1. MEDICAL MARIJUANA UPDATE FOR HEALTH CARE PRACTIONERS
PRAK NAIK, PHARM.D.
THE DRUG STORE OF PERRYSBURG
NOVEMBER 10, 2017

2. CONFLICT OF INTEREST
Owner and Operator of The Drug Store of Perrysburg
Owner and Operator of Drugstore Solutions
No other commercial or financial relationship
Off-label use may be discussed
No ownership in Cultivator, Processor or Dispensary

3. CANNABIS ADMINISTRATION, DOSING, INDICATIONS, ADVERSE EFFECTS, ETC
DESCRIBE
LAW AND COMPLIANCE INFORMATION IN THE STATE OF OHIO
REVIEW
DATA REGARDING CLINICAL USES OF MEDICAL MARIJUANA
OBJECTIVES

7. BOTANY/PHARMACOGNOSY

8. Cannabis sativa

9. Cannabis sativa and THC
Over 60 Cannabanoids identified
THC (delta-9-tetrahydrocannabinol) most active
Synthesized in 1964
Average THC content highly variable depending on the strain, climate, soil and growing conditions, and handling
Weak acid, very high lipid solubility
Binds to glass, diffuses into plastic, and is photo labile and susceptible to heat, acid, and oxidation

10. DEFINITIONS – CANNABIS
THC (tetrahydrocannabinol)
Psychoactive
CBD (cannabinol)
Non-Psychoactive

11. PHARMACOLOGY

12. CANNABINOID RECEPTORS
Two types of cannabinoid receptors: CB1 and CB2
superfamily of G-protein-coupled receptors
CB1 receptor is mainly expressed in the brain and spinal cord
Modulation of synaptic plasticity, cell migration, and neurite remodeling – regulate neurotransmitters
CB2 receptor is predominantly expressed in cells of the immune and hematopoietic systems
Controls immune cell migration both within and outside the central nervous system
Prog Neuropsychopharmacol Biol Psychiatry Jul 2; 38(1): 4–15.

15. FDA APPROVED PRODUCTS

16. FDA APPROVED PRODUCTS MARINOL® (DRONABINOL) – CAPSULE
CHEMO INDUCED N/V, ANOREXIA & WEIGHT LOSS DUE TO AIDS
SYNDROS® (DRONABINOL) – SOLUTION
CESAMET® (NABILONE) – CAPSULE, SYNTHETIC, SIMILAR CHEMICAL STRUCTURE AS THC
CHEMO INDUCED N/V

17. INVESTIGATIONAL PRODUCTS
Sativex® (nabiximols) composed of CBD and THC and administered as a metered dose oro-mucosal spray
Use: spasticity (muscle stiffness/spasm) due to Multiple Sclerosisy and pain including chronic cancer pain
Epidiolex® (cannabidiol) a liquid formulation of pure plant- derived CBD
Use: treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS)

18. MEDICAL HISTORY OF CANNABIS

19. HISTORY OF CANNABIS
One of the oldest psychotropic drugs in human history
Originating from central Asia then spread to China and India
First description by an Irish physician (O’Shaughnessy) in 1839
United States Dispensary in 1854: analgesic, sedative, anti- inflammatory, antispasmodic, anti-asthmatic, and anticonvulsant
U.S. government and popular media began condemning the use of smoked cannabis in the 1930s, linking its use to homicidal mania

20. HISTORY OF CANNABIS
Marihuana Tax Act of 1937 introduced the first federal restrictions
Law required industrial or medical users to register 38 and pay a tax on marijuana of $1/ounce
Recreational or other purposes were required to pay a tax of $100/ounce

21. AMERICAN MEDICAL ASSOCIATION & CANNABIS

22. AMA AND MARIJUANA
AMA was alone in opposing passage of Marihuana Tax Act
Objective data were lacking on the harmful effects, and passage would impede future investigations
Due to governmental pressures, marijuana was removed from the U.S. Pharmacopoeia in 1942
AMA believes Marijuana should move from Schedule I to II or III

23. AMA AND MARIJUANA
AMA recommends increase in research in marijuana and THC and CBD to better understand benefit
NIH to better administer procedures for access and grants
NIDA to be involved in distribution for research projects
NIH to create a smoke-free distribution method
To ensure free access to patients and providers where appropriate

24. LEGAL & REGULATORY

25. DEA AND MARIJUANA THC AND MARIJUANA ARE SCHEDULE I
SYNTHETICS AND DERIVATIVES ARE ALSO SCHEDULE I
Schedule I:
has a high potential for abuse
has no currently accepted medical use in treatment in the US
lack of accepted safety for use under medical supervision

