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Prescribing medicinal cannabis

Jonathon C Arnold
Deputy academic director, SUMMARY
Lambert Initiative for
Cannabinoid Therapeutics, The Australian Federal Government legalised access to medicinal cannabis in 2016.
Brain and Mind Centre1
More than 100 different cannabis products are now available to prescribe. Most are oral
Associate professor,
Discipline of Pharmacology,
preparations (oils) or capsules containing delta-9-tetrahydrocannabinol or cannabidiol. Dried-
Faculty of Medicine and flower products are also available.
Health1
As most products are unregistered drugs, prescribing requires approval under the Therapeutic
Tamara Nation
Goods Administration Special Access Scheme-B or Authorised Prescriber Scheme.
General practitioner2
Iain S McGregor Special Access Scheme Category B applications can be made online, with approval usually being
Academic director, Lambert given within 24–48 hours. However, supply chain problems may delay dispensing by the pharmacy.
Initiative for Cannabinoid
Therapeutics, Brain and By the end of 2019, over 28,000 prescribing approvals had been issued to patients, involving more
Mind Centre1 than 1400 doctors, mostly GPs. More than 70,000 approvals are projected by the end of 2020.
Professor of Most prescriptions are for chronic non-cancer pain, anxiety, cancer-related symptoms, epilepsy
Psychopharmacology,
and other neurological disorders. However, the evidence supporting some indications is limited.
School of Psychology,
Faculty of Science1 Many doctors are cautious about prescribing cannabis. While serious adverse events are rare,
1
University of Sydney there are legitimate concerns around driving, cognitive impairment and drug dependence with
2
National Institute of
products containing delta-9-tetrahydrocannabinol. Cannabidiol-only products pose fewer risks.
Integrative Medicine,
Melbourne
Introduction What is medicinal cannabis?
Legal access to medicinal cannabis products is The cannabis plant contains hundreds of
Keywords now increasing. Many countries are relaxing their bioactive molecules, most of which are as yet
cannabidiol,
restrictions on cannabis in the face of escalating uncharacterised. The two best studied cannabinoids
medical marijuana,
medicinal cannabis, community interest, commercialisation of products are delta‑9‑tetrahydrocannabinol (THC) and
tetrahydrocannabinol and strong patient demand for access. The vast cannabidiol (CBD).
majority of Australians support access to medicinal THC is responsible for the intoxicating effects of
cannabis.1 This support is galvanised by media cannabis due to its action on CB1 cannabinoid
Aust Prescr 2020;43:152–9
stories of patients with intractable conditions receptors.6 Despite intoxicating effects at higher
https://doi.org/10.18773/
austprescr.2020.052 whose lives have been transformed by cannabis- doses, clinical trial evidence generally supports the
First published based medicines.2 efficacy of THC in treating conditions such as chronic
29 September 2020 The medical profession is understandably cautious pain, spasticity in multiple sclerosis, anorexia and
around medicinal cannabis. A survey of Australian cachexia, Tourette syndrome and chemotherapy-
Corrected 9 October 2020 GPs reported that they felt uneducated around induced nausea and vomiting.7,8 Trials currently
This is the corrected access pathways, available products and the evidence underway will help to better define the role of THC as
version of the article. a therapeutic across these and other conditions.9,10
base supporting medicinal cannabis.3 Patient
Correction notice enquiries are common, yet only a small proportion CBD has a very wide range of pharmacological
available at:
of doctors feel comfortable discussing cannabis actions but no intoxicating effects. Early evidence
https://doi.org/10.18773/
austprescr.2020.073 with their patients. Overall, GPs are positive about suggests therapeutic actions of CBD at relatively high
medicinal cannabis prescribing, given sufficient doses (300–1500 mg) in treating epilepsy, anxiety and
education, particularly for serious conditions such psychosis.11-13 Numerous clinical trials are underway for
as cancer pain, chemotherapy-induced nausea and other conditions such as neuropathic pain, drug and
vomiting, epilepsy and difficult-to-treat neurological alcohol dependence and neurodegenerative disorders.
conditions.3 Specialist colleges and the Australian In many countries, CBD is readily available in over-the-
Medical Association remain conservative voices in counter nutraceutical ‘wellness’ products. These contain
the medicinal cannabis debate with concerns around very low doses (e.g. 5–25 mg) for which there is little
the limited evidence from clinical trials and possible current evidence of health benefits. Over-the-counter
adverse effects.4,5 access to CBD is not yet available in Australia, although

