Custom cures
Compounded drugs enable doctors to find just the right remedy for patients
By Shari Rudavsky
Posted: July 22, 2008

A pharmacist hand-crafting a prescription with a mortar and pestle may seem straight out of an old-fashioned apothecary.

But it's a scene that plays out every day in compounding pharmacies, at once a throwback to the drugstore days of old and a solution for some modern-day patients. The mortar and pestle have gone electronic, but they're still used to create medicine with a personal touch.

A compounding pharmacist can prepare a potion tailored to a child's body weight and flavored with a favorite taste. Or take a medicine for humans and create a topical cream to treat that child's miniature schnauzer. Or combine two prescriptions into one liquid dose for people who have difficulty swallowing, such as hospice patients. Or make a version of a prescription of a common medicine without the dye to which a customer is allergic. Or combine various "bio-identical" hormones to help postmenopausal women or men in middle age grapple with hormonal imbalances. "More than anything else, (compounding) is about the ability to meet a patient's need with something that's not off the shelf," says Jeff Jackson, owner of CustomMed Apothecary, a compounding pharmacy on the Westside. Compounding is not new. Pharmacists compounded for years before pharmaceutical companies started mass production. Hospital pharmacies still compound -- for instance, most mix intravenous bags from basic ingredients -- but the practice became less common in community pharmacies. About 15 years ago, however, compounding slowly crept back, driven largely by consumer and physician demand, those in the business say. "The pharmacist was the chemist and Betty Crocker who put ingredients together with an understanding of what those products are and how they work," said Steve Russell, president of Medaus Pharmacy, in Birmingham, Ala., which does compounding by mail. An estimated 1 percent of the approximately 4 billion prescriptions filled each year in the United States are compounded, according to the International Academy of Compounding Pharmacists, a professional organization based in Missouri City, Texas, with about 2,000 members. Using a compounding pharmacy may or may not cost you more, depending on your insurance. Some plans don't cover compounded prescriptions at all, and co-pay costs can vary from those at the pharmacy you already use. Compounding pharmacists often refer to the four Ps of their job -- pediatric patients, pain patients, pets and post-menopausal patients, which together represent about 95 percent of customers. "Anything that there's not something manufactured and there's a need for it, we can do it," says Kelley Violi, a pharmacist at Meridian North Pharmacy. Beverly Gallagher, 56, is one patient who turned to Meridian North for help. Like many patients, Gallagher learned about compounding through her own research for alternatives to traditional hormone replacement. After running a series of tests on her hormone levels, her physician wrote a prescription tailored just to her needs.
		Mix it up: Matt Rettig, a pharmacy student at Butler University, holds a freshly compounded testosterone pellet. Compounding is about "meeting a patient's need with something that's not off the shelf," says Jeff Jackson of CustomMed Apothecary. - Frank Espich / The Star

Two things appealed to her about bio-identical hormones, says the Carmel resident, who has taken them in the form of a lozenge under her tongue and gel applied daily. Since she started, all of her symptoms of menopause, from hot sweats to insomnia, have disappeared.

"I believe there's less risk involved with bio-identical hormones," says Gallagher. "And the fact that it is not just a standard formulation, that it is for me and my body, it is meeting my specific needs -- I'm a believer."

Even Gallagher's dog took compounded medicines, which the vet said helped stave off the animal's decline and eventual death by a few years.

Attesting to the mainstream popularity of compounding, some chains even offer compounding services. In the Indianapolis area, Tucker-Walgreen's on the Southside and the New Castle store give customers this option.

Indianapolis family physician Dr. Roger Spahr appreciates the flexibility that compounding pharmacies offer. They make it possible for him to prescribe medicines that may not be commercially available anymore or allow him to tweak a patient's dose.

"I've had patients on some ingredient where 10 mgs is too little and 20 mgs is too much, but they'll make 15 mgs," says Spahr, a member of BodyLogicMD, a national network of doctors who specialize in bio-identical hormones.

Spahr runs detailed tests on each patient, many of whom complain of menopausal symptoms, low testosterone or other hormonal imbalances. Based on results, he can tailor prescriptions for that person.

Not everyone is an avowed fan of compounding. The Food and Drug Administration warns consumers that there's no evidence to support the belief that bio-identical hormones, frequently used by compounding pharmacies, are safer than agency-approved drugs to treat menopause. The agency also argues that compounding pharmacies should not use one form of estrogen, estriol, which is a common ingredient, since it is not FDA-approved.

While the agency says that it is not trying to pull all compounded drugs -- or even all compounded hormone therapies -- off the market, many in the industry feel threatened by its actions. A case pending in the Fifth Circuit Court of Appeals will decide whether the FDA can require compounding pharmacists to use only those ingredients that are a part of an FDA-approved product.

"Our whole profession is in question right now," says L.D. King, executive director of the International Academy of Compounding Pharmacists.

Compounding pharmacists bristle at the idea that their products are any less rigorously prepared than those made by pharmaceutical companies.

These prescriptions are made under strictly sterile conditions with the pharmacist and anyone else in the area masked and gloved. A modernized electronic mortar and pestle has replaced the familiar standby.

"The technology that we use is light years ahead of what was used back then," says Kurt Moyer, a pharmacist with Health Care Solutions, a compounding pharmacy on the Northeastside.

The end result of that technology is what drew Karen White 21/2 hours from her home south of Bedford to consult with Spahr. White, now 60, suffered hormone depletion for four decades since having a hysterectomy.

Years ago, she tried synthetic hormones, but stopped after news surfaced of a potential link between them and cancer. She suffered bladder infections, thinning hair, mood swings and a host of other symptoms until Spahr prescribed a series of hormones. Now she uses three creams a day. The difference is so great that she has no doubt that the lengthy trip to Spahr was worth it.

"For how I feel now, I would go to Alaska," she says. "I have just barely started, but I am already dancing in the streets."