Pharmacovigilance 2.0 Results

PV 2.0 Phase I Results

Aim 1: To describe the prevalence of medications utilized and identify target medications.

Aim 1 Overview of methods

The Aim 1 cohort will comprise Medicare beneficiaries (with Part A, Part B and Part D) enrolled during the study period (2018-2020) who were age ≥ 65 years as of January 1, 2018 (index date). Medications will be identified (e.g., using NDC codes) and collapsed into unique medication categories by chemical entity. The prevalence of oral medication exposure will be determined, and rank ordered by the total number of unique patients with ≥ 1 pharmacy dispensing claims for a given medication. The Top 50 oral prescription medications (target medications) will be identified and categorized by indication (e.g., hyperlipidemia) and medication class (e.g., statin).

Aim 1 Results (summary)

The study cohort (N = 12, 180,208) included Medicare beneficiaries (age >= 65 years) with 12 months of continuous medical (Part A, B) and drug (Part D) coverage as of January 1, 2018 (index date). The average age was 76 years and 60% were female. The race/ethnicity distribution was 79% White, 8% Black, 3% Asian, and 7% Hispanic. Less than one percent (0.8%) had ESRD and 13% were disabled. Medicare Advantage and dual Medicare/Medicaid was observed for 19% and 20%, respectively. The majority of cohort members (50.7%) had Medicare coverage for >10 years. Most cohort members (88.5%) were uncensored for the 2 year follow-up period. Censoring reasons included death (9.9%) and disenrollment from Medicare Part A, B, or D (1.6%).

Overall, the stability of Medicare beneficiaries with medical and drug coverage characterizes a longitudinal cohort well suited to pharmacovigilance and drug safety research.


Aim 1 Cohort development


Aim 1 Patient Characteristics (summary)