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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe
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medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health professionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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A model quality assurance system for procurement agencies
World Health Organization
World Health Organization, United Nations Children's Fund, United Nations Development Programme, United Nations Populations Fund, World Bank
(2007)
C_WHO
This interagency report provides recommendations for assuring quality of medicines during key activities
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of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribution of pharmaceutical products.
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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
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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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Improving the quality of hospital antibiotic use is a major goal of WHO’s global action plan to combat antimicrobial resistance. The WHO Essentia
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l Medicines List Access, Watch, and Reserve (AWaRe) classification could facilitate simple stewardship interventions that are widely applicable globally. We aimed to present data on patterns of paediatric AWaRe antibiotic use that could be used for local and national stewardship interventions.
www.thelancet.com/lancetgh Vol 7 July 2019
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The availability of controlled medicines is crucial for patients requiring palliative care, pain relief and symptom management. Many individuals worldwide, especially in low- and middle-income count
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ries, continue to experience limited access to these essential medicines. Enhancing access to controlled medicines is paramount in promoting universal health coverage. This report offers a detailed situational analysis of policies and programmes aimed at improving access to affordable, high-quality controlled medicines for pain management in the WHO South-East Asia Region. The report identifies the existing barriers, challenges and possible solutions to facilitate access to such medicines across all Member States.
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Maintaining proper storage conditions for health commodities is vital to ensuring their quality. Product expiration dates are based on ideal storage conditions and protecting product quality until t
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heir expiration date is important for serving customers and conserving resources. Guidelines for the Storage of Essential Medicines and Other Health Commodities is a practical reference for those managing or involved in setting up a storeroom or warehouse. The guide contains written directions and clear illustrations on receiving and arranging commodities; special storage conditions; tracking commodities; maintaining the quality of the products; constructing and designing a medical store; waste management; and resources. It was written to meet the needs of district-level facilities; however, the guidelines and information it contains apply to any storage facility, of any size, in any type of environment.
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To mark the International Day of the African Child, Medicines for Malaria Venture (MMV) celebrated the inclusion of three
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of its antimalarial medicines on the WHO Model List of Essential Medicines (EML) and the EML for Children (EMLc). These are two artemisinin-based combination therapies (ACTs) for adults, children and infants, and a rectal artesunate formulation for the pre-referral treatment of severe malaria in young children. The approved therapies — pyronaridine–artesunate, dihydroartemisinin–piperaquine and rectal artesunate — offer child-friendly formulations and are the first-line treatment for uncomplicated malaria caused by Plasmodium falciparum and P. vivax. Inclusion in the EMLc facilitates national adoption, improves access to high-quality treatments and addresses the disproportionate malaria burden among children under five. This supports global efforts to reduce malaria mortality and advance elimination.
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Maintaining proper storage conditions for health commodities is vital to ensuring their quality. Product expiration dates are based on ideal storage conditions and protecting product quality until t
...
heir expiration date is important for serving customers and conserving resources. Guidelines for the Storage of Essential Medicines and Other Health Commodities is a practical reference for those managing or involved in setting up a storeroom or warehouse. The guide contains written directions and clear illustrations on receiving and arranging commodities; special storage conditions; tracking commodities; maintaining the quality of the products; constructing and designing a medical store; waste management; and resources. It was written to meet the needs of district-level facilities; however, the guidelines and information it contains apply to any storage facility, of any size, in any type of environment.
Available in English, French, Spanish and Russian
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Tutorial of local production of alcohol-based solution (WHO formulation)
WHO Collaborating Centre of Patient Safety Infection Control & Improving Practices; Hôpitaux Universitaires de Genève (HUG); Pharm-Ed
WHO Collaborating Centre of Patient Safety Infection Control & Improving Practices; Hôpitaux Universitaires de Genève (HUG); Pharm-Ed
(2016)
C2
14.04.2016
Pharm -Ed
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The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alc
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ohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Manufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
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Control of pollution from antibiotic manufacturing is a key part of safeguarding the longevity of antibiotics for all. Pollution contributes to ant
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ibiotic resistance and potentially undermines the effectiveness of medicines. High levels of antibiotics in water bodies downstream of manufacturing sites have been widely documented. Currently, antibiotic pollution from manufacturing is largely unregulated and quality assurance criteria typically do not address environmental emissions.
