Long-Acting Injectable Antipsychotics in a Prescription Claims Data Source: A Validation Study.

Area of Science:

• Pharmacovigilance
• Real-world evidence generation
• Medication adherence research

Background:

• Prescription claims data are widely used to assess the effectiveness of long-acting injectable antipsychotics (LAIAs).
• The accuracy of claims data for LAIA validation remains unestablished.
• Establishing validity is crucial for reliable real-world evidence.

Purpose of the Study:

• To validate key fields in prescription claims data for LAIAs: date dispensed, quantity dispensed, and days supplied.
• To compare persistence estimates derived from claims data versus medical records.
• To assess the accuracy of claims data for characterizing LAIA dosing and intervals.

Main Methods:

• Evaluation of LAIA dispensations in a Canadian prescription claims database against a random sample of medical records.
• Inclusion of adult patients with at least one LAIA prescription between April 2015 and March 2016.
• Stratification by LAIA type (first-generation, risperidone LAI, paliperidone LAI) and analysis of persistence using Kaplan-Meier and proportion of patients covered methods.

Main Results:

• Claims data demonstrated high positive predictive value (80.0%–100.0%) but low negative predictive value (0.0%–62.5%).
• Quantity and days supplied accurately reflected dose and interval for risperidone LAI (99.7%, 97.1%) and paliperidone LAI (100.0%, 76.6%).
• First-generation LAIAs showed significant underestimation in quantity dispensed (8.9%) and days supplied (28.3%). Claims- and medical record-derived persistence estimates showed no significant differences.

Conclusions:

• Quantity dispensed and days supplied are valid for estimating dose and interval for second-generation LAIAs.
• These parameters are underestimated for first-generation LAIAs in claims data.
• A substantial proportion of LAIA doses were missing from claims data, impacting overall accuracy.