MEDICAL MARIJUANA: DECRIMINALIZATION AND LEGAL

MEDICAL MARIJUANA: DECRIMINALIZATION AND LEGAL I IMPLICATIONS FOR THE PRACTICE OF PHARMACY P Henry A. Palmer C.E. Finale 2011 December 16, 2011 A presentation by Jennifer A. Osowiecki, RPh, JD Cox & Osowiecki, LLC Attorneys at Law 2 Disclosure Ms. Osowiecki has no actual or potential conflict of interest associated with this presentation. 1

Course Objectives This presentation will help attendees: Identify trends in the decriminalization and use of medical marijuana outside of Connecticut Explain the history and current state of the law in Connecticut on possession and use of medical marijuana Evaluate the intersection of state laws allowing medical marijuana use with federal laws on controlled substances Assess the impact of medical marijuana use on the professional standards, and potential liabilities, of pharmacists 3 4 Medical Benefits Per Advocates Pain Relief Nausea Glaucoma HIV Wasting syndrome Multiple Sclerosis Spasticity Anxiety PTSD Fibromyalgia GI Disorders Alzheimer s ALS Hypertension Incontinence Sleep Apnea Tourette s Syndrome Osteoporosis Diabetes Mellitus 2

5 Medical Marijuana in Other Jurisdictions Alaska Ai Arizona California Colorado DC Delaware Hawaii Maine Maryland* Michigan Montana Nevada New Jersey New Mexico Oregon Rhode Island Vermont Washington 6 California Medical Marijuana Program SB 420, effective 01/01/2001, clarified Compassionate Use Act of 1996 and required State to issue identification cards to qualified patients Physician must document that (i) patient has serious medical condition and (ii) marijuana use is appropriate Limit of 8 oz. and 6 mature plants, but court challenge says amount needed for a patient s personal use Dispensaries are licensed through local city/county ordinances Transactions are subject to sales tax (sellers must have seller s permit to collect & remit tax to State) Patients subject to arrest for possession, but may assert medical necessity defense 3

7 Michigan Medical Marihuana Program Registration Program enacted in 2008 Patient must be Michigan resident and have qualifying debilitating medical condition Only physician (not APRN or PA) may certify patient for the program No location within Michigan to legally buy marijuana, but patient or patient s designated caregiver may home grow No more than 2.5 ounces of useable marijuana, and 12 plants No protection from seizure or prosecution by the federal government 8 Rhode Island Medical Marijuana Program Registration program enacted 01/03/2006 Patient must be certified as having a qualifying debilitating medical condition Certified by any RI licensed practitioner, or CT/MA physician, with authority to prescribe drugs No more than 2.5 ounces of useable marijuana, and 12 plants A registered Compassion Center may provide marijuana to registered patients No protection from seizure or prosecution by the federal government 4

9 Connecticut & Marijuana Connecticut has a long history of proposed legislation concerning marijuana for medical use Legislation considered in: 1997, 2001, 2002, 2003, 2004, 2005, 2007, 2009, 2011 Some of the proposed legislation would have prohibited the use of crude marijuana for medical purposes Most bills considered marijuana for compassionate or palliative use to treat debilitating medical condition under physician supervision 10 Bills Considered in 2011 In 2011, the Connecticut General Assembly considered no less than 18 bills on the subject of Marijuana After consolidation and amendments, two bills on possession and medical use of marijuana were under significant discussion in 2011: SB 1014, An Act Concerning the Penalty for Certain Nonviolent Drug Offenses SB 1015, An Act Concerning the Palliative Use of Marijuana 5

11 Connecticut and Marijuana Possession SB 1014, An Act Concerning the Penalty for Certain Nonviolent Drug Offenses considered reducing the State s criminal penalties for unlawful possession of marijuana Penalties based upon amount Whether repeat offender Amount 1 st Offense Subsequent Offense 4 oz. $2,000 / 5 years $5,000 / 10 years <4 oz. $1,000 / 1 year $3,000 / 5 years Summary of SB 1014 (2011) An Act Concerning the Penalty for Certain Nonviolent Drug Offenses Proposed a reduced penalty for possession of <0.5 oz. of marijuana infraction instead of misdemeanor/felony $150 for 1 st offense; $200-$500 for subsequent Law enforcement to seize & destroy as contraband 3 rd offense would require referral to drug education program Proposed concomitant changes penalties for drug paraphernalia 12 6

