Effect of methenamine hippurate shortage on antibiotic prescribing for urinary tract infections in Norway-an interrupted time series analysis.

BACKGROUND: Despite a lack of conclusive evidence of effect, methenamine hippurate is widely prescribed as preventive treatment for recurrent urinary tract infections (UTIs) in Norway. A national discontinuation of methenamine hippurate treatment due to a 4-month drug shortage in 2019 presented an opportunity to evaluate its preventive effect on UTIs among regular users. OBJECTIVE: To estimate the impact of the methenamine hippurate drug shortage on prescription frequency of UTI antibiotics. METHODS: Data from The Norwegian Prescription Database was analysed using an interrupted time series design. The time series consisted of 56 time periods of 14 days. The model included two naturally occurring interruptions: (i) the methenamine hippurate drug shortage, and (ii) reintroduction of the drug. The study population were 18 345 women ≥50 years receiving ≥2 prescriptions of methenamine hippurate in the study period before the shortage. Main outcome measure was number of prescriptions of UTI antibiotics per 1000 methenamine hippurate users. Prescription rates of antibiotics for respiratory tract infections were analysed to assess external events affecting antibiotic prescribing patterns. RESULTS: We found a significant increase of 2.41 prescriptions per 1000 methenamine hippurate users per 14-day period during the drug shortage (95%CI 1.39, 3.43, P < 0.001), followed by a significant reduction of -2.64 prescriptions after reintroduction (95%CI -3.66, -1.63, P < 0.001). CONCLUSIONS: During the methenamine hippurate drug shortage, we found a significant increase in prescribing trend for UTI antibiotics followed by a significant decrease in prescribing trend after reintroduction. This change in trend seems to reflect a preventive effect of the drug on recurrent UTIs.

Procedural fairness in decision-making for financing a National Health Insurance Scheme: a case study from The Gambia.

Achieving universal health coverage (UHC) involves difficult policy choices, and fair processes are critical for building legitimacy and trust. In 2021, The Gambia passed its National Health Insurance (NHI) Act. We explored decision-making processes shaping the financing of the NHI scheme (NHIS) with respect to procedural fairness criteria. We reviewed policy and strategic documents on The Gambia's UHC reforms to identify key policy choices and interviewed policymakers, technocrats, lawmakers, hospital chief executive officers, private sector representatives and civil society organizations (CSOs) including key CSOs left out of the NHIS discussions. Ministerial budget discussions and virtual proceedings of the National Assembly's debate on the NHI Bill were observed. To enhance public scrutiny, Gambians were encouraged to submit views to the National Assembly's committee; however, the procedures for doing so were unclear, and it was not possible to ascertain how these inputs were used. Despite available funds to undertake countrywide public engagement, the public consultations were mostly limited to government institutions, few trade unions and a handful of urban-based CSOs. While this represented an improved approach to public policy-making, several CSOs representing key constituents and advocating for the expansion of exemption criteria for insurance premiums to include more vulnerable groups felt excluded from the process. Overload of the National Assembly's legislative schedule and lack of National Assembly committee quorum were cited as reasons for not engaging in countrywide consultations. In conclusion, although there was an intent from the Executive and National Assembly to ensure transparent, participatory and inclusive decision-making, the process fell short in these aspects. These observations should be seen in the context of The Gambia's ongoing democratic transition where institutions for procedural fairness are expected to progressively improve. Learning from this experience to enhance the procedural fairness of decision-making can promote inclusiveness, ownership and sustainability of the NHIS in The Gambia.

Developing the improved Community Health Fund in Tanzania: was it a fair process?

Tanzania developed its 2016-26 health financing strategy to address existing inequities and inefficiencies in its health financing architecture. The strategy suggested the introduction of mandatory national health insurance, which requires long-term legal, interministerial and parliamentary procedures. In 2017/18, improved Community Health Fund (iCHF) was introduced to make short-term improvements in coverage and financial risk protection for the informal sector. Improvements involved purchaser-provider split, portability of services, uniformity in premium and risk pooling at the regional level. Using qualitative methods and drawing on the policy analysis triangle framework (context, content, actors and process) and criteria for procedural fairness, we examined the decision-making process around iCHF and the extent to which it met the criteria for a fair process. Data collection involved a document review and key informant interviews (n = 12). The iCHF reform was exempt from following the mandatory legislative procedures, including processes for involving the public, for policy reforms in Tanzania. The Ministry of Health, leading the process, formed a technical taskforce to review evidence, draw lessons from pilots and develop plans for implementing iCHF. The taskforce included representatives from ministries, civil society organizations and CHF implementing partners with experience in running iCHF pilots. However, beneficiaries and providers were not included in these processes. iCHF was largely informed by the evidence from pilots and literature, but the evidence to reduce administrative cost by changing the oversight role to the National Health Insurance Fund was not taken into account. Moreover, the iCHF process lacked transparency beyond its key stakeholders. The iCHF reform provided a partial solution to fragmentation in the health financing system in Tanzania by expanding the pool from the district to regional level. However, its decision-making process underscores the significance of giving greater consideration to procedural fairness in reforms guided by technical institutions, which can enhance responsiveness, legitimacy and implementation.

