Health care organizations are preparing for US Pharmacopeia (USP) General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings (USP <800>), in which new safety standards outline enforceable safe handling protections for all health care workers to minimize exposure to toxic, hazardous drug (HD) residue.1 Because USP <800> changes how HDs are systematically controlled to prevent exposure, efforts to train health care workers and ensure adherence will lead to safer work environments.2 Despite mounting scientific evidence regarding home environmental exposure and adverse health outcomes from HDs, resistance to the use of personal protective equipment (PPE) or other safe handling measures continues among nurses.3–5 According to Hennessy and Dynan, “Resistance is based on the denial of risk, insufficient information, lack of policy enforcement or regulation, or lack of provision of safe handling devices.”6(p497) This article discusses the need for PPE use in the home care setting, where HDs are administered by patients, caregivers, or home care nurses.
Efforts to change guidelines to meet new mandatory requirements for PPE use during HD handling have not been well-accepted by nurses. Studies have shown that nurses' general use of PPE is inconsistent across the United States.4,6,7 Research conducted in home care environments is scarce and requires additional attention. Ambulatory and home care organizations are lagging in preparing for the new standards. The reasons why home care nurses choose not to wear PPE during a home visit has not been studied; however, an organization must understand how it may contribute to this concerning issue and make relevant changes to simplify and encourage HD safe-handling processes.
HD residue poses a real threat to the health and well-being of all nurses, because more oral and intravenous (IV) chemotherapy is administered to patients at home. Harmful toxic residues can infiltrate the home environment when mishandled. The National Institute for Occupational Safety and Health (NIOSH)8 reported that more than 8 million health care workers in the United States are at risk of HD exposure. Furthermore, long-term, low-level occupational exposure has been shown to increase the risk of adverse reproductive outcomes and other health consequences.9,10 Lack of diligent organization and health care worker attention, inconsistent oversight of affected patients and families, and HD environmental exposure have caused irreversible harm and death in some cases.11
Exposure in the Home Setting
Yuki et al5 tested the urine of family members of 3 patients with cancer who received at least 1 of 2 antineoplastic drugs (cyclophosphamide [CP] or fluorouracil [5-FU]) during the first 48 hours after IV chemotherapy treatment. The objectives were to determine the following: (1) whether any detectable levels of HD agents were exposed to family members; (2) whether environmental contamination occurred inside the home; and (3) how long a drug remained in the patient's urine 40 hours after treatment. Urine samples were collected from patients and family members and wipe testing was performed on common home surface areas to detect whether CP or 5-FU residues were present.5 Predetermined acceptable drug levels were 0.01 for CP and 5.00 ng/mL of urine for 5-FU. CP was detected in 8 of 12 wipe tests (0.03–7.34 ng/cm2) in 1 home. Wipe tests in homes of patients treated with 5-FU reported drug levels below the predetermined threshold; however, there are currently no defined safe levels of HD exposure.
Yuki et al5 found wipe tests from toilet seats and bathroom sink faucets had the highest level of HD residue (3.02 and 0.57 ng/cm2); floors around toilets and bathroom doorknobs measured 0.30 and 0.09 ng/cm2. Most importantly, patients continued to excrete antineoplastic drugs at low levels for more than 4 days after treatment through urine, feces, and breathing patterns.5 Family members who handle potentially contaminated waste products, such as urine, stool, vomit, or other excreta, should receive specific instructions to control the spread of residues inside the home. It is imperative that patients receiving HDs be better informed and proactive in minimizing risks.
