The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
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).
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The "Primary Healthcare Standard Treatment Guidelines and Essential Medicines List" by the South African National Department of Health provides evidence-based guidelines for diagnosing and managing common medical conditions at the primary healthcare level. This document includes treatment protocols ...for various health issues, such as infections, chronic diseases, maternal and child health, mental health, and emergency care. It aims to standardize care, promote rational medicine use, and ensure equitable access to essential medications across South Africa. The guidelines emphasize prevention, accurate diagnosis, and efficient treatment strategies to improve patient outcomes.
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The Lancet Infectious Disease Volume 25, Issue 2e77-e85February 2025
BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3379
Rapid Recommendation and visual graph. This is the fifth version (update 4) of the living guideline (BMJ 2020;370:m3379). When citing this article, please consider adding the update number and date of access for clarity. The publication of the RE...COVERY and REMAP-CAP randomised controlled trials triggered this guideline update, resulting in a strong recommendation for interleukin-6 (IL-6) receptor blockers (tocilizumab or sarilumab) in patients with severe or critical covid-19.
Prior recommendations: (a) A recommendation not to use ivermectin in patients with covid-19, regardless of disease severity, except in the context of a clinical trial; (b) a strong recommendation against the use of hydroxychloroquine in patients with covid-19, regardless of disease severity; (c) a strong recommendation against the use of lopinavir-ritonavir in patients with covid-19, regardless of disease severity; (d) a strong recommendation for systemic corticosteroids in patients with severe and critical covid-19; (e) a conditional recommendation against systemic corticosteroids in patients with non-severe covid-19; and (f) a conditional recommendation against remdesivir in hospitalised patients with covid-19.
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Meeting Report
Bangkok, Thailand 8-11 August 2016
This document was prepared in response to a need to review and potentially update the current recommendations for the antibiotic treatment of both inpatient and outpatient management of severe acute malnutrition (SAM). The current recommendations (Table 1) are based on guidelines published in 2013 i...n the WHO Pocketbook for Hospital Care for Children, and the 2013 update on SAM (outpatient management). The global threat of increasing antimicrobial resistance and new data on efficacy and safety profiles requires a re-review of the current evidence to ensure recommendations are the most appropriate. The evidence base for the use of antibiotics in children presenting with uncomplicated SAM has been recently enlarged.
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Rwanda Guidelines for variation to registered pharmaceutical products.
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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Antimicrobial resistance (AMR) is a major public health challenge, which is recognized as high priority area by the Government of India. The increasing consumption of antibiotics is one of the key drivers of antimicrobial resistance seen in bugs of public health importance. Irrational prescription o...f broad-spectrum antibiotics, poor regulations around sale of antibiotics, self-medication, lack of education and awareness regarding responsible use of antibiotics have been identified as some of the key factors driving antimicrobial resistance in our country. The ‘National Health Policy’ (2017), addresses antimicrobial resistance as one of the key issues and prioritises development of guidelines regarding antibiotic use, limiting the over-the-counter use of antibiotics, restricting the use of antibiotics as growth promoters in livestock, and pharmaco-vigilance including prescription audit inclusive of antibiotic usage in the hospital and community.
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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.
The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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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.
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Schistosomiasis is a public health problem in tropical and subtropical regions of Africa, Asia, the Caribbean and South America. It is one of the neglected tropical diseases (NTDs) - a group of diseases and conditions that affect particularly low-income populations, worldwide.
Last year, WHO laun...ched a new road map for 2021-2030 that aims to end the suffering from NTDs by 2030, in line with the Sustainable Development Goals. The road map specifically targets the elimination of schistosomiasis as a public health problem, globally.
This guideline provides evidence-based recommendations in the following areas: prevalence thresholds, target age groups and frequency of PC, establishment of WASH and snail control activities to support control and elimination of schistosomiasis, diagnostic tests for the assessment of schistosomiasis infection in animal reservoirs, in snail hosts, and in humans.
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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, equipment and supplies on site and to ident...ify 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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Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection
WHO Guidelines for the Treatment of Human African Trypanosomiasis. Web Annex B