Dr Graham Gulbransen. Associate Professor David Caldicott

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Hospital Clinical Lead Australian Drug Observatory 8:30-10:30 WS #1:

1 Dr Graham Gulbransen General Practitioner Kingsland Family Health Centre Auckland Associate Professor David Caldicott Emergency Physician Calvary Hospital Clinical Lead Australian Drug Observatory 8:30-10:30 WS #1: Medicinal Cannabis Workshop 11:00-13:00 WS #8: Medicinal Cannabis Workshop (Repeated)

2 Medicinal Cannabis Workshop Prescribing in NZ Dr Graham Gulbransen Cannabis Consultant, GP & Addiction Specialist, Auckland & Assoc Prof David Caldicott Emergency Consultant, Canberra GP CME Rotorua 7 June /44

3 Disclosures Graham Gulbransen Consultant for Cannabis Care Clinic, 131 Lincoln Rd, Henderson Speakers fees from Procare, Auckland PHO, Indivior Tilray paid for 3 meals. 3/44

4 Section 29 medicines are considered new medicines because they do not have a consent for distribution and advertising of such medicines is prohibited under section 20 of the Medicines Act. 20 Restrictions on sale or supply of new medicines (1) Except as provided in sections 25, 26(4), 28, 30, 31, and 32, this section applies to new medicines. (2) No person shall (a) sell; or (b) distribute by way of gift or loan or sample or in any other way; or (c) advertise the availability of any medicine to which this section applies before the consent or provisional consent of the Minister to the distribution of the medicine has been notified in the Gazette, or otherwise than in accordance with such conditions as may be imposed by the Minister on giving his consent or provisional consent and notified in the Gazette. 4/44

5 UIC Assoc Prof David Caldicott Canberra 5/44

6 112 Patients on CBD since Dec 2017 Indications Pain 60% Neurological symptoms 13% Females 54% Males 46% Cancers 13% Psychological distress 13% 6/44

7 Outcome after 1 month of CBD oil ADVERSE EVENTS NO BENEFIT GOOD VERY GOOD EXCELLENT NUMBER EVALUATED /05/2018 % 9% 33% 22% 25% 20% 100% 7/44

8 N= 69, % Benefit EXCELLENT 20% NO BENEFIT 33% VERY GOOD 25% GOOD 22% EXCELLENT VERY GOOD GOOD NO BENEFIT 8/44

9 Brief patient histories GENDER AGE PROBLEMS RESPONSE f 2 seizures, developmental delay VG f 45 chronic neuropathic pain anxiety very vivid dreams, quit CBD at 10 days no benefit, consider THC/CBD AE NG f 41 chronic pain, autoimmune E condition f 67 emphysema, hip and leg pain E 9/44

10 m 64 Tilray CBD25 chronic addictions no benefit N chronic pain f 43 Tilray CBD25 chronic anxiety, dysthymia N m 28 Tilray CBD100 ank spond pain feels less stiff, better mood, sleep VG alcohol abuse, depression f 64 Tilray CBD100 rheumatoid arthritis great improvement in pain E 10/44

11 m 71 Tilray CBD100 Parkinsons Disease, falls no benefit N f 35 Tilray CBD100 chronic abdominal pain small pain relief, skin better G endometriosis m 60 Tilray CBD100 hepatocellular carcinoma much reduced pain, feels tumour is halted E progressing f 67 Tilray CBD100 chronic upper body pain high dose CBD gives small relief pain G fibromyalgia and anxiety 11/44

12 Patient Feedback Patient 1. Excellent so far...i haven't had a fibromyalgia flare since I started it and haven't spent a day in bed!!!!!!!!!! Which is the first time in many years... Patient 2. The cannabis oil has been very successful. It took 3-4 weeks, as I slowly increased the doses, to finally stop my longterm serious pain issue. It is the first relief I ve had. I had two weeks with disrupted sleep. That settled down. I have had no other side effects. The relief provided by the oil has seriously improved my quality of life. Patient 3. Hi Dr. I don't know what to report back. My symptoms have continued to get worse and I am very concerned by it. I can't say the cannabis did anything to improve my current condition. I will make another appointment to see you. 12/44

