scholarly journals Worldwide Assessment of Low- and Middle-Income Countries' Regulatory Preparedness to Approve Medical Products During Public Health Emergencies

2021 ◽  
Vol 8 ◽  
Author(s):  
Alireza Khadem Broojerdi ◽  
Claudia Alfonso ◽  
Razieh Ostad Ali Dehaghi ◽  
Mohamed Refaat ◽  
Hiiti Baran Sillo

Background: Regulatory preparedness for public health emergencies is critical. However, responses to past emergencies, such as the 2009 H1N1 influenza pandemic and medical product shortages, have revealed sizable gaps in countries' regulatory capacity and preparedness. A systematic analysis of the regulatory preparedness of countries around the world has not yet been performed. The purpose of this study was to analyze and document the current regulatory preparedness status, highlight the related gaps and challenges in order to propose strategic, harmonized, and sustainable regulatory solutions to improve future responses to public health emergencies.Methods: From 2016 to 2020, we used the World Health Organization (WHO)'s Global Benchmarking Tool (GBT), a standardized instrument for identifying national regulatory authorities' strengths and gaps, to analyze the regulatory preparedness of 84 Member States, 95% of which were low- or middle-income countries. We analyzed whether participating Member States had not implemented, displayed ongoing implementation, had partially implemented, or had fully implemented 10 of the GBT's 268 sub-indicators most relevant to regulatory preparedness for public health emergencies.Findings: Only 10 Member States (12%) that underwent benchmarking had fully implemented all 10 sub-indicators related to regulatory preparedness for public health emergencies; 34 (40%) had fully implemented ≥50% of the emergency sub-indicators, and 20 (24%) had not fully implemented any of the sub-indicators. With regard to individual sub-indicators, regulatory preparedness ranged from 19 Member States (23%) fully implementing reliance on clinical trial decisions of others to 45 (59%) fully implementing legal provisions to fast-track (or expedite) marketing authorization applications.Interpretation: Many WHO Member States have limited regulatory preparedness for a public health emergency. Strengthening regulatory systems and promoting Good Regulatory Practices and reliance in these countries, to enable efficient response to emergencies, should be a global health priority.

Author(s):  
Swayam Pragyan Parida ◽  
Vikas Bhatia ◽  
Prajna Paramita Giri ◽  
Binod K. Behera ◽  
G. Alekhya ◽  
...  

Undernutrition continues to be a major public health challenge for ages. Under-five age children are still at risk of undernutrition even though there exist many policies and programs at various levels. The lower–middle-income countries (LMIC) struggle hard to combat the undernutrition epidemic. The unprecedented advent of the COVID-19 pandemic has worsened the existing undernutrition scenario. This article reviews the burden and impact of the COVID-19 on undernutrition among children. Necessary measures have to be taken to mitigate the crisis and thereby reduce the risks due to morbidity and mortality related to undernutrition. A manual search of relevant data has been taken from the website of the World Health Organization (WHO), UNICEF, Ministry Health and Family Welfare (MOHFW), government of India. (GOI). A search of relevant publications was done through electronic databases such as PUBMED.


Author(s):  
Brendon Stubbs ◽  
Kamran Siddiqi ◽  
Helen Elsey ◽  
Najma Siddiqi ◽  
Ruimin Ma ◽  
...  

Tuberculosis (TB) is a leading cause of mortality in low- and middle-income countries (LMICs). TB multimorbidity [TB and ≥1 non-communicable diseases (NCDs)] is common, but studies are sparse. Cross-sectional, community-based data including adults from 21 low-income countries and 27 middle-income countries were utilized from the World Health Survey. Associations between 9 NCDs and TB were assessed with multivariable logistic regression analysis. Years lived with disability (YLDs) were calculated using disability weights provided by the 2017 Global Burden of Disease Study. Eight out of 9 NCDs (all except visual impairment) were associated with TB (odds ratio (OR) ranging from 1.38–4.0). Prevalence of self-reported TB increased linearly with increasing numbers of NCDs. Compared to those with no NCDs, those who had 1, 2, 3, 4, and ≥5 NCDs had 2.61 (95% confidence interval (CI) = 2.14–3.22), 4.71 (95%CI = 3.67–6.11), 6.96 (95%CI = 4.95–9.87), 10.59 (95%CI = 7.10–15.80), and 19.89 (95%CI = 11.13–35.52) times higher odds for TB. Among those with TB, the most prevalent combinations of NCDs were angina and depression, followed by angina and arthritis. For people with TB, the YLDs were three times higher than in people without multimorbidity or TB, and a third of the YLDs were attributable to NCDs. Urgent research to understand, prevent and manage NCDs in people with TB in LMICs is needed.


