Clinical Challenges and Political Uncertainty

Transcription

1 Clinical Challenges and Political Uncertainty John Gaitanis, M.D. April 10 th, 2017

2 Commercial Support This activity does not have any commercial support

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4 NEW THERAPY FOR AN INTRACTABLE CONDITION 4

5 New Therapy for an intractable condition Learn as much as possible about the treatment Mechanism Side-effects Learn as much as possible about the patient Trials of well-proven therapies Did prior treatments work? Were they stopped due to side-effects? Balance risk of underlying condition against risk of therapy Provide Informed consent Permission to treatment with knowledge of possible consequences Avoid conflict of interest 5

6 Practical Considerations Make one change at a time Start low and go slow Define goals of treatment Assess treatment response Close follow-up Establish consistency of treatment 6

7 How I implemented this in my practice Only selected patients with medically refractory epilepsy Met with local dispensary to establish strains and dosing and to ensure consistency Held anti-seizure medications stable as we introduced CBD Asked patients to keep seizure journals Performed 24 hour EEGs before and after treatment Assessed anti-seizure medical levels before and after 7

8 CLINICAL CHALLENGES 8

9 INTRACTABLE EPILEPSY 9

10 Intractable Epilepsy 12 year old girl with Dravet Syndrome Multiple seizure types Generalized tonic-clonic Drop spells Episodes of staring and eye lid fluttering Multiple seizures daily (mostly drop and staring spells) Many of her breakthroughs developed when she developed a febrile illness or was over heated Multiple PICU admissions for status epilepticus and aspiration pneumonia Developmental regression after 1 year of age Non-verbal Cognitive delays 10

11 Patient History Treatments Carbamazepine (seizures worsened) Valproic acid (continued seizures) Topiramate (continued seizures) Levetiracetam (behavioral side-effects and continued seizures) Phenobarbital (no improvement) Lamotrigine (no improvement) Felbamate (seizure breakthroughs) Clobazam Ketogenic diet (no improvement) Vagus Nerve Stimulator (removed due to lead infection) 11

12 Patient History I ve heard about medical marijuana for epilepsy. Can you prescribe it? 12

13 Physician Certification Physicians are not allowed to prescribe cannabis They may only recommend its use or advise consideration In 2002, the U.S. Court of Appeals held that the First Amendment, which protects free speech, allows physicians to discuss and perhaps recommend medical marijuana use without punishment 13

14 Pediatric Certification in Massachusetts Two Massachusetts licensed certifying physicians (at least one of whom is a board-certified pediatrician or board-certified pediatric subspecialist) diagnose the qualifying patient as having a debilitating lifelimiting illness If the debilitating medical condition is not life-limiting, both physicians must determine that the benefits of the medical use of marijuana outweigh the risks A certification can only be made in the course of a bona fide physician-patient relationship 14

15 Certifying conditions in Massachusetts Cancer Glaucoma Positive status for human immunodeficiency virus (HIV) Hepatitis C Amyotrophic lateral sclerosis (ALS) Crohn s disease Parkinson s disease Multiple sclerosis Other debilitating conditions as determined in writing by a qualifying patient s certifying physician 15

16 Physician Certification These policies affect how we document visits Discourages physician involvement in treatment plan Limits physician s ability to provide written instructions Creates difficulty in charting 16

17 Intractable Epilepsy Patient was started on medical cannabis for epilepsy 20:1 CBD to THC ratio (ACDC) Starting dose 0.25 mg/pound/day. Gradually increased by 0.25 mg/pound every week to 1 mg/pound/day After starting this treatment Improved alertness Improved attention and communication No observed side-effects Seizures improved breakthroughs only during her menstrual cycle, but is otherwise not having seizures only one PICU admission since starting therapy three years ago 17

18 Intractable Epilepsy Continue to keep seizure journals Review developmental progress with teachers and parents Consider neuropsychological assessments Ensure consistency of treatment Independent lab to test treatment Monitor medication levels of anti-seizure medications Onfi (clobazam) is known to see increased levels on cannabis 18

19 TREATMENT FOR ACUTE SEIZURES/STATUS EPILEPTICUS 19

20 Status Epilepticus 2 year old girl with Dravet syndrome Generalized tonic-clonic seizures Many with fever are over 20 minutes in duration Seizures resistant to five different anti-seizure medications 20

21 Status Epilepticus For prolonged seizures, she initially used Diastat Failed to work consistently Frequent EMS calls/emergency Room visits Treatment caused sedation for entire day She now used THC 0.5 mg/pound in buccal mucosa for prolonged seizures Generally breaks seizure within 5 minutes Back to baseline within one hour For maintenance therapy, she takes CBD 3 mg/pound/day and has continued break through seizures, but frequency and severity are improved 21

22 Status Epilepticus Standard of care treat seizures with benzodiazepine at 5 minutes Consider use of a novel therapy prior to 5 minutes If therapy works, no further treatment is needed If not, standard therapy can still be administered 22

