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Linda: Welcome to the LDN radio show brought to you by the LDN Research Trust. I'm your host Linda Elsegood. I have an exciting lineup of guest speakers who are LDN experts in their field. We will be discussing low dose naltrexone and its many uses in autoimmune diseases, cancers, etc. Thank you for joining us.
Linda: Today we're joined by pharmacist Sherry Galvin from the Compounding Center in Leesburg, Virginia. Thank you for joining us today Sherry.
Sherry: Oh, thank you Linda for having me. It's always a pleasure.
Linda: So can you tell us what's been happening in your pharmacy.
Sherry: Sure, yeah. I guess the latest related to naltrexone or low dose naltrexone is we gave a lot of thought to what causes problems for patients taking low dose naltrexone, or really any chronic medication that they have to stay on long term, and the biggest thing that sort of jumped out at us was compliance. You know, making sure that the patient understands the importance of taking it daily. That the patient can take it daily and starting to drill down into that we unpacked a few things that seem to be important to patients. You know one specific to LDN was getting that dose right. The tapering up to find that magical dose, but not having so much that you start getting side effects. So, finding the right dose was important. Having the therapy be affordable was important, and convenience and sort of being easy to take were other things that patients would give us a lot of feedback on. As compounding pharmacists, we like to think of ourselves as troubleshooters. So from there we take that and sort of say okay, well, how can we help our patients make sure that they are compliant on this therapy? And we ended up developing what we call a flex dose tablet. We have LDN flex dose tabs, and it allows the patient to taper their dose very easily without having to purchase multiple different strengths. They can get one tablet that is scored four ways. It's very easy: you literally just touch on it and it'll snap in half, and you press down again it'll snap into quarters. So, the doctor and the patient can work together to make sure that they're finding that magical dose, but not so much that they're getting side effects. So it does allow some flexibility for the patient to go up or down, and again, without them having to purchase multiple different strengths. Hopefully they're therefore making it affordable.
The other piece of that is realizing - and I know a lot of pharmacies do this - realizing that our patients need convenience. They don't want to remember it's time to call and get my prescription refilled, or even realizing they’re out of pills and don't have any refills. Then that gap in in therapy happens. So we instituted what we call an auto-refill program, and the patients can self-enroll. It's not automatic. They choose to enroll or not, and we will reach out to them about a week to 10 days before their medication is due to run out, and say hey, we're gonna get this ready for you, we're gonna go ahead and ship it out to you, let us know if there's been any changes. And we've had tremendous feedback from that. It's just one less thing they have to think about in their lives.
So that's kind of the latest things for us, the LDN flex dose tablets, and the auto refill program that goes along with it. Other than that, just sort of bouncing back from COVID-related things, and being thankful that we don't have people lined up out front waiting for a shipment of masks. It was such a crazy time. So it feels a little bit more normal in here now.
Linda: So, when you collate your patient feedback, what has been the experience with side effects? What side effects have been reported to you if the dose has been too high?
Sherry: Initially, the biggest complaint we get is sleep disturbance of some sort. They might say that they can't fall asleep, or that they're having such vivid dreams that they don't feel like they're getting quality sleep, and oftentimes the physician will just recommend that they either switch the dose to the morning, or that they back down a notch on their dose to see if that fixes the problem. Occasionally we'll get a person tell us they'll have some GI side effects, but not very often. This drug is so well tolerated compared to other things on the market. We really don't get a lot of complaints about side effects, thankfully.
Linda: And what about feedback of good results? How long does it normally take a patient before they can say, "I noticed that it's working for me."
Sherry: Yes. I sometimes will have a patient tell me after two to three weeks they'll start to notice some effects, but usually it's around two to three months that they'll say hmm, you know, looking back I realize my joints aren't as swollen or stiff. Or, I am getting better rest, I can exercise a little bit more than I used to be able to, and you know I'm a big fan of a symptom diary,, for lack of a better term to call it. Because a lot of times the changes are not miraculous, but when they start really documenting how they're feeling each day, and even putting a number to it, you know, scale of one to ten, how's my pain today; scale of one to ten how's my energy level today? It really gives you a little bit more information to compare today from two months ago, instead of just saying I'm not sure this is working. The other thing that we sometimes see happen is they'll think this drug is not doing too much, and they'll stop taking it. Then that's when they realize oh wow, it really was helping me. I just wasn't tuned into how much I had improved. So that's the other thing that we hear occasionally.
Linda: And what do you say to patients when they say they don't think it's working for them? How long should I take it before I stop and say it's not for me?
Sherry: We usually try to talk to them about their dose and just ask where are they? What have they done? Did they taper up? Are they too high? It seemed like everybody was going for that 4.5 milligrams per day for the longest time. And I think now prescribers really do realize there's a milligram that works for everyone, and it's not all 4.5 milligrams. Have they overshot the dose that is needed for their condition? We usually start there and talk to them about what dose they are on. What dose have you tried? How quickly did you go to this dose? Those sorts of things. But we do try to encourage them to at least give it a four to six month trial before they say this drug hasn't helped. Because we don't want them to abandon therapy too quickly.
