Content uploaded by Yatish Byndoor
Author content
All content in this area was uploaded by Yatish Byndoor on Sep 10, 2022
Content may be subject to copyright.
Research J. Pharm. and Tech. 15(8): August 2022
3759
ISSN 0974-3618 (Print) www.rjptonline.org
0974-360X (Online)
RESEARCH ARTICLE
Knowledge, attitude and awareness of pharmacovigilance among medical
students in a tertiary care centre
Yatish Byndoor, Tamilisetti Vidya Sagar, Anupam Das
Q No-2005, SR Quarter, GSL Campus GSL Medical College, Rajahmundry, Andrapradesh.
*Corresponding Author E-mail: dr.yati1988@gmail.com, tamilisetti.sagar@gmail.com,
dranupamdas07@gmail.com
ABSTRACT:
Objective: The Purpose of this study is to assess knowledge, attitude and awareness of pharmacovigilance
among medical students in a tertiary care centre. Materials and Methods: This study was conducted at Prakash
Medical college and Hospital, Islampur, Kolhapur, Maharastra. The approval for conducting this study was
obtained from the Institutional Ethics Committee prior to the study. This was a cross-sectional, observational,
questionnaire-based study. Total 340 participants were approached, which included medical students of MBBS,
students of Nursing College, Dental College and Physiotherapy College attached to the Hospital were included
in the study. Results: Though majority of MBBS students had defined the term “Pharmacovigilance”, less than
half were able to define by BDS, BPT and Nursing students. These students are told about it in pharmacology
but not actively discussed. This shows that there is a need to stress on pharmacovigilance during undergraduate
teaching. Knowledge and attitude-based questionnaire was well answered by majority of MBBS students similar
to studies. The overall awareness about pharmacovigilance and ADR reporting was low, in all medical and
nursing students. Conclusion: This study concludes that the MBBS medical students’ knowledge and attitude
towards pharmacovigilance was by far commendable in comparison to other medical courses. Practical based
awareness regarding pharmacovigilance was very less in all stream of medical courses.
KEYWORDS: Pharmacovigilance Programme of India (PvPI), adverse drug reactions (ADRs).
INTRODUCTION:
Pharmacovigilance is an important discipline to ensure
patient safety and the appropriate and rational use of
medicines1,2. World Health Organization (WHO) defines
pharmacovigilance (PV) as “the science and activities
relating to the detection, assessment, understanding, and
prevention of adverse effects or any other drug-related
problem.”3,4. As health care professionals are the first
one who are in contact with patients taking drugs,
reporting by them is an effective way to generate early
signals of ADRs 5. It is the most practical way to detect
adverse events caused by prolonged use of drugs and
many drug-drug interactions.6 Thus, awareness among
healthcare workers and their attitude towards
pharmacovigilance are important determinants of ADR
reporting rate.
Received on 24.07.2021 Modified on 18.09.2021
Accepted on 28.10.2021 © RJPT All right reserved
Research J. Pharm. and Tech 2022; 15(8):3759-3763.
DOI: 10.52711/0974-360X.2022.00631
Pharmacovigilance and adverse drug reactions (ADRs)
reporting education are important competencies all
medical students need to obtain before they graduate and
involved in clinical practice as healthcare
professionals7,8,9. Therefore, educating healthcare
students in the school of medicine, pharmacy, or nursing
and involving them early in clinical practice to
prescribe, and/or monitor medications is essential to
ensure the safe use of medications 10. Pharmacovigilance
Programme of India (PvPI) was formed in July 2010. A
combined initiated by Central Drugs Standard Control
Organization (CDSCO), New Delhi, MoHFW,
Government of India. The All-India Institute of Medical
Sciences (AIIMS) was established as the National
Coordinating Centre (NCC) under which 22 ADR
monitoring centers (AMCs) all over India were formed
for monitoring Adverse Drug Reactions (ADR) in India.
In order to strengthen the programme, and for better
implementation, the National Coordinating Centre was
shifted to Indian Pharmacopoeia Commission (IPC),
Ghaziabad, (U.P.) from the All-India Institute of
Research J. Pharm. and Tech. 15(8): August 2022
3760
Medical Sciences (AIIMS).11
Unfamiliarity and lack of awareness with
pharmacovigilance and ADR-reporting have been
associated with ADRs underreporting by healthcare
professionals 12,13. Further, underreporting and the lack
of understanding of ADRs could lead to a greater burden
on patients, payers, and healthcare systems. Therefore,
knowledge and perception toward the safety profile of
medications are essential.
