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Background

Medical Cannabis in Maryland June 13, 2015

• 2013 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: http://mmcc.maryland.gov

• Will be formally published in June 2015 and open for comment for 30 days

The Commission

Overview of Regulations

• 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

• 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

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Overview of Regulations (Cont’d)

Overview of Regulations (Cont’d)

• Growers

• Dispensaries

• 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

• • • •

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

• 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 • 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”

• Establish identity and obtain identification card • Attest he/she is not caregiver for more than five qualifying patients • Attest he/she understands restrictions

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Physician Registration

Physician Registration Data

• Must be registered physician to issue “written certifications” to qualifying patients

• Data collected:

• Register online at Commission website • No registration fee • Registration valid for two years

• • • •

Name Social Security Number Office address, phone number, email 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

• Physician encouraged to register to treat a patient who has a condition:

• 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

• 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

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Conditions

Patient

• Chronic or debilitating disease or medical condition, or treatment, that cause:

• 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”

• • • • • • • • •

Cachexia Anorexia Wasting Syndrome Severe or chronic pain Severe nausea Seizures Severe or persistent muscle spasm Glaucoma Post Traumatic Stress Disorder (PTSD)

Physician

Bona Fide Physician-Patient Relationship

Bona Fide Physician-Patient Relationship (Cont’d)

• Treatment or counseling • Physician

• Monitor patient progress while using medical cannabis • Take medically indicated action

• 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

• To provide follow-up care • Regarding efficacy of medical cannabis as treatment • Report any adverse event associated with use of medical cannabis

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Issuing Written Certifications

Termination of Certification

• 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

• Physician shall terminate certification if

Written Certification Renewal

Patient

• Patient may seek renewal not less than 30 calendar days after issuance • Physician may renew if

• 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

• • • • •

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

• • • •

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

Dispensaries

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State Law v Federal Law • 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

Physician Protection • “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 [email protected]

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