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Peaceful feeling, or up in smoke? Medical marijuana in medicolegal context

9/30/2015

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SOURCE: Current Psychiatry
September 2015 | Douglas Mossman, MD

In recent years, public debate about mar­ijuana has acquired 2 new dimensions: (1) the wishes and medical needs of peo­ple who seek marijuana for its purported health benefits, and (2) the role of physi­cians who practice where “medical mari­juana” is legal.

This article hits 3 topics:
   • the intersection of marijuana policy and health care in the United States
   • the risks and possible benefits of mari­juana use
   • the medicolegal problems faced by physicians who might advise patients to use marijuana.
​
Legal haze
Two cannabinoids—dronabinol and nabi­lone—have received FDA approval as appetite enhancers and anti-nausea agents. Third-party payors usually cover these types of medications, but no insurer pays for medical marijuana.1 The Controlled Substances Act of 19702 classified mari­juana as a Schedule I drug because of its abuse potential, lack of accepted medical applications, and uncertain safety. The FDA has not approved marijuana use for any medical condition.

Although people commonly speak of “prescribing” marijuana, physicians cannot legally do this in the United States. What physicians may do, in the 23 states that allow medical marijuana, is recommend or certify a patient’s marijuana use—an action that has constitutional protection under the First Amendment’s freedom of speech clause.3,4

A physician may complete documenta­tion that a patient has one of the qualifying medical conditions for which the jurisdic­tion has legalized medical marijuana. Either the patient or the physician then submits that documentation to the appropriate gov­ernment agency (eg, the state’s department of health).

If the documentation receives approval, the agency will issue the patient a registra­tion card that allows possession of medi­cal marijuana, with which the patient can obtain or grow a small amount of mari­juana. The cannabinoid content of mari­juana products varies considerably,5 and physicians who certify marijuana typi­cally defer dosage recommendations to the patient or the dispensary.1

In states that allow medical marijuana, users may assert an affirmative defense of medical necessity if they face criminal pros­ecution.3,6 Possession of marijuana remains illegal under federal law, however, regard­less of one’s reason for having it.7,8 Since October 2009, the Attorney General’s office has discouraged federal prosecutions of per­sons “whose actions are in clear and unam­biguous compliance with existing state laws providing for the medical use of mari­juana.”9 But given the remaining conflicts between state and federal laws, “the legal implications of certifying patients for medi­cal marijuana remain unclear.”10

Physicians have few resources to instruct them on the legal risks of certifying medical marijuana. When Canada legalized medical marijuana, the organization that provides malpractice insurance to Canadian physi­cians told its members that “prescribing medical marijuana cannot be compared to prescribing prescription drugs” and rec­ommended that physicians obtain signed release forms documenting that they have discussed the risks of medical marijuana with patients.11 For some risky approved drugs, the FDA has established a risk evalu­ation and mitigation strategy, but no such guidance is available for marijuana.


Highlighting the benefits and risks
Proponents of medical marijuana claim that Cannabis can help patients, and dispas­sionate experts acknowledge that at least modest evidence supports the benefits of using “marijuana for nausea and vomit­ing related to chemotherapy, specific pain syndromes, and spasticity from multiple sclerosis.”10 For several other conditions— HIV/AIDS, depression, anxiety disor­ders, sleep disorders, psychosis, Tourette syndrome—evidence of benefit is poor.12 Rigorous evaluation of medical marijuana is difficult because the plant contains hun­dreds of active chemical compounds. The chemical content of marijuana is highly variable, depending on its preparation and administration,10,13—one reason why only a few good randomized controlled trials of marijuana have been conducted.

