THE PCCA BLOG

How to Establish Yourself as a Men’s Health Consultant

Wed, 22 Jan 2020 18:52:35 GMT

By Bruce Biundo, RPh, FACA, PCCA Clinical Compounding Pharmacist

Where do your male patients get their information about testosterone? About prostate health? About supplements that may help them? From my own observations, many are hearing about these things from ads running on sports talk shows, the internet or other non-medical sources. Listening to and reading some of these advertisements, I see how many men can form unrealistic notions of what “natural testosterone boosters” can do for them, or even what the appropriate and expected benefits of testosterone itself would be. And how about your physicians? While many of them are interested in helping these male patients, they may find it difficult to keep up with what you, the pharmacist, can offer them in terms of treatment options, such as who is a good candidate for testosterone, who is not and what kinds of dosing options you can provide.

Very importantly, you are likely interested in how you can initiate or increase these services to help your pharmacy improve profitability in these challenging times. As a former independent pharmacy owner myself, and longtime community pharmacist, I am very interested in helping you help your bottom line by becoming more established as a men’s health consultant. So let’s take a look at what is involved.

Have Men’s Health Information Readily Available
There are numerous sources of useful information that can help your male patients become more knowledgeable about men’s health issues. A couple books that can be very helpful are Testosterone for Life, by Abraham Morgentaler, MD, and Saving Your Sex Life, by John P. Mulhall, MD. These can be great references for you and your patients. I also find the monthly magazine Men’s Health often provides useful, up-to-date news that both you and your patients can find beneficial. With either the books or the magazine, your male patients will likely become better informed and more interested in what your pharmacy provides.

Offer Private Patient Consultation
Well-established by many pharmacists over the past 20+ years, a private consultation can be a key component in your practice. You should have an appropriate setting for this, preferably a private room, which enhances the patient’s comfort level. You should also charge appropriate professional fees for this service — for example, $60–$100 for a 20–30 minute session, more for consults lasting up to an hour. It is not uncommon for consultation fees of $175–$200 for those of sufficient skills. If you do this on a regular basis and become proficient at it, private consultations can become a lucrative part of your practice.

A typical session could include a brief discussion on testosterone, a review of the patient’s laboratory values and then a walk-through of the patient’s screening form, which he would have previously filled out. During this time, the patient will be free to ask questions on the topic, and in this environment, you, the pharmacist, can satisfy the concerns expressed. The consultation concludes with you making a therapeutic recommendation to the patient’s physician and, often, a specific recommendation to the patient for nutritional supplements. These supplements, of course, are items that your pharmacy could offer, so the patient would be able to get exactly what you recommend.

Offer Nutritional Supplements
There are many excellent products out there that are very helpful, but I want to mention three specific nutrients that appear to be particularly useful relative to male hypogonadism, or low testosterone: magnesium, vitamin D and zinc. A study showed that magnesium supplementation increased free and total testosterone, with even higher increases in men who supplemented magnesium and exercised regularly.¹ Another study showed an association between vitamin D levels and testosterone levels (i.e., men who had low vitamin D levels frequently also had low levels of testosterone).² Other articles have shown the same association. And lastly, researchers have correlated zinc status with testosterone levels; specifically, low zinc levels correlated with low testosterone levels, and restoration of the zinc deficiencies restored testosterone levels.³

Wellness Works offers professional-quality nutritional supplements for pharmacies to offer their customers, including magnesium chelate tablets, magnesium glycinate powder, vitamin D softgels, zinc monomethionine tablets and zinc lozenges.

Keep up with Testosterone Supplementation Updates
The use of testosterone by injection has been long studied; what is newer is the interest in subcutaneous injections of testosterone. An article by Kaminetsky, Jaffe and Swerdloff revealed that patients obtained consistently high levels of testosterone with 100 mg subcutaneously, as contrasted with the bi-weekly intramuscular (IM) dose of 200 mg. They cited patient comfort and convenience as advantages over the more conventional IM dosing.⁴ Subcutaneous dosing has become much more common in recent years, and may be an excellent alternative to IM injections.

