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.
more
Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
Snakebite envenoming affects millions of people worldwide annually and is a significant source of mortality. Preventing and treating the problem is complex and requires collaboration among the fields of public health, medicine, ecology, and laboratory science. After being removed from the category A... neglected tropical disease (NTD) list in 2013, snakebite envenoming was reinstated in 2017 in response to antivenom shortages and advocacy from researchers and international NGOs. In 2019, the World Health Organization (WHO) set a target to halve the number of deaths and cases of snakebite envenoming by 2030.
more
The document introduces a simple classification, minimums standards and a registration form for Foreign Medical Teams (FMTs) that may provide surgical and trauma care arriving within the aftermath of a sudden onset disaster. These can serve as tools to improve the coordination of the foreign medical... team response, and be the reference for registration on arrival as well as a possible global registration mechanism similar to what exists for urban search and rescue teams
more
As a public good, antimicrobial medicines require rational use if their effectiveness is to be preserved. However, up to 50% of antibiotic use is inappropriate, adding considerable costs to patient care, and increasing morbidity and mortality. In addition, there is compelling evidence that antimicro...bial resistance is driven by the volume of antimicrobial agents used. High rates of antimicrobial resistance to common treatments are currently reported all over the world, both in health care settings and in the community. For over two decades, the Region of the Americas has been a pioneer in confronting antimicrobial resistance from a public health perspective. However, those efforts need to be stepped up if we are to have an impact on antimicrobial resistance and want to quantify said impact.
more
Global actions to reduce antimicrobial resistance (AMR) include optimising the use of antimicrobial medicines in human and animal health. In countries with weak healthcare regulation, this requires a greater understanding of the drivers of antibiotic use from the perspective of providers and consume...rs. In Bangladesh, there is limited research on household decision-making and healthcare seeking in relation to antibiotic use and consumption for humans and livestock. Knowledge is similarly lacking on factors influencing the supply and demand for antibiotics among qualified and unqualified healthcare providers. The aim of this study is to conduct integrated research on household decision-making for healthcare and antibiotic use, as well as the awareness, behaviours and priorities of healthcare providers and sellers of antibiotics to translate into policy development and implementation
more
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
more
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.
more
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
more
Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure important aspects of a country’s pharmaceutical situation. Level 1 indicators measure the existence and ...performance of key national pharmaceutical structures and processes. Level II indicators measure key outcomes of these structures and processes in the areas of access, product quality and rational use. These indicators can be used to assess progress over time; to compare situations between countries; and to reassess and prioritize efforts based on the results.
This Fact Book gives the results of the assessment of Level I indicators conducted in 2003 and of Level II indicator surveys conducted between 2002 and 2004
more
The purpose of adding the books to the website of MCAI for download, is to make this life-saving, up-to-date information available to all who need it. Fill in a short registration field and you can download the pdf-files.
If you work in a hospital in a low income country - providing free care - y...ou are probably intitled to FREE copies of these books. MCAI will send them to you, all you have to do is to read our Flyer and fill in the request form.
more
How to address the global crisis in antibiotic research and development.
The report includes a comprehensive summary and critical evaluation of recent initiatives to overcome the barriers to achieve sustainable access to antibiotics. As antibiotic resistance will continue to develop as long as we ...depend on these medicines to treat bacterial infections, a continuous supply of new effective antibiotics is needed. The report identifies five key challenges that must be solved in order to achieve sustainable access for all, and charts out options for governmental action in response to each of them.
more
This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
more
Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
more
Prompt, effective antimalarial treatment, and supportive care can substantially reduce the rate of mortality from severe malaria. However, many children in malaria-endemic countries do not have access to health facilities or a qualified health care provider and do not receive the necessary care in a... timely fashion. Without rapid detection of danger signs and access to effective treatment, including pre-referral treatment that can be administered in the community level, many of these children with severe malaria die.
In situations where there is no immediate access to a health care facility, WHO recommends the administration of a standard dose of an effective antimalarial medicine as pre-referral treatment before referral to a facility at which complete treatment can be administered.
Rectal artesunate is the WHO-recommended pre-referral intervention in situations where artesunate injection are not feasible for children under the age of 6 years with suspected severe malaria. The intervention reduces the risk of death or permanent disability by up to 50% provided the child is referred to a health facility at which complete treatment can be administered.
This field guide is aimed at supporting the effective deployment of RAS as pre-referral treatment of suspected severe malaria in line with the WHO malaria guidelines.
more
This field study to assess the pharmaceutical situation was undertaken in Ghana in May-June 2008 using a standardized methodology developed by the World Health Organization. The study assessed medicines availability and affordability, geographical accessibility, quality and r...ational use among other issues. The survey was conducted in six regions. In each region, 6 public health care facilities, 12 private pharmacies and 1 warehouse were surveyed.
more
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).
more
The goal of the draft global action plan is to ensure, for as long as possible, continuity of successful treatment and prevention of infectious diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them.
These guidelines present evidence-based recommendations and best practice statements on use of medically important antimicrobials in food-producing animals, based on the WHO list of critically important antimicrobials for human medicine (WHO CIA List). These guidelines aim primarily to help preserve... the effectiveness of medically important antimicrobials, particularly those antimicrobials judged to be critically important to human medicine and also help preserve the effectiveness of antimicrobials for veterinary medicine, in direct support of the WHO global action plan on antimicrobial resistance
more
Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
more