scholarly journals A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines

2021 ◽  
Vol 8 ◽  
Author(s):  
Heraclio Rodriguez ◽  
Maria Lucia De Lucia
Keyword(s):  
Costa Rica ◽  
Latin American ◽  
Negative Impact ◽  
World Health ◽  
Regulatory Agencies ◽  
Regulatory Pathways ◽  
Regulatory Processes ◽  
Local Decision ◽  
Health Organization ◽  
Latin American Countries

In recent years, post-approval changes (PACs) for medicinal products have increased faster than the national regulatory agencies can attend to without causing any negative impact. This study presents a proposal for regulatory management based on our analysis of the data available from the national regulatory agencies of Latin America on the total post-approval changes evaluated, and the time spent in the process. A retrospective search on the official websites of competent national regulatory authorities (NRAs) of 14 Latin American countries (México, Guatemala, Nicaragua, Honduras, El Salvador, Panamá, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Argentina, Chile and Brazil) was conducted to collect data on post-approval changes in the last 4–6 years, up to January 2021. The NRAs considered were Brazil, México, Colombia, and Costa Rica. Our analysis was focused on the post-approval changes that required approval before implementation, those that were submitted, and those that were submitted and approved for small molecules, biologics, and biotechnological products. The results indicated differences in the regulatory processes and procedures applied by the different agencies. We also found that the implementation of the PACs was directly impacted by limited resources, which puts the medication supply for chronic treatments at risk resulting in serious consequences for patients. For local decision-making, Latin American NRAs should implement regulatory pathways already made by regulatory agencies included in the World Health Organization Listed Authorities on PAC approval to optimize their resources and to ensure the continuity of medicine supply for their patients.

scholarly journals La violencia homicida en América Latina

2009 ◽  
Vol 50 ◽  
Author(s):  
Roberto Briceño-León
Keyword(s):  
Latin America ◽  
Latin American ◽  
World Health ◽  
Data Bases ◽  
Homicide Rates ◽  
Social Classification ◽  
America Latina ◽  
Health Organization ◽  
Latin American Countries

RESUMEN: El artículo analiza la situación de la violencia homicida en América Latina, cuál es su ubicación en la situación mundial de violencia y cuáles serían las posibles explicaciones para el lugar que ocupa. Utilizando la base de datos de la Organización Mundial de la Salud se clasifican las regiones por su tasa de homicidios y se ubica a América Latina como la región más violenta. Los países de América Latina son clasificados en cuatro grupos de acuerdo a la relación de su tasa de homicidios con la tasa media mundial y se caracterizan socialmente las víctimas.Para interpretar esa situación se relacionan con los niveles de urbanización y pobreza y se presentan los factores que pueden originar, fomentar y facilitar el incremento o disminución de los homicidios y su potencial utilidad en las políticas públicas.ABSTRACT: This article explores the situation of homicide violence in Latin America, its position within the worlds violence situation and the possible explanations for that position. Using the data bases of the World Health Organization, regions are classified by their homicide rates, which puts Latin America as the most violent region. Latin American countries are set in four groups according to the relation of their homicide rates with the world’s rate, and a social classification of victims is built. For interpreting this situation, those factors are put in relation with the levels of urbanization and poverty, and the possible causes of the increase or decrease of homicides are presented, as well as their potential utility for public policy making.

scholarly journals The adult mortality profile by cause of death in 10 Latin American countries (2000–2016)

2020 ◽  
Vol 44 ◽  
pp. 1 ◽  
Author(s):  
Júlia Almeida Calazans ◽  
Bernardo Lanza Queiroz
Keyword(s):  
Cause Of Death ◽  
Latin American ◽  
Causes Of Death ◽  
Circulatory System ◽  
Adult Mortality ◽  
World Health ◽  
Epidemiological Transition ◽  
Circulatory System Diseases ◽  
Health Organization ◽  
Latin American Countries

Objective. To investigate the adult mortality profile from eight causes of death in 10 Latin American countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Paraguay, Peru, and Uruguay) from 2000 to 2016. Methods. The cause of death effect in adult mortality was calculated as the hypothetical gain in the average number of years lived in adulthood (15 to 60 years old), in a cause-deleted life table. Mortality information by cause, sex, and age group came from the World Health Organization. Results. Although the adult mortality levels are very different among the 10 countries, the pattern of mortality by cause of death is very similar. All the countries are in the intermediate stages of the epidemiological transition, with chronic degenerative diseases being predominant. Among males, circulatory system diseases and external causes are the most important causes of death in terms of the average number of years lived in adulthood. Among females, the leading causes are circulatory system diseases and neoplasms. Conclusions. Some studies have pointed out that Latin America exhibits severe difficulties in moving through some epidemiological transition phases, given the continuing high mortality from chronic diseases and violent deaths. However, between 2000 and 2016, there was a convergence among the 10 analyzed countries around the theoretical limit in the average number of years lived in adulthood. Countries that include Brazil, Colombia, Ecuador, Mexico, Paraguay, and Peru are still further away from this limit, but they have an enormous potential to increase the number of years lived in adulthood in the future.

scholarly journals What challenges does mental and neurological health research face in Latin American countries?

