, Abu-Shraie NA. Medical marijuana and the developing role of the pharmacist. Am J Health Syst Pharm. 2007;64(10):1037-1044.


For more information about medical marijuana, see PP&P’s November 2011 article, Managing Medical Marijuana in the Health-System Pharmacy, at http://www.pppmag.com/medicalmarijuana.


Jose Valdes, PharmD, is currently an assistant professor in the department of pharmacy practice at Nova Southeastern University College of Pharmacy (NSUCP) in Fort Lauderdale, Florida, where he focuses in the areas of neurology and neuropsychiatry. After earning his PharmD from NSUCP, Dr. Valdes completed a one-year pharmacy practice residency at Baptist Healthcare in Pensacola, Florida, and a one-year psychiatric pharmacy practice residency at NSUCP. His research interests include the treatment of epilepsy, neurodegenerative diseases, and other neurologic/neuropsychiatric conditions. 

William R. Wolowich, PharmD, is currently an assistant professor in the department of pharmacy practice at NSUCP. He earned his PharmD from the State University of New York at Buffalo and went on to complete a fellowship in clinical pharmacokinetics at The Ohio State University. Dr. Wolowich’s research interests include clinical pharmacokinetics, clinical toxicology, pharmacometrics, and pharmacokinetic/pharmacodynamic modeling and simulation. 

Matthew J. Seamon, JD, PharmD, is currently an associate professor and chairman of pharmacy practice at NSUCP, where he focuses on pharmacy law. Dr. Seamon 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 NSUCP while working full-time on faculty. In addition to working in academia, Dr. Seamon has practiced in clinical research, hospital pharmacy, community pharmacy, and in the pharmaceutical industry. He has published a number of papers on various pharmaco-legal topics; his primary research interests include health care policy and FDA regulation.


SIDEBAR
A Brief History of Medical Marijuana
Marijuana, the common name for the dried material harvested from the Cannabis sativa plant, contains over 421 different chemical compounds, including 60 known pharmacologically active ones referred to as cannabinoids.1 The primary psychoactive cannabinoid of marijuana is delta-9-tetrahydrocannabinol, or THC.  

Cannabis has been used as a medicine since before the Common Era to treat rheumatism, pain, and convulsions. In the 1800s, it began to be sold in the US under a number of proprietary names, and, in 1851, it was added to the US Pharmacopeia for the treatment of various ailments, including alcoholism, cholera, convulsive disorders, dysentery, excessive menstrual and uterine bleeding, gout, leprosy, and neuralgia.2,3 Throughout the 19th and early 20th centuries, the worldwide use of marijuana increased, and acceptance of the drug grew. However, public perception began to change over the next several decades because of propaganda, conflicts of interest, and reports of harmful effects on its users. An alleged connection to violence and even hysteria circulated in various media formats. 

Following the release of the French propaganda film Reefer Madness in 1936, states began to outlaw the possession and sale of marijuana, essentially through taxation.3 In 1937, the US federal government enacted the Marijuana Tax Act,4 despite objection from the American Medical Association, which supported research of the substance as a medicine.5 This law restricted the use of marijuana to medicinal purposes and required those involved in medical research on marijuana to register with federal authorities and pay taxes. Because of these burdens, usage declined, and in 1942 marijuana was removed from the US Pharmacopeia.2 Almost three decades later, the Controlled Substances Act of 1970 formally classified cannabis as a Schedule I substance in the US, thus criminalizing its use outside of research and signaling a lack of any medical utility.6 

Meanwhile, in 1976, Robert Randall, suffering from glaucoma, faced charges of marijuana cultivation. After a number of circuitous legal proceedings, the US government permitted his use under the Common Law Doctrine of Medical Necessity, which continues to this day for a small group of users.2,7 But marijuana remained illegal for other medical uses for two decades. California became the first state to legalize the use of marijuana for medicinal reasons by passing Proposition 215 (also known as the Compassionate Care Act) on November 5, 1996.8 The act allowed patients and their primary caregivers to possess and cultivate marijuana for the treatment of AIDS, cancer, muscular spasticity, migraines, and several other disorders, as long as they had a recommendation from a physician. The proposition also serves to protect physicians from legal ramifications associated with recommending marijuana to patients. Proposition 215 opened the door for a wave of medical marijuana support that continues today. 

Sidebar References

  1. Huestis MA. Human cannabinoid pharmacokinetics. Chem Biodivers. 2007;4(8):1770-1804.
  2. Medical Marijuana Pros and Cons. History of Marijuana as Medicine – 2900 BC to Present. http://medicalmarijuana.procon.org/view.timeline.php?timelineID=000026. Accessed September 10, 2014.
  3. Public Broadcasting Station. Frontline. Marijuana Timeline. http://www.pbs.org/wgbh/pages/frontline/shows/dope/etc/cron.html. Accessed September 10, 2014.
  4. Drug Library.org. Marijuana Tax Act of 1937, Pub. 238, 75th Congress, 50 Stat. 551 http://www.druglibrary.org/schaffer/hemp/taxact/mjtaxact.htm.Accessed September 10, 2014.
  5. Harrison P. American Medical Association Opposes the Marijuana Tax Act of 1937. July 10, 1937. http://www.marijuanalibrary.org/AMA_opposes_1937.html.Accessed September 10, 2014.
  6. US Department of Justice, Drug Enforcement Administration. Office of Diversion Control. Controlled Substances Act of 1970. 21 U.S.C. 801 et seq. http://www.deadiversion.usdoj.gov/21cfr/21usc/. Accessed September 10, 2014.
  7. The Daily Washington Law Reporter. United States vs Randall, Super Ct DC Crim. No. 65923-75, November 24, 1976. http://www.drugpolicy.org/docUploads/randall.pdf. Accessed September 10, 2014. 
  8. California Department of Public Health. Proposition 215 of the Compassionate Use Act of 1996. http://www.cdph.ca.gov/programs/mmp/pages/compassionateuseact.aspx.Accessed September 10, 2014.

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