Analysis of Spontaneously Reported Adverse Drug Events: Towards Developing Systems for Preventability

Area of Science:

• Pharmacovigilance
• Drug Safety
• Clinical Pharmacy

Background:

• Analyzing adverse drug reactions (ADRs) is crucial for developing effective prevention strategies.
• Spontaneous ADR reports from healthcare facilities provide valuable data for safety analysis.

Purpose of the Study:

• To analyze spontaneous ADR reports submitted to the Ghanaian Food and Drugs Authority (FDA) over a five-year period.
• To identify patterns and risk factors associated with ADRs in two health facilities.

Main Methods:

• Extracted data from duplicate spontaneous ADR reports (2014-2018).
• Assessed associations between variables (age, sex, drug source) and ADR outcomes using chi-square or Cramer's V tests.

Main Results:

• Type A reactions (65.2%) were most common, with most patients fully recovering (80%).
• Skin and Central Nervous System (CNS) were most affected organs; older patients (>30) and females showed higher CNS/skin ADR incidence.
• ADR seriousness linked to prescriber type, drug prescription status, and regimen appropriateness.

Conclusions:

• Many ADRs are preventable by improving systems to avoid rechallenging patients with offending drugs.
• Updating patient medication records and ensuring continuity of care are vital for preventing adverse drug events.