Compounded Medications in Testosterone Replacement Therapy

[Dr. Jordan Grant]
I'm probably more liberal than most urologists when it comes to this, just mainly based on being a patient myself and seeing guys who fit the bill when it comes to the symptoms, even though their numbers may look fine. I also check free testosterone. I know it's not really part of the guidelines or it wasn't at one time, even though the studies use free testosterone. I check both. If I see somebody in single digit, I convert everything to nanograms per deciliter and I see them as single-digit free T, which a lot of these guys are and they have symptoms. I have no problem treating them. I would talk about doing a trial of TRT. I think that's a reasonable thing to do. A lot of these guys, if they're honest with themselves, three months in, they don't feel any better, it's like, "You're probably not running your natural production three months in." We have ways to rebound that if we need to.

[...]

Fertility, again, I don't know if you were going to touch on that, but that's a big part of what I do, is maintenance of fertility. I don't rip guys off their testosterone. If they have zero sperm counts, we'll add HCG. If that doesn't do the trick, we'll add FSH along with it. I've just been amazed with Revive how affordable their HCG and FSH are and they work.

[Dr. Jose Silva]
Prior to going to HCG, let me ask, in terms of the compounded testosterone, are you using the testosterone cream? Are you using testosterone injections? How do you decide what to offer the patient?

[Dr. Jordan Grant]
Usually, if they've never been on anything, because a lot of guys I see are coming from other places where they've been mishandled and we'll try to dial things in, a lot of times they're already happy with what they're doing. They just want to tweak it. If they're a newbie, the first time I say injections, if they cringe and say, "I hate needles," I say, "Let's try cream." There's nothing wrong with cream. I've done both. A lot of guys coming in already have that in their head. They already know what they want to do. Then others, I say, "If you hate needles, let's try cream first. It doesn't work for everybody. Not everybody absorbs it great." Or if they just end up hating it, I've got some guys that are like, "I just can't remember to do it. I don't get that," because it's like brushing your teeth, but, "Hey, you forget, then go back to injections." We teach them how to do shots.

It's really just personal preference or based on maybe a few other things where they just don't feel right. Some guys just don't do well with injections. They still have the brain fog or they have skin outbreaks. Again, you're injecting preservatives and some people's body just don't like that. A lot of times, their skin clears up, their brain fog lifts. I can't explain it, but I definitely see it.

[Aaron Schneider, Pharm D]
To speak to the compounding aspect there, you know what, we make our testosterone injectable with grape seed oil, because of the viscosity. The reason for that is to allow us the option of either dosing IM or SubQ. Most of our patients today actually use testosterone SubQ. We found that the optimal level is actually the benefit of stabilizing the testosterone level above that minimum threshold is easier to achieve in more frequent doses SubQ rather than your once-weekly dose IM. Splitting that typical IM dose across two injections or three you see a baseline level that avoids a lot of the crash at the end of their therapy before they dose again and allows the patient to have a better baseline.

We send supplies and depending on the providers' recommendation and prescription SubQ three times a week, or twice a week. We found that early the need for education is important, because it's a little bit difficult of a draw.

Once they get used to it, it's such an easier injection. You're not dealing with the soreness, perhaps tissue tear not knowing how to dose with a 1CC syringe, trying to pick an area to dose. It's a lot more pleasant, but we do have options, creams, and other testosterone options are available. We're about to launch an oral dose as well with testosterone decanoate.

[Dr. Jose Silva]
The SubQ, it's in the forearm or where do you inject?

[Aaron Schneider, Pharm D]
It's wherever they feel doing it, honestly. A lot of guys use their abdomen and it's 50/50. Some guys love it and some guys get welts and things. Again, it's person-specific, and then obviously water-based stuff is SubQ.

[Dr. Jose Silva]
Jordan, at some point, going back to HCG, did you that there was a liability by using the compounding pharmacy?

[Dr. Jordan Grant]
I do what's right for the patient in my mind, I see no issues using compounding. I know there's stigma. I guess the stigma, and I didn't keep up with the stigma about the HCG diet. I think that's where a lot of this came from and people poo-pooed that. I'm like, nobody seemed to look into the HCG diet, realize people were eating 500 calories a day and starving themselves and that's why they were, you know what I mean? They just, "Oh, HCG, and then who knows what else they were doing?" Obviously, everything can have an effect that you don't want. HCG is one of those guys who complain of water retention and other kinds of weird things.

It's just the that it's going to happen when you're injecting a compound into your body that is like HCG it just is what it is. It's not LH, it's not identical necessarily, and it's not made like we make it naturally. Same with testosterone. I always tell that to guys, we are giving this artificially so it's not the same, but we try to get you feeling good. Anyway, that's the sidebar, but no, I have no issues using HCG, I've never thought twice about it using compounded.

[Aaron Schneider, Pharm D]
If you're working with a pharmacy make sure that they're providing you the opportunity to discuss what type of sterility testing are they doing on their products? What type of batch testing, how frequent do they test the products, how frequent do they do endotoxin testing? That's not just sterility, sterility is just a basis of knowing that it's sterile. Endotoxin testing will tell you that even a sterile product could cause a reaction locally due to potential bacterial contamination that maybe are non-infected. That's also a step that's important in a sterile-produced product. Then potency testing and how frequently they do potency of batches, and in addition to that certificates of analysis, I think those are really your basis for knowing that that particular pharmacy has some form of quality system in place.

Your certificate of analysis is a copy that I would at least ask for as a baseline, which is the quality of the product that they are using, the quality of the active pharmaceutical ingredient they are using in the medication that you are prescribing to your patient. That tells you the high degree of quality, the assay of the chemical. You really want that to be at 95% or higher. Most of our products are at 98 to 99, which is above the FDA's minimum threshold. The additional steps would be asking for a copy of a sterility test, at least to know that they're doing that type of testing and a copy of their latest endotoxin testing to ensure that they're going beyond just sterility.

Then potency would be just an addition to say, Hey, we know that this is going to be effective, because they have a good formulation that doesn't lag in potency. Even if your certificate of analysis shows the product is of high quality, if your formulation doesn't yield the potency that produces the desired effect or potency that represents the dose of that labeled product, you're not going to get the outcome you want. It's important to know those things and know the facility you're working with does those types of testing.

[Dr. Jordan Grant]
I see a lot of variability in testosterone lab levels in the same patient on some of the local-- This isn't just here. These are guys that are using it all over the place. They'll get a lab test. It's like there's nothing in there. It's nice to have a bigger compounding pharmacy that is batch testing, is doing all this stuff to ensure that it's done the right way every single time, because you don't want to get a bad batch of your testosterone cream and feel like crap for a month. I know.

[Aaron Schneider, Pharm D]
You'll get variability across some compounding pharmacies if, in fact, maybe they're making their own cream base and that cream base may not be compatible with that active ingredient and therefore it doesn't absorb correctly or with a trophy base, if it doesn't match the material or active's ability to absorb correctly, it may impact the product to actually achieve the desired effect or dose. It may have nothing to do with the active, but the formulation will matter.