Changes in Testosterone Therapy

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Hi everyone, welcome to the Game Changers Clinical Update podcast.
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I'm your host, Rachel Maynard.
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Today we'll be talking about ongoing questions and changes with the use of testosterone.
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This topic has been controversial for years and it's making headlines again, partly because the FDA has requested updates to testosterone prescribing information.
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This has led to new discussions and questions about who should receive testosterone therapy, what the evidence supports in terms of specific uses and key safety considerations.
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So today we'll discuss what's continuing to change with testosterone therapy, where we are now, and what we as pharmacists need to know to support evidence-based care.
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And so I'm very pleased to welcome our expert guests for this topic, Dr.
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Michael Nagy.
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Welcome, Michael.
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Thanks.
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Happy to be here.
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Very excited to have you here.
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And thank you so much for taking time out of Uber C's Cultural to meet with us and chat about this important topic.
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Could you share a little bit about your background and your current role and why you're interested in this topic?
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I think this will really help us understand what perspective you're coming in with.
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Sure.
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So during residency, I did some clinical research in testosterone management and the pharmacist involvement within the VA healthcare system.
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And then I spent about six years teaching endocrinology at the School of Pharmacy.
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And then the last two years developed an endocrine clinical practice within the VA.
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So managed many different conditions, but a fair number of the veterans that I see do have hypogonatism.
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And then within the VA healthcare system, do have a unique ability for pharmacist prescribing and management and monitoring of testosterone.
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And then during the last eight years, I've done a few different publications, worked on some national groups on the monitoring and appropriate monitoring for testosterone management.
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So yeah, it's been a varied path, but testosterone is probably the of the endocrine conditions I manage, one of them that I'm most qualified for and most interested in managing.
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Yeah, excellent.
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Well, I'm super excited to have your expertise on this because again, this is a controversial and sometimes confusing topic.
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And it sounds like you have you have both that sort of evidence-based perspective and also the practical perspective with actually seeing patients and prescribing this in your practice.
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So very interesting perspective that I think you'll have to bring to the discussion today.
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So before we get into some of the recent updates, maybe we can just start with a baseline of where we are now with testosterone therapy.
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What are those FDA-approved indications currently?
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And along, well, I'll let you start with that a question.
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Let's start there.
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For sure.
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Yeah.
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So currently the FDA has it approved for structural or clinically diagnosed issues for testosterone.
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So either testicular damage or pituitary damage in the brain, which is a very small subset of patients.
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And sometimes we don't always know why the testosterone levels are low.
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So that's where the current FDA indications are.
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Okay.
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And when I I think one of the things we'll talk about is uh uh hypogonadism and having a known cause versus maybe age-related declines in hypogonatism or in testosterone.
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And so could you help differentiate that a little bit and get into that?
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Because I think that's a key distinction that we need to make.
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Yeah.
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So with a known pathologic issue, there's some kind of damage to the testicle or pituitary.
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So whether it was an infection like mumps, some kind of genetic issue like Klein filters, cancer where the testicles were removed.
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And then with pituitary, some kind of damage there.
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So there's a number of different like issues that can happen with pituitary in my population, some traumatic brain injuries.
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There can be tumors or growth in the pituitary gland, which can be seen on imaging and some lab workup.
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So that's the traditional sense.
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And then there's also other issues that can kind of lower testosterone.
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So I'm sure we'll talk about obesity, we'll talk about opioid use, sleep apnea.
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But then also as men age, it's well known that the testosterone levels decrease over time.
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So around age 30, 35 is probably about peak testosterone levels in men.
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And then over the decades, the level declines naturally.
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And then in like those that are 80 plus, if you look at the criteria for low testosterone for men that are 30, a lot of men over 80 are going to have total testosterones below 300, which isn't necessarily pathologic, but I'm sure we'll talk more about it.
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And there are maybe some symptoms that could be benefited from using testosterone therapy in those men.
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So let's actually talk about that right now.
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Let's let's get into that a little bit more.
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So what I'm hearing is that the level of less than 300 is sort of your threshold for considering low testosterone.
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Would that be accurate?
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Yeah.
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So this is controversial as well.
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Um I think the best cutoff from like the endocrine society is maybe like 264.
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There's maybe 275 for total.
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It gets very confusing very fast because testosterone, there's the total amount that's in the bloodstream.
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Um, it is bound to a couple different hormones, one sex hormone binding globulin, and that hormone can be impacted by conditions like obesity and diabetes, among others.
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So in general, 275 or so is considered low.
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It also can be impacted by stress, or if someone didn't sleep well, or if they've had like recent illness.
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So when you check a level, it should be in the morning, um, fasting, and somewhere around 8 a.m.
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Um and when they're in good decently normal health with a good night's sleep.
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Um but yeah, 275 is about the cutoff of what's considered low, depending on how the assays run and those factors.
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Okay.
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And then routine screening is not recommended, I don't think.
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And so when do you when is that screening warranted?
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Yeah, and I think you talked about maybe alluded to some of the symptoms you might be thinking about, but yeah, what is your patient care process that for that?
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Yeah.
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So yeah, right now not recommended by the Endocrine Society guidelines or urologic guidelines.
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So usually it's a case where there's some kind of symptoms, usually the sexual desire, decreased sexual desire.
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Um, and they want to try and figure out what's going on.
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So after figuring out maybe other causes, whether it's depression, mental health, other things that the usually a primary care provider would work up, testosterone is often screened.
