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Optimizing Urological Care With Compounding: Insights, Applications & Access

Author Devante Delbrune covers Optimizing Urological Care With Compounding: Insights, Applications & Access on BackTable Urology

Devante Delbrune • Aug 3, 2023 • 37 hits

Urological care is expanding with the integration of compounding, a unique approach offering tailored therapies designed to improve patient outcomes. This approach shines in its adaptability, from allergen modifications to changes in administration routes. The various benefits to utilizing compounded medications in urologic practices can include increased patient satisfaction, treatment efficacy, and versatility. Compounding’s versatility is best illustrated through the utilization of medication Edex, an Alprostadil-based product utilized for treating common urologic conditions such as erectile dysfunction, fertility and testosterone-related issues. Compounding medications require close follow up and clear patient communication. Although compounding medications are relatively new, there are user-friendly and compounding-focused pharmacies providers can access for these medications, such as ReviveRX.

This article features excerpts from the BackTable Urology Podcast. We’ve provided the highlight reel in this article, but you can listen to the full BackTable Urology podcast below.

The BackTable Urology Brief

• Compounded medicines can be personalized to remove allergens or preservatives, to alter administration routes, or to add additional therapeutic agents.

• Compounding may provide a viable alternative when insurance coverage for certain drugs is unavailable.

• Compounded ICI injections can provide enhanced vasodilatory effects through the addition of substances like papaverine.

• Freeze-drying, or lyophilization, stabilizes compounds and allows for greater flexibility in transportation and storage as well as reducing the risk of product degradation.

• Insulin was reclassified as a part of an FDA initiative to reduce costs, and because HCG shares a similar peptide chain structure, it too was reclassified as a biologic. This has adversely affected access to many common compounding solutions.

• Many pharmacies have stopped producing HCG due to financial constraints, sourcing difficulties, and new facility requirements

Optimizing Compounded Medication Drawing

Table of Contents

(1) Exploring the Role of Compounding in Urology

(2) Utilizing Compounding in Urology: Patient Communication and Enhanced Customization

(3) Navigating Regulatory Shifts: The Reclassification of HCG and Its Impact on Compounding

Exploring the Role of Compounding in Urology

Compounding in urology emerges as a potent tool to address unique patient needs and overcome limitations of commercially available treatments. By altering, adding, or removing certain ingredients, compounding allows for the customization of medication to improve patient outcomes. Key examples include modifying allergens, preservatives, and administration routes. Alprostadil-based product, Edex, provides a compelling illustration of the utility of compounding. While Edex serves many patients, compounded intracavernosal injections (ICI) often prove more effective, tailoring to the patient's specific requirements with added vasodilatory mechanisms. Likewise, compounding finds use in addressing erectile dysfunction, fertility, and testosterone-related issues, where insurance coverage is often lacking. The real-world experiences of practicing physicians underscore the value of compounding, as they leverage it for improved treatments, cost-effectiveness, and patient satisfaction.

[Aaron Schneider, Pharm D]
The practice of compounding really in terms of how it applies to urology specifically is as a practice it creates unique patient treatment options that fit a specific patient's need or removes a barrier that the current commercially available product might have for a patient. This may mean removing the allergen or the ingredient that may cause that allergy reaction. Changing a preservative perhaps, or changing the route of the administration of that product. Perhaps changing it from an injectable to a topical application. Removing a dye or ingredient, removing a problematic preservative. Compounding in urology is important, because many compounded pharmaceutical treatments developed for urology provide a greater benefit to the patient than the commercially available product.

As an example, Edex, which is one of the more well-known products that has a comparable compounded formulation. Edex is, the active ingredient is alprostadil. Alprostadil is not as effective for most patients as a compounded ICI injection might be. ICI injections can be unique to that patient's need. ICI injections, also known as trimix or bix injections that are common compounded terms for those types of injections. Compounding in that case enhances the treatment by the addition of additional vasodilatory mechanisms. In some formulation that addition of let's say papaverine helps with smooth muscle relaxation and can provide a more effective treatment than the commercially available product. The list of opportunities for compounding in urology as well as other specialty areas really goes on and on.

[Dr. Jose Silva]
Aaron, in your pharmacy do you do a lot of ED or more testosterone related issues?

[Aaron Schneider, Pharm D]
A mix. We do a lot of both. Our primary focus since 2016 has been the focus of urology. We recognized early on that there was a specific need for urology and that a lot of the treatment options aren't covered by insurance. Many of them require unique formulations that are specific to those patients need. We do a lot of testosterone. We do a lot of fertility and maintenance of fertility drug products. We do a lot of erectile dysfunction as well. Really, anything that compliments urology, we've touched on it at some point if the application is necessary or perhaps there's a back quarter of need with a commercially available product.

[Dr. Jose Silva]
Jordan, how about in your practice do you use compounding for all these issues?

