THE PCCA BLOG

PCCA’s 2019 Honored Compounding Pharmacists

Fri, 11 Oct 2019 18:57:00 GMT

by PCCA

Last night at the International Seminar 2019 Awards Banquet, we proudly announced our Compounding Pharmacist of the Year and the recipient of our annual George Roentsch Scholarship. We also recognized our Canadian Compounding Pharmacist of the Year and the recipient of our Evelyn Timmons Advocacy Award, whom we originally honored at events earlier this year.

Congratulations to Jasper Lovoi III, PharmD, RPh, Our 2019 Dr. M. George Webber Compounding Pharmacist of the Year

L to R: PCCA’s Dave Sparks, Jasper Lovoi and PCCA’s Jim Smith

We presented this award to Jasper at the International Seminar Awards Banquet on October 10.

“Jasper is committed to being a resource for his colleagues and other pharmacy compounding industry professionals, especially in the sterile compounding realm,” PCCA President Jim Smith said. “His new, state-of-the-art sterile and nonsterile compounding labs are testaments to his high level of quality standards. He is well known and respected by his patients within his community and among fellow pharmacists within his PCCA colleague community.”

After graduating from the University of Houston College of Pharmacy in 2002, Jasper joined his family at Lovoi and Sons Pharmacy in Beaumont, Texas, where he introduced the practice of specialty compounding. The pharmacy joined PCCA, and through the personal marketing of bioidentical hormone replacement therapy, pediatrics and skin care, Jasper established a strong and growing compounding business for his family.

In 2008, he opened The Woodlands Compounding Pharmacy, an independent, compounding-only pharmacy. He is the pharmacist-in-charge, supervising the operation of over 26 employees, and prepares all sterile compounds. His wife, Keisha Lovoi, RPh, manages the pharmacy staff, and is also responsible for maintaining compliance with all state and federal regulations. Jasper is also the owner and founder of Bimini Cosmetics, a company he started in 2006 that provides pharmaceutical-grade anti-aging products to the public.

Jasper has served a two-year term on PCCA’s Advisory Council; frequently attends educational seminars and symposiums to learn new, more effective ways of treating his patients; networks with his fellow compounding colleagues on a regular basis; and is passionate about advocating for the profession of pharmacy compounding. In the past year, he has hosted two Congressional visits at his pharmacy to demonstrate to lawmakers the role compounding plays in health care and share patient access barriers with them.

Established in 1987, this award is presented annually to an independent compounding pharmacist who has demonstrated service excellence to patients, health care providers and pharmacy colleagues. The late Dr. M. George Webber was a longtime professor at the University of Houston College of Pharmacy, and was instrumental in the formation of PCCA in 1981. He was unwaveringly committed to meeting patient needs and upholding the highest quality and ethical standards, and shared his expertise and love for compounding with his colleagues and his students for more than 40 years.

Congratulations to Courtney Junop, BSP, the Recipient of Our 2019 George Roentsch Scholarship

L to R: PCCA’s Erin Michael and Dave Sparks; Courtney Junop; and PCCA’s Bill Letendre, Jim Smith, Lizzie Harbin and Cyndi Hicks

We presented this award to Courtney at the International Seminar Awards Banquet on October 10.

“Courtney is a true sharer and teacher, which makes her so deserving of this honor,” PCCA Director of Outside Sales Erin Michael, MBA, MS, CPhT, said. “She is always learning about new compounding opportunities and sharing these ideas as well as her own with her pharmacist colleagues. She precepts pharmacy students every year by offering a compounding and functional medicine rotation at her pharmacy. And she continually expands her practice to offer new services in order to meet the needs of patients and prescribers in her community.”

Courtney started her compounding career as a pharmacy technician, joining the staff of The Medicine Shoppe Pharmacy & Compounding Centre in Saskatoon, Saskatchewan, in 2007. She decided to return to school, and graduated with her Bachelor of Science in pharmacy from the University of Saskatchewan in 2011. She then served as the pharmacist and manager of The Medicine Shoppe until 2014, when she purchased the pharmacy.

Known throughout the Saskatchewan medical community as a compounding and functional medicine expert, Courtney regularly hosts presentations for patients and other health care professionals on a variety of compounding topics. She has received specialized training in several areas, including adrenal fatigue, nutrition, pediatric compounding, pain management, hormone replacement therapy and integrative medicine. She is currently working on her Fellowship/Master in Anti-Aging, Regenerative and Functional Medicine and Metabolic and Nutritional Medicine through the American Academy of Anti-Aging Medicine/Metabolic Medicine Institute.

