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1.
Farm Hosp ; 2024 Apr 03.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-38575411

RESUMO

OBJECTIVE: To describe the process of implementing a traceability and safe drug manufacturing system in the clean room of a Pharmacy Service to increase patient safety, in accordance with current legislation. METHODS: The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the "Good Practices Guide for Medication Preparation in Pharmacy Services" (GBPP). The following sections were parameterized in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardized work procedures, and quality controls. RESULTS: A total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardized work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition 17 were high risk, 327 medium risk, 32 low risk, and 13 quality controls. CONCLUSIONS: The computerization of the production process has allowed the implementation of a traceability and secure drug manufacturing system in a controlled environment in accordance with current legislation.

2.
Artigo em Inglês | MEDLINE | ID: mdl-38575787

RESUMO

This study aims to determinate the correlation between tobacco control policies (TCP) and the prevalence of tobacco use in the 32 Mexican states during the 2016-2017 period. This is an ecological study that measured TCP by the Tobacco Control Scale (TCS) which assigns a score (0-100) based on the level of these component's implementation: price, prohibition in public spaces, expenditures of public information campaigns, publicity prohibitions, health warnings, and treatments. We analyzed the associations between the TCS scores and prevalence of tobacco use extracted from the National Survey of Drug, Alcohol and Tobacco Consumption using Spearman correlations. Prevalence of daily smokers is negatively correlated with global TCS scores for adolescents (p = 0.026). Price showed similar negative correlations with daily prevalence in adolescents (p = 0.003), adults (p = 0.040), men (p < 0.006), and women (p = 0.040). Many Mexican states need to improve on tobacco control policies, especially targeting a key population: adolescents.

3.
Health Policy Plan ; 2024 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-38590053

RESUMO

This qualitative study maps the process of drafting and consulting on Nepal's mental health legislation from 2006 to 2017. Fourteen people were interviewed, and interviews were analysed thematically. These themes were subsequently interpreted in light of Shiffman and Smith's policy analysis framework, as the process was found to be at the agenda-setting stage. Two groups of actors were identified with different views on appropriate policy content and how the policy process should be conducted. The first group included psychiatrists who initiated and controlled the drafting process, and who did not consider people with psychosocial disabilities to be equal partners. The psychiatrists viewed forced detention and treatment as upholding people's Right to Health and lobbied the Ministry of Health and Population (MoHP) to pass the draft Acts to Parliament. The second included the rights-based civil society actors and lawyers who saw the Right to Equality before the Law as of utmost priority, opposed forced detention and treatment, and actively blocked the draft Acts at the MoHP. There is no clear legal definition of mental health and illness in Nepal, legal and mental capacity are not differentiated, and people with mental and behavioural conditions are assumed to lack capacity. The analysis indicates that there were few favourable conditions to support the progression of this policy into law. It is unclear whether the drafters or blockers will prevail in the future, but we predict that professionals will continue to have more input into content than service users due to national policy dynamics.

4.
Food Sci Biotechnol ; 33(6): 1295-1305, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38585565

RESUMO

Recently, the use of nanotechnology in food has gained great interest. Iron nanoparticles with unique chemical, physical and structural properties allow their potential use mainly as iron fortifiers, colorants and antimicrobial agents. However, in the market we can find only supplements and food colorants based on iron nanoparticles. Their use in food fortification has so far been focused only on in vitro and in vivo experimental studies, since the toxicological evaluation of these studies has so far been the basis for the proposals of laws and regulations, which are still in an early stage of development. Therefore, the aim of this work was to summarize the use of the different forms of iron nanoparticles (oxides, oxyhydroxides, phosphates, pyrophosphates and sulfates) as food additives and supplements and to resume the perspectives of legislation regarding the use of these types of nanoparticles in the food industry.

