Three Years After Enactment of the Drug Quality and Security Act
FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Here you can find informations to laws &policies, compliance action, ....
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f 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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The twentieth century ended with human African trypanosomiasis (HAT) epidemics raging across many parts of Africa. Resistance to existing drugs was emerging, and many programs aiming to contain the disease had ground to a halt, given previous success against HAT and the competing priorities associat...ed with other medical crises ravaging the continent. A series of dedicated interventions and the introduction of innovative routes to develop drugs, involving Product Development Partnerships, has led to a dramatic turnaround in the fight against HAT caused by Trypanosoma brucei gambiense. The World Health Organization have been able to optimize the use of existing tools to monitor and intervene in the disease. A promising new oral medication for stage 1 HAT, pafuramidine maleate, ultimately failed due to unforeseen toxicity issues. However, the clinical trials for this compound demonstrated the possibility of conducting such trials in the resource-poor settings of rural Africa.
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Nature, vol.513 (4 September 2014) 13-14
Accessed online January 2019, publication date unknown.
HIV-1 drug resistance (HIVDR) genotyping is an essential component of the WHO global HIVDR surveillance strategy. Plasma “gold standard” specimen type for HIVDR genotyping, but its use may not be feasible in rural, remote areas in low- and middle-income countries, since preparing and storing it ...require personnel and laboratory infrastructure that are often lacking. An alternative specimen type is dried blood spots (DBS), which can be made without special laboratory processing. DBS are more easily transported than plasma because they can be shipped at ambient temperature as non-hazardous materials using regular mail or courier services.
3rd edition
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Practical guide intended for physicians, pharmacists, nurses and medical auxiliaries. This guide is not a dictionary of pharmacological agents. It is a practical manual intended for health professionals, physicians, pharmacists, nurses and health auxiliaries invoved in curative care and drug managem...ent. We have tried to provide simple, practical solutions to the questions and problems faced by field medical staff, using the accumulated field experience of Médecins Sans Frontières, the recommendations of reference organizations such as the World Health Organization (WHO) and specialized documentation in each field. Also available in French, Spanish and Arabic
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Programmatic update
April 2012
Executive Summary
Coordinated Use of Anthelminthic Drugs in Control Interventions: a Manual for Health Professionals and Programme Managers
4th edition.
This report – now in its fourth edition – analyses the barriers and factors affecting access to treatment regimens for drug-resistant tuberculosis (DR-TB), including new and repurposed drugs. We provide detailed pricing profiles of key DR-TB drugs, using manufacturer responses to s...tandardised questionnaires and the Global TB Drug Facility website.
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This guide provides practical, step-by-step guidance on how to organize, implement, and monitor community-based care for DR TB. It is equally useful for program planning or supervision. The target audience for this guide is TB Program Managers, governments, policy makers, nongovernmental organizatio...ns (NGOs), donors and TB advocates.
This guide does not replace other guidelines and documents that contain important medical information, such as Guidelines for the Programmatic Management of Drug-resistant TB (WHO, 2008 and 2011 updates), and Management of MDR-TB: A Field Guide (WHO, 2009).
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Policy Guidelines for Health Facilities
For the first time in almost 50 years there are two new drugs for the treatment of drug-resistant TB (DR-TB): bedaquiline and delamanid. There has also been increased attention given to the safety and efficacy of “re-purposed” drugs that have been widely used to treat other infections but are al...so showing promise in the treatment of DR-TB, including linezolid and clofazimine. This special supplemental guide has been developed for nurses, because it is essential that nurses be provided with material that maximizes their ability to provide optimal support to patients who are receiving new and re-purposed drugs
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