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      Cost savings of paper analytical devices (PADs) to detect substandard and falsified antibiotics: Kenya case study

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          Abstract

          Background:

          Over 10% of antibiotics in low- and middle-income countries (LMICs) are substandard or falsified. Detection of poor-quality antibiotics via the gold standard method, high-performance liquid chromatography (HPLC), is slow and costly. Paper analytical devices (PADs) and antibiotic paper analytical devices (aPADs) have been developed as an inexpensive way to estimate antibiotic quality in LMICs.

          Aim:

          To model the impact of using a rapid screening tools, PADs/aPADs, to improve the quality of amoxicillin used for treatment of childhood pneumonia in Kenya.

          Methods:

          We developed an agent-based model, ESTEEM (Examining Screening Technologies with Economic Evaluations for Medicines), to estimate the effectiveness and cost savings of incorporating PADs and aPADs in amoxicillin quality surveillance in Kenya. We compared the current testing scenario (batches of entire samples tested by HPLC) with an expedited HPLC scenario (testing smaller batches at a time), as well as a screening scenario using PADs/aPADs to identify poor-quality amoxicillin followed by confirmatory analysis with HPLC.

          Results:

          Scenarios using PADs/aPADs or expedited HPLC yielded greater incremental benefits than the current testing scenario by annually averting 586 (90% uncertainty range (UR) 364–874) and 221 (90% UR 126–332) child pneumonia deaths, respectively. The PADs/aPADs screening scenario identified and removed poor-quality antibiotics faster than the expedited or regular HPLC scenarios, and reduced costs significantly. The PADs/aPADs scenario resulted in an incremental return of $14.9 million annually compared with the reference scenario of only using HPLC.

          Conclusion:

          This analysis shows the significant value of PADs/aPADs as a medicine quality screening and testing tool in LMICs with limited resources.

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          Most cited references35

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          Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis

          Summary Background The annual number of hospital admissions and in-hospital deaths due to severe acute lower respiratory infections (ALRI) in young children worldwide is unknown. We aimed to estimate the incidence of admissions and deaths for such infections in children younger than 5 years in 2010. Methods We estimated the incidence of admissions for severe and very severe ALRI in children younger than 5 years, stratified by age and region, with data from a systematic review of studies published between Jan 1, 1990, and March 31, 2012, and from 28 unpublished population-based studies. We applied these incidence estimates to population estimates for 2010, to calculate the global and regional burden in children admitted with severe ALRI in that year. We estimated in-hospital mortality due to severe and very severe ALRI by combining incidence estimates with case fatality ratios from hospital-based studies. Findings We identified 89 eligible studies and estimated that in 2010, 11·9 million (95% CI 10·3–13·9 million) episodes of severe and 3·0 million (2·1–4·2 million) episodes of very severe ALRI resulted in hospital admissions in young children worldwide. Incidence was higher in boys than in girls, the sex disparity being greatest in South Asian studies. On the basis of data from 37 hospital studies reporting case fatality ratios for severe ALRI, we estimated that roughly 265 000 (95% CI 160 000–450 000) in-hospital deaths took place in young children, with 99% of these deaths in developing countries. Therefore, the data suggest that although 62% of children with severe ALRI are treated in hospitals, 81% of deaths happen outside hospitals. Interpretation Severe ALRI is a substantial burden on health services worldwide and a major cause of hospital referral and admission in young children. Improved hospital access and reduced inequities, such as those related to sex and rural status, could substantially decrease mortality related to such infection. Community-based management of severe disease could be an important complementary strategy to reduce pneumonia mortality and health inequities. Funding WHO.
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            Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates.

            Streptococcus pneumoniae is a leading cause of bacterial pneumonia, meningitis, and sepsis in children worldwide. However, many countries lack national estimates of disease burden. Effective interventions are available, including pneumococcal conjugate vaccine and case management. To support local and global policy decisions on pneumococcal disease prevention and treatment, we estimated country-specific incidence of serious cases and deaths in children younger than 5 years. We measured the burden of pneumococcal pneumonia by applying the proportion of pneumonia cases caused by S pneumoniae derived from efficacy estimates from vaccine trials to WHO country-specific estimates of all-cause pneumonia cases and deaths. We also estimated burden of meningitis and non-pneumonia, non-meningitis invasive disease using disease incidence and case-fatality data from a systematic literature review. When high-quality data were available from a country, these were used for national estimates. Otherwise, estimates were based on data from neighbouring countries with similar child mortality. Estimates were adjusted for HIV prevalence and access to care and, when applicable, use of vaccine against Haemophilus influenzae type b. In 2000, about 14.5 million episodes of serious pneumococcal disease (uncertainty range 11.1-18.0 million) were estimated to occur. Pneumococcal disease caused about 826,000 deaths (582,000-926,000) in children aged 1-59 months, of which 91,000 (63,000-102,000) were in HIV-positive and 735,000 (519,000-825,000) in HIV-negative children. Of the deaths in HIV-negative children, over 61% (449,000 [316,000-501,000]) occurred in ten African and Asian countries. S pneumoniae causes around 11% (8-12%) of all deaths in children aged 1-59 months (excluding pneumococcal deaths in HIV-positive children). Achievement of the UN Millennium Development Goal 4 for child mortality reduction can be accelerated by prevention and treatment of pneumococcal disease, especially in regions of the world with the greatest burden. GAVI Alliance and the Vaccine Fund.
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              Cost-Effectiveness in Health and Medicine

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                Author and article information

                Journal
                Med Access Point Care
                Med Access Point Care
                MAP
                spmap
                Medicine Access @ Point of Care
                SAGE Publications (Sage UK: London, England )
                2399-2026
                8 March 2021
                Jan-Dec 2021
                : 5
                : 2399202620980303
                Affiliations
                [1 ]Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA
                [2 ]Duke Global Health Institute, Duke University, Durham, NC, USA
                [3 ]Department of Chemistry and Biochemistry, University of Notre Dame, Notre Dame, IN, USA
                [4 ]Department of Maternal and Child Health, UNC Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA
                Author notes
                [*]Sachiko Ozawa, Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina, CB#7574, Beard Hall 115H, Chapel Hill, NC 27599, USA. Email: ozawa@ 123456unc.edu
                Author information
                https://orcid.org/0000-0002-7169-4404
                https://orcid.org/0000-0001-5353-4063
                https://orcid.org/0000-0001-7608-9038
                Article
                10.1177_2399202620980303
                10.1177/2399202620980303
                8026160
                33834120
                5d46293b-8ba7-46dd-abc1-377a4f326e24
                © The Author(s) 2021

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 2 October 2020
                : 23 November 2020
                Funding
                Funded by: National Institutes of Health, FundRef https://doi.org/10.13039/100000002;
                Award ID: UL1TR002529
                Categories
                Research @ Point of Care
                Custom metadata
                January-December 2021
                ts1

                antibiotic,quality,substandard,falsified,medicines,return on investment,pneumonia,kenya

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