Adverse Events Reporting Following Immunization Among Mothers With Children 0-5 Years And Health Workers In Selected Health Facilities In Greater Accra Region.

ABSTRACT Introduction: Adverse event reporting remains a major public health concern. Vaccination, an essential component of the public health programme was introduced to save lives and preserve health. Unlike medicines, the expectations from vaccination are much higher and problems arising from the vaccine or vaccination may be less acceptable to the general public. Adverse events (AEFI) is defined as any unwanted medical occurrence which follows immunization and does not necessary have a causal relationship with the use of the vaccine. The identification, recording, reporting and monitoring of adverse event following immunization (AEFI) is essential to the investigation and reduction of such cases. Spontaneous reporting system is a commonly used system to report AEFIs by health workers as well as caregivers. Spontaneous and prompt reporting of AEFIs is an important activity of pharmacovigilance that help in ensuring medicine safety. Aim: To explore factors and barriers associated with adverse event reporting following immunization among mothers with children aged 0-5 years and health workers in three selected health facilities in Greater Accra Region. Method: This is a mixed method study design which involved both qualitative and quantitative approaches.. Health facilities were conveniently sampled and health workers purposively sampled to partake in the studies. Mothers were randomly selected from the three selected health facilities and secondary data was obtained from 2016-2018 ascertain the most causal vaccines reported, the common AEFIs in three selected health facilities in the Greater Accra Region. Results: Qualitative: A total of 17 interviews were conducted, 17 (100%) being females with age ranging between ≤ 30 representing 3 (17.6%) and ≥ 30 representing 14 (82.4), 10  (58.8%) have had tertiary education, 5 (29.4%) secondary education and 2(11.8%) primary education. A total of 7(41.1%) were health workers whiles 10 (58.9) were mothers. Barriers identified in the study included inadequate staff, heavy workload, fear of criticism, lack of adequate knowledge about AEFI and who to report to. Factors were identified based on three main factors (health worker factors, mothers‘ factors and health system factors) availability of forms, adequate training, built feedback system, education and sensitization, familiarity of the reporting system and monitoring and supervision. Quantitative: A total of 33 AEFI cases (34.6 per 100000 children vaccinated) was identified at the three facilities. In 2016, seven AEFI cases (22.4 Per 100000 children vaccinated), in 2017 26 AEFI cases (82.6 per 100000 children vaccinated) and one AEFI case in 2018 (3.0 per 100000 children vaccinated). This indicates underreporting as compared to the WHO recommended rate of AEFI reporting.15 (45%) represented males as compared with 18 (55%) females. The most common AEFI identified was Injection site abscess with most causal vaccine being yellow fever. Conclusion: It is necessary to develop training and educational programs to increase awareness in both mothers and health workers towards reporting of AEFIs. The information generated from this study is valuable for the public health regulators to generate new guidelines for AEFI surveillance.