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Sleeping sickness (human African trypanosomiasis [HAT]) is a neglected tropical disease with limited treatment options that currently require parenteral administration. In previous studies, orally administered pafuramidine was well tolerated in healthy patients (for up to 21 days) and stage 1 HAT patients (for up to 10 days), and demonstrated efficacy comparable to pentamidine. This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospitals in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. The overall cure rate at 12 months was 89% in the pafuramidine group and 95% in the pentamidine group; pafuramidine was non-inferior to pentamidine as the upper bound of the 95% confidence interval did not exceed 15%. The safety profile of pafuramidine was superior to pentamidine; however, 3 patients in the pafuramidine group had glomerulonephritis or nephropathy approximately 8 weeks post-treatment. Two of these events were judged as possibly related to pafuramidine. Despite good tolerability observed in preceding studies, the development program for pafuramidine was discontinued due to delayed post-treatment toxicity.

In this work, we demonstrate identity verification and concentration determination of pharmaceutical compounds via TLC using a custom 3D-printed cradle that interfaces with an ordinary mobile phone. Using single-component solutions of nevirapine, amodiaquine, and paracetamol that have been manually applied, the mobile phone-based detection instrument provides measurements that are equivalent to those obtained with a commercially available lab-based desktop TLC densitometer.

Several studies have shown effectiveness of SMS interventions to improve health workers’ practices, patients’ adherence to medications and availability of health facility commodities. To inform policymakers about the feasibility of facility-based SMS interventions, the coverage data on mobile phone ownership and SMS use among health workers and patients are needed. In 2012, a national, cross-sectional, cluster sample survey was undertaken at 172 public health facilities in Kenya. Outpatient health workers (219) and caregivers of sick children and adult patients (1,177) were interviewed. Mobile phone ownership and SMS use are ubiquitous among Kenyan health workers in the public sector. Among the patients they serve, phone ownership and SMS use are lower, and disparities exist with respect to gender, age, education, literacy, urbanization and poverty. Some of the disparities in SMS use can be addressed through mHealth interventions and enhanced implementation processes, while further growth in mobile phone ownership is needed to reduce the gap.

The objective of this study was to assess the prevalence, profile and outcome of adverse events (AEs) associated with treatment of drug-resistant tuberculosis (DR-TB) and explore possible influences of HIV disease on the occurrence of adverse events. Data were collected from treatment records of all patients treated for DR-TB at the study facility between January 2008 and February 2010. A total of 141 adverse events of varying severity were experienced in 90% (53/59) of patients.The TB/HIV co-infection rate was 53%. The prevalence of gastrointestinal tract adverse events was 64%, tinnitus 45%, joint pain 28% and decreased hearing 25%. Abdominal pains, rash, nausea, decreased hearing and joint pain were more common in HIV infected than in HIV uninfected patients.

With increasing numbers of people worldwide on antiretroviral drugs, the need for improved and sustained global drug safety monitoring or pharmacovigilance is critical. Pharmacovigilance includes monitoring for substandard products, diversion, inappropriate use, and toxicity and is an essential component of safe and effective drug usage. The Forum for Collaborative HIV Research was asked to use its neutral setting for key stakeholders from the UN and government agencies, donors, industry, academia, multilateral organizations, and implementers to discuss the creation of a sustainable global pharmacovigilance system for antiretrovirals (ARVs). Important but contrasting priorities and values among stakeholders—all of whom are dedicated to establishing global pharmacovigilance—were identified as barriers to progress. Recognition, understanding, and respect for these contrasts is a pathway for increased collaboration and cooperation that will then lead to a sustainable system involving all stakeholders including industry and experienced regulatory agencies.

The objective of this survey was to develop an indicator-based tool for systematic assessment and reporting of good pharmacy practice (GPP). The tool comprises a) a set of indicators, b) an indicator and survey manual, c) a data collection sheet, and d) Microsoft Excel based data collection and analysis tool. We developed a set of 34 pharmacy practice (PP) indicators using an iterative process to test their functionality in various pharmacy practice settings in Ethiopia, Uganda and Zimbabwe. The indicator-based survey assessed five components of PP: system, storage, services, dispensing and rational drug use. The new GPP indicator-based assessment tool proved to be an easily applicable tool for uniform assessments of pharmacy practices and identification of problem areas. It allows for both intra- and inter-country comparison and for self-assessment. However, the indicators need to be further developed to test their applicability in developed countries.

