This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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EXPERT OPINION ON DRUG SAFETY 2018, VOL. 17, NO. 11, 1129–1144.
Malaria during and after pregnancy contributes significantly to maternal mortality and adverse fetal outcomes. While effective and safe antimalarial treatments are essential, quinine — an older, less effective drug — has long bee...n favoured due to the limited safety data available on newer drugs. This review summarises the results of human studies investigating the safety and efficacy of antimalarial drugs during pregnancy and lactation.
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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 WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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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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Ivermectin is an antiparasitic drug approved for the treatment of parasitic infections, including strongyloidiasis and onchocerciasis in humans. There is a reported increase in the use of ivermectin for the prevention and treatment of COVID-19 by the public in African Union Member States.
Currently..., there is:
1. No scientific evidence from pre-clinical studies on the therapeutic effect of ivermectin for the management of COVID-19;
2. No evidence of its clinical efficacy for the management of patients with asymptomatic, mild, moderate or severe COVID-19; and
3. No safety data regarding the use of ivermectin for COVID-19 in the majority of the published studies.
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These guidelines are based on the 3rd Edition of the WHO Guidelines (Published 2015) World Health Organization’s Guidelines for the treatment of malaria. Additional literature surveys have been undertaken. Factors that were considered in the choice of therapeutic options included effectiveness, sa...fety, and impact on malaria transmission and on the emergence and spread of antimalarial drug resistance. On-going surveillance is critical given the spread of artemisinin resistance in Southeast Asia, although not yet confirmed anywhere in Africa. The guidelines on the treatment of malaria in South Africa aim to facilitate effective, appropriate and timeous treatment of malaria, thereby reducing the burden of this disease in our communities. This is essential to further reduce the malaria case fatality rates currently recorded in South Africa, to decrease malaria transmission and to limit resistance to antimalarial drugs.
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Antimalarial chemotherapy is crucial for reducing morbidity, mortality, and drug resistance, and is the cornerstone of malaria control. Existing antimalarial drugs act at different stages of the parasite’s life cycle. These drugs range from classic agents such as chloroquine and quinine to newer a...rtemisinin derivatives. They include tissue schizonticides, blood schizonticides, gametocytocides, and sporontocides. Artemisinin and its derivatives are the most effective and fastest-acting treatment against drug-resistant Plasmodium falciparum, achieving rapid parasite clearance and reducing transmission potential. Other key drugs include mefloquine, halofantrine, proguanil, sulfadoxine–pyrimethamine, atovaquone–proguanil, tetracyclines, clindamycin and azithromycin. Each of these drugs has a specific mechanism of action, pharmacokinetics, efficacy, safety profile and contraindications. Rational drug combinations and adherence to national treatment guidelines are essential for managing resistance, ensuring safety in vulnerable populations such as children and pregnant women, and optimising therapeutic outcomes in cases of both uncomplicated and severe malaria.
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Clinical guideline, Methods, Evidence and Recommendations
In this guideline the following is covered: information needs of people with chronic hep
titis B and their carers; where children, young people and adults with chronic hepatitis B a-
should be assessed; assessment of liver disease, includi...ng the use of non-invasive tests and genotype testing; criteria for offering antiviral treatment; the efficacy, safety and cost effectiveness of currently available treatments; selection of first-line therapy; management of treatment failure or drug resistance; prophylactic treatment during im-
munosuppressive therapy; and monitoring for treatment response
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This video highlights the significant risks that malaria poses to pregnant and breastfeeding women in malaria-endemic regions. It follows the stories of Angavu from Kenya, Moyinoluwa from Nigeria and Lamai from Thailand. It emphasises the severe consequences that malaria can have during pregnancy, i...ncluding miscarriage, stillbirth, low birth weight and maternal death. Due to safety concerns, pregnant women are often excluded from antimalarial drug trials, which causes long delays in effective medicines becoming available for this vulnerable group. To address this issue, the Medicines for Malaria Venture (MMV) launched the Malaria in Mothers and Babies (MiMBa) initiative, which aims to accelerate the discovery, development, and delivery of safe antimalarial treatments for pregnant and breastfeeding women. The initiative aims to close critical gaps in research, drug development, and access, ensuring that these women and their babies are better protected against malaria. The video calls for continued efforts to address the needs of underserved populations most affected by malaria.
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Combination therapy is a cornerstone of modern malaria treatment, particularly in the context of widespread multidrug resistance. Using two or more antimalarial drugs with different mechanisms simultaneously enhances efficacy, shortens treatment duration, improves compliance and delays the developme...nt of resistance. Artemisinin-based combination therapies (ACTs), such as artemether–lumefantrine, artesunate–amodiaquine and artesunate–sulfadoxine/pyrimethamine, are highly effective in rapidly clearing parasites and reducing gametocyte carriage. They are also generally well tolerated. Non-artemisinin combinations, quinine-based regimens and novel combinations (e.g. piperaquine–dihydroartemisinin) offer alternative therapeutic options, although clinical experience with these remains limited. Although ACTs are the preferred first-line treatment, factors such as cost, local drug resistance patterns, safety during pregnancy and paediatric use must inform implementation and policy decisions.
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Dengue is the fastest spreading, mosquito-borne viral infectious disease worldwide, with remarkable morbidity and mortality. In the past decades, profound contributions have been made towards understanding its epidemiology, including disease burden and distributions, risk factors, and control and pr...evention practices. Dengue continues to disseminate to new areas, including high latitude regions, and a new serotype (dengue virus serotype 5) has been identified. Vaccine research has made new progress, in which the licensed yellow fever and dengue virus quadrivalent chimeric vaccine is now under further safety assessment. In disease surveillance, because of its operational simplicity, rapidity, capability, and utility as an indicator of disease severity, dengue virus NS1 antigen detection has great promotion and application value among primary health care institutions. Vector control progress has driven new breakthroughs in biotechnology, including Wolbachia-infected Aedes and genetically modified Aedes. Both Aedes variants have been used to block transmission of the dengue virus through population replacement and suppression. In the future, vector control should still be pursued as a key measure to prevent transmission, along with anti-viral drug and vaccine research.
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Road safety is an issue that does not receive anywhere near the attention it deserves – and it really is one
of our great opportunities to save lives around the world
Patient information on safe medical treatment. Available in: Arabic, English, French, Russian, Spanish, Turkish, German.
This is the English version. For other language versions visit: http://www.patienten-information.de/kurzinformationen/arzneimittel-und-impfungen/sichere-arzneimitteltherapie
Therapeutics Information and Pharmacovigilance Centre | TIPC
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
Q 6. Does the provision of sterile injection equipment to injecting drug users reduce injecting related harm? Is advice on ways to reduce drug related harm safe and effective, using an outreach model of service delivery?
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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