Good question. In the same context as described in your previous question Rep triggered e-mails | Forum, a similar principle would apply to the naming conventions for clinical reprints attached to an RTE. Assuming the naming convention is claim-neutral (e.g. Smith, NEJM 2015) as per your example, fair balance would not be required. However, study acronyms are considered different. We review naming conventions in a similar way to subject lines or small space ads, so the RTE would require the appropriate fair balance (level of balance TBD depending on the specific language used in the naming convention) if they contain more than one of the following elements: product name, study endpoint or study name (i.e. study acronym). A combination of more than one of these elements has the potential to allude to a message/claim that requires fair balance.
-
312 - What are the steps to review and approved a website? Does the content of the site may be revised first as independent, indicating the titles subtitles, main menu, submenu, boutons, etc..? And then once approved texts, we submit the entire site with images of each page and approuved content. Or should we submit from the first revision the entire website as one ASP needed to be revised with images of the design which will present content that not approuved?
• Jennifer Carroll -
760 - What type of gating is required for a HCP website for a schedule 1 product (narcotic)? is de-indexing considered a form of gating? What type of information can be available pre-gate? can information around a patient support program be made available pre-gate for a schedule 1 (narcotic) product?
• Jennifer Carroll -
755: What type of gating is required for a HCP website for a schedule 1 product (narcotic)? is de-indexing considered a form of gating? What type of information can be available pre-gate? can information around a patient support program be made available pre-gate for a schedule 1 (narcotic) product?
• Jennifer Carroll -
742 - 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
• Jennifer Carroll -
50 - To restrict access to patient web site we usually use the DIN as an accepted method of verifying that the visitor is indeed a patient before granting access. But we are currently working on a web site for a drug where the patients never receive the product packaging. Some of them might be able to find the DIN on their drug store receipt but some receipts don't have that information. Are there other accepted methods of restricting access to a patient web site in case the DIN is not available?
• Jennifer Carroll -
712 - We have an online newsletter where we post healthcare-related information, as well as society news pertaining to our association. Our member and supporter base primarily consists of hospital pharmacists as well as a small number of architects, students, and pharmaceutical companies. We can set-up advertising on the site to require a login to limit access by the general public. My concern is with the students who are not yet healthcare professionals, the pharmaceutical organizations, and the small number of architect members. Would their exposure to pharmaceutical advertising go against PAAB standards, even if we include a disclaimer that the advertisements are meant for healthcare professionals only? When we used to have...
• Jennifer Carroll -
633 - I would like to send an email to verified healthcare professional, that email would not exceed Price, Name, Quantity, would include no claim and have a deep link to access the product monograph of this schedule A product. Do I need to submit such email to PAAB approval if ... 1- the product monograph is only accessible via this email ? 2- the product monograph is hosted on our corporate website (ungated website) ? 3- the product monograph is hosted on a gated hcp website ?
• Jennifer Carroll -
631 - We have a Enrollment Form for a PSP program that has been previously approved by PAAB. We have a PDF writeable format which we would like our PSP Field Case Managers ( Nurses) to send to our HCPs via email. Could you please provide any limitations or requirements to this, if any?
• Jennifer Carroll -
630 - We have a question regarding controlled distribution/gating of a website containing information intended for HCPs. We understand that options for creating an acceptable barrier include "URL of a website which is not indexed" (as presented during Jennifer Carroll's talk "From Email to Virtual Reality" during PAAB's 2017 National Workshop). However, we are unable to find any further information from PAAB or from Health Canada regarding what "not indexed" means in this context. Can you please elaborate, or point us to guidance documentation outlining what "not indexed" means for a site's URL, in order to create an acceptable barrier for the site?
• Jennifer Carroll -
604 - What are the requirements/limitations for emailing of Enrollment Forms to HCPs for the purpose of enrolling their patients in a PSP? We have developed an Enrollment Form (approved by PAAB) of which we have a version that is a writeable PDF (text fields can be filled out on the computer) to then be printed and signed, and would like to email this Enrollment Form to HCPs directly via the reps. Could you please inform me if this contravenes any PAAB regulation? I was unable to find anything in the PAAB code that would suggest this. Thank you!
• Jennifer Carroll -
587 - Can you please tell us more regarding gated medical information websites. What would be considered an effective and PAAB compliant gate? Verify each HCP by License #? HCP number pattern (do we need to use specific pattern depending on the type of HCP eg: Nurses, Pharmacists, Physicians. and the province)? Thanks
• Jennifer Carroll -
555 - Can we provide a link from our disease state page on our local website to our global disease state page containing information about the same topic? If a disclaimer pops up prior to the user leaving the Canadian website and viewing content on that disease state global page, are we able to do this?
• Jennifer Carroll