THE PCCA BLOG

The Vaginal Microbiome, Menopause & HRT

Thu, 09 May 2024 03:38:07 GMT

Menopause causes more than hot flashes, mood swing and changes in libido; it also impacts diseases caused by shifting changes in the vaginal microbiome. Bridget Briggs, MD, sheds light on the vaginal microbiome, its influences on a woman’s health throughout various life stages, as well as how HRT helps mediate changes — and associated diseases — in the vaginal microbiome during menopause.

by Dr. Bridget Briggs, PCCA HRT Symposium Keynote Speaker

The vaginal microbiome (VM) is a complex ecological system that includes commensal, symbiotic and pathogenic organisms that inhabit the vaginal surfaces and its cavity. These organisms include bacteria, viruses and fungi.

The composition of organisms within the VM changes throughout the various stages of a woman’s life:

Childhood: Corynebacterium spp., Escherichia coli (E. coli), and Mycoplasma spp. form the vaginal microbiome.
Puberty: At puberty, the vaginal microbial niche shifts toward other predominant colonies, including Lactobacillus spp., Atopobium and Streptococcus spp.
Reproductive Ages: During reproductive age, the vaginal microbiome houses a range of bacterial communities, including lactobacilli (L. crispatus, L. gasseri, L. jensenii and L. iners) along with anaerobic bacteria.
Menopause: Further changes in the composition of the VM include Gardnerella vaginalis, Ureaplasma urealyticum, Candida albicans and Prevotella spp., with a progressive decrease in species of lactobacillus.

VM and Lactobacillus

The composition of the vaginal microbiome can vary widely between individuals. It influences a woman’s reproductive health, immune responses and overall wellbeing. Imbalance in the microbiome is linked to bacterial vaginosis (BV), thrush (a common yeast infection), urinary tract infections (UTIs) and influences fertility.

Lactobacillus species dominate in a healthy vagina and are associated with cervicovaginal health. Disruption of the microbial status quo — notably during menopause — is associated with disease. Hormone replacement therapy (HRT), however, has shown to improve the vaginal microbiome:

Vaginal estradiol (E2) tablets resulted in substantial changes in the VM and metabolome with a lowering in pH, particularly in women with high-diversity bacterial communities at baseline.
Low pH moisturizer or placebo did not significantly impact the vaginal microbiota or metabolome despite lowering the vaginal pH.
Estradiol use may offer additional genitourinary health benefits to postmenopausal women.
A small randomized clinical trial of a vaginal probiotic in postmenopausal women found short-term decreases in proinflammatory gene pathways with increased vaginal lactobacilli.
A 2020 study conducted on 228 premenopausal women suggested that daily administration of a vaginal dose of Lactobacillus crispatus, after treatment with vaginal metronidazole, can reduce recurrence of bacterial vaginosis after 12 weeks.¹

Menopause, VM and Urinary Health

Decrease in lactobacillus results in an elevated vaginal pH and higher microbial diversity. Decreased levels may also cause vaginal epithelium atrophy (thinning of the vaginal epithelium), dyspareunia (painful intercourse), dysuria (pain when urinating) and other genitourinary symptoms of menopause (GSM), due in part from the changes in the local microenvironment.

GSM affects approximately 50% of postmenopausal women. A 2013 cross-sectional study (n = 87) showed that women with signs of mild or moderate vulvovaginal atrophy (VVA) had greater odds of having highly diverse microbiota depleted of lactobacilli than microbiota dominated by L. crispatus when compared to women with no VVA.
Use of HRT in menopause indicates the reversion of lactic acid bacteria (LAB) microbial diversity to premenopausal levels; use of HRT has also shown not to increase the prevalence of bacterial vaginosis in postmenopausal women.
Postmenopausal women have been found to display significantly lower levels of free glycogen than premenopausal women.²

Benefits of Estriol

A study on the effect of ultra-low dose estriol vaginal tablets (0.03 mg) and Lactobacillus acidophilus compared to placebo was investigated in 87 postmenopausal women. The instillation of lactobacilli and ultra-low dose estriol was found to significantly improve the vulvovaginal symptoms in these women.

A second study was conducted on 60 postmenopausal women, who were randomly assigned to receive oral isoflavone alone, isoflavone plus probiotic or hormonal replacement therapy (1 mg estradiol and 0.5 mg norethisterone acetate). After 16 weeks, the hormonal therapy group showed an increased number of lactobacilli in the vagina, similar to that seen in premenopausal state, and a decrease in vaginal pH. Conversely, no change in pH value was found in the isoflavone group and isoflavone plus probiotic group.¹

Impact of Progesterone on the VM

DMPA injection reduced total bacterial load and abundance of Gardnerella vaginalis.
Localized progesterone contraceptive also reduced lactobacillus abundance.
Progesterone inhibits vaginal epithelium proliferation. Lack of epithelial-derived glycogen in a progesterone-enriched environment may reduce lactobacillus and other bacterial abundance.
Due to increased levels of endogenous estrogen and progesterone during pregnancy, the contributions of exogenous progesterone may be obscured in pregnant women.¹

Additional Influences

The intestinal microbiota have a role in shaping the vaginal microbiota. Both are formed throughout the stages of development and are influenced by lifestyle, use of antibiotics and hormones; both produce metabolites that help guide the immune system to be tolerogenic (producing immunological tolerance) or pro-inflammatory. The use of antibiotics can have long lasting negative impacts on a person’s microbiome and promote chronic disease development. Various forms of oral, vaginal or fecal transplanted probiotics can help to influence disease states.

Interested in learning more?

Attend the July 18-19 HRT Virtual Conference, Winning with Weight Loss, Detox and the Microbiome. This highly engaging symposium features a lineup of experts shaping the field of HRT — including: Dr. Briggs; Carrie Jones, ND; Pamela Smith, MD, MPH, MS; Daniel Banov, RPh, MS; Sara Hover, RPh, FAARM; and Ranel Larson, PharmD.

