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Personalised Medicine: Compounding with Karl Landers

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Personalised Medicine: Compounding with Karl Landers

The flexibility, technology and sophistication of modern-day compounding has come a long way from it's humble origins. Compounding is now a specialised area of pharmacy available to health professionals which is ideal for those patients who have specialised needs outside of what's commercially accessible.

In today's podcast pharmacist Karl Landers takes us through the strict standards compounding pharmacies must adhere to and how as a team, the patient, practitioner and pharmacy work together to craft individualised medicines.

This niche area of practice requires expert and comprehensive education and execution to maximise its potential and something that Karl firmly has his finger on the pulse of. You can learn more from him at his forthcoming webinar with The Australian Traditional Medicine Society in May 2018

Covered in this episode

[00:29] Introducing Karl Landers
[01:51] Specialising in compounding
[04:42] Historical vs modern compounding
[08:18] The official definition of compounding
[08:59] Compounding vs manufacturing
[11:53] Quality assurance procedures
[13:43] Understanding prescribing legalities and limitations
[20:16] Common uses for compounding
[23:49] The clinical use of personalised creams
[29:10] Safety and the compounding 'triad'
[34:42] Other routes of administration
[35:51] Further education in compounding

With thanks to: 



Andrew: This is FX Medicine, I'm Andrew Whitfield-Cook. Joining us on the line today is Karl Landers, who's one of the principal pharmacists and partners of Kingsway Compounding laboratory in Brookvale, Sydney. Since 2001, he's helped build a world-leading team that specialises in individual medicine. Which prides itself on listening and empathising with both the patient and the practitioner. It's one of the most respected compounding practices in Australia and New Zealand.  
Karl is a member of the Pharmaceutical Society of Australia, the Australian College of Pharmacy, and the Pharmaceutical Society of Ireland, from where he originates. He's also been on the PCCA, the Professional Compounding Chemists of Australia Advisory Board from 2012 to 2015, and was a member of the Pharmaceutical Society of Great Britain from 1994 to 1998.  
He has a special interest in biomedical disorders and has been a guest speaker at the International PCCA Conference in America, 2009, has spoken at various support groups within the local community such as The Northern Beaches ADHD Support Group, and has given educational talks at some of the natural therapy colleges in Australia. 

Welcome to FX Medicine, Karl. How you going? 
Karl: Yeah, very good. Thank you, Andrew. 
Andrew: Now, I guess, first we have to go back to your pharmacy days. You did pharmacy in Ireland, did you? 
Karl: No, I actually did it in England. 
Andrew: In England? 
Karl: The North East of England, Sunderland University. 
Andrew: And was that where compounding, sort of, sparked your interest? Or, I mean, you would have learned compounding as part of pharmacy back then, correct? 
Karl: Yeah. Well, we did. We had, probably, half of our course was sort of around that type of pharmacy. But, it was more...I was probably more into the manufacturing side at the time. So, you know, when I did my internship, I did it with Glaxo, and that gave me a pretty good background into pharmaceutics and how to make drugs the right way, you know, how to make formulations, etc.  
So, it was actually more when I came to Australia, was where I actually got the, shall we say, the ‘bug’ for doing compounding. And it was through a journal. There was just this small little article in one of the journals that mentioned something about compounding. And I thought, "Well, this is something interesting." So, at the time, we were doing retail pharmacy with a little bit of compounding, but it wasn't called compounding then. It was called extemporaneous dispensing. 

Andrew: Yep.  
Karl: And what we were finding was we weren't quite getting...you know, we weren't seeing major improvements in quite a few of our patients, You know, that they started on a particular medication, you know, for something minor, say for example, like a bit of stomach upset or indigestion or something. And then, you know, a year or two down the track, they're on several different medicines, and interactions are occurring and they're not actually getting better.  
So, we thought, "Well, maybe if we could fine-tune what we were doing in the pharmacy compounding-side of things, we would be able to sort of minimise those effects. Maybe have a few more choices in what we can give." 

