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Exploring Extemporaneous Compounding with Diana Boot · Wellness by Designs - Practitioner Podcast

• 0:20
  Speaker 1: This is Wellness by Designs, and I'm your host, andrew Wittfield Cook.
• 0:24
  Speaker 1: Joining us today is Diana Booth, who's a pharmacist and naturopath, and today we're going to be discussing extemporaneous dispensing.
• 0:32
  Speaker 1: Welcome to Wellness by Designs, diana.
• 0:35
  Speaker 1: How are you?
• 0:35
  Speaker 1: And thanks so much for your time.
• 0:38
  Speaker 2: Hi Andrew, thank you for having me.
• 0:41
  Speaker 1: Absolute pleasure.
• 0:42
  Speaker 1: Now I guess we've got a start off.
• 0:44
  Speaker 1: We always think this is a really droll sort of topic extemp dispensing but the funny thing is we do it all day with herbs.
• 0:50
  Speaker 1: So can you just take us first a little bit through your history, and then you know delving into pharmacy.
• 0:59
  Speaker 1: Why become a naturopath?
• 1:00
  Speaker 1: What was the draw there?
• 1:04
  Speaker 2: Well, I did pharmacy straight out of school because I wanted to work in healthcare and I loved it.
• 1:10
  Speaker 2: I was a pharmacist in hospital and industry actually and community pharmacy for about 10 years and I was happily working in my local community pharmacy when I had a fellow come in with a script for blood pressure and cholesterol and acid lowering drugs and he went off to get his lunch you know normal day in the life of a pharmacist and he came back with his lunch, his scripts were ready and he had in his hand a pie, a sausage roll and a coke and I just thought, wow, this this doesn't add up.
• 1:44
  Speaker 2: You know one, on the one hand he's getting all this medicine free from the government, on the other hand, he's just filling himself up with with, with foods that are going to really damage his health.
• 1:53
  Speaker 2: So I went home that day and enrolled in a nutrition and well, that ended up in the naturopathy course.
• 2:01
  Speaker 2: I feel like maybe for me I'd always been interested in the whole food, kind of like food as medicine.
• 2:06
  Speaker 2: I grew up on a farm and you know we it was a like a open spaces, real food, ideally, sort of life for a child and I feel like what?
• 2:17
  Speaker 2: You know what, what, what we eat.
• 2:19
  Speaker 2: Well, I know for sure what we eat has an impact on our health, and so that's sort of driving the internet.
• 2:26
  Speaker 1: I think we need to add for our international listeners that growing up on a farm in Australia is whole food, wide open spaces, brown snakes, spiders the size of plates and everything else is out to kill you drop bears.
• 2:42
  Speaker 2: Exactly mouse plague.
• 2:46
  Speaker 1: So, so take us through, actually first take us through that change in paradigm shift that you had to make from that orthodox medicine where you're talking about really tightly defined, you know, drug switch on or off, they block or they up, regulate, there's very strict things.
• 3:08
  Speaker 1: And then you have to move into a world, in with nutrition, where we're talking about nourishing, supporting the more nuanced narrative, if you like was that a big?
• 3:20
  Speaker 1: Jump for you to to think about.
• 3:25
  Speaker 2: I don't really think it was, because I always knew deep down that, you know, prevention is better than cure, and so it makes much more sense, you know, and I guess I was always just aligned with that naturopathic principle of nature as healer.
• 3:42
  Speaker 2: So you know that the body has the innate ability to heal and and even though, yeah, I was sort of trained to use drugs, I I felt, for my own treatment, my own health and my family's health, I always looked at a healthy diet, exercise, meditation, all those things that I had applied to my life.
• 4:02
  Speaker 2: So it was really just, I guess, merging those two, the professional and the personal.
• 4:07
  Speaker 2: And and then it I didn't have the skills professionally to be able to help people, and so that's why I went back to do the formal training.
• 4:15
  Speaker 2: But I think, yeah, I always I did, I always sort of have that sense.
• 4:21
  Speaker 2: The leap, I think, was drugs just generally hit off on one receptor, whereas herbs and nutrients are both involved in so many different complex um um pathways.
• 4:35
  Speaker 2: And so let's say, nutrients, obviously, like magnesium and zinc and all the all the vitamins they're involved in so many different things.
• 4:42
  Speaker 2: And also herbs even like I couldn't quite get my head around how one herb could have so many different actions.
• 4:50
  Speaker 2: As a pharmacist, at first I thought that was nonsense, until I realized that one herb has lots of compounds in it.
• 4:55
  Speaker 2: So you know, it's sort of.
• 4:57
  Speaker 2: And once I realized that and and did the pharmacology of the plants, then I realized that it makes perfect sense and that I don't really think that they're that it's not, it's not such a big leap for me there.
• 5:08
  Speaker 2: They are actually sort of part of that same continuum, I guess for the healing, yeah, helping people get better because you didn't I don't mean this glibly just do herbal medicine.
• 5:20
  Speaker 1: You did pharmacognosy, didn't you?
• 5:23
  Speaker 2: oh, that's part of the herbal medicine course.
• 5:26
  Speaker 1: Yeah, that was everybody does pharmacognosy.
• 5:28
  Speaker 2: We did pharmacognosy as part of pharmacy.
• 5:30
  Speaker 2: That was a small yeah like I don't know, one or two lectures, probably back in oh I see last century sometime.
• 5:38
  Speaker 2: Yeah, yeah, but I don't know that that's.
