For Companies using WHO-DD B3 format

• For auto encoding of drugs during Case processing with WHO-DD B3 format, the dictionary is set in Console > Common Profile Switch > Case Form Configuration > Auto Encoding section.
• For MFDS E2B(R3) reporting, since it is mandatory to send the WHO Medicinal Product ID and the WHO CAS Number from C3 format, it is recommended to load the WHO-DD C3 dictionary into Oracle Argus Safety. Technically Oracle Argus Safety supports loading multiple WHO dictionary versions and formats.
• Set the WHO-DD C3 dictionary in the newly introduced Common Profile Switch in Console > Common Profile Switch > E2B > Regional Drugs Dictionary.

  Note:

  This switch shall not impact Case processing and is used only for MFDS E2B R3 reporting. Hence companies can continue to code drugs with the WHO-DD B3 format as usual.
• MFDS E2B(R3) mapping logic is designed to automatically fetch the WHO Medicinal Product ID and the WHO CAS Number from the C3 dictionary set in the Regional Drugs Dictionary based on the WHO Drug Code in the Oracle Argus Safety Case Form.

  This mapping is designed in discussion with WHO-UMC to fetch the match from C3 where Country = Unspecified, MAH = Unspecified, Formulation = Unspecified, Strength = Unspecified.

  For example, for the ABAPEN drug coded using B3 format, Oracle Argus Safety mapping logic fetches the corresponding C3 format data, as in the image below:

  

  Note:

  WHO-UMC does not provide official mapping between B format and C format. Oracle discussed this challenge with WHO-UMC, and they acknowledge the challenge. WHO-UMC are currently engaging with MFDS with the ultimate aim to create mappings between WHODrug B3 and WHODrug C3 format.

  Until official mapping between B format and C format is provided, it is recommended to use out-of-the-box MFDS E2B(R3) mapping logic in Oracle Argus Safety.