Requirement for Certification from a Health Care Practitioner. Requirement for Certification from a Health Care Practitioner

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1 Johnson County Pharmacists Association Current Status of the Iowa Ronald A. Herman, Ph.D. 1 Objectives Identify the current status of Iowa medical cannabis regulations. List the current disease conditions for which a person can seek a Registration Card. Identify the procedures that a health practitioner must follow to certify an individual for eligibility for medical cannabis. 2 Objectives Describe the role of Iowa manufacturers of medical cannabis and the role for authorized dispensers. Identify the resources available from the Iowa Department of Public Health related to medical cannabis Iowa Regulations The new legislation repealed the previous 2014 Act, Iowa Code Chapter 124D, and established a new Iowa Code Chapter 124E. The 2017 Act expanded the state s existing medical cannabidiol act in a number of ways, including: Iowa Regulations Establishment of a medical cannabidiol board. Establishing a process for licensure applications and a fee structure for patient or primary caregiver registration cards. Providing for licensure of medical cannabidiol manufacturers and dispensaries. Expansion of the list of conditions for which a patient is eligible to receive a medical cannabidiol. Making recommendations relating to the form and quantity of allowable medical uses of cannabidiol. A requirement for a real-time, 24/7 statewide medical cannabidiol registry management sale tracking system Iowa Regulations A person may knowingly or intentionally recommend, possess, use, dispense, deliver, transport, or administer cannabidiol if the recommendation, possession, use, dispensing, delivery, transporting, or administering is in accordance with the provisions of chapter 124E. Medical cannabidiol means any pharmaceutical grade cannabinoid found in the plant Cannabis sativa L. or Cannabis indica or any other preparation thereof that has a tetrahydocannbinol level of no more than three percent and that the ingredients are delivered in a form recommended by the medical cannabidiol board, approved by the Board of Medicine, and adopted by the department pursuant to rule. 6 Johnson County Pharmacists Association 1

2 Approved Conditions Any terminal illness, or cancer or AIDS/HIV if: Severe or chronic pain. Nausea or severe vomiting. Cachexia or severe wasting. Seizures, including those characteristic of epilepsy. Crohn's disease. Approved Conditions Neuromuscular disorders: Multiple sclerosis with severe and persistent muscle spasms. Amyotrophic lateral sclerosis. Parkinson's disease. Untreatable pain. Fibromyalgia or neuropathic pain not associated with a terminal condition. 7 8 Historical Perspective 2013 Laura Borgelt reported that in the 2 states with medical cannabis cards at the time: That 89% in Arizona and 94% in Colorado were registered to treat severe or chronic pain. And 14% in Arizona and 17% are registered to treat muscle spasms. Because these are the most commonly treated, there is the most information on dosing for these conditions. 9 Requirement for Certification from a Health Care Practitioner Patients, or their caregiver, must submit an application to the Iowa Department of Public Health to get a cannabidiol card. Prior to a patient submitting this application, pursuant to this rule, a health care practitioner shall do all of the following: The application must include written certification signed by the patient s health care practitioner that the patient is suffering from a debilitating medical condition. 10 Requirement for Certification from a Health Care Practitioner Health care practitioner is defined under the law as an individual licensed under chapter 148 to practice medicine and surgery or osteopathic medicine and surgery. This health care practitioner must be one of the patient s primary care providers. Physician assistants and advanced registered nurse practitioners are not authorized to provide the required certification. A health care practitioner (physician) may provide, but has no duty to provide, a written certification for a Medical Cannabidiol Registration Card. 11 Requirement for Certification from a Health Care Practitioner A physician who agrees to provide such certification, is required to do all of the following: Determine, in the health care practitioners medical judgement, whether the patient whom the health care practitioner has examined and treated suffers from a debilitating medical condition that qualifies for the use of medical cannabidiol, and if so determined, provides the patient with a written certification of that diagnosis on the application form the patient is completing; Provide explanatory information from IDPH to the patient about the therapeutic use of medical cannabidiol and the possible risks, benefits, and side effects of the proposed treatment. IDPH s Information for Iowa Patients about the Therapeutic Use of Medical Cannabidiol handout can be found at: 12 Johnson County Pharmacists Association 2