• 5:43
  Speaker 2: I'm pretty sure it's not part of the pharmacy course now it's yeah, right longer there um gotcha, but we yeah, all herbalists do, or you know, and naturopaths do pharmacognosy as part of the training and um, it just lit.
• 5:56
  Speaker 2: It lit me up, though I like.
• 5:57
  Speaker 2: If are you allowed to say that, I'm not sure it.
• 6:00
  Speaker 2: I found it very interesting um yeah just the way, the way the compounds have chemicals in them that hit off receptors and and have actions in the human body and their plants, and as humans, we've evolved alongside them, as well as alongside the foods, and that's makes sense that that they should be able to help us get better.
• 6:20
  Speaker 1: I'm like I'm so with you, particularly when we mentioned herbs, that I would, I would feel, with my knowledge now I would feel so frustrated being shackled by only nutrients and not herbs, because herbs are just so beautiful to work with.
• 6:36
  Speaker 2: I just yeah, yeah yeah, exactly yeah, anyway, and equally to be shackled by just having drugs.
• 6:42
  Speaker 2: You know, I just couldn't go back to work in a pharmacy now where I was just treating symptoms, and and so that's.
• 6:49
  Speaker 2: I guess that's part of it too.
• 6:50
  Speaker 2: It's that the paradigm shift is in, um in the.
• 6:53
  Speaker 2: In the pharmaceutical medicine world, it's all about treating symptoms, whereas in the naturopathic world it's about it's about that underlying cause and the and the nature is healer and um, yeah, yeah, that you can't.
• 7:07
  Speaker 2: You can't unlearn that either.
• 7:08
  Speaker 1: So yeah, that's why, I like to combine the two yeah all right, so let's dive into extemporaneous dispensing.
• 7:16
  Speaker 1: Firstly, a definition extemporaneous compounding what are we talking about here?
• 7:24
  Speaker 2: Well, you have to have the Latin if you want the definition.
• 7:27
  Speaker 2: Sorry, but it does feel and you know, lots of people just sort of use the word.
• 7:32
  Speaker 2: They don't really know what it means.
• 7:33
  Speaker 2: But X tempo is the Latin for of the time and it really.
• 7:40
  Speaker 2: And compounding just means mixing, so we're mixing something at a particular time for a particular person.
• 7:47
  Speaker 2: So actually in English we mostly use the word extemporaneous or a speech it's not in my vocabulary much, but for where somebody is making a speech and they're doing it off the car for at the time.
• 8:01
  Speaker 2: So that's what an extemporaneous speech would be, and an extemporaneous compounding is making something at the time for an individual person.
• 8:11
  Speaker 1: And the common thing is that extemporaneous dispensing is done all day, every day, by medical herbalists.
• 8:17
  Speaker 1: And yet, when it comes to nutrients, it's this real funny disconnect about oh no, like, how do I open a bottle of something of powder and combine it with that powder?
• 8:31
  Speaker 1: It's this weird reticence that I don't fully understand.
• 8:36
  Speaker 2: Yes, yeah, well, I think herbal manufacturing or herbal extemporaneous compounding is part of the herbal tradition.
• 8:44
  Speaker 2: Herbalists have always practiced like that.
• 8:47
  Speaker 2: Herbalists have always been taught like that.
• 8:49
  Speaker 2: I think nutraceutical medicine is probably what it's definitely newer.
• 8:54
  Speaker 2: I think traditionally, herbalists probably used herbal medicine and food as medicine, but they didn't really have this other that we now have, which is nutritional medicine, and that's where you're isolating the nutritional ingredients in nutritional compounds and finding and with testing we can now find where somebody's got a deficiency or where we understand the underlying role of the nutrients in metabolism, so we can see how a nutrient might help.
• 9:25
  Speaker 2: And so nutraceutical compounding has come into the armamentarium of a naturopath, but through the products that are ready made, so all the companies that make these products for us.
• 9:38
  Speaker 2: That's how we're accessing what I would call nutritional medicine, whereas the herbal medicine they're available.
• 9:47
  Speaker 2: They are available that way as well, but through all the ready made products with herbs in them, as you would know.
• 9:53
  Speaker 2: But they're also available, of course, in the traditional way, and so this is another way of prescribing those nutritional medicines, where you would use a very similar principle to what you're doing for an individual, for a patient with an individual prescription for herbal medicine and actually the rules are the same.
• 10:15
  Speaker 2: It's just because we're trained in herbal medicine manufacturing we don't have to think about what the rules are, but what I would like to go through what the rules are because it's accessible to naturopaths and nutritionists.
• 10:30
  Speaker 2: And it's accessible because the rules are there in place to cover them for extemporaneously combining herbs together for a patient.
• 10:39
  Speaker 2: And so the underlying the laws are set by the TGA that say naturopaths and nutritionists, homeopaths, pharmacists I think that's it have an exemption to the TGA ruling.
• 10:53
  Speaker 2: And you know that concept, the TGA exemption certificate, and we always think about that in terms of being able to access the practitioner only products, but actually also enables us to.
• 11:05
  Speaker 2: If we've got that exemption certificate, it exempts us from the rules of otherwise manufacturing a product that the TGA sets for anybody who's making TGA registered or TGA listed products.
• 11:22
  Speaker 2: And the exemption is we don't have to fit those rules because we're extemporaneously compounding it.
• 11:29
  Speaker 2: Does that make sense?