[Dr. Jordan Grant]
Yes, I use it all the time actually. I write for compounded prescriptions daily. I've been out of training almost seven years I guess out of residency. When we were in residency I didn't get any exposure to compounded medications. You hear about it, but there was kind of some stigma associated at that time. When I got out in the "real world," I worked in Shreveport, Louisiana for two years and the docs there were using compounded left and right, and man, it was great. I get to start exploring options for alternative options for especially, testosterone creams that the guys didn't want to do, injectables. There were some local compounders there at Shreveport and started doing that. Cialis wasn't generic yet, so they were doing the troches and those kind of things. That was a game changer for those guys especially like Aaron was saying, the intracavernosal injections.

Bimix, Trimix, Quadmix, that's a lifesaver to have that as an affordable option for these guys who-- I remember being a residency at the VA part-time and they'd give them four Edex. That was it. That's all you got. It was four. I think they come in the pre-packaged dose. That's what you get. It's really nice to have that option. Now I prescribe Trimix all the time. I prescribe testosterone from Revive all the time. Actually, they've got a great compounded testosterone in grape seed oil, which is a lot smoother. I have patients that have had weird reactions to the commercial oils, either the oils or some preservative in there, we'll switch them over to Revive, Grapeseed and a lot of their little acne and just weird things, they have it will clear up.

Listen to the Full Podcast

Integrating Compounding Into Your Practice with Dr. Jordan Grant and Aaron Schneider, PharmD on the BackTable Urology Podcast)
Ep 87 Integrating Compounding Into Your Practice with Dr. Jordan Grant and Aaron Schneider, PharmD
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Utilizing Compounding in Urology: Patient Communication and Enhanced Customization

Frequent issues encountered with compounding medication are insurance coverage and standard dosages.These are optimally addressed through open discussions with patients. From a technical standpoint, compounding medications can adjust not only the primary ingredients, but also the carriers and preservatives used, ultimately increasing patient compliance. Common carrier adjustment examples are freeze-drying or lyophilization to stabilize compounds, allowing for greater flexibility in transportation and storage. Although these advancements are impressive, patient education and follow-up play the largest role in ensuring successful outcomes.

[Dr. Jordan Grant]
It's very difficult. I have that conversation every day. I have to warn them, you want your insurance to cover this, number one, they may not do it, because your levels are "Normal" for what they need. Which I don't base things off the normal range for the most part. Number two, the most local pharmacies now require patients to get the small 1 milliliter vials instead of the 10. Now some guys, like in where we are in Paris, a lot of the local pharmacies still will give the 10CC vials or more smaller pharmacies and stuff.

[Aaron Schneider, Pharm D]
There's a couple areas or a couple factors that you pointed out regarding specific formulations in terms of testosterone using a Grapeseed formula versus a commercially available option. I think there's a misconception around whether or not there's a true allergy to Grapeseed oil or in fact it could be the preservative. Grapeseed oil has less of a viscosity than cottonseed or sesame oil that would be in the depo-testosterone you would find at a Walgreens or a CVS or a Walmart versus a compounded formula that has a grape seed.

In terms of unique products as well as in terms of compliance and really focused on building good quality products here at ReviveRX, one of the things that we've identified is that more often, the allergy associated with the injectable testosterone is not the oil, but it is a preservative. That's another unique aspect of compounding where we can also pivot a patient to, let's say, testosterone enanthate that uses a different preservative than one that is compatible with testosterone cypionate. More often than not, we see that allergy-related reaction go away when we do that transition from cypionate to enanthate, because of the preservative change. There's a lot of unique opportunities to serve that patient with compounded products.

[...]

We do a unique form of compounding that includes freeze-drying or lyophilization. That process removes the moisture or water from that product. It can ship in various temperature changes without impacting the efficacy of the product. Not only does it help from a cost standpoint, we can produce more vials and keep them ready to ship on the shelf versus your traditional format for a pharmacy making pre-mixed formulations that require the product to be frozen or refrigerated. The moment that product is mixed, you have a timeline that generally starts where that product begins to break down. You start to see a significant breakdown in that product once it's mixed around 30 days refrigerated. If you freeze it, you can sometimes extend it to 60 days. The uniqueness to our product being freeze-dried, the patient will receive a kit to mix it. In terms of freeze-drying it, we can ship with USPS, you can buy multiple vials, you can travel with it without worrying about the temperature change or shipping it on ice. Easy for someone to take in a carry on and get to their destination and mix it. Once it's mixed, we recommend refrigeration, but it's allowed us to help provide a better customer-consumer experience by being able to readily ship a product and then not have to worry about coordinating the pickup of the product.

The last thing I'll say about that process is really that stability factor has resulted in far fewer issues of priapism, because the variability of most compounding pharmacies if you're not freeze-drying it, you as a patient or you as a provider don't know at what point it was made. Perhaps, the patient is now receiving that medication 14 days after it's been made and in a freezer. That product is now degraded a percentage over time, because it's been made and now frozen. Perhaps, if you did a trial in the office or maybe you changed pharmacies, you may notice that there is a difference in the efficacy or let's say impact of that drug product based on when it was made versus when the patient received it.

