Arizona Hospice and Palliative Care Organization May 13, Medical Marijuana Impact on EOL Care

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1 Arizona Hospice and Palliative Care Organization May 13, 2011 Medical Marijuana Impact on EOL Care

2 Objectives Know at least 5 potential medical conditions in which medical marijuana is used Identify, describe and discuss 2 limitations to the use of marijuana in EOL-care patients List 3 classes of medications commonly used in EOL-care patients in which actual or potential drug interactions can occur with marijuana and the implications of such interactions 2

3 Medical marijuana: the latest from the AG May 4, 2011 U.S. Attorney Burke Issues Federal Prosecution Warning Regarding Arizona's Medical Marijuana Program On May 2, U.S. Attorney for the District of Arizona Dennis Burke sent a letter to the Arizona Department of Health Services (ADHS) Director Will Humble regarding ADHS s final regulations governing the Arizona Medical Marijuana Act (AMMA). Burke s letter included the following important warnings: Since marijuana is listed as a Schedule I controlled substance under the federal Controlled Substances Act (CSA), growing, distributing, and possessing marijuana in any capacity, other than as part of a federally authorized research program, is a violation of federal law regardless of state laws that purport to permit such activities. The United States Attorney s Office for the District of Arizona (USAO) will continue to vigorously prosecute individuals and organizations that participate in unlawful manufacturing, distribution and marketing activity involving marijuana, even if such activities are permitted under state law. Citing a 2009 memorandum written by then-deputy Attorney General David Ogden, Burke stated that USAOs will not focus their limited resources on seriously ill individuals who use marijuana as part of a medically recommended treatment regimen in clear and unambiguous compliance with state law. The public should understand, however, that even clear and unambiguous compliance with AMMA does not render possession or distribution of marijuana lawful under federal statute. [C]ompliance with Arizona laws and regulations does not provide a safe harbor, nor immunity from federal prosecution. 3

4 Medical marijuana: current status of legalization Legalization pending: Idaho Kansas Oklahoma Iowa Illinois West Virginia New York New Hampshire Massachusetts Connecticut Maryland 4

5 Marijuana: Derived from the Cannabis plant Indigenous to Central and South Asia Contains more than 400 different chemical compounds Major psychoactive chemical is tetrahydrocannabinol (THC) Includes at least 66 other cannabinoids which can cause different effects than THC alone Most cannabinoids are lipophilic that are easily stored in the fat Metabolized by liver Unlike typical pharmaceuticals the active ingredients in marijuana are not standardized and have variable effects between patients 5

6 Marijuana: history of use Evidence of use can be traced back thousands of years Used in ancient times in some religious ceremonies Hindus, Nihang Sikhs of India and Nepal, ancient Assyrians, Scythians, Thracians/Dacians, members of the Cult of Dionysus and shamans of the Uygur Autonomous Region of China Used in modern times for medicinal, religious/spiritual and recreational purposes Pipes dug up from the garden of Shakespeare s home in Stratford-upon-Avon contained traces of cannabis Criminalized in various countries beginning in the early 20 th century South Africa 1911, Jamaica 1913, UK and New Zealand 1920 s United States first restrictions on sales in 1906 and in 1937 (Marijuana Transfer Tax Act) to prohibit the production of hemp in addition to marijuana Marijuana is a Class 1 Scheduled drug (Federally) today In 2004 the UN estimated that about 4% of the world s adult population (162 million) use cannabis annually and about 0.6% (22 million) use it on a daily basis In 2007 it was reported that 12.6% of the US population use it at least once/year 6

7 Indications (therapeutic uses): Arizona Cancer Glaucoma Positive status for HIV AIDS Hepatitis C ALS Crohn s Disease Agitation of Alzheimer s Disease Approved indications for medical marijuana vary from state to state 7

8 Indications (therapeutic uses): Arizona A chronic or debilitating disease or medical condition that produces any of the following: Cachexia or wasting syndrome Severe and chronic pain Severe nausea Seizures (including those characteristic of epilepsy) Severe and persistent muscle spasms (including those characteristic of multiple sclerosis) Any other condition added by DHS through a public petition process Medical marijuana poses unique challenges as well as novel opportunities to manage refractory symptoms 8

9 Indications: potential other 9

10 10

11 Drug-drug interactions Opioids Neuroleptic antipsychotics SSRI sand TCA s Alcohol Sympathomimetics CNS depressants Sildenafil Anticholinergics Alpha agonists Potential interactions are extrapolated from cannabinoids with FDA approved indications. Scant data exists for smoked marijuana. 11