References

Auriemma, R.S., Scairati, R., del Vecchio, G., et al. (2021). The Vaginal Microbiome: A Long Urogenital Colonization Throughout Woman Life. Front. Cell. Infect. Microbiol. 11. Sec. Microbiome in Health and Disease. Accessed July 2021 at https://www.frontiersin.org/articles/10.3389/fcimb.2021.686167/full
Meštrović, T., Matijašić, M., Perić, M., et al. (2020). The Role of Gut, Vaginal, and Urinary Microbiome in Urinary Tract Infections: From Bench to Bedside. Diagnostics (Basel, Switzerland), 11(1), 7. Accessed December 2020 at https://pubmed.ncbi.nlm.nih.gov/33375202/

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.

Profile In Personalized Medicine - Bob Mehr

Wed, 01 Jul 2020 15:42:05 GMT

This Profile in Personalized Medicine highlights Bob Mehr, BScPharm, FAPC, President and CEO of Pure Integrative Pharmacy #25 in Fort Langley, British Columbia, Canada. He has been a proud PCCA member since 2000.

How did you start compounding? What led you to PCCA?

I became interested in compounding when I realized that many patients cannot tolerate certain commercially available pharmaceuticals, especially women suffering from symptoms of menopause. I could not imagine that one pill or one strength could look after everyone’s pharmaceutical needs.

I started to look into options. I started to do some research on the internet while also asking my colleagues in the U.S. where I could learn about the art of compounding. All signs pointed toward PCCA. So I made a call and made the commitment to attend the Primary Training course (now CORE Compounding Training) in Houston. After attending the training, I fell in love with PCCA and continued my educational path by attending all their seminars and courses, including aseptic training.

What was your toughest patient problem?

My toughest patient problem involved a postmenopausal woman unable to alleviate hot flashes, night sweats and all her other symptoms. We finally found a solution that worked for her using balanced dosing with unique formulations. I monitored her symptoms daily, and I was on the phone with PCCA clinical compounding pharmacists regularly trying to figure out how we could solve her problems. After three months of research and looking for a solution, while also working with her physician closely, we were able to relieve all her symptoms.

What has been your most satisfying patient experience?

It was back in 2003. I attended PCCA’s Aseptic Training course (now Sterility Assurance Training) in Houston. After learning all the techniques, I built a clean room in one of my pharmacies. This was a big step for me. There was a patient who had a spinal injury due to a motor vehicle accident. She would be wheelchair bound for rest of her life. Her doctor called me and asked if I could create a sterile compound for an intrathecal pain injection on a bi-weekly basis. I agreed to do it.

I just wanted to make sure I was doing all the right things to help this patient. The first time I made this sterile injection, I was so nervous. I was by the phone all day long until the doctor called me and said the procedure went well and helped the patient.

That was truly one of the moments that I will never forget in my life. I ended up making that compound every two weeks for four years. This patient came to our pharmacy every single week in her wheelchair and thanked me for giving her a higher quality of life. She still sends me thank-you letters on a regular basis.

What’s the biggest “aha” moment you’ve had as a member of PCCA?

When I first visited PCCA back in 2001, I was so impressed with the quality of experts they had and also the quality control for their ingredients.

What is your favorite PCCA base, and why?

VersaBase® Cream. It can be used in formulations for HRT, dermatological issues or cosmetics. It has no smell, is easy to work with and feels great on the skin. Our patients love this base.

What is your favorite PCCA educational event, and why?

The HRT Symposium in Las Vegas. There are always great speakers at this event, and I learn so much.

What advice would you give a new compounder?

Never, ever compromise your quality. Always buy the best ingredients, invest in your facility and equipment, and always provide your staff with ways to expand their education and training.

What is your favorite thing about your job right now?

Helping my patients to take control of their own health by educating them on what their options are.

What is your personal motto or words to live by?

"The greatest wealth is your health." – Virgil

What is the best word to describe your life?

Gratitude.

Clinical Services Spotlight - Matt Martin

Fri, 31 Jan 2020 18:34:30 GMT

By Seth Humble, Digital Content Specialist

Kentucky is a special kind of place. Roving through its rolling hills, blanketed in the wind-swept, world-famous bluegrass from which the state takes its nickname, people find themselves taken aback, perhaps even awestruck. Kentucky is a place of dusky beauty. It’s a state physically gowned and culturally capped in blue. From the roots of terra firma to the soaring musical top of the Foggy Mountain Boys, Kentucky is the kind of humble place that crafts a humble man.

“You can say that blue has always been a big part of my life,” says Matt Martin, PharmD, a PCCA clinical compounding pharmacist. “I went to Moorehead State for undergraduate work, then the University of Kentucky for my pharmacy education. So, blue and blue. And surprise, I’m a Dodgers fan — blue there, too. And now, I work for PCCA, which is of course, famously blue.

We go through the normal, beginning particulars of every get-to-know-you scenario over the phone. He works for PCCA remotely from his home state. The first thing Matt wants to tell me is about his family.

“I have a lovely wife and we have four kids: three girls and one boy. We’ve also got a 6-year-old pup named Tiny,” he says. There is a distinct kind of nostalgia that rings in Matt’s voice when he tells me about the family he grew up with. His father, an aluminum-parts production supervisor who served at the same company loyally for 40 years, encouraged Matt’s love for collecting baseball memorabilia — especially baseball cards. His mother is a deaf schoolteacher at the Kentucky School for the Deaf, but you would never know it by her incredible proficiency at reading lips. Matt talks about his young life with a breezy ease; the trademark of the Southern raconteur.

When we talk about what Matt does for PCCA, his tone changes. It’s still calm, smooth and direct, but there is a dynamism that flows into his voice when he starts talking about pharmacy compounding guidelines and regulations.

