Document Type : Original articles
Authors
1 Demonstrator of Medical Surgical Nursing
2 Assistant Professor of Clinical Oncology
3 Lecturer of Medical Surgical Nursing, Faculty of Nursing1
Abstract
Keywords
Introduction
Cancer is a generic term for a large group of diseases characterized by the growth of abnormal cells that can then invade adjoining parts of the body and/or spread to other organs. Cancer has many anatomic and molecular subtypes that each requires specific management strategies (1). Most drugs defined as hazardous drugs (HD) are cytotoxic agents mainly used in chemotherapy for their actions on killing cancerous cell (2). Long-term occupational exposure to cytotoxic drugs is associated with various carcinogenic, teratogenic and mutagenic effects (2, 3, 4).
A major advantage of chemotherapy is its ability to treat widespread or metastatic cancer whereas surgery and radiation therapy are limited. The risk of contamination with anticancer agents can occur at many points as, for example, in its manufacturing, transport, distribution, reception and storage. However, generally, the occupational activities, which present the greatest potential for chemotherapy exposure, are the preparation and administration of chemotherapeutic agents, spills, cleaning and handling the excreta of patients (5).
Exposure may results from direct contact via skin or mucous membrane as eyes (e.g. splashes), and through indirect contact by touching surfaces that have been contaminated. Inhalation of droplet aerosolization mainly because of inappropriate hygienic behavior such as eating, drinking or smoking during preparation, administration or disposal of cytotoxic drugs (CDs) in contaminated areas. Less likely routes of exposure include needle stick injuries (6).
Exposure to chemotherapy drugs is associated with many adverse outcomes for occupationally exposed individuals including but not limited to contact dermatitis; chromosomal abnormalities; fetal loss; infertility; preterm births; and an overall increase in one's personal risk for cancer (7). Pregnant nurses are at particular risk for chemotherapy exposure risks and their exposure is associated with an increased risk of spontaneous abortion (8).
Although the previous studies documented the side effects of antineoplastic drugs (ANDs) on exposed persons, healthcare workers often do not adhere to safe work practices (9, 10). This could be related to the lack of nurses’ knowledge about routes of exposure and adverse health effects induced by antineoplastic drugs. Knowledge and attitude of nurses regarding chemotherapy exposure may affect their adherence to safety measures; previous studies have reported that there is a gap between nurses’ chemotherapy knowledge and their behavior during work with antineoplastic drugs (11).
International safety guidelines for cytotoxic drug handling have been available for more than two decades. For examples, guidelines from US developed by the National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA), the Oncology Nursing Society (ONS) and the American Society of Hospital Pharmacists (ASHP) are well-accepted worldwide (3). Several recent publications have documented the ongoing failure of employers to adopt, or consistently use, recommended safety practices for handling HDs (9, 12, 13).
These guidelines recommend the application of hierarchy of control technologies to mitigate workplace hazards, which include engineering controls, administrative controls, work practice controls, and personal protective equipment (PPE) (9). All healthcare workers who work with antineoplastic drugs (ANDs) have been advised to adhere to these safety guidelines (14).
Significance of the Study
Exposure to chemotherapeutic drugs at the workplace is a significant occupational health hazards.
Aim of the Study
The aim of this study is to:
Evaluate the effect of implementing (SHPC) on nurses' knowledge and practical skills about safe handling chemotherapy.
Materials and Method
Research design:
A Quasi- experimental research design was be utilized to achieve the aim of the present study.
Setting:
The study was conducted at Minia Oncology Center in outpatient and inpatient chemotherapy departments. It affiliated by Ministry of health.
Study subjects:
Subjects of the study consisted of (50) nurses working at the chemotherapy department.
Exclusion Criteria:
Nurses who are not willing to participate in the study.
Tools:
Three tools were developed by the researcher after literature review. Tools were reviewed by a panel of five experts, four in the field of medical surgical nursing and one in the field of community health nursing, Faculty of Nursing, Minia University for validity testing.
Tool I: Arabic administered questionnaire for nurses it included three parts:
Part I: Nurses' Socio-demographic Data such as age, sex, marital status, habits, educational level, years of experience as oncology nurse and previous training about safe handling of chemotherapy.
Part II: Medical Data covers the past and present health hazards for nursing members that related to exposure to chemotherapeutic agents.
