Browsing by Subject "LMIC"

Now showing 1 - 3 of 3
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    Expanding Access to Novel Antibacterial Therapeutics in Low- and Middle-Income Countries: Leveraging Donor-Funded Pooled Procurement
    (2024-07) Swenson, Jessica Emily; Archer, Sarah E.; Coburn, Kenneth; Houchens, Christopher
    Antibiotics are one of the most significant advances of modern medicine, however, bacteria continue to evolve faster than new antibacterials are being developed. In 2019, 1.27 million deaths were directly attributable to bacterial antimicrobial resistance (AMR) globally—more than either HIV or malaria that year—with the highest death rates occurring in low- and middle-income countries (LMICs) (Murray et al., 2022). Because of limited returns on investment, multinational pharmaceutical companies have largely abandoned antibacterial development. This void has been filled by smaller product developers vastly located in the United States and Europe who have limited resources and experience in seeking licensure and commercialization in LMICs, where the need is greatest (WHO, 2021). When these smaller developers only seek regulatory approval in the high-income countries where they are located, they often cannot sell enough of their product to avoid bankruptcy because of the low volume of patients with susceptible infections there (Alm & Gallant, 2020). Building on the current body of literature, this study assessed the factors necessary to leverage an existing donor-funded pooled procurement strategy to expand its scope to include novel antibacterial therapeutics, with the goal of expanding access to these products in LMICs. Market access expansion would bring new products to patients where they are needed most while also ensuring financial viability for developers of novel antibacterials who struggle to retain financial solvency. A qualitative case study gathering expertise from individuals familiar with current procurement practices for novel antibacterials and donor-funded global procurement strategies for other infectious disease therapeutics elucidated that the Global Drug Facility (GDF) is the entity best positioned to expand scope to include novel antibacterials for AMR. An eight-stage action plan was developed to provide recommended actions, resource needs, measures of success, and an anticipated timeline over the next decade for GDF and a consortium of technical partners to implement the scope expansion. By pairing a market-driven access expansion initiative with a pragmatic approach to support financial sustainability of product developers, these critical medicines can be available for patients globally, and the AMR pipeline can support the demand for new antibacterials for decades to come.
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    Lessons learned from over a decade of data audits in international observational HIV cohorts in Latin America and East Africa
    (Cambridge University Press, 2023-11-03) Lotspeich, Sarah C.; Shepherd, Bryan E.; Kariuk, Marion Achieng; Wools-Kaloustian, Kara; McGowan, Catherine C.; Musick, Beverly; Semeere, Aggrey; Crabtree Ramírez, Brenda E.; Mkwashapi, Denna M.; Cesar, Carina; Ssemakadde, Matthew; Machado, Daisy Maria; Ngeresa, Antony; Ferreira, Flávia Faleiro; Lwali, Jerome; Marcelin, Adias; Wagner Cardoso, Sandra; Luque, Marco Tulio; Otero, Larissa; Cortés, Claudia P.; Duda, Stephany N.; Medicine, School of Medicine
    Introduction: Routine patient care data are increasingly used for biomedical research, but such "secondary use" data have known limitations, including their quality. When leveraging routine care data for observational research, developing audit protocols that can maximize informational return and minimize costs is paramount. Methods: For more than a decade, the Latin America and East Africa regions of the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium have been auditing the observational data drawn from participating human immunodeficiency virus clinics. Since our earliest audits, where external auditors used paper forms to record audit findings from paper medical records, we have streamlined our protocols to obtain more efficient and informative audits that keep up with advancing technology while reducing travel obligations and associated costs. Results: We present five key lessons learned from conducting data audits of secondary-use data from resource-limited settings for more than 10 years and share eight recommendations for other consortia looking to implement data quality initiatives. Conclusion: After completing multiple audit cycles in both the Latin America and East Africa regions of the IeDEA consortium, we have established a rich reference for data quality in our cohorts, as well as large, audited analytical datasets that can be used to answer important clinical questions with confidence. By sharing our audit processes and how they have been adapted over time, we hope that others can develop protocols informed by our lessons learned from more than a decade of experience in these large, diverse cohorts.
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    The demographics and traumatic causes of spinal cord injury in Nepal: An observational study
    (Sage, 2021) Willott, Arran; Dhakal, Raju; Groves, Christine; Mytton, Julie; Ellis, Matthew; Physical Medicine and Rehabilitation, School of Medicine
    Introduction: There has been little systematic study of the epidemiology of traumatic spinal cord injury (TSCI) in Nepal, South-East Asia, and low- and middle-income countries (LMICs) in general. One third of the global morbidity and mortality due to injuries is concentrated in South-East Asia. We need to better understand the circumstances leading to TSCI if we are to make progress with prevention. Method: The Spinal Injury Rehabilitation Centre (SIRC) in Nepal systemically collected prospective data describing people with TSCI admitted between September 2015 and August 2016. Descriptive analyses of variables yielded demographic, aetiological and clinical descriptors of this cohort. Cross-tabulations were used to explore the associations between variables. Results: Of 184 admissions over one year, males were admitted to SIRC almost 2.3 times more often than females. Young adults (21–30 years) were the largest age group (34%). The majority of TSCI resulted in paraplegia (67%) and was complete in nearly half (49%). Falls caused the majority of TSCI (69%), and falls from trees were the most common. Road traffic injuries (RTIs) were the second leading cause (29%); the majority involved two- or three-wheeled motorised vehicles and patients were most commonly driving. Conclusion: Falls were the leading cause of TSCI across both genders and all age groups, followed by RTIs, which occurred most often in young adults and men. Injury surveillance and further research would provide a greater understanding of the pattern of TSCI and enable progress in TSCI prevention and rehabilitation.