Supporting State Distributor License Validation

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To help reduce the compliance burden for users and organizations, State Distributor license information can be automatically validated when users capture an HCP’s signature. Some states require an additional State Distributor license for businesses that store and distribute dangerous pharmaceutical products. State Distributor licensing validation eliminates the need for users to manually input and check additional license information for storing and distributing dangerous products in states where State Distributor licensing is required. State Distributor licensing also supports validation for full or limited Terminal Distributor of Dangerous Drugs (TDDD) licenses, as required by the state of Ohio for businesses storing and distributing certain products. See Ohio TDDD Licensing for more information.

For example, Sarah Jones works in the state of Ohio, which requires a State Distributor license. During her visit to Dr. Ackerman’s office at Valley Hospital in Ohio, she disburses samples of Cholecap and Restolar to Dr. Ackerman. The samples she disburses are classified as Category 02/12 and Category 03/13 products under Ohio’s regulations. Before Sarah captures Dr. Ackerman's signature for the samples, the following information is validated:

  • Dr. Ackerman's state license information
  • Valley Hospital's State Distributor license for Category 02/12 and Category 03/13

Considerations

  • If the --nsl, --nslns, or --npdma section signals are on the Call2_vod page layout, State Distributor licenses are not validated

Prerequisites

Configuring State Distributor License

To enable State Distributor license validation:

  1. Grant admins the following permissions:

    Object

    OLS

    Record Types

    Field

    FLS

    Samples_State_Settings_vod

    CRU

    n/a

    • External_Id_vod
    • State_Distributor_Required_vod

    Edit

    Address_vod

    n/a

    n/a

    • State_Distributor_vod
    • State_Distributor_Expiration_Date_vod
    • State_Distributor_Status_vod
    • State_Distributor_Category_vod
    • State_Distributor_License_Exempt_vod

    Edit

    Product_vod

    n/a

    n/a

    State_Distributor_Category_vod

    Edit

    Call2_vod

    n/a

    n/a

    • State_Distributor_vod

    • State_Distributor_Expiration_Date_vod

    • Ship_State_Distributor_vod

    • Ship_State_Distributor_Expiration_Date_vod

    Edit

    Sample_Transaction_vod

    n/a

    n/a

    • State_Distributor_vod
    • State_Distributor_Expiration_Date_vod

    Edit

    Sample_Transaction_Audit_vod

    n/a

    n/a

    • State_Distributor_vod
    • State_Distributor_Expiration_Date_vod

    Edit

    Sample_Order_Transaction_vod

    n/a

    n/a

    • Ship_State_Distributor_vod
    • Ship_State_Distributor_Expiration_Date_vod

    Edit

    Sample_Order_Transaction_Audit_vod

    n/a

    n/a

    • Ship_State_Distributor_vod
    • Ship_State_Distributor_Expiration_Date_vod
     

    Content_Acknowledgement_vod

    n/a

    n/a

    Ship_State_Distributor_vod

    Edit

  2. Grant end users the following permissions:

    Object

    OLS

    Record Types

    Field

    FLS

    Address_vod

    n/a

    n/a

    • State_Distributor_vod
    • State_Distributor_Expiration_Date_vod
    • State_Distributor_Status_vod
    • State_Distributor_Category_vod
    • State_Distributor_License_Exempt_vod

    Read

    Product_vod

    n/a

    n/a

    State_Distributor_Category_vod

    Edit

    Call2_vod

    n/a

    n/a

    State_Distributor_vod

    Edit

    • State_Distributor_Expiration_Date_vod
    • Ship_State_Distributor_vod
    • Ship_State_Distributor_Expiration_Date_vod

    Read

    Sample_Transaction_vod

    n/a

    n/a

    • State_Distributor_vod
    • State_Distributor_Expiration_Date_vod

    Edit

    Sample_Transaction_Audit_vod

    n/a

    n/a

    • State_Distributor_vod
    • State_Distributor_Expiration_Date_vod

    Read

    Sample_Order_Transaction_vod (optional; for BRCs)

    n/a

    n/a

    • Ship_State_Distributor_vod
    • Ship_State_Distributor_Expiration_Date_vod

    Edit

    Sample_Order_Transaction_Audit_vod (optional; for BRCs)

    n/a

    n/a

    • Ship_State_Distributor_vod
    • Ship_State_Distributor_Expiration_Date_vod

    Read

    Content_Acknowledgement_vod

    n/a

    n/a

    Ship_State_Distributor_vod

    Read

  3. Add the following fields to the appropriate business account page layouts on the Address_vod object (optional):
    • State_Distributor_vod
    • State_Distributor_Expiration_Date_vod
    • State_Distributor_Status_vod
    • State_Distributor_Category_vod
    • State_Distributor_License_Exempt_vod (can be added to the business account or person account’s page layout)
  4. Add the State_Distributor_Category_vod field to the appropriate page layouts on the Product_vod object.
  5. Add the following fields to the appropriate page layouts on the Samples_State_Settings_vod object:
    • Name
    • State_Distributor_Required_vod
  6. Populate the State_Distributor_Category_vod field with the appropriate category information for all product records. This is required for any product distributed in a state that requires State Distributor licenses.

