State approval form - medical cannabis can be prescribed NOW via the SAS - QLD patients only

Finally Queensland Health have released the state approval application form for doctors and pharmacists to apply to Queensland Health to treat patients with schedule 9 cannabis under a SAS Category B treatment approval from the TGA.  This form can also be used for patients who may wish to try schedule 8 Sativex. If anyone needs help please send us a message. 

2 February 2016

State Approval Process: Minister's office and Director General's advice

The State approval form and process is still being held up by the TGA and was still not available from Queensland Health at the time of writing.

In the interim, the Health Minister's advisor, and the Director General's office have advised that patients/carers/doctor can send a copy of the SAS Category B treatment approval letter to the Director General, Michael Walsh, asking for state approval.

Tess Bishop, the Executive DG is working with Dr Jeannette Young, the Chief Health Officer on this issue.

The Director Generals' email address is dg_correspondence@health.qld.gov.au

Please mark your application as confidential.

Earlier in January, Queensland Health gave verbal advice about how the state approval process should work, for the patients and carers who need approval to possess, supply, administer or use "Schedule 9" cannabis in Queensland as follows:

• The patient/carer in consultation with their doctor, determines the type, ratio, form, strength, dosing of the treatment 

• The patient will also need to give their full and written informed consent to the doctor assuming full responsibility for all and any outcomes of treatment with the "unapproved" cannabis products

• Doctor applies to the TGA for SAS Category B treatment approval

• If approved, the TGA will send the doctor a Category B treatment approval letter  

• The doctor will then need to forward a copy of the SAS Category B treatment approval letter to Queensland Healh to obtain State approval to prescribe the cannabis.  If the doctor received approval from Queensland Health, patients and carers in possession of cannabis will be exempt from being charged under the Drugs Misuse Act, and in the case of parents, carers and other stateholders, they will be able to lawfully supply and/or administer the cannabis treatment to a patient or child in their care. 

Supply within Australia

• The State approval letter and SAS  Category B treatment approval letter

        should act as a supply authority, if the

         cannabis is available from an Australian

         company.

Imported Supplies from overseas

• The importer, (doctor/pharmacist or a  TGA licenced importer), sends the SAS Category B import licence and permit applications (which are separate applications to the SAS treatment approval application), SAS Category B treatment approval letter, State approval letter, to the import section of the TGA.

• The import section of the TGA will send the importer, their import licence and permit.

•  A copy of the import licence/permit is forwarded to the overseas supplier,

    with payment of goods if requested.

• If the company already holds an export licence, the goods can be sent by courier to Australia.  Note: Some companies for example in Canada and Holland already have export licence approval.

•  If the company does not hold an export licence they will need to apply to for one through their relevant health and/or customs authority.

Note: most countries have similar programs to Australia's SAS, which provide for the export of medicines, as well as import. 

Imported Supplies from overseas

• The importer - doctor/pharmacist or licenced importer emails/faxes the SAS Category B licence/import applications, copy of doctors SAS Category B treatment approval letter/number, and copy of the State approval letter to  the import section of the TGA.    

• The import section of the TGA will send the importer, their import licence and permit 

• Send a copy of the import licence/permit to the overseas supplier

• If the exporting company holds an export licence, the goods can be sent by courier to Australia. 

Please Note: Some companies for example in Canada

and Holland already have export licence approval.

• If the supplier does not hold an export licence, they will need to apply to their relevant customs agency.

Other conditions Imposed - amounts, storage etc

Queensland Health may request details ie: patient/carer photo ID etc.

In some cases, the TGA may allow the import of up to 12 months supply of some "unapproved" medicines, rather than going through the SAS process month or even quarterly, as this would be too burdensome

There may be conditions imposed on the amount of cannabis treatment the doctor/pharmacist can dispense to the patient/carer, and it may need to be collected weekly/monthly.

There may also be safety/storage/security requirements such as cannabis medicines to be kept in the fridge in a locked safety box with a key, and out of reach of children. 

Discrimination

Issues such as use by young children in daycare, schools and TAFE may also need to be addressed, as well as in employment and driving if applicable.

