Transcript Medical Marijuana in CT

Medical Marijuana
in Connecticut
The Role of the
Dispensary
Pharmacist
David Slomski, PharmD
September 1st, 2016
Objectives

Discuss History of Marijuana and Connecticut’s Legalization

Review the Physician’s Roles and Responsibilities in the CT MMP

Establish the roles of the Dispensary Pharmacist in the Connecticut Medical
Marijuana Program

Explore the various formulations and dosage options for Medical Marijuana

Describe Sativa vs Indica Recommendations and Terpene Profiles

Discuss the clinical effects of Medical Marijuana
History of Cannabis Use in
Medicine

2900 BC - Chinese Emperor Fu Hsi References
Marijuana as a Popular Medicine

In the 19th century cannabis was one of the
secret ingredients in several “patent
medicines”.

There were at least 2000 cannabis medicines
prior to 1937, produced by over 280
manufacturers

Although criminalized in the United States in
1937 against the advice of the American
Medical Association, cannabis was not
removed from the United States
Pharmacopoeia until 1942
History Continued

1970 Controlled Substance Act Classifies Marijuana as a Drug with No Accepted Medical Use

May 1985 Marinol approved by FDA as Schedule II Drug

1990 Scientists Discover Cannabinoid Receptors

November 5, 1996 California Becomes the First State to Legalize Marijuana

January 30 1997 New England Journal of Medicine Publishes Editorial Calling for Marijuana to be Rescheduled

July 1999 Marinol Reclassified to Schedule III to Increase Availability to Patients

August 5, 2004 DEA Instructs HHS to Review Marijuana for Possible Rescheduling

May 31, 2012 Connecticut becomes 17th State to Legalize Medical Marijuana
The very first state to introduce pharmacists to the program.

August 29, 2013 Justice Department Will Not Challenge State Marijuana Laws
Qualifying Conditions

Cancer

Glaucoma

Positive status for human immunodeficiency virus or acquired immune
deficiency syndrome

Parkinson’s disease

Multiple sclerosis

Damage to the nervous tissue of the spinal cord with objective
neurological indication of intractable spasticity

Epilepsy

Cachexia

Wasting Syndrome

Crohn’s disease

Post-traumatic stress disorder
Additional Approved
Conditions
Implemented April 1, 2016
Sickle Cell Disease
 Severe Psoriasis and Psoriatic Arthritis
 Post-Laminectomy Syndrome with
Radiculopathy
 Amyotrophic Lateral Sclerosis
 Ulcerative Colitis
 Complex Regional Pain Syndrome

Physician’s Role

Determining patient’s eligibility

Certifying the patient! Not writing a prescription!

Determining monthly allotment of marijuana for patient
(maximum allowed 2.5 ounces or 70 grams per month)

Provide Physician Instructions on certification if deemed
necessary.

Review PMP to evaluate patients usage and compliance.

Communicate directly with Dispensary regarding
patients progress and physicians expectations.
All Licensed Physicians in Connecticut
are Eligible to Certify Patients

Possess an active Connecticut medical license issued by the Connecticut
Department of Public Health

Practice within the State of Connecticut

Possess an active controlled substance registration issued by the
Connecticut Department of Consumer Protection that is not subject to
limitation

Possess an active DEA controlled substance registration that is not subject
to limitation

Be registered with, and able to access, the Connecticut Prescription
Monitoring Program (PMP)
Patient Qualifications for a
Registration Certificate:

Diagnosed by a physician as having one of the debilitating medical
conditions set out by the law and be certified by such physician as an
appropriate candidate for the use of marijuana.

Connecticut resident; AND

18 years of age or older; AND

Not an inmate in a Department of Corrections institution or facility.
NOTE: If a patient’s physician certifies the need for the patient to have a
primary caregiver, the patient may register one person to act as their
caregiver with respect to their palliative use of marijuana.
Qualifying Patient & Primary
Caregiver
Registration Certificates
The Certification Process

Physician must establish a Biznet account to certify patients for the
medical marijuana program.

Patient must then register with Department of Consumer Protection
through Biznet using the email and primary phone number provided to
their physician and choose a dispensary facility.

Patient needs to provide, proof of identity, proof of residency, and a
current passport picture.

The Healing Corner provides passport pictures and document upload for
patients. (other dispensaries may also)

Patients receive their picture certification good for one year.
Biznet Web Site
www.biznet.ct.gov/accountmaint/login.aspx
Physician’s Instructions
MMP Statistics as of 08/27/2015 05/31/2016 08/28/2016
Number of patients certified
5357 10624 12342
Number of patients certified per county
Fairfield
1277 2322 2586
Hartford
1169 2356 2886
Litchfield
331 660 769
Middlesex
289 646 754
New Haven
1399 2618 2952
New London
501 1164 1336
Tolland
198 481 609
Windham
193 377 450
CT Licensed Producers
 Advanced
Grow Labs- West
Haven
 Connecticut
Pharmaceutical
Solutions- Portland
 Curaleaf-
Simsbury
 Theraplant-
Watertown
Product Labeling and Testing

2 of 4 growers are growing hydroponically with two growing in soil.

Products are labeled with levels of 7 Cannabinoids


THC, THCA, CBD, CBDA, CBN, CBG, CBC
All Cannabis is tested in a Connecticut Laboratory for:

Pesticides

Mycotoxins

Bacteria

Heavy Metals

Mold
Lab Results
Product Labeling and Testing
Six MMJ Dispensaries in CT
(RFA to add 3 more in New Haven & Fairfield
Counties)
 Arrow
Alternative Care – Hartford
 Bluepoint Wellness Center – Branford
 Compassionate Care Center – Bethel
 Prime Wellness – South Windsor
 Thames Valley Alternative Relief –
Uncasville
 The Healing Corner - Bristol
3 More Approved Dispensaries
(to open soon)
 Arrow
Alternative Care 2,
Inc - Milford
 Southern CT Wellness and
Healing, LLC -Milford
 Caring Nature, LLCWaterbury
New Patient Consultation
 Patient
fills out paperwork during initial visit
 Acknowledgement
of Disclosure and Informed
Consent
 Privacy
 Patient
Policy Acknowledgement Statement
Intake Form – Demographics, Diagnosis,
Medication History, Symptoms, and History of
use.
Role of Dispensaries


Completing an initial patient assessment

What symptoms of illness is patient looking for relief from?

Is patient a naïve or experienced user?

What is the patient’s lifestyle? Working, disabled? Determine level of
discretion.
Helping patient decide which medicated product will help relieve their
symptoms

Strain, dosage form, delivery device all come into play here

Equipping patient with tools to self-assess the efficacy of their medication

Reporting any adverse events that may occur
Selecting Appropriate
Medication

This will depend on several factors

What disease state?

What symptoms is patient looking for relief from?

Daytime or evening use?

Does patient work or attend school?

Are there other individuals in the home?

Are there respiratory issues that would rule out inhalation?
What’s the Difference?
Sativa vs Indica
Therapeutic Effects: Sativa


The primary effects are on thoughts and feelings. Sativa tends to produces
stimulating feelings, and many patients prefer it for daytime use

Stimulating/energizing/uplifting

Increased sense of well-being, focus, creativity

Reduces depression, elevates mood

Relieves headaches/migraines/nausea

Increases appetite
Some noted Side-Effects from use of Sativa

Increased anxiety feelings

Increased paranoia feelings
Therapeutic Effects: Indica


The primary effects are on the body. Indica tends to produce sedated feelings,
and many patients prefer it for nighttime use

Provides relaxation/reduces stress

Relaxes muscles/spasms

Reduces pain/inflammation

Helps insomnia

Reduces anxiety

Reduces nausea, stimulates appetite

Reduces intra-ocular pressure

Reduces seizure frequency/anticonvulsant
Some noted side-effects from use of Indicas:

