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1.
Soc Sci Med ; 348: 116689, 2024 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-38564956

RESUMO

The objective of this paper is to integrate Urban Political Ecology (UPE) as a theory for identifying under-exposed urban dimensions of Antimicrobial Resistance (AMR). A UPE lens allows us to conceptualize urbanization as a ubiquitous socio-ecological process and an interpretive frame that could inform AMR governance strategies across related contexts by: a) situating AMR risks in relation to urbanization processes shaping social and political co-determinants of such systemic threats as climate change; b) aligning UPE scholarship with One Health (OH) approaches that address AMR to reveal the under-exposed link of AMR to environmental threats and broader structural dimensions that influence these threats; and c) identifying shared AMR and environmental governance pathways that inform the rationale for more equitable governance arrangements. We delineate a context in which the speed and scale of human activity in the larger context of urbanization, driven by global market integration strategies, impacts human-animal-environmental health threats such as AMR. We demonstrate how UPE scholarship can be leveraged to offer theoretical depth to approaches considering the interdependencies of AMR and climate change threats. We then propose a strategic approach focused on identifying shared governance pathways and intersectoral accountability frameworks to address upstream structural drivers of AM-Environmental threats. The co-benefits of a UPE-informed framework to human-animal-environmental health that leverages enabling policy environments to foster a more collaborative, equitable and sustainable approach to address systemic global health threats are clarified. Just as the concept of "health in all policies" emphasized taking health implications into account in all public policy development, the integration of UPE in AMR governance arrangements would emphasize the need to take other sectors into account through an intersectoral whole-of-government approach that fosters shared AMR - climate change governance pathways.

2.
Global Health ; 19(1): 82, 2023 11 08.
Artigo em Inglês | MEDLINE | ID: mdl-37940941

RESUMO

BACKGROUND: Emerging infectious diseases of zoonotic origin present a critical threat to global population health. As accelerating globalisation makes epidemics and pandemics more difficult to contain, there is a need for effective preventive interventions that reduce the risk of zoonotic spillover events. Public policies can play a key role in preventing spillover events. The aim of this review is to identify and describe evaluations of public policies that target the determinants of zoonotic spillover. Our approach is informed by a One Health perspective, acknowledging the inter-connectedness of human, animal and environmental health. METHODS: In this systematic scoping review, we searched Medline, SCOPUS, Web of Science and Global Health in May 2021 using search terms combining animal health and the animal-human interface, public policy, prevention and zoonoses. We screened titles and abstracts, extracted data and reported our process in line with PRISMA-ScR guidelines. We also searched relevant organisations' websites for evaluations published in the grey literature. All evaluations of public policies aiming to prevent zoonotic spillover events were eligible for inclusion. We summarised key data from each study, mapping policies along the spillover pathway. RESULTS: Our review found 95 publications evaluating 111 policies. We identified 27 unique policy options including habitat protection; trade regulations; border control and quarantine procedures; farm and market biosecurity measures; public information campaigns; and vaccination programmes, as well as multi-component programmes. These were implemented by many sectors, highlighting the cross-sectoral nature of zoonotic spillover prevention. Reports emphasised the importance of surveillance data in both guiding prevention efforts and enabling policy evaluation, as well as the importance of industry and private sector actors in implementing many of these policies. Thoughtful engagement with stakeholders ranging from subsistence hunters and farmers to industrial animal agriculture operations is key for policy success in this area. CONCLUSION: This review outlines the state of the evaluative evidence around policies to prevent zoonotic spillover in order to guide policy decision-making and focus research efforts. Since we found that most of the existing policy evaluations target 'downstream' determinants, additional research could focus on evaluating policies targeting 'upstream' determinants of zoonotic spillover, such as land use change, and policies impacting infection intensity and pathogen shedding in animal populations, such as those targeting animal welfare.


