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Sterile 'clean room' sets Premier pharmacy apart

The lab's special devices keep particles from getting into medicines compounded for doctors and patients.

By CHANDRA BROADWATER
Published July 11, 2006

Behind glass viewing windows in a room at Premier Pharmacy Labs, technician Tara Massonn dips a syringe into a Pyrex beaker.

As she pulls back the syringe plunger, the barrel of the plastic tube fills with a clear solution. It's a respiratory steroid used for breathing treatments.

Massonn then turns to a row of small plastic containers on the lab counter next to her. Her steady rubber-gloved hands move from one to the next, as she measures the proper amount of fluid into each container.

The mask on her face leaves only her eyes exposed. Her hair is tucked into a surgical cap, and the rest of her body is covered with a lab coat.

Vern Allen stands outside the sealed-off room, technically known as a Class 1000 Clean Room, as Massonn works.

Allen, a Hernando High School graduate, built the $70,000 room two years ago. Also known as Nations Pharmacy online, his 5,000-square-foot building is at 8269 Commercial Way, north of Weeki Wachee.

He points to the special ceiling above Massonn and explains that it is equipped with a HEPA - high efficiency particulate air - filter system, which exhausts air through vents near the floor, outside the special area.

The filters help ensure the room is sterile. It is one of several devices that keep particles from getting into the medicines, especially liquids, that the pharmacy compounds for doctors and patients.

"This is the leading edge of pharmacy today," Allen said of the lab. "It is state of the art."

Allen, 59, started the business in 1993 after working in hospital pharmacy. He has practiced in the Tampa Bay area since receiving his doctorate from the University of Florida in 1972.

While compounding, or creating more individualized medications for patients, is nothing new, Allen said that his special room is what sets Premier apart from the rest. There, he and specially trained technicians figure out the best ways to help clients with the latest technology.

"This isn't the one-size-fits-all theory," Allen said. "It's vastly different from a standard retail pharmacy where you don't have time to think twice."

The process usually starts with a one-on-one consultation to ask clients about their lifestyles and other factors, like exercise and diet. Sometimes Allen speaks with doctors first, but other times he and a patient may meet and then approach a physician.

Next, prescriptions are created: the exact dose needed for a patient, without preservatives or dyes that can cause side effects.

Online, by fax and over the phone, Premier takes orders for patients needing a variety of treatments. They include medications for diabetes, respiratory ailments, hormone replacement therapy and arthritis.

The orders usually don't cost any more than they would in a retail pharmacy, Allen said.

"We just took an order for a woman who is pregnant and whose doctor is concerned that she may lose the child," Allen said. "So the doctor has ordered an injectable hormone compound that will hopefully allow her to maintain her pregnancy."

The pharmacy also recently took an order for a nasal spray prescription that a doctor also wants an antibiotic added to.

Speaking generally about pharmacies with clean rooms, labs such as Allen's offer a level of specialization atypical to most communities, said Issam Zineh, associate professor at the University of Florida College of Pharmacy.

Clean rooms are mandatory in the making of solutions used in IVs and other liquids that come in direct contact with mucous membranes, where exposure to bacteria and other particles in the environment could be harmful. The sterility for some medications taken by mouth is not as important, he said.

"You'd be hard pressed to walk into a Walgreens or CVS and find that level of sterility," Zineh said. "It gives community access to specialty formulas they wouldn't get otherwise."

And while Premier specializes in making sterile medications, the pharmacy also mixes capsules and creams like other compounding pharmacies in the area do. These don't have to be made in such a precise environment. And they aren't always for humans.

In a smaller room next to Massonn, pharmacy techs Kristen Knoll and Michelle McConnell work on filling other prescription orders. Knoll monitors a testosterone ointment being milled in a machine while McConnell fills capsules of a medication usually used in dogs for seizures.

Premier also concocts medications for elephants, hyenas, snakes and other animals at places like Busch Gardens and zoos. Allen laughs at the amount it takes to create some veterinary prescriptions, especially for the pachyderms.

In fact, they were Premier's first clients. The theme park needed a large batch of enemas when some of the elephants had tuberculosis.

"I can't overemphasize how interesting it is to do all these different types of preparations," Allen said. "We have this infinite variety of prescriptions that we get to research and work with. We don't fill and pour prescriptions over and over 20 or 30 times a day. And we offer our clients a valuable service."

Chandra Broadwater can be reached at cbroadwater@sptimes.com or (352) 848-1432.

TO LEARN MORE

For information about Premier Pharmacy Labs, visit www.rxnations.com or call 352 597-4950.

[Last modified July 10, 2006, 19:21:02]