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Dean T. Parry RPhAVP Clinical Informatics Geisinger

Medical Marijuana Overview and Pennsylvania Law

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Objectives

1) Discuss key components of the Pennsylvania Medical Marijuana Law and impact on healthcare providers.

2) Identify recommendations and risk considerations for healthcare providers for compliance with the Pennsylvania Medical Marijuana Law.

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Endocannabinoid System

• Core functions: relax, eat, sleep, forget and protect

• In all vertebrates and many invertebrates

• Receptors are found throughout the body: in the brain, organs, connective tissues, glands, and immune cells

• Complex actions in nervous system, immune system and all of the body’s organs

• CBD1 receptors most abundant in brain which mediate the psychotropic and behavioral effects

• CBD2 receptors most abundant in immune cells and sparse in CNS

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History of Cannabis

• 8000 BCE: Hemp for rope, one of the first and oldest human agricultural crops

• 2737 BCE: Chinese Emperor Shen Nung first to formally describe therapeutic properties including malaria, constipation, rheumatic pains and, mixed with wine, a surgical analgesic

• 1000 BCE: India described for analgesia for headache/toothache, anticonvulsant for epilepsy, rabies and tetanus, anti-inflammatory for rheumatism, sedative for anxiety, antibiotic, and an appetite stimulant

• 1839 introduction into western medicine by Dr. O’Shaughnessy in his publication describing benefit for analgesia, appetite stimulant, antiemetic, muscle relaxant and anticonvulsant

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History of Cannabis, Continued

• Late 19th to early 20th century: pinnacle of western medical cannabis use. Cannabis extracts were marketed by Merck, Bristol-Myers, Squibb, Eli Lilly and others

• 1900-1930: decline in prescribing due to lack of reliable standardization, and the development of other more reliable medications for the same indications

• 1937: marijuana becomes illegal

• 1970 Controlled Substances Act makes cannabis a Schedule 1 drug with “no accepted medical use and a high potential for abuse” with severe legal consequences

• 1970s: reports coming out about efficacy for nausea and vomiting due to chemotherapy

• 1980s: reports of improvement in symptoms for HIV/AIDS patients, especially wasting

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History of Cannabis, Continued

• Originally made by a church group, entitled “Tell your Children”

• Plot tells of young people smoking marijuana which then leads to hit and run, manslaughter, suicide, rape, hallucinations, and eventual madness

• Public opinion condemns despite American Medical Association saying there are medical indications

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History of Cannabis, Continued

• 1996: California medical cannabis (MC) by popular vote and legislative acts

• 2009: Obama/ Department of Justice states prosecution of legal medical marijuana patients and distributors was not a priority as long as state laws regarding medical marijuana

• 2012: Colorado and Washington legalize recreational marijuana

• 2013: Weed Sanjay Gupta supports medical cannabis

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Venice Beach, CA 2013

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2013

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History of Cannabis, Continued

• 2016: Full legalization in 8 states plus District of Columbia

• 2016: Drug Enforcement Administration refused to reclassify MC

• 2016: PA passes medical marijuana law

• 2017: PA first round of processor/grower and dispensary licenses are awarded

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DEA Refuses Reclassification 2016

• Major concern was impact on drug-free workplaces: would medical cannabis (MC) be treated like other prescription medications?

• Concerned about moving from zero tolerance to allowing use of MC if it does not cause impairment

• No legally defined level for impairment

• No easy test for measurement

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April 17, 2016

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43 States with Cannabis Laws

• Recreational marijuana laws

• Comprehensive medical marijuana programs• Pennsylvania Law

• Limited medicinal marijuana laws• Low tetrahydrocannabinol (THC), high cannabidiol (CBD)

products.

