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1.
MMWR Morb Mortal Wkly Rep ; 69(5): 136-139, 2020 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-32027629

RESUMO

On December 21, 2018 the Food and Drug Administration (FDA) licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP) adsorbed, inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib) conjugate (meningococcal protein conjugate) and hepatitis B (HepB) (recombinant) vaccine, DTaP-IPV-Hib-HepB (Vaxelis; MCM Vaccine Company),* for use as a 3-dose series in infants at ages 2, 4, and 6 months (1). On June 26, 2019, after reviewing data on safety and immunogenicity, the Advisory Committee on Immunization Practices (ACIP)† voted to include DTaP-IPV-Hib-HepB in the federal Vaccines for Children (VFC) program.§ This report summarizes the indications for DTaP-IPV-Hib-HepB and provides guidance for its use.


Assuntos
Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas contra Hepatite B/administração & dosagem , Vacina Antipólio de Vírus Inativado/administração & dosagem , Pré-Escolar , Humanos , Esquemas de Imunização , Lactente , Licenciamento , Estados Unidos , Vacinas Combinadas/administração & dosagem , Vacinas Conjugadas/administração & dosagem
2.
JAMA ; 323(2): 185, 2020 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-31935019
3.
JAMA ; 323(2): 186-187, 2020 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-31935020
4.
JAMA ; 323(2): 185-186, 2020 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-31935021
5.
Artigo em Alemão | MEDLINE | ID: mdl-31776598

RESUMO

Vaccinations are amongst the most important and powerful preventive measures modern medicine has to offer. By their nature, vaccines represent a very complex class of biological medicines. Licensure of novel vaccines is a process conducted on the basis of a comprehensive set of well-defined legal and procedural requirements. The key aim of the regulatory evaluation of vaccines is to confirm their pharmaceutical quality, safety, and efficacy in order to conclude on the positive benefit/risk ratio that is an absolute prerequisite for granting a license.In Europe there exist four types of licensing procedures for human vaccines (national, MRP, DCP, and centralized) depending on whether the vaccine is intended to be marketed nationally, in several, or all EU countries. Modern innovative vaccines are mostly licensed via the centralized EU procedure, which also offers a certain degree of procedural flexibility for specific vaccines under defined conditions. However, the basic regulatory requirements are the same for all types of licensing procedures. In order for a license to be granted, a vaccine has to fulfill all relevant regulatory requirements as regards pharmaceutical quality, including each manufacturing and control step as well as preclinical and clinical characterization. Most importantly, clinical trials in humans conducted prelicensure to determine vaccine safety and efficacy play a key role during the licensing procedure and for decision making.The WHO prequalification procedure was implemented to enable worldwide access to medicines of approved quality. Its prime aim is to establish and ensure appropriate universally recognized regulatory standards for vaccines to be used throughout the entire world.


Assuntos
Licenciamento , Vacinação , Vacinas , Europa (Continente) , Alemanha , Humanos , Organização Mundial da Saúde
8.
Am J Bioeth ; 19(9): 60-62, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31419196
9.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(4): 297-299, 2019 Jul 30.
Artigo em Chinês | MEDLINE | ID: mdl-31460726

RESUMO

Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.


Assuntos
Equipamentos e Provisões , Licenciamento , Equipamentos e Provisões/normas , Regulamentação Governamental
10.
Expert Opin Ther Pat ; 29(8): 653-662, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31298053

RESUMO

Introduction: The Ecuadorian Institute of Intellectual Property (IEPI) granted several compulsory licenses between 2011 and 2017. In 2009, the President of Ecuador signed a decree that was intended to facilitate the request of compulsory licenses (CL) in the country, not only for Enfarma EP but for any privately owned local company in order to produce more accessible medicines. Areas covered: The national and international regulatory framework of pharmaceutical patents and the local applicability of CL in Ecuador. The authors also analyzed the results of requesting unplanned and epidemiologically unnecessary CL at a national level. Finally, the authors reviewed the effects of requesting, granting or denying CL on price per unit in the last 7 years of available data. Expert opinion: The authors think that compulsory licenses are useful tools when negotiating drug prices or when the demand cannot be satisfied due to economic constrain within the local health system. However, the authors' experience suggests that Ecuador did not have an established and reliable production system neither an adequate plan before requesting CL, therefore the positive effects of this measure were not clearly established.


