PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato...ry – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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WHO Regional Publications, Western Pacific Series No. 23
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use o...f herbal medicine in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade.
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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.
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Essential Medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy, safety and comparative cost-effectiveness. This edition of the Essential Medicines List (EML) 2017 for Ghana has been deriv...ed from its companion Standard Treatment Guidelines 2017 to ensure harmony in treatment, procurement and re-imbursements. The medicines listed have been coded according to the Health Commodity
Codes Catalogue of the Ministry of Health (2008) and their levels of use, based on the type of health facility, including midwifery practice, have been indicated.
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Chemoprevention is the use of medicines, either alone or in combination, to prevent malaria infection and its consequences. This publication provides standardized approaches for monitoring and evaluating the efficacy of medicines used for intermittent preventive treatment of malaria in pregnancy, pe...rennial malaria chemoprevention (formerly known as intermittent preventive treatment of malaria in infants), seasonal malaria chemoprevention and intermittent preventive treatment of malaria in school-aged children. It follows the recent release of new and updated WHO recommendations on these interventions.
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This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj...ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
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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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This document focuses on the management of patients affected by gambiense HAT and
constitutes an update to the WHO therapeutic guidance issued in 2013. The main changes in recommendations concern the criteria and methods for deciding the treatment among the new set of therapeutic options and the pa...rticular conditions that apply to treatment with fexinidazole, as outlined below. Because HAT is a serious, life-threatening disease and because the efficacy of fexinidazole depends on swallowing the medicine after an appropriate intake of food as well as on completing the full 10-day
treatment schedule, the recommendations regarding fexinidazole administration are considered key elements that must be carefully followed. When the conditions listed in these guidelines are not met for any individual patient, the alternative available treatments should be prescribed.
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Research Article
BMC Infectious Diseases 2014, 14:91/1471-2334/14/91
Les infections associées aux soins sont les complications les plus fréquentes qui affectent les patients hospitalisés. L'hygiène des mains est la plus efficace des mesures préventives de ces infections. Cependant, l'observance à ce geste simple parmi les professionnels médico-soignants reste ...faible, souvent inférieure à 40 %. L'hygiène des mains est essentielle à la pratique des soins de tous les professionnels médico-soignants
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these... or other herbal medicines; and
• facilitate information exchange among Member States.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these... or other herbal medicines; and
• facilitate information exchange among Member States.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these... or other herbal medicines; and
• facilitate information exchange among Member States.
more