Therapeutic Cannabis Law Physician Issues

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Therapeutic Cannabis Law Physician Issues S T U A R T J. G L A S S M A N, M D, F A A P M R M E M B E R, T H E R A P E U T I C U S E O F C A N N A B I S A D V I S O R Y C O U N C I L ( N H ) C L I N I C A L A S S I S T A N T I N S T R U C T O R, G E I S E L S C H O O L O F M E D I C I N E A T D A R T M O U T H

Objectives Provider therapeutic cannabis certification responsibilities Provider therapeutic cannabis certification concerns Other New England state medical marijuana rules/experiences Potential health effects of therapeutic cannabis use risks and benefits Marijuana product content issues Case studies of providers going beyond the regulations

Provider Certification Responsibilities He-C 401 (Therapeutic Cannabis Program Registry Rules) Adopted July 23, 2014 Effective Date August 1, 2015 (subject to change based upon Alternative Treatment Center operation) Certifying a condition, not prescribing marijuana Statutory Authority based on RSA 126-X:6, I Provider definition physician or APRN, must have active NH license and an active DEA registration

Provider Certification Responsibilities (cont) He-C 401.06 Know the qualifying medical conditions--cancer, glaucoma, positive status for HIV, AIDS, hepatitis C (currently receiving antiviral treatment), amyotrophic lateral sclerosis, muscular dystrophy, Crohn s disease, agitation of Alzheimer s disease, multiple sclerosis, chronic pancreatitis, spinal cord injury or disease, traumatic brain injury, or one or more injuries that significantly interferes with daily activities as documented by the patient s provider

Provider Certification Responsibilities (cont.) Know the signs/symptoms A severely debilitating or terminal medical condition or its treatment that has produced at least one of the following: elevated intraocular pressure, cachexia, chemotherapyinduced anorexia, wasting syndrome, severe pain that has not responded to previously prescribed medication or surgical measures or for which other treatment options produced serious side effects, constant or severe nausea, moderate to severe vomiting, seizures, or severe, persistent muscle spasm

Provider Certification Requirements (cont.) The patient must have BOTH the qualifying condition AND the signs/symptoms!! Severe pain diagnosis requires (1) documentation of previously prescribed medication or surgical measures to which the severe pain has not responded; or previously prescribed other treatment options which have produced serious side effects, AND (2) maintain medical records of all previously prescribed medication, surgical measures, and other treatments

Provider Certification Concerns Can not certify yourself or an immediate family member Can t offer any discount to patients who might use a specific ATC Can t examine a patient at a location where cannabis is sold or distributed Can t hold an economic interest in an ATC, or be employed by ATC

What About the Severely Debilitated Patient? I understand that if my application is approved, I may not be under the influence of therapeutic cannabis: (1) while operating a motor vehicle, commercial vehicle, boat, vessel, or any other vehicle propelled or drawn by power other than muscular power; (2) in my place of employment, without the written permission of my employer; or (3) while operating heavy machinery or handling a dangerous instrumentality (He-C 401.04 (a) 8 e) I understand that if my application is approved, I may not smoke or vaporize therapeutic cannabis in any public place, including a public bus or other public vehicle, or any public park, public beach, or public field. (8 f)

Notifying DHHS Nothing in He-C 401 shall prohibit a provider from notifying the department if the provider acquires information indicating that a qualifying patient: (1) Should no longer be certified for the therapeutic use of cannabis; (2) Falsified information that was the basis of the provider s written certification; (3) No longer suffers from a qualifying medical condition; or (4) Should discontinue using cannabis.

Therapeutic Use of Cannabis for Minors The applicant s custodial parent or legal guardian who is responsible for the health care decisions of the applicant shall attest that the applicant s health care provider has explained to the parent or legal guardian who is responsible for the health care decisions of the applicant the potential risks and benefits of the therapeutic use of cannabis Applicants who are minors shall submit 2 written provider certifications, one of which shall be from a pediatrician

Concerns About Certification for Therapeutic Cannabis What if I don t want to certify someone/anyone? What if I certify too many patients?

Maine Medical Marijuana Program (1999) Initially allowed for medical of marijuana starting in 1999 New Medical Marijuana Act took effect in 2009 Only a ME licensed physician with a current DEA registration can certify a patient Similar debilitating conditions and symptoms to the NH regulations Certifying physician MUST seek a second opinion from a consulting physician http://www.maine.gov/dhhs/dlrs/mmm/

Vermont Medical Marijuana Program ( 2004) Provider must have a bonafide health care professional-patient treating/consulting relationship for no less than 6 months EXCEPT in cases of terminal illness, cancer with distant metastases, or AIDS Physicians/PA s/aprn may be licensed in Vermont, New Hampshire, Maine or New York Naturopaths with special license endorsement licensed in VT only Health Care Professional Verification Form- Reasonable medical efforts have been made over a reasonable amount of time without success to relieve the patient s symptoms Conditions cancer, MS, HIV/AIDS, or a condition causing severe intractable symptoms http://vcic.vermont.gov/marijuana_registry/physicians

Rhode Island Medical Marijuana Program (2006) Physicians may be licensed in CT, RI or MA Permits Rhode Island residents with debilitating medical conditions to use marijuana if a physician certifies in writing that the marijuana may alleviate their symptoms and that the potential benefits of using medical marijuana would likely outweigh the health risks to the patient Conditions similar to NH list No specific time requirement for authorizing practitionerpatient relationship If patient is co-treating, must review prior 12 month of treatment notes from other provider http://www.health.ri.gov/healthcare/medicalmarijuana/for/ providers/

