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A retrospective analysis of reporting of adverse drug reactions to oncology

drugs: An experience from a national center of clinical excellence

Article  in  Indian Journal of Pharmacology · December 2018

DOI: 10.4103/ijp.IJP_544_17

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DOI:
10.4103/ijp.IJP_544_17
A retrospective analysis of reporting
of adverse drug reactions to oncology
drugs: An experience from a national
center of clinical excellence
Pramod Kumar Sharma, Arup Kumar Misra, Ajay Gupta, Surjit Singh,
Puneet Dhamija1, Puneet Pareek2

Abstract:
INTRODUCTION: Adverse drug reaction (ADR) is a public health problem which constitutes one of
the leading causes of morbidity and mortality worldwide. In India, only a few studies reported cancer
chemotherapy‑induced ADRs. The objectives of the present study were to assess the organ system
involved, frequency, severity, and preventability of the ADRs occurred.
MATERIALS AND METHODS: Data on ADRs of retrospective cohorts were extracted from the
filled ADR forms received from the department of radiation oncology. Descriptive statistic was used
to summarize and analyze the available data, namely patient demography, causality, severity, and
preventability of the event.
RESULTS: A total of 191 chemotherapy‑induced ADR reports were received from 164 patients during
the period March 2015 to August 2017. Almost three‑fourth of the ADRs occurred in patients who were
receiving regimens involving multiple drugs. Taxanes, alkylating agents, and platinum compounds
were the common drug groups involved. The skin (n = 90) was the most frequently involved organ
with alopecia and hyperpigmentation as most common manifestations. The severity (Hartwig and
Siegel) and preventability scales (Modified Schumock and Thornton) indicated that most reactions
were mild (54.45%) in nature and the majority of them were preventable. More than two‑third (69%)
of the reactions were related “possible” to the suspected drug as determined by the World Health
Organization causality assessment.
CONCLUSION: Chemotherapy‑related ADRs among cancer patients are worrisome. It has a
negative impact on patient quality of life and in addition increases cost of therapy. It is found that
timely reporting of chemotherapy‑related ADRs and having an effective ADR monitoring system in
place ensure preventability of the ADRs in many cases. Oncologists, Radiotherapists and Onco-
Departments of surgeons should be actively involved in ADR reporting (Onco-Pharmacovigilance) and exchange
Pharmacology and constructive information, update and educate each other about appropriate use of anticancer drugs.
2
Radiotherapy, All India Onco‑pharmacovigilance is the need of the hour and could be of immense value in reducing morbidity
Institute of Medical and mortality if practiced with utmost importance.
Sciences, Jodhpur,
Rajasthan, 1Department Keywords:
of Pharmacology, All India Adverse drug reactions, chemotherapy, onco‑pharmacovigilance, preventability, severity
Institute of Medical
Sciences, Rishikesh,
Uttarakhand, India
Introduction as “A response to a drug, which is noxious
Address for and unintended, and which occurs at doses
correspondence:
Dr. Arup Kumar Misra,
Department of
T he World Health Organization (WHO)
defines adverse drug reaction (ADR)
normally used in man for the prophylaxis,
diagnosis, or therapy of disease, or for the
Pharmacology, All modifications of physiological function.”[1]
India Institute of This is an open access journal, and articles are
Medical Sciences, distributed under the terms of the Creative Commons
Jodhpur ‑ 342 005, Attribution‑NonCommercial‑ShareAlike 4.0 License, which How to cite this article: Sharma PK, Misra AK,
Rajasthan, India. allows others to remix, tweak, and build upon the work Gupta A, Singh S, Dhamija P, Pareek P. A retrospective
E‑mail: arup2003m@ non‑commercially, as long as appropriate credit is given and analysis of reporting of adverse drug reactions to
gmail.com the new creations are licensed under the identical terms. oncology drugs: An experience from a national
center of clinical excellence. Indian J Pharmacol
Submission: 07‑09‑2017 2018;50:273-8.
Accepted: 02‑11‑2018 For reprints contact: reprints@medknow.com

