Hazardous Drugs and Worker Safety: Emerging Regulations

Approximately 8 million U.S. healthcare workers may be exposed to hazardous drugs, according to NIOSH. Occupational exposures have been shown to cause adverse health effects. Emerging regulations designed to protect workers are based on existing recommendations for safe handling.

In February, California introduced Assembly Bill (AB) 1202 that would require its state Occupational Safety and Health Standards Board to promulgate a standard for hazardous drugs, which includes antineoplastic agents or “chemotherapy.” If enacted, California will become the second state to regulate hazardous drug handling in the workplace, as the state of Washington passed a similar bill in 2011 that required its Department of Labor & Industries to adopt a hazardous drugs rule. Washington has planned a phased implementation of the rule slated to begin January 1, 2014. Similar to the new standard in Washington, the proposed California standard will be based on recommendations laid out by the National Institute for Occupational Safety and Health (NIOSH) in 2004. The NIOSH recommendations are designed to prevent occupational exposures by use of industrial hygiene principles and safe drug handling practices, e.g., engineering controls (ventilated cabinets, closed-system drug transfer devices), training, personal protective equipment (double-gloves made from materials that have been tested for chemotherapy resistance, impervious gowns, respiratory protection) and medical surveillance.

Current knowledge of the potential hazard

NIOSH estimates that 8 million U.S. healthcare workers have the potential to be exposed to hazardous drugs. Currently, NIOSH lists 167 hazardous drugs and many more new and investigational formulations may be classified as hazardous. There is clear evidence, documented by many published studies using wipe sampling and laboratory analysis, of widespread drug contamination on work area surfaces in pharmacies where hazardous drugs are prepared and treatment areas where the drugs are administered to patients. There is also evidence that actual exposures do occur, as hazardous drugs and drug metabolites have been detected in the urine of healthcare workers. Such occupational exposures can cause deleterious health effects ranging from skin rashes, headaches and flu-like symptoms to infertility, miscarriage, birth defects, leukemia and other cancers. Unlike some traditional industrial workplace chemicals, the risk assessment process for hazardous drug classes in the occupational setting will be more complex although research showing chromosomal changes in healthcare workers occupationally exposed to a class of hazardous drugs known as “alkylating agents” may help promote the risk assessment process. What remains to be identified are the measurable risks associated with chronic low-level occupational exposures to many different hazardous drug classes over the course of a working lifetime.

Compliance: ‘Shall’ vs. ‘should’

NIOSH is not the only agency with published recommendations for the safe handling of hazardous drugs. The Occupational Safety and Health Administration (OSHA), the American Society of Health-System Pharmacists (ASHP), the Oncology Nursing Society (ONS), and others have issued similar guidance over the last decade or more. Even though all U.S. healthcare employers should be utilizing available guidance to develop site-specific safe handling programs designed to protect their workers from hazardous drug exposures, a range of compliance currently exists. Washington, and now possibly California, lead the way under the force of regulation such that employers ‘shall comply’ with the recommendations. Other states will likely propose similar legislation, thus stimulating action from healthcare employers across the nation to comply, with the common goal of creating a safer healthcare working environment where hazardous drugs are handled.

Update: The state of North Carolina introduced a similar bill on April 9, 2013, which you can read in its entirety here.

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