“I talk with pharmacies, especially about regulation,” he says. “I help them understand where to find resources to best equip themselves to handle often-changing interpretation of the regulatory landscape. Legislation dictates how pharmacies are able to compound, what they are able to compound with; that legislation dictates how or if a pharmacy can help a patient. That can be very frustrating. It’s my job to help those pharmacies navigate those scenarios.”

“Legislation is something you’re clearly passionate about,” I say.

“To me, that’s why ACT is so important and, honestly, encouraging because of how many new faces I see each year that want to serve as advocates for patients,” Matt says of PCCA’s annual legislative conference in Washington, D.C. “ACT lets them share their concerns with congressional offices and advocate for patients’ access to customized medicine. It’s important to recognize that our voice, the voice of compounders, is a big voice in regulation, but not the only voice. So conveying our message in person does make a difference.”

The phone goes quiet, but I can feel the wheels of Matt’s mind turning.

“I don’t mean to go on, but something that I think is important is this: One word can have so much power to change the interpretation and the outcome for patient care,” Matt says. “So, no matter if it’s sterile or nonsterile compounding, or we’re dealing with USP guidelines it’s important to know that it takes care and focus to really navigate these documents. I want pharmacies to be able to help people, and in order to do that, I am striving to stay on top of this ever evolving regulatory system.”

I ask him what he does to understand these finer points.

“Understanding the documents, going through them line by line carefully,” he responds. “And honestly, it’s people — talking with people during inspections. Those are tense, high-pressure situations. In those moments, you want to let those people know that they are not alone, that there is someone they can talk to, someone that can help them walk through these situations. Being a person who helps them is very special to me.”

“So what can people do to prepare for those kinds of situations?” I ask.

“Pharmacies should practice for the inspection with assigned roles of who does what when the inspectors arrive. Knowing that and practicing that eases the tension if a real inspection occurs.”

“Anything else?” I follow up.

He laughs; it is a slow, self-effacing sound. “Yeah. Call me. Let’s get prepared. Let’s talk about what you should consider about your facilities, personnel, procedures, and how you can be a voice for continued access to needed compounded medications.”

This is Matt Martin — an eagle scout and native son of the Bluegrass State, who loves fall camping in the Red River Gorge. A clinical compounding pharmacist who believes that sharing special experiences with those we love is essential to a meaningful life. He was PCCA’s 2018 Employee of the Year and is a compounding legislation and regulation hawk, always looking for every possible way to empower the pharmacies he speaks to on a daily basis. PCCA is proud to call him one of our own.

Does Your DMSO Pass These 2 Tests?

Wed, 15 Jan 2020 21:01:56 GMT

By Don Bottoni, RPh, FACA, PCCA Clinical Compounding Pharmacist

Dimethyl sulfoxide (DMSO) is an interesting substance, and it has many uses in the pharmacy world. It is classified as an aprotic solvent, which means that it does not contain any hydrogen atoms and is not capable of being a proton donor. This property makes it an ideal solvent in which most chemicals are stable. It is miscible with many other solvents as well, including water. It has a high boiling point, so it will not rapidly evaporate at room temperature. It can freeze at temperatures around 68° F. If a pharmacy receives a shipment of DMSO that contains crystals, simply place the container in a warm water bath, and the crystals will dissolve. It is best not to use the DMSO until the crystals have dissolved and the container is shaken well. If the crystals are not dissolved, the liquid portion can contain a higher concentration of impurities.

Among other applications, DMSO has historically been used in compounded creams and gels as a permeation enhancer, though modern compounding bases such as Lipoderm® and PermE8® Anhydrous Gel provide superior delivery without some of the harsh properties of DMSO. Despite its prevalence, however, not all DMSOs are created equal, and there are a couple easy ways to determine if yours might be of questionable quality.

Test 1
Does the DMSO you are using have an odor? If it does, it may mean that you are using an inferior quality product. There are several grades of this chemical that are used in different industries and for various purposes, including analytical applications and the manufacturing of semiconductor devices. However, a high-quality, USP-grade DMSO — which is what we must use in pharmacy compounding — should be virtually odorless.

Test 2
Recently, we have heard from some compounders that crystals are forming when they add their DMSO to water. DMSO is a nontoxic solvent obtained as a by-product of the paper-making industry, and lower grades of it may contain other distillates and contaminants that are not freely soluble in water. Therefore, if your DMSO is forming crystals when you add it to water, it may be because of a higher level of impurities. This should not happen with a high-quality, USP-grade DMSO.

Many years ago, PCCA set the standard by finding the highest grade chemicals for the compounding pharmacies we work with. This means we offer USP-grade DMSO that contains few if any impurities and is almost odorless. It does not form crystals when added to water. This high purity may help reduce any irritations when used in topical preparations as well. We compounders are mandated by USP to use the highest grade chemicals possible. Using USP-grade DMSO helps to ensure that you are following USP guidelines and that you are compounding a quality product.

PCCA members can learn more by reading the document Not All DMSOs Are the Same on our Members-Only Website. They can also see more details on the proper thawing procedure for DMSO.

Don Bottoni, RPh, FACA, joined the staff of PCCA in January 2010 after 40 years of practice in independent pharmacies. He graduated from Texas Tech University in 1966 with a BA in chemistry and The University of Texas College of Pharmacy with a BS in pharmacy in 1969. Don’s areas of interest include nutrition, sterile compounding, bioidentical hormone replacement therapy and men’s health. Don has been a presenter at many PCCA International Seminars and at University of Texas continuing-education seminars, and he taught several classes on nutrition for PCCA in the mid-1990s.

Profile in Personalized Medicine - Rachelle Whitaker

Mon, 13 Jan 2020 18:39:53 GMT

By PCCA

Our January Profile in Personalized Medicine highlights Rachelle Whitaker, CPhT, a compounding technician at The Compounding Lab in Huber Heights, Ohio. The Compounding Lab is owned by PCCA member Tim Clark, RPh, and led by compounding pharmacist Robyn Crow, RPh.

