Medical Marijuana and its Use in Hospice and Palliative Care

Transcription

1 Medical Marijuana and its Use in Hospice and Palliative Care Terri Maxwell PhD, APRN VP, Clinical Education Enclara Pharmacia Play the 2018 Conference Post to Win Game for a chance to win different prizes each day! 1

2 Recognition Natalee Felten, PharmD, BCPS Training Manager and Quality Coordinator, Enclara Pharmacia Mary Lynn McPherson, PharmD, MA, MDE, BCPS, CPE Professor and Executive Director, Advanced Post Graduate Education in Palliative Care & Program Director, Online Master of Science in Palliative Care, University of Maryland School of Pharmacy Learning Objectives Discuss medical marijuana s clinical role in hospice and palliative care Summarize legal and regulatory issues including related and coverage status for medical marijuana use in hospice Describe components of a sample medical marijuana hospice protocol 2

3 What is Medical Marijuana? Legal definition: the use of cannabis or marijuana, including constituents like THC and other cannabinoids, as a physician recommended form of medicine or herbal therapy Marijuana Cannabis plant Comes in various forms from buds, oils, tinctures, pills or topicals Introduction Marijuana has been used for thousands of years, by cultures all over the world, for both medicinal and religious purposes In 2008 a 2,700-year-old grave in the Gobi Desert was identified as the world's oldest marijuana stash 2 primary strains: sativa ( THC) and indica ( CBD) Cannabis contains: >400 chemical compounds >100 separate cannabinoids The female buds of the plant are smoked once dried 3

4 THC vs. CBD THC (tetrahydrocannabinol) Euphoric high effect Confusion, paranoia Sleep inducing Appetite stimulant CBD (cannabidiol) Low euphoria Modulates effects of THC Many clinical uses Formulations of Marijuana Buds Ointment/ Cream/ Lotion Wine/ Beer Concentrates: hash, budder, shatter, dabs, wax, oil Transdermal Patch Oral tincture Edibles 4

5 Routes of Adminstration Route Onset Duration Inhaled smoked or vaporized Rapid 2 3 Hours Oral ingestion min 5 6 hours Oral Transmucosal min 5 6 hours Rectal min 2 8 hours Topical?? Transdermal 1 2 hours 8 24 hours Huestis MA. Human Cannabinoid Pharmacokinetics. Chem Biodivers. 2007; 4(8): Stott CG et al. Euro Journ of Clin Pharm. 2013; 69(4): Which Breed Should a Patient Buy? 5

6 Adverse Effects Anxiety: Not seen as commonly with CBD vs. THC Psychosis: Hallucinations, paranoid delusions Caution in patients with pre-existing risk factors such as family history, previous mental illness, or childhood abuse Lung Damage? Cardiac Hyperemesis syndrome a.k.a. Greenout syndrome Note: no receptors in brain stem so cannot overdose Pletcher M, et al. Association between marijuana exposure and pulmonary function over 20 years. JAMA 307, no. 2 (2012): marijuana exposure and pulmonary function over 20 years. JAMA 307, no. 2 (2012): Drug Interactions CNS depressants: Additive drowsiness, fall risk Opioids, benzodiazepines, alcohol Medications that cause tachycardia: Psychostimulants, anticholinergics, theophylline CYP450 liver enzyme inducers and inhibitors 6

7 Indications Hospice and Cannabis Main clinical uses: Seizures Adjuvant analgesic treatment Sleep disturbance Nausea Dyspnea Anorexia QOL 7

8 Seizures Treatment of refractory seizures is an active area of research Many documented anecdotal accounts in the literature Most research done on Dravet syndrome in children Data suggests CBD vs. THC is preferred Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug resistant seizures in the Dravet syndrome. N Engl J Med. 2017; 376: Pain Many clinical trials conducted to evaluate effect on pain CBD may be more effective than THC More effective for neuropathic pain (treatment resistant) vs. other types of pain Adjuvant effect for pain control in conjunction with opioids Treatments are well-tolerated and preferred by patients Wilsey B, Marcotte T, Deutsch R, et al. Low dose vaporized cannabis significantly improves neuropathic pain. J Pain Feb;14(2): Abrams DI, Couey P, Shade SB, et al. Cannabinoid opioid interaction in chronic pain. Clin Pharmacol Ther Dec;90(6): Ware MA, et al. Smoked cannabis for chronic neuropathic pain: A randomized controlled trial. Canadian Medical Association Journal 182, no. 14 (2010): E

