The purpose of this document is to provide relevant information and guidelines on
coronavirus outbreaks – and in particular the novel coronavirus SARS-CoV-2 and the
diseases it produces, COVID-19 – for pharmacists and the pharmacy workforce, both in a
primary care context (i.e. community phar...macies and primary healthcare facilities) and in
hospital settings, as well as for pharmacists working as clinical biologists in medical
analysis laboratories, for example, as clinical biologists, and offer a set of references that
may be consulted for more informationstor
more
Antimicrobial resistance (AMR) is occurring everywhere in the world, compromising the ability to treat infectious diseases, as well as undermining many other advances in health and medicine. Underlying factors that drive AMR include; weak or absent surveillance and monitoring systems, inadequate sys...tems to ensure quality and uninterrupted supply of medicines, inappropriate and irrational use of medicines including in animal husbandry, poor infection prevention and control practices, and depleted arsenals of diagnostics, medicines and vaccines as well as insufficient research and development of new products.
more
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...ion of pharmaceutical products.
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
The management of information and logistics is an essential component of health product systems. In a context of limited financial resources and morbidity and mortality sustained by persistent diseases, it is necessary to strengthen health systems through competent resources, especially human resour...ces (HR), to ensure performance, sustainability and independence from external funding. In Burkina Faso, a strong and lasting partnership between the Ministry of Health and the Bioforce Institute has existed since 2005 to address this issue. This partnership has created a favorable environment for the professionalization of health logistics and for the recognition of its significant role in health system performance.
more
This curricula guide builds on several existing products of WHO and partners, aimed at supporting countries in their effort to address the first objective of the GAP-AMR (to improve awareness and understanding of AMR). It is targeted specifically at health educators and policy planners, and applies ...a systematic modular and submodular collection of learning objectives and outcomes that are organized according to the key occupational groups involved in the use of antimicrobials in human health. It is hoped that educators, faculties of heath personnel training institutions, health regulatory institutions and other users will find it a useful resource in meeting their respective needs for strengthening health workers’ contributions to containing AMR.
more
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
more
The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to... patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
more
Phil. Trans. R. Soc. B (2010) 365, 2959–2971; doi:10.1098/rstb.2010.0143.
Agricultural ecosystems provide humans with food, forage, bioenergy and pharmaceuticals and are essential to human wellbeing. These systems rely on ecosystem services provided by natural ecosystems, including pollination, b...iological pest control, maintenance of soil structure and fertility, nutrient cycling and hydrological services. Preliminary assessments indicate that the value of these ecosystem services to agriculture is enormous and often underappreciated. Agroecosystems also produce a variety of ecosystem services, such as regulation of soil and water quality, carbon sequestration, support for biodiversity and cultural services. Depending on management practices, agriculture can also be the source of numerous disservices, including loss of wildlife habitat, nutrient runoff, sedimentation of waterways, greenhouse gas emissions, and pesticide poisoning of humans and non-target species. The tradeoffs that may occur between provisioning services and other ecosystem services and disservices should be evaluated in terms of spatial scale, temporal scale and reversibility. As more effective methods for valuing ecosystem services become available, the potential for ‘win–win’ scenarios increases. Under all scenarios, appropriate agricultural management practices are critical to realizing the benefits of ecosystem services and reducing disservices from agricultural activities.
more
China is one of the major countries for the production and use of antibacterial agents. Antibacterial agents are widely used in healthcare and animal husbandry. It plays a significant role in treating infections and saving patient lives, preventing and treating animal diseases, improving farming ef...ficiency, and guaranteeing public health security. However, antimicrobial resistance has become increasingly prominent due to insufficient research and development capacity of new antimicrobials, sales of antimicrobials without prescriptions in pharmacies, irrational use of antibacterial agents in medical and food animal sectors, non-compliant waste emissions of pharmaceutical enterprises, as well as lack of public awareness toward rational use of antimicrobials. Bacterial resistance ultimately affects human health, but the cause of bacterial resistance and consequences are beyond the health sector. Antimicrobial resistance brings increasing biosecurity threats, worsens environmental pollution, constrains economic development and other adverse effects to human society, thus, there is an urgent need to strengthen multi-sectoral and multi-domain collaborative planning to jointly cope with this issue.
more
Antimicrobial resistance is one of the most important threats to the health worldwide. Antimicrobial resistance or drug resistance is the reduction of the pharmaceutical effects of a drug against a disease or reduction of its effectiveness in improving the clinical signs of a disease. Antimicrobial ...resistance occurs naturally but misuse of antibiotics in human and animals significantly accelerates the process of developing antimicrobial resistance. In fact, antimicrobial resistance refers to the resistance of a microorganism to one or more antimicrobial drugs which had been previously sensitive to these drugs. Antimicrobial resistance can occur in a wide variety of pathogens including bacteria, parasites, viruses, fungi, and cancer cells and may threaten the life of every person, in every age, and in every country
more
MICROBIAL DRUG RESISTANCEVolume 24, Number 5, 2018ªMary Ann Liebert, Inc.DOI: 10.1089/mdr.2017.0383
Antibiotic resistance (ABR) is a worldwide publichealth concern, with serious health, economic, and so-cietal repercussions. Its emergence is attributed to the se-lective pressure exerted by antib...iotic use in the community, hospitals, veterinary health, agriculture, aquaculture, and the environment. Additionally aggravating the situation is the fact that very few new antibiotics have recently been produced by pharmaceutical companies. It is widely acknowledged that food animals are key reservoirs of antibiotic-resistant bacteria and that antibiotic usage in this population favors the emergence, selection, and spread of resistance among animals and humans, both through zoonoses (infectious diseases trans-mitted between animals and humans) and the food chain.
more
This threat assessment addresses the implications of the ongoing Marburg virus disease (MVD) outbreak in
Rwanda for the European Union/European Economic Area (EU/EEA). MVD is a severe disease in humans and,
although uncommon, it has the potential to cause epidemics with significant case fatality. ...All recorded MVD
outbreaks to date have originated in Africa. MVD is not an airborne disease and is considered not to be
contagious before symptoms appear. Direct contact with the blood and other body fluids of infected people
and animals or indirect contact with contaminated surfaces and materials like clothing, bedding and medical
equipment is required for transmission. The risk of infection is minimised when proper infection prevention and
control precautions are strictly followed. There is no approved treatment or vaccine for MVD; however, several
pharmaceuticals and candidate MVD vaccines are under investigation.
more
Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
more
First edition, November 1997 | Revised July 2002
Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program.