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568 - Questions in regards to provincial formularies: 1. Would providing the name of the "product now on province formulary" statement with the inclusion of the din number for ordering be considered exempt from PAAB? 2. If the link to the complete provincial formulary is included would this be considered the same as including the coverage criteria for the product? 3. Is including the complete provincial formulary link and directing to the section or page for product "X" be considered as providing the coverage criteria and thus requiring PAAB review?
• Jennifer Carroll -
565 - Could you please clarify the formulary message for the province of Québec. If a company mentions the following message: “Drug X: Now on RAMQ formulary (médicament d’exception code)” and not linked in any way to additional product messages or disease/corporate messages. We would not allude to the indicated use and will add the RAMQ TM. Is the above mentioned text still PAAB exempt or not. Are we in the obligation in Québec to provide code and coverage criteria every time we mention RAMQ reimbursement (then subject to PAAB). I have read the information on the PAAB website, but still having different interpretation/confusion on this. • Memo dated April 15, 2016 - Advisory regarding use of Régie de l’assurance maladie du Québec (RAMQ) in APS • PAAB ADVISORY guidance on Provincial Formulary Coverage Statements • Q 519 in the Ask PAAB section
• Jennifer Carroll -
535 - The manufacturers of a drug would like to provide patients (via HCPs) with a wallet card that alerts the patient to show the card to healthcare professionals to remind them to check for potential drug interactions. This focused bit of information is consistent with Part III. Does this require PAAB review?
• Jennifer Carroll -
524 - Hi PAAB. Do communications sent in the context of a patient assistance program need PAAB preclearance? here is the situation. we have a patient assistance program for which we would like the vendor to use a standardized and automated system to communicate information pertinent to patient's enrollment status, notifications regarding reimbursement investigations, reminders of missing information to proceed with the service etc... The issue is that all of our Patient assistance programs are named after the therapeutic area (XYZ-Onclogy; XYZ hep C, XYZ HIV...) and within the body of the letter we have to specify the name of the product for HCP to know which product the communication is related to. These communications begin after a physician has made the decision to prescribe the product and decided to enroll his patient into the program either for reimbursement investigation or compassionate...
• Jennifer Carroll -
500 - Can you advise on PAAB's role/interpretation of 'drug delivery system' advertising? Examples wold be prescription drug inhalers, injectors, etc. Would advertisements focused solely on the delivery system/technology be exempt from PAAB (perhaps as a medical device), or seen as an extension of drug advertising (and reviewed in the same manner)?
• Jennifer Carroll -
496 - Hi, would a product announcement with: the name of the product, "now available in Canada", and package shot (with no visible therapeutic claims) be considered paab exempt? if the product came in multiple pill sizes, can a shot of the pills with their sizes be allowable as the product shot?
• Jennifer Carroll -
492 - We will be running a webinar from our HCP website. The webinar will be delivered by an internal medical expert. The webinar content will be on-label and pre-cleared. HCPs will need to register for the webinar on the "events" section of our gated HCP website. This section would only contain a list of upcoming webinar events. The description for the webinar would include; title, date, time location and a basic bio of the speaker. If the webinar title does not include mention of any specific products and the remaining info is purely factual details about the event date, time & speaker credentials, does this content need to be pre-cleared by PAAB?
• Jennifer Carroll -
491 - Healthcare professionals have asked for demo syringe kits to show patients how to inject. Would this be something we would submit to PAAB for review? It would have the product name on the box, and include: demo syringes, a squeeze ball, and a dose card in the kit that was previously PAAB approved? Would it matter if a dose card was not included? To summarize, does a demo kit fit Code Section 6.6 (iv) .....use of a drug name only in a context not linked to therapeutic or promotional messages. Or is it considered a Service-Oriented Vehicle under Code section 6.4, even if it's a demo kit?
• Jennifer Carroll -
486 - Dear PAAB, Would a message that makes reference to the brand name and indication of a company's vaccines, that is intended to be posted on the company's intranet, for the purpose of informing the company's employees on what vaccines the company makes and which disease they intend to prevent, be considered promotional and require PAAB preclearance? if yes, would it make any difference if a disclaimer is added to prevent employees from sharing the information with outside people? Thank you!
• Jennifer Carroll -
467 - To whom it may concern, I am looking for some clarification regarding the definition of a “therapeutic message” per section 6.6 (iv) of the code regarding exemptions: “Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in any way.” Specifically, we would like to send a fax to pharmacists announcing the approval/availability of a new medication along with details required for their ordering systems (i.e. product code, D.I.N., etc.) Can we simply say the name + the type of medication + disease state? For example: Product X, an SSRI for treating depression, is now available in Canada? This doesn’t link to HOW X treats depression or what an SSRI does...
• Jennifer Carroll -
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.
• Jennifer Carroll