An evaluation of knowledge, attitude and practice of pharmacovigilance among medical students and doctors at a tertiary care hospital

Ravindra S. Beedimani, Sameer Uz Zaman, Subrahmanyam Darb, Sharat Chandra Potturi


Background: Drugs are one of the most commonly used interventions in medical therapeutics. Spontaneous reporting of adverse drug reactions (ADRs) is the backbone of pharmacovigilance (PV) program. Under-reporting of ADRs by prescribers was possibly due to lack of knowledge, attitude and practices regarding PV. This study was done to assess the knowledge, attitude, and practice (KAP) of medical students (grouped to sixth and eighth semester) and medical doctors about PV in a tertiary care hospital.

Methods: It was a questionnaire based cross-sectional study administered to 246 medical students and doctors. Study tool was a validated questionnaire containing 15 questions to evaluate KAP of PV among medical students and doctors. A descriptive analysis of data was done where necessary, statistical significance for associations between the group and their responses to questionnaire was provided using Pearson Chi square test and Fisher exact test.

Results: Sixty-eight percent of the participants (90% doctors; 76% eighth-semester and 46% sixth-semester medical students) know the correct definition of PV. Sixty-one percent of the participants (67% sixth-semester, 61% doctors and 53% eighth-semester) think that reporting is a professional obligation for them. Only 15% of the participants have ever been taught or trained on how to report an ADR.

Conclusions: Medical doctors and students lack adequate knowledge and practice of reporting ADRs, but they seem to have a positive attitude towards the PV program. Our study findings strongly suggest that there is a great need to create awareness amongst them to promote reporting of ADRs.


Adverse drug reactions, Doctors, Medical students, Pharmacovigilance

Full Text:



Abubakar AR, Chedi BA, Mohammed KG, Haque M. Perception of Nigerian medical students on adverse drug reaction reporting. J Adv Pharm Technol Res 2015;6:154-8.

Haile DB, Ayen WY, Tiwari P. Prevalence and assessment of factors contributing to adverse drug reactions in wards of a tertiary care hospital, India. Ethiop J Health Sci. 2013;23:39-48.

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

Bouvy JC, De Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies. Drug Saf. 2015;38:437-53.

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.

Wester K, Jonsson AK, Spigset O, Druid H, Hagg S. Incidence of fatal adverse drug reactions: a population based study. Br J Clin Pharmacol. 2008;65:573-9.

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.

Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol. 2016;48:624-8.

Upadhyaya HB, Vora MB, Nagar JG, Patel PB. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat. J Adv Pharm Technol Res. 2015;6:29-34.

Ganesan S, Sandhiya S, Reddy KC, Subrahmanyam DK, Adithan C. The Impact of the Educational Intervention on Knowledge, Attitude, and Practice of Pharmacovigilance toward Adverse Drug Reactions Reporting among Health-care Professionals in a Tertiary Care Hospital in South India. J Nat Sci Biol Med. 2017;8:203-9.

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.

Hardeep, Bajaj JK, Rakesh K. A survey on the knowledge, attitude and the practice of pharmacovigilance among the health care professionals in a teaching hospital in northern India. J Clin Diagn Res. 2013;7:97-9.

Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian J Pharmacol. 2015;47:65-71.

Chopra D, Wardhan N, Rehan HS. Knowledge, attitude and practices associated with adverse drug reaction reporting amongst doctors in a teaching hospital. Int J Risk Saf Med. 2011;23:227-32.

Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32:19-31.

Williams D, Feely J. Underreporting of adverse drug reactions: attitudes of Irish doctors. Ir J Med Sci. 1999;168:257-61.

Agarwal R, Daher AM, Mohd IN. Knowledge, practices and attitudes towards adverse drug reaction reporting by private practitioners from klang valley in malaysia. Malays J Med Sci. 2013;20:52-61.

Alshammari TM, Alamri KK, Ghawa YA, Alohali NF, Abualkol SA, Aljadhey HS. Knowledge and attitude of health-care professionals in hospitals towards pharmacovigilance in Saudi Arabia. Int J Clin Pharm. 2015;37:1104-10.