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Healthcare professionals' perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda.

ABSTRACT: BACKGROUND:Efficient testing to identify poor quality artemisinin-based combination therapy (ACT) is important to optimize efforts to control and eliminate malaria. Healthcare professionals interact with both ACT and malaria patients they treat and hence could observe, first-hand, suspect poor quality artemisinin-based combinations linked to poor malaria treatment outcomes and the factors associated with inappropriate use or treatment failure. METHODS:A cross-sectional study of 685 HCP perspectives about the efficacy of ACT between June and July 2018 at selected health facilities in Uganda. Medicine samples were obtained from the seven regions of Uganda and tested for quality using the Germany Pharma Health Fund™ minilabs. RESULTS:The average age of the 685 respondents was 30 (SD?=?7.4) years. There was an almost equal distribution between male and female respondents (51:49), respectively. Seventy percent (n?=?480) were diploma holders and the nurses contributed to half (49%, n?=?334) of the study population. Sixty-one percent of the HCPs reported having ever encountered ACT failures while treating uncomplicated malaria. Nineteen percent of HCPs thought that dihydroartemisinin/piperaquine gave the most satisfactory patient treatment outcomes, while 80% HCPs thought that artemether/lumefantrine gave the least satisfactory patient treatment outcomes, possibly due to dosing schedule and pill burden. Healthcare professionals from the Central region (OR?=?3.0, CI 0.3-1.0; P?=?0.0001), Eastern region (OR?=?5.4, CI 2.9-9.8; P?=?0.0001) and Northern region (OR?=?5.3, CI 2.9-9.9; P?=?0.0001) had a higher chance of encountering ACT failure in 4 weeks prior to the survey as compared to those from the western region. Healthcare professionals from private health facilities also had higher chances of encountering ACT failures in past 4 weeks as compared to those from public health facilities (OR?=?2.7, CI 1.7-3.9; P?=?0.0001). All 192 samples passed the quality screening tests. The random sample of 10% of all samples randomly obtained by the laboratory staff also passed the chemical content analysis and dissolution tests. CONCLUSION:ACT medicines are widely available over-the-counter to the public and it is very difficult to report and monitor a decrease in efficacy or treatment failure. The perspectives of HCPs on treatment failure or lack of efficacy may potentially guide optimization efforts of sampling methodologies for the quality survey of ACT medicines.

SUBMITTER: Ndagije HB

PROVIDER: S-EPMC7011371 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Healthcare professionals' perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda.

Ndagije Helen Byomire HB Kiguba Ronald R Manirakiza Leonard L Kirabira Elijah E Sserwanga Allan A Nabirye Leah L Mukonzo Jackson J Olsson Sten S Spinewine Anne A D'Hoore William W Speybroeck Niko N

Malaria journal 20200210 1

<h4>Background</h4>Efficient testing to identify poor quality artemisinin-based combination therapy (ACT) is important to optimize efforts to control and eliminate malaria. Healthcare professionals interact with both ACT and malaria patients they treat and hence could observe, first-hand, suspect poor quality artemisinin-based combinations linked to poor malaria treatment outcomes and the factors associated with inappropriate use or treatment failure.<h4>Methods</h4>A cross-sectional study of 68 ...[more]

PMID: 32041619

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Project description:OBJECTIVES:To compare the efficacy and safety of artemisinin combination therapies for the treatment of uncomplicated falciparum malaria in Uganda. DESIGN:Randomized single-blind controlled trial. SETTING:Tororo, Uganda, an area of high-level malaria transmission. PARTICIPANTS:Children aged one to ten years with confirmed uncomplicated P. falciparum malaria. INTERVENTIONS:Amodiaquine + artesunate or artemether-lumefantrine. OUTCOME MEASURES:Risks of recurrent symptomatic malaria and recurrent parasitemia at 28 days, unadjusted and adjusted by genotyping to distinguish recrudescences and new infections. RESULTS:Of 408 participants enrolled, 403 with unadjusted efficacy outcomes were included in the per-protocol analysis. Both treatment regimens were highly efficacious; no recrudescences occurred in patients treated with amodiaquine + artesunate, and only two occurred in those treated with artemether-lumefantrine. However, recurrent malaria due to new infections was common. The unadjusted risk of recurrent symptomatic malaria was significantly lower for participants treated with artemether-lumefantrine than for those treated with amodiaquine + artesunate (27% versus 42%, risk difference 15%, 95% CI 5.9%-24.2%). Similar results were seen for the risk of recurrent parasitemia (51% artemether-lumefantrine versus 66% amodiaquine + artesunate, risk difference 16%, 95% CI 6.2%-25.2%). Amodiaquine + artesunate and artemether-lumefantrine were both well-tolerated. Serious adverse events were uncommon with both regimens. CONCLUSIONS:Amodiaquine + artesunate and artemether-lumefantrine were both highly efficacious for treatment of uncomplicated malaria. However, in this holoendemic area, despite the excellent performance of both regimens in terms of efficacy, many patients experienced recurrent parasitemia due to new infections. Artemether-lumefantrine was superior to amodiaquine + artesunate for prevention of new infections. To maximize the benefit of artemisinin combination therapy in Africa, treatment should be integrated with strategies to prevent malaria transmission. The impact of frequent repeated therapy on the efficacy, safety, and cost-effectiveness of new artemisinin regimens should be further investigated.