Rhode Island Minimum Standards for Authorizing Medical Marijuana (2011) So called medical marijuana has not been the subject of traditional scientific studies of efficacy, safety, or even the balance of relative risks versus benefits of any disease or condition. In addition, smoking of any kind creates dangerous compounds that are then consumed by the smoker. Must do acceptable physical exam Must diagnose acceptable medical condition Must examine patient s response to traditional medical therapies, and explain risks/benefits to patient Must have semi-annual follow-ups at a minimum

Massachusetts Medical Marijuana Program (2012) Licensed MA physician Conditions are similar to NH list Physician medical opinion certifies that potential benefits outweigh the health risks to a qualifying patient As of 7/1/14, must have completed 2.0 CME for medical use of marijuana http://www.mass.gov/eohhs/docs/dph/quality/drug control/medical-marijuana/physician-guidance- 2014-8-21.pdf

CT Medical Marijuana Program (2012) Must have active CT physician license Must practice in CT Must posses an active DEA Registration Must possess an active controlled substance registration issued by the Connecticut Department of Consumer Protection that is not subject to limitation Must have a bona fide physician-patient relationship Must diagnose a debilitating medical condition Must conclude that the potential benefits outweigh the health risks, and explain this to the patient Must be available for reasonable follow up care http://www.ct.gov/dcp/cwp/view.asp?a=4287&q=509622&d cpnav= 55378 &dcpnav_gid=2109

Potential Health Benefits of Therapeutic Cannabis?? Treatment of glaucoma Decrease nausea and cachexia in cancer patients receiving chemotherapy Treatment of epileptic seizures Treatment of painful muscle spasms in multiple sclerosis patients

Health Risks of Marijuana Use (National Institute on Drug Abuse) impairment of short-term memory altered judgment and decision making mood effects, including severe anxiety and psychosis significantly reduces motor coordination slows reaction time worsen respiratory problems such as bronchitis or chronic cough may cause long-term or permanent impairment in cognitive ability and intelligence when used regularly during adolescence

Marijuana Addiction Rates 9% of people who try marijuana will become addicted Increases to 16% among people who start using marijuana as teenagers 25-50% among daily users. http://www.drugabuse.gov/publications/drugfacts/ marijuana-medicine

Therapeutic Cannabis Content Issues THC/CBD profiles What is your patient going to be using? Who is going to counsel them on which strain to use? How will you as the provider know what is in the strain that your SEVERELY DEBILITATED PATIENT is using?

Therapeutic Satisfaction and Subjective Effects of Different Strains of Pharmaceutical-Grade Cannabis J Clin Psychopharmacol. 2014 Jun;34(3):344-9 Study occurred in the Netherlands, where pharmaceutical grade medicinal cannabis is regulated/distributed by the Ministry of Health Questionnaires used; 102 patients; average age 53; used therapeutic cannabis for at least one year Medical conditions chronic pain (53%), multiple sclerosis (23%) 86% felt significant therapeutic satisfaction using cannabis 3 strains of cannabis depression, anxiety and appetite stimulation varied

Marijuana.Com Strain Recommendations for Muscle Spasms Yabba Dabba Goo Killer Purple Phishhead Kush Bob Marley White Queen Skywalker OG NO Darth Vader Kush??!! http://marijuana.com/strains/

Case Study--Montana Dr. Patricia Cole (Family Medicine, Whitefish, MT) In October 2009, saw 150 medical marijuana patients in a span of 14 ½ hours (6 minutes per patient) Fined $2,000 for substandard care by the Montana Board of Medical Examiners No documentation of physical exams, medical histories, proper dosing or risk analysis of medical marijuana Affiliated with Montana Caregivers Network http://missoulanews.bigskypress.com/missoula/marijua na/content?oid=1259716

Case Study #2--Montana Dr. Ross Horsley (Diagnostic Radiologist, Olean, NY) 5 day medical marijuana clinic in Feb/March 2010 Fined $11,000 by Montana Board of Medical Examiners, ordered to provide 100 hours of tele-radiology services to low-income patients in Montana Failed to meet the standard of care for medical marijuana patients Worked with Montana Caregivers Network http://helenair.com/news/local/crime-andcourts/medical-board-fines-cannabisdoctor/article_1f5bc508-9c23-11e2-91d5-0019bb2963f4.html

Montana Caregivers Network N.H. medical marijuana classes linked to problematic Montana Caregivers Network Concord Monitor, April 14, 2014 New Hampshire Medical Cannabis Association website was registered to the Montana Caregivers Network through April 2014 http://www.concordmonitor.com/news/1154 7198-95/nh-medical-marijuana-classeslinked-to-problematic-montana-caregiversnetwork

Case Study #3--Maine Dr. William Ortiz (internist, Caribou, ME) Saw 59 patients over 2 days at 2 different hotels in Orono, ME Fined $2,000 by Maine Board of Licensure in Medicine, based on (1) failure to create and maintain adequate medical records, and (2) the manner and location of his medical marijuana clinics Also required to reimburse Maine BOL $1,412 for cost of investigation License temporarily suspended http://bangordailynews.com/2014/09/15/health/statefines-maine-doctor-who-hosted-marijuana-clinics-inorono-hotels/

Take Home Message/Recommendations

Questions?