NIOSH Publishes Alert on Preventing Occupational Exposure to Hazardous Drugs

ENGLEWOOD, Colo. -- The National Institute for Occupational Safety and Health (NIOSH) has published its alert on the risks of environmental and occupational exposure for healthcare workers who handle antineoplastic and other hazardous drugs. The announcement is made by Baxa Corporation, the distributor of PhaSeal, the only closed system that prevents the workplace contamination threats delineated in the alert. The publication follows the March 2004 release of an electronic draft document to the NIOSH Web site.

The alert, "Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Health Care Settings," is the result of several years of collaboration by the NIOSH Hazardous Drug Safe Handling working group. This group of physicians, nurses, pharmacists and scientific experts developed the original 93-page draft alert, which has now been edited to 54 pages. The complete published alert is available on the NIOSH Web site at http://www.cdc.gov/niosh/docs/2004-165. A one-page summary for workers and employers can be downloaded from the same location.

The alert begins with a highlighted paragraph, "Warning! Working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects and possibly leukemia or other cancers."

More than 150 references are cited in the alert, which provides an extensive background review of the research and associated findings related to the adverse health effects from exposure to hazardous drugs. Affected healthcare workers include those involved in receiving and delivering the manufacturers' drug vials, pharmacy workers who prepare the drugs for delivery, nurses who administer the doses, and environmental services employees. The alert details the conditions under which exposure can occur, including drug reconstitution, drug administration, skin contact with contaminated pharmacy and patient care surfaces, transporting vials or drug syringes and bags, and decontaminating and cleaning work surfaces in preparation areas.

"The evidence documented in the Alert regarding the risks to healthcare workers is compelling," notes Baxa vice president Michael Hurst, RPh. "Extensive studies have shown developmental and reproductive effects, as well as genotoxicity and cancer itself. Current practice standards simply do not adequately address the exposure risks for pharmacy technicians and caregivers."

The publication outlines current practice standards for safe handling, while acknowledging that additional precautions should be considered. Among the Alert's recommendations are:

* "Consider using closed-system drug-transfer devices and needleless systems to protect nursing personnel during administration."

* "Consider providing supplemental equipment to protect workers further - for example, glove bags, needleless systems, and closed-system drug-transfer devices."

* "Provide syringes and IV sets with Luer-Lok fittings for preparing and administering hazardous drugs."

* "Be familiar with and recognize sources of exposure to hazardous drugs."

* "Store and transport hazardous drugs in closed containers that minimize the risk of breakage."

* "Use devices such as closed-system transfer devices, glovebags, and needleless systems for added protection:

** Use these closed-system devices inside a ventilated cabinet whenever possible to transfer hazardous drugs from primary packaging (such as vials) to dosing equipment (such as infusion bags, bottles, or pumps). Closed systems limit the potential for generating aerosols and exposing workers to sharps. Evidence documents a decrease in drug contaminants inside a Class II BSC when a closed-system transfer device is used..."

NIOSH is following this publication with a workshop to familiarize healthcare professionals with the Alert and to discuss implementation of its recommendations. This workshop, "Alert on Reducing Occupational Exposure to Hazardous Drugs in Healthcare: Converting Theory to Practice," will be held Oct. 3-5, 2004 at the Crowne Plaza Riverwalk in San Antonio, Texas. Registration is available online at http://www.cdc.gov/niosh/topics/hazdrug/conference.html.

Baxa Corporation is the exclusive US distributor of the only documented closed-system drug-transfer products for the safe handling of antineoplastic and other hazardous drugs. This system, PhaSeal, uses dry connections and a built-in expansion chamber to prevent drug aerosol leakage and subsequent transfer into the work environment. As a closed system, it contains hazardous drugs throughout the entire process of drug transfer, preparation, transport, administration and disposal -- eliminating the risks of environmental and occupational exposure.

The PhaSeal System is currently in use for handling hazardous drugs in 200 leading cancer hospitals in the US. The system is also used in progressive hospitals throughout Europe.