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A Return to the Mortar and Pestle

Pharmacists: More are making their own prescriptions--now that the guidelines are clear.


WASHINGTON — Mark Gonzalez runs a drugstore in Yorba Linda where he makes each prescription from scratch. He uses a glass mortar and pestle to mix his medicinal powders, the same tools that have served this ancient craft for generations.

Gonzalez, who opened his store, Med Specialties, last year, is one of a legion of druggists who have brought back the time-honored art of pharmaceutical compounding, which, until recently, had become all but extinct.

"This is what pharmacists originally were taught to do," Gonzalez says. "I love it, not just because it helps people, but because of its history."

Up until about three years ago, Gonzalez and other pharmacists trained in drug compounding were reluctant to use their knowledge, leery of a federal crackdown on store-made medicines.

The Food and Drug Administration, concerned that pharmacists might compromise sterility or otherwise endanger patient health, was going after pharmacists they said were "manufacturing unapproved new drugs under the guise of compounding." Many druggists--even those who were behaving legally--stopped, worried that an FDA official could walk through their front door unannounced, demanding to inspect their facilities.

The FDA "made everyone nervous . . . as if they were breaking the law," says Susan Winckler, group director of policy and advocacy for the American Pharmaceutical Assn., herself a pharmacist. "It made no sense to many pharmacists who felt that this is what they were taught, and this was how medications were made originally."

In 1997, however, Congress passed legislation reforming the FDA. Contained within the lengthy bill was a provision that explicitly sanctioned compounding and that instructed the FDA to work with state boards of pharmacy in drawing up guidelines.

Now, these rules are almost completed, and pharmacists--anticipating a new era in customized drug compounding--are returning to the field. Suddenly, compounding is enjoying a stunning renaissance.

"The new law helped to finally clear the air as to what is legal and what is not," says Loyd Allen, editor of the International Journal of Pharmaceutical Compounding. "Pharmacists now feel free to engage in compounding again."

The numbers are dramatic: In 1992, the Houston-based International Academy of Compounding Pharmacists had only 352 pharmacist members--today it boasts more than 1,500, and its ranks are growing. The academy says there are at least 250 compounding-only pharmacies. Even pharmacy schools have begun expanding their curriculum to include it as a requirement, rather than an elective, and special compounding colleges have sprung up for druggists who wish to expand their skills.

Today, less than a decade after compounding had nearly disappeared, most of the nation's 22,000 independent pharmacies are engaging in some level of compounding again--although it is rare among the nation's 30,000 chain drugstores.

Some pharmacies, like Gonzalez's, do nothing else. And, like his, many are located, not in the old-fashioned drugstore setting, but in spotless labs in office malls, where customers can stand behind a glass window and watch their medicines being made.

Traditional compounding, when available, has always been popular. Now, in today's impersonal managed care environment, customers seem even more grateful to have the individual attention. Medicines can be customized to solve an individual problem. Specific ingredients can be substituted or eliminated to avoid known allergies or side effects. Natural hormones can be used in place of prepackaged synthetic ones. Hard-to-swallow capsules can be converted into liquids that are easy to drink.

"Our whole focus is to meet a patient's needs," Gonzalez says. "Most people who come to us, come with a problem, whether it is a child who can't swallow a pill, or an elderly person who can't handle the irritating side effects of a skin cream. We can reformulate it in a way that solves the problem."

Laurie Brogan, 42, a stay-at-home mom from Oceanside who was diagnosed with multiple sclerosis in 1993, is one of those with a specific need. Brogan uses a wheelchair and for several years has been taking a muscle relaxant medication delivered to her spine through an intrathecal pump implanted in her abdomen.

The medicine helps control her muscle spasms, but the pump is ever-present--"I know it's there"--and she would like to get rid of it. She believes a new compounded medication Gonzalez has been making for her will enable her to do so.

It is a cream delivered through a patch she wears on her arm or thigh, which she changes daily. The histamine-based compound has resulted in improvements in her motor function, she says.

"Before, I couldn't stand up or move my left leg at all. Now I can kick it out," she says. "Before I couldn't stand [without support.] Now, with help getting up, I can stand. It's truly amazing."

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