5.
Artigo em Russo | MEDLINE | ID: mdl-38640204

RESUMO

In conditions of impetuous development of national digital technologies and necessity for their legal regulation, significance and possibilities of their implementation in protecting health of rising generation during childhood decade in Russia are demonstrated. The conceptual apparatus related to discussed problem is considered. The emphasis is made on preventive aspect of intersectoral state protection of health care and rights of children and adolescents aged 0-17 years. The scale of problem is especially impressive considering number of contingent over 30 million people and interests of about 24 million of family members with children. The purpose of the study is applying analytical method, content analysis and SWOT analysis to monitor main problems of intersectoral health care and rights of rising generation in Russia in conditions of implementation of information technologies; to evaluate application of legislation in force in context of their role and effect during the Decade of Children (2018-2027); to demonstrate significance of the institution of the Commissioner for rights of child under the President of the Russian Federation.


Assuntos
Atenção à Saúde , Tecnologia da Informação , Criança , Adolescente , Humanos , Federação Russa
6.
Int J Law Psychiatry ; 94: 101985, 2024 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-38579525

RESUMO

People with impaired decision-making capacity enjoy the same rights to access technology as people with full capacity. Our paper looks at realising this right in the specific contexts of artificial intelligence (AI) and mental capacity legislation. Ireland's Assisted Decision-Making (Capacity) Act, 2015 commenced in April 2023 and refers to 'assistive technology' within its 'communication' criterion for capacity. We explore the potential benefits and risks of AI in assisting communication under this legislation and seek to identify principles or lessons which might be applicable in other jurisdictions. We focus especially on Ireland's provisions for advance healthcare directives because previous research demonstrates that common barriers to advance care planning include (i) lack of knowledge and skills, (ii) fear of starting conversations about advance care planning, and (iii) lack of time. We hypothesise that these barriers might be overcome, at least in part, by using generative AI which is already freely available worldwide. Bodies such as the United Nations have produced guidance about ethical use of AI and these guide our analysis. One of the ethical risks in the current context is that AI would reach beyond communication and start to influence the content of decisions, especially among people with impaired decision-making capacity. For example, when we asked one AI model to 'Make me an advance healthcare directive', its initial response did not explicitly suggest content for the directive, but it did suggest topics that might be included, which could be seen as setting an agenda. One possibility for circumventing this and other shortcomings, such as concerns around accuracy of information, is to look to foundational models of AI. With their capabilities to be trained and fine-tuned to downstream tasks, purpose-designed AI models could be adapted to provide education about capacity legislation, facilitate patient and staff interaction, and allow interactive updates by healthcare professionals. These measures could optimise the benefits of AI and minimise risks. Similar efforts have been made to use AI more responsibly in healthcare by training large language models to answer healthcare questions more safely and accurately. We highlight the need for open discussion about optimising the potential of AI while minimising risks in this population.

7.
Heliyon ; 10(7): e29128, 2024 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-38623208

RESUMO

Pesticides are chemical constituents used to prevent or control pests, including insects, rodents, fungi, weeds, and other unwanted organisms. Despite their advantages in crop production and disease management, the use of pesticides poses significant hazards to the environment and public health. Pesticide elements have now perpetually entered our atmosphere and subsequently contaminated water, food, and soil, leading to health threats ranging from acute to chronic toxicities. Pesticides can cause acute toxicity if a high dose is inhaled, ingested, or comes into contact with the skin or eyes, while prolonged or recurrent exposure to pesticides leads to chronic toxicity. Pesticides produce different types of toxicity, for instance, neurotoxicity, mutagenicity, carcinogenicity, teratogenicity, and endocrine disruption. The toxicity of a pesticide formulation may depend on the specific active ingredient and the presence of synergistic or inert compounds that can enhance or modify its toxicity. Safety concerns are the need of the hour to control contemporary pesticide-induced health hazards. The effectiveness and implementation of the current legislature in providing ample protection for human health and the environment are key concerns. This review explored a comprehensive summary of pesticides regarding their updated impacts on human health and advanced safety concerns with legislation. Implementing regulations, proper training, and education can help mitigate the negative impacts of pesticide use and promote safer and more sustainable agricultural practices.

