Knowledge, Attitude and Practice of Pharmacovigilance among Prescribers in a Tertiary Care Hospital

Dr C   Muralidhar; Dr P  Madhavi; Mr T Rama Chakra  Kushal; Dr A R Radhika; Dr T  Chakradhar

doi:10.51168/sjhrafrica.v6i12.2299

Authors

Dr C Muralidhar Associate Professor, Department of Pharmacology, Government Medical College and Hospital, Maheshwaram, Telangana,
Dr P Madhavi Associate Professor, Department of Pharmacology, Government Medical College and Hospital, Siddipet, Telangana
Mr T Rama Chakra Kushal Final MBBS Student, Gandhi Medical College and Hospital, Secunderabad, Telangana
Dr A R Radhika Professor and Head, Department of Pharmacology, Government Medical College and Hospital, Suryapet, Telangana
Dr T Chakradhar Professor and Head, Department of Pharmacology, Government Medical College and Hospital, Maheshwaram, Rangareddy District, Telangana, India

DOI:

https://doi.org/10.51168/sjhrafrica.v6i12.2299

Keywords:

Pharmacovigilance, Adverse Drug Reactions, Knowledge–Attitude–Practice, Bachelor of Medicine and Bachelor of Surgery students

Abstract

Background:
Pharmacovigilance plays a pivotal role in ensuring medication safety by detecting, assessing, and preventing adverse drug reactions (ADRs). Despite being a professional and ethical responsibility, ADR reporting remains suboptimal worldwide, particularly among undergraduate prescribers.

Objectives:
To assess the level of knowledge, attitude, and practice regarding pharmacovigilance among MBBS student prescribers in a tertiary care hospital and to identify key barriers contributing to under-reporting of ADRs.

Methods:
A descriptive, cross-sectional, questionnaire-based study was conducted among 150 MBBS students actively involved in prescription writing during clinical postings. Data were collected using a validated 20-item KAP questionnaire covering fundamental concepts of pharmacovigilance, attitudes toward ADR reporting, reporting practices, and perceived barriers. Data were analyzed using descriptive statistics and presented as frequencies and percentages.

Results:
Among the participants, 112 (74.7%) were aware of the term pharmacovigilance, and 98 (65.3%) correctly identified its primary objective as the detection and prevention of ADRs. A positive attitude was observed, with 124 students (82.7%) acknowledging ADR reporting as a professional obligation and a vital component of patient safety. However, practical engagement was limited, as only 18 students (12%) had ever reported an ADR. The major barriers identified were lack of knowledge regarding reporting procedures (44.6%), difficulty in diagnosing ADRs (32%), time constraints (14%), and non-availability of reporting forms (9.3%).

Conclusion:
Although MBBS prescribers demonstrated satisfactory knowledge and a favorable attitude toward pharmacovigilance, actual ADR reporting practice was notably poor. This highlights a significant knowledge–practice gap that requires targeted educational and system-level interventions.

Recommendations:
Incorporating structured pharmacovigilance training into the undergraduate curriculum, conducting regular hands-on workshops on ADR identification and reporting, integrating ADR reporting into routine clinical teaching, and implementing user-friendly digital reporting platforms are strongly recommended to improve reporting behavior and enhance patient safety.

Keywords: Pharmacovigilance; Adverse Drug Reactions; Knowledge–Attitude–Practice; MBBS students

References

Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA. 1997 Jan 22-29;277(4):307-11. PMID: 9002493

Singh P, Verma S, Vaishnav Y, Joshi U, Agrawal M. Probing the in-depth analysis of Serious Adverse Drug Reactions in a tertiary care hospital of Central India. Explor Res Clin Soc Pharm. 2025 Feb 13;17:100579. doi: 10.1016/j.rcsop.2025.100579. PMID: 40061817.

Aung AK, Walker S, Khu YL, Tang MJ, Lee JI, et al. Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus. Eur J Clin Pharmacol. 2022 May;78(5):781-791. doi: 10.1007/s00228-022-03287-1. Epub 2022 Feb 16. PMID: 35171316

World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products. WHO; 2002.

Sharma M, Baghel R, Thakur S, Adwal S. Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study. BMJ Open. 2021;11(10):e052737. doi:10.1136/bmjopen-2021-052737. PMID: 34618555

Mulchandani R, Kakkar AK. Reporting of adverse drug reactions in India: A review of the current scenario, obstacles and possible solutions. Int J Risk Saf Med. 2019;30(1):33-44. doi: 10.3233/JRS-180025. PMID: 30175985

Khan Z, Karatas Y, Hamid SM. Evaluation of health care professionals' knowledge, attitudes, practices and barriers to pharmacovigilance and adverse drug reaction reporting: A cross-sectional multicentral study. PLoS One. 2023 May 24;18(5):e0285811. doi: 10.1371/journal.pone.0285811. PMID: 37224133

