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Increasing access to essential medicines through partnership: experience in developing and delivering chlorhexidine gel for newborn cord care.

ABSTRACT: Sustainable access to essential medicines in low-income and middle-income countries requires innovative cross-sectoral collaboration throughout the lifecycle of a medicine. Partnerships are essential to address the systemic challenges of global health and health inequity. Pharmaceutical companies, funders, governments, international non-governmental organisations (I-NGOs) and other key stakeholders can leverage, through effective partnership working, their unique expertise to help drive innovation and share learnings and risks. Here, we reflect on one approach taken in the development and supply of chlorhexidine digluconate 7.1% w/w gel (equivalent to 4% w/w chlorhexidine) for neonatal cord care. We describe and analyse the steps taken by GSK to increase access to chlorhexidine gel, including partnering with the I-NGO Save the Children in Western Kenya. Learning points gained along the journey are shared, together with subsequent steps taken to increase access, with the aim of making recommendations that may be applicable to similar enterprises in the future.

SUBMITTER: DeAngelis E

PROVIDER: S-EPMC9453998 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Increasing access to essential medicines through partnership: experience in developing and delivering chlorhexidine gel for newborn cord care.

DeAngelis Elena E Clarke Andrew A Gibson Rachel R Karrar Karrar K Williams Pauline P

BMJ paediatrics open 20220901 1

Sustainable access to essential medicines in low-income and middle-income countries requires innovative cross-sectoral collaboration throughout the lifecycle of a medicine. Partnerships are essential to address the systemic challenges of global health and health inequity. Pharmaceutical companies, funders, governments, international non-governmental organisations (I-NGOs) and other key stakeholders can leverage, through effective partnership working, their unique expertise to help drive innovati ...[more]

PMID: 36645765

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Project description:BackgroundOmphalitis is an important contributor to neonatal mortality in Kenya. Chlorhexidine digluconate 7.1 % w/w (CHX; equivalent to 4 % w/w chlorhexidine) was identified as a life-saving commodity for newborn cord care by the United Nations and is included on World Health Organization and Kenyan Essential Medicines Lists. This pilot study assessed the potential resource savings and breakeven price of implementing CHX for neonatal umbilical cord care versus dry cord care (DCC) in Kenya.MethodsWe employed a cost-consequence model in a Kenyan birth cohort. Firstly, the number of omphalitis cases and cases avoided by healthcare sector were estimated. Incidence rates and treatment effect inputs were calculated from a Cochrane meta-analysis of randomised clinical trials (RCTs) (base case) and 2 other RCTs. Economic outcomes associated with omphalitis cases avoided were determined, including direct, indirect and total cost of care associated with omphalitis, resource use (outpatient visits and bed days) and societal impact (caregiver workdays lost). Costs and other inputs were sourced from literature and supplemented by expert clinical opinion/informed inputs, making necessary assumptions.ResultsThe model estimated that, over 1 year, ~ 23,000 omphalitis cases per 500,000 births could be avoided through CHX application versus DCC, circumventing ~ 13,000 outpatient visits, ~ 43,000 bed days and preserving ~ 114,000 workdays. CHX was associated with annual direct cost savings of ~ 590,000 US dollars (USD) versus DCC (not including drug-acquisition cost), increasing to ~ 2.5 million USD after including indirect costs (productivity, notional salary loss). The most-influential model parameter was relative risk of omphalitis with CHX versus DCC. Breakeven analysis identified a budget-neutral price for CHX use of 1.18 USD/course when accounting for direct cost savings only, and 5.43 USD/course when including indirect cost savings. The estimated breakeven price was robust to parameter input changes. DCC does not necessarily represent standard of care in Kenya; other, potentially harmful, approaches may be used, meaning cost savings may be understated.ConclusionsEstimated healthcare cost savings and potential health benefits provide compelling evidence to implement CHX for umbilical cord care in Kenya. We encourage comprehensive data collection to make future models and estimates of impacts of upscaling CHX use more robust.

