This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation. Pharmacovigilance as a medical discipline is crucial in preventing medicin...e-related adverse effects in humans, promoting patient safety, and the rational use of medicines. The indicators proposed in this manual are based on the expected functions of pharmacovigilance centres as described in the WHO Mimimum Requirements for a Functional Pharmacovigilance System (1) (see Annex 1 of the manual).
more
The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat...ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
more
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
In light of the decline in new Ebola cases, strategies are now needed to scale down the activities and bed capacities in Ebola care facilities. These facilities include Ebola treatment units, community care centres, Ebola treatment centres and isolation centres. The Governments of Guinea, Liberia an...d Sierra Leone; WHO; CDC; ICAN and UNICEF have jointly developed this rapid guidance and checklist to assist national governments and partners as they begin this process. This rapid guidance pertains to protecting the safety and repurposing of infrastructures and resources previously used for the Ebola outbreak to care for Ebola patients.
more
First published in 2020, this toolkit is intended for clinicians working in acute care, managing adult and paediatric patients with acute respiratory infection, including severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock. The main objective is to provide key tools for us...e in the care of critically ill patients – from hospital entry to hospital discharge.
The 2022 updated version includes new tools and adapted algorithms, checklists, memory aids for COVID-19 and influenza, and the latest clinical evidence regarding clinical management of SARI. It is intended to help clinicians care for SARI patients: from epidemiology of severe acute respiratory infections, screening and triage, infection prevention and control, monitoring of patients, laboratory diagnosis, principles of oxygen therapy and different types of ventilation (invasive and non-invasive), as well as antimicrobial and immunomodulator therapies, to ethical and quality of care assessments.
The first edition is availbel in Ukrainian and Russian
more
The purpose of this document is to present and promote the minimum requirements for IPC programmes at the national and health care facility level, identified by expert consensus according to available evidence and in the context of the WHO core components.
The minimum requirements are defined as: I...PC standards that should be in place at the national and facility level to provide minimum protection and safety to patients, HCWs and visitors, based on the WHO core components for IPC programmes.
more
23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeters, patient monitors, thermometers, infusion and suc...tion pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
more
The 2019 ANA’s Principles for Nurse Staffing, Third Edition, identifies major elements needed to achieve appropriate nurse staffing, which enhances the delivery of safe, quality health care. These principles are grounded in the substantive and growing body of evidence that demonstrates the link be...tween appropriate nurse staffing and better patient outcomes and apply to all types of nurse staffing at every practice level in any healthcare delivery setting. Focused on addressing the complexities of appropriate nurse staffing decisions, the principles and supporting material in this publication will guide nurses and other decision-makers in identifying and developing processes and policies needed to improve nurse staffing.
more
This Cardiac Rehabilitation Change Package was completed by the Centers for Disease Control and Prevention (CDC) in collaboration with the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) with the purpose of helping cardiac rehabilitation programs, hospital quality improv...ement teams, and public health professionals who partner with these groups to implement systems and strategies that improve care for patients who are eligible for cardiac rehabilitation. AACVPR is a multidisciplinary professional association comprised of health professionals who serve in the field of cardiac and pulmonary rehabilitation.
more
Examining nursing practice guidelines to improve quality of care for patients with sepsis in low income countries is required. • A large amount of information about best practice standards in sepsis management is available for healthcare professionals; however, implementation and adherence to prac...tice guidelines recommended by the Surviving Sepsis Campaign remains low in low income countries.