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the Therapeutic Goods Administration (TGA) is currently

Box Useful websites for information on medicinal cannabis
examining the possibility of such simplified access.14,15
in Australia
Useful Australian websites on medicinal cannabis are
listed in the Box. • Therapeutic Goods Administration – Special Access Scheme and Authorised
Prescriber portal
Products
• Therapeutic Goods Administration – Clinical Guidance documents
Nabiximols (Sativex) is the only cannabis-based • The Office of Drug Control – list of manufacturers and suppliers
medicine currently listed on the Australian Register of
• NSW Health
Therapeutic Goods. It is an oromucosal spray containing
• Queensland Health
THC and CBD in a 1:1 ratio and is approved for treating
• Victoria Health
spasticity in multiple sclerosis. Another product,
• WA Health
cannabidiol (Epidiolex), is a plant-derived oil-based
• SA Health
formulation of CBD. It has recently been approved in
the USA and Europe for the treatment of refractory • Tasmania Health

childhood epilepsy, such as Dravet syndrome.11 The • ACT Health

TGA is currently undertaking an expedited review • NT Health
process for registration of this product in Australia. • Royal Australian College of General Practitioners position statement

All other medicinal cannabis products available in • Royal Australasian College of Physicians statement
Australia are unregistered medicines. Most of these • Australian Medical Association statement
are oral preparations, sprays or capsules of cannabis • Lambert Initiative
extracts with only a small fraction involving cannabis • Freshleaf Analytics
plant material such as the flower (intended for • NPS MedicineWise
vaporisation). The products can contain THC only,
CBD only or various ratios of CBD to THC. Around
one-third of available products are CBD only.14,16 Trace than a registered medicine. Relevant safety and efficacy
levels of other cannabinoids and bioactive compounds data and details of patient monitoring are required.
(e.g. terpenes) may also be present. There is also the option to attach any letters of support
Therapeutic doses of THC (5–20 mg) tend to be or recommendations from other treating specialists
much lower than for CBD (e.g. 50–1500 mg). Many involved in a patient’s care. Prescribing doctors typically
combined products therefore contain CBD:THC ratios report that the first few SAS-B applications are time
of 10:1, 20:1 or 50:1. consuming but that the process rapidly becomes
familiar and routine. The process for prescribing
Accessing products medicinal cannabis in Australia is outlined in Fig. 1.
Unregistered cannabis-based medicines are accessed
Usage
through the TGA Special Access Scheme Category B
(SAS-B) and the Authorised Prescriber Scheme. The vast By the end of 2019, more than 18,000 patients in
majority are via SAS-B, although some prescribing also Australia had accessed medicinal cannabis. This
occurs through the Authorised Prescriber Scheme. The prescribing was by more than 1465 medical practitioners,
latter grants approval for a doctor to prescribe a specific mostly GPs.14 The number of approvals is rapidly
product to a class of patients, rather than an individual increasing with a total of more than 28,000 individual
patient (e.g. paediatric neurologists prescribing CBD applications approved as of 31 December 2019.14 As of
products for children with refractory epilepsy). June 2020, current approvals are running at around
4500 per month. The difference between the number
SAS-B and Authorised Prescriber applications can
of patients (18,000) and number of approvals (28,000)
be submitted without cost via the TGA’s website.
reflects repeat applications for the same patients –
The online portal has a single application which
approvals are usually only provided for one year.
includes any additionally required applications for
state and territory health departments, except for State and territory regulation
Tasmania (see Table). SAS-B applications are typically THC-containing products in Australia are included in
processed within two days if all the necessary Schedule 8 (controlled drugs). Prescriptions therefore
information is provided. The vast majority of these are require approval by a state or territory health
approved without modification. department like other Schedule 8 medicines. The Table
Generally, an SAS-B application must state the summarises the current requirements. Products that
clinical justification for the use of a specific medicinal contain CBD only (at least 98% of total cannabinoid
cannabis product for a particular patient. This includes content) are Schedule 4 (prescription-only) medicines
the reasons for using an unregistered product rather and do not require such approvals.

