At the height of the nation’s recent debate over compounding, Cheri Garvin, BSPharm, President and CEO of The Compounding Center in Leesburg, VA, made a gutsy decision.
When it opened 35 years ago as Leesburg Pharmacy, the store operated as a traditional community pharmacy, with compounding of individualized medications a separate department. But by early 2013, as third-party reimbursement declined sharply and dropped below expenses, Garvin and her staff had to decide whether to refocus the business.
It had become “a numbers game, a volume game,” she explained in an interview with Pharmacy Today at her store. “It was a vicious cycle. We had to keep filling more and more prescriptions just to pay the bills for the drugs we needed to fill all those prescriptions. It left us with not as much time to develop relationships with patients—to really feel like we were making a difference.”
After breaking down the practice by department, looking at what made the most sense financially, and doing “a lot of soul searching,” Garvin and her team decided they were most passionate about compounding and patient care. The Compounding Center was born—smaller than the original pharmacy and focused primarily on compounding and medical equipment, but still in the same location.
Patients entering the recently remodeled center see all the equipment, pharmacists, and technicians at work in the glassed-in compounding lab right behind the reception desk. Within that area is a separate sterile room, also visible to patients. This philosophy of transparency helps raise awareness among patients of what compounding pharmacists do in the wake of the tragedy stemming from the New England Compounding Center, whose similar name sometimes confused customers.
The pharmacy employs a staff of 26 that includes pharmacists, pharmacy technicians, cashiers, floor staff, and sales staff. “I really couldn’t ask for a better set of people to spend my time with,” Garvin said. “Every one of my coworkers is a significant contributor, from the pharmacist to the part-time cashier.”
Patients and customers run the gamut—from a pet owner struggling to “get a pill into a dog,” to a patient diagnosed with a rare disorder who needs a drug that can’t be found anywhere, to a menopausal woman who has been through three doctors and prescribed antidepressants or antianxiety agents before she learns that she needs hormone replacement therapy. The center also serves as a rotation site for student pharmacists and for a vocational–technical high school that offers a pharmacy technician program.
Diversity is one of the things that Garvin loves the most about her role at The Compounding Center.
“I’m out there staffing as a pharmacist, filling prescriptions and talking to patients,” Garvin said. “But I also might be doing paperwork or working on HR issues, or on our strategic plan for next year, or what our financials look like today, or benchmarks that we’re measuring against.”
Garvin and her team are also involved in pharmacy education and advocacy efforts, including the push for provider status and changes in the industry required by the Drug Quality and Security Act (H.R. 3204), the new compounding and track-and-trace law enacted in November 2013.
Left to right, a few of the crew: Parker; Robert Busey, Customer Service Representative; Chris Poland, CPhT and General Manager; Josh MacPherson, CPhT; Teresa Ferris, CPhT; Mitchell; Juveria Yasmeen, Pharmacy Technician; Garvin; Megan Kilkeary, PharmD; Casey Shebest, CPhT; and Molly Benn, PharmD
The Compounding Center is the first and only compounding pharmacy in the Washington, DC, metro area to be accredited by the Pharmacy Compounding Accreditation Board (PCAB) for sterile and nonsterile compounding.
Compounders start with raw ingredients and make medicines from scratch, taking the pure chemicals, measuring or weighing them out in the exact amounts needed, and mixing them together in whatever form it takes to dispense to each individual patient based on the prescription. Examples include gluten-free formulations, medications for children who are allergic to dyes, or drugs at much lower doses or in flavors other than those commercially available.
PCAB’s accreditation standards, modeled after U.S. Pharmacopeia <795> and <797>, are rigorous. “It’s basically holding ourselves to the highest standards in the industry, and going through that process,” which involves conducting a self-evaluation, making the necessary changes to be in compliance, and undergoing a site visit that ensures the pharmacy’s policies and procedures meet PCAB standards, Garvin explained.
The pharmacy was PCAB-accredited in 2009 and is reaccredited every 3 years. Documentation is an important part of the process—from writing policies and procedures to “something as simple as noting that we are checking the refrigerator temperature every day,” she said.
Top and center rows: Ferris prepares a methylcobalamin injection in the sterile room within the compounding lab. Bottom row: Yasmeen counts capsules (left), Busey does a final verification before Benn dispenses the meds (center), and Poland stocks vitamins (right).
Garvin hears and sees daily evidence that her team's efforts really matter.
It’s the husband who calls every month to refill his wife’s hormone replacement therapy medications, telling Garvin, “I’ve got my wife back, and I’m not going to have her miss a dose.”
