Moving from assessments to implementation: promising practices for strengthening multisectoral antimicrobial resistance containment capacity.

BACKGROUND: Antimicrobial resistance (AMR) poses a global threat to human, animal, and environmental health. AMR is a technical area in the Global Health Security Agenda initiative which uses the Joint External Evaluation tool to evaluate national AMR containment capacity. This paper describes four promising practices for strengthening national antimicrobial resistance containment capacity based on the experiences of the US Agency for International Development's Medicines, Technologies, and Pharmaceutical Services Program work with 13 countries to implement their national action plans on AMR in the areas of multisectoral coordination, infection prevention and control, and antimicrobial stewardship. METHODS: We use the World Health Organization (WHO) Benchmarks on International Health Regulations Capacities (2019) to guide national, subnational, and facility actions that advance Joint External Evaluation capacity levels from 1 (no capacity) to 5 (sustainable capacity). Our technical approach is based on scoping visits, baseline Joint External Evaluation scores, benchmarks tool guidance, and country resources and priorities. RESULTS: We gleaned four promising practices to achieve AMR containment objectives: (1) implement appropriate actions using the WHO benchmarks tool, which prioritizes actions, making it easier for countries to incrementally increase their Joint External Evaluation capacity from level 1 to 5; (2) integrate AMR into national and global agendas. Ongoing agendas and programs at international, regional, and national levels provide opportunities to mainstream and interlink AMR containment efforts; (3) improve governance through multisectoral coordination on AMR. Strengthening multisectoral bodies' and their technical working groups' governance improved functioning, which led to better engagement with animal/agricultural sectors and a more coordinated COVID-19 pandemic response; and (4) mobilize and diversify funding for AMR containment. Long-term funding from diversified funding streams is vital for advancing and sustaining countries' Joint External Evaluation capacities. CONCLUSIONS: The Global Health Security Agenda work has provided practical support to countries to frame and conduct AMR containment actions in terms of pandemic preparedness and health security. The WHO benchmarks tool that Global Health Security Agenda uses serves as a standardized organizing framework to prioritize capacity-appropriate AMR containment actions and transfer skills to help operationalize national action plans on AMR.

Protocol for active safety monitoring of a cohort of patients using a dolutegravir-based antiretroviral regimen in Mozambique.

INTRODUCTION: Dolutegravir-based antiretroviral therapy (ART) is increasingly being used as the preferred first-line regimen for the treatment of HIV in low-income and middle-income countries. The National Program for the Control of STI/HIV/AIDS in Mozambique has planned a phased introduction of the tenofovir/lamivudine/dolutegravir (TLD) regimen. In 2019, concerns about a potential safety signal identified with dolutegravir identified in the results of the Tsepamo study, conducted in Botswana, led the National Directorate of Pharmacy and the National Program for the Control of STI/HIV/AIDS to establish an active pharmacovigilance surveillance system among newly placed patients on a TLD regimen. This activity aims to establish an active pharmacovigilance system to monitor adverse events in patients on a TLD regimen to support the effectiveness of Mozambique's public health programmes in improving the process of care and treatment outcomes for people with HIV/AIDS. METHODS AND ANALYSIS: This is a prospective, non-interventional, descriptive cohort study to monitor HIV patients managed with TLD at 10 sentinel health centres in Mozambique. The cohort consists of HIV-infected patients commencing treatment with TLD, either as treatment naïve patients or switched from other ART regimens. Patients have monthly routine follow-up visits for the first 3 months after starting HIV treatment with TLD, and subsequently every 3 months for a total period of 1 year. Patients are monitored to identify possible adverse events during the follow-up period. The intended size of the cohort is 3000 patients. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Commission on Bioethics in Health in Mozambique. Written informed consent is obtained from each participant who agrees to participate to have their information collected, analysed and stored. Findings will be reported to the Ministry of Health and participating health centres to inform policy and practice as well as disseminated by peer-review publications.

Strengthening multisectoral coordination on antimicrobial resistance: a landscape analysis of efforts in 11 countries.

BACKGROUND: Increasingly, there has been recognition that siloed approaches focusing mainly on human health are ineffective for global antimicrobial resistance (AMR) containment efforts. The inherent complexities of AMR containment warrant a coordinated multisectoral approach. However, how to institutionalize a country's multisectoral coordination across sectors and between departments used to working in silos is an ongoing challenge. This paper describes the technical approach used by a donor-funded program to strengthen multisectoral coordination on AMR in 11 countries as part of their efforts to advance the objectives of the Global Health Security Agenda and discusses some of the challenges and lessons learned. METHODS: The program conducted a rapid situational analysis of the Global Health Security Agenda and AMR landscape in each country and worked with the governments to identify the gaps, priorities, and potential activities in multisectoral coordination on AMR. Using the World Health Organization (WHO) Joint External Evaluation tool and the WHO Benchmarks for International Health Regulations (2005) Capacities as principal guidance, we worked with countries to achieve key milestones in enhancing effective multisectoral coordination on AMR. RESULTS: The program's interventions led to the achievement of key benchmarks recommended actions, including the finalization of national action plans on AMR and tools to guide their implementation; strengthening the leadership, governance, and oversight capabilities of multisectoral governance structures; establishing and improving the functions of technical working groups on infection prevention and control and antimicrobial stewardship; and coordinating AMR activities within and across sectors. CONCLUSION: A lot of learning still needs to be done to identify best practices for building mutual trust and adequately balancing the priorities of individual ministries with cross-cutting issues. Nevertheless, this paper provides some practical ideas for countries and implementing partners seeking to improve multisectoral coordination on AMR. It also demonstrates that the WHO benchmark actions, although not intended as an exhaustive list of recommendations, provide adequate guidance for increasing countries' capacity for effective multisectoral coordination on AMR in a standardized manner.

