Sabastian Denison, Pharm (LDN, low dose naltrexone) from LDN Research Trust on Vimeo.
Linda Elsegood: Today we're joined by pharmacist Sebastian Denison from Canada, and he's going to talk to us about the PCCA in his view as a compounding pharmacist. Thank you for joining us today, Sebastian.
Sabastian Denison, PCCA: Thank you for having me today.
Linda Elsegood: So could you explain to us who the PCCA are and what they do?
Sabastian Denison, PCCA: Well, PCCA is a first and foremost a high-quality chemical supplier, two independent pharmacies across the United States, Canada, Australia, New Zealand, and into the UK. PCCA is an acronym, and it stands for Professional Compounding Centres of America, and they started back in 1981, and they've expanded globally. That's the best way to explain it. We've been delivering the highest quality chemicals to our partners in the community since 1981. That's only one aspect of our business. We are also an umbrella organization where we actually do physical and technical training. We do clinical consulting services for independent pharmacies as well as, education components for improving clinical knowledge in different segments of healthcare. And we've generally partnered with our independent pharmacy members as well as other healthcare professional teams worldwide. So we're working with companies like American Academy of Anti-ageing Medicine, Tarsus. We're working with some new groups in the United Kingdom, certainly in Australia, New Zealand, Canada.
That's our kind of our big piece, but we provide the raw ingredients to the independent pharmacies for them to actually make customized medication for individual patients. And that means effectively is we look at a single individual patient, and we treat them as an individual need as opposed to general manufacturing where they will make one product. They may make three different strengths and hope that you fit into their dosing guidelines. We actually turn around and say, "What does the patient need based upon their specific disease state, their particular needs in that level of a disease state?" So, for example, and since we're on this particular topic, Naltrexone, we actually source the raw API, so the bulk chemical, and we will find it from the best sources in the world.
And we only source it from the companies that will qualify as FDA registered facilities or GMP, which is Good Manufacturing Practice manufacturers of these raw ingredients. And we bring them in the house. We will then take the large drum of chemical and pack it into smaller sizes and then sell it to these independent pharmacies.
Independent pharmacies have a much lower volume needs than say a manufacturing company like Pfizer. And since Pfizer is servicing a huge group of patients with one strength, they can buy it in that way. Our independent pharmacy is needed in smaller amounts because they're servicing fewer patients and usually with discrete dosing needs. When I'm talking about this, that's one example of how we take care of our independent pharmacies. Now, on the other side of the table is our compounding pharmacist and their compounding teams. So it'll be made up of technicians as well as other pharmacists. And then they take the products that we send to them, and they assemble them into personalized medical dosing and we call it compounding personalized medicine only. We talked about compounding medication. And so again, with the Naltrexone, we can do things like capsules or liquids or sublingual tablets or even topicals, or in some cases, transdermal options for the patients, depending upon their specific need. And so a perfect example is: I know many of your patients will be taking Low Dose Naltrexone tablets or capsules. And what they do is take the 50 milligrams. We're a branded product that's the one in Canada. And they will try and break up the tablet. And if you've ever tried to break a tablet and you know how difficult that can be, you crush it, you're not getting an accurate dose. How do you divide a 50-milligram tablet into 3mg aliquots accurately? In some cases, we've got patients starting at 0,5 of a milligram and dosing up 100 on the tablet. You can't lick a tablet and hope for the best.
And so what we do is we've gotten the ingredients, and we can say, "what is the dose?" We're going to start at 0.5 milligrams. Well, we can do that in an accurate, consistent manner and give that to a patient for two to four weeks and slowly titrate the patient up until we hit their 3-milligram dose, 4,5-milligram dose, 5-milligram dose.
In some cases, we've seen patients on 6 milligrams even twice a day. So that's how we can do it. Then the next part is our biggest part, and this is where I fit into our companies. I work as a clinical compounding pharmacist, and I will talk to up to 40 pharmacists a day as do 18 of my colleagues, and we will give clinical consultant services and formulation advice to help the compounding pharmacist side and the community achieve the goals and needs of the patient.
And so we will do short education services on the phone, clinical consultations on the fly. And so, for example, we might have a patient that calls, and they say, "I have Haley's Haley disease. Is Low Dose Naltrexone an option for me, and how would I give it? Or how would I take it?" And so we've made topical products. So Naltrexone at a 1% concentration and a topical for these patients who need help with their autoimmune disorder of Haley's Haley disease and allowing them to heal in a more normal fashion without this necessarily nasty scar tissue or really fragile tissue coming over. So that's pretty much how we do it.