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And then if it's low, it might come to our clinic to kind of figure it out in more general.
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Usually we have to do at least two screens, sometimes more.
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Um, and the big reason there is that we're not trying to like prove someone has low testosterone, we're actually trying to prove that their endocrine system can produce testosterone.
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Um, because one of the issues is when you start to supplement testosterone, the body then becomes more dependent on that external supplementation and that internal endogenous production of testosterone can actually be decreased.
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Oh, interesting.
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I didn't realize that.
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Okay.
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So uh I guess that's another reason to not over-index on the on the management.
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Thinking of, and that's why like you mentioned, doing such a thorough history, uh ruling out potentially other issues, all of that can be important.
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So you're looking really at not only the number, but also all of those patient symptoms and potentially multiple numbers and ensuring that the number is is is accurate.
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Any other factors that I didn't mention there, like that you're thinking about or no, you you summarize it pretty good.
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In the guidelines, they always use the words unequivocally low.
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So it's the idea is like you test it multiple times in the morning, and then if there's one that's normal, that means their body's able to produce the testosterone.
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Okay.
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Um just because it can fluctuate.
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It's a hormone that is dependent on many factors.
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Okay.
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And you did mention some of those other conditions that might affect testosterone levels.
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So I think you mentioned obesity and maybe sleep apnea and even opioids as an example.
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Maybe you could talk about a little about that because I think I think one of the biggest uh questions is around well, there may be clear causes of hypoglodinatism, which you outlined earlier, but then some of those maybe less well-known causes, I think, are where the question comes up more often.
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How do we manage these patients where we're not quite sure if one of these conditions could be contributing?
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So maybe you could speak a little bit about that.
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Yeah, I'd be happy to.
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And that's probably the majority of people we see.
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Um, there's very few that, you know, have a very clear pathologic damage to the testicles or pituitary.
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So a lot of them have these like histories that have sleep apnea or obesity, and they're having these low testosterone levels and symptoms of decreased sex drive is probably the most common, but we see a lot that are like, oh, well, we're tired, we're more fatigued, we have low energy.
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Um, we get some that are, you know, mentioning like poor mental health and depression.
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And so do the initial workup and the levels are low, but there's these complicating factors like obesity or poorly treated sleep apnea.
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I guess in the way I think about it and the way that I try and practice is we try and reverse those potential secondary causes first.
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Um, so if someone's obese and you know they haven't had a sleep study, I definitely will recommend it, especially if they have those stop bang criteria of sleep apnea, whether snoring or issues like that.
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And then when I'm working with these patients, try and talk about the positives and negatives with testosterone and even considering it.
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And if we can fix a secondary cause first, that might resolve the issues without ever having to go on testosterone therapy.
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Um, which it's not necessarily the focus of the podcast, but the the GLP ones, you know, those can improve obesity and reverse sleep apnea.
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It might take six to 12 months, but sometimes I've been starting people on those first to try and help with the metabolic profile before we focus on supplementation.
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But I mean, a number of these veterans and patients that I work with want to try testosterone.
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I'm sure we'll get into this in the podcast, but there's online clinics, people can order testosterone online nowadays.
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There's a lot of misinformation and extra information from what people are searching on on the internet.
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Um, so people will come to me with really strong desires for testosterone therapy because they're tired or or this or that.
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And sometimes it's about providing education on you know what is the data actually show from these recent trials.
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Um, there's a couple that I'm sure we'll talk about the testosterone trials in like the 2018s and then the Traverse trial that came out a couple of years ago.
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Yeah, so you highlighted a few different points that I I think are great to call out.
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One is managing any other comorbidities that might be contributing.
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And I appreciate that you called out GLP ones.
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We've talked about them several times in the podcasts, and just this idea that a lot of uh conditions that we think about are interconnected, sort of this cardiometabolic kidney and obesity, all of those things can be interconnected.
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And so that just reiterates that point that I've been hearing a few times in the past few podcasts, but also the idea of people hearing about it from various sources and having access.
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And I think that maybe, or not necessarily having access, but hearing about it wanting to uh talk to their clinicians around getting access, perhaps, and having that potentially be a difficult conversation, but also something that can open the door to an evidence-based discussion.
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And so I think I would love to know your thoughts on as you alluded to, the evidence that we had in the last decade or so and more recently.
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Let's let's summarize what evidence supports the use of testosterone.
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Let's start with that angle.
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What evidence does support the use of testosterone that maybe it did not in the past?
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Or yeah, I'll start with that.
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Yeah, a lot's changed since I was a resident 10 years ago when I was first learning about it till now.
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Um, so one of the things that was unknown 10 years ago is older men, like age-related hypogonanism.
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And when we say older, it's like 50 and above approximately.
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Um there's not like a strict age cutoff there.
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And was it safe to use?
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There were concerns about cardiovascular disease risk.
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And what was found, well, the first set of trials were called the testosterone trials, or and that was older men, and they look there were seven different studies within this group, I think it was about 700 or 800 older men with unequivocally low testosterone.
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What they showed was there's a mild improvement in sexual function.
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There wasn't any improvement in cognitive function, no significant improvement in physical function, or very, very mild, and then a small improvement in quality of life, generally thought from the improvement in sexual function.
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There was a little bit of improvement in anemia or low blood counts, like hemoglobinatocrit.
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And then it wasn't really long enough to know like cardiovascular issues, but they did show maybe a little bit of bone density increases.
