Women’s International Pharmacy is a compounding pharmacy that specializes in custom compounded bioidentical hormone prescriptions for men and women. Prescriptions are individually compounded to meet patient specific needs as directed by a licensed medical practitioner.
The compounding pharmacy is one of the most important tools available to functional medicine practitioners.
Compounding pharmacies formulate combinations of pharmaceutical-grade ingredients as prescribed by a healthcare practitioner.
This practice allows medications to be tailored specifically to an individual patient’s needs and dosages to be finely tuned.
In this episode of New Frontiers, Dr. Fitzgerald talks with Michelle Violi, PharmD, who is the dispensing pharmacy manager at Women’s International Pharmacy, about the benefits of using a compounding pharmacy and intricacies of using bioidentical hormones for a variety of conditions.
In this podcast you’ll hear:
- How to support legislation that protects compounding pharmacies
- How to choose a compounding pharmacy
- How a compounding pharmacy helps address each patient’s unique needs
- How compounding pharmacies adapt prescriptions for chemically sensitive patients
- How bioidentical hormones differ from synthetic hormones
- Why bioidentical hormones aren’t marketed commercially as often as synthetic hormones
- About the benefits and drawbacks of oral administration of hormones versus topical application
- How different hormone preparations and applications get absorbed by the body
- The role of progesterone deficiency in perimenopause symptoms and how timing progesterone replacement (when a patient takes her replacement hormones) can help with symptoms
- The importance of where topical estrogen is administered
- How practitioners and patients can contact Women’s International
- The limitations of hormone testing
- How hypothyroidism/Hashimoto’s can affect hormone therapy
- Other uses for bioidentical hormones, including vaginal or labial adhesions in young children, PMS, luteal phase defects, fertility issues, and andropause
- Bioidentical hormones for cortisol dysregulation
- How to dose T3 and T4 for thyroid
Michelle Violi is a licensed pharmacist with a passion for bioidentical hormone health. She received her PharmD degree from the University of Wisconsin-Madison School of Pharmacy. At Women’s International Pharmacy, she is the Dispensing Pharmacists Manager where she is responsible for managing a team of pharmacists in two locations, participates on the regulatory team to maintain state licenses, and is an active contributor to Women’s International’s educational resources.
Michelle is a member of the International Academy of Compounding Pharmacists (IACP) and Pharmacy Society of Wisconsin (PSW) and holds 17 state licenses. She is committed to the future of compounding as a pharmacy student preceptor with both the University of Wisconsin-Madison School of Pharmacy and Concordia University School of Pharmacy.
Dr. Kara Fitzgerald: Hi everybody, welcome to New Frontiers in Functional Medicine, where I am interviewing the best minds in functional medicine and today is no exception. We are going to be talking about all things compounding pharmacy, one of the most fundamental tools in the functional medicine clinician’s toolkit with Michelle Violi. Let me tell you about Michelle.
She’s a licensed pharmacist with a passion for bioidentical hormone health. She received her PharmD degree from the University of Wisconsin-Madison School of Pharmacy. At Women’s International Pharmacy, she’s the dispensing pharmacist’s manager, where she’s responsible for managing a team of pharmacists in two locations, participates on the regulatory team to maintain state licenses and she’s an active contributor to women’s international education resources. And, incidentally, there’s a lot of close educational resources and in our show notes you will see links to many of them. Michelle is a member of International Academy of Compounding Pharmacists and Pharmacy Society of Wisconsin and she holds 17 state licenses. That’s pretty impressive, Michelle.
She is committed to the future of compounding pharmacy and, as a pharmacy student, she perceptored with both the University of Wisconsin School of Pharmacy and Concordia University School of Pharmacy. Michelle, welcome to New Frontiers.
Dr. Michelle Violi: Thank you, Dr. Fitzgerald. Thank you for having me.
Dr. Kara Fitzgerald: It’s really great to have you on. You’re the first compounding pharmacist’s brain that I’ve gotten to pick on New Frontiers, so I’m excited about that given… as I said in the introduction, you play such a fundamental role for us in functional/integrative medicine. We were just talking beforehand: In fact you just actually did a really lovely teach-in to the clinicians with us in our clinical immersion program, but you’ve been in the crosshairs of the FDA and, as I was just telling you, I posted something recently in support of compounding pharmacies on our social media, but I see these things periodically assault my inbox where the FDA is going after compounding pharmacies and I always get sort of an anxious pit in my stomach because you’re such an important part of what we do. So, what’s going on? Are compounding pharmacies safe? What do we need to do to support you? Color this in for us.
Dr. Michelle Violi: Sure, absolutely. So, this story really goes back to the beginning of time and Women’s International has been a part of it since then. Back in the 90s, there was actually a court case that went to the Supreme Court in which the compounding legislation federally was struck down and it all just kind of stayed under the rug for a while and really came to a head again in 2013.
