Natl. J. Physiol. Pharm. Pharmacol. (2025), Vol. 15(6): 319–324

Original Research

10.5455/NJPPP.2025.v15.i6.4

Understanding pharmacovigilance: A knowledge, attitude, and practice study among medical and nursing students in a tertiary care teaching hospital

Rupa Arun Korde^1* and Priya Shodan²

¹Associate Professor, Department of Pharmacology, SDM College of Medical Sciences and Hospital, Shri Dharmasthala Manjunatheshwar University Dharwad, Karnataka, India

²Professor, Department of Pharmacology, SDM College of Medical Sciences and Hospital, Shri Dharmasthala Manjunatheshwar University Dharwad, Karnataka, India

*Corresponding Author: Dr. Rupa Arun Korde. Associate Professor, Department of Pharmacology, SDM College of Medical Sciences and Hospital, Shri Dharmasthala Manjunatheshwar University Dharwad, Karnataka, India.Email: drrupa2 [at] yahoo.co.in

Submitted: 19/04/2025 Revised: 19/05/2025 Accepted: 26/05/2025 Published: 30/06/2025

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Abstract

Background: Underreporting adverse drug reactions (ADRs) is a global issue; therefore, healthcare professionals require adequate understanding for timely reporting. Young doctors and nursing professionals must be engaged in pharmacovigilance programs to increase awareness regarding pharmacovigilance and ADR reporting.

Aim: This study aimed to evaluate the knowledge, attitudes, and practices regarding pharmacovigilance and ADR reporting among undergraduate healthcare professionals in a tertiary care teaching hospital.

Methods: The present cross-sectional, questionnaire-based descriptive study was carried out for 6 months among second-year medical (n=96) and nursing (n=91) students. A validated questionnaire consisting of 20 questions was used to assess the knowledge, attitude, and practice regarding pharmacovigilance and ADR between medical and nursing students.

Results: Most MBBS students had a better understanding of pharmacovigilance compared to nursing students, including definition (64.4%), drug safety identification (76%), ADR reporting timelines (63.5%), and international monitoring centers (58.3%). Both groups strongly agreed on the importance of integrating ADR reporting into pharmacology practicals and establishing it in hospitals, the role of reporting, and the need for pharmacovigilance education. Most MBBS students (99%) had seen the Central Drugs Standard Control Organization ADR reporting form, while only over half of nursing students (52.7%) reported awareness of ADRs during ward postings.

Conclusion: MBBS students are more aware of pharmacovigilance and the importance of ADR reporting than nursing students. Both MBBS and nursing students have minimal practical experience in reporting ADRs. Implementing effective teaching interventions can improve students’ confidence and skills in ADR reporting.

Keywords: Adverse drug reaction, Awareness, Knowledge, Pharmacovigilance.

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Introduction

Drug safety evaluation is an essential part of clinical trials for developing safe and effective treatments. However, it is impracticable to record all the potential adverse effects due to the limited patient’s exposure to the drug during the clinical trial phase and in the post-marketing period (World Health Organization, 2002). Pharmacovigilance is the science and practices concerned with the detection, assessment, understanding, and prevention of adverse reactions to medicines (World Health Organization, 2002; Pirmohamed et al., 2004). Globally, adverse drug reactions (ADRs) are reported to be the 4–6th leading cause of death (Lazarou et al., 1998). The ADR reporting rate is below 2% in India compared to the worldwide rate of 2%–3% (Shukla et al., 2024; Singh et al., 2025). Underreporting can be due to ignorance, lethargy, complacency, or insecurity.

Undergraduate students as future healthcare providers come across ADRs in outpatient and ward postings during their second year of MBBS. Hence, assessing their level of knowledge, attitude, and practices (KAP) toward these important healthcare events is crucial. Considering their initial knowledge and educating them on ADR reporting procedures will enhance reporting rates and ensure a thorough understanding of its importance for their future practice. To improve the ADR reporting culture among healthcare professionals, it is essential to develop the KAP of pharmacovigilance at the first exposure to clinical pharmacology and patient care itself (Raikar et al., 2024). Research groups in India also suggest that continued education updates healthcare professionals’ knowledge and competencies in ADRs and pharmacovigilance (Kharkar and Bowalekar, 2012; Bepari et al., 2019).

Several studies evaluated the KAP of healthcare providers toward pharmacovigilance and ADR reporting; however, very few studies focused on aspiring healthcare professionals to assess their level of knowledge (Bajaj and Rakesh, 2012; Rehan et al., 2012; Upadhyaya et al., 2012). We hypothesized that pharmacovigilance and ADR reporting knowledge among undergraduate healthcare professionals could be insufficient. Therefore, the study aims to evaluate the KAP toward pharmacovigilance and ADR reporting and then create awareness among undergraduate health care professionals in a tertiary care teaching hospital.

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Materials and Methods

The present cross-sectional questionnaire-based study was conducted for 6 months in the Department of Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, India. The study was conducted using convenient sampling, which included second-year MBBS and nursing students. First-year MBBS and nursing students, second-year dental students, interns, and postgraduate MSc nursing students were excluded. The study was initiated following approval from the Institutional Ethics Committee (SDMIEC/0219/2018) and written informed consent from the participants.