8.
Orphanet J Rare Dis ; 19(1): 147, 2024 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-38582900

RESUMO

BACKGROUND: Patient registries and databases are essential tools for advancing clinical research in the area of rare diseases, as well as for enhancing patient care and healthcare planning. The primary aim of this study is a landscape analysis of available European data sources amenable to machine learning (ML) and their usability for Rare Diseases screening, in terms of findable, accessible, interoperable, reusable(FAIR), legal, and business considerations. Second, recommendations will be proposed to provide a better understanding of the health data ecosystem. METHODS: In the period of March 2022 to December 2022, a cross-sectional study using a semi-structured questionnaire was conducted among potential respondents, identified as main contact person of a health-related databases. The design of the self-completed questionnaire survey instrument was based on information drawn from relevant scientific publications, quantitative and qualitative research, and scoping review on challenges in mapping European rare disease (RD) databases. To determine database characteristics associated with the adherence to the FAIR principles, legal and business aspects of database management Bayesian models were fitted. RESULTS: In total, 330 unique replies were processed and analyzed, reflecting the same number of distinct databases (no duplicates included). In terms of geographical scope, we observed 24.2% (n = 80) national, 10.0% (n = 33) regional, 8.8% (n = 29) European, and 5.5% (n = 18) international registries coordinated in Europe. Over 80.0% (n = 269) of the databases were still active, with approximately 60.0% (n = 191) established after the year 2000 and 71.0% last collected new data in 2022. Regarding their geographical scope, European registries were associated with the highest overall FAIR adherence, while registries with regional and "other" geographical scope were ranked at the bottom of the list with the lowest proportion. Responders' willingness to share data as a contribution to the goals of the Screen4Care project was evaluated at the end of the survey. This question was completed by 108 respondents; however, only 18 of them (16.7%) expressed a direct willingness to contribute to the project by sharing their databases. Among them, an equal split between pro-bono and paid services was observed. CONCLUSIONS: The most important results of our study demonstrate not enough sufficient FAIR principles adherence and low willingness of the EU health databases to share patient information, combined with some legislation incapacities, resulting in barriers to the secondary use of data.


Assuntos
Doenças Raras , Humanos , Teorema de Bayes , Estudos Transversais , Aprendizado de Máquina , Doenças Raras/diagnóstico
9.
Nicotine Tob Res ; 2024 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-38635413

RESUMO

INTRODUCTION: The implementation of tobacco control policies has been a neglected topic in tobacco research. A comprehensive Tobacco Action Plan including plain packaging, point-of-sale display ban, a ban on characterizing flavours (in products other than cigarettes), a strengthening of the promotion and marketing ban, a ban on the sale of novel nicotine products to minors, smoke-and nicotine-free-school hours in all schools with minors, and a significant increase in tobacco tax, was adopted in Denmark in 2019. METHODS: Eleven people involved or very close to the advocacy process were invited, two did not respond and nine attended our research centre. We used the Nominal Group Technique, a consensus method, to identify the most important driving factors for passing the Tobacco Action Plan. RESULTS: The round-robin identified 39 driving factors merged into 13 in the clarification phase. In the ranking phase, participants agreed on seven factors that they perceived have strongly influenced the political will to strengthen national tobacco control comprehensively. The most important factors were national data and evidence, a nationwide alliance with broad partnerships, a strict focus on young people, continuous media coverage, intensive lobbying by many different advocates, making it a community agenda - not a political one, and effective professional campaigns. CONCLUSION: Our findings agree with experiences from other countries that significantly improved tobacco control. The Danish strategy, including a nationwide alliance with broad partnerships, had a high influence on the political agenda. IMPLICATIONS: In this study, there was a consensus that seven factors strongly influenced the political will to comprehensively strengthen the national tobacco control in Denmark in a short time: national data and evidence; a nationwide alliance with broad partnerships; a strict focus on children and young people; continuous media coverage; intensive lobbying by many different advocates; making it a community agenda - not a political one, and effective professional campaigns. This is consistent with findings from other countries.

