Reporting Of Adverse Events Of Artemisinin Based Combination Therapies Among Patients Attending War Memorial Hospital Of The kassena Nankana Municipality

ABSTRACT

The growing need to capture data on health events using faster and efficient means makes active surveillance an alternative means to capture anti-malarial drug safety data. A prospective cohort study was conducted at the Navrongo War Memorial hospital to determine the level of adverse events reporting following the intake of artimisinin based combination therapies (ACTs) by patients with uncomplicated malaria. The study employed active follow-up by telephone or home visit to document adverse events (AEs) associated with anti-malarial drugs. Exit interviews were conducted using questionnaires. Epidata version 3.1 was used to design the data base and STATA version 13 was used for analysis. Of 417 patients who participated in the study, 413 (99.0%) were successfully followed. Of these 228/413 (55.2 %) were female, 151/413(36.6%) had basic education and 175/413 (42.4%) were aged 18-64yrs. The ACTs taken were artesunate-amodiaquine 268/413 (64.9%), artemether-lumefantrine 138/413(33.4%) and diahydroartemisin-piparaquine. Overall, follow up by phone (312/413—75.5 %) was more than four times the number done by home visits (76/413—18.4 %). Forty six per cent (191/413) of patients reported AEs. In total, 15 AE were reported, 143/193(74.1%) by telephone and 32/193 (16.6 %) by home visits and the rest by health facility visit. Events such as general malaise, restlessness, nausea, dizziness, insomnia and vomiting were commonly reported. Majority of the AEs were mild. Chi square test showed a significant relation between age, severity of AE, means of reporting, type of ACT, and reporting of adverse events. A p-value ≤0.05 was considered statistically significant. In conclusion, majority of the AEs experienced by participants in this study were mild. Seven AEs were commonly reported by phone call and home visit. Phone call was the most used means of reporting. To improve upon reporting of AEs, patients should be actively encouraged to report AEs after intake of drugs any day they visit the health facility. With the high AE reporting rate by mobile phone, its use is recommended for reporting of AEs and studies to determine relatedness of adverse events to ACTs in real life settings are recommended.