I think probably the reason for that was based on the New England Compounding Center tragedy, which I think a lot of people are probably familiar with. The unfortunate thing there was that one bad actor really spoiled the waters for many of us in terms of reputation and what we do for our patients. This particular pharmacy was acting as a manufacturer, they were not acting as a pharmacy, and they were distributing medications that they claim to be sterile throughout the United States. And, unfortunately, what happened is these medications were not sterile, they harmed many, many people, some people died and that was a very, very tragic unfortunate event.
I think what people are not aware of regarding that situation is that there were laws in place in the state where they were practicing where the state board and the powers that be there could have addressed and stopped this from happening. However, they did not and so the FDA and the federal government decided that they needed to get involved and so, in 2013, they passed the DQSA, the Drug Quality and Security Act, and basically that brought back all of those regulations that were struck down back in the 90s.
And so you can imagine, a lot of those were outdated and that’s been problematic. However, the biggest problem through all of this is that Congress established these laws and said, this is now what compounding pharmacies have to do and we said okay. However, the FDA has chosen not to follow Congress’ word. They have continued to overstep and even Congress has sent a number of notices to them informing them to back down with regards to compounding pharmacies. And, currently, there’s actually a bill right now in Congress, it’s HR1959, it’s called The Preserving Patient Access to Compounded Medications Act. And this particular act would address a number of these situations where FDA is choosing to overstep and so, we’re hoping that everybody is willing to support it. When you look at it, it’s very reasonable. It’s just allowing compounders to practice and to serve our patients and practitioners as we always have in a safe manner. So that, in a nutshell, is what’s going on.
Dr. Kara Fitzgerald: And how can we support this legislation? I know that I posted but is there a website you want us to go to? I mean, do you need voices? Does something need to be signed? Is there donations? What can we do?
Dr. Michelle Violi: Sure. Well the best thing that we can do is to contact our legislators. Right now it’s in the House, so you’d want to contact your representatives, but eventually an equal measure would have to be taken in the Senate and so, just the more voices that our Congress people hear, the more they’ll realize that this is important.
Dr. Kara Fitzgerald: And say the legislation again, the name of that that’s going through so we know exactly what to say.
Dr. Michelle Violi: Sure, of course. So, the bill is numbered HR1959 and the name of it is The Preserving Patient Access to Compounded Medications Act.
Dr. Kara Fitzgerald: Okay, perfect. Thank you so much for that. All right, so I want to ask you another question and I know maybe this is not appropriate for you to answer, but has the FDA been sort of unduly lobbied by Pharma? I mean, is there some other agenda going on or is that for another day?
Dr. Michelle Violi: Yeah. Yeah, right, I know. It’s a little hard to say. I mean, yeah certainly Big Pharma has deep pockets but I think the focus needs to be on making sure that the laws are enforceable and are followed by both sides of the fence here. Yeah, so our biggest concern is just making sure that we can follow the laws that have been put in place and that the FDA doesn’t insist on measures that aren’t necessary.
Dr. Kara Fitzgerald: Yeah, absolutely. Absolutely. I mean, and you tend to be … you guys are compounding pharmacies are smaller and that’s actually one of the really lovely things about compounding pharmacies is that you’re available and you have this strong commitment to education and clinicians, I think, and patients alike can give you a buzz and actually reach a person. There’s a lot of very important qualities that we just want to keep alive and going. So, let’s just, since we’re on this … and the other piece, one of the things you actually mentioned at our teach-in this morning was that this one 2013 pharmacy, I think they were either in Massachusetts or Rhode Island, but next door to me, I’m in Connecticut, really brought some bad attention, some really unfortunate attention. But generally speaking, you guys are held to extremely high standards.
Dr. Michelle Violi: Yes. Yes we are. Like I mentioned, we’re following federal laws. We’ve always been held to our state laws. As I mentioned this morning, pharmacy is one of the most highly regulated professions in the US and so, we have scores of laws to follow. We’re held to the standards established by USP’s, the United States Pharmacopeia, which is a non-profit organization that establishes standards for pharmacy in general and healthcare, but there are specific standards that compounding pharmacies need to follow. And then, of course, there’s the PCAB, or the Pharmacy Compounding Accreditation Board, accreditation process but a pharmacy, a compounding pharmacy can undergo, to really show that they’re going that extra mile.
Dr. Kara Fitzgerald: Okay. Well then that leads me, we’re going … I promise everybody we will jump into bioidenticals here in just a second, but then, so what do we want to think about when we’re looking for, if we’re a clinician settling into the compounding pharmacy we’re going to work with or a patient, where we want to get our product from. How do we pick a good compounding pharmacy?
Dr. Michelle Violi: Sure, sure. So, the PCAB accreditation I think is a good thing to look for. In order to become PCAB accredited, the pharmacy has to undergo an inspection, we share all of our policies and procedures, our risk management program and this is a process that occurs every three years. So, it’s not like once you’re accredited you rest on those laurels. This is something that you have to keep up and maintain. So, if a pharmacy is PCAB accredited, that’s an impressive thing. Also, just looking I think at the experience that the pharmacy has. Certainly, pharmacies that have been doing this for a while have practices and have really perfected what they’re doing. And so I think that that’s another good thing to look at. Looking at pharmacies that specialize. The pharmacy that I work at, our focus is bioidentical hormones and that’s really all we do. That’s really our area of focus and we’re really good at it and so I think, a pharmacy that is focused like that is a good thing.
