giving the green light to medicinal marijuana · • the potential of marijuana liberalization to...

Giving the Green Light to Medicinal Marijuana

An Overview of NJ’s Program and Evidence

Shereef Elnahal, MD, MBA Commissioner

Department of Health and Senior Services NJ Department of Health

Objectives

•  Learning Objectives

•  Cite the most current evidence regarding the use of medicinal marijuana to treat certain conditions • Understand the requirements of the NJ

medicinal marijuana program and the changes to the program via Executive Order #6 • Distinguish between forms and types of

medicinal marijuana available today •  Explain dosing and application options


Welcome

25,462 patients •  Increase of 10,000 since

new administration began, including 6,300 with new medical conditions

642 physicians 1,000 caregivers 6 Alternative Treatment Centers (ATC)

•  4 ATCs requested approval to expand


Patient Demographics


Forms of Therapy


Forms of Therapy

Current forms of medicinal marijuana in NJ All Patients: • Oral – primarily lozenges that dissolve in the mouth

• Topical – oils, ointments, and other formulations that are meant to be absorbed through the skin

• Flower – the “buds” that can be smoked, vaporized, or baked

Minors: • Edibles – tablets, capsules, drops or syrups that are ingested


Known Medicinal Compounds

Tetrahydrocannabinol (THC)

Cannabidiol (CBD)

Note: Heat coverts Δ9-tetrahydrocannabinolic acid (THCA) and Cannibadiolic Acid (CBDA) to THC and CBD respectively. When looking at strain information, advise patients to look at the combined total of THCA and THC, or CBD and CBDA.


Forms of Therapy

Flower Types: •  Indica •  Sativa •  Hybrid

Chemotypes:

•  1: High THC/Low CBD •  2: THC/CBD ratio

between .5 and 3.0 •  3: High CBD/Low THC


Forms of Therapy

Lozenges/Edibles •  High-CBD •  High-THC •  CBD/THC

Pictured: three types of lozenges, all with 10:1 THC:CBD ratio. Lozenges come in full dose (10 mg THC, 1 mg CBD), half (5 mg THC, .5 mg CBD) or quarter (2.5 mg THC, .25 mg CBD)


Forms and dosing

Oils


Forms and dosing

Ointment


Why Go Green? A review of the evidence base (and reasons for the lack of a more robust body of research).


Evidence: HIV/AIDS

13

From: Dronabinol and Marijuana in HIV-Positive Marijuana Smokers: Caloric Intake, Mood, and SleepHaney, etDeficiency Syndromes: August 15th, 2007 - Volume 45 - Issue 5 - p 545-554 doi: 10.1097/QAI.0b013e31811ed205. Al,.,Journal of Acquired Immune

Mean total daily caloric intake and total number of eating occasions as a function of marijuana (MJ) and dronabinol (Dronab) dose. Each active dose condition reflects the mean across 4 sessions; placebo data represent the mean across 16 sessions. Dronab and MJ were administered 4 times per day. Asterisks denote a significant difference from placebo (*P < 0.01; **P <

0.005). Error bars represent 1 standard error of the mean (SEM).


Design: •  Patients were randomly assigned to smoke either cannabis (3.56%

tetrahydrocannabinol) or identical placebo cigarettes with the cannabinoids extracted 3x daily for 5 days

Results: •  Smoked cannabis reduced daily pain by 34%

Conclusion: •  Smoked cannabis was well tolerated and effectively relieved chronic

neuropathic pain from HIV-associated sensory neuropathy •  The findings are comparable to oral drugs used for chronic

neuropathic pain.

Evidence: HIV/AIDS

Cannabis in painful HIV-associated sensory neuropathy: A randomized placebo-controlled trial

Abrams, et al.,.Neurology. 2007 Feb 13;68(7):515-21.


Evidence: Rheumatoid Arthritis

Design: • In the first randomized controlled trial assessing efficacy of a cannabis-based medicine (CBM) in treatment of pain due to rheumatoid arthritis (RA), a blend of whole plant extracts delivering approximately equal amounts of THC and CBD was compared with a placebo administered for 5 weeks Results and Conclusion: • CBM produced statistically significant improvements in pain on movement, pain at rest, quality of sleep and DAS28 (measure of disease activity) scores in patients with RA and was well tolerated • Larger scale research is indicated

Preliminary Assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis Blake, et al. Rheumatology, Volume 45, Issue 1, 1 January 2006, Pages 50–52, https://doi.org/10.1093/rheumatology/kei183


Evidence: Inflammatory Bowel Disease

Design: • 13 patients with long-standing IBD who were prescribed cannabis treatment were included. Two quality of life questionnaires and disease activity indexes were performed, and patient's body weight was measured before cannabis initiation and after 3 months' treatment

Results: • After 3 months' treatment, patients reported improvement in general health, social functioning, ability to work, physical pain. Patients had a weight gain of 4.3 ± 2 kg during treatment Conclusion: • Three months' treatment with inhaled cannabis improves quality of life measurements, disease activity index, and causes weight gain and rise in BMI in long-standing IBD patients

Impact of cannabis treatment on the quality of life, weight and clinical disease activity in inflammatory bowel disease patients: a pilot prospective studyLahat el al., Digestion. 2012;85(1):1-8. doi: 10.1159/000332079. Epub 2011 Nov 17.