Part III: Knowledge Questionnaire to assess nurses’ knowledge about safe handling chemotherapy: data from this tool was collected three times, before, immediately after and two months later of implementing protocol to evaluate the effect of this protocol on nurses’ knowledge: It consists of (30) closed questions covered the following area:
Tool II: Structured observational checklist: data from this tool was collected before implementing the protocol, immediately after implementing it and two months later to evaluate the effect of this protocol on nurses’ practical level. It consisted of four areas:-
Tool III: Safe Handling Chemotherapy Protocol (Booklet) regarding preparation, administration, disposal, and spills management. This tool was designed on learning needs of nurses at the pre assessment phase.
Scoring system:
For knowledge part: each right answer was given one score. While the scoring system of the observation checklist was as follows: each observed item, scored as either done completely = 2 or done incompletely = 1 or not done = 0. The sum of the total practices were calculated and transferred to percentage, then these scores were further classified as unsatisfactory level (less than 60%) and satisfactory level (> 6o %).
Validity and Reliability:
Content Validity of tools were tested by a jury of 5 experts, (4) of them specialized in the field of medical surgical nursing and (1) of them specialized in the field of community health nursing, Minia university to test for tools clarity, completeness and comprehensiveness. The experts reviewed the tools for its content and modifications were considered.
Reliability of tools was tested by using alpha cronbach test.
Pilot Study:
Pilot study was carried out on (5 nurses) to test feasibility, clarity, and applicability of the study tools. Results of the pilot study were considered.
Ethical consideration:
Data Collection process: include the following stages:
Tools (I, II, III) were developed and were modified by the researcher based on extensive review of the relevant literature. Tools were tested by a jury of 5 experts, (4) of them specialized in the field of medical surgical nursing and (1) of them specialized in the field of community health nursing, Minia university to test for tools clarity, completeness and comprehensiveness. The experts reviewed the tools for its content and modifications were considered. Assessment of nurses' knowledge and practical skills about safe handling chemotherapy through distribution of knowledge questionnaire to each participant to fill it and observing each nurse's performance during administration, removal of IV chemotherapy, disposal and dealing with chemotherapy spills. Distribution and implementation of safe handling protocol for chemotherapy (SHPC) with clarification. Reassessment of nurses' knowledge and practical skills about safe handling chemotherapy immediately range (one day to one week) after distributing (SHPC) protocol. Reassessment of nurses' knowledge and practical skills about safe handling chemotherapy two months later of distributing it to evaluate the gain and retention of knowledge and changes of their practice after implementation of the protocol.
Statistical Analysis:
The raw data collected was coded and entered into statistical package for social scientists (SPSS) version (20) software data sheet (15), data was then cleaned and verified using the primary source document (tool I or II). Statistical analysis was performed using SPSS version 20 where descriptive statistics were generated for categorical and continuous variables.
The association between quantified qualitative variables was assessed using Pearson's
Chi square test (x2). The exact tests (Fisher test) were used as alternative when the smallest of the expected numbers in any of the cells being less than 5. Probability (P-value) is the degree of significance, less than 0.05 was considered significant. The smaller the P-value obtained, the more significant is the result (*), less than 0.001 was considered highly significant (**) and Correlation coefficient (r) was calculated between continuous variables.
Results
Table (1): Distribution of Socio-demographic Data of Nurses among Study Group (n = 50)
Personal data |
No. |
% |
Gender |
|
|
Male |
8 |
16.0 |
Female |
42 |
84.0 |
Total |
50 |
100.0 |
Age / years |
|
|
20 – 30 |
32 |
64.0 |
31- 40 |
18 |
36.0 |
Total |
50 |
100.0 |
Mean ± SD |
23.6±10.1 |
|
Residence |
|
|
City |
19 |
38.0 |
Village |
31 |
62.0 |
Total |
50 |
100.0 |
Education |
|
|
Secondary Nursing School |
27 |
54.0 |
Technical institute of Nursing |
8 |
16.0 |
Bachelor's degree in Nursing |
12 |
24.0 |
Diploma in Nursing |
3 |
6.0 |
Total |
50 |
100.0 |
Marital status |
|
|
Single |
13 |
26.0 |
Married |
37 |
74.0 |
Total |
50 |
100.0 |
Pregnant |
|
|
Yes |
2 |
4.8 |
No |
40 |
95.2 |
Total |
42 |
100.0 |
Lactating |
|
|
Yes |
4 |
9.5 |
No |
38 |
90.5 |
Total |
42 |
100.0 |
Habits |
|
|
Smoker |
|
|
Yes |
1 |
2.0 |
No |
49 |
98.0 |
Total |
50 |
100.0 |
Years of experience/ years) |
|
|
1 – less than 5 yrs. |
18 |
36.0 |
5-10 yrs. |
8 |
16.0 |
>10 yrs. |
24 |
48.0 |
Total |
50 |
100.0 |
Mean ± SD |
5.96±4.6 |
|
Previous attending course in safe handling of chemotherapy |
|
|
Yes |
4 |
8.0 |
None |
46 |
92.0 |
Total |
50 |
100.0 |
Table (1) shows that, the majority of studied nurses were females (84%), and more than half (64%) aged between 20 to 30 years old, married (74%), lived in village (62%).Most nurses were not pregnant (95.2%) or lactating (90.5%), not smoker (98%) and don’t previously attend training about safe handling chemotherapy (92%). About half of them had graduated from secondary nursing school and have more than 1o years of experience in oncology center (54% and 48% respectively).
