Oct. 18, 2012 at 8:25 AM ET
The growing number of illnesses and deaths blamed on tainted pain shots from a Massachusetts compounding pharmacy may be the worst such outbreak of fungal meningitis in U.S. history -- but it’s not the first tied to the injections.
Five people were sickened and one died in 2002 after receiving epidural injections of the steroid methylprednisolone contaminated with the fungus Exophiala, a new review of public health records shows.
“It’s playing out about the same way, but the order of magnitude is so much greater,” said Dr. Jeffrey Engel, an epidemiologist who grappled with the outbreak that started in North Carolina and spread to four other states a decade ago.
“This is a total catastrophe.”
Methylprednisolone is the same drug initially implicated in the current outbreak tied to at least 20 deaths and 257 confirmed infections in 16 states, according to federal health officials. In recent days, two more drugs and two additional types of fungi were added to the initial concerns. Nearly 14,000 people received the potentially tainted steroids, which were distributed in 23 states, federal health officials said.
They came from New England Compounding Center of Framingham, Mass., one of several hundred compounding pharmacies in the U.S. that custom-mix drugs for individual patients.
A decade ago, some 870 patients in North Carolina got similar shots, according to press accounts at the time. A 77-year-old woman who was being treated for low back pain developed fungal meningitis and died more than four months after an epidural injection, the Centers for Disease Control and Prevention reported. Four other women ages 52 to 71 were also sickened by the tainted shots, either in their aching backs or in arthritic joints, but they recovered.
That outbreak was traced to contaminated bulk drugs and to faulty sterilization practices at the Urgent Care Pharmacy in Spartanburg, S.C., recalled Engel, who is now the executive director of the Council of State and Territorial Epidemiologists. The Food and Drug Administration issued a nationwide alert about the company's drugs and the South Carolina Board of Pharmacy issued a cease and desist order to halt all sales of the firm's products.
Engel has been watching the current outbreak closely, dismayed that the problem continues.
“Haven’t we done anything nationally to prevent this?” he said.
That case is among some 20 incidents since 1990 of recalls, serious illnesses and deaths linked to faulty compounding practices across the U.S., all gleaned from public reports. Some occurred in hospital pharmacies; others happened in compounding pharmacies that aren't required to report adverse events to regulators.
Eric S. Kastango, chief executive for the health consulting firm Clinical IQ, along with staffers at the Institute for Safe Medication Practices, a nonprofit medication advocacy group, compiled the reports and published them in a newsletter Wednesday.
Food and Drug Administration officials say they’ve logged at least 200 adverse events from 71 compounding pharmacies in the past two decades, but FDA officials did not respond to NBC News requests for a complete list of those incidents.
According to the ISMP report, the problems varied widely: Some 19,000 patients with chronic lung diseases were endangered in Missouri in 2003 by bacterial contamination of at least two batches of a compounded inhalant solution. In 2005 in Maryland, 10 patients died after receiving contaminated compounded medication used to stop the heart during surgery.
And just last year, nine patients in Alabama died and 19 were sickened by bacterial-contaminated IV nutrition solutions. In California, 16 patients developed severe eye infections after contaminated ocular injections of compounded Avastin. One patient was blinded; another developed a brain infection.
The new fungal meningitis outbreak has reignited calls for stricter oversight of compounding pharmacies, which are generally regulated by state boards of pharmacy, and exempt from regulations by the FDA.
“Ultimately there’s going to have to be a crackdown on these compounders,” said Engel.
Compounded drugs aren’t FDA-approved and they haven’t been tested for quality or safety. The pharmacies are not required to register with FDA, to disclose what products they are making, or to report problems such as illnesses and deaths that those products might cause.
On Tuesday, FDA enforcers raided the NECC’s facility; earlier in the day, the agency officials had said inspections of the facility raised questions about the sterility of any of the company’s products.
At the same time, members of Congress said they wanted answers about how the problem occurred. Massachusetts Rep. Ed Markey, a Democrat, said that NECC distributed controlled substances including morphine and fentanyl without a license.
But lawmakers have demanded stricter control over the industry before, in the early 1990s. Those efforts were stymied by compounding pharmacists, who resisted regulation. Now the industry is governed by a patchwork of state laws -- some enforced, some not -- and general uncertainty about the FDA’s role.
There are well-known steps to ensure that compounded drugs are made safely, particularly the USP 797 guidelines from U.S. Pharmacopeia, the international nonprofit that sets standards for drug safety worldwide.
The trouble occurs when some compounding pharmacies, even only a minority, fail to follow them, Kastango told NBC News.
“We’re not doing good processes, we’re not using good aseptic technique,” he said. “You look at the data and most of these events are starting with non-sterile compounding.”