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Joining us today is Fiona Wing, a Naturopath, Nutritionist and Regulatory Manager at Designs for Health. Today, we’re going to recap a webinar presented by Designs for Health in 2022.

In this episode, Fiona discusses:

  • What is the TGA, and how does it differ from the FDA
  • How ingredients get onto the ARTG
  • Where to find out more information about ingredients, such as safety
  • Why are Australian clinicians not allowed to use US-based products
  • Extemporaneous dispensing
  • What we are and are not allowed to say about health claims in our marketing
  • Adulteration issues

About Fiona
Fiona Wing has been a qualified Naturopath and Nutritionist for 20 years and worked in the retail, clinic, and behind-the-scenes for complementary medicine sponsors. She has been working in Regulatory Affairs for the last 4 years.

She has a passion for learning all there is to know about nutritional and herbal biochemistry and pharmacology which suits her in her current role as Regulatory and NPD Manager at DFH. This role requires a strong focus on TGA guidelines and legislation, being up to date with current evidence and research, and keeping an eye on emerging, well-researched ingredients and product innovation.

Fiona is a mum to two active kids aged 14 and 16. In her spare time, you can find her in her garden or walking in awe through the Blue Mountains

Connect with Fiona:



Andrew: This is “Wellness By Designs,” and I’m your host, Andrew Whitfield-Cook. Joining us today is Fiona Wing, a naturopath, nutritionist, and regulatory manager at Designs for Health. And she’ll be recapping a webinar which was presented in 2022, Essential Regs for Pracs. Welcome to “Wellness by Designs,” Fiona. How’re you going?

Fiona: Hi, Andrew. I’m good. How are you?

Andrew: Good, thank you. Now I’ve gotta ask you straight off the back…off the bat, what the heck got you interested in regs? It’s not exactly a juicy subject. It’s rather dry.

Fiona: It’s not. It’s pretty dry, and it’s really challenging and frustrating and stressful, but it is so rewarding, and that’s why I do it. I learn something new every day. The regs landscaping in Australia is an ever-changing, ever-moving beast, and there’s not a day that goes by that I do the same thing over and over again. Like every day’s different. I can create a list and then at the end of the… You know, a list for the day. And then at the end of the day, I’ve achieved nothing on the list, but I’ve actually had a really productive day doing other stuff, so… Yeah. Not a boring by any means.

Andrew: No. Now that beast, obviously that you wrangle with is the TGA, the Therapeutic Goods Administration of Australia. Can you take us through what is the TGA set up for, and how does it differ from the FDA? The… Oh, for goodness, the Federal Drug Administration of the USA?

Fiona: Yes. Yeah. In the webinar, I actually went through the three pillars of the TGA. So, they’re all about product…like they oversee products, medicinal products obviously in Australia. And their main three areas of concern are product efficacy, product quality, and product safety. So, they’ve kind of divided up into two different parts. They do like a pharmaceutical medication type part, which is the registered medicines that you get on prescription. And then they also have a complimentary medicines branch as well, which is where we fit in, in the listed medicine space. So, yeah, throughout the webinar, I was talking about how we go about putting one of our products or listing one of our products. They have a database, a registration database of all of the different products that are sold or supplied in Australia that’s called the ARTG, or the Australian Register of Therapeutic Goods.

And so we actually have to put our product onto the ARTG, list our product onto the ARTG in order to be able to get it manufactured in Australia. And also in order for us to be able to sell it or supply it to our practitioners in Australia. It differs from the FDA slightly. I’m not entirely sure of all the details, but I do know that the FDA tends to be more either pharmaceutical drugs or foods. There’s no kind of… As far as I’m aware, I could be wrong, but as far as I’m aware, there’s no space for complementary medicines as there is over here in Australia.

And as a result of that, complementary medicines in the states are regulated as foods rather than as medicines, whereas over here, our complimentary medicines are regulated as medicines and not foods. So, there’s a difference there. That’s probably the main difference between the two regulatory environments between Australia and USA. Yeah.