Abstract Two laboratories extensively investigated the use of HPTLC to perform assays on lamivudine-zidovudine, metronidazole, nevirapine, and quinine composite samples. To minimize the effects of differences in analysts' technique, the laboratories conducted the study with automatic sample application devices in conjunction with variable-wavelength scanning densitometers to evaluate the plates.

In recent years, global health initiatives have greatly increased the number of patients in low-income countries started on antiretroviral therapy (ART). This creates an urgent need to know how well HIV/AIDS programs maintain patients on therapy. Consensus, however, is lacking on practical, reliable, and valid indicators to monitor program performance on adherence. Recently, the Global Fund became the first funding organization to recommend an adherence indicator to monitor program performance. This is a welcome beginning. International organizations and national AIDS control programs have a clear and urgent need to finalize agreement about standard indicators to monitor patient adherence and retention and to begin to make such data publicly available. UNAIDS and the WHO Department of HIV/AIDS should take the lead in coordinating donor and country collaboration in this important endeavor.

To achieve a high quality global infrastructure for pharmacy, the educational system should be mapped to the required competencies of pharmacists to provide the relevant pharmaceutical services for meeting the health needs in any given country context. While no one national model may be appropriate for all systems, there are significant global health and labor and market drivers which suggest that a competency-based approach is sensible and sustainable for workforce development.

This paper explores HIV patients’ adherence to antiretroviral treatment (ART) in resource-limited contexts in Uganda and Ethiopia, where ART is provided free of charge. Qualitative semi-structured interviews were conducted with 79 patients, 17 peer counselors, and 22 providers in ART facilities in urban and rural areas of Ethiopia and Uganda. To grant patients a fair choice to successfully adhere to ART, transport costs to ART facilities need to be reduced. This implies providing patients with drugs for longer periods of time and arranging for better laboratory services, thus not necessitating frequent revisits. Services ought to be brought closer to patients and peripheral, community-based healthworkers used for drug distribution. There is a need for training providers and peer counselors, in communication skills and adherence counseling.

In recent years, new global initiatives responding to the AIDS crisis have dramatically affected—and often significantly improved—how developing countries procure, distribute, and manage pharmaceuticals. A number of developments related to treatment scale-up, initially focused on AIDS-related products, have created frameworks for widening access to medicines for other diseases that disproportionally impact countries with limited resources and for strengthening health systems overall. Examples of such systems strengthening have come in the areas of drug development and pricing; policy and regulation; pharmaceutical procurement, distribution, and use; and management systems, such as for health information and human resources. For example, a hospital in South Africa developed new tools to decentralize provision of antiretroviral therapy to local clinics—bringing treatment closer to patients and shifting responsibility from scarce pharmacists to lower level pharmacy staff. Successful, the system was expanded to patients with other chronic conditions, such as mental illness. Progress toward universal access to HIV prevention, treatment, care, and support will continue the push to strengthen pharmaceutical sectors that serve not only HIV-related needs but all health needs; health experts can likely take these achievements further to maximize their expansion into the wider health system.

The use of rapid and inexpensive nonlaboratory-based screening tests for drug quality assessments is recommended as a component of a drug quality assurance program in poor resource settings. We have established routine Minilab test procedures to screen product quality and a proficiency testing program to determine the competency of the inspectors and reliability of results. Samples for the proficiency testing were prepared by pulverizing a standard reference tablet of the appropriate drug and making serial dilutions with starch to obtain concentrations of 0, 40, and 100%. The samples, which were labeled only with the drug name and an identifying letter, were given to inspectors for quality screening using Minilab procedures. In round 1 of the proficiency test, only 3 of 28 substandard samples were correctly identified. Round 2 of the proficiency test, which was administered after a performance qualification test for the analytical method, showed much improvement: 19 of 27 substandard drugs were correctly identified, while 5 out of 9 inspectors made the correct inference on the quality of 45 samples. However, in both rounds, 2 inspectors failed to identify substandard samples, indicating that their technical competencies need to be improved for the reliability of the results. Although the thin-layer chromatography screening methods provide a rapid means for drug quality assessment, they need to be put in the hands of competent users. The inclusion of a proficiency test in the screening program provides a measure of determining competency of the personnel and reliability of the results.

