Study of knowledge, attitude, and practices towards current updates of pharmacovigilance and adverse drug reaction reporting among doctors in a tertiary care teaching hospital of Western India

Authors

  • Chirag B. Mistry Department of Pharmacology, Medical College Baroda, Vadodara, Gujarat, India
  • Shreya M. Shah Department of Pharmacology, Medical College Baroda, Vadodara, Gujarat, India
  • Vivek A. Modi Intern, Medical College Baroda, Vadodara, Gujarat, India
  • Suresh D. Mistry Department of Pharmacology, Medical College Baroda, Vadodara, Gujarat, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20180668

Keywords:

Adverse drug reactions, Attitude, Doctor, Knowledge, Pharmacovigilance, Practice, Questionnaire

Abstract

Background: In general, adverse drug reactions (ADRs) are global problems causing both morbidity and mortality. Spontaneous ADR reporting is important to monitor adverse effects of medicines but under reporting is still very prevalent so, there is a need of constant monitoring and rectification of system of Pharmacovigilance. The objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about Pharmacovigilance and to identify the reason for under reporting of ADRs.

Methods: A cross-sectional study was carried out using a pretested questionnaire among doctors with minimum qualification MBBS or B.D.S. including faculties, senior and junior residents. Subsequently, analysis of association between education and experience was done by chi square test at P-value <0.05.

Results: A pretested questionnaire was distributed among 403 doctors and 240 (59.16%) responded voluntarily. In general, 131 (54.58%) participants noted lack of time to report ADR while 90 (37.50%) participants noted no benefit of reporting already known ADR. On the other hand, total 104 (43.33%) participants were aware about need to report a serious adverse event during “Clinical Trial” within 24 hours to the Ethics Committee. Only 87 (36.25%) participants noted a need of reporting of already known ADR.

Conclusions: Participants had good knowledge and attitude towards pharmacovigilance, but the actual practice of ADR reporting is still deficient among them that can be improved by sensitization training and involvement of grass root level health care workers.

References

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

Remesh A. Identifying the reasons for under reporting of ADR: A cross sectional survey. Res J Pharm Biol Chem Sci. 2012;3:1379-86.

National Strategic Plan for. Scale Up of Pharmacovigilance in. India; Version: 1.0 National Coordination Centre-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission, Ghaziabad in technical collaboration with World Health Organization Country Office for India, 2017. Available at: http://ipc.nic.in/writereaddata/mainlinkFile/File862.pdf. Accessed 28 December 2017.

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

Muraraiah S, Rajarathna K, Sreedhar D, Basavalingu D, Jayanthi CR. A questionnaire study to assess the knowledge, attitude and practice of Pharmacovigilance in a paediatric tertiary care centre. J Chem Pharm Res. 2011;3:416-22.

Olsson S, Pal SN, Dodoo A. Pharmacovigilance in resource-limited countries, Expert Review of Clinical Pharmacology. 2015;8(4):449-60.

Meher BR, Joshua N, Asha B, Mukherji D. A questionnaire based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India. Perspectives in Clinical Research. 2015;6(4):217-21.

Kulkarni D, Esanakula H. A study of assessing knowledge, attitude and practice of pharmacovigilance among medical students of a South Indian teaching hospital. International Journal of Basic and Clinical Pharmacology. 2016;6(1):43-7.

Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, et al. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007;63:136-47.

Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2008;65:210-6.

Dhananjay K, Esanakula H. A study of assessing knowledge, attitude and practice of pharmacovigilance among medical students of a South Indian teaching hospital. Int J Basic Clin Pharmacol. 2017;6:43-7.

Kulkarni MD, Baig MS, Chandaliya KC, Doifode SM, Razvi SU, Sidhu NS, et al. 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.

Das L, Bhattacharjee P, Ghosh R, Das UK, Ray T. Knowledge, attitude, and practice of pharmacovigilance among doctors in a tertiary care teaching hospital of Tripura. Natl J Physiol Pharm Pharmacol. 2017;7(2):218-23.

Srinivasan V, Sheela D, Mridula D. Knowledge, Attitude, and Practice of Pharmacovigilance Among the Healthcare Professionals in A Tertiary Care Hospital – A Questionnaire Study. Biomed Pharmacol J. 2017;10(3).

Pharmacovigilance Programme of India(PvPI), National Coordination Centre, Indian Pharmacopoeia Commission, Gaziabad, India, 2017. Available at: http://www.ipc.gov.in/PvPI/pv_home.html accessed 28 December 2017.

Pharmacovigilance for the NABH accredited Hospitals, 2017. Available at: http://www.nabh.co/TrainingArchieves.aspx. Accessed 28 December 2017.

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Published

2018-02-22

How to Cite

Mistry, C. B., Shah, S. M., Modi, V. A., & Mistry, S. D. (2018). Study of knowledge, attitude, and practices towards current updates of pharmacovigilance and adverse drug reaction reporting among doctors in a tertiary care teaching hospital of Western India. International Journal of Basic & Clinical Pharmacology, 7(3), 524–531. https://doi.org/10.18203/2319-2003.ijbcp20180668

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Original Research Articles