MEDICAL CANNABIS USING. Perspectives, insights and real-world outcomes using medical cannabis

vol 1 issue 1 2016 USING MEDICAL CANNABIS Perspectives, insights and real-world outcomes using medical cannabis AUTHORIZING CANNABIS FOR MEDICAL PURPOSES Danial Schecter, MD FROM GRASSROOTS TO INDUSTRY Jenna Valleriani PhD(c), MA FEATURE: MEDICAL CANNABIS, DRIVING AND WORK Lydia Hatcher, MD COST COVERAGE OF MEDICAL CANNABIS Jonathan Zaid USING VAPORIZERS FOR YOUR MEDICAL CANNABIS PATIENTS Ian Mitchell, MD

CONTENTS 2 EDITORIAL BOARD Dr. Daniel Schecter, MD, CCFP Medical Director, Cannabinoid Medical Clinic Ian Mitchell B. Sc. (Pharmacology), MD (McGill), FRCP - Emergency Medicine (McMaster) Clinical Assistant Professor, Emergency Medicine UBC Staff Physician Royal Inland Hospital Emergency Department Site Scholar Kamloops Family Medicine Residency Program. Lydia Hatcher MD, CCFP FCFP, CHE, D-CAPM Associate Clinical Professor Family Medicine, McMaster University, Chief of Family Medicine, St. Joseph s Healthcare, Hamilton, ON Jenna Valleriani, PhD(c), MA Strategic Advisor for Canadian Students for Sensible Drug Policy, Co-Founder and Vice-Chair of Women Grow Toronto, and member of NORML Canada Jonathan Zaid Founder and Executive Director Canadians for Fair Access to Medical Marijuana (CFAMM) 04 Danial AUTHORIZING CANNABIS FOR MEDICAL PURPOSES Schecter, MD 06 Jenna FROM GRASSROOTS TO INDUSTRY Valleriani PhD(c), MA 11 FEATURE: MEDICAL CANNABIS, DRIVING AND WORK Lydia Hatcher, MD 14 COST COVERAGE OF MEDICAL CANNABIS Jonathan Zaid 17 USING VAPORIZERS FOR YOUR MEDICAL CANNABIS PATIENTS Ian Mitchell, MD

WELCOME 3 Greetings, After much work and collaboration with our esteemed faculty, it is with great pleasure that I welcome you to the first edition of Using Medical Cannabis. This initiative was born from a desire to drive peer-to-peer learning and sharing so as to help clinicians increase their comfort level with using medical cannabis in their practice. It is meant to act as an educational tool and to provide current information and perspectives on the utilization of medical cannabis with discussions around the opportunities and challenges that exist. The columns in this and upcoming issues will include literature reviews and commentary, case studies, tips and techniques, patient perspectives and opinion pieces, among other topics. I would be remiss not to thank the contributing authors for their unique insights and perspectives. To be able to bring experts and thought leaders together for a collective project such as this is a privilege, and we look forward to future contributions. We hope you will find these contributions both meaningful and educational, as well as think of them as an additional resource in your clinical repertoire. Sincerely, Philippe Lucas Vice President, Patient Research & Advocacy Tilray

Danial Schecter, MD Dr. Danial Schecter is the co-founder and medical director of the Cannabinoid Medical Clinic (www.cmclinic.ca). As a recognized medical expert in the field of prescription cannabinoids and medical cannabis, Dr. Schecter has given numerous presentations to fellow physicians and developed educational programs on this subject. Dr. Schecter spearheaded the creation of the Patient Handbook on Medical Cannabis, (used by many organizations as a patient education tool) and has helped thousands of patients decide if cannabinoids are right for them. AUTHORIZING CANNABIS FOR MEDICAL PURPOSES: WHAT DO HEALTH CANADA, OUR REGULATORY BODIES AND THE CMPA HAVE TO SAY? 4 Authorizing Cannabis for Medical Purposes / Danial Schecter, MD UNDER THE NEW MEDICAL MARIHUANA PURPOSES REGULATIONS (MMPR) physicians have now become the gatekeepers of medical cannabis. Every day, patients ask physicians if they are good candidates for medical cannabis and how they can gain access to medical cannabis. Unfortunately, most physicians are not knowledgeable about the manner in which patients can access medical cannabis, what their role is and who is an appropriate candidate. Furthermore, there is misinformation as to who can prescribe, who may be an appropriate patient, what are appropriate conditions and what the role of Health Canada and our own governing bodies are. Fortunately, there is actually quite a bit of guidance out there for physicians who are interested. First off, it is important to understand the MMPR and the role of Health Canada. Under the MMPR, the only way that patients are able to access medical cannabis is in the mail from a licensed producer (LP). LPs are the sole companies in Canada legally allowed to grow, sell and distribute herbal cannabis to patients. In order for a patient to register with an LP they must have a prescription from their medical practitioner (MD or Nurse Practitioner). Under the MMPR regulations, a prescription for medical cannabis is actually called a medical document for the fact that we are unable to write a prescription for a substance that does not have a DIN. As a result, prescriptions for medical cannabis are called medical documents. Under the old regulations, Health Canada was responsible for approving a patient s request to possess and grow medical cannabis, as well as selling herbal cannabis to patients if they did not want to grow their own or have someone grow for them. Under the new regulations, the only way that Health Canada is involved is through regulating LPs and ensuring they are meeting exacting standards to produce high quality, "standardized" medical cannabis. For doctors who wish to learn more about medical cannabis, potential indications and current research, Health Canada s Office of Medical Cannabis has a number of excellent resources. You can access their document Information for Health Care Practitioners; Cannabis (marihuana, marijuana) and the cannabinoids as a free download at http://www.hc-sc.gc.ca/ dhp-mps/alt_formats/pdf/marihuana/med/infoprof-eng.pdf.

