Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology: ASCO-ONS Standards.

PURPOSE: To update the American Society of Clinical Oncology (ASCO)-Oncology Nursing Society (ONS) standards for antineoplastic therapy administration safety in adult and pediatric oncology and highlight current standards for antineoplastic therapy for adult and pediatric populations with various routes of administration and location. METHODS: ASCO and ONS convened a multidisciplinary Expert Panel with representation of multiple organizations to conduct literature reviews and add to the standards as needed. The evidence base was combined with the opinion of the ASCO-ONS Expert Panel to develop antineoplastic safety standards and guidance. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: The standards presented here include clarification and expansion of existing standards to include home administration and other changes in processes of ordering, preparing, and administering antineoplastic therapy; the advent of immune effector cellular therapy; the importance of social determinants of health; fertility preservation; and pregnancy avoidance. In addition, the standards have added a fourth verification. STANDARDS: Standards are provided for which health care organizations and those involved in all aspects of patient care can safely deliver antineoplastic therapy, increase the quality of care, and reduce medical errors.

Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology: ASCO-ONS Standards.

PURPOSE: To update the ASCO-Oncology Nursing Society (ONS) standards for antineoplastic therapy administration safety in adult and pediatric oncology and highlight current standards for antineoplastic therapy for adult and pediatric populations with various routes of administration and location. METHODS: ASCO and ONS convened a multidisciplinary Expert Panel with representation of multiple organizations to conduct literature reviews and add to the standards as needed. The evidence base was combined with the opinion of the ASCO-ONS Expert Panel to develop antineoplastic safety standards and guidance. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: The standards presented here include clarification and expansion of existing standards to include home administration and other changes in processes of ordering, preparing, and administering antineoplastic therapy; the advent of immune effector cellular therapy; the importance of social determinants of health; fertility preservation; and pregnancy avoidance. In addition, the standards have added a fourth verification. STANDARDS: Standards are provided for which health care organizations and those involved in all aspects of patient care can safely deliver antineoplastic therapy, increase the quality of care, and reduce medical errors.Additional information is available at www.asco.org/standards and www.ons.org/onf.

Cancer Drug Safety Training: Comparing Distance and In-Person Simulations for Interprofessional Education.

The Multi-Professional Oncology Safety and Simulation Training (MOSST) program, supported by the National Cancer Institute was launched in Fall 2018. The original workshop was conducted in person. As the COVID pandemic hit the program was transitioned to an online/distance simulation program using best practices in healthcare simulation design and implementation. The full day workshop was moved to an online platform using Zoom and the in-person simulations were re-developed as video branching case simulations. Learner outcomes that were identical in each modality were evaluated using the evaluation metrics from the original workshop. The use of a distance simulation modality to deliver the MOSST workshop resulted in a high-quality educational experience for the learners and the educational outcomes were comparable to the in-person version. Distance simulation using virtual unfolding case studies and didactic content showed comparable subjective and objective outcomes from participating learners. This work adds to the developing body of research on distance simulation.

Evaluation of an Interprofessional Training Program to Improve Cancer Drug Therapy Safety.

PURPOSE: Drug therapy for cancer is a high-risk, high-volume clinical intervention that requires interprofessional teams. Given the complexity of anticancer drug therapy and safety concerns, an interdisciplinary team developed a novel training program for oncology registered nurses and pharmacists to improve cancer drug safety. METHODS: Participants completed preworkshop learning assessments and received access to web-based modules on six topics: hazardous drug handling, drug extravasation, hypersensitivity reaction management, sepsis recognition, immune checkpoint inhibitor toxicities, and oral oncolytic adherence. In a 7-hour workshop, participants applied module content in interactive exercises and high-fidelity simulations. Preworkshop and postworkshop questionnaires assessed changes in knowledge and confidence in each topic. Program satisfaction and changes to clinical practice or policies were assessed 3 months after the workshop. RESULTS: Two hundred ninety-two nurses and 82 pharmacists applied to participate, and 103 (35%) and 44 (54%) have participated, respectively. Long-term follow-up data were available on 133 (90%) participants. Change scores in confidence to meet program objectives increased between pre- and postworkshop (range of increase 0.6-0.8, P < .01). Knowledge scores increased significantly between pre- and postworkshop (average improvement of 3.2 points, P < .01). Overall program satisfaction was high (mean 5.0, standard deviation [0.2] on a five-point scale). Seventy-seven (60%) reported that they had made at least one clinical practice or institutional policy change at 3 months. CONCLUSION: An interprofessional education program with online modules, in-person interactive sessions, and simulation activities is a promising strategy to deliver cancer drug safety content to practicing oncology clinicians.

