USP General Chapter <800>: Considerations for Oncology Nursing Practice
Introduction
In December of 2019, the United States Pharmacopeial Convention (USP) standards USP General Chapter <800>, Hazardous Drugs – Handling in Healthcare Settings became official. These standards were first published in 2016 to describe the requirements for safely handling drugs known to be hazardous to nurses and other health care workers. The USP standards address issues related to drug administration in addition to drug compounding. The standards address every aspect of hazardous drug (HD) handling, which has implications for all organizations in which HDs are present. This article aims to explore the challenges of implementing those standards applicable to oncology nursing practice, to identify the components of a safe environment for oncology nurses who handle antineoplastic HDs, and to pinpoint barriers to compliance with safe handling and recommendations and strategies for addressing them.
Section snippets
Hazardous Drugs
The National Institute for Occupational Safety and Health (NIOSH) defines HDs as agents that pose a risk of harm to health care workers who are exposed to them during handling. HDs are drugs with one or more of the following characteristics: carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or similar structure and toxicity profiles in new drugs.1 The majority of drugs that meet the above criteria are antineoplastic agents used in the treatment
Overview of USP <800> Standards
Standards are expectations for practice that are based on empirical evidence.25 USP sets quality standards for medicines sold in the United States. General Chapter <800> addresses every aspect of HD handling to promote patient, personnel, and environmental safety.16 The standards include the requirements for facility and engineering controls, competent personnel, safe work practices, proper use of PPE, and the need for policies that address all aspects of HD handling, including HD waste
Personnel Training
The standard on personnel training details the need for job-specific training before assuming responsibility for HD handling.16 Nurses require information, education, training, and competency validation on all aspects of HD handling for which they are responsible.28, 29, 30 They must be informed about which drugs are hazardous, how HDs are identified in the setting, what are the routes of exposure, exposure opportunities, and what precautions (PPE, safety equipment, work practices, and proper
Closed System Transfer Devices
HD leaks and surface contamination may result in exposure to nurses; therefore, the USP <800> requires closed system transfer devices (CSTDs) for antineoplastic HD administration when the dosage form allows. A CSTD is a device that prevents the escape of HDs during the transfer of drug from one container to another.10 There is evidence that effective CSTDs reduce the occurrence of HD spills35 and decrease surface contamination.36,37 CSTDs vary in containing HDs and their associated vapors,38
Managing HD Spills and classification
Spills of HDs represent a high risk for health care worker exposure and surface contamination. While many clinicians consider HD spills an infrequent occurrence, approximately 50% of nurses and 50% of pharmacy staff reported spills in national study conducted in the US.41 How spills are defined in policy may result in underestimating spill occurrence. For example, nurses may not consider a small leak a spill, or may not notice a small spill of a colorless HD.42 Historically, guidelines
Decontamination of Work Surfaces
Measurable contamination of work surfaces in HD administration areas has been found in multiple studies since the early 1990s.21 As an example, one study detected cyclophosphamide residue on 55 different types of surfaces throughout a hospital environment, including unexpected surfaces such as elevator buttons, pens, blood pressure machines, and clipboards.45 Nurses can minimize surface contamination by preventing leaks or transferring residue from contaminated gloves. Because it is not always
Challenges in Implementing Safe Handling Standards
HD exposure continues to occur because of consistently lower than expected compliance with HD safe-handling recommendations.41,47, 48, 49 For example, in a recent NIOSH–sponsored study, 87% of nurses and 95% of pharmacy practitioners reported always wearing chemotherapy gloves, but double-glove use was very low (15% of nurses and 53% of pharmacy practitioners). In the same study, 38% of nurses and 20% of pharmacy staff admitted they did not always wear a gown when recommended.41 Studies have
Workload and Handling HD
Workload has frequently been implicated in nurses’ failure to use safe-handling precautions when handling HDs. It has been well documented that workers cite time pressure or lack of time as a factor that interferes with HD precaution use.47,48,54 An objective measure of workload is the number of chemotherapy patients assigned to a nurse in a day. Workload is not only related to the number of patients receiving HD, but also to patient acuity, which includes the complexity of the patient care,
Barriers to Safety
A barrier is something that interferes or impedes.63 The literature provides evidence for several barriers to the use of safety equipment. The most commonly reported barrier across occupations is time pressure or lack of time. The pace of work in some treatment settings is very fast, with rapid patient turnover. Accessing PPE and using safety equipment takes time. In situations where nurses feel rushed to provide patient care, they may choose not to spend the time necessary to follow all
Enablers of Safety
Nurse leaders can facilitate the use of safety equipment by making sure it is available in sufficient quantity to meet the needs of the work setting. When nurses perceive that proper PPE is available, they are more likely to wear it during HD handling.42 One study regarding PPE use for infection control suggests that by making adequate supplies of PPE readily available, employees may have increased perceptions of the effectiveness of PPE in preventing exposure.65 One of the most important
Implications for Nursing Practice
Nurse leaders have an important role in cultivating a positive safety climate related to HD handling. In health care organizations, the recognized components that indicate a positive safety climate include the following65, 66, 67:
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Education and training in safe practice are provided;
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Safety policies and procedures exist and compliance with these policies is expected;
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The organization provides feedback and reinforcement for safety;
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Management provides support for safety programs.
The structural
Conclusion
USP <800> standards describe all components of a comprehensive HD safe-handling program. Implementing the standards requires a concerted effort by organizational leaders and oncology staff. Nurse leaders’ role in HD safety requires understanding the intent of the standards, familiarity with safety equipment, quality monitoring for compliance, and a commitment to protecting their staff. While implementing some of the standards may be challenging, a comprehensive safe-handling program is a
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Cited by (3)
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2023, Journal of Oncology Pharmacy Practice