Adverse drug reactions reporting among nursing staff and students: a validated questionnaire based knowledge, attitude and practice study


  • Lohit K Department of Pharmacology, Sri Siddhartha Medical College, Tumakuru, Karnataka, India
  • Leena A. Department of Pharmacology, PES Institute of Medical Sciences and Research, Kuppam, Andhra Pradesh, India
  • Jose Maria Department of Pharmacology, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India
  • Amruta A. Pandit Department of Pharmacology, St John’s National Institute of Health Sciences, Bengaluru, Karnataka, India



Adverse drug reaction, Attitude, India Knowledge, Nurse, Practice


Background: Lack of knowledge regarding pharmacovigilance and adverse drug reaction (ADR) reporting among healthcare providers have been identified as major factors for under reporting of ADR in developing countries. Hence this study was planned to assess the knowledge and attitude of nursing faculty and students towards ADR reporting and also to determine the barriers to reporting ADR.

Methods: A validated questionnaire based cross sectional study conducted among the nursing faculty and students in a tertiary health care center. Data was assessed by frequency, percentage, mean and standard deviation. Statistical analysis was performed by using SPSS version 22.

Results: The composite score on knowledge on ADR reporting was found to be moderate among nursing staff, GNM and BSc nursing students. The knowledge on burden due to ADR was found to be poor among all the three categories. Around 70% of all the respondents were of the opinion that ADR reporting by one person can make a significant difference to the community. More than 80% of nursing staff and GNM students opined one should have a suspicion of possible ADR during treatment. Majority of the nursing staff were in favour of mandatory and voluntary ADR reporting in the hospital.

Conclusions: The nurses were only moderately aware of pharmacovigilance and adverse drug reaction reporting. Though the attitude towards ADR reporting was adequate, our study has shown that the actual practice of ADR reporting is unsatisfactory. Hence, it is essential to include pharmacovigilance training in the undergraduate teaching programs of nurses to promote reporting of adverse reactions.


Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385-96.

Hall M, McCormack P, Arthurs N, Feely J. The spontaneous reporting of adverse drug reactions by nurses. Br J Clin Pharmacol. 1995;40(2):173-5.

Lohit K, Vidya KR, Manjunath GN. Development and Validation of Questionnaire to Assess the Knowledge, Attitude and Practice towards Adverse Drug Reactions Reporting among Healthcare Professionals. Journal of International Medicine and Dentistry. 2016;3(2):63-72.

Kharkar M, Bowalekar S. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting. Perspect Clin Res. 2012;3:90-4.

Backstrom M, Ekman E, Mjorndal T. Adverse drug reaction reporting by nurses in Sweden. Eur J Clin Pharmacol. 2007;63(6):613-8.

Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: Knowledge, attitudes and perceptions among resident doctors. J Pharm Sci Res. 2011;3:1064-9.

Ramesh M, Parthasarathi G. Adverse drug reactions reporting: attitudes and perceptions of medical practitioners. Asian J Pharm Clin Res. 2009;2:10-4.

Ghosh S, Ali S, Chhabra L, Prasad C, Gupta A. Investigation of attitudes and perception of medical practitioners on adverse drug reaction reporting: a pilot study. T Ph Res. 2010;3:1-9.

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 Jan;17(1):21-5.

Sencan N, Altinkaynak M, Ferah I, Ozyildirim A, Ceylan EM, Clark PM. The knowledge and attitudes of physicians and nurses toward adverse event reporting and the effect of pharmacovigilance training: A hospital experience. Hacettepe University J Faculty Pharm. 2010;30(1):25-40.

Sivadasan S, Sellappan M. 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. 2014;7(1):84-9.

Backstrom M, Mjorndal T, Dahlqvist R. Spontaneous reporting of adverse drug reactions by nurses. Pharmacoepidemiol Drug Saf. 2002;11(8):647-50.

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(1):81-6.

Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitude and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: An observational study. J Nat Sci Biol Med. 2013;4:191-6.

Remesh A. Identifying the reasons for under reporting of ADR: A cross sectional survey. Res J Pharm Biol Chem Sci. 2012;3:1379-86.

Hanafi S, Torkamandi H, Hayatshahi A, Gholami K, Shahmirzadi NA, Javadi MR. An educational intervention to improve nurses’ knowledge, attitude, and practice toward reporting of adverse drug reactions. Iranian J of N and Mid Res. 2014;19(1):101-6.




How to Cite

K, L., A., L., Maria, J., & Pandit, A. A. (2017). Adverse drug reactions reporting among nursing staff and students: a validated questionnaire based knowledge, attitude and practice study. International Journal of Basic & Clinical Pharmacology, 6(3), 523–527.



Original Research Articles