But our vision is actually to improve patient lives by bringing more innovative approaches to the healthcare system. And what that means is we don't just follow what everyone else is doing. We look at individuals, and we bring every part of our experience as a company to bear on the problem of the single patient.
Everything from: "Can we do it? Yes. How do we achieve that?" And so there are so many examples where I can talk about patients in the Low Dose Naltrexone world. We had one patient who had ankle pain for years and years and tried everything under the sun. He’d seen chronic pain management specialists, seen osteo or rheumatologists and internal medicine physicians, tried everything.
We actually made a 3% Naltrexone transdermal product and applied it right over the sight of pain, and within days he started getting relief, and within weeks, most of the pain was gone. So we can tweak to the need of the patient, which is probably the bigger part for us.
Linda Elsegood: We always have people think that they could obtain a prescription for the 50-milligram tablets and make the LDN themselves.
It's something we don't recommend. What is the stance of the PCCA?
Sabastian Denison, PCCA: It's not just PCCA. If you talk to any pharmacy, healthcare professional, so this is not only the pharmacist, but this is anyone who works in a pharmacy. We always talk about accuracy and precision and this goes all the way up to manufacturing and all the way down to, "Hey, I'm going to give a patient to take home a dose and to do it to the best of their ability."
When you give someone a tablet, and you say crushing and sprinkle it over some applesauce and eat the whole thing, they're getting the whole dose. But when you're given a 15-milligram tablet to take home, immediately we start talking about accuracy and precision. Now accuracy is the target and precision is how often do you can replicate it. So the problem with breaking up a tablet is, "Are you getting the right dose each time?" And depending upon the dose, and I know that we're all on the same page within the Low Dose Naltrexone world oral dosing is: can start at anywhere from 0,5 milligram and titrate up to usually 4,5 sometimes by maybe sometimes 6, but we can't divide a 50-milligram tablet accurately, consistently at home.
And so that's number one. Number two is if we do decide to try and make it into a liquid, again, we've been doing this for 30 plus years, and we train people how to do it consistently with very good stability characteristics. There's a lot of issues just with pH of different products. So let's say someone says, "I don't really like the taste of this product." so I'm going to put it in, say, orange juice.
Well, it's got a low pH, and that can have an impact on the drug. It can have an impact on stability. Is it going to be suspended, or is it going to be too high or low solubility? And you're going to get all these products, all the products settling out and kicking on the bottom of the product. There's a lot of actual chemistry that has to be taken into account. Stability, characteristics, pH values.
There's a lot more to it than just crushing out the tablet, throwing it into some apple juice and drinking it and saying, I'm going to take a small amount. Most people don't have the necessary tools in our kitchen to compound anything. We really stress this from the position of PCCA. Accuracy, precision starts with the highest quality ingredients and the best possible training with the right tools. And it sounds really fundamentally. Of course, we want to do that but taking home the 50-milligram tablet, you may not be getting the best clinical outcomes if you're not consistent on your dosing.
That's number one. Clinical outcomes rely on the accuracy and precision that's obtained within the pharmacy level.
Linda Elsegood: And it's always a worry as well when people explain how they make their own LDN at home and they generally do it with water. They don't do it with the juice, but anyway, they take the tablet, they dissolve it, whatever, and they've got it in water.
They keep it in their fridge, and they will say that" Oh, I'm on such a low dose, it's going to last me say a month. Pharmacists have told me that you should treat it as fresh milk and taking it out, taking the lead, measuring it. It could have bacteria, anything in it, putting it in and out of the fridge, opening it, you know?
And that would be the biggest worry for me. It's that it's contaminated and you can actually make yourself ill if it isn't fresh.
Sabastian Denison, PCCA: That's where it really tends to change. And I've said this to people, within the pharmacy world as well as to patients, people who are not in the pharmacy world, how long would you put something in the fridge that you've made? So, for example, let's just talk about, let's make a soup from scratch.
How long would you leave that soup in the fridge before you would say, eh? I'm not going to eat it, and I've left it in the fridge. Even though you've made it on your stove and everything's great, and you've taken the greatest care, at what point do you say, I need to freeze that or I need to throw it away?
And so freezing medications like this, this is not going to be, you can't freeze and do it in a consistent manner, but how long would you leave the soup in the fridge and continually take it? Most people top out somewhere between five and seven days. After that it's leftover there and done.
Some people say, "Well, freeze it right away." But that's not a viable option for people who are making their Low Dose Naltrexone at home. And so not yo a month there are cases of people they're got bacterial contamination, finding fungus and moulds will grow in just straight water. Just take a glass of water and put it in the fridge.
