The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version
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of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the latest practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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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
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of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its objectives 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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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective
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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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The purpose of adding the books to the website of MCAI for download, is to make this life-saving, up-to-date information available to all who need it. Fill in a short
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registration field and you can download the pdf-files.
If you work in a hospital in a low income country - providing free care - you are probably intitled to FREE copies of these books. MCAI will send them to you, all you have to do is to read our Flyer and fill in the request form.
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Rabies is a fatal viral zoonosis and serious public health problem.1 All mammals are believed to be susceptible to the disease, and for the purposes of this document, use of the term animal refers t
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o mammals. The disease is an acute, progressive encephalitis caused by viruses in the genus Lyssavirus.
2 Rabies virus is the most important lyssavirus globally. In the
United States, multiple rabies virus variants are maintained in wild mammalian reservoir populations such as raccoons, skunks, foxes, and bats. Although the United States has been declared free from transmission of canine rabies virus variants, there is always a risk of reintroduction of these variants.The rabies virus is usually transmitted from animal to animal through bites. The incubation period is
highly variable. In domestic animals, it is generally 3 to 12 weeks, but can range from several days to months, exceeding 6 months.8 Rabies is communicable during the period of salivary shedding of rabies virus. Experimental and historic evidence documents that dogs, cats, and ferrets shed the virus for a few days prior to the onset of clinical signs and during illness. Clinical signs of rabies are variable and include inappetance, dysphagia, cranial nerve deficits, abnormal behavior, ataxia, paralysis, altered vocalization, and seizures. Progression to death is rapid. There are currently no known effective rabies antiviral drugs.
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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
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Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its objectives 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.
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10 years after the UN general assembly special session on drugs
RESULTS: Between 76 and 97% of the PHCS offered RMCAH services before the lockdown. Except in antenatal, delivery and adolescent care, there was a decline of between 2 and 6% in all the services dur
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ing the lockdown and up to 10% decline after the lockdown with variation across and within States. During the lockdown. Full-service delivery was reported by 75.2% whereas 24.8% delivered partial services. There was a significant reduction in clients' utilization of the services during the lockdown, and the difference between States before the pandemic, during, and after the lockdown. Reported difficulties during the lockdown included stock-out of drugs (25.7%), stock-out of contraceptives (25.1%), harassment by the law enforcement agents (76.9%), and transportation difficulties (55.8%). Only 2% of the PHCs reported the availability of gowns, 18% had gloves, 90.1% had hand sanitizers, and a temperature checker was available in 94.1%. Slightly above 10% identified clients with symptoms of COVID-19.
CONCLUSIONS: The large proportion of PHCs who provided RMCAH services despite the lockdown demonstrates resilience. Considering the several difficulties reported, and the limited provision of primary protective equipment more effort by the government and non-governmental agencies is recommended to strengthen delivery of sexual and reproductive health in primary health centres in Nigeria during the pandemic.
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This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary
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of the opportunities for – and threats to – expanding access to affordable antiretroviral therapy (ART).
The report is supplemented by 11 drug profiles that contain more detailed information on pricing trends and patent barriers for key antiretroviral drugs and fixed-dose combinations. Also included is an annex of conditions that define eligibility for reduced prices from 15 pharmaceutical companies.
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita
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ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring
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of products granted marketing authorization in Ghana.
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Background: Cardiovascular disease (CVD), mainly heart attack and stroke, is the
leading cause of premature mortality in low and middle income countries (LMICs).
Identifying and managing individuals at high risk
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of CVD is an important strategy to prevent and control CVD, in addition to multisectoral population-based interventions to reduce CVD risk factors in the entire population.
Methods: We describe key public health considerations in identifying and managing individuals at high risk of CVD in LMICs.
Results: A main objective of any strategy to identify individuals at high CVD risk is to maximize the number of CVD events averted while minimizing the numbers of
individuals needing treatment. Scores estimating the total risk of CVD (e.g. ten-year risk of fatal and non-fatal CVD) are available for LMICs, and are based on the main CVD risk factors (history of CVD, age, sex, tobacco use, blood pressure, blood cholesterol and diabetes status). Opportunistic screening of CVD risk factors enables identification of persons with high CVD risk, but this strategy can be widely applied in low resource settings only if cost effective interventions are used (e.g. the WHO Package of Essential NCD interventions for primary health care in low resource settings package) and if treatment (generally for years) can be sustained, including continued availability ofaffordable medications and funding mechanisms that allow people to purchase medications without impoverishing them (e.g. universal access to health care). Thisalso emphasises the need to re-orient health systems in LMICs towards chronic diseases management.
Conclusion: The large burden of CVD in LMICs and the fact that persons with high
CVD can be identified and managed along cost-effective interventions mean that
health systems need to be structured in a way that encourages patient registration, opportunistic screening of CVD risk factors, efficient procedures for the management of chronic conditions (e.g. task sharing) and provision of affordable treatment for those with high CVD risk. The focus needs to be in primary care because that is where most of the population can access health care and because CVD programmes can be run effectively at this level.
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Agodokpessi et al. Journal of Pharmaceutical Policy and Practice (2015) 8:12DOI 10.1186/s40545-015-0033-7
Benin established a revolving drug fund (RDF) for essential asthma medicines in 2008. We evaluated
the operation
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of the RDF and assessed whether there was interruption of supply of asthma medicine from 2008 to
2013.
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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 distric
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t hospitals and some accredited health centres) will 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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Background
Chronic congestive heart failure is a common condition that, if untreated, markedly impairs the quality of life and is associated with a high risk of recurrent hospitalization and death.
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Methods
This review is based on articles retrieved by a selective search in PubMed, as well as on relevant guidelines.
Results
Evidence-based treatment options are available only for congestive heart failure with a low ejection fraction. Pharmacotherapy is based on neurohumoral inhibition of the renin-angiotensin-aldosterone system and the adrenergic system. The prognosis of patients with this condition has been further improved recently through the introduction of combined angiotensin receptor antagonists and neprilysin inhibitors. Modern implantable devices are a further component of treatment. Implantable defibrillators and special pacemakers for cardiac resynchronization are well established; the utility of alternative devices (baroreflex modulation or cardiac contractility modulation) needs to be investigated in further studies. It was recently shown that the catheter-based treatment of secondary mitral regurgitation with a MitraClip improves the outcome of selected patients.
Conclusion
The treatment of chronic systolic heart failure as recommended in the relevant guidelines, with drugs and implanted devices if indicated, can significantly improve the clinical outcome.
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First edition, November 1997 | Revised July 2002
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
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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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The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, a
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nd WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in 1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
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