ASCO HAS PUBLISHED a new guideline, “Safe Handling of Hazardous Drugs: ASCO Standards,” to promote the safety of pharmacists, nurses, and all staff who handle potentially dangerous medicines, such as chemotherapy compounds.1 Safety is pivotal in the entire drug workflow, including drug mixing and preparation, storage, administration of drugs to patients, spill mitigation, and disposal management. 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.
Paul Celano, MD, FACP, FASCO
“It’s an evolving process of safety, and we need to balance the desire for safety with the proper data for developing these standards,” said Expert Panel Co-Chair Paul Celano, MD, FACP, FASCO, of The Sandra and Malcolm Berman Cancer Institute in Baltimore. “We want to ensure our nurses and pharmacists are not unduly exposed to the medications.”
Mitigating Health Risks and Complications
IN THE UNITED STATES each year, approximately 8 million health-care workers have the potential for exposure to cytotoxic and other drugs that may be hazardous to their health, through the preparation and administration of anticancer regimens comprising one or more pharmaceutical agents.2 The risks of reproductive complications and other adverse health outcomes are key concerns that the standards seek to address by preventing unnecessary exposure to such agents.
The ASCO Expert Panel endorses the best practices for safe handling of hazardous drugs as issued by the Occupational Safety and Health Administration, the U.S. Pharmacopeia General Chapter <800>, and the Oncology Nursing Society with clarifications in four key areas: medical surveillance, closed-system transfer devices, external ventilation of containment secondary engineering controls or containment-segregated compounding areas, and employee reassignment. Close-system transfer devices “mechanically prohibit transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.”3
“It’s an evolving process of safety, and we need to balance the desire for safety with the proper data for developing these standards.”— Paul Celano, MD, FACP, FASCO
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“There needs to be a certification process, which is why this evidence-based guide is so important,” Dr. Celano said.
The fourth area, employee reassignment, may occur when workers are trying to conceive, are pregnant, or are breastfeeding. At the time of hire, workers should be provided with information regarding the capacity of the organization to accommodate employee reassignment, and reviewing these options should be the shared responsibility of the employee and employer.
Challenges and Solutions
ONE OF THE CHALLENGES of medical surveillance in the context of safe handling of drugs is that it fails to meet several established criteria; there are no valid tests or techniques for detecting early signs of disease, no established levels of exposure that have been linked to adverse health effects, and no established actions in response to a particular result. However, employees should be encouraged to report occupational health issues to employee health services at the time they are experienced.
As an alternative to routine ongoing medical surveillance programs, this guideline endorses larger-scale data collection in the context of a registry of health-care workers. Data gathered as part of a registry could be used to test research hypotheses and fill important knowledge gaps. In addition to protective gear, staff training is essential to ensure that a safe work environment is achieved.
“The impetus behind the ASCO guideline is to look at it in an evidence-based way and not based on general principles,” Dr. Celano said.
It’s a field that will continue to improve as more data are gathered, which will require institutions to evaluate and reassess.
THE ASCO GUIDELINE addresses the need for clear standards concerning the safe handling of hazardous oncology drugs. More research is needed in several key areas to quantify the level of risk associated with handling hazardous drugs in current workplace settings where the hierarchy of controls is consistently applied.
Having the right equipment, employee training, measurable tactics, and safety measures can lead to healthier employees who are able to do their job to the best of their ability, which leads to the best care of patients with cancer—the ultimate priority. ■
DISCLOSURE: For full disclosures of the panel authors, visit www.jco.ascopubs.org.
1. Celano P, Fausel CA, Kennedy EB, et al: Safe handling of hazardous drugs: ASCO standards. J Clin Oncol. January 8, 2019 (early release online).
2. National Institute for Occupational Safety and Health: Personal protective equipment for health care workers who work with hazardous drugs. Available at cdc.gov/niosh/docs/wp-solutions/2009-106/. Accessed February 5, 2019.
3. National Institute for Occupational Safety and Health: NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. Available at www.cdc.gov/niosh/docs/2004-165/ pdfs/2004-165.pdf. Accessed February 5, 2019.
Originally published in ASCO Daily News. © American Society of Clinical Oncology. ASCO Daily News, January 24, 2019. All rights reserved.