Download synopsis for registration of subject for dissertation

SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION
SUBMITTED TO:
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
IN PARTIAL FULFILLMENT
OF
M.Sc (N) IN MEDICAL SURGICAL NURSING
SUBMITTED BY:
SAJANA SAKHA
MSc (N) 1st YEAR
UNDER THE GUIDANCE OF:
Mrs P. PADMAPRIYA
ASSISTANT PROFESSOR
HEAD OF DEPARTMENT
MEDICAL SURGICAL NURSING DEPARTMENT
NARAYANA HRUDAYALAYA COLLEGE OF NURSING
NO: 258/A, BOMMASANDRA INDUSTRIAL AREA
ANEKAL TALUK, BANGALORE-99
1
NAME OF THE CANDIDATE AND Ms. SAJANA SAKHA
ADDRESS
FIRST YEAR MSc (N)
NARAYANA HRUDAYALAYA COLLEGE
OF NURSING, NO: 258/A
BOMMASANDRA,
ANEKAL
TALUK,
BANGALORE-99
NARAYANA HRUDAYALAYA COLLEGE
2
NAME OF THE INSTITUTION
OF NURSING
COURSE OF STUDY AND SUBJECT
I YEAR MSC NURSING
3
MEDICAL SURGICAL NURSING
4/6/2012
4
DATE OF ADMISSION TO COURSE
5
A PRE EXPERIMENTAL STUDY TO
TITLE OF THE TOPIC
ASSESS
THE
EFFECTIVENESS
OF
PLANNED TEACHING PROGRAM ON
KNOWLEDGE AND SKILL REGARDING
SAFE HANDLING OF
CHEMOTHERAPEUTIC DRUGS AMONG
STAFF NURSES
PROBLEM STATEMENT
A PRE EXPERIMENTAL STUDY TO ASSESS THE EFFECTIVENESS OF PLANNED
TEACHING PROGRAM ON KNOWLEDGE AND SKILL REGARDING SAFE HANDLING
OF CHEMOTHERAPEUTIC DRUGS AMONG STAFF NURSES IN SELECTED HOSPITAL,
BANGALORE
ANNEXURE-I
6. BRIEF RESUME OF THE INTENDED WORK
INTRODUCTION
Cancer is the group of more than 200 diseases characterized by uncontrolled and
unregulated growth of cells. It is the major health problem that occurs in people of all ethnicities.
Although, cancer is often considered a disease of aging, with the majority of cases diagnosed
(76%) in those over the age of 55 years, it occurs in people of all ages. Globally cancers accounts
for 5.1% of total disease burden and 12.5% of all deaths.1
Many management options for cancer exist including: chemotherapy, radiation therapy,
surgery, immunotherapy, monoclonal antibody therapy and other methods which are used
depending upon the location and grade of the tumour and the stage of the disease, as well as the
general state of a person's health.2
Chemotherapy is a kind of treatment that uses drugs to attack cancer cells. It is called a
"systemic treatment" since the drug, entering through the blood stream, travels throughout the
body and kills cancer cells at their sites. The drugs may rarely be intended to have a local effect,
but in most cases, the intention is to destroy cancer cells wherever they may exist in the body.
Since chemotherapy also affects normal actively dividing cells such as those in the bone marrow,
the gastrointestinal tract, the reproductive system and in the hair follicles, most patients
experience some degree of side effects like nausea, vomiting, hair loss, mouth sores, ulcers.3
Chemotherapy is now a mainstay of cancer therapy used in the treatment of most of solid
tumours and hematologic malignancies like leukaemia’s, lymphomas, myeloma and
myelodysplastic syndromes.1
One of the primary responsibilities of the nurse in the delivery of chemotherapy is to
ensure that the correct dose of the appropriate drug is given to the appropriate individual. Despite
the fact that safeguards are in place, serious medication errors do occur. Such tragic events are
regrettable but not so remarkable when one considers the number of chemotherapy doses given
and the number of patients treated. The overall medication error rate is estimated to be 2-10%.
However, one recent survey revealed that 63% of the respondents reported that errors had
occurred at their workplace. In addition only 3% of the errors were reported to drug
manufacturers or national databases though most were reported internally. 4
Safe handling of chemotherapeutic agents during administration and disposal is critical.
Most antineoplastic agents are toxic compounds that are carcinogenic, mutagenic, or teratogenic.
Direct contact may cause irritation of the skin, eyes, and mucous membranes. Perioperative
personnel should know how to handle hazardous materials safely to protect the patient, other
staff members, and themselves. These safety precautions include appropriately identifying the
patient; correctly preparing, verifying, and documenting the chemotherapeutic agents being
administered;
consistently
wearing
personal
protective
equipment;
transporting
the
chemotherapeutic agent in a puncture-resistant container labelled “chemotherapy”; properly
disposing of the chemotherapeutic agent and supplies; and handling a spill if one occurs.5
Educational programmes about cancer and safe handling of cancer chemotherapeutic
drugs provide the nurses to safeguard themselves as well as patients. Dissemination and current
information permits the nurses in general practice and other specialities to learn about recent
advances in cancer research and ongoing clinical trials. It also includes providing education or
information about staging, current treatment regimen, clinical indication for use, guidelines of
administration, and manifestation of toxicity, appropriate intervention. In addition , the health
care professional much be familiar with the medication, mode of action, side effects an