• 11:32
  Speaker 1: But we do still have guidelines to sit within, correct.
• 11:38
  Speaker 2: Correct, yeah, and so we sit within the.
• 11:42
  Speaker 2: It's an Australian regulatory and I will read this Australian regulatory guideline for complementary medicines.
• 11:50
  Speaker 2: And if you just Google that, you'll find a big document and within that there's a section about what the exemptions are for compounding and it includes naturopaths and nutritionists, but it's also important to combine that with your understanding of the SUSMP, which is the standards for the uniform scheduling of medicines and poisons, and so or the poison schedule is known as as well.
• 12:17
  Speaker 2: But the so, again, if you just Google SUSMP, then you can see, like, say, for example, I looked up for somebody the other day Borek acid.
• 12:27
  Speaker 2: I looked up for someone recently iodine there, you know, zinc is in there or there are quite a few nutrients in there, vitamin D is in there, they're all.
• 12:37
  Speaker 2: There are rules about how, like, which schedule of medicines these, which schedule these medicines fit into.
• 12:44
  Speaker 2: So, for example, zinc is in, is unscheduled, up to 25 milligrams per dose and it's schedule, the rules.
• 12:59
  Speaker 2: I can't remember which schedule it is, but you have to have a on the between 25 and 50 milligrams per dose.
• 13:04
  Speaker 2: You have to have some writing, some writing on the label that says zinc in overdose is dangerous and we and so you know, shouldn't be taken.
• 13:15
  Speaker 2: No more than one tablet per day should be taken of this product.
• 13:19
  Speaker 2: Let's say I can't remember the exact wording obviously yeah, yeah, no, no, I totally get it.
• 13:25
  Speaker 1: That's really interesting when we're dealing with multiple nutrients, like I'd never really given much thought to.
• 13:32
  Speaker 1: We had the obligatory warnings and certainly those warnings which we weren't happy about.
• 13:37
  Speaker 1: You know CoQ10 with Warfarin and certain things like that.
• 13:40
  Speaker 1: Tga is very down on vitamin B6, pyridoxine at the moment and I see the warnings decreased from 50 milligrams in 2022 to 20 milligrams in 2023.
• 13:53
  Speaker 1: There's another story about what's true, but anyway, but I've never given much thought to just a safety warning rather than a danger warning, if you like.
• 14:09
  Speaker 1: You know, yeah, so the SUSMP.
• 14:13
  Speaker 2: Yeah, yeah, and so if you have, if you're compounding, you need to have access to the SUSMP.
• 14:19
  Speaker 2: It's online, it's very easy to find and it's, it's chunky, it's very, it's long, like every known chemical poison or otherwise is in there, and but if it's not in there, that means it's not scheduled.
• 14:32
  Speaker 2: So, you'd have to be careful.
• 14:35
  Speaker 2: But another example is vitamin D.
• 14:37
  Speaker 2: You're not allowed to compound well, you're not allowed to prescribe vitamin D over a thousand international units per day unless it's the otherwise it's scheduled for in Australia.
• 14:52
  Speaker 1: Yeah, yeah per dose.
• 14:55
  Speaker 2: I think that's per dose.
• 14:56
  Speaker 1: Yeah, yeah, yeah, you can, certainly you can.
• 15:00
  Speaker 1: You can increase the dosage you're giving to somebody per day, like, and you can use two thousand three thousand IU per day, but each unit dose has to be no more than 1000 IU or it's schedule three, like there's a seven thousand S3.
• 15:20
  Speaker 2: Oh, I see, yes, but even that is only it's labeled, as that's a weekly dose.
• 15:25
  Speaker 2: So that is true, yeah.
• 15:27
  Speaker 2: What you're saying, but it also is true to say that you can't label something Take, that's up seven thousand international unit dose Can't say take one per day, it has to say take one per week, because it's the daily the daily dose.
• 15:45
  Speaker 1: So, forgive me, so are you telling me that a practitioner cannot advocate a dose greater than 1000 IU per day for any patient?
• 15:57
  Speaker 2: Yeah, yeah, really I know.
• 15:59
  Speaker 2: Yeah, according to strictly to the SUSMP no-transcript.
• 16:03
  Speaker 2: Yeah, you can't, absolutely you.
• 16:05
  Speaker 2: You can tell the patient to do it, but you can't put on the label.
• 16:09
  Speaker 2: Yeah, right, I mean directions yes, yes, yes.
• 16:14
  Speaker 1: But I think that's where they say as or as directed by your health care practice.
• 16:19
  Speaker 2: Yeah, yeah, I just thought, let us.
• 16:24
  Speaker 1: Yeah, that's very interesting, okay, um, so yeah, take us through, though why?
• 16:30
  Speaker 1: Why are only some nutrients available in extemporaneous form?
• 16:39
  Speaker 2: So it.
• 16:40
  Speaker 2: I guess there's two ways of looking at that question.
• 16:42
  Speaker 2: Why only some nutrients available?
• 16:44
  Speaker 2: Or why are some nutrients only available in extemporaneous form?
• 16:48
  Speaker 2: So it, why are some?
• 16:50
  Speaker 2: Why are some nutrients?
• 16:51
  Speaker 2: And it all comes down to the TGA regulations and that's to do with the Like the Ostell and the Ostar.
• 16:58
  Speaker 2: So if you've got, I don't know whether it's worth going over those, whether yeah yeah, so that I mean the tip that you know.
