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Despite a historical association with poor tolerability, a comprehensive review on safety of antileishmanial chemotherapies is lacking. We carried out an update of a previous systematic review of all published clinical trials in visceral leishmaniasis (VL) from 1980 to 2019 to document any reported
...
serious adverse events (SAEs).
more
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
Under the theme “Stronger Together”, the campaign aims to offer information and strategies to assist communities in the region in better coping with the psychological impact of adverse events be
...
fore, during and after a disaster situation. It also aims to raise awareness to reduce the stigma about seeking mental health and psychosocial support.
You can download a wide range of communication material: videos, posters, radio jingles, guidebooks.
The Caribbean is highly prone to natural hazards, including seismic activity, hurricanes, landslides and floods. These events have resulted in lost lives, serious injuries and severe damage to housing and infrastructure. A single hurricane event can affect more than one island, and completely erase the gains of many years of productivity. As a result, these unpredictable hazards create disruption and have an ongoing impact on people’s lives - affecting their mental health and psychosocial well-being.
Although everyone is affected in some way by disaster events, there are a wide range of reactions and feelings that a person can experience. People may feel overwhelmed, confused or very uncertain about what is happening. They can also feel very fearful, anxious, numb or detached. People who feel safe, connected, calm and hopeful, have access to social, physical and emotional support and find ways to help themselves after a disaster, however, will be better able to recover long-term from mental health effects
more
Health care-associated infections (HAI) are one of the most common adverse events in care delivery and a major public health problem with an impact on morbidity, mortality and quality of life. At an
...
y one time, up to 7% of patients in developed and 10% in developing countries will acquire at least one HAI. These infections also present a significant economic burden at the societal level. However, a large percentage are preventable through effective infection prevention and control (IPC) measures.
more
A toolkit for pharmacists.
Emerging data show that medication errors and adverse events cause significant harm to patients’ health and
well-being. It is estimated that the burden of
...
adverse events due to medicines is now comparable to that of
widespread diseases, such as malaria or tuberculosis.1 The impacts of medication errors also represent a
burden for health systems, with the annual cost associated with medication errors estimated at USD 42 billion
worldwideharm
more
The recurrence of severe climate events combined with economic, social, and institutional fragilities leave El Salvador in an utterly critical humanitarian situation and highly vulnerable. Located in a disaster-prone subregion, El Salvador is among
...
the 20 countries at the highest risk of disasters worldwide. The successive hydrometeorological hazards that impacted El Salvador over the past two years include tropical storms Amanda and Cristóbal and hurricanes Eta, Iota, and,
more recently, Julia. These storms profoundly affected the lives and livelihoods of almost 900 000 people and significantly disrupted health services, especially at the first level of care. In addition, the country’s exposure to earthquakes, floods, and droughts is also constant. Infrastructural and institutional limitations to deal with emergencies and
low capacity to respond to adverse events are an additional challenge, which leaves the population—particularly the most vulnerable—at even higher risk.
more
Antimicrobial stewardship (AMS) describes a coherent set of actions that ensure optimal use of antimicrobials to improve patient outcomes, while limiting the risk of adverse events (including antimi
...
crobial resistance (AMR)). Introduction of AMS programmes in hospitals is part of most national action plans to mitigate AMR, yet the optimal components and actions of such a programme remain undetermined.
more
Core Elements of Hospital Antibiotic Stewardship Programs. Antibiotic Stewardship Program Assessement Tool
recommended
Centers for Disease Control and Prevention CDC
Centers for Disease Control and Prevention (CDC)
(2019)
C_CDC
A growing body of evidence demonstrates that hospital based programs dedicated to improving antibiotic use, commonly referred to as “Antibiotic Stewardship Programs (ASPs),” can both optimize the treatment of infections and reduce adverse
...
events associated with antibiotic use. This document summarizes core elements of successful hospital Antibiotic Stewardship Programs. It complements existing guidelines on ASPs from different American organizations.
more
Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of
...
adverse events (AEs) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
more
Malaria in pregnancy is a significant health problem in malaria-endemic areas. It not only causes substantial childhood morbidity and mortality but also increases the risks of adverse events for pre
...
gnant women and their developing fetuses. Most of the burden in these areas is due to infection with Plasmodium falciparum. Artemisinin-based combination therapy (ACT) has been recommended as first-line treatment for uncomplicated P. falciparum malaria in all populations, including pregnant women in their second and third trimesters, since 2006. However, for women in their first trimester of pregnancy, WHO recommended as first-line treatment a combination of quinine and clindamycin.