And how long would it be before you would stop drinking that glass of water? So what's the difference? Well, now you've added contaminants. You've added contaminants from even handling the water in a glass that hasn't been sterilized, etc. So it's nothing we would suggest we've all, most of our compounding pharmacies will always add a preservative within their suspension or solution system to prevent that microbial overgrowth.
And that's one of the keys, again, access to these products. Most people don't have parabens water at home or a preservative system that they can add to prevent that overgrowth. People who are taking a Low Dose Naltrexone, in my clinical experience already had a lot of inflammatory disorders and usually have concomitant illnesses, generally fairly fragile, adding more bacteria or yeast or mould into their gut generally can be very distressing. So why would we do that? Why would we take that risk as a healthcare professional, but more importantly, as a patient, why would you do that to yourself? Why would you drink contaminated water?
Linda Elsegood: And the other thing that always is an absolute red flag, which I wouldn't do it.
People say, Oh, I found somewhere on the internet, I can buy LDN without a prescription. " I mean, as soon as you are buying something, especially a drug, you've bypassed all the quality checks, the stability of on what's in it. People can say it's Low Dose Naltrexone because there haven't been any checks or regulations or anything.
It needn't necessarily be LDN and the MHR, which is the medicines regulatory body in the UK, it was ridiculously high. Something like 85%. I think I can't remember, so I can't be quoted on that. But it was a really high number said that the of drugs that were imported into the UK without a prescription were counterfeit.
Mostly they were just like fillers, the way there weren't any active ingredients, but sometimes the ingredients in the products were harmful. Why would anybody want to buy a prescription-only drug without a prescription? That, to me, is very scary, scarier than making your LDN, and that's scary enough.
Sabastian Denison, PCCA: As a pharmacist. There's just this thought of it makes me shudder, and I understand why people will do it. You look at the cost of the 50-milligram tablet that they're being dispensed, and they're like," okay, this isn't going to last me about a month is going to be great, and they think, Oh, this is expensive and now what I'm going to do is I'm going to go, and I'm going to do an internet search.
Oh, I can find it, and this guy is going to sell it to me, and I don't even need a prescription, and I'm going to save money." I understand how people are thinking about. But now I'm going to go back to what PCCA stands for, and I'm going to talk about what every single pharmacy and health care professional would say, as well as every regulatory authority anywhere in the UK, Europe, Canada, Australia, New Zealand, and Mexico.
Number one must be GMP compliant to sell into these countries. Number two, it is a prescription medication which requires a prescription because it has to come through these proper channels to ensure the quality, purity, and identity of those products for sale within that country. This is possibly one of the biggest concerns that we have in the evolving internet commerce is that people can go on the internet and buy anything and there are all sorts of nefarious things but this is probably the second biggest one within our healthcare world is, "Well, I can buy it online." And what happens is you have incredibly unscrupulous people who are like, "Hey, this is a big hot thing. I'm going to sell the powder and they don't even know what it is." This has actually led to a significant opioid crisis within the US and Canada.
And I don't know if it actually hits the UK in the same way. People selling one drug and actually tainting it with other drugs and they have tilt presses. You can buy tilt presses, they can be stolen and you can counterfeit tablets quite, unfortunately, easily. And so you can actually have people selling these things that they say this is what it is.
And they're just doing a bad copy of these tablets, but you're right, they're putting in a whole host of nasty ingredients that could be incredibly harmful. As I said, these patients are already fragile, and you put something in there that they shouldn't be getting or that is actually a contraindicated medication to other medications that they're taking and now we don't even know what it is or how they are becoming so ill.
PCCA as a company, we are an FDA, so this is a food and drug administration inspected facility. We would comply with all of their requirements. In Canada, we are a drug establish. It's licensed, repackager and importer in an Australian fed. Our head office there. They fall into the same regulatory authorities ended there, equivalent healthcare facilities.
In Canada, we can only actually source through GMP qualified vendors, which means unless they'd been inspected and have all of the appropriate documentation that proves what they're selling along with what we independently test again.
So once we get it, we not only do the independent a required test, but we'll actually do, it's called an IRS spec scan. So it's like an individualized fingerprint and the drug based upon really cool organic chemistry, which we'll go and do. We can identify the drug, so we know the identity, the purity and the quality of these products that we buy, and we only buy the highest quality. We reject vendors left to right and centre so that we can deliver the highest quality product to our patients who then at the end of the day, get the best clinical outcomes. But you're right, dying off the internet—10 times scarier than making it at home.
