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Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017-2021): A

Fawzi Thomas1,2, Onome T Abiri1,2, James P Komeh1,2

  • 1National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone.

International Journal of Environmental Research and Public Health
|March 25, 2022
PubMed

Insights

Adverse drug reaction reporting for antimicrobials is inconsistent, delayed, and incomplete. Active reporting and performance targets are crucial for improving patient safety and monitoring drug effects.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Antimicrobial Therapeutics
  • Public Health Monitoring

Background:

  • Adverse drug reactions (ADRs) to antimicrobials pose significant health risks, including severe illness and mortality.
  • Effective monitoring of antimicrobial ADRs is essential for patient safety and public health.
  • This study evaluates the landscape of country-wide antimicrobial ADR reporting and associated patient outcomes.

Purpose of the Study:

  • To assess the completeness, timeliness, and consistency of antimicrobial adverse drug reaction (ADR) reporting.
  • To analyze the types of antimicrobials reported and the outcomes of ADRs.
  • To identify areas for improvement in pharmacovigilance systems for antimicrobials.

Main Methods:

  • A cross-sectional study utilizing individual case safety reports (ICSRs) from a national pharmacovigilance database (VigiFlow) between 2017 and 2021.
  • Analysis of reporting trends, antimicrobial classes, data completeness, reporting delays, and patient outcomes.
  • Categorization of ADRs based on antimicrobial type and affected systems.

Main Results:

  • Inconsistent reporting patterns observed, with peaks during mass drug campaigns and minimal reporting in other years.
  • Antiparasitics dominated reports (90%), with antibiotics, antivirals, and antifungals comprising smaller proportions.
  • Significant reporting delays (median 165 days) and data incompleteness (44% with <75% variables filled) were noted.
  • Gastrointestinal ADRs were most common (60%), with 10 serious ADRs and 18 drug withdrawals recorded. Patient outcomes included recovery (59.5%) and ongoing recovery (35.5%).

Conclusions:

  • Current antimicrobial ADR reporting is characterized by inconsistency, significant delays, and incomplete data.
  • The findings highlight the need for enhanced pharmacovigilance strategies, including active reporting mechanisms.
  • Establishing clear performance targets is recommended to improve the quality and timeliness of ADR reporting for better patient safety.
Keywords:
SORT ITVigiBasehealth system strengtheningoperational researchuniversal health coverage

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