Dr Caroline West:
Hello and welcome, I'm Dr Caroline West and I'm a GP and NPS MedicineWise advisor. Today's podcast is brought to you by the TGA and NPS MedicineWise. Now, there are times when a health practitioner and their patient may decide to use a therapeutic product that is not on the Australian Register of Therapeutic Goods, the ARTG. In other words, it's an unapproved product. So, what am I talking about? Well, medicinal cannabis is an example that comes to mind. The majority of medicinal cannabis products are not approved, but practitioners can access them for patients, if they deem them suitable. And there are of course, many other unapproved therapeutic goods, including medications, that may be considered valuable to a person's management. On today's podcast, we explore which pathways can be taken to access these unapproved goods, and we get into the practical details. We're going to demystify the process. How do you use the special access scheme? Or alternatively, how do you become an authorized prescriber? How much time will it take to get the paperwork done? Do you need special training? To answer these questions and more, Dr Jess Tidemann joins me from the TGA. Jess is a GP and a medical officer at the TGA. There have been no conflicts of interest declared for this podcast. Welcome to the program, Jess.
Dr Jess Tidemann:
Thank you Caroline, thanks for having me, and us, the TGA.
Dr Caroline West:
My pleasure. Look, I know GPs and other doctors can get pretty tangled up in this, myself included. But today is really an opportunity to explore how you follow the pathway, and how straightforward it can be to get special access. But before we take a deep dive, perhaps it's worthwhile to just start with a refresher on the basics. Can we go through what is the ARTG exactly, the Australian Register of Therapeutic Goods?
Dr Jess Tidemann:
Yeah, it's a good question, Caroline. We here at the TGA talk about the ARTG all the time but recognize that it's not necessarily a part of people's day-to-day in clinical practice. It's essentially, as it says in the name, the register of therapeutic goods, so we're talking about medicines today, but it also includes biological products and devices, that are overseen, essentially, by the TGA, and have been approved for importation and supply in Australia. And we encourage, where possible, use of those products on the ARTG, noting those processes, and that oversight of these goods.
Dr Caroline West:
So we've got approved goods and then we've got unapproved goods. What does it mean when a therapeutic good is unapproved?
Dr Jess Tidemann:
Very simply put, we've just defined what an approved good is, it's on the register. Everything else is unapproved basically. If it's not on the ARTG, it is an unapproved good. And it means that the TGA has not evaluated unapproved products or goods for quality, safety, efficacy, or performance. You can't rely on that oversight of the TGA of those goods in the way that we monitor and evaluate all of those things for ARTG listed or registered products.
Dr Caroline West:
I guess it would cross somebody's mind when they hear that word unapproved, oh, does that mean it's unsafe? Does that mean it's not tried and tested? And what am I getting into here if I use an unapproved good?
Dr Jess Tidemann:
Yeah, and it's a good question. I think what is safe, and is something safe, is such a broad and complex question. I think it's important, what I would say first, is that something being unapproved doesn't necessarily mean it is unsafe. It just means that it is not approved by the TGA for supply in Australia, it's not on the ARTG. It may be that we're talking about an unapproved product that is registered or approved by another regulator in a country overseas, or it is being used in Australia, but maybe part of a clinical trial, or in some other settings, so where there perhaps have been safety considerations. It's not necessarily that there's no experience with this good, but at its most simple, is that it is not approved by the TGA in Australia.
Dr Caroline West:
And can you give me some examples of some of these unapproved goods that we may be accessing here?
Dr Jess Tidemann:
Yeah, so you mentioned in your introduction, medicinal cannabis is a big one that has got quite a profile at the moment. Also, more recently, nicotine products for use with vaping also cholecalciferol capsules or vitamin D capsules, and injections, often the higher dose forms of that. Tinidazole tablets, dexamethasone eye drops, tacrolimus ointment. And I think you probably recognize from some of those, that the actual drugs are available often in approved forms. There are a number of products that people access as an unapproved good in Australia, where there is much clinical experience with the actual active ingredient, it's just that particular product itself is not approved for use in Australia.
Dr Caroline West:
Can we get into some of the nitty-gritty now? Now, say I'm a GP, and I wish to prescribe one of these unapproved products, what are the pathways in front of me that I can choose? Because I think that GPs can get a bit overwhelmed at this point in time. They can go, oh my goodness, this just might mean more courses, more time. This is going to be very complicated. Can we strip it back and really get down to what are the choices, and how you get the ball rolling?
