cannabis science & policy summit - day 1 - williams

Medicalized

Marijuana:

A Review of

State Programs

in the USAISSDP // Cannabis Summit

April 17, 2016

Arthur Robin Williams MD MBE

Columbia UniversityDivision on Substance Abuse Department of PsychiatryNew 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 Practices① 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)

①Refill limits

②Prescription Drug Monitoring Program (PMP)

③Physician certification

7-point assessment tool① 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 variationAverage score was 1.96 (SD=2.17)

Results

Great variationAverage score was 1.96 (SD=2.17)

Bona fide relationship in 62.5% (N=15)

Results

Great variationAverage score was 1.96 (SD=2.17)

Bona fide relationship in 62.5% (N=15)

Few with restrictive criteria2 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