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SOPs for USP <800>: A Nursing Perspective
December 2018 : USP <800> - Vol. 15 No. 12

Developing standard operating procedures (SOPs) and ensuring ongoing adherence is integral to a successful hazardous drug (HD) safety program. Furthermore, it is required by USP <800>, as Section 8 states that organizations must develop SOPs to cover all aspects of HD handling.

Historically, pharmacists have not been involved in crafting and reviewing nursing SOPs, just as nurses do not normally participate in developing pharmacy-specific policies. Therefore, it is interesting that this siloed, departmental approach is uniquely addressed within the text of USP <800>, which states that facilities must have a designated person to oversee all aspects of the HD program.

While not specified in the chapter, the designated individual in most hospitals and associated outpatient departments will most likely be a pharmacist, which makes sense, since much of the content within USP <800> involves pharmacy-centric activities, and few individuals outside of the pharmacy would have the breadth and depth of requisite knowledge to oversee the HD handling program. Nonetheless, because USP <800> covers HD administration—an area typically not within the expertise and scope of pharmacy personnel—having a broad understanding of nursing practices and policies is useful in developing SOPs that describe an integrated HD program (see SIDEBAR 1). Furthermore, this approach ensures that both pharmacy and nursing department SOPs are harmonized.

Collaboration Creates Harmonization

Bridging this departmental gap may not be a challenge in organizations where an infrastructure fostering interdepartmental partnerships currently exists. However, this reciprocal approach may be more elusive in organizations where the two departments do not typically interact at this level. USP does not require that a single policy cover both departments, but SOPs must fall under the umbrella of a unified Hazard Communication Program. With the deadline for USP <800> compliance—December 1, 2019—quickly approaching, an aggressive, yet realistic, timeline for developing and finalizing SOPs must be established.

For a pharmacist overseeing an organization’s HD program, the first step is to collaborate with key members of the nursing department.1 Depending on the organization’s structure, this could include oncology nursing educators, department managers, clinical nurse specialists, and others. At a minimum, these individuals should be familiar with HD administration and other aspects of safe handling. Be sure to include essential personnel who have responsibilities outside of the oncology units, as nurses in these areas may be administering antineoplastic and non-antineoplastic HDs, and are more likely to have received insufficient safe handling training.

Conduct a Gap Analysis

Ideally, members of the interdepartmental team should be acquainted with USP <800> before initiating a gap analysis; however, this may not always be realistic. Examples of critical areas of USP <800> specific to nursing practice include the following:

  • Access to the organization’s HD list
  • Use of proper personal protective equipment (PPE)
  • Education and training
  • Administration and disposal of HDs
  • Use of a closed system drug-transfer device (CSTD)
  • Management of HD spills

While several gap analysis tools are available, a simple approach is to list salient USP <800> requirements that directly impact HD administration and compare those to the organization’s current nursing SOP. (Commercially available gap analysis tools are discussed in PP&P’s April 2017 issue: Comparison of USP <800> Gap Analysis Tools.) During this period of inquiry and discovery, any significant gaps in the nursing SOP can be identified and marked for revision. Gaps in the pharmacy SOP may be identified as well, as this is an excellent opportunity to ensure both SOPs are compliant. Note that while it is not a common practice, those nurses who may compound HDs will require sterile preparation SOPs utilizing the requirements outlined in USP <797>, as well as USP <800>.

Information to Include in Nursing SOPs

Safe HD Transport

Pharmacists may not have a clear understanding of how an HD is transported after it leaves the pharmacy. While the pharmacy may transport HDs, other departments, including nursing, may also assume this task. USP <800> Section 11.3 requires that transport information be documented in the SOP.

HD Administration

Nursing SOPs for safe HD handling must include information for all aspects and routes of administration, including IV infusions (ie, continuous, intermittent, and home), IV push, subcutaneous, intramuscular, and intravesicular, along with information about proper manipulation and administration of oral HD agents. For example, the organization’s policy for oral HD handling should specify which oral agents can and cannot be manipulated, where that manipulation is to occur, what equipment is required, and delineate requisite staff training for oral HD use.

