kate gillman & ruanne brell - avant mutual group
TRANSCRIPT
Medicinal Cannabis
Kate Gillman – Head of Medico Legal Advisory Service, Avant
Ruanne Brell – Medico Legal Advisor, Avant
Medico Legal Congress, 9 March 2017
The headlines
“I’m standing in a field of cannabis”
“One Nation: Steven Dickson introduces Bill to fast-track medicinal cannabis”
“NT Police say no leniency for medical marijuana users
when new drug-driving laws start”
“Medicinal cannabis campaign
demands better access to drug”
> Medicinal cannabis or medical marijuana
> Narcotics Drugs Act 1967 (Cth), s 4:
– A product from the cannabis plant
– Used to cure or alleviate symptoms of an injury or ailment
> Main active ingredients are tetra-hydrocannabinoid (THC) and
cannabidiol (CBD)
> Herbal cannabis with higher levels of CBD and other cannabinoids
and lower levels of THC
> Includes oil, vapour, balm, capsule or pill
What is medicinal cannabis?
Commonwealth Authority
Access Commonwealth States and
territories
Prescribing
Monitoring Doctors
Production
Quality
Supply
Suppliers and manufacturers
Who does what?
Supply
TGA
Commonwealth
> Narcotics Drugs Amendment Act 2016
> Cultivation and manufacture licensing
→ Office of Drug Control (ODC)
> Patient access schemes
> Import permit
→ Therapeutic Goods Administration (TGA)
> TGA down-scheduled cannabis from Schedule 9 (prohibited substance) to
Schedule 8 (controlled drug) – November 2016
Requirement for licences and permits to be able to grow or import, and cultivate and manufacture medicinal cannabis
General shortage of domestic supply
Supplier must be from regulated industry, compliant with the Single Convention, willing to export to Australia – Netherlands and Canada only
Cultivation other than for medicinal purposes remains illegal, including mixed purposes
Export prohibited
Supply and production
NSW TAS WA
Poisons and Therapeutic
Goods Amendment
Regulation 2016
No legislation No legislation
Specialists and GPs can
apply for authority to
prescribe
Specialists only Expert Advisory Committee
TGA Special Access
Scheme
TGA Special Access
Scheme
Medicinal Cannabis
Compassionate Access
Scheme
Controlled Access Scheme
(not yet in force)
Memorandum of
Understanding signed
between NSW and
Tasmania
MoU signed between NSW
and Tasmania – cultivation
of cannabis for research +
clinical trials
Clinical trials – children
with severe epilepsy
May be able to participate
in NSW clinical trials
Awaiting results of NSW
clinical trials before acting
further
States and territories
ACT NT SA
No legislation at present No legislation proposed No legislation, due to re-
scheduling no need for any
changes to the law
Developing a Medicinal
Cannabis Scheme
Set up a Medical Advisory
Panel
Trial for use in treatment of
melanoma run by
University of Canberra with
Cann Pharmaceuticals
Considering development
of guidelines and research
States and territories
Victoria
Access to Medicinal Cannabis Act 2016
Access to Medicinal Cannabis Regulations 2016
Eligible patients = under 18, suffer from severe epileptic seizures resistant to
other treatments, and meets prescribed criteria for condition;
or has prescribed medical condition and meets criteria for that condition
Children with severe intractable epilepsy as first patients
Specialists only
Independent Medical Advisory Committee
States and territories
Queensland
Public Health (Medicinal Cannabis) Act 2016
Public Health (Medicinal Cannabis) Regulation 2017
No limits on patient eligibility
Conditions: Epilepsy, severe muscle spasms and other MS symptoms,
palliative care and chemotherapy-induced nausea and vomiting
Three pathway options:
1. Single-patient prescriber: GPs (with specialist letter) and specialists
2. Patient class prescriber: certain specialists only – state authority not
required
3. Clinical trials
Prescribe for 3 months only, then subject to review
Clinical Guidance – only guidance in Australia, published in March 2017
States and territories
> No state legislation except in Queensland, Victoria and NSW
> Only clinical guidance is in Queensland
> Down-scheduled to Schedule 8 drug – obtain authorisation through
TGA and Special Access Scheme (SAS) or authorised prescriber
> Approval from relevant state/territory health authority, where