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But there wasn't any worsening cardiovascular issues.
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So that was a landmark trial in the fact that there was some benefit, but it wasn't a significant, like a very large change in how they were feeling.
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And then the other piece was the cardiovascular risk, so that wasn't explored well enough.
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In 2023, based on like the FDA guidance, there was a traverse trial, which is I think 5,000 men, and it was a long time frame, and they showed no increased cardiovascular risk in that.
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That's what they were looking at with testosterone in older men.
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So that helped clarify or at least decrease our concerns with testosterone use in those that might be at a little bit higher risk for cardiovascular disease in the older age.
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Um, so I don't think, oh no, I do believe the FDA actually removed the concern about the cardiovascular risk.
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I think they did too, yeah.
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Yeah, because that was originally put in 2015 when there was uncertainty, and now with that TERS trial, they've removed the cardiovascular risk warning.
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Um, so it's changed a lot with those, those would be like the two main trials that have come out this last decade.
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Okay.
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Yeah, and um, I think that's a great summary.
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And it was it's sort of interesting too, because it seems to be somewhat paralleling hormone therapy for menopause, where they had box warnings that were removed subsequently and a little bit different situation in terms of the data there.
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But um, yeah, very interesting just to see how things can evolve and and sort of that pendulum shifting a little bit because I remember learning about the cardiovascular concerns with testosterone and that with the the labeling changes in the new data, that's less of a concern than it was in the past.
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Yes, correct.
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Now, if someone's had like recent heart issues within the last six months, I probably wouldn't start someone on testosterone, but if it's been stable and no other issues, it's one that you can definitely have a discussion on.
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And I guess some of the concerns would be like if they're more active than they were before.
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Um, and maybe there's undiagnosed heart issues.
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So that's something that you want to ramp up activity slow and steady, but that's how you do with any older adult that working on health conditions.
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Yeah.
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So could you summarize for us what were the recent FDA announcements that I was alluding to in terms of updating the product information, prescribing information to reflect some of that newer data?
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And how how how how do you see that actually changing practice potentially if it happens?
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It's still TPD, but what what are they proposing or asking?
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Um Yeah, so one of the things in the FDA update was the removal of the fact that it hasn't been studied in older men.
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So in 2015, when that was out there, there weren't these trials.
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So now we have a fair amount more evidence.
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So it does make sense to kind of remove that clause saying that we don't know.
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You know, we do have this evidence.
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Um that was probably the main one.
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And then the other big one is that they are considering having this in what's called idiopathic or unknown causes of low testosterone that we could consider prescribing testosterone for older men, though there isn't a clear structural issue.
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And that would that would potentially very much expand the population that you would be managing, because at least in terms of approved uses, idiopathic hypoconitism hasn't been something that's been in the labeling.
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And you said that you do work up and rule out potential secondary causes, but this would broaden it beyond where it's a little bit stricter right now.
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And how do you think that would impact your practice?
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Yeah, so I think in some ways it will broaden it.
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Where current testosterone prescribing practices is, this will probably catch up to where it's at.
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Okay.
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Because I would say testosterone is still prescribed for those men, but it's technically off label since it isn't a clear indication.
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Okay.
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Um, but it's still, I would say, currently commonly prescribed in those men.
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So it'll kind of catch up to where current practice is, but I feel like it'll also remove some of the barriers from like work up from primary care perspectives.
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We'll probably see more people getting access to testosterone or at least getting it worked up and trialing and seeing if it helps them.
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Interesting.
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So one of the other things that I saw proposed was some changes around prostate cancer risk and changing the language and the labeling around that.
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Could you speak to that at all?
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Sure.
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So there's always been this theory because on the prostate gland, there are testosterone receptors for DHT.
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And for those that have prostate cancer, one of the big treatments is to block that with different medications and hormonal blocking agents.
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So there was always this concern that if we were to supplement testosterone, maybe it could increase the risk of prostate cancer.
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Well, it's you never 100% know the risk of prostate cancer with testosterone.
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I believe when I saw in a few different like trials or at least observational studies, was maybe one in 17,000, very rare.
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And so the evidence was kind of showing that this increased risk of prostate cancer, if at all, is very low.
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And I would still, if someone has active prostate cancer, I believe the guidance was uh in the FDA said metastatic prostate cancer, although I would be probably cautious with any cancer of the prostate.
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But the monitoring around it has always been, and prostate cancer in general has always been kind of questionable.
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I believe there was like a reduction in how often we screen for PSAs in primary care, and we have more of a risk-benefit discussion with men.
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So for that discussion with men that are starting testosterone or considering it, if they're 40 or above, I'll always get a baseline prostate-specific antigen just to see where it's at.
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We'll talk about some of the signs and symptoms of prostate growth, which is the concerns with urination.
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And then there's some recommendations for like severe bananas prosthetic hyperplasia and maybe being concerned about it, which is the uh international prostate symptom scale above 19.
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So we'll we'll talk about it at baseline just so that they're aware.
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But I also tell them that this risk is extremely low.
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Usually monitor it once a year or so.
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And what we're trying to catch is any quick rises in the prostate-specific antigen.
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Okay.
00:20:37.519 --> 00:20:46.480
But I believe the overall thought process is that the warning is probably something that's concerning a lot of people unnecessarily.
00:20:47.359 --> 00:20:55.359
Um, where if you have a more nuanced approach and just discuss it, like there is maybe a very, very small risk, we just want to screen for it.
