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,
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quality and efficacy of medicines.
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Access to medical personal protective equipment (PPE) is essential for routine healthcare delivery, and a critical tool for containing outbreaks, as well as preventing and responding to pandemics. I
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t is one of our most effective tools against COVID-19, and an undervalued tool more generally in infection control.
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Miscellaneous
Chapter J.8
Mosby’s Pocket Guide to Nursing Skills and Procedures, eighth edition, is
a practical, portable reference for students and practitioners in the
clinical setting. Grouped alphabetically, 85 commo
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nly performed skills
are presented in a clear, step-by-step format that includes:
■ Purpose for performing each skill
■ Guidelines to help students in delegating tasks to assistive
personnel
■ List of equipment required
■ Rationales to explain why specific techniques are used
■ Full-color photographs and drawings to provide visual
reinforcement
In addition, Safety Alerts are included in the skills to highlight important
information about patient safety and effective performance.
Current Standard Precautions guidelines from the Centers for Disease
Control and Prevention are incorporated throughout. Preprocedure
and postprocedure protocols are conveniently located on the inside
back cover.
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• provide scientific information on the safety, efficacy, and quality control/ quality assuran
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ce of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
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This document is part of the process for improving the quality of care in family planning. Medical eligibility criteria for contraceptive use (MEC), the first edition of which was published in 1996, prsents current World Health Organization (WHO) gu
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idance on the safety of various contraceptive e-
methods for use in the context of specific health conditions and characteristics. This is the fifth edtion of the MEC –the latest in the series of periodic updates
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PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine
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quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laboratory – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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A sanitary inspection is a simple, on-site evaluation (traditionally using a checklist) to help identify and support the management of priority risk factors that may lead to contamination of a drinking-water supply. Sanitary inspections are a well-e
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stablished and widely-applied practice. They can support water safety planning, and in some contexts, may be a simplified alternative to water safety plans.
This publication presents the World Health Organization’s (WHO’s) sanitary inspection packages. These packages update the sanitary inspection forms in WHO’s 1997 Guidelines for drinking-water quality. Volume 3: surveillance and control of community supplies. With more than 25 years of practical experience with the application of sanitary inspections, these packages have been developed from a comprehensive evidence review and established good practices.
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• provide scientific information on the safety, efficacy, and quality control/ quality assuran
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ce of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
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This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety
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and ethical considerations, and data management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high
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quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S). PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens
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and for the examination of sputum smears by direct microscopy. This edition includes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
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According to WHO, infection prevention and control (IPC) is a scientific approach and practical solution designed to prevent harm caused by infection to patients
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and health workers. It is grounded in infectious diseases, epidemiology, social science and health system strengthening. IPC occupies a unique position in the field of patient safety and quality universal health coverage since it is relevant to health workers and patients at every single health-care encounter. Poor WASH and IPC lead to health acquired infections, transmission of diseases from health facilities to communities and increased use of antibiotics and exacerbate outbreak and spread of infections- in this case- COVID- 19. On the contrary, effective IPC reduces hospital-acquired infections by at least 30% (WHO 2016).
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The Guidelines for drinking-water quality: small water supplies have been developed to address the needs and opportunities associated with small supplies to facilitate progressive improvement toward
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s safe and sustainable drinking-water services for all. These Guidelines are based on the principal recommendation in the World Health Organization’s Guidelines for drinking-water quality, and they provide guidance on applying that recommendation to small water supplies in particular. These Guidelines aim to help governments and practitioners improve the safety of drinking-water delivered through small supplies.
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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medic
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ines and pharmaceutical products promote drug resistance and lead to loss of confidence in health professionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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KEY MESSAGES
Always talk to a GBV specialist first to understand what GBV services are available in your area. Some services may take the form of hotlines, a mobile app or other remote support.
Be aware of any other available services in your area. Identify services provided by humanitarian pa
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rtners such as health, psychosocial support, shelter and non-food items. Consider services provided by communities such as mosques/ churches, women’s groups and Disability Service Organizations.
Remember your role. Provide a listening ear, free of judgment. Provide accurate, up-to-date information on available services. Let the survivor make their own choices. Know what you can and cannot manage. Even without a GBV actor in your area, there may be other partners, such as a child protection or mental health specialist, who can support survivors that require additional attention and support. Ask the survivor for permission before connecting them to anyone else. Do not force the survivor if s/he says no.
