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.
Module 5
Monitoring and Evaluation
October 2018
Module 5: Monitoring and evaluation. This module is for people responsible for monitoring Pr
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EP programmes at the national and site levels. It provides information on how to monitor PrEP for safety and effectiveness, suggesting core and additional indicators for site-level, national and global reporting.
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The guidance document provides a set of indicators for assessing the status of development, implementation and monitoring of key policy interventions for prevention and control of NCDs and injuries. It promotes city-level evidence based decision-mak
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ing processes to identify gaps and take appropriates actions to strengthen responses. Additionally, using the standardized indicators can facilitate cross-city learning, sharing best practices and lessons learnt in implementing various policy interventions.
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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 bar
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riers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (AEs) 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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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 develop
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ed and forms part of the Five Year National Strategic 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
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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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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
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in their clinical practice. Continuous evaluation of 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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Revised National Tuberculosis Control Programme
Road safety is an issue that does not receive anywhere near the attention it deserves – and it really is one
of our great opportunities to save lives around the world
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
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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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