26. WHERE CAN I SCORE SOME WEED?

27. 2016

28. 2017

29. STATE MEDICAL MARIJUANA LAWS
29 states, the District of Columbia, Guam and Puerto Rico now allow for comprehensive public medical marijuana and cannabis programs
18 states allow use of "low THC, high cannabidiol (CBD)" products for medical reasons in limited situations or as a legal defense 
In October of 2009, the Obama Administration sent a memo to federal prosecutors encouraging them not to prosecute people who distribute marijuana for medical purposes in accordance with state law

30. STATUS IN OHIO

31. OHIO ADMINISTRATIVE CODE (OAC)
3796: MEDICAL MARIJUANA CONTROL PROGRAM
RULES AND RESPONSIBILITIES – ADVISORY COMMITTEE
BOARD STANDARDS
DEFINITION OF LICENSING - RESTRICTIONS
REGISTRATION – ID CARD
PAYMENT – CLOSED LOOP SYSTEM
QUALIFYING CONDITIONS
ACCEPTABLE PRODUCTS

32. OAC 3796: QUALIFYING CONDITIONS
Acquired immune deficiency syndrome
Alzheimer's disease
Amyotrophic lateral sclerosis
Cancer
Chronic traumatic encephalopathy
Crohn's disease
Epilepsy or another seizure disorder
Fibromyalgia
Glaucoma
Hepatitis C
Inflammatory bowel disease
Multiple sclerosis

33. OAC 3796: QUALIFYING CONDITIONS
Pain - Chronic and severe
Pain - Intractable
Parkinson's disease
Positive status for HIV
Post-traumatic stress disorder
Sickle cell anemia
Spinal cord disease or injury
Tourette's syndrome
Traumatic brain injury
Ulcerative colitis
Any other disease or condition added by the state medical board under section of the Revised Code

34. OAC 3796: PERMISSIBLE FORMS
OILS
TINCTURES
PLANT MATERIAL
EDIBLES
PATCHES
ANY OTHER FORMS APPROVED BY STATE BOARD OF PHARMACY
NOTE: VAPORIZATION IS ALLOWED, SMOKING IS NOT

35. OAC 3796: THC CONTENT TETRAHYDROCANNABINOL (THC)
PLANT MATERIAL <35%
EXTRACTS <70%

36. OAC 3976: LICENSING CULTIVATOR PROCESSOR DISPENSARY
CULTIVATE PRODUCT AND SELL TO PROCESSOR
PROCESSOR
PACKAGE AND LABEL AND SELL TO DISPENSARY (CHILD- RESISTANT, LABELING THC CONTENT)
DISPENSARY
VALIDATE ID, VERIFY WRITTEN PRESCRIPTION, DISPENSE PRE- PACKAGED PRODUCT (MAX=90 DAY SUPPLY), CLOSE-LOOP

37. OAC 3796: DISPENSARY LICENSE
LIMITS BASED ON POPULATION
LUCAS (2), WOOD (1)
RESTRICTIONS ON LOCATION
WITHIN 500 FEET OF A SCHOOL, CHURCH, PUBLIC LIBRARY, PUBLIC PARK, OR PUBLIC PLAYGROUND
EXCEPTIONS: STATE UNIVERSITY, ACADEMIC CENTER, PRIVATE R&D ORGANIZATON,

38. HOUSE BILL 523 (HB 523) GENERAL ASSEMBLY: 131
SHORT TITLE: AUTHORIZES THE USE OF MARIJUANA FOR MEDICAL PURPOSES
PRIMARY SPONSOR: REPRESENTATIVE HUFFMAN
COMMITTEES: SENATE GOVERNMENT OVERSIGHT AND REFORM, HOUSE SELECT COMMITTEE ON MEDICAL MARIJUANA

39. MEDICAL MARIJUANA CONTROL PROGRAM
DEPT OF COMMERCE AND STATE BOARD OF PHARMACY
ADVISORY COMMITTEE MAKES RECOMMENDATIONS
PERMITS PATIENT TO USE MEDICAL MARIJUANA
BOARD OF PHARMACY REGISTER PATIENT AND PROVIDER – ALSO REGULATES RETAIL DISPENSARIES
DEPT OF COMMERCE LICENCES TO CULTIVATORS, PROCESSORS AND TESTING LABS
AUTHORIZES MEDICAL BOARD TO CERTIFY PROVIDERS

40. WHAT IF I WANT TO “PRESCRIBE” (READ “RECOMMEND”) MEDICAL MARIJUANA?

41. PHYSICIAN RESPONSIBILITIES
WRITTEN RECOMMENDATION AFTER OBTAINING CERTIFICATE FROM STATE BOARD OF MEDICINE
THIS RECOMMENDATION IS A MAIN COMPONENT ON AN AFFIRMATIVE DEFENSE BY PATIENT AND PARENTS/GUARDIANS OF MINORS IN MARIJUANA- RELATED CRIMES
IMPORTANT FOR PROVIDER IS CONSULT WITH LEGAL COUNSEL AND EMPLOYER
Medicalmarijuana.ohio.gov/physicians