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On the highway: Marijuana and driving
Marijuana use impairs driving ability.14 Following enactment of more lenient mari­juana laws, several states have reported higher numbers of fatally injured drivers who tested positive for Cannabis21-23 and had a positive screen of tetrahydrocannabi­nol (THC) in driving under the influence cases.24,25 One study showed that a blood THC concentration >5 ng/mL (comparable to a blood alcohol concentration of 0.15%) increased the crash odds ratio to 6.6.25,26

Marijuana impairs reaction time, informa­tion processing, motor performance, atten­tion, and visual processing.14,16,27,28 Drivers who are under the influence of marijuana make more driving errors, despite being cautious about how they react to traffic.29 Even after weeks of abstinence, previ­ous daily users of marijuana display some cognitive processing and driving-related impairments.30,31

Courts have found physicians negligent if their patients’ treatment-induced driving impairments injured others when the risk of driving-related injury was foreseeable.32 The Massachusetts case of Coombes v Florio33 lik­ened the physician’s duty to that of a liquor store that sells alcohol to a minor who sub­sequently crashes, or to a father who did not lock his firearms away from his violent adult son.

Three variables influence a court’s judgment about whether risk is “foresee­able”: “the relative knowledge of the risk as between lay persons and physicians, whether the patient has previously used the medication and/or experienced the adverse effect, and whether a warning would other­wise have been futile.”34 A physician who certified a patient to use marijuana without adequately explaining the risks of driv­ing might be vulnerable to a lawsuit if the patient’s driving accident occurred while the patient was under the influence of the drug. Recommending marijuana as a treat­ment also could lead to a malpractice action if a patient experienced and was harmed by the drug’s adverse effects.


Other drags
Another malpractice risk stems from mari­juana’s addiction potential. Although many people think Cannabis isn’t addictive, nearly 10% of all marijuana users develop depen­dence.10,17 Regular Cannabis users are more likely to use alcohol, tobacco, and “recre­ational” drugs,17,35 and using alcohol and marijuana together greatly heightens the risk of driving accidents.14,15 Although we know of no case that relates directly to mari­juana, physicians have faced lawsuits for injuries stemming from a patient’s addiction to prescription drugs,36 particularly when the patient’s behavior should have led the physician to suspect abuse or overuse.37

When certifying marijuana use, physi­cians have the same obligations that apply to more conventional medical treatment:
   • establishing a proper physician–patient relationship
   • taking an appropriate history
   • conducting a proper examination
   • reviewing records
   • developing a comprehensive treatment plan
   • weighing risks and alternatives
   • providing follow-up care.

Neglecting these steps could lead to medical board sanctions and suspension or revocation of a medical license.13

The blunt reality
We advise against recommending mari­juana for your patients. But if you have exhausted the alternatives, see marijuana as the last resort, and believe that taking the risk is worth the potential benefit, you can take some steps to reduce your legal risk.
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BOTTOM LINE
Medical marijuana is a controversial topic that demands more rigorous research and regulatory consideration. In the present climate, cautious physicians will avoid recommending marijuana to their patients. If you think that a patient has a medical indication, with no treatment option better than medical marijuana, be sure to understand the medical and legal ramifications before you authorize its use.