National Health Insurance Fund's relationship to retail drug outlets: a Tanzania case study.

BACKGROUND: Achieving universal health coverage will require robust private sector engagement; however, as many low- and middle-income countries launch prepayment schemes to achieve universal health coverage, few are covering products from retail drug outlets (pharmacies and drug shops). This case study aims to characterize barriers and facilitators related to incorporating retail drug outlets into national prepayment schemes based on the experience of the Tanzanian National Health Insurance Fund's (NHIF) certification of pharmacies and accredited drug dispensing outlets. METHODS: We reviewed government documents and interviewed 26 key informants including retail outlet owners and dispensers and central and district government authorities representing eight districts overall. Topics included awareness of NHIF in the community, access to medicines, claims processing, reimbursement prices, and how the NHIF/retail outlet linkage could be improved. RESULTS: Important enablers for NHIF/retail outlet engagement include widespread awareness of NHIF in the community, NHIF's straightforward certification process, and their reimbursement speed. All of the retail respondents felt that NHIF helps their business and their clients to some degree. As for barriers, retailers thought that NHIF needed to provide more information to them and to its members, particularly regarding coverage changes. Some retailers and government officials thought that the product reimbursement prices were below market and not adjusted often enough, and pharmacy respondents were unhappy about claim rejections for what they felt were insignificant issues. All interviewees agreed that one of the biggest problems is poor prescribing practices in public health facilities. They reiterated that prescribers need more supervision to improve their practices, particularly to ensure adherence to standard treatment guidelines, which NHIF requires for approving a claim. In addition, if a prescription has any problem, including a wrong date or no signature, the client must return to the health facility to get it corrected or pay out-of-pocket, which is burdensome. CONCLUSIONS: Little published information is available on the relationship between health insurance plans and retail providers in low- and middle-income countries. This case study provides insights that countries can use when designing ways to include retail outlets in their health insurance schemes.

Making the investment case for national regulatory authorities.

Well-functioning national regulatory authorities (NRAs) ensure access to safe, effective, quality-assured, and affordable medical products. However, the benefits of their work are often unseen and difficult to attribute, thereby making NRAs undervalued and under-resourced, particularly in low- and middle-income countries. This paper offers three key arguments NRAs and other stakeholders can use to advocate for greater investment in regulatory systems strengthening-medical products regulation effectively safeguards public health; effective regulation improves health system's efficiency by increasing access to affordable medical products, contributing to universal health coverage; and robust regulation strengthens local pharmaceutical manufacturing and bolsters pharmaceutical trade. NRAs' critical role in health systems is indisputable, yet they need to better promote their value to receive the requisite resources to function effectively.

The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity.

Many low-income and middle-income countries lack the capacity to effectively and efficiently regulate medical products in their countries. To support countries in strengthening their capacity, WHO has developed the Global Benchmarking Tool (GBT) as the global standard for objectively assessing regulatory capacity for medicines and vaccines. The GBT is a game changer because it is the first globally accepted tool for assessing and strengthening national regulatory authorities. The inclusion of an institutional development plan in the GBT methodology provides context-specific actionable steps countries can take to advance their system's functionality and maturity. The GBT facilitates coordination and improves the effectiveness of regulatory strengthening efforts. The tool also facilitates regulatory reliance and harmonisation, which helps to improve timely access to quality-assured medicines, and creates incentives for trade, particularly in countries and regions with a strong pharmaceutical manufacturing base. The GBT is a necessary tool for creating strong and effective regulatory systems, which are critical for ensuring the efficacy, safety and quality assurance of medicines and populations' timely access to these medicines. In outlining the benefits of the GBT, this paper also offers some specific ideas for strengthening the GBT framework and process.

Integrating pharmaceutical systems strengthening in the current global health scenario: three 'uncomfortable truths'.

