# Presentation: 181792

## Prilosec Label Comprehension Study

- Karen Lechter, J.D., Ph.D.
- Division of Drug Marketing, Advertising, and Communications

## 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.

## Main Study Characteristics

- Mall intercept
- N=504
- Male and female _>_age 18

## 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**

## 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

## 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%)

## 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

## 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

## 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?

## Addendum Study Results

- 						% correct
- 					   _prevention_     _relief_
- Original Question		35%		31%
- Reworded Question		69%		59%
**Even with the reworded question, comprehension is low**

## 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?

## 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**

## Addendum Study Conclusions

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

## Tested Label vs. NDA Label

- Label changed substantially after label comprehension test
- New label not tested

## 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

## 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

## NDA Label

**NDA Label was not tested**

## 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