2008 ◽  
Vol 30 (4) ◽  
pp. 328-336 ◽  
Author(s):  
Fabián Fiestas ◽  
Carla Gallo ◽  
Giovanni Poletti ◽  
Inés Bustamante ◽  
Renato D Alarcón ◽  
...  
Keyword(s):  
Latin American ◽  
Health Resources ◽  
Research Capacity ◽  
World Health ◽  
Structured Interviews ◽  
Middle Income ◽  
Neurological Research ◽  
Health Organization ◽  
Funding Opportunities ◽  
Latin American Countries

OBJECTIVE: The World Health Organization Atlas Project identified important deficiencies in world mental and neurological health resources. These deficiencies, especially evident in low and middle-income countries, can be overcome by improving research capacity. The objective of this study is to assess the status of mental and neurological research in Latin American countries and identify the main difficulties encountered in conducting research, publishing results, and shaping health policies, interventions, and programs. METHOD: Semi-structured interviews were conducted with 34 key informants from 13 Latin American countries. RESULTS: Participants reported that production of mental and neurological research in Latin American countries is low. Lack of financial and human resources, including lack of support from government agencies, were identified as the main factors contributing to the dearth of local research. The few research projects that do take place in Latin American countries are often funded at researchers' personal expense. Few policies, interventions, or programs are generated from research results. To address these deficiencies, participants called for training in research methodology, mechanisms for identifying funding opportunities, and greater recognition of their research products. CONCLUSIONS: Researchers and stakeholders recognize the need to mobilize local and international efforts aimed at strengthening research capacity and results implementation. This will lead to an overall optimization of mental and neurological research in the region.

Coronavirus diseases and pregnancy: COVID-19,SARS, and MERS

2020 ◽  
pp. 276-289
Author(s):  
Mobina Fathi ◽  
Kimia Vakili ◽  
Niloofar Deravi
Keyword(s):  
Pregnant Women ◽  
Intrauterine Growth Retardation ◽  
Negative Impact ◽  
World Health ◽  
Wuhan City ◽  
Intrauterine Growth ◽  
Exponential Increase ◽  
The World ◽  
Health Organization ◽  
Respiratory Droplets

Around the end of December 2019, a new beta-coronavirus from Wuhan City, Hubei Province, China began to spread rapidly. The new virus, called SARS-CoV-2, which could be transmitted through respiratory droplets, had a range of mild to severe symptoms, from simple cold in some cases to death in others. The disease caused by SARS-CoV-2 was named COVID-19 by WHO and has so far killed more people than SARS and MERS. Following the widespread global outbreak of COVID-19, with more than 132758 confirmed cases and 4955 deaths worldwide, the World Health Organization declared COVID-19 a pandemic disease in January 2020. Earlier studies on viral pneumonia epidemics has shown that pregnant women are at greater risk than others. During pregnancy, the pregnant woman is more prone to infectious diseases. Research on both SARS-CoV and MERS-CoV, which are pathologically similar to SARS-CoV-2, has shown that being infected with these viruses during pregnancy increases the risk of maternal death, stillbirth, intrauterine growth retardation and, preterm delivery. With the exponential increase in cases of COVID-19 throughout the world, there is a need to understand the effects of SARS-CoV-2 on the health of pregnant women, through extrapolation of earlier studies that have been conducted on pregnant women infected with SARS-CoV, and MERS-CoV. There is an urgent need to understand the chance of vertical transmission of SARS-CoV-2 from mother to fetus and the possibility of the virus crossing the placental barrier. Additionally, since some viral diseases and antiviral drugs may have a negative impact on the mother and fetus, in which case, pregnant women need special attention for the prevention, diagnosis, and treatment of COVID-19.

scholarly journals An Innovative Approach to Designing Digital Health Solutions Addressing the Unmet Needs of Obese Patients in Europe

2021 ◽  
Vol 18 (2) ◽  
pp. 579
Author(s):  
Roberta Patalano ◽  
Vincenzo De Luca ◽  
Jess Vogt ◽  
Strahil Birov ◽  
Lucia Giovannelli ◽  
...  
Keyword(s):  
Unmet Needs ◽  
Negative Impact ◽  
Digital Health ◽  
Integrated Approach ◽  
World Health ◽  
Obese Patients ◽  
Unhealthy Lifestyle ◽  
Significant Negative Impact ◽  
Related Quality ◽  
Health Organization

According to the World Health Organization (WHO), the worldwide obesity rate has tripled since 1975. In Europe, more than half of the population is overweight and obese. Around 2.8 million people die each year worldwide as a result of conditions linked to being overweight or obese. This study aimed to analyze the policies, approaches, and solutions that address the social and health unmet needs of obese patients, at different levels, in order to simulate the definition of an integrated approach, and to provide and share examples of innovative solutions supporting health promotion, disease prevention, and integration of services to improve the collaboration between the different health and care stakeholders involved across the country and in the lives of obese patients. A collaborative approach involving various levels of government and regional experts from different European countries was applied to identify, explore, and evaluate different aspects of the topic, from the innovation perspective and focusing on a European and a regional vision. Currently, people prefer more foods rich in fats, sugars, and salt/sodium than fruits, vegetables, and fiber. This behavior leads to a significant negative impact on their health-related quality of life. Changes in healthcare systems, healthy policy, and approaches to patient care and better implementation of the different prevention strategies between all the stakeholders are needed, taking advantage of the digital transformation of health and care. Such changes can support obese patients in their fight against an unhealthy lifestyle and at the same time reduce healthcare costs.