Assuntos
Custos de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Licenciamento/economia , Indústria Farmacêutica/economia , Equador , Acesso aos Serviços de Saúde , Humanos , Propriedade Intelectual , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/provisão & distribução
12.
J Clin Nurs ; 28(21-22): 3759-3775, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31216367

RESUMO

AIMS AND OBJECTIVES: To extract, examine and report the highest available levels of evidence from healthcare disciplines in the use of simulation-based education as substitution for clinical placement in prelicensure programmes. BACKGROUND: Simulation is widely employed across prelicensure health professional education to create safe, realistic clinical learning experiences for students. Whether simulation can be employed to substitute for actual clinical placement, and if so, in what proportion, replacement ratio and duration, is unclear. METHODS: A systematic review and quality appraisal of primary studies related to prelicensure students in all health disciplines, guided by the PRISMA checklist. RESULTS: Ten primary studies were included, representing 2,370 students from three health disciplines in four countries. Nine studies were experimental and quasi-experimental and methodological quality was assessed as moderate to high with good to very good inter-rater agreement. Direct substitution of simulation for clinical practice ranged from 5% to 50%. With one exception, replacement ratios were 1:1 and duration of replacement ranged from 21 hr-2 years. Levels of evaluation included measures of reaction, knowledge and behaviour transfer; no negative outcomes were reported. We appraised practicalities for design of substitution, design limitations and knowledge transfer to accreditation standards for prelicensure programmes. CONCLUSIONS: This review synthesised highest levels and quality of available evidence for substitution of simulation for clinical placement in health professional education. Included studies were heterogenous in simulation interventions (proportion, ratio and duration) and in the evaluation of outcomes. Future studies should incorporate standardised simulation curricula, widen the health professions represented and strengthen experimental designs. RELEVANCE TO CLINICAL PRACTICE: Current evidence for clinical educational preparation does not appear to be translated into programme accreditation standards governing clinical practice experience for prelicensure programmes in relevant jurisdictions. Overall, a stronger evidence base is necessary to inform future curricula and policy development, to strengthen clinical practice in health.


Assuntos
Educação Profissionalizante/normas , Ocupações em Saúde/educação , Treinamento por Simulação/organização & administração , Currículo/normas , Humanos , Licenciamento/normas
13.
Handchir Mikrochir Plast Chir ; 51(3): 193-198, 2019 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-31167280

RESUMO

BACKGROUND: The national competency-based catalogue of learning objectives in surgery (NKLC) for undergraduate surgical education in Germany consists of 230 objectives and defines competence levels for each objective. These levels range from "competence level 1: factual knowledge" to "competence level 3: independent action". The German second state examination is not based on these objectives, although it is known that assessment drives learning. This study analyses the proportion of hand surgery-based learning objectives in the NKLC and compares the results with the hand surgery questions of the German second medical licensing examination compiled by the Central German Institute for Medical and Pharmaceutical Examinations (IMPP). METHODS: Hand surgery teaching objectives in the NKLC were identified by five hand surgeons. All exam questions addressing these objectives were identified in the German second medical licensing examinations held from autumn 2009 through autumn 2014 (n = 11). The analysis included the number of hand surgery questions for each examination, the number of learning objectives and the different levels of competence. RESULTS: Forty-seven learning objectives of the NKLC were identified as "hand surgery-related" (20.4 % of all NKLC learning objectives). Nine of them were classified as learning objectives that were "only covered by hand surgery" (3.9 % of all NKLC learning objectives). Two hundred and twenty questions (6.3 % of the total number of 3480 questions) addressed hand surgery-related objectives. Per exam, an average of 20 ± 8.2 questions (minimum: 9; maximum: 37) addressed a hand surgery-related learning objective. An average of 0.5 ± 0.7 questions per exam were related to objectives that only covered hand surgery (minimum: 0; maximum: 2). During the study period, 16 learning objectives were not tested at all (13.7 % of all NKLC learning objectives). These untested objectives included 5 objectives of competence level 1 (10.6 % of all NKLC learning objectives). Six of the 9 objectives that are only covered by hand surgery were not assessed at all. CONCLUSIONS: The number of hand surgery-based learning objectives in the NKLC appears to be high. However, many of these learning objectives are not addressed in the second medical licensing examination. We recommend better adjustments between the state examinations and the NKLC.


