Support for WHODrug Link Korea dictionary

Summary

Support WHODrug Link Korea loading, configuration and coding (Enhancements 32483505 and 35361980)

Description

Oracle Argus Safety is enhanced to support loading, configuration, and coding of WHODrug Link Korea dictionary.

Loading dictionary

New options are added in Console > Tools > Dictionary Management > Dictionary Loader to support loading or overwriting the WHO Drug Link Korea B3 and C3 dictionaries. You can load the Link Korea dictionaries starting from March 2025.

The dictionary zip file must include the required files for either the B3 or C3 formats. As the Link Korea dictionary does not use an MDB file, you do not need to select one.

Before loading Link Korea, make sure the matching WHODrug Global dictionary version is already loaded; otherwise, Link Korea cannot be loaded. Set the profile switch for WHODrug Global to C3 when loading Link Korea C3 dictionary, or to B3 when loading Link Korea B3 dictionary.

Required files:

• Link Korea C3: LinkKorea_MPID.csv (for 2025 dictionaries), LinkKorea_RecordId.csv (for dictionaries released from 2026 onwards) LinkKorea_Cas.csv, Version.csv
• Link Korea B3: LinkKorea_DrugCode.csv, LinkKorea_Cas.csv, Version.csv

Other features, such as email notifications, work the same as for global dictionary loading.

Configuring dictionary

A new common profile switch is added to set Drugs(Korea) based on the Global dictionary format and version. The Ingredients code list now includes a new column, MFDS Ingredient Code, which is populated during Link Korea dictionary loading for matching ingredients using the CAS number. You can also add, edit, or delete the MFDS Ingredient Code as needed.

Drug Coding screen updates

A search criterion for MFDS Product Code has been introduced. When the Link Korea dictionary is enabled in the common profile switch, drug searches in WHODrug will also display matching MFDS Product Code records in the drug coding screen based on the Link Korea dictionary.

Additional information such as Formulation, Strength, MAH, and MFDS Ingredient Codes is also displayed to assist user selection. The selected data from the drug coding screen is populated into the Console or Case Form configuration.

The MFDS section may display one-to-one, one-to-many, or no matching records for the selected WHODrug, depending on the matching criteria.

For Link Korea C3, matching is performed based on the WHO Record ID between the Link Korea table and WHODrug Global. For Link Korea B3, matching is based on the WHO Drug Code between the Link Korea table and WHODrug Global.

Configuring license

A new field, MFDS Product Code, is added in the Business Configuration > Licenses screen to configure MFDS product code for the Korea license.

Drug coding in case form

For company products, the MFDS Product Code in the Products tab is populated based on the Console > License > MFDS Product Code field for the selected license. In the Substance Information section, corresponding MFDS Ingredient Code is populated from the Ingredients code list.

For non-company products, both the MFDS Product Code and MFDS Ingredient Codes are populated based on the selected record in the Drug Coding screen.

When MFDS Product Code is selected in the Drug Coding screen, then the same is populated in the Other Relevant History section of both the Patient tab and Parent tab.

Generate report

The MFDS E2B(R3) report generated for Korea cases (domestic post-marketed) populates both MFDS Product Code and MFDS Ingredient Code in regional elements based on the data entered in the case form.

Mapping logic has not changed for the following elements:

• PATIENTMEDICALPRODUCTID[D.8.r.1.KR.1b]
• PARENTMEDICALPRODUCTID[D.10.8.r.1.KR.1b]
• DRUGMEDICALPRODUCTID[G.k.2.1.KR.1b]
• SUBSTANCEID[G.k.2.3.r.1.KR.1b]