Code WHODrug Products

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

About WHODrug

Vault 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 coding External Products for domestic Cases for Japan and Korea and foreign Localized Cases reportable to the PMDA or MFDS, Vault may cross-reference selected codes with the Iyakuhinmei Data File (IDF) or Korea Drug Dictionary and populate the corresponding code in the applicable localized field.

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

Prerequisites

To cross reference WHODrug codes to IDF or Korea Drug Dictionary codes, your Admin must enable the applicable tool:

Code a WHODrug Product

You can code products with the WHODrug dictionary in the following ways:

  • When creating a Case Product, access the Product Browser. In the browser, select Launch WHODrug to launch the WHODrug Search 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.
    • You can select Back to Product Coding Browser in the window to open the Product Browser to code a Company Product.
  • In the Drug History section of a Case, 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.
  • When creating External Products for a domestic Case for Japan or Korea or foreign Localized Cases reportable to the PMDA or MFDS, populate the WHODrug or applicable JDrug or Korea Drug field. If your Admin has configured WHODrug cross-referencing with the corresponding dictionary and Vault finds a match, Vault populates the applicable field with the matching code.

Using the WHODrug Search Browser

You can use the WHODrug Search browser to search and code products in the following ways:

  • In the search bar, enter or change the search terms, and then select the search (search button) icon. Search runs once you enter two (2) or more characters, and returns results based on exact spelling.
  • 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.
  • 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
  • To select a WHODrug code, select the corresponding Code button.

When you save the Case Product, Vault adds the selected WHODrug product and substance details to the Case. Vault generates Product Substances to a limit of 1,500 characters based on the cumulative number of characters across all Product Substance names. To remove the details, select Clear Selection.

WHODrug Search Columns

When searching for products in the WHODrug Search browser, Vault displays the following columns:

  • Code Options: Select the Code button 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 Cross-Referencing

When coding External Products for domestic Cases for Japan and Korea and foreign Localized Cases reportable to the PMDA or MFDS, Vault supports cross-referencing WHODrug codes to the Iyakuhinmei Data File (IDF) or Korea Drug Dictionary code using the WHODrug CRT Japan or WHODrug Link Korea. When configured by your Admin, Vault does the following:

  • JDrug: You can populate this field using the Iyakuhinmei Data File (IDF). If Vault finds a match to the code you select for this field, it attempts to find a matching WHODrug MPID code using WHODrug CRT Japan mapping.
  • Korea Drug: You can populate this field using the Korea Drug Dictionary. If Vault finds a match to the code you select for this field, it attempts to find a matching WHODrug MPID code using WHODrug Link Korea mapping.
  • WHODrug: You can populate this field using the WHODrug Search browser. If Vault finds a match to the code you select for this field, it attempts to find a matching WHODrug MPID code using the applicable WHODrug CRT Japan or WHODrug Link Korea mapping.

When Vault attempts to populate a cross-referenced field, it displays a message below the field describing the result of the cross-reference. If you select Clear Selection, Vault removes the codes from both fields. If Vault finds no match or multiple matches, it leaves the corresponding field blank. When processing global Cases with PMDA or MFDS reporting requirements, Vault applies updates to Localized Case Products after Transmission generation.

Fields that Support WHODrug Coding

You can use a WHODrug code to populate information on a Case for External Products and Drug Histories.

External Product

In the Details section of an External Product, 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, Vault generates a Substance with the following details:

  • Pharmaceutical Strength
  • Drug Name
  • Preferred Name

Vault generates multiple Substances when a coded product has more than one (1) substance.

Drug History

In the Details section of a Case Drug History, 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