Evidence: Epilepsy

Design: •  213 patients qualifying for open-label Expanded Access study had to have a

treatment-resistant epileptic condition, such as Lennox-Gastaut and Dravet syndromes

•  All patients were prescribed cannabidiol in a liquid daily dose that was gradually increased up to a potential maximum of 25mg/kg over 12 weeks

Results: •  137 patients completed the study •  Number of seizures decreased by an average of 54%

Medical Marijuana Extract Curbs Seizure Frequency in Early Trial of Epilepsy PatientsDavinsky et al.., NYU Langone Medical Center 2015


Evidence: Multiple Sclerosis

Design: • 19‐week double‐blind, randomized, placebo‐controlled, parallel‐group study in subjects with multiple sclerosis spasticity not fully relieved with current therapy  Subjects were treated with nabiximols as add‐on therapy

Results: • 272 of 572 subjects achieved a ≥20% improvement after 4 weeks

Conclusion: • Study design provides a method of determining the efficacy/safety of nabiximols that more closely reflects proposed clinical practice, by limiting exposure to those patients who are likely to benefit from it  The difference between active and placebo should be a reflection of efficacy and

safety in the population intended for treatment

A randomized, double‐blind, placebo‐controlled, parallel‐group, enriched‐design study of nabiximols* (Sativex®), as add‐on therapy, in subjects with refractory spasticity caused by multiple sclerosisNovotna, et al. European Journal of Neurology 2011


Evidence: Opioids and Opioid Abuse

Design: •  Population-based, cross-sectional, longitudinal analysis of Medicaid prescription

claims data for 2011 to 2016 Results: •  State implementation of medical marijuana laws was associated with a 5.88% lower

rate of opioid prescribing (95% CI-11.55% to approximately -0.21%) •  The implementation of adult-use marijuana laws in states with existing medical

marijuana laws was associated with a 6.38% lower rate of opioid prescribing (95% CI-12.20% to approximately -0.56%)

Conclusion: •  The potential of marijuana liberalization to reduce the use and

consequences of prescription opioids among Medicaid enrollees deserves consideration during the policy discussions about marijuana reform and the opioid epidemic.

Association of Medical and Adult-Use Marijuana Laws With Opioid Prescribing for Medicaid EnrolleesWen et al., JAMA Intern Med. 2018;178(5):673-679. doi:10.1001/jamainternmed.2018.1007



Design: •  Longitudinal analysis of the daily doses of opioids filled in Medicare Part D for all opioids

as a group and for categories of opioids by state and state-level Medical Cannabis Law (MCL) from 2010 through 2015.

Results: •  Analysis results found that patients filled fewer daily doses of any opioid in states with an

MCL   States with active dispensaries saw 3.742 million fewer daily doses filled

Conclusion: •  Medical cannabis laws are associated with significant reductions in opioid prescribing in

the Medicare Part D population. This finding was particularly strong in states that permit dispensaries, and for reductions in hydrocodone and morphine prescriptions.

Association Between US State Medical Cannabis Laws and Opioid Prescribing in the Medicare Part D PopulationBradford et al., JAMA Intern Med. 2018;178(5):667-672. doi:10.1001/jamainternmed.2018.0266


Date of download: 4/16/2018 Copyright © 2014 American Medical Association. All rights reserved.

From: Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010Bachhuber, et al. JAMA Intern Med. 2014;174(10):1668-1673. doi:10.1001/jamainternmed.2014.4005

Association Between Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in Each Year After Implementation of Laws in the United States, 1999-2010. Point estimate of the mean difference in the opioid analgesic overdose mortality rate in states with medical cannabis laws compared with states without such laws; whiskers indicate 95% CIs.