Dr. Kara Fitzgerald: Yeah. And you’ve been, you must be one of the longest bioidentical compounding pharmacies out there. I mean, you’ve been around for decades, like 1985.
Dr. Michelle Violi: Yes, over 30 years at this point. Yes, we are one of the originals. Absolutely.
Dr. Kara Fitzgerald: That’s pretty neat. I’m kind of curious, what’s your, just nutshell, your early story, like how your founder ended up jumping into this.
Dr. Michelle Violi: Sure, absolutely. So, Wally Simons is our founder. He started the pharmacy as a pharmacist and pharmacy compounding for a PMS clinic that opened here in town. So yeah, they started with a lot of progesterone and then the PMS clinic didn’t make it but the pharmacy did. And so, we just kept branching out into different hormones and different areas and different dosage forms and then, I think it was about 20 years ago, he decided to retire to Arizona and in his retirement, he actually started our second branch out there. So, we have one in Madison, Wisconsin, and then another outside of Phoenix, Arizona in Youngstown. We do have a pet pharmacy out there as well at that branch. So, yes that is kind of the story of how we came about.
Dr. Kara Fitzgerald: Now that’s a pretty neat story. Wow. A PMS clinic. All right. So then, let’s just talk about why we want to go compounding. Why are you such an essential tool for us clinicians?
Dr. Michelle Violi: Yeah. So, my perspective is that each person is an individual and it is so important to look at each person and figure out what is going on with them in terms of what they need for medications and lifestyle changes and everything. And so with compounded medications it is possible to do that. We are able to make minute changes to any dose that a patient may need. I think everybody’s familiar with going to the retail setting and the practitioner may call in a prescription for an antibiotic or a blood pressure medication and have four or five doses to choose from, whereas with a compounding pharmacy, you can choose any dose and a wide variety of dosage forms as well. And so it’s really possible to tailor the therapy to the patient and make sure that it’s something that they’re going to be able to tolerate and be able to use.
Dr. Kara Fitzgerald: Right, right. And in sort of infinite combinations, certainly when we look at what we can get in the bioidentical landscape, it’s limited from a traditional pharmacy and they’re always so high dose. Like if we’re going to go Prometrium or something of that nature and the roots of delivery of course are very limited, usually oral.
Dr. Michelle Violi: Exactly. Exactly. Yes. I mean, if somebody needs progesterone, currently they can use a 100 or a 200 milligram capsule or a vaginal gel that’s at 40 or 80 milligrams I think. So, I mean it’s just very, very limited what you can get commercially.
Dr. Kara Fitzgerald: Right, right. And many of our patients need to start at much more conservative doses. The other interesting thing you mentioned this morning I enjoyed hearing about is the variety of mediums of if you’re doing a topical, the variety of options that you have there and you talked about one of the more sensitive individuals you guys are … well, I think you were just mentioning in general, but using olive oil as the delivery oil and no preservatives at all.
Dr. Michelle Violi: Right, right. Yes we work with many, many people that are very chemically sensitive and of course when somebody is chemically sensitive, you don’t always know exactly what they’re chemically sensitive too, so we do have a number of different topical forms that people can try, maybe starting with one cream and if that doesn’t work trying another cream. For people who are very, very sensitive and just really can’t tolerate anything, it’s possible for them to use the hormones in a drop form. And so, that’s basically a suspension of the drop in oil. We generally use olive oil, but we do have another oils if the patient would be sensitive to olive oil and then they would just shake that up each time they use it and apply the prescribed number of drops to either their skin or under their tongue or just even swallow it as prescribed by their practitioner.
Dr. Kara Fitzgerald: So, what are the most common uses of … actually before we get into the most common uses of bioidentical, just give me a little bit of a background of bioidentical versus synthetic and why we all want bioidentical.
Dr. Michelle Violi: Sure. So, bioidentical hormones, what that means, is that the molecule, the hormone molecule, is identical to what is produced by the body. So, if you are using a bioidentical progesterone cream, the molecule for progesterone in that cream is identical to the molecule progesterone produced by the ovaries or from the adrenal hormones in the body. And that’s very important, because on the other hand, you have synthetic, or what are termed synthetic hormones and these molecules have been slightly changed from what is produced by the body, either to patent them or to make them last longer in the body or for a variety of reasons, but I think it’s important to note that the receptor site for these hormones is very specific. And so if you’re trying to have a molecule that’s not exactly what that receptor site wants to connect with, if you’re trying to plug that into that receptor site, it’s not going to bind as well as the bioidentical hormone would and that can cause side effects and that can make it so that that molecule doesn’t work like the bioidentical molecule does in the body.