So, that was the first, sort of, how would I say? That was the first drive for us to say, "Okay, this is something we can put into our practice." And, as it turned out, then, we had a close friend of ours, name is Tony Maggi, which is a very good compounding pharmacist we met. He was doing a lot of work with autistic children at the time and he was using nutritional therapies. And when we were...we sort of collaborated and that sort of was the icing on the cake for us. Because that gave us sort of the best of all worlds, you might say. So, we could deal with, sort of, your sort of allopathic medicine, and then you could deal with your natural medicine, and the two sort of meld together. And that's how we got into the nutritional compounding. 
Andrew: Compounding has been something the pharmacists have been doing for decades, eons. You know, they used to make up Whitfield's ointment, even though there was the, you know, the pre-made things from not Gold Cross but, you know, David Craig and these suppliers. 
Karl: Yeah, that's right. It was called extemporaneous dispensing. That was very basic formulations. Been around for a long time. They had their place but, today, compounding is a completely different beast altogether. So, you know, you wouldn't be making up the compounds that we would do in a back of a retail store or anything like that. That would not be appropriate. 
Andrew: You know, I still remember pharmacists making up coal tar creams and things like that, in a specific strength, as required by a GP. For, let's say, a psoriasis or a dermatitis. Very often, they were creams. But, in the olden days, when you see these old pharmacies and you see the carboys, the glass carboys and the glass jars with squill and gentian and things like that. So, what really interests me is that pharmacists were herbalists. 
Karl: Well, yeah. Absolutely. I mean, if you want to go back a little bit further... Well, let me put it this way. Part of pharmacy is called pharmacognosy. And that's the study of the plants that are used in treatment, healings. And how you can extract things from those plants to actually, you know, make into a formulation for a person to use. 
So, yeah, it is a bit of an irony that the pharmacy, where it's more based in pharmaceuticals today, but its origins are quite firmly set in the actual herbal industry. And it just depends how far you want to go back. I mean, we've got some really old formulation books which are full of different type of herbal tinctures and things like that. Which were the norm. 

Andrew: Yeah.

Karl: And if you think of the Rx on a prescription, that actually stands for recipe.  

Andrew: Right. 
Karl: So, when the prescribers were actually doing it, they would create a recipe of what they were going to make for the patients. And yeah, every pharmacist was making up all sorts of wonderful things many years ago. But then, of course, with the advent of making it a lot easier, you know, the manufacturers started bringing out set formulations and that sort of art of, what we call, the art of compounding, which has been lost. But, it's back now. 
Andrew: So, what interests me, though, is that, now, of course, there's that part that that previous stuff is now untrue. Because it's now called pseudo-science by a lot of people. 
Karl: There's probably some sort of political agendas that go on there which aren't in the best interest of science and patient health, unfortunately. 

But, you know, to me, the proof's in the pudding. And at the end of the day, is the patient getting better? And there's many different formulations, there's many different parts of healthcare which all, sort of, combine together to help the patient. I think it's not just the pharmaceutical industry, it's not just natural therapies, it's not just chiropractors or physios. It's all of them together coming together as one, really, is the ideal. But, yeah, we'll just have to, sort of, watch this space and see how that pans out over the next number of years. 
Andrew: That's the definition of interdisciplinary. But, you know, it tends to be shanghaied in certain circles. But, do you have an official definition of what compounding is? 
Karl: Yes. Off the top of my head, I mean, it is the process and art of formulating a particular compound for an individual patient. So, it's specifically for one person. So, you can't really do double blind clinical trials on these, on compounds. Because n equals 1. So, it's basically personalised medicine. 
Andrew: I think the important thing that you mentioned there is individual. So, it's individualised medicine and therefore, it's not a batch. 

Karl: No. 