A suitable self-administered 20-item questionnaire was used for the survey to assess knowledge of the participants regarding pharmacovigilance, including both open-ended and closed-ended questions. The questionnaire includes items (KAP questions) assessing the knowledge regarding pharmacovigilance and its importance, the reporting framework, assessment of causality, detection of ADRs during phase 4 of clinical trials, etc. Each item in the questionnaire was given a score of 0 or 1. Hence, the minimum and maximum possible scores were 0 and 20. The questionnaire used consisted of three parts. The knowledge part had 12 questions, and each correct answer counts “1” point while every wrong answer count “0.”. An overall score of ≥6 was considered good knowledge (score >50% is considered as good knowledge). The attitude part is composed of 5 questions. The responses were “yes” or “no” for 4 questions and 1 question with multiple options. The third part (practice part) consisted of 3 questions with responses were yes or no. The KAP questionnaires developed were peer-reviewed and approved by the institutional internal committee. Data were compiled and entered into a Microsoft Excel sheet, and then analyzed using SPSS version 19 and presented as descriptive statistics.

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Results

Out of 187 participants, three-fourths were female 143 (76.5%), and over half of them pursuing MBBS (51.3%). The mean age of the participants was 19.48 ± 0.667 years (Table 1).

Most MBBS students had a better understanding of pharmacovigilance compared to nursing students, regarding its definition (64.4%), identifying drug safety (76%), ADR reporting timelines (63.5%), and identifying international ADR monitoring centers (58.3% correctly identified Sweden). The students also had higher awareness of the pharmacovigilance program of India (99%), regulatory bodies (94.8%), ADR causality assessment scales (61.5%), location of pharmacovigilance centers in India (58.3%), regional pharmacovigilance center (69.8%), and the WHO Committee for reporting ADRs (67.6%) (Table 2).

Both the students (MBBS and nursing students) strongly agreed to include ADR reporting under pharmacology practical and its establishment in the hospital. They also understood the critical role of ADR reporting and the need for thorough pharmacovigilance education for health care professionals. (Table 3)

A majority (99%) of MBBS students had seen adverse drug reporting forms issued by CDSCO. However, just over half of the nursing students (52.7%) were aware of ADR during their ward posting (Table 4).

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Discussion

Underreporting ADR delays the timely identification of drug safety issues, hinders thorough drug safety assessments, and negatively impacts patient safety and public health measures (Al Meslamani, 2023). Therefore, we evaluated the KAP of undergraduate health care professionals toward pharmacovigilance and ADR reporting to inform strategies for increasing awareness.

Our study demonstrated that knowledge of pharmacovigilance principles was better among MBBS students compared to nursing students. This could be due to more emphasis on pharmacological sciences in their curriculum. As per MBBS curriculum, students are trained for Enhancing Patient Safety, Improving Clinical Decision-Making, and Promoting Professional Responsibility (Abubakar and Haque, 2016). However, the attitude toward ADR reporting was comparable between the groups, suggesting that all students, regardless of academic background, recognized the importance of pharmacovigilance and ADR reporting. However, most MBBS students reported limited hands-on experience in observing or reporting ADR cases during their posting. The lack of practical knowledge underscores the importance of targeted training interventions and highlights the importance of ADR reporting to bridge the gap between theoretical knowledge and its real-world application in pharmacovigilance.

Table 1. Demographic data.

Table 2. Knowledge regarding pharmacovigilance and ADRs between medical and nursing students.

Table 3. Attitude regarding pharmacovigilance and ADRs between medical and nursing students.

Table 4. Practice of pharmacovigilance and ADR between medical and nursing students.

Consistent with our study findings, previous studies have also highlighted that although medical staff knew the importance of ADR reporting, very few reported ADR cases due to a lack of awareness of pharmacovigilance centers, resources, and experience (Muraraiah et al., 2011; Palawan et al., 2011). In another study by Kharkar and Bowalekar (2012), most medical practitioners were highly aware of ADR reporting. In Rehan et al.’s (2012) study, both resident physicians and nurses possess awareness and knowledge of ADR reporting. Some studies reported most doctors had a lack of awareness regarding ADR, its monitoring centers, or even reporting form (Amrita, 2011; Upadhyaya et al., 2012). In a recent study conducted by Shenoy et al. (2023), 90% of doctors and nurses were aware of pharmacovigilance, its components, and ADR monitoring. In Sachidananda Adiga and Adiga’s (2021) study, only 20% of nursing students knew ADRs, but only 12.5% reported them. Contrastingly, in Sanghavi et al.’s (2013) study, only 7.5% of the nursing students knew about ADR reporting. Regular awareness programs will definitely help to improve the condition, leading to betterment in society.

Limitation

The study has a few potential limitations that need to be acknowledged. Conducted in a single tertiary care teaching hospital, the findings may not apply to health care professionals in different institutions or regions, which limits generalization. However, the study provided valuable insights into ADRs and pharmacovigilance among undergraduate health professionals and highlighted the need for implementing education programs to increase their practical application. Moreover, the study provided an overview of factors for underreporting of ADRs.

Future recommendation

Future research should focus on developing and evaluating targeted interventions to train undergraduate health professionals in effective ADR reporting, ultimately improving patient care and public health outcomes.

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Conclusion

MBBS students are more aware of pharmacovigilance and the importance of ADR reporting than nursing students. However, both MBBS and nursing students have minimal practical experience reporting ADRs. Therefore, implementing effective teaching interventions, such as interactive workshops and simulation-based training, can improve confidence and skills in ADR reporting, thereby enhancing patient safety and health care outcomes.

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Acknowledgments

We would like to express our gratitude to the respected principals of the institutions who graciously allowed us to collect the data. We are particularly grateful to all the students who diligently participated in this study.

Funding

This research did not receive any specific grant from funding agencies.

Conflict of interest

There is no conflict of interest.

Authors’ contributions

Dr. Rupa A Korde and Dr Priya Shodan were responsible for the conception and design of the study, data collection and analysis, and drafting of the manuscript.

Data availability

The dataset used in this study is available from the corresponding author upon reasonable request.

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