• 17:06
  Speaker 2: The TGA, the therapeutic goods administration, has the Australian Register of Therapeutic Goods, the ARTG, and on that products are listed as either Products are on that list, as are the listed medicines, or registered medicines.
• 17:19
  Speaker 2: So listed are the.
• 17:20
  Speaker 2: There's tend to be the supplements, they're the lower, considered to be lower risk, whereas the and they're actually there only assessed for quality and safety, whereas the registered products are considered to be higher risk and they're assessed for Quality, safety and efficacy.
• 17:38
  Speaker 2: So that's the registered, they're the, they're the drugs, the pharmaceutical drugs are all in that category.
• 17:43
  Speaker 2: Other things that can be Patented tend to be in that category because you, it's a lot of work to get a product Registered, and then anybody else who just registered there's, once you've done that like it, you've done a lot of the work for somebody else, and so when it's not patented, manufacturers tend not to do that.
• 18:00
  Speaker 2: So that's the two categories Ostell or Ostar, and they're registered on the TGA.
• 18:06
  Speaker 2: The products that are not listed on the TGA but a company wants to manufacture that because there's a need, a market need for it, then that they would be the products that are not on the TGA but Are available as extemporaneous compounding only, and so so they're, they're registered in that way on the market.
• 18:28
  Speaker 2: They're not registered on the TGA, they're.
• 18:30
  Speaker 2: They're sold on the market in that way because then there's there's no product that's listed or registered on the TGA and so you're allowed to compound it.
• 18:39
  Speaker 2: Yeah, so that I mean it's because.
• 18:42
  Speaker 2: So I guess there are two ways of two things that are important in that the products that are Available as compounding products are not available on In red ready-made products.
• 18:53
  Speaker 2: So the companies create these extemporaneous products so that practitioners have access to those products Even though there's no TGA file for it.
• 19:02
  Speaker 2: Yeah, and equally they.
• 19:05
  Speaker 2: If a product is on the TGA, we're not allowed to compound it, so you can't like.
• 19:12
  Speaker 2: Magnesium glycinate is a good example of that.
• 19:14
  Speaker 2: It used to be that there was no ready-made magnesium glycinate on the market in Australia, so we used to compound it quite a lot for people, either as powder or as capsules, and PEA is another example.
• 19:23
  Speaker 2: So before it was available, we would, we were able to compound it.
• 19:27
  Speaker 2: But now it's available on the TGA, the pharmacy guidelines, so we're not allowed to compound it now.
• 19:32
  Speaker 2: And I mean it would be the same, I would apply it to a naturopath and so all equally.
• 19:38
  Speaker 2: So like, let's say, there's a product on the market that's got Zinc, magnesium, b6 and I don't know the anine.
• 19:44
  Speaker 2: Let's say, let's say you like that formula.
• 19:46
  Speaker 2: If there's something on the market that's exactly that, technically you're not really supposed to compound it because there's a ready-made product that's considered to be safer.
• 19:57
  Speaker 1: Yeah, oh, I see what you mean.
• 19:59
  Speaker 1: That's really interesting.
• 20:01
  Speaker 1: I'm just thinking about herbal medicines.
• 20:03
  Speaker 1: It's like as a disconnect there, because we can we can do extemporaneous and we can do them pre-formulated.
• 20:11
  Speaker 1: Yeah but they're not interesting in the same.
• 20:16
  Speaker 2: No, yes, but you could argue that they're not the same and that's why you can extemporaneously compound them, because they're different.
• 20:22
  Speaker 2: And I guess this is this sort of brings us to the you know, what are the benefits of compounding question that people always ask as well?
• 20:28
  Speaker 2: And One of them is the same benefit that the you, the patient, gets out of having their own formula of herbs.
• 20:36
  Speaker 2: They get that benefit of having their own formula of nutraceuticals, so it's unique to them it it fits their exact symptom picture that it doesn't have any additives that they don't need.
• 20:49
  Speaker 2: You know, that's what that all those benefits and naturopathies used to gaining from having a Personally blended, bespoke herbal medicine.
• 20:57
  Speaker 2: Then that applies equally to the nutraceutical medicines.
• 21:02
  Speaker 1: Yeah, I think you know, like how many times have have we I you know had a patient presentation and you think in your head, I'd really like that, but with this and Then you try to find that in a pre-made formula, and it's like which one.
• 21:18
  Speaker 1: So how?
• 21:19
  Speaker 1: many families do you then have, and it's like the other yeah, so compounding yes could actually reduce your stock holding, reduce your number of products that you've got to have on the shelf.
• 21:31
  Speaker 1: Yeah, so you could actually have a bespoke thing for more patients, okay, so, yeah, the next step, just things like equipment.
• 21:39
  Speaker 1: Just a brief thing on equipment how sensitive do we have to?
• 21:43
  Speaker 1: Is this the right question?
• 21:47
  Speaker 1: What quality of equipment do we have to have?
• 21:50
  Speaker 1: You know, can we just get away with some scales that we bought on Amazon, or do you really have to be, you know, calibrated and you know what's the ISO, iso level calibration.
• 22:06
  Speaker 2: Yeah, that's right.
• 22:06
  Speaker 2: Well, yes, exactly.
• 22:08
  Speaker 2: So I don't know the ISO number, but yes, there is one for for calibrating scales.
• 22:13
  Speaker 2: So I guess it.
• 22:15
  Speaker 2: That comes down to the, the doses that you're prescribing for your patient.
