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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1.HIV infections – drug therapy. 2.Anti-HIV agents – adverse effects. 3.Anti-retroviral agents. 4.Benzoxazines – adverse effects. 5.Pregnancy. 6.Disease transmission, Vertical - prevention and control. 7.Treatment outcome. I.World Health Organization
The uneven distribution of HIV risks and burdens across populations is a well-substantiated fact, though seldom publicly acknowledged. Gay men and other men who have sex with men, people who inject drugs, sex workers, and transgender women are 24, 24, 13.5, and 49 times more likely to acquire HIV, ...respectively, than other reproductive aged adults (15 years old and older). Globally, new infections among these key populations account for 45% of all new HIV infections. This figure is likely to be an underestimate, given the intense stigma associated with disclosing and reporting acquisition risks for HIV among gay men, people who use drugs, sex workers, and transgender people. In addition, HIV epidemics in the majority of low- and middle-income countries (90 of 120) have concentrated epidemics among key populations. In countries with more broadly generalized epidemics, risks are still not evenly distributed and key populations still shoulder disease burden that is markedly disproportionate.
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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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Essential Drug list on page 36!!
MICROBIAL DRUG RESISTANCEVolume 24, Number 5, 2018ªMary Ann Liebert, Inc.DOI: 10.1089/mdr.2017.0383
Antibiotic resistance (ABR) is a worldwide publichealth concern, with serious health, economic, and so-cietal repercussions. Its emergence is attributed to the se-lective pressure exerted by antib...iotic use in the community, hospitals, veterinary health, agriculture, aquaculture, and the environment. Additionally aggravating the situation is the fact that very few new antibiotics have recently been produced by pharmaceutical companies. It is widely acknowledged that food animals are key reservoirs of antibiotic-resistant bacteria and that antibiotic usage in this population favors the emergence, selection, and spread of resistance among animals and humans, both through zoonoses (infectious diseases trans-mitted between animals and humans) and the food chain.
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Dolutegravir HIV drug resistance (HIVDR) data from Africa remain sparse. We reviewed HIVDR results of Malawians on
dolutegravir-based antiretroviral therapy (November 2020– September 2021). Of 6462 eligible clients, 33 samples were submitted to South Africa, 27 were sequenced successfully, and 8 ...(30%) had dolutegravir HIVDR. Malawi urgently requires adequate HIVDR testing capacity.
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Due to the heterogeneous distribution of malaria transmission and its determinants, subnational tailoring (SNT) provides an analytical framework to facilitate the targeting of each population with appropriate intervention packages for maximum impact to inform national strategic planning and prioriti...zation based on resources available. The WHO Global Malaria Programme recommends the use of subnational data on disease epidemiology and other relevant local contextual factors to facilitate the process of SNT. Once the strategies and intervention mixes have been defined, programmes can proceed to the prioritization of
interventions for effective programming, based on available resources
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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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International Journal of Drug Policy 24 (2013) e91-98
This report describes the geographical and temporal distribution of multidrug-resistant (MDR) tuberculosis (TB) using molecular typing data reported by European Union (EU)/European Economic Area (EEA) Member States for 2015 and the preceding years.
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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This study aimed to determine the drug resistance profile of Mycobacterium tuberculosis in Mozambique and concludes that M. tuberculosis resistance to antituberculosis drugs is high in Mozambique, especially in previously treated patients. The frequency of M. tuberculosis strains that were resistant... to isoniazid, rifampin, and streptomycin in combination was found to be high, particularly in samples from previously treated patients.
J Bras Pneumol. 2014;40(2):142-147
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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.
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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Guidelines for national programmes and other stakeholders
Annexes for webposting and CD-Rom distribution with the policy guidelines
We systematically reviewed Medline as well as the references of published review articles for relevant studies of adherence to multidrug treatment of both drug-susceptible and drug-resistant TB through February 3, 2018. We included randomized controlled trials (RCTs) as well as prospective and retro...spective cohort studies (CSs) with an internal or external control group that evaluated any adherence intervention and conducted a meta-analysis of their impact on TB treatment outcomes. Our search identified 7,729 articles, of which 129 met the inclusion criteria for quantitative analysis. Seven adherence categories were identified, including DOT offered by different providers and at various locations, reminders and tracers, incentives and enablers, patient education, digital technologies (short message services [SMSs] via mobile phones and video-observed therapy [VOT]), staff education, and combinations of these interventions.
https://doi.org/10.1371/journal.pmed.1002595
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WHO’s sentinel surveys of acquired HIV resistance to dolutegravir among people receiving dolutegravir-containing antiretroviral therapy is intended for easy and frequent implementation. Results from sentinel surveys provide insight into the prevalence and year-over-year trends of dolutegravir resi...stance in adults, children and adolescents receiving dolutegravir-based ART.
This sentinel method is implemented complementary to WHO-recommended methods for estimating nationally representative levels of acquired HIV drug resistance.
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BMC Infectious Diseases (2019) 19:832
Intestinal schistosomiasis is highly endemic in Tanzania and mass drug administration (MDA) using
praziquantel is the mainstay of the control program. However, the MDA program covers only school aged children
and does not include neither adult individuals nor... other public health measures. The Ijinga schistosomiasis project
examines the impact of an intensified treatment protocol with praziquantel MDA in combination with additional
public health interventions. It aims to investigate the feasibility of eliminating intestinal schistosomiasis in a highly
endemic African setting using an integrated community-based approach.
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