25 February 2021
This technical guidance is a living document that builds on guidelines and reports of the UNAIDS Joint Programme. The definitions contained herein are working definitions that are subject to change. Updates will also be added further to the work of the multistakeholder Task Team on... community-led AIDS responses that was recently established by the UNAIDS Executive Director and the UNAIDS Joint Programme, and which will conclude its task in December 2021.
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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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Cureus 16(2): e53933. DOI 10.7759/cureus.53933
Quality Assurance (QA) and Quality Improvement (QI). The guide provides general information on how to organize, implement and follow up on quality assurance/quality improvement clinical facility and service assessments. At the website you will find checklists intended to be used with the clinical fa...cility assessment guide
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THE SYRIAN ARAB REPUBLIC, IRAQ, JORDAN, LEBANON, TURKEY, WEST BANK AND GAZA STRIP, EGYPT
Further analysis of the 1996, 2001, and 2006 Demographic and Health Surveys Data