Medication errors through a national pharmacovigilance database approach: a study for Malta

Area of Science:

• Pharmacovigilance and Drug Safety
• Medication Error Analysis
• Public Health

Background:

• Medication errors pose a significant risk to patient safety.
• Understanding the patterns of medication errors is crucial for developing targeted interventions.
• The Maltese pharmacovigilance database offers a valuable resource for identifying and analyzing these events.

Purpose of the Study:

• To identify and characterize medication errors reported in the Maltese pharmacovigilance database.
• To determine the frequency and types of medication errors.
• To describe the stages of medication use where errors occur and associated drug classes.

Main Methods:

• Retrospective analysis of Adverse Drug Events (ADEs) reported over a 5-year period in Malta.
• Identification of medication errors by comparing drug use against the Summary of Product Characteristics (SmPC).
• Classification of errors by type, seriousness, and stage within the medication use chain.

Main Results:

• 319 ADE reports met the inclusion criteria; 56 were associated with serious patient harm.
• The 50-59 and 80-89 age groups were most frequently associated with medication errors.
• 65% of errors originated in the community, primarily during prescribing (52%) and therapeutic monitoring (26%).
• Non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics were commonly involved in errors related to dosage, monitoring, interactions, and duration.

Conclusions:

• Pharmacovigilance databases are effective tools for detecting medication errors.
• The findings highlight specific areas and drug classes requiring attention to reduce medication-related harm.
• This study underscores the utility of pharmacovigilance data in enhancing medicinal product safety.