In the Journals

ASCO publishes new standards for safe handling of hazardous drugs

Monica M. Bertagnolli, MD, FACS, FASCO
Monica M. Bertagnolli

Health and safety management systems should include, at a minimum, a list of all hazardous drugs on the premises, facility and engineering controls, competent personnel, safe work practices, proper use of protective equipment, and clear policies for hazardous drug waste segregation and disposal, according to new ASCO standards.

“ASCO takes very seriously its role in promoting evidence-based standards, educating its members, and helping oncology practices implement processes that have demonstrated efficacy in protecting patients and staff,” Monica M. Bertagnolli, MD, FACS, FASCO, president of ASCO, said in a press release. “We share with other professional societies the same primary concern for the welfare of cancer care providers and their patients.”

ASCO formed an expert panel in 2017 to conduct a systematic review of literature on closed system transfer devices. Specifically, the panel searched PubMed, the Cochrane Database of Systematic Reviews and Google Scholar for studies the looked at medical surveillance and external ventilation and health effects of exposure to vapors.

The search did not find any studies that explored these health effects.

As a result, the panel endorsed the practices for safe handling of hazardous drugs issued by the Occupational Safety and Health Administration, U.S. Pharmacopeia Chapter 800, National Institute for Occupational Safety and Health (NIOSH) and Oncology Nursing Society. However, the panel also determined that conditional standards, rather than strong standards, are appropriate.

The panel’s recommendations — published in Journal of Clinical Oncology — made clarifications in four areas: medical surveillance; closed-system transfer devices; external ventilation of containment secondary engineering controls or containment segregated compounding areas; and alternative duties.

In terms of medical surveillance, the panel stated workplace occupational health programs should include policies and procedures demonstrated to effectively monitor hazardous drug contamination and to monitor individuals who have been involved in an acute exposure, such as a spill. However, a lack of data led to unclear conclusions about the role of ongoing medical surveillance programs.

NIOSH recommends using closed-system transfer devices during the transfer of hazardous drugs to infusion bags, bottles or pumps. However, because there is no standardized testing protocol to assess the performance of available closed-system transfer devices, the panel encouraged NIOSH to develop a certification process to identify effective devices.

Because external ventilation of containment secondary engineering controls or containment segregated compounding areas can be included in protective measures to reduce the likelihood of exposure, the panel recommended institutions assess their current engineering controls and add ventilation in areas where it is not currently used.

In terms of alternative duty, the panel stated that it is the shared responsibility of the employee and employer to review options for alternative work for workers who are actively trying to conceive, are pregnant or who are breastfeeding.

A lack of data on the effectiveness of these standards served as a limitation to this report.

“The evolution of oncology care as well as publication of new evidence will trigger periodic updating of and revisions to these standards,” Paul Celano, MD, director of the Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center, and colleagues wrote. “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 the comprehensive cancer center. In addition, the standards can serve as the foundation for best practices, which are evidence-based processes that help ensure safe handling in a strong culture of safety and quality.” – by John DeRosier

Disclosure s : HemOnc Today could not confirm Bertagnolli’s relevant financial disclosures at the time of publication. Celano reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

Monica M. Bertagnolli, MD, FACS, FASCO
Monica M. Bertagnolli

Health and safety management systems should include, at a minimum, a list of all hazardous drugs on the premises, facility and engineering controls, competent personnel, safe work practices, proper use of protective equipment, and clear policies for hazardous drug waste segregation and disposal, according to new ASCO standards.

“ASCO takes very seriously its role in promoting evidence-based standards, educating its members, and helping oncology practices implement processes that have demonstrated efficacy in protecting patients and staff,” Monica M. Bertagnolli, MD, FACS, FASCO, president of ASCO, said in a press release. “We share with other professional societies the same primary concern for the welfare of cancer care providers and their patients.”

ASCO formed an expert panel in 2017 to conduct a systematic review of literature on closed system transfer devices. Specifically, the panel searched PubMed, the Cochrane Database of Systematic Reviews and Google Scholar for studies the looked at medical surveillance and external ventilation and health effects of exposure to vapors.

The search did not find any studies that explored these health effects.

As a result, the panel endorsed the practices for safe handling of hazardous drugs issued by the Occupational Safety and Health Administration, U.S. Pharmacopeia Chapter 800, National Institute for Occupational Safety and Health (NIOSH) and Oncology Nursing Society. However, the panel also determined that conditional standards, rather than strong standards, are appropriate.

The panel’s recommendations — published in Journal of Clinical Oncology — made clarifications in four areas: medical surveillance; closed-system transfer devices; external ventilation of containment secondary engineering controls or containment segregated compounding areas; and alternative duties.

In terms of medical surveillance, the panel stated workplace occupational health programs should include policies and procedures demonstrated to effectively monitor hazardous drug contamination and to monitor individuals who have been involved in an acute exposure, such as a spill. However, a lack of data led to unclear conclusions about the role of ongoing medical surveillance programs.

NIOSH recommends using closed-system transfer devices during the transfer of hazardous drugs to infusion bags, bottles or pumps. However, because there is no standardized testing protocol to assess the performance of available closed-system transfer devices, the panel encouraged NIOSH to develop a certification process to identify effective devices.

Because external ventilation of containment secondary engineering controls or containment segregated compounding areas can be included in protective measures to reduce the likelihood of exposure, the panel recommended institutions assess their current engineering controls and add ventilation in areas where it is not currently used.

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In terms of alternative duty, the panel stated that it is the shared responsibility of the employee and employer to review options for alternative work for workers who are actively trying to conceive, are pregnant or who are breastfeeding.

A lack of data on the effectiveness of these standards served as a limitation to this report.

“The evolution of oncology care as well as publication of new evidence will trigger periodic updating of and revisions to these standards,” Paul Celano, MD, director of the Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center, and colleagues wrote. “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 the comprehensive cancer center. In addition, the standards can serve as the foundation for best practices, which are evidence-based processes that help ensure safe handling in a strong culture of safety and quality.” – by John DeRosier

Disclosure s : HemOnc Today could not confirm Bertagnolli’s relevant financial disclosures at the time of publication. Celano reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.