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.

Healthcare workers' informal uses of mobile phones and other mobile devices to support their work: a qualitative evidence synthesis.

BACKGROUND: Healthcare workers sometimes develop their own informal solutions to deliver services. One such solution is to use their personal mobile phones or other mobile devices in ways that are unregulated by their workplace. This can help them carry out their work when their workplace lacks functional formal communication and information systems, but it can also lead to new challenges. OBJECTIVES: To explore the views, experiences, and practices of healthcare workers, managers and other professionals working in healthcare services regarding their informal, innovative uses of mobile devices to support their work. SEARCH METHODS: We searched MEDLINE, Embase, CINAHL and Scopus on 11 August 2022 for studies published since 2008 in any language. We carried out citation searches and contacted study authors to clarify published information and seek unpublished data. SELECTION CRITERIA: We included qualitative studies and mixed-methods studies with a qualitative component. We included studies that explored healthcare workers' views, experiences, and practices regarding mobile phones and other mobile devices, and that included data about healthcare workers' informal use of these devices for work purposes. DATA COLLECTION AND ANALYSIS: We extracted data using an extraction form designed for this synthesis, assessed methodological limitations using predefined criteria, and used a thematic synthesis approach to synthesise the data. We used the 'street-level bureaucrat' concept to apply a conceptual lens to our findings and prepare a line of argument that links these findings. We used the GRADE-CERQual approach to assess our confidence in the review findings and the line-of-argument statements. We collaborated with relevant stakeholders when defining the review scope, interpreting the findings, and developing implications for practice. MAIN RESULTS: We included 30 studies in the review, published between 2013 and 2022. The studies were from high-, middle- and low-income countries and covered a range of healthcare settings and healthcare worker cadres. Most described mobile phone use as opposed to other mobile devices, such as tablets. We have moderate to high confidence in the statements in the following line of argument. The healthcare workers in this review, like other 'street-level bureaucrats', face a gap between what is expected of them and the resources available to them. To plug this gap, healthcare workers develop their own strategies, including using their own mobile phones, data and airtime. They also use other personal resources, including their personal time when taking and making calls outside working hours, and their personal networks when contacting others for help and advice. In some settings, healthcare workers' personal phone use, although unregulated, has become a normal part of many work processes. Some healthcare workers therefore experience pressure or expectations from colleagues and managers to use their personal phones. Some also feel driven to use their phones at work and at home because of feelings of obligation towards their patients and colleagues. At best, healthcare workers' use of their personal phones, time and networks helps humanise healthcare. It allows healthcare workers to be more flexible, efficient and responsive to the needs of the patient. It can give patients access to individual healthcare workers rather than generic systems and can help patients keep their sensitive information out of the formal system. It also allows healthcare workers to communicate with each other in more personalised, socially appropriate ways than formal systems allow. All of this can strengthen healthcare workers' relationships with community members and colleagues. However, these informal approaches can also replicate existing social hierarchies and deepen existing inequities among healthcare workers. Personal phone use costs healthcare workers money. This is a particular problem for lower-level healthcare workers and healthcare workers in low-income settings as they are likely to be paid less and may have less access to work phones or compensation. Out-of-hours use may also be more of a burden for lower-level healthcare workers, as they may find it harder to ignore calls when they are at home. Healthcare workers with poor access to electricity and the internet are less able to use informal mobile phone solutions, while healthcare workers who lack skills and training in how to appraise unendorsed online information are likely to struggle to identify trustworthy information. Informal digital channels can help healthcare workers expand their networks. But healthcare workers who rely on personal networks to seek help and advice are at a disadvantage if these networks are weak. Healthcare workers' use of their personal resources can also lead to problems for patients and can benefit some patients more than others. For instance, when healthcare workers store and share patient information on their personal phones, the confidentiality of this information may be broken. In addition, healthcare workers may decide to use their personal resources on some types of patients, but not others. Healthcare workers sometimes describe using their personal phones and their personal time and networks to help patients and clients whom they assess as being particularly in need. These decisions are likely to reflect their own values and ideas, for instance about social equity and patient 'worthiness'. But these may not necessarily reflect the goals, ideals and regulations of the formal healthcare system. Finally, informal mobile phone use plugs gaps in the system but can also weaken the system. The storing and sharing of information on personal phones and through informal channels can represent a 'shadow IT' (information technology) system where information about patient flow, logistics, etc., is not recorded in the formal system. Healthcare workers may also be more distracted at work, for instance, by calls from colleagues and family members or by social media use. Such challenges may be particularly difficult for weak healthcare systems. AUTHORS' CONCLUSIONS: By finding their own informal solutions to workplace challenges, healthcare workers can be more efficient and more responsive to the needs of patients, colleagues and themselves. But these solutions also have several drawbacks. Efforts to strengthen formal health systems should consider how to retain the benefits of informal solutions and reduce their negative effects.

