Operationalisation of “Chemotherapy Spill Kit” in chemotherapy administration areas

http://doi.org/10.33698/NRF0112   Kumari Sunita, Sukhpal Kaur, Firoza D.Patel

 

Abstract : Nurses are involved both in the preparation and administration of chemotherapy drugs. While preparing or administering cytotoxic drugs there are possibilities of spillage which pose exposure not only to the person handling the drugs but also to others in the unit. To prevent this exposure “Chemotherapy spill kit (CSK)” has been recommended by all the leading oncology nursing agencies. In the current study Operationalisation of “CSK” was done to assess its use among nurses employed in chemotherapy administration areas at a tertiary care hospital for one month. The study was conducted in four phases – preparation phase in which kit consisting of two parts – personal protection part and spill management part was prepared; information dissemination and demonstration phase; placement phase in which Kit was placed in all the research settings for use; and lastly observation phase in which the subjects were observed for the usage of “CSK”. A total of 22 subjects posted in the chemotherapy administration areas (Radiotherapy ward & Day care chemotherapy rooms) were observed for one month. The subjects were observed for usage of the kit everyday however analysis of the same was done at follow up 1 and 2 which was subject’s first and the last day of using the kit respectively. All the subjects used personal protection part of the kit and 17 subjects who experienced spills, used spill management part also. Total 43 small cytotoxic spillages were experienced. Various problems expressed with the personal protection part of “CSK” were, feeling suffocation with use of mask, feeling hot with disposable cap and all goggle users had problems of headache and blurred vision with goggles. Subjects who used spill management part expressed difficulty in using dissecting forceps and also verbalized that spill cleaning is time consuming. However as the usage of the “CSK” progressed among the subjects, the satisfaction to the usage of various parts of “CSK” increased significantly from follow up 1 to follow up 2 (p < .0001). Hence the usage of ‘CSK’ was recommended while chemotherapy administration

Key words :Chemotherapy, chemotherapy spill kit, nursing personnel.

Correspondence at : Kumari Sunita Saran Nagar, Ajmer Road, Jodhpur (Raj)

Introduction:For the past three decades, treatment for many cancers has relied principally on anticancer chemotherapy. With approximately 100 different antineoplastic drugs now in use1 and many more under development, drugs used to treat cancer have opened new avenues, from improving the quality of life of patients with cancer to a complete cure. As the development in the field of anticancer drugs continued, the related side effects are also evaluated 2, 3. 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 reports from several countries have documented, drug contamination of the work place, identified drugs in the urine of the workers and measured genetic responses in the workers.4 In a study done by Falck and colleagues, it was revealed that nurses, who prepared and administered antineoplastic drugs had higher indicators of mutagenic substances in their urine compared with non exposed workers5. Surveys have associated workplace exposure to antineoplastic drugs with acute health effects, primarily in nurses. These include hair loss, headaches, acute irritation and hypersensitivity as well as adverse reproductive outcomes6. A meta-analysis of 14 studies performed from 1966 to 2004 in the United States and Europe described an association between exposure to antineoplastic drugs and adverse reproductive effects in female health care workers.7 The most common reproductive effects found in these studies were increased fetal loss,8,9 congenital malformations,10 low bir th weight and infer tility.11 A significant association was identified between exposure and spontaneous abortions. A study from China reported a significant decrease in full-term births and significant increases in premature bir th, spontaneous abor tion, and congenital malformations in nursing personnel who were exposed to antineoplastic drugs.12 A study by Martin documented learning disabilities in the children of nurses who had handled antineoplastic drugs during the course of their employment.13 Exposure of health care providers to antineoplastic drugs is varied, and the routes of exposure are typically inhalation, dermal, or oral. Workers may be exposed by inhalation via droplets, particulates, and vapors when they create aerosols, generate dust by crushing tablets, and clean up cytotoxic spills14. A potential source of exposure is direct skin contact when a cytotoxic drug spill occurs and a large volume of drug is released into the environment15. As the nursing personnel are involved in administering antineoplastic, come in contact with work surfaces, floors, clean the drug spills, thus are at higher risks for exposure hazards to these drugs16-19.In view of such hazardous effects of cytotoxic drugs among nurses, need aroused to formulate policies and guidelines regarding, to identify substances which are a hazard to staff, as well as who may be exposed, how the drugs should be handled and what to do in the event of a spill or accident. They also ensure that staff has access to the ideal environment, protective clothing, policies and procedures, a system of monitoring and recording effects, and availability of a necessary equipment such as “CHEMOTHERAPY SPILL KIT” which contains every thing needed to clean up spilled cytotoxic drugs. Complying with National Institute for Occupational Safety and Health (NIOSH) and Oncology Nursing Society (ONS) standards20-22 it contains- open back gown, disposable mask, disposable cap, thick absorbent pads chemosorb pads, 2 pair thick latex gloves, dissecting forceps (for picking up glass pieces and aiding in the cleanup process) & scraper, large, absorbent, wiper towel, detergent solution (freshly prepared strong alkaline detergent ph >10), danger drug spill sign, container for Sharps Disposal, infectious Waste Tag, 8″ x 12″ Clear Poly Bag and ties, biohazard Waste Disposal Bag.In view of the literature supporting presence of “CHEMOTHRAPY SPILL KIT” in the chemotherapy handling and administration areas and the felt need of the nurses based on heavy workload of chemotherapy administration in the Radiotherapy ward, Radiotherapy Day Care and Medical Day Care Chemotherapy rooms in the hospital, need arose to operationalise the “CHEMOTHERAPY SPILL KIT” in the above said areas so that the nurses could effectively protect themselves against the exposure risk to the cytotoxic drugs.

Objective:To operationalise the use of “Chemo therapy Spill Kit” in Radiotherapy ward and Day Care Chemotherapy Rooms of PGIMER Chandigarh.

Methodology:The study was conducted at Postgra- duate Institute of Medical Education and Research (PGIMER), Chandigarh. It is a premier institution for medical and health related research of the country. The present study was done at three major chemotherapy administration areas, where nursing person- nel are administering chemotherapy i.e. Radio- therapy Ward, Radiotherapy Day Care Room and Medical Day Care Room. The Radiothe- rapy Ward is situated on the 2nd floor of the Nehru Hospital in cobalt block, caters to the admitted as well as very sick OPD patients referred by Radiotherapy Department for administration of chemotherapy and other OPD basis patients are administered chemoth- erapy in Radiotherapy Day Care Chemotherapy Room. The Medical Day Care Chemotherapy Room attends to all the surgical and medical oncology patients who are receiving chemo- therapy on OPD basis. The study was operational in design. Using purposive sam- pling 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 2008. Identification data sheet, Checklist for the preparation and maintenance of the “chemotherapy spill kit” by the nurses, Self report Performa for the nurses using “chemotherapy spill kit” and Observation checklist for the “chemotherapy spill kit” usage were the tools developed and employed in the present study. Identification data of the nurses comprised of identification code no, name of the chemotherapy unit, age, designation, sex, marital status, pregnancy status, academic and professional qualification, professional experience (total) and in the chemotherapy unit, details of any in service training on adm-inistration of chemotherapy. Checklist for the preparation and maintenance of the “chemo-therapy spill kit” contained the list of articles in the “personal protection part” and “spill management part” of the “chemotherapy spill kit”. It also indicated date of preparation of the kit and a system for the maintenance of the kit by the nurses using the kit and investi-gator, contained details of number of the arti-cles used and replaced per day in both the parts of the kit.Self report Performa for the nurses using “chemotherapy spill kit” contained details as length of use of the ‘chemotherapy spill kit” by the nurses, everyday experience of working with “chemotherapy spill kit”, details of the unsatisfaction with personal protection part/spill management part, details of experience of cytotoxic spills, their feelings of considering “chemotherapy spill kit” useful ness in self protection and need for use of the kit in regular practice and problems in the operationalisation of the “chemotherapy spill kit”. Observation checklist for the “chemo therapy spill kit usage” contained details of the activities to be observed by the investig- ator regarding the usage of “CSK”.The study was conducted in various phases- Preparation Phase in which the”CSK” was prepared using maximum of hospital resources and certain articles arra- nged by investigator. The prepared kit had two parts – ‘personal protection part’ containing articles as disposable gown, cap, mask, gog- gles which need to wear everyday by subjects before handling antineoplastic drugs and ‘spill management part’ containing articles for spill cleaning as disposable thick gown, gauge lined thick cotton pads, dissecting forceps, scraper, danger drug spill sign, detergent solution, clean water bottle, biohazard waste disposal bag etc. This part was to be used whenever a cytotoxic spillage occurred.After the preparation phase followed the Information Dissemination & Demonstration Phase in which the subjects were given general orientation about chemotherapy, related expo- sure risk and its hazards and need of a “CSK” and then demonstration of chemo-therapy spill kit, its contents and usage was given, followed by answering queries of the subjects. After this phase the “CSK” was placed in all three research settings (Placement Phase).The last was Observation Phase, initiated to assess the usage of “CSK” in all the three areas. A direct non participatory method of observation was employed. For observation each day was divided into three parts consis- ting of three hours (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, on all the days of the week. For analysis of the findings of the study, subjects were analyzed at follow up 1, their first day of using the kit and at follow up 2 which was their last day Table 1 : Usage of “CSK” (in days) N=22 Days ‘CSK’ used*      No. of subjects of using the kit. The subjects were assessed                                                                                 for the usage of the kit, various problems faced in using the kit  and their satisfaction towards the usage of kit from follow up 1 to follow 2.

Results:Demographic profile of 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 25-52 years). Majority (86.4%) were married, out of these 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 16-20 years of professional experience. A large proportion (68.2%) of the subjects had experience of two years and above, of working in chemotherapy unit.

Usage of “CSK” (in days) A total of 22 subjects used the kit. Nine subjects used it for three days each, six subjects for five days, one subject each for six, seven, nineteen, twenty and twenty one days. The remaining two subjects used it for twenty five days. The mean number of days “CSK” used was 8.4 days ± 2.31 (Table 1). The kit was used in range of 3-25 days.

03                            09

05                            06

06                            01

07                            01

19                            01

20                            01

21                            01

25                            02

* Mean (days CSK used) ± S.D= 8.4 (days) ± 2.31, range = 3-25 days

Area wise (monthly) consumption of “spill management” articles of “CSK”

Table 2 shows the monthly consumption of spill management articles in all the three research settings. The ar ticles consumed depend on the number of spills occurred in the area. Ar ticles as thick disposable gown, dissecting forceps were reusable articles. Five disposable cotton pads, detergent solution (10ml) per spill were used for cleaning. Thus in one month a total of 8 thick disposable gowns, 215 disposable cotton pads, detergent solution (430ml), six dissecting forceps, 43 scrapers and 43 biohazard waste disposal bag were used in all the three areas for cleaning total 43 spills. Maximum consumption of spill management articles was observed in Medical Day Care Centre where 29 spills occured. This was followed by Radiotherapy ward and Radiotherapy Day Centre respectively where 8 and 6 spills occured respectively.

Table 2 : Area wise (monthly) consumption of “Spill Management” articles of “CSK”.

 

Articles                            Arti cles used for spills per month Total 43  

spills
Radiotherapy ward

(8 spills)

 Radiotherapy Day Care (6 spills) Medical Day Care

(29 spills)
Disposable thick gown* 02 02 04 08
Disposable cotton pads(5/spill) 40 30 145 215
Detergent solution (10ml/spill) 80 ml 60 ml 290 ml 430 ml
Dissecting forceps* 02 02 02 06
Scraper 08 06 29 43
Biohazard waste disposal bag 08 06 29 43

 

*Reusable article

Problems expressed by the subject in using “Personal Protection Part (PPP)” and “Spill Management Part (SMP)” of the kit

Table 3 illustrates the various problems expressed by the subjects at the time of using “PPP” and “SMP” of the kit. Only 11 subjects used goggles as the remaining 11 had spectacles. All the goggle users had problems with 9 users complaining of headache and other 2 with blurred vision. For the usage of disposable mask 7 users had problems of suffocation and two subjects complained of feeling hot with disposable cap. A total of 17 subjects used spill management part of “CSK”. Spill cleaning was found time consuming by 4 subjects however 3 found use of dissecting forceps difficult and one user felt that doing disposal of clean up material is servant’s job.

Table 3: Problems expressed by subjects in using “PPP” and “SMP” of “CSK” N=22

Problems expressed                    n(%) With personal protection part

Goggles*

Headache                               09(81.8)

Blurred vision                           02(18.1) Disposable mask

Suffocation                               07(31.8) Disposable cap

Feeling hot                               02(9.0)

With spill management part**

Spill cleaning time consuming 04(23.5)

Using dissecting forceps

for cleaning difficult                     03(17.6)

      Disposal servant’s job               01 ( 5.8)

*11 subjects wore spectacles and 11 subjects’ used goggles and all the goggle users had problems.