Educating healthcare professionals on the possible
existence of unexpected adverse reactions and how to
report them to the local regulatory authorities can
facilitate the detection and assessment of drug safety
signals14. The purpose of this systematic review is to
evaluate the literature that measures the level of
healthcare students’ knowledge, attitude, and perception
of pharmacovigilance and ADRs reporting. This can
help to identify the current need for education/training
on pharmacovigilance and the research need to improve
our understanding of healthcare students’ knowledge,
attitude, and perception of pharmacovigilance. By
summarizing the published literature in this area, it
should be possible to grasp a more understanding of the
existing evidence and understand future needs for
research in this area.
Our review research questions are:
1. What is known about healthcare students’
pharmacovigilance knowledge?
2. What is known about healthcare students’ attitudes
and perceptions of pharmacovigilance?
3. Are there any validated measures to assess students’
knowledge, attitude, and perception toward PV in the
existing literature, and what could future studies add to
our understanding of the healthcare students’
knowledge, attitude and perception of
pharmacovigilance?
Study setting:
This study was conducted at Prakash Medical college
and Hospital, Islampur, Kolhapur, Maharastra. The
approval for conducting this study was obtained from
the Institutional Ethics Committee prior to the study.
The study was conducted during the period from
September 2017 to December 2017.
Study design:
This was a cross-sectional, observational, questionnaire-
based study. Total 340 participants were approached,
which included Medical students of MBBS, students of
Nursing College, Dental College and Physiotherapy
College attached to the Hospital were included in the
study.
Exclusion criteria were (1) study population consisting
of postgraduate or healthcare professionals, (2) 1st year
medical students Questionnaire was designed to assess
the demographic details of the medical students, their
knowledge of pharmacovigilance, attitudes towards
pharmacovigilance, and their awareness towards
pharmacovigilance practice.15,16,17 There were 09
questions in the questionnaire to assess the knowledge
on ADR, attitude towards pharmacovigilance and their
awareness on reporting ADR. The study was explained
to them in brief. Consent of participants was taken in
written informed consent form. A time period of one day
was given for the participants to read, understand and
answer the questions. Data collected were analysed and
percentages were calculated. Awareness among medical
students was compared using chi square test.
RESULT AND DISCUSSION:
The demographic details of the healthcare professionals
with baseline characteristics are summarized in
Table 1
Characteristics
Frequency
Gender
Male
Female
100
240
Medical Students
MBBS
Nursing
Physiotherapy
Dental
80
120
60
60
Medical student knowledge regarding
Pharmacovigilance Medical student knowledge was
assessed on important parameters.62 MBBS student
gave correct response regarding the definition of
pharmacovigilance out of 80 students and 21 Nursing,
18 BPT and 30 dental students gave correct response for
pharmacovigilance definition out of 120, 60 and 80
students respectively.56 MBBS were aware of purpose
of Pharmacovigilance compared to 24 nursing, 15 BPT
and 27 dental students. Regarding problems included in
Pharmacovigilance 33 MBBS, 17 Nursing, 15
Physiotherapy and 22 dental students gave correct
response. 61 MBBS, 24 Nursing, 10 Physiotherapy and
14 dental students gave correct response to the question
on regulatory body monitoring Pharmacovigilance out
of 80 MBBS, 120 Nursing, 60 Physiotherapy and 80
Dental students. Question on “Who can report ADR, 54
MBBS ,28 Nursing, 21 BPT and 34 dental students gave
correct response. Difference between the MBBS group
was statistically significant (P>.01) compared to all
other group of students, related to knowledge-based
questionnaire on pharmacovigilance
Research J. Pharm. and Tech. 15(8): August 2022
3761
Table 2
Knowledge Based Questions
MBBS
Nursing
BPT
BDS
Define Pharmacovigilance?
a) The science of monitoring ADR’s happening in a hospital
b) The process of improving the safety of Drugs
c) The detection, assessment, understanding & prevention of adverse effects*
d) The science detecting the type & incidence of ADR after drug is marketed.
77.5
17.5
30
37.5
The important purpose of Pharmacovigilance is?
a) To identify safety of drugs*
b) To calculate incidence of ADR’s
c) To identify predisposing factors to ADR’s
d) To identify unrecognized ADR’s
70
20
25
33.7
Pharmacovigilance includes
a) Drug related problems
b) Blood related products
c) Herbal products
d) All of the above
41.2
14.16
25
27.5
In India which Regulatory body is responsible for monitoring of ADR’s?
a) Central Drugs Standard Control Organization*
b) Indian Institute of sciences
c)) Pharmacy Council of India
d) Medical Council of India
76.2
20
16.67
17.5
Who can report ADR?
a) Health care professionals only
b) Patients and their relatives only
c) Any concerned person
d) PV authorised person (pharmacologist)
67.5
23.33
35
42.5
Awareness based questionnaire
According to 42 MBBS, 38 Nursing, 16 BPT and 13
Dental students, reporting of ADR is very important .33
MBBS, 46 Nursing, 26 BPT and 47 dental students said
that ADR reporting is important but should not be
mandatory. Only 5 MBBS student told ADR reporting is
not required compared to 36 Nursing, 18BPT and 20
dental students.