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Prescribing medicinal cannabis

Table A
 ustralian state and territory requirements for prescribing Schedule 8 medicinal cannabis products

WA VIC NSW QLD TAS NT ACT SA

General practitioner Yes* Yes Yes Yes No† Yes Yes Yes
Authorised
prescribing

TGA online portal Yes Yes Yes Yes – Yes Yes Yes
application

State Health Done Done No – unless No – unless – No – but Done Yes‡

application simultaneously simultaneously <16 years of a drug- required to simultaneously The patient
via TGA online via TGA online age or a drug- dependent notify the NT via TGA online can be put
portal portal dependent person Chief Health portal on a 2-month
person Officer if the trial (and then
patient uses health authority
a Schedule 8 approval must be
medicine for sought), if they
Documents >8 weeks are not on any
required
other Schedule 8
medicine or drug
dependent.

Clinical justification Yes Yes Yes Yes – Yes Yes Yes

and treatment plan

VOLUME 43 : NUMBER 5 : OCTOBER 2020

Cannabis-based No§ No§ No§ No§ – No§ Yes Yes
consent form

Letter of support No*# No# No# No# – No# Yes No#

from specialist

* GPs in WA are required to seek specialist approval when prescribing to children under 16 years of age or to drug-dependent individuals.
† Only specialists can prescribe in Tasmania.
‡ Patients over 70 years of age or notified palliative care patients do not need a SA Health Schedule 8 approval.
§ Cannabis-based medicine consent forms are not required, but it is recommended to have one in the patient’s records.
# Unless a GP is applying to treat a condition outside of their area of expertise.
TGA Therapeutic Goods Administration
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When prescribing for patients located in other states

Fig. 1 How to prescribe medicinal cannabis in Australia
and territories, the prescriber must be mindful of
meeting the Schedule 8 authorisation requirements
of the location in which the product is dispensed.
Patient presents for medicinal cannabis
Tasmania has stringent additional requirements so
there are few approvals in that state.14

Dispensing Is patient’s condition treatable with

medicinal cannabis? Clinician checks Patient not suitable
Medicinal cannabis products are dispensed by No
evidence (searches literature, refers to for treatment
pharmacies. It is critically important that the TGA guidance documents)
dispensing pharmacist has an understanding of the
product and has clear lines of communication with the Yes
patient and prescriber. There is often a dose titration
during the first weeks of therapy and this needs to be
In-depth assessment of condition:
clearly communicated with the patient. Patient not suitable
have red flags and comorbidities been No
for treatment
Supply chain problems can prevent access to a product ruled out?
that has been specified in the SAS-B application.
It may then become necessary for a clinical Yes
re-evaluation to find a more readily available product
and to apply for a new SAS-B permit for that product.
Have first- and second-line therapies Patient not suitable
No
No cannabis products currently have a subsidy on been trialled for condition? for treatment
the Pharmaceutical Benefits Scheme and costs can
be considerable. These are typically around $5–$15 Yes
a day,16 but substantially more for patients with
conditions such as epilepsy that require very high
Have patient factors been assessed:
doses of CBD. It is important for prescribers to have Patient not suitable
driving, unstable cardiac disease, drug No
an open conversation with their patients around likely for treatment
and alcohol abuse, mental health?
ongoing costs. Patients receiving disability pensions,
aged pensions or other Centrelink benefits may be Yes
unable to afford medicinal cannabis.

Conditions treated Therapeutic Goods Administration Patient not permitted

Rejected
application and relevant state permit for treatment
Most approvals under SAS-B are for the treatment
application process
of chronic non-cancer pain (Fig. 2). This includes
conditions such as arthritis, lower back pain, neck
Approved
pain and various forms of neuropathic pain. These
are typically treated with oral solutions that contain
THC and sometimes additional CBD. Other common Prescription and permit provided to patient
conditions among SAS-B approvals include anxiety,
cancer-related symptoms (e.g. pain, nausea,
anorexia), epilepsy, insomnia, and spasticity in Pharmacy sources and dispenses medication
multiple sclerosis (Fig. 2). CBD-only products are
being used in all of these conditions, but there is a
greater use of them in patients with epilepsy and Regular patient review with clinician
anxiety. The anxiolytic effects of CBD are described
in the literature.13,17,18
The TGA has published a series of clinical guidance
documents that summarise the available evidence trials with cannabis products7 and the recency with
for medicinal cannabis products in chronic pain, which CBD has been identified as a therapeutic
palliative care, epilepsy, spasticity in multiple sclerosis drug. Nonetheless, TGA assessments under SAS-B
and chemotherapy-induced nausea and vomiting. appear to give the benefit of the doubt with
However, definitive evidence in support of specific regard to evidence. SAS-B approvals have been
medicinal cannabis products for various conditions given for conditions such as autism, insomnia and
is often not available. This absence of evidence movement disorders despite a lack of compelling
reflects historical difficulties in undertaking clinical supportive evidence.

