Maryland state epidemiologist Dr. David Blythe said during a legislative hearing on compounding pharmacies last week that state regulations need to be reviewed in light of the meningitis case.

"The Maryland Board of Pharmacy is committed to doing everything it can to protect Maryland residents from unsafe, compounded drugs," said Blythe, according to written testimony from the hearing.

Health Secretary Joshua M. Sharfstein argued for more of a federal role in a recent New England Journal of Medicine article. He wrote that ideally the FDA would set regulations for these pharmacies and the states would play a supportive enforcement role.

In a phone interview, he said: "I don't think states alone can do it because this is a national health challenge. I think that states are an important partner, but there needs to be a national framework."

One national patient advocacy group, Public Citizen, said that the meningitis case shows weakness throughout the system, both at a local and national level. The state of Massachusetts previously found problems at the New England Compounding, but it was allowed to remain open.

Public Citizen said it would support minimum standards that all states would have to use to regulate compounding pharmacies. It also wants the pharmacies to clearly state that their drugs are compounded and not approved by the FDA.

"The failures in the meningitis incident was multi-level," said Dr. Michael Carome, deputy director of Public Citizen's health research group. "There were so many opportunities to intervene and prevent this tragedy."

The Maryland Board of Pharmacy issued letters to five compounding facilities in fiscal year 2012 because of problems found in their facilities. The pharmacies, which included Johns Hopkins Bayview Medical Center Inpatient Pharmacy — were ordered to correct the problems.

Johns Hopkins Bayview was cited because its "clean room" where drugs are mixed did not meet state standards. It lacked air pressurization, contained windows that were kept open, had floors that were not properly sealed, and the seats on the chairs in the room had ripped covers and exposed foam, according to documents.

The hospital fixed the problem or showed that in some cases they actually were in compliance, the documents said.

"During a routine Board of Pharmacy inspection, deficiencies were cited in the pharmacy environment," the hospital said in a statement. "Immediate actions were taken and full compliance was achieved. At Johns Hopkins Bayview Medical Center, patient safety is the top priority and recommendations from the Board of Pharmacy and other accrediting organizations are routinely implemented into our extensive safety and quality improvement programs."

Naesea said the board's goal is to work with the pharmacies.

"A lot of people think we should be shutting down pharmacies," Naesea said. "We want them to practice correctly and not harm anyone."

andrea.walker@baltsun.com

Twitter.com: ankwalker

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