more
In the face of rapid increases in the number of hospitalizations due to COVID-19 in Latin America and the Caribbean, coupled with shortages of human and material resources, including medical equipment and gases, there is a need to redesign models of care in the Region to optimize available resources... and ensure that more patients receive the quantity and quality of oxygen they need. Oxygen is included in the World Health Organization’s list of essential medicines and is used to care for patients at all levels of integrated health services networks. The efficacy of oxygen use in the treatment of patients with respiratory conditions caused by COVID-19 has been demonstrated, but there is great opportunity to improve the effectiveness of its use if it is used in a rational, sustainable, and safe way. Bearing in mind that the efficacy of a health technology is measured by its benefit under actual conditions of use, practical actions can be taken to improve the use of medical oxygen and avoid oxygen shortages. A drug is considered to be used rationally when patients receive it according to their clinical needs, in doses appropriate to their individual needs, for an appropriate period, and at a low cost to them and their community. By providing instruction on the rational use of oxygen and promoting it, negative repercussions can be avoided, such as loss of efficacy as a result of activities related to oxygen storage, distribution, and administration. Rational use of oxygen also involves controlling waste due to leaks in storage and distribution systems, use of gas at incorrect pressures, use of incorrectly adjusted flowmeters, and disconnections, among other problems. Another aspect to consider is the provision of adequate technical support for all oxygen production systems, in terms of maintenance and calibration, availability of electrical energy, and specific knowledge about these systems. For these reasons, a set of guidelines has been put together for the development of an efficient management system to deal with situations of oxygen scarcity, both now and in the future.
more
Thesis presented in partial fulfilment of the requirements for the degree of Master of Nursing Science in the Faculty of Health Sciences at Stellenbosch University.
The mobile clinic health care services fulfil an essential role in delivering primary health care to the dwellers in the rural commun...ities of the Western Cape. However, occupational health and safety, as well as quality assurance are issues that need to be addressed urgently. It is thus recommended that policy makers take cognizance of the specific needs of every individual mobile clinic team.
more
The WHO Ebola Virus Disease (EVD) Clinical management: living guidance contains the Organization’s most up-to-date recommendations for the clinical management of people with EVD. Providing guidance that is comprehensive and holistic for the optimal care of patients with EVD throughout their il...lness is important.
The living guidance is available in both pdf format (via the ‘Download’ button) and via an online platform in both French and English, and is updated regularly as new evidence emerges.
This first version of the Clinical management for EVD living guidance contains four new recommendations regarding use of therapeutics for EVD, this includes two strong recommendations for the use of monoclonal antibody therapies. This new living guideline is written to accompany the optimized supportive care (oSoC) for EVD standard operating procedures (5, 6). The living guideline aims to summarize high quality evidence for EVD therapeutics and make recommendations for their use.
more
Evidence-based guidelines are one of the most useful tools for improving public health and clinical practice. Their purpose is to formulate interventions based on strong evidence of efficacy, avoid unnecessary risks, use resources efficiently, reduce clinical variability and, in essence, improve hea...lth and ensure quality care, which is the purpose of health systems and services. These guidelines were developed following the GRADE methodology, with the support of a panel of clinical experts from different countries, all convened by the Pan American Health Organization. By responding to twelve key questions about the clinical diagnosis and treatment of dengue, chikungunya, and Zika, evidence-based recommendations were formulated for pediatric, youth, adult, older adult, and pregnant patients who are exposed to these diseases or have a suspected or confirmed diagnosis of infection. The purpose of the guidelines is to prevent progression to severe forms of these diseases and the fatal events they may cause. The recommendations are intended for health professionals, including general, resident, and specialist physicians, nursing professionals, and medical and nursing students, who participate in caring for patients with suspected dengue, chikungunya, or Zika. They are also intended for health unit managers and the executive teams of national arboviral disease prevention and control programs, who are responsible for facilitating the process of implementing these guidelines.