While this document provides comprehensive, up-to-date research surrounding the evidence of both herbal cannabis and prescription cannabinoids in various diseases and conditions, it does not make any attempts at therapeutic recommendations. Several misconceptions about the current regime include the belief that there are only certain conditions for which doctors can authorize medical cannabis. Although this was true under the previous system, this is no longer accurate and physicians can now authorize medical documents for any condition for which they believe cannabis is an appropriate treatment. Let s take a quick look at the position of the various associations and regulatory bodies with regards to prescribing herbal cannabis: The College of Family Physicians of Canada (CFPC) published Authorizing Dried Cannabis (Medical Marijuana) for Chronic Pain or Anxiety: Preliminary Guidance in 2015 to help doctors navigate prescribing herbal cannabis, a task that most will never have encountered in medical school or throughout their training and have minimal experience with. This valuable document is available as a free download at http://www.cfpc.ca/dried_cannabis_prelim_guidance/. This document provides a number of recommendations that may be useful for family physicians who have never considered prescribing cannabis before and have little knowledge about this novel therapeutic modality. While it is quite restrictive in suggesting who may ultimately benefit from herbal cannabis, it contains an excellent overview of how physicians should approach prescribing medical cannabis as well as some useful tips and tricks as well as practical tools. It provides a good discussion surrounding currently available evidence (and lack of), recommendations to reduce misuse, tools to assess and monitor patients and strategies as to how to prevent harm and talk with patients. Some tools that are particularly useful are the sample treatment agreement and the CAGE-AID tool that physicians should be familiar with who are considering authorizing medical cannabis. The Canadian Medical Protective Association (CMPA) has provided a number of recommendations for physicians who are considering authorizing medical cannabis. Among the more important suggestions are the following: It is important to have the necessary clinical knowledge to engage in meaningful discussions with patients about medical cannabis with consent discussions being documented in patients medical records. Physicians should not feel obligated to fill out a medical document when they are unfamiliar with its use or management or when they feel it is medically inappropriate for a patient. Physicians who choose to complete a medical document should rely on sound medical judgment and comply with their college s relevant guideline or policy. It is imperative for physicians considering authorizing medical cannabis to be familiar with their particular college guideline or policy. Almost all provincial colleges have issued a statement to help physicians navigate this new treatment modality. While there is some commonality between colleges, it is important to know the specifics of your particular province. Some general principles and unique regulations are outlined below: The guidelines and policies issues to date by most colleges consistently state that more information is required on the medical risks and therapeutic benefits of cannabis. Most colleges suggest that physicians should sign the medical document only when they have the necessary clinical knowledge to engage in a meaningful consent discussion with patients. Due to the potential long-term effects of cannabis on the developing brain many colleges discourage authorizing medical cannabis to youth under the age of 25. Many colleges note that a medical document should be considered the equivalent of a prescription and that all regulations surrounding writing a prescription apply equally to this circumstance. A number of regulators specifically state that physicians should not charge for completing a medical document or for any services associated with this act. Several regulatory bodies suggest having patients sign a treatment agreement, similar to an opioid agreement, prior to completing a medical document. A few of the colleges review where and how an assessment for medical cannabis can take place, specifically restricting them from occurring via telemedicine or requiring a specified follow up, such as every three months. The Quebec College restricts authorizing medical cannabis to patients enrolled in a recognized research project, with a provincial research project (https://registrecannabisquebec.com/en) created whereby authorizing physicians are enrolled as primary investigators. The Ontario College instructs physicians to indicate a maximum THC % when completing the medical document. While this article offers a broad review of the stance of regulatory bodies, it is strongly encouraged for all physicians to familiarize themselves with those documents pertaining to their specific situation. Although there is an emphasis on the lack of evidence surrounding the use of medical cannabis for therapeutic purposes, physicians should ultimately use their best judgment when considering authorizing this therapy. Medical cannabis can be a powerful tool to help your patients regain a suitable quality of life if they have failed to respond to more conventional therapies. 5 Authorizing Cannabis for Medical Purposes / Danial Schecter, MD