© 2018 Indian Journal of Pharmacology Published by Wolters Kluwer - Medknow 273

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Sharma, et al.: Onco‑pharmacovigilance in a tertiary care institute
It has been demonstrated by a number of studies that
drug‑induced morbidity and mortality is one of the major
health problems in our country.[2,3] The Pharmacovigilance
Programme of India (PvPI) is an initiative to address this
issue. Activities under PvPI include collection, reporting,
and follow‑up of ADRs occurring in patients. The PvPI
collate the data received from various Adverse Drug
Reaction Monitoring Centers (AMCs) in the country
and submit them on regular basis to global database
maintained at Uppsala, Sweden. The signals generated
from such activities are used to recommend regulatory
interventions in the form of banning a drug, labeling
revisions besides communicating risks to health‑care
professionals and the public. The ultimate of PvPI is
to identify, characterize, and estimate the extent of the
problem associated with drug use in the country.
Cancer is one of the three leading causes of death
in the modern world.[4] It is estimated to cause 12%
death annually worldwide.[5] The incidence of cancer
is about 70–90/100,000 persons, and prevalence is
estimated approximately 2.5 million in India.[5] Cancer
chemotherapy has improved drastically over a past
few decades. Chemotherapy is now employed as
a multimodal approach for treatment of different
malignancies and has been revolutionized with the
discovery of newer drugs for curative treatment for
certain fatal malignancies.[6]
Antineoplastic agents can damage normal cells along
with cancerous cell and have narrow therapeutic index.[7]
Patients on chemotherapy are vulnerable to ADRs as
they receive multiple drugs as a part of the anticancer
regimen. Complications secondary to chemotherapy
include an increase in morbidity and mortality.[8] The
patients after undergoing chemotherapy have a general
sense of low feeling, have restricted mobility due to the
aggravated physical discomfort, spend more time on bed,
have low sexual desire, reduce interaction with society,
and have less working capabilities.[9] In other words, the
application of chemotherapy regimens and its courses
increase the unwanted toxic side effects which gradually
aggravate the quality of life of the patients as mentioned
in Ma et al.[10] Thus, an active drug surveillance system
is needed to capture drug‑related risk information in
cancer patients. The aim of the study was to determine
the nature and severity of ADRs in cancer patients based
on ADRs received from the department of radiation
oncology. All these ADRs were reported to AMC
established under PvPI at All India Institute of Medical
Sciences (AIIMS), Jodhpur, Rajasthan, India.
Materials and Methods
AIIMS, Jodhpur, is an Institute of National Importance
established under Pradhan Mantri Swasthya Suraksha
274 Indian Journal of Pharmacology - Volume 50, Issue 5, September-October 2018
Yojana and still is in establishing stage. However, AMC
was established since the inception of outpatient services.
The ADRs received from March 2015 to August 2017
were compiled and discussed here. It was a retrospective
cohort study, and the data were extracted from the
filled ADR forms received by AMC. The same ADR
information was also entered in “VigiFlow” software for
reporting to the National Coordinating Center (NCC).
The collected data were later summarized and were used
to determine the nature and severity of ADRs. AMC is
actively involved not only in collecting ADR data from
the hospital but also spreading awareness about the need
and importance of pharmacovigilance. This is achieved
by sending weekly reminder e‑mails, regular sharing of
drug safety alerts, newsletter, other advertising materials,
running animations on television (TV) panels in inpatient
department (IPD) and outpatient department (OPD)
areas, prescription sheets including patient‑centered
message emphasizing the need for reporting ADR,
distributing pamphlets, and sensitization sessions to
health‑care professionals (HCPs) and paramedical staff.
The ADR (version 1.2) form is a simplified version of the
Central Drugs Standard Control Organization[11] adopted
by the center to facilitate reporting by the HCPs. The
HCPs either fill the ADR forms themselves or inform
the AMC telephonically. In addition, the Patient Safety
Pharmacovigilance Associate makes a regular visit
to OPD and IPD. The collected individual case safety
report was analyzed for patient demography, causality,
severity, and preventability of the event. All ADRs
were submitted to NCC through “VigiFlow” software.
ADRs were classified on the basis of Anatomical and
Therapeutic Classification System  (1999).[12] Causality
assessment of ADRs was done by causality assessment
scale proposed by the WHO Collaborating Centre for
International Drug Monitoring–the Uppsala Monitoring
Centre[13] which classifies suspected ADRs as certain,
probable, possible, unlikely, conditional/unclassified,
and unassessable/unclassifiable. The severity of the
ADRs was assessed by Modified Hartwig and Siegel
Scale[14] which gives an impression of the severity of ADRs
and tags it as mild, moderate, or severe. Preventability
of the ADRs was assessed by Modified Schumock and
Thornton Scale.[15] This scale of preventability classifies
ADRs as definitely preventable, probably preventable,
and not preventable. Descriptive statistic was used to
summarize and analyze the available data on nature and
the frequency of various ADRs.
Results
A total of 191 chemotherapy‑induced ADRs from
164 patients were received by AMC until August 2017.
The majority of ADRs occurred in the age group of
19–65 years (n = 126, 77%) with a female preponderance
(n = 88, 54%) [Figure 1]. In some patients, more than
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Sharma, et al.: Onco‑pharmacovigilance in a tertiary care institute

