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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 (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 representatives. 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.

When a medicine or vaccine is made available for use, healthcare organisations maintain regular surveillance to confirm that the medicinal product is safe and effective. The efficiency of this surveillance depends mainly on the healthcare system and medical practices in place in each country. An important element is an effective procedure for identifying and reporting any unwanted medical occurrences (adverse events) after taking a medicinal product. In countries where regular safety surveillance has not been maintained, it is important to train and mentor healthcare providers on the need to be aware of adverse events and the importance of adhering to safety reporting procedures. GSK and partners conducted a pilot project in Malawi with the aim of improving adverse event reporting by training and mentoring healthcare providers. Training sessions and continuous mentoring were conducted over 18 months, involving 443 healthcare providers at 61 healthcare facilities. There was a large increase in the number of adverse events reported: from 22 in the 16-year period before the project started to 228 during the 18-month project period. This project showed that the training and mentoring programme for healthcare providers was effective in increasing the number of adverse events reported. This enabled Malawi to join the World Health Organization's international safety reporting scheme. Other countries facing similar challenges in safety surveillance systems could benefit from a similar approach.

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Background: The use of antimicrobials is associated with the emergence of antimicrobial resistance (AMR), and self-medication increases the risk of the inappropriate use of antimicrobials. This study aims to describe the knowledge, attitudes, and practices (KAP) regarding self-medication with antimicrobials among residents in Lilongwe, Malawi. Methodology: This study has a cross-sectional, mixed-methods design. We conducted two focus group discussions (n=15) to describe community attitudes towards self-medication with antimicrobials and used a structured questionnaire to collect data on individual KAP regarding self-medication from 105 respondents. Results: Self-medication was common, and the sources of these medicines were market vendors, pharmacies, drugs shared with friends and family and those leftover from previous treatments. The lack of medical supplies, long distances to health facilities, poor attitudes of medical professionals towards patients, and past experience with the disease and treatment are the main factors that influence self-medication. KAP respondents had little knowledge of antimicrobials, their use, or any awareness of AMR. Seventy-four per cent (n=78) were unable to differentiate antimicrobials from other categories of medicines, and 92.4% wrongly responded that antimicrobials could be used to stop a fever. Concerning attitudes towards self-medication, over 54% wrongly believe that antimicrobials are effective in treating common colds. In regard to practice, 53% reported that they would use antimicrobials to treat upper respiratory infections, and 41% agreed that they must complete antibiotic therapy even if they are improving. Logistic regression analysis found that stocking antimicrobials at home for future use significantly promotes self-medication whereas an awareness of AMR would reduce self-medication. Conclusion: Self-medication is a public health risk that needs to be addressed urgently. Findings from this study point to the need for multifaceted interventions.

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