Pharmacists role in Cannabis-Based Patient Care

Pharmacist Learning Objectives Pharmacists role in Cannabis-Based Patient Care At the completion of this activity, the participant will be able to: Describe the timeline of medical cannabis programs in the United States. Discuss the implementation and status of the Illinois Medical Cannabis pilot program. Explain current proposals regarding recreational cannabis use in Illinois. Discuss the opportunities and roles for pharmacists in cannabisbased patient care. 1 2 Technician Learning Objectives Disclosures At the completion of this activity, the participant will be able to: Describe the timeline of medical cannabis programs in the United States. Discuss the implementation and status of the Illinois Medical Cannabis pilot program. Explain current proposals regarding recreational cannabis use in Illinois. Discuss the opportunities and roles for pharmacists in cannabisbased patient care. I do not have any relevant financial disclosures and/or commercial interests that conflict with the objectives and/or content of this program. 3 4

The United States Pharmacopeia (USP) officially listed cannabis up until what year? A) 1983 B) 1880 C) 1920 D) 1941 Which Department has statutory oversight for the dispensing organizations in the Illinois MCPP? A) Department of Financial and Professional Regulation B) Department of Public Health C) Department of Human Services D) Department of Health and Family Services 5 6 Are Pharmacists able to participate in the Illinois MCPP? A) No, it is a violation of the Pharmacy Practice Act. B) Yes, as long as MCPP business activities occur outside of the Pharmacy Department. C) Yes, as long as a pharmacist registers with the Department of Public Health. D) Yes, as long as a pharmacist applies for an additional license. From Marijuana to Medical Cannabis 7 8

Regulation of Marijuana 1870: USP publishes official monograph 1937: Marijuana Tax Act 1941: USP removes official monograph 1970: Controlled Substance Act 1996: Medical Marijuana established-proposition 200 (Arizona)/ Proposition 215 (California) 2012: Recreational Legalization Colorado 2013: Illinois Medical Cannabis Pilot Program established Current Status of Medical Marijuana (United States) 46 States and District of Columbia Connecticut-Pharmacists Dispensing Role (2012) Illinois-Medical Cannabis Pilot Program (2013) https://norml.org/legal/medical-marijuana-2 9 10 http://www.advancedholistichealth.org/images/cannabinoids.jpg http://www.medicinalgenomics.com/wp-content/uploads/2011/08/shutterstock_228986515-copy.png 11 12

HB1 Compassionate Use of Medical Cannabis Pilot Program Act Medical Cannabis Pilot Program (MCPP) Sponsor: Rep. Lou Lang (D-Skokie) Creates the Compassionate Use of Medical Cannabis Pilot Program Act Allows for legal possession of up to 2.5 ounces of medical cannabis by a registered qualifying patient. Allows registered non-profit medical cannabis organizations to acquire, possess, cultivate, manufacture, deliver, transfer, transport, sell, supply, or dispense cannabis, paraphernalia, or related educational materials to registered qualifying patients. Status: Public Act 98-0122 08/01/2013 13 14 MCPP Agencies Department of Agriculture Department of Agriculture Department of Financial and Professional Regulation Department of Public Health Department of Revenue Illinois State Police Involved in oversight and regulation of the cannabis cultivators 1 cultivator will be licensed per State Police District 22 State Police Districts 15 16

Department of Financial and Professional Regulation Involved in oversight and regulation of the cannabis dispensing organizations 1 dispensing organization per each Legislative (Senate) District 59 Legislative Districts plus 1 additional Separate from Medical and Pharmacy Board oversight Department of Public Health Involved in oversight and regulation of patient registration and physician procedures Established criteria for patients Creates application process for patients Annual fee of $100 A written letter of necessity is required from a physician (not a prescription) 17 18 Department of Revenue Illinois State Police Is responsible for regulation and administration of all related taxes on the State Level Taxes are imposed through this program Cultivators, Dispensing Organizations, Patients 7% Service Occupation Tax (SOT) that applies to all prescriptions applies Includes Municipal/County authority for additional tax Is responsible for oversight of the entire program through all Departments to ensure legal authority and control Maintains that MCPP does not violate Federal Law 19 20

