Agreement between self-report and prescription data in medical records for pregnant women

BACKGROUND Clinical teratology studies often rely on patient reports of medication use in pregnancy with or without other sources of information. Electronic medical records (EMRs), administrative databases, pharmacy dispensing records, drug registries, and patients' self-reports are all widely used sources of information to assess potential teratogenic effect of medications. The objective of this study was to assess comparability of self-reported and prescription medication data in EMRs for the most common therapeutic classes. METHODS The study population included 404 pregnant women prospectively recruited from five prenatal care clinics affiliated with the University of New Mexico. Self-reported information on prescription medications taken since the last menstrual period (LMP) was obtained by semistructured interviews in either English or Spanish. For validation purposes, EMRs were reviewed to abstract information on medications prescribed between the LMP and the date of the interview. Agreement was estimated by calculating a kappa (κ) coefficient, sensitivity, and specificity. RESULTS In this sample of socially-disadvantaged (i.e., 67.9% high school education or less, 48.5% no health insurance), predominantly Latina (80.4%) pregnant women, antibiotics and antidiabetic agents were the most prevalent therapeutic classes. The agreement between the two sources substantially varied by therapeutic class, with the highest level of agreement seen among antidiabetic and thyroid medications (κ ≥0.8) and the lowest among opioid analgesics (κ = 0.35). CONCLUSIONS Results indicate a high concordance between self-report and prescription data for therapeutic classes used chronically, while poor agreement was observed for medications used intermittently, on an 'as needed" basis, or in short courses.