Member States have requested WHO policy guidance on how to facilitate the implementation of national AMS activities in an integrated and programmatic approach. This policy guidance responds to that demand from Member States and is anchored in public health guiding principles in the human health sect...or. It aims to provide a set of evidence-based and pragmatic recommendations to drive comprehensive and integrated AMS activities under the purview of a central national coordination unit, National AMR steering or coordinating committees or other equivalent national authorities.
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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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The Health Sector Policy gives general orientations for the sector which are further developed in the various sub-sector policies guiding key health programs and departments. All health sub-sector policies will be updated in line with this new policy. The Health Sector Policy is the basis of nationa...l health planning and the first point of reference for all actors working in the health sector. The overall aim of this policy is to ensure universal accessibility (in geographical and financial terms) of equitable and affordable quality health services (preventative, curative, rehabilitative and promotional services) for all Rwandans. It sets the health sector’s objectives, identifies the priority health interventions for meeting these objectives, outlines the role of each level in the health system, and provides guidelines for improved planning and evaluation of activities in the health sector. A companion Health Sector Strategic Plan (HSSP) elaborates the strategic directions defined in the Health Sector Policy in order to support and achieve the implementation of the policy, and more detailed annual operational plans describe the activities under each strategy.
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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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The National Action Plan (NAP) has been developed based on the model recommended in the global Action Plan. Local data on on-going interventions were collected from technical informants in the various areas of work. These were analysed using the policy framework provided by the AMR policy document. ...Interventions were developed to address gaps in all five objectives of the global Action Plan. Further consultations were done to ensure that the recommended interventions were feasible, valid and relevant within the systemic contexts pertaining to the various affected sectors.
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The threat posed by antimicrobial resistance (AMR) to public health as well as global health security has been reiterated in umerous World Health Assembly (WHA) resolutions. AMR is also prioritized under the Global Health Security Agenda (GHSA), and India is one of the contributing countries. The Mi...nistry of Health & Family Welfare (MoHFW) identified AMR as one of the top 10 priorities for the ministry’s collaborative work with WHO. The National Health Policy 2017 identifies antimicrobial resistance as a problem and calls for effective action to address it. An international conference on AMR – “Combating Antimicrobial Resistance: A
Public Health Challenge and Priority”, was jointly organized by the Government of India and World Health Organization (WHO) in February 2016, which was attended by more than 350 participants. The Hon’ble Prime Minister, Shri Narendra Modi, and the Hon’ble Union Minister for Health, Shri J.P. Nadda have reiterated government’s commitment to tackle AMR.
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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.
The Ghanaian Cabinet approved the antimicrobial resistance (AMR)Policy and Implementation plan(hereafter referred to as the national action plan or NAP)in December 2017, whilst the country case study was in progress. This has set in motion the implementation phase for Ghana, which is a long awaited... event since the drafting of the Policy started in 2011. This case study, whilst limited in its ability to interact with all stakeholders, has identified entrypoints within the operational divisions of Ghana Health Services,as potential areas where the AMR policy platform may seek to embed AMR activities. Much work has already been done within Ghana to identify the key entrypoints within the various ministries and government agencieswhere AMR can be incorporated. These stakeholders already form part of the AMR Policy Platform which is the governance structure for AMR and have been participating actively in the development of the AMR Policy and NAP activities formulation.
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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 of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen 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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This document seeks to help health communication professionals working on the topic of immunization more effectively communicate about Events Supposedly Attributed to Vaccination and Immunization (ESAVI) by building trust in National Immunization Programs, understanding risk perceptions related to v...accination, and responding to false information related to vaccination. It includes practical dos and don’ts regarding risk communication and community engagement processes and principles, messaging, risk perceptions, handling false information, collaborating with partners, and pharmacovigilance, as well as real-world examples.
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Rwanda’s fourth health sector strategic plan (HSSP4) is meant to provide the health sector with a Strategic Plan that will highlight its commitments and priorities for the coming 6 years. It will be fully integrated in the overall economic development plan of the Government. HSSP4 will fulfill the... country’s commitment expressed in the national constitution, National Strategy for Transformation (NST) and the aspirations of the Health Sector Policy 2015. The strategies herein adhere to the Universal Health Coverage (UHC) principles towards realisation of the Sustainable Development Goals (SDGs). HSSP4 therefore lays a foundation for Vision 2050 (“The Rwanda We Want”), which will transform Rwanda into a high-income country by 2050. HSSP4 anticipates the epidemiological transition of the country, the increase in population and life expectancy and the expected increase of the health needs of the elderly, notably in Non Communicable Diseases (NCDs). HSSP4 also anticipates a decrease in external financial inflows, hence it is imperative to build secure / resilient health systems.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The operational handbook provides practical information and tools that complement the recommendations in the guidelines. The strategies described in the operational handbook are based on the latest WHO recommendations which were formulated by Guideline Development Groups using the GRADE approach. In many cases however, the recommendations in their current form lacked sufficient clinical and programmatic detail, which is important for implementation. This operational handbook complements the guidelines with practical advice based on best practices and knowledge from the fields such as pharmacokinetics, pharmacodynamics, microbiology, pharmacovigilance and clinical and programmatic management.
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Zambia has recognised the Public Health threat of antimicrobial resistance and its impact on morbidity and mortality, as well as the subsequent economic consequences. The country has recorded microorganisms which have developed resistance to antimicrobial drugs. Notable among these are; Multidrug Re...sistant Mycobacterium Tuberculosis (MDR), Human Immunodeficiency virus resistant to antiretroviral drugs, Plasmodium resistance to antimalarial drugs, and fungal species showing indications of resistance to antifungal drugs. Emergence of “Superbugs” such as Methicillin Resistant Staphylococcus aureus (MRSA), Extended Spectrum beta-lactam (ESBL) producing Klebsiella pneumoniae and Vancomycin Resistant Enterococci (VRE) have also been reported.
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