Applying a common data model to Asian databases for multinational pharmacoepidemiologic studies: opportunities and challenges.

OBJECTIVE: The goal of the Asian Pharmacoepidemiology Network is to study the effectiveness and safety of medications commonly used in Asia using databases from individual Asian countries. An efficient infrastructure to support multinational pharmacoepidemiologic studies is critical to this effort. STUDY DESIGN AND SETTING: We converted data from the Japan Medical Data Center database, Taiwan's National Health Insurance Research Database, Hong Kong's Clinical Data Analysis and Reporting System, South Korea's Ajou University School of Medicine database, and the US Medicare 5% sample to the Observational Medical Outcome Partnership common data model (CDM). RESULTS: We completed and documented the process for the CDM conversion. The coordinating center and participating sites reviewed the documents and refined the conversions based on the comments. The time required to convert data to the CDM varied widely across sites and included conversion to standard terminology codes and refinements of the conversion based on reviews. We mapped 97.2%, 86.7%, 92.6%, and 80.1% of domestic drug codes from the USA, Taiwan, Hong Kong, and Korea to RxNorm, respectively. The mapping rate from Japanese domestic drug codes to RxNorm (70.7%) was lower than from other countries, and we mapped remaining unmapped drugs to Anatomical Therapeutic Chemical Classification System codes. Because the native databases used international procedure coding systems for which mapping tables have been established, we were able to map >90% of diagnosis and procedure codes to standard terminology codes. CONCLUSION: The CDM established the foundation and reinforced collaboration for multinational pharmacoepidemiologic studies in Asia. Mapping of terminology codes was the greatest challenge, because of differences in health systems, cultures, and coding systems.

Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial.

BACKGROUND: Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. OBJECTIVE: To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. SETTING: A 421-bed district hospital in Nantou City, Taiwan. METHOD: We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann­Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P < 0.05. MAIN OUTCOME MEASURE: The change in the mean HbA1c level from the baseline to the next level within 6 months after recruiting. RESULTS: Nonparametric data (Mann­Whitney test) showed that the mean HbA1c level significantly decreased (0.83 %) after 6 months for the intervention group compared with an increase of 0.43 % for the control group (P ≤ 0.001). Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. CONCLUSION: The pharmacist intervention program provided pharmaceutical services that improved long-term, safe control of blood sugar levels for ambulatory elderly patients with diabetes and did not increase medical expenses.

Validation of the National Health Insurance Research Database with ischemic stroke cases in Taiwan.

OBJECTIVE: The National Health Insurance Research Database (NHIRD) is commonly used for pharmacoepidemiological research in Taiwan. This study evaluated the validity of the database for patients with a principal diagnosis of ischemic stroke. STUDY DESIGN AND METHODS: This cross-sectional study compares records in the NHIRD with those in one medical center. Patients hospitalized for ischemic stroke in 1999 were identified from both databases. The discharge notes, laboratory data, and medication orders during admission and the first discharge visit were reviewed to validate ischemic stroke diagnoses and aspirin prescribing in the NHIRD. Agreement between the two databases in comorbidities of ischemic stroke diagnosis was evaluated using ICD-9 codes. RESULTS: Three hundred and seventy two cases were identified from the NHIRD; among them, 364 cases (97.85%) were confirmed as ischemic stroke by radiology examination and clinical presentation. Among these confirmed cases, 344 (94.51%) were assigned 'ischemic stroke' as the principal diagnosis in the NHIRD. The overall agreement of comorbid diagnoses between the databases was 48.39%. The PPV for selected conditions also varied widely, from 0.50 for fracture to 1.00 for colon cancer. The accuracy of recorded aspirin prescriptions was higher in first post-discharge visits (PPV = 0.94) than during hospitalization (PPV = 0.88). CONCLUSION: The accuracy of the NHIRD in recording ischemic stroke diagnoses and aspirin prescriptions was high, and the NHIRD appears to be a valid resource for population research in ischemic stroke.