Assuntos
Currículo , Educação de Graduação em Medicina , Cirurgia Geral , Licenciamento , Competência Clínica , Cirurgia Geral/educação , Alemanha , Metas , Mãos/cirurgia , Humanos
14.
Chin J Traumatol ; 22(4): 223-227, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31235286

RESUMO

PURPOSE: After car accident, motorcycle accident ranks as the second leading cause of traffic fatality in Iran. This study aimed to compare the severity and clinical presentations between drivers and passengers under the same injury circumstance. METHODS: This study was conducted in the trauma center of Shiraz, Iran in 2017. Data on demographics, triage level, blood pressure, respiratory rate, Glasgow coma scale (GCS), injured body region, injury severity score (ISS), revised trauma score (RTS), and result of accident were compared between pairs of drivers and passengers. The agreement of any type of injury between drivers and passengers evaluated by Kappa test. RESULTS: This study included 143 matched pairs of drivers and passengers. Most of the pairs (84.5%) did not use helmet and 77.2% of the riders do not have driving license. ISS was significantly higher in drivers than passengers. In the unmatched pairs, drivers and passengers showed no difference in sustaining injuries in the face, head & neck, chest and soft tissue, but drivers were found more likely to suffer from injuries in the abdomen, extremities, pelvis and spine than passengers. Once one part of the matched pair suffered injury in the head & neck, face, chest, abdomen, extremities and soft tissue & skin injury, the probability that the other part had an injury in the same region was 50%, 9%, 13%, 7%, 22% and 34% respectively. Kappa value for these body regions was 0.006, 0.009, -0.006, 0.068, 0.063 and 0.001, respectively, which was significant in abdomen and extremities. CONCLUSION: Although drivers had higher level of injury severity and some different injury distributions, we recommend equal treatment to drivers and passengers. We also recommend related authorities to develop policies on helmet use, driving license and third-party insurance.


Assuntos
Acidentes de Trânsito , Condução de Veículo , Hospitalização , Motocicletas , Ferimentos e Lesões , Adolescente , Adulto , Feminino , Escala de Coma de Glasgow , Dispositivos de Proteção da Cabeça , Humanos , Escala de Gravidade do Ferimento , Irã (Geográfico) , Licenciamento , Masculino , Estudos Prospectivos , Índices de Gravidade do Trauma , Triagem , Adulto Jovem
15.
Accid Anal Prev ; 129: 309-333, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31181355

RESUMO

BACKGROUND: Poor hazard perception, or the ability to anticipate potentially dangerous road and traffic situations, has been linked to an increased crash risk. Novice and younger road users are typically poorer at hazard perception than experienced and older road users. Road traffic authorities have recognised the importance of hazard perception skills, with the inclusion of a hazard perception test in most Graduated Driver Licensing (GDL) systems. OBJECTIVES: This review synthesises studies of hazard perception tests in order to determine best practice methodologies that discriminate between novice/younger and experienced/older road users. DATA SOURCES: Published studies available on PsychInfo, Scopus and Medline as at April 2018 were included in the review. Studies included a hazard perception test methodology and compared non-clinical populations of road users (car drivers, motorcyclists, bicyclists and pedestrians), based on age and experience, or compared methodologies. RESULTS: 49 studies met the inclusion criteria. There was a high degree of heterogeneity in the studies. However all methodologies - video, static image, simulator and real-world test-drive were able to discriminate road user groups categorised by age and/or experience, on at least one measure of hazard perception. CONCLUSIONS: Whilst there was a high level of heterogeneity of studies, video methodology utilising temporal responses (e.g. press a button when detecting the potential hazard) are a consistent measure of hazard perception across road user groups, whereas spatial measures (e.g. locate potential hazard in the scenario) were inconsistent. Staged footage was found to discriminate as well as unstaged footage, with static images also adding valuable information on hazard perception. There were considerable inconsistencies in the categorising of participants based on age and experience, limited application of theoretical frameworks, and a considerable lack of detail regarding post hoc amendments of hazardous scenarios. This research can guide further developments in hazard perception testing that may improve driver licensing and outcomes for road users.