Project description:Highlights • Active post-marketing safety surveillance on ROTASIIL, an oral rotavirus vaccine, was conducted in 9940 infants in India.• Three doses of ROTASIIL were administered at 6, 10 and 14 weeks of age, along with other EPI vaccines.• Most of the AEs were pyrexia and injection site reactions caused by the concomitant injectable vaccines.• No case of intussusception (IS) was reported.• ROTASIIL was safe and well tolerated. Background ROTASIIL, an oral live attenuated bovine-human reassortant pentavalent rotavirus vaccine, was approved in 2017. This post-marketing surveillance (PMS) was conducted to collect real-world data on the safety of ROTASIIL in India. Methods Observational, active PMS was conducted in approximately 10,000 infants aged ≥ 6 weeks. ROTASIIL was administered as a 3-dose regimen, at least 4 weeks apart, beginning at ≥ 6 weeks of age concomitantly with other Expanded Programme on Immunization (EPI) vaccines. Participants were followed for one month after the last dose. The adverse events (AEs) and serious adverse events (SAEs), including intussusception (IS) reported during the follow up period were collected. Findings A total of 9940 infants were enrolled and were considered for safety analysis. Around 9913 (99.7 %) infants received 2 doses, while 9893 (99.5 %) infants completed all three doses. Total 3693 AEs were reported in 2516 (25.3 %) participants. Most of these AEs were pyrexia (78.01 % of events) and injection-site reactions (19.14 % of events). Nearly all AEs were causally unrelated to orally administered ROTASIIL and could be caused by the concomitant injectable vaccines. Only 4 AEs (2 events of vomiting and 1 event each of discomfort and pyrexia) in 4 (<0.1 %) participants could be related to ROTASIIL. AEs were of mild or moderate severity and all resolved without any sequelae. A total of 2 SAEs (acute otitis media and skull fracture) were reported in 2 (<0.1 %) participants and were not related to ROTASIIL and recovered without sequelae. No case of IS was reported. Interpretation ROTASIIL was safe and well tolerated in this study. No safety concerns were reported. Funding The study was funded by SIIPL which is the manufacturer of the study product.

Project description:Background:In Nigeria, Artemisinin-based Combination Therapy (ACT) is the recommended first line antimalarial medicine for uncomplicated malaria. However, health care providers still continue the use of less efficacious medicines such as Sulphadoxine-pyrimethamine and chloroquine. We therefore determined preference for ACT (PFA) and factors associated with PFA among healthcare providers (HCP) in Lokoja, North-Central Nigeria as well as assessed healthcare providers' knowledge of malaria case management. Methods:We conducted a cross-sectional study among physicians, nurses, pharmacists, community health officers (CHOs), community health extension workers (CHEWs) and, patent and proprietary medicine vendors (PPMVs). Interviewer-administered questionnaires were administered to collect data on respondents' characteristics, previously received malaria case management training and knowledge of malaria treatment. Knowledge scores ≥3 were categorised as good, maximum obtainable being 5. Results:Of the 404 respondents, 214 (53.0%) were males. Overall, 219 (54.2%) respondents who received malaria case management training included PPMVs: 79 (65.8%), CHEWs: 25 (64.1%), CHOs: 5 (55.6%), nurses: 72 (48.7%), physicians: 35 (47.3%) and pharmacists: 3 (23.1%). Overall, 202 (50.0%) providers including physicians: 69 (93.2%), CHO: 8 (88.9%), CHEWs: 33 (84.6%), pharmacists: 8 (61.5%), nurses: 64 (43.2%) and PPMVs: 20 (16.5%), had good knowledge of malaria treatment guidelines. Overall, preference for ACT among healthcare providers was 39.6%. Physicians: 50 (67.6%), pharmacists: 7 (59.3%) CHOs: 5 (55.6%), CHEWS: 16 (41.0%), nurses: 56 (37.8%) and PPMV: 24 (19.8%) had PFA. Receiving malaria case management training (adjusted odds ratio [aOR]) = 2.3; CI = 1.4 - 3.7) and having good knowledge of malaria treatment (aOR = 4.0; CI = 2.4 - 6.7) were associated with PFA. Conclusions:Overall preference for ACT use was low among health care providers in this study. Preference for ACTs and proportion of health workers with good knowledge of malaria case management were even lower among PPMVs who had highest proportion of those who received malaria case management training. We recommend evaluation of current training quality, enhanced targeted training, follow-up supportive supervision of PPMVs and behavior change communication on ACT use.

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Healthcare professionals' perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda.

Publications

Healthcare professionals' perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda.

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