Vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak.
All across the country, doctors, pharmacists and hospital administrators are taking a long, hard look at where they buy drugs. The ongoing outbreak of fungal meningitis, linked to a few batches of contaminated pain injections, has added another reason to worry about the safety of patients.
More than 200 people have been diagnosed with a never-before-seen type of fungal meningitis, caused by a black mold more commonly blamed for causing sinus infections. Fifteen people are dead, many having suffered from strokes.
“It bothers me as a doctor that I don’t have faith in what I am giving,” said Dr. James Williams, an emergency room physician at St. Joseph’s Medical Center in Baltimore. “I can tell you that hospitals are looking at their stocks.”
Dr. David van Ryn, an emergency physician at Elkhart General Hospital in Indiana, agrees. “It really makes you wonder about the safety of these things, not only from an infectious diseases standpoint but also when you look at the quality control, reliability. Is it the right concentration? Does it contain what it is supposed to?” he asked.
Doctors usually don’t think much about the sourcing of the drugs they prescribe. Office-based doctors generally leave it to patients to fill their prescriptions, often through a large pharmacy benefit managers such as Express Scripts or at retail pharmacies. Hospital-based doctors rely on their hospital’s pharmacy and therapeutics committee to decide what to buy and where for patients.
The outbreak appears to have been caused by three batches of a steroid called methylprednisolone, supplied by the New England Compounding Center in Framingham, Massachusetts. Compounding pharmacies are supposed to mix up drugs to order – a special cream, for instance, or a flavored syrup. NECC, however, had shipped tens of thousands of vials.
The U.S. Food and Drug Administration doesn’t do routine oversight of compounding pharmacies, leaving the responsibility to state boards of pharmacy. Massachusetts officials say they are checking the possibility that NECC had way overstepped its license.
Centers for Disease Control and Prevention
Dr. Benjamin Park, Surveillance Team Lead, updates the Incident Manager and colleagues on CDC activities in response to the 2012 fungal meningitis outbreak.
Bonnie Levin, who heads pharmacy services at Maryland-based MedStar Health, said her not-for-profit, regional healthcare system had sometimes used outside compounding pharmacies on occasion, but has stopped since news of the fungal meningitis outbreak. “This story made us stop,” Levin said in a telephone interview.
“I think it is changing the way people look at the whole industry,” she said.
Sometimes hospitals and clinics turn to compounding pharmacies because of drug shortages. Recent shortages, which have affected cancer drugs, attention deficit hyperactivity disorder drugs and others, are not as bad this year, regulators reported last month.
As of Aug. 31, there were 123 reports of new drug shortages for 2012, about a third lower than those logged for about the same period in 2011. Last year was a record year for drug shortages in the U.S., with 267 drugs in short supply.
The FDA denies that methylprednisolone was in short supply, and says there are plenty of legitimate sources for the drug.
But the source issue may have helped encourage compounders to take on a bigger role than they traditionally filled. “In the last five or 10 years all hospital and outpatient practices have been impacted so severely by drug shortages. I would imagine some of these places will take whatever they can get,” said Van Ryn.
“There have been times when we couldn’t get a drug from wholesalers or manufacturers,” Levin said. So hospitals bought from repackagers. Now, Levin said, hospitals may look to do more of the repackaging themselves.
“We are concerned about the industry and the regulators,” she said. “I expect these kinds of issues will come to our pharmacy and therapeutics committee.” The committee may look to some creative options for filling gaps in drug supply. “Many drugs have alternatives -- you can use product B instead of product A,” Levin said. “Another is to take product A and re-package it into the dosage form we need.”
Medstar hospitals have sterile rooms for doing this, she said, and will almost certainly start doing more of their own compounding.
And now Williams thinks twice when ordering up a drug for a patient he sees – even in a busy ER.
“It leads us all to wonder about the manufacturing process and the quality control,” he said. He was surprised to learn that compounding pharmacies don’t come under complete FDA regulation, and noted that states have real budget gaps, especially in the current economy. He wonders how they can oversee the compounders – whose role has blossomed in recent years.
Specialized pharmacies that mix individual solutions and creams have been blamed for the recent meningitis outbreak. NBC's Lisa Myers finds out that this isn't the first time safety concerns have been raised; since 2004, the FDA has issued 49 warning letters to compounding pharmacies.
- FDA warns drugs company about bugs -- real bugs
- Regulators say they had no clear power to stop outbreak
- Compounding pharmacies - heroes or outlaws?
- One man worries after getting tainted injection