Asian Data Resources. October 24, :30-12:30 Using pharmacoepidemiology database resources to address drug safety research

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1 Draft Asian Data Resources October 24, :30-12:30 Using pharmacoepidemiology database resources to address drug safety research Kiyoshi Kubota MD PhD FISPE NPO Drug Safety Research Unit Japan

2 Multiple choice questions 1 Select a correct one from the following 5 statements on Asian databases (Answer=2) [1] Almost all databases available in Asian countries are classified as claims database. [2] National database covering the entire nation is available in 3 Asian countries. [3] In most databases, domestic diagnosis code is used but international diagnosis code (e.g., ICD-9 or ICD-10) is not used. [4] Longitudinal dispensing data of Traditional Chinese Medicines are available in some EHR databases but in no claims database in Asia. [5] In general, information on medical expenditure are not available in Asian databases.

3 Multiple choice questions 2 Select a correct one from the following 5 statements on ethical aspects of Asian databases (Answer=3) [1] Once approval from ethics review committee is obtained, linkage to other data sources is usually easy in Asian databases. [2] Once personal identifiers are removed, individual level data can be usually shared across countries in Asia. [3] Patient's identifier and location are usually removed to protect confidentiality in most Asian databases. [4] All the diagnoses are given without masking in all Asian databases. [5] The information on date of birth and date of death is available in all Asian databases.

4 Disclosures I have nothing to diclose relevant to this presentation

5 Asian Databases Databases (DBs) and DB studies are growing in Asian countries. In January 2014, the information on current status of DBs in Asian countries has been collected by a web-based survey by the AsPEN group. This presentation shows the results of the survey plus additional information provided by each study site.

6 Background Asian Conference on Pharmacoepidemiology (ACPE) has been annually held since Asian Pharmacoepidemiology Network (AsPEN) was developed through ACPEs. AsPEN was recognized as a Special Interest Group (SIG) of ISPE in So far two papers were published by AsPEN group (see

7 Web-based survey Web-based survey was drafted by an AsPEN member Dr. Edward CC Lai The survey included 142 questions on (1) DB characteristics, (2) access policy and restrictions, (3) population demographics, (4) data components and coding system, (5) medical expenditure, and (6) traditional chinese medicine (TCM).

8 DBs surveyed by AsPEN group in January 2014 The information was obtained on 11 DBs from 7 countries including 4 claims DBs from 3 countries (Japan, Korea and Taiwan), 5 Electronic Health Record (EHR) DBs in 4 countries (China, Hong Kong, Singapore and Thailand) and 2 disease registries from 1 country (Taiwan).

9 4 Claims DBs in 2014 survey Japan (national): National Database (JNDB) Japan (commercial database): Japan Medical Data Center (JMDC) Database. Korea (national): Korea Health Insurance Review and Assessment Service (HIRA) Taiwan (national):national Health Insurance Research Database (NHIRD)

10 5 EHR DBs in 2014 survey China (one hospital): Hospital Information System of West China Hospital (HIS-WCH) Hong Kong (national): Clinical Data Analysis and Reporting System (CDARS) Singapore (national): National Electronic Health Record (NEHR) Thailand (21 hospitals): Hospital Information (HI) Thailand (1 hospital): Buddhachinaraj hospital database (BH)

11 2 disease registries in 2014 surve Taiwan Stroke Registry (TSR) Taiwan Cancer Registry (TCR)

12 Access policy and restriction Ethics committee approval: required in all countries. Linkage to other data sources: difficult/ strictly prohibited. Patient's identifier and location: usually removed to protect confidentiality in most databases. Some diseases (mental diseases or HIV infection): masked in some DBs (e.g., Taiwan NHIRD). Individual level data: not allowed to be shared across multiple countries for most DBs.

13 Population demographics Most DBs cover all age groups with some exception (e.g., JMDC DB) Information on gender: included in all DBs. Date (or month) of birth: included in all DBs. Date (or month) of death: included in all DBs except HIRA. Race/ethnicity: included in EHR DBs (except BI) and one registry (TSR).

14 Data components Demographics, diagnoses, cause of death Demographics: as in the previous slide Body Weight/Height: available in EHR DBs (except CDARS and BI) and 1 registry (TSR) Diagnoses, drugs and procedures: included in all DBs. Cause of death: included in all EHR DBs and one registry (TCR).

15 Data components Labo results, hospital/physician identifier Laboratory results: available in all EHR DBs and 1 registry (TSR) but not in claims DBs. Hospital identifiers: included in 1 claims DB (HIRA), all EHR DBs except HIS-WCH, and TSR. Physician identifiers: not included in claims DBs but included in EHR DBs (except CDARS and BI).

16 Coding systems Diagnoses ICD-9 or ICD-10: in all of 11 DBs. Drugs ATC: in all claims DBs and 1 EHR DB (HI) BNF: in CDARS. Procedures domestic codes in all DBs. ICD-9 code for operation and some of procedures: in 1 claim DB (HNIRD) and 3 EHR DBs (CDARS, NEHR and HI).

