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Two more cases of meningitis, recall of NECC drugs continues

By on October 16th, 2012

Two more Florida residents, a 74-year-old woman treated in Marion County and a 79-year-old woman in Escambia County, have been diagnosed with fungal meningitis. The two woman up the case count to 12, all related to a steroid shot for back pain.

The Florida Department of Health held a conference call Tuesday afternoon on behalf of a multi-state outbreak of meningitis from the medications of the New England Compounding Center (NECC). All medications, not just spinal injections exclusively, from the NECC, according to Florida State Surgeon General Dr. John Armstrong, has been recalled.

According to the Orlando Sentinel, on a nationwide scale, all but two of the cases of meningitis relate to epidural injections meant to relieve back pain. The paper reported U.S. Attorney Carmen Ortiz said it was premature to say what  the current investigation of the NECC will show.

“As the investigation continues, the Food and Drug Administration has now provided additional guidance on patient outreach,” Armstrong said. “Healthcare professionals and healthcare facilities that have used any New England Compounding Center injectable drugs on patients, including eye medications used in eye surgery and surgical medications used in open heart surgery, are urged to follow up with these patients at least by letter.”

Armstrong said 99 percent of patients who have been injected with potentially contaminated drugs have been contacted and only 12, of 1,038, remain to contact. He said the Department of Health is doing its best to reach every patient.

“At this time, the risk to public health is certain,” he said. “Yet, we remain vigilant in our efforts to ensure that outreach to all patients potentially affected by any NECC medication is being conducted through every possible avenue.”

Paul Doering, a professor at the University of Florida’s College of Pharmacy, said he has been following the fungal meningitis outbreak closely. Doering specializes in pharmacotherapy and translational research.

“This is something of a magnitude that I’ve never seen before,” he said.

What scares Doering about the outbreak, he said, is that there is a 28-day incubation period before signs of infection begin to show. He suspects people who have been injected over the last month must be very nervous now.

Meningitis, he said, is the “inflammation of the brain and spinal column.” Infection by injection is also high risk because of the close proximity to the spinal fluid to which the medication is injected.

Doering said the problem may lie within governmental regulation on drug production. There are different rules, he said, for centers labeled “manufacturing” and “compounding.”

He said regulations set forth by states are not as stringent on manufacturers as they are for compounders. Additionally, he said, the FDA does not have the authority to regulate anything as it relates to the practice of pharmacy and that is left to the individual states.

The FDA, Doering said, is vague as to the difference between manufacturers in producers. However, manufacturers are known for large volumes of production, production in advance of receiving prescriptions, having sales representatives, manufacturing drugs that are commercially available already and preparing drugs that have been removed from the market.

“[The meningitis outbreak] is as close to a crisis I have seen relative to manufacturing and compounding,” he said. “I guarantee you that at the national level something will take place that will change the way things are regulated.”

Kelsey Meany edited this story online.


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