Thanks to Oprah Winfrey and 21 polo horses, the world of pharmacy compounding is getting attention like never before.
First it was Winfrey, who spoke glowingly about bioidentical hormones on her talk show and wrote about them in her magazine as a therapy for symptoms of menopause. The source of the wonder hormones? Compounding pharmacies, which prepare medications for individual patients' requirements.
But then last Sunday, 21 thoroughbred horses, in South Florida for a polo match, died in rapid succession. Though the cause of death has not yet been determined, a compounding pharmacy in Ocala revealed Thursday that a specially prepared supplement given to the horses contained an incorrect mixture.
The heightened attention is new, but pharmacy compounding has been around for ages and accounts for some 30 million prescriptions a year in the United States. The customized formulas are used by patients ranging from children to the elderly, as well as cats, dogs and polo horses.
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Pharmacy compounding is the customized preparation of a medicine in a way that is not available from major drugmakers. The practice actually predates the mass production of medications, which didn't come about until the 1950s and '60s, said L.D. King, executive vice president of the International Academy of Compounding Pharmacists, which has about 2,000 members.
Besides bioidenticals for women seeking hormone treatment, compounded medications are used for patients such as:
• Children who need specific dosages or special flavors to make the medications easier to take.
• Patients taking multiple drugs who can take them more easily when they are compounded into a single dose.
• Cancer patients whose chemotherapy treatments are precisely calibrated for individual needs.
• Patients who are allergic to preservatives, binding agents or other ingredients found in mass-produced medications.
"It brings a lot of good things," said Steve Caddick, a pharmacist at Westchase Compounding Pharmacy in northwest Hillsborough County whose Web site proclaims, "If you can imagine it, we can make it!"
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Under federal law, any licensed pharmacist is permitted to compound drugs. But most don't do it. Of the 7,748 licensed pharmacies in Florida, only 42 have a special permit to compound medications, according to the state Department of Health.
That includes a handful in the Tampa Bay area. But they're not of the CVS or Walgreens variety; most are independently owned, King said.
Caddick said he has seen a steady increase in the interest in and use of compounded medications in the five years that he has been a pharmacist. At Westchase, the pharmacy produces everything from bioidentical hormones for women to antibiotics for cats and dogs, he said.
But incidents such as the polo horse deaths are sure to raise new questions about the safety of such drugs. Critics of the practice have cited the fact that the Food and Drug Administration does not regulate compounded products. Some critics claim that some compounders are overstepping their bounds, and they point to three deaths in recent years associated with compounding errors, according to a recent investigation by Prevention magazine.
Those incidents are a tiny minority of this multibillion-dollar business, say supporters, who note that compounders are regulated by state boards of pharmacy and are inspected at least once a year. Additionally, the Florida Board of Pharmacy specifies the types of products that may be compounded and has general requirements for things such as handling and packaging, and the equipment and space used for producing compounds.
The state is investigating the Ocala pharmacy, Franck's Pharmacy, which has no violations in its history, according to state Department of Health spokeswoman Eulinda Smith.
King said the risks associated with compounding medications are the same as with any drug that's dispensed — using the prescribed products in precisely measured doses is always crucial, whether in a mass-market or a compounded product.
He also said that compounding pharmacists typically undergo more training than other pharmacists. And he cited the creation of a Pharmaceutical Compounding Accreditation Board, which subjects participating pharmacies to a greater level of scrutiny.
Caddick added that all of the chemicals his pharmacy uses have met with the stringent approval of the FDA. The pharmacy will often send compounded medications it has produced to a third-party lab to ensure their quality. The drugs are produced in a sterile lab, with the pharmacists and pharmacy technicians gowned from head to toe.
Richard Martin can be reached at email@example.com or (727) 893-8330. For the latest in health news, visit tampabay.com/health