Andrew: And I think this is where some confusion comes in. There's a difference in legalities, if nothing else, than with regards to batch manufacturing. Can you briefly go through what batch manufacturing is? 
Karl: Yeah. Look, there's quite a distinct difference. So, when you manufacture something, you do it under what's called GMP practice. Which is good manufacturing practice. Now, you have to have a particular license from that. And if you're making anything that has to do with medicines, you have to get a license from the TGA, The Therapeutic Goods Administration
So, manufacturing will make one type of medication for many people. That's the biggest difference. So, the process and regulation that has to go on for that, well, you’ve got to make sure that you are 100% positive that what you're actually releasing to the public is exactly what it is. Be it for whether it could cause harm, be it be the wrong dose, or be it it doesn't work. 
So, you know, you could be making one product and they could be making a million packets of it. So, you don't want that affecting a million people if something went wrong. With compounding, you're dealing one patient. What are their needs, their specific needs? And you're going to have somebody making it from scratch. Literally, from every little active ingredient, putting it together and coming up with something to suit. 
So, there can be a bit of trial and error at the beginning. But, there's a lot of experience with it now, you know, and around the world. And there's quite a significant number of studies which show the benefits of various dosage forms that can only be compounded. 

Andrew: Right. 

Karl: So, it's very hard to upscale a compounded product to a manufacturing as well. So, there's that part as well. 
It's just, you know, for example, if you're making some capsules or tablets in manufacturing, you use magnesium stearate, which is used as a lubricant. That's not just a lubricant for the tablet, it's actually for the machines so that the powders can flow and they can make, otherwise, they'd seize up. Whereas, in compounding, we don't have to do that because we're doing it manually. 

Andrew: Got you. 

Karl: So, we don't need to use magnesium stearate. 

Andrew: Right. 

Karl: So, things like that,yeah. Manufacturing is GMP, whereas, we look at compounding as CMP, you might say, Compounding Practice, Compounding Manufacturing Practice. But, I can't use the word "manufacturing" because we definitely can't manufacture. So, we can't make up a whole load and then sell it to some people, to people for them to onsell or anything like that. That's impossible. 
Andrew: And that requires a batch, you know, where you have a "use by" date, you have a batch number, you know, you have tracking of the ingredients. Where it came from. I'm going to guess here, and forgive me if I'm wrong, but do you, then, have to be involved in testing of a batch? 
Karl: Well, yeah. Look, I suppose the way compounding has now progressed to is, for example, we would definitely test our products. We would have to do sample testing. So, we'll take random samples which we'll test to see that our processes are correct. We'll do samples to check that the technicians are actually following the standard operating procedures, making things right. 
All of those things that you would expect, like recording your batch numbers, everything, that's all done in compounding. Well, it's certainly done with us. Where we can record it to the second so we know exactly when something is being made. We have, you know, the way to be made the laboratories, you know, they have temperature, pressure, humidity controlled environments where they're critical to ensuring a consistent compound. 
So, the advancement in compounding has really gone in leaps and bounds from just a pestle and mortar. I mean, we would rarely use a pestle and mortar today because the advance in the machinery and the equipment is just so much better now that you can get a quality compound that is as good as what you would get as a manufactured product.  
Andrew: Wow. 
Karl: Yeah. So, and around the world. I mean, compounding is quite renowned around the world, especially in Brazil, United States, Europe. It's been going on for a long time before Australia sort of picked up the baton. 
Andrew: With regards to prescribed ingredients, off the top of my head, let's say, it's a pregnenolone or progesterone, troche. Being in individualised medicine, can a GP still write repeats for, like a maximum number? Let's say five repeats, seems to be the maximum? Or, does the patient have to see their practitioner each time before a refill is made? What's the legalities of that? 
Karl: Look, there isn't really much. There's not some sort of legal obligation with repeats or anything like that. And the repeats have come from what we would normally do with PBS dispensed medicines, which are just your regular thing. So, in those, there are limits as to what you can actually allow for repeats for particular reasons so that there has to be a follow-up, etc. 
Usually, what we find is with compounded products is that for the first few compounds that are made for the patient, the practitioner would have a follow-up appointment, maybe six or eight weeks later, to see how they're actually responding. 

Andrew: Yep. 

Karl: You know, we would also, you know, follow-up with the patient and see how they're getting on. If there's nothing happening, then we usually would contact the practitioner, let them know. So, maybe, there has to be a change in the dose or something like that. 

