Saturday, March 30, 2013

After fungal meningitis outbreak, agencies do battle with pharmacies ...

The Food and Drug Administration says it doesn’t have the power it needs to control compounding pharmacies that have expanded out of their traditional one-patient-at-a-time role to making mass drugs.
But consumer advocates say a recent crackdown by the agency shows it most certainly can – and should. A spate of recent FDA inspections have shown that the dirty conditions that led to an outbreak of fungal meningitis that killed 51 people and sickened more than 700 are anything but rare at pharmacies that mix up what are supposed to be “sterile” injectable drugs.
“We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk,” FDA commissioner Dr. Margaret Hamburg writes in her latest blog entry. “Over the past two months, we have inspected over 30 facilities and will continue to work to protect public health.”

That's a big step up from the previous pace, when FDA might inspect a facility, write a letter, and wait a few years before following up. Hamburg estimates there are more than 7,000 compounding pharmacies in the U.S. "We had a list of facilities we have been keeping our eye on," says FDA spokeswoman Erica Jefferson. The FDA sent Medi-Fare Drug & Home Health Center, Inc. of Blacksburg, S.C., a warning letter earlier this month, pointing out both that it wasn’t preparing products to match prescriptions and that it had “serious deficiencies in your practices for producing sterile drug product, which could lead to contamination of the products, potentially putting patients at risk.”Other FDA reports this year have pointed out patches of rust at one compounding pharmacy in St. Petersburg, Fla. and sloppy sterility practices at one in Swedesboro, N.J. It's about time, say some. “That’s the type of activity we were calling for,” says Dr. Michael Carome of the consumer group Public Citizen, which is agitating for the FDA to do more to regulate compounding pharmacies. Public Citizen has argued that the FDA has all the authority it ever needed to stop rogue compounding pharmacies, but has failed to act.
Luckily, so far, there’s not been another outbreak of illness like the one traced to the New England Compounding Center (NECC), in which 51 people have died of fungal meningitis and more than 700 infected after receiving contaminated injection steroids.
“We haven’t seen any other large-scale scale compounding outbreaks,” Dr. Michael Bell, acting director of the division of health care quality promotion at the Centers for Disease Control and Prevention, told NBC News. He says there’s a steady stream of requests from states to check, however.
The FDA is openly telling the pharmacies and drug manufacturers it regulates that things have changed since the outbreak tied to NECC. Hamburg was questioned by both House and Senate committees about how the incident could even have happened.
“They appear to have the authority to take actions against companies that engage in drug manufacturing,” Carome said. “What we are going to have to wait to see is will they stand behind the citations of violations they are making,” he added. “That is what they have failed to do previously. Hopefully it’s not just for show.”
Currently, the FDA regulates drug manufacturers, while state boards regulate pharmacies, including compounding pharmacies. But the line between what is a manufacturer and what is a compounding pharmacy can be blurry.
Compounding pharmacies are supposed to mix prescriptions one at a time, on a per-patient basis. But there’s so much demand for special formulations that hundreds of these compounders have started large-scale production. Now, they closely resemble drug manufacturers – but without the very strict oversight and long list of sterility requirements that manufacturers must follow.
Jefferson says the crackdown hasn't gone entirely smoothly. "We still run into situations where a facility has not cooperated with us," she said. "We might not be able to take samples. They might say, 'No, you can't see this.'" Then FDA has to seek help from state authorities.
Continue reading here

No comments: