Assessment of knowledge, attitude, and practice of pharmacovigilance among healthcare workers: a cross-sectional study from North India

Kanak Lata Dwivedi; Ritesh Kumar Pandey; Vandana Dwivedi; Arun Raj Pandey; Nikhil Raj

doi:10.18203/2319-2003.ijbcp20251830

Authors

Kanak Lata Dwivedi Department of Pharmacology, Hind Institute of Medical Sciences, Barabanki, UP, India
Ritesh Kumar Pandey Department of Cardiology, Chandan Hospital, Lucknow, UP, India
Vandana Dwivedi Department of Pharmacology Maharishi Vishwamitra Autonomous State Medical College, Mirzapur, UP, India
Arun Raj Pandey Department of Anaesthesiology, IMS-BHU, Varanasi, UP, India
Nikhil Raj Department of Microbiology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, UP, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20251830

Keywords:

Adverse drug reactions, Pharmacovigilance, Knowledge, Attitude, Practice, Patient safety

Abstract

Background: Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality worldwide. Pharmacovigilance (PV) plays a crucial role in detecting, understanding, and preventing ADRs to ensure drug safety. This study aims to assess the knowledge, attitude, and practice (KAP) of pharmacovigilance among healthcare professionals, identifying barriers and areas for improvement to enhance ADR reporting.

Methods: A cross-sectional study was conducted among healthcare professionals in government and private healthcare facilities in Lucknow, Uttar Pradesh, India. A structured questionnaire was distributed via Google Forms, with 265 participants responding. Statistical analysis involved descriptive statistics, summarizing categorical variables as frequencies and percentages.

Results: Among the 265 participants, 59% were aged 20-30 years, and 66.9% were female. Educational qualifications included nursing (69.6%), MBBS (12.5%), MD/MS (9.1%), and DM/MCh (3.4%). Formal training in pharmacovigilance was reported by 45.1%. Regarding knowledge, 82% correctly identified pharmacovigilance, 68.2% knew CDSCO as the regulatory body, and 57.8% were aware of the Pharmacovigilance Programme of India (PvPI). Although 41.8% frequently encountered ADRs, only 34.4% had reported multiple ADRs, while 43.2% had never reported an ADR. The main barriers included lack of knowledge about the reporting process (49%) and time constraints (30.3%).

Conclusion: Despite awareness and a positive attitude toward pharmacovigilance, ADR reporting remains inadequate due to knowledge gaps and systemic barriers. Strengthening pharmacovigilance education, simplifying reporting mechanisms, and fostering institutional support can enhance ADR reporting practices, ultimately improving patient safety.

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References

World Health Organization. Safety of Medicines. A Guide to Detecting and Reporting Adverse Drug Reactions. Geneva, Switzerland: World Health Organization. 2002.

World Health Organization (WHO). Safety of Medicines. A Guide to Detecting and Reporting Adverse Drug Reactions. Why Health Professionals Need to Take Action. Geneva: World Health Organization. 2002.

Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol. 2016;48(6):624-8. DOI: https://doi.org/10.4103/0253-7613.194855

Basavaraja CK, Sebastian J, Ravi MD, John SB. Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India. Therapeutic Adv Vacc Immunoth. 2021;9:2513. DOI: https://doi.org/10.1177/25151355211055833

Marwah R, Goel A, Moda V. Indian pharmaceutical industry and the pandemic: exploring potential and possibilities. In Pandemic Perspectives 2024: 112-32. DOI: https://doi.org/10.4324/9781003480297-8

Sahu A, Das NR. ADR Monitoring and Reporting in India. Indian J Pharm Pract. 2024;17(3):198-204. DOI: https://doi.org/10.5530/ijopp.17.3.33

Kumar S, Maharshi V. Introduction to Pharmacovigilance: Ensuring Patient Safety. InSignal Analysis in Pharmacovigilance 2025: 1-21. DOI: https://doi.org/10.1201/9781032629940-1

Prakash J, Sachdeva R, Shrivastava TP, Jayachandran CV, Sahu A. Adverse event reporting tools and regulatory measures in India through outcome of Pharmacovigilance Programme of India. Indian J Pharmacol. 2021;53(2):143-52. DOI: https://doi.org/10.4103/ijp.ijp_901_20

Desai M. Pharmacovigilance and spontaneous adverse drug reaction reporting: Challenges and opportunities. Perspect Clin Res. 2022;13(4):177-9. DOI: https://doi.org/10.4103/picr.picr_169_22

Alshabi AM, Shaikh MAK, Shaikh IA, Alkahtani SA, Aljadaan A. Knowledge, attitude and practice of hospital pharmacists towards pharmacovigilance and adverse drug reaction reporting in Najran, Saudi Arabia. Saudi Pharm J. 2022;30(7):1018-26. DOI: https://doi.org/10.1016/j.jsps.2022.04.014

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;6(1):29-34. DOI: https://doi.org/10.4103/2231-4040.150369

Güner MD, Ekmekci PE. Healthcare professionals’ pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. J Drug Assess. 2019;8(1):13–20. DOI: https://doi.org/10.1080/21556660.2019.1566137

Hussain R, Hassali MA, Hashmi F, Akram T. Exploring healthcare professionals' knowledge, attitude, and practices towards pharmacovigilance: a cross-sectional survey. J Pharm Policy Pract. 2021;14(1):5. DOI: https://doi.org/10.1186/s40545-020-00287-3

Khan LM, Al-Harthi SE, Saadah OI. Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR. Saudi Pharm J. 2013;21(3):261-6. DOI: https://doi.org/10.1016/j.jsps.2012.09.004

Amin MN, Khan TM, Dewan SM, Islam MS, Moghal MR, Ming LC. Cross-sectional study exploring barriers to adverse drug reactions reporting in community pharmacy settings in Dhaka, Bangladesh. BMJ Open. 2016;6(8):10912. DOI: https://doi.org/10.1136/bmjopen-2015-010912

Al-Hazmi N, Naylor IL. Attitude and awareness of adverse drug reaction reporting by health professionals in seven hospitals in the Holy City of Makkah, Kingdom of Saudi Arabia. J Clin Trials. 2013;3:139. DOI: https://doi.org/10.4172/2167-0870.1000139

Suyagh M, Farah D, Abu Farha R. Pharmacist's knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process. Saudi Pharm J. 2015;23(2):147-53. DOI: https://doi.org/10.1016/j.jsps.2014.07.001

Radhakrishnan R, Vidyasagar S, Varma DM. An educational intervention to assess knowledge attitude practice of pharmacovigilance among Health care professionals in an Indian tertiary care teaching hospital. Int J Pharm Tech Res. 2011;3:678–92.

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;26(7):925-31 DOI: https://doi.org/10.1016/j.jsps.2018.04.012