Effect of educational interventions on pharmacovigilance awareness among M.B.B.S. internee’s in a tertiary care teaching hospital

Navneeth Selvan, Revathy Saravanan, Sakthibalan M.


Background: Spontaneous reporting of adverse drug reactions (ADRs) has played a major role in detection of previously unobserved ADRs. In spite of setting up ADR monitoring centres, only 6-10% of all ADRs are reported which has been contributed to the lack of knowledge among healthcare professionals. This study was planned to address this aspect. To evaluate and compare the effect of educational intervention in enhancing the knowledge of MBBS internee’s regarding pharmacovigilance.

Methods: A cross sectional, educational interventional observational study was conducted using two copies of a pretested validated questionnaire (pre & post CME) with 17 questions among 130 MBBS internees. They were subjected to a Continuous Medical Education on pharmacovigilance. A hand’s on training on ADR reporting was also conducted in which they were divided into 10 batches and  asked to fill a Central Drugs Standard Control Organization Adverse Drug Reporting form on the case scenario given to them and forms were analyzed.

Results: Out of 130 internees, 114 (87.69%) and 98 (75.38%) had completely filled them. The overall awareness about pharmacovigilance increased from 62.50% to 82.25% (p< 0.0001). There was a statistically significant increase in mean value from 14.38 ± 0.3020 to 18.92 ± 0.2860 (p< 0.0001) on analyzing the knowledge scores. 90% of ADR forms revealed substantial errors, which were explained to the participants.

Conclusions: This study clearly shows that early sensitization through educational interventions at internship phase of M.B.B.S. will increase the number of ADRs being reported in our country.


MBBS interns, Pharmacovigilance knowledge, Continuous medical education, Hands on training

Full Text:



World Health Organization. Safety of medicines. A guide to detecting and reporting adverse drug reactions. Why health professionals need to take action. Geneva World Health Organization. 2002.

BaniasadiSh, Fahimi F, Shalviri G. Developing an adverse drug reaction reporting system at a teaching hospital. Basic Clin Pharmacol Toxicol. 2008;102:408-11.

Ekman E, Backstrom M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol. 2009;65:43-6.

Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol. 2001;51:81-6.

Pharmacovigilance programme of India 2010. CDSCO, Ministry of Health and Family Welfare, Government of India. 2010. Available at Accessed on 2015 June 23. Accessed on 2015 October 25.

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

Elnour AA, Ahmed AD, Yousif MA, Shehab A. Awareness and reporting of adverse drug reactions among health care professionals in Sudan. Jt Comm J Qual Patient Saf. 2009;35(6):324-9.

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. Accessed on 2015 October 25.

Jha N, Rathore DS, Rathore DS, Shankar PR, Gyawali S, Alshakka M, Bhandary S. An educational intervention’s effect on healthcare professionals’ attitudes towards pharmacovigilance. AMJ. 2014;7(12):478-89.

Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: An observational study. J Nat SciBiol Med. 2013;4(1):191-6.