Introduction
Pharmacovigilance is an
important discipline worldwide to ensure patient safety and the appropriate use
of medicines (Kumar et al., 2017). Moreover, it has a
vital role in therapeutic decision-making, either for an individual or national
or in a global perspective (Arora
et al., 2008). Pharmacovigilance
and adverse drug reactions reporting education are important competencies all
healthcare school students need to obtain before they graduate and be involved
in clinical practice as healthcare professionals (Reumerman et al.,
2018). Some of the studies demonstrated that knowledge of
pharmacovigilance is improving gradually, but unfortunately, the actual
practice of ADR reporting is still deficient among medical students and
pharmacy students (Patchva et al., 2018; Sharmind et al., 2020). Therefore,
educating healthcare students in different systems of medicine including
Ayurveda, and involving them early in clinical practice to prescribe,
administer and/or monitor medications is essential to ensure the safe use of
medications (Van eekeren et al., 2018). As future Ayurveda
practitioners, undergraduate students, postgraduate scholars, and trainees need
to be well trained on how to recognize, prevent, and report ADR.
Govt. of India established the
monitoring of the safety of Ayurveda, Siddha, and Unani (ASU) drugs under a
national level program in the year 2008, at Institute for Post Graduate
Teaching and Research in Ayurveda (IPGT& RA), Jamnagar, a constituent
institute of Gujarat Ayurved University, Jamnagar which is first of its kind institute
dedicated to Ayurveda education and research. In the year 2018, the Ministry of
AYUSH, Govt. of India reintroduced the program under the Central Sector scheme
for promoting "Pharmacovigilance of Ayurveda, Siddha, Unani and
Homoeopathy (ASU&H) drugs" (PIB 2021). However, the pharmacovigilance program, like most others around the world, suffers from underreporting of ADRs
by healthcare professionals. There is a lack of information about the reasons behind this
underreporting by healthcare professionals in general and Ayurveda healthcare students in particular, and
no studies have
explored this issue to date.
Ayurveda Healthcare students
could play a major role in the successful implementation of the program if
adequate knowledge and skill are imparted to them during their UG/PG training
career. But, at present, no significant statistics are available to understand
the knowledge, attitude, and perception of pharmacovigilance among them.
Therefore, the present study is intended to evaluate the level of knowledge,
attitude, and perception of pharmacovigilance and ADRs reporting among Ayurveda
healthcare students which will facilitate in identifying the need for
education/training on pharmacovigilance.
Material and methods
Type of study
This
is a cross-sectional, questionnaire-based study aimed to assess knowledge,
attitude, and practice towards pharmacovigilance and adverse drug reaction
reporting among Ayurveda scholars and trainees of Gujarat state, which has 24
Ayurveda colleges.
Sampling method and source of data
A convenience sampling method
was used in which Ayurveda scholars and
trainees studying and working in different Ayurveda Colleges of Gujarat
state were requested to provide their responses.
Inclusion and exclusion
criteria
Scholars and trainees
presently studying and working at Ayurveda colleges, the state of Gujarat, from
both government, private and autonomous sectors, who are willing to participate and give their consent for participation
irrespective of age, sex and experience were included in the study. Participants
who were not willing to participate were excluded from the study.
Ethical considerations
This study was undertaken
after getting ethical clearance from institutional ethics committee (IEC) vide
its meeting held on 8th
January 2021 vide agenda no.4.1
Validity and
reliability of the study tool
The survey questionnaire was
constructed after an extensive review of literature on KAP studies related to
Ayurveda (Prakash
et al., 2016; Rajesh et al., 2017) Pharmacovigilance (Toklu et al., 2008; Upadhyaya et al., 2015; Adheed et al., 2017) and healthcare workers (Rathod et al., 2014; Agarwal et al.,
2017). An initial draft was made by referring to
these available data collection instruments with suitable customization for the
present study. A questionnaire
covering points like participants' knowledge, attitude, and practice towards
pharmacovigilance, adverse drug reaction reporting, and misleading
advertisement linked to the objectives of the study was developed. A group of
pharmacovigilance experts (n=5) reviewed the questionnaire and checked for the
question's consistencies, clarity and relevance then modified accordingly. A
pilot study was conducted with the final format among the post-graduate
scholars of the institute (n=10), to evaluate the appropriateness of the
questions to the target sample and to assess whether data collection procedures
are feasible or not. Data obtained during the pilot study were excluded from
the reported study results.
Data collection
procedure
Total 29 pretested questions;
13 related to knowledge covering concept, the present structure, and reporting
of ADR, 10 on attitude and 6 on practice, in Google form, were made available
to all the targeted participants through email, as part of a series of awareness
program being conducted by intermediary pharmacovigilance centre for Ayurveda
(IPvC), institute of teaching and research in Ayurveda (ITRA), Jamnagar during
December 2020 and January 2021. Each eligible
participant was asked to complete the consent form that explained the purpose
of the study before proceeding to complete an online survey.
