442 - Hello there, I am a pharmacist from ON. I noticed some advertising from Mylan that I think is risky/dangerous and reckless in terms of the message it may be sending patients, the general public as well as pharmacists. I was wondering if I can make an anonymous complaint through this portal and in general what is the process for complaints? Details below. Mylan created a Fentanyl patch passport which is being distributed to patients who are dispensed Fentanyl by pharmacists. I have also seen it in airports on counters. The overall concept is good where they want patients to return their...
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continued ... used patches to pharmacies for proper disposal and once returned they will be provided their new prescription. Patients would attach their used patches to the passport to return to pharmacy for disposal and get dispensed a new fill of product provided they have a valid prescription of course. However, Mylan added to the Ad 1 statement that I believe is as mentioned reckless and dangerous: "To further reduce potential harm and misuse, some Fentanyl patches have less medication remaining in the patch after use. Talk to your pharmacist about your Fentanyl patch options." To imply that "further potential harm and misuse can be reduced" when there is enough residual Fentanyl left over to kill children and pets is risky. I don't know what studies have been done that demonstrates that there is less potential harm/misuse. First of all, the drug is released at the same hourly rate regardless of the amount of residual drug left in used patches and it may run out faster but can still be extremely harmful and could kill children, pets and those not use to Fentanyl depending on the concentration in the patch. We don't know if it gets into the hands of addicted individuals who wants to obtain the drug from the used patch through misuse like boiling the patch or chewing it, that their patch will fair better than those with more drug. It doesn't necessarily follow that the amount of residual drug released is more or less than any other patch without do the studies because the material may release more or less than other patches because they have different ingredients. I have not found any studies that prove their patch because it has less residual drug reduces potential harm and misuse. They don't have a PAAB logo on the Ad so I am not sure if PAAB is even allowed to investigate this but I would really appreciate your thoughts on this issue, because I think it is risky to make such unfounded claims. Do you need a formal complaint or can you investigate based on this request? What is the process for complaints? Thank you - I look forward to hearing back from you. Many thanks for your guidance on this issue.
Response: Health Canada adjudicates consumer advertising complaints about prescription products and complaints about any type of advertising (regardless of audience) deemed to put the safety of Canadians at risk. Please direct your complaint to the MHPD (Marketed Health Products Directorate). The contact information is provided below. Marketed Health Products Directorate Health Products and Food Branch Health Canada Address Locator 0701L Ottawa, Ontario K1A 0K9 E-mail: mhpd_dpsc@hc-sc.gc.ca Telephone: 613-954-6522
