scholarly journals Desafios atuais dos laboratórios de saúde pública frente às novas exigências regulatórias

2019 ◽  
Vol 19 (74) ◽  
Author(s):  
Blanca Elena Ortega Markman ◽  
Ellen Gameiro Hilinski ◽  
Fernanda Fernandes Farias

RESUMOO avanço regulatório, observado no mercado farmacêutico brasileiro nas últimas décadas, representa um impacto positivo para a população, na medida em que passa a dispor de medicamentos com melhores perfis de segurança e eficácia, reduzindo e prevenindo o risco inerente às propriedades farmacológicas e toxicológicas dos fármacos. Este estudo visa atualizar o panorama da qualidade de medicamentos no Brasil e os desafios enfrentados pelos laboratórios de saúde pública para a condução dos ensaios analíticos de monitoramento da qualidade. Com o incremento do lançamento de novas tecnologias farmacêuticas, como os biofármacos, e a publicação de nova regulamentação, como a RDC 53/2015, o atendimento às novas exigências dos órgãos regulatórios impõem desafios complexos para os laboratórios oficiais.  A notificação, identificação e qualificação de produtos de degradação em medicamentos com substâncias ativas sintéticas e semissintéticas, bem como a análise do polimorfismo e de fármacos quirais, são alguns dos exemplos que demandam o desenvolvimento e validação de técnicas analíticas com maior seletividade e complexidade. Para efetivar este avanço torna-se essencial a utilização de equipamentos robustos e modernos, assim como a capacitação do corpo analítico nos laboratórios de saúde pública. Palavras-chave: monitoramento da qualidade, medicamentos, laboratório de saúde pública, regulamentação. ABSTRACTThe regulatory improvement observed in the Brazilian pharmaceutical market on the last decades represents a positive impact for the population which now has medicines with better safety and efficacy profiles, reducing and preventing the inherent risk in the pharmacological and toxicological drug properties. This study aims to update the scenery of the quality of medicines in Brazil and the challenges faced by public health laboratories to conduct the analytical tests to quality assurance. With the increase in the launching of new pharmaceutical technologies, such as biopharmaceuticals and the publication of new regulations, such as RDC 53/2015, meet the new regulatory requirements imposes complex challenges for official laboratories. The notification, identification and qualification of degradation products in pharmaceutical products with synthetic and semisynthetic active substances, as well the analysis of polymorphism and chiral drugs are some of the examples that demand the development and validation of analytical techniques with greater selectivity and complexity. To achieve this advance, the use of robust and modern equipment is essential, as well as the training of the analytical group in the public health laboratories. Keywords: quality monitoring, medicines, public health laboratory, regulation

2020 ◽  
Vol 19 (4) ◽  
pp. 618-632
Author(s):  
A.S. Panchenko

Subject. The article addresses the public health in the Russian Federation and Israel. Objectives. The focus is on researching the state of public health in Russia and Israel, using the Global Burden of Disease (GBD) project methodology, identifying problem areas and searching for possible ways to improve the quality of health of the Russian population based on the experience of Israel. Methods. The study draws on the ideology of the GBD project, which is based on the Disability-Adjusted Life-Year (DALY) metric. Results. The paper reveals the main causes of DALY losses and important risk factors for cancer for Russia and Israel. The findings show that the total DALY losses for Russia exceed Israeli values. The same is true for cancer diseases. Conclusions. Activities in Israel aimed at improving the quality of public health, the effectiveness of which has been proven, can serve as practical recommendations for Russia. The method of analysis, using the ideology of the GBD project, can be used as a tool for quantitative and comparative assessment of the public health.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Perkiö ◽  
R Harrison ◽  
M Grivna ◽  
D Tao ◽  
C Evashwich

Abstract Education is a key to creating solidary among the professionals who advance public health’s interdisciplinary mission. Our assumption is that if all those who work in public health shared core knowledge and the skills for interdisciplinary interaction, collaboration across disciplines, venues, and countries would be facilitated. Evaluation of education is an essential element of pedagogy to ensure quality and consistency across boundaries, as articulated by the UNESCO education standards. Our study examined the evaluation studies done by programs that educate public health professionals. We searched the peer reviewed literature published in English between 2000-2017 pertaining to the education of the public health workforce at a degree-granting level. The 2442 articles found covered ten health professions disciplines and had lead authors representing all continents. Only 86 articles focused on evaluation. The majority of the papers examined either a single course, a discipline-specific curriculum or a teaching method. No consistent methodologies could be discerned. Methods ranged from sophisticated regression analyses and trends tracked over time to descriptions of focus groups and interviews of small samples. We found that evaluations were primarily discipline-specific, lacked rigorous methodology in many instances, and that relatively few examined competencies or career expectations. The public health workforce enjoys a diversity of disciplines but must be able to come together to share diverse knowledge and skills. Evaluation is critical to achieving a workforce that is well trained in the competencies pertinent to collaboration. This study informs the pedagogical challenges that must be confronted going forward, starting with a commitment to shared core competencies and to consistent and rigorous evaluation of the education related to training public health professionals. Key messages Rigorous evaluation is not sufficiently used to enhance the quality of public health education. More frequent use of rigorous evaluation in public health education would enhance the quality of public health workforce, and enable cross-disciplinary and international collaboration for solidarity.


2021 ◽  
Author(s):  
Jill V Hagey ◽  
Kevin Libuit ◽  
Frank J Ambrosio ◽  
Technical Outreach and Assistance for States Team

The Titan_Illumina_PE workflow is a part of the Public Health Viral Genomics Titan series for SARS-CoV-2 genomic characterization. Titan_Illumina_PE was written specifically to process Illumina paired-end (PE) read data. Input reads are assumed to be the product of sequencing tiled PCR-amplicons designed for the SARS-CoV-2 genome. The most common read data analyzed by the Titan_Illumina_PE workflow are generated with the ARTIC V3 protocol. However, alternative primer schemes such as the QIAseq Primer Panel are also suitable for this workflow. The primer sequence coordinates of the PCR scheme utilized must be provided in BED format along with the raw Illumina read data. Upon initiating a Titan_Illumina_PE job, the input primer scheme coordinates and raw paired-end Illumina read data provided for each sample will be processed to perform consensus genome assembly, infer the quality of both raw read data and the generated consensus genome, and assign lineage or clade designations as outlined in the Titan_Illumina_PE data workflow diagram below. Additional technical documentation for the Titan_Illumina_PE workflow is available at: https://public-health-viral-genomics-theiagen.readthedocs.io/en/latest/titan_workflows.html#titan-workflows-for-genomic-characterization Required input data for Titan Illumina PE: Illumina paired-end read data (forward and reverse FASTQ files per sample) Primer sequence coordinates of the PCR scheme utilized in BED file format Video Instruction: Theiagen Genomics: Titan Genomic Characterization https://www.youtube.com/watch?v=zP9I1r6TNrw Theiagen Genomics: Titan Outputs QC https://www.youtube.com/watch?v=Amb-8M71umw For technical assistance please contact us at: [email protected]


F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 56 ◽  
Author(s):  
Giorgio Scita ◽  
Carmen Sorrentino ◽  
Andrea Boggio ◽  
David Hemenway ◽  
Andrea Ballabeni

Basic scientific research generates knowledge that has intrinsic value which is independent of future applications. Basic research may also lead to practical benefits, such as a new drug or diagnostic method.  Building on our previous study of basic biomedical and biological researchers at Harvard, we present findings from a new survey of similar scientists from three countries.  This survey asked about the scientists’ motivations, goals and perspectives along with their attitudes concerning  policies designed to increase both the practical (i.e. public health) benefits of basic research as well as their own personal satisfaction. Close to 900 basic investigators responded to the survey; results corroborate the main findings from the previous survey of Harvard scientists.  In addition, we find that most bioscientists disfavor present policies that require a discussion of the public health potential of their proposals in grants but generally favor softer policies aimed at increasing the quality of work and the potential practical benefits of basic research. In particular, bioscientists are generally supportive of those policies entailing the organization of more meetings between scientists and the general public, the organization of more academic discussion about the role of scientists in the society, and the implementation of a “basic bibliography” for each new approved drug.


Author(s):  
Guillermo López Cala ◽  
Yolanda María de la Fuente Robles ◽  
Rosa María Fernández Alcalá

This chapter deals with accessibility, a relevant and important concept for every citizen in the improvement of their quality of life in any environment or daily situation. Specifically, an empirical study about accessibility in the public health centers of a Basic Health Area (BHA) of Jaén is carried out. From this study, accessibility deficiencies in health buildings are revealed, and explicit proposals are provided with the aim of improving accessibility in different scopes such as information and communications. The improvement plans based on the use of Technology, Information, and Communication (TIC) tools help sensory disabled users that attend to the Health Center.


2019 ◽  
Vol 79 (1) ◽  
pp. 147-157 ◽  
Author(s):  
Eirini Dimidi ◽  
S. Mark Scott ◽  
Kevin Whelan

The aim of this narrative review is to assess and present evidence on the mechanisms of action of probiotics in constipation, their effectiveness and their utilisation by patients and healthcare professionals. Chronic constipation is a common bothersome disorder that has a considerable impact on patients' quality of life. Probiotics have been increasingly investigated for their effectiveness in various disorders, including chronic constipation. Probiotics may affect gut motility and constipation through their impact on the gut microbiota and fermentation, the central and enteric nervous system and the immune system. However, evidence for the effectiveness of probiotics in the management of constipation remains varied, with some strains demonstrating improvements, while others show no effect. Despite the uncertainty in evidence and the fact that the majority of healthcare professionals do not recommend probiotics for constipation, an increased prevalence of probiotic use by people with constipation has been shown. Therefore, there is a need for public health strategies to inform the public about where strong evidence of probiotic effectiveness exist, and where evidence is still weak. Education of healthcare professionals on the increased utilisation of probiotics for constipation by the public and on current evidence for the effectiveness of specific strains is also required.


