Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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The report and an accompanying series of studies show the global uptake of the World Health Organization (WHO) Surgical Safety Checklist in its first ten years since its launch and recommend ways the Checklist can be more effectively used to improve surgical safety for millions at risk.
The report ...found that uptake has been remarkably positive: the Checklist has been adopted in almost 90% of operating rooms in countries with a high Human Development Index (HDI), a country-level measure of health, education, and standard of living. It was referenced by at least 139 (70%) of the world's countries and is included as a national standard by the health ministries of at least 20 countries. The Checklist has also had beneficial qualitative impact, introducing a culture of safety and improved communication within surgical teams, increasing patient trust, and improving job satisfaction.
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The National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), 2020-2025, presents
coordinated, strategic actions that the United States Government will take in the next five years to improve the health and wellbeing of all Americans by changing the course of antibiotic resistance.
T...his Plan is based on the U.S. Government’s 2014 National Strategy for CARB, and builds on the first National Action Plan released in 2015 by expanding evidence-based activities that have already been shown to reduce antibiotic resistance, such as optimizing the use of antibiotics in human and animal health settings.
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Internationally, there is a growing concern over antimicro-bial resistance (AMR) which is currently estimated to ac-count for more than 700,000 deaths per year worldwide. If no appropriate measures are taken to halt its pro-gress, AMR will cost approximately 10 million lives andabout US$100 trillion... per year by 2050. In contrast tosome other health issues, AMR is a problem that con-cerns every country irrespective of its level of incomeand development as resistant pathogens do not respect borders.Despite the threat presented by AMR, the 2014 WorldHealth Organization (WHO) and the recent O’Neill re-port describe significant gaps in surveillance, standardmethodologies and data sharing. The 2014 WHOreport identified Africa and South East Asia as the regions without established AMR surveillance systems.
Tadesseet al. BMC Infectious Diseases (2017) 17:616 DOI 10.1186/s12879-017-2713-1
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Coronavirus Disease-19 (COVID-19) was declared a global pandemic on 11 March 2020, and Malawi declared its first case on 2 April. As of 30 April, there were 36 confirmed positive cases of COVID-19 and 3 deaths. A State of Disaster was declared by President Arthur Peter Mutharika on 20 March and a 21...-day lockdown was implemented from 18 April to 9 May. The lockdown measures include: bans on public gatherings; closure of schools; and bans on international flights and cross-border passenger buses.
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Breastfeeding is the cornerstone of infant and young child survival, nutrition and development and maternal health. The World Health Organization recommends exclusive breastfeeding for the first 6 months of life, followed by continued breastfeeding with appropriate complementary foods for up to 2 ye...ars and beyond.1 Early and uninterrupted skin-toskin contact, rooming-in2 and kangaroo mother care3 also significantly improve neonatal survival and reduce morbidity and are recommended by WHO.
Corrigendum 23 June 2020
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To provide recommendations on the initial care of persons with acute respiratory illness (ARI) in the context of coronavirus disease (COVID-19) in healthcare facilities based on a decision-making process flowchart. These recommendations are preliminary and subject to review as new evidence becomes a...vailable. The recommendations provided in this document apply for adults olden than 18 years old.
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Human Mobility, Shared Opportunities recommends expanding legal pathways, reducing transaction costs on remittances, guaranteeing migrants’ rights, especially for women, fostering integration and social cohesion, and mobilizing diasporas. With forced migration doubling over the last 10 years to ar...ound 79 million people, tackling its causes will be essential for development.
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The report finds that, as of 3 November, in 87 countries with age-disaggregated data, children and adolescents under 20 years of age accounted for 1 in 9 of COVID-19 infections, or 11 per cent of the 25.7 million infections reported by these countries. More reliable, age-disaggregated data on infect...ion, deaths and testing is needed to better understand how the crisis impacts the most vulnerable children and guide the response
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A new report from aid agencies Age International and HelpAge International, If not now, when? criticises the humanitarian sector for its failure to address the needs of older people in emergencies. This failure contravenes several international commitments made in recent years and flies in the face ...of humanitarian principles
Download the full report here: https://www.helpage.org/download/5fb34a78e7597/
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COVID-19 has triggered the deepest global recession since the 1930s. Extreme poverty has risen for the first time in 22 years, and unemployment has increased dramatically. Women and young people aged 15 – 29 working in the informal sector are being hit the hardest. School closures have affected 91... per cent of students worldwide.
Political conflicts are more intense and taking a heavy toll on civilians, disproportionately affecting children. Women and girls are at increased risk of conflict-related sexual violence. Attacks against aid and health workers persist. For the ninth consecutive year, more than 90 per cent of casualties from explosive weapons in populated areas were civilians.
The last decade saw the highest-ever number of people internally displaced by conflict and violence, with many locked in a state of protracted displacement. There are an estimated 51 million new and existing IDPs, and the number of refugees has doubled to 20 million.
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The WHO Regional Office for Europe has established the Childhood Obesity Surveillance Initiative in more than half the countries in the Region for routine monitoring of the policy response to the emerging obesity epidemic. The aim of the Initiative is to measure trends in overweight and obesity in c...hildren aged 6.0–9.9 years to get a clear understanding of the epidemic and to allow inter-country comparisons. This document outlines the common protocol agreed for use in the Initiative.
