Health Information Exchanges (HIEs) as Novel Sources for Population-Based Post Marketing Surveillance of Medical Products: A Pilot Study from the FDA Sentinel Innovation Center

IntroductionHealth information exchanges (HIEs) provide the capability to electronically move health care information among different health care information systems and store these data for downstream use cases. However, use of data from HIEs for postmarketing surveillance of medical products is not previously explored. ObjectivesTo conduct a pilot descriptive study characterizing data from MyHealth Access Network - a statewide HIE for Oklahoma, to understand its utility for conducting pharmacoepidemiology studies. Materials and methodsMyHealth Access Network connects 95% of all hospital activity, 100% of federally qualified health center activity, and most community behavioral health clinics, tribal health systems, and independent providers in the state. As a use case to understand data in MyHealth Access Network, we characterized patients with Type 2 Diabetes Mellitus (T2DM), aged 18 years or older and treated with one of two common antidiabetic drug classes: Sodium-Glucose Co-Transporter 2 inhibitors (SGLT-2i) and Dipeptidyl Peptidase 4 inhibitors (DPP-4i) in a new user cohort design. A cohort entry date was defined based on records of medication initiation for either of the two drug classes, using dispensing data from insurance claims (when available) or prescribing data from electronic health records (EHRs) when claims were not available. Patient characteristics including demographics, comorbidities, comedications, clinical and lifestyle related factors, and healthcare utilization factors were summarized for the two exposure groups. ResultsA total of 76,018 DPP-4i initiators and 101,599 SGLT-2i initiators met our inclusion criteria. The mean age was 59 years and nearly half were women in both the groups. While there was a large proportion of those with missing race information (32% DPP-4i, 24% SGLT-2i), a majority were White (47% DPP-4i, 57% SGLT-2i). The second most reported race category was American Indian or Alaskan Natives (13% DPP-4i, 9.9% SGLT-2i), which is in line with their representation in the 2024 US Census for Oklahoma. Hemoglobin A1c (HbA1c) results were available for 63% and 66% of the DPP-4i and SGLT-2i groups with mean + SD of 8.1+ 1.9% and 8.2 + 1.9%, respectively. Serum creatinine was recorded for 67% DPP-4i and 70% SGLT-2i initiators with mean + SD of 1.30 + 1.01 mg/dL and 1.14 + 0.64 mg/dL, respectively. DiscussionHIEs may offer a promising resource for population-based postmarketing surveillance of medical products owing to their comprehensive capture of information across various healthcare settings.