appropriate administration and disposal procedure.2
6.1: NEED FOR STUDY
Cancer is an abnormal cell growth and chemotherapy is a drug regimen designed to stop
that growth. Chemotherapy can also harm healthy cells, according to the National Institutes of
Health (NIH), and cause side effects in cancer patients. Healthy cells often recover and side
effects gradually disappear in many cases. Chemotherapy is administered intravenously, orally or
intrathecally. Without taking proper precautions, nurses and other health industry workers can be
exposed to the drugs.6
According to Global Cancer factsheet, an estimated 12.7 million new cancer cases
occurred and 7.6 million deaths (around 13% of all deaths) in 2008. Lung, female breast,
colorectal and stomach cancers accounted for 40% of all cases diagnosed worldwide. In men,
lung cancer was the most common cancer (16.5% of all new cases in men). Breast cancer was by
far the most common cancer diagnosed in women (23% of all new cases in women).7
According to Department of Biostatistics and Epidemiology: Kidwai Institute of
Oncology, among males cancer of the stomach is the most predominant site of cancer
constituting 9% of the total cancers among males followed by cancers of the lung (7.0%),
oesophagus (6.6%), prostate (5.3%) and Non Hodgkin’s Lymphoma (4.6%). Among females,
cancer of the breast is the predominant site of cancer and has accounted for 24.6% of the total
cancers in females followed by cancer of the cervix (15.9%), ovary (4.9%), oesophagus
(4.7%) and mouth cancers (4.6%). Altogether, the first ten leading sites of cancers among males
and females accounted for 53.1% of the total cancers in males and about 70.9% of the total
cancers in females.8
A number of studies documented adverse health effects that are connected with
occupational exposure to antineoplastic chemotherapeutic agents. The most frequent acute
toxicities noted include nausea, vomiting, headaches, dizziness, hair loss, and liver damage.
These acute symptoms were positively correlated with the number of doses handled and the use
of protective equipment. Additionally, body mass was significantly associated with the
development of acute symptoms. Hepatocellular damage was noted in nurses employed on an
oncology unit. This symptom was associated with the employee’s duration of work exposure and
the volume of handling.9
The main role of nurses in the field of oncology is chemotherapy administration which is
sensitive domain in oncology nursing where little negligence or mistake may lead to adverse
consequences for patients, staff and environment. Literature reveals that, medication errors in
chemotherapy are a common (44%) incidence due to lack of specific knowledge and training of
the staff in chemotherapy, prescription, preparation and administration. This lacking of
knowledge and training of the staff leads to fatal incidences such as over dose of chemotherapy,
wrong calculations of drugs, wrong route of transfusion which sometimes result in patient’s
death. 10
A study on chemotherapy standard order form: preventing errors was carried out to
describe the development and implementation of one approach to standardize and document
chemotherapy orders for patients in the acute-care settings. To avoid errors in ordering,
dispensing, and administering chemotherapy that may have the potential for serious adverse
patient outcomes, a standardized order sheet was developed to consistently document
information regarding chemotherapy ordering and administration throughout the hospital. Each
component of the form is essential in promoting safety and efficiency in the chemotherapy
ordering and administration process. A standardized approach dramatically improved ordering,
dispensing, and administering chemotherapy. Multidisciplinary verification and documentation
of dose and schedule helps reduce chemotherapy-related errors.11
While handling chemotherapy drugs and other potent or hazardous drugs for their
patients, nurses must be extremely careful not to ingest them in any quantity. The National
Institute for Occupational Safety and Health (NIOSH) has released an alert outlining the risks of
handling chemotherapy drugs for nurses and millions of other health workers. People who handle
chemotherapy drugs at any point from manufacture to patient dosing and administration are at
risk. In a public alert, NIOSH estimates more than five million workers could be exposed
through various activities. Nurses and other workers are exposed through prolonged contact with
vial exteriors, counting out doses, crushing tablets, priming intravenous sets and handling
contaminated clothing or waste, among other practices. Handling chemotherapy drugs can lead
to relatively mild symptoms, like skin rashes. In other cases, adverse reproductive events and
cancer have been linked to exposure.5
The intravenous applications that have been used widely can lead to some complications
such as extravasation, ecchymosis, hematoma and phlebitis. The extravasation is one of these
complications. Extravasation leads to some undesirable happenings such as prolonged times of
hospitalization of the patients, unnecessary diagnostic procedures and even unnecessary
treatments, stress effects on the relatives of patients, extra workload for health staff and the
economic loss as well as to threatening the lives of patients. It is important for the health
professionals, who are responsible for managing of intravenous applications, to know the drugs
that cause tissue injury and take the necessary measures to prevent extravasation. Therefore, this
article defines the pathogenesis of extravasation, types, symptoms, and evidence-based
management.12
A cross sectional survey on occupational exposure to antineoplastic agents: self reported
miscarriages and still births among nurses and pharmacists investigates without antineoplastic
exposure and exposed pregnancies drugs by comparing rates of spontaneous abortion and still
births for pregnancies without antineoplastic exposure and exposed pregnancies in which the
pregnant woman or the father handled antineoplastic agents either before or during the
pregnancy. A total of 7094 pharmacy and nursing staffs were examined. 83% of pregnancies had
resulted in live birth. An additional 11 % had resulted in miscarriages and 1% had still birth.
About 21% of pregnancies the mother reported smoking during the pregnancy. Summary of the
antineoplastic handling activities reported to have occurred during and in the two years prior to
each of the pregnancies. After age during pregnancy, prior gravidity, maternal smoking during
pregnancy were controlled for exposure of the mother to or the handling of antineoplastic agents
during the pregnancy was associated with significantly increased risk of spontaneous abortion
and combined risk of spontaneous abortion and still birth . 13
A survey on Assessment of DNA damage in Japanese nurses handling antineoplastic
drugs by the COMET Assay, presents basal characteristics of the 121 nurses and 46 control
subjects. The log transformed tail length in the 121 nurses was significantly longer than that in
the 46 control subjects after adjusting for possible covariate. Likewise, the log transformed tail
length was significantly longer in the 57 nurses who had handled antineoplastic drugs for at least
6 months than in the 46 control subjects . On the other hand, the log transformed tail length and
tail moment in the 64 nurses not handling those drugs were 0.75 + 0.10 and 0.28 + 0.23
respectively and no significant differences in the COMET assay parameters were seen between
two nurse subgroups. Also, the differences in them between the nurse subgroup not handling
antineoplastic drugs and the control group did not reach the significance level of p < 0.05.
Therefore, the findings suggest that occupational exposures to such drugs may induce subtle
DNA changes in Japanese nurses. 14
A study on Turkish nurses’ information about, and administration of, chemotherapeutic
drugs shows that the average score for information levels pertaining to nurses’ protection of the
environment was 7·82 ± 0·38 of a total of 14 points, and that of self-protection was 7·94 ± 0·24
of a total of 11 points. Nurses showed that their actual administration method was insufficient
according to their level of information, with average administration evaluations of 5·46 for
protection of the environment and 6·59 for self-protection. The ratio for nurses’ usage of the
safety cabinet during the preparation of chemotherapeutic drugs was very low at 14·2%. Only
7·4% of nurses had received in-service education about chemotherapeutic. Thus, it has been
recognized that nurses’ information and administrations during preparation and administration of
chemotherapeutic drugs are of utmost vital importance in removing the harmful effects of
chemotherapeutic agents.15
A multimethod study on exploring the work of nurses who administers chemotherapy
concluded that nurses who are new to the oncology/chemotherapy area must be given the
appropriate education and supervised practice before administering chemotherapy. Although the
nurses are aware that chemotherapy practice is constantly evolving and they feel that they need
educational support to maintain their knowledge and skills. 16
Therefore the investigator is interested in studying the effectiveness of planned teaching
program on knowledge and skill of staff nurses in handling chemotherapeutic drugs
6.2: REVIEW OF LITERATURE
Review of literature is defined as board comprehensive in depth systematic and critical
review of scholarly publications in particular topic . The purpose of review of related
literature was to gain an insight in to various aspects of the problem under study such as
design, methods, instruments, measures and techniques of data collection that may prove
useful in the proposed project.
The literature review is divided into four sections
 Section A – literature review on handling of chemotherapeutic drugs and its side effects
 Section B- literature review on knowledge on safe handling of chemotherapeutic drugs
among staff nurses
 Section C- literature review on skill on safe handling of chemotherapeutic drugs among
staff nurses

Section D- literature review on effectiveness of planned teaching program on safe
handling of chemotherapeutic drugs.
SECTION A: LITERATURE REVIEW ON HANDLING OF
CHEMOTHERAPEUTIC DRUGS AND ITS EFFECTS
A descriptive study on Prevention and Management of Extravasation of Cytotoxic Drugs
revealed that extravasation of certain cytotoxic agents during peripheral intravenous
administration may cause severe local injuries. Most extravasation can be prevented with the
systematic implementation of careful administration techniques. However, the management of
this complication, the aim of which is to prevent progression to tissue necrosis and ulceration,
remains an important challenge in the care of cancer patients. Empirical guidelines recommend
the use of topical Dimethylsulfoxide and cooling after extravasation of Anthracyclines or
Mitomycin, locally injected Hyaluronidase after extravasation of Vinca alkaloids, and locally
injected sodium thiosulfate (sodium hyposulfite) after extravasation of Chlormethine
(mechlorethamine; mustine). Plastic surgery may be necessary when conservative treatment fails
to prevent ulceration. The possibility of late local reactions must also be considered in the
management of patients receiving chemotherapy.17
A case report on Extravasation: a dreaded complication of chemotherapy shows that
extravasation is a severe complication of chemotherapy. It is defined either as the escape of a
chemotherapeutic agent from a vessel into the surrounding tissues by leakage or as an
involuntary injection of a drug into the tissues. The frequency of extravasation in adults is
considered to be between 0.1% and 6%.The severity of tissue injury is dependent on the type and
concentration of the chemotherapeutic agent and the quantity injected. Prevention of
extravasation can be done by adequate guidelines of chemotherapy administration and training of
nurses is of the utmost importance. 18
The cross sectional survey on Patients' perspectives and safe handling of oral anticancer
drugs at an Asian cancer centre was conducted, the interviewer-administered survey was
undertaken at the outpatient pharmacy. Eligible patients had received at least one cycle of oral
anticancer agent treatment or had been taking oral anticancer agents continuously for 3 months.
The majority of the patients (94.2%) reported no difficulties in adherence to their oral anticancer
treatment regimens. Forty per cent of patients reported habitually washing their hands after
administering their anticancer drugs. None of the patients, except two patients receiving
Capecitabine, indicated that they habitually used gloves to handle their oral anticancer
medications. However, this survey demonstrated the need to improve patients' understanding of
the requirements for storage, handling and safe administration of oral anticancer drugs. As the
nurses are responsible for providing education , the nurses should be educated first in order to
improve patients’ safe handling of drugs.19
An analytical cross sectional study on Health Hazards among Oncology Nurses Exposed
to Chemotherapy Drugs consists of a study group and a control group of nurses. The study group
included 35 oncology nurses who were involved in direct patient care and were exposed to
chemotherapeutic drugs during their preparation and administration. The control group consists
of 29 nurses who were involved in direct patient care without being exposed to chemotherapeutic
drugs. It was found that health hazards among the study group and controls were: abortions
(31.4% vs 10.3%), infertility & sub-fertility (14.3% vs 3.4% ), premature labour (14.3% vs
17.2%), soft tissue injuries due to spills & splashes (14.3% vs 0.0%), and developmental and
behavioural abnormalities among the children of the nurses (8.6% vs 3.4%). Urine samples from
study nurses were more mutagenic than controls (40% vs 10.3%). Risky behaviour among study
nurses included: eating food in drug handling areas (45.7%), use of improper place for preparing
and handling cytotoxic drugs, expelling air from syringes filled with drugs, needle stick injuries,
unsafe handling of contaminated material and unsafe cleaning of spills. Only 22.9% of the study
nurses attended a training program about occupational health and safety and 8.6% of them
mentioned that there are nursing care guidelines for procedures for dealing with patients
receiving cytotoxic drugs as well as presence of in-service training programs. There was poor
use of protective equipment in the study group.20
A study on Chromosomal aberrations in peripheral lymphocytes of nurses and physicians
handling antineoplastic drugs shows that the frequencies of structural chromosome aberrations of
persons occupationally exposed to antineoplastic drugs without adequate protection were
measured in peripheral blood lymphocytes of 106 persons from five oncological units and in an
adequate control population. The observed chromosomal aberration frequencies were 3.3 ± 0.1
aberrations per 100 cells in the exposed group and 0.6 ± 0.1 aberrations per 100 cells in the
controls. Chromosomal aberration frequencies were not correlated with age, duration of exposure
and smoking habits. The results stress the necessity to protect hospital staff against the potential
risk related to the handling of antineoplastic drugs. 21
A study on Leukemia and reproductive outcome among nurses handling antineoplastic
drugs consists the study group, female nurses who potentially had been exposed to antineoplastic
drugs through their work and internal control group of about double the number of potentially
exposed nurses were nurses employed in the same period in other departments in the same
hospitals. It shows that the crude odd ratio miscarriages among those handling antineoplastic
drugs during pregnancy compared with the control group was 0.76 (95% Confidence interval
0.38-1.43). The analysis by exposure level showed a significantly increased risk among those in
the low exposure category. The crude odd ratio for malformations among those handling
antineoplastic drugs during pregnancy compared with the control group was 1.02 (95%
Confidence Interval 0.47-2.06). Inclusion of all nurses employed in oncology departments,
whether exposed or not, changed the Odd Ratio to 1.00 (95% Confidence Interval 0.52-1.85).
Standardization according to the age of the mother changed the risk estimate from 1.02 to 0.99
only. There were no clusters of specific malformations. The mean birth weight among children
live born to mothers handling Antineoplastic drugs during pregnancy was 3397 g compared with
3455 g in the control group. The Odd Ratio for low birth weight according to this definition
among those exposed to Antineoplastic Drugs was 1.06 (95% Confidence Interval 0. 42-2 .67).
The number of observed cancer cases (14) was close to the expected (11.69) corresponding to an
Risk Ratio of 1.20. The only significantly increased site was lymphatic and haematopoietic tissue
where the increased risk was due to two cases of leukaemia, giving an Risk Ratio for leukaemia
of 10.65 (95% C confidence Interval 1.29-38.5).22
A one year prospective study on Cancer chemotherapeutic error in hospitalized patients:
Attributable damages and extra costs was conducted in hospital detecting medication errors at
every step of the anticancer chemotherapy use process. A costs analysis was performed by
simulation of potential hospital stays and valued at the complete hospital cost of the
corresponding diagnosis related groups. Prescription errors represented 91% of errors followed
by pharmaceutical errors (8%) and administration errors (1%). A statistically significant
relationship was found between the rate of medication errors and month of the year (p = 0.001).
May and January were the months most at risk of errors, while October and November were the
least. In total, 13.4% of avoided errors would have caused a temporary injury, 2.6% a permanent
damage and 2.6% would have compromised the vital prognosis of the patient (including 4 to 8
potential deaths). If not avoided, 216 additional hospital days would have been necessary.
Thirteen medication errors reached the patient without damages except two patients, needing
reinforced monitoring. This study demonstrates that major medication errors take place in
hospital but that a dedicated control quality system allowed capturing most of them before they
reach the patient. Potential consequences for patients and cost of medication errors justify the
development of preventive actions. Thus, one of the preventive aspects is preventing
administration errors which can be done by educating the nurses through various educational
programs.23
A study on Preventing Vincristine Sulfate Medication Errors showed that describe three
types of medication errors associated with its use, and suggest strategies for vincristine sulfate
medication error prevention. Medication errors involving vincristine sulfate include over dosage
(wrong dose), name confusion (wrong drug), and incorrect administration (wrong
route).Vincristine medication errors are preventable errors that usually result in serious patient
harm and often are lethal. Nurses need to be aware of the types of medication errors that can
occur with chemotherapy agents and be familiar with clinical signs and symptoms associated
with these errors. Education should be provided to nurses for proper handling of drugs so that
they can promote patient safety by implementing specific strategies to prevent vincristine
medication errors.24
The above studies show that improper handling of chemotherapeutic drugs causes
harmful effects to both patients and the nurses who handle them. Extravasation, necrosis ,
ulceration are the challenges infront of health personnel to be prevented in order to reduce the
complications and extra burden to economy. The nurses are at risk for side effects such as
infertility, preterm labour, leukemia as well as chromosomal changes. Health care professionals
including nurses should be aware of medicine errors and specific strategies to be developed to
prevent it.
SECTION B: LITERATURE REVIEW RELATED TO KNOWLEGDE ON
SAFE HANDLING OF CHEMOTHERAPEUTIC DRUGS AMONG STAFF
NURSES
A study on Knowledge, Attitude and Safe Behaviour of Nurses Handling Cytotoxic
Anticancer Drugs suggests that the level of knowledge of the nurses concerning antineoplastics
was not satisfactory. Findings for nurses’ safety behaviour and usage of recommended health
safety measures showed that, notwithstanding the rules and regulations pertaining to
chemotherapeutic drugs, nurses did not comply with them fully. In service training is a very
effective tool to increase the level of knowledge. This study also revealed
the necessity for
improvement of the working environment and the availability of appropriate protective
equipment.25
A survey on knowledge assessment and information needs of oncology nurses regarding
in patient medication was conducted to determine how nurses master medications prescribed to
their patients and problems nurses may have with prescribed drugs and identify possible support
tools. About ninety four percentages of dosage were familiar to participants. The problems
nurses having related to medications were, in order of frequency, difficulties with notions of
therapeutic equivalents and generic drugs (89%), storage condition (81%) and dilution,
reconstruction and administration methods (79%). However, side effects, contraindications, and
drug-drug interactions were not adequately identified. Nurses reported facing problems mainly
related to drug administration, drug storage, and generic drugs and their therapeutic equivalence.
Nurses need to be made aware regarding handling of drugs by providing education and multiple
tools are in development to help nurses in these areas. 26
A study on The influence of nurses knowledge, attitudes and health beliefs on their safe
behaviour with cytotoxic drugs was conducted. Sixty‐one nurses participated in the study, 31
hospital‐based nurses daily exposed to cytotoxic drugs for the last 5 years. A gap was found between the
nurses' knowledge and their actual behaviour concerning the potential risks of cytotoxic drugs and their
use of protective measures (p< .005). Significant correlations were found among the components of the
extensive Health Belief Model (perceived susceptibility, barriers, benefits and self‐efficacy). The study's
findings support the need to promote primary prevention by providing a safe environment for the
employee by means of education, training with regard to safety measures, clear policy, written guidelines
and their enforcement. 27
A single group pre-test post- test study on Assessment of knowledge, skill and attitude of
oncology nurses in chemotherapy administration in tertiary hospital shows that The information
regarding participants’ working experience shows that the majority 18 (51%) had more than 10
years of working experience as a general nurse, while 16 (46%) had less than 5 years of work
experience as a chemo nurse, indicating that the majority of the study participants 19 (54%) had
less work experience as chemo nurse. Results of the study showed that all participants were
female, majority (80%) were undergraduates and have less working experience as chemo nurse,
and only one third (30%) were oncology trained, the mean scores of knowledge were calculated
by Cochran’s Q test. The knowledge scores have significantly increased with ‘educational
training’ (p value < 0.001) and the results of the study illustrate value of the participants attitude
was 58.2, which was higher than the other two components (knowledge and skills). The
difference in the attitude of the nurses was not found to be statistically significant in repeated
measure of ANOVA. 10
The above studies revealed that knowledge of nurse regarding handling of
chemotherapeutic drugs is less and knowledge is to be improved by conducting inservice
education, other educational programmes written guidelines and making clear policies.
SECTION C: LITERATURE REVIEW RELATED TO SKILL ON SAFE
HANDLING OF CHEMOTHERAPEUTIC DRUGS AMONG STAFF
NURSES
A cross sectional study on The handling of anticancer drugs
shows that only seven
(58%) of the 12 hospitals investigated, had a written policy for handling such hazardous
chemicals. Staff nurses were involved in preparation of cytotoxic drugs in three (25%) hospitals,
while domestic staff were involved in cleaning up spillage in five (42%) hospitals.
Administration of these drugs was mainly carried out by nursing (42%) or both staff. The site of
preparation was considered unsuitable in five hospitals (42%), due to either lack of essential
equipment such as vertical laminar flow cabinet (33%) or use of the site for preparing other
drugs gloves were used during preparation in all of these hospitals, while eye spectacles and
surgical face masks were used in six (50%) hospitals, and gowns or aprons were used in 9 (75%).
Special trays or absorbent sheets for preparation were used in 75%, while a special pad to break
open ampoules was used in 50% of investigated hospitals. A vertical laminar flow cabinet was
used in 67%, and Luer lock syringe fittings in 75%. Only in one hospital was air expelled from
syringes into a special pad. The study revealed serious inadequacies in equipment and expertise
in handling cytotoxic agents in some of the investigated hospitals. These range from absence of
written policies to lack of essential facilities and proper training and practice. Although some
effort has been made to promote the standard of safety handling of cytotoxic drugs.28
A descriptive study on Cytotoxic drug spillages among nursing personnel working in the
chemotherapy administration areas was conducted 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. 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. The mean (no. of spillages) ±
S.D = 2.53 ± 1.74. The comparison of difference in terms of spills occurrence in three research
settings using Kruskal Walli's test. A significant difference was observed in occurrence of spills
among three research settings with Kruskal Walli's P value of 0.008.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 significantly higher spills than the
subjects working in Radiotherapy Ward and Radiotherapy Day Care with P value of 0.006 and
0.051. 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. 29
The above studies show that the skill of nurses handling cytotoxic drugs is inadequate
spills in the administration site should b properly handled by proper guidelines and making
available chemotherapy spill kit.
AUTHOR(S
SECTION D: LITERATURE REVIEW RELATED TO EFFECTIVENESS
OF PLANNED TEACHING PROGRAMME ON SAFE HANDLING OF
CHEMOTHERAPEUTIC DRUGS
A cross sectional study on Educational preparation for chemotherapy administration
shows that the total of 128 (28%) nurses responded, with over 60% of these respondents being
from regional and remote areas of Queensland. Ninety four percentage of nurses involved in
administration of chemotherapy had received some education for this role. 57% of metropolitan
and 44% of regional/remote respondents agreed that there were barriers to standardizing
education regarding chemotherapy administration. These findings suggest there is considerable
variation in the level and type of educational preparation for nurses working in chemotherapy
setting. Moreover, nurses identified many barriers to acquiring chemotherapy education, with the
majority of respondents supporting the need for standardizing education programmers related to
chemotherapy administration and safe handling across the state.30
A study on The Effect of the Interventions on Basic Knowledge of and Skills of Health
Care Workers in the Preparation of Cytotoxic Drugs aimed to evaluate the effects of the
interventions including; a lecture on cytotoxic preparation and practice simulation on the basic
knowledge of and skills in the preparation of cytotoxic drugs before, immediately after, and one
month after the interventions. The results showed there was no significant differences between
basic knowledge scores in pre- compared to immediate post-tests, and in immediate compared to
1 month post-tests (p = 0.070 and 0.336 respectively). The overall results of the skills assessment
in cytotoxic drugs preparation demonstrated significant differences in scores including basic
knowledge, cytotoxic drugs preparation skills between the pre- and immediate post-tests, and
between the scores in the immediate posttest and 1month post-tests (p = 0.026 and 0.045
respectively). The immediate posttest scores were significantly higher in all aspects preparation
skills compared to those of pre-test (p = 0.001, 0.021, and 0.017 respectively). After providing
lecture, the participants’ skills in cytotoxic drug preparation is improved .31
A pre experimental study on effectiveness of planned teaching program on safe handling
of cancer chemotherapeutic drugs in staff nurses in selected setting showed that the mean post
test knowledge scores obtained by subjects (X1 =21.51). Also the mean scores were higher in all
areas of post test. Paired‘t’ test was done and was found highly significant. The significant
difference between the mean pretest and post test knowledge scores (t99 =54.048 p< 0.001).
There was no significant association between the pretest knowledge and selected variables like
total years of experience (X2 =0.1481 p<0.05) and qualification (x2 =0.2676 p< 0.05).After the
introduction of planned teaching programme there is significant increase in knowledge of staff
nurses on safe handling of cancer chemotherapeutic drugs. Increase in knowledge will bring
about changes in practice and this will in turn prevent them from hazards of unsafe handling of
chemotherapeutic drugs.2
The above studies revealed that there is need of standardizing education programs as
educational interventions increases the skills and helps to reduce the hazards for both patients
and nurses.
6.3: OBJECTIVES OF THE STUDY
1. To assess the knowledge of staff nurses regarding safe handling of chemotherapeutic
drugs
2. To assess the skills of staff nurses regarding safe handling of the chemotherapeutic drugs
3. To determine the effectiveness of planned teaching program on knowledge regarding safe
handling of the chemotherapeutic drugs
4. To determine the effectiveness of planned teaching program on skill regarding safe
handling of chemotherapeutic drugs
5. To find the association between pretest knowledge and skill regarding safe handling of
chemotherapeutic drugs and selected variables.
6. To find the correlation between pretest
knowledge and skills of safe handling of
chemotherapeutic drugs.
6.4: ASSUMPTION
1. The staff nurses have some knowledge regarding the handling of chemotherapeutic drugs
2. The staff nurses have some skills regarding the handling of chemotherapeutic drug
6.5: HYPOTHESES
1. H1- The mean posttest knowledge score of staff nurses will be significant
will be significantly higher than their mean pretest knowledge at 0.05
level of significance
2. H2- The mean posttest skill score of staff nurses will be significantly higher
than their mean pretest skill score at 0.05 level of significance.
3. H3- There will be a significant association between pretest knowledge and
selected baseline variables at 0.05 level of significance.
4. H4- There will be significant association between pretest skill and selected
baseline variables at 0.05 level of significance
5. H5- There will be significant relationship between knowledge and skill at 0.05 level of
significance.
6.6: OPERATIONAL DEFINITIONS
Effectiveness: In this study, it refers to the change in knowledge score and skill score
after the planned teaching program as measured by questionnaire
and checklist.
Assess:
To measure or check the level of knowledge and skills as measured by
questionnaire and checklist.
Knowledge:
It refers to the understanding of staff nurses regarding safe handling of
chemotherapeutic drugs like introduction about chemotherapy, its side
effects for handlers and patients, preparation, administration, spillage,
transportation, safe disposal, patient care, patient education as measured
by a structured questionnaire.
Skills:
It refers to the ability of staff nurses to handle the chemotherapeutic drugs
safely during preparation, administration, spillage ,safe disposal as
measured by check list.
6.7: DELIMITATION.

Generalization of findings was delimited to the population studied

Period of data collection is only 6 weeks
ANNEXTURE II
7. MATERIALS AND METHODS
7.1 SOURCE OF DATA

The staff nurses who are working in oncology ward in selected hospital ,
Bangalore
7.2 RESEARCH METHODOLOGY
7.2.1 RESEARCH APPROACH- quantitative research approach
7.2.2 RESEARCH DESIGNpre experimental ; one group pretest post test design
7.2.3 SAMPLE - 35
7.2.4 SAMPLING TECHNIQUE- complete enumeration technique
7.2.5 SAMPLING CRITERIA
Inclusion criteria

Staff nurses who are willing to participate in the study.

Staff nurses who are working in oncology ward

Staff nurses who had completed GNM and BSc Nursing
Exclusion criteria

Staff nurses who are not available at the time of data collection
7.2.6 VARIABLES
Dependent variablesKnowledge and skill of staff nurses regarding handling of chemotherapeutic drugs
Independent variables- planned teaching program on safe handling of
chemotherapeutic drugs
7.2.7 SETTINGS – tertiary hospital, Bangalore
7.2.8 DATA COLLECTION TECHNIQUE
Description of Tool
The tool used in the study consists of three sections
 Section A: Baseline data – Age, gender, education level, years of experience, previous
training
 Section B: Structured questionnaire to assess the knowledge regarding safe handling of
chemotherapeutic drugs
 Section C: Checklist to assess the skills regarding safe handling of chemotherapeutic
drugs
Intervention Protocol
 The study will be conducted by planned teaching on safe handling of chemotherapy
drugs.

The different aspects included are chemotherapy, side effects of improper handling of
chemotherapeutic
drugs
to
handlers
and
patients,
preparation,
administration
,transportation, spillage, waste disposal , patient care and patient education.
 The planned structured program will be of 1 hour duration in the form of lecture and
discussion among staff nurses working in oncology ward.
Data Collection Procedure

The investigator obtains permission from respective authority to
conduct the study.

Selection of subjects through complete enumeration sampling technique

Investigator introduces himself to the subjects and notifies about his
aims, objectives, and steps of the study and takes written consent.
 Pre-Test: assess the knowledge and skill of staff nurses regarding safe handling
of chemotherapeutic drugs
 Administer planned teaching programme.
 Post-Test: assess the knowledge and skill of staff nurses after one week
 Data analysis will be done by descriptive and inferential statistics.
7.2.9 DATA ANALYSIS TECHNIQUE

Descriptive statistics –Frequency, Percentage, Mean , Median ,Standard Deviation ,
Graphical representation, Karl Pearsons Correlation

Inferential-chi square test, t test
7.3 Does the study required any investigation or intervention to be conducted on
patients or other humans or animals? If so describe briefly.
YES ( planned teaching program)
7.4 Has the ethical clearance been obtained from your institution?
YES
7. REFERENCE
1. Chintamani. Lewis’s Medical Surgical Nursing. India: Elsevier ; 2011.
2. Joseph M. Effectiveness of planned teaching programme on safe handling of cancer
chemotherapeutic drugs for staff nurses in selected setting in Mangalore; Karnataka:
Rajiv Gandhi University of Health Sciences; 2005.
Available form: http://www.rguhs.ac.in/digitallibrary/hardbiblio/Nursing.doc
3. CPAA. News you can use [Internet] [cited on 2012 Oct 2012]
Available form: http// www.cpaaindia.org/infocentre/index.htm
4. Yarbo CN, Frogge MH, Goodman M. Cancer Nursing Principles and practice.6th
Edition. Massachusetts: Jones and Barlett; 2005.
5. Elice M, Linda S, Diane S . Safe Handling of Chemotherapy in perioperative setting.
AORN. April 2010; 91(4):435-53
6. Thompson J. Chemotherapy Risk for Nurses. [Internet] [ cited on 2012 Oct 25]
Available form: http://www.ehow.com/about 679881 chemotherapy-risknurses.html
7. World Cancer factsheet August 2012 [Internet] [cited on 2012 Dec 8]
Available form: http://www.iarc.fr/en/mediacentre/iarcnews/pdf/Global%20
factsheet-2012.pdf
8. Ramesh C. Department of Epidemiology and Biostatistics.[Internet] [cited on 2012
Nov 4]
Available form: http:// www.kidwai.kar.nic.in/statistics.htm
9. NIOSH ALERT. Preventing occupational exposure to antineoplastic and other
hazardous drugs in health care settings. [Internet][ cited on 2012 Oct 20]
Available form: http:// www.cdc.gov/niosh/docs/pdf
10. Najma K, Khurshid ZAK ,Tazeen SA. Assessment of knowledge, skill and attitude of
Oncology nurses in Chemotherapy administration in tertiary hospital Pakistan. Open
Journal of Nursing.2012 June :2;97-103
11. Opfler KB,Wirtz DM, Farley K. A chemotherapy standard order form: preventing
errors. Oncol Nurs Forum; 26(1):123-8
12. Adval EU, Aydinoglu N. Extravasation of vesicant/Non vesicant drugs and evidence
based management. International Journal of Caring Sciences.2012 MayAug;5(2):191-202
13. Valanis B, Vollem WM, Steale P. Occupational exposure to antineoplastic agents:
self reported miscarriages and still births among nurses and pharmists. JOEM. August
1999; 41(8): 632-38
14. Makiko S,Miwako D, Shigeko H, Noariko I, katsuyuki M. Assessment of DNA
damage in Japanese nurses handling antineoplastic drugs by the comet Assay. J
Occup Health. 2008;50:7-12
15. Kosgeroglu N, Ayranci U, Ozerdogan N, Demirustu C. Turkish nurse’s information
about, and administration of chemotherapeutic drugs. J Clin Nurs. 2006 Sep ;
15(9):1179-87.
16. Wiseman T, Verity R, Ream E, Alderman E, Richardson A. Exploring the work of
nurses who administer chemotherapy. European oncology Nursing Society. Dec
2005
Available form: http:// www,kcl,uk/teares/hmvc/external/docs/exploring-nurseschemotherapy- final .pdf
17. Bertellli, Gianfilipo. Prevention and management of Etravasation of cytotoxic drugs.
Drug Saf.1995 Apr; 12(4):245-55.
18. Schrijvers DL. Extravasation a dreaded complication of chemotherapy. Annals of
Oncology.2003; 14(3): 26-30.
19. Chan A, Leow YC, Sim MH. Patients perspectives and safe handling of oral
anticancer drugs at an Asian Cancer Center. J Oncol Pharm Practice.2009; 15:161-5.
20. Elshamy K, ElHadidi M, ElRoby M, Founda M. Health hazards among oncology
nurses exposed to chemotherapy drugs. Afr J Haematol Oncol. 2010 Jul-Sep;1(3):7078.
21. Grummt T, Grummt HJ, Schott G. Chromosomal aberrations in peripheral
lymphocyctes of nurses and physicians handling antineoplastic drugs. Mutat Res.
1993 May; 302(1):19-24.
22. Skov T, Maarup B, Otsen J, Rorth M, Wintherei KH, Lynge E. Leukemia and
reproductive outcome among nurses handling antineoplastic drugs. British Journal of
Industrial Medicine.1,992; 49:855-61.
23. Ranchon F, Salles G, Spath HM et al. Chemotherapeutic errors in hospitalized cancer
patients attributable damage and extra cost. BMC Cancer . 2011;11:478
24. Schulmeister L. Preventing Vincristine sulfate medication errors. Oncology Nursing
Forum. 2004;31(5):90-98.
25. Turk M, Davas D , Ciukliogulu M, Sacaklioglu F, Mercan T. Knowledge, attitude and
safe behavior of nurses handling cytotoxic anticancer drugs in Ege University
Hospital. Asian Pac J Cancer Prev. 2004 Apr- Jun; 5(2):164-8.
26. Daouphars M, Magali A, Bertrand E, Basuvau F, Violette S. Knowledge assessment
and information needs of oncology nurses regarding inpatient medication. Clin J
Oncol Nurs. 2012 Apr; 16(2):182-7
27. Ben AS, Shham J, Rabin S, Melzer A, Ribak J. The influence of nurses knowledge ,
attitudes and health beliefs on their sage behaviour with cytotoxic drugs in Isreal.
Cancer Nurs. 2001; 24(3):192-200.
28. Mastour S, AlGhamdi, Zaki H, AlMustafa. The handling of anticancer drugs in
Riyadh and the eastern province. Annals of Saudi Medicine. 1997;17(2):257-59
29. Kumari S, Kaur S, Patel FD. Cytotoxic drug spillages among nursing personnel
working in the chemotherapy administration on areas. Nursing and Midwifery
Research Journal. 2009 July; 5(2):116-123
30. Yates, Patsy, Dewar et al. Educational preparation for chemotherapy administration a
survey of Queensland nurses. The Australian Journal of Cancer Nursing. 4(2): 4-10
31. Chaikoolvatana A, Anansushatgul J, Wattanapong W. The effect of the interventions
of basic knowledge of and sills of health care workers in the preparation of cytotoxic
drugs at Sapparithiprasong Hospital, Ubon Ratchathani Province. IJPS . 2010;6(1):
66-76
9
Signature of the candidate :
10 Remarks of the guide
:
11 11.1 Name and Designation of the Guide: Mrs P. Padmapriya
Assistant Professor
Head of Department
Medical Surgical Nursing Department
Signature
:
11.2 Co-Guide(if any)
Signature
:
11.3 Head of Department: Mrs P. Padmapriya
Assistant Professor
Medical Surgical Nursing Department
Signature
:
12.1 Remarks of the Chairman and Principal
12
Signature: