ASSOCIATION REPORT

Medical marijuana: Policy topic for 2015 APhA House of Delegates Margherita R. Giuliano, Bithia Fikru, Stephen W. Schondelmeyer, and Jillian Dann

Editor’s note: The APhA House of Delegates adopted policy language related to medical marijuana in 1980 and most recently reaffirmed the policy in 2011. Due to increased public attention and state-level activity related to the use of medical and/ or recreational cannabis, the House will consider proposed updated policy in March 2015. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of APhA.

APhA–APPM The use of medical marijuana is an emerging health care trend for the medical community nationwide. While marijuana has been used for centuries, its potential medicinal benefits have only recently been acknowledged. In 2013, the State of Connecticut adopted Giuliano medical marijuana legislation for patients with the specific diseases outlined in the law. Throughout the controversial legislative debate, the Connecticut Pharmacists Association (CPA) was a strong advocate for bringing medical marijuana, through a regulated process, to patients in need. CPA’s position stated that if we were going to treat marijuana as a medicine, the State of Connecticut should move marijuana from a Schedule I controlled substance to a Schedule II controlled substance and mirror the current distribution system being used for any Schedule II drug. Unlike models in other states, Connecticut has integrated pharmacists into the drug selection and dispensing process. Patients have the benefit of a pharmacist in the key roles of providing a patient evaluation, including an evaluation review of all medicines the patient is currently taking, reviewing dosing recommendations, evaluating the potential of adverse events, and 10 JAPhA | 5 5 : 1 | JAN/F E B 2 0 1 5

selecting and dispensing the appropriate medication. Pharmacists believe their clinical knowledge will be critical in the documentation and evaluation components of any research initiative. It’s also exciting to see team-based care in action in the health care system: A physician authorizes the patient to be eligible to try medical marijuana and a pharmacist then selects the appropriate product based on the physician’s diagnosis. Connecticut law also requires that pharmacists input information into the Prescription Monitoring Program run by the State of Con-

necticut Department of Consumer Protection (DCP). This allows DCP staff and health professionals to know who is prescribing, who is dispensing, and who is receiving medical marijuana in a timely manner. The licensed producers are also being held to high standards and are required to do testing on each batch of marijuana produced. Producers must label the components of their “homogenized” product with tetrahydrocannabinol and cannabidiol content as well. This helps to standardize what patients are receiving and ensures reliable consistency. Certainly there have been some bumps along the way as the medical marijuana program has unfolded. To smooth the way and encourage communication, the CPA has established an Academy of Medical Marijuana Dispensaries under its umbrella; dispensary owners can gather to address issues of concern. From a business perspective, topics range from establishing a compassionate care program for patients who can’t afford the product to discussions on finding a bank to work with. How

The Association Report column in JAPhA reports on activities of APhA’s three Academies and topics of interest to members of those groups. The APhA Academy of Pharmacy Practice and Management (APhA–APPM) is dedicated to assisting members in enhancing the profession of pharmacy, improving medication use, and advancing patient care. Through the APhA-APPM Special Interest Groups (SIGs), the Academy provides members a mechanism to network and support the profession by addressing emerging issues. To access a listing of APhA-APPM SIGs, visit www.pharmacist.com/apha-appm. The mission of the APhA Academy of Pharmaceutical Research and Science (APhA–APRS) is to stimulate the discovery, dissemination, and application of research to improve patient health. Academy members are a source of authoritative information on key scientific issues and work to advance the pharmaceutical sciences and improve the quality of pharmacy practice. Through the three APhA–APRS Sections (Clinical Sciences, Basic Pharmaceutical Sciences, and Economic, Social, and Administrative Sciences), the Academy provides a mechanism for experts in all areas of the pharmaceutical sciences to influence APhA’s policymaking process. The mission of the APhA Academy of Student Pharmacists (APhA–ASP) is to be the collective voice of student pharmacists, to provide opportunities for professional growth, to improve patient care, and to envision and advance the future of pharmacy. The Association Report column is written by Academy and Section officers and coordinated by JAPhA Managing Editor Michael Posey of the APhA staff. Suggestions for future content may be sent to [email protected]

