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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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high 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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Thefirst report on Latin America and the Carribean presents key indicators on health and health systems in 33 Latin America and the Caribbean countries. . Analysis is based on the latest comparable data across almost 100 indicators including equity, health status, determinants of health, health car...e resources and utilisation, health expenditure and financing, and quality of care. The editorial discusses the main challenges for the region brought by the COVID-19 pandemic, such as managing the outbreak as well as mobilising adequate resources and using them efficiently to ensure an effective response to the epidemic.
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The Department of Health (DOH) has developed a National Integrated Sexual and Reproductive Health and Rights (SRHR) Policy.1 This policy addresses the many cross-cutting issues relating to SRH service provision, drawing together the principles, rights, and guidance for planning and implementation th...at underpin the provision of quality, comprehensive, and integrated SRHR services in South Africa. The National Integrated SRHR Policy is supported by several clinical and service delivery guidelines covering related programmatic
areas, including the National Contraception Clinical Guidelines.
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The Global Sexual and Reproductive Health Service Package for Men and Adolescent Boys has been developed to support providers of sexual and reproductive health (SRH) services to increase the range and quality of services to meet the specific and diverse needs of men and adolescent boys. This package... focuses specifically on the provision of such services integrated
within clinical and non-clinical contexts and follows a gender-transformative approach. It covers men and adolescent boys in all their diversity and takes a positive approach to SRH, seeing this not just as the absence of disease, but the positive expression of one’s gender, sex and sexuality. In doing so, this service package contributes to efforts to ensure universal access to sexual and reproductive health and rights (SRHR) as prioritized in the Sustainable Development Goals. This package is in no way intended to detract from the sexual and reproductive health and rights of women and adolescent girls, nor to divert resources, funding or attention from much-needed SRH services and programmes for women and adolescent girls.
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The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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Scientists have known for more than half a century that patients could develop resistance to the drugs used to treat them. Alexander Fleming, who is credited with creating the first antibiotic, penicillin, in 1928, cautioned of the impending crisis while accepting his Nobel prize in 1945: “There ...is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” Since then antibiotics have proved one of the most effective interventions in human medicine. Sadly, the overuse and misuse of this precious resource have brought us to a global crisis of antimicrobial resistance (AMR). To address this crisis nearly seven decades after Fleming’s lecture the first UN general assembly meeting on drug resistance bacteria was convened in September 2017.
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In 2017, 3.6 million of the estimated 10 million people with TB worldwide were “missed” by national TB programmes (NTPs). Two thirds of them are thought to access TB treatment of questionable quality from public and private providers who are not engaged by the NTP. The quality of care provided i...n these settings is often not known or substandard. Closing these gaps and ensuring patient-centred care imply that quality-assured and affordable TB services must be made available wherever people choose to seek care.
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Interagency Guidelines - This revised Interagency List of Essential Medicines for Reproductive Health presents
the current international consensus on rational selection of essential reproductive health medicines. The list is intended to support decisions regarding the production, quality assurance..., national procurement and reimbursement schemes of these medicines.
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This landscape analysis aims to:
1. Identify and document supportive policies and best practices in family planning program implementation
2. Assess the quality of family planning service provision
3. Propose recommendations for scaling up best family planning practices and new interv...entions to improve program effectiveness and increase utilization of contraception
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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.
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The Zithromax® Supply Chain Assessment Tool is designed to guide assessment team members through a series of interviews
with key informants and to establish inspection procedures when conducting logistics field assessments. The protocol allows
the assessment team to examine the readiness of the N...ational Trachoma Control Program and the District- level health
management structures to receive, manage, distribute and administer donated Zithromax® for mass drug administrati
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The resources provide both the older as well as the updated Operational Guidelines for antiretroviral therapy centres, including administrative issues, functions and establishment of centres, reporting and recording tools, measures to improve retention in HIV care, supply chain management of drugs a...nd various other aspects that are essential to ensure quality treatment for people living with HIV/AIDS.