Ideally, the HD administration SOP should include a safe, officially sanctioned method for priming IV tubing in an effort to eliminate practice drift, which can result in unsafe conditions (see SIDEBAR 2). A proper donning and doffing sequence for PPE is essential to avoiding both health care worker and environmental contamination. Depending on the services and procedures offered by the organization, an SOP should cover administration occurring during procedures (eg, intrathecal, ophthalmologic, intracavitary, and surgical). While not addressed in USP <800>, SOPs should also contain language regarding the handling of HDs by personnel who are pregnant, including conditions in which job reassignment may be warranted.2,3

CSTD Use

Although ensuring USP <800> compliance will undoubtedly result in many revisions to nursing practice, the single most significant change will be the required use of a CSTD for administration of antineoplastic HDs (where the dosage form allows). Required usage of CSTDs should encompass both syringes (for IV push, subcutaneous, and intramuscular administration) and IV tubing, and include specific details as to the connection points to which the device should be attached. As a general principle, CSTDs should be used wherever connections and/or disconnections are made at the patient’s bedside.4

All nurses must be educated on proper CSTD use; education should emphasize the importance of not removing the device. While CSTDs are recommended but not required by the chapter for HD compounding, implementing CSTD use for nursing presents an excellent opportunity for pharmacy to consider adopting a device if one is currently not in place for compounding.

Be aware that depending on how drugs are compounded, any changes in pharmacy SOPs can directly affect the nursing administration SOP. Therefore, it is crucial to have interdepartmental dialogue and nursing involvement before selecting a new device.

HD Disposal

SOPs must discuss proper disposal of all PPE, bags, tubing, and syringes used in HD administration. Although regulations vary by state, most HD waste segregation and labeling falls under the auspices of the Resource Conservation and Recovery Act (RCRA). The location of designated waste containers, and their appropriate use, should be outlined. While environmental services SOPs are typically not included in nursing SOPs, organizations should work with environmental services personnel or the organization’s subcontractor to ensure staff is properly educated and protected. The use of CSTDs on the distal end of IV tubing will help prevent leakage and decrease the likelihood of exposing environmental services personnel to HDs.4

Addressing Spills

A comprehensive nursing SOP must contain spill management information that delineates which personnel (eg, nursing, hazmat response team) are responsible for responding to spills, and lists the locations of spill kits. HD spills at the patient’s bedside or in heavily trafficked hallways pose a greater risk than those occurring in a relatively contained pharmacy environment where primary engineering controls are in use and spills are more easily contained.4,5 The SOP must describe the training requirements for spill management, including what PPE should be utilized, as well as appropriate respiratory protection for those drugs that have been shown to vaporize at room temperature.

While USP does not recommend specific equipment, the Occupational Safety and Health Administration (OSHA), ONS, and NIOSH describe appropriate use of N95 respirators for cleaning aerosols and particulates, and organic vapor full-face respirators or powered air purifying respirators (PAPRs) with organic vapor cartridges for protection against vapors. Interventions for personnel who become contaminated during a spill (ie, staff, patients, and family members), along with proper handling of linens, must also be addressed. The SOP should specify that knowingly exposed personnel be evaluated by the designated department (eg, employee health or emergency) and indicate that the requisite paperwork be completed to document the spill remediation. Events surrounding the spill must be documented in detail to help ascertain the cause(s). Understanding the etiology can help prevent future recurrence and may indicate the need for additional training. In some cases, a pattern may require reevaluating products used in HD administration.

Best Practices for Addressing Excreta

USP <800> conspicuously omits any discussion of potential contamination related to excreta. However, ONS provides best practice guidelines, which should be described in the organization’s nursing SOP. This should include both proper PPE and the time frames for its use, which is dependent on the HD administered. Consider cyclophosphamide, for example. While many HDs are excreted from the body within 48 hours, cyclophosphamide can remain in bodily excretions for up to 5 days. As such, PPE use must continue for cyclophosphamide for several days post-administration.

Staff Education and Competencies

Comprehensive, meaningful education is perhaps the most important component of SOP development.6 The nursing SOP should include information detailing the education and competencies that must be performed prior to handling HDs.