Andrew: Yeah. And, of course, I am remiss for not mentioning Medsafe in New Zealand across the ditch there. Sorry for our New Zealand listeners. So, you know, what stumps me sometimes is what is okay and what’s not, what is allowed and what’s not is not necessarily due to a safety concern. It’s due to, in many times, history, in many cases, history. It’s simply not on the list. And it requires a sponsor, i.e. a company to pay money to the TGA to say, “Yes, this has merit. Here’s the data, can we put it on the list?” And they go, “Sure, give us your money.”

Fiona: Yeah. Exactly. And it’s a lot of money too. So, for a long time, it probably didn’t necessarily incentivize a lot of people to put stuff on because once it’s on, once it’s allowable as an ingredient, anyone can use it. So, you know, it’s tens of thousands of dollars and it’s actually a process that takes a couple of years as well. So recently, the TGA have incentivized it more by offering a two-year exclusivity deal. So, if you are an entity that wants to put an ingredient into the permissible ingredients determination, and you are the one that does the research and the work…

Because they actually need you to submit a package of information on efficacy, on safety, all of that kind of stability, all of that kind of stuff. You pay them tens of thousands of dollars and wait a couple of years. And now, thankfully at the end, you get rewarded with the two-year exclusivity deal. So, you can actually… You are the only one in Australia for two years that can supply that material. After that exclusivity deal ends, then you will get other materials like potentially generic type materials or something like that, that will also come onto the market. So yeah. So it’s been a good I think.

Andrew: Yeah, I’m actually glad to hear that in a way. And that is that it’s more of an even playing field to the pharmaceutical market, which, of course, have got billions of dollars behind them. I mean, they’re juggernauts, these companies. So, of course… And yes, they have also to fulfil certain extra requirements of not just safety, but also efficacy. That’s why there’s the AUST R, not AUST L. We’ll discuss that in a tick. But one of my bones, if you like, to pick, was always, well, what’s the incentive, as you said, why would any company want to move into a market where they’re going to basically kill their profits straight away? Pharmaceutical companies are extremely profitable because they have that patentability. Yeah.

Fiona: Yeah, yeah, exactly. So, it’s nice to see we get that same advantage in our industry finally.

Andrew: Right. So I mentioned the AUST L and AUST R. Can you take us through the difference there, please?

Fiona: Yeah, sure. So the main difference is the requirements for getting that product onto the ARTG or the Australian Register of Therapeutic Goods. So, for instance, with registered medicines, you are often looking at new ingredients that have been developed by a company. So there’s no kind of history of use as there is, for instance, with turmeric, it’s got thousands of years of use documented already. So, if you are a sponsor or a company that wants to register a medicine with a new ingredient, you have to go through a whole heap of regulatory requirements before you can get that ingredient included on the register on the ARTG.

So, you have to provide the TGA with safety data, with efficacy data. There’s a whole heap of stuff you need to present to the TGA before your product is allowed to be sold before it’s actually allowed to be placed on the ARTG. So, that pre-market assessment is the main difference with listed medicines, because we are using ingredients with a long history of use there is standing safety data already.

So, there’s no pre-market assessment necessarily relevant for the types of ingredients that we use in listed medicines. So, we don’t have to go through all of that pre-assessment or pre-approval before we can put a product on the ARTG. The TGA has done all of that work for us, and they’ve set up two pieces of legislation. One is the permitted ingredients legislation, and the other is the permitted indications legislation. So, they are both pieces of legislation that have a preset list of what we can use and what we can say about our products.

So we can actually just formulate a product, get an evidence summary together, talking about what we wanna say, and putting into that evidence summary, all of the pieces of evidence that we’ve got to back up what we would like to say about the product. And then we can just go ahead and list it. We can just go ahead and put it on the ARTG. But the disadvantage to that is that we are now subject to a post-market assessment.

So, the TGA can come back to us at any time and say, “We wanna see your evidence for the claims you’re making. We wanna see your label, we wanna see this or that to make sure that you’re complying with all the myriad pieces of legislation that they’ve created for us.” So, that’s the main difference. AUST R is all pre-market, AUST L is all post-market.

Andrew: Gotcha. But at least, I get that this is headaches for commercial entities, but these headaches kind of like, you know, the sort of Pan Pharmaceuticals debacle back in the early 2000s, it was horrible to go through, but it was probably necessary because it actually raised the bar of the dietary supplements industry so that professionals could rely on the quality throughout the whole industry, if you like. So I…

Fiona: Yeah, exactly.