Jenna Valleriani, PhD(c), MA Jenna Valleriani is a PhD Candidate at the University of Toronto researching legal and illegal cannabis markets in Canada. She is also a Strategic Advisor for Canadian Students for Sensible Drug Policy, co-founder and Vice- Chair of Women Grow Toronto, and member of NORML Canada. Her research looks at the intersection between entrepreneurship, social movements and organizational theory and focuses on the evolving medical cannabis market in Canada. Jenna is also a regular contributor to the public discourse around cannabis in Canada, and has been published numerous times in the Globe and Mail, The Huffington Post, and has appeared on various radio and television shows and TV including the Steve Paikin Show and CBC s Ontario Today and the Here and Now. FROM GRASSROOTS TO INDUSTRY: THE DEVELOPMENT OF MEDICAL CANNABIS ACCESS IN CANADA 6 From Grassroots to Industry / Jenna Valleriani, PhD (c), MA IN JUNE 2013, HEALTH CANADA OPENED COMMERCIAL PRODUCTION OF CANNABIS for medical purposes to a projected billion-dollar free market. Under the old regulations, the Medical Marijuana Access Regulations (MMAR), overseen by the Medical Marijuana Access Division (MMAD), medical cannabis patients were able to purchase their medication from a sole producer authorized by Health Canada, cultivate their own cannabis, or designate a third party to grow for them (Lucas 2008). Today, the only legal way to obtain medical cannabis in Canada is through Licensed Producers (LPs) approved by Health Canada under the new regulations, the Marijuana for Medical Purposes Regulations (MMPR). Licensed producers (LPs) are companies authorized by Health Canada to grow and dispense cannabis to those with valid prescriptions from a physician under a very tightly regulated system. Since this announcement, estimates of over 1600 companies have applied to become LPs, and 32 have currently been approved for production and distribution (Health Canada 2015). Licensed Producers (LPs) in Canada must meet a variety of security and quality control requirements. The requirements include employing a quality assurance person to approve the dried cannabis, providing police, fire department and government with the location of production, and ensuring production sites have round the clock surveillance (Health Canada 2013a). Despite the growing momentum around this industry, managing commercial production on such a large scale within health, business and political contexts can be challenging. The medical cannabis program, which made Canada the second country in the world to establish a centralized medical cannabis government program (Lucas 2008), is arguably one of the most successful social movement outcomes in the drug policy reform movement. The changing federal medical cannabis access regulations, which have allowed for the open medical cannabis market we see today, represent a momentous shift in Canada. These benefits are predominantly seen in terms of access to a regulated, tested supply of medical cannabis for medical users in Canada, the expansion of research initiatives, and the professionalization of how cannabis is both produced and distributed. However, the development of the MMPR must be understood in broader context and rich history of how cannabis access unfolded following years of advocacy that challenged an unconstitutional federal access program. Many individuals and organizations pioneered for change, particularly to include easier access for patients to education, variety and better quality medicine. First, I will outline the role of medical cannabis dispensaries and how they fit into the broader

THE ROLE OF DISPENSARIES IN EARLY PATIENT ACCESS Before the development of a federal medical cannabis program, and in response to a wider unmet need for safe access and knowledge about medicating with cannabis since the late 1990s, a handful of community based cannabis dispensaries (also known as compassion clubs or medical cannabis dispensaries ) developed all across Canada (Hathaway & Rossiter 2007). Dispensaries are organizations that provide access to a range of medical cannabis products to individuals with a diagnosed medical condition. While the number of dispensaries in major cities today has exploded and represents more diverse organizational structures, at one time, medical cannabis dispensaries addressed a serious need for medical cannabis access, and they greatly increased the number of patients able to gain access to cannabis for medical purposes (Hathaway & Rossiter 2007). Medical cannabis dispensaries have always been illegal, and historically discussed as operating as an act of civil disobedience, or as occupying a grey area of the law, where their existence challenged issues of access through the legal supply channel. While they operate outside the medical cannabis program, law enforcement has traditionally tolerated best practice cannabis dispensaries who enforced strict policies surrounding admissions, limiting access to only those with verified medical conditions (Hathaway & Rossiter 2007). With the recent proliferation of dispensaries, namely in cities like Toronto, Vancouver and Victoria, many of the new dispensaries which have opened are a result of an impending recreational market ( jumping the gun so to speak), and addressing gaps in the federal access program focusing their efforts on access to onsite dispensing and to a range of cannabis products, such as tinctures, higher concentrate oils, food products and more not available through the legal channels. While things are rapidly changing with the development and expansion of the MMPR, cannabis dispensaries across Canada may arguably be one of the main sources of cannabis-based medicines for a large segment of users. However, this more recent proliferation has been heavily criticized for not following the established community norms by traditional compassion clubs including restrictive access to those with a verified medical condition, as well as criticized for the lack of transparency and quality of cannabis supply more generally. While cannabis dispensaries remain illegal, some municipalities, namely Vancouver and Victoria, have decided to control the proliferation by providing business licenses to a handful of dispensaries that meet a variety 7 From Grassroots to Industry / Jenna Valleriani, PhD (c), MA landscape of medical cannabis access in Canada, followed by the discussion of the court challenges by medical cannabis users and the development of the MMAR, and end with a more current look at the new federal medical marijuana regulations, the MMPR.

