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Patient Information

Patient Access to Medical Cannabis in Australia

In Australia, Medical Cannabis is currently generally classified as an unregistered product – unlike the registered prescription medicines that you are used to accessing through the PBS (Pharmaceutical Benefit Scheme). Despite this patients can still access Medicinal Cannabis and this is a brief guide to how this process works from the patient’s perspective.

Medicinal Cannabis  products can be accessed via the following three access pathways:

  • Special Access Scheme (SAS) There are two pathways: ‘A’ and ‘B’.
  • Authorised Prescribers
  • Clinical trials

Authorised prescribers deal with a specific group of patients with the same diagnosis. Any doctor can prescribe Medicinal Cannabis without becoming an ‘authorised prescriber.’  This method of access is often used by specialist doctors such as a doctor working exclusively with patients who have a diagnosis of HIV/AIDS or a specialist working in a neurology clinic who sees patients with Multiple Sclerosis. Clinical trials allow access but there are often specialised acceptance criteria and requirements that your doctor can guide you through if this pathway suits your needs.

If you have a diagnosis of a life-limiting illness your doctor may choose the streamlined ‘SAS A’ process but for most patients, Special Access Scheme (SAS) Category ‘B’ is the most common and quickest pathway a general practitioner can use to prescribe Medicinal Cannabis.

This document focuses on this common ‘SAS B’ pathway which facilitates access for a wide variety of patients with many different symptoms. 

 

SAS B

Medical Cannabis is not a first-line treatment. This means that, in most cases, your doctor will need to try some other treatments for the symptoms that you have.

The government considers cannabinoid therapy something that should only be used after standard treatments have been unsuccessful or caused unacceptable side-effects or hold unacceptable risks.

As part of the application your doctor will need to comment on the previous treatments that have been tried and what happened to justify the request for Medicinal Cannabis.

If you are wishing to look further into how you or a loved one may be able to access medicinal cannabis as a treatment option we advise all patients to contact their GP or Specialist.

For more information on how to access medicinal cannabis please ask your GP or Specialist to contact our team on (02) 4942 6021 or by emailing us admin@cannapacific.com.au

Please note product information is available only to medical practitioners.

Step by Step Guide: using the ‘SAS B’ pathway to access Medicinal Cannabis

STEP 1: Doctor Consultation

As a first step you should see the doctor who knows you, or the symptom you are concerned about, best. For most patients, this will be your General Practitioner, but in some cases, it may be your specialist. If, for example, you have an oncologist (cancer specialist) or respiratory physician (lung specialist) who you see regularly they may be willing to prescribe Medicinal Cannabis if the symptom of concern relates to the condition they are treating you for. 

In Western Australia, a GP requires a letter from a specialist to support the prescribing of Medicinal Cannabis. In other states, this is needed only if the GP involved does not have sufficient expertise in the specific illness involved. This can occur particularly if your symptom is due to a rare condition that the GP may not encounter often.

The doctor that you see needs to be an Australian-registered medical practitioner with appropriate qualifications and/or expertise for the condition requiring treatment. The government has indicated that it favours the involvement of your usual GP in the prescribing of Medicinal Cannabis because that doctor knows you and your health, is aware of your history and has access to your medical record. This ensures that prescribing is both appropriate and safe and also makes sure that you can receive appropriate follow-up.

 

STEP 2: Product consideration

If your medical practitioner decides that cannabinoid therapy is an appropriate treatment they will then need to determine exactly which product is suitable. They are likely to consider the following;

  • Which ‘mix’ of cannabinoids is best to treat your symptom
  • Which form of Medicinal Cannabis is best for your specific symptom
  • Product availability 
  • The ongoing costs for you
  • If it is a ‘Schedule 4’ medicine (Prescription Only) or ‘Schedule 8’ medicine (Controlled Drug) as the approval process and product delivery can differ 

The doctor will also consider the safety and quality requirements that are dictated by the government.  These requirements are set out in Therapeutic Goods Order No 93 (TGO93) and form an important part of the information that the medication supplier has to supply to the TGA (Therapeutic Goods Administration).

Remember that product choice is the responsibility of the doctor. You may have read a lot of information about Medicinal Cannabis but it is a prescribed medication and your doctor needs to consider issues such as interactions with other medications you may be on, your liver function and your family history. They will research and compare products to find which best fits your symptoms and circumstances.

 

STEP 3: Application to TGA +/- State Health

Once the doctor has decided which Medicinal Cannabis product is appropriate they will ask you to consent to the application being made. The doctor then applies for approval using the ‘SAS B’ pathway.

The doctor needs to ensure that they can meet the TGA requirements. They need to ensure that:

  • They have performed an appropriate history and examination
  • They can submit documentation detailing medications that have been trialled for the condition but have been unsuccessful or have caused side-effects
  • They have a treatment plan and a plan for your follow-up

CannaPacific is focussed on supporting General Practitioners to effectively and safely prescribe Medicinal Cannabis for their patients. We have developed an online support portal that assists the GP with the application process whilst ensuring that you and your GP remain in charge of all the decisions that affect your health and well-being. 