But, there are some people that get stabilised. If you take those troches, for example, or particular creams, what would happen is, maybe after six months that the patient is stabilised, practitioner might say, "Okay. Well, everything's working fine now. You can continue on with that dose, and here's a repeat."  
Usually, they'd only do one or two repeats because they'd like to see the patient again, maybe, you know, three or four months later just to make sure everything is right. It's not a legal issue. It's not really a legal requirement or anything like that. It's really up to the practitioner when they want to see the patient again. 
Andrew: Yes, it's more of an assessment issue. 
Karl: Yeah, it is. Yeah. So, prescribe an amount that would allow the person to have enough for at least two weeks after your next appointment. That's sort of the rule of thumb we work on, just in case there's delays or anything like that. 
Andrew: Yeah. And, of course, you know, I guess most people or many people would, many practitioners, would be aware of the compounding of prescription items. But, what confuses me a little bit is, I've been aware because I've been exposed to it. There's two GPs, locally, that do compounding of certain nutrients. 
But, compounding of nutrients is actually something that you do as well, so it doesn't have to be a prescribable item, as per a doctor's prescription. Naturopaths can use a compounding pharmacy to compound specialised nutrients that they want to get in a certain dose, a certain form, or even a certain type of nutrient, is that correct? 
Karl: Yeah. Absolutely, yeah. The legal requirements are, is that if we make up a compound, we require a prescription. Now a prescription has gotten many different meanings, you know. It's basically an order. That's what it is, it's, like, just an order form. In medical terms, we call it a prescription. 

So, a doctor, a medical doctor, is allowed to prescribe medicines on Schedule 4 and Schedule 8 in the Poison Schedule, that's what it's called. Now, they're your straightforward pharmaceutical products. Naturopaths probably wouldn't have much use for those, although, they might work in collaboration with other practitioners. 

When it comes to naturopaths prescribing, or for that matter, nutritionists or chiropractors or whatever. Usually they… having a little bit of background knowledge of that type of prescribing is pretty good. And that comes, sometimes, with training, extra training and stuff. 

But, they can actually write down, yeah, pretty much any type of formulation that they want. The strengths, the form of the raw material, sometimes it can be products or raw materials that aren't available in Australia but yet they are available and used quite successfully overseas. A compounding pharmacy can get in those raw materials and they can put together, you know, the appropriate formulation for the patient. And it really comes down to what is the practitioner's...you know, how high is the sky, you know? 
Andrew: I guess the rule of thumb here is within their scope of practice. So, you know, for instance, a naturopath can't prescribe pregnenolone, progesterone. That's out of their scope of practice. 
Karl: Yes, exactly. And so, I mean, the opportunities are just enormous for practitioners. When certain products haven't actually, you know, worked for some of their patients. So, there's plenty of some, you know, plenty of great practitioner ranges out there in Australia which are quite fine and patients have got great success in. 

But then, there's the in-between. There's just those little few that where it hasn't quite worked, or there's too much of a particular nutrient that they don't want to give. And that's where compounding can come in and say, "Well, let's formulate something specific now for that patient." And, you know, we work with the practitioner, get a little bit of background on the patients, and then come up with a formula, and then see how the patient responds. So, it's quite an enormous opportunity for naturopaths to fill in that gap now.  

Andrew: Yeah. 
Karl: And they can be guaranteed and certain that it's going to be made in the right way, and it's going to be the correct dose, and it's going to be backed up by the compounding pharmacy. 

So that's probably the other thing, is that people don't realise. That in order for us to make the compound and actually release it, we also have to do a risk assessment to make sure that it's appropriate for the patients. 
Andrew: Aha, good. 
Karl: So that if we've got any doubt that it's not appropriate, well, we just simply won't compound it. 

Andrew: Yeah. 