• 22:19
  Speaker 2: So you know, on a set of scales you've got three or two or one decimal places after the.
• 22:25
  Speaker 2: After the zero is after the decimal place.
• 22:28
  Speaker 2: So if there are three, that means it measures.
• 22:33
  Speaker 2: You can read down to one milligram, right, because we're talking grams and you've got point what?
• 22:39
  Speaker 2: Point one would be 100 grams.
• 22:40
  Speaker 2: Point oh, one would be 10.
• 22:42
  Speaker 2: Sorry, point one would be 100 milligrams.
• 22:45
  Speaker 2: Point one grams point oh one, oh one would be 10 milligrams.
• 22:49
  Speaker 2: Point oh one would be one milligram.
• 22:51
  Speaker 2: And so the rules in pharmacy at least and I think it's worth sticking to that that you can compound, you can weigh something accurately if it's 50 times the minimum number that you can read.
• 23:06
  Speaker 1: Gotcha.
• 23:07
  Speaker 2: Yeah, so if you're on your kitchen scales and it measures down to one gram, then that means that you can measure down accurately down to 50 grams, which is fine.
• 23:18
  Speaker 2: If you're baking a cake, no problem.
• 23:19
  Speaker 2: But if you, if you, if you want to make sure that you're getting an accurate dose for a patient, you need to have a better set of scales than that.
• 23:28
  Speaker 2: I mean ideally you would get them.
• 23:29
  Speaker 2: You would get them calibrated regularly, you know, just like a blood pressure monitor.
• 23:33
  Speaker 2: Ideally you would send that off for calibration once a year.
• 23:36
  Speaker 2: We send ours back to the manufacturer annually for a calibration and I just think it's probably good.
• 23:42
  Speaker 2: We send our scales off for calibration every year and I think it's good practice.
• 23:47
  Speaker 2: Yeah, so you would just have to.
• 23:49
  Speaker 2: When you're buying a set of scales, make sure that you've got enough decimal places on it to make sure to measure accurately the quantity that you want, and also ask the manufacturer if they can calibrate it for you on a as part of a regular service.
• 24:03
  Speaker 2: You know that would clean.
• 24:04
  Speaker 2: They clean them and pull them apart.
• 24:07
  Speaker 2: Make sure everything's working properly.
• 24:08
  Speaker 2: So, but you'd have to check that with the manufacturer of the scales that you buy.
• 24:12
  Speaker 1: Yeah, yeah, yeah, that's, that's a good point, yeah, so just moving on, what sort of nutrients are available on the Australian market?
• 24:20
  Speaker 1: Then, obviously there's there's going to be differences between the US market in Australia.
• 24:25
  Speaker 1: So what sort of things can we use, do, what sort of nutrients do we have at our availability to be able to use for patients in Australia?
• 24:36
  Speaker 2: Well, the ones that are available from the manufacturers that we have access to would be.
• 24:43
  Speaker 2: I mean, the obvious ones are my, you know, satole, calcium D, glucarate, nac is another one, magnesium 3 and 8, they're all the ones that are made by Designs for Health, but then there are lots more that are made by by the other companies.
• 24:59
  Speaker 2: You know, there's zinc polynate, there are lots of them, but all the other factors have them as well.
• 25:09
  Speaker 1: So can you make a decent dispensary from the availability of through various companies?
• 25:14
  Speaker 1: Can you make a decent dispensary out of those products that are available in Australia, or do you have to go to somewhere, like you know, pcca or the other pharmaceutical wholesalers, to get certain nutrients?
• 25:32
  Speaker 2: It's a limited range that's available from the supplement manufacturers?
• 25:36
  Speaker 2: Yeah, because they've got products that are already made, and so you know they're not the ingredients that they've got other ones that are not in the ready-made formulations, Whereas.
• 25:47
  Speaker 2: So if you wanting to make something that's unique to your patient and they can get away with having only one product, you're going to want to have all the other ingredients as well.
• 25:56
  Speaker 2: Yeah, so it depends.
• 26:02
  Speaker 2: I guess it depends on how, like one thing that a lot of naturopaths ask me about is can I take a ready-made product and add something else to it?
• 26:10
  Speaker 2: And you can?
• 26:11
  Speaker 2: Yes, you certainly can do that.
• 26:13
  Speaker 2: Yeah, so you could add a compounding ingredient to a ready-made product.
• 26:19
  Speaker 2: The only reason, or you can use the compounding ingredients that are available just by themselves.
• 26:25
  Speaker 2: They're labeled.
• 26:27
  Speaker 2: As for extemporaneous compounding, only because the companies are not allowed to label them because they're not TGA-listed products.
• 26:33
  Speaker 2: But that's not to say that you can't.
• 26:37
  Speaker 2: A naturopath and nutritionist can still prescribe those, but what they have to do is that they're not labeled at all, and so they have to make sure that what they write on the label meets the labeling guidelines, and that's in that same document.
• 26:50
  Speaker 2: But I can, you know, like there's a hot.
• 26:54
  Speaker 2: It's a simple list.
• 26:55
  Speaker 2: I can run through it if you like.
• 26:58
  Speaker 2: What has to be on there, like the patient name, the dose or that sort of stuff.
• 27:04
  Speaker 1: Yeah, please no run through it.
• 27:09
  Speaker 2: Okay.
• 27:09
  Speaker 2: So my first point if you just with making a label, you have to remember that there's nothing written on the packet for the patient.
