Pharmacy Linked To Meningitis Outbreak Has Long History Of Violations
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BALTIMORE (WJZ) — The pharmacy linked to a deadly meningitis outbreak in Maryland was warned about safety lapses and failed to follow standard procedures to keep drugs safe. That’s from a new investigation.
Mike Hellgren has more on the growing problems.
Contaminated drugs that came from a pharmacy in Massachusetts created a health scare for hundreds of patients in Maryland from dangerous fungal meningitis.
Now records WJZ obtained showed the New England Compounding Center had problems with contaminated medications dating back to 2003 and unsanitary conditions in 2006. An inspection just last year missed warning signs. Massachusetts investigators found dirty floor mats, a leaky boiler and vent hoods not cleaned properly.
Dr. Peter Rose with the University of Maryland Center for Health and Homeland Security says there needs to be more FDA oversight.
“They’re very basic issues that could have been remedied very quickly,” Rose said. “It’s really unfortunate because it didn’t need to come to this.”
Massachusetts inspectors found other big problems, too: lab equipment that was not tested, medications that weren’t sterilized and drugs shipped before they were tested for contaminants.
“Typically, the FDA would go back and reinspect,” said Sheldon Bradshaw, former counsel for the FDA. “Here, it appears that the FDA simply relied upon New England Compounding Center’s word that they had corrected the problems.”
The federal government found 89 different facilities in Maryland were getting drugs from that pharmacy.
The outbreak has been agonizing for patients and their families.
“It was really heartbreaking and then I didn’t want to watch the news anymore and know the death tolls,” said Tracy Clemm, the mom of a patient. “Even though they said it was early, I just had a fear that something bad could happen.”
The number of cases and deaths is still growing nationwide.
Massachusetts’ governor said the state is tightening regulations in the wake of the outbreak, ordering surprise inspections of compounding pharmacies and annual reports on what they’re producing and where it’s going.