• THC: psychological effects (high/paranoia)

• CBD: a non-psychoactive compound, helps alleviate THC effects

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Federal vs. State Legality

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Federal vs. State Legality (clear as mud)

• Marijuana is illegal under federal law due to Schedule I controlled substance status

• Marijuana is “legal” under state laws in the majority of states

• States are barred from prosecuting persons in compliance with state laws

• Individuals may be prosecuted by federal agents

• Federal laws supersede state laws

• Rohrabacher-Farr Amendment (2014): bars Dept. of Justice from using funds to enforce federal law against those in compliance with state laws was renewed May 2017 and needs to be renewed annually

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Cannabis Federal Laws

• Oversees handling, storage, and disposal of medical marijuana by facility employees raises concerns related to the federal prohibition on the possession of controlled substances

• Use of medical marijuana has implications for P&T committees

• Laws in Pennsylvania, California, Massachusetts, Minnesota, Oregon, and Washington allow employers to restrict the use of medical marijuana on their premises or during working hours

• Arizona, Delaware, Maine, Michigan, and Rhode Island prohibit disciplinary action or discrimination against employees who are registered cardholders

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Cannabis Federal Laws, Continued

• Employees have tried to use the Americans With Disabilities Act (ADA) for legal protection, but these claims have failed

• Department of Veterans Affairs prohibits the use of medical marijuana in its facilities

• 2009 U.S. Attorney General Eric Holder pursuing people who were using medical marijuana was not a priority

• 2011 DEA denied petition to reschedule marijuana due to no scientific or medical evidence to support such a move

• Attorney General, Jeff Sessions, has petitioned Congress to overturn Rohrabacher-Farr Amendment

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Pennsylvania’s Medical Marijuana LawACT 16

• April 17, 2016 Gov. Tom Wolf signed law

• PA -24th state with a comprehensive medical marijuana program

• Protects registered patients from civil and criminal penalties

• Creates a well-regulated system for safe access to medical marijuana

• Ability to tax medical cannabis

• Unclear when the department will begin accepting patient applications

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PA SAFE HARBOR LAW

294 safe harbor applications have been granted by the PA DOH to allow patients, parents and caregivers to obtain medical marijuana from other states until the PA program is up and running.

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Serious Medical Conditions

• Amyotrophic Lateral Sclerosis

• Autism

• Cancer

• Crohn’s Disease

• Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity

• Epilepsy

• Glaucoma

• HIV/ AIDS

• Huntington’s Disease

• Inflammatory Bowel Syndrome

• Intractable Seizures

• Multiple Sclerosis

• Neuropathies

• Parkinson’s Disease

• Post-traumatic Stress Disorder

• Severe chronic/intractable pain of neuropathic origin or in which conventional therapy/ opiate therapy is contraindicated or ineffective

• Sickle Cell Anemia

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PA Physician Certification

• Be currently licensed in PA and in good standing

• Be responsible for the ongoing care of the patient

• Include in the medical records of the patient a diagnosis of a qualifying condition

• Be qualified to treat the serious medical condition

• State patient is likely to receive therapeutic or palliative benefit from the use of medical marijuana

• Complete a four-hour course developed by the PA Department of Health (DOH)

• Be registered to authorize certification with the PA DOH

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PA Physician Certification, Continued

• Physician must alert DOH if the patient no longer has a serious medical decision, feels there is no longer a chance of benefit, or has died

• Inform DOH of any requirement or limitation in the form or route of administration

• Physician certification is subject to annual review

• Prescription Drug Monitoring Program database needs to be consulted• Prior to certifying patient for MC

• Before recommending any change

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What a Certifying Physician Cannot Do

• Receive payment from a patient or caregiver other than for the exam

• Receive payment from or refer patients to marijuana businesses

• Conduct an exam at a location where medical marijuana is sold

• Have an economic interest in a cultivator or dispensary

• Advertise services as a certifying physician

• Help patients obtain marijuana

• Certify themselves or a family/household member

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Physicians are NOT Determining Doses

• Patients, their caregivers, and dispensaries function as “physicians” by choosing the plant, route of delivery, titrating dosage, and timing

• Goes against standard practice in medication management

• Physicians don’t feel they have the expertise to make these decisions

• No Physicians Desk Reference to guide them

• Intensifies the controversy

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Process for Patients to Qualify

• Under continuing care of physician

• Physician is registered with PA DOH

• Physician certifies a qualifying condition

• Patient then applies to the PA DOH

• $50 charge which may be waived due to economic need

• If application is accepted, the patient and/or caregiver receives ID card, which allows access of medical marijuana from a registered PA dispensary