10.
BMC Med Ethics ; 25(1): 47, 2024 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-38643137

RESUMO

BACKGROUND: In May 2020, England moved to an opt-out organ donation system, meaning adults are presumed to be an organ donor unless within an excluded group or have opted-out. This change aims to improve organ donation rates following brain or circulatory death. Healthcare staff in the UK are supportive of organ donation, however, both healthcare staff and the public have raised concerns and ethical issues regarding the change. The #options survey was completed by NHS organisations with the aim of understanding awareness and support of the change. This paper analyses the free-text responses from the survey. METHODS: The #options survey was registered as a National Institute of Health Research (NIHR) portfolio trial [IRAS 275992] 14 February 2020, and was completed between July and December 2020 across NHS organisations in the North-East and North Cumbria, and North Thames. The survey contained 16 questions of which three were free-text, covering reasons against, additional information required and family discussions. The responses to these questions were thematically analysed. RESULTS: The #options survey received 5789 responses from NHS staff with 1404 individuals leaving 1657 free-text responses for analysis. The family discussion question elicited the largest number of responses (66%), followed by those against the legislation (19%), and those requiring more information (15%). Analysis revealed six main themes with 22 sub-themes. CONCLUSIONS: The overall #options survey indicated NHS staff are supportive of the legislative change. Analysis of the free-text responses indicates that the views of the NHS staff who are against the change reflect the reasons, misconceptions, and misunderstandings of the public. Additional concerns included the rationale for the change, informed decision making, easy access to information and information regarding organ donation processes. Educational materials and interventions need to be developed for NHS staff to address the concepts of autonomy and consent, organ donation processes, and promote family conversations. Wider public awareness campaigns should continue to promote the positives and refute the negatives thus reducing misconceptions and misunderstandings. TRIAL REGISTRATION: National Institute of Health Research (NIHR) [IRAS 275992].


Assuntos
Medicina Estatal , Obtenção de Tecidos e Órgãos , Adulto , Humanos , Tomada de Decisões , Doadores de Tecidos , Inglaterra
11.
BJA Educ ; 24(5): 147-154, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38646451
12.
Int J Biol Markers ; : 3936155241239672, 2024 Apr 13.
Artigo em Inglês | MEDLINE | ID: mdl-38613331

RESUMO

Biobanks are valuable tools for developing and applying scientific research and international cooperation through the collection of biological materials and their associated data. Systematic research following the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines was conducted in late 2022 in PubMed and Scopus, and generated 17 articles to be reviewed in depth and critically assessed using the Critical Appraisal Skills Programme Checklist due to the limited available data; 12 relevant health organizations and government websites outside of peer-reviewed journals were also included. Our research identified 44 biobanks in Latin America. In general, there is a lack of regulation and legislation guaranteeing the stored materials' quality and institutional collaboration. We believe a consensus needs to be reached regarding the terminology and definitions used for biobanks. The design for informed consent should also be agreed upon to ensure the privacy of the data shared among institutions. In conclusion, in Latin America, there is a clear need for government support in creating specific procedures for biobanks and providing further support for existing biobanks.