Dr. Kara Fitzgerald: Or make it actually less safe.
Dr. Michelle Violi: Right, right. Yes. Yeah, I mentioned the WHI study this morning when I spoke, and in that situation they saw that the MedroxyProgesterone Acetate, the synthetic progestin used in the study, actually was associated with an increased risk of breast cancer, whereas the estrogen alone was not.
Dr. Kara Fitzgerald: Right. And so just on that topic, that’s the Women’s Health Initiative Study, that’s the extremely famous, when did it come out? 27,000 women.
Dr. Michelle Violi: Right. Well, it had been going on for a while but it was actually stopped in 2002 when they were seeing this increased risk of breast cancer and they decided at that point it was no longer safe to continue with it.
Dr. Kara Fitzgerald: But you have since, or I know, again, you were talking about it this morning and we can make these citations available to folks. There’s some evidence that natural bioidentical progesterone is good. It’s safe.
Dr. Michelle Violi: Right. Yeah, there are other studies, although unfortunately not as many as we would hope because as I mentioned before, one of the reasons you change the molecule is to allow you to patent it and so we don’t see as many bioidentical hormones marketed commercially for that reason. The patent process is a little different and more difficult. And so there aren’t a lot of studies on the bioidentical hormones, there are some and certainly, the ones that we’re seeing on the bioidentical progesterone show that it’s significantly different than the synthetic progestin, in terms of a variety of different things that you would expect from the progestin.
Dr. Kara Fitzgerald: Okay. Can you actually to speak those? Since you’re bringing it up now. Just give us a little bit of a high level view and then maybe later, if you can just get a couple citations to us that would be great and we’ll just put them in our show notes.
Dr. Michelle Violi: Sure. Yeah. I guess at this point, I would just kind of leave it at that. I can certainly bring together some of those studies, but at this point I guess that I can’t speak specifically about one or another.
Dr. Kara Fitzgerald: Okay, okay. So, in general, the trend is that it appears to, that bioidentical progesterone, is safer. What about bioidentical estrogens?
Dr. Michelle Violi: Right. So, with that, the bioidentical estrogen that’s used most often commercially is estradiol, and there have been studies where the topical estradiol was compared to the oral estrogen used, most often Premarin or synthetic estrogen, and then again, I’m not sure I would be able to cite specific studies, but I know that a couple of years ago there was a group that combined the studies that had occurred since early on in the 2000s and looked at all of them and found that there was less clot risk with the estrogens that were used topically as opposed to the estrogens that were taken by mouth. And I think it’s interesting to point out there that the Estrogens used topically were estradiol, it was bioidentical as opposed to perhaps the estrogens used by mouth, where there are many more synthetic estrogens or non-bioidentical estrogens used.
Dr. Kara Fitzgerald: Yeah, that is interesting. Are most of the bioidentical estrogen, progesterone formulas individual or together, you’re delivering topically, I’m assuming.
Dr. Michelle Violi: You mean, what do we compound most often?
Dr. Kara Fitzgerald: Yes. What do you compound most often?
Dr. Michelle Violi: Sure. So, I would say it’s pretty much half and half. We see the hormones used individually at first, when somebody is trying to find the right dose. Perhaps they would have a separate estrogen cream and a separate progesterone cream and they might titrate that a little bit to meet their symptom needs and then, once they find that dose, then it’s possible to combine that. And of course it’s easier to use a combined cream as opposed to having to measure out two separate creams.
Dr. Kara Fitzgerald: Mm-hmm (affirmative), sure. And generally speaking, would you say most prescriptions are topical or is there a time when oral might be used? Or one or the other or together.
Dr. Michelle Violi: Yeah. I don’t think that I would say the majority would be topical. We see a fair amount of sublinguals as well and even oral. The thing about the capsules that we make here, we suspend the hormone in oil inside the capsule and there was a study, years ago now, but it shows that the oil-based format actually allows the hormone to be absorbed into the lymphatic system.
Dr. Kara Fitzgerald: Oh, interesting.
Dr. Michelle Violi: …which bypasses the liver. Yeah, as opposed to going directly into the stomach and then going directly to the liver where it’s broken down by the first pass metabolism. And it’s thought that there’s some activation or stimulation of those clotting factors when something is going directly to the liver full force like that. And so, we do have a number of patients and practitioners that stick with the capsule form because it is in oil.
Dr. Kara Fitzgerald: Interesting. Wow. So, it might actually bypass first pass metabolism.
Dr. Michelle Violi: Right. At least to some degree.
Dr. Kara Fitzgerald: And I know for progesterone, there’s all this secondary, or really in some cases primary, benefit beyond just helping with classic hormonal symptoms. It’s an anxiolytic. It’s protective. It might have so many oxidants properties. Speak about that.