At PCCA, we get many calls on sublingual dosing of testosterone as well, and it seems to be increasing in preference compared with the past use. Sublingual dosing has unique characteristics. Because of the rapid absorption and relatively short half-life of testosterone, it is best done several times a day at doses of 15–25 mg, as opposed to high doses once a day. The difference can be readily seen in measured hormone levels: high doses produce very high testosterone levels, but for relatively short periods of time. Better to do a lower dose several times a day, as that will be more like the body’s usual production than the high, once-a-day dose. PCCA members can see our recommended dosing-range chart for various dosage forms.

However, do you give testosterone to all men who are clearly symptomatic and low on measured levels? No. Consider the age of the patient, and inquire as to his desire to maintain fertility. Testosterone supplementation can definitely suppress spermatogenesis, resulting in decreased fertility. Consider clomiphene for those men who are low in testosterone but want to maintain fertility.⁵ Another useful agent is anastrozole, widely used as an aromatase inhibitor, which can block the production of estrogen. Given the strong influence that estradiol has in the production/suppression of the messenger hormone responsible for testosterone production, anastrozole has also shown to be somewhat useful in increasing the production of testosterone in many men.⁶ It may be considered as an alternative to clomiphene in that regard.

PCCA members with Clinical Services access can view related testosterone formulas in our database, including some in Atrevis Hydrogel®.

Develop Collegial Relationships with Physicians
This is probably the most important part of establishing yourself as a men’s health consultant: forming and maintaining professional, mutually beneficial relationships with physicians and other health care providers who are interested in working with you in caring for patients. Fortunately, doctors want your knowledge, your skills and your ability to offer useful solutions to their patients’ needs. And we help PCCA members by offering treatment options, treatment documents and up-to-date information, all of which they can share with practitioners. PCCA members can see our concise yet wide-ranging Male Hypogonadism Packet for discussion of what is involved in treating male patients with low testosterone.

I advise PCCA members to also look at our newly revised Men’s Health Reference Guide, which meticulously indexes and provides links to abstracts for over seven hundred clinical articles. I think they will find it a valuable resource for their toolkits.

Finally, always remember that we are just one call away for PCCA members with Clinical Services access. For questions, they can contact our team of clinical compounding pharmacists at 800.331.2498.

Bruce Biundo, RPh, FACA, PCCA Clinical Compounding Pharmacist, joined the PCCA staff in 1997 after many years as a community pharmacist. In 1998, as PCCA was beginning to develop educational seminars, he realized that there wasn't much focus on men and testosterone issues, and began research on the subject. In April 1999, Bruce presented what is likely the first educational event on low testosterone in men at the PCCA International Seminar. Over the years, he has made presentations at dozens of hormone seminars to physician groups locally and internationally, and has many articles published, mostly dealing with men’s health. In addition, he was a contributor to Remington: The Science and Practice of Pharmacy, 22nd edition, and is the co-author of the nutrition chapter in Aging Men's Health.

A version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

References

Cinar, V., Polat, Y., Baltaci, A. K., & Moqulkoc, R. (2011). Effects of magnesium supplementation on testosterone levels of athletes and sedentary subjects at rest and after exhaustion. Biological Trace Elements Research, 140(1), 18–23. https://doi.org/10.1007/s12011-010-8676-3
Lee, D. M., Tajar, A., Pye, S. R., Boonen, S., Vanderschueren, D., Bouillon, R., … Wu, F. C. (2012). Association of hypogonadism with vitamin D status: the European Male Ageing Study. European Journal of Endocrinology, 166(1), 77–85. https://doi.org/10.1530/EJE-11-0743
Prasad, A. S., Mantzoros, C. S., Beck, F. W., Hess, J. W., & Brewer, G. J. (1996). Zinc status and serum testosterone levels of healthy adults. Nutrition, 12(5), 344–348.
Kaminetsky, J., Jaffe, J. S., & Swerdloff, R. S. (2015). Pharmacokinetic profile of subcutaneous testosterone enanthate delivered via a novel, prefilled single-use autoinjector: A phase II study. Sexual Medicine, 3(4), 269–279. https://doi.org/10.1002/sm2.80
Moskovic, D. J., Katz, D. J., Akhavan, A., Park, K., & Mulhall, J. P. (2012). Clomiphene citrate is safe and effective for long-term management of hypogonadism. BJU International, 110(10), 1524–1528. https://doi.org/10.1111/j.1464-410X.2012.10968.x
Leder, B. Z., Rohrer, J. L., Rubin, S. D., Gallo, J., & Longcope, C. (2004). Effects of aromatase inhibition in elderly men with low or borderline-low serum testosterone levels. The Journal of Clinical Endocrinology & Metabolism, 89(3), 1174–1180. https://doi.org/10.1210/jc.2003-031467

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment.