Factors influencing precautions against antineoplastic drug exposure among nurses and nurse assistants in Thailand.

BACKGROUND: Antineoplastic drugs (AD) are important chemical risks for healthcare workers. Precautions against AD exposure include the use of appropriate personal protective equipment (PPE). Evaluation of PPE usage during patient care processes has not been reported in Thailand. We aimed to evaluate the level of PPE usage and factors predicting PPE usage among nurses and nurse assistants in Thailand. METHODS: A cross-sectional survey was conducted in a university hospital and two general hospitals. The questionnaires covered demographic characteristics, self-reported use of PPE and 7 predictive factors. Mixed-effects modeling was used to determine the association between standardized score of predictive factors and PPE usage score. RESULTS: The response rate was 78.6% and 884 participants were left for analysis after data cleaning. Among nurses (n = 499), higher PPE usage score was associated with self-efficacy (ß = 0.28, 95% CI 0.21, 0.34), workplace safety climate (ß = 0.27, 95% CI 0.20, 0.34), and conflict of interest (ß = - 0.07, 95% CI - 0.14, - 0.01). Among nurse assistants (n = 385), higher PPE usage score was associated with self-efficacy (ß = 0.27, 95% CI 0.18, 0.36), interpersonal influence (ß = 0.14, 95% CI 0.04, 0.24), workplace safety climate (ß = 10.29, 95% CI 0.19, 0.38), and conflict of interest (ß = - 0.14, 95% CI - 0.24, - 0.03). CONCLUSIONS: Several factors were associated with PPE usage among nurses and nurse assistants. Improved PPE usage against AD can be promoted through interventions that modify those factors.

Hazardous Drug Exposure: Case Report Analysis From a Prospective, Multisite Study of Oncology Nurses' Exposure in Ambulatory Settings.

BACKGROUND: Hazardous drug exposure is an occupational health hazard to oncology nurses. Sparse data are available regarding the frequency and characteristics of hazardous drug spills. OBJECTIVES: This article aims to describe nurses' hazardous drug exposures and use of personal protective equipment during drug spills. METHODS: The Drug Exposure Feedback and Education for Nurses' Safety study launched in March 2015. When drug spills occurred, consented RNs administering chemotherapy in ambulatory infusion settings completed brief questionnaires. Descriptive statistics were used to summarize equipment use and spill events. FINDINGS: Spills were common, despite the use of closed-system transfer devices. Over two years, 51 nurses from 12 participating academic infusion centers reported 61 unique spills. Spills commonly involved highly toxic drugs. Personal protective equipment use during drug spills was suboptimal. These foundational data reveal gaps in clinical practice.

USP General Chapter <800>: Considerations for Oncology Nursing Practice.

OBJECTIVES: To describe the nurse leader's role in implementing the hazardous drug safe-handling standards from USP General Chapter <800> that are most relevant to oncology nursing practice, and to provide strategies for reducing nurses' exposure to hazardous drugs. DATA SOURCES: Published literature indexed in PubMed, CINAHL, textbooks, and clinical expertise. CONCLUSION: Nurse leaders are essential to promoting a safe environment for nurses handling hazardous cancer drugs. IMPLICATIONS FOR NURSING PRACTICE: Several barriers and challenges to handling hazardous drugs exist and must be overcome before oncology nurses' exposure can be reduced.

Surface Contamination With Antineoplastic Drugs on Two Inpatient Oncology Units.