Assuntos
Doenças Transmissíveis Emergentes , Zoonoses , Animais , Humanos , Zoonoses/prevenção & controle , Zoonoses/epidemiologia , Doenças Transmissíveis Emergentes/prevenção & controle , Saúde Global , Formulação de Políticas , Políticas
3.
Artigo em Inglês | MEDLINE | ID: mdl-37947556

RESUMO

Rwanda is the first African country to implement a national HPV vaccination program in 2011. This study sought to clarify the HPV vaccination policymaking process in Rwanda through the lens of Kingdon's multiple stream framework and Foucault's concept of governmentality. Perspectives of policymakers engaged in HPV vaccination policy were gathered from published sources, along with key informant interviews. Rwanda's track record of successful vaccination programs enabled by a culture of local accountability created public and private sector incentives. Effective stakeholder engagement, health priority setting, and resource mobilization garnered locally and through international development aid, reflect indicators of policy success. The national HPV policymaking process in Rwanda unfolded in a relatively cohesive and stable policy network. Although peripheral stakeholder resistance and a constrained national budget can present a threat to policy survival, the study shows that such factors as the engagement of policy entrepreneurs within a policy network, private sector incentives, and international aid were effective in ensuring policy resolution.


Assuntos
Infecções por Papillomavirus , Humanos , Ruanda , Formulação de Políticas , África , Vacinação
4.
Lancet Planet Health ; 7(4): e336-e345, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-37019574

RESUMO

Although ideas about preventive actions for pandemics have been advanced during the COVID-19 crisis, there has been little consideration for how they can be operationalised through governance structures within the context of the wildlife trade for human consumption. To date, pandemic governance has mostly focused on outbreak surveillance, containment, and response rather than on avoiding zoonotic spillovers in the first place. However, given the acceleration of globalisation, a paradigm shift towards prevention of zoonotic spillovers is warranted as containment of outbreaks becomes unfeasible. Here, we consider the current institutional landscape for pandemic prevention in light of ongoing negotiations of a so-called pandemic treaty and how prevention of zoonotic spillovers from the wildlife trade for human consumption could be incorporated. We argue that such an institutional arrangement should be explicit about zoonotic spillover prevention and focus on improving coordination across four policy domains, namely public health, biodiversity conservation, food security, and trade. We posit that this pandemic treaty should include four interacting goals in relation to prevention of zoonotic spillovers from the wildlife trade for human consumption: risk understanding, risk assessment, risk reduction, and enabling funding. Despite the need to keep political attention on addressing the current pandemic, society cannot afford to miss the opportunity of the current crisis to encourage institution building for preventing future pandemics.


Assuntos
COVID-19 , Animais , Humanos , COVID-19/epidemiologia , Pandemias/prevenção & controle , Comércio de Vida Silvestre , Zoonoses/epidemiologia , Saúde Pública
6.
One Health Outlook ; 4(1): 2, 2022 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-35033197

RESUMO

BACKGROUND: Over the past decade, 70% of new and re-emerging infectious disease outbreaks in East Africa have originated from the Congo Basin where Rwanda is located. To respond to these increasing risks of disastrous outbreaks, the government began integrating One Health (OH) into its infectious disease response systems in 2011 to strengthen its preparedness and contain outbreaks. The strong performance of Rwanda in responding to the on-going COVID-19 pandemic makes it an excellent example to understand how the structure and principles of OH were applied during this unprecedented situation. METHODS: A rapid environmental scan of published and grey literature was conducted between August and December 2020, to assess Rwanda's OH structure and its response to the COVID-19 pandemic. In total, 132 documents including official government documents, published research, newspaper articles, and policies were analysed using thematic analysis. RESULTS: Rwanda's OH structure consists of multidisciplinary teams from sectors responsible for human, animal, and environmental health. The country has developed OH strategic plans and policies outlining its response to zoonotic infections, integrated OH into university curricula to develop a OH workforce, developed multidisciplinary rapid response teams, and created decentralized laboratories in the animal and human health sectors to strengthen surveillance. To address COVID-19, the country created a preparedness and response plan before its onset, and a multisectoral joint task force was set up to coordinate the response to the pandemic. By leveraging its OH structure, Rwanda was able to rapidly implement a OH-informed response to COVID-19. CONCLUSION: Rwanda's integration of OH into its response systems to infectious diseases and to COVID-19 demonstrates the importance of applying OH principles into the governance of infectious diseases at all levels. Rwanda exemplifies how preparedness and response to outbreaks and pandemics can be strengthened through multisectoral collaboration mechanisms. We do expect limitations in our findings due to the rapid nature of our environmental scan meant to inform the COVID-19 policy response and would encourage a full situational analysis of OH in Rwanda's Coronavirus response.