13 Testimony in Support of Changing Penalty Connecticut s Department of Public Safety supported SB 1014, and said it would: Allow for significant law enforcement procedural changes Result in cost savings to the State Make Connecticut consistent with similar procedures adopted by Massachusetts & New York Not legalize marijuana (penalties on larger amounts to remain) TRUE OR FALSE? In 2011, the Connecticut General Assembly passed SB 1014, which makes possession of less than a half ounce of marijuana an infraction (similar to a speeding ticket) rather than a misdemeanor or felony. 14 7

15 Summary of SB 1015 (2011) An Act Concerning the Palliative Use of Marijuana Physician certification of patient 18 or older with debilitating condition of: cancer; glaucoma; HIV/AIDS; Parkinson s; MS; spinal cord damage with spasticity; epilepsy; cachexia; or wasting syndrome Certification good for one year Patient permitted up to four plants (max 4 ), and one ounce of usable marijuana Home-grown permitted if done in secure area Summary of SB 1015 An Act Concerning the Palliative Use of Marijuana Palliative use may not occur: In motor/school bus or other moving vehicle In workplace On any school grounds, dormitory, college or university property At any yp public beach,,p park, recreation/youth center, or any other place open to the public In the presence of minor (<18) Qualifying patient to register with Consumer Protection within 5 days of certification 16 8

17 Testimony in Support of Palliative Use Connecticut Pharmacists Association conditionally supported SB 1015 : Put on CT s C-II Schedule (instead of C-I) Distribution only through pharmacies with special DCP application/registration Track through CT s Prescription Drug Monitoring Program Give prescribers special designation (like DEA X designation for Suboxone) Require use of licensed growers/producers (prohibit use of home-grown ) Writing on the Wall 18 9

19 TRUE OR FALSE? In 2011, the Connecticut General Assembly passed SB 1015, which provides for the palliative use of marijuana. TRUE OR FALSE? 20 Connecticut law does not permit the medical use of marijuana. 10

21 DEA Position Advocates of medical marijuana have not proposed methods for ensuring Quality Safety Efficacy Medical Marijuana does not address: Standardized composition or dosage Appropriate prescribing criteria Accountability for the product Safety regulation Methods for measuring effectiveness Insurance coverage 22 DEA Position Marijuana is properly classified as Schedule I controlled substance Smoked marijuana is not medicine Federal law permits marijuana research Federal law permits marijuana research under proper approvals and controls 11

Schedule I Substances High potential for abuse No currently accepted use in treatment in the United States Lack of accepted safety for use under medical supervision Examples of substances in C-I Marijuana (cannabis) Heroin Lysergic acid Peyote Ecstasy 23 FDA Approved Products Marinol (Dronabinol) C-III Synthetic ti delta-9-tetrahydrocannabinol t t d l (Delta-9-THC also naturally occurs in Cannabis sativa L.) INDICATIONS: AIDS wasting syndrome Nausea & vomiting with cancer chemotherapy in patients with failed response to conventional anti-emetics 2.5 mg, 5 mg & 10 mg capsules, BID 10-20% systemic availability; hepatically metabolized; high lipid solubility; high plasma protein binding 24 12

25 26 FDA Approved Products Cesamet (Nabilone) C-II Synthetic cannabinoid Indication: treatment of nausea & vomiting associated with cancer chemotherapy in patients that have failed to respond adequately to conventional anti-emetics 1 mg capsules, 1-2 mg QD or BID (max is 2 mg TID) for cycle of chemotherapy Extensive hepatic metabolism; high lipid solubility; high plasma protein binding 13

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29 30 IRS Position Section 280E of the Code disallows deductions incurred in the trade or business of trafficking in controlled substances that federal law or the law of any state in which the taxpayer conducts the business prohibits. For this purpose, the term controlled substances has the meaning provided in the Controlled Substances Act. Marijuana falls within the Controlled Substances Act. 15

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33 BATF Position Federal law prohibits any person who is an unlawful user of or addicted to any controlled substance from shipping, transporting, receiving or possessing firearms or ammunition. Marijuana is listed in the Controlled Substances Act as a Schedule I controlled substance, and there are no exceptions in Federal law for marijuana purportedly used for medicinal purposes, even if such use is sanctioned by State law. 34 17

FDA & HHS Position FDA approved a research study proposal submitted by the Multidisciplinary Association for Psychedelic Studies to determine usefulness in treatment of PTSD Despite FDA-approval and legitimate request, HHS won t provide marijuana for the study because of concerns about Outpatient vs. in-patient treatment Controls in place to prevent diversion Inclusion/exclusion criteria for study subjects 35 Special Concerns for Pharmacists Counseling Product supplier & quality Inventory & Security Special taxes, registrations, documentation Municipal ordinances/restrictions Landlord d vs. Lessee 36 18

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