In her four years as owner of The Medicine Shoppe, Courtney has gained the trust of her community. In turn, her business has grown, and she is considering expanding her practice with a second location to keep up with demand.

Established in 2010, this scholarship is given annually during International Seminar to an up-and-coming independent pharmacist and PCCA member who embodies the innovative and sharing nature for which George Roentsch was well known in the pharmacy compounding community. It provided Courtney with an all-expenses-paid trip to our 2019 International Seminar. The late George Roentsch, RPh, was the owner and pharmacist of The Apothecary in Keene, New Hampshire, and is fondly remembered for his work, which advanced the art and science of custom-made prescription medications. George was passionate about pharmacy compounding and generously shared many of his formulas and innovations with fellow compounders.

Congratulations to Jarron Yee, BSP, Our Canadian Compounding Pharmacist of the Year

L to R: PCCA’s Mike De Lisio, Corinn Ponton and Cheryl Spicer; Jarron Yee; and PCCA’s Amanda Cassel and Sebastian Denison

We presented this award to Jarron on June 20 during our HRT, Autoimmune & Pain Symposium in Toronto, Ontario.

In a video prepared for the ceremony, Sebastian Denison, RPh, PCCA Clinical Compounding Pharmacist, spoke to Jarron’s qualifications: “I think it had something to do with his advocacy, passion, marketing, attendance at events and great voice in the compounding community.”

In the same video, PCCA North American Sales Director Mike De Lisio added, “Jarron, you’ve been heavily involved not only within your province of Saskatchewan, but you’ve also led an advocacy effort in Canada, and I think this was the major reason you were selected as the 2019 Canadian Compounding Pharmacist of the Year.”

While accepting the award, Jarron said, “It is an honor to be recognized with previous recipients of the award. PCCA has been the backbone supporting my efforts to provide the best options to my patients. Sebastian has been a tremendous mentor and has been instrumental in guiding me in my career.”

Jarron graduated from the University of Saskatchewan in 2006. He has been serving the city of Regina and the surrounding area with his compounding services since 2010, when he opened the Northgate Medicine Shoppe Pharmacy. His interests revolve around helping patients with chronic pain and hormone balance issues to achieve positive health outcomes.

Jarron has achieved the professional designations of Hormone Specialist and Dermatology-Wound-Scar Specialist through PCCA’s rigorous Comprehensive Core Concepts in Compounding (C4) program. He is also currently completing his Fellowship in Anti-Aging Medicine through the Academy of Anti-Aging Medicine. Jarron hopes to combine all these specialties to provide his patients with his much sought-after expertise.

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.

Congratulations to Cathy Hance, RPh, Recipient of the 2019 Evelyn Timmons Advocacy Award

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L to R: PCCA’s Jim Smith and Lizzie Harbin, Cathy Hance, and PCCA member Jennifer Burch

We presented this award to Cathy on April 9 during our 2019 ACT Legislative Conference in Washington, D.C.

“Cathy Hance truly shares the passion of Evelyn Timmons and is well deserving of this honor,” said PCCA President Jim Smith. “Cathy and her co-owner sister, Anne Marie Megibben, are second-generation pharmacists who are well known and respected in the medical community they serve. Anne Marie’s commitment to running the daily pharmacy operations allows Cathy the opportunity to regularly attend national and local meetings to protect the profession of pharmacy compounding.”

Cathy was chosen from among 10 finalists. She has more than 30 years of experience as a pharmacist and more than 12 years of experience in compounding and pharmacy ownership. A graduate of the University of Kentucky College of Pharmacy, she and her sister learned to be the pharmacists they are today by watching their father run his own independent pharmacy for many years. They opened Compound Care Rx Plus in Louisville, Kentucky, in 2008, specializing in many areas of compounding, including male and female hormone replacement therapy, pain management, ophthalmology, dermatology, pediatrics, dental and veterinary. They also offer private consultations for hormone replacement therapy as well as lifestyle and wellness.