  7. Populate the State Distributor license fields on the address records for all business accounts in states requiring State Distributor licenses.

    If State Distributor licensing is not required for a particular address, select the State_Distributor_License_Exempt_vod check box on the address record.

    Exempt status does not apply for Category 03 products or controlled substances. For those products, State Distributor validation occurs regardless of whether the State_Distributor_License_Exempt_vod check box is selected.

    For more information on exemptions, see Possible Exemptions for State Distributor License Validation.

  8. Populate the Allowed_Products_vod field on the Territory_Field_vod object with a list of products allowed at each specific territory and account combination, if the organization has a limited license for Ohio TDDD sampling (optional). For more information on allowed products, see Defining Allowed Products.

Defining States Requiring State Distributor Licenses

Administrators must create a Sample State Settings record for each state that requires State Distributor licensing:

  1. Create a record on the Samples_State_Settings_vod object for each appropriate state.
  2. Select the State_Distributor_Required_vod check box and complete the appropriate fields.

    Ensure the CDS_Required_vod check box is not selected, and do not populate the Settings_vod field.

  3. Create a VMOC for the Samples_State_Settings_vod object for all desired offline platforms.

Validating State Distributor Licenses

When capturing a signature on a call report in a state where a distributor license is required, as long as either the HCP or HCO are not exempt, the following validation occurs on the specified location's address record:

Field

Criteria

State_Distributor_vod

Must be populated

State_Distributor_Expiration_Date_vod

Must be greater than the current date

State_Distributor_Status_vod

Must be valid

State_Distributor_Category_vod

Must contain a match for the selected products’ category, as defined in the State_Distributor_Category_vod field on the Product_vod records

In addition, the call address and call location address selected on the call report must be an exact match. Otherwise, the address cannot be validated and the user cannot capture the HCP signature for sampling. (For information on enabling users to select an address for validation when the HCP and call location address differ, see Selecting an Address for State Distributor License Validation.)

If users select an address with 12 or 13 listed in the State_Distributor_Category_vod field, detailing and sampling are limited to allowed products only. To comply with Ohio’s TDDD policies for HCOs with Category 12 or 13 limited licenses, validation ensures the selected product is listed in the Allowed_Products_vod field on the TSF_vod object. Category 12 or Category 13 limited licenses enable HCOs to store and handle specific dangerous products, in contrast with the full Category 02 or Category 03 licenses.

If validation fails for any of these fields, an error displays and users cannot capture HCP signatures or submit the call.

Capturing Sample Disbursements with State Distributor License

If the account address is eligible for the selected products, users capture the sample disbursement as usual (see Default Functionality for Call Sampling for more information). The account’s State Distributor license number displays on the signature capture page. Additionally, if the Ship_State_Distributor_vod field is populated on an Acknowledgement of Content (AOC) record, the State Distributor license number displays on the AOC signature page.

The HCP’s address and the Call Location address must be an exact match for State Distributor license validation.

If users do not have FLS edit permission for the State_Distributor_Category_vod field on the Product_vod object, and disburse samples or BRCs in a state requiring state distributor license validation, the following defaults apply to ensure sample and BRC products are disbursed only to eligible HCPs, regardless of org configuration:

  • Samples and BRCs with the Controlled Substance flag checked are considered Category 03 products for addresses in Ohio
  • Samples and BRCs where Controlled Substance flag is not checked are considered Category 02 products for addresses in Ohio

Capturing Sample Requests/BRCs with State Distributor License

When users create sample requests/BRCs on the call report, the Ship_To_Address_vod field does not display invalid addresses. The picklist only displays shipping addresses that have valid State Distributor license information or are exempt from State Distributor license requirements.

If sample requests/BRCs are selected on the call report, the Ship_State_Distributor_vod field displays the account’s State Distributor license number on the signature capture page.

Saving and Submitting Calls with State Distributor License

When users save or submit a call report for an HCP at an address with State Distributor License Information, the values in the State_Distributor_vod and State_Distributor_Expiration_Date_vod fields copy to the following locations:

  • Call2_vod record:
  • For samples, the two fields copy to the State_Distributor_vod and State_Distributor_License_Expiration_vod fields
  • For BRCs, the two fields copy to the Ship_State_Distributor_vod and Ship_State_Distributor_License_Expiration_vod fields
  • Sample_Transaction_vod record (for Samples)
  • Sample_Order_Transaction_vod record (for BRCs)

Auditing for Samples and Sample Requests/BRCs with State Distributor License

If a Sample_Transaction_vod or Sample_Order_Transaction_vod record containing State Distributor licensing information is unlocked and modified:

  • Samples – the State_Distributor_vod and State_Distributor_Licensce_Expiration_vod fields are copied to the corresponding Sample_Transaction_Audit_vod record
  • BRCs – the Ship_State_Distributor_vod and Ship_State_Distributor_License_Expiration_vod fields are copied to the corresponding Sample_Order_Transaction_Audit_vod record

Possible Exemptions for State Distributor License Validation

State Distributor License validation may not apply under certain circumstances in the state of Ohio, including:

  • Products that are Category 1 or 2 distributed to businesses owned only by a licensed practitioner or licensed practitioners
  • Products distributed to a federal facility

See appropriate state regulations for more information; for example, Ohio TDDD Licensing.

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