Second Compounding Pharmacy Shut Down in Massachusetts10/29/12
MONDAY, Oct. 29 (HealthDay News) -- Massachusetts officials have
closed a second compounding pharmacy after a snap inspection last
week revealed conditions that might threaten the sterility of its
The New York Times, Waltham, Mass.-based Infusion Resource
voluntarily surrendered its license over the weekend after
inspectors found "significant issues with the environment in which
medications were being compounded," Dr. Madeleine Biondolillo,
director of the Bureau of Health Care Safety and Quality at the
Massachusetts Public Health Department, said at a press
While she did not release details of what the inspection found,
Biondolillo did say that patients had been receiving intravenous
medications at the pharmacy, violating state law.
The pharmacy shutdown came after revelations of unsanitary
conditions at the Framingham, Mass., facility of New England
Compounding Center, the plant at the center of the ongoing
meningitis outbreak. On Friday, federal investigators said their
tour of the plant found foreign, "greenish-black" material in some
vials of the injectable steroid suspected as the cause of the
The contaminated product was one of a host of potential
violations discovered during a recent inspection of the New England
Compounding Center's plant in Framingham, Mass., U.S. Food and Drug
Administration officials said during a Friday press briefing.
"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the U.S. Food and Drug Administration's Office of Manufacturing and Product Quality, said during a news conference Friday afternoon.
As of Saturday, the U.S. Centers for Disease Control and
Prevention said that 25 people have now died and 344 people in 18
states have been sickened in the nationwide fungal meningitis
Vials from the lot Lynn described were shipped by the company to
customers this year, he said. The FDA tested 50 of these vials and
all were contaminated with fungus, he added.
The FDA also found the company was not able to keep its "clean
room" clean, Lynn said. "A clean room is a space designed to
maintain a controlled environment with low levels of airborne
particles and surface contamination," he explained.
According to the report, the company failed to keep the air
conditioner in the clean room running at night, which is standard
practice to maintain the room's humidity and temperature control.
In the past, the company itself had found mold and bacteria in the
clean room, Lynn said.
"In addition, the investigators observed a dark, hair-like discoloration in a transition room that connects directly to a room used to formulate and fill the injectable products," Lynn said.
Massachusetts officials said Tuesday that they had begun a
criminal investigation into New England Compounding Center. They
added that the company functioned as a drug manufacturer, producing
drugs for broad use, rather than filling individual prescriptions
for individual doctors, in violation of its state license,
According to published reports, state records show that the New
England Compounding Center was plagued by problems as far back as
2006. Those records, obtained by the
Associated Pressunder a public documents request, showed
there was evidence of inadequate contamination control and no
written standard operating procedures for using equipment, among
other problems, at the facility.
New England Compounding Center and Infusion Resource are both
compounding pharmacies. These pharmacies combine, mix or alter
ingredients to create 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.
Compounding pharmacies aren't subject to the same FDA oversight
as regular drug manufacturers are, but some members of Congress now
say the meningitis outbreak highlights the need for more regulatory
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 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
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
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.
Seven of the 344 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 CDC on Saturday had the following state-by-state breakdown
of cases: Florida: 22 cases, including 3 deaths; Georgia, 1 case;
Idaho, 1 case; Illinois, 1 case; Indiana: 44 cases, including 3
deaths; Maryland: 19 cases, including 1 death; Michigan: 82 cases,
including 5 deaths; Minnesota: 9 cases; New Hampshire: 11 cases;
New Jersey: 18 cases; New York: 1 case; North Carolina: 2 cases,
including 1 death; Ohio: 13 cases; Pennsylvania: 1 case; South
Carolina: 1 case; Tennessee: 74 cases, including 10 deaths; Texas:
1 case; Virginia: 43 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 be treated with intravenous drugs in a
The U.S. National Library of Medicine has more about
injections for back pain.
Copyright © 2012
. All rights reserved.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.