Ganesan S, Sandhiya S, Reddy KC, Subrahmanyam DK, Adithan C. The Impact of the Educational Intervention on Knowledge, Attitude, and Practice of Pharmacovigilance toward Adverse Drug Reactions Reporting among Health-care Professionals in a Tertiary Care Hospital in South India. J Nat Sci Biol Med. 2017 Jul-Dec;8(2):203-209. doi: 10.4103/0976-9668.210014. PMID: 28781488

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 Sci Biol Med. 2013 Jan;4(1):191-6. doi: 10.4103/0976-9668.107289. PMID: 23633861

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 Oct;2(4):129-36. doi: 10.4103/2229-3485.86883. PMID: 22145123

AlShammari TM, Almoslem MJ. Knowledge, attitudes & practices of healthcare professionals in hospitals towards the reporting of adverse drug reactions in Saudi Arabia: A multi-centre cross sectional study. Saudi Pharm J. 2018 Nov;26(7):925-931. doi: 10.1016/j.jsps.2018.04.012. Epub 2018 Apr 26. PMID: 30416347

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. Perspect Clin Res. 2015 Oct-Dec;6(4):217-21. doi: 10.4103/2229-3485.167102. PMID: 26623394

Kalikar MV, Dakhale GN, Shrirao M. Effect of educational intervention on awareness of pharmacovigilance among medical undergraduates in a tertiary care teaching hospital. Perspect Clin Res. 2020 Apr-Jun;11(2):92-96. doi: 10.4103/picr.PICR_16_19. Epub 2020 May 6. PMID: 32670835.

Nair MK, Douglas R. Knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a teaching hospital of South Kerala, India. Int J Basic Clin Pharmacol. 2017;6(4):754-758. doi:10.18203/2319-2003.ijbcp20170955.

N IO, Kp S, R JR, Mg R. Barriers to and facilitators of healthcare professionals in ADR reporting in a tertiary care hospital in India. BMC Health Serv Res. 2025 Jan 28;25(1):166. doi: 10.1186/s12913-024-12139-w. PMID: 39875957

Mulkalwar S, Chitale S, Dandage P, Bapat S, Tilak AV, Patil S. Evaluation of the Effectiveness of the Adverse Drug Reaction Alert Card System in Preventing the Recurrence of Adverse Drug Reactions. Cureus. 2024 Jul 16;16(7):e64653. doi:10.7759/cureus.64653

Chhabra KG, Sharma A, Chhabra C, Reddy JJ, Deolia SG, Mittal Y. Knowledge, Attitude, and Practices regarding Pharmacovigilance and Adverse Drug Reaction reporting among Dental Students in a Teaching Hospital, Jodhpur, India: A Cross-sectional Study. J Contemp Dent Pract. 2017 Oct 1;18(10):964-969. doi: 10.5005/jp-journals-10024-2157. PMID: 28989138.

Shukla S, Sharma P, Gupta P, Pandey S, Agrawal R, Rathour D, et al. Current Scenario and Future Prospects of Adverse Drug Reactions (ADRs) Monitoring and Reporting Mechanisms in the Rural Areas of India. Curr Drug Saf. 2024;19(2):172-190. doi: 10.2174/1574886318666230428144120. PMID: 37132145

Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian J Pharmacol. 2015 Jan-Feb;47(1):65-71. doi: 10.4103/0253-7613.150344. PMID: 25821314

Putri RA, Ikawati Z, Rahmawati F, Yasin NM. An Awareness of Pharmacovigilance Among Healthcare Professionals Due to an Underreporting of Adverse Drug Reactions Issue: A Systematic Review of the Current State, Obstacles, and Strategy. Curr Drug Saf. 2024;19(3):317-331. doi: 10.2174/0115748863276456231016062628. PMID: 38989832.

Kopciuch D, Zaprutko T, Paczkowska A, Ratajczak P, Zielińska-Tomczak Ł, et al. Safety of medicines-Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process. Pharmacoepidemiol Drug Saf. 2019 Dec;28(12):1543-1551. doi: 10.1002/pds.4792. Epub 2019 May 30. PMID: 31148344

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 Jan-Mar;6(1):29-34. doi: 10.4103/2231-4040.150369. PMID: 25709967.

Hazell L, Shakir SA. Under-reporting of adverse drug reactions : a systematic review. Drug Saf. 2006;29(5):385-96. doi: 10.2165/00002018-200629050-00003. PMID: 16689555

Hingorani SK, Shah AY, Mehta CD. Educational intervention to improve knowledge, attitude, and practice of pharmacovigilance among resident doctors at a tertiary care hospital. Perspect Clin Res. 2023 Apr-Jun;14(2):75-80. doi: 10.4103/picr.picr_37_22. Epub 2022 Jul 27. PMID: 37325579

Routledge PA, Bracchi R. Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews. Br J Clin Pharmacol. 2023 Aug;89(8):2377-2385. doi: 10.1111/bcp.15791. Epub 2023 Jun 4. PMID: 37194555