THE MEDICAL CANNABIS PROGRAM IS ONE OF THE MOST SUCCESSFUL SOCIAL MOVEMENT OUTCOMES IN THE DRUG POLICY REFORM MOVEMENT of standards around location and access. On the other hand, Toronto, a city that unexpectedly surpassed Vancouver in the number of dispensaries rapidly opening across the city, did not take the licensing approach, where over 40 dispensaries were closed and raided in May 2016. This signals the discretionary and complex variety of responses by municipalities to the issue of unlicensed cannabis retail stores. A COURT-ORDERED PROGRAM Medical cannabis dispensaries in Canada are part of a longstanding and controversial existence of medical cannabis access in Canada. The Medical Marihuana Access Program (MMAP) in Canada was not something proactively initiated, but instead relied on a court order that directed Health Canada to create a federal medical cannabis access program (Lucas 2008; 2009). This was the result of a case in 1999, where an individual who used cannabis to manage the symptoms of HIV/AIDS faced charges for possession and cultivation of cannabis. In this case, the Ontario Supreme Court affirmed he had a right to legal access for medicinal purposes without jeopardizing his liberty (Lucas 2008; 2009; see Wakeford v. the Queen, 1999). As a result, the Marihuana Medical Access Program (the Program) was first established, allowing individuals to possess cannabis and/or produce a limited number of cannabis plants for medical purposes with a physician-issued exemption under Section 56 of the CDSA (Canadian Gazette 2012; Lucas 2008; 2009). Soon after in 2000, an individual with epilepsy was charged with possession and cultivation of cannabis, and brought his case to the Ontario Court of Appeals. In this case, Section 56 of the CDSA was declared unconstitutional because of the lack of regulation (Lucas 2008; 2009). As a result of this case, the government was afforded one year to introduce regulations surrounding fair access to medical cannabis for individuals with a legitimate medical condition (see Parker v. the Queen, 2000). Finally, in 2001, the court-ordered Marihuana Medical Access Division (MMAD), which managed the Marijuana Medical Access Regulations (MMAR), was established and available for Canadians. This new set of regulations replaced Section 56 of the Controlled Drug and Substances Act (CDSA). The MMAR permitted cannabis use by patients with terminal illnesses and serious medical conditions (Jones & Hathaway 2008). Within its first year, Health Canada authorized 500 patients and by December 2012, a total of 28,115 individuals were authorized to possess cannabis for medical purposes (Health Canada 2013b). The MMAR included three important components: the Authorization to Possess (ATP), Personal Production Licenses (PPL) and Designated Production Licenses (DPL), where an Authorization to Possess is the legal right to possess cannabis for medical purposes, a Personal Production License is the right to legally cultivate cannabis for medical purposes, and the Designated Production License is the right to allow a third party to cultivate cannabis for medical purposes on the patient s behalf. In 2003, the co-founder of a medical cannabis dispensary in Toronto was raided and arrested three years into its operations and subsequently closed. The medical cannabis dispensary served medical cannabis users both those authorized under the MMAR, and those who had a verification of illness (but for various reasons were unable to access the MMAR). The co-founder, Warren Saul Hitzig, along with a group of authorized MMAR patients, brought a joint application to the Superior Court of Justice in Ontario, challenging the MMAR s constitutionality. They successfully argued that although they were authorized to possess cannabis for their medical purposes, the lack of access to a regulated supply forced them to the black market for both their cannabis and cannabis seeds (to grow their own supply), and violated their section 7 rights to life, liberty and security of the person. Health Canada responded by contracting a sole producer, Prairie Plant Systems in Manitoba, to distribute cannabis, a single strain, for medical purposes to authorized Canadians. Since its creation in 1999, the MMAD faced many legal challenges which highlighted the program s shortfalls at addressing the needs of patients in Canada (Lucas 2009; for example, see Wakeford v. the Queen, 1999; Parker v. the Queen, 2000; R v. J.P 2003; Hitzig v. the Queen, 2003; Hitzig v. Canada 2005; R v. Long 2007; R v. Bodner/ Hall/Spasic 2007; Sfetkopoulos v. Canada 2008; R v. Mernagh 2011). These decisions led to the overhaul of the MMAR, and the introduction of a new program in 2013. 8 From Grassroots to Industry / Jenna Valleriani, PhD (c), MA

9 MMPR MMAR From Grassroots to Industry / Jenna Valleriani, PhD (c), MA OPENING UP THE MEDICAL CANNABIS MARKET In 2013, new regulations, the MMPR, were unveiled and opened the production and distribution of medical cannabis to Licensed Production companies approved by Health Canada. Thus, under the new regulations, the dispensary model is not supported, confounded by the enactment of mandatory minimums in November 2012 for cultivation and trafficking. However, the MMPR in Canada made some important changes to how Canadians access medical cannabis, such as a shorter and more accessible application process, quality-assured product and a distribution model that allows patients access to a variety of strains of dried cannabis and low-potency oils 1. Under the MMPR, Licensed Producers are authorized to distribute cannabis through the mail only. While most offer only dried cannabis, nine of 31 Licensed Producers are authorized to also produce and distribute low-potency oils and fresh cannabis (Health Canada 2015). To access a legal supply of cannabis for medical reasons through a Licensed Producer, an individual must have their physician fill out a one page medical document, akin to a prescription, which is submitted directly to one 1 The availability of low-potency oils was an amendment resulting from R v. Smith (2015), where the Supreme Court of Canada unanimously ruled that the restriction permitting only the legal possession of dried marijuana infringed on the right to liberty and security of the person under section 7 of the Canadian Charter of Rights and Freedoms. Prior to this ruling, medical cannabis patients in Canada were not legally allowed to possess cannabis derivatives for medical use. To remedy this violation, the Supreme Court declared medical marijuana users are able to possess cannabis in any form for medical purposes, allowing patients to make reasonable medical choices without the threat of criminal prosecution. Less than a month later, Health Canada responded by expanding the MMPR to include the production and distribution of low-potency cannabis oils by Licensed Producers with a supplemental license. Licensed Producer, and the cannabis is mailed directly to the individual. This represents a drastic difference from the MMAR (the old program), where patients were able to legally access only one strain from the only authorized producer in Canada, or grow their own. Under the old system, patients were largely unhappy with the quality of cannabis from this sole producer, which often came milled, and many patients felt a single strain could not address all their medical needs. The MMPR, however, now offers patients a variety of different strains, where each variety is known to have a different therapeutic profile and effect. Some of the biggest challenges facing the MMPR today include (1) physician s hesitancy to prescribed medical cannabis (rooted in a host of considerations such as provincial college recommendations, unfamiliarity of the endocannabinoid system and lack of proper scientific studies), (2) operating solely on a mail-order model which may not address the needs of all patients, and (3) cost, where medical cannabis is typically not covered by insurance because it does not have a Drug Identification Number. However, some of the benefits include (1) a wide variety of access to cannabis strains which are cultivated using strict quality assurance guidelines and are tested, (2) the widening of patient access through physician education and investment in research, as well as (3) the professionalization and standardization of the industry more generally, which will likely impact a number of issues at both the micro and macro level, such as the stigmatization felt by patients using medical cannabis (see Belle-Isle & Hathaway 2007; Bottorff et al. 2013).

