Adverse drug event reporting systems: a systematic review.

Area of Science:

• Pharmacovigilance
• Drug Safety
• Health Informatics

Background:

• Adverse drug events (ADEs) are critical safety concerns in medication use.
• Standardized international reporting of ADEs is currently lacking.
• Existing ADE reporting systems exhibit significant heterogeneity.

Purpose of the Study:

• To synthesize and analyze the types and variety of data collected within global ADE reporting systems.
• To identify inconsistencies in data fields and reporting concepts across different ADE reporting platforms.

Main Methods:

• A systematic literature search was conducted across four electronic databases and grey literature.
• Data extraction from eligible ADE reporting systems was performed by two independent reviewers.
• Data synthesis involved collapsing fields, eliminating duplicates, and analyzing relationships using visual software.

Main Results:

• 108 ADE reporting systems were identified, containing 1782 unique data fields mapped to 33 reporting concepts.
• While reporting concepts showed consistency, data fields and response options varied considerably.
• Limited clarification of terminology and use of multiple drug/disease dictionaries (e.g., MedDRA) were observed.

Conclusions:

• Substantial variability in ADE data fields limits data comparability and aggregation across different reporting systems.
• Developing a common, standardized dataset is crucial for optimizing ADE data quality, comparability, and reporting rates.
• Standardization will enhance drug safety surveillance and research efforts globally.