Pharmacists' roles are evolving from that of compounders and dispensers of medicines to that of experts on medicines within multidisciplinary health care teams. In the developing country context, the pharmacy is often the most accessible or even the sole point of access to health care advice and services. Because of their knowledge of medicines and clinical therapeutics, pharmacists are suitably placed for task shifting in health care and could be further trained to undertake functions such as clinical management and laboratory diagnostics. Indeed, pharmacists have been shown to be willing, competent, and cost-effective providers of what the professional literature calls "pharmaceutical care interventions"; however, internationally, there is an underuse of pharmacists for patient care and public health efforts. A coordinated and multifaceted effort to advance workforce planning, training and education is needed in order to prepare an adequate number of well-trained pharmacists for such roles. Acknowledging that health care needs can vary across geography and culture, an international group of key stakeholders in pharmacy education and global health has reached unanimous agreement that pharmacy education must be quality-driven and directed towards societal health care needs, the services required to meet those needs, the competences necessary to provide these services and the education needed to ensure those competences. Using that framework, this commentary describes the Pharmacy Education Taskforce of the World Health Organization, United Nations Educational, Scientific and Cultural Organization and the International Pharmaceutical Federation Global Pharmacy and the Education Action Plan 2008–2010, including the foundation, domains, objectives and outcome measures, and includes several examples of current activities within this scope.

A cross-sectional survey was performed in 24 systems of care providing antiretroviral medications in Ethiopia, Kenya, Rwanda, Tanzania, and Uganda to examine current practices in monitoring rates of treatment adherence and defaulting. Only 20 of 48 facilities reported routinely measuring individual patient adherence levels; only 12 measured rates of adherence for the clinic population. The rules for determining which patients were included in the calculation of rates were unclear. Fourteen different definitions of treatment defaulting were in use. Facilities routinely gather potentially useful data, but the frequency of doing so varied widely. Individual and program treatment adherence and defaulting are not routinely monitored; when done, the operational definitions and methods varied widely, making comparisons across programs unreliable. There is a pressing need to determine which measures are the most feasible and reliable to collect, the most useful for clinical counseling, and most informative for program management.

During 2014, the World Federation of Public Health Associations (WFPHA) conducted an on-line survey of its 82 PHA members, to identify the state of organizational governance of national public health associations, as well as the factors that influence optimal organizational governance. Responses were received from 62 PHAs. The two most important factors that support governance effectiveness were a high degree of integrity and ethical behavior of the PHA’s leaders (77%) and the competence of people serving on the PHA’s governing body (76%). Lack of financial resources was considered the most important factor that negatively affected organizational governance effectiveness (73%). Lack of mentoring for future PHA leaders; ineffective or incompetent leadership; lack of understanding about good governance practices; and lack of accurate information for strategic planning were identified as factors influencing PHA governance effectiveness. Critical elements for PHA sustainability included diversity, gender-responsiveness and inclusive governance practices, and strategies to build the future generation of public health leaders.

Ethiopia has achieved rapid expansion of TB microscopic centers for acid fast bacilli (AFB). However, external quality assurance (EQA) services were, until recently, limited to few regional and sub-regional laboratories. In this paper, we describe the decentralization experience and the result of EQA using random blinded rechecking. We decentralized sputum smear AFB EQA from 4 regional laboratories (RRLs) to 82 EQA centers and enrolled 956 health facilities (HFs) in EQA schemes. From 2012 to 2014 (Phase I), the false positivity rate declined from 0.6% to 0.2% and false negativity fell from as high as 7.6% to 1.6% in supported HFs. In HFs that joined in Phase II, FN rates ranged from 5.6% to 7.3%. The proportion of HFs without errors increased from 77.9% to 90.5% in Phase I HFs and from 82.9% to 86.9% in Phase II HFs. Overall sensitivity and specificity were 95.0% and 99.7%, respectively. Positive predictive and negative predictive values were 93.3% and 99.7%, respectively. Decentralizing blinded rechecking of sputum smear microscopy is feasible in low-income settings. While a comprehensive laboratory improvement strategy enhanced the quality of microscopy, laboratory professionals' capacity in slide reading and smear quality requires continued support.

