Health professionals’ practice to care cytotoxic drug handling and associated factors: The case of university of gondar specialized hospital

Abstract

Background

Health care professionals are potential to be in contact with cytotoxic drugs during their daily work activities. The study aimed to assess the practice of health professionals to care for cytotoxic drugs and associated factors in the University of Gondar Specialized Hospital.

Methods

Cross-sectional study design was employed. EPI Info 7 was used for data entry and then exported into SPSS 20 for statistical analysis. Frequencies and mean with standard deviation were computed. Logistic regression had been performed to find out associated factors. Crude’ and adjusted Odds’ ratio with 95% uncertainty interval was done. Variables with a p < 0.05 were declared as significant factors for practice of cytotoxic drug handling.

Results

The study used four-hundred and twelve health professionals took part in the study with 97.4% response rate. The mean age of study participants was 29.9 years ranging from 20–60 years and twenty (53.4%) participants were males. One hundred and fifty-five (37.6%) health professionals had good cytotoxic drug handling practice. Attending an average of 4–9 patients per day (AOR = 2.12, 95% CI: 1.05, 4.22), Medium work stress (AOR = 2.01, 95% CI: 1.04, 3.90), availability of cytotoxic drug handling manual (AOR = 2.51: 95% CI: 1.22, 5.12), and good knowledge (AOR = 4.09, 95% CI: 2.35, 7.11) were significantly associated with cytotoxic drug handling practice.

Conclusion

The practice of cytotoxic drug handling care was low. It demands the engagement of the health sector to avert such inadequate practice and has to focus on delivering knowledge and logistics for the practice of cytotoxic drug handling.

Keywords

Cytotoxic drugs practice health professionals

Introduction

Anticancer drugs (chemotherapeutic agents) are used as treatment options for oncologic cases. Evidence for continued risk of occupational exposure is abundant.¹ Poor management of waste is a potential risk to healthcare workers and the community.² In Ethiopia, the growing population with lifestyle changes showed an increasing burden of cancer.³ In an earlier study, cervical cancer was the major cause of mortality in Ethiopia.⁴ Chemotherapeutic drugs are cytotoxic substances that can be used for the treatment of cancer. Exposure to cytotoxic drugs⁵ may occur during drug preparation, mixing,^6,7 drug administration,⁸ transportation, and cleaning spills and waste disposal.⁹ Significant amounts of CD can enter into the body via inhalation of the powder and liquid aerosols, unprotected skin and mucous membranes, oral exposure may occur from hand-to-mouth contact or ingestion or drinks and needle stick injury^10–12 for staff exposed to antineoplastic agents exists in the workplace.¹³

In many countries, national health authorities focus on promoting actions aimed to protect individuals who are potentially in contact with CD.^14–17 Health professional organizations and government agencies have developed guidelines in the past 2 decades, concerned about the health risk of occupational exposure to hazardous drugs to protect health care workers from cytotoxic effects of antineoplastic drugs.^16,18 Most published guidelines on safe handling of cytotoxic drugs addressed the hospital setting, but lack practical guidelines for use within an oncology office.¹⁹ Although there has been a significant increase in the availability and use of CDs, the guidelines regarding safe handling are still evolving.²⁰ Several studies revealed that CDs are hazardous to healthcare workers, particularly Nurses, Pharmacists and Cleaners who may come in contact with these CDs during their daily activities.²¹ Other studies have assessed work exposure to CD could result in various toxicological effects that can potentially damage health professionals during their activities.^20,22 As stated by previous studies, one of the reasons for CD exposure is due to inappropriate use of personal protective equipment and wrong cleaning procedures.¹⁸ Priorities have to be given to reduce major work-related health risks and associated factors and to plan possible management mechanisms.²³ Cancer treatment services are insufficient, and it is observed that no cancer related activity documentation and less staff are involved in cancer treatment centers.³ Even though there has been an improved concern and responsiveness about the issue of safe handling of CDs, many health professionals still do not follow the adopted guidelines and procedures in the hospital settings and are not using the recommended personal protective equipment.²⁴ For that reason, health professionals’ practice needs understanding of toxicities and the protection measures used while preparing and administering these CDs.^17,25–27 This study was the first of its type to assess the practice of health professionals to care for cytotoxic drugs and possible associated factors in University of Gondar Specialized Hospital.