9 Nausea Meta analysis demonstrating efficacy, particularly in chemotherapy-induced nausea Studies with patients using whole plant marijuana or natural cannabinoids like CBD are lacking Several studies showed smoked marijuana did not alleviate nausea better than standard treatment (ex: ondansetron), but was more preferred by patients Machado Rocha FC, et al. (2008), Therapeutic use of Cannabis sativa on chemotherapy-induced nausea and vomiting among cancer patients: systematic review and meta-analysis. European Journal of Cancer Care, 17: Söderpalm H, et al(2001). Antiemetic efficacy of smoked marijuana: subjective and behavioral effects on nausea induced by syrup of ipecac. Pharmacology, biochemistry, and behavior Cachexia/Anorexia Evidence for promoting weight gain inconclusive The munchies are real, based upon patient feedback Cannabis did increase appetite, +/ weight gain in several studies Some studies did not show benefit over traditional therapies Possibly helpful in patients for whom it s important to eat Haney et al. Dronabinol and Marijuana in HIV-Positive Marijuana Smokers Caloric Intake, Mood, and Sleep. J Acquir Immune Defic Syndr (5): Cannabis In Cachexia Study, J Clin Oncol (21): p Foltin, R et al. Effects of smoked marijuana on food intake and body weight of humans living in a residential laboratory Appetite

10 Dyspnea Studies dating back to the 1970 s demonstrated improvements in lung function immediately after smoking Marijuana inhaler studied but never made it to market In patients with lung disease, consider alternatives to the inhaled route If the inhaled route is necessary, vaporization may be preferred Tashkin DP, Shapiro BJ, Lee YE, Harper CE. Effects of smoked marijuana in experimentally induced asthma. Am Rev Respir Dis Sep;112(3): Williams SJ, et al. Bronchodilator effect of delta tetrahydrocannabinol administered by aerosol of asthmatic patients. Thorax 31 no 6 (1976): Insomnia Few randomized, controlled trials available Drowsiness/ sleepiness often listed as a side effect in trials evaluating marijuana for other conditions Doses should be used in moderation to prevent anxiety THC more effective than CBD Russo, Ethan B., Guy, Geoffrey W. and Robson, Philip J. (2007), Cannabis, Pain, and Sleep: Lessons from Therapeutic Clinical Trials of Sativex, a Cannabis-Based Medicine. Chemistry & Biodiversity, 4:

11 Dementia & Parkinson s Several studies with cannabis in patients with dementia and Parkinson s Results are inconclusive Zach Klein Film: Prescribed Grass Documentary filmmaker, certified marijuana instructor Anecdotal results: Patients calmer, more relaxed, able to write better, possibly able to discontinue other medications Geke A.H et al. Tetrahydrocannabinol for neuropsychiatric symptoms in dementia Neurology May 2015, Lotan et al. Cannabis (Medical Marijuana) Treatment for Motor and Non Motor Symptoms of Parkinson Disease: An Open Label Observational Study. Clinical Neuropharmacology: March/April ( 2) Prescribed Glass. A documentary by Zach Klein. Society of Cannabis Clinicians. Accessed 2017 Jul. Available from: grass/ QOL Improvement Study in March 2018 evaluating safety and efficacy of medical cannabis in population of 2736 elderly patients 564 patient died within 6 months of treatment After 6 months of treatment, 94% reported improvement in QOL and pain level was reduced from a median of 8 down to 4 on a scale of 0 10 Most common adverse events: dizziness (9%) & dry mouth (7%) After 6 months, 18% stopped using opioid analgesics or reduced their dose Abuhasira R, et al. Epidemiological characteristics, safety and efficacy of medical cannabis in the elderly. European Journal of Internal Medicine 49 (2018)

12 Poll How is placebo marijuana, meant to be smoked in placebo-controlled trials, made available? A) Herbal marijuana substitute B) A special breed of grass bred to look similar to marijuana C) Actual marijuana with the active ingredients removed, in a process similar to coffee decaffeination Poll How is placebo marijuana, meant to be smoked in placebo-controlled trials, made available? A) Herbal marijuana substitute B) A special breed of grass bred to look similar to marijuana C) Actual marijuana with the active ingredients removed, in a process similar to coffee decaffeination 12

13 Summary Marijuana has many active compounds CBD seems to have more medical benefit than THC Marijuana appears to be relatively safe and effective for a variety of conditions More studies are needed to better understand its role in hospice and palliative care Regulations 13

14 Federal Regulations Cannabis is listed in Schedule I of the federal Controlled Substances Act No medical value and high potential for abuse No large scale clinical trials to prove its use but restrictions make doing trials difficult Justice Dept. advised that states and local gov t can authorize cannabis use (2013) Drew a distinction between use by seriously ill persons and large scale for profit commercial enterprises Trump administration taking a stronger stance Not FDA approved (ingredients vary) State Regulations 14

