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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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.
The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of ...patient samples, the issue of compatible blood and its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels.
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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.
The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV ...ht medbox">medicines in developing countries as of April 2014. The focus is primarily on those ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
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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 situa...tion. 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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The recommendations cover the level of blood pressure to start medication, what type of medicine or combination of medicines to use, the target blood pressure level, and how often to have follow-up ...checks on blood pressure. In addition, the guideline provides the basis for how physicians and other health workers can contribute to improving hypertension detection and management.
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Tis first edition describes the standard operating procedures for health products for NTDs amenable to preventive chemotherapy and the medicines donated to treat them. These include albendazole for lymphatic filariasis and soil-transmitted helminthi...ases; azithromycin for trachoma and yaws; diethylcarbamazine citrate for lymphatic filariasis; ivermectin for onchocerciasis and lymphatic filariasis; mebendazole for soil-transmitted helminthiases; praziquantel for schistosomiasis; and triclabendazole for foodborne trematodiases. Standard operating procedures for diseases amenable to case management will be covered in subsequent editions, including the application process for requesting medicines (Chapter 1). In the meantime, the procedures described in the rest of the document apply for both case management and preventive chemotherapy NTD health products.
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As we approach World Asthma Day on the May 2, 2023, we reflect on the theme “ Asthma Care for All”. Prevalence of Asthma is increasing amongst children, adolescents and adults. Under-diagnosis, underutilization of inhaled corticosteroids, inaccessibility of treatment, and unaffordability of ...n class="attribute-to-highlight medbox">medicines are amongst the challenges that low-middle income countries are faced with. This commentary seeks to highlight the challenges, the resources available and to suggest recommendations that can be implemented to improve asthma care for all and reduce burden of asthma in Africa.
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Issue Brief 31: Antimicrobial resistance (AMR) can occur when viruses, bacteria, parasites and fungi change over time. There is no longer a response to medicines, and the infection treatment gets really difficult which increases the risk of a disesa...se spread, which can lead to severe health problems. AMR is an increasing threat to global public health worldwide that requires cross-sectional and cross-disciplinary action. It is present in every country and is spurred by several human-made factors, including over- and/or inadequate use of antibiotics, poor hygiene and infection prevention control, and excessive usage of antibiotics outside the health care sector e.g. in life stock production.
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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 the public health system. The primary reason for holding stocks of ...medbox">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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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...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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This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation. Pharmacovigilance as a medical discipline is crucial in preventing ...lass="attribute-to-highlight medbox">medicine-related adverse effects in humans, promoting patient safety, and the rational use of medicines. The indicators proposed in this manual are based on the expected functions of pharmacovigilance centres as described in the WHO Mimimum Requirements for a Functional Pharmacovigilance System (1) (see Annex 1 of the manual).
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Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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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 medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the f...ormulation 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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One health Response to AMR Containment.
In a significant move for the public health sector, Kerala has become the first state in India to launch an action plan to combat the growing cases of antimicrobial immunity, arising primarily from irrational use of ...>medicines and excessive antibiotics used in livestock and poultry.
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This user guide is designed to provide national malaria control programmes with general information on glucose-6-phosphate dehydrogenase (G6PD) deficiency. Individuals with this condition may be at risk of adverse effects from medicines commonly use...d to cure Plasmodium vivax malaria, as well as from other medicines and substances.
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Pakistan Global Antibiotic Resistance Partnership (GARP) was formed in the wake of international and national efforts for AMR curtailment. A group of experts from microbiology, infectious diseases and veterinary medicine ...formed a core group at the organizational meeting of GARP in Kathmandu, Nepal in July 2016. In the meeting, this core group was expanded to include other members from different sectors with the selection of the Chair and co-chairs. These were asked to serve on a voluntary basis, in their own individual capacities, with no personal gains, or gains to the institutions to which they are affiliated. The first phase of GARP took place from 2009 to 2011 and involved four countries: India, Kenya, South Africa and Vietnam. Phase one culminated in the 1st Global Forum on Bacterial Infections, held in October 2011 in New Delhi, India. In 2012, phase two of GARP was initiated with the addition of working groups in Mozambique, Tanzania, Nepal and Uganda. Phase three has added Bangladesh, Lao PDR, Nigeria, Pakistan and Zimbabwe to the network to date.
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How to address the global crisis in antibiotic research and development.
The report includes a comprehensive summary and critical evaluation of recent initiatives to overcome the barriers to achieve sustainable access to antibiotics. As antibiotic resistance will continue to develop as long as we ...depend on these medicines to treat bacterial infections, a continuous supply of new effective antibiotics is needed. The report identifies five key challenges that must be solved in order to achieve sustainable access for all, and charts out options for governmental action in response to each of them.
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