Project description:BackgroundIn September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process.MethodsWe conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives.ResultsThe most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media.ConclusionsMedia framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects.

Project description:Children and adolescents in developing countries continue to be disproportionately affected by cancer and have significantly lower survival rates (30%) than their counterparts in high-income countries (80%). This disparity is driven by poor access to childhood cancer medicines. The World Health Organization and St. Jude Children's Research Hospital launched the Global Platform for Access to Childhood Cancer Medicines to provide continuous supply of quality childhood cancer medicines to developing countries. As much movement has not been seen with the platform, this research aimed to develop a stakeholder-informed guidance to support effective implementation of the platform and maximize opportunities to deliver on its intended goals. This study was guided by the Consolidated Framework for Implementation Research (CFIR). Participants were recruited based on the stakeholder categories framework and included policymakers from the Ministry of Health, organizations implementing access to medicines programs in Nigeria, medicines logistics providers, and health professionals and personnel at service delivery points such as oncologists and pharmacists. Data collection involved key informant interviews using a pilot-tested semi-structured interview guide. Data analysis was done by thematic content analysis. Ethical approval was obtained from the National Health Research Ethics Committee of Nigeria and the Ethics Review Board of University of Toronto. The findings reveal critical insights spanning five domains of the CFIR framework, each contributing uniquely to understanding the multifaceted issues of childhood cancer medicine access with a view to understanding pathways to implementation of the platform. Successfully implementing the platform could entail a partner-driven approach, integration with existing programs to avoid fragmentation, supporting capacity strengthening at the primary care level, and engaging patients and communities. This information was used to suggest a nuanced implementation framework for the platform in Nigeria and similar settings which could be beneficial for improving access for children who desperately need childhood cancer medicines to survive.

Project description:BackgroundWhole-genome sequencing data are available from several large studies across a variety of diseases and traits. However, massive storage and computation resources are required to use these data, and to achieve sufficient power for discoveries, harmonization of multiple cohorts is critical.ObjectivesThe Accelerating Medicines Partnership Parkinson's Disease program has developed a research platform for Parkinson's disease (PD) that integrates the storage and analysis of whole-genome sequencing data, RNA expression data, and clinical data, harmonized across multiple cohort studies.MethodsThe version 1 release contains whole-genome sequencing data derived from 3941 participants from 4 cohorts. Samples underwent joint genotyping by the TOPMed Freeze 9 Variant Calling Pipeline. We performed descriptive analyses of these whole-genome sequencing data using the Accelerating Medicines Partnership Parkinson's Disease platform.ResultsThe clinical diagnosis of participants in version 1 release includes 2005 idiopathic PD patients, 963 healthy controls, 64 prodromal subjects, 62 clinically diagnosed PD subjects without evidence of dopamine deficit, and 705 participants of genetically enriched cohorts carrying PD risk-associated GBA variants or LRRK2 variants, of whom 304 were affected. We did not observe significant enrichment of pathogenic variants in the idiopathic PD group, but the polygenic risk score was higher in PD both in nongenetically enriched cohorts and genetically enriched cohorts. The population analysis showed a correlation between genetically enriched cohorts and Ashkenazi Jewish ancestry.ConclusionsWe describe the genetic component of the Accelerating Medicines Partnership Parkinson's Disease platform, a solution to democratize data access and analysis for the PD research community. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. This article is a U.S. Government work and is in the public domain in the USA.

