Records Show Problems at Steroid Pharmacy as Far Back as '06
TUESDAY, Oct. 23 (HealthDay News) -- State records show that the Massachusetts specialty pharmacy at the epicenter of the nationwide meningitis outbreak was plagued by problems as far back as 2006, according to published reports.
The records, which were obtained by the Associated Press under a public documents request, said there was evidence of inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the New England Compounding Center, the news service reported.
The problems were corrected that year, the AP reported.
On Monday, a congressional committee asked the Framingham-based company for records going back a decade.
As of Tuesday, U.S. health officials reported that cases linked to the outbreak have risen to 308, with the number of deaths unchanged at 23. The latest count found deaths and infections spread across 17 states, according to the U.S. Centers for Disease Control and Prevention.
Meningitis is a potentially fatal inflammation of the lining surrounding the brain and spinal cord.
Federal health officials said last week that fungus found in steroid injections produced by the company matched the fungus linked to the meningitis outbreak. The officials said they'd confirmed the presence of the fungus, Exserohilum rostratum, in unopened vials of a steroid produced by the New England Compounding Center.
The vial came from one of three lots recalled by the company last month, officials from the CDC and the U.S. Food and Drug Administration said.
The steroid, methylprednisolone acetate, is injected into patients for back and joint pain. The company has since shut down operations and stopped distributing its products, health officials said.
The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the three lots, and nearly 97 percent of them have been contacted for medical follow-up.
All of the fungal meningitis patients identified so far were thought to be injected with methylprednisolone acetate from the Massachusetts pharmacy, according to the CDC.
Four of the 308 cases involve what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These joint infections aren't considered as dangerous as injections near the spine for back pain that have been linked to the potentially fatal meningitis infections.
The FDA said it was advising all health care professionals to follow up with any patients who were given any injectable drug from or produced by the New England Compounding Center. These drugs include medications used in eye surgery, and a heart solution purchased from or produced by the company after May 21.
The New England Compounding Center is what's known as a compounding pharmacy. These pharmacies combine, mix or alter ingredients to create specific drugs to meet the specific needs of individual patients, according to the FDA. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.
The CDC on Monday had the following state-by-state breakdown of cases: Florida: 19 cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case; Illinois, 1 case; Indiana: 40 cases, including 2 deaths; Maryland: 17 cases, including 1 death; Michigan: 68 cases, including 5 deaths; Minnesota: 7 cases; New Hampshire: 10 cases; New Jersey: 17 cases; New York: 1 case; North Carolina: 2 cases, including 1 death; Ohio: 11 cases; Pennsylvania: 1 case; Tennessee: 70 cases, including 9 deaths; Texas: 1 case; Virginia: 41 cases, including 2 deaths.
Health officials said they expect to see more cases of the rare type of meningitis, which is not contagious, because symptoms can take a month or more to appear.
Infected patients have developed a range of symptoms approximately one to four weeks following their injection. People who have had a steroid injection since July, and have any of the following symptoms, should talk to their doctor as soon as possible: worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body or slurred speech, the CDC said.
Infected patients must receive intravenous drugs in a hospital.
Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers are, and some members of Congress now say the meningitis outbreak highlights the need for more regulatory control.
The U.S. National Library of Medicine has more about injections for back pain.
SOURCES: Oct. 23, 2012, updated statistics, U.S. Centers for Disease Control and Prevention; Oct. 18, 2012, news release, U.S. Centers for Disease Control and Prevention, and U.S. Food and Drug Administration; Associated PressRelated Articles
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