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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Emergence of antimicrobial resistance is a result of the use, overuse and misuse of antibiotics both in humans and animals. In Ethiopia, there are indications on the misuse of antibiotics by health care providers’, unskilled practitioners, and drug consumers. These coupled with rapid spread of res...istant bacteria and inadequate surveillance contributed to the problem. Bacterial infections are the major causes of death in Ethiopia. Studies on antibacterial resistance and on bacterial infections have shown that emerging antibacterial resistance threatens the management of bacterial infections; however, the prevention and containment has received far too little attention.
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Doc. No.: INS/GDL/001-(Annexes)
A summary of the national drug situation
Maldives has made significant strides in the area of infectious disease prevention and control. This is exemplified by elimination of malaria from Maldives in 2015 and successes in TB control. In addition, Maldives is a front runner in infectious disease prevention through successful water, sanitati...on, hygiene and vaccination campaigns and coverage. However, given the limited evidence that exists with respect to the occurrence of resistant organisms in the nation, it is hard to estimate the exact antimicrobial resistance (AMR) scenario. Also, it becomes difficult to compare the current situation with other countries in the region. Moreover, limited evidence exists on the trends of use of antimicrobial agents (AMA) in Maldives. Although, recent prescription audits have indicated overuse of antibiotics, especially for common conditions such as flu, cough and fever.
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Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.