• Dharini B Department of Pharmacovigilance, SDSTRC and Rajiv Gandhi Institute of Chest Diseases. Bengaluru, Karnataka, India.
  • Nagarjuna Reddy V Indira Gandhi Institute of Child Health, Bengaluru, Karnataka, India.
  • Deepalakshmi M Department of Pharmacy Practice, JSSCP, Ooty, Tamil Nadu, India.
  • Pramod Kumar A National Coordination Center Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India.


 Objective: The objective of this study is to assess awareness of Pharmacovigilance among the healthcare professionals and to evaluate the impact of an educational intervention for improving awareness of Pharmacovigilance among the nursing staff and nursing students from Bengaluru, Karnataka, India.

Methods: A cross-sectional study was carried out using a validated questionnaire that included demographic details and 20 survey items to evaluate the participants’ knowledge, attitude, and perception (KAP) on adverse drug reactions (ADRs) and Pharmacovigilance. All participants received an interactive educational intervention in the form of a lecture. A pre- and post-KAP questionnaire survey was used to evaluate the impact of educational intervention among the participants. The Statistical Package for Social Sciences statistical software, version 16, was used to analyze the data.

Results: A total of 103 healthcare professionals in the study responded to the pre- and post-KAP survey questionnaires. 66 nursing students and 37 nursing staff were involved in the study. The increased awareness among the study subjects about pharmacovigilance between pre- and post-intervention was statistically significant (p<0.001) which showed the effectiveness of educational intervention carried out.

Conclusion: The results show that participants in the study were only moderately aware of ADR monitoring. However, they had expressed a positive attitude toward Pharmacovigilance and ADRs reporting. There is a need to create awareness among the nursing fraternity about ADR reporting for improving the spontaneous reporting.

Keywords: Pharmacovigilance, Knowledge, Attitude, and perception questionnaire, Adverse drug reactions.


