Special Access Scheme Portal

Petra Bismire

I'd just like to start this afternoon by acknowledging the traditional owners and custodians of the lands on which we're meeting here today. In Canberra that's the Ngunnawal people but I understand there'll be people from all around Australia today so I'd like to pay my respects to elders, past, present and emerging and extend that acknowledgement and respect to any Torres Strait islander or Aboriginal people here today.

My name's Petra Bismire. I'm director of the Experimental Products Section. My team looks after access to unapproved medicines namely via the Special Access Scheme and Authorised Prescriber Scheme. As you're aware we're making some changes to the SAS and Authorised Prescriber online system and so today's presentation is about those changes, what's changing and what support we'll be offering. So I'll be taking you through what the changes are including a walkthrough of the SAS dashboard changes.

And then as we mentioned there will be a short break for some questions before moving on to the Authorised Prescriber dashboard changes. If you're not an Authorised Prescriber or are not interested in becoming one, if that information's not relevant to you, do feel free to exit at that point. We'll also be going through where to go for support. And again another opportunity to ask questions at the end of the second part of the presentation.

Okay, so what's changing? The main changes to the online system will be to the look and feel and the way that you navigate through the system. For the SAS dashboard the state specific forms for medicinal cannabis applications for some states and territories have been updated. And that's in order to comply with legislative changes. Likewise we've removed Queensland to reflect recent legislative change there. So there'll be no specific Queensland form required.

For the AP dashboard the process for applying for nicotine products has been streamlined and that's in response to a recent scheduling decision to make nicotine schedule 4 for all human therapeutic use, which you may be aware of. And additionally we've made changes to allow submission of six-monthly patient data reports to be made via the online system. I'll go through the first the look and change in navigation aspects of the system, so that's applicable to all users. From Monday 15th March we'll actually be using a new portal.

The current link that you're using will redirect to the new portal and it will take you to the regulatory and compliance portal that you see here. From here you will click the SAS, the Special Access Scheme icon that's highlighted here in red and that will take you to the SAS and AP online systems that you're familiar with. The login process will just be as normal.

Once you log in you will be taken to a page here where you press either the SAS or Authorised Prescriber dashboard and you can begin a submission as normal. You can see just a few things look a little bit different. The content is unchanged. However the colour scheme and the layout and navigation will be slightly different so may take some getting used to. For example in order to navigate through the portal where currently tabs are across the top of the page, they'll now be displayed down the left hand side as you can see here in this view.

I'll walk you through the specific SAS dashboard changes now. As I mentioned the major changes specific to SAS are specific to medicinal cannabis. So currently if you require state or territory authorisation there's an additional step in step 5 of the portal which is a state or territory specific form. And so we've updated the forms for New South Wales, ACT and Victoria to reflect specific legislative changes in those jurisdictions.

And as I mentioned the Queensland form has been removed entirely. And that's following legislative change in Queensland. The Queensland approval is now only required for cases where the patient is considered drug dependent and you're seeking to treat them a schedule 8 medicinal cannabis product. If that is the case, that you're treating a drug dependent patient with a schedule 8 medicinal cannabis product you'll be required to go directly to the Queensland health site.

The process for all other states is unchanged and where you do need state or territory authorisation you'll be required to select the relevant state from the dropdown menu.

For New South Wales, New South Wales have advised us that authorisation is now only required where your patient is drug dependent or under 16, so the New South Wales specific form is now updated to reflect this. If you select New South Wales in your earlier step to state that you need New South Wales authorisation you'll be taken to this page here that's displayed. And you'll be required to answer these questions directly. Is the patient drug dependent? And there's a definition as per NSW legislation here. And is the patient under 16 years?

Now if you answer no to both of those questions you won't be able to proceed because New South Wales authority won't be required. The rest of the form is relatively unchanged aside from just the presentation so that will be as normal.

For the ACT, the ACT has also made some legislative changes and is now collecting some additional information and not requiring some other information. So we've included an additional question again regarding whether your patient is drug dependent and the definition is provided on this page exactly as per the ACT legislation.

So this will be up to the prescriber's discretion to determine whether your patient is drug dependent and whether this particular information needs to be indicated to the territory government.

