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.
There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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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 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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The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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This guide is a resource for physicians and other health care professionals who provide care and treatment to patients with drug-resistant tuberculosis.
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 medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, 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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The purpose of this manual is to define a limited number of indicators that will objectively describe the management and use of antimicrobials in hospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. T...he indicators in this manual will complement the existing WHO (1993) indicators of outpatient antimicrobial use suggested in How to Investigate Drug Use in Health Facilities (including percentage of encounters in which an antibiotic was prescribed and percentage of medicine costs spent on antibiotics) and will address the need for antimicrobial indicators for inpatient conditions.
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant
tuberculosis (XDR-TB) increasingly occur in resource-constrained settings.
In the context of a national response to MDR- and XDR-TB, health workers in
TB clinics (in district hospitals and some accredited health centres) wil...l need
to diagnose MDR-TB, initiate second-line anti-TB drugs, and monitor MDRTB
treatment.
Management of MDR-TB: a field guide was created to help health workers
carry out these tasks. It is a job aid that medical officers and TB nurses
are meant use frequently during the day for quick reference. This module
is closely related to other clinical guideline modules in the Integrated
Management of Adolescent and Adult Illness (IMAI) series. In particular, the
approach to chronic disease management is taken from General principles
of good chronic care in the IMAI series.
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The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information... on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
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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 document describes the key areas that national governments should consider for the introduction and scale-up of point-of-care (POC) diagnostics within national programmes, as new innovative POC technologies are being introduced into the market. The next steps taken to include these new innovati...ons within the broader context of national diagnostic networks of conventional laboratories could influence the achievement of the 2030 Fast Track targets for ending the AIDS epidemic.
POC diagnostics, when strategically introduced and integrated into national diagnostic networks, may help catalyse changes that improve the way diagnostics and clinical services are delivered. This document distils this understanding based on programmatic and market experiences of introducing POC diagnostics through catalytic investments in POC HIV technologies across numerous countries in sub-Saharan Africa.
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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The Antimicrobial Resistance Benchmark has evaluated for the second time how the most important players in the antibiotic market are addressing the rise of resistance and the global need for appropriate access to antibiotics. Although we can see progress — it’s hanging by a thread.
We have reac...hed a tipping point where large and prominent drugmakers have retreated from the antibiotics field and smaller innovative biotech companies have gone bankrupt due to the poor financial rewards on offer.
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This guideline provides advice in regards to applications for Marketing Authorisations for antimicrobial veterinary medicinal products (VMPs) on the data required and the methodology to be used for performing an assessment of the risk to public health from antimicrobial resistance (AMR) due to use o...f the product. The scope of the guidance extends to VMPs intended for food producing species and to the transmission of AMR by the foodborne route or through direct contact with treated animals.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The document provides information on different aspects of care and support for TB patients. In particular, the handbook provides practical guidance on the implementation of the interventions that enable treatment adherence such as social support, treatment administration options, digital adherence technologies. The practical guidance also includes models of care for all TB patients, models of care for children and adolescents, integrated care for TB, HIV and comorbidities, engagement of private sector, managing of TB in health emergencies. This new practical handbook also includes two important chapters on health education and counselling, and palliative care for patients with TB.
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The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The operational handbook provides practical information and tools that complement the recommendations in the guidelines. The strategies described in the operational handbook are based on the latest WHO recommendations which were formulated by Guideline Development Groups using the GRADE approach. In many cases however, the recommendations in their current form lacked sufficient clinical and programmatic detail, which is important for implementation. This operational handbook complements the guidelines with practical advice based on best practices and knowledge from the fields such as pharmacokinetics, pharmacodynamics, microbiology, pharmacovigilance and clinical and programmatic management.
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There is an expanding market of no- and low-alcohol beverages (NoLos). However, their effects on global ethanol consumption and public health are still questioned. Policies and regulations about NoLos’ availability, acceptability and affordability are lacking and evidence about their benefits is l...imited. Concerns have been raised about the impact of NoLos in reducing alcohol consumption and its associated harm and the possible drawbacks and implications, such as misleading minors, pregnant women, abstainers or those seeking to stop drinking about their actual ethanol content. Further, there are concerns about the implications of NoLo branded products being displayed close to the brand’s main alcoholic beverages and their potential to subtly lead to new occasions of drinking. There is a need to monitor their consumption and impact on aggregated alcohol consumption to understand the public health implications of NoLos. The alcohol by volume content of NoLos must be defined, harmonised and clearly labelled. NoLo marketing needs to be regulated to protect children, pregnant women and those seeking to stop drinking. Fiscal and pricing policies to reduce the affordability of products with higher strengths of ethanol may favour a shift towards lower alcohol strength beverages.
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