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Medical Marijuana

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A brief discussion of medical marijuana from the pharmacist perspective

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Medical Marijuana

  1. 1. Medical Marijuana Taha Y. Taha PharmD/PhD Candidate UIC College of Pharmacy Drug Information Rotation
  2. 2. Objectives Discuss the background of medical marijuana Assess the efficacy and safety of medical marijuana Explain the legal implications of medical marijuana
  3. 3. What is Marijuana? Dried leaves of the Cannabis sativa plant. Other species also used for psychoactive properties, such as C. afghanica or C. indica to make hashish. Has been used for centuries medicinally and recreationally. First described as a medicine in Chinese medical references dating to 2373 B.C. Initially classified as a legitimate medical compound by the U.S. Pharmacopeia (USP) in 1851, but was criminalized (taxed) by the “Marihuana Tax Act of 1937” and later removed from USP in 1942. Currently listed by the Drug Enforcement Administration (DEA) as a schedule I controlled substance
  4. 4. >60 Inactive Compounds
  5. 5. National Institute of Drug Abuse (NIDA) strains THC content widely variable (0.001-13%) and none of the strains are considered to have high CBD content.
  6. 6. Pharmacokinetics Cannabinoids are highly lipophilic. Rapidly absorbed into the blood from inhaled marijuana smoke, with plasma levels becoming detectable within seconds and peak plasma levels noted in fewer than 10 minutes. Bioavailability from smoking marijuana varies based on depth of inhalation, puff, and breath-holding duration. Smoking marijuana through a pipe instead of a cigarette can result in higher cannabinoid absorption because this results in less side stream smoke. Slow and erratic absorption orally resulting in irregular plasma levels, and reaching peak concentrations in 1-2 hours. Cannabinoids are acid-labile and degraded in the stomach thereby significantly reducing absorption. They also exhibit extensive first- pass effect. Crosses placenta and found in breast milk.
  7. 7. Social View and Demographics Characterizing the followers and tweets of a marijuana-focused Twitter handle.
  8. 8. Impact of Legalization – Colorado November 2000: legalization of medical marijuana. October 2009: the US Department of Justice issued a directive that it would not pursue federal prosecution against people who comply with state laws After this announcement, applications to Colorado’s medical marijuana registry increased from 300 per month to 1000 per day. Colorado now leads the nation in per-capita medical marijuana registrants. Colorado physicians have recommended marijuana for an estimated 163,856 patients, more than 2% of Colorado’s population.
  9. 9. Medical Use Potential benefits in stimulating appetite (especially in AIDS), chemotherapy-induced nausea and vomiting (CINV), severe pain, some forms of spasticity, and glaucoma. Importance of focusing research efforts on the therapeutic potential of synthetic or pharmaceutically pure cannabinoids.
  10. 10. Pharmaceutical Products in the U.S. Dronabinol (synthetic trans isomer of THC dissolved in sesame oil contained within a gelatin capsule). FDA-approved for CINV anorexia associated with weight loss in AIDS patients. Nabilone, is a synthetic cannabinoid that mimics the action of THC. It is FDA- approved for CINV.
  11. 11. Other Pharmaceutical Products Nabiximols is a whole-plant extract of marijuana, and contains THC and CBD in a 1.08:1.00 ratio. Available as a buccal spray. Currently in clinical trials (148 studies recruiting) for the treatment of pain, and is approved for use in Canada and parts of Europe for the treatment of spasticity from multiple sclerosis. A liquid containing CBD without THC will also soon become available in the U.S. through a clinical trial to treat rare forms of childhood epilepsy (Lennox-Gastaut syndrome and Dravet syndrome). A phase 2 clinical trial of this drug in patients with schizophrenia is also currently ongoing.
