A descriptive study of knowledge of Pharmacovigilance and adverse drug reactions among second professional undergraduate medical students in a teaching hospital

Authors

  • Rehana Tabassum Department of Pharmacology, Government Medical College, Srinagar, Jammu and Kashmir
  • Mohammad Younis Bhat Department of Pharmacology, Government Medical College, Srinagar, Jammu and Kashmir
  • Samina Farhat Department of Pharmacology, Government Medical College, Srinagar, Jammu and Kashmir

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20150885

Keywords:

Adverse drug reactions, Pharmacovigilance, Knowledge, Underreporting, Questionnaire

Abstract

Background: Adverse drug reactions (ADRs) are adverse consequences of drug therapy being one of the leading causes of morbidity and represent a substantial burden of healthcare resources. Though Pharmacovigilance program was started in India in 1982, the awareness about it is much lower and underreporting of ADRs is a common problem with only 6-10% of all ADRs being reported. The objective of this study was to analyze the baseline knowledge of awareness regarding the ADRs and Pharmacovigilance activity in the undergraduate medical students who are future doctors of society so as to foster a culture of reporting ADRs, to fulfill various it is lacunaes and make adjustments of medical student’s curriculum in order to improve practice of reporting.

Methods: A cross-sectional survey was conducted among second professional medical students in July 2015 to assess the knowledge of ADRs and Pharmacovigilance activities using a questionnaire to collect the information. Part “A” consisted of choosing the most appropriate answer and Part “B” included replying with “Yes” or “No.” Data were expressed as percentage proportions.

Results: Out of the total of 150 enrolled students, 134 filled and returned the questionnaire with students having a mediocre knowledge about Pharmacovigilance and majority of them (94%) vouching that reporting of ADRs should be mandatory as it is going to benefit patients (99.2%).

Conclusions: Our study revealed that there are gaps between knowledge regarding ADRs and Pharmacovigilance that needs to be addressed on priority basis for the success of the Pharmacovigilance program and better clinical management of patients in general.

 

References

WHO. Policy perspectives on medicines. Pharmacovigilance: ensuring the Safe Use of Medicines. Geneva: World Health Organization; 2004. Available at http://www.who.int/medicines. Accessed 03 July 2015.

WHO. The Importance of Pharmacovigilance. Geneva: WHO; 2002.

Rajesh R, Vidyasagar S, Nandakumar K. Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients. J Adv Pharm Technol Res. 2011;9:48-55.

Lazarou J, Pomeranz BH, Corey PN. Incidence of ADR in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1000-5.

World Health Organization. Safety of Medicines: a Guide to Detecting and Reporting Adverse Drug Reactions. WHO/EDM/QSM/2002. Geneva: WHO; 2002.

Ayani I, Aguirre C, Gutiérrez G, Madariaga A, Rodríguez-Sasiaín JM, Martínez-Bengoechea MJ. A cost-analysis of suspected adverse drug reactions in a hospital emergency ward. Pharmacoepidemiol Drug Saf. 1999;8(7):529-34.

Wu WK, Pantaleo N. Evaluation of outpatient adverse drug reactions leading to hospitalization. Am J Health Syst Pharm. 2003;60(3):253-9.

Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004;329(7463):15-9.

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.

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). Int J Pharm Ther. 2013;3(3):10-8.

Amrita P, Kharbanda B. Knowledge, attitude and skills of nurses of Delhi towards adverse drug reaction reporting. Indian J Pharm Pract. 2012;5:45-51.

Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital--their severity and cost involved. Pharmacoepidemiol Drug Saf. 2003;12(8):687-92.

Rehan HS, Vasudev K, Tripathi CD. Adverse drug reaction monitoring: knowledge, attitude and practices of medical students and prescribers. Natl Med J India. 2002;15(1):24-6.

Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res. 2011;2(4):129-36.

Graille V, Lapeyre-Mestre M, Montastruc JL. Drug vigilance: opinion survey among residents of a university hospital. Therapie. 1994;49(5):451-4.

Cosentino M, Leoni O, Banfi F, Lecchini S, Frigo G. Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district. Pharmacol Res. 1997;35(2):85-8.

Bharathan B, Raju NA. Survey about the knowledge, attitude and practice of adverse drug reaction reporting among doctors in Bangalore City. Sixth Annual Conference of the Society of Pharmacovigilance (India); November 11-12, 2006; Kurupanidhi College of Pharmacy, Bangalore, India.

Palaian S, Ibrahim MI, Mishra P. Health professionals’ knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharm Pract (Granada). 2011;9(4):228-35.

Fadare JO, Enwere OO, Afolabi AO, Chedi BA, Musa A. Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in Northern Nigeria. Trop J Pharm Res. 2011;10(3):235-42.

Vora MK, Paliwal NP, Doshi VG, Barvaliya MJ, Tripathi CB. Knowledge of adverse drug reactions and pharmacovigilance activity among the undergraduate students of Gujarat. Int J Pharm Sci Res. 2012;3(5):1511-5.

Li Q, Zhang SM, Chen HT, Fang SP, Yu X, Liu D, et al. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J (Engl). 2004;117(6):856-61.

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Published

2016-12-23

How to Cite

Tabassum, R., Bhat, M. Y., & Farhat, S. (2016). A descriptive study of knowledge of Pharmacovigilance and adverse drug reactions among second professional undergraduate medical students in a teaching hospital. International Journal of Basic & Clinical Pharmacology, 4(5), 1016–1020. https://doi.org/10.18203/2319-2003.ijbcp20150885

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Original Research Articles