Methods

Study setting, design, and period

Institutional based cross-sectional study was employed at the University of Gondar Specialized Hospital, northwest Ethiopia, which is located 728 Km away from Addis Ababa, the capital city of Ethiopia. University of Gondar Specialized Hospital is a teaching Hospital which acts as a referral center for the nearby General Hospitals. It provides referral services for over 5 million inhabitants in the northwest region of Ethiopia. The data collection period was from June to August 2019.

Population

We used all University of Gondar Specialized Hospital Health professionals working in different departments of the Hospital including cancer treatment center as source population. The study populations were all University of Gondar Comprehensive Specialized Hospital Health professionals working in different departments of the Hospital including cancer treatment center who were present at the time of data collection.

Inclusion and exclusion criteria

All Health Professionals working in University of Gondar Specialized Hospital were included. Health Professionals who were severely ill during the data collection period, who had never been assigned to a cancer treatment center and those Health Professionals who had confirmed cancer were excluded.

Sample size calculation and sampling technique

The sample size (n) was calculated using a single population proportion formula with the assumptions of the proportion = 0.5 (no previous study in Ethiopia), 95% uncertainty interval, and margin of error (d) = 5%. After adding a non- response rate of 10%, the final sample size was 423. Simple random sampling technique was used for selection of Health Professionals to be included in the study.

Instruments

We used a semi-structured, pretested self-administered questionnaires to collect the required data after preparing the questionnaire by reviewing different literature.^18,28–30 The questionnaire consisted of different items regarding Sociodemographic characteristics and practice of health professionals on cytotoxic drug handling. The overall reliability of the items used for CD handling practice was performed, and we found a Cronbach's alpha of 0.87 which is good reliability. Four professional nurses were recruited to distribute and return the questionnaire and facilitate the collection process.

Variables of the study

Dependent variable: practice to care handling of cytotoxic drugs

Independent variables: Sex, age in years, marital status, educational level, work experience, Profession, working hours per week, work stress, ever attended training, ever taking courses related to CD, availability of personal protective equipment, knowledge and attitude towards cytotoxic drug handling.

Operational definition

Practice: Respondents were asked 12 practice questions about whether they always prepare CDs in preparation room, always prepare CDs in biological safety cabinet, never do risky behaviors like eat and drink in preparation room, do not store CDs in preparation room, follow guidelines and standards for handling of CDs, always wear personal protective equipment during preparations of CDs, always wear personal protective equipment during administration of CDs, use of biological safety cabinet for all preparations, management of accidents in handling of CDs, always wear personal protective equipment during transport and storage of CDs, manage accidents as spoils based on standard protocols, record and report all accidents in handling of CDs, consult clinical pharmacist about safe handling of CDs and consult occupational medicine specialists about related health problems. Study participants who scored mean and above of the questions were considered as having good practice to care on cytotoxic drugs.

Knowledge: Respondents were asked 13 knowledge questions. Study participants who scored mean and above of the questions were considered as having good knowledge.³¹

Statistical analysis

Epi-info 7.1 was used for data entry and then exported into SPSS version 20 for computing, recording, and statistical analysis. Mean with standard deviation (SD) and frequency with percent were computed to descriptive results of the study. Logistic regression was used to explain the relationship between practice of drug handling and independent variables. Bi-variable analysis was executed to determine crude association between practice and each independent variable. An independent variable with a p-value of < 0.2 was selected for multivariable logistic regression. A variable with a p-value of ≤ 0.05 with 95% uncertainty interval was treated as a significant factor for practice towards cytotoxic drug handling.

Data quality control

Quality control was considered starting from questionnaire design until the analysis process. It was pretested and facilitators were trained about the purpose of study and ethical issues in the process of data filling. Pretest was done among 30 health professionals outside the study area, and we amended the questionnaire based on difficulties we faced during the pretest

Results

The study used four-hundreds and twelve health professionals with a 97.4% response rate. The mean age of respondents was 29.9 years (±5.43) which ranged from 20 to 60 years. From the participants, two-hundred and twenty (53.4%) participants were males. Three-hundred and thirty-nine (82.3%) participants attained the educational level of a Bachelor's degree. About one-hundred and forty-two (34.5%) participants had a minimum of 2 years work experience. One-hundred and ninety-six (47.6%) professionals were nurses. In the current study, one-hundred and seventeen (28.4%) participants had reported that they have had work stress out of work, and 172 (41.7%) participants reported having high workload (Table 1).

Table 1.

Sociodemographic characteristics of study participants in the university of gondar specialized hospital, gondar, Ethiopia, 2019 (n = 412).

Variable	Categories	Frequency (n)	Percent (%)
Sex	Female	192	46.6
Sex	Male	220	53.4
Age in years (by mean)	Mean = 29.92(±5.43), Min = 20 Max = 60
Age in years (by category)	20–25	69	16.7
	26–28	133	32.3
	29–31	91	22.1
	32–60	119	28.9
Marital status	Married	226	54.9
Marital status	Unmarried	186	45.1
Education level	Diploma	26	6.3
	Bachelor degree	339	82.3
	Masters and above	47	11.4
Work experience in years	1–2	142	34.5
	3–4	66	16.0
	5–8	137	33.3
	8–37	67	16.3
Profession	Nurse	196	47.6
	Pharmacy	112	27.2
	Medicine	18	4.4
	Midwifery	69	16.7
	Laboratory	17	4.1
Working hours per week	30–38	45	10.9
	39–43	161	39.1
	44–55	97	23.5
	56–110	109	26.5
Work stress out of work	Very low	51	12.4
	Low	84	20.4
	Medium	160	38.8
	High	117	28.4
Average number of patients contacted per day	4–9	100	24.3
	10–14	85	20.6
	15–29	59	14.3
	30–2	16	40.8
Work load	None	32	7.8
	Low	43	10.4
	Medium	165	40.0
	High	172	41.7

Cytotoxic drug handling practice

One-hundred and seventy (41.3%) health professionals had taken courses directly related to cytotoxic drug handling. From these related courses, chemotherapy related was reported to be the highest 118 (28.6%). Forty-one (10%) participants attended training about cytotoxic drugs, with 23(5.6%) health professionals attending training in the last 2 years. Eighty-two participants (19.9%) reported the availability of a cytotoxic drug handling manual in their work setting. From the participants, 155(37.6%) had good cytotoxic drug handling practice (Table 2).

Table 2.

Items related with practice to care cytotoxic drug handling among health professionals at the university of gondar specialized hospital, northwest Ethiopia, 2019 (n = 412).

Variable	Categories	Frequency	Percent (%)
Ever attended training about cytotoxic drug handling	Yes	41	10.0
Ever attended training about cytotoxic drug handling	No	371	90.0
Taking training within the last 2 years	Yes	23	5.6
Taking training within the last 2 years	No	389	94.4
Ever taking course directly related with CDs handling	Yes	170	41.3
Ever taking course directly related with CDs handling	No	242	58.7
The subtopics taken as a course regarding cytotoxic drug handling	Safe preparation	53	12.9
	Safe administration	50	12.1
	Safe transport	40	9.7
	General oncology	19	4.6
	Chemotherapy	118	28.6
	Radiotherapy	19	4.6
	Hazards of CDS	16	3.9
Presence of cytotoxic drug handling manual on working setting	Yes	82	19.9
	No	330	80.1
Practice to care cytotoxic drugs	Good	155	37.6
Practice to care cytotoxic drugs	Poor	257	62.4
Knowledge about cytotoxic drug handling	Good	217	52.7
Knowledge about cytotoxic drug handling	Poor	195	47.3
Attitude towards cytotoxic drug handling	Good	224	54.4
Attitude towards cytotoxic drug handling	Poor	188	45.6

Associated factors of good practice to care handling of cytotoxic drugs

Age, educational level, profession, average patients attended per day, work stress, ever attending training on cytotoxic drugs within the last two years, ever taking courses related to cytotoxic drugs, Presence of a cytotoxic drug handling manual at working setting, and knowledge of cytotoxic drugs were candidate variables for the final model and entered into multivariable logistic regression.

In the final model; health professionals who were attending an average of 4–9 patients per day had 2-fold (AOR = 2.12, 95% CI: 1.05, 4.22) better practice than those who attended 30–200 patients per day. Participants who experienced very low workload out of work had 3.5 times (AOR = 3.52, 95% CI: 1.45,8.56) better practice of CD handling than those who reported high work load out of work, health professionals who had low work load out of work had 6 times (AOR = 6.47, 95% CI: 3.00,13.97) better practice than those who had high work stress, and those with medium work stress had 2 times (AOR = 2.01, 95% CI: 1.04,3.90) better practice than those health professionals who reported high work stress. Health professionals who worked in units where there are cytotoxic drug handling manuals had 2.5 times (AOR = 2.51: 95% CI: 1.22, 5.12) better cytotoxic drug handling practice than those who worked in units without cytotoxic drug handling manual. Participants who had good knowledge experienced 4-fold (AOR = 4.09, 95% CI: 2.35, 7.11) better practice than those with poor knowledge about cytotoxic drug handling (Table 3).

