Safe Handling of Oral Chemotherapeutic Agents Among Nurses in Oncology Units

Introduction

In the past 30 years, cancers and non-communicable diseases have surpassed infectious diseases as the primary cause of death. Globally, there were 17 million new cancer cases and 9.6 million cancer deaths [1,2]. In 2019, 20 043 new cancer cases were reported to the Saudi Cancer Registry (SCR), with women (55.3%; N = 11 087) affected more than men (44.7%; N = 8 956) [3]. In Saudi Arabia, the incidence and prevalence of cancer are expected to triple by 2030, driving up healthcare expenses and creating a financial burden on the country [4].

Cancer therapy involves the use of chemotherapeutic drugs that have cytotoxic properties [5]. So severe are their potential side effects that there has been a great deal of focus on patients’ immune systems and their activation via biological therapies [6]. With regard to healthcare providers, the high patient load and extensive use of chemotherapeutic agents raises concerns about the potential hazards of these agents for this cohort. During the 1970s, evidence highlighted the risk of adverse effects from antineoplastic drugs on healthcare workers due to occupational exposure. Since then, reports from several countries have documented drug contamination in the workplace and measured genotoxic responses in workers [7]. Due to inadequate control measures, oncology healthcare workers have faced the danger of exposure to antineoplastic drugs and experienced acute adverse health effects [8].

Occupational exposure of employees and those around them is directly impacted by how well they carry out their tasks. Employees must meet the most recent requirements for working practices and be aware of the workplace hazards presented by these substances [9]. Despite safe handling guidance, however, recommended practices are not always followed, [10] and nurses’ skills and experience in the safe handling of cytotoxic medicines are often insufficient [11]. In addition, it is still necessary to fully address the occupational hazards for healthcare workers who handle these drugs in the course of their duties. Due to their involvement in administering oral chemotherapy drugs, nurses are at particular risk. Hence, this study aimed to assess awareness surrounding the safe handling of oral chemotherapeutic agents among nurses working in oncology units. Furthermore, it investigated the relationship between the nurses’ demographic characteristics and their safety practices when handling such agents.

II. LITERATURE REVIEW While there are dangers associated with numerous therapeutic groups of oral medications, the majority of oral chemotherapy drugs are dangerous due to their modes of actio n [12]. A study to identify potential exposures to antineoplastic drugs and factors influencing safety behavior reported that chemical residue from antineoplastic drugs was found in the workplace, and the low use of personal protective equipment (PPE) indicated potential exposure [13]. Another study gauging the frequency and distribution of workplace exposure to anticancer agents found that most employees (75%) fall within the moderate exposure category [14]; yet another found surface contamination [15]. Facilities in low-income countries reported lower median safety practices than those in middle-income countries. There exist large variability and significant gaps in the safe handling of chemotherapy agents; the most significant differences can be attributed to personnel, the preparation process, and incident management [16].