Debilitating Medical Conditions SB2636 Amends the MCPP Agitation of Alzheimer s disease Myoclonus HIV/AIDS Nail-patella syndrome Amyotrophic lateral sclerosis (ALS) Arnold-Chiari malformation Cancer Causalgia Chronic inflammatory demyelinating polyneuropathy Crohn s disease CRPS (complex regional pain syndrome Type II) Dystonia Fibrous dysplasia Glaucoma Hepatitis C Hydrocephalus Hydromyelia Interstitial cystitis Lupus Neurofibromatosis Parkinson s disease Post-concussion syndrome Post-Traumatic Stress Disorder (PTSD) Reflex sympathetic dystrophy Residual limb pain Rheumatoid arthritis Seizures (including those characteristic of Epilepsy) Severe fibromyalgia Sjogren s syndrome Spinal cord disease Spinal cord injury Spinocerebellar ataxia Syringomyelia Tarlov cysts Sen. Iris Martinez, D-Chicago Adds seizures (including those characteristic of epilepsy) to list of debilitating medical conditions Would allow persons under the age of 18 to be registered for medical cannabis use if they suffer from seizures Status: Public Act 98-0775 Multiple sclerosis Tourette syndrome Muscular dystrophy Traumatic brain injury Myasthenia Gravis Cachexia/wasting syndrome http://www.dph.illinois.gov/topics-services/prevention-wellness/medical-cannabis/debilitating-conditions 21 22 SB33 Amends the MCPP MCPP Patient Requirements Sen. Michael Hastings, D-Matteson Adds PTSD (post-traumatic stress disorder) to list of debilitating medical conditions Status: 2 nd Reading Senate (03/12/2015) Be a resident of the state of Illinois at the time of application and remain a resident during participation Have a qualifying medical condition; Have a signed physician certification for the use of medical cannabis; Can not have been convicted of an excluded offense (a felony under the Illinois Controlled Substances Act, Cannabis Control Act or Methamphetamine Control and Community Protection Act, or similar provisions in a local ordinance or other jurisdiction), unless the Department waives such a conviction(s); and Be at least 18 years of age 23 24

MCPP Dispensing Organizations MCPP Cultivators Provide information in the following areas: Suitability of Proposed Dispensing Organization Business and Operations Plan Security Plan Recordkeeping and Inventory Plan Financial Disclosures Misc.: such as Research Plan and Substance Abuse Prevention Plan Application Fee: $35,000 initial, $25,000 renewal Provide information in the following areas: Suitability of Proposed Facility Staffing and Operations Plan Security Plan Product Safety and Labeling Plan Business Plan Application fee: $25,000 25 26 Pharmacist Role in MCPP Role of the Pharmacist in Medical Cannabis No official role per statute/rule Board of Pharmacy encouragespharmacists to be involved with their patients that are in the program Pharmacists may participate or apply to become a dispensing organization Related business activity not to occur in Pharmacy Department 27 28

APhA Policy on Role of the Pharmacist in the Care of Patients Using Cannabis-2015 APhA Policy on Role of the Pharmacist in the Care of Patients Using Cannabis-2015 APhA advocates for the resolution of the federal and state conflicts surrounding the legal status of cannabis and its various components. APhA supports regulatory changes to further facilitate clinical research related to the clinical efficacy and safety associated with the use of cannabis and its various components APhA encourages health care provider education related to the clinical efficacy, safety, and management of patients using cannabis and its various components APhA advocates that the pharmacist collect and document information in the pharmacy patient profile about patient use of cannabis and its various components and provide appropriate patient counseling. APhA supports pharmacist participation in furnishing cannabis and its various components when scientific data support the legitimate medical use of the products and delivery mechanisms and federal, state, or territory laws or regulations permit pharmacists to furnish them. APhA opposes the furnishing of cannabis and its various components for medical purposes unless performed by licensed health care professionals whose scope of practice includes the dispensing of prescription medications and who comply with state and federal regulations. APhA supports the clinical judgment of pharmacists to decide whether to furnish cannabis and its various components for medical use where allowed by law. APhA opposes pharmacist involvement in furnishing cannabis and its various components for recreational use. 29 30 IPhA Policy on Marijuana - 2018 Recommendations for Pharmacists IPhA supports that pharmacies be the only mechanism for medical and recreational cannabis to be distributed to the public utilizing the same legislative manner used currently to store, record, and distribute controlled substances. IPhA supports pharmacist direct involvement in furnishing cannabis and its various components for medical and recreational use. IPhA supports the development and promotion of healthcare provider education related to the clinical efficacy, safety, and management of patients using cannabis and its various components. IPhA supports that pharmacists provide cannabis-related pharmacist-delivered patient care services in accordance with the Joint Commission of Pharmacy Practitioners Pharmacists Patient Care Process. IPhA supports legislative and regulatory changes to further facilitate clinical research related to the clinical efficacy and safety associated with the use of cannabis and its various components. Engage your patients that are enrolled and participating in the program. Perform a Comprehensive Medication Review and complete an Action Plan for the patient. Communicate with the patient s physician on recommendations for any treatment adjustments. 31 32

