Preventing Exposure to Hazardous Drugs: Engineering-control recommendations in the NIOSH Alert
May 24, 2007
In summary, in 2004 NIOSH published an alert titled "Preventing Occupational exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings". The data reveals evidence of health effects such as skin rashes, developmental and reproductive effects and possibly cancer. The studies provide evidence that workers are being exposed to hazardous drugs and are experiencing serious health effects despite current work-practise.
The alert highlight the importance of using ventilated cabinets, such as biological safety cabinets (BSCs) and barrier isolators, designed to protect workers from exposure to hazardous drugs in health care facilities. When aseptic technique is required for a hazardous drug such as chemo drugs, health care facilities should provide a work environment that protects both the worker and the hazardous drug from contamination by following recommendations from the NIOSH alert, as well as the applicable regulations from the USP Chapter <797> and individual state boards of pharmacy. The ventilated cabinet design options identified to provide both aseptic technique and aerosolized drug containment include Class II BSCs, Class III BSCs, and aseptic-containment isolators. Horizontal laminar airflow workbenches should never be used for the preparation of a hazardous drug.
The alert recommends that hazardous drugs be prepared within a dedicated area devoted solely to preparing hazardous drugs and that access to this area should be restricted to authorized personnel. The alert recommends that the ventilated cabinets's exhaust be HEPA filtered and directed to the outdoors whenever possible. Proper cabinet performance is also emphasized; the performance of ventilated cabinets should be certified every 6 months, consistent with OSHA's requirements for Class II BSCs.
NIOSH warns that a closed-system drug transfer device should not be used as a substitute for a ventilated cabinet during compounding processes where hazardous drugs are used. It is also important to use appropriate work practises and personal protective equipment (PPE), including double gloves and protective gowns, even when using a closed-system device.
The cabinet's adequacy will depend on the hazardous drug's occupational exposure limit, the amount of ambient aerosol from the process, the frequency of the process and the various physical characteristics of the aerosol. NIOSH alert recommends not using a ventilated cabinet that re-circulates air inside the cabinet or that exhausts air back into the room environment.
This article was written by Duane Hammond ad Kenneth R. Mead,MS,PE and published in Pharmacy Purchasing & Products, Vol.3 No.2.