The World Health Organization 1 defines Pharmacovigilance (PV) as the science and activities focused on detecting, assessing, understanding, and preventing adverse effects or any other problems related to medicine use. Adverse drug reactions (ADRs) are significant contributors to both morbidity and mortality worldwide and are also known to lead to longer hospital stays and increased treatment costs 2, 3. The primary goal of pharmacovigilance is to minimize the risk of drug-related harm to patients. Since all medications have the potential to cause adverse effects, administering a drug inherently involves some level of risk 4. Health care professionals play an important role in reporting and monitoring of adverse reactions. Medication safety is a shared responsibility among physicians, nurses, pharmacists, and other healthcare workers. Knowledge, Attitude, and Practice (KAP) studies are effective tools for evaluating ADR reporting among healthcare professionals in relation to pharmacovigilance.

In 17 studies conducted in Europe, the proportion of adverse drug reactions leading to acute hospital admissions varied between 0.5% and 12.8% 3. Furthermore, in 10 studies, the percentage of hospital patients experiencing an ADR ranged from 1.7% to 50.9% 5, 6. In the United States, adverse drug reactions are responsible for 100,000 to 218,000 deaths each year, making them the third leading cause of death after heart disease and cancer 7. Stausberg 8 reports that the rate of in-hospital adverse drug reactions is 5.6% in the United States and 3.2% in the United Kingdom. In the United Kingdom, the total annual expenditure for admissions linked to adverse drug reactions was approximately £466 million, whereas in the USA, the estimated cost for ADR-related admissions in ambulatory care settings was expected to exceed $177 billion 7, 9. In Saudi Arabia, Khan et al.10 conducted a study at King Abdulaziz University Hospital in Jeddah and found an incidence rate of adverse drug reactions of 3.1% in a retrospective study and 5.5% in a prospective study involving hospitalized internal medicine patients. Another study conducted at the same hospital among hospitalized pediatric patients found an incidence rate of adverse drug reactions of 4.5% in a retrospective analysis and 8.2% in a prospective study 10. In Asia, a recent study from South Korea found that consumers are more likely than healthcare workers to report therapeutic ineffectiveness 11.

Low-and middle-income countries (LMICs), like Lesotho, face specific challenges in pharmacovigilance, including the limited integration of pharmacovigilance systems despite recent efforts to harmonize regulations within regional economic communities 12. There is a need to translate reporting tools into numerous local languages and address the high patient-to-healthcare worker ratios with very short consultation times 13. Moreover, there is a scarcity of well-trained pharmacovigilance personnel, coupled with minimal budgetary support from national governments. High staff turnover, which requires substantial training resources, and low awareness of pharmacovigilance among healthcare workers, decision makers, and consumers further complicate the issue 14. The very low reporting rates and poor-quality spontaneous reports hinder robust signal detection analyses. There is also a lack of collaboration between public health programs and national medicines regulatory authorities, limited investment in pharmacovigilance activities during mass drug administration for neglected tropical diseases, and high use of herbal and traditional medications, often through self-medication. Furthermore, regions affected by disruptive conflicts face jeopardized systems, and limited access to drug utilization data makes it difficult to reliably estimate the true safety risks of medication use 15. In Lesotho, the pharmacovigilance program is still in the infancy stage, having just started in the year 2018. The national pharmacovigilance centre is located at the Ministry of Health of Lesotho. According to the Uppsala Monitoring Centre (UMC), Lesotho became an Associate Member of the WHO Programme for International Drug Monitoring (PIDM) in 2020 16.

There is a strong correlation between ADR reporting and the knowledge, attitudes, and practices of healthcare professionals 17. Studies 18, 19, 20 from various settings reveal that inadequate knowledge and understanding of pharmacovigilance among healthcare professionals contribute to a high rate of underreporting of adverse drug reactions. Data on KAP studies related to pharmacovigilance among newly graduated nursing staff are limited in the literature. Therefore, a questionnaire-based comparative study was designed to assess KAP regarding PV among newly graduated nursing staff before and after an educational intervention, specifically a pharmacovigilance training workshop.

A pre–post interventional, questionnaire-based study was conducted to evaluate the impact of an educational intervention on newly graduated nurses’ knowledge and awareness of pharmacovigilance and adverse drug reaction reporting. A total of 197 newly graduated registered nurses from six nurse training institutions in Lesotho participated in the study. The participants were provided with an electronic informed consent form, an electronic questionnaire and guaranteed the confidentiality of the collected information. Questions that could reveal personal details, such as the participant's name, contact information, and the name of their organization, were avoided. The participants were assured that the study's results would be published anonymously. The intervention involved a sensitization workshop designed to enhance newly graduated registered nurses' understanding of pharmacovigilance and adverse drug reaction reporting.

The authors then conducted a 5 day blended educational intervention via a face-to-face lecture and Zoom meetings, using a PowerPoint presentation to assist with the educational guide. Each session lasted between 40 and 60 minutes. The educational guide was created by the authors, drawing on literature, educational materials from the CDC website 21, 22 and pharmacovigilance training material from the Ministry of Health in Lesotho. The guide covered key topics, including an overview of pharmacoepidemiology (PE) and its relationship with PV, basic PV concepts, components of adverse drug events (ADEs), investigations and causality assessment of ADRs, diagnosis, management, and prevention of ADRs, monitoring and ensuring medication safety, the national PV system, and the role of PV in public health programs (PHPs). It was presented and assessed by the second author who is an expert in the field of clinical pharmacy. The presentation was followed by hands-on training on filling out the ADR reporting forms as per the case history provided. Prior to the workshop, participants were emailed a link to an electronic questionnaire, referred to as the pre-test, following a brief description of the study. On average, it took participants about 30 minutes to complete the pre-test. At the end of the training session, the posttest was conducted with the same questionnaire and was collected after 30 minutes. The pre-test and posttest were analyzed using statistical methods.

