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Medicalized
Marijuana:
A Review of
State Programs
in the USA
ISSDP // Cannabis Summit
April 17, 2016
Arthur Robin Williams MD MBE
Columbia University
Division on Substance Abuse
Department of Psychiatry
New York State Psychiatric Institute
Symbolic Laws 1979-1991
 5 states
 Legalized marijuana with a “prescription”
 Symbolic because federal law prohibits
prescribing a schedule I drug
 Virginia (1979)
 New Hampshire (1981)
 Connecticut (1981)
 Wisconsin (1988)
 Louisiana (1991)
MMJ Laws 1996-Current
 23 states and DC (N=24)
 California was first in 1996
 Range of programs
 Initially just protective of possession
 Increasingly regulated
 2009 as dividing line for medical programs
 CBD research programs (15 states)
Recreational (dark), Medical (medium)
+ CBD Research (light green) as of 2015
The Medical Model:
The role of physicians
 Comprehensive H&P
 Make a diagnosis (in your area of expertise)
 Treatment plan with specific objectives
 Informed consent: risks and benefits
 Longitudinal management
 Seek consultation from colleagues
 Document the rationale
The Medical Model:
Pharmaceuticals
 Physician oversees dose
 FDA approved (efficacy and safety)
 Current Good Manufacturing Practices
① Manufacturing regulations and dispensed via
licensed pharmacy (separate party from MD)
② Medication is clearly labeled, consistent
 One month supply, typically not filled early
 Route of administration safest available
The Medical Model:
Controlled substances
 More restrictive
 For meds with increased risk/abuse potential
 Certifying MD registered with state (DEA
license)
① Refill limits
② Prescription Drug Monitoring Program (PMP)
③ Physician certification
7-point assessment tool
① Bona fide doctor patient relationship
② Non-smoked cannabis
③ Licensed manufacturing/dispensing
④ Standardized testing/labeling
⑤ 30-day refill limitations
⑥ Link to PDMP
⑦ Physician training/certification
7-point assessment tool
Results
Great variation
Average score was 1.96 (SD=2.17)
Results
Great variation
Average score was 1.96 (SD=2.17)
Bona fide relationship in 62.5%
(N=15)
Results
Great variation
Average score was 1.96 (SD=2.17)
Bona fide relationship in 62.5%
(N=15)
Few with restrictive criteria
2 non-smoked marijuana
3 PMPs
3 physician training
Results (N=24)
10 Medicalized programs
Mean score 4.1 (SD=1.4)
14 Non-Medical programs
Mean score 0.43 (SD=0.51)
State characteristics by group
Medicalized
(N=10)
Non-Medical
(N=14)
P Value
Legislative Act (%) 90.0 28.6 .004
Mean Years Since
Passage (SD)
2.7 (0.50) 13 (1.18) <0.0001
Region (N) West (0)
Midwest (2)
Northeast (5)
South (3)
West (10)
Midwest (1)
Northeast (3)
South (0)
.13
2008 Population Densitya
(persons/sq land mile) (SD)
1,454.1 (939.9) 146.45 (70.1) .11
State GDP (M)b (SD) 393,429 (113,390) 296,314 (142,521) .62
Mean Enrollment per
100,000 Residentsc (SD)
58 (31.7) 1,030 (160.3) .002
State characteristics by group:
 First wave MMJ programs 1996-2009
 Voter initiatives in Western states
 Not consistent with medical model
 Second wave MMJ programs 2009-
current
 Legislatures in Northeast/Midwest states
 More highly regulated
Medicalized (yellow) and
Non-Medical (green) Programs (N=24)
Association between medicalization
and enrollment rates
Enrollment by group (October, 2014):
 Non-medical (N=14)
 1,129,759 participants
 99.4% of participants nationwide
 Medical (N=5)
 7,310 participants
 1/20th rate of enrollment (58 v. 1,030)
Case Study: New York
 121 pages of regulations
 Only 20 dispensaries statewide
 $200,000 fee for registered organizations
 Physicians must complete a 4-hour
course
 5 brands with many criteria
 95-105% content of indicated THC and CBD
 Low THC 1:20 and 50:50 brands
 Non-commercial names
 Non-smoked products only
Thank you!
