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

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.

The FDA had released a list of medical facilities earlier this week, but took it down for accuracy reasons. The corrected list was released late Tuesday night. The regulatory agency said the list was taken from New England Compounding, so it might not be complete.

The list comes as regulators and investigators have raised more questions about issues at New England Compounding.

Massachusetts officials released a report this week that found the company released drugs before sterility tests came back, issued drugs without a prescription and, in general, did not follow proper sterilization guidelines.

A New England Compounding attorney said in a statement this week that it had a long-standing practice of working closely and cooperatively with the Massachusetts Board of Registration in Pharmacy and the Massachusetts Department of Public Health.

"Based on that history, it is hard to imagine that the Board has not been fully apprised of both the manner and scale of the company's operations," the statement read. "NECC's transparency in dealing with the Board since inception in 1998 demonstrates its good-faith intention to operate in compliance with the requirements of its license. Furthermore, the company's intention and best efforts at compliance are equally applicable in every other state in which it has been licensed."



Maryland facilities that received drugs from New England Compounding Center:

•Annapolis Surgery Center, 2629 Riva Road, Suite 106, Annapolis

Anne Arundel Medical Center, 2001 Medical Parkway, Annapolis

•Atlantic General Hospital, 9733 Healthway Dr., Berlin

•Atlantic Plastic Surgery, 106 Milford St., Suite 305, Salisbury

•Baltimore Eye Surgical Center, 6231 N. Charles St., Baltimore

•Baltimore Pain Management, 9110 Philadelphia Road, Baltimore

•Baltimore Washington Medical Center, 301 Hospital Dr., Glen Burnie

•Berlin Interventional Pain Management, 10308 Old Ocean City Blvd.

•Box Hill Surgery Center, 100 Walther Ward Blvd., Abingdon

•Burton, Gary, M.D., 4000 Mitchellville Road, Suite 306, Bowie

•Calvert Memorial Hospital Pharmacy Department, Prince Frederick

•Carroll Hospital Center, 200 Memorial Ave., Westminster

•Center for Pain Management¿ Hagerstown, 1150 Professional Court

•Chesapeake Eye Surgery Center, 2002 Medical Parkway, Suite 330, Annapolis

•Chesapeake Otolaryngology Associates, 205 Steeple Chase Dr., Suite 303, Prince Frederick

•Chesapeake Plastic Surgery, 802 Bestgate Road, Suite A, Annapolis

•Chevy Chase Facial Plastic Surgery, 8401 Connecticut Ave., Suite 107, Chevy Chase

•Civista Medical Center, 5 Garret Ave., La Plata

•Cumberland Valley Surgery Center, 1110 Professional Court, Hagerstown

•Dimensions Surgery Center, 14999 Health Center Dr., Bowie

•Doctors Community Hospital, 8118 Good Luck Road, Lanham

•Dulaney Eye Institute, 901 Dulaney Valley Road, Towson

•Elman Retina Group, 9114 Philadelphia Road, Suite 310, Baltimore

•Eye Consultants of Maryland, 21 Crossroads Dr., Owings Mills

•Eye Surgery Center of White Marsh, 9512 Harford Road, Suite 5, Baltimore

•Family Foot & Ankle Associates of Md., 7900 Old Branch Ave., Suite 110, Clinton

•Forbes Ambulatory Surgery Center, 7501 Forbes Blvd., Suite 103, Lanham

•Fort Washington Hospital, 11711 Livingston Road, Fort Washington

•Frederick Memorial Hospital, 400 W. 7th St., Frederick

•Glaucoma Consultants, 6565 N. Charles St., Baltimore

•Good Samaritan Hospital¿Baltimore, 5601 Loch Raven Blvd., Baltimore

•Greater Baltimore Medical Center, 6701 N. Charles St. (5th-floor pharmacy), Baltimore