The response to emergency public health challenges such as HIV, TB, and malaria has been successful in mobilising resources and scaling up treatment for communicable diseases. However, many of the remaining challenges in improving access to and appropriate use of medicines and services require pharmaceutical systems strengthening. Incorporating pharmaceutical systems strengthening into global health programmes requires recognition of a few 'truths'. Systems strengthening is a lengthy and resource-intensive process that requires sustained engagement, which may not align with the short time frame for achieving targets in vertical-oriented programmes. Further, there is a lack of clarity on what key metrics associated with population and patient level outcomes should be tracked for systems strengthening interventions. This can hinder advocacy and communication with decision makers regarding health systems investments. Moving forward, it is important to find ways to balance the inherent tensions between the short-term focus on the efficiency of vertical programmes and broader, longer-term health and development objectives. Global health programme design should also shift away from a narrow view of medicines primarily as an input commodity to a more comprehensive view that recognizes the various structures and processes and their interactions within the broader health system that help ensure access to and appropriate use of medicines and related services.

Implementing an Integrated Pharmaceutical Management Information System for Antiretrovirals and Other Medicines: Lessons From Namibia.

The success of the Namibian government's "treatment for all" approach to control and stop the country's HIV epidemic is dependent on an uninterrupted supply of antiretrovirals (ARVs) for people living with HIV. The public health system in Namibia, however, was constrained by an inefficient paper-based pharmaceutical information system resulting in unreliable and inaccessible data, contributing to persistent stock-outs of ARVs and other essential pharmaceuticals. This article describes the incremental implementation of an integrated pharmaceutical management information system to provide timely and reliable commodity and patient data for decision making in Namibia's national antiretroviral therapy (ART) program and the Ministry of Health and Social Services (MoHSS). The system has 4 interlinked information tools: (1) the Electronic Dispensing Tool (EDT) that manages the dispensing and inventory of antiretrovirals at service delivery points; (2) the EDT national database, which facilitates the flow, storage, and collation of ART data at the central level; (3) the Facility Electronic Stock Card used to manage pharmaceutical stocks and report inventory movement data to the national level; and (4) the Pharmaceutical Management Information Dashboard that integrates all 3 tools plus the warehouse management tool used by the central and regional medical stores into 1 dashboard that serves as a platform for the analysis and dissemination of pharmaceutical information throughout the health system. Implementing the pharmaceutical management information system was a prolonged and complicated process, with key challenges related to user acceptance and human resource constraints. The integrated pharmaceutical management information system enables Namibia to collect more than 90% of transactional commodity and patient dispensing data from more than 85% of all ART sites. Health managers use information from the system for medicine quantification decisions and to improve pharmaceutical service delivery. The MoHSS and its partners in the national ART program use the information for monitoring the World Health Organization early warning indicators for HIV drug resistance; ART defaulter tracing; and for planning, reporting, and research purposes. Namibia's pharmaceutical management information system demonstrates the feasibility and benefits of integrating related tools while maintaining their specialized functionality to address country-specific information and inventory management needs.

Defining pharmaceutical systems strengthening: concepts to enable measurement.

Pharmaceutical products are indispensable for improving health outcomes. An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information. This work adds clarity to the concept of pharmaceutical systems and their strengthening by proposing holistic definitions on the basis of systems thinking. It provides a practical starting point for measuring the progress of pharmaceutical systems strengthening.

The emergence of global attention to health systems strengthening.

After a period of proliferation of disease-specific initiatives, over the past decade and especially since 2005 many organizations involved in global health have come to direct attention and resources to the issue of health systems strengthening. We explore how and why such attention emerged. A qualitative methodology, process-tracing, was used to construct a case history and analyse the factors shaping and inhibiting global political attention for health systems strengthening. We find that the critical factors behind the recent burst of attention include fears among global health actors that health systems problems threaten the achievement of the health-related Millennium Development Goals, concern about the adverse effects of global health initiatives on national health systems, and the realization among global health initiatives that weak health systems present bottlenecks to the achievement of their organizational objectives. While a variety of actors now embrace health systems strengthening, they do not constitute a cohesive policy community. Moreover, the concept of health systems strengthening remains vague and there is a weak evidence base for informing policies and programmes for strengthening health systems. There are several reasons to question the sustainability of the agenda. Among these are the global financial crisis, the history of pendulum swings in global health and the instrumental embrace of the issue by some actors.

Has aid for AIDS raised all health funding boats?

Global health analysts have debated whether donor prioritization of HIV/AIDS control has lifted all boats, raising attention and funding levels for health issues aside from HIV/AIDS. We investigate this question, considering donor funding for 4 historically prominent health agendas-HIV/AIDS, health systems strengthening, population and reproductive health, and infectious disease control-over the decade 1998-2007. We employ funding data from the Development Assistance Committee of the Organization for Economic Cooperation and Development, which tracks donor aid. The data indicate that HIV/AIDS may have helped to increase funding for the control of other infectious diseases; however, there is no firm evidence that other health issues beyond the control of infectious diseases have benefited. Between 1998 and 2007, funding for HIV/AIDS control rose from just 5.5% to nearly half of all aid for health. Over the same period, funding for health systems strengthening declined from 62.3% to 23.9% of total health aid and that for population and reproductive health declined from 26.4% to 12.3%. Also, even as total aid for health tripled during this decade, aid for health systems strengthening largely stagnated. Overall, the data indicate little support for the contention that donor funding for HIV/AIDS has lifted all boats.