89 Md. facilities bought drugs from firm linked to meningitis outbreak

More sterility problems found at New England Compounding Center

October 24, 2012|By Andrea K. Walker, The Baltimore Sun

The federal Food and Drug Administration identified 89 medical facilities in Maryland that bought drugs from the Massachusetts manufacturer being investigated for a national fungal meningitis outbreak.

The facilities are among more than 3,000 in numerous states that the FDA said received drugs from the New England Compounding Center as evidence of widespread sanitary issues at the company continues to come to light.

The list of facilities in Maryland covers a large swath of the medical community. It includes hospitals such as the University of Maryland Medical Center, Greater Baltimore Medical Center and Northwest Hospital, as well as doctors' offices, clinics and rehab facilities.

The medical facilities on the new list bought drugs other than preservative-free methylprednisolone acetate, an injectable steroid used most often to ease back pain. That drug has been linked to the outbreak. Federal regulators previously identified only those facilities, including seven in Maryland, that bought that steroid, but want the medical community and the public to be aware of other potential risks.

"The New England Compounding Center had lapses in sterility and so the FDA wants clinicians and patients and the public to be aware that there is an increased risk, given their findings," said Dr. Lucy Wilson, a medical epidemiologist at the Maryland Department of Health and Mental Hygiene's infectious disease bureau.

So far, Wilson added, the outbreak has been linked to just three lots of the steroid drug.

"Be vigilant, be aware, but the real risk is the link to those three lots," Wilson said.

Earlier this month, the FDA recommended that medical facilities contact patients who received any injectable drugs that were shipped from New England Compounding on or after May 21. Before that, as the outbreak spread, regulators asked medical facilities to get rid of any drugs they got from New England Compounding even if those drugs have not been implicated in the meningitis outbreak.

Fungal meningitis cases continue to grow, sickening 317 people and killing 24 in 17 states. In Maryland 17 people have been sickened and 1 has died.

Several Maryland hospitals contacted Wednesday said they have stopped using drugs from New England Compounding.

"As soon as the FDA alert came out about NECC in general we took everything off the shelf that we had from them," said Lisa Polinsky, director of pharmacy for LifeBridge Health in Baltimore. LifeBridge's Northwest Hospital and Sinai Hospital of Maryland bought drugs from the company.

The hospitals purchased a topical cream and an injectable medication used in neurology cases. Because of privacy concerns Polinsky would not say if patients had received any of the medications, but said that the hospitals were following FDA guidelines on contacting patients.

Katzen Eye Group purchased single doses of the drug Avastin, which is used to treat wet age-related macular degeneration and diabetic macular edema. While there was no link to contamination, the group said it is closely following patients who received the drug.

"We immediately notified all patients who were treated with Avastin and will continue to follow-up with them to ensure their continued safety and well-being," said Dr. Richard Edlow, Katzen's CEO.

The University of Maryland Medical Center said it destroyed any drugs from New England Compounding earlier this month. It did not purchase any injectables from the company, so it was not contacting patients, said a spokeswoman, Karen Lancaster.

Baltimore Washington Medical Center, owned by the University of Maryland Medical System, destroyed any drugs from the company on Oct. 8 and also did not buy an injectables, she said.

The outbreak has prompted calls for stronger regulation of compounding pharmacies, which are monitored and licensed by state boards, unlike drug manufacturers, which are under the FDA's jurisdiction.

Critics say that as the compounding pharmacy industry evolved from mom-and-pop businesses into large facilities that act more like drug manufacturers, it has opened the door for more contamination. Demand for compounding has increased because of drug shortages.

Greater Baltimore Medical Center in Towson said it does not use compounding pharmacies regularly but has turned to them more as drugs grow harder to find.

"We try not to send things out to a compound pharmacy, but with the drug shortage and patients who need medication, we are sometimes left in a lurch," said Charles Haile, GBMC's chief of infectious disease and chairman of the pharmacy committee. "The FDA is not doing enough to nip this issue in the bud and allow for a better supply chain,"

GBMC has contacted patients by letter who received injectable hormones and injectable drugs used in eye surgery, Haile said.

Mercy Medical Center also said drug shortages played a role in its use of compounding pharmacies. The hospital said it is contacting patients who have received injectable medications produced by New England Compounding.

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