WEST PALM BEACH, Fla. — Pharmacist Ephrem Degefu’s shelves are stocked with clean, white bottles of powdered chemicals, all essential ingredients in hundreds of commonly used medications.
But Degefu isn’t repackaging medications like your typical corner drugstore. He’s making them.
Degefu is a compounder, a pharmacist who custom-mixes drugs for patients. Although they have been around for centuries, compounding pharmacies are getting attention because of the recent deaths of 21 elite polo horses that were given a lethal cocktail of drugs erroneously mixed up by a compounding pharmacy in Florida.
In contrast to the arduous and expensive process by which new pharmaceutical products come to market, critics say oversight of compounders is spotty and that patients — human and animal — are sometimes given medications that regulators never tested.
Occasionally, the results are deadly.
“The whole system is full of holes, or maybe it’s not even a system,” said Larry Sasich, a pharmacist and professor at Lake Erie College of Osteopathic Medicine School of Pharmacy in Erie, Pa.
Others say that they serve a vital role and that mistakes are rare.
“There are just a lot of patients who need a medication that’s not commercially manufactured,” said L.D. King, executive director of the International Academy of Compounding Pharmacists. “And I think it’s well-regulated, and it’s improving.”
The polo horses began dying April 19, just before a championship match near West Palm Beach. They were given a cocktail of vitamins and minerals from a Florida compounding pharmacy that has acknowledged using too much selenium in the mix. Like many others, the pharmacy mixes medications for animals and people.
From 1990 to 2005, the U.S. Food and Drug Administration documented at least 240 serious illnesses and deaths associated with improperly compounded products. The agency noted that the numbers may be considerably higher because compounders aren’t required to report ill effects. Still, it’s a tiny fraction of the thousands who suffer adverse reactions to manufactured, FDA-approved drugs every year.
In 2007, three people in Oregon died after using a poorly made compounded drug that was 10 times stronger than it was supposed to be. The Oregon Department of Justice sued the Texas pharmacy that produced it, later settling the case.
In 2006, the FDA issued a warning letter to a Maryland pharmacy for a bacteria-contaminated solution it created for use in open-heart surgeries. The drug caused severe infections in five patients at a Virginia hospital. Three of them died.
And in 2005, the agency recalled a product that was distributed to eight states after two Washington, D.C., patients were blinded and several others injured from use of a compound that was also contaminated with bacteria.
There are about 5,000 pharmacies nationwide that specialize in compounding, according to King. They fill about 38 million prescriptions each year — about 1 percent of the roughly 4 billion prescriptions dispensed annually, he said.
But many more traditional pharmacies also do some form of compounding, he said, including Walgreens and other national chains. And hospitals also do it regularly.
“Hospitals have a huge rate of medication errors, whether it’s a wrong dose or a wrong drug,” King said. “Mistakes are unfortunately all too common in health care, and compounding pharmacies are not going to be immune.”
The FDA does recognize the need for compounding pharmacies that alter and create medications to meet patients’ needs, but the agency considers them all unapproved drugs and has not verified their safety or effectiveness.
Instead, regulation is left mostly to the states, but the rules vary from state to state and enforcement is sparse, said Sasich, who called it a “shadowy industry” operating under standards “more akin to the Third World.” And unlike drug manufacturers, compounders don’t need to have their products tested before giving them to patients.
The need for compounders
Patients who turn to compounders include people who are allergic to inactive ingredients in FDA-approved medicines, or those who need a different dose or a different form of deliverysuch as a cream, powder or injectable liquid — than what is commercially available. Any licensed pharmacist can compound drugs, but a doctor’s prescription is required.
21 Number of elite polo horses given a lethal dose of selenium in drugs mixed up by a compounding pharmacy.