Author(s):  
Chris Bullen ◽  
Jessica McCormack ◽  
Amanda Calder ◽  
Varsha Parag ◽  
Kannan Subramaniam ◽  
...  

Abstract Background: The global COVID-19 pandemic has disrupted healthcare worldwide. In low- and middle-income countries (LMICs), where people may have limited access to affordable quality care, the COVID-19 pandemic has the potential to have a particularly adverse impact on the health and healthcare of individuals with noncommunicable diseases (NCDs). A World Health Organization survey found that disruption of delivery of healthcare for NCDs was more significant in LMICs than in high-income countries. However, the study did not elicit insights into the day-to-day impacts of COVID-19 on healthcare by front-line healthcare workers (FLHCWs). Aim: To gain insights directly from FLHCWs working in countries with a high NCD burden, and thereby identify opportunities to improve the provision of healthcare during the current pandemic and in future healthcare emergencies. Methods: We recruited selected frontline healthcare workers (general practitioners, pharmacists, and other medical specialists) from nine countries to complete an online survey (n = 1347). Survey questions focused on the impact of COVID-19 pandemic on clinical practice and NCDs; barriers to clinical care during the pandemic; and innovative responses to the many challenges presented by the pandemic. Findings: The majority of FLHCWs responding to our survey reported that their care of patients had been impacted both adversely and positively by the public health measures imposed. Most FLHCs (95%) reported a deterioration in the mental health of their patients. Conclusions: Continuity of care for NCDs as part of pandemic preparedness is needed so that chronic conditions are not exacerbated by public health measures and the direct impacts of the pandemic.


2014 ◽  
Vol 27 (3) ◽  
pp. 511-529 ◽  
Author(s):  
Sudeepa Abeysinghe

ArgumentScientific uncertainty is fundamental to the management of contemporary global risks. In 2009, the World Health Organization (WHO) declared the start of the H1N1 Influenza Pandemic. This declaration signified the risk posed by the spread of the H1N1 virus, and in turn precipitated a range of actions by global public health actors. This article analyzes the WHO's public representation of risk and examines the centrality of scientific uncertainty in the case of H1N1. It argues that the WHO's risk narrative reflected the context of scientific uncertainty in which it was working. The WHO argued that it was attempting to remain faithful to the scientific evidence, and the uncertain nature of the threat. However, as a result, the WHO's public risk narrative was neither consistent nor socially robust, leading to the eventual contestation of the WHO's position by other global public health actors, most notably the Council of Europe. This illustrates both the significance of scientific uncertainty in the investigation of risk, and the difficulty for risk managing institutions in effectively acting in the face of this uncertainty.


F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 2522 ◽  
Author(s):  
Dylan Collins ◽  
Joseph Lee ◽  
Niklas Bobrovitz ◽  
Constantinos Koshiaris ◽  
Alison Ward ◽  
...  

The World Health Organisation and International Society of Hypertension (WHO/ISH) cardiovascular disease (CVD) risk assessment charts have been implemented in many low- and middle-income countries as part of the WHO Package of Essential Non-Communicable Disease (PEN) Interventions for Primary Health Care in Low-Resource settings. Evaluation of the WHO/ISH cardiovascular risk charts and their use is a key priority and since they only exist in paper or PDF formats, we developed a simple R implementation of the charts for all epidemiological subregions of the world. The main strengths of this implementation are that it is built in a free, open-source, coding language with simple syntax, can be modified by the user, and can be used with a standard computer.


