Published: 2020-01-24

Assessment of knowledge and reporting of adverse drug reaction in resident doctors in a teaching hospital in North India

Vaishalee Punj, Mushtaq Ahmad Hakeem


Background: This study was done to assess the knowledge, attitude and practices of residents towards pharmacovigilance in a teaching hospital in North India.

Methods: A cross-sectional study was conducted among residents of Chintpurni Medical College and Hospital, Pathankot (CMC&H). A questionnaire containing 17 questions was distributed to 80 residents of CMC&H, Pathankot. This study was conducted over a period of 3 months from July to September, 2017.

Results: 64 out of the 80 residents (80%) responded to questionnaire. Among the respondents, 6% did not know the term adverse drug reaction (ADR) and almost 18% did not witness any ADR during clinical practice. Among those who witnessed ADRs nearly 25% could not ascertain the type of ADR. Those who ascertained ADRs claimed that upto 60% suspected ADRs required short hospitalisation. 6% residents did not consider ADRs avoidable and almost 25% residents did not consider ADRs predictable. 37% residents did not report the ADRs to anyone and nearly 43% did not know whom to report the ADRs. More than 18% claimed that they were not taught about PV in undergraduate curricular practical training teaching. Up to 31% residents claimed that nobody ever discussed with them about ADR reporting during internship.

Conclusions: According to this study, residents lack adequate knowledge and practice of reporting ADRs. This study suggests a greater need to create awareness amongst them to promote reporting of ADRs. This study also suggests that incorporation of Pharmacovigilance in medical curriculum will strengthen pharmacovigilance activity.


Pharmacovigilance, Adverse drug reaction, Reporting, Knowledge, Residents

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WHO. Adverse reaction. WHO, 1972. Available at: Accessed on 30 October 2019.

Giardina C, Cutroneo PM, Mocciaro E, Russo GT, Mandraffino G, Basile G, et al. Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study. Front Pharmacol. 2018;9:350.

Lindquist M. VigiBase, the WHO Global ICSR Database System: basic facts. Drug Inf J. 2008;42(5):409-19.

FDA. Questions and Answers on FDA's Adverse Event Reporting System (FAERS). Available at: Accessed on 4 November 2019.

Stergiopoulos S, Brown CA, Felix T, Grampp G, Getz KA. A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals. Drug Saf. 2016;39(11):1117-27.

Kalaiselvan V, Thota P, Singh GN. Pharmaco-vigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol. 2016;48(6):624-8.

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(1):65-71.

Upadhyaya P, Seth V, Moghe V V, Sharma M, Ahmed M. Knowledge of adverse drug reaction reporting in first year postgraduate doctors in a medical college. Ther Clin Risk Manag. 2012;8:307-12.

Baitha U, Ranjan P, Sarkar S, Arora C, Kumari A, Dwivedi SN, et al. Development of a self-assessment tool for resident doctors’ communication skills in India. J Educ Eval Health Prof. 2019;16:17.

Agarwal M, Ahmed J, Roy V. Knowledge, Attitude, and Practice About Pharmacovigilance Among Healthcare Providers of a Tertiary Care Teaching Hospital in New Delhi (India). MAMC J Med Sci. 2017;3:146-51.

Sundaran S, Udayan A, Hareendranath K, Eliyas B, Ganesan B, Hassan A, et al. Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients. Pharmacy (Basel). 2018;6(4):108.

Nisa Z U, Zafar A, Sher F. Assessment of knowledge, attitude and practice of adverse drug reaction reporting among healthcare professionals in secondary and tertiary hospitals in the capital of Pakistan. Saudi Pharm J. 2018;26(4):453-61.

Nair PN, Chalmers L, Peterson MG, Bereznicki B, Castelino LR, Bereznicki L. Hospitalization in older patients due to adverse drug reactions - the need for a prediction tool. Dovepress. 2016:11;497-505.

Sharma PK, Singh S, Dhamija P. Awareness among tertiary care doctors about Pharmacovigilance Programme of India: Do endocrinologists differ from others?. Indian J Endocr Metab. 2016;20:343-7.

Schutte T, Tichelaar J, Reumerman M O, Eekeren R V, Rissmann R, Kramers C, et al. Pharmacovigilance Skills, Knowledge and Attitudes in our Future Doctors - A Nationwide Study in the Netherlands. Basic Clin Pharmacol. 2017;120:475-81.

Shankar PR, Subish P, Mishra P, Dubey A K. Teaching pharmacovigilance to medical students and doctors. Indian J Pharmacol. 2006;38:316-9

Guidance Document For Spontaneous Adverse Drug Reaction Reporting Version: 1.0. Available at: Accessed on 13 November 2019.