 Mark Olfson MD MPH
 Silvia Martins MD PhD
 June Kim MS
 Herbert D. Kleber MD

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Cannabis Science & Policy Summit - Day 1 - Williams

  • 1. Medicalized Marijuana: A Review of State Programs in the USA ISSDP // Cannabis Summit April 17, 2016 Arthur Robin Williams MD MBE Columbia University Division on Substance Abuse Department of Psychiatry New York State Psychiatric Institute
  • 2. Symbolic Laws 1979-1991  5 states  Legalized marijuana with a “prescription”  Symbolic because federal law prohibits prescribing a schedule I drug  Virginia (1979)  New Hampshire (1981)  Connecticut (1981)  Wisconsin (1988)  Louisiana (1991)
  • 3. MMJ Laws 1996-Current  23 states and DC (N=24)  California was first in 1996  Range of programs  Initially just protective of possession  Increasingly regulated  2009 as dividing line for medical programs  CBD research programs (15 states)
  • 4. Recreational (dark), Medical (medium) + CBD Research (light green) as of 2015
  • 5. The Medical Model: The role of physicians  Comprehensive H&P  Make a diagnosis (in your area of expertise)  Treatment plan with specific objectives  Informed consent: risks and benefits  Longitudinal management  Seek consultation from colleagues  Document the rationale
  • 6. The Medical Model: Pharmaceuticals  Physician oversees dose  FDA approved (efficacy and safety)  Current Good Manufacturing Practices ① Manufacturing regulations and dispensed via licensed pharmacy (separate party from MD) ② Medication is clearly labeled, consistent  One month supply, typically not filled early  Route of administration safest available
  • 7. The Medical Model: Controlled substances  More restrictive  For meds with increased risk/abuse potential  Certifying MD registered with state (DEA license) ① Refill limits ② Prescription Drug Monitoring Program (PMP) ③ Physician certification
  • 8. 7-point assessment tool ① Bona fide doctor patient relationship ② Non-smoked cannabis ③ Licensed manufacturing/dispensing ④ Standardized testing/labeling ⑤ 30-day refill limitations ⑥ Link to PDMP ⑦ Physician training/certification
  • 10.
  • 11.
  • 13. Results Great variation Average score was 1.96 (SD=2.17) Bona fide relationship in 62.5% (N=15)
  • 14. Results Great variation Average score was 1.96 (SD=2.17) Bona fide relationship in 62.5% (N=15) Few with restrictive criteria 2 non-smoked marijuana 3 PMPs 3 physician training
  • 15. Results (N=24) 10 Medicalized programs Mean score 4.1 (SD=1.4) 14 Non-Medical programs Mean score 0.43 (SD=0.51)
  • 16. State characteristics by group Medicalized (N=10) Non-Medical (N=14) P Value Legislative Act (%) 90.0 28.6 .004 Mean Years Since Passage (SD) 2.7 (0.50) 13 (1.18) <0.0001 Region (N) West (0) Midwest (2) Northeast (5) South (3) West (10) Midwest (1) Northeast (3) South (0) .13 2008 Population Densitya (persons/sq land mile) (SD) 1,454.1 (939.9) 146.45 (70.1) .11 State GDP (M)b (SD) 393,429 (113,390) 296,314 (142,521) .62 Mean Enrollment per 100,000 Residentsc (SD) 58 (31.7) 1,030 (160.3) .002
  • 17. State characteristics by group:  First wave MMJ programs 1996-2009  Voter initiatives in Western states  Not consistent with medical model  Second wave MMJ programs 2009- current  Legislatures in Northeast/Midwest states  More highly regulated
  • 18. Medicalized (yellow) and Non-Medical (green) Programs (N=24)
  • 20. Enrollment by group (October, 2014):  Non-medical (N=14)  1,129,759 participants  99.4% of participants nationwide  Medical (N=5)  7,310 participants  1/20th rate of enrollment (58 v. 1,030)
  • 21. Case Study: New York  121 pages of regulations  Only 20 dispensaries statewide  $200,000 fee for registered organizations  Physicians must complete a 4-hour course  5 brands with many criteria  95-105% content of indicated THC and CBD  Low THC 1:20 and 50:50 brands  Non-commercial names  Non-smoked products only
  • 22. Thank you!  Mark Olfson MD MPH  Silvia Martins MD PhD  June Kim MS  Herbert D. Kleber MD