Dr Jess Tidemann:
Absolutely, and look, I still practice clinically, and I very much relate to that feeling of overwhelm in general practice. We're time poor, we're expected to be across endless different issues and processes, and so I very much appreciate how challenging it can be, both to find the time in the moment, but also if you feel like it's not something that you're familiar with. There's two pathways to accessing unapproved goods. It'll become clearer when I actually explain what they are. The first one is, authorized prescriber, and that is the preferred pathway, and I'll explain why. And second, is the special access scheme. Authorized prescriber, as it hints in the name, is that the doctor who applies and gets this type of access to prescribe unapproved goods, they are being authorized as a prescriber, rather than it being linked to a particular patient. This pathway is preferred, because it actually then allows the medical practitioner who has obtained this authorized prescriber status, to supply a particular good. I mentioned dexamethasone eye drops. If I applied and had approval to prescribe that, then I get approval, or I get authorized prescriber status, to prescribe that particular product for a particular indication to my patients. And they can then seek access to that good. So there are requirements where authorized prescribers have to do some fairly minor reporting to the TGA. Numbers of patients that they treat six-monthly, and depending on the product, the usual way for a prescriber to access is, they need Human Research Ethics Committee approval, and then they put a TGA application online. And then as I say, they can prescribe for numerous patients for this particular good.
I imagine people are thinking, ooh, Human Research Ethics Committee, that sounds complicated and time-consuming, actually within that, there's a subset, or our Established History of use Pathway. Which is actually an increasingly long list of products, that essentially, we've got quite a record of them having been prescribed by a wide range of doctors in Australia for specific indications. And so that is essentially a more streamlined authorized prescriber pathway, so the doctor doesn't need ethics committee approval to access that. And products like nicotine for vaping, and a number of other goods that are commonly used for specific indications, are on that list. That's certainly preferred, and it is an upfront administrative requirement for the doctor. But it doesn't have ongoing application burden. With the special access scheme, that is linked to an individual patient. If I, as a doctor, was applying to prescribe a particular good under the special access scheme, it would be for an individual patient, for an individual product. It's often less appropriate if there's going to be an ongoing prescribing need, because you're going to have to repeatedly go through that process. Or as I said, if you are wanting to be able to prescribe to a number of different patients, because as a GP, we all have lots of patients, and so it's often more helpful, if we then are able to offer that to a number of patients. And it'll depend on the good. And within the special access scheme pathway, again, there's three sub-pathways that have different requirements, depending on the specific circumstance. One is simply a notification pathway, particularly with seriously ill patients, recognizing that it's not reasonable for there to be significant administrative burden in such circumstances. And others, it depends on the product, as to which sub-pathway they fit into.
Dr Caroline West:
You've summarized that there are two pathways in front of you that you could follow. The authorized prescriber, as you say, is the preferred path, because ... Am I hearing that's a simpler pathway, if you are going to be prescribing that class of medication, for example, to a range of people, it would be easier to be an authorized prescriber, rather than for each individual, get a special access-
Dr Jess Tidemann:
Absolutely.
Dr Caroline West:
... scheme access? Do I need to have extra training, for example, in this group of products. I suppose that applies to all things that are in the unapproved categories. But I mean, from that point of view, what does a GP need to do to prepare to become an authorized prescriber? Do they need to do courses?
Dr Jess Tidemann:
No, I mean, the good thing, from the TGA perspective, in terms of the actual requirements for an authorized prescriber, no, there is no specific training. You certainly don't need to train to use our system, hopefully, as there's been a lot of improvements to our online system. And really, if you have had a discussion, and made a decision with a patient, that a particular product is appropriate for their treatment, that's really the only point that you need to get to. And then from the TGA perspective, it's the documentation and the online process. And certainly, as you said, if you're looking at prescribing to multiple patients, or particularly prescribing a product repeatedly over time, authorized prescriber is absolutely the best pathway. And certainly, I would like to encourage doctors not to be put-off by the TGA requirements for these goods, if they otherwise are comfortable prescribing, and making a decision, that that product is an appropriate part of that patient's treatment. That there's certainly no special requirements for them then to access the authorized prescriber, or if appropriate, special access scheme pathways. Trying to remove that as a burden or an area of concern.