13 Patient Distress Firstly Symptoms are distressing: imagine your feelings if you had to live with unrelenting pain, anxiety, insomnia, incurable cancer, spasms or seizures but note that 40% get very good help with CBD oil 13/44

14 Secondly Medications cause distress: strong drugs can have nasty side-effects and often they don t work 14/44

15 Thirdly Doctors add to the distress Patients say their doctors have never heard of CBD or say its illegal Or they don t know how to prescribe CBD Pain specialists and neurologists often say there is not enough evidence hey, 40% of my patients report significant benefit, way better than many medicines, and the literature contains abundant evidence. Listen to our patients, and read the BOOKS! 15/44

16 Fourthly Legal distress: patients report buying cannabis from dodgy dealers or fear prosecution for possession. 16/44

Cannabis consultations since 1997 Sebastopol, California President

17 Introduction Jeffrey Y. Hergenrather, MD General practice physician Solo private practice Cannabis consultations since 1997 Sebastopol, California President and founding member of The Society of Cannabis Clinicians I have no financial relationships to disclose. 17/44

18 Developing the Treatment Plan Jeffrey Y. Hergenrather MD Cannabis consultant Sebastopol, CA, USA United In Compassion Melbourne Convention & Exhibition Centre June 23-25, /44

19 Conditions in Clinical Practice Rank order - Hergenrather 2017 Pain (acute pain, chronic inflammatory, neuropathic) Mental disorders (all kinds) Cancers Gastrointestinal disorders Insomnia Migraine headaches Harm reduction, alternative to opioids... Spastic disorders Autoimmune disorders Neurodegenerative disorders Glaucoma Skin diseases Epilepsy, Autism, Tourettes, ADD, Dystonia, Dementia AIDS and other infections 19/44

20 Have you any patients who are stuck? Conventional medicines just not working? 20/44

21 Six Pathways to medicinal cannabis 21/44

22 Prescribing medicinal cannabis 1. Sativex Approved condition 2. Sativex Unapproved use 3. Pharmaceutical grade cannabis-based product without consent for distribution 4. Non-pharmaceutical grade 5. CBD products 6. Compassionate cannabis 22/44

23 23/44

24 1. Restriction on the Supply of Sativex Approval to Prescribe, Supply and Administer (Approval No. 2016/AP305) MS: spasms not managed by conventional medicine Medical practitioners acting on the written recommendation of a Neurologist may prescribe Sativex The prescriber is required to state multiple sclerosis & Neurologist name on the prescription form. 24/44

25 Restriction on the Supply of Sativex Approval to Prescribe, Supply and Administer (Approval No. 2016/AP305) Medical practitioners with a vocational scope of practice of Internal Medicine (specialising in neurology), registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, for the treatment of multiple sclerosis; or any other medical practitioner registered with the Medical Council of New Zealand when acting on the written recommendation of one of the medical practitioners with the vocational scope described above, for the condition specified. The name of the recommending medical practitioner with the appropriate vocational scope must be endorsed on the prescription form. The prescriber is required to state the condition being treated (ie multiple sclerosis ) on the prescription form. 25/44

26 2. Sativex unapproved use Form 2 6 pages GP & Specialist signatures Process time 1 4 weeks. SPECIAL AUTHORITY FORM My proposal for an efficient approval system!!! However, as GPs we know that evidence based medicine doesn t work for everyone, we work in zones of therapeutic uncertainty 26/44

27 Form 2 27/44

28 Form 2 28/44

29 3. Application for Ministerial approval to prescribe a pharmaceutical grade cannabisbased product without consent for distribution in New Zealand under Regulation 22 of the Misuse of Drugs Regulations 1977 * Please note that the Government does not support the use of unprocessed or partially processed cannabis leaf or flower preparations for medicinal use. 29/44

30 Nothing available in NZ 3. Application for Ministerial approval to prescribe a pharmaceutical grade cannabisbased product without consent for distribution in New Zealand under Regulation 22 of the Misuse of Drugs Regulations 1977 Please note that the Government does not support the use of unprocessed or partially processed cannabis leaf or flower preparations for medicinal use. 30/44