For how long have you been compounding?
I was 19 years old when I started compounding. I took my first pharmacy job in 2004 at a long-term care pharmacy. Since that time, I have had the opportunity to work in several different compounding settings.

When did you learn about compounding? Why did you start compounding?
Over the years, I've learned sterile and nonsterile compounding working in long-term care, a home infusion pharmacy and a local hospital. I took my love for compounding to a new level when I joined The Compounding Lab in 2017.

I was so excited to learn how to make things like capsules, suppositories, lollipops (my favorite), troches and more. Robyn Crow, our compounding pharmacist, and the other techs taught me so much, and I am truly grateful for the knowledge they have given me. One of the things I think we do best at The Compounding Lab is hormone replacement therapy. Robyn is so great at working with doctors to develop the best regimen for each individual patient. Hormone issues affect such a large percentage of our population; I know this personally, as I suffer with polycystic ovary syndrome (PCOS). When hormones are out of whack, they can really take a toll on your physical and mental well-being, so I find it very rewarding that we are able to help our patients get that part of their lives back. Pediatric medications are another one of my favorites.

What do you find most fulfilling about compounding?
I love that we can make a medication for our patients who are children that may not be commercially available in a pediatric dosage, but could be very beneficial to their treatment. Not only does it help the child with their condition, but it also gives the parent(s) peace of mind.

What are some of your favorite PCCA formulas? What do you like about them?
My favorite PCCA formula to compound is for tetracaine lollipops (PCCA Formula #5380). We have received very good feedback from patients and their doctors. They are fun to compound, and it makes me happy that we can help these patients.

PCCA members with Clinical Services access can see Rachelle’s favorite formula for tetracaine lollipops in our formula database.

What is one of your favorite compounding success stories?
We have a young patient with rheumatoid arthritis who was practically bedridden before her doctor ordered allergy testing and found that the medications she was taking to help her arthritis were actually making her sick. Since coming to us to make her medications allergen free, she has been able to enjoy a higher quality of life.

What advice would you give to a new compounder?
I would tell them to take it slow. It takes time and patience to develop good technique. Also, take notes and do your research. There is so much to learn that it can seem overwhelming at times. I have been doing this for years and feel like I learn something new almost every day. If you stick with it, and it is something you really enjoy, it can be the best career path you will ever take!

Clinical Services Spotlight - Tricia Heitman

Mon, 16 Dec 2019 15:13:00 GMT

by Seth Humble, Digital Content Specialist

Though winter is at its full height when we meet, Tricia Heitman brandishes an unyielding summertime smile. After a few minutes of typical introductions, I ask, “You’ve been at PCCA for...”

Her eyes widen with excitement. “I’ve been at PCCA for 20 years, six months, and six days.”

“What does two decades mean to you?”

“I started right out of college here. After my father convinced me to get my PharmD, I became a resident at PCCA under Andy Glasnapp. Andy saw something in me that I never would have seen. I remember very vividly that on my first day, I took 11 calls. These days I take about 25 calls a day. Dave Sparks was my first boss, and he was so incredibly supportive and good to me. I’m very thankful for how this opportunity started.”

She sighs, her eyes drifting upward into a cloud of memories. “A lot of maturing happened here. I started here when I was 25. That maturing could be summed up in how I have learned how to help people who are in stressful situations or people who disagree with me. It has taught me how to listen better, try to understand people’s needs better. That is a large part of our job here in Clinical Services, and I think that is why we are so effective. Everyone in our department works hard to listen actively. It is a great joy to be able to help people that way, especially pharmacies. When I listen well to them, it means that I’m listening to the patients they serve, and I get to help them both.”

“So,” I interject, “you might say that listening well has a compounding effect.”

It’s a criminally bad pun.

Tricia laughs, mostly out of what I assume is politeness.

Sitting there, I cannot help but hear the sincere gratitude in her voice. I ask her why being in Clinical Services for PCCA has been so rewarding for her. Her answer does not disappoint.

“I like to imagine all the people we’ve helped over the years. Clinical Services’ reach doesn’t just touch the lives of people working in compounding pharmacy, it touches the lives of patients and the families of those patients. When we help pharmacists apply solutions to their patients’ problems, it means the next time they experience that same issue, they’ve been equipped with a solution.”

“So would you say that personalized medicine has a rippling effect?” I ask.

Tricia’s eyes light up, confirming. “Oh, absolutely.”

“What area have you found the most rewarding?”

“I’ve always been invested in pediatrics. Don’t get me wrong, I love helping people with all sorts of questions and challenges, but I started in pediatrics. I was headed to Children's Hospital Colorado to accept a residency before Andy asked me to be a resident at PCCA. There’s no way to know everything in pediatrics. It is a huge sphere of knowledge, but it doesn’t scare me — it excites me. I want to help kids; my heart goes out to them. I want children to have the very best medicine and the absolute best experience with their medicine. My knowledge in pediatrics is probably the biggest thing I bring to the table, but everyone in Clinical Services is always happy to pitch in. And that’s really what makes our team so powerful: We aren’t just a group of pharmacists, we’re a community. We’ve built that up over years and years and years together; that’s really important, knowing that there is a trust there that’s been earned. We’re a team, a real team, and that trust is a trust all of us lean on.”

“If you hadn’t gone into pharmacy, what would you have become?” I ask.

“A horticulturist. I would have absolutely loved that.”

“Do you dabble?”

“I do! I have a tiny garden, a little herb garden, and an antique rose garden. I’m into succulents. But I’m also a good Texas girl, so I have cabbage and collard greens. Gardening is very spiritual for me; it’s mindless, so it allows me to reflect and focus on growing things.”

“And that helps you with the clinical side of your life, being able to grow things?” I ask.

