Vol 3-3 Commentary

Commentary: Is Sustainability an Option While Implementing Programs to end TB by 2030?

Colleen Longacre1, Hala Jassim AlMossawi1, Yogan Pillay2, Neeraj Kak1*

1University Research Co., LLC (URC); Chevy Chase, MD, USA

2National Department of Health; Pretoria, Gauteng, South Africa

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Vol 3-3 Review Article

Review of Paediatric Deep Neck Space Infection

Sheetal Mungul, Shivesh Maharaj*

Johannesburg Academic Hospital, School of Neurosciences, Department of Otolaryngology, University of the Witwatersrand, Johannesburg, South Africa

Pediatric deep neck space infection is an important entity that often requires hospitalisation for antimicrobial therapy. There is a higher pattern of drug resistance in lower income countries such as South Africa. Resource limitations, poor access to healthcare, nutritional deficiencies and immune deficiency necessitate appropriate antimicrobial use as resistance may have a greater socioeconomic impact relative to higher income countries.

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Vol 3-3 Research Article

Rifampicin Bioavailability in Fixed-Dose Combinations for Tuberculosis Treatment: Evidence and Policy Actions

Pankaj Sadaphal1, Krishnapada Chakraborty1, Hala Jassim-AlMossawi1, Yogan Pillay2, Giorgio Roscigno3, Anil Kaul4, Neeraj Kak1*, Refiloe Matji1, Lindiwe Mvusi2, Anthony DeStefano1

1University Research Co. LLC, Maryland, USA

2Department of Health South Africa, Pretoria, South Africa

3NEXT2People Foundation, Geneva, Switzerland

4Center for Health Sciences, Oklahoma State University, Tulsa, OK

Purpose: The pharmacokinetics (PK) of anti-tuberculosis drugs, including their bioavailability (BA), significantly impacts the efficacy and effectiveness of tuberculosis (TB) treatment regimens. Rifampicin, one of the most important drugs in the treatment of drug-sensitive tuberculosis, has been used increasingly in fixed-dose combinations (FDCs). This paper reviews and analyzes available data on BA and PK of rifampicin with a focus on FDCs, from published studies and reports.

Methods: Using PubMed as the primary database, Cochrane and other relevant databases, a systematic review of literature was conducted to identify studies on the bioavailability and efficacy of rifampicin in FDCs versus single drug formulations. A number of keywords including “bioavailability”, “rifampicin”, “fixed dose combinations”, and “pharmacokinetics” were used in various combinations. The search covered the period 1980 to 2016. Priority was given to articles on rifampicin bioavailability in fixed dose combinations used in the program setting, and human studies that used the World Health Organization (WHO) approved BA/PK protocol and sample size (≥22 patients).

Findings: More than 450 original peer-reviewed articles, reviews and reports, were assessed for this analysis. Eleven papers, which included data from high-TB-burden countries (South Africa, India, and China), raised significant concerns about rifampicin bioavailability within FDCs; the authors of the studies discussed multiple factors associated with low bioavailability, including drug formulation and quality, storage environment, patient factors, and concomitant diseases.

Implications: Recent studies and reviews point to the problem of low bioavailability of rifampicin in fixed dose combinations. However, in the field, it remains a hidden or unrecognized factor leading to poor treatment outcomes. It is difficult to study the issue thoroughly unless there is awareness among TB program personnel of its existence, and adequate laboratory and research support is available to national tuberculosis programs (NTPs). In stemming the tide of tuberculosis multi-drug resistance (MDR) and extensive drug resistance (XDR), it is paramount to ensure that rifampicin bioavailability is adequate in FDCs, and to detect and address any deviation from recommended target ranges. There is a need for strategies to minimize the undesirable clinical effects of reduced rifampicin bioavailability in FDCs, and for effective utilization of quality-assured drugs within NTPs programs; these can help NTPs support effective case management in line with the international TB care standards, while taking into consideration the factors affecting drug absorption and therapeutic concentration.

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Vol 3-3 Research Article

Universal Health Coverage - Inclusion of TB in National Health Insurance Programs and Recommendations for Expansion of Coverage of TB Services in LMICs

Hala Jassim AlMossawi1, Neeraj Kak1*, Yogan Pillay2, Refiloe Matji1, Sharanya Joshi1

1Center for Innovations and Technology, University Research Co., LLC, Chevy Chase, MD, USA

2National Department of Health, Pretoria, South Africa

Background: Increasingly lower- and middle-income countries have moved towards the adoption of National Health Insurance (NHI) models as a means to support sustainable financing for Universal Health Care. National Health Insurance in the form of government-led, publicly supported and/or centrally managed insurance programs in various forms have been introduced in countries such as Brazil, Cambodia, China, Rwanda, Mexico, South Africa, and Thailand and have demonstrated important successes. The impact of these insurance programs on the use of tuberculosis (TB) services and outcomes is unclear.

Objectives: This assessment examines how TB is included (or neglected) in the service delivery package in NHI programs and how effectively NHI programs interact with National TB Programs (NTP) and other TB control stakeholders to plan, implement, and measure TB service use. This assessment aims to analyze the extent to which several NHI programs currently in place or in development in high-burden TB countries have integrated TB services. It synthesizes the findings of assessments in four countries - Thailand, Peru, Philippines, and India - which have adopted publicly supported health insurance programs.

Results: The four case studies demonstrate that the integration of TB services with national health insurance can have a positive effect on access to services and their quality. On the other hand, each of the models assessed impose different types of restrictions which can limit the utilization of services. Some restrictions are planned and are part of the design of the insurance model. Others, however, are indirect or unintended consequences of implementation. As it relates to TB, the findings of the assessment have highlighted the need to carefully examine the impact of restrictions in terms of access and use of TB services. In Thailand, the case study found that long wait times at facilities discouraged patients from obtaining services through national health insurance. In the Philippines, the case study found that many patients perceive that they will have to pay direct and indirect costs for TB services in the public sector and prefer instead to seek treatment in the private sector, including pharmacies, to reduce costs. The primary goal of publicly-supported health insurance programs is to improve access to care for a vulnerable segment of the population and, especially as it relates to TB, have the potential to play an important role in improving public health. However, specific objectives for health insurance programs are not typically defined in terms of disease objectives. In countries with significant burdens of key diseases like TB which threaten to jeopardize overall population health (as well as long term growth and development), specific considerations should be made to ensure that the NHI program is designed to be a driving force for controlling the epidemic. The decision to develop and adopt a publicly-supported insurance model should ideally form part of broader health systems reform efforts, and the design of the insurance model should, therefore, include features geared at reinforcing and advancing the country’s health systems strengthening objectives. An issue facing each country, in different degrees, is the separation between the functions of the NTP and the insurance planning and implementation agency. The addition of an insurance program, and possibly other agencies with financing or regulatory functions, adds another level of complexity in terms of planning, organizing, and delivering health services.

Conclusion: A key overarching conclusion from the assessment is that strong coordination is needed between health policymakers and program managers to carefully design models for integration of TB services under national health insurance. Careful planning is needed to ensure that all parties understand their roles and responsibilities within the systems and that health providers are motivated to provide high-quality TB services, and patients have incentives to utilize the services.

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