The use of recommended engineering controls and PPE varied among settings, and was better in non-profit and government settings [17]. No matter how much experience nurses have with chemotherapy, it is recommended that they regularly refresh their expertise and knowledge of rules, to guarantee that relevant guidelines are applied [18]. Some literature found that nurses’ knowledge of chemotherapy and handling of chemotherapeutic agents was inadequate [19]. Few researchers have confirmed that nurses’ knowledge of handling drugs is acceptable, [20] and the knowledge and expertise of nurses regarding the proper management of cytotoxic medications were lacking when delivering routine care in cancer wards [21]. A study in Saudi Arabia, which included four hospitals in the Riyadh region, demonstrated a lack of knowledge among healthcare professionals, including oncology nurses [22]. Despite possessing extensive knowledge about exposure risks, oncology nurses face barriers to the adoption of personal protective practices. These include challenges in using personal protective equipment (PPE) and conflicts of interest, which hinder the widespread implementation of such safety measures [23, 24]. The research found scant information about the education of chemotherapy nurses or their safety requirements [25]. One study highlighted that, even if nurses’ knowledge, attitude and practice scores regarding the safe handling of chemotherapy drugs (CDs) were inadequate, the use of personal protective equipment (PPE) during the various steps of CD handling was noted [26]. In some settings, the availability of the special treatment room was absent; the nurses did not use special PPE and were ignorant about the importance of medical checkups, and none underwent through regular medical checkups [27]. Concerning safe handling precautions, most participants rarely used eye protection [28,29]. Wearing PPE was seen as an obstacle to professional image and performance: nurses compromised safety for efficiency and prioritised social roles over professional ones. Experienced nurses believed that, as insiders, they had sufficient clinical wisdom to avoid occupational exposure to chemotherapy toxicity [30]. Though adherence to safe handling practices can substantially reduce potential exposure for healthcare workers, several workplace factors affect such handling [31]; in particular, the workplace safety atmosphere, work environment, and oncology nursing experience [32]. Despite the lack of guidelines for acceptable or allowable surface concentrations of these drugs in the healthcare setting, wipe sampling as a screening tool can be part of a comprehensive safe-handling program to assess and reduce environmental contamination by antineoplastic drugs [33]. Furthermore, c ompared with ordinary devices, a closed-system transfer device can significantly lower the chemical contamination of barrier isolators, even though it does not entirely eliminate contamination [34]. USP Chapter 800, a legally binding standard, outlines standards for limiting occupational exposure in healthcare workers and insists that hospitals, clinics, and all locations where Hazardous drugs (HDs) are produced or administered, and where medical staff may come into contact with HD residue, must adhere to these guidelines [35]. Healthcare professionals must use their professional judgment, expertise, and common sense when applying these principles, taking into account the standards of any applicable accrediting organisations and changing federal, state, and local legislation [36]. Some of the major issues identified with regard to the safe management of antineoplastic medications (oral, parenteral, or intrathecal) were associated with the prescription, preparation, distribution and administration thereof [37-39]. As oncology nurses and others are entrusted to assist with patient care, [40] ongoing evaluation of the workplace is necessary to foster a climate of safety and create a culture that supports the wellness of nurses, their patients, and the general public [41]. Safe handling protects healthcare professionals (HCPs); nonetheless, the above reviews raise severe concerns about nurses’ knowledge and safe handling of chemotherapeutic agents. While there have been several studies on the topic, oral chemotherapy medications are rarely the focus of the literature, which focuses on chemotherapeutic drugs in general. This significant knowledge gap leaves the question as to whether nurses can safely handle oral chemotherapeutic medications, which pose a risk to both nurses and patients. III. METHODOLOGY Study design: The study utilised a cross-sectional descriptive design, and was carried out between July 2022 and March 2023.

Setting and participants:

Participants were recruited from a tertiary healthcare setting in Riyadh, KSA. One hundred and seventy-three nurses worked in the oncology units within this setting, providing care for cancer patients. Using the purposive sampling technique, 120 of these were selected to participate in the study. Included were those nurses working in the oncology wing who handled chemotherapeutic drugs or agents, were willing to participate in the survey, and were fluent in English. Nurses who did not handle chemotherapeutic agents and those not directly involved in patient care were excluded. Sample size: We used another study as a reference to estimate the sample size for this study [21], with a 72.6% prevalence of safe handling for oral chemotherapeutic agents, a finite population correction was applied to the total nurse population of 173 (working in oncology units).

Data collection:

Data were collected by a research assistant, using a self-administered, structured questionnaire from a previous study [34]. Written permission was obtained from the author to use the questionnaire. This tool consists of five sections: (1) Demographic data; (2) Storage, which includes four items; (3) Handling, which includes 21 items; (4) Disposal and cleaning of contaminated materials, which includes three items; and (5) Training and education, which includes five items. The three options for response were ‘yes’, ‘not sure’, and ‘no’, with ‘yes’ considered the correct option except for items 4, 8, 24, 25, and 26, where ‘no’ was the correct answer. All responses were expressed in percentages.

Ethical considerations:

This study was reviewed and approved by the Institutional Review Board (IRB), with IRB Log no. 22-264, and followed the guidelines of the Declaration of Helsinki. Before enrollment, researchers explained to participants the purpose of the research, and that participation in the survey was voluntary. Furthermore, all participants were informed about anonymity, confidentiality, and the option of voluntary termination at any time.

