Southwestern Conference on Medicine Presented by: Karen Wright RN BSN ARM CPHRM MICA Risk Management Services

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1 Southwestern Conference on Medicine 2012 Presented by: Karen Wright RN BSN ARM CPHRM MICA Risk Management Services

2 16 states and DC have enacted laws to legalize medical marijuana. California was the first state to pass law (1996) and Delaware was 16 th state (2011). Arizona was 15 th state (2010). All states have established a medical marijuana possession limit. Only 5 states, including Arizona, will accept other states registry cards. 2

3 Nationally, it appears that most criminal cases involving medical marijuana are directed at the distributors or dispensaries of medical marijuana. On October 19, 2009, U.S. Attorney General Eric Holder issued a memorandum to federal prosecutors in states allowing for the use of medical marijuana stated: Federal resources should not be focused on individuals whose actions are in clear and unambiguous compliance with existing state laws providing for the medical use of medical marijuana. In a statement accompanying the memo he added, but we will not tolerate drug traffickers who hide behind claims of compliance with state law to mask activities that are clearly illegal. 3

4 State licensing boards recognize legal use of medical marijuana. The boards hold physicians to accepted standards that any reasonable and prudent physician would follow when recommending or approving any medication. Adequate review of history, In person examination, Provision of informed consent, Periodic review of the treatment s efficacy, Referrals/consultations as needed, and Proper record keeping that supports the decision to recommend the medical use of marijuana. 4

5 Meeting the standard of care. Loss of chance doctrine. Aggravation of a pre-existing condition. Future harm. Lack of informed consent. Third party endangered. Addiction or abuse. 5

6 What any other reasonably prudent, similarly trained and experienced physician would consider. Limited scientific research regarding marijuana to support its effectiveness, risks, benefits, dosages, interactions with other drugs and impact on pre-existing conditions. No established quality controls in the manufacturing process. 6

7 Physicians Desk Reference and drug manufacturer warnings are often used to establish standard of care in medical negligence cases. Since marijuana does not have a product warning, a jury could consider it unreasonably dangerous. Historically, physicians rely on FDA s process for approving new drugs. Marijuana is not approved by FDA. Recommending a non-fda approved drug may be difficult to sell to a jury. 7

8 Error in diagnosis reduces the patient s chances of survival. Over-reliance on patient s self-diagnosis or failure to perform a thorough evaluation may lead to a missed or delayed diagnosis. Marijuana may mask an undiagnosed comorbidity resulting in improper or delayed treatment. 8

9 Marijuana may further compromise patient s pre-existing ailment or condition. Negative effects on immune system may place already immuno-suppressed patients, such as patients with HIV or cancer, at greater risk for viral and bacterial infections. Although there are conflicting studies, smoking marijuana may contribute to additional airway irritation in patients with existing pulmonary disease. 9

10 Allegations regarding increased risk of future injury and also anxiety that risk may materialize in future. Clinical trials have shown marijuana: Affects phases of the reproductive process, Has more carcinogens than tobacco, Is an addictive substance, and May be gateway drug to the use of cocaine, heroin and other psychoactive substances. 10

11 Courts recognize clinician s responsibility to adequately inform patients regarding the risks, benefits and alternatives of a specific therapy. Explaining risks and benefits may be difficult when recommending marijuana because there is no drug manufacturer, no FDA approval, no standard chemical composition (potency and quality), no standard dose, and little clinical information regarding interaction with other drugs. 11

12 Possibility that physician/patient relationship is sufficient to impose a duty to protect unidentifiable, unknown third parties, who are endangered by a patient. A study conducted by the Department of Transportation, National Highway Traffic Safety Administration concluded that relatively lowmoderate doses of THC (the major psychoactive ingredient in marijuana) impairs driving. In combination with alcohol there were very severe effects on driving performance. 12

13 According to the U. S. Department of Health and Human Services there is scientific and medical evidence that marijuana has a high potential for abuse. Marijuana is an addictive substance. 13