 

STEP 4: Approval

The TGA will receive the application and, if everything is in order, issue an approval. Occasionally they may request more information from the doctor. Currently, if you live in NSW, Victoria, Queensland, WA, SA or the  NT when the doctor receives an approval from the TGA they can proceed and issue the prescription.

For certain controlled Schedule 8 medicines doctors in the  ACT and Tasmania need to take a second step and apply to their State Health Department as well. Unfortunately, each Australian State and Territory has slightly different requirements for patients trying to access Medical Cannabis depending on which schedule listing the medical cannabis products fall under.

 

STEP 5: Patient Access

Once the doctor receives approval they can generate the prescription and approval for Medical Cannabis and you can then take these to your choice of pharmacy. Pharmacists do not usually keep Medicinal Cannabis on the shelves and it is important to remember that the script is item, manufacturer and patient-specific. The relevant Health Department approvals are sent to the wholesaler by the pharmacy. Wholesalers then release the specific prescribed product to the pharmacy who will finally dispense it to you.

Medicinal Cannabis is a safe medication but it often requires a process of careful titration to be effective. It is important to return to see the prescribing doctor for follow-up and to ensure that you follow the prescribing directions carefully.

Frequently asked questions

What is medicinal cannabis?

‘Medicinal cannabis’ refers to pharmaceutical cannabis preparations such as oil, tinctures and other extracts, intended for human therapeutic use.
Medicinal cannabis contains specific active cannabinoids in known amounts and mixtures, which can be carefully controlled, standardised and administered for patient use.

Is medicinal cannabis legal in Australia?

Yes it is, the Australian government passed legislation in 2016 legalising cannabis for medicinal use. The law states that medicinal cannabis can only be prescribed legally by a doctor or specialist that either prescribes a product listed on the ARTG (Australian Register of Therapeutic Goods) or has been approved to prescribe through the Special Access Scheme or Approved Prescriber process.

All other forms of cannabis including recreational are still illegal.

How is medicinal cannabis different from recreational cannabis?

Technically both medicinal and recreational cannabis all come from the same plant genus, the difference is in the cannabinoid profile of each plant. Recreational cannabis varieties are predominantly female as they produce flowers, where the majority of the cannabinoids exist. They are generally bred to produce large quantities of THC with little to no CBD or other cannabinoids. This is done as a way to get the desired psychoactive effect.
Medicinal grade cannabis is bred to maximise the therapeutic properties of the plant. The plant varieties bred generally see higher CBD content and balanced cannabinoid profiles with treatment specific breeds being grown.

What is the difference between THC and CBD?

THC is the most abundant part of cannabis responsible for its psychoactive effects. In comparison to THC, CBD is the second most abundant, non-psychoactive part of the cannabis plant. Both THC and CBD have been shown to have therapeutic benefit for a range of medical conditions. Medicinal cannabis preparations have different ratios of THC to CBD.

Which medical conditions or diseases are medicinal cannabis products able to treat?

The Therapeutic Goods Association (TGA) imposes no restrictions on the indication/s for which a doctor may apply to access an unapproved medicinal cannabis product for their patient. However, before a patient considers this treatment option they must be aware that cannabinoid therapy can only be used after standard treatments have been unsuccessful or caused unacceptable adverse effects with the exception being patients in palliative care.

What form does medicinal cannabis come in?

Medicinal cannabis comes in many forms including ingestible oils and capsules, oral sprays, inhalers and dried flowers. The most common form of medicinal cannabis in Australia is extracted cannabis oils which come in different cannabinoid ratios and concentrates that are then easily administered and adjusted using a dropper bottle.

How do I get information on medicinal cannabis products?

Information about medicinal cannabis products is limited to doctors and pharmacists, due to these products being unregistered prescription medications with the TGA. You should make an appointment to see your GP or specialist to discuss this treatment option.

I’d like to be prescribed medicinal cannabis. What do I do and what is the process?

It is recommended that you make an appointment to visit your usual treating GP or specialist as they will have a good understanding of any current medical conditions and medications you are currently taking. If your doctor decides that you are suitable for cannabinoid treatment they will then determine which product may suit your condition and circumstances. With your consent, your doctor will then apply for federal and state approval via the Special Access Scheme (SAS B) pathway. In NSW, once your doctor has been given approval they may then prescribe medicinal cannabis to you. You should then take the prescription to your pharmacist where it will then be ordered.

How long will it take for the TGA to review my application once submitted by my doctor?

The process for approval can take anywhere up to 2 business days. If your doctor is unfamiliar with the process for prescribing medicinal cannabis they can contact us directly.

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