12 Drug-disease interactions Psychiatric disturbances Cardiac disease Respiratory disease Vertigo Cancer Immunosuppressed states Based on its pharmacology marijuana may adversely affect patients. 12

13 Medical marijuana, the CoP s and plan of care The Medicare Conditions of Participation for Hospice state that a drug profile review must evaluate all prescription, over the counter, herbal and alternative treatments that could affect drug therapy. Therefore, regarding medical marijuana: A thorough medical and social history should be conducted Patients should be screened for potential drug-drug and drug-disease state interaction If prescribed medical marijuana, patients should be urged to consult regularly with a physician and maintain a bona-fide patient-physician relationship and be advised to follow all laws and procedures in painstaking detail Any evidence of marijuana use should be held in strict confidence and all records should comply with HIPPA regulations Marijuana remains illegal under the Federal CSA. Any recommendations for use by those not authorized to prescribe can be met with disciplinary actions 13

14 14

15 Adverse Effects Cardiovascular effects Tachycardia, hypertension, palpitations, syncope, orthostatic hypotension, stroke, paroxysmal atrial fibrillation, TIA s, acute MI s Pulmonary effects Increased symptoms of chronic bronchitis Central nervous system effects Dry mouth, nausea, drowsiness, numbness Visual disturbances Blurred vision, dry eyes, photophobia, mydriasis, reddening of the conjunctiva Psychological dysfunction Interference with memory formation or linear memory, focus, hallucinations, delusions, depersonalization, fear of dying, anxiety, paranoia, depression 15

16 Withdrawal Symptoms Restlessness Anxiety Irritability Insomnia Muscle tremors Sweating Altered heart rate No medications are approved for the treatment of withdrawal symptoms associated with marijuana 16

17 Available products and routes of administration Synthetic cannabinoids Marinol (dronabinaol -USA) Oral capsule 2.5mg, 5mg, 10mg $8- $35/dose Sativex- (delta-9-thc -Canada) Buccal/Sublingual spray Cesamet (nabilone -USA) Oral capsule 1mg $25/dose Levonantradol (currently only used in research) Cannabis (plant) Pulmonary Oral Smoked Vaporization Incorporated into food Cookies, brownies Incorporated into liquids Sodas, beers, tinctures, tea IM injection 17

18 Medical marijuana beverages 18

19 Medical marijuana foodstuff 19

20 Efforts of medical marijuana entrepeneurs 20

21 Clinical studies with cannabinoids Data exists from clinical studies for: Nausea and Vomiting Appetite stimulation Analgesia Multiple Sclerosis Spinal cord injuries Hepatitis C ALS HIV/AIDS Rheumatoid Arthritis Tourette s syndrome Epilepsy Glaucoma Parkinson Disease Dystonia Dementia 21

22 Other proposed uses of cannabinoids Intractable Hiccough Migraine Asthma Mood Phantom limb pain Insomnia Anxiety management Pain of Sickle Cell disease Crohn s Disease Fibromyalgia To reduce opioid use in gastrointestinal pain 22

23 Clinical data/ evidence Evidence runs the continuum of anecdotal reports through randomized doubleblind trials Trials to date have many limitations associated with them: A variety of products have been evaluated Marinol, Cesamet, Sativex, Rimonabant (removed from market), Levonantradol. Few have included cananbis or smoked marijuana Lack of standardization: varying dosages (amount/frequency), route of administration, measurement of efficacy, reporting of adverse effects, length of trial, administration technique Inconsistent patient inclusion and exclusion criteria Unblinding in crossover studies due to lack of effect with placebo See the addendum for a representative list of studies that have been performed with cannabinoids Clinical data exists primarily for oral THC and sublingual nabilone. Scant data exists for smoked marijuana 23

24 Conclusions Clear evidence to support the use of medical marijuana does not currently exist Cannabis exhibits interesting therapeutic potential for the management of symptoms arising from multiple diseases states frequently experienced by hospice and palliative care patients While cannabinoids may prove effective to manage symptoms, their use should be limited to treat symptoms that are refractory to typical agents. Cannabinoids should NOT be used as first line agents. Each condition has its own pathology and it remains to be determined which cannabinoid and route of administration is the most suitable for symptom management while causing the lowest incidence of undesirable effects Patient use of medical marijuana should be noted in the patient record in order to best evaluate treatment interventions 24

25 Acknowledgements Mark Heisler, PharmD. Hospice of the Valley, Phoenix, Arizona Jenny Bongartz, cpharmd, University of Iowa College of Pharmacy For their assistance in proving information, supplemental material and references used in developing this presentation. 25

26 26

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