7.
Global Health ; 17(1): 128, 2021 11 06.
Artigo em Inglês | MEDLINE | ID: mdl-34742296

RESUMO

BACKGROUND: A special session of the World Health Assembly (WHA) will be convened in late 2021 to consider developing a WHO convention, agreement or other international instrument on pandemic preparedness and response - a so-called 'Pandemic Treaty'. Consideration is given to this treaty as well as to reform of the International Health Regulations (IHR) as our principal governing instrument to prevent and mitigate future pandemics. MAIN BODY: Reasons exist to continue to work with the IHR as our principal governing instrument to prevent and mitigate future pandemics. All WHO member states are party to it. It gives the WHO the authority to oversee the collection of surveillance data and to issue recommendations on trade and travel advisories to control the spread of infectious diseases, among other things. However, the limitations of the IHR in addressing the deep prevention of future pandemics also must be recognized. These include a lack of a regulatory framework to prevent zoonotic spillovers. More advanced multi-sectoral measures are also needed. At the same time, a pandemic treaty would have potential benefits and drawbacks as well. It would be a means of addressing the gross inequity in global vaccine distribution and other gaps in the IHR, but it would also need more involvement at the negotiation table of countries in the Global South, significant funding, and likely many years to adopt. CONCLUSIONS: Reform of the IHR should be undertaken while engaging with WHO member states (and notably those from the Global South) in discussions on the possible benefits, drawbacks and scope of a new pandemic treaty. Both options are not mutually exclusive.


Assuntos
Regulamento Sanitário Internacional , Pandemias , Saúde Global , Humanos , Cooperação Internacional , Pandemias/prevenção & controle , Organização Mundial da Saúde
8.
Soc Sci Med ; 256: 113007, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32464418

RESUMO

Within international healthcare systems the neglect of mental health and challenge in shifting from institutional to community care have been recurrent themes. In analysing the challenges, we focus on the case study of Canada by exploring the manner in which health law and policy evolved to inhibit community-based mental healthcare, and compare the resulting funding landscape from an international perspective. The historical institutionalist analysis draws on the literature and healthcare finance data. As a spending statute, the Canada Health Act defines the terms on which the federal government finances publicly insured provincial healthcare. Despite the goal to support physical and mental well-being by removing financial barriers to access health services, exclusion of community care offered by non-physicians (such as psychotherapy) from the terms of the Act inhibited its fulfilment. Diminished federal transfers deepened the disincentive for provinces to establish community care: mental health declined from 11 to 7 percent of provincial healthcare spending from 1979 to 2014. Governance oversight was passed to provinces whose competing demands on diminished resources limited their capacity to extend care. Accountability was found fragmented as neither government stepped-in to ensure the continuum of care, even as federal transfers were restored and evidence of cost-effectiveness grew. Although American and Canadian funding patterns are similar, other OECD countries invest between 13 and 18 percent of healthcare expenditures on mental health. Lessons from the Canadian case are the manner in which its federal structure and intergovernmental dynamics shaped health policy, and the importance of ensuring representation from a range of perspectives in policy development. Federal financial incentives were also found to profoundly impact the expansion of community-based mental healthcare. Evidence shows that public insurance for community supports would reduce healthcare expenditures and employer productivity loss, resulting in savings of $255 billion over 30 years.