more
Maternal mortality has fallen significantly in recent years, especially in countries that have emphasized the prevention of its main causes, such as hemorrhagic and infectious complications and hypertension , including in the Region of the Americas. In its final report on the Plan of Action to Accel...erate the Reduction of Maternal Mortality and Severe Maternal Morbidity, the Pan American Health Organization (PAHO) reported a continuing downward trend in maternal mortality, with an 18.1% reduction in the maternal morbidity ratio during the period 2010-2015 . From a pathophysiological perspective, death events are a common end result of a wide spectrum of complications leading to multi-organ dysfunction. However, there is a group of women in this situation who survive, despite the seriousness of their condition. This high number of patients––who were in serious condition
but did not die––reflects the actual health conditions in an institution or a country. For this reason, there is a need to create indicators to estimate morbidity in women due to diseases and incidents that occur during pregnancy, childbirth, and the puerperium. To this end, we propose conducting epidemiological surveillance of an indicator that includes women who survived after presenting a potentially fatal complication during pregnancy, childbirth, or the puerperium, reflecting quality medical attention and care (5, 6). This indicator
is maternal near-miss (MNM), which refers to extremely severe maternal morbidity––cases of a severity that
brings women very close to the death event. After adjusting the definition to a specific population and time,
MNM is defined as a case in which a woman nearly died, but survived a complication that occurred during
pregnancy, childbirth, or within 42 days of termination of pregnancy
more
The Infection prevention and control in the context of coronavirus disease 2019 (COVID-19): a living guideline consolidates technical guidance developed and published during the COVID-19 pandemic into evidence-informed recommendations for infection prevention and control (IPC). This living guideline... is available both online and PDF.
**This version of the living guideline (version 5.0) **includes the following seven revised statements for the prevention, identification and management of SARS-CoV-2 infections among health and care workers:
a good practice statement on national and subnational testing strategies;
a good practice statement on passive syndromic surveillance of health and care workers;
a good practice statement on prioritizing health and care workers for SARS-CoV-2 testing;
a good practice statement on protocols for reporting and managing health and care worker exposures;
a good practice statement to limit in-person work of health and care workers with active SARS-CoV-2 infections;
a statement on high-risk exposures and quarantine; and,
a conditional recommendation on the duration of isolation for health and care workers.
Understanding the updated section
Prevention of infections in the health care setting includes a multi-pronged and multi-factorial approach that includes IPC and occupational health and safety measures and adherence to Public Health and Social Measures in the community by the health workforce. The underlying infection prevention and control strategy of this section is the notion that early identification of symptomatic cases, testing and quarantining/isolating health and care workers decreases the risk of nosocomial infection to patients and to other health and care workers.
more
Infection prevention and control (IPC) in a CTC/ CTU IPC are all practical measures taken in the healthcare facility to prevent harm caused by infections to patients, health workers and communities.
The main goal of IPC in the cholera response is to
• To reduce transmission of health care-as...sociated infections of cholera and any other infectious disease
• To enhance the safety of staff, patients and visitors
• To enhance the ability of the organization/health care facility to respond to an outbreak
• To reduce the risk of the hospital (health care facility) itself amplifying the outbreak
Water, Sanitation and Hygiene (WASH)
WASH are all measures taken to guarantee environmental hygiene, safe water of all used within the health facility. It encompasses water, sanitation, waste management, cleaning within the health facility which in this case is CTU/C. A complete WASH package in the CTU/CTC reduces the risk of spread of Vibrio cholerae inside and outside the CTC/CTU.
The probability of spreading or acquiring cholera through a CTC/CTU can be highly reduced when proper IPC and WASH measures are respected, followed and monitored. These measures are, in principle, valid in CTC/CTUs and ORPs, although they need to be adapted to the specific characteristics of the facility concerned.
more
The Infection Prevention and Control (IPC) Guidelines aim to support healthcare workers improve quality and safety health care. The Guidelines further aim to promote and facilitate the overall goal of IPC by providing evidence-based recommendations on the critical aspects of IPC, focusing on the fun...damental principles and priority action areas. All health service organizations should consider the risk of healthcare-associated infection(s) (HAI) and antimicrobial resistance (AMR) transmission to implement these recommendations. The IPC Guidelines also set national standards for the prevention and control of HAIs and to ensure compliance to the National Quality Standards.
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 (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.
more