Further, it s important to note that many stakeholders are awaiting the results of the most recent court case launched on March 19 th, 2014. In Allard et al. v Her Majesty the Queen (2016), the Federal court invalidated the MMPR regulations, but suspended that declaration for six months to allow the federal government to address issues around access and availability. This case was sparked during the transition from the MMAR to MMPR, which no longer included the right to grow one s own cannabis supply as of April 1, 2014. In this case, a group of patients first sought an injunction to allow patients to continue to grow their own cannabis until their challenge against the new program could be heard in court. The injunction was successfully granted for patients with valid personal production licenses, and legal patients from the old program were able to continue growing despite the MMPR s regulations banning home growing. Recently, the court ruled that the loss of growing rights for individuals under the new federal program has restricted access for many patients (namely, section 7 Charter rights to life, liberty and security of the person ). The court decided that restricting patients to purchase only from a Licensed Producer diminished their health and safety because of the access and availability concerns. The government was given six months to address this, which is due at the end of August 2016. Many speculate this will include on site dispensing options such as pharmacies, and allow authorized patients to grow their own (limited) cannabis supply. CONCLUSIONS ON THE EVOLVING LANDSCAPE IN CANADA Today, the MMPR continues to expand its reach, with 39,668 registered patients at the end of December, 2015 (Health Canada 2015), and estimates of around 65,000-70,000 currently registered through the MMPR (Koven 2016). This growth is a reflection of access that began in its earliest form through the work of pioneering dispensaries and should not be forgotten. However, the role of proper regulation and standardization afforded under the MMPR has paved a positive path of change to how Canadians access medical cannabis. Future solutions will continue to address research into the benefits of medical cannabis, the challenging role given to physicians and other healthcare providers, providing cannabis- based medicines in a variety of forms, and improving patient access and education. Alongside the development of legalization for personal use of cannabis in Canada, the program will continue to rapidly evolve, and provide new and innovative ways to provide safe, affordable and consistent access to medical cannabis users across the country. REFERENCES 1. Belle-Isle, L. & Hathaway, A. D. (2007). Barriers to access to medical cannabis for Canadians living with HIV/AIDS. AIDS Care 19: 500 506. 2. Bottorff, J.L, Bissell, L., Balneaves, L.G., Oliffe, J.L., Capler, R., & Jane Buxton. Perceptions of Cannabis as a stigmatized medicine: a qualitative descriptive study. Harm Reduction Journal 10 (2). Retrieved online http://www.harmreductionjournal.com/content/10/1/2. 3. Hathaway, A.D. & Rossiter, K. (2007). Medical Marijuana, Community Building, and Canada s Compassionate Societies. Contemporary Justice Review. 10(3): 283 296. 4. Health Canada. (2013a). Application tov Become a Licensed Producer under the Marihuana for Medical Purposes Regulations (MMPR). Health Canada. Retrieved online August 2013 at http://www.hc-sc. gc.ca/dhp-mps/marihuana/info/app-demande-eng.php. 5. Health Canada. (2013b). Marihuana Medical Access Program Statistics Medical Use of Marihuana. Health Canada. Retrieved online August 2013 at http://www.hc-sc.gc.ca/dhp-mps/marihuana/stat/index-eng.php. 6. Health Canada. (2015). Market Data. Health Canada. Retrieved online June 10, 2016 at http://www.hc-sc.gc.ca/dhp-mps/marihuana/info/ market-marche-eng.php 7. Jones, C. & Hathaway, A.D. (2008). Marijuana medicine and Canadian physicians: Challenges to meaningful drug policy reform. Contemporary Justice Review 11(2): 165 175. 8. Koven, P. (2016). Marijuana point man Bill Blair praises Canada s Licensed Producers. Financial Post. Retrieved online June 1, 2016 at http://business.financialpost.com/news/agriculture/marijuanalegalization-point-man-bill-blair-praises-canadas-licensed-producers 9. Lucas, P. (2008). Regulating Compassion: an overview of Canada s federal medical cannabis policy and practice. Harm Reduction Journal 5 (5): 1-13. 10. Lucas, P. (2009). Moral Regulation and the Presumption of Guilt in Health Canada s Medical Cannabis Policy and Practice. International Journal of Drug Policy 20: 296-303. 10 From Grassroots to Industry / Jenna Valleriani, PhD (c), MA

11 MEDICAL CANNABIS, DRIVING AND WORK Lydia Hatcher, MD Authorizing Cannabis for Medical Purposes / Danial Schecter, MD YOUR PATIENT, PAT, has been given medical cannabis from a specialist. Pat is asking you about work and driving risks. Pat drives to and from work and has a municipal job that requires some computer skills and some basic accounting work at times. How do you counsel this patient? Unfortunately, at the present time there is no specific research on the psychoactive effects of non-recreational use of medical cannabis when being used in the workplace. Most of the research around driving relates to recreational use, use with alcohol and use with other sedating drugs. So what information do you give Pat?