Assuntos
Atenção à Saúde , Serviços de Saúde Mental , Canadá , Gastos em Saúde , Humanos , Responsabilidade Social
9.
Artigo em Inglês | MEDLINE | ID: mdl-31817581

RESUMO

With the rapid rise of fast food consumption in Canada, Ontario was the first province to legislate menu labelling requirements via the enactment of the Healthy Menu Choice Act (HMCA). As the news media plays a significant role in policy debates and the agenda for policymakers and the public, the purpose of this mixed-methods study was to clarify the manner in which the news media portrayed the strengths and critiques of the Act, and its impact on members of the community, including consumers and stakeholders. Drawing on data from Canadian regional and national news outlets, the major findings highlight that, although the media reported that the HMCA was a positive step forward, this was tempered by critiques concerning the ineffectiveness of using caloric labelling as the sole measure of health, and its predicted low impact on changing consumption patterns on its own. Furthermore, the news media were found to focus accountability for healthier eating choices largely on the individual, with very little consideration of the role of the food industry or the social and structural determinants that affect food choice. A strong conflation of health, weight and calories was apparent, with little acknowledgement of the implications of menu choice for chronic illness. The analysis demonstrates that the complex factors associated with food choice were largely unrecognized by the media, including the limited extent to which social, cultural, political and corporate determinants of unhealthy choices were taken into account as the legislation was developed. Greater recognition of these factors by the media concerning the HMCA may evoke more meaningful and long-term change for health and food choices.


Assuntos
Dieta Saudável , Fast Foods , Rotulagem de Alimentos/legislação & jurisprudência , Restaurantes/legislação & jurisprudência , Comportamento de Escolha , Ingestão de Energia , Feminino , Preferências Alimentares , Humanos , Masculino , Ontário
10.
Front Psychiatry ; 10: 61, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30837903

RESUMO

Background: Societal capacity to address the service needs of persons with concurrent mental health and substance-use disorders has historically been challenging given a traditionally siloed approach to mental health and substance-use care. As different approaches to care for persons with concurrent disorders emerge, a limited understanding of current models prevails. The goal of this paper is to explore these challenges along with promising models of coordinated care across Canadian provinces. Materials and methods: A scoping review of policies, service coordination and access issues was undertaken involving a review of the formal and gray literature from 2000 to 2018. The scoping review was triangulated by an analysis of provincial auditor general reports. Results: Models of concurrent disorders service were found to have evolved unevenly. Challenges related to the implementation of models of collaborative care and local networks that foster service coordination and policy accountability were found to inhibit integrated care. Conclusion: Emergent models of coordinated care were found to include collaborative care, regional networks with centralized access to care, clinical information-sharing, cross-training, improved scope of care to include psychologists and alignment of physician incentives with patient needs to better support patient care.

11.
Global Health ; 14(1): 86, 2018 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-30134929

RESUMO

BACKGROUND: As a transnational policy network, the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aligns international regulatory standards to address the pressures of globalization on the pharmaceutical industry and increase access to new medicines. Founding ICH members include regulators and pharmaceutical industry trade associations in the European Union, the United States and Japan. In this paper we explore the manner in which state interdependence fosters the conditions for regulatory harmonization by tracing the underlying parallels between ICH and member state pharmacogovernance to clarify emergent patterns in regulatory policy convergence. RESULTS: A shift to the life cycle approach to pharmaceutical regulation corresponded with international convergence in pre-market standards as emphasis shifted to post-market standards where convergence remains unresolved. Transnational pharmacogovernance was found to concentrate regulatory authority within a co-regulatory model of bilateral negotiation with pharmaceutical trade associations in defining safety and efficacy standards. Given a context of state interdependence, parallels were found between transnational and ICH member pharmacogovernance modes that guide policy development. Divergent modes of state regulatory governance that re-calibrate perceptions of risk and risk mitigation were found to coincide with post-market policy dissonance. CONCLUSION: Although interdependence fostered harmonization in pre-market standards and aligned with increased focus on post-market approaches, the confluence of divergent state governance modes and perceptions of risk may inspire improvisation in post-market standards. As the ICH expands to an ensemble with a greater global reach, further research is needed to clarify the manner in which interdependence shapes transnational pharmacogovernance and the conditions that foster policy convergence in the public interest.


