Patient Info
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751: If I am developing a patient brochure for a medication, I know I am restricted to Part 3 of the PM. However, structurally, am I able to flow content in a way that is more digestible and clear to the patient - or am I subject to the structure Part 3 lays out? I find the content jumps all around and is very challenging to follow, and I am looking to restructure so that the flow is more friendly from a patient information consumption perspective. Everything will be referenced to Part 3 as required. Is this ok?
• Jennifer Carroll -
738 - Would it be acceptable to use an image in a patient support material (PSP) if the same image is being used in healthcare professional branded material? The product only has one indication and PSP material would specifically be distributed to patients prescribed the product for the approved indication.
• Jennifer Carroll -
719 - With regards to question #645, the question asked about repurposing a piece approved for DTC use with "potential patients". Is a potential patient not viewed as a consumer? I thought the definition of patient was restricted to those who had already been prescribed a drug. I had previously been advised by a PAAB reviewer that pieces for "potential patients" would be reviewed as DTC. Could you please clarify the differences in these audiences? Thank you.
• Jennifer Carroll -
687 - Regarding teaching tools (slides, desktop tool) used by HCPs to educate patients: Is it possible to include efficacy information in a piece to be used by HCPs with patients, recognizing it would be a clinic-based tool and not something taken away by the patient? Is there a regulation or code that prohibits HCPs from educating patients about efficacy results? Is there any resource that explains why this information is not included in part 3 of the Product Monograph?
• Jennifer Carroll -
497 - I would appreciation clarification of Section 6.6 of the code related to patient information direct from and consistent with the Product Monograph in combination with gating requirements. If a video is created that walks a patient through how to administer the injection as per part III, does not mention what the product is used for, and that video is posted (with no gating) on the company's website right below the product monograph for that product (as you know companies typically have a page on their company site with all their product monographs posted)......is 1) that video exempt from PAAB review and 2) Can the video be left ungated in this situation (i.e. Does proximity to the monograph pose an issue)? Thank you.
• Jennifer Carroll -
475 - Can you describe the patient condition, consistent with the indication in your promotional material? As an example, the patient has suffered in silence many years before seeing the doctor, tried other treatments and is now seeking help. This example would be supported by authoritative sources. If not an option in promotional APS would it be possible in unbranded APS. Thank you.
• Jennifer Carroll -
459 - I'm working in a branded patient-information brochure that includes disease information and dosing. All the content is consistent with part III of the TMA. Does this piece require fair balancing copy? If so, what information is required in the fair balance for patient pieces?
• Jennifer Carroll -
457 - We have been asked to update a patient information booklet for people who have been prescribed the drug. The drug has two indications. Patients may have both conditions, but it's most likely that they have been prescribed the drug for only one of the conditions. Both indications are for adults only and both indications are described in the same Part 3 and use the same patient information booklet. Our drug is coming out with an adolescent indication for only one of the indications. We want to update the patient information booklet to include the adolescent indication. I think it should be fine to add the adolescent indication to the existing approved booklet as long as the adolescent info is in the same Part 3 from which the patient information booklet was developed. Are there any other considerations for putting the adolescent info in a separate booklet? There is not much new content to Part 3 except the age change. Thanks!
• Jennifer Carroll -
452 - We are creating an unbranded teaching easel for physicians to use with patients. The easel is highly visual but does show some disease statistics and mentions classes of drugs/protocols, but not specific brands. Because this piece is never given to the patient, does it come under the same content rules as tools the patient would take home? We want to minimize clutter and just let the physician speak to the images and answer patient questions. For example: - For disease stats, does all of the information on how the stats were collected have to be on the piece? If so, can it just be put on the back of the page that the physician sees, but the patient does not? - In the section where drug classes/protocols are named, does safety information have to be included? If so, again, can this be placed on the physician-view side only? Thank you.
• Jennifer Carroll