Like at home, you're still getting a prescription drug that's come through a reliable source. It may not work as well because you're kind of not doing it quite right, but you know at least you're not going to come to serious harm where it's getting something off the internet is like... In Canada we have people spike drugs with things like Fentanyl and Carfentanil, where 1mg dosing can actually cause people to die. I've heard of things where people are mixing all sorts of nasty drugs just to give people a feeling of effect without actually having an intent of effect. People who are selling stuff on the internet, and they're selling cheaper, and without a prescription, that should be not even a red flag. That should be a stop backup and understand you are putting your own health serious risks and then not to mention if you aren't actually getting the drug and you're importing a legal drug from a supplier avoiding the normal channels, your regulatory authority, channels, whichever country you're in, you can be in a lot of legal troubles. So it's a bad situation. So please don't go and do that. Contact the pharmacy and ask them if they can compound it.
Linda Elsegood: And the most important thing is with the prescription drug, you do need the prescription, and you need that prescription filled by a reputable pharmacy. I mean, once you've done those two things, hopefully, the product, in this case, LDN is going to give you the best outcomes possible.
Sabastian Denison, PCCA: Well that's what we find over and over yet. Every pharmacy can compound. We'll start with that. Most pharmacies don't. When they jump in, and they're like, oh," I can just make this up," they, they're overconfident in their abilities. What happens is the patients aren't getting the outcomes that they're looking for, so they abandoned the treatment option.
That's pretty much the worst-case scenario. If they do get it from the pharmacy that isn't specializing in compounding. If they are specializing in compounding, they find that number one, they're getting better clinical outcomes, number two, because they're getting PCCA products and PCCA training there, they know they're getting a good quality product that isn't going to bring anything else along for the ride that could be causing them as, again, fragile patients. We don't want them to be in a harmed by anything else that comes along. I'll give you a perfect example. In our compounding pharmacy, very quickly, we learned that lactose is not a good excipient to be used for patients getting any Low Dose Naltrexone product, be it Ms, Fibromyalgia, any of the autoimmune disorders, migraine or pain patients and the reason why is because Naltrexone was actually causing other GI issues for them. And this patient, in particular, they would come in and be like," did you meet with no, the lactose because I'm getting a bad gut reaction."
And so we learned very quickly from our clinical experience not to do that. This is how we counsel all of our memories, all 4,000 and anyone who's working with us to be careful with this if it's being used. And so you've seen this shift in that true compounders and delivering the highest quality product, the accurate dose consistently without any other bad stuff come along with that.
We talked about someone in Wisconsin. Every time we talked to him, he's got a new story for me about how well the patient has done and coming from another pharmacy, and" I was getting it at the chain pharmacy down the street, and it just wasn't working.
And I thought about giving up, but I was told by my doctor to come and see you. What are you doing so differently?" And that's the key is we specialized in this.
Linda Elsegood: What is the filler of choice that you recommend your pharmacists to use?
Sabastian Denison, PCCA: My personal favourite is a product called magnesium glycinate. It is a magnesium salt form that we know is better absorbed than other magnesium salts. It comes with about 15% magnesium, and so I've suggested a certain sized capsule that would deliver roughly 400 milligrams of magnesium glycinate along with your specific Naltrexone dose. And they're like, "why would you do that?
Why would you suggest this? Why don't you just use the cheapest stuff possible?" Number one, magnesium is a really good supplement for every patient. A lot of the oxide versions of magnesium caused diarrhoea, even at 400 and 500 milligrams for these patients, but the glycinate is very well tolerated for the GI.
So we can deliver magnesium, which has over 350 functions in the body metabolically for patients. It's actually an anti-inflammatory. It can actually help with patients with pain. It can help regulate hormones. It can actually help with sleep patterns as well. So that's my favourite, magnesium glycinate, along with the Naltrexone.
This is a particular product that we make. It's inert. Non-reactive. We call it excipients. That's the name. And it's actually a really effective well-tolerated product that goes along with the Naltrexone. I've seen people also use things that are specific to a patient, ginger root powder, rice flour.
I've seen people even add it and say, "well, what else have you got? " Because they can't tolerate anything. What I like to use it is my first option is what the patient needs. Will be my first choice if the patient needs something different. But we generally, stay away from lactose.
We stay away from anything that will cause the patient any sort of sensitivity or harm, magnesium steroids, Sodium lauryl sulfate, these are really highly sensitizing to these patients. They'll get a lot of GI upset or inflammation.
Linda Elsegood: So well, we have run out of time, but thank you so much. You've been our guest today. This was Sebastian Dennison, who's a pharmacist, and he was talking about the PCCA and how LDN is made. So we've learnt a lot from you today.
Thank you very!
Sabastian Denison, PCCA: You're welcome!
Linda Elsegood: PCCA helps pharmacists and prescribers create personalized medicine that makes a difference in patient's lives. That's why they provide the highest quality products, education, and support above any other compounding organization.
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