Abstract:
Background: Adverse drug reactions affect patient safety and healthcare quality. Nurses’
involvement in pharmacovigilance is vital for effective monitoring, timely reporting, and
management of ADRs, in accordance with guidelines by the National Medicines Regulatory
Authority (NMRA).
Objective: To assess the level of knowledge regarding the monitoring and reporting of ADRs
among nurses attending KIU University
Methods: A descriptive cross-sectional study was carried out among registered nurses working at
government hospitals in Sri Lanka and attending KIU (a non-state university in Sri Lanka) for
higher studies. Participants were recruited through simple random sampling. Data were collected
using a researcher-developed, pre-tested, online questionnaire comprising sections on baseline
characteristics and knowledge on monitoring and reporting practices of ADRs. Total scores were
used to assess overall knowledge, categorized as follows: >80-good, 60-80-moderate, <60-poor-
knowledge. Data was analysed using descriptive and inferential statistics with SPSS.
Results: The study included 400 participants. The mean±SD age and working experience were
35.37±4.06 years and 10.51±4.63, respectively. The majority were female (94.5%) and had
received training on ADR (60.5%). The mean±SD total knowledge score was 85.05±23.60, with
72.8% scoring ≥80.01, indicating a high level of ADR awareness. The mean±SD score for ADR
monitoring knowledge was 65.86±25.18, indicating a moderate to high level of understanding,
while the mean score for ADR reporting knowledge was 56.26±26.45, reflecting moderate-
awareness. Chi-square analysis showed significant associations between ADR knowledge and age
(p=0.000), gender (p=0.033), work experience (p=0.000), clinical setting (p=0.000), involvement
in patientcare (p=0.000), and prior ADR training (p=0.000), emphasizing the importance of
experience and training in enhancing ADR-related knowledge.
Conclusion: Despite reporting moderate-level knowledge regarding the monitoring and reporting
of ADRs, expansion of nurses’ knowledge and practice is vital. Monitoring and reporting ADRs
were associated with the selected personal and professional characteristics. Integration of
pharmacovigilance into nursing education, and the implementation of user-friendly ADR reporting
systems are recommended.