14 Like any other expanded area of practice, before certifying patients for the medical use of marijuana or becoming a Medical Director of a Dispensary, physicians should: Determine if expanded service benefits your current patient population and is consistent with your practice values and business plan, Have a well thought out policy in your practice. Be knowledgeable regarding your role and responsibilities under state law, Acquire knowledge, training or even certification in addiction medicine, and Remember that you can decline to certify a patient for the medical use of marijuana. 14

15 The states and DC that have legalized the medical use of marijuana have developed their own laws. It s important to review your state s laws and carefully comply with them. 15

16 Legalization of marijuana for medical use was a voter initiative that received 50.13% of the vote. AZ Department of Health Services (ADHS) implemented a regulatory system for the distribution of marijuana for medical use, including: A system for approving, renewing, and revoking the registration of qualifying patients, designated caregivers, nonprofit dispensaries and dispensary agents. Allows qualifying patient to obtain limited amounts of marijuana for medical use. Qualifying patient must have a debilitating medical condition as defined in ADHS regulations. Final regulations released mid

17 December 17, 2010: ADHS posts an informal draft of the Rules. December 17, 2010 January 7, 2011: ADHS received public comment on the informal draft Rules. January 31, 2011: ADHS posts official draft Rules for public comment. February 14 17, 2011: ADHS held 4 public meetings about the draft Rules. The intent of these public meeting was to listen to comments, concerns and suggestions for improvement or solution related to the Arizona Medical Marijuana Program draft Rules. January 31 February 18, 2011: ADHS accepted public comment on a revised draft of the Rules. March 28, 2011: ADHS published the final Rules that will be used to implement the ACT. April 14, 2011: ADHS begins to accept applications for qualified patients and caregivers. May, 2011:In response to letter from AZ US A/G, Governor suspended dispensary portion of Act. January, 2012: Federal Court declined to address issue Governor asked ADHS to implement dispensary portion of Act. 17

18 AZ developed regulations for the medical use of marijuana. A physician may certify a patient meets AZ criteria for the medical use of Marijuana. AZ law defines a physician as a Doctor of Medicine, Doctor of Osteopathic Medicine, a Naturopathic Physician or a Homeopathic Physician. A Physician Assistant or Nurse Practitioner are not able to certify a qualifying patient. Keep in mind that under federal law, Marijuana is a Schedule 1 Narcotic and cannot be prescribed by a physician. 18

19 Patient must have a legally qualifying debilitating medical condition (DMC). Such as, cancer, glaucoma, AIDS, Crohn s disease, Hepatitis C, agitation of Alzheimer s and ALS. DMC must produce (by itself or from its treatment) certain qualifying symptoms. Such as, cachexia, severe and chronic pain, seizures, including those characteristic of epilepsy, severe or persistent muscle spasms and severe nausea. The diagnosis of a DMC must be accompanied by qualifying symptoms to justify a marijuana certificate. 19

20 Strict compliance with the Act and its regulations affords protections from state criminal prosecution for patients and physicians. AZ law recognizes legalized marijuana in limited circumstances. Marijuana remains illegal under federal law. US Department of Justice stated it will only prosecute physicians who are not in strict compliance with the law. 20

21 Physician must provide: Written certification which includes a specific ADHS form. Dated and signed by a physician. Form demonstrates that in the physician s professional opinion the patient is likely to receive therapeutic or palliative benefit from medical use of marijuana. 21

22 Specify the qualifying debilitating medical condition. Answering and initialing all questions on the form, As well as explaining potential risks and benefits. Sign and date the written certification after a full assessment of pt s medical history and an in person physical examination has been completed. Must be within 90 calendar days appropriate to presenting symptoms and qualifying debilitating medical condition. 22

23 Review medical records from previous 12 months, including those from other treating physicians. Give special attention to pt s response to conventional medications and medical therapies. Also review the qualifying pt s profile on the AZ Board of Pharmacy Controlled Substances Prescription Monitoring Program database. 23