Andrew: …separate professionals and industry there, pointedly. But regarding things like pharmacovigilance, where can we find out more about ingredients and products? Like, if we are talking about adverse reactions to… Well, you mentioned curcumin versus paracetamol, where can we look this data up?

Fiona: So there is a website that you can go to that is overseen by the TGA. It might even be part of the TGA’s website, actually. It’s called the data…database of Adverse Event Notifications, or the DAEN. So, you can just search that up in a Google search, and it will take you straight to that website, and you can pop in an ingredient name like paracetamol or curcumin turmeric. Whatever ingredient you want to search, you can pop that in and it will come up with all the different adverse events that have ever been notified to the TGA. So, it is a really interesting website to have a look at actually.

Andrew: Yeah. Yeah. I think it goes back to 1971 too.

Fiona: Yeah, it’s There’s a lot of information in there.

Andrew: A lot of information. And you can do date range restrictions. There’s also, not just for ingredients, for drugs, but there’s also medical devices as well. So, for instance, people can look up the history of, you know, let’s say the issues that were brought to light about what was it, cobalt in hip prosthesis. There was also the bladder mesh issue that was raised. Breast implants is another one. So you can look up these medical devices.

I remember years and years ago, there was also a bit of a furore when one of the companies that supplies a spacer device made claims that they didn’t…had no data, they just copied another company. So, this is interesting. This is pharma…Pharmaceutical companies doing the wrong thing by making these outlandish claims, which were not supported by data, they got pulled out.

Fiona: Yeah. As they should.

Andrew: Yeah. As they should. That’s right. But it’s also a great thing to look at, you know, it doesn’t really highlight contamination issues, but you can look up how bad or how good is…how safe is natural medicine versus pharmacological therapy? Now, you know, there’s attendant risks with both, I get it but it gives you confidence, certainly, in your prescribing. And to me, it’s one of the things where I rest easy when we’re attacked and I go, “Well, hang on. What about that?”

Fiona: Yes.

Andrew: You know?

Fiona: Yeah. We were just talking about that this morning, actually. I got a notification just… Sorry, this is a bit off the subject, but I got a notification yesterday about an article that appeared in the “New England Journal of Medicine” in July about vitamin D not being associated with the prevention of fracture risk unless you’re taking it with calcium. And so, as a result, the TGA are doing a big sweep of complementary medicines that contain vitamin D, and they’re gonna be looking at evidence and claims and things like that. And, you know, we were kind of talking about vitamin D supports bone health and codeine kills 30,000 Australians every year. So, really, where’s the priority? So yeah, they can get a little bit overbearing sometimes, but…

Andrew: It is splitting hairs, particularly when you get calcium supplements that basically are the same as quickies.

Fiona: Yes.

Andrew: And they’re prescribed to elderly patients who need bone health. It’s like, “Really?”

Fiona: Yeah. Yeah. Exactly.

Andrew: We can get off track on a whole rant here, but anyway…

Fiona: No, it’s time.

Andrew: What about… No, that’s right, too. So to try and bring it back to what pracees need to know, what do they need to be aware of when making claims about a disease? Let’s say they’re gonna be doing a public talk to the local community. What do they have to be cautious of when making claims about the merits of complementary medicines?

Fiona: It’s a tricky one. My mind’s automatically going to the advertising code because there are provisions in there that state that health professionals such as naturopath nutritionists aren’t allowed to make any kind of testimonials or endorsements about particular products or ingredients. However, context is key. So, if you are holding like just a talk in front of a group of people that’s not being recorded, potentially you could, you know, just talk about the benefits generally of the ingredient or the product that you, you know, wanting to talk about.

It’s when you kind of get into the realm of, “I’d really like to sell this product to you, or I really want you to use this product,” and you are putting, you know, your face to this information on Instagram or, you know, writing a blog on your website, or something like that, where you’re… It’s such a complicated…it’s such a minefield, Andrew, because you’ve really gotta be aware of what you are saying as well.