Whereas, with freeze-drying, it's 100% efficacy at the time in which it's mixed, because that water's been removed within minutes or it's gone into a holding pattern where, over time, that water's been removed within a matter of hours and it doesn't impact the quality of that product. It's in a dry powder format. The patient receives it with a bacteriostatic water vial mixing instructions and then dosing instructions. Our current priapism rate is less than 0.001% of the total dispense vials of product that we've made over the last six years.
[...]
The few cases that ended up in priapism that were significant, it was because the patient didn't follow our instructions, but we can offer that if necessary. I think today we have a total of about five cases over the last six years of priapism that resulted in some type of emergency room visit, urgent care visit, or late phone call to one of our pharmacists.

Navigating Regulatory Shifts: The Reclassification of HCG and Its Impact on Compounding

The realm of compounding medication is ever changing, and concern for misuse comes with increasing legislative regulations for manufacturers to follow. A recent piece of legislation passed by the Food and Drug Administration (FDA) in 2013 to reclassify insulin, and thereby reduce insulin cost for consumers, inadvertently reclassified HCG and other fertility medications as biologics. They were placed together due to their similar peptide chain structures and molecular origins. This change imposed prohibitions on compounding materials due to the difficulty of pharmaceuticals meeting the new specific facility requirements for hazardous material handling. As of 2020, HCG, a previously over the counter fertility medication, was placed under stringent guidelines affecting access for both compound facilities and patients.

[Dr. Jose Silva]
Jordan, you mentioned HCG and FSH. There's been notorious that some companies are not doing it. Aaron, what do you have to say about that?

[Aaron Schneider, Pharm D]
In 2013, the FDA came up with a plan to reduce the cost of insulin and not intentionally to create an impact of re-classifying HCG or any of these fertility medications. The FDA's position is not to impact the economy or the financial means of affording a medication. Their primary role is to protect the public, to make sure that facilities who are producing pharmaceuticals or even supplements are operating in a way that follows good manufacturing practices to make safe and effective products for the public, not to design a path for a way to manipulate the market to reduce the cost of a drug.

They just decided that they needed to reclassify insulin as a biologic. At the time insulin was insulin, it didn't really have a drug category. You had insulin-like products and you had insulin. Those were two different categories. In order for them to create a path for insulin to be under the umbrella of biologics manufacturers that would hold a registration to do so or manufacture with a biologics registration, they reclassified insulin. They created a way to bridge insulin into that category and essentially defined it as a material that was of animal origin or human origin of a certain peptide chain based on its molecular structure.

That loose classification whether it was on purpose or an accident looped in all these other drugs with a similar qualification, and unfortunately, that included HCG, that included FSAs, so included gonadorelin, menotropins, other drug products, and they seemingly most of them fell into the fertility category.

The reason that biologics are really prohibited or that classification prohibits certain types of compounding, is because they want to protect the people who are manipulating the product. They're not really focused on what happens to the end user, because once the end user is using it the expectation is that they're the ones that need it.

The FDA defined that in 2018 even before that memorandum was released, which is included in the reference document of mixing, reconstitution, and diluting of biologics for the purpose of compounding. It's a reference document, you can pull down from the FDA's website.

In 2020 when this came to light, we recognized where we had a significant patient need, we were following all the necessary steps to continue to compound it and compounded pursuant to the FDA's recommendations. What's challenging, I think for a lot of urologists that come to us or have found us by way of knowing that we're still offering that product compounded when we can and the commercial available is not able to be dispensed, they're confused, because they've likely heard from another pharmacy that the FDA told them they couldn't.

The FDA visits facilities and they do a risk assessment based on what product they're producing and perhaps can they maintain the FDA's recommendations for how to produce a product or how to provide the supportive documentation for the ingredients they're using to compound with. If there's questions around whether or not the sources were capable of producing a safe and effective product or perhaps using an unregistered source for material or just not following the process that is defined in that guidance document brings a question.

It's recognized as safe given it's status as a biologic, it's considered a hazardous material, which is the other area where it made it difficult for compounding pharmacies to produce. If you're going to categorize it as a hazardous material, there are some compounding regulations and requirements that require your facility to be set up to produce it in the first place. There are facilities that likely didn't want to make the investment for one product to accommodate that reclassification. You need a hazardous compounding area, which is a negative pressure room to accommodate that type of material for compounding. If you don't have that type of environment and really that environment is designed to protect the individual compounding with the material, if you don't have that type of environment, it then opens you up to state regulatory guidance.

Podcast Contributors

Dr. Jordan Grant discusses Integrating Compounding Into Your Practice on the BackTable 87 Podcast

Dr. Jordan Grant

Dr. Jordan Grant is a practicing urologist in Paris, Texas.

Aaron Schneider, PharmD discusses Integrating Compounding Into Your Practice on the BackTable 87 Podcast

Aaron Schneider, PharmD

Dr. Aaron Schnieder is a pharmacist and co-founder of ReviveRX.

Dr. Jose Silva discusses Integrating Compounding Into Your Practice on the BackTable 87 Podcast

Dr. Jose Silva

Dr. Jose Silva is a board certified urologist practicing in Central Florida.

Cite This Podcast

BackTable, LLC (Producer). (2023, March 15). Ep. 87 – Integrating Compounding Into Your Practice [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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