Bohlandt et al3 conducted an environmental and biological study inside 13 homes of patients being treated for cancer to assess for HD residues. The researchers wanted to determine whether HD levels were measurable in the cohabitants of treated patients' urine samples. Thirteen study participants received outpatient IV chemotherapy in an oncology infusion clinic. Two hundred sixty-five wipe samples were taken from home surfaces that included bathroom toilets, floor and sink handles, and shared kitchen surfaces. Every sample had substantial levels of HD residues, confirming that toxic residues had spread throughout the home setting, but cohabitant urine samples did not detect any trace of exposure.3
A systematic literature review by Crickman and Finnell7 covered 13 years of articles from 1979 to 2014 to understand the need to implement HD control measures in different settings. Health care workers, especially those who provide personal care for treated patients, are among the highest at-risk population. The findings are worrisome because families often become primary caregivers after chemotherapy treatment. Recommendations regarding PPE selection and choice, competencies, professional oversight, and medical monitoring of health care workers are outlined in the USP <800> standards. Organizations will be required to review internal practices regarding HD handling and update current policies and procedures accordingly. The review by Crickman and Finnell7 stressed the need to educate and inform the public on HD exposure risks.
Clark et al12 developed a field study to investigate the influence of role definitions on the association between safety climate and employee organizational citizenship behavior. Providing safe working conditions requires a significant commitment on the part of leadership and stakeholders. Unfortunately, an organization's obligation to provide safe, patient-centered care often overshadows or conflicts with ensuring safe working conditions for staff members who provide that care. The authors summarized by stating that nurses who feel appreciated by the organization are more likely to go above and beyond expectations to provide optimal patient care.12
In 2017, He et al13 conducted a cross-sectional, multistate survey offered to Oncology Nursing Society members (N = 654) to examine whether the organization's safety culture correlated with nurses' use of PPE. The study involved nurses working in ambulatory care centers in 3 US states; 67% of the oncology nurses responded to the survey. Nurses self-reported that 26% were involved in an HD spill, 90% wore only 1 pair of chemotherapy-approved gloves, and other PPE use was infrequent.14 One tool used to collect data was the Revised Hazardous Drug Handling Questionnaire by Polovich and Clark.15 The sample mean for PPE use was 2.4 (standard deviation [SD] = 1.0) out of a maximum score of 5.0. He et al13 stressed the need for organizations to commit to a culture of safety that may include modifying the nurse's workload and environment of care to accommodate safe handling practices and self-protection during the HD-handling process.
Nurses' Responsibility to Provide Safe Care
The most recent study by Friese et al16 concluded that, despite decades of research, PPE use remains suboptimal, and professional organizations, policymakers, clinical experts, and health care systems must align to guide best practices to ensure public safety. The randomized controlled study took place from 2015 to 2017 and involved 12 academic ambulatory oncology centers across the United States and included nurses who handled HDs (N = 396). Nursing participants accessed a secure website and completed learning modules and questionnaires to self-report PPE use. The researchers found that the intervention did not improve PPE adherence and suggested that leaders standardize education and policies that reflect personal accountability with the safe handling steps and PPE expectations.16 Under USP <800>, efforts to provide oversight with safe handling processes will no longer be considered optional, even for home and hospice nursing care.
Dejoy et al17 examined predictors of PPE use, safe handling components, and adverse events associated with HD exposure in nurses (N = 1814) and concluded that adherence to recommendations is inconsistent. Interestingly, PPE use was worse and less predictable among more experienced nurses during chemotherapy administration than among their less-experienced colleagues. Dejoy et al17 assessed organizational safety climate and nurses' perceived safety climate regarding PPE, engineering controls, and adverse events associated with IV HDs. Dejoy et al17 found that nurses' perceptions about being exposed to HDs were minimal and that they understood organizational policies to be merely guidelines for added personal protection. A comprehensive health and safety program emphasizing hazard controls is critical to promote safer behavior among all health care workers.
SUMMARY OF THE EVIDENCE
This literature review indicates that HD controls are inconsistent and that workplace contamination may lead to health care worker and patient exposure. It is also evident that toxic residues can permeate the home environment after patients receive chemotherapy and may have long-lasting effects on the environment and the community where patients reside. Summaries from the literature reviews reflect gaps in education, safety measures, and controls. Both international and national research conducted in ambulatory oncology practices support stricter, even mandatory, PPE use and endorse environmental and biological monitoring for the detection of harmful residues, similar to radiation exposure monitoring and controls.3,13 Recommendations for environmental sampling and the action level depend on the type of measurable contamination detected. Because there is currently no standard for acceptable limits for HD surface contamination, environmental wipe sampling is currently recommended by USP <800> but not required.
