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Compounding Pharmacy: Traditional Practice Fills Vital Niche

Issue: June 2008

By: Stacy Schwan

Long since the days when Grandpa dispensed made-to-order medicines from the gleaming counter of his storefront pharmacy, the art of pharmaceutical compounding still occupies a vital niche in our modern health care delivery system. While giant pharmaceutical companies compete for market share with patented and mass produced, brand name drugs, compounding pharmacies quietly provide custom-tailored medications for the many situations where “off-the-rack” just won’t do.

The United States Pharmacopeia estimates that 30-40 million prescriptions are compounded each year in the U.S. Compounded medicines are especially useful where commercial preparations are no longer available, or not in a dosage or form that can be tolerated by a patient.

Trends in Compounding

Think “compounding pharmacy” and what may first come to mind is the controversial topic of bio-identical hormone replacement therapy (or BHRT) which, though available for years prior, took center stage in 2004 when actress Suzanne Somers wrote about it in her book The Sexy Years.

But BHRT is only one arena where compounding pharmacies are in high demand. Compounded medicines are utilized in a vast array of applications spanning from head to toe and from birth to the grave. Lionel Jara, R.Ph., head pharmacist at the well-known Santa Clara Drug in San Jose, says that over half of the medicines dispensed by his pharmacy are compounded for diverse communities ranging from major hospitals to pro sports teams to veterinarians.

“Hospice is a big one - we deal with a lot of pain and anti-nausea preparations for hospice,” says Jara. “We also do a lot of transdermal pain management for worker’s comp, hormone replacement for men and women, topical anesthetics for dermatology and pediatric medications. We make sublingual lozenges called ‘troches,’ nasal sprays and sterile eye drops. In essence we formulate anything that is no longer made or special dose or requires different delivery systems. Whatever physicians can’t get or don’t have, or call for special formulations, we tackle.”

Santa Clara Drug also has an “ultra-clean room” for preparations requiring sterile ingredients and conditions. “It takes a high level of commitment to develop the delivery systems and obtain the pure chemicals,” Jara says. Still the satisfaction he gets from helping patients with chronic pain, or diabetic neuropathy, or autism, or myriad other special needs, makes it all worthwhile.

Bob Brensel, R.Ph., is the owner and president of ScriptWorks, a compounding pharmacy in Walnut Creek. “My dad was a pharmacist and he taught me how to compound,” he says. “He graduated from pharmacy school in ‘38 or ’39. Back then we only had about five drugs on the market so compounding was just about all he did.”

Although the demand for compounding dwindled considerably during the 1950’s as the major pharmaceutical companies brought more and more drugs to market, Brensel says he has seen compounding make a comeback in the last two decades. The Professional Compounding Centers of America (PCCA) was established in Houston in 1981 to provide tools and training for its compounding pharmacist members, which now number more than 3,500. “I credit them with the resurgence of compounding,” Brensel says. Brensel also credits PCCA for igniting his own passion for compounding, to the point where it now makes up 80-90% of his business.

Challenges and Rewards

Though the rewards of practicing compounded pharmacy are many, so, too, are its challenges.

For one, managed care and compounding don’t mix very well. Most insurance companies won’t pay for the time it takes to compound, which is often considerable. Altruism aside, compounding can make it difficult to run a profitable business.

Pharmacy technician Kathy Clayworth owns Clayworth Pharmacy with her pharmacist husband James Clayworth, R.Ph. They make compounded medicines primarily for hospice and for veterinarians, as well as some BHRT. However, Clayworth says, they are gradually moving away from compounding, not because they want to, but because it isn’t feasible from a business standpoint. “No one wants to pay you for your time,” she says. “That has been the biggest disappointment.”

Still, the Clayworths will continue to do some compounding, mostly for personal reasons. “Both my husband and I have had family members in hospice, and we feel it is important to do,” she says. “It really does feel like you’re doing something to help patients.”

This idea—that you can actually create a substance that will make life better for others—can be a powerful draw for those considering entering the industry. The art of compounding taps the inner well of idealism, creativity, and scientific inquisitiveness that that motivates many sharp young talents to become pharmacists in the first place. Nothing can replace the psychic rewards inherent in coming up with a new formula or preparation that helps a patient who might otherwise fall through the cracks.

To illustrate this point, Brensel tells a story about a call he received from Stanford Medical Center regarding a 9-year-old patient who had suffered seizures most of his life:

“They had put him on adult medicine, and he was having to chew the oral tablets up. At one point he wouldn’t do it anymore—he just refused. He had a seizure, and fell through a shower door, and had to have plastic surgery. That’s when Stanford called and said ‘what can you do for us?’”

Taking the challenge, Brensel and his staff spent hours developing a formula to disguise the medicine, ultimately creating gummy bears in the boy’s favorite flavors—bubble gum and grape. “He went from having three seizures a day to where he was having three a month,” says Brensel with obvious satisfaction.

For Brensel, and thousands of pharmacists like him, this is what it’s all about. “This is my dream pharmacy,” he says. “It’s what a pharmacy should be.”

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