Compounding pharmacies rise in popularity but bring questions about safety

Compounded drugs are also sometimes cheaper; the steroid the clinic bought from the Massachusetts company was about $2 less per vial. Compounding pharmacies often have supplies of such workhorse pain medicines as fentanyl, midazolam and propofol when the usual suppliers have run out.

According to a guidance document issued in 2002, the FDA says the distinguishing feature of compounding pharmacies is that they make “drug products . . . on a customized basis for an individual patient.” A similar assertion appears in the warning letter the agency sent to the New England Compounding Center in 2006.

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Reuters news service reported on Saturday that a dozen e-mail messages it obtained show that the Massachusetts company regularly filled orders without having individual patient prescriptions in hand, as is required by state law. The requirement to have patient-specific prescriptions appears to have been violated by other companies as well.

For example, the Maryland physician said that when he orders drugs for his few multiple sclerosis patients, he sends prescriptions with their names on them. But “for everything else,” he said, “we just send [compounders] a script for a case of 50 or whatever we’re buying, and they send us the drug.”

He’s never really thought of compounding pharmacies as different, less regulated, under-the-radar enterprises.

“From our perspective, they look like any of our other vendors,” he said. “They’re licensed and inspected; they have nice, pretty Web sites and sales teams and inspections. They look no different from Upjohn.”

Uses at Johns Hopkins

Johns Hopkins Hospital stocks 3,000 different drugs or dosage forms in its pharmacy. Twenty-six come from three compounding pharmacies, although Daniel Ashby, director of the hospital pharmacy, thinks of those suppliers more as “repackagers.”

There are several reasons an institution as august as Johns Hopkins Hospital uses compounders. Sometimes they are the only source of a drug in short supply. Sometimes they can provide a safer formulation of a medicine. Compounders reformulate some drugs into pediatric doses and label them in a way that clearly distinguishes them from adult doses. A third reason involves the concept of “beyond use dating.”

Ashby explained that some drugs have to be on hand for immediate use by patients. However, if a dose is drawn into a syringe from a large vial and not used within a specified period of time — usually 24 hours — it has to be thrown away.

Compounders prepare such doses (usually in small bags of IV fluid) and then test them for sterility and potency after a specified period, usually a month or longer. If the drugs pass the tests, the compounders are allowed to sell such repackaged drugs with a labeled shelf-life of weeks or months (although never as long as the shelf-life of the vial they came from). This allows the hospital to create a small stockpile of the drugs with the confidence that most of it won’t have to be thrown away.

“We would buy quantities from them that could be dispensed to multiple patients,” Ashby said.