Table (2): Frequency Distribution of Nurse's Knowledge about Methods of Exposure to Chemotherapy Hazards in Pre, Immediately Post and after 2Months of Implementing Safe Handling Chemotherapy Protocol (n = 50)
|
Correct Answer |
|||||||
Items |
Pre (n= 50) |
Immediate (n=50) |
After 2 Months (n=50) |
Fisher test |
P – value |
|||
No. |
% |
No. |
% |
No. |
% |
|||
|
|
|
|
|
|
|||
1. Common methods of exposure to chemotherapy hazards among nursing personnel? |
19 |
38.0 |
43 |
86.0 |
34 |
68.0 |
X2 = 25.521 |
.001** |
2 Exposure to chemotherapy hazards can occurs? |
19 |
38.0 |
39 |
78.0 |
35 |
70.0 |
X2= 19.015 |
.001** |
3. Avoid\decrease exposure to of chemotherapy hazards? |
37 |
74.0 |
46 |
92.0 |
40 |
80.0 |
5.691 |
.058 NS |
4. Avoid exposure to chemotherapy hazards? |
29 |
58.0 |
43 |
86.0 |
41 |
82.0 |
X2= 12.342 |
.002** |
5. Wrong exposure during the preparation and administration of chemotherapy cause hazards to nurses? |
35 |
70.0 |
48 |
96.0 |
45 |
90.0 |
14.808 |
.001** |
6. Harmful effects that can be caused by the wrong exposure to chemotherapy? |
23 |
46.0 |
42 |
84.0 |
39 |
78.0 |
19.628 |
.001** |
7. High risk Person for health Problems in wrong Handling? |
31 |
62.0 |
42 |
84.0 |
39 |
78.0 |
6.837 |
.03* |
X2, p: and p values for chi square test
NS = not significant
* = statistically significant P≤ 0.05
**= high statistically significant P – value ≤ 0.01
Table (2) exhibits that there was statistical significant differences improvement of nurse's knowledge in nearly most questions about methods of exposure to chemotherapy hazards between Pre, immediately posts and after 2 months of implementing safe handling chemotherapy protocol (SHPC).
Table (3): Mean Scores of Nurses Regarding (Cancer, Chemotherapy and Safe Handling Chemotherapy, and Total Knowledge Level) in Pre, Immediately Post and after 2 Months of Implementing Safe Handling Chemotherapy Protocol (n = 50)
Knowledge |
Score allotted |
Pre |
Immediate |
Post 2 months |
F |
P – value |
Mean ± SD |
Mean ± SD |
Mean ± SD |
||||
Cancer |
(2) |
1.0 ± .0 |
1.9 ± .2 |
1.8 ± .4 |
225.821 |
.0001** |
Chemotherapy |
(7) |
4.2 ± 1.4 |
6.4 ± .9 |
6.0 ± 1.1 |
54.136 |
.0001** |
Safety handling |
(21) |
8.6 ± 3.8 |
17.0 ± 1.7 |
14.8 ± 2.3 |
127.639 |
.0001** |
Total knowledge |
(30) |
12.9 ± 4.8 |
25.4 ± 2.0 |
22.7 ± 2.8 |
187.900 |
.0001** |
**= high statistically significant P – value ≤ 0.01
Table (3) demonstrates that there were highly statistical significant differences improvement of Mean nurses knowledge Scores (Mean ± SD) regarding (cancer, chemotherapy and safe handling chemotherapy, and of total knowledge) in pre, immediately post and after 2 months of implementing safe handling chemotherapy protocol.