00:20:55.440 --> 00:20:58.079
Uh, but the likelihood is maybe one in 10,000.
00:20:58.880 --> 00:20:59.200
Okay.
00:20:59.519 --> 00:20:59.839
Okay.
00:21:00.240 --> 00:21:02.799
Well, that is reassuring and and good context to have.
00:21:04.240 --> 00:21:14.960
So when thinking about what I'm hearing is that a lot of the proposed labeling changes would just be sort of catching up with current practice.
00:21:15.119 --> 00:21:24.400
Is there anything else that's that would sort of significantly impact prescribing or clinician decision making based on these announcements?
00:21:24.480 --> 00:21:26.720
Or is that just a nutshell summary?
00:21:27.200 --> 00:21:28.720
No, I I think there's more to it.
00:21:28.799 --> 00:21:33.359
So I think that it is kind of catching up, but there's always been this stigma.
00:21:33.440 --> 00:21:35.680
I think you mentioned it with like the menopause trial.
00:21:35.759 --> 00:21:38.240
So I think this is trying to reduce some of that stigma.
00:21:38.480 --> 00:21:38.720
Okay.
00:21:38.960 --> 00:21:43.920
And then if for men, it's probably a very difficult conversation for many to even bring up.
00:21:44.160 --> 00:21:55.119
So highlighting that, you know, maybe there is some benefit to it, there's less risk than we initially thought, and maybe it's a conversation that can be had more often in our primary care visits.
00:21:55.519 --> 00:21:58.079
Um, so I think that's part of it.
00:21:58.240 --> 00:22:08.720
And then there's still a lot under So in the FDA panel and guidance, they're mentioning like low testosterone levels might be linked to heart disease or other things, which we're still not certain of.
00:22:08.960 --> 00:22:11.599
And maybe there's some more exploration there.
00:22:12.079 --> 00:22:15.680
So I think you had a hit the nail earlier.
00:22:15.839 --> 00:22:18.400
Like all these things are interconnected.
00:22:18.559 --> 00:22:21.359
What we don't necessarily know is what's causing what.
00:22:21.599 --> 00:22:28.640
And is a low testosterone level for someone that's unhealthy with diabetes and sleep apnea just a sign that they're generally unhealthy?
00:22:29.039 --> 00:22:29.279
Right.
00:22:29.839 --> 00:22:35.759
Not the that the testosterone low testosterone is causing it, but it's something that we can see from someone that's unhealthy.
00:22:36.160 --> 00:22:44.880
And then the other big area that we should probably definitely discuss are like the testosterone clinics that are out there.
00:22:44.960 --> 00:22:55.359
Um, because that's really impacting care and sometimes positively, but also sometimes there are some concerns that should be had from pharmacists.
00:22:55.599 --> 00:22:59.039
I'm not sure how the prescriptions are getting to the patients at the end of the day.
00:22:59.119 --> 00:23:05.519
I think a lot of it's online prescribing coming from out of state, but that can lead to a lot of issues down the road.
00:23:06.319 --> 00:23:08.000
Have you had experience with that yourself?
00:23:08.079 --> 00:23:09.119
It sounds like you have.
00:23:09.359 --> 00:23:16.319
And how so what what has your patients' experiences been and how have you been managing that in your practice?
00:23:16.640 --> 00:23:19.759
Yeah, it's kind of a headache, I'll be honest.
00:23:19.920 --> 00:23:30.319
Um, because the initial workup and the screening that you'd probably want beforehand is incomplete at the best of times or just non-existent.
00:23:30.640 --> 00:23:41.920
Um so you're getting these men that have been prescribed it, started it and and maybe found some benefits and they want to stay on it, but they want to switch over to somewhere where it might be a little lower cost for them.
00:23:42.000 --> 00:23:45.680
Because a lot of these clinics are out of pocket, they're high, higher cost.
00:23:46.079 --> 00:23:49.759
And so you're trying to figure out like what what do we do?
00:23:50.000 --> 00:23:53.920
Because we don't know how it got started, if it was appropriate.
00:23:54.640 --> 00:24:08.480
And so a lot of these cases, like the best way to do it, and it's not an easy thing, is to come off it and then retest it after a few months and just see like is there true low levels, or was this just started um outside of it?
00:24:08.640 --> 00:24:20.960
So, and then the other issue is that like maybe these men now do have secondary hypoconatism because um they were started on it, maybe they've been on it for years and now their body became dependent on it.
00:24:21.200 --> 00:24:22.160
Right, right.
00:24:22.799 --> 00:24:26.400
Which is unfortunate, but I've seen that too.
00:24:26.640 --> 00:24:46.960
And then this is a very controversial part, but a lot of these guys come to me and they're like, Well, in this functional medicine, you know, a place that I went, they're said, Well, our testosterone should be closer to the highest end of the normal range, kind of closer to 800 to 1,000, which is very different than what our guidelines will say.
00:24:47.599 --> 00:24:49.680
Um, so their body got used to that.
00:24:49.839 --> 00:24:58.319
And so when you try and lower it to the normal range to prevent some of those potential risks, they're they don't feel as good.
00:24:59.039 --> 00:25:10.880
They were used to these much higher levels, and like that's their plus, which is difficult to talk about because none of the trials and none of the evidence we have were shooting for those ranges.
