Adverse drug reactions (ADRs) remain an important cause of preventable morbidity and additional healthcare burden. Davies et al. conducted a prospective study of 3,695 hospital patient episodes, and reported that 14.7% had at least one ADR, of which about half were definitely or possibly avoidable, and that ADRs directly extended hospital stays in over one-quarter of those who had them [1]. Such observations highlight the importance of effective post-marketing surveillance and timely recognition of medicine related harm. Pharmacovigilance is the process of identifying, evaluating, understanding and preventing adverse effects and other medicine-related issues, and spontaneous ADR reporting is still a valuable source of real-world safety signals. Although it is crucial, spontaneous pharmacovigilance systems are always plagued by under-reporting. Lopez-Gonzalez et al. conducted a systematic review that showed that the knowledge and attitudes of healthcare professionals were significantly linked to their reporting behaviour, with ignorance, lethargy, insecurity, diffidence and uncertainty about what to report being common factors associated with under-reporting [2]. These knowledge and attitude related barriers are modifiable and were also found in a subsequent systematic review update, which showed that they remain a barrier to spontaneous reporting despite the growing focus on pharmacovigilance education [3]. The results indicate that raising awareness alone is not enough unless healthcare professionals are also provided with practical knowledge, confidence and easy reporting channels. Nurses play a special role in pharmacovigilance due to their ongoing participation in medication administration, monitoring and direct patient care. They are in a good position to identify suspected ADRs and report them due to their close contact with patients. A systematic review of the literature, however, that specifically looked at nurses revealed a persistent gap between knowledge and practice: 84.6% of respondents felt that reporting ADRs was important for patient or medicine safety, but 67.1% had experienced an ADR in their professional practice, and only 21.2% reported an ADR; lack of knowledge or training was the most common barrier identified [4]. Likewise, a survey of nurses in a teaching hospital in the United Arab Emirates revealed that there was a low level of awareness of pharmacovigilance centres and uncertainty about ADRs, fear of submitting an incorrect report and lack of knowledge about reporting procedures were significant barriers, with 86.8% of respondents saying that training was important for enhancing reporting [5]. The problem is especially pertinent in the Indian context where healthcare professionals are involved in the Pharmacovigilance Programme of India (PvPI) through the ADR Monitoring Centres. In a study of 130 nurses in a tertiary care hospital in India, Jain et al. found that while there was satisfactory interest and awareness, there was no adequate reporting practice of ADR and highlighted the need for training and better communication to enhance reporting practice [6]. These results justify the use of the complementary domains of knowledge, attitude and practice for the evaluation of pharmacovigilance, because good attitudes can be associated with poor procedural knowledge and reporting rates. Educational interventions may be a potentially modifiable strategy to address these gaps. Jha et al. showed that a structured educational intervention resulted in a significant improvement in the pharmacovigilance knowledge and attitude scores among the healthcare professionals [7]. In particular, Palaian et al. assessed a pharmacovigilance educational module for nursing students and found that there was a significant increase in knowledge after the intervention, indicating the feasibility of structured pharmacovigilance education in the nursing context [8]. A more recent study of an educational intervention for healthcare professionals (HCP) pre–post design also demonstrated an increase in pharmacovigilance knowledge and perceptions following targeted training [9]. Taken together, these studies indicate that active educational strategies can be used to help close