The International Academy of Compounding Pharmacists estimates there are 3,000 pharmacies in the United States providing medicines like the steroid injection that is believed to be the source of a fungal meningitis outbreak. NBC's Rehema Ellis reports.
State and federal health officials called for new legislation on Thursday giving them clearer power to regulate pharmacies like the Massachusetts facility whose products are suspected of killing 14 people and making at least 170 sick. A rare fungal meningitis has been linked to contaminated pain injections from the plant, federal health officials said on Thursday.
The officials said they’re looking into what action they can take against the New England Compounding Center, which has been in trouble before and which they said appears to have been breaking state and federal laws. Food and Drug Administration and Massachusetts state officials said they didn’t have all the powers they needed to stop the pharmacy from making and distributing drugs on a wide scale.
One case was reported in Idaho, making 11 states where cases have been reported, the Centers for Disease Control and Prevention reports. Cases have now been reported in Idaho, Minnesota, Michigan, Indiana, Ohio, Tennessee, Florida, North Carolina, Virginia, Maryland and New Jersey.
The New England Compounding Center and a sister pharmacy, Ameridose, have closed. NECC has recalled all its drugs although the fungal infection is linked to just one of its products, an injectable steroid called methylprednilosone.
The good news, says the CDC, is that nearly all of the 14,000 people who got doses of the steroid have been notified. “We are happy to say we have contacted over 12,000 or nearly 90 percent of these nearly 14,000 patients,” said Dr. Todd Weber, CDC’s incident manager for the outbreak.
Fungus has been identified in 50 vials taken from the New England Compounding Center, said Deborah Autor, FDA’s deputy commissioner for global regulatory operations and policy. FDA had issued warnings to NECC in 2006 about some of its practices, including splitting drugs into smaller doses, cautioning that they were not sterile enough.
Autor said NECC assured FDA in writing that it was in compliance with all state and federal laws.
“It’s incredibly complicated to explain what our authority is and is not,” Autor told reporters on a telephone briefing.
Congress passed a law in 1997 giving FDA more power over compounding pharmacies, which are supposed to custom-mix drugs to order on an individual prescription-by-prescription basis. For instance, a compounding pharmacist can make a pill into liquid form, or add flavoring to a drug so a child will take it. But the law also stopped these pharmacies from advertising, and the Supreme Court said this provision was unconstitutional. Now the law is in limbo and so is some of FDA’s authority.
The rest is left to state board of pharmacy to regulate. In the meantime, pharmacies have “evolved,” Autor said. Consumer advocates and some members of Congress say they have turned to mass-production. “Compounded drugs are not approved by FDA and do not undergo pre-market review,” Autor said. She said FDA would like to work with Congress, the pharmacy industry and others to craft better laws and regulations and said it was a shame it took this crisis to bring matters to a head.
“It is very, very complicated, our ability to take action here,” Autor said.
Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health had similar complaints. “We urge Congress to act quickly to address the need for new laws at the federal level,” Biondolillo told the briefing.
“This organization chose to apparently violate the licensing requirements under which they were allowed to operate.”
Asked how officials missed the huge volume of drugs that NECC was shipping—they shipped thousands of doses of the suspect steroid alone to at least 23 states, Biondolillo said her agency wasn’t authorized to monitor volume.
As for patients, CDC says the symptoms are subtle and hard to detect, and predicts more people will be found to have been infected as doctors investigate.
Ten of the people infected have been infected with a black mold called Exserohilum rostratum, CDC says. While at first the outbreak was linked to another mold called Aspergillus, just one of 11 patients whose tests have come back so far has been infected with that particular fungus.
Both of the molds are found commonly in nature - in soil and on plants. Aspergillus can cause lung infections and has in rare cases caused meningitis. Exserophilum can cause skin infections and can infect the heart, but had not been found in spinal fluid before. This particular type of meningitis cannot be passed from person to person -- the injections are the source. CDC's Weber said there's also one case of a man who was injected in his ankle, but it's not entirely clear he has a fungal infection yet. The man doesn't have meningitis, but has an infection in his ankle.
People have typically begun feeling ill from one to four weeks after they had a pain injection into the spine, CDC said. It’s tricky to diagnose the infection because symptoms are subtle and the spinal tap needed to confirm there’s a problem is itself an invasive and painful procedure. “Infected patients have had very mild symptoms that are only slightly worse than usual. For example, many infected patients have had slight weakness, slightly worsened back pain, or even a mild headache,” CDC says.
Doctors don’t want to do the spinal puncture unless patients really feel ill. If they do have inflammation and if they did get methylprednilosone from one of the suspect batches, patients must start weeks of infusion therapy with two strong antifungal drugs.
Here’s CDC’s advice: Patients who have had an epidural steroid injection since May 21, 2012, and have any of the following symptoms, should talk to their doctor as soon as possible:
- New or worsening headache
- Sensitivity to light
- Stiff neck
- New weakness or numbness in any part of your body
- Slurred speech
- Increased pain, redness or swelling at your injection site
“We know we are not out of the woods yet,” Weber said.