Figure Legend:



Evidence

National Academies of Sciences, Engineering and Medicine

•  Comprehensive review of scientific evidence

•  Assessed current research quality regarding therapeutic benefits of cannabis

•  Outlined gaps in research and

recommended improvements


Evidence

Recommendations: •  Address research gaps through

partnerships with public agencies, philanthropic organizations, and clinical research groups

•  Improve quality of research by setting standards for cannabis research

•  Improve surveillance capacity

•  Address research barriers •  DEA Schedule I classification--highest potential for

abuse & the potential to create psychological and/or physical dependence


Evidence

Improving Research Quality •  Develop a minimum dataset for observational

and clinical studies, standards for research methods and design, and guidelines for data collection methods

•  Adaptation of existing research standards to cannabis research needs

•  Development of uniform terminology for

clinical and epidemiological cannabis research

•  Standardized and evidence-based question banks for research and surveillance


Short term side effects

Marijuana Benzodiazepines Opioids Steroids Sedation Sedation Sedation Fluid retention Impaired short-term memory Dizziness Dizziness High blood pressure Impaired motor coordination Weakness Nausea

Problems with mood, memory, behavior

Altered judgement Unsteadiness Vomiting Weight gain Paranoia Loss of orientation Constipation Insomnia

Confusion Respiratory depression Blurred vision


Effects of long term use

Marijuana Benzodiazepines Opioids Steroids

Associated with greater risk of developing psychoses Cognitive impairment Constipation Cataracts Increased risk of social anxiety disorder Adverse effects on sleep

Sleep-disordered breathing High blood sugar

Potential lasting cognitive deficits

Increased risk of fall and fracture

Increased risk of overdose (2 in 1000 risk of death)

Increased risk of infections

Increased risk of bronchitis (smoking only)

Increased risk of depression, anxiety, other mental health conditions Depression Thinning bones Risk of severe withdrawal after only 1 month of regular use

Increased risk of fall and fracture

Suppressed adrenal gland hormone production

87% increase in all cause mortality

Thin skin, bruising, slower wound healing


Addiction, Withdrawal and Overdose

MarijuanaPrescription Benzodiazepines Prescription Opioids

Use disorder prevalence 9%

As many as 23% of long term users 8-12% develop addiction

Severity of withdrawal Minor Major Major

Worst Symptoms

Dysphoria, Disturbed Sleep, Decreased Appetite

Severe Depression, Catatonia, Convulsions, Death

Abdominal Cramps, Pain, Anxiety, High Blood Pressure, Severe Cravings, Depression

Overdose Deaths (2015) 0 8,791 22,598


Other Notable Risks of Cannabis Use

Recommendation of medicinal cannabis use must be weighed extra-carefully for the following populations: •  Children •  Pregnant women

For children: evidence suggests that adolescent cannabis use correlates with negative effects on brain development, and can lead to increased risk of developing cannabis use disorder later in life.

For pregnant women: evidence suggests that cannabis use leads to lower birth weight. Longer term effects on children need to be studied, but limited evidence points to potential negative effects on attention span and learning after birth.


Barriers and Opportunities in Research

•  Barriers •  Schedule I drug per both federal and state law/rules •  By extension, lack of funding. •  Lack of robust datasets that connect medicinal marijuana

administration with clinical variables (outcomes, other medications, etc.)

•  Fear of federal law enforcement actions on administration, storage, etc.

•  Opportunities •  Regulatory scheduling changes with NJ Department of Law and

Public Safety underway •  NJ Healthcare Information Network as a mechanism to build robust

datasets •  Academic medical center and university partnerships in the Murphy

Administration


Executive Order #6:

Expanding Access

to Medicinal Marijuana


Executive Order #6

•  Directed the NJ Department of Health to review the Medicinal Marijuana Program to improve access to patients, reduce regulatory burdens, and increase physician participation

•  60 day timeline •  After internal review, issued Executive Order #6

Report to Governor on March 23, 2018


Executive Order #6

•  Report included three sets of recommended actions:  Immediate (through executive action)  Regulatory (through rule-making process)  Statutory (through legislation)


EO6: Immediate Action

•  Expanded conditions •  Reduced fees •  Physician name

publication optional •  Mobile Access •  Allow ATC satellites •  Allow 2 caregivers per

patient


EO6: Regulatory Action

•  Streamline process for the addition of new conditions for treatment with medicinal marijuana

•  Create separate endorsements in permitting

process: dispensary, processor, cultivator

•  Eliminate 10% THC limit

•  Eliminate psychiatrist evaluation for minors


EO6: Statutory Action

•  Allow edible forms for all patients, not only minors •  Allow patients access to more than one ATC •  Allow marijuana as a first-line treatment for all

qualifying conditions •  Eliminate 2 ounce per month limit for terminal

patients •  Raise limit for all others over time •  Remove non-profit requirement for original ATCs


EO6: Future Considerations

•  Redesigning patient/physician portal •  Home delivery •  Using external labs for quality control •  Elimination of sales tax •  Review of ATC permitting and background check

process


Requirements and Eligibility



Physician requirements:

• Active NJ medical license, in good standing, issued by the Board of Medical Examiners;

• Active Controlled Dangerous Substances (CDS) registration, issued by the NJ Division of Consumer Affairs, which is not subject to limitation; and

•  Practice within the State of New Jersey.



