DRAFT SLIDES FOR NDA 21-213 ADVISORY COMMITTEE PRESENTATION

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DRAFT SLIDES FOR NDA 21-213 ADVISORY COMMITTEE
PRESENTATION
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Mevacor CC Label Comprehension Study 201

• Karen Lechter, J.D., Ph.D.
• Division of Drug Marketing, Advertising, and
  Communications
• July 13, 2000

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Presentation Overview

• Purpose and Methodology of Label Comprehension
  Studies
• Mevacor Study Characteristics and Results
• Potential for Misuse
• Comparison with Earlier Labels
• Conclusions

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Purpose and Methodology of Label Comprehension
Studies
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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 lt8th grade reading

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Methodology of Label Comprehension Studies

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

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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

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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)

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Procedure

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

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• Mevacor Study Characteristics

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Mevacor Study Characteristics

• Open ended 6
• Multiple choice 34
• Biasing series 2
• Leading questions 4
• Response choices faulty 12

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Mevacor Study Characteristics contd

• Assume information 5
• Matching info. on label 3

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Mevacor Study Characteristics contd

• 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
• No questions about self-use

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Communication Objectives

• Condition product is for
• Correct dosage
• /dose, /day, /week
• Appropriate age/gender
• men age 40, women post menopause
• Things to do before use
• know total cholesterol level
• call toll-free number if unsure
• know Rx products currently taking

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Communication Objectives, contd

• Appropriate total and LDL cholest. levels for use
• When talk to Dr.
• total cholesterol over 240
• heart disease, stroke, diabetes
• hypertension
• drink 3 or more alcohol beverages

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Communication Objectives, contd

• Warnings against use if
• taking cyclosporine, erythromycin
• taking other cholesterol drugs
• taking 500 mg. niacin/day
• have or have had hepatitis or liver disease
• pregnant or breast-feeding, or may become pregnant

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Communication Objectives, contd

• Serious muscle side effects can occur if use
  other drugs with Mevacor CC

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Additional Objectives

• Do internal package materials enhance
  comprehension of important elements?
• Is this label better than label in earlier study?
• Do subgroups score similarly to representative
  sample?
• Low literate
• Safety risk

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Participants

• N502
• Age 18 and older
• Not necessarily concerned about cholesterol
• 84 Low Literate (below 9th grade reading)
• 96 Safety Risk
• contraindicated meds
• allergic
• hepatitis or liver disease
• Other Ineligible

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Results--Well Understood

• Purpose for using 97
• Dosing 96-99
• Things to know before use 91-94
• total-c, Rx drugs, call if unsure
• Who must consult Dr. before use 90-93
• heart disease, stroke, diabetes
• Age/sex or menopause
• requirements 92-94

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Results--Well Understood

• Do not use if
• Pregnant or breast feeding 93
• Use gt500 mg niacin/day 90
• Use other cholesterol drugs 88
• Label says
• talk to Dr. if 3 drinks/day 91
• potentially serious s.e.s if use with
• other drugs 91

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Results--Moderately Understood

• Do not use if
• Have/had hepatitis or liver disease 83
• Use erythromycin 80
• Use cyclosporine 81

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Results--Poorly Understood

• Which women and men cannot use
• Pre-menopausal 59
• doesnt say 28
• Menlt40 56
  doesnt say 33
• gt240 mg/dL talk to Dr. 70
• can use 18

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Results--Data Not Clear

• Check cholesterol in 8 weeks 85
• Use with diet and exercise 85-86

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No Data

• Could participants use product themselves?
  (cross-checked with medical information)
• Need several criteria at once for use (total-C,
  LDL, age for men, menopausal status for women)
  

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Lower Low Literacy Scores

• Low literate scored lower than non-low literate
  on 16 questions
• Range of differences was 8-22 percentage points
• Average difference12 percentage points

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Safety Risk Scores

• Scored the same as non-Safety Risk for
• all but 3 items

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Scores After Internal Materials

• Premenopausal women should not use 59-77
• Men lt age 40 should not use
  56-74
• Total cholesterol gt240 should not use
  70-87
• Most numerical differences not significant
• Methodology confounded by 2 tests

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• Potential For Misuse

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Potential for Misuse

• Correct
• Premenopausal women 59
• Men lt40 56
• Total-Cgt240 mg/dL 70
• Simultaneous application of criteria

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• Comparison with Earlier Label

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Comparison with Earlier Label

• Comparisons with prior label comprehension
  results inappropriate
• No head-to-head comparisons

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• Conclusions

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Conclusions

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

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Conclusions

• Significant numbers may not understand who should
  not use
• Inadequate information on
• simultaneous requirements for use
• need further cholesterol checks
• applying information
• appropriate self-selection

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Conclusions

• Evidence inadequate to conclude consumers can
  use safely and effectively in an OTC situation