Annually, more than 8 million U.S. health care personnel are potentially exposed to the risks associated with handling hazardous drugs. Since the 1970s, peer reviewed scientific literature has cited the potential adverse health effects associated with healthcare worker occupational exposure to chemotherapeutic drugs mixed and administered to cancer patients. Federal agencies, scientific agencies, professional societies, and accreditation bodies have increased awareness and provided guidelines and recommendations for safe handling of hazardous drugs.
However, for four decades there have been no rules and regulations or standards of practice for healthcare entities to protect healthcare workers handling hazardous drugs.
This presentation focuses on new Standards of Practice for an old problem that has the potential for catastrophic harmful health effects from occupational exposure and the legal implications associated with failing to meet the requirements necessary to comply to the USP <800> standards of practice.
Although antineoplastic (cancer) drugs remain the principal focus, the National Institute of Occupational Safety and Health (NIOSH) has recognized and categorized non cancer drugs that pose a health risk for healthcare workers. NIOSH has established criteria for classifying these drugs and the potential occupational diseases associated with exposure.
Conclusion: The Duty and Standards of Practice established by USP<800> became official on December 1, 2019. Regulatory oversight will be provided by the Food and Drug Association (FDA) and other federal agencies such as OSHA as well as accreditation bodies such as ACHA and The Joint Commission. This presentation demonstrates the history and potential for occupational disease associated with handling of hazardous drugs; how the USP <800> standards of practice provide protection against such occupational exposure and the battlefield of causation associated with lack of compliance to these standards.
Notably, this presentation is not focused on specific hazardous drugs but rather in providing the legal community with a background of a healthcare worker problem, new standards of practice to protect healthcare workers handling hazardous drugs, and applicable resources for engaging in the battlefield of causation.