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Patients

• ID card protects from arrest/conviction if possession of medical marijuana is in form/quantity allowed under patient’s certification

• Patient can have up to 2 caregivers

• Caregivers receive separate ID cards

• One person cannot be caregiver to more than 5 patients

• Caregivers must submit their finger prints and may not have any criminal drug offenses

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What a Patient Cannot Do

• Grow marijuana

• Drive under the influence of marijuana

• Give or sell marijuana to anybody

• Possess marijuana on a school bus or school grounds

• Use marijuana in a public place

• Smoke marijuana

• Use dried leaf or whole plant marijuana

• Purchase food or drinks infused with marijuana

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Patients Prohibited in PA

• From certain activities if serum level of THC is greater than 10 nanograms/ml • Chemicals requiring a government or state permit

• High voltage electricity or any public utility

• Utilize medical marijuana working at heights or confined places including mining• No blood limit defined

• Legal driving limit in Colorado is THC of 5 nanograms

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Pennsylvania’s Employers’ Rights

• Employers may prohibit the patient from performing any duty they deem to be life-threatening to the patient or other employees even if it has a negative financial impact on the patient

• Employer may prohibit the patient from performing any duty they deem a public health or safety risk even if it has a negative impact on the patient

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Future Changes in the Program

• Medical Marijuana Advisory Board of the PA DOH• Secretary of Health

• Physician General

• Police Commissioner

• President of the Chiefs of Police Association

• President of the District Attorneys Association

• Chairman of the State Board of Pharmacy

• Commissioner of Professional and Occupational Affairs

• Appointees by • Governor

• President pro tempore of Senate

• Majority and minority leaders of the Senate

• Majority and minority Leaders of the House

• Governor appointee of a patient, family member, or patient advocate

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Medical Cannabis Research

• PA DOH must develop a research program to determine the impact of medical cannabis on serious conditions

• DOH must create a database for serious conditions

• Once they have 25 patients with a serious condition they will petition the FDA and DEA to do research

• State advisory committee will review research findings and make recommendations to the legislature for changes to the act

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Legality of the PA Medical Marijuana Law

• The federal government cannot force states to criminalize conduct that is illegal under federal law

• The federal government cannot force state and local police to enforce federal laws

• No known cases in any of the states that have authorized the use of medical marijuana of the federal government prosecuting an individual for a small amount of marijuana

• MC still remains illegal under the Controlled Substance Act

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What are hospitals doing in other states?

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Maine

• Hospitals prohibit the use of medicinal cannabis during inpatient stays

• Concerns exist regarding losing federal license

• CMS makes no allowance for Schedule I controlled substances

• Lack of research on cannabis, drug interactions and side effects

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Minnesota Hospital Association

Three templated policies.

1) Not allowed in the hospital.

• Even though the law permits it for registered patients with qualifying conditions

• Registered users asked to immediately remove the substance from the facility. If not possible, it will be secured with their other belongings.

• All unregistered patients who possess cannabis will have it removed pursuant to the hospital's policy on disposal of illegal drugs

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Minnesota Hospital Association, Continued

2a) Allowed and administered by patients.

• Only patients registered with the state's program with their own supply will be permitted to use medical cannabis in the hospital.

• If a clinician deems the inpatient continuation of the therapy appropriate, patients or their caregivers will self-administer the medical cannabis and

• It will be securely stored in the patient's room, with the registered designated caregiver, or in another designated area defined by the hospital.

• Documentation in the EHR will not be required.

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Minnesota Hospital Association, Continued

Allowed and administered by nurses. Similar to option 2a, the hospital

• Will permit the use of medical cannabis if deemed appropriate by the patient's physician.

• Medical cannabis will be part of the medication process.

• Medical cannabis will be administered by a nurse and stored securely in an automated dispensing cabinet or a locked storage area.

• Documented in the EHR as a continuation of therapy order, not a medication order.

