Does Legality equal Legitimacy? The challenges of fostering safe practice with state legalization of marijuana

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1 Does Legality equal Legitimacy? The challenges of fostering safe practice with state legalization of marijuana Carla Lomuscio, LCSW, Betsy Long, MSW and Amy Carver, PharmD

2 Disclosures We have no financial disclosures We will be discussing (not endorsing) use of products that may represent violation of state and federal laws We are informed, however not experts of medical marijuana

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4 Definitions Cannabis: synonymous with marijuana Cannabinoids: chemical compounds that interact with cannabinoid receptors in the body. There are more than 100 cannabinoids derived from cannabis, including THC and CBD. 9 THC: tetrahydrocannabinol principal psychoactive cannabinoid has the most medical claims CBD: Cannabidiol Minimal psychoactive effects has the most medical promise

5 Colorado Law vs Federal Law

6 Research Some benefits found in patients with Epilepsy, multiple sclerosis, movement disorders Anecdotal reports Minimal studies with clear efficacy Children s Hospital Colorado Observational Studies Cancer and Blood Disorders Cannabidiol (CBD) for seizures Epilepsy Gastrointestinal

7 Cannabinoid Education Team Inpatient consult service consisting of social workers and pharmacists Consult requests initiated by primary medical team Goal of team is to ensure the safest possible use of MMJ products within our institution Provide support to medical team Provide education and support to family Create safe environment for honest engagement and full disclosure of MMJ use Provide resources to encourage compliance with existing laws Address risks and safety concerns Evaluate for appropriateness of therapy

8 Cannabinoid Education Team- Scope of Consult Provide education about Colorado regulations Medical Marijuana Registry Federal regulations Impact on CHCO and risk associated with federal funding Assist in getting the Waiver of Liability signed Assessment of patient safety concerns by Social Work Assessment of product by Pharmacist Documentation of the consult in the patient s electronic medical record.

9 Children s Hospital Colorado Policy Medical Marijuana: Patient Use Created in March 2016 Use is at the discretion of the provider and may be prohibited at any time In the absence of medical marijuana registration card (Red Card), family will be informed that it is against hospital policy and Colorado state law to administer medical marijuana CHCO Release and Waiver of Liability Form must be signed Medical staff must advise the patient/family on possible risks & benefits associated with use Family assumes all responsibility associated with storage and administration Only oral and topical dosage forms permitted (inhaled products prohibited) Acknowledgement of patient medical marijuana use entered on patients emar (recreational use prohibited) Medical providers and staff may not administer medical marijuana RN documents administration on the emar per patient/family report

10 Role of Pharmacist Discuss the family s expectations of the product Determine if the product is actually what they think it is Was product obtained online or at a local dispensary? FDA warning letters Assess for potential drug interactions with current medications THC is metabolized by CYP3A4, CYP2C19 & CYP2C9 CBD is metabolized by CYP3A4 & CYP2C19 and also inhibits CYP2C9, CYP2C19, CYP2D6, & CYP3A4 Discuss possibility of additive toxicity with other medications

11 Product Options THC vs CBD, combination products, hemp oil (<0.3% THC) Oral vs topical vs inhalation Variable absorption Quality and sterility Quality testing (product consistency/potency) Mold and fungal contamination Pesticide residue

12 Role of Social Worker Provide a safe environment for caregiver to discuss current cannabinoid products Explore alternative treatments utilized Ensure safe storage of product Process outcomes of cannabinoid product use Explore knowledge of Colorado medical marijuana registry Provide education about registry and red card

13 Colorado Red Card Requirements to Apply as caregiver: Apply Online vs Mail 2 Physician certifications licensed Parent Colorado ID/license Birth certificate Care-giver ID if not parent $15.00 cost Approved Conditions Cancer Glaucoma HIV/AIDS Cachexia Persistent muscle Spasm Seizures Severe nausea or severe pain

14 Social Work and Mandated Reporting What does Social Work report? According to the Colorado Children s Code Title Persons required to report child abuse or neglect any person specified who has reasonable cause to know or suspect that a child has been subjected to abuse or neglect or who has observed the child being subjected to circumstances or conditions which would reasonably result in abuse or neglect shall immediately report or cause a report to be made of such fact to the county department of social services or law enforcement agency

15 Colorado Children s Code Continued (III) Any case in which a child is a child in need of services because the child's parents, legal guardian, or custodian fails to take the same actions to provide adequate food, clothing, shelter, medical care, or supervision that a prudent parent would take. The requirements of this subparagraph (III) shall be subject to the provisions of section (VI) Any case in which, in the presence of a child, or on the premises where a child is found, or where a child resides, a controlled substance, as defined in section (5), C.R.S., is manufactured or attempted to be manufactured; Controlled substance: an illegal drug that can have a detrimental effect on a person's health and welfare (VII) Any case in which a child tests positive at birth for either a schedule -1 controlled substance, as defined in section , C.R.S., or a schedule-ii controlled substance, as defined in section , C.R.S., unless the child tests positive for a schedule-ii controlled substance because of the mother s lawful intake of such substance as prescribed.