The collected data were entered into a Microsoft Excel spreadsheet for evaluation. A paired t-test was used to assess the pretest and posttest scores of newly graduated nursing staff. All results were recorded in Excel, and the statistical calculations were performed using GraphPad InStat. A P-value of less than 0.05 was considered statistically significant.

Pharmacovigilance has grown in importance recently as a key element of effective drug regulation systems, clinical practice and public health programs 23. Health care professionals play an important role in reporting ADRs, with spontaneous reporting remaining an essential tool in detecting and reporting ADRs to avoid harm as much as possible. A total of eleven questions were used to evaluate a newly graduated registered nurse’s knowledge and awareness of PV and ADRs, two questions assessed attitudes, and two other questions assessed the practices. Details of the responses to the knowledge-related, attitude-related and practice-related questions are presented in Table 2.

The results indicated that newly graduated registered nurses generally lacked knowledge of pharmacovigilance, adverse drug reactions, and the existence of the National Pharmacovigilance Unit before the intervention. However, after receiving educational intervention, their post-test scores significantly improved, highlighting the importance of education in the success of the PV program. A study conducted by Gupta et al.24 assessed the knowledge, attitude, and practices (KAP) of doctors, nurses, and pharmacists but did not include an educational intervention. Their findings suggested that while awareness and attitudes toward PV were gradually improving among healthcare professionals, the actual practice of ADR reporting remained inadequate. Similarly, a study by 25 found that only 39.6% of healthcare professionals were aware of the National Pharmacovigilance Centre, with nurses accounting for 27.2%, physicians 39.2%, and pharmacists 70.27%. However, these results contradicted the findings of Suyagh et al. 26, which indicated that pharmacists also had poor knowledge of the pharmacovigilance system.

Knowledge of the criteria for identifying serious ADRs in the nursing pretest group was found to be poor, with only 8.3% demonstrating awareness. This may be attributed to the fact that newly graduated registered nurses have had limited exposure to ADRs, making them less familiar with the criteria. Overall, there was a significant increase in knowledge scores after the intervention, particularly regarding the definition and types of ADRs, serious ADRs, and the benefits of reporting ADRs to medicine regulatory authorities. These findings highlight the importance of incorporating PV and ADR education into pre-service training, as well as the need for ongoing educational sessions for healthcare workers. The results of this study suggest that newly graduated registered nurses were strongly influenced by the educational sessions on PV, including hands-on training in ADR reporting. These findings align with previous studies by Bagewadi et al. 27, Augustine et al. 28, and Suveges 29.

In this study, the total pre-intervention knowledge-attitude (KA) score (mean ± standard deviation) for knowledge was 27.63 ± 21.62, while the attitude score was 98 ± 14.14. Following the intervention, the mean knowledge score significantly increased to 113.81 ± 7.38, and the attitude score rose to 114.5 ± 6.36. A statistically significant improvement in the correct response rate (P < 0.0001) was observed in the knowledge domain after the educational intervention. In the analysis of attitudes and practices, most newly graduated registered nurses agreed that ADR reporting is necessary and contributes to public health improvement. However, none of the participants had received prior training on completing ADR forms. Three primary reasons were identified as barriers to ADR reporting: uncertainty about whether an ADR had occurred, lack of time to report ADRs, and the belief that a single ADR report is insignificant. Medications are the most commonly used therapeutic interventions, and their rational use is essential. Failure to ensure drug safety can lead to severe consequences, ranging from lifelong disability to mortality. Conversely, consistent ADR reporting enhances drug safety 30. Many low- and middle-income countries struggle with low ADR reporting rates, which limits the generation of pharmacovigilance signals and data 31. The participants in this study demonstrated similar challenges in ADR reporting. The failure to document ADR reports reflects poor reporting practices among healthcare professionals, potentially leading to drug safety issues 32. Several studies have reported similar findings, showing that despite encountering ADRs in their practice, most healthcare professionals do not report them 33, 34, 35, 36.

Various technical terms related to pharmacovigilance, such as ADR, reporter, reportee, causality, and outcome, were explained using non-medical examples, drawing parallels with burglary. This novel approach was found to be highly engaging and made the session easier to understand.

Bagewadi et al.27 and Augustine et al.28 evaluated the effectiveness of educational interventions on PV among undergraduate medical students and medical interns, respectively. Both studies concluded that enhancing knowledge of PV and ADR reporting plays a crucial role in promoting drug safety and ensuring the rational use of medicines in the future.

The comparison of the pretest score and posttest core is definitive proof that educational intervention is very helpful in improving knowledge, attitudes, and practices of pharmacovigilance among newly graduated registered nurses. This study suggests that including a pharmacovigilance module in nursing curricula and providing educational interventions on PV are necessary to increase awareness and reporting of adverse drug reactions by newly graduated registered nurses and practicing nurses who are at the forefront of health care delivery.