**Total 17 subjects used SMP and 8 expressed problems with spill management part

Comparison of subjects as per satisfaction to the usage of various parts of “CSK” As depicted in table 4 at follow up 1, half of the subjects (50%) were satisfied using personal protection part; however at follow up 2, majority (81.8%) of the subjects became satisfied to its usage. For satisfaction to both parts of the kit no subject was satisfied to the usage of both parts of the kit at follow up 1 however a large proportion of the subjects (68.18%) became satisfied to the usage of both parts of the kit at follow up 2. On applying Mc Nemar’s test for assessing any significant difference in the satisfaction among subjects from follow up 1 to follow up 2, the P value<.0001 came out to be highly significant showing that as the duration of the use of kit progressed subjects satisfaction to the usage of parts of the kit also increased significantly.

Table 4 : Comparison of subjects as per satisfaction to usage of various parts of “CSK” N=22

Part of “CSK” used Satisfaction to usage of “CSK” at P value

(Mc Nemar’s test)
Follow up 1** Follow up 2***
Personal Protection Part 11(50.0) 18(81.8) <.0001
Both parts* 0 15(68.18)  

*Both parts refer to both personal protection as well as spill management part of “CSK” Follow up 1* *is subject’s first day of using “CSK”

Follow up 2 ***is subject’s last Day of using “CSK”

Discussion:Chemotherapy agents are considered life-saving chemicals because of their ability to eradicate malignant diseases as well as increase disease-free survival for patients with cancer1. But studies have found that through occupational exposure to antineoplastic drugs, health care providers are at risk for harmful effects.2 The Occupational Safety and Health Administration classifies chemotherapy a hazardous drug. Characteristics of hazardous drugs include carcinogenicity,teratogenicity, reproductive toxicity, and organ toxicity.3 Healthcare providers including nurses are at risk for exposure while preparing and administering chemotherapy, cleaning up spills, and handling excreta of patients 48 hours after they receive chemotherapy.3,4 There has been a significant risk associated with the exposure of anti neoplastic drugs during pregnancy. Higher rates of infertility, spontaneous abortions, still births, premature labor and congenital anomalies have been documented. Statistically significant difference in low bir th weight infants and learning disabilities in children born to exposed mothers has been observed11-13. However in the present study two of the subjects were in their third trimester of pregnancy and had been working in the Radiotherapy Ward for more than 12 months. They were handling antineoplastic drugs with wearing gloves and mask only as protective measure.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.22 However in the present study majority of the nurses employed in these areas were in child bearing age group i.e. 25-49 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 1 human carcinogens. Given enough time and exposure to health care workers can cause cancer23. However in the present study these drugs are commonly administered in all the three research settings and more than half (68.2%) of the subjects were working in these areas for more than 2 year. In a study quoted by chemotherapy site specific group, antineoplastic drugs spillages occured during handling and administration of these drugs. The spillages were observed 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 patients24. In the present study also the study subjects experienced a total of 43 small spills with a mean of 2.5 spills. Majority (77.3%) of the subjects experienced spills. More than half of (52.9%) experienced spillage at the surface of preparation of cytotoxic drug (table) and remaining (47%) over both surface of preparation and the gloves worn by the subject.During Operationalisation of the “chemo- therapy spill kit” the problems expressed with the use of personal protection part were feeling suffocation with the use of mask for 7 subjects, feeling hot with disposable cap on for 2 subjects and out of 11 goggle users all had problems with 9 subjects complaining of headache and 2 subjects expressed blurred vision with goggles. All 22 subjects were comfortable with the use of thick latex gloves and disposable gown. For the problems with spill management part of “CSK” 4 subjects found using dissecting forceps difficult for cleaning spill and one subject considered disposal of the clean up material as servant’s job.In a retrospective study of the medical records of the patients in Bhaktapur cancer hospital regarding management of and handling of cytotoxic drugs it was found that limited financial resources, inadequate knowledge and lack of training of personnel handling drugs were the contributing factors for inappropriate handling of cytotoxic drugs25. In the present study also the similar findings were revealed before operationalising “CSK”, however after Operationalisation of the kit and providing the subjects with personal protection and spill management articles a high usage of the kit by the subjects was noticed in all the three areas. Using Mc Nemar’s test a significant increase in the satisfaction level as per the usage of various parts of the kit was found among the subjects from follow up 1 to follow up 2 (P<.0001).It is thus concluded that Operational- isation of the “Chemotherapy Spill Kit” ” among nurses working in chemotherapy administration areas of a tertiary hospital was successful. Hence provision of ‘CMK’ was recommended in the areas where Chemotherapy is administred and necess- itating nursing administrators to provide articles to maintain the kit in regular practice.

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