to the World Health Organization, “Pharmacovigilance is defined as the science
and activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other possible drug-related problem,
particularly long term and short term adverse effects of medicines”(1-4). Pharmacovigilance
is also known as Drug Safety and abbreviated PV or PhV possessing various roles
like identifying, documenting and quantifying of drug related injuries(5-6).
Pharmacovigilance greatly focuses on adverse drug reactions (ADRs) which are
defined by WHO as “a response to a medicinal product which is noxious,
unintended and which occurs at doses normally used in man for prophylaxis,
diagnosis or therapy of disease or for the restoration, correction or
modification of physiological function” (7-8).
addition to drugs pharmacovigilance often involved in monitoring of herb-drug
interactions which was often lead to serious consequences necessitating the
safety monitoring(9). Adverse drug reactions are not rare; an
incidence has been documented in different clinical settings implicating that Serious ADRs account for 6.7% of all hospital admissions
and occur in 10-20% of hospitalized patients (10). ADRs are more common with the multiple drug
therapy and with each additional medication taken by the patient the hazard of
an ADR episode gets multiplied by 1.14 thereby directly increasing length of
stay (11-12). Adverse drug reactions may also result in slackened
quality of life, increased physician visits, hospitalizations, and even death.
In addition, they result in increased health care costs. Thus they place a substantial encumbrance on health care resources (4).
ADRs are even can be considered as the
fourth leading cause of death ahead of diabetes, pulmonary disease, AIDS and
road traffic accidents (13). With these credentials the present
study was conducted with the aim of monitoring and reporting ADRs which would
ultimately benefit the health of the patients. The study was also intended to
identify areas which should be addressed to improve the reporting rate.
The main objectives of the present study were to:
ü To analyze the reported ADRs for causality, severity,
predictability and seriousness.
identify the vulnerable patients and most common drug/s causing ADRs.
of the suspected ADRs to the PvPI.
prospective observational study, involving spontaneous reporting through active
methods (pharmacist actively looking for suspected ADRs) and passive methods
(stimulating prescribers to report suspected ADRs) was carried out in all
departments of a tertiary care teaching hospital, Kadapa over a period of 18
months between January 2016 to July 2017.
Functioning of the ADR reporting
daily basis, health care professionals (HCPs) were informed regarding the
importance of monitoring and reporting of ADRs. ADRs reported by the HCPs in
institutional suspected ADR reporting form and ADR notification form were
analyzed for their completeness, credibility and correctness’. Suspected ADRs
that meet PvPI reporting criteria were separated and documented in PVPI
suspected ADR reporting form(14).
Data were carefully evaluated for quality, based on the following
essential elements: patient initials,
date of reaction, description of the reaction or problem, suspected medication/s,
concomitant medical product/s including self-medication and herbal remedies and
initial notification of a suspected ADR, additional details were collected
concerning previous allergies, concomitant medications, co-morbidities, ADR
management and outcome, and other details necessary for evaluation through
direct interview with the reporter and patients, and/or evaluation of patient
suspected ADRs were then reported to 3 PvPI ADR monitoring centers (AMCs) viz.,
Kurnool Medical College, Madras Medical College and Sri Venkateswara Medical
College. On monthly basis we have received the acknowledgements with unique
numbers i.e. AMC number and Worldwide Number for reported ADRs from these centers.
Worldwide number and AMC number given for the suspected and reported ADRs were
entered into the documented reporting forms and the same was communicated to
the reporters and entered into the data base of ADRs.
have also encouraged the patient care takers to report all suspected ADRs using
reporting modalities like directly reporting suspected ADRs to the treating
physician, clerkship and internship practicing students of pharm D.
Evaluation of data
The reactions were analyzed based on the
patients’ age and gender were considered in the evaluation. In accordance
patients were divided into nine age groups.
the ADRs were analyzed for their severity, seriousness and the system affected.
seriousness of the reaction was assessed by using the PvPI criteria i.e. Life
threatening, Required intervention to Prevent permanent impairment/damage, Hospitalization/Prolonged
hospital stay, Disability, congenital anomaly and Death(14).
severity of the reaction was determined and categorized as mild, moderate and
severe according to the classification system of Hartwig’s Severity Assessment Scale(15)
ADRs were categorized based on the organ system affected.
No single method was universally accepted for
assessing the causal relationship of drug to adverse reactions as various
algorithms & methods are in use according to the individual preference(16,17,18)
.Here, we have assessed the causality
establish the relationship between the drug and the reaction by using WHO Causality assessment scale (19,20). And
preventability to check and correct the rationality of the therapy, it was done
by using the classification system of modified Schumock and Thornton scale(21). During the study period, a
total of 254 ADRs in accordance to the PVPI criteria were reported. Among them ADR occurrence were
found to be similar in both genders with slight female preponderance stating no
significant difference in the
incidence of ADRs in this hospital. Ratan J. Lihite et al,
Vijaykumar et al (23,
27). reported that females were more prone to develop ADRs.