We've also updated the Victoria form. Not much has changed from the Victorian form perspective except the link, so you might be able to read here, to see the department's policy. That's the Victorian department of health's policy on issuing schedule 8 permits please click here, that here link has been updated. That's the only change for Victoria.

However I would just mention that the Victorian Public Health Emergency Order that's been in place is being revoked on 27th March 2021 so that is from the 28th March prescribers in Victoria will be required to obtain a schedule 8 treatment permit for patients. But I recommend that you get in contact with Victoria if you have any questions regarding that.

In terms of support for the changes for SAS, to the SAS dashboard, we'll be updating the online guidance documents available on the TGA website and we'll also be holding weekly online training sessions. The dates are displayed here. Every Wednesday for the next three weeks we'll be having drop-in sessions available via Webex where you're welcome to drop in and then ask any questions that you have. If you're interested in attending any of these sessions please just send us an email. That's eps@health.gov.au

And one last thing to be aware of is that the SAS and AP online system will be undergoing some IT work over this weekend and won't be available before launch on Monday morning. So the online system will be unavailable from 12pm Saturday until 8pm on Sunday.

Max

Hey everyone this is Max here, one of the moderators. Petra we've just got a question here in regards to the Queensland state health authorities and how that process may have changed.

Petra Bismire

Thanks Max. The question was just asked whether you will still submit as previously. And that's correct, so where you come across the question, is state or territory authorisation required, provided your patient isn't drug dependent you'll be able to select no to that question and move through the portal as usual. As always it's up to the prescriber in question to know and understand the jurisdictional requirements in the state or territory in which you're practising.

Max

Thank you. There's another question here in regard to the paper versions of category A, B and C. Are these still being accepted by the TGA or is the aim to transition to the portal? As a follow up question as well there in regards to whether it is automatically provided to the wholesaler or provider of the SAS products.

Petra Bismire

Thanks Max. At this stage we are still accepting paper versions. Of course we do prefer or encourage use of the online system just to allow us faster processing times.

And no, the portal doesn't send a copy of either the application or the decision to the wholesaler. Where state or territory authorisation is requested the state-specific form gets sent to the relevant state or territory. However the decision letter gets sent to the applicant of the form.

Max

A further question here. Will sponsors be able to submit the six-monthly SAS reporting via the online system?

Petra Bismire

Thanks. So this is for SAS reporting. No, that's not a function that we currently have available unfortunately.

Max

Thank you. And will you be planning to publish the Frequently Asked Questions guidance on the new updates?

Petra Bismire

Yes we're updating the guidance documents for both SAS and AP for use of the online system and that'll be available on our website shortly. Okay, so that seems to be the end of the questions. As always if you have any further questions please do reach out to us. The best way to contact us is via our email, eps@health.gov.au

Now I'll be walking through the Authorised Prescriber specific changes so if you're not interested in this information, if it's not applicable to you please do feel free to drop out now. This slide shows the view of the updated portal that will be available from Monday. To access the Authorised Prescriber dashboard you'll click on the Authorised Prescriber dashboard button at the top there.

At the top there you'll see that in addition to your usual button to allow a new Authorised Prescriber application there's also the ability for a streamlined application process for nicotine specifically. And this is in response to a recent scheduling decision for nicotine. Nicotine is now schedule 4 for all human therapeutic use. That's been a clarification of the current scheduling and that's being implemented as of 1st October this year.

In order to become an Authorised Prescriber of nicotine products the process is now very simple. For certain products that have been deemed by the TGA to have an established history of use no ethics committee approval is required to become an Authorised Prescriber. Nicotine is one of those products and so there are now two pathways within the online system, one for those products which have been deemed to have an established history of use and one for all other products.

Nicotine is included in that list and that no longer requires ethics committee approval and we have this specific button. So essentially to apply to the TGA to become an Authorised Prescriber of inhaled nicotine products you will just click on this button and select new nicotine AP application. The system will pre-fill the dosage form and indication as you can see in that second picture. The indication will be smoking cessation and your personal information will be filled in based on information that you've provided at the time of registration.

You'll then be asked to read the privacy statement and if you're satisfied you can press yes and then you simply submit your application by clicking submit. The application will then be reviewed by the TGA and you'll receive a decision letter. So that's the process for applying to become an Authorised Prescriber for nicotine products. As you can see very simplified.