Dr. Michelle Violi: Sure. Yeah, progesterone, and I’m sure as your listeners know, as a woman, is progressing into perimenopause, it’s usually the progesterone levels that fall first because a woman misses ovulation, the corpus luteum doesn’t form. And so, usually those symptoms of perimenopause tend to be difficulty sleeping, anxiety, irritability, water retention, a lot of those things that you can draw back to progesterone deficiency. During perimenopause, often times, it’s a time of estrogen dominance and so the estrogen levels may not be exceptionally high and maybe they’re even a little bit low, but when compared to the balancing progesterone aspect, the estrogen is dominant.
And so when I think of progesterone symptoms, I tend to think of PMS or perimenopausal type symptoms. Progesterone tends to be the calming, soothing, relaxing hormone to balance estrogen’s more stimulatory energizing properties. And so, right, those would be the things that I would expect from progesterone.
Dr. Kara Fitzgerald: And that might be, to achieve some of those benefits, you would need to go orally versus topically or what?
Dr. Michelle Violi: Sure. Progesterone actually is, when it’s metabolized by mouth, it is broken down and some of those metabolites cause some drowsiness. And so, if somebody is having difficulty sleeping, I would suggest going with an oral dosage form relatively close to bedtime and that may actually help somebody fall asleep as opposed to just maintaining sleep like a cream dosage form may do.
Dr. Kara Fitzgerald: Now, do you guys … so, do you do the progesterone in that oil-based capsule that you were just talking about? Was that how you would deliver it? Where it’s absorbed into the lymphatics or would you want those secondary metabolites? So, do you want first pass metabolism?
Dr. Michelle Violi: Right. Well, yes. So, all that we do here are the hormones in oil inside the capsule. We actually don’t do any dry powder tablets or capsules. And right. So as I was saying, the majority of it is thought to go through the lymphatic system and bypass the first pass. But you are still sending that through the digestive system and so it’s going to have a different metabolism process than something going through the skin. The enzyme systems are going to be different.
Dr. Kara Fitzgerald: Yeah. That’s interesting. Okay, so you’re still getting the benefits. All right. So, topically there’s a lot of different ideas around where to apply it, the mucosa versus skin, wrists versus say inner thigh, rotating spots. What do you think? Michelle, does Women’s International have any kind of position on that? Or do they defer to the clinician? Or what are your comments?
Dr. Michelle Violi: Yes, good question. We actually tend to defer to the physician on that or the prescriber I should say, the practitioner. And what I can say though is that we’ve seen used pretty much everywhere. Thin skin, fatty tissue, the only place that we really wouldn’t want to see, say estrogen used is anywhere that it may make its way into the breast tissue. So, one prescription, I think, recommended to the sides of the chest and I did call and ask about that because that’s pretty close to the breast tissue. But yeah, in general, I would say thin skinned areas, to help with absorption, you wouldn’t want to put it somewhere that’s very rough or doesn’t have a good absorption capability, but as far as whether thin skinned or fatty tissue, I don’t think that it seems to matter very much. We’ve seen people have success either way.
Dr. Kara Fitzgerald: Okay. All right. I remember a friend of mine once suggested that you would get almost like a sustained release if it accumulated in the fatty tissue.
Dr. Michelle Violi: That’s interesting. As the hormones are produced by your own body, they’re moving through all of the tissues and there’s no reason that you should have any kind of an accumulation. If you’re having an accumulation, then that would indicate that the dose is too high for you. So, I hadn’t heard or even really run in …
Dr. Kara Fitzgerald: Okay. Yeah, this was during my residency. It just stuck out in my mind because we were always debating do you rotate, do you go to thin skin, do you go to different sites, do you stay in the same site. I mean, it’s sort of the perennial conversation for people prescribing bioidentical.
Dr. Michelle Violi: I wish I could give you a definitive answer. I do not …
Dr. Kara Fitzgerald: No problem. It’s a good answer. I probably, if I were you, I would probably just yeah, stay out of it and make the hormones. What about using mucosal delivery?
Dr. Michelle Violi: Oh, so say vaginal or even inside the mouth or…?
Dr. Kara Fitzgerald: Yeah. Mm-hmm (affirmative). Yup.
Dr. Michelle Violi: Yeah. So, inside the mouth is going to be similar to like a sublingual administration, where technically it should bypass the first pass through the liver as well. The sublingual route does. However, of course, if somebody is swallowing something that doesn’t have that oil buffer, they are still going to have some oral type effect in that respect. With regard to administering vaginally, we do see the hormones used vaginally, but mostly for treating that area specifically or trying to relieve symptoms in that area. I do know that some practitioners tend to use the vaginal route for systemic effect and I don’t have a lot of experience with that.
Dr. Kara Fitzgerald: Okay. Okay. Just actually as we’re talking about this, it’s occurring to me there are a number of either newly minted clinicians or seasoned physicians transitioning into functional medicine that listen to our podcast. As far as actually learning nuts and bolts of prescribing bioidentical, I know that you’ve got some nice resources on your site. Is that something that you can connect us with or do you have any thoughts on where to learn how to do this?