Assuntos
Indústria Farmacêutica , Regulamentação Governamental , Cooperação Internacional , Política Pública , União Europeia , Humanos , Japão , Estados Unidos
12.
BMC Public Health ; 18(1): 497, 2018 04 13.
Artigo em Inglês | MEDLINE | ID: mdl-29653531

RESUMO

BACKGROUND: Social accountability is a participatory process in which citizens are engaged to hold politicians, policy makers and public officials accountable for the services that they provide. In the Fifteenth Ordinary Session of the Assembly of the African Union, African leaders recognized the need for strong, decentralized health programs with linkages to civil society and private sector entities, full community participation in program design and implementation, and adaptive approaches to local political, socio-cultural and administrative environments. Despite the increasing use of social accountability, there is limited evidence on how it has been used in the health sector. The objective of this systematic review was to identify the conditions that facilitate effective social accountability in sub-Saharan Africa. METHODS: Electronic databases (MEDLINE, PsycINFO, Sociological Abstracts, Social Sciences Abstracts) were searched for relevant articles published between 2000 and August 2017. Studies were eligible for inclusion if they were peer-reviewed English language publications describing a social accountability intervention in sub-Saharan Africa. Qualitative and quantitative study designs were eligible. RESULTS: Fourteen relevant studies were included in the review. The findings indicate that effective social accountability interventions involve leveraging partnerships and building coalitions; being context-appropriate; integrating data and information collection and analysis; clearly defined roles, standards, and responsibilities of leaders; and meaningful citizen engagement. Health system barriers, corruption, fear of reprisal, and limited funding appear to be major challenges to effective social accountability interventions. CONCLUSION: Although global accountability standards play an important guiding role, the successful implementation of global health initiatives depend on national contexts.


Assuntos
Setor de Assistência à Saúde , Responsabilidade Social , África Subsaariana , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
13.
Int J Health Plann Manage ; 33(1): e279-e292, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29027260

RESUMO

BACKGROUND: Malaria is a major global health challenge. This study aims to clarify the manner in which contextual factors determine the use and maintenance of bed nets and the extent to which malaria prevention policy is responsive to them in Southern Benin. METHODS: Semi-structured interviews and direct observations were undertaken with 30 pregnant women in the municipality of So-Ava from June to August 2015. Key informants in the Ministry of Health and local community health workers were also interviewed regarding malaria prevention policy formation, and the monitoring and evaluation of bed net interventions, respectively. Data were analyzed through categorical content analysis and grouped into themes. RESULTS: The majority of pregnant women participants (80%) declared non-adherence to instructions for hanging and maintaining insecticide-treated nets (ITNs). The distributed bed nets were washed like clothes, which affected their bio-efficacy, and were in poor condition (ie, torn or had holes). Multiple factors contributed to the poor condition of ITNs: Pregnant women's limited understanding of risk including their inability to connect the key environmental factors to personal risk, gendered responsibility for installing bed nets, and lack of public measures that would enable women to re-treat or access new bed nets as needed. Poverty that determined structural aspects of housing such as the size and quality of homes and access to bed nets exacerbated the challenges. CONCLUSION: Institutionalizing an iterative process of monitoring, review, and responsive adaptation throughout the entire policymaking cycle would better support malaria preventive policy implementation in Benin.