15 General State Requirements Registration and training requirements for health care practitioners Written recommendation from a licensed physician Qualifying conditions Rules vary from state to state Register for a medical marijuana ID card (not required in CA and run through counties) Approved dispensaries Proxy/caregiver rules Transporting Possession/cultivation limits 15

16 California Regulations Approved by Prop 215 in 1996 Ensured that seriously ill persons had the right to obtain and use cannabis for medical purposes when deemed appropriate by a physician and protected from criminal prosecution or sanction Afforded protection to physicians if they recommend cannabis The Medicinal and Adult Use Cannabis Regulation and Safety Act (MAUCRSA) Established a uniform licensing regime for both medial and adult-use cannabis effective 1/2018 Licensing requirements for cultivation, transportation, distribution, etc. May 22-24, 2018 CAHSAH CHAPCA Annual Conference 31 California Medical Board Guidelines Patient-physician relationship Must be attending physician Conducted a medical evaluation Patient evaluation Documented medical exam and history of current and PMH, social hx, drug and alcohol hx, family hx, previous therapies tried, etc. Use of telehealth is permissible Informed and shared decision-making Discussion of risks and benefits May 22-24, 2018 CAHSAH CHAPCA Annual Conference 32 16

17 California Medical Board Guidelines cont d Treatment agreement Clear objectives of treatment, goals, treatment and evaluation plan and exit strategy Signed by patient Qualifying conditions Recommendations are at the discretion of the physician Not limited to cancer, anorexia, AIDs, chronic pain, spasticity, glaucoma, arthritis, and migraine Ongoing monitoring Regular re-assessment and at least annual review May 22-24, 2018 CAHSAH CHAPCA Annual Conference 33 California Medical Board Guidelines cont d Consultation and referral Indicated for those with substance use disorder or co-occurring mental health problems Medical records Outlines information that should be included Review of the CURES system Signed treatment agreement Physician conflicts of interest Office cannot be in or connected to a dispensary or receive financial interest from a dispensary or cultivation center May 22-24, 2018 CAHSAH CHAPCA Annual Conference 34 17

18 State-dependent rules: In California, the caregiver needs to provide services beyond just providing marijuana Caregivers State Marijuana Law Resource Procon.org 18

19 California State Website Challenges for Patients Mandatory registration (physician s recommendation, gov t issued ID, proof of residency) Initial cost for physician visit to get certified Registration fees (range from $0 $200) Use of registry ID cards across state lines (ot allowed in CA) Number of approved dispensaries Some states smoking not allowed; edibles only allowed for minors 19

20 Challenges for Hospices Question legitimate medical therapy Willingness to write for medical cannabis Physician certification & training requirements Staff lack fundamental understanding (various types, edible vs. smoked, etc.) Concern about turning off referral community Lack of policies or procedures Who Pays? Not federally approved so funds from the Medicare Hospice Benefit can NOT be used cover cost Cost should be covered by the patient out of pocket 20

21 Poll 1. Does your hospice have a policy/procedure for medical marijuana? Yes No 2. Does your hospice offer training to your staff about medical marijuana? Yes No Hospice Policies & Procedures 21

22 Procolizing Medical Cannabis Background Various states have passed laws legalizing the use of medical marijuana. Despite the decriminalization of medication marijuana in many states, according to federal law it is illegal. However, the United States Department of Justice has formally stated that they will not prosecute medical marijuana users complying with state regulations. Due to increasing legalization at the state level and increasing availability, medical marijuana use is increasing. Based on the potential indications for medical marijuana, our hospice patients may be using medical marijuana to treat their symptoms, in addition to traditional medications. Seasons Hospice & Palliative Care Protocol with permission Procolizing Medical Cannabis 1. Seasons Hospice (SH) clinicians will be offered education on medicinal marijuana with an emphasis on possible side effects and drug interactions. 2. The SH nurse will ask the patient and/or caregiver if the patient is using medical marijuana and document in the designated section in the nurse visit note of the EMR. 3. If the patient is using medical marijuana, the SH nurse will educate the patient on the potential for side effects and drug interactions. 4. The SH nurse will inform Seasons pharmacy vendor when a patient is using medical marijuana during medication profiling, so the pharmacist can check for drug interactions. Seasons Hospice & Palliative Care Protocol with permission 22