23 INPATIENT TREATMENT PLAN 23

24 Inpatient treatment plan 12 year old girl with Dravet syndrome Prior treatments included: valproic acid topiramate lamotrigine levetiracetam pheytoin phenobarbital zonisamide rufinamide lacosamide ketogenic diet vagus nerve stimulator 24

25 Inpatient Treatment Plan She is now taking THCA 10 mg in the morning and at noon and 20 mg at night, on which she is doing well with a substantial improvement in seizure frequency She also uses an oral rescue of TCH 12 mg as needed to break prolonged seizures works within seconds She is now being admitted with fever and increased frequency and duration of seizures 25

26 Inpatient Treatment Plan The only therapy to consistently work has been cannabis Can it be given in hospital? If not, is it safe to stop? 26

27 Inpatient Treatment Plan Can it be given in the hospital? Hospitals and pharmacies are mandated by the Centers for Medicare and Medicaid (CMS) to verify and dispense all home medications and supplements administered to inpatients Yet, dispensing a schedule I drug is a violation of the Controlled Substance Act These federal requirements are at odds with each other 27

28 Inpatient Treatment Plan In May, 2016 Connecticut Gov. Danniel Malloy signed legislation, HB 5450, to protect nurses who administer medical marijuana to qualified patients in hospital settings from any criminal, civil, or disciplinary action Connecticut and Maine are the first states to explicitly provide immunity to hospitals that permit patients to medicate with cannabis Yet, Controlled Substance Act states: When federal law or regulations differ from state law or regulations, the practitioner is required to abide by the more stringent aspects of both the federal and state requirements 28

29 Inpatient Treatment Plan Inpatient Options Stop all cannabis products Risk status epilepticus and possibly death Patient self-administer Violates CMS requirements Hospital pharmacist can verify and dispense Satisfies CMS, but violates DEA Don t ask don t tell Creates problems for charting, documentation, and avoiding medication interactions 29

30 THE CHALLENGES OF A SECOND OPINION 30

31 Second Opinion 10 year old boy diagnosed with intractable epilepsy Seizures characterized by eye blinking, facial grimacing, and shaking movements EEG showed generalized spike and slow wave discharges Actively treated on six seizure medications clobazam oxcarbazepine lacosamide rufinamide lamotrigine clonazepam 31

32 Second Opinion Patient s mother started CBD prior to first visit and escalated dose to 0.5 mg/pound/day Seizures increased with that change Upon further increases in CBD dose, seizures escalated 32

33 Second Opinion Is CBD making the seizures worse? 33

34 Second Opinion Patient was admitted for video EEG The clinical seizures were found not to be epileptic in nature Patient was diagnosed with psychogenic non-epileptic seizures, but also has an underlying generalized epilepsy He has since been slowly tapered off of all of his anti-seizure medications He continues to take CBD at night only Seizure control has been excellent and he is much more alert off the anti-seizure medications Improvements in academic achievement Improved behavioral regulation 34

35 Second Opinion Psychogenic non-epileptic seizures Seen in between 10 to 40% of patients with epilepsy Should always be considered seizures inexplicably worsen despite escalations in treatment Clinical characteristics of seizures changes Emphasizes the importance of having a thorough history and adequate work-up 35

36 TREATMENT IN SCHOOL 36

37 Treatment in School 3 year old girl with history of infantile spasms intractable drop seizures Refractory to multiple medications Now showing excellent response to Otto #2 (1 mg/pound/day) 37

38 Treatment in School Twice daily dosing of Otto #2 resulted in afternoon seizures Higher morning doses resulted in mild sedation Seizures and side-effects improved with mid-day dose School is unable/unwilling to provide therapy 38

39 Treatment in School Schools receive federal title I funding Most schools have zero tolerance policies for drugs on campus Nurses fear their own liability in administering cannabis 39

40 Treatment in School Parents are often forced to drive to school to administer treatment themselves Many schools do not allow them to do so on school grounds Alternatively, the morning dose can be increased to cover the school day Risks sedation Higher risk of afternoon seizures 40

41 Treatment in School Presently, only four states have laws permitting administration on school grounds (New Jersey, Maine, Colorado, Washington) Allow legal guardians to administer treatment Students can not be punished for its use 41

42 TRAVEL 42

43 Travel 6 year old girl Medically refractory epilepsy and cerebral palsy Seizures well controlled on ACDC Make a Wish trip to state without approval for medical marijuana Mom called TSA Stated it will not be a concern from departing airport, but could not guarantee safety of arrival airport 43

44 Travel Parents are given bad and worse options Risk bringing CBD in luggage? Fed-ex treatment to arrival destination? Hold treatment for the duration of vacation? Cancel trip? 44

45 CLINICAL CHALLENGES AND POLITICAL UNCERTAINTY 45

46 Political Challenges and Political Uncertainty Current scheduling of cannabis creates multiple challenges Documentation and Counseling Inpatient School Travel Places patients at risk of harm Physicians, nurses, pharmacists, and hospitals fear legal jeopardy Limits physicians willingness to oversee treatment Hinders in-patient care Prevents proper documentation 46

47 PRIMUM NON NOCERE 47

48 Questions 48