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BACKGROUND/RATIONALE:
Recent publicity (for example, rofecoxib-associated myocardial infarction) has dramatically demonstrated current difficulties identifying and estimating the incidence and clinical impact of medication-associated adverse events (AE). Reasons for these difficulties include: (a) the high cost of prospective AE monitoring, (b) incomplete reporting of AE's, (c) limitations on generalizing AE clinical trial data to clinical practice, and (d) the large number of medication patient exposure years that may be required to recognize infrequent AE's. Analyses of the VA's very large national clinical and administrative databases, supplemented with medical record review and Medicare data, provide a unique opportunity to identify medication related AE's and determine their impact on the cost of health care. In the present study, AE's associated with treatment of rheumatoid arthritis (RA) with anti-tumor necrosis factor (anti-TNF) agents, methotrexate, and leflunomide will be used as a model.
OBJECTIVE(S):
The broad goal of this project is to integrate sociodemographic, clinical, and pharmacy data available in the VA's national databases, supplemented with medical record review, to identify, characterize, and assess the incidence and costs of adverse medication events. Specifically, among patients with RA, we will: (a) determine the incidence and risk factors for infectious and non-Hodgkin lymphoma complications associated with treatment with anti-TNF agents, and the incidence and risk factors for interstitial lung disease (ILD) complications associated with treatment with methotrexate and leflunomide; (b) determine the validity of AE-related data obtained from VA centralized databases by comparing national database data with data abstracted from electronic medical records of selected patients with RA at eight medical centers across the United States; and (c) estimate the cost of AE's associated with treatment of RA with anti-TNF agents, and methotrexate and leflunomide.
METHODS:
Research team: The project is based at the St. Louis VAMC and includes investigators at the Hines and Denver VAMC's, Washington and St. Louis Universities, and five other collaborating VAMC's.
National databases: The research group will utilize national VA database resources located at the Pharmacy Benefits Management (PBM), the Austin Automation Center (AAC), the VA Information Resource Center (VIReC), and the National Health Data Repository (NHDR) to address AE issues.
Data validity: To evaluate the validity of data obtained from national databases, selected medical records at 8 VAMC will be abstracted using standardized methods.
FINDINGS/RESULTS:
No results at this time.
IMPACT:
Prior research has amply documented the impact of adverse medication events on the quality and cost of care. The proposed study will evaluate the feasibility of using the VA's national databases to identify and study clinically significant AE's and estimate their cost. The results will be disseminated to VA policy makers and health care providers through the VAMedSAFE program, and through publications in the peer reviewed journals.
PUBLICATIONS:
None at this time.
DRA:
Health Services and Systems
DRE:
Resource Use and Cost
Keywords:
none
MeSH Terms:
none
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