13.
Med Clin (Barc) ; 2024 Apr 16.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-38632033

RESUMO

BACKGORUND AND OBJECTIVE: Royal Decree 888/2022 establishes that the evaluation of disability situations is carried out by multiprofessional teams responsible for assessing and recognizing the degree of disability. The participation of professionals in the healthcare and social fields can be valuable in providing reports from which the necessary data for the proper assessment of disability can be obtained, with the ultimate goal of providing comprehensive assistance to people with disabilities. MATERIALS AND METHODS: An analysis and summary of Royal Decree 888/2022, which has recently come into effect, is performed, focusing on the most relevant aspects for professionals in the healthcare and social fields. RESULTS: The recognition and classification of the degree of disability are the responsibility of the autonomous communities, and the assessments are issued by multiprofessional teams. To do this, four components are evaluated using the criteria outlined in the annexes of the Royal Decree itself. Each criterion generates a score that is combined to obtain a single score, the Final Disability Degree of the Person. CONCLUSIONS: The pathology that causes the disability must have been previously diagnosed by the Healthcare System and considered permanent. Its evaluation is based on the evidence of objective clinical findings that are documented and supported by clinical reports. For this reason, it is important to maintain an accurate medical history, document reviews, and provide all relevant evidence.

14.
Front Public Health ; 12: 1354698, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38645462

RESUMO

Breed-Specific Legislation is a type of law that bans or restricts ownership of specific dog breeds. Some local governments - including over seventy municipalities in the state of Missouri - have enacted Breed-Specific Legislation to prevent injuries from dog bites. Several studies from the peer-reviewed literature have found that aggressive behavior is not associated with any particular dog breeds and, since 2018, at least a dozen municipalities in Missouri have repealed these laws. To evaluate the impact of Breed-Specific Legislation on public safety, the 2010-2015 rates of emergency department visits for dog bite-related injuries in Missouri municipalities with and without Breed-Specific Legislation were compared. Propensity-score matched negative binomial regression models were used to assess the effect of breed restrictions on injury rates while balancing the samples on population characteristics and estimates of dog ownership. After matching the sample on population, housing and dog ownership estimates, no association was found between emergency department visits for dog bite injuries and whether the municipality enacted Breed-Specific Legislation. However, the incidence rate ratio of emergency room visits for dog bite-related injuries increased by 13.8% for every 1% increase in the percentage of males aged 5 to 9 in the population (p < 0.01). This study has found breed discriminatory laws have not reduced the risk of emergency department visits for injury from dog bites in Missouri. There appears to be no greater risk to public safety as local governments move to repeal existing breed bans.


Assuntos
Mordeduras e Picadas , Serviço Hospitalar de Emergência , Pontuação de Propensão , Cães , Animais , Missouri/epidemiologia , Mordeduras e Picadas/epidemiologia , Humanos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Masculino , Feminino , Criança , Adulto , Adolescente , Pessoa de Meia-Idade , Pré-Escolar , Adulto Jovem , Propriedade/estatística & dados numéricos , Propriedade/legislação & jurisprudência , Cidades , Idoso , 60530
15.
Preprint em Português | SciELO Preprints | ID: pps-8434

RESUMO

Bill 6007/2023 proposes significant changes to the National System of Ethics in Clinical Research with Human Beings. The justification is that the debureaucratization of the system would contribute to scientific progress. The article analyzes the main points of the bill, to verify the adequacy between what is proposed and the expected outcomes: normative level; time of analysis; role of the central organ; consent; post-study treatment; placebo; monitoring; and measures resulting from non-compliance. Although the normative level and the proscription of placebo, except when there is no proven effective intervention, offer a protective effect. The other changes either do not contribute to increasing the protection of the participants or effectively loosen moral obligations towards them. The lack of protections and guarantees does not speed up research, as is often argued, but, on the contrary, can cause more risk to participants and lead to discredit and distrust of science.


O Projeto de Lei (PL) 6007/2023 propõe reformulações significativas do Sistema Nacional de Ética em Pesquisa Clínica com Seres Humanos. A justificativa apresentada é que a desburocratização do Sistema contribuiria para o avanço científico. O artigo analisa os aspectos mais significativos do PL, a fim de verificar a adequação entre a proposta e os efeitos esperados: nível normativo; tempo da análise; papel do órgão central; consentimento; tratamento pós-estudo; placebo; monitoramento; e, medidas resultantes de descumprimento. Embora o nível normativo e a vedação do uso de placebo quando da existência de tratamento comprovadamente eficaz ofereçam efeito protetivo, as demais alterações ou não contribuem para aumentar a proteção do participante ou efetivamente flexibilizam obrigações éticas presentes na atual regulamentação. A desproteção dos participantes não acelera pesquisas, como se costuma argumentar, podendo, ao contrário, além de causar mais risco, levar ao descrédito e desconfiança em relação à ciência.