Karl: And that's a very good backup support to have with practitioners as well so that they understand that there are some things that, you know, may not be the best things even though there might be some minor studies on them, or there might be studies done in mice, or there might be studies done in whatever. But, to apply to a person in a clinical setting just might not be the most appropriate thing. 
Andrew: What does fill me with curiosity is, why aren't naturopaths and herbalists using this already? Particularly, naturopaths, because a herbalist will be compounding every day of the working week. That's what herbal medicine is. It's compounding a particular preparation for a particular patient. And there, indeed, are extemporaneous nutrients made by supplement companies.  
But, what I don't understand is why naturopaths don't use pharmacies that are well equipped, particularly from a quality perspective, you know, a cleanliness perspective with the equipment that you have, indeed, the requirements that you've got to have, to be able to use these compounds for their patients on an ongoing basis. 

So, my next question is, what nutrients do you find are more common? What do you get use of? 
Karl: Well, look, to be honest with you, there's nothing specific. It's pretty much everything. I mean, you know, all your vitamins, all your minerals, amino acids, herbs. It's pretty much anything that's not an S4. 
Andrew: Right. 
Karl: So, yeah, the choice is limitless, really. And it just comes down to what, again… how that formulation would be the most appropriate for that patient. So, for example, you know, a simple one would be, say, for example, zinc transdermal cream, okay? In pharmacy terms, in compounding terms, a zinc transdermal is a way of getting zinc through the skin, through the dermis, into the bloodstream. So, you're getting systemic absorption. 

Now, you can...usually, people that have got zinc deficiencies, have got absorption issues to begin with. So, compounding a zinc transdermal is a very easy way of getting zinc into the patient without, you know, having to go through the gut. So, it bypasses. You end up, you can use much lower doses, it's nice and easy and, you know, for people where they might have skin conditions as well, they don't get good absorption, things like that, these things really can penetrate even the toughest skins, shall I say. 

Andrew: Right.  
Karl: But, they're also very good for children. So children, infants, where they're not going to be swallowing capsules or tablets or anything like that. And some of the things just don't taste too good. Very easy way of getting a nutrient through the skin. 

Andrew: Ahhh. 

Karl: And that's just one of many. I could go through zinc, you can go through all of your Bs. A lot of the water soluble ones, vitamins, are very easy to get through the skin. And you can get multiples. So, there's plenty of studies done showing that you can get, you know, five, six different nutrients or minerals through the skin at the same time. And what the practitioner would do would be to… from the test results that they have, decide, "Yes, we need some of this. They're not absorbing it. We've tried it orally, it hasn't worked. We'll try the cream."  
So, after about eight weeks, they would retest again and then you get a gauge on how much they're absorbing over that period of time and there might be an adjustment in the dose, up or down. And, sometimes, that gives the window to be able to introduce oral preparations again further down the track. So, try not to think of it as using a transdermal cream all the time, but use it as a way of bridging a gap, you might say. 
Andrew: Yeah. Just thinking about creams, what... Obviously, you've got a base to carry the active in. 
Karl: Yeah. 
Andrew: Do you change the base at all with different skin types, different maybe, conditions that you might be treating? 
Karl: Absolutely, yeah. The choice of the base is very important. So, luckily, today, that there are quite a few compounding companies that supply a whole raft of different bases, and they're all excellent. So, they can get really large molecules through the skin, they can get very ionic molecules through the skin, you know, poorly soluble. It's quite complex, the formulations, the base formulations themselves. But, the result is that the person gets the absorption of the active. 

We also make our own, for example. So, there’s, you know, we understand the pharmacokinetics and the pharmaceutics of doing that. So, you can make up your own particular bases. We try and use our own, if we can, because we have, certainly, you know, some sensitive patients. And some of the ingredients that might be in some of the bases that are, sort of, readily available just might not be appropriate for some people. 

Andrew: Yep.

Karl: Especially autistic children. 
Andrew: That's a good point to carry on with. Do you find that, maybe, autistic children respond with a feel? Let's say, they might respond better to a cream which disappears into the skin rather than an ointment which tends to sit onto the skin and get absorbed slowly. Do you find that issue? 
Karl: Yeah. Absolutely. Yeah. They're very tactile and, yeah, the different places you can apply it. Some people will apply it around the neck and the back, you know, so the kid gets a little bit of a massage at the same time. 