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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...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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Procurement and supply management activities are fundamental to consistent and reliable access to essential medicines and health products. To reduce the impact of CVD, action needs to be taken to improve prevention, diagnosis, care and management of CVD diseases. Affordable essential medicines and t...echnologies to manage CVD disease must be available where and when they are required. Medicines and technologies need to be managed appropriately to ensure that the correct medicines are selected, procured in the right quantities, distributed to facilities in a timely manner, and handled and stored in a way that maintains their quality. This needs to be backed up by policies that enable sufficient quantities to be procured in order to reduce cost inefficiencies, ensure the reliability and security of the distribution system, and encourage the appropriate use of these health products. In order to avoid stock-outs and the disruption of treatment, all related activities need to be conducted in a timely manner, with performance continually monitored, and prompt action taken in response to problems that may arise. Additionally, medication must be dispensed correctly and used rationally by the healthcare provider and patient alike. The purpose of this guide is to explain the necessary steps.
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Estimating the size of key affected populations (KAP) provides important data for planning and implementing an effective response to the HIV epidemic. In the Philippines, these KAP include males who have sex with males (MSM), female sex workers (FSW), and injecting drug users (IDU). Given the diffic...ulty in reaching these populations, as well as their high mobility, the process consequently entailed a specific methodology to directly estimate the size of KAP.
The national estimate of MSM was 531,500 or 2.2% (1.8%-3.2%) of males aged 15-49. Within this MSM estimate, figures for transgender women (TGW) and male transactional sex workers (MSW) were determined. The national estimate for TGW was 122,800 or about 0.50% (0.40%-0.75%) of males aged 15-49, and 23% of the MSM population. Meanwhile, MSW comprised 0.35% (0.29%-0.53%) of the male population aged 15-49 and 16% of the MSM population, giving a best estimate of 86,600.
The estimate of combined RFSW and FFSW was 66,100 or 0.28% (0.19%-0.40%) of females aged 15-49. Meanwhile, there are approximately 10,000 to 21,700 IDU or 0.04%-0.09% of males aged 15-49.
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Tuberculosis (TB) is, and should be, a curable disease; however, each year significant numbers of patients acquire or develop drug-resistant TB, which has a much lower cure rate. Patients with drug-resistant TB have a high prevalence of symptoms; hence, staff caring for these patients should h...ave some familiarity with palliative care, so that general palliative care principles are available to all patients. The timely identification, and addressing, of adverse events occurring during the treatment course is considered as general palliative care for those receiving curative treatment. This publication summarizes the general palliative care approach, which is recommended for use in settings and services that occasionally treat palliative care patients, but do not provide palliative care as the main focus of their work. The review focuses on 18 high TB priority countries of the WHO European Region.
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All malaria-endemic countries in the Region of the Americas have taken on the challenge to eliminate the disease and to put in place measures to orient their health programs and strategies in that direction. This manual explains how to implement measures to achieve malaria elimination and prevent it...s reestablishment by increasing the intensity and quality of interventions, reorienting initiatives, reducing delays that favor transmission, and ensuring adequate monitoring to adjust interventions. In this regard, the first suggested step is to stratify the territory - so that interventions and population groups can be planned and prioritized - and then implement diagnosis, treatment, investigation and response (DTI-R) actions as a key strategy aimed at effectively eliminating the disease and preventing its reestablishment in all strata. In addition, the document seeks to operationalize the concept of "surveillance as an intervention" promoted by the World Health Organization through the Global Technical Strategy for Malaria 2016-2030 and highlights the importance of communities having access to early diagnosis and treatment. Finally, the manual also includes management and monitoring aspects that must be taken into account to eliminate the foci with transmission.
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This publication is intended for professionals training or practicing in mental health and not for the general public. The opinions expressed are those of the authors and do not necessarily represent the views of the Editor or IACAPAP. This publication seeks to describe the best treatments and pract...ices based on the scientific evidence available at the time of writing as evaluated by the authors and may change as a result of new research. Readers need to apply this knowledge to patients in accordance with the guidelines and
laws of their country of practice. Some medications may not be available in some countries and readers should consult the specific drug information since not all dosages and unwanted effects are mentioned. Organizations, publications and websites are cited or linked to illustrate issues or as a source of further information. This does not mean that authors, the Editor or IACAPAP endorse their content or
recommendations, which should be critically assessed by the reader. Websites may also change or cease to exist.
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This report presents the findings of the Estimating the Size of Populations through a Household Survey (ESPHS) study that took place in 2011. The study utilized a single household survey to estimate the size of several key populations, including sex workers, men who have sex with men (MSM), injectin...g drug users (IDU), and clients of sex workers. These populations include several groups outlined in the National Strategic Plan for HIV and AIDS as most at risk for HIV infection, specifically sex workers and MSM.
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