• 27:16
  Speaker 2: So everything the only information that the patient is getting is from the prescriber.
• 27:21
  Speaker 2: So you just have to keep that.
• 27:23
  Speaker 2: I think that's important to keep top of mind.
• 27:24
  Speaker 2: And the rules are you have to have the name of the patient, the name of the prescriber, the form, which means, like the capsules or powder or cream, the quantity, as in the number of doses, the ingredients in each dose, but like the name of the ingredients, the strength of the ingredients.
• 27:44
  Speaker 2: You have to have clear directions for the patients.
• 27:47
  Speaker 2: You have to have storage conditions, the date of dispensing, the date of expiry, a unique identifying number.
• 27:53
  Speaker 2: So we have a prescriber, a dispensing number.
• 27:58
  Speaker 2: You have to have the name, address and phone number of the person compounding it and it has to say keep out of reach of children, and that has to be written in red.
• 28:08
  Speaker 1: Right, okay, you know what.
• 28:11
  Speaker 1: You brought up something really interesting there about the number of doses, and this is something where practitioners can track, if you like, compliance, but also by doing so you can make it less confusing for patients.
• 28:25
  Speaker 1: What I mean by here is, let's say, some pre-formulated product comes in a bottle of 60 tablets or capsules and you've said to take two per day.
• 28:34
  Speaker 1: That's one month's odd supply.
• 28:37
  Speaker 1: Now you've got a massive bottle of magnesium three and eight which, if you take it at the dose that you've recommended, would probably last you six months or something, not the least of which.
• 28:50
  Speaker 1: That's a bigger purchase for the patient.
• 28:52
  Speaker 1: But the other one is it starts to get confusing when the patients are sort of having one month's supply of this and five months supply of that and all over the shop, whereas if you dispensed, even if that single magnesium three and eight into a one month supply, there you got your pre-formulated one month supply, your compounded one month supply, and you've got one month supply.
• 29:14
  Speaker 1: I'll see you in one month.
• 29:16
  Speaker 2: So not just making it easy.
• 29:18
  Speaker 1: Yeah, yeah, not just making it easy for the patient, but also making it more affordable for the patient as well.
• 29:28
  Speaker 2: Yeah, yeah, that's, that is true.
• 29:30
  Speaker 2: And so that's why I'm saying, like, the practitioner can prescribe just the simple.
• 29:34
  Speaker 2: You know, it's like a herbal medicine simple, you're just prescribing.
• 29:38
  Speaker 2: It's labeled for extemporaneous compounding, but that doesn't mean that you have to compound it as in mix it with something else.
• 29:46
  Speaker 2: You can just prescribe it as it is, but you do have to meet those labeling requirements.
• 29:51
  Speaker 1: Yeah, yeah, okay.
• 29:53
  Speaker 1: So what's the practical?
• 29:54
  Speaker 2: next step for compounding.
• 29:56
  Speaker 1: Oh sorry, yeah, that was yeah, no, no, no.
• 29:59
  Speaker 2: I would say, if you want to have something that's unique to that patient and that fills all their needs, you can do that with compounding, but you would have to add in all the, all the micronutrients as well.
• 30:14
  Speaker 2: And so when you're adding in the micronutrients, that that makes the dispensary unwieldy, really, and that's when it would be worthwhile talking to a compounding pharmacy just to get access to all the the smaller, the less the the ingredients where you're going to use less often.
• 30:33
  Speaker 1: So you might be using.
• 30:34
  Speaker 2: Osetol is a great example where the you know the dose would be one to well up to 18 grams in some clinical trials.
• 30:42
  Speaker 2: But if you're, you know you're using one gram of something times 30 doses or times 60 doses, then you know you're going to get through your 100 gram job pretty quickly, whereas if you're prescribing 150 micrograms of iodine you wanted to add to a formula for somebody, then it's going to take you a long time to get through your minimum purchase of that and realistically it's going to be.
• 31:08
  Speaker 2: I mean, do naturopaths and nutritionists have access to those ingredients that are TGA approved in Australia?
• 31:15
  Speaker 2: Not that I have found, because I just use the pharmaceutical supply whole silence.
• 31:21
  Speaker 2: And the other thing I think to consider is like, from a pharmacy point of view, there are three levels of compounding.
• 31:28
  Speaker 2: So this simple, complex and sterile.
• 31:30
  Speaker 2: Simple compounding would be like this sort of thing with the calcium D-glucorate plus anosotol.
• 31:35
  Speaker 2: Let's say, if you wanted to make that formula, or just plain old magnesium 3-in-8 where you're taking, you're just decanting it out of the jar, like you suggested, and put it into a smaller jar.
• 31:43
  Speaker 2: So that's simple compounding.
• 31:47
  Speaker 2: We started talking about the equipment that you need and we didn't finish that.
• 31:52
  Speaker 2: But I'll finish this idea first.
• 31:54
  Speaker 2: So that's simple.
• 31:54
  Speaker 2: Compounding.
• 31:56
  Speaker 2: Complex compounding is where the doses are smaller and that's where you want to make sure that your homogeneity of your ingredient mix is really good, probably better than you can get in a mortar and pestle, but you can get good homogeneity in a mortar and pestle.
• 32:11
  Speaker 2: But the smaller the dose and the smaller the therapeutic window which I think that's where the difference between the minimum effective dose and the maximum dangerous or the upper safe level dose the narrower that window, the smaller the dose, the more problematic the side effects.