Do not proactively identify or seek out GBV survivors. Be available in case someone asks for support.
Remember your mandate. All humanitarian practitioners are mandated to provide non-judgmental and non-discriminatory support to people in need regardless of: gender, sexual orientation, gender identity, marital status, disability status, age, ethnicity/tribe/race/religion, who perpetrated/committed violence, and the situation in which violence was committed. Use a survivor-centered approach by practicing:
Respect: all actions you take are guided by respect for the survivor’s choices, wishes, rights and dignity.
Safety: the safety of the survivor is the number one priority.
Confidentiality: people have the right to choose to whom they will or will not tell their story. Maintaining confidentiality means not sharing any information to anyone.
Non-discrimination: providing equal and fair treatment to anyone in need of support.
If health services exist, always provide information on what is available. Share what you know, and most importantly explain what you do not. Let the survivor decide if s/he wants to access them. Receiving quality medical care within 72 hours can prevent transmission of sexually transmitted infections (STIs), and within 120 hours can prevent unwanted pregnancy.
Provide the opportunity for people with disabilities to communicate to you without the presence of their caregiver, if wished and does not endanger or create tension in that relationship.
If a man or boy is raped it does not mean he is gay or bisexual. Gender-based violence is based on power, not someone’s sexuality.
Sexual and gender minorities are often at increased risk of harm and violence due to their sexual orientation and/or gender identity. Actively listen and seek to support all survivors.
Anyone can commit an act of gender-based violence including a spouse, intimate partner, family member, caregiver, in-law, stranger, parent or someone who is exchanging money or goods for a sexual act.
Anyone can be a survivor of gender-based violence – this includes, but isn’t limited to, people who are married, elderly individuals or people who engage in sex work.
Protect the identity and safety of a survivor. Do not write down, take pictures or verbally share any personal/identifying information about a survivor or their experience, including with your supervisor. Put phones and computers away to avoid concern that a survivor’s voice is being recorded.
Personal/identifying information includes the survivor’s name, perpetrator(s) name, date of birth, registration number, home address, work address, location where their children go to school, the exact time and place the incident took place etc.
Share general, non-identifying information
To your team or sector partners in an effort to make your program safer.
To your support network when seeking self-care and encouragement.
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Despite the considerable improvement in global health, millions of people still lack access to quality health services, including access to effective antimicrobial medicines, or are impoverished as a result of health spending. At the same time, anti
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microbial resistance – a consequence of overuse and misuse of antimicrobials – is increasingly a barrier to accessing effective care. The declining effectiveness of antibiotics is driven by multiple factors, many of which can be addressed through well functioning primary health care. However, primary health care has not always had much attention in national health sector responses to
antimicrobial resistance, which often focus on tertiary care, laboratory detection and surveillance. The three pillars of primary health care (community engagement, front-line health services including primary care and essential public health, and multisectoral action on wider health determinants) are central not just to Universal Health Coverage and the Sustainable Development Goals, but also to an effective response to antimicrobial resistance.
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This editorial will consider the often heralded and sometimes belittled Surgical Safety Checklist (SSCL) for its general benefits, potential utility,
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and range of evidence attesting to its value in quality and safety improvement.
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The evolving epidemic of type 2 diabetes mellitus has challenged health-care professionals. It stands among the leading causes of mortality in the present world. It warrants new and versatile approaches to improve mortality
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and the associated huge quality-adjusted life years lost to it once diagnosed. A possible venue to lower the incidence is to assess the safety and efficacy of various diabetes prevention strategies. Diet and exercise have a well-developed role in the prevention of weight gain and, ultimately, diabetes mellitus type II in high-risk individuals. However, high-risk individuals can also benefit from adjunct pharmacotherapy. In light of this information, we decided to conduct a systematic review of randomized controlled trials. This article summarizes the evidence in the literature on the pharmacological prevention of diabetes in high-risk individuals.
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The document "Priority medical devices list for the COVID-19 response and associated technical specifications" complements this guideline.
This document provides interim guidance on the quality,
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performance characteristics and related standards of personal protective equipment (PPE) to be used in the context of COVID-19. This includes WHO Priority Medical Devices, specifically: surgical masks, non-surgical masks, gloves, googles, face shields, gowns and N95 masks. It is intended for procurement agencies, occupational health departments, infection prevention and control departments or focal points, health facility administrators, biomedical and materials engineering, PPE manufacturers and public health authorities at both national and facility levels.
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