Data management and
analysis
The
survey questionnaire was analyzed question-wise and their percentage value was
calculated with the help of a microsoft excel spreadsheet in MS office 2010. The result is presented using simple frequencies with percentages in
appropriate tables.
Results
Total
1790 scholars and trainees registered for participating in the survey for 17
different colleges of Gujarat state. Among them, 97.15 % (n=1739) were BAMS
students, 2.68 % (n=48) were MD scholars and 0.17 % (n=3) were PhD scholars.
The majority of the participants i.e 81.79 % (n=1464) were from private
colleges having experience between 0-1 years. Details of participants with
regards to their gender, qualification, service sector, and experience are
provided in Table 1.
Discussion
To the best of our knowledge,
this is the first study in India that evaluates the knowledge attitude, and
practice of Ayurveda students toward pharmacovigilance and ADR reporting. In
the present study, an overall response rate of more than 90 % was recorded.
This figure can be regarded as exceptionally high, especially when compared
with those of other studies on the same topic carried out among pharmacy,
dental, and medical
students from different
parts of India (Limaye et al., 2018; Chhabra et al., 2017; Gaude et al., 2018).
Along with the early detection
of ADRs pharmacovigilance facilitates the identification of both, risk factors and
the mechanism underlying the ADR. Although there is an established national pharmacovigilance programme for Ayurveda, Siddha, Unani, and Homoeopathy
(ASU&H) drugs, the reported number of ADRs
is very little. To improve the reporting rate, it is essential to improve the
knowledge of healthcare professionals regarding ADR reporting and PV. The right
time to do it is probably during undergraduate and postgraduate education.
Because students could play a major role in the successful implementation of
the program if adequate knowledge and skill are imparted to them during their
training career.
The present study demonstrates
that the majority of the respondents were having a good knowledge regarding the
concept of pharmacovigilance and ADRs in terms of their definitions and
purposes (Table 3). But, a complete knowledge regarding the structure of the National and
International pharmacovigilance program (Table 4), reporting the ADR and its
format was still lacking (Table 5). The study found that
only 46.88 % of the participants knew about the availability of specific ADR reporting forms for ASU&H drugs. The limited information regarding the location
of the present national pharmacovigilance co-ordinating centre, the official
website of the pharmacovigilance program can be attributed to restricted information regarding recent advances and updates of
pharmacovigilance in the present curriculum. This lacuna can be improved by educational interventions as reports from
the published study also reveals a significant improvement in reporting ADR by
healthcare professionals after educational intervention (Bagewadi et al., 2018). Available
literature also shows that interactive educational intervention on PV among
undergraduate medical students and healthcare
professionals (Bagewadi et al., 2018; Rajesh et al., 2011) were found to be effective in increasing awareness. However, some studies conclude that only knowledge does not help in increased
ADR reporting. The educational intervention like power point presentation and
also hands on training in filling up the ADR forms and causality assessment
will overcome the practical issues when compared to the studies done by having
lectures alone as an intervention (Kalikar et al., 2020).
As
per the results obtained in the study, 40. 38 % of participants think that ADR
reporting is a professional obligation for them. It is noteworthy to mention
that, the majority of the participants (87. 95 %) think reporting of adverse
drug reaction of ASU&H drugs is necessary and Pharmacovigilance should be
taught in detail to all the healthcare professionals (87. 0 %) which coincide
with the study done on resident doctors by Gupta et al. who identified 89. 5 %
of resident doctors suggest the necessity of ADR reporting (Gupta et al., 2011). Similarly, another study also finds 82 % of medical students and
prescribing doctors felt the need for ADR reporting (Rehan et al., 2002). ADR reporting should be made mandatory to
physicians, pharmacists, and nursing staff as per 76. 51 % respondents. In
contrast to this, in a questionnaire-based study to evaluate the knowledge,
attitude, and practice of pharmacovigilance among doctors practicing
alternative systems of medicine in Southern India, only 12. 5 % thought that
reporting an ADR with ASU& H drugs is necessary (Rajesh et al., 2017).
Even though the ADR reporting was considered to be
important by a large majority of the participants (87. 95 %), the actual practices of ADR reporting were very low.
Only 8.23 % of the respondents
stated that they had reported an ADR previously. Some of the previous studies
also cited similar findings of under-reporting of ADR despite considering it as
important (Desai
et al., 2011). The major problem
associated with reporting ADRs is identified to be difficulty in deciding whether ADR has occurred or not
which is following the previous reports (Vallano et al., 2005). An interesting
observation was that 20.28 % feel that,
a single unreported case may not affect the ADR database. This attitude shows the passive perception and ignores the importance
of reporting ADRs.
