7
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      An observational assessment of the safety of mass drug administration for trachoma in Ethiopian children

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background

          The International Trachoma Initiative (ITI) provides azithromycin for mass drug administration (MDA) to eliminate trachoma as a public health problem. Azithromycin is given as tablets for adults and powder for oral suspension (POS) is recommended for children aged <7 y, children <120 cm in height (regardless of age) or anyone who reports difficulty in swallowing tablets. An observational assessment of MDA for trachoma was conducted to determine the frequency with which children aged 6 mo through 14 y received the recommended dose and form of azithromycin according to current dosing guidelines and to assess risk factors for choking and adverse swallowing events (ASEs).

          Methods

          MDA was observed in three regions of Ethiopia and data were collected on azithromycin administration and ASEs.

          Results

          A total of 6477 azithromycin administrations were observed; 97.9% of children received the exact recommended dose. Of children aged 6 mo to <7 y or <120 cm in height, 99.6% received POS. One child experienced choking and 132 (2%) experienced ≥1 ASEs. Factors significantly associated with ASEs included age 6–11 mo or 1–6 y, non-calm demeanor and requiring coaxing prior to drug administration.

          Conclusions

          There is a high level of adherence to the revised azithromycin dosing guidelines and low incidence of choking and ASEs.

          Related collections

          Most cited references9

          • Record: found
          • Abstract: found
          • Article: found
          Is Open Access

          Risk of adverse swallowing events and choking during deworming for preschool-aged children

          Background In areas where the prevalence of soil-transmitted helminthiasis (STH) is >20%, the World Health Organization (WHO) recommends that deworming medication be given periodically to preschool-age children. To reduce risk of choking-related deaths in children <3 years old, WHO recommends that deworming tablets be crushed and given with water. Little is known about how widely this is practiced or its effectiveness. Methodology and principal findings Albendazole distributions for STH were observed for children 1–4 years old in 65 sites in India and Haiti. Information was recorded on child demographics; child demeanor immediately before, as well as struggling or resistance during albendazole administration; tablet form (i.e., crushed or not); and adverse swallowing events (ASEs), including choking, spitting; coughing; gagging; vomiting; and expelling a crushed tablet in a “cloud” of powder. Of 1677 children observed, 248 (14.8%) had one or more ASEs. ASE risk was 3.6% with whole tablets, 25.4% with crushed tablets, and 34.6% when crushed tablets were mixed with water. In multivariate analysis, ASE risk was significantly associated with children 1 year (OR 2.7) or 2 years (OR 2.9) of age; male gender (OR 1.6); non-content child demeanor (fearful, fussy, or combative) before albendazole administration (OR 4.3); child struggling when given albendazole (OR 2.1); and giving water, either after the tablet or mixed with it (OR 5.8). Eighteen (1.1%) children choked, none fatally; 17 choking incidents occurred with crushed tablets. In a multivariate analysis that controlled for distribution site, the only significant risk factor for choking was non-content demeanor (OR 20.6). Conclusions and significance Deworming-related choking deaths in young children are preventable. In our sample, risk of choking could have been reduced by 79.5% if deworming tablets were not given to young children who were fussy, fearful, or combative or who struggled to resist tablet administration, with only an 18.4% reduction in drug coverage.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: found
            Is Open Access

            Efficacy and Safety of a Single-Dose Mebendazole 500 mg Chewable, Rapidly-Disintegrating Tablet for Ascaris lumbricoides and Trichuris trichiura Infection Treatment in Pediatric Patients: A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study

