US meningitis outbreak (25 dead): Pharmacy staff 'aware of bacteria' in sterile rooms

The FDA uncovered some four dozen reports of potential contamination in company records, stretching back to January this year.

The report comes from an FDA inspection of the Framingham, Massachusetts-based company earlier this month after steroid injections made by the company were tied to an outbreak of fungal meningitis.

FDA officials confirmed last week that the black fungus found in the company’s vials was the same that has struck down 338 people across the US, causing 25 deaths.

The New England Compounding Centre’s lawyer said the pharmacy “will review this report and will continue our cooperation with the FDA”.

Compounding pharmacies like NECC traditionally fill special orders placed by doctors for individual patients, turning out a small number of customised formulas each week. They have traditionally been overseen by state pharmacy boards, though the FDA occasionally steps in when major problems arise.

Some pharmacies have grown into much larger businesses in the last 20 years, supplying bulk orders of medicines to hospitals that need a steady supply of drugs.

The FDA report provides new details about NECC’s conditions, which were first reported by state officials earlier this week. The drug at the centre of the investigation is made without preservative, so it is very important that it be made under highly-sterile conditions.

Compounding pharmacies prepare their medications in clean rooms, which are supposed to be temperature-controlled and air-filtered to maintain sterility.

But FDA inspectors noted that workers at the pharmacy turned off the clean room’s air conditioning every night. FDA regulators said that could interfere with the conditions needed to prevent bacterial growth.

Inspectors also say they found a host of potential contaminants in or around the pharmacy’s clean rooms, including green and yellow residues, water droplets and standing water from a leaking boiler.

Additionally, inspectors found “greenish yellow discolouration” inside an autoclave, a piece of equipment used to sterilise vials and stoppers. In another supposedly sterile room inspectors found a “dark, hair-like discolouration” along the wall. Elsewhere FDA staff said that dust from a nearby recycling facility appeared to be drifting into the pharmacy’s rooftop air-conditioning system.

The FDA declined to characterise the severity of the problems at NECC or to speculate on how they may have led to contamination of the products made by the pharmacy. It emphasised that the report was based on “initial observations” and that the agency’s investigation was continuing.

The agency also provided new details about the pharmacy’s handling of the steroids it recalled last month. The company recalled three lots of steroids made since May that totalled 17,676 single-dose vials of medicine – roughly equivalent to 20 gallons. The shots are mainly used to treat back pain.

According to the agency’s report, the pharmacy began shipping vials from the August lot to customers on August 17. That was nearly two weeks before the pharmacy received test results from an outside laboratory confirming the sterility of the drug. When FDA scientists went back and tested the same lot this month, they found contamination in 50 vials.

Outside experts said the report painted a picture of a dysfunctional operation.

“The entire pharmacy was an incubator of bacteria and fungus,” said Sarah Sellers, a former FDA officer who left the agency in 2008 after unsuccessfully pushing it to increase regulation of compounding pharmacies. She now consults for drug manufacturers.

“The pharmacy knew this through monitoring results, and chose to do nothing.”