00:25:10.960 --> 00:25:17.920
So, you know, maybe there is higher risk of clots or heart disease in those because that's super therapeutic at that point.
00:25:18.319 --> 00:25:19.359
Sure, sure.
00:25:20.160 --> 00:25:23.599
So, and and just to what where's the normal range typically?
00:25:23.680 --> 00:25:28.000
Like what do what are most people sort of shooting for if you're if you're managing a patient in practice?
00:25:28.319 --> 00:25:37.519
Yeah, so it depends on the exact form that you're using, but generally somewhere between 400 and 700 total testosterone, like the appropriate time frames.
00:25:37.680 --> 00:25:41.039
So that's typically a replacement level that you shoot for.
00:25:41.519 --> 00:25:55.440
So yeah, when you get these patients that were managed in a different way uh that weren't guideline or evidence-based, it's sometimes hard to shift the framework when they want to come to like normal practice.
00:25:55.759 --> 00:25:56.880
Yeah, yeah, absolutely.
00:25:57.039 --> 00:26:09.279
And so that leads well into the question of some of the safety concerns with testosterone, whether it's at higher dosing or or typical dosing, what are those safety concerns that we want to be thinking about?
00:26:09.680 --> 00:26:10.079
Sure.
00:26:10.400 --> 00:26:13.599
For the topical agent, transference to others is always a big one.
00:26:13.680 --> 00:26:17.920
So you're putting on your skin, you have to be very careful in how you apply it.
00:26:18.319 --> 00:26:26.240
Um, and then for any of them, we get worried about erythrocytosis, which is the formation of red blood cells at too high of a rate.
00:26:26.319 --> 00:26:29.599
And that could be a concern for clots or blood clots.
00:26:29.680 --> 00:26:35.839
So we monitor complete blood counts, usually every three to six months, and then upon dose changes.
00:26:36.079 --> 00:26:39.279
So those are two big ones with the injection.
00:26:39.359 --> 00:26:42.640
There's injection site reactions, concerns about that.
00:26:43.359 --> 00:26:49.599
Um, there's always been a link to blood clots, partially because of erythrocytosis.
00:26:49.839 --> 00:26:53.599
There's been some mixed evidence on increased risk of that.
00:26:53.759 --> 00:26:56.559
So it's something I'll monitor for, I'll always ask about.
00:26:56.640 --> 00:27:07.200
And if someone's had a blood clot, we have to make sure if it was unprovoked or provoked, and talk about like the safety there and the risks of testosterone there.
00:27:07.839 --> 00:27:11.680
Um, certain formulations have specific side effects.
00:27:11.759 --> 00:27:17.839
So there's a every three-month injection that has a concern for a pulmonary um microemboli.
00:27:18.319 --> 00:27:22.640
I don't prescribe in my clinic, so I don't have as much experience with that part of it.
00:27:22.960 --> 00:27:28.160
Umily skin and acne are common ones that I see.
00:27:29.279 --> 00:27:32.319
There's definitely some risk for mood fluctuation.
00:27:33.039 --> 00:27:37.200
More so with the injection over the topical, because the topical is applied every day.
00:27:37.279 --> 00:27:39.920
It's maybe more stable, steady state.
00:27:40.160 --> 00:27:50.559
With the intermuscular injections, I'll tell my patients that hey, you know, you might notice a little bit of difference from day one of the cycle to the last day of the cycle.
00:27:51.039 --> 00:27:54.559
And decreasing the duration of the cycle.
00:27:54.640 --> 00:28:00.319
So every two weeks versus every one week can potentially help with that, just doing a lower dose more frequently.
00:28:01.119 --> 00:28:05.680
Um, so those are a lot of the side effects that we talk about.
00:28:05.839 --> 00:28:15.359
And then we've kind of already covered the prostate cancer, and then a lot might come and talk about the cardiovascularists, and I basically tell them what the evidence has shown recently.
00:28:15.680 --> 00:28:16.160
Mm-hmm.
00:28:16.319 --> 00:28:16.720
Mm-hmm.
00:28:17.279 --> 00:28:26.640
So I guess when you have patients who are, say, coming to you after they have been taking testosterone from another source.
00:28:26.960 --> 00:28:34.480
Um is the safety consideration a big part of your discussion, or how how how do you navigate those?
00:28:34.559 --> 00:28:35.759
Because I see that as being really difficult.
00:28:35.839 --> 00:28:44.559
And I could see it being very difficult to have a patient come off of it even for a short amount of time to sort of reassess and try to get to a baseline evaluation.
00:28:44.640 --> 00:28:46.079
So how do you handle that?
00:28:46.480 --> 00:28:47.519
It is extremely difficult.
00:28:47.680 --> 00:28:52.480
And we're not always successful, but it's just talking about it from like a level of concern.
00:28:52.559 --> 00:28:58.640
It's like we don't know what will happen long term if you stay at these high levels, but it wasn't how it was studied.
00:28:58.799 --> 00:29:02.480
So, you know, in theory, these are potentially higher risk for you.
00:29:02.640 --> 00:29:10.319
You know, if it's something that you want to do and switch over, you know, in general, if we have the baseline data, we can usually continue it.
00:29:10.480 --> 00:29:18.880
If we need to do the workup, then we'll have them hold it for a certain amount of time and recheck to see if their levels are truly low.
00:29:19.279 --> 00:29:29.839
But it's coming from that like motivational interviewing standpoint, that concern for their long-term well-being and health, because they do have decades of life left to live.