Procedural fairness and the resilience of health financing reforms in Ukraine.

In 2017, Ukraine's Parliament passed legislation establishing a single health benefit package for the entire population called the Programme of Medical Guarantees, financed through general taxes and administered by a single national purchasing agency. This legislation was in line with key principles for financing universal health coverage. However, health professionals and some policymakers have been critical of elements of the reform, including its reliance on general taxes as the source of funding. Using qualitative methods and drawing on deliberative democratic theory and criteria for procedural fairness, this study argues that the acceptance and sustainability of these reforms could have been strengthened by making the decision-making process fairer. It suggests that three factors limited the extent of stakeholders' participation in this process: first, a perception among reformers that fast-paced decision-making was required because there was only a short political window for much needed reforms; second, a lack of trust among reformers in the motives, representativeness, and knowledge of some stakeholders; and third, an under-appreciation of the importance of dialogic engagement with the public. These findings highlight a profound challenge for policymakers. In retrospect, some of those involved in the reform's design and implementation believe that a more meaningful engagement with the public and stakeholders who opposed the reform might have strengthened its legitimacy and durability. At the same time, the study shows how difficult it is to have an inclusive process in settings where some actors may be driven by unconstrained self-interest or lack the capacity to be representative or knowledgeable interlocutors. It suggests that investments in deliberative capital (the attitudes and behaviours that facilitate good deliberation) and in civil society capacity may help overcome this difficulty.

Criteria for the procedural fairness of health financing decisions: a scoping review.

Due to constraints on institutional capacity and financial resources, the road to universal health coverage (UHC) involves difficult policy choices. To assist with these choices, scholars and policy makers have done extensive work on criteria to assess the substantive fairness of health financing policies: their impact on the distribution of rights, duties, benefits and burdens on the path towards UHC. However, less attention has been paid to the procedural fairness of health financing decisions. The Accountability for Reasonableness Framework (A4R), which is widely applied to assess procedural fairness, has primarily been used in priority-setting for purchasing decisions, with revenue mobilization and pooling receiving limited attention. Furthermore, the sufficiency of the A4R framework's four criteria (publicity, relevance, revisions and appeals, and enforcement) has been questioned. Moreover, research in political theory and public administration (including deliberative democracy), public finance, environmental management, psychology, and health financing has examined the key features of procedural fairness, but these insights have not been synthesized into a comprehensive set of criteria for fair decision-making processes in health financing. A systematic study of how these criteria have been applied in decision-making situations related to health financing and in other areas is also lacking. This paper addresses these gaps through a scoping review. It argues that the literature across many disciplines can be synthesized into 10 core criteria with common philosophical foundations. These go beyond A4R and encompass equality, impartiality, consistency over time, reason-giving, transparency, accuracy of information, participation, inclusiveness, revisability and enforcement. These criteria can be used to evaluate and guide decision-making processes for financing UHC across different country income levels and health financing arrangements. The review also presents examples of how these criteria have been applied to decisions in health financing and other sectors.

Evidence-Informed Deliberative Processes for UHC: Progress, Potential and Prudence Comment on "Evidence-Informed Deliberative Processes for Health Benefit Package Design - Part II: A Practical Guide".

In their recent article on evidence-informed deliberative processes (EDPs) for health benefit package decisions, Oortwijn et al examine how the different steps of EDP play out in eight countries with relatively mature institutions for using health technology assessment (HTA). This commentary examines how EDP addresses stakeholder involvement in decision-making for equitable progress towards universal health coverage (UHC). It focuses on the value of inclusiveness, the need to pay attention to trade-offs between desirable features of EDP and the need to broaden the scope of processes examined beyond those specifically tied to producing and using HTAs . It concludes that EDPs have contributed to significant progress for health benefit design decisions worldwide and holds much potential in further application. At the same time, this commentary calls for prudence: investments in EDPs should be efficiently deployed to enhance the pre-existing legislative, institutional and political framework that exist to promote fair and legitimate healthcare decisions.

