Medical Cannabis in Maryland A presentation to

Maryland Nurses Association

Maritime Institute Linthicum Heights, Maryland

October 13, 2016 By

Deborah Miran Maryland Medical Cannabis Commission

mmcc.maryland.gov And

Debra Kimless, MD Forwardgro, LLC

OUTCOMES

• DISCUSS THE DEVELOPMENT OF THE MARYLAND MEDICAL CANNABIS PROGRAM

• EXPLAIN HOW THE ACTIVE INGREDIENTS IN

CANNABIS INTERACT WITH THE ENDOCANNABINOID SYSTEM

Background

• In 2013, Maryland General Assembly created Natalie M. LaPrade Medical Cannabis Commission to carry out program to dispense cannabis to Maryland patients based on “Academic Medical Centers

Background

• Revised in 2014: • Created current model with growers/dispensaries

• Revised again in 2015 and 2016 • Added additional practitioners including NPs

Commission

• 16 Commissioners • Secretary of Health and Mental Hygiene • Representative of Comptroller • 14 Appointees of Governor

– Staggered terms – Chairman appointed by Governor – Includes a nurse and 2 patient advocates

Regulations

• Commission started developing regulations in fall of 2013

• Many drafts and public comment • Final Regulations became effective

September 14, 2015

Code of Maryland Regulations

• COMAR Title 10: Department of Health and Mental Hygiene

• Subtitle 62: Natalie LaPrade Medical Cannabis Commission Regulations

• Chapters 1 to 35 • Link to regulations on Commission

website: mmcc.maryland.gov

Program Principles

• Principles of Maryland’s Medical Cannabis Program: – Ensure proper security and protection of public

safety – Assure the highest quality medicine is produced

and distributed – Expedite patient access

Grower/Processor/ Dispensary licenses • For Growers, Dispensaries and Processors,

there are two stages in applying:

First stage – Pre-approval: • Complete a detailed application and submit by deadline • Application reviewed, scored and ranked by

independent third party reviewer

Licenses con’t.

Second stage – Issue License: • Pre-approved applicant completes financing,

construction, hiring, training, etc. and prepares to open • Commission investigates financial background • Applicant tells Commission that it is ready for

inspection of premises and operation • Commission inspects premises, reviews S.O.P.s, training • If inspection passed , Commission awards license to

start operating

Current Status of Program

• Commission received 1081 applications:

• 146 grower applications • 124 processor applications • 811 dispensary applications

• 15 growers and 15 processors were selected on

August 5, 2016

• Visit mmcc.maryland.dhmh.gov • Click physician registry and register as a

certifying physician • Form requires name, address, BOP license,

CDS license • Select medical conditions • Sign attestations

Physician Registration

Qualifying Conditions

• Cachexia • Anorexia • Wasting Syndrome • Severe and/or chronic pain • Severe nausea • Seizures • Severe or persistent muscle spasm • Glaucoma • PTSD

Other Registries

• Patient- Will include basic identification and demographics, ID card optional

• Caregiver- Same as patient, must be over 21, ID card required

• Minor patients- Same as patient, parent/guardian declaration required and notarized

• Written certification form

Qualifying Patients

• Patient must register with Commission before physician can issue written certification

• Patient must – Live in Maryland; or – Be physically present in Maryland for the purpose

of receiving medical care from a medical facility in Maryland

• If younger than 18 years old, parent or guardian must be caregiver

• No fee for patient unless patient desires ID card

Qualifying Patients

• Physician and patient must have a “bona fide” relationship:

• Treatment or counseling relationship • Physician has

– 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

Qualifying Patients

Bona fide relationship (Continued) • Reasonable expectation physician will

– 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

Costs to Physicians and Patients • No fees to be paid by physicians • No fees to be paid by patients to register or to

obtain a written certification • If patient wishes to obtain an identification card

from the Commission, fee $50

Current Status of Program

• Commission now registering physicians • Over 180 physicians registered • Registry for patients should be released in

November

Written Certifications ”The Prescription” • Issue by logging onto commission website

– Physician’s name, license number, telephone number

– Patient’s name, DoB, address, county – Condition(s) requiring medical cannabis – Date patient is qualified – (Optional) Print out certification for patient use

Written Certification-con’t.

• Basic quantity limit of 30-day supply • 30-day supply defined as:

– 120 grams of usable cannabis or – 36 grams of Delta9-THC in a medical cannabis

infused product

• Physician may authorize greater quantity on determination that those amounts inadequate to meet patient’s medical needs

Written Certification-con’t.

• 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-con’t.