Lydia Hatcher, MD Dr. Hatcher graduated with her MD in 1982 from Memorial University of Newfoundland. In 1984, she received certification with the College of Family Physicians of Canada (CFPC) and in 1994, was certified with the Canadian College of Health Service Executives. In 1998, she received the Canadian Psychiatric Association s annual Mental Health Awareness Award. In 2001, the College of Family Physicians of Canada awarded her a fellowship. She has been doing pain management for over 25 years. Her focus is on a bio-psychosocial approach to pain management. She does a significant BASIC CANNABINOID FACTS Of the two main active ingredients in cannabis, tetrahydrocannabinol (THC) is the one that is psychoactive. It crosses the blood brain barrier and causes the high experienced by users. Cannabidiol (CBD), on the other hand, does not cross the blood brain barrier and therefore does not have a psychoactive component. So, if your patient has a CBD-only product, there should be little added risk with driving or work. Of course you need to have a discussion with your patient to make sure they understand that if they do feel different they need to judge themselves accordingly. Most products available from Licensed Producers (LPs) have a combination of THC and CBD. We also know that with levels of THC less than 9% there is far less risk of euphoria and dysphoria than with higher THC levels. We also know that when CBD is combined with THC the psychoactive effect of the THC is lessened. Again it is important to tell your patient to start low and go slow and see how they feel. Use of alcohol with cannabinoids has been clearly shown to negatively enhance the psychoactive and cognitive effects and diminish motor skills and ability to perform complex tasks. amount of teaching in chronic pain across the country and is a physician assessor for the College of Physicians and Surgeons of both Ontario and Newfoundland & Labrador. She chairs a subcommittee for the National Opioid Use Guideline Group. She is a member of the Canadian Academy of Pain Management and the Canadian Pain Society. She is a committee member of the CFPC community of practice in chronic pain. She is an Associate Clinical Professor of Family Medicine at McMaster University and Chief of Family Medicine at St. Joseph s Healthcare in Hamilton, Ontario. WHAT DO THE GUIDELINES SAY? In 2014, the College of Family Physicians of Canada (CFPC), based on the Marijuana for Medical Purposes Regulations (MMPR), released a guideline document. This was only about dried cannabis, as oils were not available at that time. In their recommendations for strategies to prevent harm they suggested that patients taking dried cannabis should be advised not to drive for four hours after inhalation, six hours after oral ingestion and eight hours after inhalation or oral ingestion if the patient experiences euphoria. They also note that Health Canada states that the ability to drive or perform activities requiring alertness may be impaired for up to 24 hours following a single consumption. THE COLLEGE OF FAMILY PHYSICIANS OF CANADA LE COLLÈGE DES MÉDECINS DE FAMILLE DU CANADA 12 Medical Cannabis, Driving and Work / Lydia Hatcher, MD TREATMENT AGREEMENTS AND SAFETY: When signing a treatment agreement with your patient for medical cannabis use it is prudent to have a discussion with them, just like we do with opioids, to talk about risks and safety, especially if they are performing jobs that require precision, attentiveness, use of motorized equipment, etc. Just like with opioids, we know that when patients are on long-term stable doses they are unlikely to have mental impairment. The same may be true for medical cannabis. However, at the present time, if your patient was pulled over while driving, tested and showed positive for THC, likely they would not be covered by their insurance and they may be in fact at risk of being charged by police for impaired driving. Authorizing Dried Cannabis for Chronic Pain or Anxiety PreliminAry guidance September 2014