OBJECTIVES: To measure surface contamination with antineoplastic drugs on inpatient oncology units and to characterize nursing staff personal protective equipment (PPE) use and factors that predict this use. SAMPLE & SETTING: A descriptive pilot study of two inpatient oncology units at Duke University Hospital in Durham, North Carolina, administering etoposide and cyclophosphamide. METHODS & VARIABLES: Surfaces in four patient rooms and select shared areas were swabbed with methanol, acetonitrile, and water. Samples were analyzed by liquid chromatography tandem mass spectrometry. Nursing staff (N = 27) answered questions about their demographics, PPE use, and factors that influence PPE use via online survey. RESULTS: Contamination with cyclophosphamide and etoposide was detectable and quantifiable in 61% and 31% of surfaces tested, respectively. Nursing staff reported suboptimal use of PPE when administering, disposing, and handling excreta of patients. Workplace safety climate was predictive of PPE use. IMPLICATIONS FOR NURSING: The potential for contamination with antineoplastic drugs in inpatient oncology units presents exposure risks for healthcare workers, patients, family members, and visitors. Future research and interventions to limit exposure and increase routine surface sampling should focus on those areas of greatest contamination, including toilet seats, a prominent finding from the current study.

Personal Protective Equipment: Evaluating Usage Among Inpatient and Outpatient Oncology Nurses.

BACKGROUND: Chemotherapy agents have long been considered hazardous, and safety for healthcare providers when administering these drugs is a primary concern. Personal protective equipment (PPE) is known to decrease exposure to hazardous drugs. Studies report that PPE is underused among healthcare providers in inpatient and outpatient settings. OBJECTIVES: The purpose of this study was to examine the use of PPE among inpatient and outpatient nurses while administering hazardous chemotherapy agents. METHODS: This cross-sectional, descriptive study used the Hazardous Drug Handling Questionnaire (HDHQ) to measure nurses' self-reported use of PPE. FINDINGS: Results of the HDHQ indicated that nurses are not using PPE as recommended by hazardous drug administration guidelines. Interventions for proper PPE usage include interprofessional collaboration among oncology nurses, administrators, organizations, and healthcare systems to ensure the safety of healthcare providers, patients, and family caregivers.

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology

Purpose: To update the American Society of Clinical Oncology (ASCO)/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods: The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results: The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion: As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards.

U.S. Pharmacopeial Chapter <800>: Be Ready to Comply by July 2018 
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The U.S. Pharmacopeial Convention's "Chapter <800> Hazardous Drugs-Handling in Healthcare Settings" is a new part of the National Formulary that describes standards-expectations for practice-for all aspects of handling and administering hazardous drugs (HDs). Some of the standards will require changes in policies, procedures, and practices for nurses. This article provides an overview of the new standards and the impact they will have on nurses who prepare and administer chemotherapy and other HDs.
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Occupational Exposure to Antineoplastic Agents.

Approximately 8 million health care workers are unnecessarily exposed to highly toxic drugs used to treat cancer; antineoplastic drugs can contribute to negative health effects for these workers. The drugs have been detected in the urine of workers and on the floors and counters of worksites. Safety precautions that could reduce the risk of exposure are underutilized. This cross-sectional study of 163 oncology health care workers used a survey to measure workplace and individual factors, and environmental sampling to measure surface contamination. The study objective was to identify potential exposures to antineoplastic drugs and factors influencing safety behavior. Personal protective equipment (PPE) use was lower than recommended; unit of employment was significantly associated with PPE use. Chemical residue from antineoplastic drugs was found, revealing potential exposures. Workplace safety must be a higher organizational priority. The contamination of common work areas where PPE use is not expected was of utmost concern.

Testing an Intervention to Decrease Healthcare Workers' Exposure to Antineoplastic Agents.