24 Physician must disclose to the qualifying pt any personal or professional relationship with the dispensary. 24

25 A physician who provided the written certification may notify ADHS if: The pt no longer has a debilitating medical condition; The physician no longer believes the qualifying pt receives therapeutic or palliative benefit from the medical use of marijuana; or The physician believes the qualifying patient is not using the medical marijuana as recommended. ADHS will notify the pt that registry identification card is void and no longer valid. 25

26 ADHS will periodically review the demographics of qualifying patients. Information will be provided to licensing Board if ADHS determines a physician providing written certification may be engaging in unprofessional conduct. 26

27 Medical-pot probe flags 8 doctors ADHS pulled names of physicians who had written more than 200 recommendations for certification. Resulted in ten names. Patient records were compared with AZ Board of Pharmacy Controlled Substances Prescription Monitoring Program database and found 8 of 10 physicians failed to review drug histories on many of their patients. Three allopathic physicians Five naturopaths 27

28 ADHS has no authority over AZ physicians so they reported the 8 physicians to their regulatory boards. These 8 physicians: Certified nearly half of the 10,000 Arizonans certified to use medical marijuana. Failed to check pts prescription-drug histories, as required. 28

29 Authorize a person to undertake any task under the influence of marijuana that constitutes negligence or professional malpractice. Authorize possessing or using medical marijuana on a school bus, on the grounds of a preschool, primary school or in a correctional facility. Authorize smoking marijuana on a public transportation or in a public place. 29

30 Authorize operating, navigating or being in actual physical control of a motor vehicle, aircraft, or motorboat while under the influence of marijuana. Require a government medical assistance program or private health insurer to reimburse for costs associated with medical use of marijuana. Require an owner of private property to allow the use of marijuana on that property. Require an employer to allow the ingestion of marijuana in the workplace. Prevent a nursing care or other residential or inpatient healthcare facility from adopting reasonable restrictions on the provision, storage and use of marijuana by residents or patients. 30

31 Assist patients in obtaining marijuana. Dispense marijuana. Cultivate or possess marijuana for patient use. Profit in any way from a dispensary which provides medical marijuana. Physically assist patient in using marijuana. Recommend marijuana without a justifiable medical cause. 31

32 Inform medical liability carrier of new area of practice. Be knowledgeable about role and responsibilities under state law. Acquire knowledge, training or even certification in addiction medicine. Have demonstrable knowledge of physiologic effects of marijuana, its side effects and interactions with other drugs. 32

33 Recommend marijuana only in context of on-going physician patient relationship. Examination for the DMC for which marijuana is being recommended must be in person and within last 90 days. Document pt has failed to respond to other conventional medications to treat ailment. Document a treatment plan with goals and objectives for use of medical marijuana. 33

34 Determine if pt has misused marijuana or other psychoactive and addictive drugs before recommending the pt for medical marijuana. Document the patient was counseled regarding the medical risks of use of marijuana. At a minimum include: Infection, pulmonary complications, suppression of immunity, impairments of driving skills, and habituation. Have patient sign informed consent form. 34

35 Conduct and document reviews annually or more frequent as warranted. If marijuana is directed at helping pain control issues, consider utilizing pain scales, pain diaries or other pt centered data collection tools. Take steps to determine medical marijuana use is not masking an acute or treatable progressive condition or that use will lead to worsening of pt s condition. Be sure to document thoroughly! 35

36 What are the duties/responsibilities of becoming a Medical Director for a dispensary? The duties are detailed in the Act. Include providing guidance to both dispensary staff and clients. 36

37 In light of communication from the US Attorney, dispensary and dispensary agent portions of Act were suspended on May 27, AZ Attorney General filed suit asking for a declaratory judgment from a federal court regarding legality of the Act. The federal court refused to address the issue. In January, 2012, after careful consideration, the Governor asked ADHS to implement the dispensary portion of the AZ Medical Marijuana Act. 37

38 ADHS is working on the rules for setting new dates for accepting dispensary applications. On January 25, 2012, the ADHS s Director indicated the agency is working to set new dates to accept dispensary applications. Goal is to accept applications in April, ADHS then has 45 days to review and award dispensary licenses. Up to 125 dispensary licenses could potentially be awarded by mid-june. 38