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to handle drug returns and package size and dosing of new dosage forms are issues as well. CPA has also established a database to track product quality issues as producers come to market. There is a gap in clinical evidence because proper studies have not yet been conducted on medical marijuana. Supporting evidence does not yet demonstrate the potential benefits patients may receive. Because of this lack of evidence in the current use of medical marijuana, outcomes research on this medication will take time. After producers were selected and dispensaries chosen, CPA brought all stakeholders and DCP staff together to meet with the Executive Director of the Canadian Consortium for the Investigation of Cannabinoids (CCIC). The purpose of this initial meeting was to continue the conversation on the use, efficacy, and evidence-based research and education that was needed concerning the endocannabinoid system and therapeutic applications of medical marijuana. Currently, CPA is working in collaboration with the dispensaries, producers, and leading university researchers to have studies conducted. These will provide the evidence and outcomes data necessary to validate many of the clinical claims regarding the safety and effectiveness of medical marijuana. The results and data gleaned from the study will help inform policymakers and regulatory agencies about safety aspects of medical marijuana; clinicians about best practice guidelines and safety issues; and medical marijuana producers about the efficacy of their products in realworld situations. Because of the specifics in the Connecticut regulations, pharmacists are integral to both the data collection and dispensing activities; Connecticut’s pharmacists will also be able to use a comprehensive and data-driven approach when educating patients about their medical use 12 JAPhA | 5 5 : 1 | JAN/F E B 2 0 1 5

of marijuana. Connecticut pharmacists are truly the pioneers in this emerging industry who can serve as a model for the rest of the country. Some lessons learned are as follows: 1. Be proactive with legislation that is introduced. Don’t just go along for the ride. Instead, be ready to drive the bus. 2. Insist that medical marijuana is treated like a controlled substance; this allows for easier enforcement through prescription monitoring programs. 3. Collaborate with the regulatory agency to work through the processes to ensure that all dispensary owners are being told the same thing. Establish a frequently asked questions document. 4. Pharmacists need to be aware of the risks associated with owning a dispensary. Although somewhat protected, they can still be arrested for selling an illegal drug. 5. Unless changes are made to federal laws in the banking industry and tax laws, our dispensaries face challenges with financial matters. 6. Integrating pharmacists into the process will yield opportunities to provide great data to determine the evidence-based benefits of using medical marijuana. As pharmacists we take an oath that we will “enhance and advocate changes that improve patient care.” The pharmacists in Connecticut are now positioned to be true pioneers in fulfilling this promise. Margherita R. Giuliano, BSPharm, CAE Executive Vice President Connecticut Pharmacists Association

APhA–APRS In recent years, 31 states and the District of Columbia have passed legislation authorizing some form of medical marijuana use.1 Four states (Washington, Colorado, Oregon, and Alaska) have passed legislation allowing use of marijuana ja p h a.org

for recreational purposes.2 The increasing availability of marijuana for medical and recreational use raises a number of policy issues of interest and concern Fikru to pharmacists. While there are two cannabinoid receptor agonists approved by the Food and Drug Administration (FDA), this commentary will focus on the medical use of state-authoSchondelmeyer rized, non-FDAapproved forms of marijuana.3 State/federal conflicts The legal framework of this country includes a separation of powers between the states and the federal government, with the individual states governing the practice of health professionals. The federal government has jurisdiction over goods and services in interstate commerce, including the approval and marketing of drug products for medical purposes. While the definition of what constitutes a drug product is addressed by both federal and state laws, states may define certain substances as drug products differently than federal law as long as such drug products are limited to production and distribution within that state and the product does not enter into interstate commerce. At the federal level, marijuana is classified as a Schedule I substance by the Drug Enforcement Administration (DEA), meaning that it is considered to be a drug “with no currently accepted medical use” and with “a high potential for abuse.”4 In contrast, the jurisdictions mentioned above have defined that there are, or potentially are, current or experimental medical uses for marijuana, deeming a federally classi-