“Without a doubt. But my clinical work is extremely important to me.” There’s a lilt in Tricia’s voice when she mentions the importance of her work.

“What would be an example of your clinical work?” I ask.

“Take for example — I’ll give you one that came up twice. There was a 5-year-old with ovarian cancer who was having a lot of perineal pain. Knowing the signs of pain and how children in pain behave, I could clearly see that this was neuropathic pain. The child wasn’t sleeping more than two to three hours a night, and with the laundry list of medications she was on, she was just absolutely miserable when trying to sleep. Her doctor wanted to take a certain track with her pain treatment, but I suggested that before they take that road, to give us a chance to help her pain. We did a great deal of research, and we collaborated, and with patience and time and literature, we were able to advise on a path of treatment. We work diligently to understand medications, their side effects, and how physiology will respond to those medications. I’m really proud of my years here. There are always challenges, but I’m so happy I chose this profession. I think helping patients like this is proof that personalized medicine is worth fighting for.”

This is Tricia Heitman.

At the time of this article’s completion, she has worked at PCCA for 20 years, six months and 15 days. She believes in growing things. From growing the succulents, herbs and roses in her home garden to laboring the well-tilled soil of knowledge inside her mind, or enjoying the fruits of community in our Clinical Services department. It’s clear after meeting her that Tricia’s sunny disposition, diligence and hard work are how she’s managed to grow so many things so quickly.

The Top 5 Blog Posts of 2019

Wed, 11 Dec 2019 16:29:00 GMT

By PCCA

And just like that, The PCCA Blog is closing its first full calendar year in the world. Between January and November of 2019, we published 71 blog posts and attracted tens of thousands of readers just like you, many of whom have subscribed as well. Thank you to all of our readers and subscribers for making it a wonderful year. We’re grateful to be able to produce content that professionals in the pharmacy compounding industry find valuable. Below are some of our top-performing posts of the year, reflecting some of the biggest changes that our area of health care is experiencing along with the ever-present need for research-based clinical information.

1. Notable Changes in the New USP <795>
Even though implementation of the new USP General Chapter <795> has been delayed due to appeals, it is still crucial to have a full and nuanced understanding of it. In this post, PCCA Clinical Compounding Pharmacist Matt Martin, PharmD, addresses notable changes to the new USP guidelines and provides some considerations for implementation.

2. An Innovative Option for Hirsutism: Topical Metformin
Clinically, hirsutism “refers to women with excess growth of stiff, pigmented hair (known as ‘terminal hair’) in a male pattern,” explains PCCA Clinical Compounding Pharmacist Sara Hover, RPh, FAARM. But she has exciting news about a potential option for women with hirsutism as well.

3. Oral vs. Topical Estrogen: What the Literature Is Showing about Health Risk
Compounded bioidentical hormone replacement therapy (BHRT) is an important treatment option for women around the world. Colleagues and patients alike come to experts like Pamela Smith, Nat Jones and Sara Hover for guidance. In this two-part post, they cover this all-too-important topic in the BHRT conversation, showing what current literature says about the usage of oral vs. topical estrogen.

4. Upcoming Changes to PCCA Formulas per the New USP <795>, <797> and <800>
The new and revised USP chapters affect many aspects of compounding, including formulas. In this post, PCCA Director of Formulation Development Melissa Merrell Rhoads, PharmD, details the updates we’re planning to make to our formulas based on the new USP guidelines. Pro tip: Look at the types of updates we’re going to make to our formulas as a guide for changes you should consider in your own.

5. Notable Changes in the New USP <797>
The new USP General Chapter <797> implementation is delayed because of appeals just like USP <795>, and that gives compounders more time to become familiar with it. Let Dylan Herr, RA/QA Development Manager at Eagle, help with that. She understands that this version makes significant revisions to the old one, and in this post, she provides you with an overview of those changes and strategies for implementing them.

We’re hard at work planning more content for 2020 that we hope will help you serve patients and grow your business, so keep an eye on The PCCA Blog. If you like what you see, consider subscribing. We’ll send you email notifications when we publish new posts. And if you’re already a subscriber, sit back and relax. We’ll be in touch.

Profile in Personalized Medicine - Charles Wall

Fri, 06 Dec 2019 18:42:00 GMT

This Profile in Personalized Medicine highlights Charles Wall, DPh, owner of Heartland Apothecary located in Knoxville, Tennessee. A PCCA member since 2009, Charles graduated from Samford University for both his undergraduate and pharmacy school education.

How did you start compounding? What led you to PCCA?
After being in sterile IV pharmacy for the first 15 years of my career, I completed the nuclear pharmacy program at Purdue University and needed my practical hours. I trained at a nuclear-medicine site that also made a few compounds a day and found this model interesting. When I started the pharmacy, I intended to open as a nuclear site first and add compounding to our pharmacy services later, but due to the market, I flipped the model and started compounding first and never looked back. I had known about PCCA for a long time and reached out to Tim Adams of PCCA Outside Sales with some general questions, and we just took it from there.

What was your toughest patient problem? How did you solve it?
We had a patient with recurrent vaginal yeast who was unresponsive to commercially available products. So we worked with her health care provider to develop a suppository that included four antibiotics and antifungals that we recommended based on her lab test results. After two rounds of therapy, the patient reported improvement and the symptoms have subsided. The patient is experiencing a reduction in pain as well as other issues. We used PCCA formulas and combined a couple in order to offer the patient ease of application, and the results have been well received.

What has been your most satisfying patient experience?
Extending the life of an elderly canine patient who was experiencing seizures. She enjoyed a year of nearly seizure-free life.

What is the biggest “aha” moment you’ve had as a member of PCCA?
The exposure to others who practice at the cutting edge of the profession. Seeing others approaching this niche area and using it to springboard onto other things and not be boxed in .