This is due to the fact that number of consultations in this hospital was
similar in view of gender base.
to pediatrics and geriatrics the frequency of ADRs were more in adults, as
this population were found to be visiting frequently to hospitals and drug
usage is often more in them. reflecting similarity
with study results of Lobo et al. Neha Tabassum et al, kiran roy et
al, singh et al
(3,5,11,13) and conflicted result with study of Vijaykumar et al (27) who reported ADRs more in geriatrics
Through this study, we found most of ADRs from the
department of General Medicine followed by Psychiatry and Dermatology as more
consultations were found in these departments in this hospital .Consistent
results were reported by studies of Sneha Gangisetty et al., Sangeetha Raja
et al., Pankaj Gupta et al., M. Shamna et al (1,6,22,24)
is essential to confirm whether the reaction is because of drug alone or other
factors also involved in ADRs occurrence, most of the studies reported that the
majority of the reported ADRs were assessed to be possible. The results of this
study were found to be quite consistent with previous studies of Sneha
Gangisetty et al, sivanandy palanisamy et al, kiran roy et
al, Arul Kumaran Govindarajan et al (1,5,25,26)
Assessment of severity is also essential to take
necessary action against the drug continuation, in our study most of the ADRs
were mild, and fortunately, the incidence of severe ADRs is low with similar ground
work of singh et al , Kiran Roy et al , Vijaykumar et al (5, 11,27)
Preventability assessment helps in improving
rational drug use, in our study we found majority off ADRs were probably
preventable, which indicates that rational/individualized drug therapy can
minimize/prevent the majority of ADRs .The results were similar to previous
ground work by Sneha Gangisetty et
al. , Neha Tabassum et al. (1,3)
regulatory authorities consider the seriousness of the ADRs as one of the
important parameter in making decisions on the marketing of drugs as it relates
the safety information of marketed drug. Seriousness of the ADRs in our study was
assessed by using PvPI criteria through which we found majority of ADRs were
serious reactions requiring intervention and increased hospitalization. Our
results conflicted with study results of kiran
roy et al (5)
were various categories of drugs that cause the ADR. In our study, majority of ADRs were observed
in admitted patients, and usage of antibiotics was found to be high in
hospitalized patients for prophylactic and curative therapy, replicating a
reason for considering antibiotics to be the major drug involving. The results
were consistent with previous studies conducted by singh et al, Sneha Gangisetty et al, lobo et al, Neha
Tabassum et al, kiran roy et al,
Arul Kumaran Govindarajan et al, Vijaykumar et al (1,3,5, 11,13,26,27)
outcomes of ADRs were recovering in many cases. There were few ADRs whose
outcome was unknown since the patients were followed only up to their discharge
and hence the complete outcome information was not available.
an ADR plays a vital role in preventing the risks associated and is an
important strategy in health care. In our study more than half of ADRs were
managed by means of adding other drug that will treat the ADR occurred.
study suggests that there is a need of spontaneous ADR reporting from all the
departments of this tertiary care hospital for monitoring and assessment of ADRs.
This study also warrants further research in this part of India for the
development of possible intervention strategies to reduce burden of ADRs. The present study showed a major reporting among Pharm D clerkship and
internship practicing students .Out of all 254 ADR’s reported, only 10 were
reported by the physicians and the reporting rate was nil among nurses.
There are various probable reasons identified for underreporting
such as lack of aptitude and knowledge of physicians, time constraint,
non-accessibility of ADR (IPC) reporting forms, lack of incentives etc.,. In
our interaction with clinicians, similar reasons for underreporting were found.
But all the health care professionals provided their support in confirming the
ADR. In this
hospital, it was observed that the documentation of ADRs were unintentionally
get missed which could be because of work related stress and forgetfulness,
lack of knowledge and awareness about the importance of drug safety monitoring,
poor knowledge of ADR reporting programme objectives, and busy outpatient
setting, and many clinicians do not consider reporting a priority. This study
suffers the main drawback of spontaneous reporting system i.e. underreporting.
Thus, ADR monitoring should be strengthened in this diversified region by
sensitizing and encouraging healthcare providers to report ADRs.
study concluded that the spontaneous reporting of Adverse Drug Reactions is
fairly good in this hospital. Although the ADRs in the present
study were non serious and preventable, monitoring and management of such ADRs
through therapeutic interventions would be beneficial in better patient care.
Hence pharmacists have an important responsibility in monitoring and safety of
medicines. The results provided an insight to the healthcare providers on the
importance of monitoring and reporting of Adverse Drug Reactions. There is a
need to improve awareness among the clinicians to emphasize their role in
voluntary reporting of ADRs, on generating quality reports, critically monitor
the ADRs so as to prevent them further.