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. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA 1997;277:301-6.
3. World Health Organization. Requirements for Adverse Reaction Reporting. Geneva, Switzerland: World Health Organization; 1975.
4. Hanafi S, Torkamandi H, Hayatshahi A, Gholami K, Javadi M. Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting. Iran J Nurs Midwifery Res 2012;17:21-5.
5. Ahmad SR. Adverse drug event monitoring at the food and drug administration. J Gen Intern Med 2003;18:57-60.
6. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the united states, 1969-2002: The importance of reporting suspected reactions. Arch Intern Med 2005;165:1363-9.
7. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: A systematic review. Drug Saf 2006;29:385-96.
8. Moride Y, Haramburu F, Requejo AA, Bégaud B. Under-reporting of adverse drug reactions in general practice. Br J Clin Pharmacol 1997;43:177-81.
9. Heeley E, Riley J, Layton D, Wilton LV, Shakir SA. Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001;358:1872-3.
10. Figueiras A, Tato F, Fontaiñas J, Gestal-Otero JJ. Influence of physicians’ attitudes on reporting adverse drug events: A case-control study. Med Care 1999;37:809-14.
11. Williams D, Feely J. Underreporting of adverse drug reactions: Attitudes of Irish doctors. Ir J Med Sci 1999;168:257-61.
12. Perlík F, Slanar O, Smíd M, Petrácek J. Attitude of Czech physicians to adverse drug reaction reporting. Eur J Clin Pharmacol 2002;58:367-9.
13. Belton KJ, Lewis SC, Payne S, Rawlins MD, Wood SM. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 1995;39:223-6.
14. Hasford J, Goettler M, Munter KH, Müller-Oerlinghausen B. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002;55:945-50.
15. Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Physicians’ attitudes and adverse drug reaction reporting: A case-control study in Portugal. Drug Saf 2005;28:825-33.
16. Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJ, Aronson JK, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the committee on safety of medicines. Br J Clin Pharmacol 1996;42:423-9.
17. Feely J, Moriarty S, O’Connor P. Stimulating reporting of adverse drug reactions by using a fee. BMJ 1990;300:22-3.
18. Shuka SS, Bina G, Pandey R, Rao SP, Singh V, Amber V. Importance of pharmacovigilance in Indian pharmaceutical industry. Asian J Res Pharm Sci 2012;2:4-8.
19. Von Laue NC, Schwappach DL, Koeck CM. The epidemiology of preventable adverse drug events: A review of literature. Wien Klin Wochenschr 2003;115:407-15.
20. Wu WK, Pantaleo N. Evaluation of outpatient adverse drug reactions leading to hospitalization. Am J Health Syst Pharm 2003;60:253-9.
21. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: Predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf 2007;16:223-8.
22. Olsson S. The need for pharmacovigilance. In: Gupta SK, editor. Pharmacology and Therapeutics in the New Millennium. New Delhi: Narosa Publishing House; 2001. p. 502-8.
23. Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:14.
24. Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001;51:81-6.
25. Subish P, Izham M, 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. Int J Pharm 2007;6:1-5.
26. Rajesh R, Vidyasagar S, Nandakumar K. Retracted by plagiarism: Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients. Pharm Pract (Granada) 2011;9:48-55.
27. Ministry of Health and Family Welfare, Government of India. Pharmacovigilance Programme of India 2010. CDSCO, Ministry of Health and Family Welfare, Government of India; 2010.
28. Hajebi G, Mortazavi SA, Salamzadeh J, Zian A. A survey of knowledge, attitude and practice of nurses towards pharamacovigilance in Taleqani hospital. Iran J Pharm Res 2010;9:199-206.
29. Ulfvarson J, Mejyr S, Bergman U. Nurses are increasingly involved in pharmacovigilance in Sweden. Pharmacoepidemiol Drug Saf 2007;16:532-7.
30. Backstrom M, Mjorndal T, Dahlqvist R. Spontaneous reporting of adverse drug reactions by nurses. Pharmacoepidemiol Drug Saf 2000;11:647-50.
31. Shalini S, Mohan S. A study on the awareness and attitude towards pharmacovigilance and adverse drug reaction reporting among nursing students in a private university, Malaysia. Int J Curr Pharm Res 2015;7:84-9.
32. Arjun TN, Sudhir H, Gouraha A, Jain S, Chavan K, Dayma A. Assessment of knowledge, attitude and practice related to pharmacovigilance among the healthcare professionals in a teaching hospital in central India: An questionnaire study. World J Pharm Pharm Sci 2015:4;785-99.
33. Patil A, Gurav YA, Thorat MB, Walsangikar SD. Survey of pharmacovigilance awareness among healthcare professionals. Int J Pharm Ther 2014;4:31-4.
34. Kamtane RA, Jayawardhani V. Knowledge, attitude and perception of physicians towards Adverse drug reaction reporting: A Pharmacoepidemiological study. Int J Pharm Pharm Sci 2012;4:698-704.
35. Gupta SK, Nayak RP, Shivaranjani R, Vidyarthi SK. A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India. Perspect Clin Res 2015;6:45-52.
36. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Saf 2009;32:19-31.
37. Sindhuja CH, Shafiya begum SK, Suryateja P, Sudha P. Knowledge, attitude and behavior of community pharmacists towards adverse drug reactions. Int J Pharm Pharm Sci 2015;7:258-61.
38. Chatterjee S, Lyle N, Ghosh S. A survey of the knowledge, attitude and practice of adverse drug reaction reporting by clinicians in eastern India. Drug Saf 2006;29:641-2.
359 Views | 390 Downloads
How to Cite
B, D., N. Reddy V, D. M, and P. K. A. “KNOWLEDGE, ATTITUDE, AND PRACTICE TOWARD PHARMACOVIGILANCE AND ADVERSE DRUG REACTION REPORTING AMONG NURSING STAFF AND STUDENTS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 11, no. 3, Mar. 2018, pp. 62-67, doi:10.22159/ajpcr.2018.v11i3.22700.
Original Article(s)