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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Recommendations and Summary
This report explores the impact of COVID-19 on humanitarian access in the initial months of the crisis, including both the delivery of assistance and performance of protection activities. It examines the varying crisis responses, including the shift to a more localized a...pproach in certain cases. The analysis draws on case research from Colombia, Myanmar, Nigeria, South Sudan and Yemen, as well as on wide-ranging interviews with humanitarian practitioners and experts from around the world. The research was conducted between August – November 2020. It does not make claims about the legitimacy of government decisions to restrict access – indeed, in many instances, there appeared to be a clear objective of limiting the spread of COVID-19 – but instead focuses on how access limitations have affected the delivery of aid.
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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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This field study to assess the pharmaceutical situation was undertaken in Ghana in May-June 2008 using a standardized methodology developed by the World Health Organization. The study assessed medicines availability and affordability, geographical accessibility, quality and r...ational use among other issues. The survey was conducted in six regions. In each region, 6 public health care facilities, 12 private pharmacies and 1 warehouse were surveyed.
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