The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
The European Medicines Agency (EMA) is evaluating potential COVID-19 treatments and vaccines to enable promising medicines to reach patients as soon as possible. It is also interacting with medicine
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developers and making use of real-world data to monitor the safety and effectiveness of medicines used in patients with COVID-19.
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On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation
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was to agree on the most important PPCs for drugs to protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in develop
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ing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
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Long Acting Muscarinic Antagonists (LAMA) such as tiotropium and glycopyrronium are used in the management of COPD1. They have been shown to improve lung function, quality of life and exercise tolerance. They have also been associated with reduced COPD-related exacerbations, associated hospitalisati
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ons and duration of hospital stay. Both the South African Thoracic Society (SATS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD), guidelines recommend the use of long acting anticholinergic drugs (or long acting beta agonists) in moderate to very severe disease as defined by lung function (FEV1). The most up to date guideline, utilizing the GRADE methodology (European Respiratory Society guidelines of 2017), confirms their superiority over long acting β agonists (LABA) as monotherapy for COPD in that LAMA's have demonstrated greater efficacy in terms of exacerbation reduction, with similar safety profile.2 These recommnedations are supported by published peer-reviewed
evidence including individual papers and Cochrane reviews.
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14.04.2016
Pharm -Ed
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The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited
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resources, it is essential to respect the Good Manufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
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The new, all oral, 20-month MDR-TB regimens range from US $1,600* (using bedaquiline and linezolid for 6 months and levofloxacin as the fluoroquinolone) to US $2,100* (using linezolid for 12 months and moxifloxacin as the fluoroquinolone.
This statement aims to provide guidance and recommendation to African Union Member States in responding to the following questions:
What should countries do when announcing identification of a herbal remedy or medicine?
What are the implications for the rest of the continent?
This series of supportive tools are based on the WHO Therapeutics and COVID-19: living guideline. They are intended to provide supportive information for healthcare workers who are prescribing, administering and monitoring patients receiving nirmatrelvir-ritonavir for non-severe COVID-19.
Interim Guidance, 12 July 2021; This tool was developed to assess present and surge capacities for the treatment of COVID-19 in health facilities. It allows health facilities to assess the availability and status of stockout of critical COVID-19 medicines
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, equipment and supplies on site and to identify areas that need further attention to enable the facility to respond effectively to the pandemic. The tool encompasses key components that are essential to managing COVID-19 in a hospital setting, including:
health workforce (numbers, absences, COVID-19 infections, staff vaccinated for COVID-19 health workforce management, training and support);
medicines and medical supplies for management of COVID-19;
IPC capacities (protocols, safety measures, guidelines) and the availability of personal protective equipment (PPE) for staff;
diagnostic testing, imaging and patient monitoring devices and supplies
medical equipment for management of COVID-19, including O2 administration;
COVID-19 vaccine readiness ;
beds and space capacity.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in develop
...
ing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in develop
...
ing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working
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on different regulatory activities. The medicine market authorization system is one of the top priority areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
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This document updates the earlier version published in April 2020. In recent weeks, information on the potential use of chloroquine or hydroxychloroquine for the treatment of people with COVID-19 has been disseminated in academic journals and public media. Although there are now ongoing clinical tri
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als testing the efficacy and safety of several medicines for COVID-19, as of the date of this document, there is a lack of quality evidence to demonstrate chloroquine and/or hydroxychloroquine are effective in the treatment of COVID-19. Evidence is recently emerging via small studies with sub-optimal methodologies that are conflicting.
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Antimicrobial resistance (AMR) is a global human, animal, plant and environment health threat that needs to be addressed by every country. The impacts of AMR are wide-ranging in terms of human health, animal health, food security and safety, environ
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mental effects on ecosystems and biodiversity, and socioeconomic development. Just like the climate crisis, AMR poses a significant threat to the delivery of the 2030 Agenda for Sustainable Development. The response to the AMR crisis has been spearheaded through the global action plan on antimicrobial resistance (GAP-AMR), developed by the World Health Organization (WHO) in 2015, in close collaboration with the Food and Agriculture Organization of the United Nations (FAO) and the World Organisation for Animal Health (WOAH), and formally endorsed by the three organizations’ governing bodies and by the Political Declaration of the high-level meeting of the United Nations General Assembly on AMR in 2016. In 2022, the three organizations officially became the Quadripartite by welcoming the United Nations Environment Programme (UNEP) into the alliance “to accelerate coordination strategy on human, animal and ecosystem health”.