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.

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.

Asylum seekers' health and use of health services in Norway. / Asylsøkeres helse og bruk av helsetjenester i Norge.

BACKGROUND: Many asylum seekers arrived in Norway during autumn 2015, and there has been a call for more knowledge regarding the health of this group. The aim of this exploratory literature review was to investigate the state of knowledge about asylum seekers' health and use of healthcare services in Norway. MATERIAL AND METHOD: We conducted two literature searches for the periods 2007-2017 and 2017-2019 in 12 databases using the keywords 'refugees' and related terms, with a filter for research undertaken in or about Norway and published in Norwegian or English. The title and summary were read first, after which relevant articles were read in full text. Publications concerning asylum seekers in Norway and related to health and/or use of health services were included. RESULTS: A total of 28 publications met the criteria for inclusion: 22 peer-reviewed articles and six reports. The most common topics were mental health and infectious diseases. Other topics that the studies dealt with were nutrition, functional impairment and healthcare services. INTERPRETATION: Little research has been undertaken on asylum seekers' health and use of healthcare services. Research on asylum seekers' health in Norway primarily concerns mental health and infectious diseases, and there is little research on other somatic disorders.

Targeting TB or MRSA in Norwegian municipalities during 'the refugee crisis' of 2015: a framework for priority setting in screening.

IntroductionIn 2015, there was an increase in the number of asylum seekers arriving in Europe. Like in other countries, deciding screening priorities for tuberculosis (TB) and meticillin-resistant Staphylococcus aureus (MRSA) was a challenge. At least five of 428 municipalities chose to screen asylum seekers for MRSA before TB; the Norwegian Institute for Public Health advised against this.AimTo evaluate the MRSA/TB screening results from 2014 to 2016 and create a generalised framework for screening prioritisation in Norway through simulation modelling.MethodsThis is a register-based cohort study of asylum seekers using data from the Norwegian Surveillance System for Communicable Diseases from 2014 to 2016. We used survey data from municipalities that screened all asylum seekers for MRSA and denominator data from the Directorate of Immigration. A comparative risk assessment model was built to investigate the outcomes of prioritising between TB and MRSA in screening regimes.ResultsOf 46,090 asylum seekers, 137 (0.30%) were diagnosed with active TB (notification rate: 300/100,000 person-years). In the municipalities that screened all asylum seekers for MRSA, 13 of 1,768 (0.74%) were found to be infected with MRSA. The model estimated that screening for MRSA would prevent eight MRSA infections while prioritising TB screening would prevent 24 cases of active TB and one death.ConclusionOur findings support the decision to advise against screening for MRSA before TB among newly arrived asylum seekers. The model was an effective tool for comparing screening priorities and can be applied to other scenarios in other countries.

Transcriptomic data from two primary cell models stimulating human monocytes suggest inhibition of oxidative phosphorylation and mitochondrial function by N. meningitidis which is partially up-regulated by IL-10.