            Abstract. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a new chewable, rapidly-disintegrating mebendazole (MBZ) 500 mg tablet for Ascaris lumbricoides and Trichuris trichiura infection treatment. Pediatric patients (1–15 years; N = 295; from Ethiopia and Rwanda) excreting A. lumbricoides and/or T. trichiura eggs were enrolled. The study had a screening phase (3 days), a double-blind treatment phase (DBP, 19 days), and an open-label phase (OLP, 7 days). Patients received MBZ or placebo on day 1 of DBP and open-label MBZ on day 19 ± 2 after stool sample collection. Cure rates (primary endpoint), defined as species-specific egg count of 0 at the end of DBP, were significantly higher in the MBZ group than placebo for A. lumbricoides (83.7% [72/86; 95% CI: 74.2%; 90.8%] versus 11.1% [9/81; 95% CI: 5.2%; 20.1%], P < 0.001) and for T. trichiura (33.9% [42/124; 95% CI: 25.6%; 42.9%] versus 7.6% [9/119; 95% CI: 3.5%; 13.9%], P < 0.001). Egg reduction rates (secondary endpoint) were significantly higher in the MBZ group than placebo for A. lumbricoides (97.9% [95% CI: 94.4; 99.9] versus 19.2% [95% CI: −5.9; 41.5]; P < 0.001) and T. trichiura (59.7% [95% CI: 33.9; 78.8] versus 10.5% [95% CI: −16.8; 32.9]; P = 0.003). Treatment-emergent adverse events (TEAEs) in MBZ group occurred in 6.3% (9/144) of patients during DBP and 2.5% (7/278) during OLP. No deaths, serious TEAEs, or TEAEs leading to discontinuations were reported. A 500 mg chewable MBZ tablet was more efficacious than placebo for the treatment of A. lumbricoides and T. trichiura infections in pediatric patients, and no safety concerns were identified.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa—Ethiopia, Kenya, Rwanda, and Tanzania

              Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.
                Bookmark

                Author and article information

                Contributors
                Journal
                Trans R Soc Trop Med Hyg
                Trans R Soc Trop Med Hyg
                trstmh
                Transactions of the Royal Society of Tropical Medicine and Hygiene
                Oxford University Press
                0035-9203
                1878-3503
                October 2022
                01 February 2022
                01 February 2022
                : 116
                : 10
                : 917-923
                Affiliations
                International Trachoma Initiative, The Task Force for Global Health , Decatur, GA 30030, USA
                Focus Area for Compassion and Ethics, The Task Force for Global Health , Decatur, GA 30030, USA
                International Trachoma Initiative, The Task Force for Global Health , Addis Ababa, 1000, Ethiopia
                International Trachoma Initiative, The Task Force for Global Health , Decatur, GA 30030, USA
                International Trachoma Initiative, The Task Force for Global Health , Decatur, GA 30030, USA
                International Trachoma Initiative, The Task Force for Global Health , Addis Ababa, 1000, Ethiopia
                International Trachoma Initiative, The Task Force for Global Health , Addis Ababa, 1000, Ethiopia
                Disease Prevention and Control Directorate, Federal Ministry of Health , Addis Ababa, 1000, Ethiopia
                Pharmaceutical Logistics Management Unit, Federal Ministry of Health , Addis Ababa, 1000, Ethiopia
                Federal Ministry of Health , Addis Ababa, 1000, Ethiopia
                Federal Ministry of Health , Addis Ababa, 1000, Ethiopia
                Dana Center for Preventative Ophthalmology, Johns Hopkins University , Baltimore, MD 21287, USA
                International Trachoma Initiative, The Task Force for Global Health , Addis Ababa, 1000, Ethiopia
                International Trachoma Initiative, The Task Force for Global Health , Decatur, GA 30030, USA
                International Trachoma Initiative, The Task Force for Global Health , Addis Ababa, 1000, Ethiopia
                Author notes
                Corresponding author: Tel: + 1 678 306 1658; E-mail: daddiss@ 123456taskforce.org
                Article
                trac006
                10.1093/trstmh/trac006
                9526842
                35106593
                83c32207-b6da-4596-91d4-1a8da6b1720e
                © The Author(s) 2022. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution- Non-Commercial License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@ 123456oup.com

                History
                : 29 September 2021
                : 08 December 2021
                : 28 January 2022
                : 01 February 2022
                Page count
                Pages: 7
                Funding
                Funded by: Pfizer Inc., DOI 10.13039/100004319;
                Categories
                Original Article
                AcademicSubjects/MED00860
                AcademicSubjects/MED00290

                Medicine
                airway obstruction,azithromycin,mass drug administration,pharmacovigilance,program evaluation,trachoma

                Comments

                Comment on this article