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HIV and TB programs have rapidly scaled-up over the past decade in Sub-Saharan Africa and uninterrupted supplies of those medicines are critical to their success. However, estimates of stock-outs are largely unknown. This survey aimed to estimate the extent of stock-outs of antiretroviral and TB medicines in public health facilities across South Africa, which has the world's largest antiretroviral treatment (ART) program and a rising multidrug-resistant TB epidemic. We conducted a cross-sectional telephonic survey (October-December 2015) of public health facilities. Facilities were asked about the prevalence of stock-outs on the day of the survey and in the preceding three months, their duration and impact. Nationwide, of 3547 eligible health facilities, 79% (2804) could be reached telephonically. 88% (2463) participated and 4% (93) were excluded as they did not provide ART or TB treatment. Of the 2370 included facilities, 20% (485) reported a stock-out of at least 1 ARV and/or TB-related medicine on the day of contact and 36% (864) during the three months prior to contact, ranging from 74% (163/220) of health facilities in Mpumalanga to 12% (32/261) in the Western Cape province. These 864 facilities reported 1475 individual stock-outs, with one to fourteen different medicines out of stock per facility. Information on impact was provided in 98% (1449/1475) of stock-outs: 25% (366) resulted in a high impact outcome, where patients left the facility without medicine or were provided with an incomplete regimen. Of the 757 stock-outs that were resolved 70% (527) lasted longer than one month. There was a high prevalence of stock-outs nationwide. Large interprovincial differences in stock-out occurrence, duration, and impact suggest differences in provincial ability to prevent, mitigate and cope within the same framework. End-user monitoring of the supply chain by patients and civil society has the potential to increase transparency and complement public sector monitoring systems.

In 2008, there were an estimated 440,000 new cases of MDR-TB globally. This review describes critical challenges to be addressed and policy changes to be made for progress worldwide in preventing and controlling MDR-TB. Multidrug-resistant (MDR) tuberculosis is defined as disease caused by strains of Mycobacterium tuberculosis that are at least resistant to treatment with isoniazid and rifampicin; extensively drug-resistant (XDR) tuberculosis refers to disease caused by multidrug-resistant strains that are also resistant to treatment with any fluoroquinolone and any of the injectable drugs used in treatment with second-line anti-tuberculosis drugs (amikacin, capreomycin, and kanamycin). MDR tuberculosis and XDR tuberculosis are serious threats to the progress that has been made in the control of tuberculosis worldwide over the past decade. 1 , 2 In 2008, an estimated 440,000 cases of MDR tuberculosis emerged globally. 1 India and . . .

Background The frequent occurrence of medicine stockouts represents a significant obstacle to tuberculosis control in South Africa. Stockouts can lead to treatment alterations or interruptions, which can impact treatment outcomes. This study investigates the determinants and effects of TB drug stockouts and whether poorer districts are disproportionately affected. Methods TB stockout data, health system indicators and TB treatment outcomes at the district level were extracted from the District Health Barometer for the years 2011, 2012 and 2013. Poverty terciles were constructed using the Census 2011 data to investigate whether stockouts and poor treatment outcomes were more prevalent in more impoverished districts. Fixed-effects regressions were used to estimate the effects of TB stockouts on TB treatment outcomes. Results TB stockouts occurred in all provinces but varied across provinces and years. Regression analysis showed a significant association between district per capita income and stockouts: a 10% rise in income was associated with an 8.50% decline in stockout proportions. In terms of consequences, after controlling for unobserved time invariant heterogeneity between districts, a 10% rise in TB drug stockouts was found to lower the cure rate by 2.10% ( p  < 0.01) and the success rate by 1.42% ( p  < 0.01). These effects were found to be larger in poorer districts. Conclusions The unequal spread of TB drug stockouts adds to the socioeconomic inequality in TB outcomes. Not only are stockouts more prevalent in poorer parts of South Africa, they also have a more severe impact on TB treatment outcomes in poorer districts. This suggests that efforts to cut back TB drug stockouts would not only improve TB treatment outcomes on average, they are also likely to improve equity because a disproportionate share of this burden is currently borne by the poorer districts.

IntroductionDespite WHO’s recommendations and the 2023–2030 Tuberculosis (TB) action plan, uptake of TB preventive treatment (TPT) remains suboptimal. In this paper, we use two countries of the WHO Europe Region, the Republic of Moldova and Georgia, that are at different stages of implementation of TB prevention policies, as a case study to examine health system barriers and facilitators to TPT scale-up.MethodsIn this case study, we used methods of qualitative research—interviews with three stakeholder groups: health service providers and National TB Programme staff; civil society organisations and international partners or donors. The data were collected via videoconference, transcribed, then coded and analysed using NVivo V.14. Thematic analysis was conducted.ResultsFacilitators for TPT delivery in both settings include an established TB clinical network, well-functioning communication systems and an uninterrupted supply of TPT medicines.In both settings, healthcare providers generally exhibit positive attitudes towards treating TB infection; however, some remain sceptical and cautious, particularly regarding prescribing TPT without confirmation of TB infection, a challenge compounded by limited access to testing for TB infection. Evidence of TB infection is also important for patients’ decisions on initiation and adherence to treatment. Other barriers to effective service delivery of TPT include shortages and high workload of primary healthcare personnel, ambiguity in the role of family doctors in the management of TPT and low prioritisation of TPT during regular monitoring visits.ConclusionsThe case study identified similar challenges in the rollout of TPT across both settings, highlighting common barriers hindering effective implementation. For optimal TPT rollout, enhancing provider confidence, improving access to testing for TB infection and strengthening integration with primary healthcare with refined roles of family doctors are essential. Both settings would also benefit from improved monitoring and evaluation systems and prioritisation of TB prevention in monitoring.

The prospects for global tuberculosis control in the near future will be determined by the effectiveness of the response of countries to their burden of multidrug-resistant (MDR; resistance to, at least, isoniazid and rifampicin) tuberculosis. During the 2009 World Health Assembly, countries committed to achieve universal access to MDR-tuberculosis care by 2015. We assessed the progress towards the 2015 targets achieved by countries accounting for 90% of the estimated MDR-tuberculosis cases in the world in 2011. We analysed data reported to WHO by 30 countries expected to have more than 1000 MDR-tuberculosis cases among notified patients with pulmonary tuberculosis in 2011. In the 30 countries, 18% of the estimated MDR-tuberculosis cases were enrolled on treatment in 2011. Belarus, Brazil, Kazakhstan, Peru, South Africa, and Ukraine each detected and enrolled on treatment more than 50% of their estimated cases of MDR-tuberculosis. In Ethiopia, India, Indonesia, the Philippines, and Russia, enrolments increased steadily between 2009 and 2011 with a mean yearly change greater than 50%: however, in these countries enrolment in 2011 was low, ranging from 4% to 43% of the estimated cases. In the remaining countries (Afghanistan, Angola, Azerbaijan, Bangladesh, China, Democratic Republic of the Congo, Kenya, Kyrgyzstan, Moldova, Mozambique, Burma, Nepal, Nigeria, North Korea, Pakistan, South Korea, Thailand, Uzbekistan, and Vietnam) progress in detection and enrolment was slower. In 23 countries, a median of 53% (IQR 41–71) patients with MDR-tuberculosis successfully completed their treatment after starting it in 2008–09. Six countries (Belarus, Brazil, Kazakhstan, Peru, South Africa, and Ukraine) can achieve universal access to MDR-tuberculosis care by 2015 should they sustain their current pace of progress. In other countries a radical scale-up will be needed for them to have an effect on their MDR-tuberculosis burden. Unless barriers to diagnosis and successful treatment are urgently overcome, and new technologies in diagnostics and treatment effectively implemented, the global targets for 2015 are unlikely be achieved. WHO.

Background Studies of the quality of tuberculosis (TB) diagnostic evaluation of patients in high burden countries have generally shown poor adherence to international or national guidelines. Health worker perspectives on barriers to improving TB diagnostic evaluation are critical for developing clinic-level interventions to improve guideline implementation. Methods We conducted structured, in-depth interviews with staff at six district-level health centers in Uganda to elicit their perceptions regarding barriers to TB evaluation. Interviews were transcribed, coded with a standardized framework, and analyzed to identify emergent themes. We used thematic analysis to develop a logic model depicting health system and contextual barriers to recommended TB evaluation practices. To identify possible clinic-level interventions to improve TB evaluation, we categorized findings into predisposing, enabling, and reinforcing factors as described by the PRECEDE model, focusing on potentially modifiable behaviors at the clinic-level. Results We interviewed 22 health center staff between February 2010 and November 2011. Participants identified key health system barriers hindering TB evaluation, including: stock-outs of drugs/supplies, inadequate space and infrastructure, lack of training, high workload, low staff motivation, and poor coordination of health center services. Contextual barrier challenges to TB evaluation were also reported, including the time and costs borne by patients to seek and complete TB evaluation, poor health literacy, and stigma against patients with TB. These contextual barriers interacted with health system barriers to contribute to sub-standard TB evaluation. Examples of intervention strategies that could address these barriers and are related to PRECEDE model components include: assigned mentors/peer coaching for new staff (targets predisposing factor of low motivation and need for support to conduct job duties); facilitated workshops to implement same day microscopy (targets enabling factor of patient barriers to completing TB evaluation), and recognition/incentives for good TB screening practices (targets low motivation and self-efficacy). Conclusions Our findings suggest that health system and contextual barriers work together to impede TB diagnosis at health centers and, if not addressed, could hinder TB case detection efforts. Qualitative research that improves understanding of the barriers facing TB providers is critical to developing targeted interventions to improve TB care.