What is your favorite PCCA base, and why?
LoxaSperse® . It has so many useful applications and great results. One patient in particular had issues absorbing drugs. We tried several different capsule formulas and fillers, and we achieved adequate absorption by adding a low percentage of LoxaSperse to the formula. The resulting levels have stabilized, and the patient is now enjoying better quality of life.

What is your favorite PCCA educational event, and why?
In my first C3 compounding course at PCCA, I made some lifelong friends and was exposed to more about compounding than I ever would have expected.

When was the last time a patient thanked you?
It seems almost daily we hear from patients on hormone replacement therapy about how it has improved their lives and their spouses’ lives.

What is the one thing you would say to new compounders?
I preach it to students in each pharmacy school rotation: Use the profession as an entry to other things you enjoy — be it investing, another hobby or another profession. Pharmacy compounding allows you to grow quickly, so use that opportunity early, and you will reap many benefits later.

PCCA’s 2018 Canadian Compounding Pharmacist of the Year

Mon, 25 Feb 2019 15:27:11 GMT

Congratulations to Allan Baker, RPh, of Macdonalds Prescriptions in Vancouver, British Columbia, for being named our 2018 Canadian Compounding Pharmacist of the Year. Amanda Cassel, PCCA Canada Office Manager, presented the award to Allan on September 15, 2018, during our Pain/Nutrition Seminar in Calgary, Alberta.

At the event, PCCA representatives and several of Allan’s colleagues from his Concierge Compounding Group welcomed him to the stage. His wife, Marla, son, and daughter-in-law joined him to help celebrate the honor. Several friends and colleagues shared how important he has been to them personally and professionally, including Mike De Lisio, PCCA North American Sales Director; Menia Costopoulos, PCCA Vice President of Sales & Marketing; Sebastian Denison, RPh, PCCA Clinical Compounding Pharmacist; Jim Smith, PCCA President; and Dave Sparks, PCCA CEO.

“At PCCA, we have a tradition and a legacy of honoring excellence, and we are proud to associate with the very best in pharmacy compounding,” Jim said, “and Allan, you are definitely in that circle.”

When accepting the award, Allan said, “As a pharmacist, I get the most enjoyment out of the patient interaction. Compounding is such a one-on-one way of practicing pharmacy.”

Allan is a second-generation pharmacist, graduating from the University of British Columbia, Faculty of Pharmacy in 1988. After working with a national chain, Allan wanted to become an independent pharmacy owner like his father, Bill Baker. Allan has proudly owned and operated Macdonalds Prescriptions since 1992.

He joined PCCA in 1998, and over the years, he has completed more than 460 hours of specialized compounding education in various areas, including pediatrics, dermatology, pain management, hormone replacement, veterinary and more. Allan was our Pharmacist of the Month in October 2009, and also served on PCCA’s Advisory Council. He is associated with the BC Pharmacy Association and The Association of Compounding Pharmacists of Canada.

PCCA Canada’s Compounding Pharmacist of the Year award is presented annually to a Canadian independent pharmacist who has demonstrated service excellence to patients, health care providers and pharmacy colleagues.

New Episodes Added to The Mortar & Pestle: A PCCA Podcast

Thu, 31 Jan 2019 17:57:26 GMT

New Episodes Added to The Mortar & Pestle: A PCCA Podcast

The Mortar & Pestle is a PCCA podcast for the compounding pharmacy world. Whether you are a pharmacy owner, staff pharmacist, technician, marketer or a patient using personalized medicine, this is a home for you, and we encourage you to subscribe. Hosts Mike De Lisio and Sebastian Denison, RPh, along with a guest list of the industry’s most influential leaders, will explore a cross-section of topics impacting today’s compounders.

This is your front-row seat to conversations with pharmacists at the forefront of science and medicine, experts in the fields business, marketing and entrepreneurship, and visionary leaders who share the belief that custom medicine is the future.

New Episodes for January 2019

Episode 7: Live with Special Guest Dr. Pam Smith
Pamela Wartian Smith, MD, MPH, MS, joins Mike and Sebastian live at 2018 International Seminar in Houston, Texas, to discuss the role of physicians in helping patients through personalized medicine.

Listen to Episode 7

Episode 8: Optimizing Your Pharmacy’s Business with Bryan Prescott
Bryan Prescott, PharmD, PCCA Director of Management Coaching Services, joins Mike and Sebastian in the studio. They discuss ways that pharmacy owners can optimize their businesses through employee empowerment, developing and executing marketing plans, adding services to complement product lines, and much more.

First Look!

Listen to Episode 8

In Case You Missed It
Listen to our sixth episode with special guest Saad Dinno, RPh, FIACP, FACA, who joins Mike and Sebastian to discuss how compounders can touch patients’ lives through personalized medicine. Listen here.

Profiles in Personalized Medicine - Christopher Cox

Wed, 30 Jan 2019 16:22:42 GMT

Christopher Cox, PharmD, Smith Rexall Drugs, Pleasant Grove, Utah

How did you start compounding? What led you to PCCA?
I was exposed to compounding—not including the one day during pharmacy school—on a student rotation at Smith Rexall Drug. I was blown away by the versatility and ingenuity of compounding. I was amazed to learn a customized medication could be created for an individual’s unique needs. I kept wondering, why is this not a staple of modern medicine? Why isn’t everyone doing this? I immediately saw the value, benefit and importance of compounding and knew I had found my professional home. I have been with Smith Rexall Drug ever since, 12 years, and plan to die here, with a mortar and pestle in my hands.

What has been your most satisfying patient experience?
Compounding has the ability to provide healing and relief from physical, mental and emotional pain and suffering. Suffering comes in many different shapes and sizes. From the emotional pain of teenage facial scars to the physical pain of head and neck radiation burns. From the mentally fatigued parent of a noncompliant child to the hospice patient experiencing physical, mental and emotional pain from end-of-life complications. Witnessing pain and suffering, in its many shapes and sizes, turn into relief, hope and peace are some of my favorite memories. This is why I compound.