Because I talk a little bit about it in the webinar that I held, but when you list a product on the ARTG, you also list all of the indications, the health indications, that you hold evidence for, that you want to…you know, you have pracees use this product for. So, for instance, if we go back and use curcumin, you might have evidence to say that it helps with gut health or joint health. And so they’re the indications that you put on the listing for that product.

So, if you’re a practitioner and you are wanting to promote, say, our curcumin product, you will need to know what health indications we have associated with that product on the ARTG before you talk about it. Because you might wanna talk about the benefits that turmeric has to brain and nervous system health, or cardiovascular health, talking about our product. But our product may not have those indications on the ARTG. So that would actually be a non-compliant ad or a non-compliant blog because you’re talking about indications that are outside of what’s on the ARTG. That’s one reason why it’s non-compliant.

The other reason why it’s non-compliant is that you’re endorsing one of our products, and you are a health professional, and that’s also not allowed. And that’s where it gets really grey as well because when you look through the ad code, it actually talks about not just products, but ingredients too. So, you know, you can’t as…

Andrew: Oh, really?

Fiona: …even as a doctor. Yeah. And that to me, if I can just get personal for a little bit, doesn’t make a huge amount of sense. Because if you are a doctor or a naturopath and you wanna put something on your Instagram page about how great ubiquinol is for the heart, you actually can’t do that which just… It doesn’t make a lot of sense…

Andrew: No, that’s repression.

Fiona:  It is. Yeah. It is. And…

Andrew: That’s not just suppression, that’s oppression. I mean, it’s always… Like, I’ve been quite stalwart on this about not mentioning brands with whatever I do. And one of the reasons is because as a nurse, I don’t wanna be seen to be having pecuniary interests. However, it’s vital that people learn about ingredients and how to use them, particularly when those ingredients are available across brands.

Fiona: Yeah. Yeah.

Andrew: I mean, how would any doctor, orthodox doctor, forget complementary medicine, talk about [inaudible 00:18:52] if they’re not allowed to talk about an ingredient. I mean, that doesn’t make any sense.

Fiona: I know, I know. The way the TGA words their legislation is very particular. Occasionally, I believe it’s careless. But generally, it’s very, very particular and very, very targeted. They tend to do this kind of stuff on purpose. And yeah, it’s hard to try to convince yourself that they don’t have another agenda sometimes, really is. Yeah.

Andrew: I’ve often said this with regards to some studies that use, you know, insanely small doses, ridiculous doses that aren’t from therapeutic in nature at all. And I’ve said previously, I said, “Well, the researchers are either stupid or mischievous, and I can’t believe they’re stupid.” So, anyway, we digress. So, for some of us, I guess this carries on with this rant. For some of us who might be a little bit more mature than yourself, senior, señor, or whatever.

I remember the Pan Pharmaceuticals debacle back in the early 2000s, I think it was 2003. I think it was April. And what happened was there was a drug that was made by Pan Pharmaceuticals that was found to be outside the allowable limits. That drug was a travel sickness drug. And what ensued from there was almost total shutdown…well, it was total shutdown of Pan Pharmaceuticals’ supply of all products, including vitamins, except that I did note that a very rare… I think there was only like 200 prescriptions used in Australia, of a very rare antidepressant, an MAOI inhibitor, was still being made by Pan, and the advice by the TGA was to keep taking it, which was totally contrary to all supplements. Stop taking all supplements, no supplement was found to be outside the limits.

Fiona: No, no. And all of those supplements were… Sorry. I was gonna say, all of those supplements that were recalled were cancelled from the ARTG as well. Which meant that once, you know, those sponsors or those companies found other manufacturers to make those products, all of those products had to be re-listed back onto the ARTG. So, it was a huge impact to industry, absolutely huge. Absolutely huge.

Andrew: Massive impact to industry. There was a lot of collateral damage, companies went by the by. Pan Pharmaceuticals in the end won. They counter-sued or they sued the TGA and won. But the collateral damage was huge. I do remember there was at least one suicide from that. But what’s interesting to me is what you said about the amount of income that that must have generated for the TGA.

Fiona: Would’ve been huge. I’m not sure back then how much it would cost to put a product on the ARTG. These days it’s about a thousand dollars a product. I’m not sure what it would’ve been back then, but there would’ve been… Yeah. A fair bit of money going into the TGA through all listings. Yeah. Yeah.