Andrew: Right. 

Karl: It relaxes them. They get a nice response from it. So, you know, yeah, I suppose. What can I say? Yeah, it definitely makes an enormous difference, yeah, for those children. In fact, a lot of the preparations we make are usually in transdermal, to begin with, for those children. 
Andrew: Got you. And I was wondering about patient compliance. But, I guess, as you say, if they're receiving a massage, then it requires the application by, you know, somebody, usually, their parent or their caregiver. So, I would imagine, then, that the compliance is actually high, not low. 
Karl: It is. Absolutely. That's one of the biggest problems with anybody taking medicine, is compliance. And if you can get...that's the number one thing. Sometimes, it doesn't matter how you try and get it in, but they have to be using it consistently. Usually, we find that taking anything more than twice a day, it becomes pretty much falling off a cliff in terms of compliance. It just gets too hard.  
So, if you can, even...twice a day is the ideal, because even if you do it once a day, people can forget a day. 

Andrew: Yeah. 

Karl: Whereas, if you're doing it twice a day, the worst that they'll do is usually forget one dose, which means they could take their next dose straight away, and move on and continue with it. So, it sort of has a little bit of a safety net as well. 
Andrew: Good advice. And what about practical things like staining? You know, it actually flows on from what you said. I'll always remember, mum, you know, when we had a cold, she'd rub on the Vicks and it just felt gunky. But, there was something nice about it but you really had to wear a crappy T-shirt to bed, or else it was everywhere.  

Karl: That’s right, yeah. 
Andrew: So, what about things like that? Let's say, for instance, I work with calendula cream quite a bit with supporting my cancer patients. And that, I tell you, it's a bugger to stain. Do you have an issue with that? Or, do you tend to just...you know, it tends to be whatever the characteristics of the ingredient is? 
Karl: Yeah, it can be. One of the things with staining, it might have to do with the formulation. So, if you're using a transdermal, there shouldn't be any issue with staining because you're going to get it all fully absorbed. 

Now, having said that, there are certain ingredients that have...may last a little bit longer in the skin. But, it's not a lot. If you take, you know, pyridoxal-5-phosphate, for example. It looks yellow on the skin when it's applied, but depending on who it's being applied to and the condition of the skin, for some people, within a minute, it disappears, and for other people, that could be 5 or 10 minutes before it disappears. 

Andrew: Yep. 

Karl: And that's probably more reflection on the health of their skin more than anything else. 

Andrew: Yep, Yep. 

Karl: But, the staining, no. I mean, iron doesn't stain. We've got formulations now where we can do where people can get iron in the transdermal as well and it doesn't stain. 
Andrew: Wow. Oh, that's really useful. 
Karl: Yeah. So, the advances, shall I say, in formulations, you know, it's just grown exponentially over the last 10 years. And there's so many different ways. Even some items where people would like to take them and they smell, you know, the particular ingredients, well, now, there's ways of actually masking those smells and stuff so people can find it more tolerable, you know. 
Andrew: Yeah. I'm thinking, you know, like pregnant women with B Vitamins.

Karl: Absolutely yeah.

Andrew: You know, multivitamins and things like that, they gag very often and they become super sensitive to otherwise innocuous smells. Karl, what about things like safety? So, you know, running through my mind is the old, you know, topical application of an NSAID. If they were also taking a beta blocker and an ACE inhibitor, and you might have a triple whammy. Now, I would imagine that that's probably a dose-related thing, probably more likely with an oral formulation. But, do you have any issues that you've got to consider with regards to safety, maybe the kidneys, kidney function or anything?  
Karl: Yeah. Look, the good thing, I suppose, is that when you do a compound and dosing, is you start with the lowest dose that works, to begin with. So, there's always something in the background that you have to be aware of with anything that you put into your body. So, anything you put into your body, first of all, be it natural or be it, you know, a pharmaceutic or whatever, there's always a potential for an adverse effect, and it can be caused by different things. 
So, you can have an adverse effect by the drug itself. So that the metabolites that are coming from it actually have an adverse effect on the patients. But then, you can also have nutrients and stuff where you might be giving too much of a particular type of nutrient, which is causing imbalance in the biochemistry, and that's causing a reaction in the patients that is unpleasant. And that becomes a dosing issue. 