Some of Cathy’s advocacy efforts on behalf of her community and the compounding industry include regularly attending PCCA’s annual ACT Legislative Conferences and IACP’s annual Compounders on Capitol Hill events to promote compounding at the federal level. She also holds a constant presence at Kentucky State Board of Pharmacy meetings and hosts members of Congress at her pharmacy to secure their support for compounding. She also continually enhances her knowledge about pharmacy compounding and shares this knowledge with her pharmacy colleagues, patients and medical community.

Established a year after her death in 2011, this annual advocacy award pays tribute to Evelyn Timmons, RPh, a pioneer and nationally renowned figure in the use of bioidentical hormones for women, as well as a long-standing advocate of pharmacy compounding. As one of the first female pharmacists in Arizona, she received numerous national awards during her career. Evelyn was the first woman president of the American College of Apothecaries (ACA), and was among the first full fellows of the International Academy of Compounding Pharmacists (IACP).

Want to see what else is going on at International Seminar 2019? Check it out.

A New Anhydrous Base for Female Hormone Delivery

Fri, 11 Oct 2019 13:52:00 GMT

By PCCA

This morning at International Seminar 2019, attendees packed into the ballroom to hear our Chief Scientific Officer Gus Bassani, PharmD, deliver his PCCA Innovation presentation. This is where Gus reveals the much-anticipated new PCCA products every year. This time, he introduced the audience to VersaBase® Anhydrous HRT, the pharmacy compounding industry’s first proprietary anhydrous base developed specifically to deliver female bioidentical hormones through the skin, such as estriol, estradiol and progesterone.

PCCA Chief Scientific Officer Gus Bassani introduces
International Seminar attendees to VersaBase Anhydrous HRT.

This new base is the latest addition to the VersaBase family of vehicles, and it uses a patent-pending delivery system that improves both the solubility of hormones and their permeation into and through the skin. This is typically difficult to achieve with an anhydrous base, but our Director of Research and Development Daniel Banov, MS, RPh, and his team have spent their careers inventing products that surpass what most consider possible. This one is no exception. VersaBase Anhydrous HRT performed comparably to VersaBase Cream (the industry standard for women’s topical HRT) during in vitro testing that demonstrated it delivering our Special Micronized Progesterone into and through human skin tissue.

VersaBase Anhydrous HRT also complements our newer anhydrous bases that we first released in 2018 to address changing needs in the compounding industry. Like PermE8™ Anhydrous Gel and W06™ Anhydrous Topical Gel, this newest base has water activity lower than 0.6 (Aw < 0.6), which qualifies it as anhydrous according to the standards in the latest version of USP General Chapter <795>. Therefore, formulations in these bases have longer default beyond-use dates (BUDs), which the chapter allows for nonaqueous dosage forms. This can save compounders thousands of dollars per formulation because the medications do not have to be stability tested in order to have the longer BUD. It also makes compounds more convenient for patients, since they won’t have to return to the pharmacy as often for prescription refills. To increase efficiency further, most of the VersaBase Anhydrous HRT formulas that we have tested and published in the PCCA formula database do not require the use of an ointment mill, which reduces both compounding time and cleanup time.

Also on The PCCA Blog: Why Water Activity Matters in Pharmacy Compounding

PCCA members with Clinical Services access can visit our formula database to see the numerous VersaBase Anhydrous HRT formulas that we have already developed to help eet the needs of patients. If they have questions about compounding with this base, they can contact our clinical compounding pharmacists at 800.331.2498.

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 references cited did not necessarily evaluate PCCA products or formulas included in these statements. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment.

New Episodes Added to The Mortar & Pestle: A PCCA Podcast — June 2019

Wed, 26 Jun 2019 13:26:38 GMT

by PCCA

The Mortar & Pestle is a podcast for the pharmacy compounding world. Whether you are a pharmacy owner, staff pharmacist, technician, marketer or patient using personalized medicine, this is a home for you. Co-hosts Mike De Lisio and Sebastian Denison, RPh, along with a guest list of the industry’s most influential leaders, 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 Podcast Episodes for June 2019

Episode 20: Autoimmune Disorders and Compounding with Sara Hover
Sara Hover, RPh, FAARM, PCCA Clinical Compounding Pharmacist, joins Mike and Sebastian to discuss the world of autoimmune disorders and how Sara thinks compounding may be able to help patients with them. She also goes over a few conditions she’s heard about from pharmacies around the world and what she has done to help patients through compounding.

