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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

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Draft slides for nda 21 198 advisory committee presentations

Pravachol 10 label comprehension study
Pravachol 10 Label Comprehension Study

Karen Lechter, J.D., Ph.D.

Division of Drug Marketing, Advertising, and Communications

July 14, 2000

Presentation overview
Presentation Overview

  • Purpose and Methodology of Label Comprehension Studies

  • Pravachol Study Characteristics and Results

  • Potential for Misuse

  • Tested label vs. NDA label

  • Conclusions

Purpose 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
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
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
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”)


  • Show outer carton

    • Usually leave in view

  • Ask questions

  • May show leaflet, brochure, etc.

    • Leave in view

  • Ask questions

Pravachol study characteristics
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
Pravachol Study Characteristicscont’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

  • Communication objectives guide questionnaire development

    • Based on label information

    • Some may be designated key or primary

Communication objectives cont d
Communication Objectives, cont’d

Primary Objective

Whether consumers understand they should see a doctor before using Pravachol 10

Communication objectives cont d1
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 d2
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 d3
Communication Objectives, cont’d

  • Did not test simultaneous application of requirements for use

  • Did not test about risk factors for heart disease


  • 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
Low Literate Results

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

Results well understood
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
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
Results--Moderately Understood

  • Age for men (77%)

  • Age for women (80%)

  • See doctor after 8 weeks (82%)

Data not clear
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
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
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
No Data, cont’d

  • Special circumstances when consult Dr.

    • cholesterol above 240 mg/dL, HDL very low

    • have 1 risk factor for heart disease:



      family history of heart disease

  • Understanding treatment failure, success, long-term benefits

No data cont d1
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
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 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

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

Tested vs. NDA Labels, cont’d

Tested vs nda labels cont d1

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 vs nda labels cont d2

Tested Label

Not Drug Facts Format

NDA Label

Drug Facts Format

Tested vs. NDA Labels, cont’d


  • 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


  • Participants understand some important aspects of the label

  • Some issues moderately or poorly understood, or results unclear

  • Critical information not tested


  • 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
Conclusions, cont’d

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

Conclusions cont d1
Conclusions, cont’d

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