42. WHAT QUANTITY LIMITS ARE THERE FOR MEDICAL MARIJUANA?

43. DISPENSARY RESPONSIBILITIES
2.83g plant material
295mg THC – patch, lotion, cream or ointment
110mg THC – oil, tincture, capsule or edible
590mg THC – oil for vaporization
Maximum dispensed is 90 day supply – can be as mixed products
Codes.ohio.gov/oac/3796

44. CLINICAL USE

46. EVIDENCE-BASED DATA (MAYO CLINIC)
CATEGORY
GRADE
CHRONIC PAIN B
MULTIPLE SCLEROSIS
AMYOTROPHIC LATERAL SCLEROSIS (LOU GEHRIG’S DISEASE) C
APPETITE STIMULATION
ATOPIC DERMATITIS
BRAIN INJURY
CHEMOTHERAPY RELATED NAUSEA/VOMITING
DERMATITS
EPILEPSY

47. EVIDENCE-BASED DATA (MAYO CLINIC)
CATEGORY
GRADE
GLAUCOMA C
HUNTINGTON’S DISEASE
NEUROMUSCULAR DISEASE
RHEUMATOID DISEASE
SCHIZOPHRENIA
SLEEP DISORDER
TOURETTE’S SYNDROME
EATING DISORDER

48. DOES MEDICAL MARIJUANA DECREASE THE AMOUNT OF OPIOID USE IN PATIENTS?

49. MARIJUANA AND OPIOID USE
THEORY IS THAT USE REDUCES OPIOID ADDICTION
RESEARCH FOCUSING ON CBD (NON-PSYCHOACTIVE) – THOUGHT IS REDUCED ANXIETY AND CRAVINGS
Journal of Neuroscience: CBD decreased heroin cravings in rats that had previously been trained to self-administer heroin

50. DRONABINOL AND OPIOID USE
SPONSOR: New York State Psychiatric Institute and NIDA
Two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals
Randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals
Participants will be randomized into one of two conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid (N=40)

51. MARIJUANA AND OPIOID USE
June H. Kim et al. “State Medical Marijuana Laws and the Prevalence of Opioids Detected Among Fatally Injured Drivers”, American Journal of Public Health 106, no. 11 (November 1, 2016): pp
Objectives: To assess the association between medical marijuana laws (MMLs) and the odds of a positive opioid test, an indicator for prior use
Results: State-specific estimates indicated a reduction in opioid positivity for most states but not statistically significant
age-stratified analyses indicated a significant reduction in opioid positivity for drivers aged 21 to 40 years (P < .001)

52. MARIJUANA AND OPIOID USE
Powell D, Pacula RL, Jacobson M. Do Medical Marijuana Laws Reduce Addiction and Deaths Related to Pain Killers? RAND Corporation; 2015. (funded by NIDA)
Objectives: To study the impact of medical marijuana laws on problematic opioid use
Results: evidence using difference-in-differences, event study, and synthetic control group methods that states providing legal access to marijuana through dispensaries experience lower treatment admissions for addiction to pain medications
potential unintended benefit of these laws: a reduction in the misuse of prescription opiates.

53. MARIJUANA AND OPIOID USE
Bradford AC, Bradford WD. Medical Marijuana Laws Reduce Prescription Medication Use In Medicare Part D.
Health Affairs;  2016 Jul 1;35(7):
Project HOPE—The People-to-People Health Foundation, Inc
Objectives: Review data about whether medical marijuana is being used clinically in Medicare population
Results: data on all prescriptions filled by Medicare Part D enrollees from to 2013, we found that the use of prescription drugs for which marijuana could serve as a clinical alternative fell significantly
overall reductions in Medicare program and enrollee spending when states implemented medical marijuana laws were estimated to be $165.2 million per year in 2013

54. WHAT DOES THE FUTURE HOLD?

55. FUTURE DIRECTION NEW INDICATIONS NEW FORMULATIONS
HEALTH OUTCOME STUDIES
COST-BENEFIT ANALYSIS
LEGAL UPDATE
COMMERCE

56. TAXATION NEWS ARTICLE Michael Blood, Associated Press November 5, 2017
New Taxation for California Market in 2018
Recreational: costs about $35 to buy a small bag of good quality medical marijuana in LA
Same purchase will be up to $60 due to taxes (state, city)
higher taxes for businesses and consumers give the state's thriving illicit market a built-in advantage
Medical: increase in price will be less, but there will be increase in taxes

57. THANK YOU FOR YOUR ATTENTION
ANY QUESTIONS OR COMMENTS: