Original Article

J Oncol Pharm Practice

0(0) 1–10
A study to assess the impact of ! The Author(s) 2021
Article reuse guidelines:
pharmaceutical care services to cancer sagepub.com/journals-permissions
DOI: 10.1177/10781552211005003
patients in a tertiary care hospital journals.sagepub.com/home/opp

Kavya Karthikeyan1, Vinayak B Sunil1, Soumya M Alex1 and

Madhu CS2

Abstract
Introduction: Clinical pharmacist can enthusiastically involve in oncology department through utilizing the skills and
knowledge to support wide variety of functions in patient care. The impact of pharmaceutical care services in oncology
department were analysed through various approaches including the analysis of knowledge level of patients towards the
disease and its management through patient counselling, monitoring of performance status, observing of ADR and drug
safety. Incidence of cancer was scrutinized during the study.
Methodology: A Prospective interventional study was conducted from November 2019 to March 2020 with the support
of institutional ethical approval at oncology department of Lourdes hospital, Ernakulam. 133 patients were included with
all type of cancer. Data collected through Performa with KAP questionnaire and direct interview was conducted.
Statistical significance was evaluated through p value of <0.001 Result: 123 patients were completed both questionnaire.
Among this 69.91% were females and most of the patients belonged to 50 – 65yeras age group and carcinoma was
frequently reported type. End of the study showed significant change in the knowledge level of patients after interaction
with the clinical pharmacist. 26 ADRs were reported including solitary and multiple ADRs. Recommendations associated
with drug reconstitution, administration were frequently given to the nurses. Most of the interventions to improve
therapeutic outcome of the patients were accepted by the oncologist.
Conclusion: Clinical pharmacist can actively participate in all aspects of the oncology department in association with
physician and other health care providers to improve the therapeutic outcome and quality of life of patients.

Keywords
Cancer, clinical pharmacist, pharmaceutical care services, therapeutic outcome
Date received: 12 February 2021; revised: 12 February 2021; accepted: 4 March 2021

Introduction it depends on the presentation of signs and symptoms.

The drugs which are used in the management of cancer
are known as antineoplastic agents. Apart from the
beneficiary effect in disease management they required
special precautions from preparation to storage
because of the narrow therapeutic index.
When the adverse event appears within 24 hours after
administration of anticancer drugs, it can be considered
as acute1 (e.g; Cisplatin induced acute emesis,
Irinotecan induced diarrhea). Factors involved in the
development of ADRs are nature of agent, dose and

Antineoplastic agents and chance of adverse 1

Department of Pharmacy Practice, St. Joseph’s College of Pharmacy,
Cherthala, India
drug reactions 2
Department of Oncology, Lourdes Hospital, Ernakulam, India
Antineoplastic agents act by interfere with the growth
Corresponding author:
or killing the cancerous cells. Apart from the cancerous Soumya M Alex, Department of Pharmacy Practice, St. Joseph’s College
cells, normal cells may get affected by the action of of Pharmacy, Cherthala, Alappuzha, India.
these agents and it can be acute or delayed in nature, Email: soumyamarysm@gmail.com
2 Journal of Oncology Pharmacy Practice 0(0)
dosage, duration of treatment. Most of the agents
affect mainly on quickly dividing cells like blood cells
and cell lining on stomach, intestine and mouth. The
common side effects are nausea, vomiting, mucositis,
diarrhea and anemia.2
Antineoplastic agents and drug interactions
Interactions of antineoplastic agents will induce alter-
ation in effectiveness and associated side effects of the
therapy. Antineoplastic agents can interact with each
other i.e. interactions occur in between different classes
of antineoplastic agents3 (e.g.: 5Fluoruracil Vs
Leucovorin4). They can also interact with other class
of drugs (e.g.: Warfarin5) and food (Lapatinib Vs grape
fruit) to produce alteration in absorption and excretion
of agents, by interfering different mechanism including
alteration in protein binding, enzyme induction or inhi-
bition. Most of the antineoplastic agents are substrates
of cytochrome iso-enzymes such as CYP3A4, CYP2B6
and CYP2D6. They alter the elimination of drugs to
change the activity or toxicity by enzyme induction or
inhibition. Eg: Fluconazole, antifungal agent which is a
CYP3A4 iso-enzyme interact with cyclophosphamide.
Some of the interaction may be pharmacodynamic in
nature e.g.: Procarbazine Vs Amphetamine.4
Reconstitution, administration and storage of
antineoplastic agents
The anticancer drugs can be administered as in oral,
parenteral includes intravenous, subcutaneous and
intramuscular forms with or without dilutions. To
reduce the harm to the patient’s precautions on dilu-
tion, administration, infusion rate, side effects, reac-
tions and storage should be monitored. Storage
temperature and conditions of drugs may vary; it
should be mentioned on drug labels. During prepara-
tion of drug for administration, special requirement of
heating, ventilation, air conditioning, HEPA (high effi-
ciency particulate air filters), protective clothing recom-
mendations are required.6,7
Karnofsky performance scale
It is a valuation tool for analysing the functional
impairment especially in cancer patients to compare
the effectiveness of different therapies and assess the
prognosis of individual patients. In cancer patients;
need for chemotherapy, dose adjustment and palliative
care suggestions can be determined by using this scale.
Scoring consists of 100 to 0, where 100 indicate the
perfect health and 0 is expiry.
Role of clinical pharmacist in oncology department
A CP (clinical pharmacist) can actively participate in
cancer care by collaborating with the physician and
other health care professionals. They can involve in
all phases of treatment. I.e. during selection of therapy,
a CP in the Oncology department can provide infor-
mation about the pharmacology of drug, dosing adjust-
ments, adverse drug effect. And they can also answer
the queries about the off label uses, on-going clinical
trials and recent updated information on the existing
agents. In the chemotherapy order preparation CP can
verify the patient demographics, dose calculations
using BSA (Body Surface Area), pattern of prescrip-
tion, medication history. Timing of administration, dil-
uent and infusion rate, dosages can be closely
monitored by a clinical pharmacist and reduce the
chances of errors or harm to the patient. Review of
laboratory values help to assess the pre-existing dis-
ease, chemotherapy induced toxicity and requirement
of dosage adjustment and progression of treatment.
Ensuring the necessary medications like prophylaxis,
premedication and supportive cares are significant in
cancer care. Providing information about orally or
written forms to the patient like patient counseling ses-
sions will definitely improve the QOL (quality of life)
of the patient by improving medication adherence. A
clinical pharmacist in oncology department can incor-
porate the skills and knowledge to support wide variety
of functions in all aspects of patient care.8,9
The study clearly supports that the elaborated role
of CP in one of the major medical department. And the
external support system to introduce the concept in
accurate manner is also significant in nature.
Materials and methods
Methodology
A prospective interventional study from November
2019 to March 2020 was conducted after obtaining
the approval of hospital ethical review committee.
The study was carried out under the chief consultant
in oncology department of Lourdes hospital, Cochin,
Ernakulam. It is a 500 bed tertiary care multispecialty
referral teaching hospital with wide range of amenities.
Patients were selected based on convenient sampling
method from the oncology department comprising
inpatients and outpatients who satisfied the inclusion
and exclusion criteria.
Inclusion criteria.
• All type of cancer patients presented in IPD (in
patient department) as well as OPD (outpatient
department)
Karthikeyan et al.
• Patients above 18 years of age
Exclusion Criteria.
• Pregnant and lactating women
• Patients who were not willing to participate in the
study
• Patients who got discharged against medical advice.
• Cancer patients who have psychiatric illness.
Data collection
The data were collected using specially designed data
collection form. Patient laboratory as well as treatment
details was extracted from medical records. In addition
to this direct interaction with the patients from IPD
plus OPD and/or caregivers and health care providers
were carried out during patient’s two hospital visits
including initial visit and follow up.
Data collection tools
Direct interviewing of the patient, specially designed
data collection form, KAP (Knowledge Assessment
Practice) questionnaire, Karnofsky performance score
NARANJO and WHO ADR (world health organiza-
tion – adverse drug reaction) documentation form
were used.
Study method
Study population was the inpatients and outpatients of
oncology department; they were randomly designated
to the study on the basis of inclusion and exclusion
criteria. During the first interview of the inpatients as
well as outpatients, informed consent was obtained
from the patient or legally represented caregiver.
Details regarding the demographics and treatment
details including history about the disease as well as
home medications were entered in the predesigned
data collection form. Patient or care giver was inter-
viewed with the validated KAP questionnaire;
Knowledge, attitude, practices of the patients who par-
ticipated in our study was reviewed and assessed. The
KAP questionnaire consists of 21 questions with a total
score 21 which included 13 questions related to
“Knowledge”, 4 related to “Attitude” and 4 related
to “Practice”. The ADRs were monitored and these
reactions were analyzed by using WHO-UMC (world
health organization – Uppsala Monitoring Centre)
causality assessment scale and Naranjo adverse drug
reaction probability scale. Drug interactions associated
with antineoplastic agents were monitored using a
chart that was prepared with the help of a software
system, Up-To-Date and the precautions of reconstitu-
tion and administration of these agents were also care-
fully considered during the study period to ensure the
3
quality of life of patient. To minimize the chance of
side effects and drug interactions, pre-medications
were patterned during chemo-chart preparation and
the significance of precautions about the handling
and (administration) of antineoplastic agents were pro-
vided to the nursing staffs through specifically designed
precaution charts. Different types of cancer occurrence
were categorized and to increase the awareness about
the disease, importance of its management, dietary
changes, chances of side effect and necessary safe-
guards were explained through patient counseling to
improve the medication adherence and to enhance the
therapeutic outcome. On follow up, the patients were
reassessed with the same KAP questionnaire and the
scores were compared with the previous. The follow up
was done either in person and/or via the telephone.
Awareness chart about the necessary precaution asso-
ciated with highly toxic antineoplastic drugs were pre-
pared for nursing staffs by using the software Adobe
Photoshop. As an exemplary of pharmaceutical care
services in oncology department were got through
direct interaction with clinical pharmacists of various
multi-speciality hospitals.
Descriptive statistical analysis
The collected data were compiled using Microsoft
Excel and were presented using tables and graphs. To
identify the association of data chi-square test and
paired sample t test were employed. And statistical sig-
nificance was censored by using p-value <0.001. The
data were tabulated, analyzed and compared with rel-
evant studies.
Results
Details of patients enrolled in the study
In this study a total of 133 patients met the inclusion
and exclusion criteria were enrolled and we completed
the study with 10 drop outs due to certain reasons. All
the patients (100%) completed the first questionnaire
and 123 patients (92.48%) completed second question-
naire, remaining seven patients (5.26%) were expired
and three (2.25%) were drop outs. Out of the study
population, 86(64.66%) were female patients and 47
(35.33%) were male patients. Majority of patients
were in the age group of 50-65years; A total of 86
patients (64.66%) among which 56 females 42.10%)
and 30 males (22.55%). Least number of patients was
in the age class 18-33. In the study most of the subjects
were of the population were primary school educated
(42.85%) and having moderate level economic status
(70.67%). Considering on both dietary and social
habits of the study population 98.49% were practicing
4 Journal of Oncology Pharmacy Practice 0(0)
Table 1. Categorization of carcinoma.
Number
Type of carcinoma of patients Percentage (%)
Breast 47 35.33%
Colorectal 14 10.52%
Esophagus 4 3%
Gastric 2 1.50%
GE Junction 2 1.50%
Genitourinary 17 12.78%
mixed diet and among the 47 male patients having
alcoholics (2.25%), smokers (6.01%) and both
(4.51%).
Categorization of the cancer
On categorization of cancer affected organs during the
study period, a total of 112 (84.21%) carcinoma were
reported, among this CA Breast was found to be the
most frequently reported one (35.33%). In the study
period most of the sample population was diagnosed
with cancer (63.90%) in the year 2019 (Table 1).
Analysis of adverse drug reactions
A total of 26 ADRs were reported including multiple
ADRS (81%) and solitary ADR (19%), in that hema-
tologic system was more prone to the adverse drug
reactions (61.53%). Seven cases were of GI system
(26.92%), 2 cases of immunology (7.69%) and a case
of respiratory system involvement (3.84%) were
reported (Figure 1).
WHO- UMC causality and Naranjo adverse
drug reaction probability assessment scale were used
and it reveals most of the ADRs were probable in
both WHO (88.46%) and Naranjo (65.38%) followed
by possible in Naranjo (34.61%) and WHO (11.53%)
(Table 2).
Among 26 ADR were associated with capecitabine
(30.76%), irinotecan(15.38%), bleomycin (3.84%) and
other class of drugs (Figure 2).
Analysis of KAP
Out of 133 patients 123 were completed the follow up,
while analysing the base line score 90 patients (73.17%)
having medium score (8-14), 32 patients (26.01%) were
having high (15-21) score and one patient had low (7)
score. After providing patient education to the study
population, the score was reassessed in the further
follow up (Table 3). The mean and SD (standard devi-
ation) were calculated and the paired samples T test
was applied in the score of knowledge assessment in
baseline and follow up. Since significance (p-value) is
Number
Type of carcinoma of patients Percentage (%)
Hepatopancreatic 6 4.51%
Hypopharynx 1 0.75%
Lung 16 12.03%
Supraglottis 1 0.75%
Tongue 2 1.50%
less than 0.001, we conclude that the average improve-
ment in the knowledge, 3.821 is significant. In the score
of attitude assessment in baseline and follow up mean,
SD and paired samples T test were practiced and the
significance (p-value) is less than 0.001, it concludes
that the average improvement in the patient attitude,
0.886 is significant,
Mean, SD and T value to compare the baseline and
follow up patient knowledge of practice assessment
were done. Later the significance (p-value) is less than
0.01 and concludes that an average improvement in the
knowledge, 0.967 is significant (Table 4). So there is a
statistically significant impact of patient education on
knowledge and attitude regarding cancer and its treat-
ment and practice in cancer treatment among the study
population.
Comparison of mean scores at baseline and follow
up after counseling was done (Figure 3).
Karnofsky performance score
Performance status of study population was
assessed by Karnofsky performance scale. Out of
the 133 patients most of them having the score of
80 (68.42%), the score represent that the patients
were able to carry normal activities but with
effort; some signs or symptoms of disease and least
score was 30 (.7518%). 17 patients (12.78%)
had score 90, 12 patients had score 70 and patients
having score 60,50,40 are 5, 4 and 3 respectively
(Figure 4).
Pharmaceutical interventions
According to the recognition of interventions during
the study out of 53 interventions 48 (90.56%) were
accepted by the Oncologist and the clinical significance
of the reported interventions were more belonged to
moderate class (54.71%) followed by high (28.30%)
and minor (7.51%). Five interventions (9.43%) were
rejected including two (3.77%) each in high & moder-
ate class and one in minor (1.88%). There is no signif-
icant association between intervention class and
acceptance at p value >0.05. Because of majority of
Karthikeyan et al. 5

61.53%
70.00%
60.00%

PERCENTAGE
50.00%
40.00% 26.92%
30.00%
20.00% 7.69%
3.84%
10.00%
0.00%

Haematology Respiratory Immunology GI

Figure 1. System wise ADRs reported.

Table 2. Causality and probability assessment of ADRs.

Number of Number of
WHO UMC causality criteria ADRs (%) Naranjo criteria ADRs (%)

Certain 0
Probable 23 (88.46%) Definite 0
Possible 3 (11.53%) Probable 17 (65.38%)
Unlikely 0 Possible 9 (34.61%)
Unclassified 0 Doubtful 0
Unclassifiable 0

Others 7.69%

Panitimumab 7.69%

Paclitaxel 7.69%

Irinotecan 15.38%
SUSPECTED DRUGS

Imatinib 3.84%

Doxorubicin 7.69%

Docetaxel 3.84%

Carboplatin 7.69%

Capecitabine 30.76%

Bortezomib 3.84%

Bleomycin 3.84%

0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00%

PERCENTAGE

Figure 2. ADRs and Suspected drugs.

6 Journal of Oncology Pharmacy Practice 0(0)

Table 3. Overview of KAP.

Baseline Follow up

Number of patients Percentage Number of patients Percentage

Low (7 ) 111111 0.8130 0 0

Medium (8–14) 90 73.17 1 0.8130
High (15–21) 32 26.01 122 99.18
Total 123 123

Table 4. Approval status of interventions during study.

Accepted Rejected

Interventions F % F % Df X2 P value

Minor 4 7.51% 1 1.88% 2 1.084 0.582

Moderate 29 54.71% 2 3.77%
High 15 28.30% 2 3.77%

12
11.11

10

8 7.29
MEAN

4.26
3.79
4
3.29
2.9

0
Knowledge Attitude Practice
Base line Follow up after counselling

Figure 3. Comparison of mean scores at baseline and follow up after counseling.

interventions were accepted irrespective of intervention
class (Minor, Moderate, High (Table 4).
Considering the reported interventions, most of the
interventions were related to under treatment (45.28%)
and they were accepted. Out of 12 (22.64%) interven-
tions were associated with drug selection 11 (20.75%)
were accepted and one (1.88%) was rejected. And in
interventions of over dose/under dose 6 (11.32%) were
accepted and 3 (5.66%) were rejected. In treatment
duration associated interventions 5 (9.43%) were
accepted and one (1.88%) was rejected (Figure 5).
Safety in reconstitution, dilution, stability, storage,
compatibility and administration of antineoplastic
agents and concomitant drugs
During the study period, out of 133 patients analysed,
108 patients were monitored (81.20%) who were
Karthikeyan et al. 7

0%

100 12.78%

90 68.42%

80 9.02%
SCORE

70 3.75%

60 3.00%

50 2.25%

40 0.75%

30 0%

0% 10% 20% 30% 40% 50% 60% 70%

Figure 4. Karnofsky performance score.

0%
Under treated 45.28%

1.88%
Treatment duration
9.43%

5.66%
Over dose/under dose
11.32%

1.88%
Drug selection
20.75%

0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 45.00% 50.00%

Rejected Accepted

Figure 5. Category of interventions.

