Introduction Health 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.

Objectives To 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 methods MyHealth 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.

Results A 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.

Discussion HIEs may offer a promising resource for population-based postmarketing surveillance of medical products owing to their comprehensive capture of information across various healthcare settings.

Dr. Khurshid and Eliel Oliveira are co-founders of Pulsar Health, a software IT company. Dr. Desai reports serving as Principal Investigator on investigator-initiated grants to the Brigham and Womens Hospital from Novartis, Vertex, and Bayer on unrelated projects. Dr. Schneeweiss is co-principal investigator of an investigator-initiated grant to the Brigham and Womens Hospital from Boehringer Ingelheim unrelated to the topic of this study. He is a consultant to Aetion Inc., a software manufacturer of which he owns equity. His interests were declared, reviewed, and approved by the Brigham and Womens Hospital and MGB HealthCare System in accordance with their institutional compliance policies. All other authors have no conflicts of interest to disclose relative to this work.

This project was supported by Master Agreement 75F40119D10037 from the US Food and Drug Administration (FDA). FDA coauthors reviewed the study protocol, statistical analysis plan, and the manuscript for scientific accuracy and clarity of presentation. Representatives of the FDA reviewed a draft of the manuscript for presence of confidential information and accuracy regarding statement of any FDA policy. The views expressed are those of the authors and not necessarily those of the U.S. FDA.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This Sentinel project is a public health surveillance activity conducted under the authority of the Food and Drug Administration and, accordingly, is not subject to Institutional Review Board oversight. Additionally, the MyHealth Access Network governance committee comprising local stakeholders and data contributors, reviewed and approved the secondary use of the data for this query.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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The data that support the findings of this study are not publicly available due to privacy restrictions.