PERFORMANCE OF THE NURSING TEAM IN THE HUMANIZATION OF NORMAL DELIVERY

2021 ◽  
Keyword(s):  
Latin American ◽  
World Health ◽  
Normal Delivery ◽  
Normal Birth ◽  
Natural Event ◽  
Quality Of Delivery ◽  
Delivery Services ◽  
Women's Role ◽  
The Moment ◽  
Health Organization

Historically, birth was considered a natural event, respected until the sixteenth century as an exclusively female movement. From the moment that the delivery began to happen inside the hospital with the participation of doctors in the process of the same, the woman stopped being the most important person and active of that event. Therefore, in order to change in this scenario, the World Health Organization and the Ministry of Health have been guiding and implementing behaviors that should be stimulated during childbirth, such as the presence of a companion, the supply of fluids, the use of non-invasive techniques for relief of pain and freedom of choice of birth position, among others. The study aims to verify in the literature the systematization of knowledge about the awareness of the benefits of normal delivery, pointing out the behaviors performed that favor the woman's role. This is a literature review, with descriptive and explanatory character, in the databases Scientific Electronic Library (ScIELO), Latin American and Caribbean Literature in Health Sciences (LILACS); And the National Library of Medicine (PUBMED, from 2008 to 2019), using the following descriptors: normal delivery, humanization, humanization in normal birth, women's role, and the result was three categories: The synthesis of the articles allowed us to understand that there are already some changes in the care of women during labor, but that there is still a lack of knowledge about the role of women in the labor market. It is concluded that in order for women to take part in labor and delivery, humanization becomes necessary, which is evidenced by the need to improve access and quality of delivery services.

Incidence of Infection and Mortality in Surgeries of Sports Injuries during COVID-19 Pandemic at GTTH, ahore, Pakistan

2021 ◽  
Vol 15 (8) ◽  
pp. 1846-1848
Author(s):  
Sarmad Khalil ◽  
Hizbullah Riaz Ansari ◽  
Ali Ijaz Ahmad ◽  
Abdullah Ali Mohammad Al-Hutam ◽  
Majid Zaheer ◽  
...  
Keyword(s):  
Sports Injuries ◽  
Negative Impact ◽  
Cruciate Ligament ◽  
World Health ◽  
X Rays ◽  
Keywords Anterior Cruciate Ligament ◽  
Anterior Cruciate ◽  
Health Organization ◽  
Keywords Anterior Cruciate ◽  
Related Mortality

Aim: To find out if there was a negative impact or consequence of performing surgeries related to sports injuries during COVID-19 period when most of the hospital services were suspended all over the globe. Study design: Prospective study Place and duration of study: Department Orthopaedic and Spine, Ghurki Trust Teaching Hospital, Lahore from 19thMarch 2020 to 6thAugust 2020. Methodology: Seventy patients with sports injuries were enrolled. The history and thorough clinical examination, X-rays and CBC along with other relevant investigations were recorded. The patients were discharged in 24 to 74 hours period intervals and all the necessary SOPs regarding COVID-19 were strictly followed. Results: None of the patients who underwent procedure developed infection or acquired coronavirus illness after discharge from the hospital or during follow-ups in OPD. Conclusion: The surgeries performed during COVID-19 did not result in wound infection or patient-related mortality. Keywords: Anterior cruciate ligament (ACL), Arthroscopy, COVID-19, Pandemic, Posterior cruciate ligament (PCL), Sports injuries, Infection, World Health Organization (WHO)

scholarly journals In Memoriam Dietrich Hoffmann

2011 ◽  
Vol 24 (6) ◽  
pp. 254-256 ◽  
Author(s):  
H Klus ◽  
M Kunze ◽  
Beiträge Editors of
Keyword(s):  
New York ◽  
International Organizations ◽  
Tobacco Industry ◽  
World Health ◽  
Regulatory Agencies ◽  
International Agency ◽  
The World ◽  
In Memoriam ◽  
Health Organization ◽  
National Governments

AbstractDietrich Hoffmann passed away on April 20, 2011, at his home in Larchmont, New York. He had suffered from Parkinson's disease for more than 20 years. With Dietrich Hoffmann's death the tobacco community lost one of its most prominent scientists, who was familiar with all areas of tobacco research. His work guided and influenced a whole generation of scientists working in the tobacco industry, universities, regulatory agencies, national governments or international organizations, such as the World Health Organization and the International Agency for Research on Cancer (IARC). It is an obligation of honor for the authors M. Kunze, H. Klus, and the editors of BeiträgezurTabakforschung International publish a short tribute in memory of Dietrich Hoffmann.

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