335 - I'm creating a document for a drug that pharmacists will hand to the patient along with their filled prescription for this drug at the drug store. This document will include, "what you should know about the drug", "different medical conditions the drug treats" as well as "how the drug works." Will I need to add "Important Safety Information" to this document and if so what aspects will I need to include in this?
Jennifer Carroll last edited by
For all sections you've listed, the content must emanate from part III of the product monograph. Where there are multiple distinct part III sections (e.g. for different conditions or formats) an entirely different document for distribution must be created. The tonality in the document must be non-promotional. Make sure you read PAAB code section 6 at the onset of your project. Yes, if you discuss the proposed content from part III of the PM, you should also provide safety information. This safety information should be derived from part III of the PM, not be the healthcare professional advertising safety information. As the product has already been selected, you can focus on boxed & bolded content from part III of the PM in addition to content describing what can go wrong on the medication and what to do about it (e.g. when it is sufficient to set-up a doctor's appointment versus when you need to go to the ER etc.)