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In the face of rapid increases in the number of hospitalizations due to COVID-19 in Latin America and the Caribbean, coupled with shortages of huma
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n and material resources, including medical equipment and gases, there is a need to redesign models of care in the Region to optimize available resources and ensure that more patients receive the quantity and quality of oxygen they need. Oxygen is included in the World Health Organization’s list of essential medicines and is used to care for patients at all levels of integrated health services networks. The efficacy of oxygen use in the treatment of patients with respiratory conditions caused by COVID-19 has been demonstrated, but there is great opportunity to improve the effectiveness of its use if it is used in a rational, sustainable, and safe way. Bearing in mind that the efficacy of a health technology is measured by its benefit under actual conditions of use, practical actions can be taken to improve the use of medical oxygen and avoid oxygen shortages. A drug is considered to be used rationally when patients receive it according to their clinical needs, in doses appropriate to their individual needs, for an appropriate period, and at a low cost to them and their community. By providing instruction on the rational use of oxygen and promoting it, negative repercussions can be avoided, such as loss of efficacy as a result of activities related to oxygen storage, distribution, and administration. Rational use of oxygen also involves controlling waste due to leaks in storage and distribution systems, use of gas at incorrect pressures, use of incorrectly adjusted flowmeters, and disconnections, among other problems. Another aspect to consider is the provision of adequate technical support for all oxygen production systems, in terms of maintenance and calibration, availability of electrical energy, and specific knowledge about these systems. For these reasons, a set of guidelines has been put together for the development of an efficient management system to deal with situations of oxygen scarcity, both now and in the future.
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Cardiovascular diseases, principally ischemic heart disease (IHD), are the most important cause of death and disability in the majority of low- and lower-middle-income countries (LLMICs). In these c
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ountries, IHD mortality rates are significantly greater in individuals of a low socioeconomic status (SES).
Three important focus areas for decreasing IHD mortality among those of low SES in LLMICs are (1) acute coronary care; (2) cardiac rehabilitation and secondary prevention; and (3) primary prevention. Greater mortality in low SES patients with acute coronary syndrome is due to lack of awareness of symptoms in patients and primary care physicians, delay in reaching healthcare facilities, non-availability of thrombolysis and coronary revascularization, and the non-affordability of expensive medicines (statins, dual anti-platelets, renin-angiotensin system blockers). Facilities for rapid diagnosis and accessible and affordable long-term care at secondary and tertiary care hospitals for IHD care are needed. A strong focus on the social determinants of health (low education, poverty, working and living conditions), greater healthcare financing, and efficient primary care is required. The quality of primary prevention needs to be improved with initiatives to eliminate tobacco and trans-fats and to reduce the consumption of alcohol, refined carbohydrates, and salt along with the promotion of healthy foods and physical activity. Efficient primary care with a focus on management of blood pressure, lipids and diabetes is needed. Task sharing with community health workers, electronic decision support systems, and use of fixed-dose combinations of blood pressure-lowering drugs and statins can substantially reduce risk factors and potentially lead to large reductions in IHD. Finally, training of physicians, nurses, and health workers in IHD prevention should be strengthened.
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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 im
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prove prevention, diagnosis, care and management of CVD diseases. Affordable essential medicines and technologies 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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These guidelines for the National Pharmacovigilance and Medicine Information System in Rwanda have been developed to ensure that safe, efficacious and quality medicines are made available to all Rwa
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ndans.
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The Ideal Clinic Realisation and Maintenance (ICRM) programme was initiated by the National Department of Health in July 2013 in order to systematically improve primary health care (PHC) facilities and the
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quality of care they provide. The Ideal Clinic framework/dashboard sets out the standards for PHC facilities to provide good-quality health services. An Ideal Clinic is defined as a clinic with good infrastructure, adequate staff, adequate medicines and supplies, good administrative processes, and sufficient adequate bulk supplies. Applicable clinical policies, protocols and guidelines are adhered to, and it harnesses partner and stakeholder support.
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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 affor
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dability, geographical accessibility, quality and rational 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.
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The National pharmaceutical policy aligns itself to the Government vision for development of the health sector, as defined in Vision 2020, the Millennium Development Goals and the Economic Development for Poverty Reduction Strategy and the National
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Health Policy. The pharmacy policy addresses, among other challenges, the establishment of functional National Medicines Regulatory Authority that will implement all the regulatory functions, lack of local manufacturing facilities, lack of pricing policy of health commodities and technologies in private sector. This policy is based on the following key priorities: the Quality assurance, accessibility and the rational use of medicines, other health commodities and technologies.
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Accessed: 02.05.2020
These interim IPC recommendations for health settings have been developed through the contributions of many individuals and institutions, such as the Centers for Disease Control-Kenya; ITECH; US Agency for International Develop
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ment (USAID) Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program; and WHO that are committed to ensuring that the transmission of COVID-19 to HCWs and the public within the health care setting is limited. The Ministry of Health (MOH) through the Directorate of Health Standards Quality Assurance and Regulations wishes to thank all the contributing authors led by the sub-committee on case management and IPC for the COVID-19 response for their expertise and time given to writing these guidelines.
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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
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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.
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There is strong demand for alternatives to pharmaceuticals for a variety of common illnesses due to concerns of safety, efficacy, and a desire for more “natural” products. Despite this growing i
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nterest, “conventional” healthcare providers may have little to no knowledge about herbal medicines, which is further compounded by the sometimes misleading information in the media and on the internet. This course provides the necessary background for providers to begin to incorporate herbal medicines into their practice, particularly in regards to their therapeutic properties, efficacy (or lack thereof), and safety concerns, including quality control and potential adverse effects
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