The aim of the GAP-AMR is to ensure the continuity of successful treatment with effective and safe medicines.
Its strategic objectives include:
• improving the awareness and understanding of AMR;
• strengthening the knowledge and evidence base through surveillance and research;
• reducing the incidence of infection through effective sanitation, hygiene and infection prevention measures; optimizing the use of antimicrobial medicines in human and animal health; and
• developing the economic case for sustainable investment that takes account of the needs of all countries and increasing investment in new medicines, diagnostic tools, vaccines and other interventions.
With the adoption of the GAP-AMR, countries agreed to develop national action plans (NAPs) aligned with the GAP-AMR to mainstream AMR interventions nationally. Individually, the Quadripartite took action to advance AMR interventions in their respective sectors. FAO adopted a resolution on AMR recognizing that it poses an increasingly serious threat to public health and sustainable food production, and developed an AMR action plan to support the resolution’s implementation. For its part, WOAH developed a strategy on AMR aligned with the GAP-AMR, acknowledging the importance of a One Health approach to AMR. Similarly, more recently, UNEP’s governing body, the United Nations Environment Assembly, recognized that AMR is a current and increasing threat and a challenge to global health, food security and the sustainable development of all countries, and welcomed the GAP-AMR and the NAPs developed in accordance with its five overarching strategic objectives
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There is strong demand for alternatives to pharmaceuticals for a variety of common illnesses due to concerns of safety, efficacy, and a desire for more “natural” products. Despite this growing interest, “conventional” healthcare providers ma
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y have little to no knowledge about herbal medicines, which is further compounded by the sometimes misleading information in the media and on the internet. This course provides the necessary background for providers to begin to incorporate herbal medicines into their practice, particularly in regards to their therapeutic properties, efficacy (or lack thereof), and safety concerns, including quality control and potential adverse effects
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Antimicrobial resistance (AMR) is a threat to human and animal health and refers to the ability of microorganisms to defy the medicines prescribed. For instance when antibiotics are used improperly, such as an incorrect dose, insufficient duration o
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r wrong frequency, resistance is heightened. The misuse of antimicrobials affects their efficacy, and increasingly more infections and diseases become untreatable. Many gains made in modern medicine throughout the 20th century will be lost, making AMR a global public and animal health issue that requires concerted action. AMR and the use of antimicrobials (AMU) affect food safety and security, people’s livelihoods, as well as economic and agricultural development.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in develop
...
ing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
Our target end-users are those with limited literacy. It is a challenging task to achieve success in this group as so much of what is "obvious" to those of us with good literacy skills is totally obscure to those who have never had the opportunity to learn the meaning of e.g. an arrow shape and what
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it is meant to represent. Our pictograms have been tested mainly in our local Xhosa population, so we cannot guarantee universal generalisability (as is the case for any other pictograms). Categories in the database include Dosage and frequency; Route of administration; Additional medicine instructions; Side effects or indications; Storage of medicines; Tablets, capsules, bottles, droppers; Miscellaneous; TB-related pictograms
A common application relates to their use with medicines where they may serve to convey instructions, precautions, storage requirements, warnings, as well as medicine indication or side effects to patients or consumers. Many examples of diverse application of pictograms in the health literature have been described including health promotion materials, wound care instructions, asthma prevention and treatment, injury prevention, discharge instructions, self-care guidance, paediatric anaphylaxis plan, organ and body donation, CT scan risks and benefits, driving risks, safety symbols, decision aids for treatment, and patient-reported outcomes dashboards, amongst others.
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