applicable
> Identify source and supplier – import licence if required from TGA
> Mainly for severe seizures associated with epilepsy in children
resistant to other forms of treatment
> Approval for 12 months; 3 months in Queensland
Summary
Clinical indication
> Some evidence of potential
benefits for:
> Multiple sclerosis – severe
spasticity
> Chemotherapy induced
nausea and vomiting
> Palliative care – nausea,
vomiting and pain
> Drug resistant epilepsy -
Dravet and Lennox-Gastaut
syndromes
> Many claims of benefits
lack evidence
> Research focused on
looking at which
cannabinoids are effective
Cannabinoids for Medical Use
A Systematic Review and
Meta- Analysis
Whiting, Woff, Deshpande
JAMA 2015 313 (24)
79 randomised clinical trials – 6462
people covering:
• Nausea/vomiting – chemotherapy
• Chronic pain
• MS spasticity
• Depression / anxiety
• Sleep disorder
• Glaucoma
• Tourette’s Syndrome
Most trials showed improvements in
symptoms but not of statistical
significance in all trials
Increased risk of short term adverse
events
No difference based on type of
cannabinoid used
No studies evaluate long term impact
Further studies required: should
assess patient relevant outcomes,
quality of life, adverse events
Literature
Clinical trials
NSW Clinical Trials
Children with severe epilepsy 2016
$3.5m partnership with GW
Pharmaceuticals + Sydney Children’s
Hospital
Cannabidivann (CBN)
Epidiolex
Chemotherapy induced nausea 2016
Collaboration with RPA/Cancer
Centres; Tilray (Canada)
1st stage – 80 patients
2nd stage – RCT – 250 people
Palliative care 2017
Delayed from July 2016
Youth mental illness to start June 2017
Professor McGory + Orygen 12 – 15 year olds
Anxiety and depression
Clinical trials
QLD clinical trial
Children with severe epilepsy
March 2017
Centre for Children’s Health Research
and Lambert Initiative (Syd Uni)
Epidiolex
30 children
Victorian clinical trial
Children with severe epilepsy
March 2017
Cannabidiol – Tilray (Canada) 29 children with intractable epilepsy
nominated by paediatric neurologists
ACT clinical trial
Melanoma
2017
University of Canberra and Cann
Pharmaceuticals
2 year project
Steps to prescribing medicinal cannabis
> 24 year old patient with
mental health problems and
chronic non cancer pain
asks GP for medicinal
cannabis – can it be
prescribed?
> 40 year old patient with
severe spasticity from
multiple sclerosis asks
neurologist for medicinal
cannabis – can it be
prescribed?
Medico-legal obligations
> Duty to exercise reasonable care and skill
when prescribing medications
> Defence to a claim in negligence -
exercise a standard of care that, at the
time the service is provided, is widely
accepted in Australia by peer
professional opinion as competent
professional practice, and that is not
irrational (Civil Liability Act 2002 (NSW))
Commonwealth: Australian Advisory Council on the Medicinal
Use of Cannabis
• Members announced on 15 February 2017
• Role:
– advice on prescribing guidelines
– evidence for clinical conditions
– advice on regulatory framework
Queensland: Clinical Guidance: for the use of medicinal
cannabis products in Queensland
• December 2016 (published January 2017)
• Interim guidance pending publication of national guidance
documents in 2017
Clinical Guidelines
> Not a first line therapy for any
indication
> Only considered where
conventional treatments are
unsuccessful or the side effects are
intolerable
> Medical practitioners need:
– scientific evidence that the
proposed type of medicinal
cannabis is effective for a patient’s
condition or symptoms; and
– knowledge of the risks, benefits,
potential complications and drug
interactions associated with the
product.
> Medical practitioners should
ensure they access available
literature to determine the
efficacy and safety of the product
they wish to prescribe
AND
Medical practitioners should
be aware that, in prescribing
an unapproved therapeutic
good, they take full
responsibility for the use of
that product as with any other
unapproved product
Queensland clinical guidelines
Contraindications
> History of hypersensitivity to any cannabinoid.
> Severe and unstable cardio-pulmonary disease
> Personal or family history of schizophrenia or other psychotic illness.
