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Assuming you can ensure that your web platform is only being accessed by Canadian physicians, what are the rules about the content that is on the website? Does the fact that the physician agrees to be "subscribe" open a channel to the information being PAAB exempt on the premise that the physician "Requested" this information? We are thinking of CME materials, disease-relation information (with and without drug mentions), videos of speaker conferences, etc.) We are also thinking of information about the sponsor's ongoing clinical trials.
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Voir réponse [+]
I am not sure I fully understand the question. Please call me if I am off topic. Information provided to an individual in response to a request for information that has not been solicited in any way is not considered to be advertising for the sale of a drug and is therefore exempt from PAAB review. This specific exemption applies only when the information provided is limited specifically to that content which was requested by the HCP. Note that the mechanism for requesting this content and the mechanism for receiving it must be kept completely separate from drug advertising. For any information other than that which was explicitly requested, one must assess whether the drug advertising regulations apply by using the Health Canada policy document "The Distinction Between Advertising and Other Activities". If the advertising regulations apply, the content should be submitted for PAAB review. Also see PAAB code section 6.6.
276
If you recorded a speaker event (sponsored dinner conference) and want to post it on a website, can you? What rules is the content subject to and what is acceptable in terms of efforts or means by which you would make HCPs aware of the availability of this recorded presentation?
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Voir réponse [+]
If the content is advertising once posted on the website, it requires PAAB review. Please refer to the Health Canada guidance document "The Distinction Between Advertising and Other Activities" to determine whether it is advertising. Note that we'd require a copydeck for a formal review to approval. If you are uncertain whether it falls in the advertising realm, feel free to ask us by using our written opinion service (i.e. provide the content and clarify the context in which it will be posted). Refer to the fee schedule on PAAB website.
Here are some examples:
- If either the website or the recorded event emphasizes or favours the sponsor's product, the recording will be reviewed as a product branded APS (e.g. disease information posted on a product website is reviewed in the context of the brand).
- If neither the website nor the recorded event emphasize/favour the sponsor's but they discuss issues relating to drug therapy, the recording will be reviewed as an editorial APS.
- Disease information with no mention of drug therapy or even issues relating to drug therapy placed on a corporate website in a manner which does not link to a product in any way would be exempt from PAAB review.
275
We have prepared a Patient Tear Off Sheet for Product X which provides information on the indication, dosing/administration, side effects, talk to your doctor immediately if you have x,y and z and interactions with drugs. My question is with respect to "Product X may interact with drugs to treat: Chest pain, angina (e.g. amyl nitrate "poppers") HIV infections (e.g. indinavir or itraconazole) Fungal infections (e.g. ketoconazole or itraconazole) Infections (e.g. gatifloxacin) Irregular heartbeat (e.g. amiodarone, sotalol, quinidine, procainamide) Prostate problems or high blood pressue (e.g. alpha-blockers). I would like to propose a change to Infections (in the list above) to replace "e.g. gatifloxacin" with "e.g. erythromycin and chlarithromycin" because these latter 2 drugs are contraindicated with use with product X (and are missing from the list)...and because gatifloxacin 400 mg is no longer available in Canada. There is a 0.3%
gatifloxicin eye-drop solution available in Canada but it has no clinical bearing on the drug-drug interactions that were investigated with Product X. Note that the 0.3% gatifloxacin eye drop solution is not mentioned in the current approved Label for Product X. Only the 400 mg gatifloxacin is mentioned in Part 1/2 of the Product Monograph under Warnings/Precations, Drug-Interactions and Detailed Pharmacology. Health Canada did not inform us of the removal of 400 mg gatifloxacin product...and we have only just stumbled upon gatifloxacin in Section 3 of the PM (which states: Drugs that may interact with Product X include - gatifloxacin (used to treat infections). We propose to revise this statement in the product label with Health Canada. If this tear off sheet is intended to provide relevant patient information, would it be OK to replace "gatifloxacin" with "erythromycin and chlarithromycin". Or does "gatifloxacin" need to remain in this list...and "erythromycin and clarithromycin"
be added too. Looking forward to your response. Thank you.