Statistical analysis:

Data was analysed using statistical software SPSS version 25.0 (IBM, Armonk, NY, USA). The questionnaire included 34 variables, grouped into four sections: storage; handling; disposal and cleaning of contaminated materials; and education and training. The correct answers for each section were totaled, and their mean converted into percentage scores. The association between socio-demographics and the four aspects of safe handling was measured using a Chi-square test, while the least significant difference between percentage mean scores and socio-demographics was measured using the Mann Whitney U test and the Kruskal Wallis H test, as applicable. A 95% confidence interval was applied.

IV. RESULTS

Demographic data:

The questionnaire was distributed to 120 participants, and the response rate was 100%. The majority of participants were female, 110 (91.7%); and registered nurses, 105 (87.5%). Most of the nurses, 101 (84.2), had received training on the safe handling of chemotherapy drugs. The participants’ demographic characteristics are summarised in Table 1.

Safe handling procedures for oral anticancer agents (OACAs): (OACAs). The correct response response rate per category was: storage, 77.7%; handling, 65.86%; disposal of contaminated materials, 94.45%; and education and training, 89.68%.

Association between safe handling practices and demographic variables:

Tables 3a-3d compare the participants’ safe handling scores with their demographic and professional characteristics. The scores indicate that nurses’ years of experience and their positions at work have a significant influence on their knowledge regarding storage. Nurses with fewer than two years’ experience had significantly less storage knowledge than those in other experience intervals (p=0.002). Furthermore, the scores of charge nurses and unit managers were higher than those of registered nurses (p=0.078), and nurses who had received training had significantly greater storage knowledge than those who had not (p=0.029). Females’ handling scores were significantly higher than males’ (p = 0.040). Moreover, nurses with > 10 years’ experience had higher scores than those with < 10 years; the difference was significant (p = 0.039). Increasing years of experience in an oncology unit had a direct bearing on scores in the category of disposal of contaminated waste (p = 0.030). Nurses who had received training on the safe handling of chemotherapy drugs had a higher mean score (92.1 ± 20) than those who had not (76.8 ± 30.7); the difference was significant (p= 0.002). This suggests that training is an effective way to improve nurses’ knowledge and skills in this area.

