Custom-Made Meds
Pharmacy Mixes, Blends Ingredients So Results Are More Palatable, Efficient For Humans, Pets

By JANICE PODSADA Courant Staff Writer

February 28, 2007

VERNON -- When Eeyore, a lop-eared rabbit, contracted a brain infection, he refused to take his medicine. And giving a pill to a bunny is no easy task, said his owner, Nancy Ainsworth: "They've got teeth."

After days of hand-wringing and some bloodletting, Ainsworth's veterinarian urged her to contact Gene Gresh, a pharmacist and the owner of the Pioneer Health Compounding Pharmacy in Vernon.

Gresh formulated a liquid, blueberry-flavored antibiotic; Eeyore lapped it up. "I used it as a salad dressing on his evening meal of greens," Ainsworth said. "While a veterinarian can give you a pill or a liquid, they can't formulate it into a form or flavor that's palatable to your pet.

Whether it's a cat, a horse or a hamster, Gresh or one of his lab technicians can usually entice Goldie or Squeakers to smack their gums and swallow their meds.

The Pioneer Health pharmacy specializes in compounding - the science of mixing, blending and preparing medications to fit a patient's particular needs, Gresh said.

"Tailoring the medication to the patient - that's the key benefit of compounding," Gresh said.

Compounding benefits not only animals, but also people. In fact, 75 percent of Gresh's clients are doctors' patients. Every compounded medication is produced according to a doctor or certified prescriber's prescription, Gresh said.

For 18 years, Gresh, 49, owned a conventional pharmacy - Market Square Pharmacy in Newington. Twelve years ago, he tried his hand at compounding. Under a doctor's direction, he prepared an anti-inflammatory salve for a woman with heel spurs who got no relief when she took the medication in tablet form.

"She rubbed the cream onto her foot and, within a month, she was out playing tennis and golf. I realized what we could do," Gresh said. By bypassing the stomach and the liver, where most drugs are metabolized, "we were able to go directly to the site where we wanted the medication to work," he said.

Since then, Gresh has, in consultation with doctors, compounded drugs for hundreds of patients - from an autistic child who couldn't swallow an antibiotic in pill form to a physician. "I developed shingles," said Dr. Deanna Cherrone of Avon. Instead of downing an antiviral drug, Cherrone asked Gresh to create an antiviral ointment. "I didn't develop any blisters. My husband said I had the mildest case of shingles ever."

Four years ago, Gresh sold his conventional pharmacy and launched the Pioneer Health pharmacy. It's one of only a handful of compounding pharmacies in Connecticut and 1,800 in all of the United States and Canada.

Gresh describes his business as profitable, but would not disclose his start-up costs or revenue. The compounding laboratory occupies a central place in the pharmacy. "You won't find this kind of lab in a conventional pharmacy," he said.

On a recent morning, lab manager Peter Casinghino and his daughter, lab assistant Randi Casinghino, were preparing an anti-inflammatory cream. A special Plexiglas flow hood protected them from being exposed to the chemicals used to prepare the prescription ointment. "Since I got involved in compounding, it has changed my life," Gresh said. "Patients come in with gifts and cards. We never had this at my conventional pharmacy."

Before the rise of drug manufacturers in the 1940s, a compounding pharmacy and an ordinary pharmacy were one and the same, said Joshua Wenderoff, a spokesman for the International Academy of Compounding Pharmacists, an industry group established in 1991. "When you needed a pharmaceutical treatment, they'd prepare it for you," Wenderoff said.

In the past 10 years, compounding has made a huge resurgence, said Robin Bogner, a professor of pharmaceutical science at the University of Connecticut School of Pharmacy who teaches pharmacy students how to make capsules, ointments and suppositories. Although most patients can have their prescription needs "met by a manufactured dose, there are some, particularly pediatric and geriatric patients, who cannot or will not take pills," Bogner said.

Just as a spoonful of sugar helps the medicine go down, so, too, can a transdermal gel that's absorbed through the skin, or an inhaler, or even a suppository. Hospice and elderly patients who have difficulty swallowing can have their medication turned into a liquid or gel that can be applied to the skin, Gresh said. Cancer or AIDS patients, who must often down a dozen pills a day, can have them safely compounded into one dose. And patients allergic to the fillers and binders that drug manufacturers use to encapsulate a drug's active ingredients can often obtain a compounded version that does not contain the allergen.

But although some physicians have become staunch advocates of compounding, not everyone is enthralled by the procedure. In 2005, Wyeth, a New Jersey-based drug manufacturer, filed a citizen's petition with the federal Food and Drug Administration to ban the compounding of some prescription hormones used to treat symptoms of menopause and pre-menstrual syndrome. The company also requested that compounding pharmacies be subject to the same regulations as drug manufacturers, which are required to undergo extensive testing when they formulate any new drug. Thus far, more than 50,000 people have sent comments asking the FDA to disregard the petition, Wenderoff said.

At this point, the petition has not been addressed, Wenderoff said, nor has the agency issued a clear timetable indicating when it will be discussed. The assertion that compounding pharmacists are drug manufacturers isn't true, Gresh said. "We don't manufacture new drugs here," Gresh said. "Every ingredient we work with is FDA-approved. We work with doctors. It's very scientific."

Compounding, however, is not always covered by health insurance providers. Ron Sylvain, the pharmacy's manager, estimates that about 25 percent to 30 percent of patients receive some sort of reimbursement from their insurer for compounded drugs - "and that's just a guess," he cautioned. The good news is that the cost of compounding a medication can sometimes be less than the co-payment, Gresh said. "We make an anti-inflammatory cream which costs about $15, which is less than the $30 co-pay many patients pay."

"Our biggest cost is labor. It's not like we pull a bottle off the shelf," said Gresh, whose pharmacy houses an 8-foot by 11-foot chemical room filled with the active ingredients necessary to make hundreds of medications, from testosterone creams to a tuna suspension used to coax cats to swallow this or that bitter pill. A compounding pharmacy is one means for small, independent pharmacies to carve out a niche for themselves and compete with the big chains, Wenderoff said.

"But it's more than just a business strategy. They're meeting legitimate pharmaceutical needs," he said. That need can be profound. One of the most dramatic recoveries, Gresh recalled, involved a woman who was confined to a nursing home. Wracked by bone pain that would not yield to pain pills, he consulted with her doctor over an alternative drug delivery method. "We made up a suppository for her," Gresh said "Her husband went home for lunch and a shower. By the time he came back, she was sitting up and talking on the telephone. Those are the stories you remember."

Contact Janice Podsada at jpodsada@courant.com.
Copyright 2007, Hartford Courant