Disclosures
The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

References
1. Hill KP. Medical marijuana for treatment of chronic pain and other medical and psychiatric problems: a clinical review. JAMA. 2015;313(24):2474-2483.
2. Controlled Substances Act title 21, §801.
3. Frezza C. Medical marijuana: a drug without a medical model. Georgetown Law J. 2013;101:1117-1145.
4. Conant v Walters, 309 F3d 629, 637 (9th Cir 2002).
5. Vandrey R, Raber JC, Raber ME, et al. Cannabinoid dose and label accuracy in edible medical cannabis products. JAMA. 2015;313(24):2491-2493.
6. Thompson AE. JAMA patient page. Medical marijuana. JAMA. 2015;313(24):2508.
7. United States v Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483 (2001).
8. Gonzales v Raich, 545 U.S. 1 (2005).
9. Ogden DW. Memorandum for selected United States Attorneys on investigations and prosecutions in states authorizing the medical use of marijuana. http://www. justice.gov/opa/blog/memorandum-selected-united-state-attorneys-investigations-and-prosecutions-states. Published October 19, 2009. Accessed July 11, 2015.
10. D’Souza DC, Ranganathan M. Medical marijuana: is the cart before the horse? JAMA. 2015;313(24):2431-2432.
11. Picard A. Pot-prescribing doctors warned. The Globe and Mail. http://www.theglobeandmail.com/news/national/ pot-prescribing-doctors-warned/article22506373. Published October 19, 2005. Accessed July 21, 2015.
12. Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA. 2015;313(24):2456-2473.
13. Barthwell AG, Baxter LE, Cermak T, et al. The role of the physician in “medical” marijuana: American Society of Addiction Medicine. http://www.aoaam.org/usr/ ASAM_Med_Marijuana_White_Paper_Final.pdf. Published September 2010. Accessed July 11, 2015.
14. Ramaekers JG, Berghaus G, van Laar M, et al. Dose related risk of motor vehicle crashes after cannabis use. Drug Alcohol Depend. 2004;73(2):109-119.
15. Hartman RL, Huestis MA. Cannabis effects on driving skills. Clin Chem. 2013;59(3):478-492.
16. Kondrad E, Reid A. Colorado family physicians’ attitudes toward medical marijuana. J Am Board Fam Med. 2013;26(1):52-60.
17. Hall W. What has research over the past two decades revealed about the adverse health effects of recreational cannabis use? Addiction. 2015;110(1):19-35.
18. Huang YH, Zhang ZF, Tashkin DP, et al. An epidemiologic review of marijuana and cancer: an update. Cancer Epidemiol Biomarkers Prev. 2015;24(1):15-31.
19. Delforterie MJ, Lynskey MT, Huizink AC, et al. The relationship between cannabis involvement and suicidal thoughts and behaviors. Drug Alcohol Depend. 2015;150:98-104.
20. Radhakrishnan R, Wilkinson ST, D’Souza DC. Gone to pot-a review of the association between cannabis and psychosis. Front Psychiatry. 2014;5:54.
21. Masten SV, Guenzburger GV. Changes in driver cannabinoid prevalence in 12 U.S. states after implementing medical marijuana laws. J Safety Res. 2014;50:35-52.
22. Pollini RA, Romano E, Johnson MB, et al. The impact of marijuana decriminalization on California drivers. Drug Alcohol Depend. 2015;150:135-140.
23. Salomonsen-Sautel S, Min SJ, Sakai JT, et al. Trends in fatal motor vehicle crashes before and after marijuana commercialization in Colorado. Drug Alcohol Depend. 2014;140:137-144.
24. Urfer S, Morton J, Beall V, et al. Analysis of Δ9- tetrahydrocannabinol driving under the influence of drug cases in Colorado from January 2011 to February 2014. J Anal Toxicol. 2014;38(8):575-581.
25. Couper FJ, Peterson BL. The prevalence of marijuana in suspected impaired driving cases in Washington state. J Anal Toxicol. 2014;38(8):569-574.
26. Drummer OH, Gerostamoulos J, Batziris H, et al. The involvement of drugs in drivers of motor vehicles killed in Australian road traffic crashes. Accid Anal Prev. 2004;36(2):239-248.
27. Ashton CH. Pharmacology and effects of cannabis: a brief review. Br J Psychiatry. 2001;178:101-106.
28. Schwitzer T, Schwan R, Angioi-Duprez K, et al. The cannabinoid system and visual processing: a review on experimental findings and clinical presumptions. Eur Neuropsychopharmacol. 2015;25(1):100-112.
29. Neavyn MJ, Blohm E, Babu KM, et al. Medical marijuana and driving: a review. J Med Toxicol. 2014;10(3):269-279.
30. Bosker WM, Karschner EL, Lee D, et al. Sustained abstinence improves psychomotor function in chronic daily cannabis smokers. Paper presented at: SOFT 2012: Society of Forensic Toxicologists 2012 Annual Meeting; July 1-6, 2012; Boston, MA.
31. Fabritius M, Augsburger M, Chtioui H, et al. Fitness to drive and cannabis: validation of two blood THCCOOH thresholds to distinguish occasional users from heavy users. Forensic Sci Int. 2014;242:1-8.
32. Annas GJ. Doctors, drugs, and driving—tort liability for patient-caused accidents. New Engl J Med. 2008;359(5):521-525.
33. Coombes v Florio, 877 NE2d 567 (Mass 2007).
34. McKenzie v Hawaii Permanente Medical Group, Inc. 47 P3d 209 (Haw 2002).
35. Ilgen MA, Bohnert K, Kleinberg F, et al. Characteristics of adults seeking medical marijuana certification. Drug Alcohol Depend. 2013;132(3):654-659.
36. Osborne v United States, 166 F Supp 2d 479 (SDW Va 2001).
37. Conrad-Hutsell v Colturi, 2002 Ohio App. LEXIS 2740 (2002).
38. Edersheim JG, Stern TA. Liability associated with prescribing medications. Prim Care Companion J Clin Psychiatry. 2009;11(3):115-119.