2016 ◽  
Vol 3 ◽  
Author(s):  
C. L. H. Bockting ◽  
A. D. Williams ◽  
K. Carswell ◽  
A. E. Grech

The World Health Organization (WHO) reports that low- and middle-income countries (LMICs) are confronted with a serious ‘mental health gap’, indicating an enormous disparity between the number of individuals in need of mental health care and the availability of professionals to provide such care (WHO in 2010). Traditional forms of mental health services (i.e. face-to-face, individualised assessments and interventions) are therefore not feasible. We propose three strategies for addressing this mental health gap: delivery of evidence-based, low-intensity interventions by non-specialists, the use of transdiagnostic treatment protocols, and strategic deployment of technology to facilitate access and uptake. We urge researchers from all over the world to conduct feasibility studies and randomised controlled studies on the effect of low-intensity interventions and technology supported (e.g. online) interventions in LMICs, preferably using an active control condition as comparison, to ensure we disseminate effective treatments in LMICs.


Author(s):  
Raiiq Ridwan ◽  
Md Robed Amin ◽  
Md Ridwanur Rahman

Since December 2019, when a cluster of atypical pneumonia cases were identified in Wuhan, China a new disease has spread across the world. COVID-19 has since become the biggest pandemic in a century, touching lives in almost every country in the world. At the outset of COVID-19, the World Health Organization advised for testing to become a priority so that patients with COVID-19 could be quickly identified, isolated and treated to interrupt transmission of disease. However, testing shortages have been an increasing problem in low and middle income countries. Even when tests are available, it has proved time-consuming. Therefore, we propose a symptom-based tool to assist in the diagnosis of COVID-19 management in low and middle income Countries. It is based on the symptoms that have so far been described in the literature and advises the frontline healthcare worker on how to diagnose the likelihood of having COVID-19 and separate the patient into Red (very likely), Yellow (possible) and Green (unlikely) categories. J Bangladesh Coll Phys Surg 2020; 38(0): 71-75


2015 ◽  
Vol 12 (S1) ◽  
pp. S-16-S-19 ◽  
Author(s):  
Anne Aboaja ◽  
Puja Myles ◽  
Peter Hughes

This paper describes the evaluation of a pilot e-supervision programme, with a focus on feasibility. The findings suggest that e-supervision in mental health using the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP) Intervention Guide and case-based discussions is valued by participants and can improve the knowledge, confidence and beliefs of primary care doctors in low- and middle-income countries.


Author(s):  
Chastin SFM ◽  
J. Van Cauwenberg ◽  
L. Maenhout ◽  
G. Cardon ◽  
E. V. Lambert ◽  
...  

Abstract Background Physical inactivity is a global pandemic associated with a high burden of disease and premature mortality. There is also a trend in growing economic inequalities which impacts population health. There is no global analysis of the relationship between income inequality and population levels of physical inactivity. Methods Two thousand sixteen World Health Organisation’s country level data about compliance with the 2010 global physical activity guidelines were analysed against country level income interquantile ratio data obtained from the World Bank, OECD and World Income Inequality Database. The analysis was stratified by country income (Low, Middle and High) according to the World Bank classification and gender. Multiple regression was used to quantify the association between physical activity and income inequality. Models were adjusted for GDP and percentage of GDP spent on health care for each country and out of pocket health care spent. Results Significantly higher levels of inactivity and a wider gap between the percentage of women and men meeting global physical activity guidelines were found in countries with higher income inequality in high and middle income countries irrespective of a country wealth and spend on health care. For example, in higher income countries, for each point increase in the interquantile ratio data, levels of inactivity in women were 3.73% (CI 0.89 6.57) higher, levels of inactivity in men were 2.04% (CI 0.08 4.15) higher and the gap in inactivity levels between women and men was 1.50% larger (CI 0.16 2.83). Similar relationships were found in middle income countries with lower effect sizes. These relationships were, however, not demonstrated in the low-income countries. Conclusions Economic inequalities, particularly in high- and middle- income countries might contribute to physical inactivity and might be an important factor to consider and address in order to combat the global inactivity pandemic and to achieve the World Health Organisation target for inactivity reduction.


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