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AMC doesn't use steroid linked to meningitis outbreak

October 10, 2012
By CHRIS KNIGHT, Senior Staff Writer, and The Associated Press , Adirondack Daily Enterprise

SARANAC LAKE - Officials at Adirondack Medical Center say the hospital isn't currently using, and has never distributed, an injectable steroid that's been linked to a deadly meningitis outbreak across the country.

AMC spokesman Joe Riccio said the hospital has received a lot of phone calls from patients in its pain management program, asking if the steroid shots linked to the outbreak have been used by the hospital.

"Whenever there's a situation like this, people become concerned," Riccio said. "We want to let the public and our patients know that the treatment in question is not something we have purchased or distributed."

The Centers for Disease Control and Prevention said Tuesday that the number of people sickened by the meningitis outbreak has now reached 119 cases, including 11 deaths. States reporting at least one illness include New Jersey, Tennessee, Michigan, Virginia, Indiana, Florida, Maryland, Minnesota, North Carolina and Ohio.

Officials have tied the outbreak of rare fungal meningitis, an inflammation of the lining of the brain and spinal cord, to steroid shots for back pain. The steroid was made by the New England Compounding Center, a specialty pharmacy located in Framingham, Mass. At least one contaminated vial was found at the company, which distributed as many as 13,000 of the contaminated steroid shots to 23 states, including New York.

State Health Department officials say 425 people in New York have received the shots, but there are no reported meningitis cases in New York. The CDC last week said the New York tainted shipments went to Dr. Sunil Butani in Mineola, Obosa Medical Services in Mount Vernon and Rochester Brain and Spine in Rochester.

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Chuck Dilzer, pharmacist at Kinney Drugs in Saranac Lake, said the manufacturer that's being blamed for the outbreak is what's known as a compounding pharmacy, which prepares custom-mixed drugs that aren't commercially available.

"If there's a demand for a particular drug product - it could be injectable, a capsule or an ointment - that prescribers or medical treatment folks want that's in an unusual strength or concentration, these compounding pharmacies will take the raw materials or a commercially made product and dilute it, alter it so it meets the request," Dilzer said. "They are inspected pretty stringently, so I was surprised that this happened, but every now and then, things happen."

Some politicians think these kinds of pharmacies need more regulation. In the wake of the meningitis outbreak, a pair of Democratic lawmakers - U.S. Reps. Rosa DeLauro of Connecticut and Edward Markey of Massachusetts - are calling for stricter federal oversight of compounding pharmacies.

Unlike drugs manufactured by large pharmaceutical companies, compounded drugs have never been reviewed for safety and effectiveness by FDA. Compounding pharmacies have long operated in a legal gray area between state and federal laws. Efforts to more tightly regulate the industry have been knocked down by federal courts, including the Supreme Court.

Despite that history, Markey said Tuesday the FDA should have authority to bar compounding pharmacies from using ingredients that haven't been cleared by the agency. The congressman says his legislation would also require the pharmacies to report all safety issues to the FDA.

"Unfortunately, compounding pharmacies are a 19th century service operating in a 21st century industry, and we need to update and strengthen the rules that govern these operations so that patients can safely benefit from the unique service they offer," said Markey, who sits on the House Energy and Commerce Committee, which oversees the FDA.

DeLauro sent a letter Tuesday to Department of Health and Human Services Secretary Kathleen Sebelius, asking what additional powers would help the department improve the safety of compounded drugs.

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Contact Chris Knight at 518-891-2600 ext. 24 or cknight@adirondackdailyenterprise.com.

 
 
 

 

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