the gap between positive attitudes toward reporting of suspected reactions and the actual capacity to identify, document, and report reactions. In this backdrop, the present study was carried out among the nursing staff of a tertiary care hospital in chikkaballapur to determine the baseline knowledge, attitude and practice regarding pharmacovigilance and to see the impact of hands-on pharmacovigilance training. Special focus was given to the recognition and reporting of ADR, awareness of the institutional ADR Monitoring Centre and its contact number, knowledge of Pharmacovigilance Programme of India, familiarity with ADR-reporting forms, and changes in overall and domain-specific KAP scores after training

Study design and setting A single-group pre-test–post-test quasi-experimental study, incorporating a cross-sectional baseline assessment, was conducted during 2025 among nursing staff at the tertiary care hospital. The study was undertaken to assess baseline knowledge, attitude, and practice (KAP) regarding pharmacovigilance and to evaluate the effect of hands-on pharmacovigilance training on these outcomes. Study participants The study population comprised nursing staff working at the hospital during the study period. Participants who completed the baseline pharmacovigilance KAP questionnaire were included in the baseline assessment. A total of 87 nursing personnel contributed to the pre-training analysis. For evaluation of the effect of the intervention, only participants with an identifiable pre-training and post-training questionnaire pair were included in the within-participant analysis. Paired pre- and post-training observations were available for 56 participants. Eligibility criteria Inclusion criteria Nursing personnel were eligible for the study if they: 1. were working as nursing staff at the hospital during the study period; 2. participated in the baseline pharmacovigilance KAP assessment; and 3. provided sufficient questionnaire responses for calculation of the relevant KAP scores. For the pre–post assessment of training effectiveness, participants were additionally required to have participated in the pharmacovigilance training programme and to have both pre-training and post-training assessments that could be linked at the individual level. Exclusion criteria Non-nursing healthcare personnel were excluded from the study. For the paired intervention analysis, participants who did not have a post-training assessment or whose pre- and post-training records could not be reliably linked were excluded from the paired comparison. Study instrument Knowledge, attitude, and practice regarding pharmacovigilance were assessed using a structured 20-item questionnaire. The instrument consisted of three domains: knowledge (7 items; Q1–Q7), attitude (9 items; Q8–Q16), and practice (4 items; Q17–Q20). The knowledge domain assessed awareness of pharmacovigilance and adverse drug reactions (ADRs), identification of ADRs requiring reporting, responsibility for ADR reporting, awareness of the institutional ADR Monitoring Centre, knowledge of its telephone contact details, and awareness of the Pharmacovigilance Programme of India (PvPI). The attitude domain assessed perceptions regarding the importance of ADR reporting, professional responsibility for reporting, drug safety, contribution of ADR reporting to patient safety, inclusion of pharmacovigilance in healthcare education, confidence in ADR reporting, perceived usefulness of pharmacovigilance training, willingness to participate in future training, and perceptions regarding under-reporting of ADRs. The practice domain assessed previous experience of encountering an ADR, previous ADR reporting, familiarity with ADR reporting forms, and previous exposure to ADR-reporting training. The questionnaire also collected demographic information, including age, designation, and department. Data collection procedure The pharmacovigilance KAP questionnaire was administered to nursing personnel before the training intervention. The pre-training assessment was used to establish baseline levels of knowledge, attitude, and practice. Following completion of the baseline assessment, participants underwent hands-on pharmacovigilance training focused on ADR recognition and reporting. The training addressed key aspects of pharmacovigilance, including the role of healthcare professionals in ADR reporting, awareness of the institutional ADR Monitoring Centre, the Pharmacovigilance Programme of India, and practical aspects of ADR reporting and use of the reporting form. After the training intervention, the same questionnaire was administered as a post-test to assess changes in pharmacovigilance-related knowledge, attitude, and practice. Pre- and post-training questionnaires were linked at the participant level using the available participant identifiers, and only unambiguously matched records were used for paired statistical analyses. Scoring of knowledge, attitude, and practice Questionnaire responses were coded dichotomously. Each correct knowledge response was assigned a score of 1, while an incorrect or non-scorable response was assigned a score of 0. For attitude items, a favourable pharmacovigilance-related response was assigned a score of 1 and an unfavourable response a score of 0. For practice items, an affirmative response indicating the specified pharmacovigilance-related experience or activity was assigned a score of 1. For the knowledge domain, the maximum possible score was 7. The correct response to the item on the full form of ADR was Adverse Drug Reaction; identification of serious, non-serious, frequent, and rare ADRs was considered the correct response regarding ADRs requiring reporting; and recognition of all healthcare professionals as potential ADR reporters was considered correct. The maximum possible attitude score was 9. The item asking whether all drugs are safe was reverse-scored, such that a response of “No” represented the favourable response. For the item concerning inadequate reporting of ADRs, a response acknowledging ADR under-reporting was considered favourable. The maximum possible practice score was 4. The overall KAP score was calculated by summing the three domain scores, yielding a maximum possible score of 20. Domain scores were also expressed as percentages of their respective maximum attainable scores to facilitate comparison across domains. Outcome measures The principal study outcomes were: 1. baseline knowledge, attitude, practice, and overall KAP scores regarding pharmacovigilance; and 2. within-participant changes in knowledge, attitude, practice, and overall KAP scores following hands-on pharmacovigilance training. Secondary outcomes included changes in individual questionnaire responses, including awareness of pharmacovigilance, awareness of the institutional ADR Monitoring Centre and its contact details, awareness of PvPI, recognition of ADR-reporting responsibilities, previous exposure to ADR reporting forms, and ADR-reporting-related practice. Statistical analysis Baseline characteristics and KAP responses were summarized using descriptive statistics as mean ± standard deviation (SD), median with interquartile range (IQR), or n (%), as appropriate. Baseline analyses included 87 participants, while pre–post comparisons were performed in 56 matched participants. Changes in KAP domain scores were assessed using the Wilcoxon signed-rank test, with mean paired differences, 95% confidence intervals, and Cohen’s dz reported as measures of effect. Changes in individual dichotomous questionnaire items were evaluated using the exact McNemar test, with Benjamini–Hochberg correction for multiple comparisons. All tests were two-sided, with p<0.05 considered statistically significant. Analyses were performed using SPSS version 30. Ethical considerations The study was conducted in accordance with applicable institutional and ethical standards, and participant confidentiality was maintained during data handling and analysis.

