A Return to the Mortar and Pestle

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.”

Most important, her pump-delivered medication has been reduced--with no ill effects--from more than 220 micrograms daily to less than 40. “It’s making a big difference,” she says. “I really believe I’m going to be able to get off this pump.”

Modern Technology Ensures Accuracy

Today’s compounding still relies on many of yesterday’s tools, but with a little boost from modern technology to save time and ensure accuracy.

Druggists still use an ointment slab and a spatula, for example, to mix topical medications--but then they put the preparation in a special machine that disperses the ingredients uniformly, eliminating remaining granules and powder spots that are difficult to get rid of by hand.

Or, instead of the folded powder paper used to painstakingly shake powder into gelatin capsules one by one, compounding druggists now can use a machine that “allows us to fill 100 capsules at a time with complete accuracy,” Gonzalez says.

Compounding was the norm among pharmacies until the 1960s, when many--lulled by the era of mass-produced pharmaceuticals--abandoned it. Of those remaining, many were frightened by the FDA actions, which were intended to prevent pharmacists from manufacturing drugs in bulk for sale to doctors and even other drugstores.

Compounding by individual prescription has never been illegal, and there are no restrictions on pharmacists who want to inform doctors that they do compounding. But the FDA worried that some pharmacists were doing so much advance compounding, and promoting specific products, that it was tantamount to manufacturing.

“We wanted to draw a line in the sand and tell pharmacists, ‘If you stay on one side, this agency will consider it the traditional practice of pharmacy . . . but if you cross it, we will treat you like a manufacturer,’ ” says one FDA official who asked that his name not be used. “A lot of guys got very upset that the FDA was going into pharmacies. They felt they had the God-given right to make this stuff up and sell it.”

The new law provides for cooperation between the FDA and state boards of pharmacy--which regulate pharmacy practices--in determining how to monitor compounding. And it calls upon the FDA to establish a list of specific drugs that it determines are too dangerous to be compounded safely.

The list, which is being developed by an FDA advisory committee, is expected to include products with complicated delivery systems, such as metered-dose inhalers and patches, and medicines that must be kept absolutely sterile throughout each step of production, such as eyedrops or injectable drugs. Sterility has always been an issue, according to the FDA, which investigated a 1990 Pittsburgh case where two patients each lost an eye due to a bacterial infection caused by contaminated eyedrops made by a compounding pharmacist.

“If they [the pharmacists] know what they’re doing, it’s not a problem--but [this Pittsburgh pharmacist] didn’t keep sterility very well,” says the FDA official. “There are things that can happen.”

Major drug manufacturers are unhappy with the growing popularity of compounding, saying the practice raises major patient safety issues. Industry officials cite, among other things, potential problems with sterility, dosages and time-release drugs.

“I have very great concerns about dosage, particularly if it’s a product where the amount that I am getting has to be carefully calibrated, and where the physician has to keep adjusting the dosage,” says Marjorie Powell, assistant general counsel to the Washington-based Pharmaceutical Research and Manufacturers of America.

She admits to a large degree of skepticism about the legitimacy of compounding-only pharmacies, although she acknowledges she cannot prove any are breaking the law.

“If, in fact, what they are doing is compounding full time, then they are essentially manufacturers--even if they have the prescriptions,” she says. “(And) I don’t believe they are working prescription-by-prescription.”

Difficult to Make a Living Compounding

Druggists agree that compounding alone does not yet pay. Some, like Barker’s Pharmacy in Mattituck, N.Y., on eastern Long Island, do both conventional prescription-filling and compounding--because compounding alone can’t support the business.

But compounding druggists hope compounding’s growing popularity will increase sales.

“We’re paying our bills through our other stuff,” says Barry Barth, a co-owner of Barker’s. “Right now, we’re only filling about three [compounded] prescriptions a day. When we get to 10, we will be generating enough to set up our own separate site for compounding only.”

In many cases, insurance companies will reimburse for compounded drugs--although not at a high enough level to compensate for the druggist’s labor. As a result, some compounding druggists won’t take insurance, Barker’s and Gonzalez’s stores among them.

“A medication may cost me $1 in ingredients, but $50 in time, and when insurance companies reimburse, they usually only pay the cost of ingredients,” says Gonzalez, who works on a cash-only basis.

He defends his no-insurance policy, saying that compounded prescriptions are less expensive than the out-of-pocket cost of brand name, off-the-shelf drugs for those who lack prescription coverage.

Also, “suppose you have an elderly patient with arthritis who is taking something for pain, and also having to take something for stomach problems that are a side effect of the pain medication,” he says. “I can take the pain medication and turn it into a cream that’s not commercially available, and she will never have that side effect because she is applying it right to the site of the pain.”

Vada Chapel, 74, is “very pleased” with the topical cream Gonzalez prepares for her. A retired archeologist who now lives in Fullerton, she paid a price for a career that kept her constantly on her knees--damage that led to arthritis, diagnosed about five years ago.

At times, the discomfort became so bad that she couldn’t walk. She took oral nonsteroidal anti-inflammatory drugs to ease the pain, but they wreaked havoc with her gastrointestinal tract--a common side effect of such medications. Her physician sent her to Gonzalez, who prepared a special cream that she rubs directly into both knees.

“I’m able to move around more fluidly, and I’m getting pain relief without doing any damage to my stomach,” she says. “I have no stomach problems at all anymore.”

Besides customer satisfaction, Gonzalez, who graduated from the Chicago College of Pharmacy in 1998, says his rewards also come in other ways. He worked for conventional pharmacies, where “I was filling 300 to 400 prescriptions a day, and got burned out,” he says.

He says he is filling up to 20 prescriptions a day, up from 11 a month when he first opened a year ago.

“My dream is to get to the point where I can open an old-fashioned compounding-only corner drugstore,” he says, one that will remind people of those of a generation ago, “with old-style wooden cabinets--and even a soda fountain.”