Important: The information in this article is not legal advice and is not being provided by lawyers. If you have questions about the law, please consult a legal practitioner.
In November 2021, the Therapeutics Goods Administration (TGA) changed the medicinal cannabis access framework to help streamline the process. The changes mean that as of late November ‘21, prescribers of medicinal cannabis apply for approval to prescribe patients based on product categories, not individual products.
In this article, we’ll explain the old and new frameworks and the implications of these changes on everyone involved in the medicinal cannabis framework. If you’re interested in learning about the confusion created by these framework changes, we recommend you read our Generic or Open Script Article.
The only patient-facing change that the category scripts creates is that when a product goes out of stock, the pharmacist may contact the doctor and determine with the prescriber which alternative product is suitable for the patient without another patient consultation. Here’s what the article covers:
- How do the current application and prescribing system work?
- Before changes and current process
- Implications for prescribers, pharmacists and patients
- Conclusion (includes specific FAQs)
How do the current application and prescribing systems work?
To answer this question fully, we’ll give you an overview of how the application and approval system worked before the changes and how the current system works. We’ll cover the Special Access Scheme (SAS) and Authorised Prescriber (AP) Schemes so you get the complete picture.
It’s important to note that these changes to the TGA guidelines are about the application to authorise prescribing a product for a patient and how the approval works. The TGA is not specifically guiding the scriptwriting and dispensing process. So, while some of the articles you may read make it seem like the TGA is making rules around State prescriber and dispensing guidelines, the TGA has always stated that local rules apply.
Please also note that the application processes are more complicated than outlined in the section below. Therefore, we’ve chosen to leave out the details so you understand the concepts rather than the detailed framework.
Old application process
Old Special Access Scheme (SAS) Guidelines
Under the old rules, health professionals could apply via the SAS to get approval to prescribe medicinal cannabis. The old application was for the authority to prescribe:
- A single patient with a
- Specific product for a
- Specific condition
This meant that, upon approval, the health professional could prescribe the approved product to that patient using a single script. If the prescriber wanted to change or add a new medication, the prescriber would need to apply for each product or new product. Repeats did not need a new script, and TGA approvals were generally valid for 24 months.
Old Authorised Prescriber (AP) Guidelines
For a prescriber to become an AP, they needed to apply for Human Research Ethics Committee (HREC) or endorsement from a specialist college and then apply to the TGA for the AP approval. AP applications to the TGA were submitted for authorisation to prescribe:
- A specific product for a
- Specific condition(s) to
- Unlimited patients with that condition
This meant that, upon approval, the health professional could prescribe a specific product for the conditions they were approved for to any patient with those conditions. The AP did not need to apply for every script they wrote but needed to provide reporting to the TGA once every six months. They could always use the SAS pathway if the AP wanted to prescribe outside of their AP authorisation.
Current application process
New Special Access Scheme (SAS) Guidelines
Under the new SAS pathway guidelines, prescribers now apply to the TGA for the authorisation to prescribe:
- A category of products for a
- Specific condition to
- A single patient
If approved, a prescriber may write a script for any product within the approved category. The new rules also mean that if the prescriber wants to add or change medications within that category, they do not have to re-apply. This is particularly important when products go out of stock.
New Authorised Prescriber (AP) Guidelines
Under the new AP framework, the TGA created two main pathways. One requires an HREC or specialist college endorsement and approval by the TGA, and the other, called the Established History of Use pathway (EHOU), only requires TGA approval. Similar to the SAS pathway changes, the approvals are now for:
- A category of products for a
- Specified condition(s) to
- Unlimited patients with that condition
Again, we’ve left several details on these changes out of the description to make it easier to understand; however, the key takeaway is that prescribers are applying for approval to prescribe a category of products rather than a single product.
NOTE: The EHOU pathway only applies to Category 1, 2 & 3 oils or capsules and is limited to
- Chronic Pain (Cat 1, 2 & 3) and
- Anxiety (Cat 1 & 2) and
- only applies to Adult patients.
