Medicinal cannabis – A hazy issue

By MIPS | Following TGA guidance

The Therapeutic Goods Administration has tightened regulations around the prescribing of medicinal cannabis, which means there are greater potential legal hazards for healthcare practitioners. 

Medical cannabis

MIPS has been made aware that some practitioners may be prescribing, are considering prescribing or have been approached for prescriptions of medicinal cannabis. 

MIPS Claims

To date, MIPS has not received a notification or claim concerning any act, error or omission in the treatment of a patient prescribed medicinal cannabis however, we strongly recommend that practitioners understand their obligations to their state/territory’s drugs and poisons authority and the Therapeutic Goods Administration (TGA) before considering prescribing medicinal cannabis.

Caution to MIPS members

MIPS recommends that you contact us prior to commencing prescribing medicinal cannabis by completing a Practice Assessment Questionnaire. Where practitioners see patients on the referral of a GP and patients are appropriately screened, consented and monitored, and your practice is in accordance with AHPRA and Medicare requirements, MIPS will be able to extend cover. Where consultation is exclusively via telehealth for the prescription of medicinal cannabis or any schedule 8 or 9 drugs, MIPS does not have a membership classification and is unable to extend cover. MIPS considers each practitioner’s approach on an individual basis.

Before taking a role where you will be expected to see patients who are likely candidates for medicinal cannabis it is advisable to assess the practice's processes and consider if the practice is unfairly passing the liability to you.

Legislation

Victoria was the first jurisdiction to introduce some legislation to allow for the prescription of medicinal cannabis through the Access to Medicinal Cannabis Act 2016 (Vic)  However, since the Act’s introduction the Commonwealth Government passed the Narcotic Drugs Amendment Act 2016 (Cwlth) which has made it legal to expand access for patients across Australia. In Victoria, according to the health.vic.gov.au website:

With imports now available and no restrictions on patient groups under the Commonwealth regulatory schemes, Victorian patients have access to medicinal cannabis (if prescribed by their doctor) regardless of age or medical condition. All patients are now 'eligible' patients.
This means that prescribing doctors in Victoria are able to prescribe medicinal cannabis for any medical condition, provided they have the relevant Commonwealth approvals from the Therapeutic Goods Administration, and - if the product is a Schedule 8 product - a Schedule 8 Treatment Permit under the Victorian Drugs Poisons and Controlled Substances Act.

This provides a broad definition of an eligible patient but in reality, it is somewhat more restrictive. 

TGA Approved Provider

The TGA have approved one medicinal cannabis product: Nabiximols (Sativex®). This can be used for “treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy”. Practitioners must be authorised to prescribe Schedule 8 drugs in their jurisdiction in order to prescribe Nabiximols.

Any other medicinal cannabis products (ie unapproved products) these can only be prescribed with special permission obtained from the TGA through any of the following:

Authorised Prescriber Scheme

Practitioners can apply for this where patients genuinely require an unapproved product. If successful, practitioners are granted authority to become an 'Authorised Prescriber' of a specific medicinal cannabis to specific patients (or type of patients). As of 30 Nov 2018, there were 52 authorised prescribers.

Special Access Scheme

Practitioners can apply where there are exceptional clinical circumstances. There are multiple pathways defined by the TGA. Up to 30 Nov 2018, the TGA reported a total of 2,339 approved applicants under category B of the Special Access Scheme.

Clinical trials

MIPS also provides indemnity for members involved in clinical trials. Cover is subject to approval but provided at no additional cost. Members can apply to MIPS through the Clinical Trial and Research Project Notification form

The TGA provide further guidance about prescribing medicinal cannabis, specifically for the:

  • treatment of multiple sclerosis
  • treatment of palliative care patients
  • treatment of epilepsy in paediatric and young adult patients
  • prevention or management of nausea and vomiting
  • treatment of chronic non-cancer pain

While the guidelines do not prohibit the prescription of medicinal cannabis for other conditions, both MIPS and the TGA have an expectation that the treating doctors use their judgement. The TGA advise that:

As with all therapies medical practitioners must exercise their professional judgment in determining if this [medicinal cannabis] is an appropriate product for an individual patient. In general terms, the less critical the clinical need for the proposed product, the higher the degree of evidence needed to support the use of that product. At this time, we suggest that the use of medicinal cannabis may be considered only when registered medicines have been tried and proven unsuccessful in managing the patient's symptoms or medical condition.

Check list for practitioners considering prescribing medicinal cannabis:

  • Obtain a (or check your) permit with your state/territory’s drugs and poisons authority for Schedule 8 drugs
  • Prescribe only Nabiximols (Sativex®) for treating spasticity due to multiple sclerosis (MS)
  • Seek TGA approval to prescribe any unapproved forms of medicinal cannabis (currently anything other than Nabiximols) under either the Special Access Scheme or the Authorised Prescriber Scheme
  • Contact MIPS to request consideration for confirmation of your indemnity cover specific to how you intend to practice

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The materials provided are for educational purposes only. Whilst all reasonable care has been taken in preparing these materials, including the accuracy of the information supplied, MIPS does not accept any liability whatsoever arising out of the use or reliance of the information provided. Contact MIPS 24/7 Clinico-Legal Support 1800 061 113 or education@mips.com.au for specific advice.