Antimicrobial resistance (AMR) occurs when disease-causing pathogens are able to withstand the killing or suppressing power of antimicrobial medicines. This phenomenon increases the global burden of infectious diseases and strains health systems.This course aims to improve the learner's awareness an...d understanding of the basic principles of AMR, the impact AMR has on individuals and society, and why it is a major public health concern.
A complementary course, Antimicrobial Resistance (Part 2), describes interventions that address the multiple factors contributing to AMR across the health system.
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DOI 10.15252/emmm.201404792 |Published online 30.12.2014
EMBO Molecular Medicine(2014)emmm.201404792
Exciting new treatment approaches make the management of hepatitic C one of the most rapidly developing areas of medicine. The Flying Publisher short Guide to Hepatitis C is an up-to-date source of information for physicians, residents and advanced medical students.
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
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Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
2nd edition. A Guide to Managing Medicines for All Health Workers. Available for purchase via following link https://www.twn.my/title2/books/HAI.htm
Where there are no trained pharmacists serving communities, other categories of health workers are called upon to order, buy, store, dispense and ad...vise people on rational use of medicines. Where There Are No Pharmacists explains how to order them, store them, prepare them, dispense them and use them safely and effectively - it is about managing medicines. Information to help communities benefit from the use of medicines is also included.
This book walks readers through each step, covering topics ranging from policy issues to patient education. It provides guidance for anyone who is doing the work of a pharmacist; anyone who sells, dispenses, prepares, manages, or explains to others how to use medicines.
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How WHO works to prevent drug use, reduce harm and improve safe access to medicines
For several years, agencies supporting preparedness and response to cholera outbreaks have supplied medicines and medical devices through the Interagency Diarrhoeal Disease Kits (IDDK).
In an effort to better align the presentation and content of the kits to field needs, the composition of the ch...olera kits has been reviewed by WHO and its partners in 2015 and again in 2020. The content of all modules have been slightly revised with no changes except for the cholera laboratory check list.
The revised cholera kits 2020 are designed to help prepare for a potential cholera outbreak and to support the first month of the initial response for 100 cases. The overall package consists of six different kits, each divided in several modules.
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The first important change is a new priority ranking of the available medicines for MDR-TB treatment, based on a careful balance between expected benefits and harms. Treatment success for MDR-TB is currently low in many countries. This could be increased by improving access to the highest-ranked med...icines for all patients with MDR-TB.
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The project will support preventive actions, traditional medicine and the coordination and
implementation capacities of the national framework for HIV/AIDS control.
Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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This guideline covers making people aware of how to correctly use antimicrobial medicines (including antibiotics) and the dangers associated with their overuse and misuse. It also includesmeasures to prevent and control infection that can stop people needing antimicrobials or spreadinginfection to o...thers. It aims to change people's behaviour to reduce antimicrobial resistance and thespread of resistant microbes.
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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.
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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
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DOI:https://doi.org/10.1016/S2213-2600(20)30316-7
The Lancet Respiratory Medicine
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
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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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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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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 was to agree on the most important PPCs for drugs t...o 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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