Feelings of tiredness

“Fuzzy” thinking
Dosage Options
Inhalation Route


Smoking-burning or combustion

Onset = 90 seconds, Duration = ~2 hours

Least efficient; “Up in Smoke”, but most economical up
front

Inhaling toxins – CO, tar, many others
Vaporizing- heating below point of combustion

Temp range 375 to 410 degrees Fahrenheit

Eliminate toxins, better for lungs

Units range in cost, size, shape, and effectiveness
Portable Vaporizer Options
Volcano – Table Top Vaporizer
Extracts

Supercritical CO2 extraction of essential oils from the cannabis plant

These oils can be used to prepare alternate dosage forms
 Pre-filled
cartridges
 Tinctures
 Sublingual
films
 Edibles
 Capsules
 Topical
 Oral
preparations
Syringe
Sublingual Delivery

Options include tinctures, sprays, oils, sublingual films

Onset of 15 to 30 minutes, duration of effect ~4 hours

Convenient for naïve patients or patients who prefer
not to inhale
Oral Administration

Options include edibles, oils, oral syringes

Onset 1 to 2 hours, duration 4 to 6 hours

Difficult to determine effective dose, but has advantage
of less frequent dosing once optimum dose is
determined
Chemical Constituents of
Cannabis

Total number of natural compounds identified in C.
Sativa is 489

Cannabinoids (70)

Terpenes (120); Flavonoids (23);

Hydrocarbons (50); Amino acids (18),

Proteins glycoproteins and enzymes (11);

Nitrogenous compounds (27)
Major Cannabinoids

Delta-9-tetrahydrocannabinol (THC) is the primary psychoactive
compound that binds to CB1 receptors, and is responsible for the effect
most patients are familiar with.

Clinical Effects:

Analgesic

Anti-inflammatory

Anti-emetic

Antispasmodic

Antidepressant

Appetite Stimulant

Neuro-protective

Reduces Intraocular eye pressure


Cannabidiol (CBD) is non-psychoactive and binds at CB2 receptors in
the periphery. Modulates THC psychoactivity.

Anti-epileptic

Anti-inflammattory

Anti- anxiety

Anti-nausea

Anti-proliferative

Spasm relief

Neuro-protective
Cannabinol (CBN) is mildly psychoactive a somewhat selective CB2
receptor agonist. It is metabolite of THC.

Analgesic

Anti-spasm

Anti-inflammatory
Cannabis Terpenes (120)
Definition of Terpenes – any of various unsaturated hydrocarbons found in the
essential oils of plants. Aromatic, Modulate effects of Cannabinoids.
Pinene- aroma is pine, found in pine needles, rosemary, basil, and dill. (antiinflammatory, bronchodilator)
Myrcene- aroma musky, earthy, found in mango, thyme, hops. (analgesic,
muscle relaxant, sedative)
Limonene- aroma is citrus, found in fruit rinds, rosemary, and peppermint.
(anxiolytic)
Carophyllene- aroma is peppery, spicy, found in black pepper, basil, cloves.
(gastric cytoprotective)
Adverse Effects of Marijuana

General Population Considerations:
-Comorbidities (medical and psychiatric)
-Concomitant use of other medications
-Substance abuse issues

General drug considerations:
-Very low toxicity/lethality
-Most effects short-term
-Experienced users report fewer AE’s
-Most common: dizziness, dry mouth, drowsiness

Overall:
-Poorly studied in medical use
-Mostly addressed from population studies in recreational use
Side Effects of Marijuana

Euphoria

Difficulty concentrating and performing complex tasks

Changes in perception

Short term memory loss

Drowsiness

Transiently increased heart rate and blood pressure

Interferes with REM sleep

Anxiety and confusion in some people, and rarely
paranoia

*Side effects can be reduced by using alternate dosage
forms*
Cannabis Dosing

Same as with any therapeutically active substance

Start with minimally effective dose

Monitor response and side effects

Increase dose in small increments as indicated

Change preparations as needed
Cannabis Dosing

Typical starting dose may depend on familiarity with
cannabis

Bear in mind psychoactivity of THC

+/- 5mg-10mg THC orally HS or as tolerated during the
day

Inhaled: One draw, hold briefly, assess effect after 2
minutes, repeat if needed.