Patient Qualifications:

•  Proof of current New Jersey residency;

•  Bona fide relationship with a physician; and

•  Diagnosed with a qualifying medical condition



Bona fide relationship: a relationship in which the physician has ongoing responsibility for the assessment, care and treatment of a patient’s debilitating medical condition whereby:

•  The physician-patient relationship must have existed for at least one year; or

•  The physician has seen or assessed the patient for their debilitating medical condition on at least four office visits; or

•  The physician, after a thorough medical history and physical examination of the patient, assumes the responsibility for providing management and care of the patient’s debilitating medical condition.



Qualifying Conditions Debilitating:

  Amyotrophic lateral sclerosis   Multiple sclerosis   Terminal cancer   Muscular dystrophy   Inflammatory bowel disease (IBD), including Crohn’s disease   Terminal illness, if the physician has determined a prognosis of less than 12 months of life. Resistance, or intolerance, to conventional therapy:   Seizure disorder, including epilepsy   Intractable skeletal muscular spasticity   Glaucoma   Post-Traumatic Stress Disorder (PTSD) Severe or chronic pain, severe nausea or vomiting, cachexia or wasting syndrome resulting from the condition or treatment of:   Positive status for human immunodeficiency virus (HIV)   Acquired immune deficiency syndrome (AIDS)   Cancer


New Qualifying Medical Conditions

 Added in March 2018:

 Chronic pain related to musculoskeletal disorders

 Migraine

 Anxiety

 Chronic pain of visceral origin

 Tourette’s Syndrome


Breakdown of New Patients


Requirements and Eligibility: Chronic Pain

Qualifying Conditions Chronic pain related to musculoskeletal disorders – Accepted petitions   Chronic pain   Chronic non-cancer pain   Chronic pain as a result of daily sciatic nerve pain   Sporadic hemiplegic migraine   Complex regional pain syndrome   Neural foraminal stenosis   Cauda Equina Syndrome   Arnold-Chiari Malformation   Neuropathic Pain   Rheumatoid Arthritis; Arthritis; Psoriatic Arthritis   Systemic Lupus   Chronic late stage Lyme’s disease with pain and depression   Opioid use disorder   Fibromyalgia/Osteoarthritis


Opioid Use Disorder

  Petitioned on 9/7/2016   Reviewed and recommended by Review Panel in 2017   Accepted on 3/22/2018, but only for patients where opioid use disorder resulted from the use of opioids for chronic pain   DOH considering broader use


Medicinal Marijuana Review Panel

•  The Medicinal Marijuana Review Panel reviews petitions and makes recommendations to the Commissioner on approval or denial of a petition to add other medical conditions or treatment as qualifying debilitating medical conditions.

Review Panel Members Alex Bekker, MD PhD – Chairperson Cheryl Kennedy, MD – Vice Chairperson J. Paul Carniol, MD – President of NJ BME Mary Bridgeman, PharmD Mary Johansen, PhD, NE-BC, RN Petros Levounis, MD, LA Jessica Scerbo, MD Stephanie Zarus, PharmD

•  The Panel consists of the President of the Board of Medical Examiners or the President’s designee, other nationally board certified physicians, and non physicians.


Physician Portal


Delivering a Safe Product:

Testing, Medical Review, Strain Library, and Dosing


Testing

DOH Public Health Environmental Lab Department of Agriculture

  Cannabinoid Profile   Metals   Pesticides

  Mold   Other contaminants

  126 distinct strains Lab tested


Strain Library

•  DOH developed a Medicinal Marijuana Strain Library which is available to registered physicians and patients through the MMP registry

•  The library contains lab testing results of available strains of medicinal

marijuana cultivated by the ATCs


Dosing for New Patients •  Emphasize vaporizing or oral administration over smoking

•  For oral administration, strongly advise limiting THC initially to under 5mg per dose (under 2.5 mg if they want to limit impairment). Standard dose of THC is 5-10 mg

•  Oral administration usually can take 2+ hours to take effect with these effects lasting longer versus vaporization and smoking

•  Advise new patients to wait at least 2 hours before taking an additional

dose, or preferably wait to adjust next dose. Recommend they increase dose incrementally (adding no more than 5mg THC)

•  For vaporization and smoking, recommend they start with no more than

2-3 inhalations, 1 at a time, with a few minutes in between

•  CBD has not been shown to have psychoactive effects on its own, so for patients that want to limit impairment, recommend a high CBD (>5%)/low THC strain(<5%)


Q+A

•  Customer Service Number: (609) 292-0424

•  Customer Service Email: [email protected]

• www.state.nj.us/health/medicalmarijuana/contact

Follow us on Twitter: @ShereefElnahal

@NJDeptofHealth

giving the green light to medicinal marijuana · • the potential of marijuana liberalization to...

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