A Questionnaire based Cross-sectional Study to assess Knowledge, Attitude and Practice of Pharmacovigilance and Adverse Drug Reaction Reporting among Postgraduate Medical students in a Tertiary Care Teaching Hospital of South India
Pavithra M S1, Vijendra R2, Suja Xaviar3*
1Department of Pharmacology, Kempegowda Institute of Medical Sciences and Research Centre,
Bengaluru – 560070.
2Department of Pharmacology, Kempegowda Institute of Medical Sciences and Research Centre,
Bengaluru – 560070.
3Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research,
Puducherry – 605006.
Background: Spontaneous reporting of adverse drug reactions (ADRs) is one of the most common methods to obtain safety data. Lack of awareness is a major reason for under reporting. Hence, this study was undertaken to evaluate the knowledge, attitude and practices (KAP) of the postgraduates about pharmacovigilance and ADR reporting in Kempegowda Institute of Medical Sciences (KIMS), Bengaluru, a tertiary care teaching hospital.
Materials and Methods: A cross-sectional questionnaire-based survey was conducted among postgraduate students in a tertiary care teaching hospital in South India to evaluate the participants’ knowledge, attitude, and practice (KAP) on ADRs and Pharmacovigilance. A pre-designed and validated questionnaire containing 14 questions was used to assess knowledge, attitude and practice. The filled KAP questionnaires were analyzed and their percentage value was calculated by using Microsoft Excel spreadsheet. Results: A total of 120 postgraduate students participated in the study. Around 81% of participants agreed that reporting of ADRs is a professional obligation and all ADRs should be reported. They did not have adequate knowledge regarding the purpose of monitoring ADRs and 22.5% of study participants were unclear as to where and how to report ADRs. Unfortunately, only 12.5% of participants actually reported ADRs due to lack of proper sensitization and knowledge of pharmacovigilance and ADR. Conclusion: This study revealed that the postgraduate students have a good attitude towards ADR reporting. However, they lack knowledge and the actual practice of ADR reporting is still lacking among them. There is a need to create awareness among the health care professionals about ADR reporting and pharmacovigilance. Educational interventions targeting the medical fraternity should be implemented to help improve spontaneous reporting and knowledge of pharmacovigilance and ADR.
Adverse drug reactions (ADRs) are a major concern globally. They affect both children and adults and are a leading cause of morbidity and mortality.1-4 ADRs impose an enormous economic burden on the society and the prevalent health-care systems.5,6,7
Post marketing surveillance of drugs plays a huge role in the risk management associated with drugs once they come into the market.8, 9 Spontaneous reporting has had a major impact in contributing to the success of the pharmacovigilance program. Healthcare professionals play a pivotal role in contributing to signal detection of unsuspected and unusual ADRs previously undetected during the initial evaluation of a drug.10, 11, 12 However, under-reporting is a major draw-back of spontaneous reporting.11, 13, 14, 15 An estimate of only 6–10% of all ADRs are reported.16, 17 This high rate of under-reporting can lead to the delay of signal detection leading to a negative impact on the public health. ADRs account for about 5-20% of hospital admissions.3, 4 World Health organization (WHO) defines ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man, for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.”18
Various studies point out the inadequacy in knowledge about pharmacovigilance among health care professionals and poor attitude towards reporting.19, .20 Hence, assessment of awareness among the medical fraternity is important to increase the rate of reporting of ADRs.
As future practitioners, it is important to train the postgraduate students to recognize, prevent and report ADRs. This study was therefore aimed at investigating the knowledge, attitude and practice of pharmacovigilance and adverse drug reaction reporting among postgraduate medical students in a Tertiary Care Teaching Hospital of South India.
MATERIALS AND METHODS:
The study was conducted at KIMS, Bengaluru, a tertiary care teaching hospital in South India for a period of 3 months from June to August 2017. Approval was duly taken from Institutional Ethics Committee to conduct the study. The study was conducted according to the Declaration of Helsinki guidelines.
Type of study:
It was a cross‑sectional, anonymous, KAP questionnaire study.
Convenient sampling method was used to enroll the postgraduate medical students in the study.
Conduct of the study:
Before the start of the study, the KAP questionnaire toward pharmacovigilance and ADR reporting was developed by referring previous study14 and peer viewed by expert faculties from our department of pharmacology. The finalized validated KAP questionnaire consisted of 14 questions. (Appendix 1). The questionnaire was distributed to the study participants after explaining the purpose of the study and obtaining informed consent. They were given a time of 1 day to return back the duly filled form. The performance was assessed by scores (0 = No/Not answered/incorrect, and 1 = Yes/ correct), and the total score was calculated. The KAP survey questionnaire was analyzed, question‑wise and their percentage value was calculated with the help of Microsoft excel spread sheet in MS Office 2007.
In our study, postgraduate resident doctors (n = 120) were enrolled from different departments. Enrolled residents include 1st year (n = 50), 2nd year (n = 40), 3rd year (n = 30) [Table 1]. Out of the total (n = 120) postgraduate students, 76 males and 44 females filled the questionnaires. The mean age of the participants was 25.32±3.12 years.