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Mayo Clinic Rochester, Minnesotta

• Permitted if patients are registered with the state program

• Product must be in its original container

• Admitting physician decides if continuation of therapy is appropriate

• Only capsules and oral liquid are allowed

• Medication is not stored in or dispensed by the pharmacy

• Physicians write an order for cannabis continuation to alert nursing and pharmacy staff

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Research Controversy

• Medical cannabis advocates and legislators feel there is extensive evidence that cannabis helps disease states and specific symptoms

• Much of the scientific community feels there is little to no proven efficacy of medical cannabis

• Where is the disconnect?

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Clinical Trials

• Laboratory Testing- experiments in animals and human cells• If successful, data is sent to the FDA for approval to continue

testing in humans.

• Human Clinical Trial Phases• Phase I studies assess the safety of a drug

• Phase II test the efficacy of a drug or device

• Phase III randomized and blind testing in several hundred to several thousand patients

• Phase IV studies are Post Marketing Surveillance Trials after the drug is released

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Unique Issues that Impede MC Testing

• Schedule I status

• Difficult to get a research permit for Schedule I

• University of Mississippi has the only approved source of MC but limited supply

• Marijuana is not one chemical substance

• At least 489 different compounds

• 18 different chemical classes

• When smoked the combustion process increases the number to over 2000

• No standardization of MC

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National Academy of Sciences Engineering and Medicine January 2017

• Adults with chemotherapy-induced nausea and vomiting, oral cannabinoids are effective antiemetics.

• Adults with chronic pain, patients who were treated with cannabis or cannabinoids are more likely to experience a clinically significant reduction in pain symptoms.

• Adults with multiple sclerosis (MS)-related spasticity, short-term use of oral cannabinoids improves patient-reported spasticity symptoms.

• For these conditions the effects of cannabinoids are modest; for all other conditions evaluated there is inadequate information to assess their effects.

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Chronic Pain

• Most common condition patients use medical cannabis Light et al. (2014)

• 94% of Colorado medical marijuana ID cardholders

• Some individuals are replacing the use of conventional pain medications (e.g., opiates) with cannabis

• Recent study of patrons of a Michigan medical marijuana dispensary suggested a 64% reduction in opioid use (Boehnke et al., 2016)

• Medicare Part D enrollees with medical access to cannabis suggest a significant reduction in the prescription of conventional pain medications Bradford and Bradford, 2016)

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Safety Concerns

• Contaminants• Fungus, bacteria, pesticides

• Pulmonary function• Unlike tobacco, no increase in lung cancer rate, or COPD

• Neurocognitive impairment• Memory, verbal skills

• Early onset chronic use has the greatest effect on brain development, decreasing IQ, developing amotivational syndrome

• Schizophrenia and Psychosis• In young adults with pre-disposing factors

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Safety Concerns

• Toxicity and overdose• No known cases of fatalities

• Panic attacks, psychosis, convulsions

• Greatest risk is in children with respiratory depression/coma

• Cannabis withdrawal syndrome• Abrupt discontinuation in heavy users causes symptoms in 1-2

days

• Irritability, reduced appetite, anger, insomnia

• Can look like a low grade opioid withdrawal

• Cannabis Addiction• 9% who use recreational cannabis

• 17% if they start using in early teens

• Risk unknown in medical usage

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Contraindications

• Current, past or family history of schizophrenia

• History of hypersensitivity to cannabinoids or smoke

• Severe cardiopulmonary disease

• Severe liver or kidney disease

• Pregnancy or planned pregnancy

• Breastfeeding

Caution

• COPD

• History of substance abuse

• Non-psychotic psych conditions (anxiety/panic attacks)

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Glitches may Slow the Marijuana Process

Patriot News Sept. 14, 2017 article

• Office of of Open Records reprimanded the DOH

• Said the DOH “had failed to act in good faith” in the handling of the application process

• They felt that the process was not transparent

• DOH feels they are on track to have dispensaries with MC by early 2018

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Public Opinion and Medical Marijuana

• 85% of Pennsylvanians believe medical marijuana is in the public’s best interest

• Politicians want the tax revenue

• Marijuana is legal as medicine in most states and recreationally in some

• As healthcare professionals our number one concern is patient safety

• Our traditional system of medication evaluation and approval has not been up to the challenge

• Our job is to gain as much knowledge so we can advise our patients effectively

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Questions/Comments?