31 4. Non-pharmaceutical grade cannabisbased products 31/44

32 4. MoH guidelines for > 2% THC 32/44

33 4. Non-pharmaceutical grade cannabisbased products The following matters are taken into account when assessing applications for Ministerial approval to prescribe nonpharmaceutical grade cannabis-based products regulated by Regulation 22 of the Misuse of Drugs Regulations 1977: a. severe or life-threatening condition b. evidence that reasonably applicable conventional treatments have been trialled and the symptoms are still poorly controlled c. evidence that the risk/ benefit of the product has been adequately considered by qualified clinical specialists that is, the risk of treatment with an unproven product is less than the risk of non-treatment and account has been taken of any evidence of potential benefit and weighed against known adverse effects d. application from a specialist appropriate to the medical condition being treated or the Chief Medical Officer of a District Health Board e. applicant or specialist prescriber has sought adequate peer review eg, Hospital Ethics Committee approval, Drug or Therapeutics Committee review, review by other specialists in the condition being treated and/or specialist colleagues involved in the treatment of the patient f. provision of a Certificate of Analysis, preferably from an accredited laboratory, so that the concentration of the active ingredient(s) is known g. patient or guardian has provided informed consent. 33/44

34 5. Alternatives to Sativex In practical terms the changes mean CBD would be able to be prescribed by a doctor to their patient and supplied in a manner similar to other prescription medicine. Peter Dunne, Associate Minister of Health, 2/6/17. 34/44

35 These regulations, which came into force on 7 September 2017, amend the Misuse of Drugs Regulations 1977 Most of the amendments apply in respect of products that contain cannabidiol but do not contain, or contain only small quantities of, other cannabinoids usually found in cannabis (CBD products) [if it contains other cannabinoids usually found in cannabis, contains those cannabinoids in a quantity that, in total, constitutes no more than 2% of the total quantity of cannabinoids in the product.] ie must be 98% CBD 35/44

36 Those amendments allow a medical practitioner, a person who holds a licence to operate a pharmacy under the Medicines Act 1981, or a person who holds a licence to deal in controlled drugs under the Act to import a CBD product without a licence to import the product and to possess and supply that CBD product: allow CBD products to be supplied, administered, or prescribed without the approval of the Minister of Health: 36/44

37 Those amendments (continued) except CBD products from the storage requirements that apply to other controlled drugs: except prescriptions for CBD products from the requirement to be on an approved form that applies to prescriptions for other controlled drugs: allow CBD products to be prescribed in a quantity sufficient for use for a period of 3 months: except CBD products from the requirements of Part 6 of the principal regulations (which relate to record keeping and returns). 37/44

Cannabidiol (CBD) A non-intoxicating cannabinoid

synergistic Hepatic metabolism: CYP 3A4, 2D9

38 Cannabidiol (CBD) A non-intoxicating cannabinoid Anticonvulsant effects Anxiolytic, antipsychotic Neuroprotective:?dementia Analgesia: THC+CBD > THC or CBD alone; synergistic Hepatic metabolism: CYP 3A4, 2D9 inhibition:?clinically relevant Doses:? mg oral / day prescribed 10-50mg oral / day OTC for wellness 38/44

39 Tilray CBD oil has been available in NZ since 7/12/17 39/44

40 CBD25 costs $235 and CBD100 costs $570 at the pharmacy. They last about 1 to 2 months. The pharmacy orders them in from CDC Christchurch & they arrive the next day. They last about 6 months out of the fridge. 40/44

41 41/44

42 Sativex dosing 42/44

43 6. Compassionate Cannabis Medical Cannabis Awareness NZ, Questions about prescribing medicinal cannabis can be ed to 43/44

44 45. Good prescribing practice MCNZ September 2016 If you dispense medicines that you also prescribe, you must always act in the patient s best interests and respect their freedom to choose where to have the medicines dispensed. 46. You should limit fees for dispensing medicines to the cost of the medicines and any reasonable handling costs. You must advise the patient of these fees. 44/44

45 Any Questions? Nga mihi nui Thank you. 45/44

MISUSE OF DRUGS (MEDICINAL CANNABIS) AMENDMENT BILL

MISUSE OF DRUGS (MEDICINAL CANNABIS) AMENDMENT BILL CannabisCare NZ Ltd, March 2018 COMPASSION Let s start with compassion If your Pain Specialist said there was no treatment for your chronic pain, would