Preferences of healthcare workers for provider payment systems in The Gambia's National Health Insurance Scheme.

BACKGROUND: The Government of The Gambia introduced a national health insurance scheme (NHIS) in 2021 to promote universal health coverage (UHC). Provider payment systems (PPS) are strategic purchasing arrangements that can enhance provider performance, accountability, and efficiency in the NHIS. This study assessed healthcare workers' (HCWs') preferences for PPS across major service areas in the NHIS. METHODS: A facility-based cross-sectional study was conducted using a probability proportionate to size sampling technique to select an appropriate sample size. Health care workers were presented with options for PPS to choose from across major service areas. Descriptive statistics explored HCW socio-demographic and health service characteristics. Multinomial logistic regressions were used to assess the association between these characteristics and choices of PPS. RESULTS: The majority of HCW did not have insurance coverage, but more than 60% of them were willing to join and pay for the NHIS. Gender, professional cadre, facility level, and region influenced HCW's preference for PPS across the major service areas. The preferred PPS varied among HCW depending on the service area, with capitation being the least preferred PPS across all service areas. CONCLUSION: The National Health Insurance Authority (NHIA) needs to consider HCW's preference for PPS and factors that influence their preferences when choosing various payment systems. Strategic purchasing decisions should consider the incentives these payment systems may create to align incentives to guide provider behaviour towards UHC. The findings of this study can inform policy and decision-makers on the right mix of PPS to spur provider performance and value for money in The Gambia's NHIS.

The role of drug regulatory authorities and health technology assessment agencies in shaping incentives for antibiotic R&D: a qualitative study.

BACKGROUND: Few antibiotics have entered the market in recent years despite the need for new treatment options. Some of the challenges of bringing new antibiotics to market are linked to the marketing authorization and health technology assessment (HTA) processes. Research shows great variation in geographic availability of new antibiotics, suggesting that market introduction of new antibiotics is unpredictable. We aimed to investigate regulatory authorities' and HTA agencies' role in developing non-financial incentives to stimulate antibiotic research and development (R&D). METHODS: We conducted individual, semi-structured, stakeholder interviews. Participants were recruited from regulatory authorities (EMA and FDA) and HTA agencies in Europe. Participants had to be experienced with assessment of antibiotics. The data were analyzed using a deductive and inductive approach to develop codes and identify key themes. Data were analyzed using thematic analysis including the constant comparison method to define concepts, and rival thinking to identify alternative explanations. RESULTS: We found that (1) interpretation of key concepts guiding the understanding of what type of antibiotics are needed vary (2) lack of a shared approach on how to deal with limited clinical data in the marketing authorization and HTA processes is causing barriers to getting new antibiotics to market (3) necessary adaptations to the marketing authorization process causes uncertainties that transmit to other key stakeholders involved in delivering antibiotics to patients. CONCLUSIONS: A shared understanding of limited clinical data and how to deal with this issue is needed amongst stakeholders involved in antibiotic R&D, marketing authorization, and market introduction to ensure antibiotics reach the market before resistance levels are out of control. Regulatory authorities and HTA agencies could play an active role in aligning the view of what constitutes an unmet medical need, and direct new economic models towards stimulating greater diversity in the antibiotic armamentarium.

Willingness to pay for a National Health Insurance Scheme in The Gambia: a contingent valuation study.

In pursuit of universal health coverage, many low- and middle-income countries are reforming their health financing systems and introducing health insurance schemes. As part of these reforms, lawmakers in The Gambia enacted 'The National Health Insurance Bill, 2021'. The Act will establish a National Health Insurance Scheme (NHIS) that pays for the cost of healthcare services for its members. This study assessed Gambians' willingness to pay (WTP) for a NHIS. Using multistage sampling design with no replacement, head/co-head of households were presented with a hypothetical health insurance scheme from July to August 2020. Their WTP and factors influencing WTP were elicited using a contingent valuation method. Descriptive statistics were used to describe sample characteristics. Lopez-Feldman's modified ordered probit model and linear regression were applied to estimate respondents' WTP as well as identify factors that influence their WTP. More than 90% of the respondents-677 (94.4%) were willing to join and pay for the scheme. Half of these respondents-398 (58.8%) agreed to pay the first bid of US dollars (US$) 20.78 or Gambian dalasi (GMD) 1000. The average WTP was estimated at US$23.27 (GMD1119.82), whereas average maximum amount to pay was US$26.01 (GMD1251.16). Results of the two models together showed that gender, level of education and household income were statistically significant, with the latter showing negative influence on WTP. The study found that Gambians were largely receptive to the scheme and have stated their willingness to contribute. Our findings can inform policymakers in The Gambia and other sub-Saharan countries when establishing contribution rates and exemption criteria during social health insurance scheme implementation.

Climate Change, Community Action, and Health in the Anglophone Caribbean: A Scoping Review.

Objective: This scoping review investigates the status of research focusing on the nexus of community action, climate change, and health and wellbeing in anglophone Caribbean Small Island Developing States (SIDS). Methods: This review was guided by Arksey and O'Malley framework and utilized the PRISMA-ScR checklist. We searched Medline/OVID, PsychInfo, VHL, Sociological Abstracts, Google Scholar, and Scopus to capture interdisciplinary studies published from 1946 to 2021. Results: The search yielded 3,828 records of which fourteen studies met the eligibility criteria. The analysis assessed study aim, geographic focus, community stakeholders, community action, climate perspective, health impact, as well as dimensions including resources/assets, education/information, organization and governance, innovation and flexibility, and efficacy and agency. Nearly all studies were case studies using mixed method approaches involving qualitative and quantitative data. Community groups organized around focal areas related to fishing, farming, food security, conservation, and the environment. Conclusion: Despite the bearing these areas have on public health, few studies explicitly examine direct links between health and climate change. Research dedicated to the nexus of community action, climate change, and health in the anglophone Caribbean warrants further study.

National adaptation and implementation of WHO Model List of Essential Medicines: A qualitative evidence synthesis.

BACKGROUND: The World Health Organization Model List of Essential Medicines (WHO EML) has played a critical role in guiding the country-level selection and financing of medicines for more than 4 decades. It continues to be a relevant evidence-based policy that can support universal health coverage (UHC) and access to essential medicines. The objective of this review was to identify factors affecting adaptation and implementation of WHO EML at the national level. METHODS AND FINDINGS: We conducted a qualitative evidence synthesis by searching 10 databases (including CINAHL, Embase, Ovid MEDLINE, Scopus, and Web of Science) through October 2021. Primary qualitative studies focused on country-level implementation of WHO EML were included. The qualitative findings were populated in the Supporting the Use of Research Evidence (SURE) framework, and key themes were identified through an iterative process. We appraised the papers using the Critical Appraisal Skills Programme (CASP) tool and assessed our confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation working group-Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual). We screened 1,567 unique citations, reviewed 183 full texts, and included 23 studies, from 30 settings. Non-English studies and experiences and perceptions of stakeholders published in gray literature were not collected. Our findings centered around 3 main ideas pertaining to national adaptation and implementation of WHO EML: (1) the importance of designing institutions, governance, and leadership for national medicines lists (NMLs), particularly the consideration of transparency, coordination capacity, legislative mechanisms, managing regional differences, and clinical guidance; (2) the capacity to manage evidence to inform NML updates, including processes for contextualizing global evidence, utilizing local data and expert knowledge, and assessing budget impact, to which locally relevant cost-effectiveness information plays an important role; and (3) the influence of NML on purchasing and prescribing by altering provider incentives, through linkages to systems for financing and procurement and donor influence. CONCLUSIONS: This qualitative evidence synthesis underscores the complexity and interdependencies inherent to implementation of WHO EML. To maximize the value of NMLs, greater investments should be made in processes and institutions that are needed to support various stages of the implementation pathway from global norms to adjusting prescribed behavior. Moreover, further research on linkages between NMLs, procurement, and the availability of medicines will provide additional insight into optimal NML implementation. PROTOCOL REGISTRY: PROSPERO CRD42018104112.

Avoiding health technology assessment: a global survey of reasons for not using health technology assessment in decision making.

INTRODUCTION: Despite the documented benefits of using health technology assessments (HTA) to inform resource allocation in health care systems, HTA remains underused, especially in low- and middle-income countries. A survey of global health practitioners was conducted to reveal the top reasons ("excuses") that they had heard from colleagues, policymakers or other stakeholders for not using HTA in their settings. METHODS: There were 193 respondents to the survey. Most responses were from individuals in research organisations (37%), ministries of health (27%) and other government agencies (14%). Participants came from Southeast Asia (40%), the Western Pacific (30%), Africa (15%), Europe (7%), the Americas (7%) and the Eastern Mediterranean region (2%). RESULTS: The top five reasons encountered by respondents related to lack of data, lack of technical skills for HTA, the technocratic nature of the work, the lack of explicit decision rules and the perception that HTA puts a "price on life". CONCLUSIONS: This study aimed to understand and address the top reasons for not using HTA. They fall into three categories: (1) misconceptions about HTA; (2) feasibility issues; and (3) values, attitudes and politics. Previous literature has shown that these reasons can be addressed when identified, and even imperfect HTA analyses can provide useful information to a decision-maker.