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Fig. 2 A
 pprovals for medicinal cannabis products in October 2019*

2500
 Schedule 4 (prescription-only medicine)
2250
 Schedule 8 (controlled drug)
2000

1750
Number of approvals

1500

1250

1000

750

500

250

0
e

ia

ty

nia

pai c

pto in

ty

ain
hi
rain

ms
PTS
alg

sym r pa
tici

xie
lep

pat
om

cp
my

An
Mig

Epi

and Cance
spa

oni
uro
In s
ro

Ch r
Ne
Fib

MS

Conditions

PTSD post-traumatic stress disorder

MS (multiple sclerosis) spasticity includes approvals for MS spasm, pain and spasticity.
Epilepsy includes approvals for epilepsy, seizure and psychogenic seizures.
Neuropathic pain includes approvals for neuropathic pain and peripheral neuropathy.
Anxiety includes approvals for anxiety and social anxiety disorder.
* Data are for 3364 approvals under Special Access Scheme Category B. Sourced from Freedom of Information Request
#1409 to the Therapeutic Goods Administration.

Adverse effects can be minimised with careful titration and also by

It is recommended that medical practitioners combining with CBD which may have antipsychotic
discuss with their patients the risks and benefits of and anxiolytic effects. Regular review of patients
medicinal cannabis so that the patient can provide is recommended.
informed consent to this therapeutic pathway. CBD has been shown to be well tolerated at very high
Patients need to be given information about doses (up to 5000 mg).23 CBD is a potent inhibitor of
common and serious adverse effects. Cannabis, various cytochrome P450 enzymes.24,25 Higher doses
THC and CBD are generally well tolerated by patients may increase plasma concentrations of anticonvulsant
with few serious adverse effects.6,19-22 At higher drugs such as clobazam and topiramate.26 Children
doses, THC can have sedative effects and make with epilepsy who are on concomitant anticonvulsant
naïve users feel dizzy and ‘spaced out’.6,19-22 Appetite drugs may be vulnerable to related adverse effects
stimulation (‘the munchies’) is also common with such as sedation, gastrointestinal upset and elevated
THC.6 A typical intoxicating dose of THC in a naïve liver transaminase levels.11,27 In clinical trials outside
user is at least 10 mg, although some patients may of childhood epilepsy the only significant side effect
be more sensitive. Starting low and slowly titrating with CBD was diarrhoea.27 Interactions of CBD with
the dose upwards is the best practice. The more drugs such as benzodiazepines, antidepressants and
troubling symptoms of THC intoxication, such as opioids appear unlikely to be clinically significant
paranoia, severe anxiety and psychotic reactions, in adult clinical populations, but more research