Table (4) Relation between Nurses' Practices in Pre, Immediately and Post Two Months after Implementing Safe Handling Chemotherapy Protocol (n = 50)
Items |
Pretest |
Immediate |
After 2 months |
Fisher |
P-value |
|||
No. |
% |
No. |
% |
No. |
% |
|||
During procedure (administration of chemotherapeutic drugs) |
|
|
|
|
|
|||
Unsatisfactory |
50 |
100.0 |
41 |
82.0 |
41 |
82.0 |
10.227 |
.006** |
Satisfactory |
0 |
.0 |
9 |
18.0 |
9 |
18.0 |
||
Post procedure (removal IV chemotherapy and disposal) |
|
|
|
|
|
|||
Unsatisfactory |
26 |
52.0 |
3 |
6.0 |
4 |
8.0 |
38.017 |
.000** |
Satisfactory |
24 |
48.0 |
47 |
94.0 |
46 |
92.0 |
||
Total practice level |
|
|
|
|
||||
Unsatisfactory |
45 |
90.0 |
9 |
18.0 |
10 |
20.0 |
49.743 |
.0001** |
Satisfactory |
5 |
10.0 |
41 |
82.0 |
40 |
80.0 |
**= high statistically significant P – value ≤ 0.01
Table (4) exemplify that, there were statistical significant differences improvements between nurses' practices in pre, immediately and post two months after implementing safe handling chemotherapy protocol.
Figure (1) Distribution of Nurses’ practices (completely done steps) Regarding Dealing with a Chemotherapy Spillage on Nurses' Skin, Eyes and Clothes'/Bed linen among Study Group Pre, Immediately and Post Two Months after Implementing Safe Handling Chemotherapy Protocol
Figure (1) illustrates that before implementing the Protocol 0% of nurses were appropriately dealing with chemotherapy spillage on the nurses' skin, dealing with chemotherapy splashes into nurses' eyes, which increase significantly immediately and after 2 months of implementing safe handling chemotherapy protocol. The figure also cleared that in pre implementing the protocol nearly all nurses not wear gloves or wash clothes separately that contaminated with chemotherapy. While this increase significantly (100%) immediately and post two months after implementing safe handling chemotherapy protocol.
Discussion
This study aimed to evaluate the effect of implementing safe handling protocol for chemotherapy (SHPFC) on nurses’ knowledge and practical skills. Knowledge is critical to safe nursing practices in all settings, but it is especially significant when a knowledge deficit of the nurse practices threatens personal safety or the safety of the patient. Past research suggests that chemotherapy may have unintentionally compromised the oncology work setting for more than thirty years (16). An extensive review of comprehensive standards associated with hazardous drug administration and the use of personal protective equipment (PPE) may be necessary to determine if policies and regulations need to be updated to correspond with current evidence (17).
The demographics of this study agree in many aspects with those of many other studies done among nurses. In terms of gender, majority of the participants in this study were females; similar to that of Hassan MA., (2014) (18), Orujlu, et al (2015) (11), MM Mohsen, ME Fareed (2013) (19). Polovich (2010) (20) supported study findings and mentioned that, the majority of nurses were female. This reaffirms the notion that nursing is still predominantly female dominated profession (21) .
Concerning the level of education, majority of the nurses in this study had diploma in nursing. This was in agreement with other studies done by Abd Al-Magid, (2012) (22) and Hassan MA., (2014) (18) where majority of nurses are diploma holder. Chaudhary R.et al (2012) (6) study however revealed that the majority of the studied nurses had university degree. S Rizalar et al (2012) (23) consistent with study results and clarified that the majority of nurses in Turkey are graduates of bachelor degree. In this study, it is notable that, approximately three- thirds of studied nurses did not attend previous training courses in safe handling of chemotherapy. Al-Attar (2015) (24) cleared that most of nurses had not attended training sessions regarding chemotherapy precautions in oncology units (95%). Moreover, this finding is comparable to MM Mohsen, ME Fareed (2013) (19) who concluded that the majority of both groups did not be trained previously about chemotherapy. The vast majority of nurses were females, aged between 20 to 30 years old, married, diploma holder, have more than 10 years of experience in oncology center, lived in village, were not pregnant or lactating, not smoker and do not previously attend training about safe handling chemotherapy.