PURPOSE/OBJECTIVES: To develop and test a worksite intervention that protects healthcare workers who handle antineoplastic drugs from work-related exposures. 
. DESIGN: Intervention study. 
. SETTING: A university hospital in a large midwestern metropolitan area and its outpatient chemotherapy infusion clinic.
. SAMPLE: 163 staff (nurses, pharmacists, and pharmacy technicians) who work with antineoplastic agents.
. METHODS: A self-report survey measured workplace and individual factors to assess use of personal protective equipment (PPE). Wipe samples were tested for surface contamination. An intervention incorporating study findings and worker input was developed.
. MAIN RESEARCH VARIABLES: PPE use was the dependent variable, and the independent variables included knowledge of the hazard, perceived risk, perceived barriers, interpersonal influence, self-efficacy, conflict of interest, and workplace safety climate. 
. FINDINGS: PPE use was lower than recommended and improved slightly postintervention. Self-efficacy and perceived risk increased on the post-test survey. Chemical residue was found in several areas. Awareness of safe-handling precautions improved postintervention. The unit where nurses worked was an important predictor of safety climate and PPE use on the pretest but less so following the intervention. 
. CONCLUSIONS: Involving staff in developing an intervention for safety ensures that changes made will be feasible. Units that implemented workflow changes had decreased contamination. 
. IMPLICATIONS FOR NURSING: Worksite analysis identifies specific targets for interventions to improve antineoplastic drug handling safety.

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

Minimizing Occupational Exposure to Antineoplastic Agents.

The inherent toxicity of antineoplastic drugs used for the treatment of cancer makes them harmful to healthy cells as well as to cancer cells. Nurses who prepare and/or administer the agents potentially are exposed to the drugs and their negative effects. Knowledge about these drugs and the precautions aimed at reducing exposure are essential aspects of infusion nursing practice. This article briefly reviews the mechanisms of action of common antineoplastic drugs, the adverse outcomes associated with exposure, the potential for occupational exposure from preparation and administration, and recommended strategies for minimizing occupational exposure.

Antineoplastic drug exposure in an ambulatory setting: a pilot study.

BACKGROUND: Exposure to antineoplastic drugs confers health risks to workers, yet little is known about the exposure after a drug spill, nor has the relationship between exposure and organizational factors such as staffing and work environment been studied. OBJECTIVE: The aim of this study was to evaluate drug spills prospectively using biological measures and correlate drug spills with organizational factors. METHODS: Prospective questionnaires with 8-hour timed urine samples were collected from nursing and pharmacy personnel who reported drug spill events in 1 academic health center's infusion center. Urine was collected similarly from workers who did not report a spill. Liquid chromatography tandem mass spectrometry techniques identified detectable drug levels. After the prospective sampling period, workers were surveyed on workloads, practice environment, and safety behaviors. RESULTS: From 81 eligible individuals, 40 participated in the prospective study and 19 completed retrospective questionnaires. Four spills were reported by 9 personnel, as multiple employees were exposed to drug spills. Four participants who reported a spill showed detectable levels of antineoplastic drugs. Four participants who did not report a spill had detectable levels of docetaxel. Compared with respondents who did not report a spill, collegial relations with physicians were significantly poorer for workers who reported spills. CONCLUSIONS: The study protocol successfully captured drug spill reports and biological samples. Workers have detectable levels of antineoplastic drugs through both drug spills and environmental contamination. IMPLICATIONS FOR PRACTICE: Multisite research studies and practice-based quality improvement approaches are needed to improve adherence to personal protective equipment use and safe handling procedures.

Reproductive health risks associated with occupational exposures to antineoplastic drugs in health care settings: a review of the evidence.

OBJECTIVES: Antineoplastic drugs are known reproductive and developmental toxicants. Our objective was to review the existing literature of reproductive health risks to workers who handle antineoplastic drugs. METHODS: A structured literature review of 18 peer-reviewed, English language publications of occupational exposure and reproductive outcomes was performed. RESULTS: Although effect sizes varied with study size and population, occupational exposure to antineoplastic drugs seems to raise the risk of both congenital malformations and miscarriage. Studies of infertility and time to pregnancy also suggested an increased risk for subfertility. CONCLUSIONS: Antineoplastic drugs are highly toxic in patients receiving treatment, and adverse reproductive effects have been well documented in these patients. Health care workers with long-term, low-level occupational exposure to these drugs also seem to have an increased risk of adverse reproductive outcomes. Additional precautions to prevent exposure should be considered.

2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy.

In 2009, ASCO and the Oncology Nursing Society (ONS) published standards for the safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup participants developed recommended standards, which were presented for public comment. Public comments informed final edits, and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recommendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition, the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards.