How To Determine The Patterns Of Cytotoxic Drug Spillages

Transcription

1 Cytotoxic drug spillages among nursing personnel working in the chemotherapy administration areas. Kumari Sunita, Sukhpal Kaur, Firoza D. Patel Abstract : Nurses, during preparation and administration of cytotoxic drugs are at higher risk to the dreadful side effects of these drugs. To determine the patterns of the cytotoxic drug spillages & the exposure of the nurses to these spillages, an observational assessment was carried out in the Chemotherapy administration areas (Radiotherapy Ward, Radiotherapy and Medical Day Care Rooms) at a tertiary care hospital. A direct non participatory observation was carried out for one month to assess the subjects. All the nursing personnel (22) who were posted in the chemotherapy administration areas participated in the study. During one month observation, 77.3% of the nurses experienced small spills (< 5ml or 5 gms). The common site of the spillage for more than half (52.9%) of the subjects was surface of preparation of the drug and 47% experienced spillage over both surface of preparation and the gloves worn by them. The prevalence of spill per person in all the three research settings was 1.3, 2 and 3.6 respectively for Radiotherapy Ward, Radiotherapy and Medical Day Care Chemotherapy rooms. Results suggest that drug spills are common in chemotherapy administration areas. Guidelines to manage the cytotoxic drug spills to be displayed in the unit and a "chemotherapy spill kit" to manage cytotoxic spills should be made available in all the chemotherapy administration areas Key words : Cytotoxic drug spillages, nursing personnel. Correspondence at : Kumari Sunita Shri Raj Bahadur, Saran Nagar, Ajmer Road, Jodhpur (Raj.) Introduction Toxicity of antineoplastic drugs is known since 1940's 1, when they were first introduced for the treatment of cancer. During the 1970's evidence came to light indicating that health care workers may be at risk for harmful effects from antineoplastic drugs as a result of occupational exposure. Since that time repor ts from several countries have documented drug contamination of the work place, identified drugs in the urine of the 116

2 workers and measured genetic responses in the workers. 2,3 The first evidence documenting occupational exposure in health care workers was provided by a study by Falck and colleagues. 4 Nurses who prepared and administered antineoplastic drugs had higher indicators of mutagenic substances in their urine compared with non exposed workers. A dose response was also observed in the urine mutagenicity frequency with additive exposure over the workweek that decreased over the weekend. This study suggested that nursing personnel were being occupationally exposed to mutagenic antineoplastic drugs. These findings were supported by numerous studies examining urine mutagenicity, chromosomal aberrations, sister chromatid exchanges, and other endpoints in studies on pharmacists and nurses who handle antineoplastic drugs. 5, 6 In another study adverse effects were noticed on the integumentary, gastrointestinal, nervous system and reproductive system. Both acute side effects as headache, dizziness, nausea, vomiting, irritation, itching and long term side effects as genetic abnormalities in the offspring's of the nurses who handled chemotherapy drugs were observed 7. A study from China repor ted a significant decrease in full-term births and significant increase in premature bir th, spontaneous abor tion, and congenital malformations in nursing personnel who were exposed to antineoplastic drugs. 8 A recent study by Mar tin documented learning disabilities in the children of nurses who had handled antineoplastic drugs during the course of their employment. 9 A significantly increased risk of leukemia has been reported among oncology nurses identified in the Danish cancer registry for the period 1943 to The same group found an increased risk of leukemia in physicians employed for at least six months in a department where patients were treated with antineoplastic drugs. 11 Exposure to cytotoxic drugs can occur by various activities as by direct contact when preparing & administering cytotoxic drugs & cleaning cytotoxic spills, inhalation, storage and at the time of doing disposal of cytotoxic waste 12. Exposure through cytotoxic drug spills which commonly occurs during reconstitution and dilution of cytotoxic drugs poses a significant risk to the person handling without adequate protection. 13,14 Cytotoxic drug spillages can be categorized as small spillages (less than 5ml or 5 gms.) and larger spills (more than 5ml or 5gms.). 15 Keeping in view the serious side effects of cytotoxic drugs and increased risk of facing cytotoxic drug spillages during handling & administration this study was conducted to assess the patterns of the cytotoxic drug spillages amongst the nursing personnel posted in the chemotherapy administration areas at a tertiary care hospital. Material and Methods The study was conducted at Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh. It is a premier institution for medical and health 117

3 related research of the country. The present study was done at three major chemotherapy administration areas of PGIMER, where nursing personnel are administering chemotherapy i.e. Radiotherapy Ward, Radiotherapy Day Care Room and Medical Day Care Room. The Radiotherapy Ward is situated on the 2nd floor of the Nehru hospital in cobalt block. It caters to the admitted as well as very sick OPD patients referred by radiotherapy department for administration of chemotherapy. The OPD basis patients are administered chemotherapy in Radiotherapy Day Care Chemotherapy Room and Medical Day Care Chemotherapy Room attends to all the surgical and medical oncology patients who are receiving chemotherapy on OPD basis. Using purposive sampling technique a total of 22 nursing personnel working in all the above said areas was taken up for the study. The study was carried out in the month of July- August Tool for data collection consisted of 'Demographic data sheet' which contained the personal details of the study subjects including age, gender, grade, educational qualification, professional qualification & experience in chemotherapy unit. An 'Observation Performa' for cytotoxic drug spillages was also developed by the investigator which contained the details of cytotoxic spillages, frequency of spills, nature of the spill and site of the spill. Validity of both the tools was assessed by seeking opinions of 5 experts in Medical surgical nursing and oncology depar tment. The reliability of the tools was assessed using test retest method. Both the tools developed were found to be valid and reliable. A direct non participatory method of observation was employed to observe the study subjects in all the three areas. For observation each day was divided into three parts consisting of three hours each (8 am -11 am) first part (11 am - 2 pm) second part, (2 pm - 5 pm) third part and the observation was planned in such a way that all the three areas were observed equally in all the three parts of the day and on all the days of the week. All the nursing personnel handling antineoplastic drugs during study period in the research settings were observed. Results Table 1 depicts the demographic profile of the study subjects. A total of 22 subjects were enrolled in the study. About half (45.4%) of the subjects were more than 41 years of age. The mean age of the subjects was 38.91years ± 6.85 (range years). Majority (86.4%) of the subjects were married, out of which two subjects were pregnant. As per the qualification of subjects majority (86.4%) were diploma in nursing and only three (13.6%) were graduate in nursing. About half (45.5%) of the subjects had years of professional experience. A large proportion (68.2%) of the subjects had experience of two years and above, of working in chemotherapy unit. 118

4 Table 1 : Demographic profile of study participants N=22 Variables n ( % ) Age (years) (09.1) (22.7) (22.7) >41 10(45.5) Marital status Married 19(86.4)* Unmarried 03(13.6) Qualification Diploma in nursing 19(86.4) Graduate in nursing 03(13.6) Professional Experience < 5 years 02(09.1) 5-10 years 03(13.6) years 04(18.2) years 10(45.5) >21 years 03(13.6) Working experience in Chemotherapy unit <1 year 02(09.1) 1-2 year 05(22.7) 2 years and above 15(68.2) Mean age (yrs) ±S.D = 38.91(yrs)±6.85, Range yrs * Out of 19 married subjects, 2 were pregnant Table 2 depicts the distribution of study subjects and prevalence of cytotoxic drug spills in the research settings. About half of the subjects (45.5%) were observed in Radiotherapy Ward, more than one third (36.4%) were observed in Medical Day Care Room and remaining (18.2%) were observed in Radiotherapy Day Care Room. Seventeen subjects experienced a total of 43 cytotoxic drug spillages. About half of the subjects (47.0%) who experienced spills were working in Medical Day Care, however about one third (35.3%) were employed in Radiotherapy ward and the remaining (17.6%) were in Radiotherapy Day Care. About two third of the spillages i.e 29 (67.4%) occurred in Medical Day Care with a prevalence rate of 3.6 spills per person and the minimum spills (6) were observed in Radiotherapy Day Care with a prevalence rate of 2.0 spills per person. 119

5 Table 2 : Distribution of study subjects and Prevalence of cytotoxic drug spills in Research Settings Research setting Number of Number of Number of Prevalence of subjects subjects (small) spill (per working experienced spills* person) n=22 spills n=43 f(%) n=17 f ( % ) f( % ) Radiotherapy Ward 10(45.5) 6(35.3) 08(18. 6) 1.3 Radiotherapy Day 04(18.2) 3(17. 6) 06(14.00) 2.0 Care Room Medical Day Care Room 08(36.3) 8(47. 1) 29(67.4) 3.6 * Mean (no. of spillages) ± S.D = 2.53 ± 1.74 Table 3 depicts the amount of the cytotoxic spills experienced by the subjects. All the spills experienced were small spills with 41% of the spills of 1 ml size and other 41% of 0.5 ml size and the remaining 12% of the spills of 1.5 ml size. Table 3 : Amount of cytotoxic drug spills Amount of spillage n (%) 0.5 ml 8 (47) 1 ml 7 (41) 1.5 ml 2 (12) N=17 Table 4 shows the site of cytotoxic drug spills experienced by the subjects. More than half (52.9%) of the subjects experienced spillage at the surface of preparation of cytotoxic drug (table) and the remaining (47%) experienced spillage both at the surface of preparation (table) as well as the gloves worn by the subjects. Table 4 : Site of Cytotoxic Drug Spills Site of the spillage n (%) N=17 Surface of preparation( table) 9 (53.0) Surface of preparation(table) and gloves worn by subject 8 (47.0) Table 5 shows the comparison of difference in terms of spills occurrence in three research settings using Kruskal Walli's test. A significant difference was obser ved in occurrence of spills among three research settings with Kruskal Walli's P value of.008. When three Research settings were evaluated for significant difference among themselves using post hoc analysis, it was found that subjects in Medical Day Care experienced 120

6 significantly higher spills than the subjects working in Radiotherapy Ward and Radiotherapy Day Care with P value of.006 and.051 respectively. Table 5 : Comparison of difference in occurrence of spills in Research Settings using Kruskal Walli's test and post hoc analysis Research Setting Cytotoxic Kruskal Post Hoc spills Walli's Analysis n=43 test Kruskal (P value) (P value) Radiotherapy Ward (RW) 08(18. 6).008*.006* Radiotherapy Day Care Room (RDC) 06(14. 0).051** Medical Day Care Room (MDC) 29(67. 4) Discussion * Significant difference in experience of cytotoxic spills in all the three research settings. * Subjects working in MDC experienced significantly higher spills than subjects in RW. ** Subjects working in MDC experienced significantly higher spills than RDC. Cytotoxic drugs are frequently used in oncology practice. There has been a significant risk associated with the exposure of anti neoplastic drugs during pregnancy. Higher rates of infertility, spontaneous abortions, still bir ths, premature labor and congenital anomalies has been documented. Statistically significant difference in low bir th weight infants and learning disabilities in children born to exposed mothers has been observed 2-6. In the present study two of the subjects in the age group years were in their third trimester of pregnancy and had been working in the Radiotherapy Ward for more than 12 months. The united states Pharmacopeia feels so strongly regarding reproductive, teratogenic and developmental risks that they required the health care workers of childbearing age to sign a document acknowledging that they have been trained and understand the hazards associated with these drugs before they are allowed to with these agents. 16 However in the current study majority of the nurses employed in these areas were in child bearing age group i.e years. The international agency for research on cancer (IARC) has designated cer tain cytotoxic drugs as azathioprine, cyclophosphamide, busulfan, thiopenta, etoposide, chlorambucil, cyclosporine and mephalan as group one human carcinogens. Given enough time and exposure to health care workers can cause cancer 17, however in the present study these drugs were commonly administered in 121

7 all the three research settings and more than half (68.1%) of the subjects were working in these areas for more than 2 year and above. The antineoplastic drugs are mainly administered intravenously and require reconstitution and dilution. Proper Preparation, administration and disposal of these drugs is the responsibility of the nurses employed in these areas. During handling and administration of these drugs, spillages can occur which can pose an exposure risk. The spill can be small (<5ml or 5gm) or a large spill (> 5ml or 5gm) 12. In a study quoted by chemotherapy site specific group has also revealed that during handling and administration of antineoplastic drugs spillages occur. The spillages were obser ved at the site of preparation, during priming of intravenous tubing's, removal of air from parenteral systems and during connecting or disconnecting of the IV lines from the patients 16. In the present study also the study subjects experienced a total of 43 small spills with a mean of 2.5 spills. More than two third (77.3%) of the subjects experienced spills. More than half (52.9%) of spillages occured at the surface of preparation of cytotoxic drug (table) and remaining (47%) over both surface of preparation and the gloves worn by the subject. All the spills were small in size with (41%) of 1 ml size, (47%) of 0.5ml size and the remaining (12%) of 1.5 ml size. However cytotoxic dr ug spills during expulsion of air, priming of IV tubing's, connecting and disconnecting IV lines could not be measured and recorded accurately. But study subjects agreed that the spills occur during above said activities. There was significant difference in the experience of spills among all the three research settings (P =.008), the most significant difference was observed between the Medical day care and Radiotherapy Ward (p =.006). It is recommended by all the leading oncology organizations that additional precautions should be taken to manage the cytotoxic drug spill as wearing double gloves, thick gown, goggles, following alternative cleaning with detergent and water solution, 12 but in the study it was observed that the study subjects were not taking any additional precautions and were cleaning spill with a cotton swab in one stroke and then again preparing drugs over the same surface. Even the surface of preparation was visibly seen to be coated with some red colored cytotoxic drug preparations as adriamycin. The subjects were unaware of their skin contamination by direct touching over the surface of preparation and clothes which were touching against the cytotoxic drug coated surface of preparation. However subjects repor ted to have acute effects itching, redness over their hands after handling the cytotoxic drugs. To conclude the nursing personnel working in chemotherapy administration areas are at risk of exposure to hazardous drugs through spillages. It is thus recommended that they should be provided in-service education for proper handling of chemotherapy drugs and made aware of the exposure risk and provided with adequate personal protection 122

8 articles. A "Chemotherapy Spill Kit" which is a necessity in all chemotherapy administration areas to effectively manage the spillages without posing an exposure risk to the person should be made available in all the areas. References 1. World Health Organization. Cancer: WHO cancer control programmes. Available at: / accessed on march Thomas H. Preventing occupational exposures to antineoplastic drugs in health care settings.ca Cancer journal for clinicians 2006; 56: Valanis BG, Vollmer WM, Labuhn KT, Glass AG. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. Am J Hosp Pharm 1993; 50: Falck K, Gröhn P, Sorsa M, et al. Mutagenicity in urine of nurses handling cytostatic drugs. Lancet 1979; 1: Sorsa M, Anderson D. Monitoring of occupational exposure to cytostatic anticancer agents. Mutat Res 1996; 355: Sessink PJ, Bos RP. Drugs hazardous to healthcare workers. Evaluation of methods for monitoring occupational exposure to cytostatic drugs. Drug Safe 1999; 20: Baker ES, Connor TH. Monitoring occupational exposure to cancer chemotherapy drugs. Am J Health Syst Pharm 1996;53: Zhao SF, Zhang XC, Wang QF, Bao YS. The effects of occupational exposure of female nurses to antineoplasic drugs on pregnancy outcome and embryonic development. Teratology 1996; 53: Martin S. Chemotherapy handling and effects among nurses and their offspring. Paper presented at the oncology nursing society 30th annual congress; april 28- May, 2005; Orlando. 10. Skov T, Maarup B, Olsen J. et al. Leukaemia and reproductive outcome among nurses handling antineoplastic drugs. Br J Ind Med 1992; 49: Skov T, Lynge E, Maarup B. et al. Risk for physicians handling antineoplastic drugs. Lancet 1990; 336: National Institute for Occupational Safety and Health. NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Publication No Washington DC: US Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention; Polovich M, White JM, Kelleher LO. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA:Oncology Nursing Society; Available at: www. guideline. gov/ summar y/ summary.aspx?doc_id_8337. Accessed August 21, Chemotherapy and biotherapy guidelines and recommendations for practice.2nd Ed Oncology nursing society, American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. American Journal of Hospital Pharmacists 1990; 47: Pharmaceutical compounding sterile preparation. The United States Pharmacoepia, 27th rev, and the national formulary, 22nd edition. Rockvelle, MD: the United States pharmacoepial convention, 2004; International agency for research on cancer. IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans. Lyons, France: World health organization, International agency for research on cancer;