Compounding Pharmacy Risks Targeted by FDA After Meningitis Outbreak
Federal drug regulators have focused their attention on what they consider to be “high risk” compounding pharmacies in the wake of a fungal meningitis outbreak last year, which killed nearly 50 people nationwide.
The FDA conducted surprise inspections at about 30 compounding pharmacies across the country last month, citing four for serious violations.
FDA officials indicate that they compiled the list based off of adverse event reports, previous inspections and other data which suggested those pharmacies could be a danger to the public.
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The four compounding pharmacies that received citations were:
- Amazaohealth Corporation in Tampa, Florida
- Central Admixture Pharmacy Services, Inc. in Chicago, Illinois
- PharMEDium Services, LLC in Cleveland, Mississippi
- Lee Pharmacy, Inc, in Fort Smith, Arizona
Most of the citations were for poor sterilization and quality control procedures, the kinds of deficiencies that could cause drugs to be a danger to human health.
Outbreak Linked to Massachusetts Compounding Pharmacy
The crackdown is in response to a fungal meningitis outbreak that is believed to have started from contaminated drugs distributed by the New England Compounding Center (NECC) in Massachusetts, which sent out thousands of vials of epidural steroid injections that were nonsterile and contaminated.
The U.S. Centers for Disease Control and Prevention (CDC) believe that 14,000 people in the U.S. were exposed to the contaminated drugs nationwide before an October NECC epidural steroid injection recall was announced.
At least 714 cases of fungal meningitis were tracked back to the vials, which were distributed to hospitals and pain management centers nationwide. Officials have linked 48 deaths to the drugs compounded at NECC.
The FDA came under intense scrutiny in the aftermath of the outbreak, since both the agency and Massachusetts health officials had repeatedly expressed concerns about NECC in the past and even warned that a health problem from its drugs could occur, but critics say no real action was taken, and both state and federal officials claim they had no real power to shut the facility down.
NECC faces a growing number of fungal meningitis lawsuits following the outbreak, and declared bankruptcy late last year under the weight of the oncoming litigation. The owners may also face state and federal criminal charges.
Fungal meningitis causes inflammation of the spinal cord and protective membranes covering the brain. The inflammation generally causes an infection of the fluid surrounding the brain and spinal cord. Treatment and recovery can take months. In addition, CDC officials said there were also injection site infections caused by the tainted vials that could complicate patient recovery.
This week the CDC released additional guidance for doctors and other health care workers on how to treat the potential infections and possible damage to the central nervous system.
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