Project description:IntroductionChlorhexidine cord care is an effective intervention to reduce neonatal infection and death in resource constrained settings. The Federal Ministry of Health of Ethiopia adopted chlorhexidine cord care in 2015, with national scale-up in 2017. However, there is lack of evidence on the provision of this important intervention in Ethiopia. In this paper, we report on the coverage and determinants of chlorhexidine cord care for newborns in Ethiopia.MethodsA standardized Nutrition International Monitoring System (NIMS) survey was conducted from January 01 to Feb 13, 2020 in four regions of Ethiopia (Tigray, Amhara, Oromia, and Southern Nations, Nationalities and Peoples Region [SNNPR]) on sample of 1020 women 0-11 months postpartum selected through a multistage cluster sampling approach. Data were collected using interviewer-administered questionnaires in the local languages through home-to-home visit. Accounting for the sampling design of the study, we analyzed the data using complex data analysis approach. Complex sample multivariable logistic regression was used to identify the determinants of chlorhexidine cord care practice.ResultsOverall, chlorhexidine was reportedly applied to the umbilical cord at some point postpartum among 46.1% (95% confidence interval [CI]: 41.1%- 51.2%) of all newborns. Chlorhexidine cord care started within 24 hours after birth for 34.4% (95% CI: 29.5%- 39.6%) of newborns, though this varied widely across regions: from Oromia (24.4%) to Tigray (60.0%). Among the newborns who received chlorhexidine cord care, 48.3% received it for the recommended seven days or more. Further, neonates whose birth was assisted by skilled birth attendants had more than ten times higher odds of receiving chlorhexidine cord care, relative to those born without a skilled attendant (adjusted odds ratio [AOR]: 10.36, 95% CI: 3.73-28.75). Besides, neonates born to mothers with knowledge of the benefit of chlorhexidine cord care had significantly higher odds of receiving chlorhexidine cord care relative to newborns born to mothers who did not have knowledge of the benefit of chlorhexidine cord care (AOR: 39.03, 95% CI: 21.45-71.04).ConclusionA low proportion of newborns receive chlorhexidine cord care in Ethiopia. The practice of chlorhexidine cord care varies widely across regions and is limited mostly to births attended by skilled birth attendants. Efforts must continue to ensure women can reach skilled care at delivery, and to ensure adequate care for newborns who do not yet access skilled delivery.

Project description:BackgroundChlorhexidine-gluconate (CHG) impregnated dressings may prevent catheter-related bloodstream infections (CRBSI). Chlorhexidine-impregnated sponge dressings (sponge-dress) and gel dressings (gel-dress) have never been directly compared. We used the data collected for two randomized-controlled trials to perform a comparison between sponge-dress and gel-dress.MethodsAdult critically ill patients who required short-term central venous or arterial catheter insertion were recruited. Our main analysis included only patients with CHG-impregnated dressings. The effect of gel-dress (versus sponge-dress) on major catheter-related infections (MCRI) and CRBSI was estimated using multivariate marginal Cox models. The comparative risks of dressing disruption and contact dermatitis were evaluated using logistic mix models for clustered data. An explanatory analysis compared gel-dress with standard dressings using either CHG skin disinfection or povidone iodine skin disinfection.ResultsA total of 3483 patients and 7941 catheters were observed in 16 intensive care units. Sponge-dress and gel-dress were utilized for 1953 and 2108 catheters, respectively. After adjustment for confounders, gel-dress showed similar risk for MCRI compared to sponge-dress (HR 0.80, 95% CI 0.28-2.31, p = 0.68) and CRBSI (HR 1.13, 95% CI 0.34-3.70, p = 0.85), less dressing disruptions (OR 0.72, 95% CI 0.60-0.86, p < 0.001), and more contact dermatitis (OR 3.60, 95% CI 2.51-5.15, p < 0.01). However, gel-dress increased the risk of contact dermatitis only if CHG was used for skin antisepsis (OR 1.94, 95% CI 1.38-2.71, p < 0.01).ConclusionsWe described a similar infection risk for gel-dress and sponge-dress. Gel-dress showed fewer dressing disruptions. Concomitant use of CHG for skin disinfection and CHG-impregnated dressing may significantly increase contact dermatitis.Trials registrationThese studies were registered within ClinicalTrials.gov (numbers NCT01189682 and NCT00417235 ).

Dataset Information

Increasing access to essential medicines through partnership: experience in developing and delivering chlorhexidine gel for newborn cord care.

Publications

Increasing access to essential medicines through partnership: experience in developing and delivering chlorhexidine gel for newborn cord care.

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