Table 3.

Associated factors of good practice to care cytotoxic drug handling among health professionals at the university of gondar specialized hospital, gondar, northwest Ethiopia, 2019 (n = 412).

Variables	Categories	Practice to care CDs		COR (95% CI)	AOR (95% CI)
Variables	Categories	Good (%)	Poor (%)	COR (95% CI)	AOR (95% CI)
Age in years	20–25	30(19.4)	39(15.2)	1.52(0.83,2.79)	1.40(0.63,3.14)
	26–28	51(32.9)	82(31.9)	1.23(0.73,2.06)	1.16(0.61,2.20)
	29–31	34(21.9)	57(22.2)	1.18(0.67,2.08)	1.30(0.65,2.60)
	32–60	40(25.8)	79(30.7)	1	1
Education	Diploma	15(9.7)	11(4.3)	2.64(1.00,7.07)	2.06(0.56,7.61)
	Bachelor	124(80.0)	215(83.7)	1.12(0.56,2.13)	1.42(0.64,3.15)
	Masters +	16(10.3)	31(12.1)	1	1
Department	Nurse	81(52.3)	115(44.7)	2.29(0.72,7.27)	2.27(0.57,9.01)
	Pharmacy	35(22.6)	77(30.0)	1.48(0.45,4.86)	1.79(0.41,7.71)
	Medicine	12(7.7)	6(2.3)	6.5(1.47,28.80)	2.92(0.47,18.38)
	Midwifery	23(14.8)	46(17.9)	1.63(0.48,5.55)	0.1.40(0.33,5.99)
	Laboratory	4(2.6)	13(5.1)	1	1
Average patients attended per day	4–9	54(34.8)	46(34.8)	2.62(1.57,4.39)	2.12(1.05,4.22)*
	10–14	23(14.8)	62(24.1)	0.83(0.46,1.48)	0.62(0.28,1.34)
	15–29	26(16.8)	33(12.8)	1.76(0.96,3.23)	1.20(0.93,4.28)
	30–200	52(33.5)	116(45.1)	1	1
Work stress out of work	Very low	23(14.8)	28(10.9)	3.36(1.64,6.87)	3.52(1.45,8.56)*
	Low	47(30.3)	37(14.4)	5.19(2.77,9.72)	6.47(3.00,13.97)***
	Medium	62(40.0)	98(38.1)	2.59(1.48,4.51)	2.01(1.04,3.90)*
	High	23(14.8)	94(36.6)	1	1
Ever attending training regarding CD handling	Yes	27(17.4)	14(5.4)	3.66(1.86,7.23)	1.10(0.31,3.68)
Ever attending training regarding CD handling	No	128(82.6)	243(94.6)	1	1
Within 2 years training	Yes	15(9.7)	8(3.1)	3.34(1.38,8.06)	1.31(0.29,5.87)
Within 2 years training	No	140(90.3)	249(96.9)	1	1
Ever taken courses directly related to CDs	Yes	56(36.1)	114(44.4)	0.71(0.47,1.07)	0.67(0.37,1.28)
Ever taken courses directly related to CDs	No	99(63.9)	143(55.6)	1	1
Availability of manual	Yes	52(33.5)	30(11.7)	3.82(2.30,6.34)	2.5(1.22,5.12)*
Availability of manual	No	103(66.5)	227(88.3)	1	1
Knowledge	Good	105(67.7)	112(43.6)	2.72(1.79,4.13)	4.09(2.35,7.11)***
Knowledge	Poor	50(32.5)	145(56.4)	1	1

Hosmer and Lemshow good−ness−of fit (p)=0.547, *significant at p<0.05, ** p<0.01 and *** p<0.001.

Discussion

The current study was the first in its kind to assess the practice of health professionals to care for cytotoxic drugs in Ethiopia. The aim of the study was to assess practice to care cytotoxic drugs and find out associated factors of it.