We’ve focussed on the category change because people have interpreted the category approval as “A prescriber can now write a blank category script which entitles the patient and pharmacist to choose the product.”
Implications for prescribers, pharmacists and patients
For prescribers and health professionals, the TGA made these changes for various reasons.
The changes that moved away from product-specific TGA approvals to category approvals were to reduce the admin and workload for prescribers, pharmacists and the TGA when products go out of stock and for scenarios where the prescriber wants to change the product to a similar product for clinical reasons (where the products are within the same category).
The changes to the AP Framework with the addition of the EHOU pathway were to allow prescribers who have experience with medicinal cannabis to reduce their admin burden and to streamline access to medicinal cannabis products that the TGA deems to be less risky than dose formats like flower.
As a result, more prescribers have taken the steps to become Authorised Prescribers, and we’ve seen SAS B approval numbers decrease as a percentage.
The implication is that when patients are eligible for medicinal cannabis, they’re likely to get access to their medication more quickly because their prescriber is more likely to be an AP. When products go out of stock Australia-wide, patients don’t need to wait for weeks to see their prescriber to access a new script for a product in stock. Pharmacists may now substitute products that are out of stock Australia-wide and don’t need to deal with upset patients because of the red tape and resulting lag in approvals.
In making these updates to the framework, the TGA has streamlined parts of the process to improve access to medicinal cannabis for patients. The reduction in admin from category approvals has been a factor in getting more health professionals to try prescribing medicinal cannabis. More prescribers have become APs, which means less wait time for products, and patients have better access to medication when products go out of stock Australia-wide, which is unfortunately still happening regularly.
While these outcomes seem positive for all parties involved, not everyone has received the changes as positive. The TGA category changes have raised questions and, at times, conflict around whether Generic/Open Scripts are valid prescriptions and if pharmacies should dispense these scripts.
While the TGA has provided clear guidance around the implications of the category changes, the TGA does not regulate prescribers and pharmacists. Some health professionals around the country argue that the Generic/Open Script is a valid prescription. To learn more about this ‘new’ prescription format, read our Generic or Open Script Article.
What does the new TGA category approval system mean for me as a patient?
In theory, the new category system impacts patients positively but doesn’t involve the patient at all.
The new category approval system means that a prescriber no longer needs to apply to the TGA to write a script for a new product in the same category. It also means that if your prescribed product goes out of stock, you shouldn’t be required to make a new appointment – your pharmacist should be able to organise a product substitution or contact your prescriber to work with them to select a new product. It will depend on how your prescription is written.
Is it possible to get a cannabis category script without a specific brand or product listed?
No. There is no such thing as a Category Script. Some clinics and prescribers will write what people call a Generic or Open Script, but that is not a prescription for a category of products.
If you receive a Category Script, be aware that a pharmacy will likely be unable to fill the script. If a pharmacy receives a category script, they may contact your prescriber and explain how to write a proper prescription for medicinal cannabis.
What if my product goes out of stock? Can the pharmacist substitute products?
These guidelines were created so that prescribers do not need to re-apply for a new script to provide the new product. That, however, does not mean that a pharmacist will automatically be able to swap products without speaking with the prescriber. This will depend on how your prescription is written. From speaking with multiple pharmacists and looking at the VIC Health information above, it seems that the correct process would be:
- Pharmacist confirms stock outage (countrywide, not just from a single distributor).
- Pharmacist checks whether the script says “no substitution”.
- If the script doesn’t have “no substitution” the pharmacy may substitute. If “no substitution” applies then…
- Pharmacist contacts prescribing practitioner, discusses and determines a suitable substitution.
- Pharmacist creates a record of the interaction with the prescriber and can dispense the new medication.
It’s vital to note that out of stock in point 1 means Australia-wide. Pharmacists often rely on distributors for stock levels when a single distributor’s stock level does not necessarily reflect the stock Australia-wide. It’s best to ask your pharmacist to contact the product sponsor to confirm stock availability, not just the distributor.