16.
Violence Gend ; 11(1): 14-21, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38516063

RESUMO

Reproductive coercion and abuse (RCA) removes or reduces reproductive autonomy and decision-making. RCA-focused research is mostly situated within a health care perspective, with much less focus on sociolegal or criminological considerations. This article reports a summary of findings from an examination of existing Australian family violence legislation to discern whether these provisions could facilitate improved responses to RCA. The study analyzed whether and how RCA is reflected within legislative definitions of family violence across Australia, to determine their potential protective scope. The state of South Australia is the only jurisdiction to provide explicit reference to behaviors regarded as RCA, but many definitions within the family violence legislation in other jurisdictions implicitly cover RCA. While such implicit coverage may hinder the recognition of RCA as a form of family violence, it may also provide sufficient flexibility to enable RCA to be addressed through the legal application of current family violence policy and legislation-with consequential potential benefits for the identification and support of victim-survivors.

17.
Front Psychol ; 15: 1196926, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38495420

RESUMO

This paper takes a terminological approach to the concept of high intellectual abilities, highlighting the distinctive aspects of the way it is addressed in the Portuguese educational context. It outlines the existing conceptual differentiation in the field of higher abilities, emphasizing how the main characteristics are described and including the strengths and weaknesses of current teaching and learning processes in Portugal. As we will show, educational work with these students in Portuguese schools is characterized by unequal regulation compared to other educational needs, by an imbalance of educational processes aimed at these gifted students, and by clear underdiagnosis that sometimes leads to them being ignored in the classroom, with the consequent harm that this can cause to their overall development and to their academic and professional careers. The paper emphasizes the importance of teacher training in Portugal as an aspect that could be key to reversing, as far as possible, this gap in educational processes-which currently include educational inclusion for all their students as part of the key action principles in the Portuguese educational system.

