Developing a Standardized and Reusable Method to Link Distributed Health Plan Databases to the National Death Index:...

Area of Science:

• Pharmacovigilance and drug safety research.
• Health data linkage and electronic health records.
• Public health surveillance and mortality research.

Background:

• Premarket clinical trials may not identify all medication risks, such as increased mortality.
• Postmarket safety surveillance is crucial for public health protection.
• Existing electronic health plan databases often lack systematic death and cause-of-death information.

Purpose of the Study:

• To develop generalizable and reusable methods for linking multiple health plan databases with the National Death Index Plus (NDI+).
• To enable robust postmarket safety surveillance of medications.
• To support the US Food and Drug Administration's (FDA) mission to protect public health.

Main Methods:

• Establish efficient administrative workflows for multicenter Institutional Review Board (IRB) approval.
• Implement a distributed NDI+ linkage process protecting patient privacy.
• Develop standardized criteria for NDI+ match selection and harmonization of linked data across health plans.

Main Results:

• The study will estimate mortality incidence and rates using linked health plan and NDI+ data.
• Results will be compared to existing estimates to assess the linkage approach's performance.
• Findings will inform future studies requiring NDI+ linkage in distributed database settings.

Conclusions:

• A reusable, distributed NDI+ linkage approach will be developed and tested.
• Standardized methods will enhance the FDA's ability to assess medication-related mortality risks.
• This work supports real-world, postmarket safety evaluations.