What is the biggest “aha” moment you’ve had as a member of PCCA?
Most times the simplest solution is the best solution. Time and time again, the solutions to many of my patients’ problems are the simplest. This has been my experience in all facets of compounding.

What is your favorite PCCA base, and why?
MucoLox™. I love its innovative bioadhesive properties that solve some unique problems.
Biopeptide Biocosmetic™. Wow, this hidden gem has been an amazing facial-cream base. Never had a base that patients love, love, love this much.

What is your favorite PCCA educational event?
The HRT Symposium in Las Vegas. It’s a great place to take providers and learn together, and it’s the best provider/pharmacist networking event of the year.

What is some patient gratitude you have received?
I compounded a topical cream that included lorazepam, haloperidol, diphenhydramine and metoclopramide for a patient experiencing extreme anxiety and nausea. Her doctor prescribed it because she has chronic bowel disease and doesn’t absorb or tolerate medications. This compounded medication was a game-changer for her, and she was able to get on the road to recovery. She was so grateful.

This is similar to PCCA Formula #12485, a topical cream in Lipoderm®. PCCA members can access it here.

What advice would you give to new compounders?
Jump in; the water’s warm. There are many regulations, accreditations and potential setbacks. Yep, it can be tough, but your profession needs good compounders, and your patients need good compounders. The rewards far outweigh the price.

A New Choice in Customized Medication for Pain Management

Mon, 07 Jan 2019 16:17:18 GMT

A New Choice in Customized Medication for Pain Management

This article was updated 10/19/2020

At our International Seminar in 2018, we were excited to debut PermE8^® Anhydrous Gel, a compounding base that holds a lot of potential for compounding pharmacies and their patients.

PermE8 is an anhydrous gel that can hold multiple active pharmaceutical ingredients and deliver them through the skin comparably to Lipoderm ^®, the industry standard for permeation-enhancing bases. PermE8 is ideal for compounded medication related to pain management, sports medicine, oncology and many other specialties.

We developed PermE8 because we wanted to help compounders to extend default beyond-use dates (BUDs) for their penetration-enhancing topical preparations without having to spend thousands of dollars on stability testing. This makes customized medications more efficient for compounders and more convenient for their patients.

At the same time, we wanted to improve on older anhydrous bases to invent something that delivers active pharmaceutical ingredients very well, has a silky texture that isn’t greasy and spreads easily on the skin.

Below is some additional information about this base. We have developed and tested over 45 formulas with PermE8 that PCCA members with Clinical Services access can find in our formula database, and we will continue to create more.

Benefits for Compounders

Lower Operating Costs
PermE8 is anhydrous, allowing for prolonged default BUDs without having to spend thousands of dollars on stability testing, and increasing operational efficiency for compounders making anticipatory batches
Higher Performance
In vitro testing shows that PermE8 significantly outperformed Anhydrous Lipoderm in delivering ketoprofen through human skin tissue (Figures 1 and 2)
Broader Application
It is a stable base that can accommodate multiple drugs in one preparation, including those in salt forms and those not stable in aqueous environments

Benefits for Patients

Convenience
It is anhydrous, which allows for longer BUDs and less-frequent prescription refills
Pleasant Application
PermE8 isn’t tacky or oily, and spreads on the skin more easily than some other anhydrous bases, such as Anhydrous Lipoderm

Delivery Performance

We tested PermE8 to compare it to two of our other transdermal bases: the industry-leading Lipoderm, as well as Anhydrous Lipoderm, our first-generation anhydrous base for permeation-enhancing topical compounds.

The in vitro testing showed that PermE8 performed comparably to Lipoderm and significantly outperformed Anhydrous Lipoderm. (Figures 1 and 2.)

Figure 1: Amount of Ketoprofen Special Micronized USP 10% (μg) Delivered into and through ex Vivo Human Abdomen Skin over 40 Hours from a Single Application

Figure 2: Mean Flux (μg/cm2/hr) Results: Percutaneous Absorption of Ketoprofen Special Micronized USP 10% through ex Vivo Human Abdomen Skin over 40 Hours from a Single Application

Note

We still recommend that compounders use Lipoderm for their permeation-enhancing topical compounds, and we have numerous Lipoderm-based formulas with extended BUDs that have been studied using stability-indicating methods. But for compounders who need prolonged BUDs for formulas that do not have stability studies behind them, we recommend using PermE8.

PCCA Compounding Pharmacist of the Month: December 2018

Thu, 06 Dec 2018 19:41:00 GMT

PCCA Compounding Pharmacist of the Month:
December 2018

Jack Nie, RPh

Of Nie’s Pharmacy & Wellness Center in Independence, Kentucky

Years in Compounding: 20

Path to Compounding:

I always found compounding interesting. As a young pharmacist, working in the hospital world and later for chain pharmacy, I was always intrigued by the uniqueness of it. I was not fulfilled by hospital or chain pharmacy, though. In the chain world, I was a supervisor of 25 stores. I felt unfulfilled in that position and left to gain experience in independent pharmacy.

I knew others who were compounding and found it intriguing and thought it was a great opportunity for an independent. When the opportunity to rejoin my father in the family business came up, I jumped on it. After a couple of years of attempting to convince my partner-father that we needed to invest in this rebirth called pharmacy compounding, he capitulated. We joined PCCA and began our journey.

I love the diversity of custom medications we can provide and their associated challenges, as well as the gratitude of the patients, their caregivers and prescribers. Solving their unique problems is the most fulfilling thing about what I do.

Favorite Formula:

I cannot say I have a favorite PCCA formula. I am always in awe of the different dosage forms and combos in the PCCA formula database. And those wise guys in the Pharmacy Consulting Department, they have a great deal of experience you can use.