one ADR was observed. Monotherapy constitutes only transfusion secondary to anemia, or febrile neutropenia.
50 (26%) drug reactions, while 141 (74%) reactions were Assessment by Modified Schumock and Thornton Scale
from those who received these drugs as a part of a of ADR preventability showed that most of the ADRs
multidrug regimen. The various indications for the use of belonged to the category of “preventable” (n = 174).
chemotherapy were tumors of the breast, lung, ovary, oral The majority of the reactions were related “possible”
cavity, lymphoma, and other malignancies [Figure 2]. The (more than two‑third) to drugs as determined by
observations revealed that skin as an organ was involved causality assessment [Figure 6].
in almost half of the total ADRs reported followed by
hematological (n = 43; 23%), gastrointestinal (n = 33; 17%),
renal, nervous, and other systems (n = 25; 13%) [Figure 3].
Alopecia, hyperpigmentation of the skin and nail,
thrombophlebitis, bone marrow depression, neuropathy,
and vomiting were among the common reactions
observed [Figure 4]. Docetaxel, carboplatin, cisplatin,
and cyclophosphamide were the most common drugs
involved in ADRs in the study population [Figure 5].
Most reactions were mild (54.45%) in nature and the
remainder being moderate (44.50%) and severe (1.04%)
as assessed by Modified Hartwig and Siegel Scale.
There were a total of 45 (including one death) serious
adverse events that required hospitalization or caused
prolongation of existing hospitalization due to either
intractable vomiting, electrolyte imbalance, blood

Figure 2: Distribution of types of malignancy in the study population (n = 124)

Figure 1: Distribution of adverse drug reactions according to the age (years)

Figure 3: Frequency of adverse drug reactions based on the organ system involved Figure 4: Type with frequency of adverse drug reactions