• 32:30
  Speaker 2: Then you start to worry about am I getting the right dose to the right patient at the right time?
• 32:35
  Speaker 2: Whereas if you're talking magnesium three and eight, where the where the dose is sort of 500 to 2000 milligrams is would be like an average dose range for magnesium three and eight, then it's less of a concern.
• 32:52
  Speaker 2: If accidentally they get, you know, 450 milligrams instead of 500, we're not too worried about that.
• 32:59
  Speaker 2: Whereas if they accidentally get 300 micrograms of iodine per day, again I mean it's not.
• 33:06
  Speaker 2: Or maybe 300 micrograms of selenium per day, let's say you know you that that's more of a problem and it and it's harder to get that exactly right at that tiny, tiny end of the dose range.
• 33:18
  Speaker 1: So can I ask then, if you're dealing with I actually think your example of iodine is a perfect one.
• 33:25
  Speaker 1: So let's say you've, you've, you want 150 micrograms per day of iodine, certainly well within the upper limits, right?
• 33:37
  Speaker 1: But let's say you now want to make a mixture and you want to provide a month's worth of iodine within that mixture, then you've got to think about settling and, as you said, the homogeneity of it.
• 33:54
  Speaker 1: So if you're taking into account settling, would you therefore, instead of using a powder to control each potential mishap, let's say would you therefore go now?
• 34:07
  Speaker 1: I'm not happy about you taking a powder, I'd prefer that you have a capsule, and I'll make you up a capsule dose compounding.
• 34:14
  Speaker 2: Exactly, that's right.
• 34:16
  Speaker 1: Yes.
• 34:17
  Speaker 2: And so that's what we would then call complex compounding, because it's I mean, it's not hard to make capsules, it's just there's quite a bit of setup and the equipment required and all that sort of stuff and it's labor intensive, it's not.
• 34:31
  Speaker 2: Don't be thinking that you're just going to smash up the capsules.
• 34:34
  Speaker 2: If you're going to get it right, it's yeah, it's time consuming.
• 34:37
  Speaker 2: If you want to get the dose in each capsule right, you've got to.
• 34:39
  Speaker 2: There's a whole formula with adding an inert filler which we can use.
• 34:47
  Speaker 2: Vitamin C or probiotics or magnesium glycinate is often there, often things that we would use as fillers, or it's just like a cellulose, a very inert plant based fiber.
• 35:02
  Speaker 2: So anyway, that's what I would call.
• 35:04
  Speaker 2: That's what we call complex compounding.
• 35:05
  Speaker 2: And then there's sterile compounding and that's where you need a sterile, sterile unit where you know you double scrubbing and like the airflow is important and it's a whole setup of a sterile unit and in a sterile unit then you would that.
• 35:20
  Speaker 2: That's the next level of compounding, where you do like injections and eye drops, things that have to be sterile.
• 35:26
  Speaker 2: But complex compounding is is is not as elaborate as sterile and simple.
• 35:34
  Speaker 2: So simple, complex, sterile unit, like they're this sort of continuum of difficulty and importance in getting it exactly.
• 35:41
  Speaker 2: The margin of error increase.
• 35:43
  Speaker 2: The importance in getting that margin of error absolutely right increases.
• 35:48
  Speaker 1: Yeah, yeah.
• 35:50
  Speaker 1: And what about delivery types?
• 35:51
  Speaker 1: Like we always just assume, with extemporaneous compounding, that we're going to be taking it orally, even if it's in a different dosage form like capsules or powder.
• 36:01
  Speaker 1: But what about other forms, like, for instance, I was podcasting with Lisa Mone, who deals with extremely fussy eaters, and she says sometimes, because there's even a texture issue, because the muscles of their mouth are poorly developed, yeah, they can't chew properly, and so she'll, she'll go to a cream, and it blew my mind.
• 36:24
  Speaker 1: I thought, oh my goodness, yes, how how small minded have I been.
• 36:29
  Speaker 1: So so what about absorption kinetics and things like this?
• 36:34
  Speaker 1: Like how, that's a whole another ballgame in it?
• 36:38
  Speaker 2: It is, it's worth just trying it.
• 36:42
  Speaker 2: If a patient, a particular child, won't absorb it, won't take, sorry, won't tolerate it.
• 36:49
  Speaker 2: The, we, the, the stat, you would start at a standard equivalency of pretty much one to one.
• 36:55
  Speaker 2: But you tend to get better absorption across the skin and particularly across the mucosal membrane.
• 37:00
  Speaker 2: The absorption is better than through the gut because it doesn't have to do that first pass effect through the liver.
• 37:05
  Speaker 2: So you're getting the, you're getting it's going straight into the bloodstream across the, across the skin or across the, especially across the transmucosal membrane.
• 37:16
  Speaker 2: So like we make these little sub sublingual trotias we call them, and they, you can use those in the mouth or in the vagina or in the vagina or as well, and you get really good absorption or also positive in in the rectum because you get, you get better absorption that way for many drugs and nutrients if they're not take, if they won't take them orally.
• 37:41
  Speaker 1: Okay.
• 37:41
  Speaker 1: So here's a question.
• 37:42
  Speaker 1: Previous, let's say five years ago, we were able to.
• 37:50
  Speaker 1: We had available to us in Australia these probiotics in a pessary form designed for intravaginal delivery for the treatment of bacterial vaginosis and candid catatosis, things like that.
