(SLA-064) Development and Use of a Novel Crosswalk to Evaluate Tablet or Pill Dosage Size in Real World Data

Background: Biopharma teams must consider many factors to develop patient-centric medicines, including patient perceptions about the proposed dosage form. Previous qualitative research suggests that larger tablets or capsules can impact adherence and persistence, but the quantitative impact of dosage size on prescription medication use is currently unknown.

Objectives: To augment a claims database used for pharmacoepidemiology research by linking it to an external source with dosage form information and provide a use case for such linkages.

Methods: This study created a crosswalk between oral tablets and capsules listed in the Merative MarketScan Redbook database and medications in the National Library of Medicine DailyMed database, which includes information on dosage form (eg, tablet or capsule length in millimeters). We then analyzed the Merative MarketScan database (2023) to identify adults with continuous enrollment who were dispensed ≥1 prescription medication as oral tablets or capsules. Data on use of medications was summarized by dosage form size (ie, < 10mm, 10-19.9mm, ≥20mm).

Results: Among the 217,398 unique 11-Digit NDCs for tablets/capsules, 31.3% had dosage size information. However, among all dispensed tablets/capsules (n=315,640,833), 99.1% of dispensings had dosage size information using exact NDC and 99.98% of dispensing when using imputations.
When evaluating categorical maximal dosage sizes using real-world data, 12.4% of adults’ maximal dosage size was < 10mm, 46.4% was 10-19mm, and 41.3% was ≥20mm. When evaluating females aged 18-64 years, females 65+, males 18-64, and males 65+, 37.4%, 47.7%, 43.3%, 43.4% were dispensed a medication ≥20mm, respectively.

Conclusions: This novel crosswalk, which had a substantial linkage rate to dispensed medications, can provide insights into medication use by dosage size such as informing patient-centric inputs into early drug development and enabling medication dosage sizes to be incorporated into real-world evidence.