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 (MR...A) nor a national medicine quality control laboratory – 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 Me...dicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main obj...ective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to strengthen 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 ...to-highlight medbox">medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use of 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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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 ...ight medbox">efficacy, safety and comparative cost-effectiveness. This edition of the Essential Medicines List (EML) 2017 for Ghana has been derived 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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Long Acting Muscarinic Antagonists (LAMA) such as tiotropium and glycopyrronium are used in the management of COPD1. They have been shown to improve lung function, quality of life and exercise toler...ance. They have also been associated with reduced COPD-related exacerbations, associated hospitalisations and duration of hospital stay. Both the South African Thoracic Society (SATS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD), guidelines recommend the use of long acting anticholinergic drugs (or long acting beta agonists) in moderate to very severe disease as defined by lung function (FEV1). The most up to date guideline, utilizing the GRADE methodology (European Respiratory Society guidelines of 2017), confirms their superiority over long acting β agonists (LABA) as monotherapy for COPD in that LAMA's have demonstrated greater efficacy in terms of exacerbation reduction, with similar safety profile.2 These recommnedations are supported by published peer-reviewed
evidence including individual papers and Cochrane reviews.
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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 evalu...ating the efficacy of medicines used for intermittent preventive treatment of malaria in pregnancy, perennial 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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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...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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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...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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Research Article
BMC Infectious Diseases 2014, 14:91/1471-2334/14/91
Antimalarial drug resistance has emerged as a threat to global malaria control efforts, particularly in the Greater Mekong subregion. Drawing on data collected through more than 1000 therapeutic efficacy studies as well as molecular marker studies <...span class="attribute-to-highlight medbox">of Plasmodium falciparum drug resistance, the Report on antimalarial drug efficacy, resistance and response: 10 years of surveillance (2010–2019) presents a decade’s worth of data on drug efficacy and surveillance, as well as recommendations to monitor and protect the efficacy of malaria treatment in the decades to come.
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Antimicrobial resistance (AMR) is a threat to human and animal health and refers to the ability of microorganisms to defy the medicines prescribed. For instance when antibiotics are used improperly,... such as an incorrect dose, insufficient duration or wrong frequency, resistance is heightened. The misuse of antimicrobials affects their efficacy, and increasingly more infections and diseases become untreatable. Many gains made in modern medicine throughout the 20th century will be lost, making AMR a global public and animal health issue that requires concerted action. AMR and the use of antimicrobials (AMU) affect food safety and security, people’s livelihoods, as well as economic and agricultural development.
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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 interest, “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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• 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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The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal med...icines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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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...pan> 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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Drugs and medical supplies are dispensed at the cutting edge level of the interface between the public health system and the people. Availability or lack of it brings either credit or discredit to t...he public health system. The primary reason for holding stocks of medicines and medical supplies in a proper scientific manner is to ensure continuous and uninterrupted availability to prevent stock-outs, especially of critical items of supply while at the same time ensuring that stocks of medicines do not get expired. An efficient inventory management is a pre-requisite for optimal stock management. It enables the management of health facilities to know the current pattern of consumption of drug trends over a period of time and also variances. The environmental control of the drugs and other medical supplies play an important role to keep the products' efficacy intact. Some medicines and vaccines need special storage temperature, otherwise, there may be wastage. The quality of the medicines can be adversely affected by poor storage, transportation and distribution. Thus, maintaining proper storage condition for health commodities is vital for ensuring their quality. So, by this training, CDMU wants to educate different people dealing with medicines and equip them for the roles they have to perform efficiently so that the wastage does not take place or can be minimized.
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance ...s="attribute-to-highlight medbox">of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation of 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).
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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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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 ...light medbox">of the technical consultation was to agree on the most important PPCs for drugs to 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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