8 Journal of Oncology Pharmacy Practice 0(0)
50% 50%
Recommendations Made Recommendations Not Needed
Figure 6. Recommendations associated with administration of
antineoplastic agents.
Figure 7. Precaution card of methotrexate.
having reconstitution of drugs. Apart from reconstitu-
tion, dilution, compatibility, stability, administration
and storage conditions were also analysed. Out of the
108 patients, 54 recommendations (50%) associated
Figure 8. Precaution card of cisplatin.
with administration was made and proceeded
(Figure 6).
To minimize the chance of side effects, drug inter-
actions and errors associated with handling, adminis-
tration and storage of drugs a standard format was
prepared in the form of precaution cards to the nursing
staffs (Figures 7 to 9).
Discussion
Young Ho Yun et al conducted “web based tailored
education program for disease-free cancer survivors
with cancer-related fatigue; a randomized control
trial” in the year 2012. Out of 273 patients enrolled
most of them were belonged to the age group 20 -
65 years in both genders and more number of female
patients than males10. In our study female patients were
more commonly reported with cancer and the frequent-
ly reported age group was 50 to 65 years old. These
may indicates that the female gender is at increased
risk of cancer. When analysing the dietary habits
most of samples were following a mixed dietary
habits. In the study no one in the sample population
was illiterate and most of them were moderately eco-
nomic this may influences the QOL. Because of analy-
sing the performance score according to karnofsky
Karthikeyan et al.
Figure 9. Precaution card of cyclophosphamide.
more number of patients was scored 90; they were
symptomatic in nature but were able to do their
normal activity. A similar study on “pharmacist led
medication education in cancer pain control” was con-
ducted by Yan Wang et al in 2013.There the perfor-
mance status of cancer patients was analyzed using
ZUBROD ECOG WHO scale. In that study patients
were categorized into 5groups and most of the patients
were having performance status score 1 both in control
group (67.5%) and interventional group (66.7%) and
least of them having score 3 in control (2.6%) and
interventional (2.4%) group.11 The significant increase
in the KAP score after the interaction with the CP was
an indicator of the impact of CP in improving thera-
peutic outcome of the patients. Chen J et al conducted
a research on “Knowledge attitude and practice
towards daily management of peripherally inserted cen-
tral catheters (PICC) in critically ill cancer patients dis-
charged from intensive care units” in 2018. 152 patients
were enrolled and end of the study disclosed that KAP
scores have a positive correlation (p value - <0.05).12
Similar study known as “Impact of Clinical Pharmacy
Services on KAP and QOL in Cancer Patients: A
Single-Center Experience” was conducted by Yang
Wang et al in 2015. A total of 155 patients were par-
ticipated and 147 patients were complted the study.
9
End of the study reveals a significant intensification
in the knowledge of patients on the follow up with a
p- value of <0.05.13 During the study carcinoma was
most frequently reported type, and in that breast
cancer was common in the year 2019. “A study on
spontaneous adverse drug reaction monitoring in
oncology; our experience” by Kaur k et al in 2015
indicates that carcinoma was most frequently reported
followed by leukaemia. In the current study shows that
the second most reported type was myeloma. When
comparing with other class of drug the risk of ADRs
were high in case of antineoplastic agents. In our study
26 ADRs were reported and most of them are associ-
ated with capecitabine. The study conducted by Kaur
K et al reports 2500 ADRs in 14,475 patients and the
common agents responsible for the ADRs were plati-
num compounds followed by pyrimidine analogues14.
Both studies indicate than antimetabolites having
increased risk for ADRs. The intervention about the
drug selection, under treatment, dosing and treatment
duration may interfere with the therapeutic outcome
and most of these were implemented with the accep-
tance of oncologist. “EPICC study; evaluation of phar-
maceutical intervention in cancer care”, a study was
conducted by N Vantard et al in 2015, to evaluate
the pharmaceutical interventions in cancer care. They
were analysed 29,589 prescriptions, out of these 54% of
drug related interventions were found, in that most of
them were over/under dosage15. In our study over
dose/under dose was found to be in the third position.
Proper instructions regarding to the preparation to
storage of antineoplastic agents were provided then
analyzed. And precaution cards were delivered to the
nursing staffs to avoid the confusion and complications
of certain antineoplastic agents suggested by the oncol-
ogist. In association with the physician and healthcare
team a CP can definitely implement the pharmaco-
therapeutic aspects of patient care.
Conclusion
Our study engrossed the impact of pharmaceutical care
services to cancer patients in a tertiary care hospital.
Cancer was deliberated as the second most leading
cause of death worldwide, in our study, 84.96% of
study population was reported with carcinoma in
2019. The knowledge assessment on the disease and
its management of sample population was one of the
momentous objectives of our study. End of the study
shows a significant improvement in KAP levels of
patient after interaction with clinical pharmacist with
a p-value <0.001. Our study also supports that ADRs
are a solitary detriment of antineoplastic agents. The
study implies that a clinical pharmacist can actively
participate in association with other health care
10
providers in oncology department to minimize the
chance of interactions, errors in administrative meas-
ures from reconstitution to storage and ensure the
proper precautions and prophylaxis. The high accep-
tance rate of clinical pharmacist interventions were also
ensures a better therapeutic outcome to the patients.
These are the truthful indicator of an impact of a clin-
ical pharmacist in oncology to progress the adherence
with proper knowledge about their disease via building
a channel between the physician and patients.
Acknowledgements
We are grateful to our faculties, oncologist, nursing staffs,
college management and hospital management for the neces-
sary support, guidance and facilities.
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.
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