Effect of Developing Safety Handling Protocol for Chemotherapy on Nurses' Knowledge and practices at Minia Oncology Center

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:

• Cancer definition and methods of treating cancer.
• Chemotherapy definition, mechanism of action, and routes of administration.
• Methods, signs & symptoms of exposure to chemotherapy hazards.
• Safe handling chemotherapeutic during (administration, extravasation, disposal and spill.)

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:-

• Nurse’s practical skills before administering chemotherapeutic drugs (work area, transport and storage of chemotherapy drugs).
• Nurse’s practical skills while administering chemotherapeutic drugs.
• Nurse’s practical skills during disposal of chemotherapy drugs waste.
• Nurse’s practices in dealing with a chemotherapeutic agent spillage.

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:

• Informed oral nurses' consent was obtained after explanation of the study aim.
• Nurses' were informed that their participation was voluntary, their privacy and right   to withdraw from the study was respected.
• The anonymity, Security and confidentiality of collected data were ascertained.

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)

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) 

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)  

**= 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)

**= 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.