It was the parents who told her, “My child would not be alive if it weren’t for you.” Their baby, who had been in the hospital Neonatal Intensive Care Unit, needed a liquid formulation of a cardiac drug because the dosage in a tablet would have been too high. The pharmacy made a liquid formulation, and the parents were able to bring their baby home and administer the drug at home.
It was the customer who needed a specially prepared antibiotic for pet sugar gliders, an Australian marsupial so named because of its sweet tooth and ability to glide through the air like a flying squirrel. Garvin and her team had to figure out how to get the medication into the animals. Could they flavor the antibiotic so the sugar gliders would eat it? “They like sweet stuff, so we did tutti frutti or pina colada,” Garvin said.
It’s the gratitude of the mother of two boys with mitochondrial disorder; the pharmacy compounded medications for her first child and is now doing so for his brother.
It was the relief of the pet owner who came in with a prescription for a very large dose of vitamin K for blood clotting. Her two dogs, show Dobermans, had gotten into rat poison on her farm. They had been in the animal emergency hospital a week for blood transfusions and couldn’t go home until the drugs were located and the prescription was filled. Their owner had been to 10 other pharmacies until someone recommended The Compounding Center. Because the dose was so big, Garvin told her she’d get the dogs started with a few capsules and would have the rest of the order the next day. “She was just thrilled,” Garvin said.
It was the call from a parent of a young girl with pneumonia, who couldn’t swallow a capsule without gagging. A liquid formulation of an antibiotic was so bitter it made her throw up. She needed a formulation that could be sprinkled onto yogurt, Garvin said, or maybe a gummy bear or lollipop formulation. Finding the formulation that worked with the drug’s active ingredient required careful troubleshooting and understanding how the drug works, she said.
“To make those products, you have to heat up the base; the lollipop base has to be liquid, then you mix the active ingredient,” Garvin explained. “Some drugs aren’t stable at that temperature, so you really have to go back to your chemistry, your biochemistry, to say, ‘Does this even make sense?’”
It’s also the pharmacy’s work with hospice patients who need medications but can no longer swallow. Instead of receiving multiple injections throughout the day to control pain, fever, and seizures, they might be treated with suppositories or with a pain gel rubbed on a forearm and absorbed through the skin.
A Leesburg native, Garvin grew up working in Ben Franklin Craft stores, the retail business her parents owned throughout the area. By the time she headed off to George Mason University, she’d vowed never to go into retail, she said. Instead, she would major in biology and become a teacher.
But while home on Christmas break during her sophomore year, Garvin had a conversation with community pharmacist Bruce Roberts, BSPharm, then the owner of Leesburg Pharmacy. She confessed she wasn’t sure that teaching was right for her. “He said, ‘Cheri, I’ve known you all my life. I really think you should think about pharmacy school,’” Garvin said.
Roberts told Garvin that pharmacy was a great profession. Garvin thought about it and shadowed Roberts at the pharmacy over the break. Then she went back to school, talked to her counselor, decided Roberts was right—and entered Virginia Commonwealth University’s (VCU) School of Pharmacy the following year.
After earning her BSPharm degree in 1990, she returned to Leesburg and the pharmacy, where she worked with Roberts for 6 years before embarking on a varied career in the field, including at a hospital; working with third-party payers for a disease management company; and as a lab instructor at VCU, teaching pharmacy students practical and compounding skills.
When Garvin’s father passed away unexpectedly in 2001, she and her husband returned to her hometown to help her mother with the family’s Ben Franklin business. Roberts, who was leaving Leesburg Pharmacy to serve as Executive Vice President and CEO of the National Community Pharmacists Association, heard Garvin was moving back and asked her to return to the pharmacy. She started as manager and eventually, in 2009, bought the business from Roberts with her business partner, Jay Gill, PharmD.
“Bruce still is my biggest mentor,” said Garvin. “We connect pretty regularly just to say, ‘Hey, what do you think about this? What do you think about that?’” Because of this experience, Garvin tells student pharmacists to “never say never,” to always be open to whatever might come their way.
“I’m enjoying what I’m doing,” she said. “It’s a challenge every day.”
When a prescription is received (e-prescribed, faxed, phoned, or brought in), the data entry techs enter the prescription, bill insurance, and communicate with the patient about payment and pick-up/delivery time. Next it moves to the compounding lab to be made. After the lab pharmacist checks it off on the formulation record, the prescription moves to the fill station, where the tech packages it for patient use (creams in tubes or pumps, capsules in vials, liquids in bottles) and puts all appropriate labeling together. The techs in the lab and at the filling station check the data entry against the prescription before it goes to the quality assurance pharmacist for final verification. Finally, the prescription is ready for patient pick-up or delivery/shipping. New prescriptions are held for counseling (patient is phoned if it's a mailing).