Linda: We did a survey several years ago now and found that LDN did something for most people, even if it was stopping the progression. If they were having a rapid progression, it had halted that. But there were a few patients that it had halted the progression but it hadn't actually helped with any symptom relief. And then in between 15 and 18 months when you would think they wouldn't notice anything else they then started getting symptom relief. That was quite an unusual thing. So we actually say a lot longer than you. If you're okay taking it and you can afford to take it, we would always say take it for like 18 months before you give up. And exactly what you were saying when people say no definitely not working for me; no, I'm going to stop within two or three months they want to get back on it again because they had forgotten just how ill they felt previously. Yes. Yes that's always a thing isn't it. So in your practice, what would you say at the moment is the main condition that you're using LDN for?
Sherry: I would say the main condition would be the sort of the grouping, and I don't mean to say they're the exact same thing, but the grouping of either chronic fatigue syndrome or fibromyalgia seems to be the biggest, but we do have a lot of patients who have various autoimmune conditions, whether that be rheumatoid or psoriatic arthritis, things along those lines. Irritable bowel, Crohn's, that group of people as well would probably be the next biggest category, if I could put them in a group. But it's amazing what we hear people using it for, always seems to be some new thing, although probably if you drill down to it, a lot of what we hear complaints about are somehow connected to either autoimmune or some kind of chronic inflammatory cause.
Linda: And the patients with CFS, ME, fibromyalgia are usually the patients that have ultra-sensitivity to drugs, any drugs, and especially LDN. So usually in my experience, those people don't even start on 0.5, they quite often have to start even lower and have to titrate it slowly, as their system gets used to it. Is that what you found in the pharmacy?
Sherry: Yes, and a lot of times these patients also come to us with other sensitivities that make them very concerned about the medication, so one of the things that we like to make sure is, we keep it simple, make sure that the tablet is as clean as it can be with no allergens in it, no fillers that would cause any sensitivities, because we do see that a lot with our patients. They have a lot of sensitivities. So yes, very low dose, ultra low dose if you want to call it that, and a slow taper. That's the other thing: a lot of times, especially more at the beginning when we were beginning to use this years ago, we would see where the prescription would be written “Take one dose for a week and then increase for a week and then increase for a week”. We typically go a little bit longer, a little bit slower taper if you will.
Linda: In your pharmacy, you were saying about being careful of fillers. etc. What different dosage forms do you compound?
Sherry: We do a liquid dosage form for patients that need a very low dose. It can be done as a drop under the tongue, is what we normally recommend. We have immediate release tablets We have an immediate release flex dose tablets that I described earlier that can be broken into quarters. And we also do capsules. We still have some call for capsules. There are patients who, for whatever reason, don't like the tablets. And where the oral dosage forms are fairly small, the tablets are approximately the size of a mini-M&M, and the capsules are about that size around, but maybe a quarter of an inch long. We try to keep them small, because we do have patients that will complain of trouble swallowing.
Linda: You do a cream or….
Sherry: Sorry, I missed that. Yes, for our derm patients we do topicals for different skin conditions. The other thing that we have recently been requested to make is topical formulations for veterinary patients. Not so much for cats because they just lick everywhere, but dogs, if they have dermatitis or allergic reactions, we have found that topical LDN is very helpful. We also had a request for an LDN vaginal product, only once, but we have done that as well.
Linda: What about eye drops and nasal spray?
Sherry: I have not had a request for that. We do a lot of different nasal sprays, but we have not done LDN in a nasal spray to my knowledge. Eye drops get a little bit tricky in the US, because of our regulations. Oftentimes when you're making a sterile product, which an eye drop would be a sterile product, the expiration dates are so short that it makes it almost impossible to be a reasonable therapy - you can't have the patient come back every three days for a new bottle of eye drops - without a bunch of stability studies, which then shoots the cost of the preparation up so much the patient can't afford it. So eye drops do get a little sticky in terms of nothing having to do with the ingredient, more to do with the regulations.
Linda: There are pharmacies that do eye drops for dry eye and Sjogren’s syndrome. But I've also been told that the nasal spray helps with dry eye as well.
Sherry: That is a very interesting concept, because there's just been a drug released on the commercial market in the US that is a nasal spray. Its indication is for dry eye. So a very interesting thought, yeah. We may have to talk to some of our ophthalmologists around the area, because we do have a lot of dry eye. All of us are in front of our computers way too long now, right. Yeah, especially the last couple of years. So dry eye has really gone through the roof. Excellent tip. I'm gonna take that and talk to a couple of our ophthalmologists around the area.
Linda: Well let me know how it gets on. I do have dry eye, and I might have to have eye surgery, which is scaring me, but I would love to get hold of some nasal spray. So next time I'm in the US, I'll probably visit a doctor and see if I can have a prescription for dry eye. That would be here quite good.
Sherry: Yes, yeah, that's a that's a very interesting thought. Yeah.
Linda: Even though it's not actually directly in your eye, when you squirt it up your nose or passage, of course it's getting up into the inside, isn't it? So it makes sense to me that it would potentially work quite well.
Sherry: Yes, yep that does make sense.
Linda: Well it's been wonderful speaking with you today Sherry, and I can't wait till next time.
Sherry: Oh, thank you so much. I hope you have a wonderful day and I appreciate being able to catch up with you.
Linda: Any questions or comments you may have please email me Linda Linda at ldnrt.org. I look forward to hearing from you. Thank you for joining us today we really appreciated your company until next time stay safe and keep well