Half of the Ugandan population obtains medicines from the public sector. Yet, we found only 3/5 of 455 inspected public health facilities meet Good Pharmacy Practice (GPP) standards. Facilities using SPARS (the Supervision, Performance Assessment, and Recognition Strategy) tended to perform better than unsupervised facilities, substantiating the value of supporting supervision interventions in GPP areas that need strengthening. Non-compliant indicators can be improved through practices and behavioral changes; some require infrastructure investments. We conclude that regular National Drug Authority inspections of public sector pharmacies in conjunction with interventions to improve GPP adherence can revolutionize patient care in Uganda.

Ethambutol (EMB) resistance can evolve through a multistep process, and mutations in the ubiA (Rv3806c) gene appear to be responsible for high-level EMB resistance in Mycobacterium tuberculosis. We evaluated the prevalence of ubiA and embB (Rv3795) mutations in EMB-resistant strains originating from Africa and South Korea. No differences in embB mutation frequencies were observed between strains from both origins. However, ubiA mutations were present in 45.5% 6.5% of the African EMB-resistant isolates but in only 9.5% 1.5% of the South Korean EMB-resistant isolates. The ubiA mutations associated with EMB resistance were localized to regions encoding the transmembrane domains of the protein, whereas the embB mutations were localized to regions encoding the extramembrane domains. Larger studies are needed to investigate the causes of increased ubiA mutations as a pathway to high-level EMB resistance in African countries, such as extended EMB usage during tuberculosis treatment.

In the past 30 years, debate has raged over maternal influence on infant death in Northeast Brazil. Scheper-Hughes, in two acclaimed articles and a book, sparked the controversy by alleging that nordestina mothers disinvest disfavored children of resources, thereby contributing to their deaths. We propose an interpretation of maternal investment through retrospective contextualization of a three-tiered series of factors. Between 2011 and 2013, we analyzed 316 ethnographic interviews about childhood death collected in the interior of Ceará. Our subsample comprises 58 death narratives from grieving mothers whose children died during the 12 months preceding the interview between 1979 and 1989; follow-up studies of 13 of those grieving mothers were conducted in 2011. Our sample closely resembles that of Scheper-Hughes, and from its stories we identify seven contexts—historical, political, economic, ecological, biological, social, and spiritual—that constrict how mothers grieve. Each context interrelates with the others, forming a cultural niche that regulates accepted emotionality, modes of suffering, roles of authority figures, and so on. We explore these contexts, offering alternatives to Scheper-Hughes’s theory, and conclude that a community-wide tendency to neglect never existed.

A child's risk of developing tuberculosis (TB) can be reduced by nearly 60% with administration of 6 months course of isoniazid preventive therapy (IPT). However, uptake of IPT by national TB programs is low, and IPT delivery is a challenge in many resource-limited high TB-burden settings. Routinely collected program data was analyzed to determine the coverage and outcome of implementation of IPT for eligible under-five year old children in 28 health facilities in two regions of Ethiopia. A total of 504 index smear-positive pulmonary TB (SS+) cases were reported between October 2013 and June 2014 in the 28 health facilities. There were 282 under-five children registered as household contacts of these SS+ TB index cases, accounting for 17.9% of all household contacts. Of these, 237 (84%) were screened for TB symptoms, and presumptive TB was identified in 16 (6.8%) children. TB was confirmed in 5 children, producing an overall yield of 2.11% (95% confidence interval, 0.76-4.08%). Of 221 children eligible for IPT, 64.3% (142) received IPT, 80.3% (114) of whom successfully completed six months of therapy. No child developed active TB while on IPT. Contact screening is a good entry point for delivery of IPT to at risk children and should be routine practice as recommended by the WHO despite the implementation challenges.