Dr Caroline West:
Totally, so if the GP can actually refine their skills, and have the confidence to step forward. I think a lot of it is a confidence issue. When you're not used to doing something, you sort of balk it because you think, oh my goodness, this is just going to take another chunk out of my busy day, where I'm already overwhelmed with COVID patients, and everything else. But what's interesting is, that this service is a free service, correct?
There's no fee.
Dr Jess Tidemann:
No fee.
Dr Caroline West:
And yet, a lot of clinics are actually charging, I've noticed not only a consultation fee, but a dispensing fee to do the paperwork, of another $250. We've talked about fragmenting care, when the GP doesn't use these pathways themselves, but there's also the cost to the patient. And often that initial consultation will come up to $350 plus, and that's a lot of money for somebody managing a chronic condition, so it is also about equity and access. It's great to be able to explore this, and perhaps bust a few myths out there. And can you take me through some of the other commonly used pathways, or products that may be familiar to some GPs, that would also be reason to use these pathways? You referred to some of them earlier in the program.
Dr Jess Tidemann:
Yeah, there's a number of antibiotics that, as I mentioned, there are a number of products that are perhaps available in some other dose form, but a particular dose form isn't available. One that GPs may come across is levofloxacin. It is quite commonly used to treat treatment-resistant helicobacter pylori. There'd be increasingly few GPs who've actually had a patient who's been in this situation, where they've been diagnosed with H. Pylori, they've had their standard triple therapy, that includes amoxicillin and erythromycin. Their infection hasn't been resolved. They've got ongoing symptoms. You maybe even seek some advice. I've certainly had someone in this situation. You seek some advice from maybe Infectious Diseases, or the local gastro, and you need some levofloxacin. And one of the issues is, and I should have mentioned earlier, this also is where we can end up with unapproved goods, is that levofloxacin is on the ARTG, so there is an approved product that's usually available in Australia. But maybe there's a shortage, or there's no stock available at the moment. And so, what you need to do is, you still need to prescribe for this patient, but because you can't get that approved good, that's normally available, you need to prescribe a different levofloxacin product, that perhaps is approved by an overseas regulator, but not normally supplied in Australia. So, it's for quite a standard indication, it's just that supply can certainly affect all of this. Noting that this isn't expected to be an ongoing treatment need, this would be very appropriate for the special access scheme pathway, because you've got one individual patient, you've got a particular treatment that is just a specific course. And actually, I mentioned that there's the sub-pathways within special access scheme, and this levofloxacin is listed in category C. Which is actually a notification pathway, because as I mentioned, this is quite a common indication. And so, the prescriber needs to complete a category C special access scheme form online within 28 days of issuing the prescription, or the supply of the good, and that's basically it. They need to, as I said, do the online process. And it really, is more about notifying the TGA that you've prescribed that unapproved good to a patient, rather than involve seeking permission and waiting. As long as you've got consent from the patient, they understand the circumstances, you write the script, the pharmacy takes the role for actually organizing the supply, you submit your notification online, and that's the end of it. That's a specific one. If it was an ongoing need, I mentioned maybe a nicotine vaping product is an alternative. If you make a decision that nicotine vaping, you've got a patient who's tried alternative approved nicotine replacement therapy. They're having a really hard time quitting. They want to try vaping. This is going to be more of an ongoing need. This isn't a one-off script, so an authorized prescriber application would be much more appropriate in this situation. And again, you also then would be in a situation of being able to prescribe for other patients, not just the one individual patient, so you would apply for authorized prescriber for vaping nicotine, for smoking cessation as the indication. And again, applying online for that. You'd need to report numbers of patients that you were prescribing that product to, six-monthly. But you're not applying over, and over again, filling out paperwork each time. There is that upfront investment. But again, we talked before about time, and being very time poor in general practice, that you should be able to do these online applications in the consult with the patient there.
Dr Caroline West:
How many minutes do you reckon? I mean, obviously, a lot of the time is going to be around exploring whether that unapproved product is suitable. And then once that decision is made, and it's actually the prescribing applying pathway, let's say you're an authorized prescriber, how much extra is it going to add to your consultation time to actually go through the paperwork side of things? Which paperwork is the wrong word, because it's all electronic.