23 Procolizing Medical Cannabis 5. The SH nurse will inform the medical director/hospice physician and entire IDG when a patient is using medical marijuana. 6. Seasons clinicians will not participate in any aspect of recommending, administering, or providing medical cannabis (marijuana). 7. A SH physician may discuss medical marijuana with the patient and caregiver at his/her discretion. 8. If the attending physician is also a Seasons employee and practices in a state where medical marijuana is legal, it will be at his/her discretion to participate in the recommending or ordering process. Seasons Hospice & Palliative Care Protocol Other Conundrums Balancing act legal in your state, but federally illegal Accommodations for those in ALFs or nursing homes? What if someone is smoking or using illegally? (less an issue in CA) Where to store it? Tracking dosing (especially in nursing homes) Objection by staff or nursing home residents Dealing with smoking Assist in medicating especially for those with dementia 23

24 Questions? References Casarett, D. J. (2015). Stoned: A doctor's case for medical marijuana. Abuhasira R, et al. Epidemiological characteristics, safety and efficacy of medical cannabis in the elderly. European Journal of Internal Medicine. March (49): Aggarwal SK, Blinderman CD. The Palliative Care Network of Wisconsin (PCNOW) Fast Fact #279: Cannabis for Symptom Control. [cited 2017 Jun 10]. Available at: Huesti MA. Human Cannabinoid Pharmacokinetics. Chem Biodivers. 2007; 4(8): Berkovic SF. Cannabinoids for Epilepsy Real Data, at Last. N Engl J Med May 25;376(21): Pletcher M, et al. Association between marijuana exposure and pulmonary function over 20 years. JAMA 307, no. 2 (2012): marijuana exposure and pulmonary function over 20 years. JAMA 307, no. 2 (2012): Karschner EL, et al. Plasma Cannabinoid Pharmacokinetics following Controlled Oral 9 Tetrahydrocannabinol and Oromucosal Cannabis Extract Administration. Clin Chem. 2011; 57(1): Melton SD. Stirring the Pot: Potential Drug Interactions With Marijuana. Medscape article June 8. Ware MA, et al. Smoked cannabis for chronic neuropathic pain: A randomized controlled trial. Canadian Medical Association Journal 182, no. 14 (2010): E Haney et al. Dronabinol and Marijuana in HIV Positive Marijuana Smokers Caloric Intake, Mood, and Sleep. J Acquir Immune Defic Syndr (5): Cannabis In Cachexia Study, J Clin Oncol (21): p Abuhasira R, et al. Epidemiological characteristics, safety and efficacy of medical cannabis in the elderly. European Journal of Internal Medicine 49 (2018)

25 References cancer/treatment/cam/hp/cannabis pdq#section/all Wilsey B, Marcotte T, Deutsch R, et al. Low dose vaporized cannabis significantly improves neuropathic pain. J Pain Feb;14(2): Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug resistant seizures in the Dravet syndrome. N Engl J Med. 2017; 376: Wilsey B, Marcotte T, Deutsch R, et al. Low dose vaporized cannabis significantly improves neuropathic pain. J Pain Feb;14(2): Abrams DI, Couey P, Shade SB, et al. Cannabinoid opioid interaction in chronic pain. Clin Pharmacol Ther Dec;90(6): Cannabis In Cachexia Study. Comparison of orally administered cannabis extract and delta 9 tetrahydrocannabinol in treating patients with cancer related anorexia cachexia syndrome: a multicenter, phase III, randomized, double blind, placebo controlled clinical trial from the Cannabis In Cachexia Study Group. J Clin Oncol (21): p Tashkin DP, Shapiro BJ, Lee YE, Harper CE. Effects of smoked marijuana in experimentally induced asthma. Am Rev Respir Dis Sep;112(3): Williams SJ, Hartley JP, Graham JD. Bronchodilator effect of delta1 tetrahydrocannabinol administered by aerosol of asthmatic patients. Thorax Dec; 31(6): Machado Rocha FC, et al. (2008), Therapeutic use of Cannabis sativa on chemotherapy induced nausea and vomiting among cancer patients: systematic review and meta analysis. European Journal of Cancer Care, 17: Söderpalm H, et al(2001). Antiemetic efficacy of smoked marijuana: subjective and behavioral effects on nausea induced by syrup of ipecac. Pharmacology, biochemistry, and behavior Geke A.H et al. Tetrahydrocannabinol for neuropsychiatric symptoms in dementia Neurology May 2015, Lotan et al. Cannabis (Medical Marijuana) Treatment for Motor and Non Motor Symptoms of Parkinson Disease: An Open Label Observational Study. Clinical Neuropharmacology: March/April ( 2)

26 Speaker Information Terri Maxwell PhD, APRN VP, Clinical Education Enclara Pharmacia Philadelphia PA May 22-24, 2018 CAHSAH CHAPCA Annual Conference 51 26