Study participants The baseline pharmacovigilance KAP analysis included 87 nursing staff. Among participants with age recorded (n=84), the mean age was 25.2 ± 5.0 years; 71 (81.6%) of the total cohort were aged 20–29 years. Staff nurses comprised 71 (81.6%) of participants (Table 1). Table 1. Baseline characteristics of participants (n=87) Characteristic Value Age, years, mean ± SD (recorded n=84) 25.2 ± 5.0 Age 20–29 years 71 (81.6%) Age 30–39 years 10 (11.5%) Age 40–49 years 3 (3.4%) Age not recorded 3 (3.4%) Staff nurse 71 (81.6%) Other nursing designation 12 (13.8%) Designation not recorded 4 (4.6%) Values are n (%) unless otherwise indicated. Percentages are based on the baseline cohort (n=87). Baseline knowledge, attitude and practice At baseline, the mean overall KAP score was 13.20 ± 2.58 out of 20. Attitude was the strongest domain, whereas practice showed the lowest relative score (Table 2). Only 39 (44.8%) participants were aware of the ADR Monitoring Centre telephone numbers, 33 (37.9%) had previously encountered an ADR, and 20 (23.0%) reported prior ADR-reporting training. In contrast, favourable attitudes were common: 82 (94.3%) believed ADRs should be reported and 85 (97.7%) considered ADR training sessions helpful. Table 2. Baseline pharmacovigilance KAP scores (n=87) Domain Maximum score Mean ± SD Median (IQR) % of maximum Knowledge 7 4.15 ± 1.62 4 (3–5) 59.3 Attitude 9 7.54 ± 1.07 8 (7–8) 83.8 Practice 4 1.51 ± 1.28 1 (0–2.5) 37.6 Overall KAP 20 13.20 ± 2.58 13 (11–15) 66.0 KAP, knowledge, attitude and practice; IQR, interquartile range. Impact of hands-on pharmacovigilance training Paired pre- and post-training data were available for 56 participants. Scores increased significantly in knowledge, attitude, practice and overall KAP (all p<0.001; Table 3). Overall KAP increased from 13.25 ± 2.55 to 17.39 ± 1.42, corresponding to a mean gain of 4.14 points (95% CI 3.40–4.88) and a large within-participant effect (Cohen's dz=1.50). Overall KAP improved in 51 (91.1%) participants. The largest proportional gains were observed in knowledge and practice, while attitude improved from an already high baseline level (Figure 1). Table 3. Change in KAP scores following hands-on training (paired n=56) Domain Pre-training mean ± SD Post-training mean ± SD Mean change (95% CI) Wilcoxon |Z|; p Cohen's dz Improved n (%) Knowledge 4.16 ± 1.71 6.27 ± 0.94 2.11 (1.64–2.57) 5.860; <0.001 1.21 45 (80.4%) Attitude 7.55 ± 0.95 8.09 ± 0.67 0.54 (0.28–0.80) 3.676; <0.001 0.55 29 (51.8%) Practice 1.54 ± 1.33 3.04 ± 0.95 1.50 (1.15–1.85) 5.604; <0.001 1.14 42 (75.0%) Overall KAP 13.25 ± 2.55 17.39 ± 1.42 4.14 (3.40–4.88) 6.232; <0.001 1.50 51 (91.1%) p-values are from two-sided Wilcoxon signed-rank tests. |Z| denotes the standardized Wilcoxon statistic. Cohen's dz is the standardized within-participant effect size. Item-level changes after training Nine questionnaire items showed significant paired improvement after Benjamini–Hochberg correction (Table 4). The most pronounced gains involved awareness of the ADR Monitoring Centre and its telephone numbers, awareness of the Pharmacovigilance Programme of India, exposure to the ADR reporting form, and ADR-reporting training. For example, awareness of the centre telephone numbers increased from 23 (41.1%) to 54 (96.4%), and prior ADR-reporting training increased from 14 (25.0%) to 46 (82.1%) (Figure 2). Table 4. Item-level paired improvements remaining significant after multiplicity correction (n=56) Item Pre n (%) Post n (%) Improved / worsened Exact McNemar p BH-adjusted p Q1 Heard of pharmacovigilance 37 (66.1%) 55 (98.2%) 18 / 0 <0.001 <0.001 Q4 All healthcare professionals can report ADRs 28 (50.0%) 43 (76.8%) 16 / 1 <0.001 <0.001 Q5 Knows ADR Monitoring Centre at the hospital 30 (53.6%) 55 (98.2%) 25 / 0 <0.001 <0.001 Q6 Aware of ADR Monitoring Centre telephone numbers 23 (41.1%) 54 (96.4%) 31 / 0 <0.001 <0.001 Q7 Aware of the Pharmacovigilance Programme of India 28 (50.0%) 51 (91.1%) 23 / 0 <0.001 <0.001 Q16 Believes ADRs are not adequately reported 14 (25.0%) 28 (50.0%) 22 / 8 0.016 0.036 Q17 Has ever come across an ADR 22 (39.3%) 39 (69.6%) 20 / 3 <0.001 0.001 Q19 Has seen an ADR reporting form 29 (51.8%) 53 (94.6%) 26 / 2 <0.001 <0.001 Q20 Has undergone ADR-reporting training 14 (25.0%) 46 (82.1%) 32 / 0 <0.001 <0.001 Improved/worsened denotes discordant paired responses (0→1 / 1→0) used in the exact McNemar test. BH, Benjamini–Hochberg; ADR, adverse drug reaction. Abbreviations: ADR, adverse drug reaction; BH, Benjamini–Hochberg; CI, confidence interval; HCP, healthcare professional; KAP, knowledge, attitude and practice; PvPI, Pharmacovigilance Programme of India.