Assuntos
Condução de Veículo/psicologia , Percepção , Acidentes de Trânsito/prevenção & controle , Acidentes de Trânsito/estatística & dados numéricos , Adolescente , Conscientização , Ambiente Construído , Humanos , Licenciamento/legislação & jurisprudência , Licenciamento/normas , Pedestres , Gravação em Vídeo
16.
J Dent Hyg ; 93(3): 37-43, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31182567

RESUMO

Purpose: The importance of upholding and maintaining professionalism is even greater in a digital world particularly for health care providers entrusted to care for patients and maintain privacy laws. Studies suggest that specific consequences of violation of professionalism and other ethical standards have not been well established. The purpose of this study is to identify how online social media behaviors influence the licensure and enforcement practices of dental professionals.Methods: A non-experimental descriptive electronic survey research design was utilized for this study. A total of 52 surveys consisting of questions relating to social media and the licensure of and practice act enforcement of dental professionals were sent to the executive directors of the dental boards in the United States.Results: Of the surveys that were sent (n=52), 18 responses were received for a 35% response rate. Overall, respondents indicated a lack of social media usage surveillance initiated by state dental boards. Incidents of online unprofessional behavior came to the attention of the board a variety of ways and with a range of consequences. Overall, there was a level of concern reagarding online activities by licensees that may be in violation of laws, rules and regulations of the state or the dental board exists. However, no state dental licensing boards are currently in the process of creating a social media policy.Conclusion: Dental boards are aware of potential online unprofessional behaviors and have implemented various consequences. Dental boards should consider developing policies to address potential online unprofessional behavior to protect the public that they serve.


Assuntos
Mídias Sociais , Humanos , Licenciamento , Privacidade , Má Conduta Profissional , Inquéritos e Questionários , Estados Unidos
17.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(3): 192-196, 2019 May 30.
Artigo em Chinês | MEDLINE | ID: mdl-31184077

RESUMO

In order to strengthen the integration of reform system and build a comprehensive integration of openness and innovation, the medical device registrar system has become the institutional choice to promote the reform of the medical approval system and the innovation and development of the industry. The system allows scientific researchers, R&D institutions and enterprises to become applicants for medical device registration and to consign the production of samples and products, thus realizing the separation of market license and production license, and breaking the binding relationship between registration and production in current regulations. The medical device registrar system has laid a theoretical foundation for remolding the management system of medical devices, and has also made practical exploration for improving the reform of the medical devices supervision system, so it has important theoretical and practical significance.


Assuntos
Aprovação de Equipamentos , Indústrias , Sistema de Registros , Licenciamento
19.
Global Health ; 15(1): 42, 2019 06 27.
Artigo em Inglês | MEDLINE | ID: mdl-31248441

RESUMO

BACKGROUND: Recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country's income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals. METHODS: We used a multivariate logistic model to regress attempts to issue compulsory licensing on the characteristics of the intellectual property system, controlling for macro context variables and other explanatory variables at a country level. RESULTS: A total 139 countries, selected from members of the World Trade Organization, were divided into a CL-attempted group (N = 24) and a non-CL-attempted group (N = 115). An attempt to issue compulsory licensing was associated with population (+) and a dummy variable for other regions, including Europe and North America (-). After controlling for macro context variables, mature intellectual property system was positively associated with attempting compulsory licensing. CONCLUSIONS: Our study provided evidence of an association between attempting compulsory licensing and matured patent systems. This finding contradicts our current understanding of compulsory licensing, such as compulsory licensing as a measure to usurp traditional patent systems and sometimes diametrically opposed to the patent system. The findings also suggest a new role of compulsory licensing in current patent systems: compulsory licensing could be a potential alternative or complement to achieve access to medicines in health systems through manufacturing and exporting patented pharmaceuticals.


Assuntos
Propriedade Intelectual , Legislação de Medicamentos , Licenciamento , Estudos Transversais , Humanos
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