Dr. Michelle Violi: Absolutely. Yes. The Women’s International Pharmacy is very committed to education, in addition to of course compounding the medications. Our website has a lot of information on it and in fact, through our website, you’re able to sign up for our newsletter. We do put out an e-newsletter on a monthly basis with some topics involving hormones and I think that that’s a great way to get familiar with the hormones and what you might use them for and what not. Just kind of a nice little monthly reminder and update there. Additionally, Women’s International has pharmacists that have been on staff for a long time. Our cumulative knowledge here is very high and so we would invite any practitioner to just give us a call. We’re happy to brainstorm or if you just want to pick our brain or if you have a patient that you’re looking at and you’re thinking, okay well I want to accomplish this but what dosing should I start with? We are more than happy to help out in that respect.
Dr. Kara Fitzgerald: Okay, that’s great to hear. And again, we’ll just put your contact information up on our site, so folks can access it there. What about patients? If they’ve got questions on what they’re doing? Can they reach out to you as well?
Dr. Michelle Violi: They sure can and in fact, a lot of times we do end up speaking with the patient first. Where they’ll call and say, my best friend from book club is using your hormones, tell me about what I need to do to start this. She’s feeling and looking great. And so yes, often times we do speak with patients and we do have patient level information as well that we’re able to provide to them. And so, yeah sometimes patients bring that back to their practitioners and that’s kind of how the relationship starts.
Dr. Kara Fitzgerald: Okay good, good. What about, I want to ask you about testosterone and I also want to talk to you … well, I actually have a handful of other hormone related questions, but I’m curious too about testing. What do you think about testing? I mean, are you recommending that anyone using bioidentical get baseline and follow up? Are you recommending a particular form of test? Urine? Urine with metabolites? Blood, et cetera? I mean, what do you think about that?
Dr. Michelle Violi: Yes. Testing, that’s a big issue or a big topic I should say. And I think maybe the one that has changed the most throughout the years that I’ve been here at Women’s International Pharmacy. I’ve been here for almost 20 years and when we started, it was all blood testing and 24-hour urine testing and then saliva testing became more popular and then practitioners were starting to see that if their patients were using topical dosage forms that the saliva test results weren’t really pairing with what they were seeing for symptoms. And now I know that there’s a blood spot test that’s available. However, the research supporting that and the results there are a little bit new and a little bit uncertain.
So, I guess my baseline comment on testing is the patient’s symptoms are the most important and so, while it might be helpful to get a baseline test just to see if something is way out of whack, if you’re a working with a postmenopausal woman, you can likely assume that their estrogen and progesterone levels are low. And then based on that, starting with an average dose and looking at their symptoms, it’s really important to not get too wrapped up in the testing I think. It’s a useful tool but we often have patients or practitioners that do a very thorough test on the patient or the patient brings it to us and say, what dose do I need? Look at my test and the answer is, well how are you feeling? And so, as far as testing, I guess what I would say is that it could be a useful tool, but I think it can be easy to get wrapped up in it and think that that’s going to give you the final answer and it really doesn’t.
Dr. Kara Fitzgerald: Yeah. Right. Right. It does ultimately come back to how our patients are feeling. I would say that one of the best uses for testing, in my experience and opinion, would be looking at metabolites and making sure their clearing estrogens as cleanly as possible.
Dr. Michelle Violi: Yes. Yep. That makes sense. I think that’s a great idea and perhaps considering some DIM or ITRIC or if you’re seeing those carcinogenic metabolites elevated.
Dr. Kara Fitzgerald: Yeah, exactly. So, testosterone, what are your … I’m sure that you’re compounding up a whole lot of it and just speak about that and its role in women’s health and how you’re preparing that, how you’re compounding testosterone commonly.
Dr. Michelle Violi: Sure. So most often for women, we do compound for men as well and we do compound a fair amount of topical testosterone for men. For women I would say that we see topical and oral capsules used most often. Trying to obtain just a consistent blood level with a consistent dose using a certain amount per day is really something that we’re used to seeing. We see dosing anywhere from, it’s very interesting the dosing range is quite wide for women and I think that that probably has something to do with varied absorption capabilities, but we see anywhere from maybe a quarter of a milligram up to 10 milligrams a day on average. And so, I mean that’s a really big range. Also, we see testosterone used kind of on a PRN basis in a vaginal cream to be used genitally prior to sexual activity. We see patients using it that way. And also, maybe combining a little bit in with a vaginal cream to help with the muscles in that area, perhaps thinking in terms of urinary symptoms or prolapse.
Dr. Kara Fitzgerald: Yep. That’s great. Yeah. I think that that can be extremely useful. You just mentioned absorption and again, sorry folks I keep parqueting back to the teach-in that we had, you mentioned, well I’ve got two questions on absorption, I don’t want to forget about. One is that, in your experience, it’s extremely variable. So, are there any conditions that you’re more likely to see absorption issues, both orally and topically? Like, what would you say about that? And then I also want to just highlight the fact that you mentioned absorption and hypothyroidism on our teach-in, I just want you to talk about that again, so sort of big picture when we’re concerned about absorption and then hypothyroidism.