00:29:29.920 --> 00:29:34.880
And some are very motivated to stay on it, some don't want to pause it at all.
00:29:35.119 --> 00:29:45.119
And the hard part is if you're thinking about their overall well-being, you know, they still can probably get it from the online source um or somewhere else.
00:29:45.279 --> 00:29:56.319
So I also try and always educate them on like the risks, what they need to monitor for, make sure like their outside person, whoever is getting this prescribed to them or however they're getting it, hopefully is doing that monitoring.
00:29:57.440 --> 00:30:00.799
Um, so that they know what should be getting done.
00:30:01.039 --> 00:30:01.519
Mm-hmm.
00:30:01.680 --> 00:30:02.079
Mm-hmm.
00:30:02.319 --> 00:30:05.359
Yeah, that just seems like a really it seems very difficult.
00:30:05.440 --> 00:30:10.880
And but as you say, keeping the patient in the center of that conversation and having them at the heart of it.
00:30:10.960 --> 00:30:18.079
If you're trying to do what's best for the patient, hopefully those discussions would become easier with you know, prioritizing their well-being, their health.
00:30:18.319 --> 00:30:18.559
Yep.
00:30:18.799 --> 00:30:19.200
Yep.
00:30:19.440 --> 00:30:28.000
But but it's important for all pharmacists out there because we think about med rec and issues and and like this is another thing that the people can get online very easily.
00:30:28.079 --> 00:30:35.119
So it's something that um we should all be aware of because someone could have started it even if it wasn't prescribed.
00:30:35.279 --> 00:30:38.559
And unfortunately, I mean, I've seen some where like they say they got it.
00:30:38.640 --> 00:30:45.839
I look at the prescription drug monitoring database, which in theory this should be in since it's a controlled substance, but it's not showing up sometimes.
00:30:46.160 --> 00:30:46.640
Interesting.
00:30:46.880 --> 00:30:47.839
Okay, okay.
00:30:48.079 --> 00:31:05.200
So sort of have to do that additional digging in some cases to figure out if if or just talking with the patient, as you said, during med rec or any sort of med update process, evaluating what they're taking, both over-the-counter prescription from online mail order, all of those things.
00:31:05.359 --> 00:31:05.519
Yep.
00:31:05.680 --> 00:31:12.079
And also, you know, also thinking about topical forms, which maybe patients aren't thinking about as a as a medication in the same way.
00:31:12.240 --> 00:31:21.519
And so actually, another question is there any difference in risk in terms of the different dosage forms, safety considerations, or even efficacy considerations that you're thinking about?
00:31:21.599 --> 00:31:25.920
How when you're sort of making that initial selection in a patient who is appropriate?
00:31:26.240 --> 00:31:26.480
Yeah.
00:31:26.640 --> 00:31:28.799
In theory, efficacy should be the same.
00:31:29.119 --> 00:31:39.759
The topical might be a little bit slower to get in the system, but in theory, it should be equally as effective as long as it's getting in and applied correctly and regularly.
00:31:39.920 --> 00:31:44.640
Um, sometimes the application can be difficult, sometimes timing of it, just remembering to apply it.
00:31:44.720 --> 00:31:49.039
And then it's not the most nice feeling or sensation to apply.
00:31:50.480 --> 00:31:54.000
First, the injections, some people really are afraid of needles.
00:31:54.240 --> 00:32:00.160
And the most common injection is still the vial and syringe because it's very, very affordable and cost effective.
00:32:00.400 --> 00:32:08.000
So we try and do injection training, but if it's every week, we don't have the clinical resources to have them come in and do like a in-clinic injection.
00:32:08.079 --> 00:32:13.039
So we train them to do it at home and then have them do their own injections.
00:32:13.200 --> 00:32:22.000
So in terms of side effect profile, topical as that transference risk, we talked about the injection as the injection site reactions.
00:32:22.079 --> 00:32:26.079
And I see like a little bit more mood fluctuation throughout the cycle.
00:32:26.960 --> 00:32:27.279
Okay.
00:32:27.759 --> 00:32:38.240
And in terms of counseling points and thinking about onset of benefit, when do you typically tell patients to that they can expect to see improvement in symptoms?
00:32:38.400 --> 00:32:40.960
Because I can imagine that would be also a very difficult thing to assess.
00:32:41.039 --> 00:32:45.759
And do you have sort of like a baseline tracking or how how do you handle that?
00:32:46.960 --> 00:32:48.559
That's a very good question.
00:32:48.880 --> 00:32:52.960
So the levels usually come up two to two to four weeks in theory.
00:32:53.119 --> 00:32:58.079
We don't usually test that early or don't follow up that early because symptoms are delayed often.
00:32:58.400 --> 00:33:00.720
Sometimes it depends on how long they've had the issue.
00:33:00.799 --> 00:33:05.759
So if they've had it for years, we kind of expect it to be slower in terms of benefit.
00:33:05.839 --> 00:33:11.759
Um, so we might follow up in like three months, at most six months, somewhere in that time frame, but usually about three months after.
00:33:11.920 --> 00:33:24.400
And hopefully finding some improvement in symptoms will monitor the blood counts, the testosterone, the CDC at that point to make sure it's safe and then that the levels have improved.
00:33:24.880 --> 00:33:27.680
Um so yeah, about three months.