The current study further clarifies that, before implementing safe handling chemotherapy, about half of nurses were unaware of exposure methods to chemotherapy hazards, type of these hazards and how to avoid it, which increase significantly after implementation of the protocol. This is corroborated with, Chaudhary and Karn, (2012) (6) study, their results show that the staff handling the cytotoxic drugs (CDs) does not have a satisfactory level of knowledge regarding the risk factors. This result is in support of the findings of Bolbol SA, et al., (2016) (25) study who presented that, nurses highlighted to the lack of periodic training regarding the use of PPE and risks in different workplaces. This lack of knowledge on preventive measures is of concern because it increases the health workers’ risky behavior (25).
These findings were similar with those of Chen et al,(2013) (26) who reported that mean score for chemotherapy exposure knowledge was increased from 5.7 to 8.6 out of 15 which was still proportionally lower than that of US nurses (10.9 out of 12) ( 20). More fundamentally, however nurses need more education about chemotherapy in nursing school and through in-hospital continuing education. In this respect Kosgeroglou et al. (2006) (27) who added that the overall high rates of adherence to safety guidelines are consistent with the higher level of awareness of hazardous related to chemotherapy. In contrary to current study results Orujlu, et al, (2015) (11) who reported that the majority of nurses in their study were aware of routes of exposure to antineoplastic drugs (ANDs). However, the establishment of systematic training programs could increase its level.
Furthermore, the finding of the present study show that, the Safe Handling Chemotherapy Protocol had led to the improvement of Mean nurses knowledge Scores (From 12.9 ± 4.8 to 25.4 ± 2.0 and to 22.7 ± 2.8 respectively) regarding (Total knowledge) in pre, immediately post and after 2 months of implementing safe handling chemotherapy protocol respectively.
Abd Al-Magid, (2012) (22) Ala attar (2015) (24) and Mohsen, et al, (2013) (19) supported the results of recent study and reported that there is a great improvement in knowledge score after application of standards. High knowledge levels among the nurses are important to improve their adherence to the safety measures and to elevate their sense of well-being though knowledge alone may be insufficient to ensure the complete precaution use (3, 19, 20). In the same line Abbasi, K., (2016) (28) who reported that, overall, the findings of nurses’ knowledge assessment reflect the effectiveness of education and training, which has been claimed as a useful tool to improve the nurses’ knowledge on cytotoxic drug handling. Hospitals and clinics must provide safe handling education and training to improve the knowledge of staff and to demonstrate the organizational support (7).
Moreover, the present study demonstrates that there was improvement in nurses' skills (during procedure, post procedure and total practices) after implementing the Safe Handling Chemotherapy Protocol. In accordance to our study results, Mohsen, et al (2013)(19) and Hassan, et al (2014) (18) reported that there was significant improvement of total nurses’ practice score after educating them with the chemotherapy safety protocol, also mentioned that each organization and profession must set standards and objectives to guide staff and practitioners in performing safe and effective care.
The current study clears that, before implementing safe handling chemotherapy protocol, there is poor nurses' practice related to dealing with chemotherapy spillage on nurses' skin, clothes'/bed linen and splashes into nurses' eyes, which differ significantly in positive way after implementing of the protocol. This is related partially in the present study to unavailable of some supplies (chemotherapy spill kits) and decrease awareness of proper dealing with chemotherapy spillage. In the same line Ala attar (2015) (24) who mentioned that a lack of education and the inconvenience of safety equipment may prevent many nurses from taking appropriate precautions for themselves.
In this respect Abd Al-Magid, (2012) (22) stated that, the level of nurse's performance regarding (management of chemotherapy spill) improved immediately in most items, and the supplies were a barrier to carry out the steps such as (obtain drug spill kit).In agreement with current findings Hassan MA.,(2014) (18) agree with finding of the present study and reported that inadequate level of practice on post procedure (not done) toward safe handling chemotherapy included repeat use of warm soapy, wash the clothes/linen separately). In the same direction Rizalar, S.,(2012) (23) and reported that Forty-eight percent of nurses have experienced spillage of drug and found that only few nurses had proper actions in case of contamination.
In other similar studies, nurses reported the availability of spill kits in their workplace (9, 29) which is opposite to results of the present study. For better management of spills in the accidental release, the presence of suitable kit is necessary and is recommended for the studied hospitals.
Conclusion:
Overall, the results of this study indicate a significant improvement of knowledge, and practices among the nurses handling chemotherapy drugs after Safe Handling Chemotherapy Protocol (booklet).
Recommendations
Based on the findings of the present study:
Health care professionals who are responsible for handling chemotherapeutic drugs should be adherent to implementation of (SHPFC).