Listen to Episode 20

Episode 19: Compounding for the Veterinary World with Deborah Clark
Deborah Clark, BSPharm, RPh, PCCA Clinical Compounding Pharmacist, joins Mike and Sebastian to discuss customized medicine for veterinary needs. In addition to interesting compounding options, Deborah also shares marketing ideas she’s seen and used.

Listen to Episode 19

In Case You Missed It
Listen to our 18th episode with Gus Bassani, PharmD, Chief Scientific Officer of PCCA, where he tells the story of how he started his compounding career at a pharmacy in Alaska. Gus, Mike and Sebastian also discuss the value that the FormulaPlus™ database brings to PCCA members and how Gus leads his team with the goal of innovating everywhere. Listen here.

Maintaining Patients’ Access to Personalized Medicine

Wed, 24 Apr 2019 19:45:32 GMT

By Amy Shank, PCCA Director of Government Relations

Nearly 50 PCCA members converged in Washington, D.C., on April 9–10 for our seventh annual ACT Legislative Conference on Capitol Hill. In total, these pharmacists met with nearly 100 lawmakers during Congressional appointments to ask for their support of patient access to compounded medications.

Specifically, PCCA members discussed two recent developments related to pharmacy compounding with their lawmakers, and asked for their support:

H.R. 1959, the Preserving Patient Access to Compounded Medications Act of 2019, which is bipartisan legislation that Reps. Morgan Griffith, R-VA, and Henry Cuellar, D-TX, reintroduced in the House of Representatives in March 2019
A letter to the FDA asking that the agency correct the definition of “distribution” in the reissued Memorandum of Understanding so that it does not include patient-specific dispensing. This bipartisan effort is led by Congressman Peter Welch, D-VT, and Congressman Morgan Griffith, R-VA

Rod Harbin of Wellness Pharmacy and PCCA's Lizzie Harbin along with Ginny Isbell of Madison Drugs
meeting with Rep. Robert Aderholt, R-AL, during PCCA’s ACT Legislative Conference.

H.R. 1959
Reps. Morgan Griffith, R-VA, and Henry Cuellar, D-TX, first introduced The Preserving Patient Access to Compounded Medications Act to the House of Representatives two years ago. However, all legislation not enacted by December 2018 expired, so Reps. Griffith and Cuellar reintroduced this legislation in March as H.R. 1959. It addresses the FDA's implementation of the 2013 Drug Quality and Security Act, which has resulted in limiting and in some cases denying access to compounded medications for many patients and prescribers.

There are four major components of this legislation:

It allows office-use compounding consistent with state law
It clarifies that pharmacies dispensing medication pursuant to a patient-specific prescription are not impacted by the Memorandum of Understanding (MOU). As background, the FDA's current draft proposal to implement the MOU includes an overly broad definition of “distribution” that includes the dispensing of medications across state lines. This is important for pharmacies licensed in more than one state. In states that do not enter into an MOU with the FDA, pharmacies could only send 5% of their prescriptions to patients outside their state, which would severely limit patients’ access. Fixing the definitions would alleviate many potential access barriers
It clarifies that the definition of an “applicable” United States Pharmacopeia or National Formulary monograph includes both drug and dietary supplement monographs. Currently, the FDA is taking the position that only substances with drug monographs may be included as active ingredients in compounded medication for humans
It clarifies that during the inspection process, the current records exemption applies to all pharmacies, including compounding pharmacies

What You Can Do
We encourage compounders to contact their Representatives’ offices about this legislation. You can read about how to do that under “Contacting Your Representative” below. When you do, consider these suggestions:

Explain that this bipartisan legislation (H.R. 1959) was recently introduced
Explain any current patient access barriers you, your prescribers or your patients are experiencing, and why the legislation would help. For example:
- The FDA's current prohibition of medications compounded for office use is barring access for your prescribers and patients, but H.R. 1959 addresses this
- The FDA’s current draft proposal to implement the MOU may significantly limit patients’ ability to receive their compounded medications from pharmacies in other states, but this legislation would alleviate this potential access barrier
- You can no longer include substances with dietary supplement monographs as active ingredients in compounded medications because the FDA only considers drug substance monographs to be “applicable.” The only exceptions to this are substances on the FDA’s “positive list” of ingredients that can be lawfully compounded, or ingredients in Category 1 of the FDA’s interim list of bulk substances for 503A pharmacies (You can read more about that here)
Ask the staff member if your Representative will cosponsor the legislation, and thank them for researching the proposal
Mark your calendar, and make a note to follow up with the staffer about 2–3 weeks after your initial conversation to determine if they need more information

We also encourage compounders to contact their U.S. Senators’ offices and ask them to introduce companion legislation to H.R. 1959. You can call the Congressional switchboard at 202.224.3121, ask them to connect you to your Senator’s office, and then ask to speak with your Senator's heath legislative aide.

