Compounding Pharmacists

October 2001 | Health Conscious

Compounding Pharmacists

by Rebecca Ephraim, RD, CCN

A growing number of pharmacists are changing the way they practice. They are shunning the typical pharmaceutical drug grind and joining the ranks of health professionals who emphasize more natural approaches. They’re called compounding pharmacists and they have become expert in the art and science of preparing custom medications for patients. Although exact numbers are hard to come by, there are probably between two and three thousand pharmacists practicing compounding techniques in the United States today. Most continue to be involved in the typical dispensing of manufactured drugs as well. But a small subgroup of compounding pharmacists — possibly no more than a couple hundred — is breaking free of a role in healthcare that they consider frustrating and unhealthy.

Larry Frieders, who’s been a practicing pharmacist for thirty years, is one of them. "More and more of what I was doing was taking [pills] out of one bottle and putting them into another bottle and hoping that everything worked out okay. Over time the emphasis was placed on volume.... I was competing with the giant drugstores. I felt uncomfortable in that situation and I think for me that was a wake-up call to say,‘Larry, you’ve got more responsibility than just volume.’"

In addition, the increasing toxic side effects that seem to be a hallmark of many pharmaceutical drugs haunted his ethical integrity. "They’re [the drugs] getting more and more toxic...more dangerous out there." He sites the cholesterol-lowering drug Baycol as one example. Baycol was yanked off the market last August because of its deadly side effect that caused muscle cells to break down. Or, he adds, other drugs with potential side effects, such as hormone replacement therapies or blood pressure drugs or Ritalin-type medications, or, or, or.... "On one hand you can say, well, yes, but those toxic drugs do have overriding benefits where there’s a net gain...and people, in general, are better off...but I’m not necessarily of that philosophical bent." Frieders says he loathes the idea that among the people who are treated with powerful drugs there are some who will encounter seriously incapacitating side effects. It’s not an approach on which he wanted to base his pharmacy practice.

So what does a health professional who’s educated to dispense drugs do when he doesn’t like the drugs he’s dispensing? He makes his own! In 1997, Frieders, who owns Option Care Compounding Pharmacy in Aurora, Illinois, began specializing in compounding methods. "I’ve removed all the standard prescription items and now what I do is dispense only those things that I can compound...that I think have merit or value...[things like] pain medications for unrelenting pain and [natural] hormone medications for women who want to rebalance their hormone structure."

Conventional medicine has always accepted the idea that some patients are not good candidates for mass-produced drugs. They may be allergic to preservatives or dyes in the drugs or sensitive to standard drug strengths. In these cases, a compounding pharmacist can prepare a drug to alter its strength, eliminate the allergens, or make it more digestible or palatable.

A compounder can also put a drug in a form that doesn’t have to be taken orally, thus avoiding dangerous side effects. For example, one of the ugly side effects of a widely used group of pain relievers, nonsteroidal anti-inflammatory drugs (NSAIDs), is that they can irritate the stomach and often lead to inflammation of the stomach lining (gastritis), ulcers, bleeding, or perforation of the lining. In fact, it’s estimated that twenty thousand deaths a year are caused by the serious side effects of NSAIDs. Imagine, people taking a drug that’s supposed to make them feel better but ends up killing them!

A compounding pharmacist can make up NSAIDs that can be administered sublingually (absorbed under the tongue) or transdermally (absorbed through the skin when applied as a cream). Either of these delivery methods avoid the gastrointestinal tract altogether and, consequently, avoid damage to the stomach.

Drugs that are taken orally have to go through the liver to be broken down. Frieders points out that up to 90 percent of the active ingredients in a drug can be lost through the liver pathway, not to mention that the patient may have to contend with debilitating side effects. He says by applying many drugs transdermally, pharmacists can use as little as 5 or 10 percent of the standard dose and eliminate many dangerous side effects. As compounded drugs often have a short shelf life they are not practical for mass production.

A few pharmacists specialize in "nutritional" compounding, remedies that work with the body as opposed to "pushing the body to do something it doesn’t want to do," as pharmacist David Nicoletti puts it. Nicoletti, a compounding pharmacist in Tucson, Arizona, is a favorite among alternative-minded M.D.s and (licensed) naturopaths — physicians who focus on holistic and nontoxic therapies. "I prefer a nutritional or a holistic approach to a problem if it’s possible. But I still have a lot of respect for pharmaceuticals. I know when it’s time to use something like that in acute situations."

When making presentations, Nicoletti, who’s also a certified clinical nutritionist (C.C.N.), emphasizes an integrative medicine approach. "If you have a patient in acute pain, you’re going to need some pharmaceuticals to get them over the hump and then you can use alternative therapies to smooth everything out and get them to where you want them. But I still believe there’s a place for both." For instance, Nicoletti advises using opiates such as morphine for serious pain. He says the reaction from doctors is, "’Oh they’re toxic; they’re bad! People get addicted!’ I say,‘Can somebody tell me one death they know of from an opiate?’ And I remind them that the opiates have been around for thousands of years and are one of the safest classes of drugs." Drug companies have a vested interest in aggressively marketing new drugs for which they have patents so many of the old yet very effective (and less toxic) drugs fall out of favor.

Compounding pharmacists, like their conventional counterparts, need a prescription from a physician before dispensing drugs. So working with conventionally trained M.D.s who base much of their practice on invasive pharmaceutical drugs can be a sticky wicket for natural-minded compounding pharmacists. However, most of their compounding business is patient driven. In other words, patients who learn about the virtues of compounding over mass-produced drugs tell their doctors they’d like to pursue this avenue. Frieders says, "When a patient comes to me and says‘I’ve tried and tried and Dr. XYZ just won’t agree with me,’ [I tell them] there are other doctors. We help them find [physicians] who will be more supportive of them."

At the same time, Dave Mason, R.Ph., C.C.N., who pursues his compounding practice in Edmund, Oklahoma, is hopeful that prevailing attitudes will begin to give way to less invasive therapies. "There are plenty of doctors out there who are open and willing to listen especially in light of the Baycol recall. They’re starting to realize that maybe there is something to our complementary side but also that maybe the drugs that they’ve taken for granted...may not quite be what they’re cracked up to be."

He, like his colleagues Nicoletti and Frieders, compounds a variety of medications that are nutritional or more natural. Some of the more popular requests include amino acid blends (put into capsules for specific amino acid deficiencies), vitamin injectibles (shots for vitamin deficiencies) and, a big seller these days, natural hormone replacement therapy for women. It’s technically referred to as bio-equivalent hormone replacement therapy as the hormones used (estrogens, progesterone, and testosterone) are identical to the body’s natural hormones but derived from wild yam and soy plant sources. Patients, doctors, and pharmacists find that when these are used in place of the commercially available synthetic hormone replacement therapy and tailored to the individual woman’s specific needs, side effects such as bleeding, mood swings, breast tenderness, skin eruptions, and weight gain are minimized or nonexistent.

Compounding can be more expensive than the mass-produced drugs and it’s iffy as to whether health insurance will cover specific medications. But this maverick breed of compounding pharmacist has joined the ranks of those wanting a more healthful health-care system. As Frieders puts it, "We’re always going to be butting heads with the established way of doing things."

Disclaimer: This column is for information only and no part of its contents should be construed as medical advice, diagnosis, recommendation or endorsement by Ms. Ephraim.