Status of Pharmacovigilance Systems in the North Eastern Region of Kenya

Abstract

Background: Pharmacovigilance (PV) activities are important in identifying the safety and effectiveness of medicines in the general population, decreasing medication-related morbidity and mortality, and promoting the rational use of medications. An effective PV system supports the early detection, assessment, understanding and mitigation of adverse outcomes associated with medicines and medical products. This study highlighted the gaps that exist within the PV systems of the North Eastern region of Kenya (NERK) and possible areas of intervention by various stakeholders. Objective: To assess the pharmacovigilance systems in the North Eastern Region of Kenya Methodology: This cross-sectional study assessed the PV systems in thirty health facilities using a Health Facility Assessment Form for PV indicators. They were selected using a stratified random sampling method. The data collected from these facilities was scored using the Harmonized Indicators for Assessing and Monitoring Pharmacovigilance Systems in the East African Community Partner States User Manual. In the second arm, 306 healthcare workers (HCWs) were recruited into the study and interviewed through a questionnaire. Convenient sampling targeted nurses, pharmaceutical personnel, and clinicians. Data was collected using a questionnaire to assess the knowledge, attitudes and practices (KAP) of pharmacovigilance among HCWs from health facilities. The health facility indicators scored were computed; knowledge, attitude, practice, and factors hindering PV were analysed descriptively using Microsoft Excel 2016. Ethical approval was obtained from KNH/UoN ERC (P135/02/2023) and the respective county ethical committees. Descriptive and regression analyses were conducted using STATA version 13.0 software. xiii Results: Amongst HCWs, majority were male, (n=188, 61.4%) aged 26 to 38 years (n=127, 42.5%) with nurses as the predominant cadre (n=118, 59.8%), and diplomas as the highest qualification (n=243, 79.4%). In facility assessments, the majority (n=26, 86.7%) of health facilities scored 0 points. In the knowledge assessment, majority (n=139, 45.8%) scored between 60–80% while 218 (71.2%) scored 100% in the attitude assessment. Majority of respondents (n=174, 56.9%) had experienced a single reportable PV incident in the past 12 months. The main hindrances to PV activities included lack of motivation (n=286, 93.3%), absence of a professional environment for discussion (n=265, 86.7%) and fear of legal liability (n=193, 63.3%). Statistically significant differences in knowledge scores were observed among professional groups (χ² = 36.91, df = 5, p <0.01) and educational qualifications (χ² = 102.3, df = 5, p <0.01). Specialists achieved the highest median knowledge score, while nurses had the lowest. Professional groups and educational qualifications played a role in predicting the variations in the knowledge assessment score, emphasizing the need for targeted interventions. Conclusion: A significant proportion of health facilities demonstrated inadequacy in their PV systems. The findings underscore the importance of addressing reporting barriers and enhancing knowledge to foster a vigilant PV culture in healthcare settings