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fied illegal substance as legal within those locations (and under specified conditions). Unclear role of providers Physicians and pharmacists are faced with challenging decisions with regard to recommendations for use and distribution of marijuana.5,6 Health providers should be concerned with the health impact of marijuana regardless of whether it is used for medical or recreational purposes. In most states authorizing the medical use of marijuana, the procedure for marijuana access differs from the normal method of provider-written orders and pharmacydispensed prescriptions, thus circumventing the checks and balances between medicine and pharmacy with respect to the prescribing and dispensing of medications. Since the legal status of marijuana use and distribution differs at the federal level from the various states, health providers are uneasy about implementing individual state medical marijuana laws when their provider status with federal agencies (e.g., DEA) may come under scrutiny. If challenged, a provider’s DEA authorization may be withdrawn or of even more concern, the provider may be subjected to criminal prosecution for violating federal laws when enabling marijuana use within the scope of state laws. There is a need for federal and state laws to be examined and to be coordinated, if not standardized, with respect to marijuana use and distribution. Lack of appropriate research The state laws enabling medical use of marijuana also address, allow, or even encourage research on the safe and effective use of marijuana. Marijuana is a natural product that has been used experimentally in various forms for treating a variety of medical conditions such as severe nausea and vomiting associated with cancer chemotherapy, 14 JAPhA | 5 5 : 1 | JAN/F E B 2 0 1 5

weight loss associated with human immunodeficiency virus infections and cancer, glaucoma, and others.7,8 While a number of studies and publications examine medical marijuana use, most are anecdotal or a series of case reports. Very few of these research studies have used scientifically rigorous and valid methods or well-controlled research designs to assess the safety, effectiveness, or long-term use of marijuana.9 In addition, these studies have not been subjected to the review and evaluation that FDA would give to research for drug products being considered for market approval in the United States. The state laws authorizing marijuana use for medical purposes have been passed largely as a result of public opinion rather than scientific evidence.8 While public opinion and scientific evidence are both important and relevant, as a society we have not traditionally allowed use of drug products without adequate scientific evidence. Lack of standardized processes and products Once we have established evidencebased appropriate uses of marijuana, health professionals and patients alike are faced with the challenge of confirming that the product being used is pure, unadulterated, and consistent in delivering the desired therapeutic effect. Without a known and reliable level of potency, it is not possible to appropriately and effectively dose a patient being treated for a specific medical condition. How can we assure that the marijuana products sold meet these standards when they have not been approved through the usual process of FDA scrutiny? It also seems inefficient, if not completely redundant, for the many states to develop individual good manufacturing procedures, standards for purity and potency, and other procedures for assuring the quality, safety and effectiveness of marijuana products being sold for medical purposes. ja p h a.org

Bithia Fikru, PharmD, MPA-HSA PhD Candidate and Research Analyst Stephen W. Schondelmeyer, BS, PharmD, MPubAdm, PhD, FAPhA Professor and Director PRIME Institute Department of Pharmaceutical Care & Health Systems College of Pharmacy University of Minnesota Minneapolis, MN 1.

Arias JJ, Barraza L, Weidenaar K. State medical marijuana laws. The Network for Public Health Law. 2014. http://www. net workforphl.org/_asset/z478y9/ State-Medical-Marijuana-Law-Table. pdf. Accessed December 1, 2014.

2.

Governing data. State marijuana laws map. http://www.governing.com/ gov-data/state-marijuana-laws-mapmedical-recreational.html. Accessed December 3, 2014.

3.

Borgelt LM, Franson KL, Nussbau AM, Wang GS. The pharmacologic and clinical effects of medical cannabis. J Human Pharmacol Drug Ther. 2013;33(2):195–209.

4.

United States Drug Enforcement Administration. Drug scheduling. http:// www.dea.gov/druginfo/ds.shtml. Accessed December 3, 2014.

5.

Seamon MJ, Fass JA, ManiscalcoFetchtl M, Abe-Shraie N. Medical marijuana and the developing role of the pharmacist. Am J Health-Syst Pharm. 2007;65:1073–1044.

6.

Marcoux RM, Larrat EP, Vogenberg FR. Medical marijuana and related legal aspects. Health Care Law. 2013;38(10):612–619.

7.

National Conference of State Legislatures (NCSL). State medical marijuana laws. http://www.ncsl.org/research/ health/state-medical-marijuana-laws. aspx; Accessed November 26, 2014.

8.

Bostwick JM. Blurred boundaries: the therapeutics and politics of medical marijuana. Mayo Clin Proc. 2012; 87(2):172–186.

9.

ClinicalTrials.gov. Medical cannabis use. http://clinicaltrials.gov. Accessed November 26, 2014.

