A KAP study of pharmacovigilance among junior residents and interns of a tertiary care hospital


  • Rupa Arun Korde Department of Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India
  • Radhika M. S. Department of Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India




Adverse drug reactions, attitude, knowledge, Pharmacovigilance, prescribing practice


Background: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. An “adverse drug reaction” is any noxious, unintended and undesired effect of a drug, which occurs at a dose used in humans for prophylaxis, diagnosis, therapy or modification of physiological functions. Reporting of adverse events and adverse drug reactions is the commonest method utilized for generating safety data. Lack of awareness about Pharmacovigilance is one of the most important causes of such under-reporting. Spontaneous reporting system is considered the main mechanism of pharmacovigilance study for gathering information about ADRs. Hence this study was undertaken to assess the knowledge, attitude and practice regarding Pharmacovigilance among junior residents and interns in a tertiary care hospital.

Methods: A cross-sectional study was carried out in 134 doctors using pre-validated 20 item questionnaire with details of participant’s information followed by questions regarding knowledge, attitude and prescribing practice of pharmacovigilance was used as a tool, administrated to all the resident doctors and the collected data was analysed.

Results: Our study revealed that knowledge about pharmacovigilance was not adequate to JRs and INTs. Survey results revealed that the knowledge of pharmacovigilance among doctors 63 (88.73%) JR and 49 (77.78%) INTs had a knowledge score of less than 50%. This shows that only few doctors are aware about the pharmacovigilance programme. The assessment of questionnaire based on attitude regarding pharmacovigilance shows that 21 (29.58%) JR and 17 (26.98%) of INTs had attitude score of 70% and above. The attitude score was less compared to the knowledge score of JRs and INTs. 52 JR and 58 INTs stated that they have not been trained on how to report ADRs and basic orientation about pharmacovigilance which hinders the process of practicing pharmacovigilance. Conclusions: For the success of Pharmacovigilance programmes only knowledge and attitude regarding Pharmacovigilance is not enough as is evident from our study. Success of Pharmacovigilance programmes depend also upon the effective practice of Pharmacovigilance by healthcare professionals.


World Health Organization Collaborating Center for International Drug Monitoring. The importance of pharmacovigilance. Safety monitoring of medicinal products. Geneva: World Health Organization; 2002.

World Health Organization Collaborating Center for International Drug Monitoring. Geneva: World Health Organization; 1984. WHO publication DEM/NC/84.153 (E).

WHO. Safety of Medicines. A guide to detecting and reporting adverse drug reactions. Why health professionals need to take action. Geneva, World Health Organization; 2002. WHO/EDM/QSM/2002.2

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45.

John LJ, Mohamad A. Reporting of ADR: an exploratory study among nurses in a technical hospital. Ajman, United Arab Emirates. Daru J Pharm Sci. 2012;20(44):2-6.

Feely J, Moriarty S, O' Connor P: Stimulating reporting of adverse drug reaction by using a fee. Br Med J. 1990;300:22-3.

Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJM, 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.

Lee KK, Chan TY, Raymond K, Critchley JA. Pharmacists’ attitudes toward adverse drug reaction reporting in Hong Kong. Ann Pharmacother. 1994;28(12):1400-3.

Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf. 2007;16(2):223-8.

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.

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 Pharm Tech Res. 2011;3:678-92.

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

Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Saf. 2009;32:19-31. [PubMed: 19132802]

Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol. 1999;48:623-7. [PMCID: PMC2014371] [PubMed: 10583035]

Muraraiah S, Rajarathna K, Sreedhar D, Basavalingu D, Jayanthi CR. A questionnaire study to assess the knowledge, attitude and practice of Pharmacovigilance in a paediatric tertiary care centre. J Chem Pharm Res. 2011;3(6):416-22.




How to Cite

Korde, R. A., & S., R. M. (2018). A KAP study of pharmacovigilance among junior residents and interns of a tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 7(11), 2178–2183. https://doi.org/10.18203/2319-2003.ijbcp20184324



Original Research Articles