  12. 12. Evidence for Medical Use – N&V Marijuana: Crossover studies with fairly small sample size (n<200). Mainly smoked marijuana vs. oral THC or placebo. Mixed results. Bias due to smell and smoke compared to oral form. The variability in smoking patterns. Pharmaceutical products: Dronabinol: superior in treating N&V but increased side effects such as drowsiness, dizziness, hypotension, lightheadedness, euphoria, and hallucinations. Nabiximols: effective for delayed emesis but not for acute emesis after chemotherapy Nabilone found to be as effective as N&V medications but with increased side effects
  13. 13. Evidence for Medical Use – Pain Marijuana: RCT’s in which vaporized or smoked marijuana was compared to placebo. Small sample size (<50). Mixed results but mainly favoring marijuana. Bias of smell and smoke compared to oral form. Placebo effect. Pharmaceutical products: Nabiximols: better than oral THC for pain, but was not effective for neuropathic pain. One study showed efficacy in RA Dronabinol: effective for chronic cancer pain. Nabilone: not effective for neuropathic pain, but was effective for headache from medication overuse
  14. 14. Evidence for Medical Use – Appetite & Weight Loss Marijuana: mostly cross over studies in healthy and HIV patients. compared smoked marijuana to oral THC or placebo. showed benefit in increasing caloric intake. Pharmaceutical product: Dronabinol: was shown to have similar effect as smoked marijuana for patients with Alzheimer’s
  15. 15. Evidence for Medical Use – Cancer Some very limited studies in vitro and in vivo suggesting antineoplastic effect. Contradictory to the fact that marijuana can cause cancer itself. Most of the studies that have looked for a link between marijuana smoking and cancer have been case-control studies in which individuals with cancer were compared with those without the disease. In these studies, tobacco smoking was found to be an important confounder.
  16. 16. Marijuana and Reduction of Opioid Overdose Mortality
  17. 17. Marijuana and Reduction of Opioid Overdose Mortality Cont.
  18. 18. Safety Recently published DEA 45-page report.
  19. 19. Safety Effects of Short-term Use Effects of Long-term Use Impaired short-term memory Addiction (9% of users) Impaired motor coordination Altered brain development Impaired judgment Lower IQ (esp. in adolescents) Paranoia Symptoms of chronic bronchitis Psychosis Increased risk of schizophrenia
  20. 20. Safety Twins who used cannabis by age 17 had odds of other drug use, alcohol dependence and drug abuse/dependence that were 2.1 to 5.2 times higher than those of their co-twins, who did not use cannabis before age 17.
  21. 21. Safety Substance Abuse and Mental Health Services Administration (SAMHSA) report
  22. 22. Remaining Challenges Method of delivery (e.g., smoked, vaporized, oral) and patient individuality (e.g., severity of condition, inhalation and exhalation habits, functional lung capacity, gastrointestinal absorption) cause great variability in the effect of medical cannabis. The lack of quality control (e.g., contaminated products, non-standardized doses) makes it difficult for clinicians to recommend particular formulations. Other concerns about medical cannabis include the need for adequate monitoring and prevention of addiction. Close surveillance of patients will ensure appropriate use of these medications, and training and education should be made available to providers whose patients use cannabis. Unfortunately, surveillance, training, and education are not available in most health systems, which often delimit the patient–physician relationship to a recommendation to use cannabis. Improved study methodologies, including the use of standard formulations and/or dosages and larger study populations, are needed for future investigative efforts to determine appropriate uses of medical cannabis.
  23. 23. Legalization
  24. 24. Physician’s Attitudes Towards Prescribing – Colorado 76% agreed medical marijuana should be included in Colorado’s Physician Drug Monitoring Program. 92% agreed that doctors should have ongoing relationships with patients for whom they recommend medical marijuana, a stipulation that was not incorporated into law until June 2010.
  25. 25. Physician’s Attitudes Towards Prescribing – Colorado 80% agreed training should be incorporated into medical school curricula. 92% agreed that continuing medical education (CME) about medical marijuana should be made available to primary care physicians
  26. 26. Role of the Pharmacist Connecticut is the only state in which a pharmacist can dispense inhaled cannabis for medical use. Before being dispensed, the product must be deemed “pharmaceutical grade” by a state-appointed laboratory. Other states, like Minnesota, are considering legislation that gives pharmacists a consultative role within the manufacturing and dispensing process.