Hospital-wide education may present significant logistical challenges. While safe handling education is typically provided for nurses working in oncology departments, it may be absent for staff in other parts of the hospital. USP <800> does not differentiate by role or specialty; therefore, to ensure compliance with the chapter, the number of nurses requiring education and competency assessments may increase significantly.1

Closely linked to education is the requirement that the organization’s HD list be accessible to all staff. This is particularly salient for staff working outside of the oncology departments, who may not be familiar with HDs.

Quality Improvement Initiatives

Having well-written SOPs does not automatically equate to a culture of workplace safety or policy compliance. Research suggests that adherence to SOPs increases when an ongoing quality improvement program is in place.7 Quality improvement initiatives should validate whether staff are following SOPs and also can be used to hone the focus of educational initiatives. Including champions within the nursing department in quality improvement activities can assist in improving the safety culture surrounding HD usage.8

Conclusion

While often perceived as simply a regulatory requirement, robust SOPs are critically important; they provide a tangible framework for ensuring safety and competency in HD handling. Encouraging participation in the development process by those staff whose work practices are impacted by the SOPs helps increase their commitment to compliant practices. Interdepartmental cooperation is necessary to ensure all HD-related SOPs are in sync, and has the added benefit of forging a collegial working environment. 

References

  1. Eisenberg S. Hazardous drugs and USP <800>: Implications for nurses. Clin J Oncol Nurs. 2017;21(2):179-187.
  2. Connor TH, Lawson CC, Polovich M, et al. Reproductive health risks associated with occupational exposures to antineoplastic drugs in health care settings. J Occup Environ Med. 2014;56(9):901-910.
  3. Coyne J. Ask the Expert: How Can You Accommodate Pregnant Employees in an HD Environment? Pharm Purch Prod. 2014;11(10):24.
  4. Eisenberg S. USP <800> and strategies to promote hazardous drug safety. J Infus Nurs. 2018;41(1):12-23.
  5. Friese CR, McArdle C, Zhao T, et al. Antineoplastic drug exposure in an ambulatory setting: A pilot study. Cancer Nurs. 2015;38(2):111-117.
  6. Pirschel C. Setting the Standards: Implementing Evidence-Based Oncology Standards in Your Practice (January 3, 2017). ONS Voice. https://voice.ons.org/news-and-views/setting-the-standard. Accessed October 23, 2018.
  7. Yoshida J, Koda S, Nishida S, et al. Association between occupational exposure and control measures for antineoplastic drugs in a pharmacy of a hospital. Ann Occup Hyg. 2013;57(2):251-260.
  8. Eisenberg S. A call to action for hazardous drug safety: Where we have been and where we are now. Clin J Oncol Nurs. 2016;20(4):20-4AP.

Seth Eisenberg, RN, OCN, BMTCN, professional practice coordinator for infusion services at the Seattle Cancer Care Alliance Ambulatory Clinic, has worked in the field of oncology since 1983. His experience includes 32 years in hematopoietic stem cell transplantation.

 


 

SIDEBAR 1

Sources for Nursing SOPs

Nursing HD SOPs and policies and procedures (P&Ps) are often developed based on guidelines published by:

Sidebar References

  1. Polovich M, Olsen M, Lefebvre K. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (4th ed). ONS Press, 2014: Pittsburgh, Pennsylvania.
  2. Polovich M, Olsen MM, eds. Safe Handling of Hazardous Drugs (3rd ed). ONS Press; 2017: Pittsburgh, Pennsylvania.

SIDEBAR 2

Evaluating IV Tubing Setups

Bedside administration of HDs is strongly influenced by how the drugs are compounded, and safe HD handling at the bedside is uniquely related to IV tubing setups. ONS guidelines do not specify whether primary or secondary tubing should be used; instead, guidelines stress the importance of practices that minimize or eliminate the potential for HD exposure.

Examples of tubing and safe priming-related principles are described in TABLE 1. Spiking into the HD bag at the bedside without the use of a CSTD dry spike, or removing an empty HD bag after infusion without a CSTD, must be prohibited in the SOP, as these practices can result in exposure.1

Sidebar Reference

  1. Power L. ASHP Guidelines on Handling Hazardous Drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.

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