SELECT Label Comprehension Studies Mevacor ™ Daily

SELECT Label SELECT Label Comprehension StudiesComprehension StudiesMevacorMevacor™™ Daily DailyCapt. Laura Shay, RN, MS, C-ANPCapt. Laura Shay, RN, MS, C-ANPDivision of Nonprescription Clinical Evaluation Division of Nonprescription Clinical Evaluation

Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research

2Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007

Overview• Label comprehension (LC) study

• OTC Mevacor Label Development

• CUSTOM LCS

• SELECT LCS

• Muscle Warning LCS

• Summary

Purpose of Label Purpose of Label Comprehension StudyComprehension Study

OTC labels must:

“. . .be likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.”

21 CFR 330.10 (a)(4)(v)

Purpose of Label Purpose of Label Comprehension StudyComprehension Study

• To evaluate whether or not consumers can comprehend important communication objectives on the label

– Literate and low literate subjects

– Diverse population: Representative of the U.S. population

• CUSTOM LCS

• SELECT LCS

• Summary

OTC Mevacor Label ParadigmsOTC Mevacor Label Paradigms • 2000: 10 mg Mevacor

– Label: Total Chol. paradigm- Total Chol. follow-up

• 2005: 20 mg Mevacor OTC– Label: LDL paradigm-LDL follow-up

• 2007: 20 mg Mevacor Daily– Label 1: LDL paradigm-LDL follow-up – Label 2: Total Chol. paradigm-Total Chol. follow-up

OTC Mevacor OTC Mevacor Consumer StudiesConsumer Studies

• 2004: 20 mg Mevacor OTC (Custom Label)– CUSTOM actual use study

• A Consumer Use Study of OTC Mevacor (CUSTOM)– CUSTOM label comprehension study

• 2007: 20 mg Mevacor Daily (SELECT labels)– SELECT LCS – Muscle Warning LCS – SELECT self-selection study

• Self Evaluation of Lovastatin to Enhance Cholesterol Treatment (SELECT)

• CUSTOM LCS

• SELECT LCS

• Summary

CUSTOM Label 2004

CUSTOM Results: Selection CriteriaCUSTOM Results: Selection Criteria Communication Objectives Communication Objectives

0% 100%20% 40% 80%60%

LDL/HDL (54-59%)

Risk Factor: MI (37%)

Correct Age (57%)

Comprehension

CUSTOM Results: CUSTOM Results: Safety Communication ObjectivesSafety Communication Objectives

Comprehension

0% 100%20% 40% 80%60%

breast feeding (77%)

unexplained muscle pain (79%)

allergy to lovastatin (72%) pregnant (74%)

liver disease (69%)

Woman <55 (55%)

CUSTOM Results: Self-SelectionCUSTOM Results: Self-Selection

• Included a self-selection question

• Of 209 subjects who stated they “could start

Mevacor OTC today”

–1% were correct (n=3) on all the label

criteria (age, LDL, risk factors, medical

history, pregnancy status and

medications)

Deficiencies Listed in the Deficiencies Listed in the February 23, 2005 Not Approvable LetterFebruary 23, 2005 Not Approvable Letter

• Modify and retest the package label – pregnancy warning– unexplained muscle pain warning – liver disease warning

• Justification if deviate from Drug Facts format (21 CFR 201.66(d))

• Demonstrate that consumers can make an appropriate self-selection decision based on the information contained on the label

• CUSTOM LCS

• SELECT LCS

• Summary

SELECT-LDL Label 2007

Back of the Box

Inside Flap

Bottom of Box

LDL-Label LDL-Label vs.vs.

