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

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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Publication Details

Journal
International Journal of Basic & Clinical Pharmacology
Published
2025-06-24
DOI
https://doi.org/10.18203/2319-2003.ijbcp20251830
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
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0.00
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article

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

Nikhil Raj, Kritica Dwivedi, Arun Raj Pandey, Rohit Pandey et al.
3 links
International Journal of Basic & Clinical Pharmacology
Pharmacovigilance and Adverse Drug Reactions
article

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

Nikhil Raj, Kritica Dwivedi, Arun Raj Pandey, Rohit Pandey, Vandana Dwivedi
article en

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.

International Journal of Basic & Clinical PharmacologyVol. 14(4)
Maharishi International University (US), Sahara Hospital (IN), Dr. Ram Manohar Lohia Institute of Medical Sciences (IN), Institute of Medical Sciences (IN), Indian Institute of Technology BHU (IN), Banaras Hindu University (IN)
Openalex Percentile: Top 86%
Pharmacovigilance and Adverse Drug Reactions
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