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Low vitamin D associated with age-related cognitive decline and dementia

9/28/2015

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SOURCE: Functional Medicine University
​​Michael Jurgelewicz, DC, DACBN, DCBCN
In a new study published earlier this month in JAMA Neurology, researchers demonstrated a significant association between vitamin D insufficiency and cognitive decline that is specifically seen in Alzheimer's disease and dementia.

The results reinforce the importance of identifying vitamin D insufficiency among the elderly. Here, low vitamin D levels were associated with significantly faster rates of decline in memory and executive function performance.

This study included approximately 400 men and women participating in research at the Alzheimer's Disease Center in Sacramento, Calif. The participants had a mean age of 76 and were either cognitively normal, had mild cognitive impairment, or had dementia.

At the start of the study, the participants' serum vitamin D levels were measured and the results showed that vitamin D deficiency and insufficiency were prevalent among all participants. Twenty-six percent were found to be deficient while thirty-five percent were insufficient.

At the 5 year follow-up, vitamin D deficient participants experienced cognitive decline at rates 2-3 times faster than those with sufficient vitamin D levels. The researchers expected to see cognitive decline in individuals with low vitamin D status; however, they did not expect how profoundly vitamin D impacts cognition.

There is enough evidence to recommend that health care providers should discuss daily vitamin D supplementation with their elderly patients. 

Vitamin D deficiency is a common problem that is associated with many health consequences, yet this deficiency could easily be addressed. Sun exposure is the ideal source of vitamin D, but for most of us, sunlight itself is not enough; our bodies require us to obtain vitamin D from other sources. Some racial and ethnic groups are at greater risk of low vitamin D because the higher concentration of melanin that makes their skin darker also inhibits vitamin D synthesis. Many people avoid the sun or cover up with protective clothing due to the dangers of overexposure. In addition, most of us spend a great deal of time inside under fluorescent lights and away from natural light. Also, depending on the particular time of year and what latitude you live at, you may not be able to get adequate vitamin D from the sun. In some locations this can be most of the year.

Reference:
Charles DeCarli, MD et al. Vitamin D Status and Rates of Cognitive Decline in a Multiethnic Cohort of Older Adults. JAMA Neurology, September 2015 DOI: 10.1001/jamaneurol.2015.2115


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Prescribing Clozapine in the US: New RequirementS

9/17/2015

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SOURCE: Psychopharmacology Institute
September 15, 2015

FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines

  • The prescribing information for clozapine has been revised to incorporate new requirements for prescribing clozapine and monitoring patients for neutropenia.
  • The requirements to monitor, prescribe, dispense, and receive clozapine are now incorporated into the new, shared Clozapine REMS Program, which replaces the six individual clozapine registries. The REMS program includes all clozapine medicines in order to provide a centralized point of access for prescribers and pharmacists in managing the risk of neutropenia. Starting October 12, 2015, clozapine will be available only through the Clozapine REMS Program.
  • Important changes to the neutropenia monitoring recommendations and treatment algorithm for clozapine include:
    • Absolute neutrophil count (ANC) is the only test result accepted in the Clozapine REMS Programto monitor for neutropenia:
      • If the patient is an outpatient, the ANC must be reported to the Clozapine REMS Program before clozapine is dispensed.
      • If the patient is an inpatient, the ANC must be reported within 7 days of the most recent blood sample.
    • Patients with benign ethnic neutropenia (BEN) can now be treated with clozapine.
    • There are two ANC monitoring algorithms:
      • For general population patients, i.e., those without benign ethnic neutropenia (BEN), interrupt treatment if neutropenia is suspected to be clozapine-induced for ANC less than 1,000 cells per microliter.
      • For patients with BEN, interrupt treatment if neutropenia is suspected to be clozapine-induced for ANC less than 500 cells per microliter.
    • Although re-challenging patients who develop severe neutropenia during treatment with clozapine is not recommended, under the revised prescribing information prescribers will have more flexibility to make individualized treatment decisions for their patients if they determine that the risk of psychiatric illness is greater than the risk of recurrent severe neutropenia.
      • The National Non-Rechallenge Master File (NNRMF) will be discontinued on October 12, 2015. Patients were listed in the NNRMF if they had a WBC less than 2,000 cells per microliter or an ANC less than 1,000 cells per microliter.
      • All patients listed in the NNRMF will be automatically transferred to the Clozapine REMS Program and clearly identified.
  • Prescriber Certification in the Clozapine REMS Program
    • Starting October 12, 2015, health care professionals who wish to prescribe clozapine to outpatients or inpatients must be certified in the Clozapine REMS Program. To become certified in the Clozapine REMS Program, prescribers must:
      • Review the prescribing information for clozapine,
      • Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers,
      • Successfully pass the Knowledge Assessment for Healthcare Providers, and
      • Complete and submit the one-time Clozapine REMS Prescriber Enrollment Form.
    • Prescribers can be certified through the Clozapine REMS Program website atwww.clozapinerems.com, or by faxing completed forms to 844-404-8876. For more information or to request materials, call the Clozapine REMS Program at 844-267-8678.
    • Prescribers who currently treat patients with clozapine will have additional time to complete their certification and will have access to the Clozapine REMS Program to manage current patients. The Clozapine REMS Program will contact current prescribers to provide instructions on how to access the Clozapine REMS Program website.
  • Prescribing Clozapine
    • Managing existing patients:
      • All patients registered in any of the existing clozapine registries within the last three years and all patients listed in the NNRMF will be automatically transferred into the Clozapine REMS Program.
      • Starting October 12, 2015, prescribers will no longer be able to enroll or manage patients through the other clozapine patient registries. All patient management activities will be handled through the Clozapine REMS Program.
    • Managing new patients:
      • Prescribers must be certified in the Clozapine REMS Program in order to enroll new patients.
      • Generally, to enroll a new patient prescribers must:
        • Provide the patient or caregiver with What you Need to Know about Clozapine: A Guide for Patients and Caregivers,
        • Inform the patient or caregiver about the risk of severe neutropenia associated with clozapine and about the Clozapine REMS Program requirements, and
        • Complete and submit Patient Enrollment Form.
      • Prescribers can enroll patients through the Clozapine REMS Program website at www.clozapinerems.com, or by faxing the completed Patient Enrollment Form to 844-404-8876.
    • Prescribers may designate other health care professionals or office staff to enroll patients and enter ANC results on their behalf.
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Substance Use in Women

9/2/2015

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Women face unique issues when it comes to substance use, both biological (sex) and cultural (gender). This new online resource provides information on the importance of scientific research into sex and gender issues related to drug use. It includes research summaries about women and commonly abused drugs, including marijuana and prescription medications. Additionally, this new Web section summarizes the latest research related to drug use while pregnant or breastfeeding, along with what science has told us about sex and gender differences in drug addiction treatment. It also looks at other issues related to drug use, including co-occurring mental health disorders, women and violence, and the importance of including women in research.
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