For Companies using WHO-DD C3 format
For drugs autoencoding during case processing with WHO-DD C3 format, the dictionary is set in Argus Console > System Configuration > System Management (Common Profile Switches) > Case Form Configuration > Auto Encoding section.
Note:
This switch will have no impact on case processing and it is used only for MFDS E2B(R3) reporting.
WHO Medicinal Product ID and WHO CAS Number are captured and transmitted as outlined in the table below.
For details, refer to the Business Rules defined in the E2B(R3) export mapping document.
| Element ID | Element description | Data capture and transmitted from |
|---|---|---|
| D.8.r.1.KR.1a | WHO-DD version | Console > Common Profile Switch > E2B > Regional Drugs Dictionary |
| D.8.r.1.KR.1b | Medicinal Product ID
(Patient Past drug Therapy) |
Case Form > Patient > Other Relevant History > WHO Medicinal Product ID |
| D.10.8.r.1.KR.1a | WHO-DD version | Console > Common Profile Switch > E2B > Regional Drugs Dictionary |
| D.10.8.r.1.KR.1b | Medicinal Product ID
(Parent Past drug Therapy) |
Case Form > Parent > Other Relevant History > WHO Medicinal Product ID |
| G.k.2.1.KR.1a | WHO-DD version | Console > Common Profile Switch > E2B > Regional Drugs Dictionary |
| G.k.2.1.KR.1b | Medicinal Product ID
(Suspect/Concomitant/Interacting Products) |
Case Form > Product > WHO Medicinal Product ID |
| G.k.2.3.r.1.KR.1a | WHO-DD version | Console > Common Profile Switch > E2B > Regional Drugs Dictionary |
| G.k.2.3.r.1.KR.1b | Substance ID
(Ingredients of Suspect/Concomitant/Interacting Products) |
WHO CAS Number is retrieved from WHO-DD C3 dictionary
WHO_DRUG_C_SUBSTANCE table using Case Form > Product > Substance Information > Substance Name |
For WHO drugs
- Case Form > Patient > Other Relevant History > WHO Medicinal Product ID
- Case Form > Parent > Other Relevant History > WHO Medicinal Product ID
When drugs are coded during case processing with the WHO-DD C3 format, the WHO Medicinal Product ID is automatically populated from the WHO Drug browser.
For Company drugs
In Oracle Argus Safety Console, set the WHO Drug Code for company products. This will store the WHO Drug Code in LM_PRODUCT.DRL_ID and also the corresponding Medical Product ID in LM_PRODUCTS.MEDICINAL_PROD_ID.
When this Product is added in the case, the WHO Medicinal Product ID would be populated in Case Form > Product.
Note:
During the E2B(R2/R3) import, the WHO Medicinal Product ID will be populated if the incoming XML contains a WHO Drug product that has a single match with the WHO Drug dictionary. This is applicable for WHO Medicinal Product ID on the Products tab, on the Patient tab > Other Relevant History section and on the Parent tab > Other Relevant History section.