These guidelines for the National Pharmacovigilance and Medicine Information System in Rwanda have been developed to ensure that safe, efficacious and quality medicines are made available to all Rwandans.
The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to... patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
Therapeutics Information and Pharmacovigilance Centre | TIPC
DNDi is now striving to make fexinidazole available to the majority of people who have T.b. gambiense sleeping sickness. We are supporting a three-year access and pharmacovigilance study that began in 2020 and have so far carried out in-country training of relevant staff in 250 hospitals and... health centres in T.b. gambiense-endemic countries; and updated national treatment and pharmacovigilance guidelines in Angola, Central African Republic, the Democratic Republic of Congo, Equatorial Guinea, Guinea, and Chad.
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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
STGs are designed to assist health care professionals in making decisions about appropriate, effective patient care. However, health managers often have trouble setting and meeting the high standards required of modern, developed health care systems. With stakeholders expressing concern over issues ...such as strength of evidence, transparency, conflicts of interest, and effective implementation, it is clear that many health care professionals need further guidance in developing and making use of STGs.
This manual guides health professionals through the process of establishing and implementing STGs, placing special emphasis on the low- and middle-income country (LMIC) context. By including tools, templates, and success stories as well as hyperlinks to useful resources, the manual helps health practitioners understand not only important concepts of treatment guidelines, but also how they can best be used in practice.
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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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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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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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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 of products granted marketing authorization in Ghana.