• 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 renewal

Quality-Cannabis as Medicine

• Goal to produce medicine that is consistent, batch to batch, lot to lot

• Growers and processors encouraged to produce cannabis in a range of means and routes of administration

• Growers and processors to produce plant varieties and products containing high CBD levels, in addition to other plants & products

Quality-Testing Requirements

• Producers must test all products for potency and purity

• Producers must perform stability testing to assure shelf life

• Producers must retain samples sufficient for follow-up testing in the event of a complaint

Quality-Reporting

• Complaints, adverse events and recalls – All licensees and registered physicians must be

prepared to receive, organize, record and respond to complaints and reports of adverse events

– All substantive complaints and reports of serious adverse events must be investigated

– If re-analysis reveals that the retention sample does not meet specification, producers must order a recall

Dispensaries ”The Pharmacy” • Dispensaries to be located throughout the

state: – Up to two per each of 47 state senatorial

districts – Up to 15 associated with licensed growers

(not counted in senatorial district allocation)

Dispensaries-Training

• Extensive training of dispensary agents in: – Pharmacology of cannabis – Potential therapeutic and adverse effects of

cannabis – Dosage forms and pharmacodynamics – Potential drug interactions – Recognition of symptoms of substance use

disorders and acute intoxication

At Dispensary

• Patient or caregiver goes to the dispensary, or contacts dispensary for delivery by dispensary

• Patient or caregiver presents proof of identity • Dispensary logs onto Commission database to

confirm validity of written certification and amount of Cannabis that can be dispensed

• Patient consults trained dispensary agent on appropriate medication

At Dispensary • Every time cannabis is dispensed, the patient

must acknowledge that the patient is not immune from liability or prosecution for: – Operating a vehicle under the influence of medical

cannabis – Smoking in a public place – Smoking in a motor vehicle – Acting under the influence in a manner that would

constitute negligence or professional malpractice. – Smoking cannabis on private property where not

allowed

At Dispensary

• Patient also must acknowledge: – It is illegal to transfer the cannabis to any person – Obtaining medical cannabis does not exempt

patient from prosecution under federal law – Scientific research has not established the safety

of the use of medical cannabis by pregnant women

– Use of medical cannabis to treat a medical condition is not approved by the U.S. FDA

1940-CBD IDENTIFIED by Roger Adams, Madison Hunt, J.H. Clark

32

1964 RAPHAEL MESCHOULAM IDENTIFIED AND SYNTHESIZED THC

33

1988 CB1 RECEPTOR WAS DISCOVERED 1993 CB2 RECEPTOR WAS DISCOVERED

34

1992 DISCOVERED ANANDAMIDE N-arachindonoylethanolamine AEA

35

1995 2 AG WAS IDENTIFIED 2-ARACHIDONOYLGLYEROL

36

ENDOCANNABINOID SYSTEM

• ENDOGENOUS LIGANDS– ENDOCANNABINOIDS

AEA/ 2-AG • RECEPTORS- CB1/CB2 • ENZYMES-

SYNTHESIS/HYDROLYSIS

37

ENDOCANNABINOID SYSTEM FUNCTION

38

39

LD50 IBUPROFEN: 636mg/kg

CAFFEINE :192mg/kg

NICOTINE: 50 mg/kg

HEROIN: 22 mg/kg

It would take a 70kg man to smoke 1,500 lbs in a 15 minutes time period to die

40

Therapeutic Index= Toxic Dose÷Effective Dose

Over the counter drugs- 1:20

Prescription drugs- 1:10

Cannabis- 1:20,000-1:40,000

41

42

43

FAIR AND BALANCED

Potential Warnings with Cannabis use: • TACHYCARDIA

• HTN

• SOMNOLENCE

• HYPEREMESIS

• EUPHORIA

• ALTERED TIME PERCEPTION/PARANOIA,HALLUCINATIONS

• TOLERANCE

44

• PATIENTS OPERATING HEAVY MACHINERY • HISTORY OF SEVERE HEART DISEASE • HISTORY OF SEVERE HTN • HISTORY OF MI

45

46

47

48

49

SYNTHETIC single molecule FAAH INHIBITOR by BIAL Pharma

Fri Jan 15, 2016 French drug trial disaster leaves one brain dead, five injured Experimental painkiller that has left one person brain-dead and five seriously ill has been given to NINETY people, warns French health minister – and there is NO antidote

50

51

52

53

PHYTOCANNABINOIDS

54

CANNABIS-THE PLANT

LATIN NAME: Cannabis sativa • Chemical manufacturing factory • Over 100 phytocannabinoids-cannabinoids

found in plants • Over 50 terpenes-reason for the particular

scent • Psychoactivity found in only a few of the

100+ cannabinoids

55

56

THCA THC

57

CBDA CBD

58

DECARBOXYLATION

59

THCA

• Anti-Spasmotic/Muscle Relaxant

• Anti-Proliferative

• Anti-Inflammatory

• Anti-Emetic

• Anti-Epileptic

• Insomnia

• Pain Relief

60

THC • Psychoactive and Energetic

• Analgesic/Pain relief

• Anti-Bacterial

• Anti-Emetic

• Bronchodilator

• Appetite Stimulant

• Neuro-protective

61

CBDA

• Anti-Bacterial

• Anti-Emetic

• Anti-Inflammatory

• Anti-Proliferative

• Pain Relief

• Anti-Anxiety

62

CBD

• Non-Psychoactive

• Analgesic

• Anti-Anxiety

• Anti-Bacterial

• Anti-Convulsive

• Neuro-protective

• Antidote for THC toxicity

63

CBGA

• Anti-Bacterial

• Pain Relief

• Anti-Inflammatory

• Anti-Proliferative

64

METHODS OF ADMINISTRATION

• Inhalation: Combustion v. Vaporizing

• Sublingual-Buccal

• Oral

• Rectal

• Topical

65

SMOKING

66

VAPORIZING

67

SUBLINGUAL/BUCCAL

68

ORAL

69

RECTAL

70

TOPICALS

71

SUMMARY

72

QUESTIONS????

73

74