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  3. DTCA/I, consumer secondary audience
  4. When is an HCP involved or considered "involved" in the dissemination of consumer APS?
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

When is an HCP involved or considered "involved" in the dissemination of consumer APS?

Scheduled Pinned Locked Moved DTCA/I, consumer secondary audience
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  • M Offline
    M Offline
    Maryssa
    wrote on last edited by
    #1

    Per this newsletter (https://www.paab.ca/resources/targeting-consumer-materials-to-patients-through-healthcare-professionals), we understand that APS which have been approved for consumers by ASC may be subject to PAAB review if an HCP is involved in the decision to disseminate consumer information.

    We are hoping you can provide clarity on the limitations of this guidance and provide more details about which situations would be considered HCP involvement in disseminating consumer information.

    For example,

    1. If an ASC approved poster is hung up in a waiting room, is it now subject to PAAB-review through HCP or patient guidance because HCP's or patients may walk through the waiting room and see it?
    2. When a sales rep or other 3rd party leaves ASC approved materials in the waiting room, the physicians are typically aware of what content is being left in their waiting room and likely reading/reviewing it themselves. Are these pieces then subject to PAAB review for HCPs and not just consumers?
    3. If an APS is created to make an HCP aware of an ongoing consumer campaign and links out to the consumer website/material, but there is no request for them to share it with their patients, is the attached consumer tool subject to PAAB review as an HCP APS?
    4. If a physician hears a radio ad approved for consumers which mentions a website that is approved for consumers and decides to tell their patient about it, does that mean the consumer website should be subject to PAAB review as a patient APS?

    Thanks in advance for any clarity you can provide to help us help our clients understand how this guidance can be applied.

    Jennifer CarrollJ 1 Reply Last reply
    0
    • M Maryssa

      Per this newsletter (https://www.paab.ca/resources/targeting-consumer-materials-to-patients-through-healthcare-professionals), we understand that APS which have been approved for consumers by ASC may be subject to PAAB review if an HCP is involved in the decision to disseminate consumer information.

      We are hoping you can provide clarity on the limitations of this guidance and provide more details about which situations would be considered HCP involvement in disseminating consumer information.

      For example,

      1. If an ASC approved poster is hung up in a waiting room, is it now subject to PAAB-review through HCP or patient guidance because HCP's or patients may walk through the waiting room and see it?
      2. When a sales rep or other 3rd party leaves ASC approved materials in the waiting room, the physicians are typically aware of what content is being left in their waiting room and likely reading/reviewing it themselves. Are these pieces then subject to PAAB review for HCPs and not just consumers?
      3. If an APS is created to make an HCP aware of an ongoing consumer campaign and links out to the consumer website/material, but there is no request for them to share it with their patients, is the attached consumer tool subject to PAAB review as an HCP APS?
      4. If a physician hears a radio ad approved for consumers which mentions a website that is approved for consumers and decides to tell their patient about it, does that mean the consumer website should be subject to PAAB review as a patient APS?

      Thanks in advance for any clarity you can provide to help us help our clients understand how this guidance can be applied.

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hey @maryssa

      The relevant standards of the PAAB Code of Advertising Acceptance are applicable to APS directed at HCPs and APS directed at patients when there is HCP involvement. This remains true regardless of how else the APS may be used.

      In questions 1 and 2, leaving physical copies of APS in an HCP's practice constitutes distribution involving the HCP. The HCP maintains full control over which materials are allowed to remain in their practice. It would be prudent, as a best practice, to seek permission from the HCP before leaving such materials in their practice.

      In question 3, the messaging is directed specifically to the HCP. The fact that the messaging is about a consumer campaign does not exempt it from the applicable provisions of the PAAB Code for the message itself. If inclusion of the DTC website/material is for awareness only, it would not subject to PAAB review. However, should there be copy that suggests the material is intended for consumption by the HCP or disseminated to patients through the HCP, e.g. “Tools and resources…”, “Learn more at…”, then the website/material would be subject to PAAB review.

      Conversely, in question 4, the HCP is receiving the message as a member of the general public. Therefore, the PAAB Code does not apply. While the question may be framed humorously (I would hope), the general public includes individuals from all walks of life, even HCPs.

      Don't forget the Advisory - APS in Patient Interaction Areas as well.

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