Self titration: 1 to 2 draws every 2 to 3 hours as needed
and as tolerated

Edibles: starting dose 5mg increase in 5mg increments
to desired effect
Pharmacodynamics of
Cannabinoids

Mechanism of action identified in the 1990s, after discovery of the
cannabinoid receptors

CB1 receptors


Found in CNS and blood vessels
CB2 receptors

Found in CNS and diversely in periphery (immune cells, sensory nerves, retina)
Drug Interactions

Little data exists regarding drug interactions with cannabinoids in humans.

Due to drowsiness side effect – caution with sedative medications.

THC is metabolized by CYP2C9 and CYP3A4.

CYP2C9 inhibitors would be expected to increase the plasma
concentration of THC. Some of these are amiodarone, cimetidine,
metronidazole, fluoxetine, fluvoxamine, fluconazole.

Ketoconazole, clarithromycin, erythromycin, verapamil, and itraconazole
inhibit CYP3A4 so also could increase THC plasma levels.

CBD is a potent inhibitor of multiple cytochrome P450 enzymes (CYP1A2,
CYP2B6, CYP2C9, CYP2D6 and CYP3A4)

CBD may therefore exhibit significant pharmacokinetic interaction with
other pharmacological agents including antiepileptic drugs
Prescription Cannabinoids




Dronabinol (Δ-9 tetrahydrocannabinol – THC) (2.5 - 10mg) (Marinol)

Oral capsule

Approved for chemotherapy-induced nausea and vomiting and anorexia associated with HIV/AIDS
Nabilone (0.25 - 1.0mg) (Cesamet)

Oral capsule

Approved for chemotherapy-induced nausea and vomiting
Nabiximols (2.7mg THC + 2.5mg CBD) (Sativex)

Oromucosal spray

Approved in Canada for multiple sclerosis-associated neuropathic pain, spasticity and advanced
cancer pain
Herbal cannabis (varying THC levels)

State programs (USA)

Federal programs (Canada, Holland)

No formal ‘approval’
Questions?
References

Ben Amar M (2006). "Cannabinoids in medicine: a review of their therapeutic
potential" Journal of Ethnopharmacology (Review) 105 (1–2): 1–25.

Borgelt LM, Franson KL, Nussbaum AM, Wang GS (February 2013). "The
pharmacologic and clinical effects of medical cannabis". Pharmacotherapy (Review)
33 (2): 195–209.

Wang T, Collet JP, Shapiro S, Ware MA (June 2008). "Adverse effects of medical
cannabinoids: a systematic review". CMAJ (Review) 178 (13): 1669–78.

Bowles DW, O'Bryant CL, Camidge DR, Jimeno A (July 2012). "The intersection
between cannabis and cancer in the United States". Crit. Rev. Oncol. Hematol.
(Review) 83 (1): 1–10.

Corey-Bloom J, Wolfson T, Gamst A, Jin S, Marcotte TD et al. (2012) Smoked
cannabis for spasticity in multiple sclerosis: a randomized, placebo-controlled trial.
CMAJ 184: 1143-1150.

Naftali T: Cannabis induces a clinical response in patients with Crohn's disease: a
prospective placebo-controlled study. Clin Gastroenterol Hepatol 2013;11:12761280.

Pharmacy Times “Drug Interactions with Marijuana” John R. Horn, PharmD, FCCP,
and Philip D. Hansten, PharmD, published online: Tuesday, December 9, 2014