16 Mandated Reporting -Bruising, child physical abuse -Drug exposed infant or child who tests positive for uncontrolled substances to include prescription drugs and marijuana -Domestic Violence -Neglect, Injurious Environment -Failure to Thrive -Sexual Abuse concerns and the perpetrator lives in the home or has contact with children -High Risk psychosocial concerns -Beyond Control of Parent

17 Mandated Reporting Continued Clinical Social Work Families are not assessed for abuse or neglect based on MMJ use only CHCO is not reporting patients or families using MMJ products for children with medical conditions. Referrals may be warranted if additional risk factors, safety concerns arise during assessment. CHCO is reporting ingestions and infants who are born drug positive

18 Colorado Department of Human Service Response to Reporting Colorado 64 Counties Child Welfare System governed by each county. Variation in Interpretation of the Children's Code. Liberal vs. conservative counties. State Level Administration- Report all.

19 What are other Community Hospitals reporting? Rocky Mountain Hospital for Children No formal policy for MMJ Allow parents to administer while in patient Denver Health and University of Colorado Health No formal policy for MMJ products

20 Cannabinoid Education Team -What we do NOT do We do not prescribe medical marijuana We do not advise on dosing of medical marijuana We do not endorse use We do not police: We won t engage social services/law enforcement for lack of Red Card

21 Cannabinoid Education Team Consult Examples -Is this an appropriate consult request? 1) Parents interested in pursuing MMJ for their 8 year old child who is an oncology patient with loss of appetite and persistent nausea 2) Medical team wants their patient to stop smoking pot due to a chronic lung condition. Consulted us to reinforce the dangers associated with smoking marijuana. 3) Patient receives CBD oil as a maintenance medication for the treatment of seizures. Medical team was uncomfortable providing the consent form and ordering the MAR acknowledgment because the patient didn t have a Red Card.

22 Legal Risks Marijuana is a Drug Enforcement Administration (DEA) Schedule 1 Drug (c) Any person eighteen years of age or older who sells, transfers, or dispenses any amount of marijuana or marijuana concentrate, with or without consideration, to any person under fifteen years of age commits a class 3 felony, and the court shall be required to sentence the defendant to the department of corrections for a term that is at least the minimum in the presumptive range but no more than the maximum term authorized for the punishment of a class 3 felony. For offenses committed on or after July 1, 1985, the fine shall be in an amount within the presumptive range set out in section (1) (a) (III). Federal Drug Administration No current scientifically-based research approved by the FDA to be safe and effective Clinical Risk of Licensure and employment Department of Regulatory Agencies (DORA) Risk to the Hospital Funding Out of State Families Obama Administration versus Trump Administration

23 Ethical Consideration Across Medical Providers MD, Nurses & Pharmacist Benefits vs. Risks Patient- Doctor relationship Autonomy Potential Harm Palliative Care Schedule 1 substance, cannot prescribe Drug interactions Physicians Code of Ethics Research

24 Continued Social Work -Mandated Reporting, Federal vs State Laws -Parents are given the authority to make medical decisions for their children -Child and parent safety

25 Case Study 1 Susie a 4 year old female diagnosed with a seizure disorder presented to the Neurology Outpatient Clinic. Parents initially tried recommended FDA approved seizure medications and ketogenic diet, however eventually did not feel the were sufficient and agreed to only use cannabinoid products. Parents report they are making CBD oil in the home for the patient. In Susie s last visit parents shared that the CBD oil is not working and they have started using a vaporized form of marijuana that does contain THC. What steps should the treating physician take next? What ethical concerns arise during this situation? Do you feel this is a mandated report?

26 Case Study 2 Avery is a 4 month old infant currently hospitalized in the Neonatal Intensive Care Unit and has been diagnosed with Schwachman- Diamond Syndrome (inherited condition that affects bone marrow, pancreas and skeletal system). A consult is placed as mother verbalized desire to start patient on medical marijuana products. Mother shared desire to use products since his syndrome predisposes him to cancer and she wanted to prevent cancer. What steps should the cannabinoid education team take when meeting with this family? What ethical concerns arise during this situation? Do you feel this is a mandated report?

27 Our Path Case Study 1 Consult Social Work to assess for child safety Ethical Concerns Parents want to help their child, however are putting her at potential risk Parents attempted to use FDA approved medications first Mandated report- yes

28 Our Path Case Study 2 Consult meeting Listened to parent and validated feelings/concerns Provided education with diagnostic limitations of red card Provided literature regarding effects of marijuana on brain development Ethical Concerns: Infant Mother desire to help her child versus lack of education Mandated Report: No

29 References Federal Drug Administration. (2017, February, 28). Retrieved from Colorado Department of Public Health & Environment. (2017). Retrieved from National Conference of State Legislatures. (2017, April 21) Retrieved from Children s Hospital Colorado Colorado Children s Code The American Society of Addiction Medicine. The role of the Physician in medical marijuana AMA, Physician s Code of Ethics.

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