Optimizing Urological Care With Compounding: Insights, Applications & Access

[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.

[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.