Accessing medicinal cannabis in South Australia can be a complex process, but understanding the steps involved can help patients navigate the system. This blog post will outline the necessary requirements and procedures to obtain medicinal cannabis legally, including consulting with a medical practitioner, obtaining a prescription, and understanding the different TGA prescribing pathways for accessing unapproved medicinal cannabis products.
TGA Prescribing Pathways: Navigating Special Access Scheme B and Authorised Prescriber
When it comes to accessing unapproved medicinal cannabis products in South Australia, medical practitioners must navigate the Therapeutic Goods Administration (TGA) prescribing pathways. The two primary pathways are the Special Access Scheme B (SAS B) and the Authorised Prescriber (AP) Scheme. Both routes ensure patient safety and oversee the use of unapproved therapeutic goods, including medicinal cannabis products.
Special Access Scheme B (SAS B)
The SAS B pathway allows doctors to prescribe unapproved medicinal cannabis products for individual patients on a case-by-case basis. This pathway is most commonly used and caters to situations where a patient requires a specific product not approved by the TGA for human therapeutic use.
To apply for SAS B, the medical practitioner must:
- Complete the relevant online TGA application form, supplying detailed information about the patient, their medical condition, and the proposed treatment plan
- Obtain the necessary state or territory approvals, such as from the South Australian Drugs of Dependence Unit (DDU)
Once the TGA approves the application, the doctor can prescribe the unapproved medicinal cannabis product for the designated patient.
Authorised Prescriber (AP) Scheme
The AP Scheme targets experienced medical practitioners who wish to prescribe a particular unapproved medicinal cannabis product for a specific medical condition across multiple patients. By becoming an “authorised prescriber,” the medical practitioner gains the authority to prescribe the unapproved product without applying for individual SAS B approvals.
To become an authorised prescriber, the medical practitioner must:
- Demonstrate their expertise in the condition being treated and their familiarity with the unapproved medicinal cannabis product
- Submit an application to the TGA, including a clinical justification for using the product, a treatment plan, and a patient monitoring protocol
- Obtain the necessary state or territory approvals, such as from the DDU
- Secure endorsement from a Human Research Ethics Committee (HREC) or a specialist college
Once approved, the authorised prescriber can prescribe the unapproved medicinal cannabis product to patients with the specified medical condition without applying for individual SAS B approvals.
Key Differences between SAS B and Authorised Prescriber
- SAS B focuses on individual patient access on a case-by-case basis, while the AP Scheme allows for prescribing to multiple patients with a specific medical condition
- The AP Scheme necessitates endorsement from an HREC or a specialist college, while SAS B does not
- The AP Scheme is more fitting for medical practitioners with expertise in a particular condition and familiarity with a specific unapproved medicinal cannabis product
South Australian Drugs of Dependence Unit Requirements
Regardless of whether the medical practitioner is using the SAS B or AP Scheme to prescribe medicinal cannabis, they must also obtain approval from the South Australian Drugs of Dependence Unit (DDU). The DDU is responsible for monitoring and regulating the prescription of controlled drugs, including medicinal cannabis products, within the state.
The medical practitioner must submit an application to the DDU, providing details about the patient, their medical condition, and the proposed treatment plan. Once the DDU approves the application, the doctor can proceed with prescribing the medicinal cannabis product.
Medical Conditions and Insufficient Clinical Evidence
While medicinal cannabis may be prescribed for various medical conditions, it is important to note that there is often insufficient clinical evidence to support its use for many conditions. This lack of clinical evidence is one reason why the TGA has not approved many medicinal cannabis products for human therapeutic use. As a result, medical practitioners must rely on the SAS B or AP Scheme to prescribe unapproved medicinal cannabis products to patients who may benefit from them.
Accessing Medicinal Cannabis through a Pharmacy: A Step-by-Step Guide
After obtaining a prescription for medicinal cannabis from an authorised medical practitioner, patients can access their prescribed medicinal cannabis products through a licensed pharmacy. Here is a step-by-step guide to accessing medicinal cannabis through a pharmacy.
- Locate a Pharmacy Dispensing Medicinal Cannabis Products: Not all pharmacies stock medicinal cannabis products, so it is crucial to find a pharmacy that dispenses them. Patients can ask their doctor for recommendations or search online for pharmacies in South Australia that offer medicinal cannabis.
- Present Your Prescription: Bring your medicinal cannabis prescription to the chosen pharmacy. The pharmacist will need to verify the prescription, ensuring that it meets the South Australian regulatory requirements for controlled drugs and that it was issued by an authorised medical practitioner.
- Discuss Medicinal Cannabis Use with Your Pharmacist: Just like with other prescription medicines, it is essential to discuss the use of medicinal cannabis products with your pharmacist. They can provide valuable information on dosage, potential drug interactions with other medicines you may be taking, and advice on how to safely store and administer your prescribed medical cannabis products.
- Understand the Costs: Medicinal cannabis products are not typically covered under the Pharmaceutical Benefits Scheme (PBS). Consequently, patients may need to pay the full cost of the product. It is crucial to discuss the pricing of the prescribed medicinal cannabis product with the pharmacist to understand the financial implications of your treatment.
- Adhere to the Treatment Plan: Once you have received your medicinal cannabis product from the pharmacy, it is vital to follow your doctor’s treatment plan, including the dosage and frequency of use. Regularly communicate with your medical practitioner and pharmacist to discuss your progress, any side effects, or concerns regarding the medicinal cannabis product.
Key Takeaways
- Accessing medicinal cannabis in South Australia involves multiple steps, including consulting with a medical practitioner, obtaining a prescription, and navigating the TGA prescribing pathways (SAS B and AP Scheme).
- Both the SAS B and AP Scheme allow medical practitioners to prescribe unapproved medicinal cannabis products, but they cater to different scenarios and have distinct requirements.
- Medical practitioners must also obtain approval from the South Australian Drugs of Dependence Unit (DDU) before prescribing medicinal cannabis.
- Insufficient clinical evidence for many medicinal cannabis products has led to their unapproved status by the TGA, requiring the use of SAS B or AP Scheme for prescription.
- After obtaining the necessary approvals and prescription, patients can access medicinal cannabis products through a licensed pharmacy in South Australia.
- It is essential to follow the prescribed treatment plan and maintain open communication with your medical practitioner and pharmacist to ensure the best possible treatment outcomes when using medicinal cannabis.
For South Australians
IvyMed Clinic located in the Pasadena Shopping Centre has medical professionals that are part of the authorised prescriber scheme so individual TGA approval is not required. IvyMed doctors can guide you through accessing medicinal cannabis in South Australia depending on your individual circumstances.