BACKGROUND: Biological interpretation of DNA microarray data may differ depending on underlying assumptions and statistical tests of bioinformatics tools used. We used Gene Set Enrichment Analysis (GSEA) and Ingenuity Pathway Analysis (IPA) to analyze previously generated DNA microarray data from human monocytes stimulated with N. meningitidis and IL-10 ("the model system"), and with meningococcal sepsis plasma before and after immunodepletion of IL-10 ("the patient plasma system"). The objectives were to compare if the two bioinformatics methods resulted in similar biological interpretation of the datasets, and to identify whether GSEA provided additional insight compared with IPA about the monocyte host response to meningococcal activation. RESULTS: In both experimental models, GSEA and IPA identified genes associated with pro-inflammatory innate immune activation, including TNF-signaling, Toll-like receptor signaling, JAK-STAT-signaling, and type I and type II interferon signaling. GSEA identified genes regulated by the presence of IL-10 with similar gene sets in both the model system and the patient plasma system. In the model system, GSEA and IPA in sum identified 170 genes associated with oxidative phosphorylation/mitochondrial function to be down-regulated in monocytes stimulated with meningococci. In the patient plasma system, GSEA and IPA in sum identified 122 genes associated with oxidative phosphorylation/mitochondrial dysfunction to be down-regulated by meningococcal sepsis plasma depleted for IL-10. Using IPA, we identified IL-10 to up-regulate 18 genes associated with oxidative phosphorylation/mitochondrial function that were down-regulated by N. meningitidis. CONCLUSIONS: Biological processes associated with the gene expression changes in the model system of meningococcal sepsis were comparable with the results found in the patient plasma system. By combining GSEA with IPA, we discovered an inhibitory effect of N. meningitidis on genes associated with mitochondrial function and oxidative phosphorylation, and that IL-10 partially reverses this strong inhibitory effect, thereby identifying, to our knowledge, yet another group of genes where IL-10 regulates the effect of LPS. We suggest that relying on a single bioinformatics tool together with an arbitrarily chosen filtering criteria for data analysis may result in overlooking relevant biological processes and signaling pathways associated with genes differentially expressed between compared experimental conditions.

Maximising access to achieve appropriate human antimicrobial use in low-income and middle-income countries.

Access to quality-assured antimicrobials is regarded as part of the human right to health, yet universal access is often undermined in low-income and middle-income countries. Lack of access to the instruments necessary to make the correct diagnosis and prescribe antimicrobials appropriately, in addition to weak health systems, heightens the challenge faced by prescribers. Evidence-based interventions in community and health-care settings can increase access to appropriately prescribed antimicrobials. The key global enablers of sustainable financing, governance, and leadership will be necessary to achieve access while preventing excess antimicrobial use.

Delinking Investment in Antibiotic Research and Development from Sales Revenues: The Challenges of Transforming a Promising Idea into Reality.

Kevin Outterson and colleagues outline a model to address access, conservation, and innovation of antibiotics.

Conceptual and institutional gaps: understanding how the WHO can become a more effective cross-sectoral collaborator.

BACKGROUND: Two themes consistently emerge from the broad range of academics, policymakers and opinion leaders who have proposed changes to the World Health Organization (WHO): that reform efforts are too slow, and that they do too little to strengthen WHO's capacity to facilitate cross-sectoral collaboration. This study seeks to identify possible explanations for the challenges WHO faces in addressing the broader determinants of health, and the potential opportunities for working across sectors. METHODS: This qualitative study used a mixed methods approach of semi-structured interviews and document review. Five interviewees were selected by stratified purposive sampling within a sampling frame of approximately 45 potential interviewees, and a targeted document review was conducted. All interviewees were senior WHO staff at the department director level or above. Thematic analysis was used to analyze data from interview transcripts, field notes, and the document review, and data coded during the analysis was analyzed against three central research questions. First, how does WHO conceptualize its mandate in global health? Second, what are the barriers and enablers to enhancing cross-sectoral collaboration between WHO and other intergovernmental organizations? Third, how do the dominant conceptual frames and the identified barriers and enablers to cross-sectoral collaboration interact? RESULTS: Analysis of the interviews and documents revealed three main themes: 1) WHO's role must evolve to meet the global challenges and societal changes of the 21st century; 2) WHO's cross-sectoral engagement is hampered internally by a dominant biomedical view of health, and the prevailing institutions and incentives that entrench this view; and 3) WHO's cross-sectoral engagement is hampered externally by siloed areas of focus for each intergovernmental organization, and the lack of adequate conceptual frameworks and institutional mechanisms to facilitate engagement across siloes. CONCLUSION: There are a number of external and internal pressures on WHO which have created an organizational culture and operational structure that focuses on a narrow, technical approach to global health, prioritizing disease-based, siloed interventions over more complex approaches that span sectors. The broader approach to promoting human health and wellbeing, which is conceptualized in WHO's constitution, requires cultural and institutional changes for it to be fully implemented.

