The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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The purpose of the guideline is to provide information to stakeholders on the necessary requirements for a complete prequalification dossier for insecticide-treated nets (ITNs). Its aim is to establish the baseline for dossier requirements which are necessary to assess ITN products for the purposes ...of prequalification, describe the data requirements for fulfilling each dossier module, and to provide standardized information for applicants and testing facilities generating data for ITN prequalification dossiers. The document is supported by implementation guidance documents which provide specific information and considerations for how applicants may approach the generation of supporting information and compilation of a complete product dossier.
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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.
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Japan has been implementing projects of global extension of medical technologies under an official development assistance policy to improve public health and medicine by promoting Japanese medical technologies worldwide. The current work examines the impact and goals of implementing this new scheme.... The scheme has involved dozens of projects that sent Japanese experts to partner countries and that invited their counterparts to Japan to showcase Japanese medical technologies. Approximately 50 projects have been implemented in 24 countries over 5 years, and 19,638 individuals have been trained. As a result, the introduced technology was adopted in national guidelines in 4 projects and the introduced equipment was procured in the partner country in 17 projects. In total, 912,334 individuals have benefitted from the introduction of these medical technologies. The concept of "creating shared value" (CSV) could help promote project success by both creating economic value and encouraging social progress. However, the sustainability of that business model remains in question in terms of the internationalization of CSV. Several successful projects improved medical care and led to new business opportunities.
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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A Guide to the Application of the WHO Multimodal Hand HygieneImprovement Strategy and the “My Five Moments for Hand Hygiene”Αpproach
WHO has published the first-ever guidance on the clinical management of diphtheria. The only previously available guidance was an operational protocol. The new guidance followed the rigorous process for developing guidance at WHO.
It addresses the use of Diphtheria Antitoxin (DAT) in the treatmen...t of diphtheria. There is a worldwide shortage of DAT and evidence based recommendations on the use of DAT were requested by many Member States.
The guidance also includes new recommendations on antibiotics. In patients with suspected or confirmed diphtheria, WHO recommends using macrolide antibiotics (azithromycin, erythromycin) rather than penicillin antibiotics.
This clinical practice guideline has been rapidly developed recognizing the global increase in diphtheria outbreaks. Outbreaks of diphtheria in Nigeria, Guinea and neighbouring countries in 2023 have highlighted the urgent need for evidence-based clinical practice guidelines for the treatment of diphtheria. Given the sporadic nature of outbreaks, many clinicians in the affected regions have never managed acute diphtheria and its related complications. Diphtheria remains a neglected disease and vaccination is the top priority. At the same time, for patients with diphtheria, access to antibiotics, DAT and supportive care can be lifesaving.
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Standard Treatment Guideline
El paquete de capacitación de nivel básico fue pensado para apoyar la capacitación del personal o los voluntarios, para que suministren sillas de ruedas manuales y cojines apropiados a los niños, niñas, hombres y mujeres que tienen problemas de movilidad pero pueden sentarse erguidos sin apoyo ...postural adicional. El propósito del Cuaderno del participante es desarrollar las habilidades y los conocimientos del personal que presta servicios de sillas de ruedas. El Cuaderno del participante contiene ejercicios que ayudarán a los participantes a practicar y desarrollar sus habilidades y conocimientos. El Cuaderno del participante contiene material de las lecciones, las presentaciones de diapositivas y el manual de referencia. Se recomienda a los participantes que conserven su cuaderno para usar como referencia futura.
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Offering additional pre-exposure prophylaxis (PrEP) choices has the potential to increase uptake and effective use of PrEP, and of HIV prevention overall, as it allows people to choose a method that they prefer.
In this guideline, WHO recommends an offering long-acting injectable lenacapavir (LEN...) as an additional HIV prevention choice, as part of combination HIV prevention approaches. LEN, administered twice a year as PrEP, has been shown to be highly effective at reducing the risk of HIV acquisition. In this guideline, WHO also recommends using HIV rapid diagnostic tests (RDTs) for individuals initiating or continuing long-acting injectable PrEP, such as LEN and long acting injectable cabotegravir (CAB-LA). Flexible HIV testing approaches are essential for ensuring that testing does not become a barrier to accessing or continuing PrEP, including long-acting injectable options.
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Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis. Web Annex B
This document provides interim guidance for effective risk communication around Zika virus transmission and potential complications. A causal relationship between Zika virus infection and these potential complications has not yet been proven. In this uncertainty, effective communication strategies s...hould be implemented to enable people to take the best informed decisions about protecting themselves, their families and communities. This interim guidance is intended to be used by risk and health communication managers, staff and volunteers at global, regional or country level; communications professionals; anthropologists; sociologists; healthcare providers;hospital administrators; community leaders; programme managers;
and policymakers.
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Glaucoma is a leading cause of irreversible blindness globally. In Malawi, glaucoma accounts for 15.8% of the blindness among people aged 50 years and above. Blindness from glaucoma is preventable with early detection and timely treatment. However, glaucoma management remains a challenge to eye care... providers due to its asymptomatic progression.
These guidelines inform eye care providers about the requirements for early detection of glaucoma, and the appropriate assessment and management of glaucoma patients. The guidelines also demonstrate the need for ophthalmologists to work with secondary-level eye care providers. With
glaucoma being a permanently blinding condition, it is vital to ensure that all eye care providers are adequately equipped with skills and resources for the early detection and management of glaucoma.
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WHO’s sentinel surveys of acquired HIV resistance to dolutegravir among people receiving dolutegravir-containing antiretroviral therapy is intended for easy and frequent implementation. Results from sentinel surveys provide insight into the prevalence and year-over-year trends of dolutegravir resi...stance in adults, children and adolescents receiving dolutegravir-based ART.
This sentinel method is implemented complementary to WHO-recommended methods for estimating nationally representative levels of acquired HIV drug resistance.
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n October 2019, WHO convened the first meeting of the Buruli ulcer laboratory network (BU-LABNET) in Yaoundé, Cameroon, bringing together 11 laboratories from nine countries at the Pasteur Centre of Cameroon (CPC), the network’s Coordinating Centre. The network was formally established at th...is meeting (1) and its members were those present. The objective of BU LABNET is to improve diagnosis of Buruli ulcer based on polymerase chain reaction (PCR) using standardized testing protocols, involving external quality assurance programmes and sharing knowledge among member laboratories.
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