Andrew: One thing that I have seen throughout my time, and it’s… If you wanted me to point a finger at the most common one that I’ve seen, it’s passion flower. Forgive me, actually, is it passion flower? No, it’s skullcap adulterated with Stefania. That’s been the most common one, even though we’ve seen kava go off because some idiot in Germany used an acetone extract. There was an issue in Australia, but it was deemed not to be the kava. Indeed, it was the skullcap that was adulterated. But kava got blamed.

And so kava got taken off for many, many months. And it was the work of Jerome Sarris that brought it back and others. But, you know, we’ve seen it with uva ursi. So what happens with adulteration issues…forgive me, I shouldn’t say that. Uva ursi was not an adulteration issue. Uva ursi was a choice. Thank you. So, what happens with regard to decisions that are made by the TGA that are sometimes being shown later to be an error? What happens with changing that landscape back so that clinicians can use nutrients and herbs? Here’s a recent one, Vitamin B6 six dose with peripheral neuropathy, just recent.

Fiona: reduced. Yeah, they reduced the dose and they reduced the threshold dose for the warning as well. I think sometimes, you know, the TGA do… They’re constantly surveilling the landscape for adverse events and, you know, evidence that pops up about just like the vitamin D stuff that I was mentioning before. And they do tend to take a lot of notice of that kind of stuff and they tend to act on it sometimes, not necessarily…

Andrew: Thoughtfully.

Fiona: Yeah, they do ask… I’m a member of the Complimentary Medicines Australia Regulatory Committee, and we see a lot of this stuff before it actually gets enacted and happens on the market. And sometimes, you know, the TGA will suggest something, they’ll put it out to a consultation process, and you can give them all the feedback in the world, but at the end of the day, they’ll just kind of do what they wanna do anyway. So, you know, occasionally it is a little bit difficult.

And with that B6, I know as part of the Regs committee, we did submit some information to the TGA just about, you know, historical safety data, and historical adverse events and things like that. Because one of their pillars is safety, they do tend to take a really, really strong hand on anything to do with safety. So, if any of those kind of things come up, sometimes it doesn’t matter what kind of, you know, public submissions or consultation results they get, they will do what they kind of had in mind all along anyway. So, it is a tricky one sometimes.

Andrew: Okay. But again, you know, if they’re so hell-bent on safety and safety is their major concern, there was work done by Reid et al from New Zealand, and they were looking at calcium supplements for osteoporosis. This is over a decade old now. What they found was that calcium citrate in high doses, they said increased cardiovascular events. Any movement? Nothing.

Fiona: No.

Andrew: So…

Fiona: Yeah, it’s really hard. That particular situation’s a bit of a bugbear of mine because I’m a massive fan of vitamin k2. And I actually wrote or helped kind of get some collateral together for a submission that one of our raw material suppliers put to the department of health’s national osteoporosis strategy to try to get K2 included in that strategy. But unfortunately…it wasn’t successful, unfortunately. But still, yes, in spite of the data that we have on calcium, they don’t seem to wanna budge. And now with the vitamin D stuff, they’re still kind of seeming to drill down on, “Don’t just take calcium.” You know, So, sometimes it’s a little bit weird. But… Yeah.

Andrew: Inequitable is a word that comes to mind. And I should point out, by the way, this is high dose of calcium citrate prescribed by GPs for their elderly patients. Still available, no question. Look, I remember being sceptical of it. I remember it. I remember Professor Peter Ebeling being sceptical of that data. And yet Reid and his group comes out, and I think there’s, I don’t know, three or four papers now. It says, “This is real guys.” Maybe it takes other groups until the TJ will act on it or before it becomes truth.

Fiona: Yeah. Yeah. I’m not sure. I remember what… We had a webinar by a very well-known, and very well-loved cardiologist a few months ago on k2. And I actually put that question to him and he said science tends to move one funeral at a time. That was very…

Andrew: He’s very good, Ross, isn’t he?

Fiona: He is.

