Elise Amendola / AP
Two men stand guard outside the entrance to Ameridose LLC in Westborough, Mass., earlier this month. The firm has been temporarily shutted and has recalled all of its unexpired drugs because of Food and Drug Administration worries about sterility.
Fallout from a deadly outbreak of fungal meningitis blamed on contaminated pain shots may worsen the nation’s ongoing drug shortage crisis -- just as health officials were getting a handle on the problem.
Food and Drug Administration officials say they’re taking urgent steps to ramp up production, distribution and even importation of six critical drugs after a sister company to the pharmacy at the heart of the outbreak voluntarily recalled all of its products this week because of concerns about sterility.
“FDA is aware that the voluntary shutdown of Ameridose and the recall of Ameridose products may affect supplies of certain life-saving drugs for some health care systems,” officials said.
Ameridose LLC, of Westborough, Mass., agreed to a voluntary shutdown and pulled more than 1,800 unexpired drugs this week after FDA inspectors said they couldn’t guarantee the sterility of the medications.
The firm is co-owned by owners the New England Compounding Center of Framingham, Mass., whose products are blamed for the growing outbreak of fungal meningitis and joint infections that now have sickened 404 people in 19 states. Twenty-nine people have died, the Centers for Disease Control and Prevention reported Friday.
Though the recall is necessary to ensure safety, it can’t help but affect the supply of critical medications for hospitals that turned to compounding pharmacies as sources, said Erin Fox, director of the Drug Information Service at the University of Utah, which tracks drug shortages.
“It just has to be hitting hospitals as another crisis,” she said.
At risk are drugs such as such as sodium bicarbonate injections, widely used to stabilize critically ill patients suffering from sepsis, heart attacks or other cardiac problems.
The problem is part of the aftermath of the NECC crisis, in which patient infections have been tied to three lots of an epidural steroid known as methylprednisolone made by NECC. Five separate types of fungi have been detected in people or products linked to the pharmacy, the CDC reported this week.
In addition, the FDA detected 10 types of bacteria in lots of two other drugs -- betamethasone and cardioplegia solution -- made by the now-shuttered compounding pharmacy.
The NECC shut-down took about 2,400 lots of drugs out of the market, company records indicate. The Ameridose recall adds to to the total. Together, the loss of the drugs may exacerbate ongoing shortages that have left hospitals scrambling since 2010 -- or earlier.
Last year was the worst in the U.S. for new drug shortages, with 267 recorded, according to Fox. This year, only 158 new shortages have been logged, thanks to new FDA notification requirements and aggressive intervention by the agency, experts say.
However, “leftover” shortages from previous years, have reached an “all-time high,” with 282 active shortages, Fox said. That compares with 256 active shortages at the same time last year.
“This reflects that FDA is able to prevent new shortages from happening, particularly with the new notification requirements, but most of the shortages are caused by manufacturing problems, which FDA can’t really fix.”
FDA officials are urging domestic suppliers to step up production and they are working with a potential foreign producer to import the drugs, said Sarah Clark-Lynn, an FDA spokeswoman. Clark-Lynn said it was premature for the agency to identify the potential new importer.
The FDA has the authority to temporarily import drugs in critical shortage if the shortage can't be resolved domestically. Currently, six drugs are being imported in the U.S. under that arrangement. Clark-Lynn said it was premature for the agency to identify the new importer.
The six drugs critical drugs affected by the Ameridose shut-down include sodium bicarbonate injections as well as succinylcholine injections, an emergency muscle relaxant; atropine sulfate injection, used to prevent abnormal heart rhythms and low blood pressure; the anesthetics bupivacaine and lidocaine and furosemide injections used to treat congestive heart failure and water retention.
“We’ve been working with all of the different regulatory tools that we have,” said Clark-Lynn.
However, the agency has been criticized by groups such as Public Citizen, an advocacy agency, for using ongoing drug shortages as an "excuse" to allow compounding pharmacies such as NECC and Ameridose to act as large-scale drug manufacturers, but without the required scrutiny.
"Any such decisions by the agency may well have contributed to the circumstances that allowed the current public health catastrophe to occur," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group. The organization is calling for an investigation into whether an FDA lack of oversight contributed to the outbreak.
FDA officials have said they didn't have the authority to regulate compounding pharmacies like manufacturing firms and that the oversight was delegated to the states.
The loss of the supply from compounding pharmacies such as NECC and Ameridose may mean that hospitals will have to mix doses of the drugs themselves. That can be challenging because of the complicated US Pharmacopeia chapter 797 rules governing preparation of sterile drugs -- and it could lead to problems such as medication errors caused by staffers performing unfamiliar procedures, Fox said.
For hospital pharmacists, the Ameridose problem likely means that an already bad situation will get worse. Dr. Thomas Burnakis, coordinator of clinical pharmacy services at Baptist Medical Center in Jacksonville, Fla., says that hospitals will have to ration scarce drugs for the sickest patients, pay higher fees to obtain the critical drugs and hope that everyone who needs treatment gets it.
“It’s not hard to come up with a scenario with the potential for patients to be harmed,” Burnakis said.
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