Assuntos
Política de Saúde , Mosquiteiros , Benin , Agentes Comunitários de Saúde , Feminino , Humanos , Entrevistas como Assunto , Malária/prevenção & controle , Cooperação do Paciente , Gravidez , Desenvolvimento de Programas , Fatores Socioeconômicos
14.
Health Care Women Int ; 38(3): 238-252, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-27617916

RESUMO

Although malaria in pregnancy predisposes women to increased perinatal mortality and morbidity, complex issues underlie its persistence. To develop a better understanding of the factors affecting women's access to Intermittent Preventive Treatment in Benin, we used the theoretical lens of "sensemaking" to clarify policymakers', health professionals', and women's perspectives concerning preventive policies and barriers to access. Several assumptions were found to underlie Benin's malaria preventive policy that contribute to the unintended effect of deterring pregnant women in poverty from accessing preventive treatment. Health system dysfunctions including drug shortages and deficiencies in health care professionalism exacerbate the unintended effect.


Assuntos
Tomada de Decisões , Acesso aos Serviços de Saúde , Malária/prevenção & controle , Pobreza , Gestantes , Benin , Feminino , Reforma dos Serviços de Saúde , Humanos , Serviços de Saúde Materna/economia , Gravidez , Adulto Jovem
15.
J Law Med Ethics ; 44(4): 602-613, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-28661249

RESUMO

Diverse legal and regulatory measures are used internationally to control the information provided during pharmaceutical sales visits. Little is known about the comparative effectiveness of these measures however. We analyzed the perceptions of regulators, pharmaceutical industry officials, health professionals, and consumer respondents concerning these approaches in Canada, France, and the United States using an empirical realist interests-based approach. Interviews focused on the aims and effectiveness of regulation, barriers and enablers to regulation and suggestions for improvement. An alignment was found in North America regulator and industry respondents' satisfaction with the status quo and their view that further intervention is unfeasible and unnecessary. Health professionals generally expressed a lack of confidence in the impact of regulations on sales visit information while consumer advocates voiced their disappointment in both regulators and health professionals for their failure to counteract the influence of pharmaceutical marketing. Regulator and industry respondents in France differed from their North American counterparts in their willingness to increase and diversify the scope of regulatory interventions. As the first international comparison of regulatory experiences in this sector, the findings highlight the universal need for more focused and inclusive discussions among groups about how to tailor regulations to achieve public health goals.


Assuntos
Enganação , Indústria Farmacêutica , Marketing , Canadá , França , Humanos , América do Norte , Estados Unidos
16.
Health Policy ; 111(1): 86-94, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23523344

RESUMO

OBJECTIVES: Natural health products (NHPs) are rapidly increasing in popularity, public consumption and of regulatory concern internationally. Canada has implemented regulations for these products in response to concerns over quality, safety and efficacy. We conducted a narrative review of the NHP regulations in order to understand the contextual factors underlying the regulations' implementation. METHODS: Qualitative research involved a documentary analysis, semi-structured key informant interviews with government representatives, industry and consumer groups, and observation at a consultation meeting. RESULTS: The research reflected difficulties in defining the products as they fall between drugs and foods. Challenges in implementation such as time to process applications, staffing issues and clarity around labelling and evidence assessment are highlighted. Areas where important steps were taken and process improvements made to streamline the procedures are emphasized. CONCLUSIONS: In establishing a regulatory approach that comprehensively addresses NHPs as a distinct class of products, Health Canada's experience offers important insights. While several points of turbulence occurred through the implementation process, regulatory oversight has involved scrutinizing new products commensurate with their perceived inherent risks. Areas that require further progress include the development of a system of surveillance for adverse effects from both a passive reporting and an active surveillance perspective.