Andrew: Ahh. 

Karl: Yeah. So, you have to keep an eye on how the patient responds. So, the feedback from your patient is extremely important. Which we encourage. As soon as anybody starts any compound, is that, if there's anything unusual, if you feel anything unusual, doesn't matter whether you think it's small or big or whatever, let us know and we can actually then see whether that's related to something else. 
Andrew: Yeah. Well, I would actually...I was thinking about this, that it would actually encourage the collaboration between you and the practitioner, with the patient's well-being in the middle. So, it really does become this two-way, you know, talk about management. 
Karl: It's what we call a triad, okay. The practitioner, the compounding, and the patient. And it's the three collaborating together, which is very important. You know, the response from the patient, how they feel, what's changed. You know, some of the things we do is, for some people that try, they will write out, you know, some of their symptoms of things that they feel need to be addressed. And we tell them to put it into an envelope and leave it and don't look at it. And now, when you go through some of the treatment, we'll have a look. In six months' time, write down again now how you're feeling. And then they do a nice comparison. And 99 times out of 100, they're actually doing a hell of a lot better and there's a few things on that list that have disappeared. 
Andrew: Yeah. Now, you said something very interesting to me earlier on, in that it's not just nutrients and your pharmaceutical preparations, but herbs as well. Do you tend to do liquid herbs or do you have dry formulations as well? 
Karl: We have dry, yeah. The reason we prefer to do dry has to do with contamination. So, when anything goes into a liquid, there's a potential for contamination or growth of, you know, microbial growth, etc. And also, stability issues. 

So, while, you know, giving something in a small dose, some herbs and stuff, and see how they respond for a week or two, that's all great. But, from a compounding perspective, we have to be able to justify any expiry dates. Our "best before" dates that we actually put on our compounds. And that can be in the form of doing our own testing and seeing what the results are, you know, a few long term studies, or looking at literature research and seeing, you know, what would be the stability of something.  
So, for example, if you made some… a liquid preparation. Probably you can't get much more than 14 days on that unless you start having a study on it. You may be able to go a month on some things but, usually, that's about it. Especially, if you don't put anything like preservatives or anything like that, which is what most people don't want to have in their preparations. 

So, we've got to be careful from that aspect of, you know, we could be giving them something else. An infection or something like that. 
Andrew: And people will drink straight from the bottle, you know that. 
Karl: Absolutely. Yeah. So, the dry preparations are much better, they're easier to work with. They can be formulated to a powder. You know, a powder blend, they can take a scoop of it or something and mix that with something else, if they want. Something that they might, you know, have a drink that they particularly, you know, like the flavour of, you mix in with that.  
And other things we do is make masking syrups. Which are really good when, for some people where we’d make the capsules and they don't want to swallow the capsules. So they'll open the capsules and they'll mix it into a little bit of this mixture. And the combined effect is that they end up getting a much more palatable dose of their medicine. So, there's easy ways around that, you know, in terms of all the taste issues and whatnot. 
Andrew: Yeah. What about particular routes of administration? Now, we've mentioned creams. But let's just say, for instance, somebody wanted a calendula pessary for treating vaginal thrush. Would that be something applicable? You could do that from a naturopathic prescription? 
Karl: Yeah, absolutely. 
Andrew: Yeah? 
Karl: Yeah. The issues that we would be looking at to make that, would be its stability next to heat. 

Andrew: Right. 

Karl: So, part of the process of making a suppository is that you have to use some heat. But, it's not much. I think of around 58 degrees. 

Andrew: Yep. 