Total Cholesterol-Label Total Cholesterol-Label

SELECT Label Paradigms

Women age 55 years or older Man age 45 years or older

LDL between 130-170

Must have one or more risk factors (listed…)

*including low HDL 1 to 39

(*not gender specific)

Total Cholesterol

Women age 55 years or older Man age 45 years or older

Total Chol. between 200-240

Men: No HDL requirement Women: HDL between 1 and 59 Men : No risk factors require Women: At least one or more

risk factors (listed…)

Selection Criteria

SELECT Label Comprehension SELECT Label Comprehension Study DesignStudy Design

• Primary objective:

To measure consumer comprehension of key communication messages on the label

• Secondary objective:

To test comprehension of two different usage

paradigms based on LDL-C and Total-C

Study Design Study Design

• Parallel two group design

• Random assignment– LDL label (LDL-C)– T. Chol. label (Total-C)

SampleSample• Cholesterol concerned individuals• 20 geographically dispersed malls• Inclusion/Exclusion criteria

– 18 years or older, – speak/read English, – have not participated in a market research survey in

the mall in the past 3 months – Not a healthcare provider– Not employed by advertising/marketing/healthcare

product company

Sample SizeSample Size

LDL Label

• Rep. Sample=307

Total Chol. Label

• Rep. Sample=303

Sample Total n=816

* Augmented

• Low Literate=155* • Low Literate=160*

Data Collection Data Collection • Trained interviewer/scripted questionnaire

• Open-ended

– Example: “What is Mevacor Daily used to treat?”

• Scenario questions

– Example: Diane has been taking Mevacor Daily for

several weeks. She now is feeling muscle pain that

she can not explain. Is it ok or not ok for her to

continue using Mevacor daily?

– “Why did you say that?”

Data AnalysisData Analysis• Step 1: Analysis of initial response to “ok or not

ok” question:– Correct – Incorrect

• Step 2: Analysis of follow-up question (“Why did you say that?”):– Correct (“truly” correct-eliminated “guessers”)– Acceptable (“talk to a doctor”)– Correct + Acceptable

SELECT Labels Results:SELECT Labels Results:Selection Criteria Communication ObjectivesSelection Criteria Communication Objectives

Comprehension

0%100%20% 40% 80%60%

LDL/HDL (64%-78%)

T.Chol/HDL (70%-86%)

Correct Age: both labels (86-92%)

Risk Factor MI: (29%-44%) Overall Scores

T. chol

SELECT Results (Both Labels): SELECT Results (Both Labels): Safety Communication Objectives Safety Communication Objectives

Comprehension

0% 100%20% 40% 80%60%

Liver Disease (84-94%)

Allergy to lovastatin (91-99%)

Pregnant (94-98%)

Unexplained Muscle Pain (96-98%)

Breast Feeding (94-97%)

Woman <55/Female Subjects (92%)

Key Communication Objectives Key Communication Objectives

CUSTOM LCS CUSTOM LCS VSVS..

SELECT LCSSELECT LCS

Results CUSTOM vs. SELECT Results CUSTOM vs. SELECT Selection Criteria Communication Objectives Selection Criteria Communication Objectives

0%100%20% 40% 80%60%

•Age

• LDL/HDL

• T. Cholesterol/HDL

SELECTCUSTOM

54-59% 64-92%

Results CUSTOM vs. SELECT Results CUSTOM vs. SELECT Selection Criteria Communication Objectives Selection Criteria Communication Objectives

0%100%20% 40% 80%60%

29-44%

Risk Factor (MI)

Results CUSTOM vs. SELECT Results CUSTOM vs. SELECT Safety Communication Objectives Safety Communication Objectives

0% 100%20% 40% 80%60%

SELECTCUSTOM

•Liver Disease•Woman <55/Female Subjects•Pregnant/Breast Feeding•Unexplained Muscle Pain•Allergy to lovastatin

55-79% 84-99%

CUSTOM vs. SELECTCUSTOM vs. SELECT

• Follow-Up Lipid Testing

• What to do if LDL has not reached goal

CUSTOM : When to Retest Lipids

SELECT: When to Retest Lipids

Question: When to Retest LipidsQuestion: When to Retest Lipids

• CUSTOM LCS: 71-87% correct*

• SELECT LCS: 45-62% correct

*In the CUSTOM actual use study, ~70% of the subjects obtained a follow-up cholesterol test

CUSTOM: CUSTOM: What to do if LDL has not reached goalWhat to do if LDL has not reached goal

SELECT: SELECT: What to do if LDL/T.C. has not reached goal What to do if LDL/T.C. has not reached goal

