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Questions mises à jour jusqu’au: 4 octobre 2021
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Hi PAAB, I was wondering if expert guidelines for treatment option algorithms (first line, second line) are allowed to be included in branded pieces directed at HCPs. The goal would not be to compare treatments but to see under which situations / for what patients a therapy would be preferred. (Patient profile?) Thanks for your help!
This question has two parts to it. First, lets address “expert guidelines”. For consideration as evidence to support place in therapy messages, we first look to Canadian consensus guidelines, to ensure consistency with current Canadian medical opinion. In the absence of Canadian guidelines we can consider US or North American guidelines. Please see AskPAAB #593 for more guidance on the use of non-Canadian consensus guidelines. The guidelines must be endorsed or recognized by an authoritative medical body and it should be nationally recognized. It is not sufficient for the guidelines to simply be published and peer-reviewed. With respect to off-label content, guidelines cannot be used to support treatment recommendations which extend beyond a product’s monograph.
The second part of this question relates to the content in the APS which the guidelines are intended to support (i.e. “see under which situations/ for what patients a therapy would be preferred”). We can consider guidelines to support claims related to “place in therapy”, however patient selection may entail broader topics (e.g. concomitant conditions, age, gender, etc.). Selection of one first-line product over another generally suggests comparative significance, for which consensus guidelines would not be an acceptable source.
My client is preparing an HCP website that will include brand promotion as well as offer samples. The site will be 'gated' which will involve a landing page that asks the viewer if they are a Canadian physician and require that they input their license number. Does the website require a validation process to ensure that the license numbers and the physician name are accurate? Could the 'validation' be limited to ensuring that the correct number of digits/letters are input (as opposed to confirming that those numbers match to a licensed physician). I look forward to your feedback. Thank you! LC
We would like to disseminate a branded dosing app to HCPs via the Apple/Google stores. Since app stores are open to the public, is this possible if (A) the app description/screenshots are limited to name-only and (B) the app reviews are disabled? The app itself would be password protected, so could only be opened by HCPs (consumers could download the app but not open it).
Yes. The responsibility of the manufacturer is to ensure the entire consumer visible content does not go beyond “name, price, quantity”. This includes both the app store content (including search terms) and the portion of the app visible prior to verification. While disabling the “reviews” helps to mitigate risk, it is not required. If the reviews remain active however, the sponsor would be responsible for monitoring and moderating them. So disabling “reviews” can help avoid non-compliance with the regulations.
Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?
Data on file would be acceptable for a claim about “# of patients treated with drug/device X worldwide”. Likewise, availability in X countries could be supported by data on file. Note that these claims should not be linked to or suggest safety or efficacy.
We have an 8 page print leave-behind detail aid that includes full dosing information. We are thinking of redoing this tool with a half page sized tear off flap that has key reminder information on the dosing. Does this flap have to contain all of the dosing information, or can it just contain e.g., the steps and an example calculation. Thanks.
This would require a separate review of the tear off pad to ensure it meets the standards of the code as a stand alone piece. Often information which is required in an APS is based on the specific claims made and whether or not those claims require qualification. That said, in theory it may be possible to create a half page piece with selective dosing information, however this will be highly dependent on the product’s monograph and claims being made. The selective dosing information would generally require a prominent disclaimer “For more information related to dosing and administration please refer to the product monograph” and any dosing related cautionary copy or safety related issues would likely be required in the APS.