Rep. Michael Burgess, R-TX, greets conference attendees for their Congressional appointment during PCCA’s ACT Legislative Conference.

Redefining “Distribution” in the MOU
PCCA members taking part in our ACT Legislative Conference also asked their lawmakers to co-sign a bipartisan letter by Congressman Peter Welch, D-VT, and Congressman Morgan Griffith, R-VA, which asks the FDA to correct the definition of “distribution” in its draft MOU so that it does not include patient-specific dispensing. The letter explains that the FDA’s current definition contradicts industry precedent as well as current law.

Under the current MOU proposed by the FDA, all prescriptions that are dispensed would be counted as being distributed. When the time comes for each state to decide if it will sign the MOU, compounding pharmacies may be limited to sending out only 5% of their compounded prescriptions to patients in other states if their state does not sign the MOU, the letter explains. This could significantly impact many patients who need to receive compounded medication from pharmacies in other states.

What You Can Do
This bipartisan letter is open for other lawmakers to sign, and we encourage compounders and patients to contact their members of congress to do so. You can read about how to do that under “Contacting Your Representative” below. When you do, consider these suggestions:

Ask them to sign the Welch-Griffith letter to the FDA to maintain patient access to the pharmacy of their choice, no matter where they live
Explain that the FDA’s current definition of “distribution” in the draft MOU is overly broad and would limit patient access if left in the current form

Your Congressional office can contact either Congressman Welch’s office or Congressman Griffith’s office to sign the letter, or for additional information. Please note that the letter is only open for lawmakers to sign, and not for outside organizations or private companies.

Rep. Jaime Herrera Beutler, R-WA, speaks to ACT Legislative Conference attendees at
the legislative breakfast as they prepare to depart for Congressional appointments on Capitol Hill.

Make Your Voice Heard
At our ACT Legislative Conference in Washington, D.C., Rep. Buddy Carter, R-GA, the only pharmacist currently serving in Congress, and Rep. Jaime Herrera Beutler, R-WA, spoke about the state of compounding issues in Congress, and why making the trip to Washington to educate lawmakers matters. We know that the best advocates for pharmacy compounding and patient access to compounded medications are those who have heard from their constituents, either in Washington, D.C., or at a pharmacy visit in their district.

Whether or not you were able to join us in Washington, and whether or not you are a PCCA member, we still need your help in contacting your Representatives. Please review the information in this blog post and contact your Congressional Representative’s office now.

Contacting Your Representative
If you are not certain who your Representative is in Congress, don’t worry. You can find them here. Once you find your Representative, you can follow these steps:

Call the Congressional switchboard at 202.224.3121
Ask to speak with your Congressional Representative's office
When they connect you, ask for the Representative’s health legislative aide
Discuss these issues with that staff member

Once you’ve connected with your lawmaker, also consider inviting them to tour your pharmacy and discuss these issues in person. It makes a lasting impression, and they will be more informed by seeing your practice firsthand. Lawmakers are back home during the August district work period, and they are in the process of building out their summer schedules now.

PCCA members, keep your eye on the Public Affairs page of the Members-Only Website for updates on these and other legislative issues. For additional information, members can call us at 800.331.2498.

Amy Shank, PCCA’s Director of Government Relations, previously served as Vice President of Capitol Hill Consulting Group (CHCG), where she advised pharmacy, pharmaceutical and university clients on federal legislative priorities. Amy also has over 10 years of experience in the United States Senate. She was the Director of Oversight and Investigations for the Senate Health, Education, Labor and Pensions Committee. She was also a senior policy advisor to the Senate HELP Committee. Amy was a senior analyst for the Chairman of the Senate Budget Committee, former Senator Don Nickles, R-OK, and began her legislative career in his Republican Whip Office as a policy advisor.