Dr. Michelle Violi: Absolutely. Yeah. So, let’s start with oral. The big topic of the week I guess, or of the year, is the microflora and the microbiome in the gut and making sure that that’s healthy, making sure the gut is healthy as kind of the seats of our immune system, making sure that that we’re not experiencing a leaky gut situation which of course leads to all kinds of inflammation and allergic type responses and if somebody doesn’t have a healthy gut, go figure they’re not going to absorb things orally very well. Nutrients from their food but also oral medications and hormones as well.
So, if somebody is really struggling with a gut dysbiosis or gut health, I would recommend going toward the topical route or even sublingual or vaginal suppositories, but avoiding the oral route. And then in regard to topical absorption, as you mentioned, there are various things that can affect the absorption of things through the skin, just having rough dry skin is going to make the skin less likely to take up the hormones. And one way that that can happen is if somebody is dealing with hypothyroidism. Of course, dry skin is a symptom of hypothyroidism, they’re also dealing with the mixed edema of the tissues and just in general, I would say that if I’m working with somebody that has hypothyroidism, it doesn’t seem like their topical absorption is as good.
Dr. Kara Fitzgerald: Mm-hmm (affirmative). Interesting. So hypothyroidism, or Hashimoto, autoimmune hypothyroidism often comes with gut issues as well. We see the gut involvement. So, in those cases, you might just deliver it sublingually or intervaginally?
Dr. Michelle Violi: That’s possible. Or I guess I would just try and see what works best for them. As they’re using the hormones, the hope is that they’re also addressing their health in other ways as well.
Dr. Kara Fitzgerald: Yes, and currently. That’s right.
Dr. Michelle Violi: And so, right, right. So, if the hormones are just one part of the picture, hopefully as their gut becomes healthier, perhaps they’ll absorb better and they’ll experience more benefit from the hormones.
Dr. Kara Fitzgerald: Yeah. Okay. Okay, good. All right. What else? What are some of the other common uses of bioidentical? Besides testosterone, estrogen and progesterone.
Dr. Michelle Violi: Sure. Yeah, so I think it’s important to note that when people think of hormones, often times they think, ‘oh menopausal women, they need hormones, they’re not making them anymore.’ But, I think that it’s good to consider all ages and all situations where hormones may be important. We start sometimes in very young children with vaginal or labial adhesions. Certainly PMS, we see women using the hormones to address that. Moving onward, certainly menopause and whatnot, but there are different conditions throughout. Branching out into like the luteal phase defect situation in fertility, certainly for men dealing with andropause. I think it is just important to consider that when you’re looking at condition, perhaps there’s a hormonal component.
Dr. Kara Fitzgerald: Right. Yes. I would say that that’s a good chance. That’s a good chance. I mean, just thinking about, again we were discussing HPA imbalances, the classic adrenal fatigue today, where for whom isn’t that an issue. We’re all on this continuum to one extent or another. You mentioned two books I just want to bring up, let’s talk a little bit about actually going back to the idea of adrenal fatigue or HPA imbalance, the James Wilson book and the William Jeffries book you mentioned, I’ll put links to these in the podcast, but just talk about treating with Cortisol.
Dr. Michelle Violi: Sure. So, as a body becomes fatigued and as I mentioned during my teach-in this morning, we live in a high paced, stressful world. All of us are expected to multitask and to complete maybe more than our bodies ever should, but it can be fulfilling as well, but I think it’s interesting that as somebody pushes themselves like that, something has to give and often times that’s their adrenal glands. Their adrenal glands produces the DHEA and Hydrocortisone and those are the hormones that keep you going during times of stress. And eventually, the adrenal glands may say, ‘I’m done, I am exhausted, you’ve put me through enough.’ And so at that point, it can be helpful to supplement with DHEA and also with a small amount of hydrocortisone.
Usually what we see is the hydrocortisone is administered to mimic what the body does naturally, which of course is the peak in the morning and then the slow drop throughout the day. Often times, people with adrenal fatigue have a lower peak or no peak or if they do have that peak, it drops pretty much immediately from there. And so, just kind of evening out or mimicking that curve can be helpful to provide the person the opportunity to heal. And I think that’s important to point out too. The hydrocortisone can help them heal but it’s really their body that needs to do the healing. This is providing them an environment under which they can step back and allow the healing process to begin. It’s not necessarily the hydrocortisone itself that provides that healing.
Dr. Kara Fitzgerald: Mm-hmm (affirmative). Yeah. And it sounds like a lot of the clinicians that you’re working with are doing a full, they’re working with the whole person. They’re not just providing symptom relief with hormones. They’re doing the underlying work with the person. Would you say that that’s true, that that has happened? In your 20 years time, has there been more of a movement to treat the whole person or has that always been the case?