Karl: From my memory with calendula, I don't think there's any issues with that. That's not a problem. A lot of the herbs and a lot of the nutrients and things are very heat-stable, so there usually isn't any issue. Yeah, and you can put in whatever. You can put in the calendula, you can put in anything else that you might think of. I know some people have even managed to get some probiotics into some of the pessaries, as an example. 
Andrew: Yeah. Just a couple of last questions. I guess the first one is obvious, turnaround. And the last one is, where can practitioners, natural health practitioners, get further information or maybe contact you to discuss the potential of them using a compounding pharmacist for their, you know, nutritional requirements in certain patients? 
Karl: Yeah, look, the way practitioners should start is basically contacting the compounding pharmacy. So, for us, we would actually sit down with them. Sometimes, we sit down with them and we talk with them about what their needs are, certain patients that they might see a lot of, with certain conditions. So, the specific type of formulations they'd like to be working with. We work with them. So, it's a learning curve that, you know, you have to start somewhere. But, as time goes on, we've found some naturopaths to become very versatile in how they use compounds. And they start to understand a lot more of the formulations and how they are. 

So, the number one thing, yes, is contact us, is get in touch. Information-wise, there's plenty of websites out there. I mean, we've got a practitioner portal in ours where people can sign up. And then, when you look at the particular compound or look at the nutrients or whatever that you just put in the search, you can find a whole number of compounds related to that. And then, with that, is there's information on how to prescribe, there's information like white papers and research articles and things like that which we're growing organically, as we speak. 

Andrew: Yeah. 

Karl: There are ways. There's also conferences. There's conferences that go on about compounding, explaining how, you know, to use certain nutrients, minerals, in compounding, and why you can, you know...you learn things about why this form would be better than that form. You know, why a sulfate isn't as good as a glycinate but it's very good in a liquid.  
There's all the different forms, there's so many different forms that you can get now, different nutrients and minerals that...there's a few core ones and then there's a few where, you know, you've got to try something else, you've got to try different forms. So, it's not the formulation, it's just that that active isn't the right for that patient. 

Andrew: Yeah.

Karl: And, yeah, and, as I said, the knowledge will grow. The knowledge will grow. And look, it's only a phone call away. As we say, "Just pick up the phone, you'll get through to a compounding pharmacist and you'll get the information, hopefully, that you need." And, you know, yeah, it's collaborative, it's great. We like it because we get a lot more contact, social contact as well, with the practitioners. And yeah, at the end of the day, the patient is the one that we're trying to get better.  
Andrew: Well, I’ve got to say, I've learned so much just speaking with you. I'll definitely be using more of compounding. This is awesome, like, things that I never even thought of. 
Karl: Yeah. It's definitely, from the days, from the old days of compounding where, you know, making things up at the back. Today, the advancements and what happens, you know...like, we've got, like, for example, ISO 9001 standards, which is internationally recognised. It's that level that it's gone up to. 

Andrew: Yep. 

Karl: This is what people have to understand, it's very highly sophisticated and very much stressed on quality and consistency. That you just can't get from what you used to have years ago. 
So, all of that sort of extemporaneous stuff will probably phase out and people can now get really top quality, personalised medicine. It's just brilliant. That's why we love it. Yeah. 
Andrew: Fantastic. Fantastic information. Thank you so much for joining us on FX Medicine today, Karl. Brilliant. 
Karl: Pleasure, Andrew. Thank you very much. 
Andrew: This is FX Medicine. I'm Andrew Whitfield-Cook.

Additional Resources

Karl Landers 
Kingsway Compounding 
ATMS Webinar: An introduction to compounding and how it can be incorporated into your clinical practice
Pharmaceutical Society of Australia
PCCA: Professional Compounding Chemists of Australia
Australian College of Pharmacy
TGA: Good Manufacturing Practice (GMP), an overview
Therapeutic Goods Administration (TGA)
TGA: Scheduling Basics


The information provided on FX Medicine is for educational and informational purposes only. The information provided on this site is not, nor is it intended to be, a substitute for professional advice or care. Please seek the advice of a qualified health care professional in the event something you have read here raises questions or concerns regarding your health.

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