The present study shows that the attitudes of nursing staff were generally favorable towards pharmacovigilance at baseline, but there were significant gaps in knowledge and practice, especially in the latter. The mean baseline attitude score was 83.8% of the maximum possible score, whereas knowledge and practice were 59.3% and 37.6%, respectively. After hands-on pharmacovigilance training, there was a significant increase in KAP score in all domains, ranging from 13.25±2.55 to 17.39±1.42 in matched participants. The mean gain of 4.14 points and large within-participant effect size (Cohen's dz=1.50) suggest that the intervention had a significant short-term effect rather than a small one. This is similar to the results of Ganesan et al., who assessed the KAP of 235 doctors and nurses in a tertiary care hospital in South India and observed a significant increase in KAP after an educational intervention (p<0.0001). Importantly, the reporting of ADR doubled in the year following the intervention, indicating that education may have an impact beyond questionnaire performance to reporting behaviour [10]. Similarly, the greatest percentage improvements were seen in knowledge and practice, and attitude showed less improvement as it was high at baseline. This ceiling effect is clinically relevant: favourable attitudes alone do not necessarily ensure that nurses know where, how, or what to report. Munshi and Maurya found a similar long-term trend in 390 nursing students and staff. They had a baseline score of 17.53% for knowledge, 72.86% for attitude and 39.69% for practice; following pharmacovigilance sensitisation, their scores were 30.77% for knowledge, 85.92% for attitude and 37.21% for practice [11]. The contrast with our results is remarkable as practice in the present study increased from 1.54±1.33 to 3.04±0.95, with a mean improvement of 1.50 points and a large effect size (dz=1.14). This could be due to the hands-on approach of the present training, which explicitly covered the recognition of ADR, reporting forms, awareness of the institutional ADR Monitoring Centre and reporting procedures. It also implies that interventions focused on procedural competence could be more effective in altering practice-related responses than only sensitisation-based interventions. The need for targeted education is further supported by Shenoy et al. who conducted a study on 42 doctors and 115 nurses in a tertiary care teaching hospital with a 20-item pharmacovigilance questionnaire. The one-hour educational session resulted in a significant improvement in knowledge among nurses (Z=−8.808, p<0.001) and doctors, and lack of knowledge or awareness was identified as the greatest perceived barrier to reporting ADR [12]. Our results further confirm this finding by showing that not only knowledge in general, but also specific aspects of pharmacovigilance operations have improved. Among the paired participants, awareness of the institutional ADR Monitoring Centre rose from 53.6% to 98.2%, awareness of its telephone numbers rose from 41.1% to 96.4%, and awareness of PvPI rose from 50.0% to 91.1%. These gains are especially important because if healthcare personnel know that they should report ADRs, but don't know the institutional reporting pathway, such awareness alone is of limited practical value. This knowledge–practice gap has been reported in other nursing groups. Alan et al. conducted a survey of 329 nurses and midwives in four hospitals in Turkey, and found that about 45% knew about pharmacovigilance, but only 23.3% could define it correctly. While 24.3% were aware that ADRs should be reported to a centre, only 1.2% could correctly identify the national pharmacovigilance centre [13]. Specific procedural knowledge was relatively high, but not complete, in our baseline cohort, especially in terms of contact details and the national programme. The significant post-training improvements in these areas indicate that gaps in practical knowledge can be quickly addressed through institution-specific teaching. Likewise, Vural et al. assessed 112 nurses and found that 70.5% of them were aware of the necessity of reporting ADRs, but only 34.9% knew that the reporting should be done to the designated pharmacovigilance contact person, only 8% knew the Turkish Pharmacovigilance Centre and only 8% had reported an ADR during their professional life [14]. The gap between positive attitudes and limited reporting behaviour is similar to our baseline results, with 94.3% saying that ADRs should be reported, 97.7% saying that ADR training is useful, but only 37.9% having encountered an ADR and 23.0% having received ADR-reporting training. The results support the idea that a positive attitude of the professional is essential but not enough, and that repeated practical exposure and knowledge of reporting systems seem to be equally crucial. A similar example is from India. The level of knowledge of the burden of ADRs among nursing staff and students was low, but approximately 70% of them believed that the reporting of a single individual could make a difference, and more than 80% of the nursing staff and general nursing students agreed that active suspicion of ADRs during treatment is desirable [15]. They found that, despite relatively positive attitudes, actual reporting practice was still unsatisfactory, which is in line with the domain pattern of our cohort at baseline. The increase in familiarity with ADR reporting forms in our study (from 51.8% to 94.6%) is important as it shifts from conceptual acceptance to operational readiness. The results of Adiga and Banavalikar also highlight the practical challenges encountered by nurses. Of the nurses working in a secondary-care setting, 72.5% had witnessed at least one ADR and 45% had reported an ADR to a higher authority. However, 31% reported that there were no reporting forms available, 24.45% were not aware of where to report and 82.5% believed that regular awareness programmes were needed [16]. These observations are very similar to the focus of our intervention on reporting forms, local contact information and ADR-reporting procedures. The increase in practice-related scores and item-level responses is therefore biologically and educationally plausible, since the training directly targeted barriers that were previously identified in similar nursing populations. Multicentre evidence also suggests that despite the growing awareness of drug safety, knowledge and practice of pharmacovigilance remain deficient. In Malaysia, Mahfodz et al. found that the mean KAP score was 57±11 for hospital nurses, with 37.4% having poor ADR knowledge and 48.9% having poor reporting practices. The nurses who were older than 30 years and who had more than 10 years of experience were significantly more likely to have good knowledge and reporting practices [17]. The mean age of our cohort was 25.2 years and 81.6% were aged 20–29 years. The marked improvement in KAP following training in this relatively young nursing workforce may thus be especially relevant, since structured early-career pharmacovigilance training may help to build reporting habits before less effective patterns become ingrained. The item-level findings offer further information about the operation of the intervention. Nine questionnaire items remained significantly improved after Benjamini–Hochberg correction. The awareness of pharmacovigilance increased from 66.1% to 98.2%, recognition of all healthcare professionals as potential reporters of ADRs rose from 50.0% to 76.8%, awareness of the ADR Monitoring Centre rose from 53.6% to 98.2% and awareness of PvPI rose from 50.0% to 91.1%. The percentage of exposure to ADR reporting forms rose to 94.6%, and reported prior ADR-reporting training rose from 25.0% to 82.1%. These changes were all in the positive direction, indicating that the intervention had a positive impact on conceptual knowledge and familiarity with the local reporting infrastructure. The improvement in the attitude domain was less than in knowledge or practice, but this does not mean that the intervention effect was not strong. The baseline attitude was already high, so there was not much room for further improvement. Indeed, the mean attitude score increased from 7.55±0.95 to 8.09±0.67, with a moderate effect size (dz=0.55). Knowledge and practice, on the other hand, started at much lower levels and thus had a much greater potential for change. This domain-specific response supports the utility of reporting KAP components separately, in addition to an overall score. There are a few limitations to be noted. The study employed a single group pre-test–post-test design without a control group, and thus the results of improvement cannot be attributed to the intervention alone with the same degree of confidence as in a randomized design. Of the 87 baseline participants, only 56 had unambiguous matches with post-training records, raising the possibility of attrition or selection bias. The outcomes were based on self-reported ADR reporting behaviour in response to questionnaires, and the post-training assessment was largely based on short-term change. Furthermore, this study was performed in one institution, and the results may not be generalizable. The study has several strengths, however. It employed paired analysis at the participant level, measured knowledge, attitude and practice separately, reported effect sizes and confidence intervals, and used multiplicity correction for item-level comparisons. Most significantly, the hands-on intervention resulted in substantial gains in the areas that were lowest at baseline, including practical knowledge of ADR reporting systems. The results of this study suggest that repeated, institution-specific, hands-on pharmacovigilance training should be integrated into continuing nursing education, and further studies are needed to assess whether these gains are maintained and whether they lead to increased reporting of ADRs in the real world.

Hands-on pharmacovigilance training significantly improved knowledge, attitude, practice, and overall KAP among nursing staff. The greatest gains were seen in knowledge and practice, particularly in awareness of ADR reporting systems and procedures. These findings support incorporating practical, institution-specific pharmacovigilance training into continuing nursing education.

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