Background: Isoniazid preventive therapy (IPT) has been shown to reduce the risk of tuberculosis (TB) among people living with HIV (PLHIV). In 2017, India began a nationwide roll-out of IPT, but there is a lack of evidence on the implementation and the challenges. Objectives: Among PLHIV newly initiated on antiretroviral therapy (ART) from January 2017 to June 2018, to: (i) assess the proportion who started and completed IPT and (ii) explore reasons for non-initiation and non-completion from health-care providers' and patients' perspectives. Methods: An explanatory mixed-methods study was conducted in two selected districts of Karnataka, South India. A quantitative phase (cohort analysis of routinely collected program data) was followed by a qualitative phase involving thematic analysis of in-depth interviews with providers (n = 22) and patients (n = 8). Results: Of the 4020 included PLHIV, 3780 (94%) were eligible for IPT, of whom, 1496 (40%, 95% CI: 38%-41%) were initiated on IPT. Among those initiated, 423 (28.3%) were still on IPT at the time of analysis. Among 1073 patients with declared IPT outcomes 870 (81%, 95% CI: 79%-83%) had completed the six-month course of IPT. The main reason for IPT non-initiation and non-completion was frequent drug stock-outs. This required health-care providers to restrict IPT initiation in selected patient subgroups and earmark six-monthly courses for each patient to ensure that, once started, treatment was not interrupted. The other reasons for non-completion were adverse drug effects and loss to follow-up. Conclusion: The combined picture of 'low IPT initiation and high completion' seen in our study mirrors findings from other countries. Drug stock-out was the key challenge, which obliged health-care providers to prioritize 'IPT completion' over 'IPT initiation'. There is an urgent need to improve the procurement and supply chain management of isoniazid.

In recent years, venture capital approaches have delivered impressive results in identifying and funding promising health discoveries and bringing them to market. This success has inspired public sector experiments with \"social venture capital\" approaches to address the dearth of affordable treatment and prevention for diseases of the developing world. Employing the same focus on well-defined and measurable objectives, and the same type of connections to pool and deploy resources as their for-profit counterparts, social venture capitalists seek to use the tools and incentives of capitalism to solve one of its biggest failures: the lack of drugs and vaccines for diseases endemic to low-income populations. As part of a larger trend of partnerships emerging in health product donation and distribution, public-private partnerships for pharmaceutical development have led research and development (R&D) efforts to generate more accessible and efficacious products for diseases such as malaria, tuberculosis, and AIDS. In this article, three R&D-focused partnerships are explored: the International AIDS Vaccine Initiative; the Medicines for Malaria Venture; and the newly formed Global Alliance for TB Drug Development. The article highlights key elements essential to the success of these ventures.

Millions of people cannot access essential medicines they need for deadly diseases like malaria, tuberculosis (TB) and HIV/AIDS. There is good information on the need for drugs for these diseases but until now, no global estimate of the impact drugs are having on this burden. This paper presents a model measuring companies' key malaria, TB and HIV/AIDS drugs' consequences for global health (global-health-impact.org). It aggregates drugs' impacts in several ways-by disease, country and originator-company. The methodology can be extended across diseases as well as drugs to provide a more extensive picture of the impact companies' drugs are having on the global burden of disease. The study suggests that key malaria, TB and HIV/AIDS drugs are, together, ameliorating about 37% of the global burden of these diseases and Sanofi, Novartis, and Pfizer's drugs are having the largest effect on this burden. Moreover, drug impacts vary widely across countries. This index provides important information for policy makers, pharmaceutical companies, countries, and other stake-holders that can help increase access to essential medicines.

From 2012 through 2014, the United States experienced acute shortages and price escalations of several first-line anti-tuberculosis (TB) medications. Because secondary TB drug regimens are longer and adverse events occur more frequently with them, we sought to conservatively estimate the cost, to patients and the health care system, of TB treatment and medication adverse events from alternative regimens during drug shortages. We assessed the cost of treatment for TB disease in the absence of isoniazid (INH), rifampin (RIF), or pyrazinamide (PZA), or both INH and RIF. We simulated adverse events based on published probabilities using a monthly discrete-time stochastic model. For total costs, we summed costs of medications, routine testing, and treatment of adverse events using procedural terminology codes. We report average cost ratios of TB treatment during drug shortages to standard TB treatment. The cost ratio of TB treatment without INH, RIF, or PZA to standard treatment was 1.7 (Range: 1.2, 2.3), 4.9 (Range: 3.2, 7.3), and 1.1 (Range: 0.7, 1.7) times higher, respectively. Without both INH and RIF, the cost ratio was 18.6 (Range: 10.0, 39.0) times higher. When the prices for INH, RIF and PZA were increased, the cost for standard treatment increased by a factor of 2.7 (Range: 1.9, 3.0). The percentage of patients experiencing at least one adverse event while taking standard therapy was 3.9% (Range: 1.3%, 11.8%). This percentage increased to 51.5% (Range: 20.1%, 83.8%) when RIF was unavailable, and increased to 82.5% (Range: 41.2%, 98.5%) when both INH and RIF were unavailable. Our conservative model illustrates that an interruption in first-line anti-TB medications leads to appreciable additional costs and adverse events for patients. The availability of these drugs in the United States should be ensured. Models that incorporate the effectiveness of alternative regimens, delays in treatment initiation, and TB transmission can provide broader perspectives on the impact of drug shortages.