18.
Hum Reprod ; 2024 Mar 21.
Artigo em Inglês | MEDLINE | ID: mdl-38514452

RESUMO

STUDY QUESTION: Would the different regulatory approaches for preimplantation genetic testing (PGT) in Europe permit the implementation of preimplantation genetic testing using polygenic risk scores (PGT-P)? SUMMARY ANSWER: While the regulatory approaches for PGT differ between countries, the space provided for potential implementation of PGT-P seems limited in all three regulatory models. WHAT IS KNOWN ALREADY: PGT is a reproductive genetic technology that allows the testing for hereditary genetic disorders and chromosome abnormalities in embryos before implantation. Throughout its history, PGT has largely been regarded as an ethically sensitive technology. For example, ethical questions have been raised regarding the use of PGT for adult-onset conditions, non-medical sex selection, and human leukocyte antigen typing for the benefit of existing siblings. Countries in which PGT is offered each have their own approach of regulating the clinical application of PGT, and a clear overview of legal and practical regulation of PGT in Europe is lacking. An emerging development within the field of PGT, namely PGT-P, is currently bringing new ethical tensions to the forefront. It is unclear whether PGT-P may be applied within the current regulatory frameworks in Europe. Therefore, it is important to investigate current regulatory frameworks in Europe and determine whether PGT-P fits within these frameworks. STUDY DESIGN, SIZE, DURATION: The aim of this study was to provide an overview of the legal and practical regulation of the use of PGT in seven selected European countries (Belgium, France, Germany, Italy, the Netherlands, Spain, and the UK) and critically analyse the different approaches with regards to regulatory possibilities for PGT-P. Between July and September 2023, we performed a thorough and extensive search of websites of governments and governmental agencies, websites of scientific and professional organizations, and academic articles in which laws and regulations are described. PARTICIPANTS/MATERIALS, SETTING, METHODS: We investigated the legal and regulatory aspects of PGT by analysing legal documents, regulatory frameworks, scientific articles, and guidelines from scientific organizations and regulatory bodies to gather relevant information about each included country. The main sources of information were national laws relating to PGT. MAIN RESULTS AND THE ROLE OF CHANCE: We divided the PGT regulation approaches into three models. The regulation of PGT differs per country, with some countries requiring central approval of PGT for each new indication (the medical indication model: the UK, the Netherlands), other countries evaluating each individual PGT request at the local level (the individual requests model: France, Germany), and countries largely leaving decision-making about clinical application of PGT to healthcare professionals (the clinical assessment model: Belgium, Italy, Spain). In the countries surveyed that use the medical indication model and the individual requests model, current legal frameworks and PGT criteria seem to exclude PGT-P. In countries using the clinical assessment model, the fact that healthcare professionals and scientific organizations in Europe are generally negative about implementation of PGT-P due to scientific and socio-ethical concerns, implies that, even if it were legally possible, the chance that PGT-P would be offered in the near future might be low. LIMITATIONS, REASONS FOR CAUTION: The results are based on our interpretation of publicly available written information and documents, therefore not all potential discrepancies between law and practice might have been identified. In addition, our analysis focuses on seven-and not all-European countries. However, since these countries are relevant players within PGT in Europe and since they have distinct PGT regulations, the insights gathered give relevant insights into diverse ways of PGT regulation. WIDER IMPLICATIONS OF THE FINDINGS: To the best of our knowledge, this is the first paper that provides a thorough overview of the legal and practical regulation of PGT in Europe. Our analysis of how PGT-P fits within current regulation models provides guidance for healthcare professionals and policymakers in navigating the possible future implementation of PGT-P within Europe. STUDY FUNDING/COMPETING INTEREST(S): This project has received funding from the European Union's Horizon 2020 research and innovation program under the Marie Sklodowska-Curie grant agreement no. 813707. The authors declare no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

19.
J Am Pharm Assoc (2003) ; : 102070, 2024 Mar 18.
Artigo em Inglês | MEDLINE | ID: mdl-38508518

RESUMO

BACKGROUND: North Carolina (NC) House Bill 96, effective February 2022, enabled trained immunizing pharmacists across the state to prescribe hormonal contraceptives (HCs). However, the extent and barriers to deployment are unknown. The purpose of this study was to describe the uptake and challenges from outpatient pharmacists who trained to provide HCs in an outpatient practice to assist others in the implementation of this service. OBJECTIVES: The primary objective was to estimate the proportion of trained NC pharmacists who provided HCs in an outpatient setting. The secondary objective was to identify barriers during the implementation of this service. METHODS: This cross-sectional, anonymous, web-based survey was emailed on December 13, 2022 to NC-licensed pharmacists enrolled in the required training. A reminder email was sent on January 10, 2023, with all responses considered up to January 31, 2023. Pharmacists licensed in NC who performed at least 50% of their clinical practice in an outpatient setting were included. The primary endpoint was having prescribed HC (Y/N). All endpoints were analyzed using descriptive statistics. RESULTS: Of 1,633 pharmacists eligible, 96 completed responses were included in the analysis (5.9%). Training was incomplete in 11/96 (11.5%), and 66/96 (68.8%) completed the training without implementing the service. Of the remaining 19/96 (19.8%) that developed a HC service, 15/96 (15.6%) had prescribed HCs. Among the 15 prescribing pharmacists, all reported positive patient feedback, while 7/15 reported improved job satisfaction. Among all 96 respondents, barriers reported included time constraints (49%) and a lack of appropriate reimbursement (43.8%). CONCLUSION: Few HC-trained NC outpatient pharmacists are prescribing HCs. Addressing prescribing barriers would potentially expand the scope of this service and further innovate the outpatient pharmacy setting.

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