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).
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The results of a large-scale systematic review and meta-analysis have published in PLOS Neglected Tropical Diseases. This research aimed to collate all reported serious adverse events (SAE) in visceral leishmaniasis (VL) clinical trials and quantify the incidence of mortality during the first 30 day...s of therapy. The analyses, which included clinical data from more than 35,000 patients, found that mortality following treatment was an extremely rare event and serious adverse events following treatments were poorly reported.
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FIELD GUIDE for staff at the central, intermediate and peripheral level
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 before, during and after a disaster situation. It also aims to raise awareness to reduce the stigma abou...t 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
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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
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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 w...orldwide. 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.
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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 (A...Es) 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.
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Against this background of nearly 20 years of experience of research, development and
improvement in patient safety, the role of incident and adverse event reporting, as well as the
benefits that derive from it, is still a work in progress.This document has two main purposes:
• to provide an up...-to-date perspective on patient safety incident reporting and
learning systems currently in place, including how to fill in existing gaps in these
systems;
• to provide practical guidance on the establishment and effective use of patient
safety incident reporting and learning systems.
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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 antimicrobial 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.
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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 summ...arizes core elements of successful hospital Antibiotic Stewardship Programs. It complements existing guidelines on ASPs from different American organizations.
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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 impacts of climate change. Increased frequency and inten...sity 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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Learn what scientists look for in the different phases of a clinical trial for a vaccine. What does it mean when a vaccine trial is halted due to an adverse event? WHO’s Dr Kate O’Brien explains in Science in 5 this week
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...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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