• 38:03
  Speaker 1: And then what happened is there was a law change whereby any supposed internal apparently the vagina result internal, so any internal delivery had to be sterile.
• 38:15
  Speaker 1: So therefore you had to sterilize the probiotics.
• 38:18
  Speaker 1: I you've now got dead probiotics which basically kiboshed that whole therapeutic avenue.
• 38:25
  Speaker 1: Can we therefore mix probiotics and put them into a pessary form still legally in Australia?
• 38:32
  Speaker 1: Actually, don't know that.
• 38:49
  Speaker 2: I don't know the answer to that question, can you?
• 38:52
  Speaker 2: I mean we can make them.
• 38:57
  Speaker 2: The question is is it legal?
• 38:59
  Speaker 2: But also, we tend to capture the use trends vaginally as well for probiotics and that's off label and I mean I see practitioners doing that, but it would.
• 39:14
  Speaker 2: Yeah, that's a good question about whether that would, because then that is for internal use and should that be sterilized and therefore not gonna be effective.
• 39:22
  Speaker 2: But women use capsules trans in the vaginal space all the time for probiotics.
• 39:31
  Speaker 1: Yeah, yeah, okay.
• 39:32
  Speaker 1: So next question forgive me for taking liberty with this one, but so would you prefer to choose a certain type of capsule, like, for instance, a vegan capsule, a totally plant-based capsule, rather than a gel cap?
• 39:50
  Speaker 1: Any preference there, like have you got any knowledge there?
• 39:55
  Speaker 2: For vaginal use.
• 39:56
  Speaker 2: Do you mean or do you?
• 39:57
  Speaker 1: mean for oral use.
• 39:58
  Speaker 1: Yes, Oral.
• 40:00
  Speaker 2: All right vaginal Vaginal.
• 40:02
  Speaker 2: I would tend towards a veggie cap actually for vaginal use, because you're gonna get the breakdown is easier with a veggie cap.
• 40:15
  Speaker 2: They're not as solid as a gelatin capsule, yeah, so you probably gonna get a bit of a better A bit of a better With the vaginal microbiota a lot more readily.
• 40:25
  Speaker 2: Yeah, yeah, and you would get a better breakdown as well.
• 40:30
  Speaker 2: Cool.
• 40:31
  Speaker 2: I would imagine then using gelatin.
• 40:35
  Speaker 1: Diana, this is such an interesting topic.
• 40:38
  Speaker 1: There's so many avenues we can go.
• 40:40
  Speaker 1: Where can we find out more about this?
• 40:44
  Speaker 2: I've done a webinar, which is on our website at naturalscriptcomau, and so that explains how to do, how to create a compounded prescription using our platform, and then we would make it for you.
• 40:59
  Speaker 2: And I've also got a webinar coming up with Designs for Health, which is we'll focus on their ingredients, of course, but I'll mention all the other ones as well, that how to formulate those, the equipment that you need.
• 41:14
  Speaker 2: I'll go over the labeling requirements and all that sort of thing.
• 41:17
  Speaker 2: Yeah, there'll be more information about it there.
• 41:19
  Speaker 2: So it depends on if you wanna do it yourself.
• 41:22
  Speaker 2: There's probably more information in the Designs for Health webinar.
• 41:26
  Speaker 2: But if and lots of practitioners they wanna compound, they wanna create the compounds for their patients, but they don't necessarily wanna actually do the work themselves Because of the equipment that required, the calculations of the dosages, all that sort of thing.
• 41:41
  Speaker 2: Or perhaps they wanna include ingredients that they don't have access to, and for that we can do that for them.
• 41:49
  Speaker 2: That's that webinar on Natural Scripts that explains how to use our platform to create those scripts.
• 41:54
  Speaker 1: Yeah, so just one more time what's your website again?
• 41:58
  Speaker 2: That's naturalscriptscomau Natural Scripts, and that's a platform for Plural.
• 42:04
  Speaker 2: No, just one, no, just, no, that's at the end.
• 42:07
  Speaker 2: Natural Scripts.
• 42:08
  Speaker 2: Natural Scripts yeah, gotcha, and that's a platform for naturopaths, nutritionists and other healthcare professionals to upload scripts for their patients.
• 42:17
  Speaker 2: So we do all the ready-made products, but our main focus is bespoke, compounded, extemporaneously prepared medicines.
• 42:26
  Speaker 2: So you might wanna add, you can do a nutraceutical formulation, you can do a liquid herbal formulation and then you might wanna add a ready-made any of the ready-made products.
• 42:36
  Speaker 2: We've got those as well.
• 42:38
  Speaker 1: Yeah, it's true, beautiful.
• 42:39
  Speaker 1: I look forward to learning a lot more in this webinar and certainly on the information on your website.
• 42:46
  Speaker 1: Thank you so much for taking us through Extent Compounding Today Diner.
• 42:49
  Speaker 1: It's been great.
• 42:50
  Speaker 2: Okay, thanks, andrew.
• 42:53
  Speaker 1: Cheers and thank you everyone for joining us today.
• 42:55
  Speaker 1: Remember you can catch up on all the show notes.
• 42:58
  Speaker 1: We'll put as much information as we can up on the website, on the Designs for Health website and of course, you can catch up on all the other podcasts there as well.
• 43:06
  Speaker 1: I'm Andrew Whitfield Cook.
• 43:07
  Speaker 1: This is Wellness by Designs Music.