  27. 27. Role of the Pharmacist Counsel patients on effects of marijuana on cognition; the risks associated with inhaled carcinogens, which may lead to certain types of cancers; respiratory ailments such as chronic obstructive pulmonary disease; and risks to the reproductive system. Assess drug-drug interactions with opioids, barbiturates, central nervous system depressants and others.
  28. 28. Illinois Compassionate Use of Medical Cannabis Pilot Program Act Effective January 1st, 2014 and good for 4 years until expired or renewed. Eligibility: patients with “debilitating medical condition” (see next slide) How to apply? Physician approves the patient and mails in a Physician Certification Form Patient applies for a Medical Marijuana Registry Identification Card via the Illinois Department of Public Health. Patient obtains medical marijuana from a registered dispensary (2.5 Oz max in 14 days). Cultivation centers: managed by Department of Agriculture, maximum of 22 centers. Dispensaries: managed by IDFPR, maximum of 60 dispensaries. Taxes paid by cultivation centers Where to smoke? Legally in the premises of your own home. Illegal elsewhere under the Smoke Free Illinois Act
  29. 29. Pharmacists Role in Illinois? Joseph Friedman, RPh, MBA “My dispensary will also have what pharmacists call a non-sterile lab. Its purpose would be to produce a variety of dosage forms that will address the needs of each and every patient.” “Capabilities will include capsules, topical creams and ointments, tinctures, oils, oral liquids, and edibles. Gummy squares and lollipops, for example, help cancer patients and other people who should not be inhaling smoke cope with break-through pain.”
  30. 30. Others in Illinois Provide resources for physicians and patients on obtaining medical marijuana in Illinois. Medical Marijuana of IL Good Intentions Chicago Quantum9
  31. 31. Conclusions As the use of medical marijuana gains greater acceptance, it is likely that pharmacists will be called upon to counsel patients. Although dispensing pharmacists might receive some legal protection from their individual state, they would be clearly violating federal laws concerning controlled substances and could possibly risk losing their license. Pharmacists must also be careful to never recommend a source of medical marijuana, provide specific instructions for the drug’s use, or obtain the drug for a patient’s use.
  32. 32. References Hi HL. An archaeological and historical account of cannabis in China. Econ Bot 1974;28:437–48. Aggarwal SK, Carter GT, Sullivan MD, ZumBrunnen C, Morrill, R, Mayer JD. Medicinal use of cannabis in the United States: historical perspectives, current trends, and future directions. J Opioid Manag 2009;5:153–68. Kramer J. Medical Marijuana for Cancer. CA Cancer J Clin 2015;65:109-122. Volkow N, et al. Adverse Health Effects of Marijuana Use. N Engl J Med 2014;370:2219-27. • Cavazos-Rehg P, et al. Characterizing the Followers and Tweets of a Marijuana-Focused Twitter Handle. J Med Internet Res. 2014 Jun; 16(6): e157. • Kondrad E, et al. Colorado Family Physicians’ Attitudes Toward Medical Marijuana. J Am Board Fam Med 2013;26:52– 60. • Bachhuber M, et al. Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999- 2010. JAMA Intern Med. 2014;174(10):1668-1673. • Linskey M, et al. Escalation of Drug Use in Early-Onset Cannabis Users vs. Co-twin controls. JAMA 2003;289:427- 433. • Budney A, et al. Marijuana Dependence and Its Treatment. Addict Sci Clin Pract. 2007;4(1):4–16. • Borgelt L, et al. The Pharmacologic and Clinical Effects of Medical Cannabis. Pharmacotherapy 2013;33(2):195– 209. • Burgdorf J, et al. Heterogeneity in the composition of marijuana seized in California. Drug and Alcohol Dependence 2011;117:59– 61.
  33. 33. Medical Marijuana Taha Y. Taha UIC College of Pharmacy NMH Pharmacy Drug Information Questions?

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