In the current study, the good practice to care for cytotoxic drugs among health professionals was 37.6% (95% CI: 32.92%-42.28%). This is consistent with other cross-sectional studies in Egypt,²⁸ Pakistan,³² and Turkey.¹⁷ Other studies reported a higher percentage of health professionals with good cytotoxic drug handling, as evidenced in Nairobi³⁰ and Iran.²⁹ This could be due to differences in the study setting in that the cancer treatment units had been recently established and not advanced in the university of Gondar Specialized Hospital, training about safe handling practice of cytotoxic drugs were not adequately given to those health care professionals as well as the health education system of the country might not adequately address the risk of cytotoxic drug side effects.^27,33

In the final model, average number of patients contacted per day, work stress out of work (None, Low and Medium), availability of cytotoxic drug handling manual and good knowledge were significantly associated with good care of cytotoxic drug handling practice.

Health care professionals having a lower number of patients contacted per day (4–9) had 2-fold good cytotoxic drug handling practice as compared to those health professionals contacting a higher number of average patients (30–200) per day. This association might be because health care professional having lower number of contacted patients are free to observe better techniques, give expected cares and required procedures as compared to those health care professionals having a high number of patients contacted per day as they are crowded to deal with expected activities to achieve good practice²⁷ Participants having lower work stress out of the hospital had good level of cytotoxic drug handling practice as compared with participants having higher work stress. This might be because health professionals who had stress out of the regular working area could not read or seek knowledge regarding drug handling, or could have inadequate general knowledge.²⁷ The other possible reason might be the tension of house related work leading health professionals not to focus on their professional work responsibilities. The crowded work at home could have implication for the individual's quality of working life.³⁴

Study participants who accessed the availability of cytotoxic drug handling manual had 2-fold better cytotoxic drug handling practice than others who did not access cytotoxic drug handling manual. This might be because good practice can be achieved through the availability of manuals related to cytotoxic drug handling, and it is obviously true to say manuals are very important to follow procedures and expected techniques so that a good level of practice can be achieved.²⁷ Health professionals with good knowledge have 4-fold better cytotoxic drug handling practice as compared to those who have poor knowledge of cytotoxic drug handling. Several previous studies supported that good knowledge of cytotoxic drug handling can improve good practice of cytotoxic drug handling.^29,30,32 It is not amazing that having good knowledge of cytotoxic drug handling could have a good level of cytotoxic drug handling practice, as knowledge is the base for practice to be taken place and adequately addressed.³⁵ Similarly, good practice was also significantly associated with good knowledge of CDs in previous published articles which was part of this project.³¹ In this study, attitude was not significantly associated with practice of CDs. However, practice was significantly associated with attitude of CDs in a previous published article which was the parts of this project.³⁶

The possible limitations in the current study include social desirability and recall bias. Besides, the cause-effect relationship cannot be established as this is a cross-sectional study. The study was self-reported and might not indicate the actual practice they did in the workplace.

Conclusion

The study showed that the practice of cytotoxic drug handling in Gondar University specialized hospital was poor. Regardless of the constricted scope of the study and the various constraints, the results of the current study may be assumed to be an important addition to the existing body of cytotoxic drug handling practice in Ethiopia. Increasing utilization of chemotherapeutic agents in treating patients with malignancy has led to the potential for widespread exposure of healthcare workers who come into contact with patients or these agents in the workplace. It is therefore recommended to access cytotoxic drug handling manual, reduce average patients contacted per day by increasing number of staffs, train health professionals to the specific job area before beginning duties and incorporate CDs handling related course contents while revising curricula to raise the skills thereby improving good practice to appropriate cytotoxic handling by health professionals so that reduction of possible adverse effects of cytotoxic drugs. The authors recommend future projects regarding the practice of cytotoxic drug handling by direct observations of workplace contamination.

Footnotes

Acknowledgements

The authors are grateful for study participants, University of Gondar and data collectors.

Ethical approval and consent to participate

Ethical approval was gained from the ethical committee of School of Pharmacy, University of Gondar with ethical review protocol number: SOP/559/2019. Written consent was given to each participant to assure their willingness of participation, and no identifiers were listed in the questionnaire to make it confidential.

Consent for publication

Not applicable

Availability of data and materials

The dataset is found and can be obtained at the corresponding author upon reasonable request

Authors’ contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, have drafted or written, or substantially revised or critically reviewed the article, have agreed on the journal to which the article will be submitted, reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage. All are agreed to take responsibility and be accountable for the contents of the article.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Wudneh Simegn

Abbreviations

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