Dr Jess Tidemann:
Yes, that's right, paperwork. Good question, I have to confess, I haven't timed myself whoa to go. But also, I probably wouldn't be a good person to time, given that I'm actually familiar with our website. But I think, look probably roughly 10 minutes. I'm envisaging, if you've got someone and they've done the usual. They have booked a short appointment, and they've come in, and they've said, "I want to look at this." You are perhaps using that time to have a chat with them about it, and as you say, the bulk of the consult is really discussion about what's appropriate, and pros and cons, and all of that. If you were concerned about time, getting them to book a follow-up with a plan to do the actual process in that time and issue the script, or if you had a bit longer. And noting that when we say about 10 minutes, that for the authorized prescriber pathway, that's a one-off upfront. That's not going to be every time you're issuing a prescription or having that conversation with a patient.
Dr Caroline West:
To just recap, so far, the good news is, you don't need special training, you just need to familiarize yourself with the pathways. Authorized prescriber is the preferred option, if you are going to be repeatedly using a particular product. And I'm hearing that it's not as hard as I imagine a lot of GPs would be imagining at this point. And that the advantage of that is, if you are able to manage the application for the unapproved product, maintain continuity of care with that patient. You're going to be totally across what they're actually taking, to add to their medication chart, and having those ongoing conversations into the future about the appropriateness of that product, with continuation or discontinuation.
Dr Jess Tidemann:
Absolutely.
Dr Caroline West:
And some of those opportunities, quite frankly, are lost when somebody goes to a specialized extra clinic on the side. In terms of the takeaways from your end of things, what do you think is really important to stress?
Dr Jess Tidemann:
I think the key thing – that a lot of work has been done to make the application processes for both authorized prescriber and special access scheme, less onerous. Recognizing that it has historically been a burden for doctors and wanting to remove that and make it more accessible. That there's lots of information on our website, and that it should largely be an intuitive process. And where possible, opt for the authorized prescriber pathway, because it will be less burdensome for the clinician. And as you would expect, most of the discussion, as it should be, will be focused on what does the patient need? What's happening? What might be an appropriate part of treatment? And that the actual TGA application should be a small part of that, overall. And hopefully shouldn't turn doctors off considering ... If there's an unapproved good that they feel is the best option for that patient, not to be put off helping the patient access that, by the TGA requirements.
Dr Caroline West:
And I know that NPS MedicineWise has some great resources in this area as well. There's one that's called, Medicinal Cannabis Access Pathways Frequently Asked Questions for Prescribers. And the thing I like about that, is that it does a bit of handholding, if you like. It takes you through the pathway that you have to follow and makes it far easier to understand. From the login, and how you get the approval and endorsement, and what needs to be done to actually follow that through. And as you say, you've got some good resources as well, on the TGA website.
Dr Jess Tidemann:
Yes, and they're so important, because I think as prescribers, we ultimately, want to do the right thing by our patients, and certainly don't want to cause them harm. I understand people not having gone through the process are often worried about doing it for the first time, making sure they get it right, and NPS and our website have great resources. And I think I would encourage GPs who have maybe had patients bring this up before, but thought it was all too hard, or are interested in this, to have a look at those resources. And you might find that next time something comes up where an unapproved good may be appropriate for a patient, you might hopefully find that you feel more confident undertaking this process.
Dr Caroline West:
So Jess, I guess one of the things that people will be most interested in, is the pathways for medicinal cannabis. And I know that medicinal cannabis is being used for a range of chronic conditions, and there's been incredible consumer interest, and GPs have also been prescribing this at record rates. If a GP is to go down that pathway with their patient, where they decide it's something they'd like to explore, what are the steps that a GP would need to consider? Should they become an authorized prescriber, for example, if they're going to be dispensing medicinal cannabis? Can you talk us through that?