3 Manufacturers and Dispensaries The Iowa law requires that there be two licensed manufactures for medical cannabis and that they begin providing product by Dec. 1, Only 1 manufacturer applied, MedPharm Iowa. They were granted a license and have begun to prepare the currently approved preparations. The IDPH recently approved a second manufacturer Iowa Relief LLC to be operational by July 1, Tincture 30 ml Dropper Bottle Elevated THC 3% and CBD 0.3% 10 mg THC and 1 mg CBD per 0.3 ml dropper Balanced THC/CBD 3% of each 10 mg THC and 10 mg CBD per 0.3 ml dropper Low THC 0.3% and CBD 3% 1 mg of THC and 10 mg CBD per 0.3 ml dropper Elevated CBD 10% and THC 0.1% 100 mg CBD and 1 mg THC per 1.0 ml dropper Nanosuspension (30 ml dropper bottle) Elevated THC 3% and CBD 0.3% 10 mg THC and 1 mg CBD per 0.3 ml dropper Balanced THC/CBD 3% of each 10 mg THC and 10 mg CBD per 0.3 ml dropper Low THC 0.3% and CBD 3% 1 mg of THC and 10 mg CBD per 0.3 ml dropper Elevated CBD 10% and THC 0.1% 100 mg CBD and 1 mg THC per 1.0 ml dropper. Softgel (30 capsules per bottle) Elevated THC 3% and CBD 0.3% 10 mg THC and 1 mg CBD per capsule Balanced THC/CBD 3% of each 10 mg THC and 10 mg CBD per capsule Low THC 0.3% and CBD 3% 1 mg of THC and 10 mg CBD per capsule Other Dosage Forms Transdermal Liposome Cream 30 and 60 gm metered dose TopiClick applicator Elevated CBD 10% THC 1% Delivers 100 mg CBD, 10 mg THC per 1 gm. Suppository Balanced THC/CBD 1% of each Delivers 10 mg of each THC and CBD per suppository. 17 Manufacturers and Dispensaries The Iowa law requires that there be five licensed dispensaries for medical cannabis and they begin operation by Dec. 1, There were 24 applications submitted, 5 licenses were granted: Have a Heart Compassion Care Council Bluffs Have a Heart Compassion Care Davenport Iowa Cannabis Company Waterloo MedPharm Iowa Windsor Heights MedPharm Iowa Sioux city 18 Johnson County Pharmacists Association 3

4 PMID: Helpful Resources Borgelt LM, Franson KL, Nussbaum AM, Wang GS. The pharmacologic and clinical effects of medical cannabis. Pharmacotherapy Feb;33(2): PMID: Volkow ND, Compton WM, Weiss SR. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23): PMID: Helpful Resources The National Academy Sciences Engineering and Medicine published a 484 page book in January 2017: The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research It is available for purchase, or to read online: Pharmacology Cannabis Cannabis sativa Cannabis indica Cannabis ruderalis A leafy annual Some species attaining heights of more than 10 feet. Each leaf has 5 to 10 leaflets radiating from the top of the stalk. These leaflets are soft textured, roughly 7 10 inches long, with regular dentations like a saw blade. The glandular hairs on the leaflets produce a resin mixture. 21 Cannabis Chemistry Contains more than 460 known isolated chemicals. 60 are grouped under the name cannabinoids. Delta-9-tetrahydrocannabinol, also known as THC Other cannabinoids include delta-8-tetrahydrocannabinol, cannabinol, and cannabidiol (CBD) Marijuana also contains alkaloids, steroidal compounds mixtures of volatile components. 22 Cannabis Chemistry 60 of these cannabinoids in the plant Delta-9-tetrahydrocannabinal (THC) Is the main psychoactive component of cannabis. It is an approved marketed drug, dronabinol (Marionol ). Nabilone This is an approved semi-synthetic cannabinoid. There are several more under investigation Johnson County Pharmacists Association 4

5 Cannabidiol (CBD) Is the main non-psychoactive compound. It is in the commercially available oral mucosal spray (Nabiximol ) or as an oral solution (Sativex and Epidiolex ). These are not approved in the U.S., but are currently being studied as investigational Role of the ECS The ECS is a regulatory system for several functions/responses such as mood, appetite, memory and pain. The system has also been viewed as an important aspect in the regulation of homeostasis, a simple biological process in the human body that involves striking a balance in the internal conditions. 27 Role of the ECS The overexpression of cannabinoid receptors has been found to influence the natural defense immune system. The ECS also plays a vital role in the control of neuropathic pain. There is the analgesic ability that lies within the cannabinoid agonists that is used in the treatment of the pain. 28 Clinical Endocannabinoid Deficiencies Autism Bipolar Epilepsy Fibromyalgia Inflammatory bowel diseases Migraine Neurodegenerative diseases Post traumatic stress disorder Endocanabinoid System Russo. Clinical Endocannabinoid Deficiency. Cannabis Cannabinoid Res. 2016;1(1): Johnson County Pharmacists Association 5