Recommendations of American Society of Addiction Medicine (ASAM) regarding medical marijuana If legalized, marijuana should be produced, controlled, and stocked like other prescription drugs (e.g., standardized production by pharmaceutical companies and limited to sale by pharmacies). Marijuana should undergo FDA approval like other drugs Smoking should not be used as route of marijuana delivery States and local ballot initiatives should not interfere with federal drug approval process Medical use of marijuana should be restricted to prescription by physicians who: Adhere to the same professional standards for patient care as for other drugs and conditions Are trained to recognize and treat substance abuse addiction Do not prescribe for children without knowledge/consent of parents Opioid Alternative Pilot Program 33 34 OAPP requirements Goals and background information Must be at least 21 years old Must be a resident of Illinois Licensed physicians must certify the patient has a medical condition for which an opioid has been or could be prescribed based on generally accepted standards of care Long term goal: reduce opioid deaths Registered patients may purchase 2.5 ounces of medical cannabis every 14 days Physician certifications are valid for 90 days but can be renewed $10 fee required for each 90 day registration period A patient is not required to surrender their opioid prescription unless a physician requires it based on their treatment plan http://www.dph.illinois.gov/topics-services/prevention-wellness/medical-cannabis/opioid-alternative-pilot-program http://www.dph.illinois.gov/topics-services/prevention-wellness/medical-cannabis/opioid-alternative-pilot-program 35 36

Cannabis use disorder (DSM5) Disorders, Risk factors and Complications of cannabis use Taking the substance in larger amounts or for longer than meaning to Wanting to cut down or stop using the substance but not able to Spending a lot of time getting, using, or recovering from use Cravings and urges to use Not managing to do work, home, or school activities Continuing to use, even when it causes relationship problems Giving up important social, occupational, or recreational activities because of use Continuing to use, even when it causes dangerous situations Continuing to use, even with physical or psychological problems that could have been caused or made worse by use Needing more to get the desired effect (tolerance) Development of withdrawal symptoms, which can be relieved by taking more of the substance 37 38 Risk factors for addiction or polydrug use Begin in adolescence as the brain is not fully developed until early to mid-20s Weekly cannabis use Hookah use History of mental health problems Complications of cannabis use Withdrawal syndrome (DSM5) Cannabis intoxication (DSM5) Amotivational syndrome Polydrug use 39 40

Withdrawal syndrome Cannabis intoxication Develops when ceasing or dramatically decreasing heavy use of cannabis results in some of the following Irritability Anger/aggression Anxiety Depression Restless/ness Sleep difficulty Decreased appetite/weight loss Cannabis withdrawal is typically shorter and milder than nicotine withdrawal Symptoms appear within 2 hours of cannabis use At least 2 symptoms: Sharp increase in heart rate Dry mouth Increase in appetite Conjunctival injections (edema of eye lids) PLUS Dysfunctional changes (usually disruptive) in physiological or psychological functioning, mood or cognition stemming from CNS impairment due to cannabis use without another logical explanation for symptoms 41 42 Amotivational syndrome and polydrug use Amotivational syndrome: a pattern of behavior with apathy/reduced goal-directed behavior, dullness, impaired judgment, decreased concentration and memory, and loss of interest in personal hygiene Polydrug use (AKA gateway for other drugs of abuse): especially when starting as adolescents Cocaine, prescription drug abuse Tobacco/alcohol use and abuse Illinois Legislation regarding recreational marijuana 43 44

