Medical Cannabis in Maryland

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1 Background Medical Cannabis in Maryland June 13, law created Natalie M. LaPrade Medical Cannabis Commission in DHMH to carry out law Expanded by General Assembly in 2014 and 2015 HB 490 passed overwhelmingly in General Assembly and signed by Governor Larry Hogan in May 2015 Regulations under development since May 2014 Latest draft available on Commission website: Will be formally published in June 2015 and open for comment for 30 days The Commission Independent commission that function within Department of Health and Mental Hygiene Develop policy, procedure, guidelines and regulations to implement medical cannabis program Sixteen-member commission that includes physicians, law enforcement, a nurse, a pharmacist, an attorney, government officials, etc. Maintain website Overview of Regulations Regulations detail establishment and oversight of all licensees Medical cannabis to be grown initially by 15 licensed growers, who also will be eligible for a dispensary license Licensed processors convert leaf into products such as ointments, salves, lotions and vaporizable extracts Two licensed dispensaries per State senatorial district Independent testing laboratory to inspect all products, confirm they meet specifications prior to release 1

2 Overview of Regulations (Cont d) Growers Premise may be concrete building, green house or secure outdoor field Must have adequate security Grower must implement strict controls and standard operating procedures to assure product consistency and safety Facilities are subject to inspection by Commission Each batch tested by independent testing laboratory with certificate of analysis Overview of Regulations (Cont d) Dispensaries Premise is separate from growing or processing facility Product package must be plain, opaque and tamper-evident Label must identify active components and strength Patients and caregivers may obtain product from dispensary or have it delivered by dispensary agent Adverse events must be reported Patients Caregivers Must register with the Commission Establish identity Obtain registration number Limited to 30-day supply with written certification 120g usable cannabis or 36g of THC Dispensary tracks quantity dispensed Physician and patient have bona fide physician-patient relationship Must be aged 21 or older Designated by patient to assist with medical use of medical cannabis by administering and obtaining medical cannabis from licensed dispensary For patient under the age of 18, caregiver must be parent or legal guardian Must register with Commission Establish identity and obtain identification card Attest he/she is not caregiver for more than five qualifying patients Attest he/she understands restrictions 2

3 Physician Registration Must be registered physician to issue written certifications to qualifying patients Register online at Commission website No registration fee Registration valid for two years Physician Registration Data Data collected: Name Social Security Number Office address, phone number, address Maryland Board of Physicians license number Attest Maryland license to practice medicine: Active Unrestricted In good standing Registered to prescribe controlled dangerous substances in Maryland Physician Registration Submission General Registration Web form check boxes Complete standard patient evaluation History Physical exam Symptom review Other pertinent information Assess patient outcome, provide follow-up care Check off medical conditions for which physician might issue certifications for medical cannabis Identify other patient inclusion criteria Reasons physician may deny certification Physician encouraged to register to treat a patient who has a condition: That is severe For which other medical treatments have been ineffective For which symptoms can reasonably be expected to be relieved by medical use of cannabis 3

4 Conditions Patient Physician Chronic or debilitating disease or medical condition, or treatment, that cause: Cachexia Anorexia Wasting Syndrome Severe or chronic pain Severe nausea Seizures Severe or persistent muscle spasm Glaucoma Post Traumatic Stress Disorder (PTSD) Patient registered with Commission Physician and patient have bona fide physician-patient relationship Patient meets physician inclusion criteria Patient does not meet exclusion criteria Physician has determined the potential benefits of medical use of cannabis likely outweigh the health risk for the patient Bona Fide Physician-Patient Relationship Treatment or counseling Physician Reviewed patient s relevant medical records Completed an in-person assessment of the patient s medical history and current medical condition Created and maintained records of patient condition in accord with medically accepted standards Bona Fide Physician-Patient Relationship (Cont d) Monitor patient progress while using medical cannabis Take medically indicated action To provide follow-up care Regarding efficacy of medical cannabis as treatment Report any adverse event associated with use of medical cannabis 4

5 Issuing Written Certifications Log on to Commission website Include physician s name, license number, telephone number Patient s name, DoB, address, county Condition(s) requiring medical cannabis Date patient is qualified Print out certification for patient use at a dispensary Termination of Certification Physician shall terminate certification if Patient meets exclusion criteria Treatment no longer medically necessary Adverse effects outweigh medical benefits Evidence patient is diverting cannabis May terminate for abuse of any substance Notify Commission of termination in one (1) business day Written Certification Renewal Patient Dispensaries Patient may seek renewal not less than 30 calendar days after issuance Physician may renew if Patient is still registered Bona fide physician-patient relationship still exists Patient meets inclusion criteria Patient does not meet exclusion criteria Medical benefits likely outweigh health risks Cannot renew without full in-person patient assessment within 365 days before reissuance Dispensary expected to train staff in medical use of cannabis Dispensary expected to counsel patients on choice of medication dosage, route of administration Rare for patient to obtain 30-day supply (120 grams) all at once Patient may obtain any amount, up to the 30-day supply limit of the written certification Dispensary will record weight, lot and batch number of medication dispensed Physician can obtain dispensary records of patient use Dispensary required to provide quarterly reports to the Commission Cost: $10-$25 per gram 5

6 State Law v Federal Law Physician Protection States authorizing medical cannabis since 1996 Federal government has never sued a state to block its law Federal statute forbids dispensing cannabis A prescription is a doctor s order to a pharmacy to dispense medication Doctors cannot prescribe cannabis Government may not initiate an investigation of a physician solely on the basis of a recommendation of marijuana within a bona fide physician patient relationship Professional speech entitled to the strongest protection our Constitution has to offer, according to Contant v Walters, 309 (9 Cir. 2002, cert. denied 2003) Contact: mmcc.maryland.gov dhmh.medicalcannabis@maryland.gov 6