Idaho's few compounding pharmacies face new rules and a changing industry

adutton@idahostatesman.comJuly 9, 2013 

Dozens of people in the U.S. died in the outbreak last fall of fungal meningitis, traced back to contaminated steroid injections from the New England Compounding Center. As a result, things are changing at Idaho's compounding pharmacies.

Idaho's pharmacy regulators are rewriting the rules for compounding, and at least one local pharmacy is taking action to reassure customers. "The rules are changing," says Berk Fraser, deputy executive director of the Idaho State Board of Pharmacy.

Compounding pharmacies in the Treasure Valley

Click on an Rx symbol for the name, address and compounding status of a pharmacy.

The board will start taking public comment on the rules in August.

"We've just never had any compounding rules," Fraser says. "We started before [the meningitis outbreak], just discussing compounding rules, and it really came to a head at that point. ... This was scary, and I don't believe we had any [deaths] in our state, but you want to get ahead of the curve."

At the same time, state and federal lawmakers are trying to increase oversight of compounding pharmacies. The U.S. Food and Drug Administration had already sent inspectors to some pharmacies, but it cranked up its regulatory actions after the outbreak.

The outbreak also prompted a small Kuna pharmacy to seek national certification.

Travis Walthall, a pharmacist who lives in Meridian, first learned compounding - "like doing a recipe" - in pharmacy school at the University of Wyoming in Laramie. After criss-crossing the country and working at Wal-Mart pharmacies for several years, he took a spot behind the counter at Vic's Family Pharmacy in downtown Kuna.

"I think [the business] has come a long way since 1997," when he was in pharmacy school, he says.

But compounding remains a special craft learned on the job, with students being introduced to it at schools including Idaho State University.

"A lot of the students we have from ISU still have very little awareness of the process," he says.

Walthall fell in love with the Treasure Valley and bought the store in March 2010 with a loan from a South Carolina bank. He renamed it Custom Rx and set a goal of getting it nationally certified.

Custom Rx on March 8 became the only Treasure Valley pharmacy to have a stamp of approval from the Pharmacy Compounding Accreditation Board, by meeting standards laid out in a 50-page manual. For a pharmacy as active as Custom Rx, it costs $1,250 a year to be accredited. The pharmacy also must pay all costs for a board surveyor to visit.

Accreditation is not necessary for a pharmacy to do compounding. In fact, most pharmacies do basic compounding - a simple mix of two ointments, a drug suspended in liquid to be taken orally. A small slice of those pharmacies - a dozen in the Valley - make custom medications like hormone replacement therapy, and even fewer have sterile laboratories to make injections or eyedrops.

Custom Rx falls in the middle range. Walthall and his staff make an average of eight compound prescriptions a day - a fraction of the 3,000 prescriptions they fill each month. (That's about one-fourth the volume of a big-box retailer pharmacy, he says.) The pharmacy's sales are in the $1.5 million to $2.5 million range, Walthall says.

Their customers usually come in with orders for hormone replacement therapy and pain medication - two kinds of drugs that require only the most meticulous tweaks. The pharmacy also mixes medicine for premature babies whose needs can't be met by mass-produced pills, creams or solutions.

Susan Tomey, an acute-care nurse practitioner for Trinity Family Medicine in Meridian, started sending her patients to Walthall's pharmacy in 2008, before he bought it and long before it was certified. He has become a sounding board and a colleague to her.

"When I have questions, I need somebody to ask who's an expert," she says. "He has opened early for me to supply medications for the clinic. He has waited late for me to get there in the evenings."

Sherri Harper, a Kuna resident and pharmacy customer for the past four years, relies on Walthall and his staff for two monthly prescriptions. She tells a story to illustrate one reason for her loyalty.

When Harper's mother died in April, Harper needed a prescription filled before leaving town. It was a Saturday, and she didn't have 24 hours to wait - the usual prescription processing time. The pharmacy not only filled her prescription right away, but an employee "gave me a box of Kleenex and said, 'You're going to need this for the flight,' " she says.

Harper says it makes all the difference to have a local pharmacist who knows her prescription needs and answers all her questions about safety and quality, but also takes time to "bend over backwards" for her.

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Audrey Dutton: 377-6448

 

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