Associated Press/AP - This photo provided by the Minnesota Department of Health shows shows vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak.
One of the compounders Johns Hopkins Hospital uses is Ameridose, a company that has common ownership with the New England Compounding Center and that has temporarily ceased operation as state and federal officials review its safety and sterility procedures.
Another is AnazaoHealth in Tampa. It supplies certain specialty pain medications but only in response to patient-specific prescriptions for them, both Ashby and the company said.
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The third is PharMEDium of Lake Forest, Ill. One of the drugs Hopkins gets from them is calcium gluconate, sometimes used in severe heart-rhythm disorders; another is magnesium sulfate, used to treat a life-threatening condition of pregnancy called pre-eclampsia. Ashby said the hospital does not send patient-specific prescriptions with orders for those drugs.
The company wouldn’t make anyone available to answer the question of whether PharMEDium ships drugs only in response to orders naming individual patients.
A Chicago public relations firm provided a statement saying that PharMEDium follows FDA guidelines and that the agency “has inspected our compounding pharmacies regularly over the years.” But it didn’t answer the question.
‘A really unfortunate event’
A year ago in July, an elderly woman came to the Bascom Palmer Eye Institute at the University of Miami, groaning in pain and with a cloudy eye whose vision was disappearing.
Roger A. Goldberg, an ophthalmology resident, quickly determined the interior of the woman’s eye was infected. She told him that one day earlier it had been injected with Avastin, a drug for people with macular degeneration.
Goldberg thought the complication, which occurs in 1 in 2,000 injections, was supremely bad luck. But when the next patient he saw was another woman with nauseating pain and an infected eye who had been injected with Avastin by the same doctor, he knew something was up.
Both women had gotten Avastin in prefilled syringes made by a compounding pharmacy. It was contaminated with a virulent strain of Streptococcus bacteria.
In all, seven women and five men treated at four South Florida clinics got the infection. Only one has recovered full sight. Seven lost complete vision in the injected eye, and in five the eye was removed. One person, injected in the only useful eye, is blind.
“It’s been a really unfortunate event,” said Goldberg, who published an account of the outbreak in the American Journal of Ophthalmology this year.
But he doesn’t think the way to prevent tragedies is to ban compounding pharmacies from providing Avastin to eye doctors — it’s just too good a deal for patients.
Avastin is a cancer drug sold by its manufacturer, Genentech, in 4- and 16-milliliter vials. Eye doctors need only 0.1 of a milliliter to treat macular degeneration. Compounding pharmacies repackage the drug into the tiny amounts required by ophthalmologists and sell them for $50 a dose. This is officially an “off-label use” of Avastin because the FDA hasn’t approved it for eye disease.
The alternative is a slightly different medicine called Lucentis. It has gone through all the testing required to get FDA approval for use in the eye. It sells for $2,000 a dose and is also made by Genentech.
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