Dr Jess Tidemann:
Yeah, you're absolutely right, there's been a lot of growth in use of these products. And I mean there are a couple of medicinal cannabis products on the ARTG, but there's a large number that are available as unapproved goods. Chronic pain is definitely the largest group, or main indication, that we are seeing these products used for. Often GPs, and I've certainly been in this situation, have a patient that comes and asks about it. You've often supported them through trying a lot of other medicines, therapies, various options. And someone, a friend, has told them that they've been using medicinal cannabis, and they come to you because they're interested in trying it out themselves. If you decided that this was an appropriate thing to try for this patient, and identify a product, the important thing is, obviously having a conversation with the patient that it's an unapproved good. And making sure that they're aware of that. And what that means, in terms of not having been assessed for safety, efficacy, and quality by the TGA. You do a consent process with the patient. You create an online account. All of these applications are done on our online portal. This would be appropriate for authorized prescriber, because you're expected to be prescribing over time for this patient, and also you may decide that you may have other patients for whom you'd want to be able to prescribe as well. And so, as I mentioned, you can expect to receive approval within three business days. That allows you to prescribe ongoing for that patient, but also, if you had other patients, perhaps in similar presentation, you'd write them a prescription, the patient sets about organizing supply through their pharmacy. And the approval is actually for a period of five years, so when I said it really is more a one-off, rather than repeated application process. As long as it's a product that falls in that category, for that indication, you can also prescribe to other patients, and that individual initial patient, for five years. And you do need to report the numbers of people you're prescribing for six-monthly to the TGA. But those are not detailed onerous reports, it's really just for us to have an idea of the numbers that people are prescribing for, who are doing it through that authorized prescriber pathway.
Dr Caroline West:
I reckon a lot of consumers would be quite surprised that their GPs can dispense, because there's been the proliferation online of high profile medicinal cannabis clinics that imply they have expert doctors, who just specialize in this field, and who have all the paperwork at hand to apply on your behalf. For a hefty fee, I have to say. Your first consultant and the application is often billed at $350 plus. But I guess, what we need to do is have a conversation, don't we, with our patients... as a GP, to really explore those options for them. And make it clear, that actually as their GP, we can actually manage their care in those domains. If they wish to access an unapproved product that we've discussed, and have agreed is a good thing to pursue, then in fact, as a GP, you can follow that pathway.
Dr Jess Tidemann:
Yeah, and it's important to note, this is separate to any cost for dispensing of the actual product, because that would happen at the pharmacy level. But yes, you're right, I think we know general practice, primary care, is cost effective. And yes, I think there's probably a lot of GPs, a bit intimidated by what they think the process involves, or the impression that is given by, perhaps the reluctance to engage in this area.
Dr Caroline West:
Yeah, I think I would've been in that category, of the intimidated GP. Especially when it first started to roll out. But now that I've had the process demystified for me, I realize that in fact, as a GP, I can actually become an authorized prescriber, and it's not an onerous commitment in terms of time.
Dr Jess Tidemann:
Yes.
Dr Caroline West:
No training is required. And you can actually segue it into the rest of your management of that person.
Dr Jess Tidemann:
Yes, as always, the work is in the discussion with the patient about what they're presenting with, and what appropriate treatment options might be. And I think the actual administrative TGA online application process is a small part of that. The important time-consuming part is in the discussion, and ongoing care of the patient, which obviously applies to whatever you're prescribing.
Dr Caroline West:
Obviously medicinal cannabis is not the only type of product that's on the unapproved product list, but you also mentioned at the beginning of the program some other examples. But I think there are also some antibiotics that are used, or maybe accessed through the unapproved products?
Dr Jess Tidemann:
Yeah, there are definitely some different antibiotics, antifungals, steroid products. It may be that some version or form of those are approved in Australia, but a particular form isn't, so sometimes an injection form versus a tablet form. And one may be appropriate for a particular indication but is only accessible as an unapproved good.
Dr Caroline West:
Well, thanks so much for your time today. I've been talking with Dr Jess Tidemann from the TGA, who is also a GP, so she's been wearing both hats with us today on the program, which has been terrific. And I think you've done a terrific job in demystifying the process for us, with TGA pathways to access unapproved goods. And hopefully after today's program, GPs, and other prescribers, will have more confidence in following those pathways. I appreciate your time. And as we've said through the show, there are plenty of great resources on the TGA website, and the NPS MedicineWise website, if people would like more information, because let's face it, it's really hard to remember all of this information, and information does change. Having some of those flowcharts for prescribing is really helpful. I'm sure you'd agree, Jess?
Dr Jess Tidemann:
Yes, absolutely. I certainly can't keep it all in my head. I have extensive bookmarks in my internet browser, as a GP.
Dr Caroline West:
Yes, ditto. So, it's always good to back up with what you recall in some other format. Thank you so much. And of course, anybody listening that would also like any extra information on CPD points for today's podcast, please go to the NPS MedicineWise website. And that's all we have time for today, Jess, but thank you once again for being with us, and thank you to the TGA.
Dr Jess Tidemann:
Thank you NPS and Caroline for having me.
Dr Caroline West:
My pleasure. I'm Dr Caroline West, bye for now.