Implementing large-scale programmes to optimise the health workforce in low- and middle-income settings: a multicountry case study synthesis.

OBJECTIVES: To identify factors affecting the implementation of large-scale programmes to optimise the health workforce in low- and middle-income countries. METHODS: We conducted a multicountry case study synthesis. Eligible programmes were identified through consultation with experts and using Internet searches. Programmes were selected purposively to match the inclusion criteria. Programme documents were gathered via Google Scholar and PubMed and from key informants. The SURE Framework - a comprehensive list of factors that may influence the implementation of health system interventions - was used to organise the data. Thematic analysis was used to identify the key issues that emerged from the case studies. RESULTS: Programmes from Brazil, Ethiopia, India, Iran, Malawi, Venezuela and Zimbabwe were selected. Key system-level factors affecting the implementation of the programmes were related to health worker training and continuing education, management and programme support structures, the organisation and delivery of services, community participation, and the sociopolitical environment. CONCLUSIONS: Existing weaknesses in health systems may undermine the implementation of large-scale programmes to optimise the health workforce. Changes in the roles and responsibilities of cadres may also, in turn, impact the health system throughout.

Why were so few randomized trials of public health and social measures conducted during the COVID-19 pandemic? The Norwegian experience.

BACKGROUND: Few randomized trials of public health and social measures were carried out during the COVID-19 pandemic. We report on the major barriers we faced when we tried to run such trials. METHODS: We reviewed all randomized trials proposed and initiated by the Centre for Epidemic Interventions Research in Norway during the COVID-19 pandemic. RESULTS: Of the 18 proposed trials, 11 trials were not implemented. One of the key legal and ethical barriers to conducting the trials was the Norwegian Health Research Act, which demands informed consent from all participants who are exposed to an intervention. A lack of sufficient political support was also a challenge, as was unpredictability, due to shifting disease incidence and changing recommendations from the authorities. CONCLUSION: Strengthening the evidence base for public health and social measures in pandemics will require political and public understanding and support and a legal framework that allows for the conduct of such trials.

Educational inequalities and self-reported health among men and women aged 18-49 years in Yangon Region, Myanmar: analysis of a population-based, cross-sectional study.

OBJECTIVES: To estimate the prevalence of good self-reported health (SRH) in subpopulations based on the social determinants of health and to investigate the association between education (measured in years of schooling) and good SRH among men and women aged 18-49 years in Yangon Region, Myanmar. DESIGN: Analysis of data from a population-based, cross-sectional study conducted in Yangon, Myanmar, from October to November 2016. A multistage sampling procedure was employed, and structured face-to-face interviews were conducted with standardised questions adapted from the Myanmar Demographic and Health Survey. Prevalence ratios (PRs) with 95% CIs were estimated using Poisson regression analyses by sex. SETTING: Urban and rural areas of Yangon Region, Myanmar. PARTICIPANTS: The sample included 2,506 participants (91.8% response rate) aged 18-49 years and excluded nuns, monks, soldiers, institutionalised people and individuals deemed too ill physically and/or mentally to participate. RESULTS: The prevalence of good SRH was 61.2% (95% CI 59.3 to 63.1), with higher rates among men (72.0%, 95% CI 69.3 to 74.5), younger individuals (69.2%, 95% CI 66.2 to 72.1), urban residents (63.6%, 95% CI 60.8 to 66.3), extended family dwellers (66.6%, 95% CI 63.7 to 69.4) and those with a higher level of education (66.0%, 95% CI 61.3 to 70.5). After adjusting for confounders (age and area of residence), the association between years of schooling and SRH (PR) was 1.01 (95% CI 1.01 to 1.02, p=0.002) in men and 1.01 (95% CI 0.99 to 1.02, p=0.415) in women. CONCLUSIONS: Good SRH was more prevalent among men than among women. Additionally, a 1-year increase in education was associated with a 1% increase in the prevalence of good SRH among men, whereas the association was not statistically significant among women. In order to enhance the educational benefits of health in Myanmar, we recommend a higher focus on the length of education and addressing gender inequalities in wage return from education.

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.

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.

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.