00:33:27.759 --> 00:33:42.079
Hopefully, we're seeing some benefit, and then within six months, I think the ACP guidelines basically said if they haven't found any benefit within 12 months, you really should talk about stopping the treatment for the older men that you know might want to try out it.
00:33:42.319 --> 00:33:56.480
Because the other thing that we talk about too is that if there's a clear issue with really low testosterone, you know, we should and in younger men with some kind of testicular pituitary, the symptomatic benefit is very strong.
00:33:56.799 --> 00:34:03.680
But in age-related low testosterone, sometimes that symptom benefit is not as much as they were told it might be.
00:34:03.920 --> 00:34:04.240
Okay.
00:34:04.480 --> 00:34:13.920
So I always will ask, like, have you noticed any improvements in terms of sexual function desire, erectile dysfunction, and then whatever the other baseline symptoms might have been.
00:34:14.719 --> 00:34:20.559
Um and so a lot of it is very subjective, and that does get very hard to know if there has been benefit.
00:34:20.639 --> 00:34:27.440
We don't, as far as I know, there's no standardized symptom scale or anything that we have them fill out or that's available.
00:34:27.679 --> 00:34:28.000
Yeah.
00:34:28.320 --> 00:34:30.320
So it's yeah, it's a lot of times very subjective.
00:34:30.400 --> 00:34:41.440
And then when you follow up, you never know what's going on in their life, whether it's sometimes a breakup or they're not, you know, stress or work or financial issues like that will all impact performance and the answer to that.
00:34:41.599 --> 00:34:41.840
Of course.
00:34:42.880 --> 00:34:43.519
Yeah.
00:34:44.559 --> 00:34:54.480
And so I think that goes to the point around, like we do with all medications, continuing to reassess that the patient's getting benefit from it and uh are they tolerating it well.
00:34:54.719 --> 00:34:57.760
Is there any concern about prolonged use?
00:34:57.840 --> 00:35:00.559
So say, like in terms of a deprescribing perspective?
00:35:00.719 --> 00:35:06.239
Are you thinking about it more so with certain patients after certain periods of time or at certain ages?
00:35:08.400 --> 00:35:12.239
Yeah, especially in like this population that the FDA is kind of talking about.
00:35:12.480 --> 00:35:13.280
It's a good question.
00:35:13.440 --> 00:35:17.119
The longer they're on it, it's very possible that their body got more used to it.
00:35:17.360 --> 00:35:23.760
You you don't always know, but usually if it's stopped, the first month or two you'll probably feel worse or they'll feel worse, I should say.
00:35:23.920 --> 00:35:32.079
Um, but then in theory, the gonadal function should kick in over time to back to where their baseline was before they were on it.
00:35:32.239 --> 00:35:39.840
Um but if someone's stopping it, you'd want to monitor, you'd want to follow up and just make sure that that does happen where there are improvements.
00:35:40.000 --> 00:35:43.280
Um so you wouldn't want to stop it and then do nothing.
00:35:43.760 --> 00:35:44.480
Sure, sure.
00:35:44.719 --> 00:35:45.039
Okay.
00:35:45.679 --> 00:36:07.280
And I guess for pharmacists, regardless of their practice setting, if they're sort of maybe on the receiving end of the prescription and not prescribing it like in your case, what sorts of things should they be discussing up front or how how what what are the most important things that should happen in a counseling conversation?
00:36:07.599 --> 00:36:07.920
Yep.
00:36:08.000 --> 00:36:09.119
So administration.
00:36:09.280 --> 00:36:14.639
There's a lot of details with administration, depending on the formulation, just to make sure it's done properly.
00:36:14.960 --> 00:36:19.920
Um, expected benefit, time to benefit, and potential side effects.
00:36:20.000 --> 00:36:22.639
So going above just like oily skin and acne.
00:36:22.800 --> 00:36:32.800
And then just I would just make sure that they're getting regularly monitored with some kind of provider that's doing care for them so that they can do the proper blood tests and and management.
00:36:32.960 --> 00:36:39.360
I think from the outpatient like dispensing side, it is a very difficult conversation to be had at the counter.
00:36:39.440 --> 00:36:49.679
Um, but trying to come at it from like a safety perspective and making sure that at least from the conversation you're having, things seem to be in order and appropriate.
00:36:50.000 --> 00:36:50.400
Mm-hmm.
00:36:51.440 --> 00:37:04.239
Well, I think we've covered a lot of ground and you've been super helpful in clarifying where we are with the evidence and just sort of putting everything in perspective, again, given some of these changes and updates that we've been hearing about.
00:37:04.800 --> 00:37:13.840
What else is there that we haven't touched on that I want to make sure we address anything that you might have wanted to highlight in terms of uh considerations for safety, efficacy, patient selection, all of those sorts of questions?
00:37:14.000 --> 00:37:15.519
Anything we didn't touch on?
00:37:15.920 --> 00:37:20.239
I think there's only one other piece, and it'll be interesting to see what happens moving forward.
00:37:20.320 --> 00:37:26.480
But I believe the FDA did talk about maybe removing testosterone from the controlled list of patients.
00:37:26.639 --> 00:37:29.280
Um, at least that's one of the recommendations from the expert panel.
00:37:29.360 --> 00:37:36.320
I don't know if it will happen or not, but that will change, I think, part of the paradigm and just the stigma around it.
00:37:36.559 --> 00:37:42.159
Um so I feel like we will probably see more prescriptions for it.
