The American Society of Clinical Oncology (ASCO) convened an expert panel to establish a set of standards for the safe handling of hazardous drugs, according to a report published in the Journal of Clinical Oncology. The ASCO standards are intended to mitigate exposure-related health hazards related to the preparation and administration of anticancer regimens.
Members of the panel represent various clinicians involved in cancer care, including physicians, pharmacists, researchers, and nurses. Panelists also have extensive experience in the day-to-day operations of oncology centers, including freestanding and hospital-based settings in urban and rural areas throughout the United States.
“The overarching goal is to develop a set of evidence-based standards that are applicable to diverse workplaces where hazardous drugs are handled for oncology care,” wrote the authors. Drugs are defined as hazardous based on their association with genotoxicity, carcinogenicity, teratogenicity, fertility impairment or reproductive toxicity, and/or serious organ toxicity at low doses.
The expert panel considered existing standards for endorsement in its ASCO standards. For the most part, the panel endorsed standards established by the US Occupational Safety and Health Administration (OSHA), the US Pharmacopeia (USP) Chapter 800, the National Institute for Occupational Safety and Health (NIOSH) 2004 Alert, and the Oncology Nursing Society (ONS). However, the panel found that data on health outcomes associated with exposure to hazardous drugs and the impact of controls to mitigate this exposure and risk are lacking.
The panel identified 4 areas it determined required additional evidence review: medical surveillance, closed-system transfer devices (CSTDs), external ventilation of containment secondary engineering controls (C-SECs) or containment segregated compounding areas (C-SCAs), and alternative duties.
Additional evidence review included a systematic review of the literature on closed system transfer devices (CSTDs) using PubMed and a search for studies on medical surveillance and external ventilation/health effects of exposure to vapors in the Cochrane Database of Systematic Reviews, PubMed, and Google Scholar. In addition, the panel solicited public comment and considered its merits in the report.
For the 4 areas named, consensus-based statements were developed that consider the associated potential benefits (eg, prevent or reduce adverse health outcomes) and harms (unnecessary or uncertain procedures or technologies, inconvenience, anxiety, false sense of security, overdiagnosis or misdiagnosis, and cost and physical constraints) to healthcare workers.
The authors suggest these standards may serve as a foundation for establishing best practices for safe handling of hazardous drugs. “The standards were created with applicability in mind; that is the standards need to be as applicable in the small practice setting as they are in a comprehensive cancer center,” the authors state in their conclusion.
Celano P, Fausel CA, Kennedy EB, et al. Safe handling of hazardous drugs: ASCO standards [published online January 8, 2019]. J Clin Oncol.doi: 10.1200/JCO.18.01616