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    • K

      FB on PSP Enrolment Forms
      • kshulist

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      Jennifer Carroll

      Hello @kshulist

      Enrolling a patient in a support program means that the decision to prescribe the product has already been made (i.e. patient is on the drug). Additionally, given the type of information on the form (e.g., including dosing or monitoring info), the form is not considered promotional but rather administrative in nature. Given these two reasons, indication/FB is typically not required. However, should promotional messaging be added (in the context of an HCP completed PSP enrolment form), indication and fair balance would indeed be required. For a patient completed enrolment form, no promotional messages would be acceptable and therefore the form would be administrative.

    • M

      Clinical Trial Recruitment Materials
      • munitalp

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      Jennifer Carroll

      Good Morning @munitalp

      As the recruitment piece is not target to HCPs, there should be no reference to the manufacturers product, generic name or brand name. Furthermore, the copy should not state the company name. It should be limited to something similar to “a Canadian manufacturer” and “investigating a product”. The trial name, study acronym or logo can be easily linked to the company and products and therefore would also not be acceptable for a clinical trial recruitment piece under the distinction document.

      Inclusion criteria which restrict to patients which have had prior treatment with specific products can be referred in a non-promotional way.

    • G

      Patient support program leave behind
      • GMC

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      Jennifer Carroll

      Good Morning @tmcd

      The PSP is a service offered by the sponsor and for the sponsors brand, it is therefore subject to the PAAB code and would not be deemed exempt.

    • 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

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      Jennifer Carroll

      Hey @NatBourre
      We have not received a response at this time. We will reach out to Health Canada to see what the status of this question is. In the interim, we will continue to apply our understanding that this cannot been done as this would contravene consumer regulations.

    • G

      If making a branded website for patients such as 'Product.ca' that has information about what the product treats - is it necessary to gate that website because consumers can see it?
      • gbrl88

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      Jennifer Carroll

      Hey @Infoseeker, Section 3 of the Food and Drug Act, prohibits advertising to the general public of any drug (whether Rx or non-Rx) as a treatment for a disease listed in Schedule A. Promotion of drugs for prevention of Schedule A does not contravene this section of the Act. The Food and Drug Regulation C.01.004 also states that where a person advertises to the general public a prescription drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantify of the drug. If the brand falls into these categories, then yes, a gate would be required.

    • Jennifer Carroll

      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

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    • Jennifer Carroll

      746 - Can HCP branded materials and Patient branded materials utilize the same creative? If not, how different must the 2 be? What elements (colours, key features) can be shared between the two campaigns?
      • Jennifer Carroll

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    • 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

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    • 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

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    • Jennifer Carroll

      701 - Can HCP advertising and Patient advertising (not consumer) feature the same campaign visual, design and statement, with the understanding that the information within the campaign is in context for each audience. (Patient information driven from Part III of the PM)?
      • Jennifer Carroll

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    • 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

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    • Jennifer Carroll

      569 - Can you use before and after photos that show a drug's efficacy in a patient brochure?
      • Jennifer Carroll

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    • 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

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    • Jennifer Carroll

      474 - Dear PAAB. Can sales reps distribute disease information directly to patients?
      • Jennifer Carroll

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    • Jennifer Carroll

      471 - Can branded patient brochures have the same visuals as branded physician brochures?
      • Jennifer Carroll

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    • Jennifer Carroll

      469 - Dear PAAB. Is it acceptable in branded APS to illustrate the patient journey using data from authoritative sources? For example, the patient has suffered for years and has tried a number of treatments before seeking medical advice. Thank you.
      • Jennifer Carroll

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    • Jennifer Carroll

      461 - Dear PAAB. Can information from Section I and II be used in patient information? Secondly, how does PAAB define something as "promotional" versus factual information for patient information? Thank you.
      • Jennifer Carroll

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    • 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

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    • 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

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    • 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

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