Strategies and Challenges in Coding Ambiguous Information Using MedDRA^®: An Exploration Among Norwegian...

Area of Science:

• Pharmacovigilance and Drug Safety
• Medical Terminology Standardization
• Regulatory Affairs

Background:

• The Medical Dictionary for Regulatory Activities (MedDRA®) is crucial for standardizing medical information in pharmacovigilance.
• Previous studies indicate inconsistent MedDRA® coding across platforms, but the reasons remain unclear.

Purpose of the Study:

• To investigate the reasoning and strategies used by pharmacovigilance officers when coding ambiguous adverse events.
• To categorize coding inconsistencies and identify their sources within the MedDRA® system.

Main Methods:

• A cross-sectional study involving surveys and focus group interviews with Norwegian pharmacovigilance officers.
• Participants coded ambiguous adverse events, and their selections were compared to a Standard Term Selection (STS).
• Thematic analysis of focus group discussions explored coding challenges and strategies.

Main Results:

• Only 36% of survey answers precisely matched the STS, with inconsistencies varying by task.
• The most frequent inconsistency was term substitution (30%), followed by omissions (18%) and additions (6%).
• Challenges included translating lay to medical terms, English translations for Norwegian terms, and fitting complex descriptions into MedDRA®.

Conclusions:

• Coding inconsistencies in MedDRA® are influenced by ambiguity in terminology and translation challenges.
• Tailored training programs and clear institutional guidelines are essential to address these inconsistencies.