The other major feature that we've changed for the Authorised Prescriber is the ability to submit six-monthly patient data reports directly via the online portal. As you may be aware Authorised Prescribers aren't required to notify the TGA every time they supply an unapproved good but they must provide us with reports of numbers of patients treated during a six-month period. This information can now be submitted directly via the portal.

In order to do that you go to the Authorised Prescriber Reports button highlighted here in red and refer to the report for the current reporting period and select edit. Here's a view of what you'll see if you select edit and then you'll be taken to this page which asks you to enter the number of new patients which you treated during that six-month period and the total number of prescriptions or devices provided during that six-month period.

For medicines a prescription is considered a single supply of an unapproved product and if you provided repeats they should be considered as an additional prescription for reporting purposes. You are required to report both these fields, number of new patients and number of prescriptions or devices that you provided during that six-month period even if that number is zero. Following entry of that patient data you'll be asked to read and submit the privacy statement and submit your report.

Again I'd just like to reiterate the support that we'll be offering. We'll be running weekly online training sessions every Wednesday for the next three weeks for drop-in sessions via Webex. If you're interested in attending one of these please send us an email, eps@health.gov.au and again we'll be updating the SAS and AP online system guidance documents.

Max

We have a question here. Can TGA approval letters be uploaded to the TGA online portal in case an email copy is missed or deleted or there are any server issues?

Petra Bismire

Thanks Max. Yes, if you're using the TGA online system, SAS and AP online system, on your personal dashboard you can access all of the applications that you've drafted or submitted, view the status, and if a decision has been made then you'll be able to view that decision letter from the portal. You can also download that decision letter too. There's further information on how to do that in the SAS online system guidance document or you're welcome to email eps@health.gov.au but yes that is a functionality that's currently available and that won't be changing with the new version of the online system.

Max

Thank you Petra. Another question here, do the APs get reminded to submit the six-monthly reports with this new system?

Petra Bismire

Yes, with the implementation of the new system that goes live as of Monday Authorised Prescribers will get a reminder 14 days before the end of the reporting period that they're able to report. The reporting periods are January to June and July to December so 14 days before the end of that period you'll receive a reminder that you'll be required to submit six-monthly reports. We would prefer that you do this via the online system. I think it's easier for both the doctors and for our internal staff. But there is still the opportunity available to report via a downloaded pdf form which can be filled in and then emailed to Authorised Prescribers.

Max

Okay, thank you for that. Another question, can someone do the six monthly reports on behalf of the doctors or does it have to be the doctor themselves?

Petra Bismire

Thanks Max, it is a condition of the approval letter that the doctor provides a six monthly report of the patient data, so yes it would have to be the doctor themselves that signs off on the data that is submitted and that's done by electronic signature or by being logged into the system is taken to be doctor as authorised in order to submit that information via the online system.

Max

Thank you for that Petra, another question here will it be a function to apply for more than one authorised prescriber at a time, instead of multiple single applications?

Petra Bismire

Thanks for that question. So that is something we are looking at addressing, so that is an issue that we are aware of and something we are keen to address in future updates, but unfortunately at this stage that they do continue to be made individually.

Max

Alright thank you Petra. So probably going to take the one more question here. This question regards to if someone has just had their first SAS medicinal cannabis application approved do they then need to also get Authorised Prescriber permits in the future.

Petra Bismire

Thanks for the question, no so to clarify there are two major pathways to access unapproved goods, one is the Special Access Scheme where the doctor applies each time for each individual patient to access an unapproved good. Alternatively there's the Authorised prescriber Scheme where the doctor becomes and Authorised Prescriber of a particular product and they aren't required to then submit or notify the TGA every time they supply, rather they submit these six monthly reports. So typically speaking it would be one or the other, you would apply via SAS or via AP. If you are wanting to become an Authorised Prescriber in most cases you will require ethics committee approval unless your product is on a list of medicines which has been deemed by the TGA to have an established history of use. Those are the two pathways, I hope that answers the question.

Well thanks everyone, I think that's the end of the questions for now. Thanks for attending I will just hand back over to Will, as always if you any questions please don't hesitate to get in touch.