System and site readiness for conducting active surveillance of adverse Events following Immunization in Addis Ababa, Ethiopia.

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Addis Abeba University


Background: Vaccine pharmacovigilance (PV) aims to detect, assess, comprehend, communicate and manage adverse events following immunization (AEFI). To help distinguish vaccine related AEFIs from coincidental occurrences, an active PV prospective surveillance programs (e.g. hospitalbased sentinel sites) are needed. We describe our experience in assessing system and facility readiness for implementing a pilot active AEFI PV in Addis Ababa, Ethiopia. Method: Three hospitals were selected for this study after objectively evaluating all the government hospitals in Addis Ababa using parameters ;ongoing collaborations with the Ethiopian Food and Drug Authority (EFDA), previous experience in research, being referral government hospital and proximity to key AEFI stakeholders in Addis Ababa. We developed a readiness assessment together with scoring tool and system readiness assessment tool by adapting published framework. The site assessment was conducted via in person interview of specific departments in each hospital while a desk review of AEFI guideline, Expanded Program for Immunization (EPI) guideline, EFDA and Ethiopian Public Health Institute (EPHI) website was done for system readiness. Results: Three out of thirteen (23.1%) hospitals in Addis Ababa met the criteria for our site assessment. During the system readiness assessment, we found that essential components were in place, Specific regulation and proclamation on AEFI surveillance except mentioning responsibility of every stakeholder on the guideline was, however absent. Based on the scoring tool, Tikur Anbessa Specialized Hospital (TASH) scored 94 out of 155 (60.6%), Saint Paul Hospital Millennium Medical College scored 75 out of 155 (48.38%) and Gandi Memorial Hospital scored 62 out of 155 (40%). Paper-based records were used by all departments except those of laboratory and radiology in TASH and SPHMMC. International Classification of Disease (ICD) 9/10 coding was only used in TASH. Copies of national AEFI guidelines were not present in all departments and reporting forms were found only in 4 departments surveyed across the three hospitals. Staff at both Gandi Memorial Hospital and SPHMMC reported absence of training on AEFI surveillance. Conclusion: TASH has the highest score after assessing readiness for piloting active AEFI surveillance. We also identified the following areas for improvement in all hospitals to ensure successful implementation: training, making guideline and reporting forms available, and ensuring a system that accommodates paper-based and electronic record systems.