More contaminated drugs found, but Ellsworth hospital says its medication still safe

By Jackie Farwell, BDN Staff
Posted Nov. 02, 2012, at 5:13 p.m.

Federal regulators have detected contamination in two more drugs made by a Massachusetts pharmacy tied to a deadly meningitis outbreak, but neither medication made its way to Maine, except in a topical form still considered safe.

Regulators announced Thursday that they had found bacterial contamination in preservative-free betamethasone, an injectable steroid for treating joint pain, and cardioplegia solution, a medication used in heart surgeries, that were made by the New England Compounding Center.

Maine Coast Memorial Hospital in Ellsworth received multiple doses of betamethasone from the now-closed pharmacy, but in a topical gel form that has not been linked to contamination problems.

According to an Oct. 23 list released by the U.S. Food and Drug Administration, no Maine hospitals or doctors received the injectable form of betamethasone or cardioplegia solution from NECC.

Injectable betamethasone is different from another injectable steroid made by NECC that has been implicated in a fungal meningitis outbreak. A fungus detected in a steroid called methylprednisolone acetate manufactured by NECC is being blamed for the outbreak that has spread to 19 states, sickening 377 people, 28 of whom have died.

The tainted methylprednisolone acetate also was not received or used in Maine. The state has recorded no cases of fungal meningitis, though health officials are monitoring 74 Maine residents who were treated in New Hampshire with the contaminated steroid injections.

The Maine Board of Pharmacy voted Thursday to immediately suspend NECC’s license to operate in the state.

The outbreak prompted an Oct. 6 recall of all of NECC’s products. Maine Coast Memorial Hospital had already removed the topical betamethasone from its shelves, said Tim McCall, pharmacy director.

“We pulled and quarantined everything” from NECC, he said.

Most drugs made by the Framingham, Mass., pharmacy have not been linked to illnesses. But the FDA recommended that patients who received the products be notified about the potential risk of infection.

More than 30 health care organizations in Maine were customers of NECC. None purchased the tainted methylprednisolone acetate.

Federal regulators also are testing the injectable betamethasone and cardioplegia solution for fungus. Results are pending.

The FDA had said previously that it was investigating whether the cardioplegia solution and medications used in eye surgeries were connected to the outbreak.

The “clinical significance” of this week’s discovery of bacteria in the two new NECC products “is not known,” the FDA said in a statement.

Some of the types of bacteria identified in NECC’s injectable betamethasone and cardioplegia solution are rarely reported to cause disease in humans, the FDA said. As of Thursday, the U.S. Centers for Disease Control and Prevention had not received any reports of laboratory-confirmed cases of bacterial infections linked to the two drugs.

The findings “reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics and health care providers should not use any NECC-supplied products,’’ the statement said.

NECC has suspended operations and is being investigated for its role in the meningitis outbreak. Investigators there have found standing water from a leaking boiler, filthy floor mats and records indicating drugs were shipped before sterility tests were returned.

The outbreak has stirred calls for stricter regulation of compounding pharmacies, which step in to manufacture medicines when drugs from pharmaceutical companies become unavailable or when patients need custom-made formulations.

The industry is loosely regulated by the FDA and state pharmacy boards. Maine has no compounding facilities that operate on a large scale, but some individual pharmacies mix their own drug formulations as needed.

Scrutiny has also fallen on a sister company of NECC called Ameridose LLC. The Westborough, Mass., company was closed on Oct. 10 and issued a voluntary recall of all of its products this week after the FDA directed it to improve its sterility testing procedures.

Ameridose is a major supplier of common injectable drugs, such as morphine, lidocaine and the anticoagulant heparin. Maine hospitals are among some of its customers.

The company said Wednesday that it had not received any reports of adverse reactions to its recalled drugs. The FDA said it recommended the recall “out of an abundance of caution.”

The Maine Board of Pharmacy also took action Thursday on Ameridose, voting to ask the company to surrender its license to do business in Maine, according to Doug Dunbar, a spokesman for the Maine Department of Professional and Financial Regulation, which oversees the board.

Board members have offered NECC a consent agreement. If the pharmacy signs off on it, its license in Maine would be revoked.

The Associated Press and Reuters contributed to this report.

http://bangordailynews.com/2012/11/02/health/contamination-found-in-more-drugs-made-by-mass-pharmacy/ printed on September 22, 2014