Relative contraindications
> Not recommended under 25 years
> Severe liver or renal disease
> Drug dependence, including nicotine and heavy users of alcohol
> Other medications especially other sedatives such as opioids and
benzodiazepines
> Paediatric and elderly patients
Queensland clinical guidelines
> Written consent
> A duty to provide the patient with
sufficient information about the
material risks of a procedure or
treatment to enable the patient to
make an informed decision about
whether to undergo the procedure or
treatment.
> Advice on benefits, risks and
alternative treatments specific to the
patient
Step 1 - informed consent
TGA Requirements
A patient should be specifically
informed of the following:
• that the product is not approved
in Australia;
• the possible benefits of
treatment and any risks and side
effects that are known;
• the possibility of unknown risks
and late side effects; and
• any alternative treatments using
approved products which are
available.
> Research has shown that
cannabis use has an effect on a
person’s driving ability.
> Unlike alcohol, there is generally
no applicable concentration of
cannabis that can be identified as
an indicator of impairment.
> THC is the main
psychoactive component of
cannabis.
> It is illegal for any patient
being treated with medicinal
cannabis containing THC to
drive while undergoing
treatment.
> Eg. Sativex – positive THC
urine test
> It may take up to 5 days for
80 – 90% of total dose to be
excreted
Warning on driving – QLD clinical guidelines
Therapeutic indications – QLD Guidelines
> Multiple
Sclerosis
Clinical indication – Severe spasticity - Non
responsive to medications
Contraindicated - family history schizophrenia /
severe personality disorder/ psychiatric
disorder
Products – Nabiximols – Sativex nasal spray -
TGA approved - sourced from overseas
Evidence
• Moderate / Good
Side effects – Risks
• Dizziness, somnolence, anxiety, memory,
disorientation
Therapeutic indications – QLD guidelines
Chronic pain
> More research needs to be undertaken in this area to determine the types
of pain most likely to respond to medicinal cannabis products,
> Pain management has not been included in the patient-class prescriber
pathway at this time.
> Pain specialists or GPs, on the written recommendation of a pain
management specialist, may access the single-patient pathway if they
believe a trial of medicinal cannabis is warranted for an individual patient.
> Medical practitioners will be required to provide high-quality and up-to-date
evidence of safety and efficacy.
Clinical indication confirmed
No contraindications
Warned of benefits and risks and alternative treatments
Warned cannot drive
Informed consent obtained in writing
Proceed to state approval process if required or go straight to
TGA process if not required
Step 2 – state approval process if required
> Clinical indication for use (e.g. severe seizures refractory to standard
anti-epileptic drugs)
> Explain why you are prescribing the treatment, including efficacy and
potential harms, and the scientific evidence to support the treatment
> Explain how this drug will form part of the treatment plan for the patient,
including any previous pharmacotherapy and/or non-pharmacotherapy
> Describe the planned clinical review of the patient to monitor efficacy,
harms and adherence
> Describe the pre-defined, objective outcomes that need to be met to
judge whether the treatment should be continued
State approval process – NSW
TGA Website: responsibilities of the prescriber
> Unapproved therapeutic goods have undergone
little or no evaluation of quality, safety or efficacy
by the Therapeutic Goods Administration
> Therefore, the responsibility for prescribing an
unapproved product rests with the prescriber.
Step 3 - TGA special access scheme
> Identify supplier – local v overseas?
> Treatment plan
–treatment goals for medical cannabis use
–frequency of dispensing
–monitoring arrangements
–exit strategy
–3 monthly review (QLD)
Step 4 – supply and treatment plan
> Public Health (Medicinal Cannabis) Act 2016 (QLD)
provides protection from civil liability
> provided the medical practitioner has acted in good faith
and without negligence
> protection may not extend to the TGA approval process
Protection from liability
General disclaimer
The information in this presentation is general information relating
to legal and/or clinical issues within Australia (unless otherwise
stated). It is not intended to be legal advice and should not be
considered as a substitute for obtaining personal legal or other
professional advice or proper clinical decision-making having
regard to the particular circumstances of the situation.
While we endeavour to ensure that documents are as current as
possible at the time of preparation, we take no responsibility for
matters arising from changed circumstances or information or
material which may have become available subsequently. Avant
Mutual Group Limited and its subsidiaries will not be liable for any
loss or damage, however caused (including through negligence),
that may be directly or indirectly suffered by you or anyone else
in connection with the use of information provided in this document.
Important notices