APhA–ASP Despite legalization and increased use of medical marijuana, pharmacists and student pharmacists have

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not defined the profession’s role in the care of patients using medical marijuana. The impact that medical marijuana has on the practice of pharmacy will Dann vary with practice location and patient population, but it seems safe to say that in the 31 states and the District of Columbia where marijuana has been legalized in some fashion, pharmacists are likely interacting with patients using medical marijuana as an adjunctive treatment. I believe pharmacists and student pharmacists should educate themselves about medical marijuana, inquire about medical marijuana use (much as we do for other medications), and care for patients without judgment. I do not believe the role of pharmacists and student pharmacists is necessarily as an advocate for use of medical marijuana but as an advocate of medical marijuana research. To uphold our Oath of a Pharmacist, legalization of medical marijuana may require more education, clinical experience, and research among pharmacists and student pharmacists. Education The first issue we need to address as a profession is how to appropriately educate pharmacists and student pharmacists to better care for our patients while using medical marijuana. We must understand this drug’s adverse effects, interactions, and risks and benefits. We should look at medical marijuana as we do adjunctive medications by being prepared to ask about marijuana use regularly and to counsel patients appropriately. Educational efforts should focus on improving communication skills and asking patients about medical marijuana use to fully understand their treatment regimens. In addition to asking the question, we must also prepare to ad16 JAPhA | 5 5 : 1 | JAN/F E B 2 0 1 5

dress a patient’s concerns regarding medical marijuana; pharmacists and student pharmacists should have training during pharmacy school curricula and through continuing education. One recently formed organization, National Association of Cannabis Pharmacy, was established with one of their goals being addressing this concern by developing advanced training for practitioners. To best care for our patients, we must have some understanding of the available data or be prepared to research marijuana to address patient concerns. Clinical role Armed with knowledge and the habit of asking about marijuana use, we must be able to discuss pharmacologic issues and potential risk and benefits. Many drug–drug interactions, both observed and theoretical, as well as adverse effects and safety concerns have been reported and are available in resources such as Natural Medicines Database.1 Admittedly, the level of evidence for most of the reports is low, but it reminds us of what we should keep in mind when managing our patients. In addition to marijuana’s pharmacology and potential effectiveness, we should always be thinking of our patient’s safety and the risks that are associated with marijuana. As a Schedule I drug, regulation on production, purity and tetrahydrocannabinol concentration of marijuana products is limited. This presents safety concerns that should be addressed during counseling, as do packaging, restricting access by children, and formulations of appropriate dosage forms. Smoked products cause chronic inflammation, resulting in symptoms of bronchitis and increase risk of respiratory tract infection. Additionally, marijuana use has been shown to impair driving ability and is associated with increased rates of motor vehicle accidents.2 Informing patients of these concerns is of great importance to ensure patient safety during medical marijuana use. ja p h a.org

Research While the body of literature related to medical marijuana use is limited and studies are usually indication specific, it is clear through a literature search that research is being conducted, giving us valuable insight to better care for our patients. As clinicians, I believe it is pharmacists’ and student pharmacists’ role to encourage high quality research. In the 31 states and District of Columbia where medical marijuana is legal, we know patients are using medical marijuana as therapy. I expect that the number of patients and the conditions being treated with medical marijuana will continue to grow, and research on pharmacology, therapeutic effectiveness, short-term and long-term effects, and safety is needed now. Pharmacists and student pharmacists need to define their role in the management of patients using medical marijuana. We can be a source of reliable information and open to discussing medical marijuana while not endorsing its use. Stepping into this role will improve patient outcomes, continue to build rapport with our patients and display our commitment to the Oath of the Pharmacist. Acknowledgment: The author wishes to thank Dr. Laura Borgelt for her assistance in the preparation and review of this article. Jillian Dann Student Pharmacist and APhA–ASP Chapter President 2014–15 Skaggs School of Pharmacy and Pharmaceutical Sciences University of Colorado, Denver, CO [email protected] doi: 10.1331/JAPhA.2015.15500 1. Marijuana. In: Natural medicines comprehensive database. Stockton, CA: Therapeutic Research Faculty. Updated November 12, 2014; accessed November 24, 2014. 2. Volkow ND, Baler RD, Compton WM, Weiss SR. Adverse health effects of marijuana use. N Engl J Med. 2014;370:2219–2227.

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Medical marijuana: policy topic for 2015 APhA House of Delegates.

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