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
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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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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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
STATUTORY INSTRUMENTS | SUPPLEMENT No. 8 28th March, 2014 | STATUTORY INSTRUMENTS SUPPLEMENT | to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014 | Printed by UPPC, Entebbe, by Order of the Government. | STATUTORY INSTRUMENTS | 2014 No. 37.
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
The Zimbabwe National Pharmacovigilance Policy Handbook, 2nd Edition updates the November 2013 version to indicate the Zimbabwe National Pharmacovigilance (PV) Centre’s compliance with the WHO Pharmacovigilance Indicators Handbook 2015.
Tuberculosis (TB) is, and should be, a curable disease; however, each year significant numbers of patients acquire or develop drug-resistant TB, which has a much lower cure rate. Patients with drug-resistant TB have a high prevalence of symptoms; hence, staff caring for these patients should h...ave some familiarity with palliative care, so that general palliative care principles are available to all patients. The timely identification, and addressing, of adverse events occurring during the treatment course is considered as general palliative care for those receiving curative treatment. This publication summarizes the general palliative care approach, which is recommended for use in settings and services that occasionally treat palliative care patients, but do not provide palliative care as the main focus of their work. The review focuses on 18 high TB priority countries of the WHO European Region.
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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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Chagas disease (CD) is caused by Trypanosoma cruzi. When acquired, the
disease develops in stages. For diagnosis, laboratory confirmation is required, and an extensive assessment of the patient’s health should be performed. Treatment consists of the administration of trypanocidal drugs, which may... cause severe adverse effects. The objective of our systematic review was to analyze data contained in the CD published case reports to understand the challenges that patients and clinicians face worldwide.
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Cardiovascular disease is a major cause of disability and premature death throughout the world, and contributes substantially to the escalating costs of health care. The underlying pathology is atherosclerosis, which develops over many years and is usually advanced by the time symptoms occur, genera...lly in middle age. Acute coronary and cerebrovascular events frequently occur suddenly, and are often fatal before medical care can be given. Modification of risk factors has been shown to reduce mortality and morbidity in people with diagnosed or undiagnosed cardiovascular disease.
This publication provides guidance on reducing disability and premature deaths from coronary heart disease, cerebrovascular disease and peripheral vascular disease in people at high risk, who have not yet experienced a cardiovascular event. People with established cardiovascular disease are at very high risk of recurrent events and are not the subject of these guidelines. They have been addressed in previous WHO guidelines.
Several forms of therapy can prevent coronary, cerebral and peripheral vascular events. Decisions about whether to initiate specific preventive action, and with what degree of intensity, should be guided by estimation of the risk of any such vascular event. The risk prediction charts that accompany these guidelinesb allow treatment to be targeted accord-
ing to simple predictions of absolute cardiovascular risk.
Recommendations are made for management of major cardiovascular risk factors through changes in lifestyle and prophylactic drug therapies. The guidelines provide a framework for the development of national guidance on prevention of cardiovascular disease that takes into account the particular political, economic, social and medical circumstances.
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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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