•Greenspring Surgery Center, 2700 Quarry Lake Dr., Suite 100, Baltimore

•Hanover Parkway Surgery Center, 7300 Hanover Dr., Suite 204, Greenbelt

•Harford County ASC LLC, 1952 Pulaski Highway, Edgewood

•Health Associates P.A., 2700 Quarry Lake Dr., Suite 200, Baltimore

•Holy Cross Hospital, 1500 Forest Glen Road, Silver Spring

•Katzen Eye Group, 1209 York Road, third floor, Lutherville

•Katzen Eye Group, 8201 Philadelphia Road, Rosedale

•Katzen Eye Group (Baltimore), 301 St. Paul Place, Baltimore

•Kevin R. Doring DDS, 3179 Braverton St., Suite 100, Edgewater

•Kevin Thomas DPM PC, 560 Riverside Dr., A¿101, Salisbury

•Laurel Regional Hospital, 7300 Van Dusen Road, Laurel

•Longevity Medical Spa LLC, 8600 Snowden River Parkway, Columbia

•Mercy Medical Center¿Md., 301 St. Paul Place, Baltimore

•Meritus Medical Center, 105 Enterprise Lane, Suite 3, Hagerstown

•Metropolitan Ophthalmology Associates, 5530 Wisconsin Ave., Suite 1527, Chevy Chase

•Mid¿Atlantic Neurosurgical Assoc., Outpatient Infusion Services, Baltimore

•Mid¿Atlantic Surgery Pavillion, 1111 Beards Hill Road, Aberdeen

•Montgomery Surgery Center, 46 West Gude Dr., Rockville

•Northwest Hospital, 5401 Old Court Road, Randallstown

•Ophthalmology Assoc. of Greater Annapolis, 83 Church Road, Arnold

•Ortho Maryland, 2700 Quarry Lake Dr., Baltimore

•Pain Medicine Specialists, 8322 Bellona Ave., Towson

•Parris¿Castoro, 620 Boulton St., Bel Air

•Pembrooke Square Surgery Center, 11370 Pembrooke Square, Waldorf

•Peninsula Eye Center, 101 Milford St., Salisbury

•Peninsula Orthopaedic Associates, P.A., 1675 Woodbrook Dr., Salisbury

•Peninsula Regional Medical Center, 100 E. Carroll St., Salisbury

•Piccard Surgery Center, 1330 Piccard Dr., Suite 102, Rockville

•Prince George's Hospital Center, 3001 Hospital Dr., Cheverly

•Rejuvenation Medical Aesthetics, 205 Steeple Chase Dr., Suite 304, Prince Frederick

•Robert Andrew Medical Spa, 1151 Route 3 North, Gambrills

•Roy A. Rosenthal, M.D., Andrew Siekanowicz, Silver Spring

•Saint Joseph Medical Center, 7601 Osler Dr., Towson

•Salisbury Foot + Ankle, 106 Milford St., Suite 403, Salisbury

•Sastry, S.M., M.D., Cambridge Professional Center, Waldorf

•Shady Grove Adventist Hospital, 9901 Medical Center Dr., Rockville

•Shady Grove Podiatry, 16220 Frederick Ave., Gaithersburg

•Silver Spring Ophthalmology, 8630 Fenton St., Suite 800, Silver Spring

•Sinai Hospital, 2401 W. Belvedere Ave., Baltimore

•Southern Maryland Hospital Center, 7503 Surratts Road, Clinton

St. Agnes Hospital, 900 Caton Ave., Baltimore

•Suburban Hospital Healthcare¿Cardio, 8600 Old Georgetown Road, Bethesda

•Suburban Hospital¿Health Care, 8600 Old Georgetown Road, Bethesda

•Summit Orthopaeadics, 5530 Wisconsin Ave., Chevy Chase

•Surg. Center of Greater Annapolis, 83 Church Road, Arnold

•Surgcenter of Bel Air, 209 Thomas St., Bel Air

•Surgeons Surgical Center, 940 Seton Dr., Cumberland

•Surgery Center of Easton, 510 Idlewild Ave., 110 Easton

•Surgery Center of Potomac, 3203 Tower Oaks Blvd., Rockville

•The Eye Surgery Center Ltd., 8905 Fairview Road, Silver Spring

•The G Spa International, 9001 Woodyard Road, Suite A, Clinton

•The Orthopaedic Center, 9420 Key West Ave., Suite 300, Rockville

•The Retina Group of Washington, 5454 Wisconsin Ave., Chevy Chase

•University of Maryland Med. Center, 22 S. Greene St., Baltimore

•Washington Adventist Hospital, 7600 Carroll Ave., Takoma Park

•Washington Adventist Hospital¿Cardio, 7600 Carroll Ave., Takoma Park

•Washington Eye Physicians & Surgeons, 5454 Wisconsin Ave., Chevy Chase

SOURCE: Food and Drug Administration

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