SB 316/HB 2353: Cannabis legalization Avenues for Restorative Justice Illinois residents age 21+ may purchase/possess 30 grams (1 ounce) Adults (21+) may indoor cultivate up to 5 plants per household Municipalities, employers, and landlords can restrict or prohibit use Revenue from cannabis sales will support law enforcement and pay for public education campaigns, substance abuse treatment and programs to repair harms to communities adversely affected by the War on Drugs Public consumption of cannabis, including driving and driving under the influence of cannabis remains illegal Cannabis businesses must abide by rules for location, security, packaging and advertising Products sold by dispensaries must be labeled for safety and potency Expunge criminal records Expand Illinois model by adding more categories of license. These will have varying points of capital entry and will give victims of the War on Drugs the opportunity to access and participate in this nascent cannabis industry Promote investment in communities most impacted by the War on Drugs. Restoring Our Communities will provide a mechanism to direct resources to human service providers and community-based organizations in the neighborhoods most impacted by prohibition 45 46 Summary of proposal for SB 316/ HB 2353 Legalization of marijuana is proposed to help tax and regulate adult-use cannabis; as marijuana is already being used illegally in Illinois. Illinoisans believe that prohibition has simply not worked Municipalities, employers, and landlords have the right to deny use. Public consumption of cannabis will remain illegal. Revenue from cannabis sales will directly go towards law enforcement, education, and substance abuse treatment programs in Illinois. Federal Legislation regarding marijuana 47 48

HR 420: Regulate Marijuana Like Alcohol Act Decriminalization of Marijuana Removal of marijuana in any form from all schedules of controlled substances Legalizes the use of marijuana as it would no longer be considered a controlled substance Exception: It s unlawful to ship or transport marijuana from any place outside the U.S. or its territories Must have a permit issued by the Secretary of Treasury to sell, contract to sell, ship, cultivate, produce, manufacture, or package Review Questions and References https://www.congress.gov/bill/116th-congress/house-bill/420/text 49 50 The United States Pharmacopeia (USP) officially listed cannabis up until what year? A) 1983 B) 1880 C) 1920 D)1941 The United States Pharmacopeia (USP) officially listed cannabis up until what year? A) 1983 B) 1880 C) 1920 D)1941 51 52

Which Department has statutory oversight for the dispensing organizations in the Illinois MCPP? A) Department of Financial and Professional Regulation B) Department of Public Health C) Department of Human Services D) Department of Health and Family Services Which Department has statutory oversight for the dispensing organizations in the Illinois MCPP? A) Department of Financial and Professional Regulation B) Department of Public Health C) Department of Human Services D) Department of Health and Family Services 53 54 Are Pharmacists able to participate in the MCPP? A) No, it is a violation of the Pharmacy Practice Act B) Yes, as long as MCPP business activities occur outside of the Pharmacy Department C) Yes, as long as a pharmacist registers with the Department of Public Health D) Yes, as long as a pharmacist applies for an additional license Are Pharmacist able to participate in the MCPP? A) No, it is a violation of the Pharmacy Practice Act B) Yes, as long as MCPP business activities occur outside of the Pharmacy Department C) Yes, as long as a pharmacist registers with the Department of Public Health D) Yes, as long as a pharmacist applies for an additional license 55 56

References References HB1: http://ilga.gov/legislation/publicacts/98/pdf/098-0122.pdf SB2636: http://ilga.gov/legislation/publicacts/98/pdf/098-0775.pdf Medical Cannabis Pilot Program Site: http://mcpp.illinois.gov Illinois General Assembly: http://ilga.gov Proposed Controlled Substances Act Rules (DFPR): http://www.cyberdriveillinois.com/departments/index/register/register_volume38_issue10.p df Proposed Controlled Substances Act and PMP Rules (DHS): http://www.cyberdriveillinois.com/departments/index/register/register_volume38_issue22.p df Proposed Pharmacy Practice Act Rules: http://www.cyberdriveillinois.com/departments/index/register/register_volume38_issue20.p df HR420: https://www.congress.gov/bill/116th-congress/house-bill/420/text How pharmacists can counsel patients on medical marijuana : http://www.pharmacist.com/how-pharmacists-can-counsel-patients-medical-marijuana Medical marijuana and the developing role of the pharmacist : http://axon.psyc.memphis.edu/~charlesblaha/7705/papers_08/samantha_daniel_medical_marij uana.pdf Using Medical Marijuana Safely : http://www.pharmacy.arizona.edu/sites/default/files/pdfs/using%20med%20marijuana%20final.p df The Pharmacologic and Clinical Effects of Medical Cannabis : http://coruraltrack.org/wpcontent/uploads/2013/09/mmj-pharmacotherapy-article-published-version-2013.pdf Cannabis for therapeutic purposes: Patient characteristics, access, and reasons for use : http://download.journals.elsevierhealth.com/pdfs/journals/0955-3959/piis0955395913001357.pdf The Marijuana Policy Project: www.mpp.org NORML: www.norml.org Opioid Alternative Pilot Program: http://www.dph.illinois.gov/topics-services/preventionwellness/medical-cannabis/opioid-alternative-pilot-program 57 58