Bottom of Box

Question: What to do if LDL has not Question: What to do if LDL has not reached goalreached goal

• CUSTOM LCS: 54-68% correct*

• SELECT LCS: 59-69% correct

*In the CUSTOM actual use study, ~75% of the

subjects made a correct decision on whether to continue to use Mevacor Daily based on their LDL results

• CUSTOM LCS

• SELECT LCS

• Summary

PurposePurpose

To measure in-depth consumer comprehension of the warning about unexplained muscle pain, tenderness or weakness after starting Mevacor™ Daily contained in the Drug Facts and the internal package materials

Muscle LCS Label 2007

Quick Quick Start Start

GuideGuide

Package Insert/Brochure Package Insert/Brochure

MagnetMagnet

Study DesignStudy Design

• One group (LDL label)

• Sample Size:– Rep. Sample=316– Low literacy=104

• Cholesterol interested individuals/malls

• Inclusion/Exclusion

Data Collection Data Collection

• Trained interviewer/scripted questionnaire

• Questionnaire– Scenario – Open-ended– Closed-ended– All questions not focused on muscle warning

Muscle LCS ResultsMuscle LCS Results

• Correct responses to questions related to:– the side effect of muscle pain – stop using Mevacor if develop muscle pain

• 97-98%• Correct responses to questions related to:

– What happens if someone who develops muscle pain continues using Mevacor• 75-85%

Muscle LCS Results cont.Muscle LCS Results cont.

• Responses to question : “how likely would he/she contact a doctor if he/she developed muscle pain while taking Mevacor Daily?”

– Extremely – Very likely– Somewhat likely– Not at all likely– Not too likely

• Unknown whether or not respondents understood if they should talk to a ‘doctor’

Muscle Results cont.Muscle Results cont.

• Most respondents understood that muscle pain is a side effect of lovastatin and a person who develops unexplained muscle pain should stop taking Mevacor™ Daily (96-98%).

*In the CUSTOM actual use study, 60% of the

subjects who developed unexplained muscle pain (38 out of 63 subjects), stopped using lovastatin. (CUSTOM LCS: 79% correct comprehension )

• CUSTOM LCS

• SELECT LCS

• Summary

Summary Summary

• Well designed studies– A lot of useful qualitative data– Validation of correct responses

• The major communication elements on the label were tested with one exception: – The part of the pregnancy warning that describes

women who may become pregnant

• Areas of improved comprehension from CUSTOM label

SafetySafety

• Correct Responses (~ >90%)– Muscle warning (need to stop taking) (96-98%)– Correct age (86-92%)– Pregnancy* (94-98%) – Breast feeding* (94-97%)– Liver disease (84-94%)– Muscle warning (continue using) (75-85%)

*Of those who were incorrect on the pregnancy and breast feeding questions– Unable to find the pregnancy warning on the label

Selection CriteriaSelection Criteria

– Age/LDL/T. Chol/HDL (64-92%) (~80%)

– Risk factor MI (29-44%)

Lipid Testing/Follow-upLipid Testing/Follow-up

• When to retest (45-62%)

• What to do if have not reached goal (59-69%)

SummarySummary• The pregnancy/breastfeeding, liver, and muscle

warnings were better understood• There was improved comprehension of the

selection criteria (esp. T. Chol) with the exception of the one risk factor tested (MI)

• There was a decrease in comprehension that lipids should be retested in 6 weeks

• There was no improvement in comprehension what to do if have not reached goal

• Overall comprehension levels were similar for the low literate study population

Self-Selection Self-Selection

SELECT Self-Selection Study

Linda Hu, Medical Officer

Division of Nonprescription Clinical Evaluation

AcknowledgementsAcknowledgements• Review Team

– Andrea Leonard Segal, M.D.

– Joel Schiffenbauer, M.D.

– Daiva Shetty, M.D.

– Linda Hu, M.D.

– Stan Lin, Ph.D.

– Michael Koenig, Ph.D.

– Matthew Holman, Ph.D.

– Mary Lewis, RN

SELECT Label Comprehension Studies Mevacor ™ Daily

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