Discussion

The issue of medication safety is particularly significant in the case of anticancer therapies, due to the high potential for harm posed by these agents and the disease context in which they are used [39]. Guidelines exist that recommend safe prescribing, dispensing, and administration of chemotherapy and related agents used in cancer treatment, [41] and standard guidelines education improves knowledge and performance with regard to safe handling practices [19]. While chemotherapy providers have generally developed and implemented good practices around the safe delivery of intravenous chemotherapy, there remain issues associated with orally administered antineoplastics [42]. Despite exponential growth in the use of oral anticancer medications, the knowledge about these medications and guidelines for their safe handling have not kept up to date with the speed with which the medications have been applied in clinical practice. They pose severe hazards to any personnel handling them, as well as to patients and their caregivers [43]. As nurses are front-line healthcare professionals who provide direct care for patients and are involved in the handling of oral chemotherapeutic agents, they should be well versed in the safe handling practices required for such agents. Our study indicated that most nurses were aware of the appropriate safe storage protocols and adhered to best practices. Conversely, a multi-centre study conducted in Bangladesh [26] reported that around half of the studied nurses had been exposed to chemotherapy agents, and a more significant proportion, 58.3%, were not aware of the health hazards of oral and parenteral drugs and did not use the designated treatment room. Regarding the handling of OACAs, nearly half of the participants in our study answered that they handle and administer OACAs without precautions. In alignment with the findings of the present study, similar studies have highlighted a misconception among patients and healthcare workers that OACAs are less harmful, carry a lower exposure risk, and are safer to handle [44]. This highlights the need to improve both patients’ [45] and healthcare workers’ [21] understanding of the requirements for storage, handling, and safe administration of oral anticancer drugs. However, contradicting our findings, a study [28] conducted in Jordanian hospitals revealed that nurses fully complied with the safe handling requirements for OACAs. Our study demonstrates the nurses’ awareness of hospital-wide policies regarding the handling and administering of ACAs. This finding is supported by another study [18] which found that most nurses knew about the safety guidelines for administering chemotherapy. Another study revealed full compliance in all hospitals regarding the availability of policies and procedures for the safe handling of antineoplastic agents and the availability of a reporting system. In the current study, a good percentage of the participants were confident that they performed OACA manipulations, such as compounding, crushing, cutting, or splitting, in a biological safety cabinet or isolator, and used disposable personal protective equipment. In contrast, another study conducted in Jordanian hospitals [28] reported that the participants were least compliant with working inside the biological safety cabinet (65.1%). Other studies reported the safety design of their workplace to be rather poor [49]; and, it was noted that the utilization of personal protective equipment was lower when specific safety handling procedures were not in place [17]. These contradictory findings suggest that safe practices vary according to the management’s approach to safety and perceived risk, and the availability of precautionary measures in healthcare settings. Most of the nurses in the present study were aware of the need to use personal protective clothing and equipment to minimise exposure and health risks, and the participants used gloves to dispense OACAs. Other studies contradicted these findings, [25,29] reporting that PPE was identified as an obstacle to professional image and performance, d efective use of PPE during various steps of handling chemotherapy drugs, and reduced adoption of personal protective practices among oncology nurses [23,27]. Our study found that most nurses have received training on the safe handling of chemotherapy drugs and are supported at institution level with appropriate education. Studies highlight this aspect, noting that training on safe handling enhances compliance [31]. In the current study, most nurses acknowledged that all disposable materials used while handling OACAs are disposed of as chemotherapy waste according to the local waste disposal guidelines, and packaging and supplies for OACAs are disposed of in specially designated chemotherapy buckets. In alignment with this finding, another study [28] revealed that the items with full compliance in all hospitals were the availability of policies and procedures for the safe handling of antineoplastic agents, the availability of reporting systems, and the availability of sharps containers. Contradicting the findings of this study was a study [8] that revealed that t he implemented exposure controls for preparation, administration, cleaning, and waste disposal were not in line with the safe handling guidelines. The current study found that the nurses knew about safe handling practices; this was supported by another study with similar findings [18]. Our findings revealed that nurses with higher education, those with more experience, and those who have received training were more aware of correct storage practices with regard to OACAs. Furthermore, those with more experience in the oncology unit had more awareness concerning the disposal of contaminated waste, although the difference was not statistically significant. This finding contradicted a study that reported a statistically significant difference between the practice score and the nurses’ cadre [18]. Our findings suggest that gender and years of experience play a role in handling skills, with women and more experienced nurses generally performing better. Nurses with more years of experience also had significantly higher scores in the category of disposal than. Supporting this finding, another study [18] revealed that years of experience had a statistically significant association with the safe handling of chemotherapy drugs. Overall, nurses with experience and training scored significantly higher than those without. This finding is promising since it shows that trained nurses generally understand the significance of safe handling procedures for OACAs, and suggests that training is an effective way to improve nurses’ skills and knowledge in the area.

VI. STRENGTHS AND LIMITATIONS It should be remembered that this study is based on a survey of just 120 nurses. Given the limited sample size, the results might not represent all trained nurses. Hence, caution should be exercised when generalising these results. Additionally, the study is cross-sectional and identifies associations between the variables; it cannot determine cause-and-effect relationships. Despite these drawbacks, the study offers insightful information about qualified nurses’ safe handling techniques, and can guide educational and training initiatives to enhance the ability of nurses to safely handle OACAs.

Conclusion

Our study indicates that most trained nurses adhere to safe OACA handling procedures. Nonetheless, there is space for improvement in certain areas, such as using gloves when handling OACAs and understanding the value of keeping OACAs in a well-ventilated place. Our findings revealed a high demand to improve nurses’ knowledge about the safe handling of oral chemotherapeutic agents. Hospitals might offer instruction on all facets of safe handling, such as using PPE, proper disposal of OACAs, and ways to prevent unintentional exposure. Moreover, the study itself might affect nurses’ judgment when caring for cancer patients and handling oral chemotherapeutic agents, by highlighting essential gaps in the management of such agents. VIII. DECLARATION OF INTERESTS The authors have no conflicts of interest to disclose.

Funding

The study received funding from King Fahd Medical City, Riyadh, Kingdom of Saudi Arabia (RFA 022-010).

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