Separation of patient consent information on a PSP form
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laraholmes 28 Feb 2025, 11:11
Is patient consent information required to be clearly, visually separated from HCP information on a PSP form? I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient? I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?
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laraholmes 28 Feb 2025, 11:11
Is patient consent information required to be clearly, visually separated from HCP information on a PSP form? I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient? I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?
Hello @laraholmes
Let’s break the q’s down for simplicity:
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Is patient consent information required to be clearly, visually separated from HCP information on a PSP form?
a. Yes -
I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient?
a. We cannot comment on examples that we have not seen. From a general questions perspective, we can state that patients should not be exposed to healthcare professional advertising. We have seen scenarios where the use and training of the tool have been restricted to only showing the patient the section they are intended to sign as “consent”. In some cases, consent is strictly verbal and therefore the patient would not be privy to the other copy on the piece. We’re happy to have a conversation discussing specific pieces if you’d like to reach out to info@paab.ca. -
I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?
a. This appears to be a specific comment about a specific file. The clarifying question should be asked in the context of that file and review since various factors may be taken into consideration. As a general response to a general question, note that part I of the TMA is intended for healthcare professionals. Part III contains the indication in a format that has been deemed to be appropriate for patients. The use of language often varies between the two sections of the TMA based on the intended audience.
Hope that helps. As a courtesy, please remember that the forum is a courtesy service. While we do our best to respond within one business day, we have competing priorities. If you require a more timely response, please submit a request for a general ticket call.
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Hello @laraholmes
Let’s break the q’s down for simplicity:
-
Is patient consent information required to be clearly, visually separated from HCP information on a PSP form?
a. Yes -
I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient?
a. We cannot comment on examples that we have not seen. From a general questions perspective, we can state that patients should not be exposed to healthcare professional advertising. We have seen scenarios where the use and training of the tool have been restricted to only showing the patient the section they are intended to sign as “consent”. In some cases, consent is strictly verbal and therefore the patient would not be privy to the other copy on the piece. We’re happy to have a conversation discussing specific pieces if you’d like to reach out to info@paab.ca. -
I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?
a. This appears to be a specific comment about a specific file. The clarifying question should be asked in the context of that file and review since various factors may be taken into consideration. As a general response to a general question, note that part I of the TMA is intended for healthcare professionals. Part III contains the indication in a format that has been deemed to be appropriate for patients. The use of language often varies between the two sections of the TMA based on the intended audience.
Hope that helps. As a courtesy, please remember that the forum is a courtesy service. While we do our best to respond within one business day, we have competing priorities. If you require a more timely response, please submit a request for a general ticket call.
@jennifer-carroll Thank you very much for the very comprehensive and helpful response!
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