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Strategies to Approach Medicines Litigation: An Action Research Study in Brazil.

ABSTRACT: Background: In the last decades, litigation has been increasingly used to access medicines in Brazil. This phenomenon has led to the development of diverse strategies to reduce its negative impact on the organization of pharmaceutical services. In spite of that, managers still face difficulties dealing with lawsuits. Objective: This study aims to report the planning and implementation of strategies to approach medicines litigation in a municipality located in the southeast region of Brazil. Methods: Mixed methods were employed through an action research cycle. A network coordination team included researchers from university and municipal managers. The scenario analysis comprised the characterization of pharmaceutical services and the profile of medicines lawsuits. Afterward, strategies were planned to deal with the central problem identified. The action plan involved educational outreach visits and distribution of printed materials for health professionals, evaluated through opinion survey. Group conversations were conducted with the users of the public health system, followed by thematic analysis of reports. Results: The characterization of pharmaceutical services in the municipality revealed that treatments supplied were in accordance with the National Medicines Policy. In addition, a sector was implemented to attend demands for non-incorporated medicines. In spite of the services available, the characterization of lawsuits indicated that the main claimants were users of the public health system, requiring non-incorporated medicines, with therapeutic alternatives available. Thus, educational outreach visits were held in 14 health units (23 physicians in total). Everyone who answered the evaluation declared that they were very satisfied with the approach. Group conversations with the users of the health system reached 227 participants in total. In regard to users' perception about pharmaceutical services, thematic analysis of reports identified three main categories including aspects related to medicines provided, users assisted, and quality of service. Conclusion: The study described the first cycle of an action research project to develop strategies to approach medicines litigation at the municipal level. The application of educational outreach visits for health professionals and group conversations with health system users is a promising approach to improve access to information about pharmaceutical services in Brazil.

SUBMITTER: Machado FLDS

PROVIDER: S-EPMC8100662 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:To evaluate and determine the value of monitoring models developed by the Mahidol Oxford Tropical Research Unit and the East African Consortium for Clinical Research, consider how this can be measured and explore monitors' and investigators' experiences of and views about the nature, purpose and practice of monitoring.A case study approach was used within the context of participatory action research because one of the aims was to guide and improve practice. 34 interviews, five focus groups and observations of monitoring practice were conducted.Fieldwork occurred in the places where the monitoring models are coordinated and applied in Thailand, Cambodia, Uganda and Kenya. Participants included those coordinating the monitoring schemes, monitors, senior investigators and research staff.Transcribed textual data from field notes, interviews and focus groups was imported into a qualitative data software program (NVIVO V. 10) and analysed inductively and thematically by a qualitative researcher. The initial coding framework was reviewed internally and two main categories emerged from the subsequent interrogation of the data.The categories that were identified related to the conceptual framing and nature of monitoring, and the practice of monitoring, including relational factors. Particular emphasis was given to the value of a scientific and cooperative style of monitoring as a means of enhancing data quality, trust and transparency. In terms of practice the primary purpose of monitoring was defined as improving the conduct of health research and increasing the capacity of researchers and trial sites.The models studied utilise internal and network wide expertise to improve the ethics and quality of clinical research. They demonstrate how monitoring can be a scientific and constructive exercise rather than a threatening process. The value of cooperative relations needs to be given more emphasis in monitoring activities, which seek to ensure that research protects human rights and produces reliable data.

Project description:The escalating cost of civil litigation is leaving many defendants and plaintiffs unable to meet legal expenses such as attorney fees, court charges and others. This significantly impacts their ability to sue or defend themselves effectively. Related to this phenomenon is the ethics discussion around access to justice and crowdfunding. This article explores the dimensions that explain the phenomenon of litigation crowdfunding. Using data from CrowdJustice, a popular Internet fundraising platform used to assist in turning legal cases into publicly funded social cases, we study litigation crowdfunding through the lenses of the number of pledges, goal achievement, target amount, length of description, country, case category, and others. Overall, we see a higher number of cases seeking funding in the categories of human rights, environment, and judicial review. Meanwhile, the platform offers access to funding for other less prominent categories, such as voting rights, personal injury, intellectual property, and data & privacy. At the same time, donors are willing to donate more to cases related to health, politics, and public services. Also noteworthy is that while donors are willing to donate to education, animal welfare, data & privacy, and inquest-related cases, they are not willing to donate large sums to these causes. In terms of lawyer/law firm status, donors are more willing to donate to cases assisted by experienced lawyers. Furthermore, we also note that the higher the number of successful cases an attorney presents, the greater the amount raised. We analyzed valence, arousal, and dominance in case description and found they have a positive relationship with funds raised. Also, when a case description is updated on a crowdsourcing site, it ends up being more successful in funding-at least in the categories of health, immigration, and judicial review. This is not the case, however, for categories such as public service, human rights, and environment. Our research addresses whether litigation crowdfunding, in particular, levels the playing field in terms of opening up financing opportunities for those individuals who cannot afford the costs of litigation. While it may support social justice, ethical concerns with regards to the kinds of campaigns must also be addressed. Most of the ethical concerns center around issues relating to both the fundraisers and donors. Our findings have ethical and social justice implications for crowdfunding platform design.

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Strategies to Approach Medicines Litigation: An Action Research Study in Brazil.

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