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!
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Voir réponse [+]
I believe you mean “Are there any other considerations for putting the adolescent info in the same booklet?
” You’ve emphasized that there is a single part III in the TMA. The fact that there is a single Part III discussing the both conditions and the adolescent population in the context of one of those conditions is important to your argument that inclusion in the piece would be acceptable. The main additional point which jumps out to me is the need to be consistent with the context in which the adolescent content is presented in Part III. Keep in mind that post-approval changes (such as the one you are proposing) require that the piece be submitted to the PAAB for review such that we can review the issue in its complete context.
For additional general guidance relating to patient information, please refer to the following guidance document:
http://www.paab.ca/resources/pdfs/code-revision/External_Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf
456
We have several questions regarding risk of linkage between disease/indication and another company's product (brand name or non-proprietary name) when purchasing keywords for Search Engine Marketing for a disease-support website and App (both are unbranded) for patients:
a) Can we use a competitor's prescription product brand name as the keyword, when the brand name is not marketed in Canada?
i. Same question - this time the non-proprietary name is the keyword? This question is to address situations in which the same medicinal ingredient is marketed in Canada but under a different brand name.
b) Can we use a competitor's non-prescription product brand name as the keyword, when the brand name is not marketed in Canada? We understand linkage between product and indication in not an issue in this situation; we would like to know if it is still acceptable (morally/ethically).
i. Same question - this time the non-proprietary name of the non-prescription product is the keyword?
c) Can we use a competitor's prescription product brand name or non-proprietary name as the keyword, when the product is marketed in Canada?
i. Can we use a competitor's non-prescription product brand name or non-proprietary name as the keyword, when the product is marketed in Canada?
d) Are we required to submit the SEM campaign (keywords, Ad text, etc) for this disease-support website and App to PAAB or ASC for review? ASC has already reviewed and approved both the website and App.
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Voir réponse [+]
A-C) Keywords and other Meta data tags that refer to competitor products are prohibited because it is deemed unethical per PAAB s6.5.10 & s6.5.11. This applies to products which are approved in Canada and those which are not. This applies regardless of whether the product is Rx or non-Rx. Finally, note that the non-proprietary name is considered a representation for the competitor (i.e. s6.5.10 & 6.5.11 apply to the competitor’s non-proprietary name as well).
D) No you are not required to submit this to PAAB. The PAAB requires review of SEM campaigns tied to online tactics which have been reviewed by PAAB. If these materials have been reviewed by ASC, you may want to inform them of the existence of SEM such they can determine whether they need to review it.
455
What is the recommended mechanism to validate Healthcare Professional status (i.e. gating mechanism) for a website with potentially some consumer advertising content? Some websites ask for Canadian professional license number, but is it a requirement to verify this information (e.g. license number, name, etc.) once it's obtained? If so, with what database/organization?
454
For an HCP-directed piece relating to a patient program, where brand name and indication are given in addition to the monitoring schedule from warnings & precautions, what level of balance would be required?
453
We are creating a branded device for pharmacist’s physicians to use with patients. The easel is highly visual but does show some disease statistics and mentions classes of drugs/and social protocols, with specific brands of medication. Because this piece is never given to the patient, it comes under the same content rules as tools the patient would take home. Please let me know if you want the device.
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Voir réponse [+]
I am not certain, but I believe you are asking whether the piece is exempt from preclearance. If it is created by the drug manufacturer or an agent acting on their behalf, it would appear to require PAAB review from the limited information provided. This type of assessment is best done through our written opinion service (refer to the fee schedule on our website) as we’d be able to base the ruling on the actual content and more details about how it came to be.
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.
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Voir réponse [+]
Specific answers to your questions would require me to know the actual content. I can confirm that it is indeed possible to set up the counselling tool such that, in normal/intended use, some surfaces will be visible only to the HCP while others will be visible to the individual who is being educated. The requirements relating to each surface will then be driven by the intended audience (in normal use) for the surface. Please call the PAAB office if you require additional guidance on this matter.
451
Dear PAAB. I understand pharmacokinetics is considered "non-clinical" information. Is "indication" and "dosing" considered non-clinical information? It would appear to me the condition in which a drug is studied and hence approved and also the dose at which safety and efficacy is determined is extremely clinically relevant and would be considered "clinical information". Thank you for your consideration.
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Voir réponse [+]
A product’s Health Canada approved indication and dosing is clinically relevant. Please note the following common advertising submission pitfalls relating to this topic (not an exhaustive list):
- Indication and/or dosing comparisons across TMAs are not deemed to be clinically significant. Refer to PAAB code s5.10.2. Although an individual product’s indication and dosing info is clinically significant, the significance of the incremental difference in indication/dosing between multiple products is generally unknown.
- Claims relating to efficacy and/or safety (e.g. duration of effect) must be based on evidence rather than being inferred from characteristics such as dosing frequency. For example, a TMA recommendation for “once daily dosing” does not necessarily equate to “24 hour efficacy”.
450
Is it possible to attach patients' testimonials to a tool destined to inform patients on how to optimally use a medication they are already using?
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Voir réponse [+]
Not sure what you mean by “attach”, also not sure what you mean by a testimonial in the context of dosing instructions. Any content promoting beneficial aspects of dosing/administration would not be accepted. You’ll find discussion on this and other considerations relating to patient information in the patient information guidance document on the PAAB website. Give particularly close attention to sections which relate to the need to be non-promotional and to be consistent with part III of the PM. For your convenience the link follows: http://www.paab.ca/resources/pdfs/code-revision/External_Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf
449
Hello, I am an international Arab candidate. I have been working for GlaxoSmithKline since 2008 in the sales and marketing field. I have plenty of contribution in communication and marketing, as I am planning to study for an advertising diploma in Canada. What will be the percentage for me to find a job in the medical advertising field after graduation? Thanks for your support.
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Voir réponse [+]
PAAB is a preclearance body for drug advertising. We do not forecast the job market in this industry. You can learn more about PAAB by reading Q&A #160 and #264 (i.e. “What is PAAB?” and “What are the functions of PAAB?” respectively) and by visiting our website at www.paab.ca.
448
If a copy deck was first developed in French, can we submit it for review in French, or would it need to be translated to English and the initial review performed on the English?
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Voir réponse [+]
You can make a first submission in either English or French. S1 and S8.