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The WHO Regional Office for Europe has established the Childhood Obesity Surveillance Initiative in more than half thecountries in the Region for routine monitoring of the policy response to the emerging obesity epidemic. The aim of the system is to measure trends in overweight and obesity in childr...en aged 6.0–9.9 years for accurate understanding of the epidemic and to allow inter-country comparisons. This document outlines the data collection procedures agreed for use in the Initiative.
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Published OnlineJuly 14, 2021https://doi.org/10.1016/S2214-109X(21)00164-9. New Lancet research offers the first comprehensive analysis of the growing footprint of noncommunicable and injury-related neurological disorders to India’s overall disease burden.
Takeaways from 1990 to 2019 In terms ...of total disability adjusted life years:
• The share of noncommunicable neurological disorders doubled from 4% to 8.2%.
• Injury-related neurological disorders increased from 0.2% to 1.1%
• The contribution of communicable neurological disorders decreased from 4.1% to 1.1%
• Stroke, epilepsy, cerebral palsy, and headache disorders were among the largest contributors to DALYs.
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The humanitarian situation in the Central African Republic (CAR) has further worsened over the past six months. Election-related violence that broke out in mid-December 2020 has had a devastating effect on civilians. Thousands of people have been forced to flee, human rights violations have surged, ...hundreds of schools and dozens of hospitals have been forcibly closed and food prices have skyrocketed. This deterioration occurred in an already alarming context, with more than half of the population (2.8 million people) in need of humanitarian assistance and protection and 1.9 million people in acute need. In the past five years, there have never been as many people in humanitarian distress in CAR as today.
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Ghana's attempt to regulate health care waste management started in 2002 with the development of guidelines on health care waste manage-ment by the Environmental Protection Agency (EPA). In 2006, the Ghana Health Service (GHS) also developed the Health Care Waste Management Policy and Guidelines as ...a single document.
Although awareness on Health Care Waste Management (HCWM) has improved in recent years, there is the need for a systematic approach to improve on effective segregation, safe collection, and storage, as well as ultimate treatment before disposal.
This guideline seeks to ensure that HCW is managed effectively in compliance with existing International Conventions that Ghana is a signatory to, national laws and regulations, and others to be passed in future.
Recommendations for better management of HCW in the nation's health care facilities have been presented in this document. Also, standard operating procedures (SOPs) have been developed to provide
guidance to various levels of the health facilities.
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March 2021. “A Decade of Destruction: Attacks on health care in Syria,” highlights with chilling detail how this 10-year war strategy has turned hospitals from safe havens into no-go zones where Syrian civilians now fear for their lives.
A new story book that aims to help children understand and come to terms with COVID-19 has been produced
With the help of a fantasy creature, Ario, “My Hero is You, How kids can fight COVID-19!” explains how children can protect themselves, their families and friends from coronavirus and how to... manage difficult emotions when confronted with a new and rapidly changing reality.
Available in more languages
The book – aimed primarily at children aged 6-11 years old – is a project of the Inter-Agency Standing Committee Reference Group on Mental Health and Psychosocial Support in Emergency Settings, a unique collaboration of United Nations agencies, national and international nongovernmental organizations and international agencies providing mental health and psychosocial support in emergency settings.
Available in different languages
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Because of the limited access to more powerful diagnostic tools, there is a paucity of data regarding the burden of fungal infections in Burkina Faso. The aim of this study was to estimate the incidence and prevalence of serious fungal infections in this sub-Saharan country. We primarily used the na...tional demographic data and performed a PubMed search to retrieve all published papers on fungal infections from Burkina Faso and its surrounding West African countries. Considering the prevalence of HIV infection (0.8% of the population) and a 3.4% incidence of cryptococcosis in hospitals, it is estimated that 459 patients per year develop cryptococcosis. For pneumocystosis, it is suggested that 1013 new cases occur every year. Taking into account the local TB frequency (population prevalence at 0.052%), we estimate the prevalence of chronic pulmonary aspergillosis at 1120 cases. Severe forms of asthma with fungal sensitization and allergic bronchopulmonary aspergillosis are estimated to affect 7429 and 5628 cases, respectively. Vulvovaginal candidiasis may affect 179,000 women, and almost 1,000,000 children may suffer from tinea capitis. Globally, we estimate that roughly 1.4 million people in Burkina Faso (7.51% of the population) suffer from a serious fungal infection. These data should be used to drive future epidemiological studies, diagnostic approaches, and therapeutic strategies.
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The report identifies major global gaps in WASH services: one third of health care facilities do not have what is needed to clean hands where care is provided; one in four facilities have no water services, and 10% have no sanitation services. This means that 1.8 billion people use facilities that l...ack basic water services and 800 million use facilities with no toilets. Across the world’s 47 least-developed countries, the problem is even greater: half of health care facilities lack basic water services. Furthermore, the extent of the problem remains hidden because major gaps in data persist, especially on environmental cleaning.
This report also describes the global and national responses to the 2019 World Health Assembly resolution on WASH in health care facilities. More than 70% of countries have conducted related situation analyses, 86% have updated and are implementing standards and 60% are working to incrementally improve infrastructure and operation and maintenance of WASH services. Case studies from 30 countries demonstrate that progress is being propelled by strong national leadership and coordination, use of data to direct resources and action, and the mutual benefits of empowering health workers and communities to develop solutions together.
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