Nonexposure of a substantial
proportion of participants (43.07 %) to any articles related to the topic drags
the individual away from the current updates of the program. A major proportion
of the respondents have not experienced adverse drug reactions during their
professional practice and 81.54 % have not reported any ADRs. This may be due
to a lack of training or lack of proper follow-up in identifying the ADR. Even a large number of respondents were also
not familiar with reporting misleading advertisements which shows the
importance and need of continuous awareness generation which can certainly help
in improving the reporting rates. Studies had also
shown that enhancing the knowledge and attitude of the medical graduates helps
in the practice of increasing ADR reporting to the concerned authorities (Wallace et al., 1995; Suveges et al., 1995).
Conclusion
Results of the study showed
better knowledge and attitude, but limited practice toward pharmacovigilance
and ADR reporting. The findings of the study suggest the scope for improving
the awareness among the students who will be the mainstay of health care delivery
in the future. For this, there is a need for incorporating educational
intervention as they are proven to be an effective tool in improving knowledge,
attitude, and practice. Revision and inclusion of updates related to the
pharmacovigilance programme in the curriculum would also help them to detect
adverse effects and report to the concerned authorities.
Funding
Ministry of Ayush Government
of India under Central Scheme of Ayush Oushadhi Gunvatta evum Uttpadan
Samvardhan Yojana (AOGUSY).
Conflict of interest
The authors declare no
conflict of interest.
Acknowledgement
Authors are thankful to Ministry of Ayush, Govt.
of India for funding the project, all the participants in the survey and
experts to review the questionnaires and Director, ITRA for all help.
References
Adheed, K. S., Haydar, F.
A., & Ghassan, S. A. (2017).
Knowledge, Attitude and Practice towards Pharmacovigilance and Adverse Drug
Reaction Reporting among Pharmacy Students in Basra University, Iraq. International Journal of Pharmaceutical
Sciences and Research, 46(2), 83-87.
Agarwal, M. (2017). Knowledge,
Attitude, and Practice About Pharmacovigilance Among Healthcare Providers of a
Tertiary Care Teaching Hospital in New Delhi (India). MAMC J Med Science, 3(3), 146-151.
Arora, D. (2008).
Pharmacovigilance obligations of the pharmaceuticals companies. Indian Journal of Pharmacology, 40(5), 13-16.
Bagewadi, H. G., Deodurg, P. M.,
Patil, B. V., Dass, A. P. (2018).
Knowledge, attitude, perceptions and assessment of effectiveness of educational
intervention on pharmacovigilance among undergraduate medical students at
Gulbarga Institute of Medical Sciences, Kalaburagi. International Journal of Basic & Clinical Pharmacology, 7(1), 103Ð108.
Chhabra, K. G., Sharma, A., Chhabra, C., Reddy,
J. J., Deolia, S. G., & Mittal, Y. (2017). Knowledge, Attitude, and
Practices regarding Pharmacovigilance and Adverse Drug Reaction reporting among
Dental Students in a Teaching Hospital, Jodhpur, India: A Cross-sectional
Study. The journal of contemporary dental practice, 18(10),
964Ð969.
Desai, C. K., Iyer, G., Panchal, J., Shah, S.,
& Dikshit, R. K. (2011). An evaluation of knowledge, attitude, and practice
of adverse drug reaction reporting among prescribers at a tertiary care
hospital. Perspectives in clinical research, 2(4),
129Ð136.
Gaude, O. S., & Desa, S.
(2018). Assessment of knowledge, attitude, and practices of pharmacovigilance
and adverse drug reaction reporting among final year medical students-A
questionnaire-based study in a tertiary care hospital in Goa. National Journal of Physiology, Pharmacy and
Pharmacology, 8(12), 1657Ð1661.
Gupta, P., & Udupa, A.
(2011). Adverse Drug Reaction Reporting and Pharmacovigilance: Knowledge,
Attitudes and Perceptions amongst Resident Doctors. Journal of Pharmaceutical Sciences and Research, 3(2), 1064-1069.
Kalikar, M. V., Dakhale, G. N., & Shrirao,
M. (2020). Effect of educational intervention on awareness of pharmacovigilance
among medical undergraduates in a tertiary care teaching hospital. Perspectives
in clinical research, 11(2), 92Ð96.
Kumar A. (2017). Pharmacovigilance: Importance,
concepts, and processes. American journal of health-system pharmacy: AJHP : official journal of the American Society of
Health-System Pharmacists, 74(8), 606Ð612.
Limaye, D., Shah, P., Shah,
A., Pillay, R., Modak, V., Chaudhari, A., Sydymanov, A., Limaye, V., Pitani, R.
S., Sathe, S., Fortwengel, G. (2018). A study to determine the knowledge of
pharmacovigilance among pharmacy students from Mumbai university. International Journal of Research in Medical
Sciences, 6(8), 2621-2625.
Patchva, L. D. (2018). Study
on the knowledge of pharmacovigilance among medical students. International Journal of Basic &
Clinical Pharmacology, 7(6), 1105-1108.
PIB. (2004). Press Information
Bureau Government of India. Retrieved 15 June 2021, from https://pib.gov.in/PressReleasePage.aspx?PRID=1542977
Prakash, B. G., Subash, K. R.,
Reddy, V. C. K., Sujith, K. D. S., Jyothi, P. K., Rao, U. K. (2016). Knowledge, attitude and practice
of pharmacovigilance among Ayurvedic practitioners: A questionnaire survey in
Andhra Pradesh, India. National Journal
of Physiology, Pharmacy and Pharmacology, 6(5), 475-479.
Rajesh, B., Dharani, D. R.,
& Waseem, A. (2017). Assessment
of knowledge, attitude and practice of pharmacovigilance among doctors
practicing alternative systems of medicine in Southern India: A questionnaire
based study. National Journal of Physiology,
Pharmacy and Pharmacology, 7(1), 119-122.
Rajesh, R., Vidyasagar, S.,
& Verma, D. M. (2011). An educational intervention to assess knowledge
attitude practice of pharmacovigilance among health care professionals in an
Indian tertiary care teaching hospital. International
Journal of PharmTech Research, 3(2), 678-692.
Rathod, K. & Panchal, A.
(2014). Knowledge, attitude and practice of community pharmacists of Gujarat
towards adverse drug reactions. International
Archives of Integrated Medicine, 1(1), 18Ð25.
Rehan, H. S., Vasudev, K., & Tripathi, C. D.
(2002). Adverse drug reaction monitoring: knowledge, attitude and practices of
medical students and prescribers. The National medical journal of India, 15(1),
24Ð26.
Reumerman, M., Tichelaar, J., Piersma, B.,
Richir, M. C., & van Agtmael, M. A. (2018). Urgent need to modernize
pharmacovigilance education in healthcare curricula: review of the
literature. European journal of clinical pharmacology, 74(10),
1235Ð1248.
Sharmind, N., Marzia, A.,
Syeda, F. H. M., & Hamza, A., M. (2020). Knowledge and Attitude about
Pharmacovigilance: A Cross-sectional Study Involving Pharmacy Students of
Selected Universities in Bangladesh. Journal
of Pharmacovigilance, 8(5), 28-29.
Suveges, L.G., Gesy, K., Wallace, S., Blackburn,
J.L., & Appel, W.C. (1995). Adverse Drug Reaction Reporting Part II:
Evaluation of the Saskatchewan Pilot Project for a Regional Reporting Program
in Canada. Therapeutic Innovation & Regulatory Science, 29, 581
- 589.
Toklu, H. Z., & Uysal, M. K. (2008). The
knowledge and attitude of the Turkish community pharmacists toward
pharmacovigilance in the Kadikoy district of Istanbul. Pharmacy world
& science: PWS, 30(5), 556Ð562.
Upadhyaya, H. B., Vora, M. B., Nagar, J. G.,
& Patel, P. B. (2015). Knowledge, attitude and practices toward
pharmacovigilance and adverse drug reactions in postgraduate students of
Tertiary Care Hospital in Gujarat. Journal of advanced pharmaceutical
technology & research, 6(1), 29Ð34.
Vallano, A., Cereza, G., Pedr˜s, C., Agust’, A.,
DanŽs, I., Aguilera, C., & Arnau, J. M. (2005). Obstacles and solutions for
spontaneous reporting of adverse drug reactions in the hospital. British
journal of clinical pharmacology, 60(6), 653Ð658.
van Eekeren, R., Rolfes, L., Koster, A. S.,
Magro, L., Parthasarathi, G., Al Ramimmy, H., Schutte, T., Tanaka, D., van
Puijenbroek, E., & HŠrmark, L. (2018). 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, 41(11), 1003Ð1011.
Wallace, S. M., Suveges, L.
G., & Gesy, K. F. (1995). Adverse drug reaction reporting part I: A survey
of pharmacists and physicians in Saskatchewan. Drug Information Journal, 29, 571-579.
-26-38.fld/image001.gif){kind=small}
Rabinarayan Acharya a, *, Raghavendra Naik b, Sourav Rang c, Chitrangad A. Jani d,
Galib R e, Sudipt Rath f-26-38.fld/image003.gif){kind=small}
-26-38.fld/image005.gif)