17 Medical expenditure Total paid (total paid per month for Japan): included in all claims and EHR DBs except CDARS. Total paid of drugs: included in 2 claims DBs (HIRA and NHIRD). Some concepts sometimes do not exist No concept of "co-payment" in Japan No concept of "coordination benefits" in Japan and Taiwan.

18 Traditional Chinese Medicines Traditional Chinese Medicines (TCMs): used in all participating countries. Longitudinal dispensing data for TCMs: available in claims DBs in Japan and Taiwan and an EHR DB in China. Thai herbal medicine: used only in Thailand and included in BI.

19 Description on each database The National Database (JNDB) of Japan since 2009 April >128 million Universal multi-payer health-care system since JNDB includes all claims issued after April Use for secondary purposes (e.g., research) since No unique identifier used in health care system two types of encrypted identifiers are newly created inside JNDB.

20 Description on each database The Japan Medical Data Center (JMDC) Database since 2005 Jan > 2.3 million One of commercially available DBs in Japan sometimes used in the AsPEN studies Not representative Working age and children: overrepresented Elderly: underrepresented. Data of (1) claims, (2) enrollment and (3) health screening are available. All patients are anonymized.

21 Description on each database The Health Insurance Review and Assessment Service (HIRA) of Korea since 2008 Dec > 50 million Universal multi-payer healthcare insurance coverage in Single-payer system and then HIRA database since Information for about 50 million Koreans. Patient IDs are encrypted. Medical institution identification number is available.

22 Description on each database National Health Insurance Research Database (NHIRD) of Taiwan since 1996 Jan 23 million Single-payer National Health Insurance program since 1995 covering 99% of population. National Health Research Institute (NHRI) maintains NHIRD and makes it accessible for research purposes. Personal identifiers are encrypted

23 Description on each database Hospital Information System of West China Hospital (HIS-WCH), since 2008 Aug > 5 million Data from one hospital. Detailed information on Chinese herbal products.

24 Description on each database The Clinical Data Analysis and Reporting System (CDARS) of Hong Kong since 1995 Jan > 7 million Health services are provided by Hong Kong Hospital Authority (HA) for 7 million residents. CDARS for research and audit since 1995 from Data in Clinical Management System (CMS) Data are completely anonymised

25 Description on each database National Electronic Health Record (NEHR) of Singapore since 2011 Jan > 5 million National electronic health record (NEHR) system since to improve healthcare by information from a central repository of aggregated data available to all public healthcare institutions, some of community hospitals, GPs and Agency for Integrated Care (AIC)

26 Description on each database The Hospital Information (HI) of Thailand since 2003 Jan > 1 million HI covers patients with different healthcare schemes in Ubon Ratchathani province. HI has been used in research e.g., Evaluation of Diabetic Management Program. Patient identifiers are encrypted for research and policy purposes.

27 Description on each database The Buddhachinaraj hospital database (BH) of Thailand since 2008 Jan > 0.35 million Single hospital DB data of about 350,000 out-patients. Four subdbs in-patient, out-patient, pharmacy, and charge subdbs. Individual identifiers are encrypted

28 Description on each database Taiwan Stroke Registry (TSR) since 2006 Aug >100,000 Registry of acute stroke since More than 110,000 patients in 56 hospitals Information on acute phase Medication, risk factors, findings, interventions, and hospital course. Information on chronic phase Barthel index score and modified Rankin Scale (mrs) at 1, 3, and 6 months

29 Description on each database Taiwan Cancer Registry (TCR) since 2003 Jun >720,000 Registry since 1996 nationwide in 2003 following Cancer Prevention Act in Newly diagnosed malignant neoplasms in hospitals with 50 or more beds Information Demographic, primary cancer diagnosis, date of diagnosis, histology, tumor stage and therapies

30 Prescription sequence symmetry analysis (PSSA) using Asian DBs PSSA analysis for antipsychotic and acute hyperglycaemia by AsPEN group (PDS 2013; 22:915) Simple Common Data Model (CDM) with a table consisting of 3 fields (patient, drug, date) used. AsPEN members of some countries then started to establish legitimate CDM.

31 Observational Medical Outcomes Partnership (OMOP) CDM Introduction of OMOP CDM by AsPEN members of some countries since Local data are converted to 18 tables PERSON, VISIT_OCCURRENCE, DRUG_EXPOSURE, CONDITION_OCCURRENCE, so on. Each table has several fields with a fixed field name.

32 Data Characterization and Quality Control Problems requiring improvement were found in the processes of data characterization and quality control. e.g., What should be given to DRUG_EXPOSURE_START_DATE and DRUG_EXPOSURE_END_DATE in Japan where only "month" but not "date" is available?

33 Mapping of terminology Diagnoses (ICD-9/10 and SNOMED CT) OK Drugs (ATC and RxNorm) at ingredient level: OK drugs with the same dose form: can be difficult Medical Procedures (with CPT4) procedures not covered by ICD-9: can be difficult

34 Other issues in establishing CDM in Asian countries SAS "standard" in Western countries not routinely used in some Asian countries SAS university edition (free version of SAS) may help establish CDM in Asian countries

35 Summary Databases in Asian countries exist and are used. Record linkage to other data sources usually very difficult or strictly prohibited Introduction of CDM across Asian countries started in some of Asian countries.

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