00:37:42.400 --> 00:37:58.719
Um there could be some improved accessibility, which could be very beneficial to a number of men out there, but we do have to probably put up more guardrails too, because there's a there are long-term risks and there are potentials for inappropriate prescribing.
00:37:58.960 --> 00:38:04.000
And there is a lot of social influence and misinformation out there on the potential benefits.
00:38:04.159 --> 00:38:16.000
So, as pharmacists, I think we definitely need to be aware of where we're at currently and just try to put the patient first and really come at from that angle.
00:38:16.559 --> 00:38:25.599
I think that's going to be key in the next five years because I feel like they'll there'll be a lot of changes coming forward with testosterone prescribing and dispensing.
00:38:25.920 --> 00:38:27.119
Yeah, it sounds like it.
00:38:27.199 --> 00:38:36.880
And I'll be interested to see from an outpatient perspective if some of these labeling changes go through, will there be any differences in prior authorization requirements, insurance coverage, that sort of thing too?
00:38:37.039 --> 00:38:42.960
Because if if part of the intent is to increase access, will those restrictions still be in place?
00:38:43.199 --> 00:38:46.400
I don't know if you have any insight on that, probably not given your setting.
00:38:46.800 --> 00:38:47.679
Not not yet.
00:38:47.920 --> 00:38:50.880
We we in my system are still very strict on the prescribing.
00:38:51.119 --> 00:38:56.639
They have to really do meet all those criteria that are out there for unequivocally low testosterone.
00:38:56.719 --> 00:39:03.679
So it is very hard to get, and that's where a lot of these patients are going outside to get it from online sources.
00:39:03.840 --> 00:39:13.599
Um, I mean, I it's a in some ways, hopefully it'll be beneficial because you know if we loosen the criteria slightly, but then it's monitored and safely monitored.
00:39:13.920 --> 00:39:14.159
Right.
00:39:14.400 --> 00:39:17.039
I think that will be a probably a good thing overall.
00:39:17.360 --> 00:39:18.159
Right, right.
00:39:18.639 --> 00:39:20.880
Super interesting conversation, Michael.
00:39:21.039 --> 00:39:22.239
Very, very excited to have you.
00:39:22.320 --> 00:39:24.000
And this is just very enlightening for me.
00:39:24.079 --> 00:39:31.599
I just I think it's great to hear again the perspective on this and and making the parallel to hormone therapy for menopause.
00:39:31.679 --> 00:39:37.119
It is a good connection for me to be thinking about because I wasn't necessarily thinking about testosterone in that way.
00:39:37.199 --> 00:39:53.599
But as you said, focusing on the safety considerations, appropriate use, even with some of the changes that might be happening and just individualizing care, making sure patients are aware of expectations and that monitoring focus just seems like a really good point to drive home.
00:39:53.920 --> 00:39:56.719
So, Michael, it is our Game Changers Clinical Update podcast.
00:39:56.800 --> 00:40:01.119
And so we always wrap up with what is the game changer that you want our listeners to know about this topic?
00:40:01.199 --> 00:40:04.960
What is the sort of one bottom line takeaway you'd want them to leave with?
00:40:05.440 --> 00:40:06.239
Right, Rachel.
00:40:06.320 --> 00:40:08.079
So, bottom line takeaway.
00:40:08.320 --> 00:40:12.239
We are going to see probably more testosterone prescriptions, more men on it.
00:40:12.480 --> 00:40:22.719
And the role as the healthcare provider and pharmacist on the team is just to make sure it's safe, um, effective, and appropriate, the right dose for the right patient, the right time, the right drug.
00:40:22.880 --> 00:40:36.880
And then just coming at it in a non-judgmental way and really being open to ask like those subjective questions about how the medication's helping them and what potential risks that they may be having.
00:40:37.039 --> 00:40:39.679
So that's probably the main takeaway.
00:40:40.400 --> 00:40:42.639
Yeah, I I agree based on what you shared.
00:40:42.719 --> 00:40:45.440
That's a very great bottom line, summarized it well.
00:40:45.599 --> 00:40:49.920
And again, thank you so much for your insights on this very tricky topic, I think.
00:40:50.079 --> 00:41:00.480
And hopefully we'll have some more coming out in the next year or so, and we'll have you back on and chat about it again as we get more insight from from what's happening from FDA's perspective.
00:41:00.559 --> 00:41:01.199
We'll see.
00:41:01.599 --> 00:41:02.159
I'd be happy to do that.
00:41:02.320 --> 00:41:02.960
Thank you so much, Michael.
00:41:03.280 --> 00:41:03.599
You're welcome.
00:41:03.760 --> 00:41:04.960
Yeah, really appreciate your time.
00:41:05.199 --> 00:41:05.840
Appreciate it.
00:41:07.119 --> 00:41:09.280
Well, we talked about a lot of great practical tips today.
00:41:09.519 --> 00:41:12.800
These will all be summarized in the practice resource that goes along with this podcast.
00:41:12.960 --> 00:41:16.079
Uh, we hope today's conversation gave you something useful to bring back to your practice.
00:41:16.159 --> 00:41:16.960
That's always our goal.
00:41:17.199 --> 00:41:22.800
Before you go, be sure to claim your continuum education credit, your time and engagement count, and we want to make sure you get credit for it.
00:41:23.039 --> 00:41:25.280
Thank you so much for being part of the Game Changers community.
00:41:25.440 --> 00:41:27.599
We look forward to a conversation with you all next week.