2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Miguel A. Galán-Martín ◽  
Federico Montero-Cuadrado ◽  
Enrique Lluch-Girbes ◽  
M. Carmen Coca-López ◽  
Agustín Mayo-Iscar ◽  
...  

Abstract Background Chronic musculoskeletal pain affects more than 20% of the population, and the prevalence is increasing, causing suffering, loss of quality of life, disability, and an enormous expenditure on healthcare resources. The most common location for chronic pain is the spine. Many of the treatments used are mainly passive (pharmacological and invasive) and poor outcomes. The treatments currently applied in the public health system do not comply with the recommendations of the main clinical practice guidelines, which suggest the use of educational measures and physical exercise as the first-line treatment. A protocol based on active coping strategies is described, which will be evaluated through a clinical trial and which could facilitate the transfer of the recommendations of the clinical practice guidelines to a primary care setting. Methods Randomised and multicentre clinical trials, which will be carried out in 10 Primary Care centres. The trial will compare the effect of a Pain Neuroscience Education program (six sessions, 10 h) and group physical exercise (18 sessions program carried out in six weeks, 18 h), with usual care physiotherapy treatment. Group physical exercise incorporates dual tasks, gaming, and reinforcement of contents of the educational program. The aim is to assess the effect of the intervention on quality of life, as well as on pain, disability, catastrophism, kinesiophobia, central sensitisation, and drug use. The outcome variables will be measured at the beginning of the intervention, after the intervention (week 11), at six months, and a year. Discussion Therapeutic interventions based on active coping strategies are essential for the treatment of chronic pain and the sustainability of the Public Health System. Demonstrating whether group interventions have an effect size is essential for optimising resources in such a prevalent problem. Trial registration NCT03654235 “Retrospectively registered” 31 August 2018.


2015 ◽  
Vol 33 (1) ◽  
pp. 25-41 ◽  
Author(s):  
Jeffrey E. Jarrett

Purpose – The purpose of this paper is to suggest better methods for monitoring the diagnostic and treatment services for providers of public health and the management of public health services. In particular, the authors examine the construction and use of industrial quality control methods as applied to the public providers, in both the prevention and cure for infectious diseases and the quality of public health care providers in such applications including water quality standards, sewage many others. The authors suggest implementing modern multivariate applications of quality control techniques and/or better methods for univariate quality control common in industrial applications in the public health sector to both control and continuously improve public health services. These methods entitled total quality management (TQM) form the foundation to improve these public services. Design/methodology/approach – The study is designed to indicate the great need for TQM analysis to utilize methods of statistical quality control. All this is done to improve public health services through implementation of quality control and improvement methods as part of the TQM program. Examples of its use indicate that multivariate methods may be the best but other methods are suggested as well. Findings – Multivariate methods provide the best solutions when quality and reliability tests show indications that the variables observed are inter-correlated and correlated over time. Simpler methods are available when the above factors are not present. Research limitations/implications – Multivariate methods will provide for better interpretation of results, better decisions and smaller risks of both Type I and Type II errors. Smaller risks lead to better decision making and may reduce costs. Practical implications – Analysts will improve such things as the control of water quality and all aspects of public health when data are collected through experimentation and/or periodic quality management techniques. Social implications – Public health will be better monitored and the quality of life will improve for all especially in places where public development is undertaking rapid changes. Originality/value – The manuscript is original because it uses well known and scientific methods of analyzing data in area where data collection is utilized to improve public health.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 720-720
Author(s):  
Megan Wolfe ◽  
Molly French ◽  
John Shean

Abstract SIGNIFICANCE. Older adults can contribute wisdom, skills, and time to communities. The public health sector has unique capabilities for creating conditions that promote health, foster community connections, and quality of life. METHODS. Two frameworks provide public health (PH) with core strategies to improve outcomes for all older adults. The Framework for Creating an Age-Friendly Public Health System (AFPHS) supports the PH role, as demonstrated by 37 of Florida’s 67 county health departments that are piloting the AFPHS Framework. The Healthy Brain Initiative’s (HBI) State and Local Public Health Partnerships to Address Dementia is a framework for action used by PH to promote cognitive health, improve care for cognitive impairment, and increase caregiving supports. Both frameworks call for utilizing regional data and cross-sector partnerships. IMPLICATIONS. PH can contribute to community-wide initiatives to promote well-being and community connections for older adults. Cross-sector partnerships can start by using available tools and planning guides.


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