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is required. Given this uncertainty, upwards dose or not.3 There are educational events, online courses
titration is a valid precautionary practice in patients and accredited workshops such as those by the Royal
given CBD-containing products, particularly if they Australian College of General Practitioners. Doctors
are also taking other medicines. who do not want to prescribe may wish to direct their
patients to one of the many clinics specialising in
Effects on driving cannabis access that have been established in many
Driving is a key issue to discuss with patients as it Australian capital cities.
is currently illegal to drive while being treated with
Despite the exponential rise in approvals under the
products containing THC. At present in Australia, if
SAS-B scheme, surveys suggest that many Australians
THC is detected in oral fluid by mobile drug testing,
continue to self-medicate with illicit cannabis.34,35
patients can be prosecuted. There is currently no
Indeed, the National Drug Strategy Household
exemption for people with a legitimate prescription
Survey recently reported that 600,000 Australians
for THC. There is however evidence suggesting
use cannabis for medicinal purposes, but only 3.9%
that driving impairment is modest in those who
obtain it via legal pathways.36 The reasons for this
repeatedly use THC.28,29 Current tests can detect
may include the high cost of unregistered cannabis-
cannabis for several hours after THC consumption, but
based products compared to illicit cannabis (which
there are large individual differences so some patients
is often home-grown), the inability to find a doctor
are more vulnerable to a positive test than others.30
who will assist in making an application to the TGA,
Patients should wait at least six hours after consuming
lack of knowledge of official access pathways, and a
THC-containing products before driving and be aware
reticence to discuss cannabis use with a doctor.34,35
that, even then, they remain vulnerable to prosecution
under current laws. Issues associated with workplace Illicit cannabis products are likely to be suboptimal
use of THC-containing products also need to be as therapeutics. They probably contain a great
carefully considered, especially for patients working in deal of THC and little CBD37 and may also contain
transportation industries and in workplaces requiring contaminants such as pesticides and heavy metals.
the safe operation of heavy machinery. Artisanal cannabis oils used in Australia to treat
intractable childhood epilepsies have pronounced
CBD is not intoxicating. There are no restrictions
variation in their cannabinoid composition. In some
around driving while taking CBD-only products.
cases, products that were purported to be CBD-
THC contamination of CBD products is a significant
dominant were actually rich in THC.38 Products
worldwide issue and it is therefore prudent for
obtained through official schemes must abide by the
doctors and patients to request certificates of analysis
Australian standard TGO 93 for medicinal cannabis.
from the manufacturer.31
While there is an intent to enable access to quality-
Withdrawal controlled medicines via the SAS-B and Authorised
Cannabis is euphorigenic and can be habit- Prescriber schemes, the current framework remains a
forming, leading to dependence in approximately work in progress. It is arguably still short of meeting
10% of recreational users. Sudden withdrawal can community expectations around access for patients.
cause a clinically significant but relatively benign A recent Australian Senate Inquiry14 has offered
withdrawal syndrome that includes mild sleep numerous recommendations for improving patient
and appetite disturbances, cannabis craving and access to products, as well as identifying strategies
emotional lability.32 The likelihood of drug-seeking to improve the education of doctors in this rapidly
behaviour in patients wishing to use medicinal developing and sometimes challenging area of
cannabis products should be carefully assessed by clinical practice.
prescribers. Patients using higher doses of THC are
best gradually titrated off THC-containing products Jonathon Arnold is Deputy academic director of the
when discontinuing their use. Withdrawal from CBD Lambert Initiative for Cannabinoid Therapeutics,
does not appear to be associated with any significant a philanthropically funded research centre at the
discontinuation syndrome.33 University of Sydney. He has served as an expert witness
in various medicolegal cases involving cannabis and
Current and future challenges advised the World Health Organization in their recent
Prescribing medicinal cannabis may feel like a ‘leap in expert reviews of cannabis. His research is funded
the dark’ for many GPs who feel uneducated in this by the Lambert Initiative and the Australian National
emerging area of clinical practice. Australian doctors Health and Medical Research Council (NHMRC).
are fielding daily enquiries about medicinal cannabis Jonathon Arnold and Iain McGregor hold patents on
from their patients, so it is prudent to learn more cannabinoid therapies (PCT/AU2018/051089 and PCT/
regardless of whether they wish to prescribe cannabis AU2019/050554).

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Iain McGregor is Academic director of the Lambert Acknowledgement: This work was supported by the
Initiative for Cannabinoid Therapeutics. He has served Lambert Initiative for Cannabinoid Therapeutics. The
as an expert witness in various medicolegal cases authors gratefully acknowledge Barry and Joy Lambert
involving cannabis, has received honoraria from Janssen, for their continued support. They are grateful to Little
is currently a consultant to Kinoxis Therapeutics, and Green Pharma for assistance in the preparation of
has received research funding and fellowship support the Table, and Rhys Cohen and Melissa Benson for
from the Lambert Initiative, NHMRC and Australian assistance in the preparation of Fig. 2.
Research Council. He holds a variety of patents for non-
cannabinoid therapeutics.

Tamara Nation has received a speaker fee honorarium

from Althea, Spectrum Therapeutics/Canopy Growth,
Cannatrek and a case-study fee from Entoura.

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FURTHER READING
NPS MedicineWise. Medicinal cannabis: what you need to know.
https://www.nps.org.au/professionals/medicinal-cannabis-what-
you-need-to-know [cited 2020 Sep 1]

Full text free online at nps.org.au/australian-prescriber 159