Sterile compounding lessons to be learned

February 27, 2013

The importance of cleanliness and being proactive were the two most important lessons learned following the New England Compounding Center’s practices that led to the nationwide fungal meningitis outbreak, said sterile compounding expert Eric Kastango, MBA, RPh, FASHP.

The importance of cleanliness and being proactive were the two most important lessons learned following the New England Compounding Center’s practices that led to the nationwide fungal meningitis outbreak, said sterile compounding expert Eric Kastango, MBA, RPh, FASHP.

"This is probably the most catastrophic event that has happened in my lifetime, as it relates to compounding," Kastango said during a web seminar Feb. 20 sponsored by Pharmacy OneSource.

In October 2012, the FDA issued a 483 form to NECC, detailing the filthy conditions of its main clean rooms, gown rooms, prep rooms, and adjacent rooms, as well as observations of vials of methylprednisolone acetate (preservative free) 80 mg/mL from one of the lots known to be contaminated with fungus.

"It's mind-blowing," Kastango said of FDA's findings. "If you have a person in a clean room, you're going to have micro-organisms."

It was noted that the air-conditioning was turned off at 8 pm to 5:30 am in the clean room, according to personnel who were interviewed during the FDA inspections.

In February 2012, NECC reported bacteria and mold beyond the action level near hood 5, an overgrowth of bacteria near hood 5 in April 2012, and an overgrowth of bacteria near horizontal hoods in June 2012.

In the gown room of clean room 1, there were 17 instances of bacteria over the action level that NECC reported from February 2012-July 2012 and 8 instances of mold over the action level reported from February 2012-August 2012. The preparation room was also contaminated with high level bacterial and mold counts, according to FDA’s report.

"The lesson learned is you don't shut off you’re A/C, you keep your facility air-conditioned," Kastango said.  "It also speaks to that fact that they had bacteria and mold showing up and they really weren't doing anything about it.”

Kastango said he thought in the future, the frequency of monitoring and testing of compounding pharmacies would increase.

"The question is, 'how did someone not respond to this?'" he said.

Kastango suggested that compounding pharmacies conduct smoke studies to determine the airflow in their facilities.

"We have always been told as pharmacists and technicians that filters are bulletproof," Kastango said. "We're finding out that is not the truth.

Kastango also recommended:

  • Proper hand-washing

  • Wearing the correct garb

  • Ensuring a knowledgeable, engaged staff

  • Controlling and monitoring the facility environment

  • Using unidirectional airflow

"To achieve a state of control, don't let the micro-organisms in there," he said. "If you have a clean environment, you can maintain it."

Kastango, a member of the 2010-2015 USP Compounding Expert Committee, disclosed that his thoughts and views during the web seminar were his own and not representative of USP.