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”

> What is medicinal cannabis?

> Legislative framework

> Medico legal considerations

Agenda

> 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

Legislative framework

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

Medico legal considerations

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

Overview of prescribing process

Questions

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

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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