THE RESEARCH The Canadian Centre on Substance Abuse in 2015 showed that among young drivers, driving after using cannabis is more prevalent than driving after drinking. Cannabis impairs the cognitive and motor abilities necessary to operate a motor vehicle and doubles the risks of crash involvement. Downey et al., 2013, in their research they showed, not surprisingly, that combining cannabis with even small amounts of alcohol increases the negative effects on driving skills. Unfortunately, there is absolutely no research yet regarding patients using medical cannabis as opposed to people using it recreationally, and this obviously does have implications. However, a large case control study conducted by the National Highway Traffic Safety Administration (Hartman et al.) in the United States found no significant increase in motor vehicle crash risks attributable to cannabis after controlling for drivers age, gender, race and presence of alcohol. Hartman, et al. reviewed and evaluated the current literature in 2013 on cannabis effects on driving. He noted from their studies that experimental data showed the drivers attempts to compensate by driving more slowly after smoking cannabis, but control deteriorated with increasing task complexity. Despite reported tolerance in frequent smokers, complex tasks still showed impairment. Combining cannabis with alcohol enhanced the impairment (especially lane weaving). They summarized that future cannabis and driving research should emphasize challenging tasks such as divided attention and include occasional and chronic daily cannabis smokers. The study also noted that increasing blood THC concentrations added to their risks. A study by Heustis, et al., with a small number of young adults in a driving simulator using different strengths of THC, showed that drivers with higher levels of THC did do more lane weaving. This study looked at the amount of THC smoked while they were driving, not the after effects. The author commented that it took years to develop 0.08 breath alcohol limits based on many studies and time from last drink etc., none of which have been studied for cannabinoids. Nearly all the above research has been done with recreational cannabinoid use. All of these studies involved smoked cannabinoids, not ingested. It should also be noted that much of this research involves adults between the ages of 19-25, other than population studies. These trend towards not showing higher risk of crashes if alcohol is not involved. THE BOTTOM LINE WHAT TO TELL TO PAT While the available research has some controversy, it is prudent to be clear with Pat. Using oils or edibles from LP s will guarantee a stable known dosing effect. It is safest to start with a product with THC less than 9% and preferably a higher CBD content to offset the psychoactive component. It is also important to review your College and Regulatory bodies information as these may change at any time and you should be following their guidelines. Sign a treatment agreement with Pat downloadable from the CFPC website or your provincial college website. Pat should first try the product when there is no driving/ work required for 24 hours, such as on a weekend or days off. As we recommend with any medication that can cause sedation or altered consciousness, if Pat does feel sedated, stoned or otherwise not normal, the guidelines must be followed. This will protect Pat, you the prescriber and the public from harm. REFERENCES 1. Health Canada; Drugs and Health Products; Information for Health Care Professionals: http://www.hc- sc.gc.ca/dhp-mps/marihuana/med/ infoprof-eng.php. (Accessed June 10th 2016) 2. College of Family Physicians of Canada: Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary Guidance from the College of Family Physicians of Canada. Mississauga, ON: College of Family Physicians of Canada; 2014. 3. Beirness, DJ et al., The Canadian Centre on Substance Abuse, 2015, Clearing the Smoke on Cannabis, Cannabis Use and Driving. 4. Downey LA, et al,: The effects of cannabis and alcohol on simulated driving: Influences of dose and experience. Accid Anal Prev. 2013, 50: 879 86. 10.1016/j.aap.2012.07.016 5. Hartman, R. L.et al, Cannabis Effects on Driving Skills, Clinical Chemistry 2013 March, 59 (3) 478-92. 6. Huestis, M. A. (2007). Human cannabinoid pharmacokinetics. Chem. Biodivers. 4: 1770-1804. 13 Medical Cannabis, Driving and Work / Lydia Hatcher, MD

Jonathan Zaid Jonathan Zaid is a Knowledge Integration student at the University of Waterloo and Founder and Executive Director of Canadians for Fair Access to Medical Marijuana (CFAMM). Since 2007 he has been suffering from New Daily Persistent Headache, which causes constant chronic head pain and insomnia. After trying all available interventions to no avail, Jonathan finally gained some relief from medical cannabis. In 2014, Zaid founded non-profit patients rights group Canadians for Fair Access to Medical Marijuana, which aims to help others navigate, and ultimately improve, the issues and challenges associated with medical cannabis COST COVERAGE OF MEDICAL CANNABIS: 3RD PARTY GROUP BENEFITS 14 Cost Coverage of Medical Cannabis / Jonathan Zaid AS MEDICAL CANNABIS WAS APPROVED through court cases rather than Health Canada s regulatory process, it is in a different regulatory category than every other medication and doesn t carry a Drug Identification Number (DIN). Due to its unique classification, cannabis is not included in formularies and must be added onto insurance plans as a separate expense or through a special claim. It is up to patients to advocate to their plan sponsor (i.e., employer, student union, etc.) to add coverage for medical cannabis onto their plan. Affordability of medical cannabis is a key and urgent issue Canadian patients face. Although many Licensed Producers offer financial assistance to patients with low incomes, many patients question the fact medical cannabis is not included in drug formularies and their claims are almost always denied.

Recent research suggests that More than half of [patients] reported that they were sometimes or never able to afford to buy sufficient quantity of [cannabis for therapeutic purposes] to relieve their symptoms, and approximately one third reported that they often or always choose between cannabis and other necessities (e.g. food, rent, other medicines) because of lack of money. 2 Moreover, many patients report that they switch back onto less effective medications with more side effects, usually opioids, because they are covered. Although advocating for coverage is a challenging task, there are instances where cannabis has been successfully covered under 3rd-party private insurance, most notably the coverage veterans receive through the Department of Veterans Affairs. When cannabis has been successfully covered under group benefits, it has been under either Health Spending Accounts (HSA) or through large-scale group benefit plans (see table below). There has yet to be any widespread coverage under public plans, smaller-scale group benefits, or individual s insurance plans, mainly due to a lack of DIN and increased financial risk being taken on by the insurer/ government rather than the plan sponsor. Health Spending Accounts allow for patients to submit various medical expenses to receive reimbursement up to a yearly maximum. Many HSAs determine eligible claims on the basis of if the claim is for a CRA eligible medical tax-deductible good. As cannabis obtained through the MMPR/Licensed Producers is indeed a CRA eligible deduction, this means that cannabis can easily be claimed to many HSAs. The main caveat to this type of coverage is that HSAs are generally capped smaller compared to drug benefits, often limited at under $1000 annually. Large-scale institutional benefits plans offer more adaptability, which allow patients to advocate to coverage on these types of plans. As cannabis is not included in the formulary, patients must advocate directly to their plan sponsor and ask for them to permit a special claim or add- on/allow coverage for medical cannabis so it will be considered an eligible expense. The insurer on these plans acts as the administrator of the plan but it s up to the plan sponsor to decide what type of coverage they want to obtain for their plan s members (i.e. employees, students, etc.). 15 Cost Coverage of Medical Cannabis / Jonathan Zaid PROS/CONS OF BENEFITS FOR CANNABIS PROS CONS HEALTH SPENDING ACCOUNT Coverage easier to obtain Generally don t have to disclose cannabis use Already available to many patients Often capped to small annual amount Not part of regular drug benefits / formulary LARGE-SCALE GROUP BENEFITS More adaptable, dependent on plan sponsor coverage/contract Larger plans have better ability to cover expensive drugs Generally much larger coverage limits Involves in-depth advocacy to plan sponsor Takes longer to get coverage May have to disclose use to plan sponsor (employer) 2 Belle-Isle, L., Walsh, Z., Callaway, R., Lucas, P., Capler, R., Kay, R., & Holtzman, S. (2014). Barriers to access for Canadians who use cannabis for therapeutic purposes. International Journal of Drug Policy, 25(4), 691 699. http://doi.org/10.1016/j.drugpo.2014.02.009

