Code WHODrug Products

Use Vault Safety to search for and add medicinal product codes from the WHODrug dictionary.

About WHODrug

Vault Safety supports the IDMP-compliant WHODrug dictionary in the C3 format for standardized coding of medicinal products. Access the WHODrug dictionary to add External Products or Drug History to a Case. When you open the WHODrug Search window, Vault filters the codes based on the reported product name and country. When processing global or domestic Cases or foreign Localized Cases that are reportable to the PMDA, Vault also supports cross-referencing WHODrug codes to the applicable Japan Drug Dictionary (JDD) codes.

For more information about coding Products that are not included in the WHODrug dictionary, see Auto-Code and Browse Products.

Prerequisite

To cross reference WHODrug codes to JDD codes, your Admin must enable the JDrug and WHODrug Cross Reference Tool.

Code a WHODrug Product

Access the WHODrug dictionary from a Case in the following ways:

• When creating a Case Product, access the Product Browser. In the top-right corner of the dialog, select Launch WHODrug to launch the WHODrug Browser.
  • When coding an External Product, if the Product (Reported) or Country Obtained field is populated, results are filtered to those values. For global Cases, the Product (Reported) term appears below the Search bar. For Domestic Cases, the Product (Reported) English term appears below the Search bar.
  • Optionally, you can select Back to Product Browser in the top-left corner of the dialog to open the Product Browser to code a Company Product.
• In the Drug History section, select Create. On the Create Case Drug History page, beside the WHODrug field, select Search WHODrug.
  • When coding Drug History, if the Drug Name (Reported) or Country Obtained field is populated, results are filtered to those values.

Once in the WHODrug Browser, perform the following to search and code a product:

1. In the Search bar, enter or change the search terms, and then select the search () icon. Search runs once you enter two (2) or more characters, and returns results based on exact spelling.
2. To filter the search results, in the Search bar you can enter the following:
   • To filter by country, enter country:{code}, where {code} is the ISO three-letter country code. For example, Cholecap country:USA.
   • To filter by generic drugs only, enter generic:y. For example, Cholecap generic:y.
3. To broaden the search results, select one or more of the following Search Columns:
   • Preferred Name: Generic names for the product substance
   • Drug Name: Drug trade names
   • Name Specifier: Product name differentiators, such as For Children or Sustained Release
   • MPID: Medicinal Product Identifiers (MPID)
   • Drug Code: Alphanumeric drug codes
4. To add a WHODrug code, select Code.
5. Save the page.

Result

The WHODrug control field appears on the Create Case Product page. When you save the Case Product record, Vault adds the selected WHODrug Product and Substance details to the Case. Product Substance records are created to a limit of 1,500 characters based on the cumulative number of characters across all Product Substance names. To remove the Product and Substance details, select Clear Selection.

WHODrug Search Window Columns

The following table describes the WHODrug Search window columns.

Column	Description
Code Options	Select Code to apply a product from the WHODrug dictionary
Preferred Name	The generic names for the active product substance or substance combination
Drug Name	The brand name under which the product is sold
Name Specifier	The product name differentiators, such as For Children or Sustained Release
Pharmaceutical Strength	The strength of the active substance
Pharmaceutical Form	The pharmaceutical form in which the product is sold
Country	The country where the product is marketed
Country Code	The ISO three-letter country code
MAH	The Marketing Authorization Holder (MAH) in the country of sale
ATC1	The Anatomical Therapeutic Chemical Classification System level one code and a description of the anatomical group
ATC2	The Anatomical Therapeutic Chemical Classification System level two code and a description of the therapeutic subgroup
ATC3	The Anatomical Therapeutic Chemical Classification System level three code and a description of the therapeutic or pharmacological subgroup
ATC4	The Anatomical Therapeutic Chemical Classification System level four code and a description of the chemical, therapeutic, or pharmacological subgroup
MPID	The Medicinal Product Identifier (MPID) for the product
Drug Code	The unique identification code for the drug name and active substances
Generic	Whether the product is a generic product
Preferred	Whether the product is a preferred brand-name drug

WHODrug Code to JDrug Code Cross-Referencing

In the Case Products section of a domestic Case for Japan, if your Admin has configured your Vault to cross reference WHODrug codes to JDrug codes for External Products and you have not already coded any JDrug details in the JDrug field, Vault attempts to populate the JDrug code that matches the selected WHODrug code. To indicate the source of the selected WHODrug code, Vault sets the External Product Coding Status field on the Case Product to Coded with Browser. Vault indicates the JDrug code mapping status as follows:

• If Vault finds a matching code in the JDrug dictionary:
  • Vault populates the JDrug field with all available details.
  • To indicate the source of the JDrug details on the related Localized Case Product, Vault sets the External Product Coding Status field to Coded with CRT.
• If Vault does not find a matching code in the JDrug dictionary or WHODrug CRT Japan or finds multiple matching codes in the JDrug dictionary:
  • Vault leaves the JDrug field blank.
  • On the related Localized Case Product, Vault sets the External Product Coding Status field to one (1) of the following:
    • Could not be coded with CRT (code not found in Dictionary)
    • Could not be coded with CRT (code not found in CRT)
    • Could not be coded with CRT (multiple codes found)

If you select Clear Selection to remove the WHODrug code and its related details, Vault clears the JDrug and External Product Coding Status fields.

When processing a global Case with PMDA reporting requirements, Vault applies Localized Case Product updates after Transmission generation. To indicate the source of the WHODrug code on the global Case Product, Vault sets the External Product Coding Status field to Coded with Browser. On the related Localized Case for Japan, to indicate JDrug coding status, Vault sets the External Product Coding Status value using the same logic as described above for Japan domestic Cases.

Fields that Support WHODrug Coding

You can use a WHODrug code to populate information on a Case for External Product and Drug History records.

External Product

In the Details section of an External Product page, code the WHODrug product details. When you add a WHODrug code, Vault populates the following Registration fields when available:

• Pharmaceutical Strength, Drug Name (Preferred Name)
• Registration Country, Holder/Applicant
• MPID
• MPID Version

When a coded product includes a Preferred Name, a Substance record is created and includes the following details:

• Pharmaceutical Strength
• Drug Name
• Preferred Name

Multiple Substance records are created when a coded product has more than one substance.

Drug History

In the Details section of a Case Drug History page, code the WHODrug product details. When you add a WHODrug code, Vault populates the following Registration fields when available:

• Pharmaceutical Strength, Drug Name (Preferred Name)
• MPID
• MPID Version