6 Mechanism of Action THC is a partial agonist that works near the CB1 receptor in the brain results in many of the psychoactive effects. CBD is an inverse agonist, it reverses the effect of the agonist. Mechanism of Action Pain relief generally it is helpful to have both present. Also true for the anti-spasmodic effect in MS. However, for epilepsy, generally you want just the CBD present General Risks After ingestion or inhalation of marijuana, users may experience undesirable effects: Dry mouth, nausea, and vomiting. Cardiovascular effects including tachycardia, and an increase in blood pressure. Reduced sperm counts, sperm structural abnormalities, and motility changes have all been reported. Abnormal menstruation has been associated with longterm marijuana use in females. Effects of Short-term Use Impaired short-term memory, making it difficult to learn and to retain information. Impaired motor coordination, interfering with driving skills and increasing the risk of injuries. Volkow ND, Compton WM, Weiss SR. Adverse health effects of marijuana use. N Engl J Med. 2014;371(9): Effects of Short-term Use Altered judgment, increasing the risk of sexual behaviors that facilitate transmission of sexually transmitted diseases. Ansell EB, Laws HB, Roche MJ, Sinha R. Effects of marijuana use on impulsivity and hostility in daily life. Drug Alcohol Depend In high doses, paranoia and psychosis. Compton MT. Evidence Accumulates for Links Between Marijuana and Psychosis. Medscape; Cannabidiol Side Effects 213 children with refractory epilepsy 29 (14%) - Diarrhea 44 (21%) - Sleepy feeling (Somnolence) 36 (17%) - Tiredness (Fatigue) 12 (6%) - Inactivity (Lethargy) 7 (3%) - Sound Sleep (Sedation) 10 (5%) - Walking Abnormally (Gait Disturbance) 12 (6%) - Weight Increased 10 (5%) - Weight Decreased 31 (15%) - Decreased Appetite 15 (7%) - Increased Appetite Johnson County Pharmacists Association 6

7 Long-term or Heavy Use Effects Addiction in about 9% of users. Increased risk of chronic psychotic disorders. Cognitive impairment and poor educational outcomes. Diminished life satisfaction and achievement. Semple DM, McIntosh AM, Lawrie SM. Cannabis as a risk factor for psychosis: systematic review. J Psychopharmacol. 2005;19(2): Radhakrishnan R, Wilkinson ST, D'Souza DC. Gone to Pot - A Review of the Association between Cannabis and Psychosis. Front Psychiatry. 2014;5: Adverse Effects Summary Some people develop tolerance to these undesirable effects on repeated exposure. Some are more susceptible to the desirable medical effects while others are more prone to the undesirable physiological consequences. The euphoric affect is generally seen at doses of mg of THC. 38 Examples of Treatments The scientific evidence comes from: NASEM: The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research The examples use the dosage forms currently approved and made by MedPharm. 39 Chronic Pain Management All of the dosage forms have been studied, but most of the studies done have focused on a balanced THC/CBD product. Analgesic effect may have several mechanisms: Neuronal activity in the central brain, Descending nerve pathways Prostaglandin inhibition (inflammatory pathways). Generally, the higher the THC content the more effective the pain relief. 40 Pain Management Studies have evaluated THC alone to relieve pain: Doses of 5 20 mg of THC (dronabinol) Generally mg was required to relieve pain. This was considered equivalent to mg of codeine. A large RCT evaluated nabiximol (5mg of each THC and CBD per spray) sprays (5-50 mg of THC) was effective, but higher doses were not. 41 Tx Options for Pain Based on these reports start with a balanced THC/CBD product. Balanced Tincture or Nanosuspension: Dose mg of THC per day, 2-3 x/day 10 mg THC and 10 mg CBD per 0.3 ml dropper So ml/day Start 0.3 ml (10 mg) twice a day, then increase to 3 times a day if insufficient response in 2-3 days. One bottle would last 30 days. 42 Johnson County Pharmacists Association 7

8 Tx Options for Pain The soft gel capsule could be used. One capsule twice a day initially, then increase to 1 three times a day if needed. The suppository could be used if the patient cannot take anything by mouth, but note that it has low THC. The ointment is probably not the best: low THC & needs to be absorbed to be effective. 43 Scientific Evidence The following Neuro-Psych conditions are addressed in the NASEM publication but have not been listed as approved by Iowa: Anxiety Sleep disturbances Dementia Depression PTSD 44 Scientific Evidence Anxiety There is limited evidence that cannabis or cannabinoids are effective for improving anxiety symptoms, as assessed by a public speaking test, in individuals with social anxiety disorders (cannabidiol) (Conclusion 4-17) Sleep disturbances There is moderate evidence that cannabis or cannabinoids are effective for improving short-term sleep outcomes in individuals with sleep disturbance associated with obstructive sleep apnea syndrome, fibromyalgia, chronic pain, and multiple sclerosis (cannabinoids, primarily nabiximols) (Conclusion 4-19) 45 Scientific Evidence Dementia There is limited evidence that cannabis or cannabinoids are ineffective for improving symptoms associated with dementia (cannabinoids) (Conclusion 4-13) Depression There is limited evidence that cannabis or cannabinoids are ineffective for reducing depressive symptoms in individuals with chronic pain or multiple sclerosis (nabiximols, dronabinol, and nabilone) (Conclusion 4-18) PTSD There is no evidence to support or refute a statistical association between cannabis use and The development of posttraumatic stress disorder (Conclusion 12-10) 46 Summary It is important to carefully sift through scientific studies already done to determine the evidence for medical cannabis not just in comparison to placebo but also compared to active treatments that are the current standard of care. When there is inadequate evidence, then additional studies should be done before recommendations are made about the appropriate use of marijuana or its components. 47 Johnson County Pharmacists Association 8