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Voir réponse [+]
There is generally no need to disclose risks relating to concomitant use with particular products which have been completely withdrawn from the Canadian market. BUT the fact that the specific agent, gatifloxacin, is presented as an example denotes that the risk extends to other drugs used to treat infections. It is therefore clear that the risk relating to concomitant use with drugs used to treat infections must still be conveyed in some manner (albeit not necessarily by including "gatifloxacin" as the example). Assessment of the complete monograph typically reveals signals indicating which agents could be used as examples in place of the withdrawn product. It is possible that your proposed plan is workable, but this could only be confirmed after assessment of the complete product monograph in the context of the therapeutic area (and the corresponding current medical practice).
274
I run a medical information line for patients and Healthcare providers for a pharma company. Do I need to either read or have on the front end recording the safety statement from the PI prior to speaking with the customer?
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Voir réponse [+]
Medical information lines for which individuals call to ask unsolicited questions do not fall under the scope of the PAAB.
273
Hi, I will be following PAAB regulations to ensure that an unbranded disease information piece qualifies as being 'PAAB exempt'. I will also be submitting it to PAAB (simply to get a letter saying that it is PAAB exempt). Is it necessary that the review papers we are referencing DO NOT make mention of treatement options anywhere as well (even though our APS will not make mention of treatment options/categories)? Or is it ok if the review paper discusses treatments so long as we dont make mention of them in the APS?
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Voir réponse [+]
The primary purpose of the review paper should not be to discuss treatment options. If it is then the APS you create could be deemed "editorial" in nature and subject to PAAB review. What is your intent? You should try to find a reference that discusses the disease only, not focussed on treatments. It may be exempt if all the treatments are balanced, see the Health Canada document The DIstinction Between Advertising and Other Activities 'Consumer Brochure'.
272
We are developing a patient-directed instructional guide on how to use an injectable medication. The format is a flip chart, with visual instructions on one side (for the patient), and more detailed instructions on the reverse side (for the nurse's eyes only). Given the new PAAB code, and the fact that this is a HCP-delivered patient APS based on Section III of the product monograph, would the lowest level of fair balance suffice?
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Voir réponse [+]
In this case, probably no. The HCP portion of the flip chart would be reviewed as an HCP piece, and therefore it would be required to meet the guidelines and restrictions for HCP material. The level of fair balance would be based on the content that is presented within the HCP portion of the piece. The PAAB guidance document "Guidance on base fair balance level selection and placement" provides a list of considerations when determining the appropriate level of fair balance. This document outlines the types of messages that are associated with each of the levels of fair balance. The HCP presentation (and weblink) should not be visible to the patient.
271
With the PAAB Approval comes an expiry date....is it a requirement to have this expiry date printed on the final promotional piece along with the PAAB logo? Or is it optional?
270
In the US, promotional materials may use the term "new" for a period of six months from the first date of marketing by the company. Does the PAAB code or guidances have a similar requirement? (been searching but not finding).
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Voir réponse [+]
Yes. PAAB code section 11 of the PAAB code states: Use of the word 'new' or statements implying "new" in advertising should be restricted to 1 year after initial marketing.
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If our company has materials we plan to have in market for June 2013, can we use the new format fair/balance or must we continue to use the current format until July 2013?
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Voir réponse [+]
The new fair balance format can be used. However, print materials may not replace the PAAB format PI with a URL to the product monograph until July 1st.
268
Dear PAAB, We are developing a gated HCP website that requires the HCP to enter his/her license number to gain access to the site. Who provides the database of physician license numbers which our site will "ping" (cross-check against)? If it is an outside source/organization, is there any fee for this?
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Voir réponse [+]
The key is to validate that these are indeed HCPs. This may be done by an outside organization (in which case there may be a fee associated with this) or the validation could be done within your organization if you can maintain a current database of physicians.