Based on a review of the evidence conducted in 2022, WHO now recommends artemether–lumefantrine, the ACT with the most human safety data available, as the preferred treatment for uncomplicated P. falciparum malaria in the first trimester of pregnancy. This document presents all relevant evidence on the effects and safety in early pregnancy of artemisinins and partner medicines used in ACTs from both studies in experimental animals and observational studies in humans.
more
Climate change is one of the most urgent challenges for people and ecosystems worldwide. The recently published sixth Assessment Report (AR6) of the Intergovernmental Panel on Climate Change (IPCC) stresses the occurrence of widespread adverse impac
...
ts of climate change. Increased frequency and intensity of extreme weather events, as well as slow-onset processes cause enormous losses and damages to human and natural systems. Marginalized groups and people in vulnerable situations are often disproportionally affected. While the impacts of climate change already become more tangible and threatening, action for addressing them remains insufficient. Adaptation to climate change is, thus, becoming a necessity for governments, companies, and private citizens.
To provide practical and scientifically sound guidance on how to conduct vulnerability assessments, GIZ published its Vulnerability Sourcebook in 2014. The Vulnerability Sourcebook was used in over twenty different GIZ partner countries and provides a step-by-step guidance for designing and implementing a vulnerability assessment. It is also one of the methodological foundations for the ISO 14091:2021 standard on vulnerability, impacts and risk assessment for climate change adaptation.
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Patient Safety is a health care discipline that emerged with the evolving complexity in health care systems and the resulting rise of patient harm in health care facilities. It aims to prevent and reduce risks, errors and harm that occur to patients during provision of health care. A cornerstone of
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the discipline is continuous improvement based on learning from errors and adverse events.
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These WHO guidelines which were updated in 2018, are valid for any country and suitable to local adaptations, and take account of the strength of available scientific evidence, the cost and resource implications, and patient values and preferences.
The 2018 edition of the guidelines includes the re
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vision of the recommendation regarding the use of 80% fraction of inspired oxygen (high FiO2) in surgical patients under general anaesthesia with tracheal intubation and the update of the section on implementation. Between 2017 and 2018, WHO re-assessed the evidence on the use of high FiO2 by updating the systematic review related to the effectiveness of this intervention to reduce SSI and commissioning an independent systematic review on adverse events potentially associated with it. Based on the updated evidence, the GDG decided to revise the strength of the recommendation from strong to conditional.
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Interim Guidance, published 11 January 2021.
The cold chain is necessary to prevent damage to vaccines caused by heat exposure. However, improper use of cold chain equipment may cause damage to freeze-sensitive vaccines (i.e. those vaccines containing alum adjuvant or oil-emulsion adjuvant). Studie
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s conducted in several countries with hot and cold climates show frequent occurrences of sub-zero temperatures in the cold chain. The most common cause of exposure to freezing temperature is the failure to correctly condition ice packs prior to transport. Vaccines that are inadvertently frozen lose potency, increase wastage rates and increase the risk of adverse events following immunization (AEFI). Vaccine carriers protect vaccine potency during immunization sessions and transport to outreach sites. This guidance document is intended to help inform which type of vaccine carrier to select based on local context, to maintain vaccine quality, especially at service delivery points.
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Tuberculosis (TB) is, and should be, a curable disease; however, each year significant numbers of patients acquire or develop drug-resistant TB, which has a much lower cure rate. Patients with drug-resistant TB have a high prevalence of symptoms; hence, staff caring for these patients should h
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ave some familiarity with palliative care, so that general palliative care principles are available to all patients. The timely identification, and addressing, of adverse events occurring during the treatment course is considered as general palliative care for those receiving curative treatment. This publication summarizes the general palliative care approach, which is recommended for use in settings and services that occasionally treat palliative care patients, but do not provide palliative care as the main focus of their work. The review focuses on 18 high TB priority countries of the WHO European Region.
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Clinical features and management of human monkeypox: a retrospective observational study in the UK
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Cases of human monkeypox are rarely seen outside of west and central Africa. There are few data regarding viral kinetics or the duration of viral shedding and no licensed treatments. Two oral drugs, brincidofovir and tecovirimat, have been approved for treatment of smallpox and have demonstrated eff
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icacy against monkeypox in animals. Our aim was to describe the longitudinal clinical course of monkeypox in a high-income setting, coupled with viral dynamics, and any adverse events related to novel antiviral therapies.
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About one fourth of the world’s population is estimated to have been infected with the tuberculosis (TB) bacilli, and about 5–10% of those infected develop TB disease in their lifetime. The risk for TB disease after infection depends on several factors, the most important being the person’s im
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munological status. TB preventive treatment (TPT) given to people at highest risk of progressing from TB infection to disease remains a critical element to achieve the global targets of the End TB Strategy, as reiterated by the second UN High Level Meeting on TB in 2023. Delivering TPT effectively and safely necessitates a programmatic approach to implement a comprehensive package of interventions along a cascade of care: identifying individuals at highest risk, screening for TB and ruling out TB disease, testing for TB infection, and choosing the preventive treatment option that is best suited to an individual, managing adverse events, supporting medication adherence and monitoring programmatic performance.
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