Specific measures are being taken within the National Tuberculosis Control Programme (NTP) to address the MDR TB problem through appropriate management of patients and strategies to prevent the propagation and dissemination of MDR TB.
The term "Programmatic Management of Drug Resistant TB" (PMD...T) refers to programme based MDR TB diagnosis, management and treatment. This guideline promotes full integration of basic TB control and PMDT activities under the NTP, so that patients with TB are evaluated for drug resistance and are placed on the appropriate treatment regimen and properly managed from the outset of treatment, or as early as possible. The guidelines also integrate the identification and treatment of more severe forms of drug resistance, such as extensively drug resistant TB (XDR TB).
At the end, the guideline introduces new standards for registering, monitoring and reporting outcomes of multidrug resistant TB cases.
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Following the encouraging initial results of the pilot project, the Ministry of Health is committed to increasing access to MDR-TB diagnosis, treatment and care. An expansion plan for the programmatic management of drug-resistant TB has been developed and forms part of the Five Year National Strateg...ic Plan for TB Control, 2011-2015. The long-term goals of the MDR-TB expansion plan are threefold:
1. Diagnosis of MDR-TB in all groups of patients at risk for MDR-TB
2. Diagnosis of MDR-TB in all HIV-infected TB patients
3. MDR-TB treatment for all patients diagnosed with MDR-TB under WHO-endorsed treatment protocols
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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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Framework for implementation.
The END TB Strategy.
Therapeutics Information and Pharmacovigilance Centre | TIPC
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
UNAIDS/WHO Working group
HIV/AIDS and STI surveillance 2015 / Reference
Confronted with the important issue of patient safety, in 2002 the Fifty-fifth World Health Assembly adopted a resolution urging countries to pay the closest possible attention to the problem and to strengthen safety and monitoring systems. In May 2004, the Fifty-seventh World Health Assembly approv...ed the creation of an international alliance as a global initiative to improve patient safety. The World Alliance for Patient Safety was launched in October 2004 and currently has its place in the WHO Patient Safety programme included in the Information, Evidence and Research Cluster.
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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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This manual summarizes key issues related to the safety of NTD medicines and their administration, with a focus on essential medicines used in mass drug administration (MDA), also called preventive chemotherapy. It can be used as a standalone reference manual, but is intended to be used in conjuncti...on with the accompanying training modules, which provide practical instruction, and the aide-mémoires. Versions of the aide-mémoires and training modules are available respectively for both (i) programme managers and district-level health officials and (ii) community drug distributors and community health workers
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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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Antimicrobial resistance (AMR) is a global human, animal, plant and environment health threat that needs to be addressed by every country. The impacts of AMR are wide-ranging in terms of human health, animal health, food security and safety, environmental effects on ecosystems and biodiversity, and ...socioeconomic development. Just like the climate crisis, AMR poses a significant threat to the delivery of the 2030 Agenda for Sustainable Development. The response to the AMR crisis has been spearheaded through the global action plan on antimicrobial resistance (GAP-AMR), developed by the World Health Organization (WHO) in 2015, in close collaboration with the Food and Agriculture Organization of the United Nations (FAO) and the World Organisation for Animal Health (WOAH), and formally endorsed by the three organizations’ governing bodies and by the Political Declaration of the high-level meeting of the United Nations General Assembly on AMR in 2016. In 2022, the three organizations officially became the Quadripartite by welcoming the United Nations Environment Programme (UNEP) into the alliance “to accelerate coordination strategy on human, animal and ecosystem health”.
The aim of the GAP-AMR is to ensure the continuity of successful treatment with effective and safe medicines.
Its strategic objectives include:
• improving the awareness and understanding of AMR;
• strengthening the knowledge and evidence base through surveillance and research;
• reducing the incidence of infection through effective sanitation, hygiene and infection prevention measures; optimizing the use of antimicrobial medicines in human and animal health; and
• developing the economic case for sustainable investment that takes account of the needs of all countries and increasing investment in new medicines, diagnostic tools, vaccines and other interventions.
With the adoption of the GAP-AMR, countries agreed to develop national action plans (NAPs) aligned with the GAP-AMR to mainstream AMR interventions nationally. Individually, the Quadripartite took action to advance AMR interventions in their respective sectors. FAO adopted a resolution on AMR recognizing that it poses an increasingly serious threat to public health and sustainable food production, and developed an AMR action plan to support the resolution’s implementation. For its part, WOAH developed a strategy on AMR aligned with the GAP-AMR, acknowledging the importance of a One Health approach to AMR. Similarly, more recently, UNEP’s governing body, the United Nations Environment Assembly, recognized that AMR is a current and increasing threat and a challenge to global health, food security and the sustainable development of all countries, and welcomed the GAP-AMR and the NAPs developed in accordance with its five overarching strategic objectives
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Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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