1. 1 Prilosec Label Comprehension Study Karen Lechter, J.D., Ph.D. Division of Drug Marketing, Advertising, and Communications

2. 2 Purpose of Label Comprehension Studies 21 CFR 330.10(a)(4)(v) [OTC labels shall be written] in such terms as to render them likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.

3. 3 Main Study Characteristics Mall intercept N=504 Male and female >age 18

4. 4 Main Study Characteristics 4 cohorts: 1. heartburn sufferers (N=197) 2. heartburn non-sufferers (N=104) 3. low literate (<8th grade reading) [N (sufferers) =101; N (non-sufferers) =54)] 4. must ask doctor before use (N=117) --take certain meds., pregnant, nursing

5. 5 Product Purpose When asked purpose of product: 99% prevention or relief or both –65% relief –18% prevention –16% prevention and relief Label says prevention and relief

6. 6 Do Consumers Understand? What to do after 14 days of use (83%) What to do if trouble swallowing (81%) When take to prevent if expect stress (80%) When take to prevent if expect meal (83%) –Low literate (75%) If can take 2 within 24 hours (2 Q’s) (81%, 83%) –Low literate (74%, 81%)

7. 7 Troubling Result 74% of cohort 4 (should see doctor before use) incorrectly said they would use the product to prevent and relieve (2Q’s) 21% correct--would not use

8. 8 Addendum Study Does wording of question about self-use in cohort 4 contribute to incorrect responses? Compared responses to original self- use question with new self-use question N=58 (29 in each arm) All should ask doctor before use: –pregnant, nursing, taking certain drugs

9. 9 Addendum Study Questions Original questions: If you wanted to prevent/relieve heartburn, would you use Prilosec 1 yourself? New questions: If you were a heartburn sufferer and you wanted to prevent/relieve heartburn, would it be okay for you (,personally,) to use Prilosec 1 yourself, or not?

10. 10 Addendum Study Results % correct prevention relief Original Question35%31% Reworded Question69%59% Even with the reworded question, comprehension is low

11. 11 Additional Addendum Study Questions If prior response is incorrect: Is there anything you would do prior to taking this product, or not? If prior response is incorrect: Considering your current health and medications you are currently taking, would it be necessary for you to contact a doctor prior to using this product yourself, or not?

12. 12 Additional Addendum Study Questions If prior response is incorrect: Are you currently taking any of the following medications? diazepam, warfarin, phenytoin If prior response is incorrect: Are you currently taking any of the following medications?Valium, Coumadin, Dilantin Results of leading questions have uncertain value

13. 13 Addendum Study Conclusions Group that should consult with physician before use demonstrates problems in both studies 59%-69% correct responses to new question

14. 14 Tested Label vs. NDA Label Label changed substantially after label comprehension test New label not tested

15. 15 Tested Label vs. NDA Label NDA label added – Causes of symptoms for prevention – Allergy warning – “Do not use” section – Do not use with acid reducers – New drugs to ask about – Wording about taking for prevention – Amount of water to drink

16. 16 Tested Label vs. NDA Label NDA label Specified # days after which see doctor Changed 14 day limit to 10 days Ask pharmacist as well as doctor about drugs Changed wording: trouble swallowing, pregnancy, directions, storage instructions Reversed--relief and prevention indications and directions Bolded and added warning symbol to instruction not to take more than 10 days

17. 17 NDA Label NDA Label was not tested

18. 18 Summary Consumers associate product with relief –65% said it is for relief Data suggest potential for substantial use by persons who should consult doctor first Some information is not strongly communicated Most recent label not tested –Differs significantly from tested label