PPE for HD Handling
For all antineoplastic HDs, 2 pairs of chemotherapy gloves tested to the American Society for Testing and Materials standard are worn.18 For administering injectable antineoplastic HDs, gowns shown to resist permeability by HDs, in addition to 2 pairs of chemotherapy gloves, should be worn.18 For administering other HDs, the entity must establish policies describing the PPE required. Table 5 of the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, provides additional recommendations for PPE based on the HD formulation and activity.8 PPE requirements are based on guidance provided by NIOSH, including the organizational policy and procedures, occupational safety plan, and assessment of risk if performed.19,20 Personnel compounding sterile HDs must wash their hands with soap and water.
Barriers to PPE Use in the Home
In 2014, Leiss stated, “The patient's home is not subject to the control of the home health/hospice agency; employers of nurses who provide care in the patient's home are exempt from the requirements to ensure that the nurses use PPE and safety devices in this setting.”21(p492) This statement refers to the handling of bloodborne pathogens in the home setting. This nursing population is at a higher risk for exposure to bloodborne pathogens and, more recently, HDs prescribed in various forms (eg, IV, oral, topical, injectables, and others) without consideration to safety devices or PPE needs. The PPE required to handle bloodborne pathogens or infectious waste is not sufficient for HD handling and is often not available for home care workers at the time of the visit. The Occupational Safety and Health Administration requires that home health agencies provide PPE to their staff but cannot enforce a citation against the agency if staff in the home fail to use PPE, because the agency has no control over the worksite or patient's home in this case. Similar to studies in controlled settings, nurses' use of PPE varied according to whether they had enough time during patient visits and whether PPE was available during the home visit. Leiss21 concluded that a safety climate supported by an organization is instrumental in increasing nurses' use of PPE in the home care/hospice setting.
Change is often difficult, especially when there are inconsistencies in the evidence presented by experts in the field. Skepticism about the need for donning PPE in the home setting may become problematic because the risks of exposure increases for home health care workers. Providing enough time for nurses to comply with safety measures and ensuring that PPE is available in the home are not enough to sustain best practices. Interventions that drive successes in PPE adherence will depend on a cohesive and committed team of nurses and pharmacists who are willing to collaborate in the best interest of the health care worker, patients and families, and the environment.
Some common themes emerged when reviewing the literature on the lack of nurses' compliance and adherence to PPE use during HD handling. Many different interpretations of the USP <800> standards require thoughtful consideration as to how requirements are implemented in a nonclinical setting. Incorporating a hospital's plan to reduce the risks of HD exposure does not translate well to patients' homes, although USP <800> provides clear and concise expectations for all health care worker protections in all settings. Incorporating an evidence-based approach to HD management in the home is vital to protect health care workers, patients and families, and the environment from involuntary exposure.
1. US Pharmacopeial Convention. General chapter 800: hazardous drugs
–handling in healthcare settings. In: United States Pharmacopeia National Formulary (USP 39-NF 34). Rockville, MD: The United States Pharmacopeial Convention; 2016. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare
. Accessed June 5, 2019.
2. Andrews S, Dill J. USP <800>;. Hosp Pharm. 2018;53(3):132–133. doi:10.1177/0018578718763850.
3. Bohlandt A, Sverdel Y, Schierl R. Antineoplastic drug residues in the homes of chemotherapy patients. Int J Hyg Environ Health. 2017;22(4):757–765. doi:10.1016/ijheh.2017.03.005.
4. Rudnitzki T, McMahon D. Oral agents for cancer: safety challenges and recommendations. Clin J Oncol Nurs. 2015;19(3):41–46. doi:10.1188/15S1.CJON.41-46.