Dr. Michelle Violi: Yes. I would say that there has always been, well especially me being here at a compounding pharmacy where we focus on the individual. However I would say that throughout the years we’re seeing more and more of that from more and different types of practitioners. So, that’s wonderful to see.
Dr. Kara Fitzgerald: Yeah. Right. It is neat, I know and you’ve brought it up a number of times how essential it is. What would be the classic prescription when using hydrocortisone and having it track with the rhythm of the body? What would that look like?
Dr. Michelle Violi: So, Dr. Jeffries would recommend 5 milligrams four times a day and his thought is that you’re still having that curve and so, basically you’re just lifting that curve a little bit by giving a baseline dose. However, we do see other practitioners maybe doing a 10 milligram in the morning and then a five and then a 2.5, maybe for patients that don’t even have that curve because their adrenals have been so exhausted. I would say that there’s not one way to do it. I’ve seen success in both respects.
Dr. Kara Fitzgerald: Now is that in a capsule? Is that the common way that it’s delivered or do you ever do it in a suspension? I mean, how is hydrocortisone delivered?
Dr. Michelle Violi: Most often it would be in the capsule form just because it’s easy, you’re doing this four times a day. It’s pretty hard for people to administer any dosing four times a day and so most people do prefer the capsule. If they would prefer an under the tongue route, the nice thing about the capsules is they’re gelatin, we also have vegi capsules available, but either one would just dissolve under the tongue and you could use it that way. So, it’s nice and easy. We have seen creams used in the past, but that’s pretty unusual. It’s usually by mouth.
Dr. Kara Fitzgerald: Okay. Okay. Well, let’s see, what other questions do I have for you? Thyroid. I mean, you’ve got to be doing loads of thyroid, talk a little bit about that.
Dr. Michelle Violi: Sure. So, as I mentioned this morning in the teach-in, there are two different routes to go with thyroid. We have the individual hormones, the T3 and the T4, that we can compound with and then on the other side, there is porcine thyroid which is basically taken from the thyroid gland of the pig. The porcine thyroid contains T3 and T4, as well as the other thyroid factors. So, it’s been beneficial for many people that there are other thyroid factors involved. However, the dose can be increased up or down but the ratio between the T3 and the T4 can’t be changed. And so that’s why some people do go with the T3 and the T4 in a capsule form. Say somebody is using 50 micrograms of T4 and 15 micrograms of T3 and the practitioner decides, well we need to go up to 20 micrograms of T3, we can make that adjustment when we’re using the individual hormones as opposed to the porcine related hormone.
Dr. Kara Fitzgerald: I know you’ve seen what the answer is to this because I’ve seen it in my practice. I mean, some people are sensitive to some of the additional variables in the porcine glandulars.
Dr. Michelle Violi: Yes. Yes. That is very true.
Dr. Kara Fitzgerald: Yeah. Right. All right. So, what about DHEA, pregnenolone? I mean, any other hormones that you’re using pretty routinely?
Dr. Michelle Violi: Yes. The pregnenolone and the DHEA, I would say are most often used together with the other hormones as kind of a balancing hormone. Perhaps you might see a cream that contains a [inaudible] which might be estradiol and estriol and progesterone and testosterone with a little bit of DHEA and pregnenolone thrown in. I would say that’s the most common way that we see it. We do also see DHEA used alone in capsule form or cream form. There are studies indicating that much higher dosing of DHEA may be helpful with certain types of autoimmune disease, specifically Lupus. And so, sometimes we’ll see doses of DHEA 100 or 150, but usually those are for pretty specific circumstances.
Dr. Kara Fitzgerald: Yeah. Right, right. And we do see side effects sometimes.
Dr. Michelle Violi: Right. Right. Definitely. Just like any other hormone, the DHEA, if you’re getting too much can have adverse effects or if you’re getting too little, you’re not going to see benefit. There’s a sweet spot there for each of the hormones.
Dr. Kara Fitzgerald: All right. Well, we’re coming to the close of our time together. It’s been really helpful and I know that there are clinicians and patients or just consumers alike listening and wanting more information, just really wanting to get into prescribing bioidenticals and wanting just the nuances of how to talk to our patients about it, how to prescribe the right form, how to track for symptom resolution or excess and Women’s International can help with all of that. And do you have just comments on next steps for folks here listening today?
Dr. Michelle Violi: Sure, absolutely. I would say get in touch, just give us a call or check out our website, that’s a really good place to start. As I mentioned, there is a lot of really good information there about the hormones, about various things that involve the hormones regarding conditions and whatnot. So, check out our website and when in doubt, give us a call and speak with a pharmacist.
Dr. Kara Fitzgerald: That’s really terrific, Michelle. Thank you so much for joining me on New Frontiers today and I can’t wait for this legislation to just go through and you guys are able to just get on with your good work. And I’m sure that we will be talking again soon.
Dr. Michelle Violi: Wonderful. Thank you so much for having me Dr. Fitzgerald.
Dr. Kara Fitzgerald: Absolutely.