PCCA members have access to over 9,500 proprietary formulas, including over 135 FormulaPlus™ formulations with extended beyond-use dates backed by stability-indicating methods.

Success Story:

I remember a few years ago, a woman called to set up a consultation with me upon her physician’s suggestion. She suffered from adrenal and hormone issues as well as fibromyalgia. I discussed her situation with her and the prescriber, and I suggested some options, which the doctor agreed with.

After about eight months, we got some flowers delivered to the pharmacy from her husband. The note attached said, simply, “Thanks for giving me my wife back.” The day she came in for a follow-up consultation (a little over one year later), this 58-year-old woman literally did back flips down our first-aid aisle.

Advice for New Compounders:

Attend as many events as you can and network with a diverse group of your colleagues. You can learn a little from each. Early on, we joined Bill Letendre’s Compounding Pharmacy Management Services group and more recently a PCCA Concierge Compounding group. I would encourage you to plug in to these resources.

The views and therapies expressed in the above article are those of the interviewee and may not be endorsed by PCCA. The 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. Every patient is unique, and formulas should be adjusted to meet their individual needs.

Nie’s Pharmacy & Wellness Center is owned by Jack Nie, RPh.

PCCA Compounding Technician of the Month: December 2018

Wed, 05 Dec 2018 20:12:00 GMT

PCCA Compounding Technician of the Month:
December 2018

Linda Cunningham, CPhT

Of Hopewell Pharmacy and Compounding Center in Hopewell, New Jersey

Years in Compounding: 21

Path to Compounding:

My father is a pharmacist. He owned a store for over 20 years, and I worked for him for 17 years. It was a family-oriented store—independent—and my parents, my brother and I worked together there. I loved filling prescriptions and learning the field as well as working with customers who became like family to us. It was the kind of job you enjoyed going to every day.

After my father sold the business to a pharmacy chain, I worked there another three years until I found a job opening at Hopewell, and applied. I interviewed for the technician job, and was told it was in compounding. It sounded very interesting, and a bit of a challenge, so I took the job. I loved it instantly. My favorite thing to do is make capsules using the Jaansun Capsule Machine.

We did some minor compounding at my father's store, but nothing like what goes on at Hopewell. I have watched this business grow from making tryptophan capsules and many hormones when Gene Ragazzo, RPh, and Jim Palmieri, RPh, first started compounding, to expansion of the labs, flow hoods, and finally the USP <800> lab under our new owners, Joann Hobson and Eric Jaderlund, RPh.

Hopewell is moving forward, always developing ways to improve products, reduce the risk of cross-contamination and deliver quality medication that we techs are very proud to call our own. By working hand in hand with our knowledgeable pharmacists, and formulas from PCCA, our team is able to improve our products and provide answers for our customers’ needs.

Compounding has proven to be a unique way of tweaking medication to fit all the special needs of our customers. Whether it's developing something that tastes good or relieving pain with a cream, I only see a positive flow for the compounding business. There’s always something new coming down the pike. It keeps things interesting!

I love knowing that the medication I make is helping someone feel better. It's very satisfying to work with formulas to create a product you are proud of. There is a camaraderie between the technicians in my lab, a constant feeling of teamwork every day as we prepare the prescriptions and send them on their way.

Working together with the pharmacists, creating new products and fulfilling the customers’ needs is very satisfying to me. You really feel like you are making a difference. It's a very unique job, which takes a lot of hard work, training and dedication. All of our employees together make it quite an operation.

Favorite Formulas:

I have loved making capsules from the first time I used the Jaansun Capsule Machine. If I had to talk about a favorite, it would be making nasal irrigation capsules. Budesonide is the one we make the most of, but we are seeing more and more made with antibiotics and combinations.

Check out the PCCA-exclusive Jaansun Capsule Machines and accessories here. PCCA members can find capsule formulations for nasal irrigation that include budesonide here.

Success Stories:

There have been so many successes at Hopewell. Most are just a simple “thank you” for caring enough to get their medication to them in a timely fashion. I feel that our whole team, from the pharmacists to the clerks, work very hard to make sure our operation proceeds in a positive and timely fashion. We are always striving to satisfy the customer’s every need, from the moment we receive the prescription to when they pick it up. We are part of a community, one that we value very much.

Advice for New Compounders:

It takes a certain kind of person to understand all that goes into compounding a medication. There are definitely techniques to learn, and a good technician will develop their own style. I've learned a lot since the beginning of my career, and I never seem to stop learning about new products, new formulas and new ways to satisfy any customer. It could be mastering the flavor of a suspension, or how smooth their creams are—many times experimenting to get them just right.

Hopewell Pharmacy and Compounding Center is owned by Joann Hobson and Eric Jaderlund, RPh.

Vote for Your Favorite Compounding Kiki Challenge Video

Thu, 18 Oct 2018 18:55:00 GMT

This year, to help generate excitement for International Seminar 2018, we created our first-ever social media video contest: The Compounding Kiki Challenge. Throughout the month of September, PCCA members created music videos in their pharmacies with a remixed version of Drake’s hit song “In My Feelings.”

The remixed song, dubbed “The Compounding Kiki,” features lyrics by Whitney Andrews, PCCA Events Management and Culture Specialist, vocals by Bené Taylor, PCCA Assistant Warehouse Team Leader, and instrumentals by Soundcloud artist KayGW Beats.

Five PCCA member pharmacies submitted videos for the Compounding Kiki Challenge, and we need your help choosing a winner! The pharmacy whose video receives the most votes will win a FREE registration to International Seminar 2018 and a FREE lunch for their entire pharmacy staff.

To vote, simply view the video submissions below, select your favorite and press the “submit” button. Thank you to everyone who participated in this year’s contest, and may the best music video win!

Note: If voting on a mobile device, the survey below will appear as two pages.

Limit one vote per person. Full contest rules are available here.