5. Yuki M, Sekine S, Takase K, Ishida T, Sessink P. Exposure of family members to antineoplastic drugs via excreta of treated cancer patients. J Oncol Pharm Pract. 2013;19(3):208–217. doi:10.1177/107815521245966.
6. Hennessy K, Dynan J. Improving compliance with personal protective equipment
use through the model for improvement and staff champions. Clin J Oncol Nurs. 2014;18(5):497–500. doi:10.1188/14.CJON.497-500.
7. Crickman R, Finnell D. Systematic review of control measures to reduce hazardous drug exposure for healthcare workers. J Nurs Care Qual. 2016;31(2):183–190. doi:10.1097/NCQ0000000000000155.
8. National Institute for Occupational Safety and Health. Health and safety practices survey of healthcare workers. Antineoplastic drug administration–predictors of adherence to safe handling practices among hospital nurses. https://www.cdc.gov/niosh/topics/healthcarehsps/antineoadminpredic.html
. Accessed May 6, 2019.
9. Connor TH, Zock M, Snow A. Surface wipe sampling for antineoplastic (chemotherapy) and other hazardous drug residue in healthcare settings: methodology and recommendations. J Occup Environ Hyg. 2016;13(9):1–33. doi:10.1080/15459624.2016.1165912.
10. Hon CY, Teschke K, Demers PA, Venners S. Antineoplastic drug contamination on the hands of employees working throughout the hospital medication system. Ann Occup Hyg. 2014:58(6):761–770. doi:10.1093/annhyg/meu019.
11. Investigate West website. Smith C. Lifesaving drugs, deadly consequences. http://www.invw.org/2010/07/09/chemo-main/
. Accessed June 5, 2019.
12. Clark O, Zickar M, Jex S. Role definition as a moderator of the relationship between safety climate and organizational citizenship behavior among hospital nurses. J Bus Psychol. 2014;29(1):101–110. doi:10.1007/s10869-013-9302-0.
13. He B, Mendelsohn-Victor K, McCullagh M, Friese C. Personal protective equipment
uses and hazardous drug spills among ambulatory oncology nurses. Oncol Nurs Forum. 2017;44(1):60–65. doi:10.1188/17.ONF.60-65.
14. Martin S, Larson E. Chemotherapy-handling practices of outpatient and office-based oncology nurses. Oncol Nurs Forum. 2003;30(4):575–581. doi:10.1188/03.ONF.575-581.
15. Polovich M, Clark PC. Factors influencing oncology nurses' use of hazardous drug safe-handling precautions. Oncol Nurs Forum. 2012;39(3):E299–E309. doi:10.1188/12.ONF.E299-E309.
16. Friese CR, Yang J, Mendelsohn-Victor K, McCullagh MC. Randomized controlled trial of an intervention to improve nurses' hazardous drug handling. Oncol Nurs Forum. 2019;46(2):248–256. doi:10.1188/19.ONF.248-256.
17. Dejoy DM, Smith TD, Woldu H, Dyal MA, Steege AL, Boiano JM. Effects of organizational safety practices and perceived safety climate on PPE
usage, engineering controls, and adverse events involving liquid antineoplastic drugs among nurses. J Occup Environ Hyg. 2017;14(7):485–493. doi:10.1080/15459624.2017.1285496.
18. American Society for Testing and Materials. [ASTM D6978-05]. Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. West Conshohocken, PA: ASTM International; 2019. doi: 10.1520/D6978-05R19.
19. Connor TH, MacKenzie BA, DeBord DG, Trout DB, O'Callaghan JP; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs
in healthcare settings, 2016. https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf
. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Publication No. 2016-161. Accessed June 5, 2019.
20. Boiano J, Steege A, Sweeney M. Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. J Occup Environ Hyg. 2014;11(11):728–740. doi:10.1080/15459624.2014.916809.
21. Leiss J. Safety climate and use of personal protective equipment
and safety medical devices among home care and hospice nurses. Ind Health. 2014;52(6):492–497. doi:10.2486/indhealth.2014-0074.