This photo provided by the Minnesota Department of Health shows shows vials… (Minnesota Department of…)
Pharmacy compounding, the mixing of drugs for individual patients, was once a quaint activity depicted on drug-store calendars from the 1950s. It has roared back in the 21st century, driven by the rise of out-of-hospital surgical care, the high prices and shortages of drugs, and the real or imagined benefit of “personalized medicine.”
Today, nearly every place medical care occurs — hospitals, doctor’s offices, home-health companies — now gets at least some of its drugs in forms that aren’t available off the shelf from pharmaceutical houses.
The practice burst into the national spotlight this month when cases of a rare brain infection, widely scattered across the country, were linked to a drug mixed by a compounding pharmacy in Massachusetts. As of Saturday, 198 illnesses and 15 deaths had been reported from 13 states.
Hospital pharmacists no longer compound drugs just for premature infants or patients with unusual conditions. Corner druggists see compounding as a more lucrative and interesting job than bagging blister-pack prescriptions. Chain drug stores are getting into the business. And entrepreneurs are taking up mortar and pestle to meet the demand, one of them being the New England Compounding Center, which is at the middle of the current outbreak.
That company in Framingham, Mass., shipped nearly 18,000 vials of methylprednisolone acetate, a steroid injected around the spinal cord to relieve pain, to buyers in 23 states. How many of the vials were contaminated is unknown. About 14,000 people have been injected with material from the three tainted lots. Health officials expect more cases of fungal meningitis to appear.
Whether that volume of sales tipped the company out of the category of “compounding pharmacy” and into that of “drug manufacturer” is a matter of dispute. So is the issue of who has principal responsibility — Massachusetts’s pharmacy board or the federal government’s Food and Drug Administration — to oversee such operations and prevent disasters like the one that’s happening.
What’s not in dispute is how much U.S. medicine has come to rely on this little-known and little-regulated part of the economy.
Compounded drug benefits
“It’s like buying your electricity from a different supplier. It looks like you’re getting the same stuff, but evidently you’re not,” says a physician at one of the seven outpatient treatment centers in Maryland that received methylprednisolone from a contaminated lot from the New England Compounding Center. A pain specialist, he’s been using compounding pharmacies “for at least five years, closer to 10.” He spoke on the condition of anonymity on the advice of his lawyer.
Compounders are especially important for patients with multiple sclerosis who get a mixture of drugs that are not commercially available and are continuously infused into the spinal canal. The clinic also turns to compounders for preservative-free injectable steroids because some of the doctors there think that alcohol preservatives in conventional preparations can be irritating.
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.
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.”