Andrew: I have to ask also, with regards to labelling claims and restrictions and things like that, and availability of supplements in Australia, we also have for years, for decades, being dispensing in an extemporaneous fashion, liquid herbs. Liquid herbs still have to be…correct me if I’m wrong, still have to be on the ARTG

Fiona: If they’re sold as a single product, yes. In the case of like the big 500 mil bottles of herbs that a practitioner using their dispensary and extemporaneously compound, they don’t necessarily need to be on the ARTG. Because practitioners will be a little bit of this, a little bit of that, and not actually just selling that whole big 500 mil bottle as one, you know, treatment, one piece of treatment. So, that’s where we get into that extemporaneous kind of compounding, which gives the practitioner an exemption from needing to be a manufacturer, basically. So they don’t need to go through all that TGA licensing  They’ve got an exemption for that kind of stuff, so… Yeah.

Andrew: Gotcha. But they’ve got obviously, like… How do I word this one correctly? I remember back in the day when I used to be able to provide in the environment that I was working in, S2 herbs like gelsemium, and lobelia. So, certainly, there’s gotta be some regulatory framework for them. They can’t just be giving out Rauwolfia and ephedra, for instance. That’s…

Fiona: Yeah, exactly. And those types of herbs will appear in the poison schedule. So that’s a different type of…

Andrew: Oh, so that’s what it’s got to do with…

Fiona: …legislation as well. That’s what it’s, yeah. So, if it’s not on the poison schedule but it’s not in the permitted ingredients legislation. So for instance, N-acetylcysteine, L-theanine, mag-threonate, that kind of stuff you will often see as extemporaneously compounded products because they’re not on the poison schedule. Whereas something like lobelia is, so you would not be able to provide that herb as an extemp herb. Yeah.

Andrew: Got it. Got it. So, what points do we have to be aware of when we are dispensing extemporaneous ingredients? You mentioned a few there.

Fiona: Yeah, yeah, there’s a number. But basically the powders…we did get a question on the back of the webinar about this and about, you know, labelling and making sure you are kind of encouraging quality of use in the product with your client. And the main thing that you really have to make sure you’re doing is, either by labelling or otherwise, providing your patient with really direct, clear guidelines on how to use the product. Labelling is the best way to do that.

And we all do it with…when we’re, you know, doing herbal medicines, you’d never give someone just an amber bottle full of herbs with no label on it because you don’t know how they’re gonna go home and use that product. But also it identifies who the user is. It identifies how you want the product to be used, the dose that you want that person to take, to make sure that they’re using it safely as well. Because, you know, my kind of thought is, I always think of what is the repercussion of this? If I do A, what will necessarily follow?

So, you know, if you’re giving someone an extemp product and you don’t label it and that person misuses it, and has an adverse event and ends up in the hospital, that’s your fault. You might have verbally told the person how to use it, five minutes later when they get in their car, it’s gone. So, just to cover yourself, more than anything else and then also to make sure that patient is using that product properly and safely, it really is best practice to use, you know, labels and…

Andrew: I know that this is very rarely done, but my personal choice as well because of wanting to be transparent to other practitioners; if the patient would decide to go to another practitioner for their care, that’s their prerogative. And I hold that in sacrosanct…as sacrosanct. And that is with my labelling, I list all things, all ingredients in that liquid herbal formula. That’s just my choice.

Rather than just document it in my patient notes, I also put it on the label so that that can be repeated somewhere else, wherever they go. But with regards to extemporaneous dispensing of nutrient, let’s say L-theanine because that’s a good one, that’s one of my faves. What do we have to be aware of? Just putting L-theanine, do we have to say an extract? Do we have to say forgive me, an extract regarding to liquid herbs, but do we have to have any information about that ingredient or do we just have to say the dose that’s contained in the bottle and the dosage that you want to give that patient? Is that all we need?

Fiona: Yeah, you’d need to also put what it is so that it can be identified in the case of an adverse event, who it’s for so that, you know, if… And again, this is to cover yourself. So, if you give to… If I give it to Andrew, and you take it home, and your wife starts taking it, and your wife has an adverse event and ends up in the hospital, then I can say, “Well, I prescribed it to Andrew; I didn’t prescribe it to Andrew’s wife.” So that’s covering you as well. The dosage instructions, how much you want that person to take, the date that you dispensed it, the date that it expires… Yeah, off the top of my head, they’re probably the most important things.