Compounding Update: HCG

Wed, 08 Jan 2020 19:07:47 GMT

By Matt Martin, PharmD, PCCA Clinical Compounding Pharmacist, and Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development

The FDA has provided a preliminary list of products that were originally approved as drug products, but that will be considered biologic products as of March 23, 2020.¹ Human chorionic gonadotropin, or HCG, is one of these drugs that will now be deemed a biologic product. This means that, starting on March 23, 2020, pharmacies will no longer be able to compound with HCG, and we will be retiring all PCCA formulas that include it at that time.

Background

“Drugs” are generally approved under Section 505 of the Food, Drug, & Cosmetic Act (FD&C Act) while “biologics” generally receive a biologics license under Section 351 of the Public Health Service Act (PHS Act). Traditional pharmacies compounding medications and dispensing them by prescription are considered 503A pharmacies under the FD&C Act. While Section 503A of the FD&C Act provides pharmacies some exemptions, it does not provide an exemption from requiring approval for a biologics license under Section 351 of the PHS Act — meaning that pharmacies cannot compound with biologic products.² You can read more about this framework in the FDA’s guidance document titled “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.”

Potential Compounding Options

However, compounding is about attempting to solve the needs of patients through innovation in a partnership with the patient and their practitioner. For PCCA members with Clinical Services access, our team of pharmacists are ready to help examine formulations in our database and evaluate if they might be appropriate for patients.

With that in mind, we have a number of potential compounded formulations for compounders’ consideration if FDA-approved products do not meet the needs of their patients. When HCG had previously been part of a regimen for testosterone therapy, one option for men’s health is the use of anastrozole, as it will help the body continue to make testosterone to minimize the negative-feedback effects of testosterone therapy.^3,4,5

PCCA members with Clinical Services access can find a list of example formulas that include anastrozole and testosterone in a variety of dosage forms on our Members-Only Website.

Matt Martin, PharmD, is a Clinical Compounding Pharmacist at PCCA. He joined the PCCA Clinical Services department in September 2014. Matt graduated from Morehead State University with a BS in Chemistry in 2002, and received his PharmD from the University of Kentucky College of Pharmacy in 2006. Prior to joining the PCCA team, Matt worked in compounding pharmacy for more than eight years, and has experience with both sterile and non-sterile preparations.

Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development, received her pharmacy degree from Mercer University in Atlanta, Georgia, in 1995. She currently is involved with and oversees the development and implementation of new formulas at PCCA. She had more than six years of compounding experience with pharmacies in Georgia and Florida prior to joining the PCCA staff in 2004. Her areas of interest include women’s health, veterinary and pain management compounding.

References
1.   U.S. Food & Drug Administration. (2019). Preliminary list of approved NDAs for biological products that will be deemed to be BLAs on March 23, 2020 [PDF File]. Retrieved from https://www.fda.gov/media/119229/download
2.   U.S. Food & Drug Administration. (2018). Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application: Guidance for industry [PDF File]. Retrieved from https://www.fda.gov/media/90986/download
3.   Charnow, J. A. (2013). Anastrozole improves testosterone therapy. Renal & Urology News. Retrieved from https://www.renalandurologynews.com/home/departments/mens-health-update/hypogonadism/anastrozole-improves-testosterone-therapy/
4.   DiGiorgio, L., & Sadeghi-Nejad, H. (2016). Off label therapies for testosterone replacement. Translational Andrology and Urology, 5(6), 588–849. https://dx.doi.org/10.21037%2Ftau.2016.08.15
5.   National Institute on Aging. (2018). Effects of aromatase inhibition versus testosterone in older men with low testosterone: Randomized-controlled trial. Retrieved from https://clinicaltrials.gov/ct2/show/NCT00104572