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462 - Hi Patrick, We are planning a card that is for patients to carry with them, showing that they have been prescribed product X, which dose, physician contact info, etc (basically a wallet card). We are also preparing a stand for these cards that would sit in the physician's office. Each time they prescribe a patient product X, they grab a card from the stand and fill it out with the patient. The objective of the card is to instruct patients they need to show this card to other HCPs, to ensure these HCPs do not co-administer certain products with product X. Our question: can the card be submitted as patient-directed and the holder as physician-directed, as the holder will never leave the physician's office? The holder really is meant as instruction for the physician. Thank you.
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Yes. In this case, the patient card would be submitted as a patient information APS. With regards to the holder, it would be submitted as an HCP APS if, and only if, it will not be visible to people who aren’t HCPs. However, content which is openly visible in the examination room would need to follow the provisions in the following link: http://www.paab.ca/resources/pdfs/Guidance for APS E 11 18 2009.pdf This link is not relevant if the material is intended to be kept out of sight from consumers and patients in the physician’s office.
