This is the nightmare every patient fears: receiving a tainted medication that triggers a serious disease. Unfortunately, that nightmare is a reality for potentially thousands of people who received a steroid shot for pain.
So far 11 people in 10 states have died and 119 are ill from fungal meningitis apparently caused by contaminated injections of preservative-free methylprednisolone acetate.
Some 13,000 people in 23 states may be at risk for contracting this rare form of fungal meningitis that isn’t contagious but can cause serious illness and death.
“It’s very scary,” Dr. Justin Hata, director of the UC Irvine Center for Pain Management, told TakePart. “You assume that if something is packaged and says it’s sterile and for medical use that it’s safe to give.” Hata added that the center isn’t supplied by the compounding pharmacy involved in the recall.
The fungal meningitis outbreak is part of a complex issue that involves compounding pharmacies that are only partially regulated by the Food and Drug Administration, and a rise in the use of injectable pain medication.
The tainted drugs have been traced back to the New England Compounding Center in Framingham, Mass., which voluntarily shut down after health officials deemed it the source of the drugs. A CDC update over the weekend said the NECC expanded its recall to include “all products currently in circulation that were compounded at and distributed from its facility in Framingham.”
During a recent teleconference, Ilisa Bernstein, director of the Office of Compliance in FDA's Center of Drug Evaluation and Research, said that microscopic examination of a sealed vial of methylprednisolone acetate revealed a fungal contaminant.
Questions during the teleconference made it apparent that as much as authorities are trying to get a handle on the fungal meningitis outbreak, there’s still a lot they don’t know, such as other medications being contaminated, and whether or not sterility testing was done before the drugs were shipped.
Pharmacies have done compounding since the 19th century, when pharmacists prepared doctor-requested special formulations and combinations of medications that weren’t already manufactured. While local pharmacies still do that today, drug shortages have driven the growth of individual compounding pharmacies across the country.
The International Academy of Compounding Pharmacists says there are about 7,500 pharmacies in the U.S. that specialize in advanced compounding services, and of those, 3,000 do sterile compounding.
As for who regulates these pharmacies, the IACP says several authorities play a role: The State Boards of Pharmacy make sure they follow proper practices, the FDA ensures the drugs’ active ingredients and integrity, and the Drug Enforcement Administration oversees how controlled substances are handled.
But some think the FDA should play a much larger role in regulating compounding pharmacies. MedPage Today reported that three members of the House of Representatives Energy and Commerce Committee have requested an investigation. An excerpted letter to the committee chairman said the fungal meningitis outbreak “raises serious concerns about the scope of the practice of pharmacy compounding...and the current patchwork of federal and state laws and systems that oversee this practice.”
Just what are these injections, who uses them and what are they for? Hata says methylprednisolone acetate is a common steroid used to reduce inflammation and decrease pain, and in his practice it’s typically used to treat arthritic joints, muscle strain injuries and conditions such as tendinitis and bursitis. Although his clinic no longer uses this specific medication for epidurals—injections usually given to treat back pain and sciatica—others do.
Millions are affected by actue or chronic pain in the U.S., says the American Academy of Pain Medicine, and the cost can be measured in work hours lost and healthcare charges. Pain management clinics are commonplace in most cities.
“I give talks and ask the audience how many people have dealt with pain, and 90 percent will raise their hand,” Hata says. “We give hundreds of epidural injections a month.”
Blame an aging and overweight population for the boom in the demand for pain meds. People are living longer and doing more, and bodies weren’t built to last forever. “As the patient population gets older, there are going to be more wear and tear types of problems,” he says.
The CDC, FDA and local authorities are continuing to monitor and investigate the fungal meningitisoutbreak; the CDC also offers a patient guide that advises people on what to do if they suspect they were given the medication.
Do you think the FDA should increase its regulation of compounding pharmacies? Let us know in the comments.