Patient Information

Dannie Newmandannien&@paab.caPAAB Reviewer

Thought Process Sequence

Is the piece only about the specific product which was prescribed?

2

Arbace HCT is a tablet containing both arbsartanand the diuretic hydrochlorothiazide. Can we create a patient counselling tool which is brandedfor both Arbace and Arbace HCT?

No

Thought Process Sequence

Is the piece only about the specific product which was prescribed?

Is the drug content consistent with Part III of the Product

Monograph?AND

Is the disease content on label and supported by standard setting organizations or authoritative sources?

4

Standard Setting Organizations

What they are:• Group generally considered to be a credible source for

patient information • Package complex medical information in a manner

which is easy for patients to understand

What they aren't: • A person• A commercial website • Controlled by pharma

5

Standard Setting Organizations

Examples:• Patient groups (e.g., the Asthma Society of Canada)

• Medical institutions (e.g., a hospital) • Health care professional organizations

(e.g., Canadian Nurses Association)

• Consensus groups (e.g., Canadian Diabetes Association)

6

Thought Process Sequence

Is the piece only about the specific product which was prescribed?

Is the drug content consistent with Part III of the Product

Monograph?AND

Is the disease content on label and supported by standard setting organizations or authoritative sources?

Is the piece non-promotional?

7

Thought Process Sequence

Is the piece only about the specific product which was prescribed?

Is the drug content consistent with Part III of the Product

Monograph?AND

Is the disease content on label and supported by standard setting organizations or authoritative sources?

Is the piece non-promotional?

Is risk information from Part III of the Product Monograph

required?

8

Questions