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Are Naturopathic Doctors included in the definition of 'health care practitioners' when determining whether promotional material needs to be reviewed by PAAB?
Yes. As per the definition of HCP within the PAAB code, HCP’s are “licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing pharmacy and other related disciplines”. Naturopathic doctors would fall under the scope of the PAAB code for advertising to healthcare professionals.
Hi, We would like to highlight specific market data for our brand. We seem to fall into the guidelines that PAAB has put together but the specific data we would like to highlight is the new patient share (this consists of naive and switch patients). It would be a "leader" or "#1" claim. This data is from the private payer database (RxDynamics). Is this type of data allowable? I've done leader market claims as it relates to the total prescriptions dispensed but have never tried this type of data. Thank you.
The RxDynamics provides a measure of patient longitudinal drug utilization within a particular market. As it tracks utilization on a patient level, it captures whether a patient is new to a drug (within the analyzed window). For example, the dataset can be considered for claims like “#1 dispensed [drug category e.g. PDE5 Inhibitor] as initial therapy”. Make sure the data & claim relate to a drug category (not a disease) per the following guidance: www.paab.ca/Retention_and_market_share_claims.pdf
Also note that the requirements relating to “leader” type claims from the marketshare supplementary guidance apply as to all other PAAB code provisions (for example, switch messages are often incomplete and overly selective).
Also note that we’ve received submissions which aimed to support this sort of claim with NRx data from the GPM (Geographic Prescription Monitor) database. This is not acceptable.
Trademark acknowledgement: RxDynamics and GPM are trademarks of IMShealth|Brogan
Can you use before and after photos that show a drug's efficacy in a patient brochure?
Patient brochures should be non-promotional. The information should focus on educating patients about particular diseases/conditions and optimal use of the product by the patient for whom it has been prescribed. (PAAB code s.6.4.3) Before and after photos depict a magnitude of improvement. This is promotional in nature. It is therefore not generally acceptable to include them in patient brochures.
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?
Inclusion of the DIN on a piece does not in and of itself, disqualify it from being exempt from PAAB preclearance. Copy restricted to the product name, message of “now on formulary” and the DIN would be considered exempt from preclearance. Inclusion of the link to the full formulary listing would create a link between the product and the therapeutic use and would render the piece subject to PAAB review (no longer PAAB exempt).
Inclusion of the link does not negate the need for the coverage criteria to exist on some pieces. For example, if the coverage code is presented on the piece, the coverage criteria must be presented within that piece. Linking to the coverage criteria would not be sufficient. Please also be advised that the Regie de l’assurance maladie du Quebec has specific requirements for coverage claims. Please see the advisory document on the PAAB website.
We would like to know if we can make a claim about the % of patients who would recommend a specific treatment to other patients. The % is published in a retrospective study done on patients who were taking this specific therapy. It is a patient reported outcome that is not in the Product Monograph. Please advise if there is any way to put such a claim through.
References used to support treatment recommendations in drug advertising should be based on Canadian Consensus Guidelines, as treatment recommendations should be consistent with current Canadian medical opinion and practice. A retrospective study reporting patient opinion would not meet these rigors. (PAAB code section 3.2)
Hi PAAB, Section 1 of the Code provides that it applies to APS directed to HCPs (as well as patient information distributed via HCPs). Corporate websites target consumers rather than HCPs. However, it seems that PAAB considers corporate websites presenting information on the company's products as corporate APS (s. 7.4 of the Code) that must be submitted to PAAB. Does it mean that the Code also applies to material that does not target HCPs? If the corporate website presents general information on a disease or a class of products, does it need to be submitted to PAAB or would it be considered as DTCI? Thank you.
A non-gated corporate website is intended for the general public and would be subject to the consumer federal regulations, not the PAAB code (assuming that you are not somehow linking HCP advertising to particular pages of the corporate site other than the home page). The PAAB offers an opinion service for DTC pieces including institutional messages. The Health Canada document "The Distinction Between Advertising and Other Activities" is used as the basis of this assessment.
A consumer facing institutional message is a communication which provides information about a pharmaceutical manufacturer concerning topics such as its philosophy, activities, and product range. There must be no emphasis on one or more products. The central purpose must clearly be to inform broadly about the institution rather than its products.
If the corporate message is directed at Healthcare professionals, PAAB Code section 7.4 should be applied.
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
The formulary message above is exempt from PAAB review. There is no obligation to provide a formulary code or coverage criteria, as long as the statement is not linked to a therapeutic message or the products indicated use. However, if formulary code and/or coverage criteria are included, then this message is subject to PAAB review.
Based on advisory board recommendations for supportive tools, a company would like to create an unbranded "reference tool" which documents the metabolic pathways for drugs in a particular therapeutic area. This would be a service item distributed by the representatives. Information would be taken primarily from Product monographs and in a few cases, the literature. Is there any reason this would not be allowed? what would be the constraints?
It is feasible to create a piece which includes a side-by-side comparison of product properties such as metabolic pathways. These comparisons are reviewed based on section 5.10.2 of the PAAB code which specifies that the information must be from the individual Product Monographs, we would question the use of other sources for this type of comparison. We caution that the presentation should not imply comparative clinical significance, and must be complete, in that other data relevant to the presentation also contained in the Product Monographs must not be omitted. This is also critical when creating an unbranded (i.e. editorial) tool as the piece must contain objective and balanced information with no emphasis on information about the sponsor’s product. We caution that selectively choosing a product property/feature (e.g. metabolic pathways), which may create a comparison that is beneficial to the sponsor’s product will not be acceptable in an unbranded context. A good rule of thumb is, if you can identify the sponsors product based on the information presented, then it is not an editorial (s. 7.5).
If an advertiser is looking to target an ad to healthcare professionals, what is the accepted definition of "healthcare professional" and how strictly enforced by Health Care Canada is the requirement of that targeting?
For the purposes of the PAAB code, a healthcare professional is defined in s11 as licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and other related disciplines. I am not sure what you mean with regards to enforcement of targeting requirements by Health Canada. The sponsor must ensure that there is a mechanism to prevent secondary audiences from accessing the content which exceeds the restrictions for consumer materials (i.e. HCP content must be restricted to HCP audiences). This can be done through controlled distribution of the content or, in the context of materials accessed through the internet, a gating mechanism.
Can we develop a sales aid where the user can select specific topics (efficacy, safety, cost) and then present these to a physician? The concept is to create a custom presentation based on the needs of the physician. So if a physician only wants to hear about efficacy and cost, those would be the only sections to appear. This would be like adding tabs to a print sales aid but since digital, we can create the sections that will appear based on the customers need
To accomplish this, the e-detail tool would need to be separated into a core deck (which includes at least the indication & FB). The core deck would be intended to always be presented. The rest of the content would be separated by the client into expansion decks. The core deck and each expansion deck are submitted as separate files. The expansion decks would be reviewed with the understanding that none, some, or all of those decks may be presented in any sequence but always after the core deck. i.e. review judgements will be made with this flexibility in mind. For more info see Q&A # 307 & 198.
Patrick Massad
Deputy Commissioner
Pharmaceutical AdvertisingDinner Meeting
Cocktails: 5:30 p.m.
Dinner: 6:30 p.m.
Panel Discussion: 7:00 p.m.