Assuntos
Produtos Biológicos/normas , Controle de Medicamentos e Entorpecentes , Canadá , Rotulagem de Medicamentos/legislação & jurisprudência , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Controle de Medicamentos e Entorpecentes/organização & administração , Órgãos Governamentais , Humanos
17.
J Health Polit Policy Law ; 38(3): 545-71, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23418364

RESUMO

The Canadian constitution divides the responsibility for pharmaceuticals between the federal and provincial governments. While the provincial governments are responsible for establishing public formularies, the majority of the safety and efficacy information that the provinces use comes from the federal government. We interviewed drug plan officials from eight of the ten provinces and two of three territories regarding their views on the Canadian drug safety system. Here we report on the following categories: the federal drug approval system; the strengths and weaknesses of the federal system of postmarket pharmaceutical safety (i.e., pharmacosurveillance); resources available to support provincial formulary decision making; provincial roles in pharmacosurveillance; how the drug safety system could be improved; and the role of the Drug Safety and Effectiveness Network, a recently established virtual network designed to connect researchers throughout Canada who conduct postmarket drug research. Next, we place the Canadian system within an international context by comparing informational asymmetry between government institutions in the United States and the European Union and by looking at how institutions support each other's roles in sharing information and in jointly developing policy through the International Conference on Harmonization. Finally, we draw on international experiences and suggest potential solutions to the concerns that our key informants have identified.


Assuntos
Pessoal Administrativo/psicologia , Regulamentação Governamental , Segurança do Paciente , Preparações Farmacêuticas , Farmacovigilância , Canadá , Tomada de Decisões , Formulários Farmacêuticos como Assunto , Humanos , Política , Pesquisa Qualitativa
18.
Soc Sci Med ; 75(1): 165-70, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22521677

RESUMO

Although international medicines regulators adopt a common system to assess the safety and efficacy of new drugs, pre-market evaluation is recognized as incomplete given the much larger post-market experience to follow. Adverse drug reactions contribute to more than 100,000 deaths in the United States annually and are among the top 10 leading causes of death. Regulators are developing active surveillance approaches to assess the risks of medicines in the post-market phase to enhance passive adverse drug reaction reporting systems that capture only one to ten percent of ADRs. The objective of this study is to compare international approaches to active surveillance and the manner in which regulatory agencies access and use post-market evidence in their decisions. A conceptual framework is used to guide the comparative analysis of pharmacovigilance governance and policy in the United Kingdom, France, the European Union, the United States and Canada using data gathered from key informant interviews and document review. While research networks are emerging internationally, we found a greater reliance on industry funding and oversight of post-market research in Europe compared to an emphasis on publicly funded programs in North America.


Assuntos
Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Política de Saúde/legislação & jurisprudência , Farmacovigilância , Tomada de Decisões , Controle de Medicamentos e Entorpecentes/estatística & dados numéricos , Europa (Continente) , Humanos , Internacionalidade , América do Norte , Vigilância de Produtos Comercializados/métodos , Vigilância de Produtos Comercializados/normas , Vigilância de Produtos Comercializados/estatística & dados numéricos , Pesquisa Qualitativa
19.
Int J Integr Care ; 10: e60, 2010 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-21289999

RESUMO

OBJECTIVE: Modes of governance were compared in ten local mental health networks in diverse contexts (rural/urban and regionalized/non-regionalized) to clarify the governance processes that foster inter-organizational collaboration and the conditions that support them. METHODS: Case studies of ten local mental health networks were developed using qualitative methods of document review, semi-structured interviews and focus groups that incorporated provincial policy, network and organizational levels of analysis. RESULTS: Mental health networks adopted either a corporate structure, mutual adjustment or an alliance governance model. A corporate structure supported by regionalization offered the most direct means for local governance to attain inter-organizational collaboration. The likelihood that networks with an alliance model developed coordination processes depended on the presence of the following conditions: a moderate number of organizations, goal consensus and trust among the organizations, and network-level competencies. In the small and mid-sized urban networks where these conditions were met their alliance realized the inter-organizational collaboration sought. In the large urban and rural networks where these conditions were not met, externally brokered forms of network governance were required to support alliance based models. DISCUSSION: In metropolitan and rural networks with such shared forms of network governance as an alliance or voluntary mutual adjustment, external mediation by a regional or provincial authority was an important lever to foster inter-organizational collaboration.

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