In a way, cannabis patients are being treated a bit different than other patients, as they must approach their plan sponsor to get coverage, which in turn often discloses their cannabis use to the sponsor. This is sometimes of concern to patients who do not wish to share this information with their employer. The process to advocate for coverage is not easy and there are many roadblocks put up throughout the process. In many instances the plan sponsor will look at claims from a financial perspective. In cases where patients have gone off more expensive treatments from being on medical cannabis there is financial benefit to the plan sponsor, so they are more likely to cover cannabis. It is vital that physicians support patients advocacy in every way possible. Letters of support, medical information and history, and a recommendation for coverage can go a long way in helping patients making their case to their plan sponsor. Physicians should make it clear from the onset if they will support patients through the process, as without their support it will make it very hard for patients to substantiate their claims. Advocating for cannabis to be covered under benefit plans is not a quick process. Unfortunately quite often stigma and misconception are big element of why claims are denied, so it s important for patients to talk with plan sponsors and other stakeholders to help educate them on medical cannabis. Canadians for Fair Access to Medical Marijuana recently launched an Individualized Insurance Educational Program that works with selected patients to provide personal education for every step of the process. Although it s still limited right now, there are some available options for patients to obtain coverage under 3rd party health benefits. Unfortunately, many patients on disability or with low incomes may not have these benefits, yet the patients advocating for private coverage will help pave the way for broader cost coverage in the future. 16 Cost Coverage of Medical Cannabis / Jonathan Zaid

Ian Mitchell, MD Ian Mitchell is an emergency physician practicing in Kamloops, British Columbia. His area of interest is reducing opiate deaths with the use of Take Home Naloxone and the substitution of opiates with cannabis for chronic pain. He is a qualified investigator for an RCT of cannabis for PTSD and is also involved with research as the Site Scholar for the Kamloops Family Medicine program. He blogs less often than he should at www. clinicalcannabisincontext.tumblr.com. USING VAPORIZERS FOR YOUR MEDICAL CANNABIS PATIENTS 17 Using Vaporizers for your Medical Cannabis Patients / Ian Mitchell, MD ONE OF THE DIFFICULTIES IN ADVOCATING FOR THE MEDICAL USE OF CANNABIS is getting around the smoking issue. It is hard to convince a 21st century physician that inhaling the smoke from burning plant material represents good clinical practice. I would tend to agree. As a physician, I don t want anyone to smoke cannabis that s what vaporizers are for. WHAT IS A VAPORIZER AND WHY USE ONE? Vaporizers are a relatively recent innovation, appearing in the literature only in the last 20 years. They use hot air to heat a cannabis sample up to a temperature that is below combustion, but at a point where the cannabinoids will be vaporized and can be inhaled. By controlling the temperature of the cannabis and avoiding combustion, the amount of carbon monoxide, benzene and other toxins inhaled is dramatically reduced (1). Research has shown that regular cannabis users who switch to a vaporizer suffer from fewer respiratory symptoms (2). While cannabis smoke has not been shown to cause COPD or lung cancer, vaporizers are an easily accessible harm reduction method for minimizing any respiratory complications from cannabis use. Many Canadians with asthma have avoided smoking cannabis for fear of worsening their symptoms. These patients may tolerate a vaporizer and thereby benefit from the bronchodilatory properties of THC (3). While oral cannabis products are likely easiest for institutional use, there have been several hospitals in Canada that have approved the use of vaporizers. In a notable case from 2014, Charles Bury, long-time editor of the Sherbrooke Record, was given permission to use his vaporizer in his hospital bed, as he was dying from liver cancer. This prompted his hospital, CHUS, to develop a policy for vaporizer use. Some institutions provide special vaporizers for patient use, while others provide a ventilated space for patients to use their own vaporizer (4). In addition to lung health, there are a number of other reasons why patients should choose a vaporizer over smoking. Using a vaporizer results in far less odor than smoking and is less likely to attract unwanted attention and stigma. This can be helpful in reducing complaints from neighbours for patients who live in multi-unit dwellings. Vaporizers are also able to extract more cannabinoids from a given sample than smoking. With smoking, only about 25% of the cannabinoids in the sample were taken into the body. A recent examination of various vaporizers shows the extraction rate was much higher, and varied from 60% 80%. (5). There are also anecdotal reports of patients