Table 1: Demographic details of postgraduate students (n=120)
Year of residency
1st year 2nd year 3rd year
30 (25) 18 (15) 28 (23.3)
18 (15) 16 (13.3) 10 (8.3)
*Figure in parenthesis represents percentage.
Response rate: One hundred and fifty questionnaires were distributed among the medical postgraduates and 120 responded to give a response rate of 80%.
About 81% of participants agreed that ADR reporting is a professional obligation. Only 22.5% were aware of the National Pharmacovigilance Programme of India. A good 96% agreed that reporting of ADRs is necessary. 66.3% post-graduate students were aware that the most important purpose of pharmacovigilance is to assess the safety of a drug. Only 12.5% post-graduate students actually reported ADRs. Time constraints in reporting ADRs was a challenge for 35% of postgraduate students. 25.5% of postgraduate students did not know where and how to report an ADR. 80% were not aware about ADR reporting form. 85% reported that ADR reporting should be voluntary.
The postgraduate students have a good attitude towards pharmacovigilance and ADR reporting as shown by the total KAP score in figure 1.
Figure 1: Total KAP scores
The present study is a questionnaire-based survey conducted to assess the knowledge, attitude and practice of pharmacovigilance and ADR reporting among postgraduate students in a tertiary care teaching hospital.
Underreporting of ADR is a well-recognized global problem associated with spontaneous ADR reporting system. The knowledge, attitude and practice of healthcare professionals have a huge impact in spontaneous reporting of ADRs.21, 22, 23
Hence, the present study was undertaken to assess the knowledge, attitude and practice of postgraduates on ADR reporting. A total of 120 postgraduate students from various specialties had participated in the survey.
From this study, it was clear that the students have inadequate knowledge about pharmacovigilance, which is in accordance with the finding of Vora et al.24 Pharmacovigilance aims to ensure patient safety and rational medicine use and has played a vital role in detection of ADRs. However, previous studies point out that under-reporting of ADRs is one of the major problems encountered with pharmacovigilance program.25 Major cause for substantial under reporting is deficiency of knowledge and skill about pharmacovigilance program, which was reflected in our study, and it corroborates with the finding of studies done previously.26,27 This can be overcome by periodically training the healthcare professionals through educational intervention programs like continuous medical education (CME), and workshops on pharmacovigilance.28 Students exhibited better attitude, but limited knowledge and poor practice toward pharmacovigilance. The findings of the study suggest a great scope for improving the awareness and knowledge about pharmacovigilance among the students who constitute to be the backbone of health care.29, 30 Hence, there is a need for continuous educational interventions like CME and workshops, and it should also be incorporated in their curriculum.31, 32
The present study reveals that majority of participants have good attitude about hospital-based ADR monitoring. ADR reporting can be further enhanced by improving access to ADR reporting forms, using user-friendly methods such as electronic reporting and by educational intervention programs for sensitization regarding pharmacovigilance and ADR reporting system. This can to some extent help in improving the ongoing pharmacovigilance activities.
CONFLICTS OF INTERESTS:
All authors have none to declare.
The author(s) received no financial support for the research, authorship, and/or publication of this article.
We gratefully acknowledge the participation of the postgraduate medical students of Kempegowda Institute of Medical Sciences (KIMS), Bengaluru, Karnataka, India.
1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta‑analysis of prospective studies. JAMA 1998; 279:1200‑5.
2. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18 820 patients. BMJ 2004; 329:15‑9.
3. Oshikoya KA. Adverse drug reaction in children: Types, incidence and risk factors. Niger J Paediatr2006; 33:29‑35.
4. Martínez‑Mir I, García‑López M, Palop V, Ferrer JM, Rubio E, Morales‑Olivas FJ. A prospective study of adverse drug reactions in hospitalized children. Br J Clin Pharmacol 1999; 47:681‑8.
5. Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009 11; 9:14.
6. Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med 2003; 18:57‑60.
7. Abdullahi Rabiu Abubakar, Nordin Bin Simbak, Mainul Haque. Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment. Research J. Pharm. and Tech. 7(9): Sept. 2014 Page 1091-1098.
8. 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
9. Priyanka Paruthi, Ganesh Pansare, Avinash Khairnar. Use of Triggers to Detect Adverse Drug Reaction Induced By Cardiovascular Drugs in Outpatient Department in Nasik City. Research J. Pharm. and Tech. 4(12): Dec. 2011; Page 1819-1821.
10. Meyboom R, Osslen S, Thorogood M. Teaching pharmacovigilance. In: Mann RD, Andrews EB, editor. Pharmacovigilance. Chichester: John Wiley and Sons; 2002. p. 505‑8.
11. Pharmacovigilance programme of India 2010. CDSCO, Ministry of Health and Family Welfare, Government of India. 2010. Available from: http://www.cdsco.nic.in/pharmacovigilance.html. [Last accessed on 2020 March 31].
12. 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
13. Hartigan‑Go K. Pharmacovigilance and the pursuit of rational drug use: The Philippines experience. Uppsala Rep 2001; 14S: 1‑4.
14. 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
15. Sornalakshmi. K, Vadivu. G, Sujatha G, Hemavathi. D. A Survey on using Social Media Data Analytics for Pharmacovigilance. Research J. Pharm. and Tech 2017; 10(10):3474-3478. doi: 10.5958/0974-360X.2017.00621.7
16. Green CF, Mottram DR, Brown AM, Rowe PH. Attitudes of hospital pharmacists to adverse drug reactions and the ‘yellow card’ scheme: A qualitative study. Int J Pharm Pract 1999; 7:247‑55
17. Amrita P, Kharbanda B. Knowledge, attitude and skills of nurses of Delhi towards adverse drug reaction reporting. Indian J Pharm Pract 2012; 5:45‑51.
18. Geneva, Switzerland: Office of Publications; 2002. World Health Organization (WHO) (A) World Health Organization. The Importance on Pharmacovigilance. Safety Monitoring on Medicinal Products. WHO/EDM/QSM/2002.
19. Perlik F, Slanar O, Smíd M, Petracek J. Attitude of Czech physicians to adverse drug reaction reporting. European journal of clinical pharmacology. 2002 Aug 1; 58(5):367-9.
20. Hasford J, Goettler M, Munter KH, Müller-Oerlinghausen B. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. Journal of clinical epidemiology. 2002 Sep 1; 55(9):945-50.
21. Palaian S, Ibrahim MI, Mishra P. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharm Pract (Granada) 2011; 9:228-35
22. Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: An observational study. J Nat Sci Biol Med. 2013; 4(1):191-6.
23. 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.
24. Vora MB, Paliwal NP, Doshi VG, Barvaliya MJ, Tripathi CB. Knowledge of adverse drug reactions and pharmacovigilance activity among the undergraduate students of Gujarat. Int J Pharm Sci Res 2012; 3:1511-5
25. Anuradha CR, Komathi J, Subashree A. A cross-sectional study on the knowledge, attitude, and practices of pharmacovigilance among health-care professionals at a tertiary care teaching hospital. National Journal of Physiology, Pharmacy and Pharmacology. 2020;10(08):682-7.
26. Al Rabayah AA, Esra’a Mahmoud Hanoun RH, Rumman A. Assessing knowledge, attitude, and practices of health-care providers toward pharmacovigilance and adverse drug reaction reporting at a comprehensive cancer center in Jordan. Perspectives in clinical research. 2019 Jul; 10(3):115.
27. Radhakrishnan R, Vidyasagar S, Varma DM. An educational intervention to assess knowledge attitude practice of pharmacovigilance among health care professionals in an Indian Tertiary Care Teaching Hospital. Int J PharmTech Res 2011; 3:678-92. Back to cited text no. 21
28. Subish P, Mahamed Izam MI, Mishra P, Shankar PR, Alam K. Education session for pharmacy students on pharmacovigilance. A preliminary study. J Clin Diagn Res 2010; 4:2427-32.
29. Kumar S, Badruddeen, Singh S P, Juber A, Khan M I. Evaluation of dermatological adverse drug reactions in a tertiary care hospital of northern India. Research Jour Pharm and Tech. 2019; 12(7): 3517-3521.
30. Chinnu Scaria, Ananthu Satheesh, Pooja Prabhakar, Juno J. Joel, Shishir Kumar. Evaluation of Adverse Drug Reactions and their Management in Psychiatric in-Patients. Research J. Pharm. and Tech. 2019; 12(7):3455-3461. doi: 10.5958/0974-360X.2019.00585.7
31. 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
1. Have you heard of ADR? Yes/ No
If yes, expand ADR
2. Have you ever seen ADR reporting form?
a. Yes b. No
3. Have you ever reported ADR to Pharmacovigilance centre?
a. Yes b. No
4. Do you think ADR reporting is necessary?
a. Yes b. No
5. Do you think ADR reporting is a professional obligation?
a. Yes b. No
6. Is there any Pharmacovigilance committee in your institution?
a. Yes b. No
7. Do you know regarding National Pharmacovigilance Programme of India (NPVPI)?
a. Yes b. No
8. Do you think that it is necessary to report only serious and unexpected reactions?
a. Yes b. No
9. Which of the following factor discourage you from reporting ADRs?
a. Lack of time
b. Single unreported case may not affect ADR database
c. Difficult to say whether ADR has occurred or not.
10. Healthcare professionals responsible for reporting ADRs in hospital is/are
a. Doctor c. Pharmacist
b. Nurses d. All the above
11. Do you think reporting ADR should be voluntary?
a. Yes b. No
12. Have you ever experienced ADR in your patient during your practice?
a. Yes b. No
13. Do you think ADR reporting should be compulsory?
a. Yes b. No
14. Purpose of Pharmacovigilance is
a. To identify safety of the drug
b. To calculate incidence of ADRs
c. To identify predisposing factors to ADRs
d. To identify previously unrecognized ADRs
Received on 09.04.2020 Modified on 18.04.2021
Accepted on 24.10.2021 © RJPT All right reserved