Patients/carers should not face any discrimination in any of these areas, as cannabis should be treated as any other lawfully prescribed medicine.

The application form and process for state approval will be on the Queensland Health website when the issues with the TGA and Queensland Health are finalised.

Interim decision will be made at the ACMS meeting, March 2016.

Final decision May 2016.

Public Comments Invited prior to committee consideration by close of business 18 February.

The TGA have proposed that the Standard for the Uniform Scheduling of Medicines and Poisons (the SUSMP or the Poisons Standard) be amended to place 'some' cannabis-derived substances, 'when used in particular ways,' in Schedule 8 of the Standard ... to enable appropriate access to medicinal cannabis products by creating new Schedule 8 entries for the following substances for internal human therapeutic use:

Cannabis (plant and flowering tops),

Botanically derived extracts (or derivatives) of cannabis, and

Tetrahydrocannabinols (THC) where they are botanically derived from cannabis.

including when prepared or packed for therapeutic use, and where the substances:

1. have been produced or manufactured in accordance with the Narcotic Drugs Act 1967; or

2. have been imported in accordance with the Customs (Prohibited Imports) Regulations 1956.

Except when included elsewhere in Schedule 8 or Schedule 4.

Cannabis and THC would remain Schedule 9 substances: for human therapeutic use when it does not fit the above criteria, or when not for human therapeutic use, or does not fit any other current exceptions.

Options for additional controls through an entry in Appendix D of the SUSMP could include one of the following:

1. restriction of access to state/territory authorised medical practitioners (current Item 1 - Poisons available only from or on the prescription or order of an authorised medical practitioner); or

2. restricting access to:  clinical trials conducted under the TG Act when unapproved products including these substances are used i.e. Clinical trial Notification (CTN) or Clinical Trial Exemption (CTX); AND supply as an unapproved product through the TGA Special Access Scheme Category B or the Authorised Prescriber scheme similar to the current Item 3 (Poisons available only from or on the prescription or order of a medical practitioner authorised or approved by the Secretary of the Commonwealth Department of Health under section 19 of the Therapeutic Goods Act 1989.); or

3. restricting access by creating an entry such as "Poisons available only from or on the order of a specialist physician"

Queensland Health have advised that the form and process for State approval will be up on their website shortly as it has been held up waiting on the TGA to finalise some issues.

They have also confirmed that the process will be as follows:

1. Your doctor first obtains SAS treatment approval by completing the TGA Category B form and faxing it to the TGA. The TGA will send an approval letter to the doctor.

2. State approval - the doctor/patient/carer completes the State approval form once this is available for download from the Queensland Health website. 

3. If the cannabis is available from an Australian drug importer; or a medical cannabis company as part of a trial, the doctor or a pharmacist can send copies of both the SAS and State approvals to that company to organise supply. 

4. If the cannabis medicine needs to be imported - the doctor or a pharamacist needs to make a separate application to the import section of the TGA for an import permit and licence and attaches both the SAS treatment approval letter and State approval.

5. If approved the import section of the TGA will issue the permit and licence to the doctor or pharmacist. A patient cannot apply for the permit or licence. 

6. A copy of the import permit and licence will then need to be sent to the exporter who will need to have permission from the exporting country to export to Australia.

Canada has given several companies approval to export ie Tliray. We are waiting for confirmation on other countries however most countries have a similar program to the SAS and export should be able to be arranged through these programs. 

If you are interested in accessing "unapproved" cannabis medicines speak with your doctor and pharmacist and research what products you are considering using. Provide your doctor with as much information as possible i.e: product information and details of the company willing to supply. 

The patient/carer needs to give the doctor written informed consent assuming full responsibility for all and any adverse outocmes of using the "unapproved" treatment.

Please also check with the TGA and Queensland Health before proceeeding as the patient/carer are responsiblle for costs involved such as payment for cannabis medicines (not on PBS) and import, export and shipping fees. 

You can read more about the SAS and find contact details for the TGA and Queensland Health on our website here.