# Presentation: 695041

## DRAFT SLIDES FOR NDA 21-198 ADVISORY COMMITTEE PRESENTATIONS

## Pravachol 10 Label Comprehension Study

- Karen Lechter, J.D., Ph.D.
- Division of Drug Marketing, Advertising, and Communications
- July 14, 2000

## Presentation Overview

- Purpose and Methodology of Label Comprehension Studies
- Pravachol Study Characteristics and Results
- Potential for Misuse
- Tested label vs. NDA label
- Conclusions

**Purpose and Methodology of Label Comprehension Studies**

## 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
- Low comprehension= _<_8th grade reading

## Methodology of Label Comprehension Studies

- Malls, other public gathering places
- Special populations recruited from
- 	phone lists
- 	advertisements
- May or may be potential users

## Types of Questions

- Open-ended--no response suggested
- Closed-ended--possible responses given
- 		true/false, yes/no, multiple choice
- Levels of questions
- 	simple--identify if information is on label
-    more difficult--regurgitate or recognize
-    even more difficult--apply information

## Types of Questions to Avoid

- Leading questions--suggest response
- Questions assuming knowledge
- Provide information participant may not know
- Series of questions, most answered the same way (e.g. “see a doctor”)

## Procedure

- Show outer carton
- 	Usually leave in view
- Ask questions
- May show leaflet, brochure, etc.
- Leave in view
- Ask questions

**Pravachol Study Characteristics and Results**

## Pravachol Study Characteristics

- Open ended				6
- Multiple choice       		      16
- Assume knowledge			3
-   (must do something before and 1 yr;
-    some diseases should not use)
- Confounded results			2

## Pravachol Study Characteristics cont’d

- No hypotheticals--do not know if can
- apply information to variety of situations
- Could have avoided leading questions
- Could have produced more confidence in results

## Communication Objectives

- Communication objectives guide questionnaire development
- Based on label information
- Some may be designated key or primary

## Communication Objectives, cont’d

**Primary Objective**
-    Whether consumers understand they should see a doctor before using Pravachol 10

## Communication Objectives, cont’d

**Secondary Objectives**
- Product purpose
- lower cholest. if 200-240 mg/dL after diet & exercise
- Who should not use
- diabetes or coronary heart disease
- already taking Rx for cholesterol
- liver disease or _>_ 3 alcoholic drinks/day
- taking erythromycin
- pregnant

## Communication Objectives, cont’d

- Secondary Objectives, cont’d
- Who should use
- non-pregnant females _>_55
- males _>_35
- people with total cholest. 200-240 mg/dL
- Need follow-up evaluations
- Report muscle pain to doctor

## Communication Objectives, cont’d

- Did not test simultaneous application of requirements for use
- Did not test about risk factors for heart disease

## Participants

- N=612
- Age 25 and older
- Not necessarily concerned about cholesterol
- 163 Low Literate (below 9th grade reading)
- Quotas for sex, age

## Low Literate Results

-   No differences in responses from low-literate, t-tests p_<_.05

## Results--Well Understood

- Purpose for using 			   (90-95%)
- At least 1 disease precluding use (97%)
- 3 diseases precluding use	        (71%)
- Do not use if heart disease,
-    diabetes, liver disease 	           (88-90%)
- Do not use if pregnant,
-    drink 3 alcohol                              (87%)

## Results--Well Understood, cont’d

- Not for normal cholesterol,
- 	pregnant, or hepatitis 			(87%)
- See doctor if unusual muscle
- 	pain or tenderness 			(93%)

## Results--Moderately Understood

- Age for men 				      (77%)
- Age for women 			      (80%)
- See doctor after 8 weeks 	      (82%)

## Data Not Clear

- Must see Dr. before use  	   (82-95%)
- Must see Dr. after 1 year 	        (86%)
- Questions assumed participants knew
- they had to do something

## Where Tested Label Needs Work

- Don’t use if take erythromycin      (65%)
- Eliminated in latest label
- Don’t take if Rx cholest. meds.     (73%)
- Appropriate cholesterol range       (76%)
- 250-300 mg/dL OK to use                   (17%)
- Tested label--range on own line
- NDA label, range on line with LDL
- Age for men and women      (77%-80%)
- Age 18 for all on new label

## No Data

- Could participants use product themselves? (cross-checked with medical information)
- Need several criteria at once to use
- New label--drops age/sex, adds LDL

## No Data, cont’d

- Special circumstances when consult Dr.
- cholesterol above 240 mg/dL, HDL very low
- have 1 risk factor for heart disease:
- smoking,
- hypertension
- family history of heart disease
- Understanding treatment failure, success, long-term benefits

## No Data, cont’d

- Importance of diet and exercise
- What healthy cholesterol is
- Label says continue treatment if reach healthy cholesterol
- Label says may need Rx if have not reached healthy level
- “Healthy” not defined

## Potential for Misuse

- 17% said appropriate for 250-300 mg/dL
- 	May signal potential for inappropriate use
- May use without combination of factors necessary--not tested
- 	e.g., may use if in correct total range but may ignore LDL requirements

**Tested Label vs. NDA Label**

## Tested vs. NDA Labels

_**Tested Label**_
- At top:  Before you start: SEE YOUR  DR. to check cholest.levels and discuss risk factors for heart disease
- Pictogram of doctor and patient and statement “See Your Dr. Before Use on side of Use section

_**NDA Label**_
- Nothing at top
- No pictogram or separate statement to see doctor before use

## Tested vs. NDA Labels, cont’d

_**Tested Label**_
- Cholesterol 200-240 mg/dL
- Men _>_age 35; women _>_age 55

_**NDA Label**_
- Cholesterol 200-240 mg/dL
- LDL >130 mg/dL
- Do not use if under age 18

**Notes:**
...

## Tested vs. NDA Labels, cont’d

_**Tested Label**_
- Do not use if take erythromycin
- “Do not use” section with 6 bullets
- 1 “Ask a Dr. before use” section

_**NDA Label**_
- Nothing about erythromycin
- “Do not use” section with 3 bullets
- Some “Do not use information” moved to 4 sections about asking a doctor, pharmacist, or health care professional before use

## Tested vs. NDA Labels, cont’d

_**Tested Label**_
- Not Drug Facts Format

_**NDA Label**_
- Drug Facts Format

**Conclusions**

## Conclusions

- Label substantially modified in content and format after study
- New Drug Facts format
- New information added, some deleted
- Do not know how well new label works

## Conclusions

- Participants understand some important aspects of the label
- Some issues moderately or poorly understood, or results unclear
- Critical information not tested

## Conclusions

- For tested label, significant numbers may not understand
-  age/sex
-  when see Dr. based on time
-  erythromycin, other cholesterol medicines
-  total cholesterol
- Inadequate information on
-  simultaneous requirements for use
-  applying information
-  appropriate self-selection

## Conclusions, cont’d

-    Questionable if results of label comprehension test applicable to NDA label due to major differences in format and content

## Conclusions, cont’d

-    Evidence inadequate to conclude consumers can use safely and effectively in OTC setting