78 MBBS were positive regarding inclusion of
Pharmacovigilance in UG Curriculum out of 80
students.84 Nursing student said yes for inclusion of
pharmacovigilance in UG Curriculum and 26 students
said no for inclusion out of 120 Nursing students. 44
Physiotherapy students and 68 Dental students were
positive to include in curriculum in contrast to 14
physiotherapy and 11 BDS who said no for inclusion.
67 MBBS, 104 Nursing, 55 BPT and 72 dental students
have not seen Pharmacovigilance cell in hospital out of
80, 120, 60 and 80 students respectively
77 MBBS, 114 Nursing, 60 Physiotherapy and 78
Dental students have never seen ADR forms out of 80,
120, 60 and 80 students respectively.
There was no statistical significance (P< 0.5) between
all the groups of students when compared for awareness-
based questionnaire.
Importance of ADR Reporting in Views of Medical
Students
Figure 1
Opinion Regarding Inclusion of Pharmacovigilance
in Ug Curicullum
Figure 2
Research J. Pharm. and Tech. 15(8): August 2022
3762
Have You Ever Seen Pv Cell in Hospital
Figure 3
Have You Seen Adr Form/Reporting Before?
Figure 4
Though majority of MBBS students (77%) had defined
the term “Pharmacovigilance”, less than half were able
to define by BDS, BPT and Nursing students which was
similar to study done by Katyal et al.18 These students
are told about it in pharmacology but not actively
discussed. This shows that there is a need to stress on
pharmacovigilance during undergraduate teaching.
Knowledge and attitude-based questionnaire was well
answered by majority of MBBS students similar to
studies done by Marko 19.The overall awareness about
pharmacovigilance and ADR reporting was low, in all
medical and nursing students20.
LIMITATION:
The major limitation of the present study is that the
study findings could not be applied to wider health care
professionals as the study was restricted to students.
Therefore, it is recommended that several studies of
similar kind especially in community setup need to be
conducted to know the awareness and attitude of
healthcare professionals in community and their practice
of pharmacovigilance. To maintain more secure
utilization of medications, there is a requirement for an
active pharmacovigilance framework at all the levels of
health care. Subsequently, the requirement of better
system of reporting ADRs has been approved as a best
need activity to avert ADRs in health care system21,22.
This will help to find out the present status and to
develop strategies to improve the ADR reporting system
in India.
CONCLUSION:
This study concludes that the MBBS medical students
knowledge and attitude towards pharmacovigilance was
by far commendable in comparison to other medical
courses. Practical based awareness regarding
pharmacovigilance was very less in all stream of
medical courses.
REFERENCES:
1. Kumar A. Pharmacovigilance: Importance, concepts, and
processes. American Journal of Health-System Pharmacy. 2017;
74(8):606–12. https://doi.org/10.2146/ajhp151031 PMID:
28235869
2. Badar Uddin Umar, Mainul Haque. Adverse Drug Reactions in
Bangladeshi Health Care Setup: An Update. Research J. Pharm.
and Tech. 8(11): Nov., 2015; Page 1598-1602. doi: 10.5958/0974-
360X.2015.00287.5
3. Ragul Viknesh V, Saranya P. Pharmacovigilance - An Overview
in a Pharmacist Perspective. Research J. Pharm. and Tech. 2020;
13(8):3941-3946. doi: 10.5958/0974-360X.2020.00697.6.
10.5958/0974-360X
4. Adamu Yau, Nordin Bin Simbak, Mainul Haque.
Pharmacogenovigilance: A Potential Tool in Pharmacovigilance.
Research J. Pharm. and Tech. 7(12): Dec. 2014; Page 1476-1482.
10.5958/0974-360X
5. Raj Purnima , Temburnikar Pankaj , Rathore M , Verma Vijay,
Pandey SN . Antibiotics Induced Adverse Drug Reaction
Monitoring in a Teaching Hospital in Chhattisgarh. Research J.
Pharmacology and Pharmacodynamics; 2012; 4(1): 13-16.
10.5958 2321-5836
6. Oates JA. The science of drug therapy. In: Brunton LL, editor.
Goodman & gilman‟s the pharmacological basis of therapeutics.
11th ed. New York: McGraw-Hill; 2006. p. 133-5.
7. Reumerman M, Tichelaar J, Piersma B, Richir M, van Agtmael
M. Urgent need to modernize pharmacovigilance education in
healthcare curricula: review of the literature. European journal of
clinical pharmacology. 2018; 74(10):1235–48.
https://doi.org/10.1007/s00228-018-2500-y PMID: 29926135
8. Arun Sharma, S Amarnath, S Jaikumar, S. Basalingappa, S.
Ramaswamy, M. Thulasimani. Assessment of Knowledge about
Pharmacovigilance among Medical Students in Puducherry.
Research J. Pharm. and Tech. 7(4): April, 2014; Page 447-449.
10.5958/0974-360X
9. Bhavana B. Bhat, Udupa N, Sreedhar D. Knowledge and attitude
of Ayurvedic Physicians towards Adverse drug reactions and
reporting methods in Udupi region. Research J. Pharm. and Tech.
2018; 11(1): 117-120 doi: 10.5958/0974-360X.2018.00022.7
10. Van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G,
AlRamimmy H, et al. What future healthcare professionals need to
know about pharmacovigilance: introduction of the WHO PV
core curriculum for university teaching with focus on clinical
aspects. Drug safety. 2018; 41(11):1003–11.
https://doi.org/10.1007/s40264-018-0681-z PMID: 29949100
11. Pharmacovigilance Program of India (PvPI) [homepage on the
internet] .The start of the programme. Updated on Jan 30,
2017.Available from: http://www.ipc.gov.in/PvPI/pv_home. html
12. Varallo FR, Guimarães SdOP, Abjaude SAR, Mastroianni PdC.
Causes for the underreporting of adverse drug events by health
professionals: a systematic review. Revista da Escola de
Enfermagem da USP. 2014; 48(4):739–47.
Research J. Pharm. and Tech. 15(8): August 2022
3763
13. Olsson S, Pal SN, Stergachis A, Couper M. Pharmacovigilance
activities in 55 low-and middle-income countries. Drug safety.
2010; 33(8):689–703. https://doi.org/10.2165/11536390-
000000000-00000 PMID: 20635827
14. Hailye Birhane, Mojahidul Islam, Damen H/mariam, Vijender
Singh. Pharmacovigilance: Adverse Drug Reactions (ADRs) in
Pediatric patients in Ethiopia. Retrospective Study. Research J.
Pharm. and Tech 2021; 14(3):1499-1506. doi: 10.5958/0974-
360X.2021.00266.3
15. Rajesh R, Vidyasagar S, Varma DM. An educational intervention
to assess knowledge, Attitude, practice of pharmacovigilance
among healthcare professional in an Indian tertiary care teaching
hospital. Int J Pharm Tech Res. 2011;3(2):678-92.
16. Subish P, Izham MM, Mishra P. Evaluation of the knowledge,
attitude and practices on adverse drug reactions and
pharmacovigilance among healthcare professionals in a Nepalese
hospital: A preliminary study. Internet J Pharmacol. 2008;6:1.
[Google Scholar]
17. Pimpalkhute SA, Jaiswal KM, Sontakke SD, Bajait CS, Gaikwad
A. Evaluation of awareness about pharmacovigilance and adverse
drug reaction monitoring in resident doctors of a tertiary care
teaching hospital. Indian J Med Sci 2012;66:55 61
18. Katyal J, Arora E, Gupta YK. Impact of increased focus on
pharmacovigilance on knowledge and attitude towards adverse
drug reaction reporting among medical students in India.
International Journal of Risk & Safety in Medicine.
2019(Preprint):1–10.
19. Marko S. A study of knowledge, attitude, and practice of
pharmacovigilance among medical students at a tertiary care
teaching hospital in Madhya Pradesh, India. National Journal of
Physiology, Pharmacy and Pharmacology. 2019; 9(9):851–5.
20. Yaser M. AlWorafi, Sanah Hasan, Nageeb M. Hassan, Ahmed A.
Gaili. Knowledge, Attitude and Experience of Pharmacist in the
UAE towards Pharmacovigilance. Research J. Pharm. and Tech.
2021; 14(1):265-269. doi: 10.5958/0974-360X.2021.00047.0
21. S Lincy, M Greeshma, E Maheswari, S Tharanath, Subeesh
Viswam. An Empirical Study to assess the Pattern and Predictors
of Adverse Drug Reactions associated with Polypharmacy in the
Department of General Medicine. Research J. Pharm. and Tech
2018; 11(11): 5042-5048. doi: 10.5958/0974-360X.2018.00919.8.
10.5958/0974-360X.2018.00919.8
22. Rayees N M, Sampath Kumar, Bharath Raj K C, Rajesh K S, Juno
J Joel, Prasanna Shama K, Gururaja M P, Nandakumar U P. A
Prospective Observational Study on Adverse Drug Reactions in
General Medicine Department of a Tertiary Care Teaching
Hospital. Research J. Pharm. and Tech. 2019; 12(5):2289-2298.
doi: 10.5958/0974-360X.2019.00382.2