Moving the global response towards the universal test and treat model will pose huge challenges to public health systems in resource-limited settings, including global and local supply chain systems. These challenges are especially acute in Africa, which accounts for over 70% of the persons affected by HIV.To ensure that there are enough anti-retrovirals available to treat the nearly 25 million people that will require them by 2020 represents a near doubling of the ARV supplied to treat the 13 million currently on treatment. Similarly, to monitor those on treatment means an unprecedented scale-up of viral load testing throughout Africa. Larger issues include whether the capacity exists at the local level to handle these commodities when they arrive in the most severely affected countries, including considerations of the human resources and costs needed to make this strategy effective. We believe that such ‘‘real world’’ analysis of proposed strategies and policies is essential to ensure their most effective implementation.

In this opinion paper, we discuss lessons learned from the global scale-up of these laboratory devices and the pathway to tapping the potential of laboratory-generated information in the field of TB by using connectivity. Responding to the demand for connectivity, innovative third-party players have proposed solutions that have been widely adopted by field users of the Xpert® MTB/RIF assay. The experience associated with the utilisation of these systems, which facilitate the monitoring of wide laboratory networks, stressed the need for a more global and comprehensive approach to diagnostic connectivity. In addition to facilitating the reporting of test results, the mobility of digital information allows the sharing of information generated in programme settings. When they become easily accessible, these data can be used to improve patient care, disease surveillance and drug discovery. We list several examples of initiatives that should allow data sources to be combined to improve the understanding of the epidemic, support the operational response and, finally, accelerate TB elimination.

We reviewed literature on HIV and tuberculosis in sub-Saharan African prisons published between 2011 and 2015, and identified data from only 24 of the 49 countries in the region. Where data were available, they were frequently of poor quality and rarely nationally representative. Prevalence of HIV infection ranged from 2·3% to 34·9%, and of tuberculosis from 0·4 to 16·3%; detainees nearly always had a higher prevalence of both diseases than did the non-incarcerated population in the same country.We identified barriers to prevention, treatment, and care services in published work and through five case studies of prison health policies and services in Zambia, South Africa, Malawi, Nigeria, and Benin. These barriers included severe financial and human-resource limitations and fragmented referral systems that prevent continuity of care when detainees cycle into and out of prison, or move between prisons. These challenges are set against the backdrop of weak health and criminal-justice systems, high rates of pre-trial detention, and overcrowding. A few examples of promising practices exist, including routine voluntary testing for HIV and screening for tuberculosis upon entry to South African and the largest Zambian prisons, reforms to pre-trial detention in South Africa, integration of mental health services into a health package in selected Malawian prisons, and task sharing to include detainees in care provision through peer-educator programmes in Rwanda, Zimbabwe, Zambia, and South Africa. However, substantial additional investments are required throughout sub-Saharan Africa to develop country-level policy guidance, build human-resource capacity, and strengthen prison health systems to ensure universal access to HIV and tuberculosis prevention, treatment, and care of a standard that meets international goals and human rights obligations.

It is well known that safe delivery in a health facility reduces the risks of maternal and infant mortality resulting from perinatal complications. What is less understood are the factors associated with safe delivery practices. We investigated factors influencing health facility delivery practices while adjusting for multiple other factors simultaneously, spatial heterogeneity, and trends over time. We fitted a logistic regression model to Lot Quality Assurance Sampling (LQAS) data from Uganda in a framework that considered individual-level covariates, geographical features, and variations over five time points. We showed that ease of access, maternal age and education are strongly associated with delivery in a health facility; after accounting for this, there remains a significant trend towards greater uptake over time. We used this model together with known demographics to formulate a nascent early warning system that identifies candidate districts expected to have low prevalence of facility-based delivery in the immediate future. We provided a statistical method for using inexpensive and routinely collected monitoring and evaluation data to answer complex epidemiology and public health questions in a resource-poor setting.

Uganda introduced a multipronged intervention, the supervision, performance assessment, and recognition strategy (SPARS), to improve medicines management (MM) in public and not-for-profit health facilities. This paper, the first in a series, describes the SPARS intervention and reports on the MM situation in Uganda before SPARS (baseline).


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