Evaluations of public health interventions produced by health technology assessment agencies: A mapping review and analysis by type and evidence content.

OBJECTIVES: Health technology assessments (HTAs) have been suggested as a strategy to bridge the evidence-to-policy gap in public health. It is unclear to what extent HTAs have been prepared to assist decisions to implement public health interventions (PHIs). We aimed to describe the experience of HTA agencies by mapping, classifying, and analyzing the evidence content of HTAs of PHIs. METHODS: We systematically searched databases of 35 HTA agencies from 18 countries for evaluations of PHIs between 2008-2018. Interventions were classified using the International Classification of Health Interventions and the evidence content analysed with the INAHTA Product-Type-mark checklist. RESULTS: Only 1010 (9%) of HTAs were on PHIs. 500 (50%) publications targeted Body Systems and Functions, 302 (30%) Health-related Behaviours, 137 (14%) the Environment and 44 (4%) Activities and Participation Domains. Out of 734 publications perused, few met the criteria of full-HTAs (71;10%) or mini-HTAs (110;15%). Most were rapid reviews (420;57%). 72% of all reports came from only 6 countries. CONCLUSION: HTAs on PHIs were uncommon relative to clinical interventions. HTAs on population-based PHIs were less comprehensive in quality and rigor of the evidence. Countries with more resources and mature HTA-systems had done the most evaluations. Exploring the experiences of forerunners could help overcome barriers to evaluations of PHIs and exploit the full potential of HTAs to promote evidence-based public health.

Promoting Intersectoral Collaboration Through the Evaluations of Public Health Interventions: Insights From Key Informants in 6 European Countries.

BACKGROUND: Intersectoral collaboration is critical to the successful implementation of many public health interventions (PHIs). Little attention has been paid to whether and how processes at the stage of evaluation can promote intersectoral collaboration. The objective of this study was to examine European experiences and views on whether and how the evaluation of PHIs promote intersectoral collaboration. METHODS: A qualitative study design was used. We conducted semi-structured interviews with 15 individuals centrally involved in the evaluation of PHIs in 6 European countries (Austria, Denmark, England, Germany, Norway, and Switzerland). Questions pertained to current processes for evaluating PHIs in the country and current and potential strategies for promoting intersectoral collaboration. Transcripts were analyzed using thematic analysis to identify key themes responding to our primary objective. RESULTS: Experiences with promoting intersectoral collaboration through the evaluation of PHIs could be summarized in 4 themes: (1) Early involvement of non-health sectors in the evaluative process and inclusion of non-health benefits can promote intersectoral collaboration, but should be combined with greater influence of these sectors in shaping PHIs; (2) Harmonization of methodological approaches may enable comparison of results and facilitate intersectoral collaboration, but should not be an overriding goal; (3) Involvement in health impact assessments (HIAs) can promote intersectoral collaboration, but needs to be incentivized and be conducted without putting overwhelming demands on non-health sectors; (4) A designated body for evaluating PHIs may promote intersectoral collaboration, but its design needs to take account of realities of policy-making. CONCLUSION: The full potential for promoting intersectoral collaboration through the evaluation of PHIs appears currently unrealized in the settings we studied. To further promote intersectoral collaboration, evaluators and decision-makers may consider the full range of strategies characterized in this study. This may be most effective if the strategies are deployed so that they reinforce each other, value outcomes beyond health, and are tailored to maximize political priority for PHIs across sectors.

Evidence-Informed Deliberative Processes for HTA Around the Globe: Exploring the Next Frontiers of HTA and Best Practices Comment on "Use of Evidence-informed Deliberative Processes by Health Technology Assessment Agencies Around the Globe".

This comment reflects on an article by Oortwijn, Jansen, and Baltussen about the use and features of 'evidence-informed deliberative processes' (EDPs) among health technology assessment (HTA) agencies around the world and the need for more guidance. First, we highlight procedural aspects that are relevant across key steps of EDP, focusing on conflict of interest, the different roles of stakeholders throughout a HTA and public justification of decisions. Second, we discuss new knowledge and models needed to maximize the value of deliberative processes at the expanding frontiers of HTA, paying special attention to when HTA is applied in primary care, employed for public health interventions, and is produced through international collaboration.