Andrew: Gotcha. But, of course, being extemporaneous dispensing, meaning for one patient, you don’t need batch numbers, you just… Because it should be from a stock source.

Fiona: Yes, that’s right. You can. When I was in practice, I always used to note down the batch number just in case there were any manufacturing issues that occurred with it and I could go back and that’s…

Andrew: Of the source material? Brilliant. Okay. That’s a good point.

Fiona: Yeah. If I have an issue with it or if you know it’s clumping up or it’s got discolouring or something like that, I can call Designs for Health and say, “Oh look, I’ve just got a batch of this.” And then Designs for Health can actually go back to the manufacturer and we can kind of investigate what might have gone wrong. So batch number’s important for traceability.

Andrew: Gotcha. Now, years ago… Last question, I’m sorry because I know this is really dry stuff for most pracees, but I actually find it intensely interesting and critical for safe practice. It’s one of my big things. So with regards to… In the olden days, it used to be a blue card, a physical card. Nowadays, it’s all done online on the TGA website. But an adverse event notification. Have you ever done one? What sort of steps do you go through? What important points do we need to get across to practitioners that it’s okay to do this, we need more data about safety this far.

Fiona: It’s absolutely okay to do it. And it’s actually best practice due diligence. You know, it’s so important to do it.

Andrew: Ethical practice.

Fiona: Because like you said, it gives… Yeah, absolutely. I’ve done a couple, they still do the blue card, but it’s a downloadable form now that you hand out, and they basically look for things… It’s really big on, can you identify that this product has caused this interaction. So they also ask for things like has the patient got any other health conditions that might have kind of contributed to that adverse event. Are they taking any other medications? They get the age, and details of the adverse event as well, like what actually happened. Did you stop taking the product? All of that kind of stuff.

So they get a little bit of a history as well as what actually happened. So yeah. And then you submit that, and it is all an online process now. So you submit that to the TGA, and then they send you a notification back that they’ve received that. But then, you know, if you’ve got, you know, multiple adverse event reports for the same product or the same ingredient in a product, that’s when a little flag might be raised and the TGA will come back and they’ll say, “We’ve noticed this happening.” And then, you know, you kind of go from there. You either do a product recall, or you do an investigation. Yeah. And it kind of goes from there, but yeah, they happen. They definitely happen.

Andrew: Yeah. But, you know, to settle people’s minds, years ago, a friend of mine, a very dear friend of mine, an extremely competent registered nurse, multidisciplinary, and she was prescribing kava and the patient had an adverse reaction. And this really hit home to this friend of mine and she lost her faith, if you like, in kava. And I said, “Hang on, settle down here.” Now, this is an extremely competent specialist nurse. And after quite a few weeks, and much silence, by the way, by the psychiatrist that was also attending to this patient, we found out that the patient was also on a drug that was on the watch list by the TGA for this exact side effect. So, I was like…

Fiona: Oh, wow.

Andrew: …”Guys, can we, you know…?”

Fiona: Yeah.

Andrew: Forgive me for being glib here and using a medical term, but it was if you hear hooves think horses, not zebras. Think of the drug, not the herb.

Fiona: Yeah, exactly.

Andrew: Anyway.

Fiona: Exactly. Yeah. But the herb’s always gonna be the bad guy.

Andrew: Yes. Always, always. Yearly, annually, it happens.

Fiona: Yep. Yeah.

Andrew: Fiona, I really thank you for your mind and for your diligence with Regs because, as I said, it is a rather dry subject, but we need people like you to drill down and get to the real issues and also find out how ingredients can be made available for practitioners in Australia. And it’s only through the diligence of industry that this happens. So, I thank you for your work and I’m sure that all of the Reg consultants and advisors within the complementary medicine industry will receive the due thanks of all of our listeners, thanks so much for joining us today though.

Fiona: No problem. Thank you, Andrew. It was a pleasure.

Andrew: And remember, you can catch up on all the show notes. We will be posting quite a few links so that you can learn and use these links, and all the other podcasts as well on the Designs For Health website. I’m Andrew Whitfield-Cook. This is “Wellness by Designs.”

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