Indian Journal of Pharmacology - Volume 50, Issue 5, September-October 2018 275

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Sharma, et al.: Onco‑pharmacovigilance in a tertiary care institute
Figure 5: Suspected drugs involving in causing adverse drug reactions. *EGFR
inhibitors = Epidermal growth factor receptor inhibitors, PTK = Protein tyrosine
kinase inhibitors
Discussion
ADRs due to cancer chemotherapy are quite challenging
as it impacts the quality of life of patients and
also to the providers who manage such cases. [16]
Chemotherapy‑related ADRs increase mortality rate as
well as escalate the cost of the therapy.[17] In India, the
scenario is worse as compared to developed countries
as only 1% of global data of ADRs due to cancer
chemotherapy is reported in India.[18,19] In our country,
due to the low ratio of doctor to patient, most of the
events are not reported citing many reasons, i.e., lack of
time, low motivation, ignorance, and lethargy. In spite
of having trained medical professional in our country,
sometimes doctors are hesitant to report because they
fear litigation and think that ADR reporting might
go against them. Ignorance on the part of the HCPs
regarding how to report and no awareness about
onco‑pharmacovigilance could have contributed to
underreporting.[20,21]
In our study, we found that majority of the ADRs occurred
in females[22] and increased incidence in female patients
might be due to hormonal changes occurring during
different stages of life that might cause an alteration in
the pharmacokinetic profile of the drugs.[23] Majority
of the ADRs occurred in the age group of 19–65 years,
which is similar to Astolfi et  al.[24] Our findings also
showed that most of the ADRs (29.8%) were seen in the
age group of 51–60 years as most patients belonged to
this age group which is consistent with results of other
studies.[25,26] The metabolizing capacity and the excretory
functions are generally diminished as a person ages and
there are also pharmacokinetic and pharmacodynamic
alterations of drugs in the body and thus increasing the
chances of ADRs.[27]
In our study, most common cancers that had been
treated in our setup were breast cancer (n = 39; 23.07%)
followed by ovarian (n = 26; 15.38%), bronchogenic
276 Indian Journal of Pharmacology - Volume 50, Issue 5, September-October 2018
Figure 6: Causality, severity, and preventability assessment
(n = 21; 12.42%), and oral cavity cancer (n = 16; 9.46%)
very similar to reported earlier.[25] As a whole, Indian data
on cancer indicate that the most common cancer among
males is oropharyngeal and in females is cervical.[28] The
variation in type that we have observed [Figure 2] could
be due to the geographical location, dietary habits, and
lifestyle.[29] However, this needs to be further explored
in a different study.
ADRs occurring only due to chemotherapy were
taken into consideration. The most common drugs
causing ADRs were docetaxel (14.2%), carboplatin
(11.9%), cisplatin (11.5%), paclitaxel (9.2%), and
cyclophosphamide (8.8%). Results of the present analysis
are in accordance with reports from a similar study.[26] In
our study, microtubule‑damaging drugs account for
most of the ADRs as they were most prescribed in a
proportionately higher ratio of females which was
similar to Astolfi et al.[24]
Among the reported ADRs, common ones were
alopecia (17.27%), hyperpigmentation of the skin
and nail (14.65%), thrombophlebitis (9.42%), bone
marrow depression (8.37%), vomiting (8.376%), and
diarrhea  (4.71%). The findings were quite similar to a
study by Saini et al.[1] Other ADRs experienced by the
patients were nausea, burning micturition, constipation,
skin rash, and others. Our study is in contrast to studies
carried out by Mallik et al. which had neutropenia as the
most common ADR, while Lau et al. reported constipation
to be the most common ADR.[30,31] In our opinion, this
difference could be due to either more frequent use of
drugs that have bone marrow suppressing effects in one
study or overuse of opioid to control intractable pain in
many malignancies in another.
In this study, only ADRs were taken into account
which occurs due to chemotherapy. Our study has
assessed three different parameters of an ADR, namely
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Sharma, et al.: Onco‑pharmacovigilance in a tertiary care institute
the causality, severity, and preventability due to the
different management plans adopted on the basis
of the stage of cancer, cost of the management, and
patient‑related factors, thus providing basic information
regarding the safety profile of anticancer drugs. The
WHO causality assessment scale indicated that 70%
of the reactions were “possible,” which is similar to
another onco‑pharmacovigilance study.[32] As anticancer
regimens usually include multiple drugs and the
explanation, we propose that the other drugs in the
regimen might contribute to the reaction observed.
Furthermore, it cannot be completely ruled out that sign
and symptoms of the disease may sometimes simulate
as an ADR in these terminally ill patients. Moreover,
information with regard to drug withdrawal secondary
to the adverse reaction lack in the majority as ADRs
are quite common with such drugs and withdrawal is
usually rare in such cases. On the severity scale, most of
the reactions were of mild grades which do not warrant
stopping or changing of the drug. Preventability scales
showed that majority of the ADRs were preventable.
An important limitation of the study is that the
re‑challenge test was not done in any case due to
medical and ethical issues that are the reason behind
labeling only two reactions as being “certain.” As
it was a retrospective study, there are chances of
underreporting and incomplete documentation of ADRs
data, particularly from initial few reports. We expect that
in the near future, the reporting of ADRs will further
improve subsequent to the increase in faculty strength
of the department.
Conclusion
We may conclude that an effective monitoring and
reporting system (onco‑pharmacovigilance) will
be the most effective tool for better management of
chemotherapy‑related ADRs. Practices such as an early
detection, timely intervention, avoiding agents with
overlapping toxicity, or changing the offending agent
and substituting it with an alternative agent are few
suggestions. Onco‑pharmacovigilance will increase
the bulk of data on frequency, severity, outcome, etc.,
associated with anticancer drug use, particularly in the
Indian population. We suppose that this will definitely
help envisage strategy to prevent or deal with them more
effectively. Medical, radio, and surgical oncologists,
clinical pharmacologists, and other health‑care providers
involved in the care of cancer patients must all be involved
in the onco‑pharmacovigilance program to enhance the
quality of data generated by exchanging and updating
each other with constructive information. In addition,
they should also ensure effective communication and
education concerning the appropriate use of drugs in
cancer patients.
Indian Journal of Pharmacology - Volume 50, Issue 5, September-October 2018 277
The methods for ADR detection, evaluation, and
monitoring should be strengthened from the
grass‑root level, especially in oncology. The role
of pharmacovigilance program in monitoring the
safety cancer chemotherapy should be evaluated for
detection of newer and rarer ADRs. Improvement in
spontaneous reporting of ADRs in oncology can only be
achieved through sensitization and awareness lectures
using audiovisual means not only to HCPs but also
to residents, interns, and nurses as well. In addition,
patient population should also be encouraged to report
whenever they feel anything that in their opinion is not
normal. Laboratory staff may also be vital in detecting
any abnormality in laboratory tests consequent to drug
exposure. Moreover, to strengthen ADR detection and
reporting at grass‑root level, the public at large may
play an important role if they are well informed in their
own language about proper use and safety of drugs
through various means, i.e., TV, radio, print media, social
media or public awareness lecture, etc. The motivation
for voluntary reporting of ADRs for preventing the
morbidity and mortality in this vulnerable population
could be of immense importance.
Acknowledgment
We need to acknowledge and appreciate the efforts of the
radiation oncology department. In spite of the shortage
of health‑care staff and availability of only one faculty
member, the flow of ADR reporting never got stagnant.
We also acknowledge the constant support and guidance
provided by the National Coordinating Centre, IPC,
Ghaziabad, Ministry of Health and Family Welfare,
Government of India, from time to time.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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