Published: 2017-11-23

Awareness of pharmacovigilance and adverse drug reactions among second professional MBBS students of a medical college in Kerala, India

Abdul Aslam P., Jihana Shajahan, Sangeetha Purushothaman


Background: Pharmacovigilance is the science and activities related to detection, assessment, understanding and prevention of adverse drug reactions (ADR). The major challenge faced by the pharmacovigilance programme of India is underreporting. It is mainly due to lack of awareness, knowledge, attitude and practice among health care professionals. The main objective of this study was to assess the knowledge, attitude and practices of second professional MBBS students towards ADR reporting and to provide a session on pharmacovigilance as an intervention to increase their awareness since they are the future budding doctors.

Methods: This questionnaire based study was conducted among 158 second professional MBBS students of Travancore Medical College, Kollam, Kerala. A pretest was conducted using the questionnaire followed by which a two-hours session on ADR reporting and Pharmacovigilance was given. A posttest was done with the same questionnaire. The response of the KAP questionnaire were analysed separately for pretest and posttest in percentages and based on scores and was compared.

Results: Out of the158 students participated all the students successfully completed the questions of both pretest and posttest within stipulated time frame. In pretest 3 (1.9%), 101 (64%), 43 (27.1%) candidates were categorized to excellent, good and poor respectively. In posttest 155 (98.1%), 3 (1.9%) were in excellent and good category respectively. There was not even a single candidate in poor category. There was a marked increase in the knowledge and awareness of the students after the two hours intervention session on ADR reporting and pharmacovigilance which was statistically significant (p= 0.001).

Conclusions: This study revealed the awareness of second professional MBBS students towards ADR reporting and Pharmacovigilance in our institution and also clearly showed the importance of early sensitization through educational interventions, which improved the KAP in pharmacovigilance in them. Educating medical students will improve the challenge of underreporting of ADRs and will increase the numbers of ADRs reported in our country.


Adverse drug reaction (ADR), Pharmacovigilance, Pharmacovigilance programme of India (PvPI)

Full Text:



World Health Organization. Fact sheet: Safety of medicines. A guide to detecting and reporting adverse drug reactions. Why health professionals need to take action, 2002. Available at: Accessed 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.

Handbook of resolutions and decisions of the World Health Assembly and Executive Board. 1972;11948. Geneva: World Health Organization, 1973.WHA16.36 Clinical and pharmacological Evaluation of Drugs.

Van Boxtel CJ, Santoso B, Edwards IR, editors. Drug Benefits and Risks: International Textbook of Clinical Pharmacology-Revised 2nd Edition. Ios Press; 2008.

Vigibase LM. The WHO Global ICSR Database System: Basic Facts. Drug Information J. 2008;42:409-19.

National coordination centre. Pharmacovigilance programme in India, Indian pharmacopoeia commission Ghaziabad; 2017. Available at: Accessed 25 March 2017.

Pharmacovigilance programme of India 2010. CDSCO, Ministry of Health and Family Welfare, Government of India; 2010. Available at: Accessed 25 March 2017.

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

Vallano A, Cereza G, Pedros C, Agusti A, Danes I, Aguilera C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol. 2005;60(6):653-8.

Nadeem MN, Vaseem A, Maqdoom M. Across-sectional study evaluating the awarenss of pharmacovigilance among MBBS interns of teaching hospital in south India, Int J Basic Clin. Pharmacol. 2016;5:2468-75.

Dhananjay K, Esanakulla H. A study of assessing knowledge, attitude and practice of pharmacovigilance among medical students of South Indian teaching hospital. Int J Basic Clin Pharmacol. 2017;6.

Tabassum R, Bhat MY, Farhat S. A descriptive study of knowledge of Pharmacovigilance and adverse drug reactions among second professional undergraduate medical students in a teaching hospital. Int J Basic Clin Pharmacol. 2015;4:1016-20.

Vakade KP, Sangisetti VM, Binayke MV, Abhavathi VN, Nayak BB. An evaluation of knowledge, attitude and practice of pharmacovigilance among interns in a tertiary care teaching hospital of North Maharashtra, Int J Basic Clin Pharmacol. 2016;5:2321-5.