Browsing by Author "Kigahe, Brown"

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    Challenges in Establishing A Cohort-Event Monitoring Drug Safety Study in Ifakara And Rufiji HDSS
    (2011-08) Amuri, Mbaraka; Kigahe, Brown; Njozi, Mustafa; Masanja, Irene M.; Selemani, Majige; Dan, Kajungu; Khatib, Rashid A.; Adounvo, Sharon A.; Abdulla, Salim; Binka, Fred; Dodoo, Alexander
    The recommended artemisinin combination therapy (ACT) for treatment of uncomplicated malaria in Tanzania is artemether-lumefantrine (AL). Although Artemisinin and its derivatives are generally thought to be safe, there is currently little or no data on its safety among populations in Tanzania. In view of this INESS established a phase IV study to evaluate safety of AL through comprehensive pharmacovigilance in large populations with the aim of documenting rare adverse drug reactions and to characterize known effects in ‘real-life’. The methodology employed is cohort event monitoring which is observational, longitudinal and prospective. Patients with diagnosis of malaria for whom AL was prescribed were recruited into the cohort from four health facilities in each HDSS. Information on demographics, use of all medicines, mode of diagnosis of malaria, presenting signs and symptoms, co-diagnoses, events suspected as adverse drug reactions, reasons for stopping the drug and cause of death (if any) were collected using standardized questionnaire. They were followed up on 7 to 10 days after AL was dispensed. This report is on the number recruited so far and the challenges in getting the cohort going. 9028 patients were recruited. 9016 (99.8%) completed follow-up on day 7, of which 668 (7.4%) were done by telephone calls. 12 (0.13%) were lost during follow-up. The main challenges encountered are getting enough trained staff to recruit and follow up patients since CEM is quite labour intensive. 38 health providers and 10 field workers were recruited and offered the relevant training in collaboration with regulatory authorities. This helped to overcome the human resource challenge. Another challenge involved is the difficult to reach areas which are cut off especially during the rainy season. Follow up by telephone was adopted for these areas and this helped to reduce number of lost to follow-up. Setting up a cohort event monitoring program takes time and is demanding in terms of human resource. Training is very important in overcoming this. Involvement of all stakeholders and sponsors is a key to success
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    Predictors of Antibiotics Co-Prescription with Antimalarials for Patients Presenting With Fever in Rural Tanzania
    (2013-11) Njozi, Mustafa; Amuri, Mbaraka; Selemani, Majige; Masanja, Irene M.; Kigahe, Brown; Khatib, Rashid A.; Dan, Kajungu; Abdulla, Salim; Dodoo, Alexander
    Successful implementation of malaria treatment policy depends on the prescription practices for patients with malaria. This paper describes prescription patterns and assesses factors associated with co-prescription of antibiotics and artemether-lumefantrine (AL) for patients presenting with fever in rural Tanzania. From June 2009 to September 2011, a cohort event monitoring program was conducted among all patients treated at 8 selected health facilities in Ifakara and Rufiji Health and Demographic Surveillance System (HDSS).It included all patients presenting with fever and prescribed with AL. Logistic regression was used to model the predictors on the outcome variable which is co-prescription of AL and antibiotics on a single clinical visit. A cohort of 11,648 was recruited and followed up with 92% presenting with fever. Presumptive treatment was used in 56% of patients treated with AL. On average 2.4 (1 -- 7) drugs was prescribed per encounter, indicating co-prescription of AL with other drugs. Children under five had higher odds of AL and antibiotics co-prescription (OR = 0.63, 95% CI: 0.46 -- 0.85) than those aged more than five years. Patients testing negative had higher odds (OR = 2.22, 95%CI: 1.65 -- 2.97) of AL and antibiotics co-prescription. Patients receiving treatment from dispensaries had higher odds (OR = 1.45, 95% CI: 0.84 -- 2.30) of AL and antibiotics co-prescription than those from served in health centres even though the deference was not statistically significant. Regardless the fact that Malaria is declining but due to lack of laboratories and mRDT in most health facilities in the rural areas, clinicians are still treating malaria presumptively. This leads them to prescribe more drugs to treat all