39 Develop and provide training to dispensary agents at least once a year. Training topics should include, but are not limited to: Guidelines for providing information to qualifying patients related to risks, benefits, and side effects associated with medical marijuana. Guidelines for providing support to qualifying patients related to their self assessment of symptoms. Recognizing signs and symptoms for substance abuse. Guidelines for refusing to provide medical marijuana to an individual who appears to be impaired or abusing medical marijuana. Development and implementation of review and improvement processes for patient education and support. 39

40 For the development and dissemination of educational materials for qualifying patients and caregivers. Including: Alternative medical options for the qualifying patient s debilitating medical condition; Information about possible side effects and contraindications for medical marijuana and possible impairment when operating a motor vehicle or heavy machinery, when caring for children or of job performance. 40

41 Guidelines for notifying the physician who provided written certification for medical marijuana if side effects or contraindications occur. A description of the potential for differing strengths of medical marijuana strains and products. Information about potential drug/drug interactions, including interactions with alcohol, prescription drugs, non-prescription drugs and supplements. 41

42 Techniques for the use of medical marijuana and marijuana paraphernalia. Information about different methods, forms, and routes of administration. Signs and symptoms of substance abuse, including tolerance, dependency and withdrawal. A listing of substance abuse programs and referral information. 42

43 System for patient or the designated caregiver to document the qualifying patient s pain, cachexia or wasting syndrome, nausea, seizures, muscle spasms, or agitation that includes: A log book for tracking the use and effects of specific medical marijuana strains and products; A rating scale for pain, cachexia or wasting syndrome, nausea, seizures, muscles spasms and agitation; Guidelines for self assessment or, if applicable assessment by designated caregiver; and Guidelines for reporting usage and symptoms to physician providing written certification, as well as any other treating physicians. 43

44 Medical Director is responsible for developing policies and procedures for: Refusing to provide medical marijuana to an individual who appears to be impaired or abusing medical marijuana and Restricting a medical director of a dispensary from providing written certification for medical marijuana for a qualifying patient obtaining medical marijuana from the dispensary. 44

45 Be knowledgeable regarding the role and responsibilities under state law. Acquire knowledge, training or even certification in addiction medicine. Obtain knowledge of the physiologic effects of various strains and forms of administration of medical marijuana. Increase familiarity regarding possible side effects and interactions with other drugs in order to evaluate and educate dispensary patients, caregivers and staff. Carefully follow all provisions of the law concerning effective oversight of the dispensary staff and patients. 45

46 Be an active participant in the activities of the dispensary. Be cavalier in making appropriate recommendations concerning medical needs of qualified patients requiring special attention for substance abuse or the danger of masking an underlying medical condition. 46

47 Chronic marijuana users may also be polysubstance users. Adding marijuana to chronic use of opiates could expose them to medication interactions and more significant and potentially dangerous side effects than the marijuana itself. 47

48 Consider periodic drug testing for medical marijuana users and exclude from certification patients who are found to be using illicit drugs. For those patients on prescription opioids, your documentation should demonstrate whether the patient is: Getting any benefits from the marijuana use, Experiencing any side effects, or Having other co-morbid problems associated with the chronic pain (e.g. depression, anxiety disorder sleep, cognitive disturbance, memory problems, or other behavioral issues such as isolation and withdrawal. 48

49 If chronic marijuana use is worsening or interfering with management of underlying condition, consider recommending the marijuana use be stopped. If patient resists recommendations and refuses to adapt marijuana usage, despite negative consequences of marijuana use, a well-documented medical record will assist in any medical legal challenges. Certification can be withdrawn. If patient s marijuana use suggests abuse and dependence, consider discharging patient from care or referring to an addiction specialist. 49

50 50

51 AZ Department of Health Services The DEA Position on Marijuana, January, Guidelines of the Council on Scientific Affairs Subcommittee on Medical Marijuana Practice Advisory, California Medical Association. 51

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