Knowledge, attitude and practice towards pharmacovigilance among postgraduate medical students at a tertiary care hospital: a cross sectional questionnaire based study

Vishnu K., Mamatha K. R., Jayanthi C. R.


Background: Adverse drug reaction (ADR) is major global health problem affecting both children and adults. ADRs are among the leading cause of mortality and morbidity leading to prolonged hospitalization. Hence, spontaneous reporting of ADRs by healthcare professionals forms the backbone of pharmacovigilance. Therefore, there is an urgent need for sensitization about drug safety monitoring among healthcare professionals (HCPs).

Methods: A cross sectional questionnaire based study was conducted among 200 postgraduate medical students between April 2016 and May 2016 using a pre-validated questionnaire. Descriptive statistics was used for analysis.

Results: Among 200 questionnaires distributed, only 150 provided responses reflecting a response rate of 75%. The postgraduates who understood the definition of adverse drug reaction and pharmacovigilance were 90% and 64% respectively. The most encouraging finding was 97% of postgraduates thought that reporting an ADR was necessary which in turn increases the patient safety. 60% postgraduates were unaware that the nurses and pharmacists also had the responsibility of reporting ADR. The postgraduates who encountered ADRs during clinical practice were 79% whereas reporting was only 2%.

Conclusions: This study suggests that even though majority of postgraduates have better knowledge and attitude towards pharmacovigilance and ADR, the practice of reporting ADRs is inadequate. Therefore, there is an urgent need for educational intervention in the form of training programmes and continued medical education (CME) periodically to encourage ADR reporting among the postgraduates.


Adverse drug reaction, Knowledge, Pharmacovigilance, Practice

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Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA. 1998;279(15):1200-5.

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(4):301-6.

Dharmadhikari PP, Date AP, Patil KS. Knowledge, attitude and practice among healthcare professionals of adverse drug reactions reporting in a tertiary care centre. Int J Basic Clin Pharmacol. 2015;4(2):300-5.

World Health Organization. Safety of Medicines. A guide to detecting and reporting adverse drug reactions. Geneva, Switzerland: World Health Organization;2002.

Guidance document for spontaneous adverse drug reaction reporting. India: Indian Pharmacopoeia Commission. 2014;80.

Bansode AA, Zad VR, Sawat SD, Dudhal KS. Awareness about Pharmacovigilance among Resident doctors in a tertiary care hospital. Journal of Evolution of Medical and Dental Sciences. 2015;4(2):207-10.

WHO. World Health Organization. The importance of pharmacovigillance. Safety Monitoring of Medicinal Products. Essential Medicines and Health Products Information Portal. Geneva: WHO. 2002;1-52.

Chandrakapure AR, Giri SP, Khan IN, Mateenuddin M, Faheem M. Pharmacovigilance: a study to evaluate knowledge, attitude and practices of and impact of educational intervention among doctors in teaching hospital, in rural area of Jalna, India. Int J Basic Clin Pharmacol. 2015;4(3):427-31.

Karelia BN, Piparava KG. Knowledge, attitude and practice of pharmacovigilance among private healthcare professionals of Rajkot city. Int J Basic Clin Pharmacol. 2014;3(1):50-3.

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

Chetty S, Parida A, Adiga S, Bairy KL. Knowledge, attitude and practice of health care professionals towards adverse drug reaction reporting in a south Indian teaching hospital. World Journal of Pharmaceutical Research. 2014;3(3):4263-71.

Rehan HS, Sah RK, Chopra D. Comparison of knowledge, attitude and practices of resident doctors and nurses on adverse drug reaction monitoring and reporting in a tertiary care hospital. Indian J Pharmacol. 2012;44(6):699-703.

Gupta P, Udupa A. Adverse Drug Reaction Reporting and Pharmacovigilance: Knowledge, Attitudes and Perceptions amongst Resident Doctors. Journal of Pharmaceutical Sciences and Research. 2011;3(2):1064-9.

Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. Adverse drug reactions reporting culture in Pharmacovigilance Programme of India. Indian J Med Res. 2014;140(4):563-4.

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(1):29-34.

Kamtane RA, Jayawardhani V. Knowledge, attitude and perception of physicians towards adverse drug reaction (ADR) reporting: A pharmacoepidemiological study. Asian J Pharm Clin Res. 2012;5(3):210-4.

Kulkarni MD, Baig MS, Chandaliya KC, Doifode SM, Razvi SU, Sidhu NS. Knowledge, attitude and practice of pharmacovigilance among prescribers of government medical college and hospital, Aurangabad (Maharashtra). International journal of pharmacology and therapeutics. 2013;3(3):10-8.