Just over a year ago, a fungal meningitis outbreak linked to contaminated pharmaceutical products sickened approximately 740 people in 20 states and killed 64. The fungus was found in injections of methylprednisolone acetate, a steroid, that was manufactured by New England Compounding in Framingham, Mass.
The fall 2012 outbreak was one of the largest incidents of drug contamination in American history, and it raised flags about the regulation of compounding pharmacies and hospitals that mix sensitive pharmaceutical components.
This past fall in Highlands County, Florida Hospital Heartland Medical Center decided to take its own steps to ensuring patients' safety by revamping the pharmacy "clean room." The new and improved compounding area opened at the beginning of December and consists of a 10-by-14 glass-enclosed space within the pharmacy with an anteroom, a positive pressure room and a new negative pressure room.
In one room, a positive pressure device keeps air flowing at a rate that prevents air particulates and germs from settling on the medication components, which creates contamination.
In the negative pressure room, a barrier isolator allows technicians to work with sensitive compounds by placing their hands through gloves built into a Plexiglass box. A negative pressure hood constantly sucks air out of the box. The device protects the technician from coming into contact with fumes from dangerous chemotherapy components as well as protects the medication.
An anteroom between the two rooms gives technicians a place to properly wash, gown and glove themselves. It also houses an emergency eye wash.
When asked if a system like the one in the pharmacy could have prevented the 2012 fungal meningitis outbreak, Florida Hospital Heartland Medical Center Pharmacy Director Mala Cullipher said, "Absolutely."
"Hospitals all across the U.S. have to comply with United States Pharmacopeia 797 guidelines. NECC did not follow good manufacturing practices," Cullipher said.
USP 797 established the first comprehensive quality standards surrounding the design of and procedures used in sterile compounding areas, according to the USP797.org website.
In order to be compliant with USP 797, labs must have procedures in place such as proper gowning, gloving and hand-washing techniques. Minimizing air particulate contaminants in the clean room and using proper spill clean-up procedures are also part of compliance.
Cullipher said she performs glove fingerprint tests on her staff every six months, which involves the technicians placing their gloved fingerprints on an agar dish so the growth of any microorganisms can be seen. Cullipher also said that traffic in and out of the clean room is minimized by assigning one technician to work in the room for the entire week and using pass-throughs to get compounded medications out of the clean room and into the main pharmacy area.
Cullipher said the pharmacy was already compliant with USP 797 before the remodel was completed at the beginning of December, but "we're making it consistent with an environment that will facilitate additional safety measures."
The hospital is also the first in the Adventist Health System to have the new, higher-level model of clean room recommended by USP 797. Some of the medications compounded in the room include intravenous preparations of antibiotics, chemotherapy drugs and epidurals. A ribbon-cutting ceremony complete with a blessing of the room by pastor Linda Lynch was held Dec. 21.
"It looks like NASA," joked interim CEO Warren Santander. He said he was supportive of Cullipher's request to remodel the clean room. "It's good to be able to stay abreast of the new technology," Santander said.
Besides the deadly nature of the fungal meningitis outbreak, the patients who survived also struggled with lengthy complications from the treatment, which doctors described as "tough or even tougher than chemotherapy."
The antifungal medications needed to treat the outbreak are expensive as well, Cullipher said.
Installing the new clean room was "a big undertaking" Cullipher said, but she's pleased at the support of the administration for the endeavor.
"Hospitals do take measures to ensure the safety of their patients and to create quality controls within the organization that are adhered to (in order to) prevent untoward events," Cullipher said.