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SELECT Label Comprehension Studies Mevacor â„¢ Daily

SELECT Label Comprehension Studies Mevacor â„¢ Daily. Capt. Laura Shay, RN, MS, C-ANP Division of Nonprescription Clinical Evaluation. Center for Drug Evaluation and Research. Overview. Label comprehension (LC) study OTC Mevacor Label Development CUSTOM LCS SELECT LCS Muscle Warning LCS

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SELECT Label Comprehension Studies Mevacor â„¢ Daily

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  1. SELECT Label Comprehension StudiesMevacor™ Daily Capt. Laura Shay, RN, MS, C-ANP Division of Nonprescription Clinical Evaluation Center for Drug Evaluation and Research

  2. Overview • Label comprehension (LC) study • OTC Mevacor Label Development • CUSTOM LCS • SELECT LCS • Muscle Warning LCS • Summary

  3. Purpose of Label Comprehension 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)

  4. Purpose of Label Comprehension 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

  5. Overview • Label comprehension (LC) study • OTC Mevacor Label Development • CUSTOM LCS • SELECT LCS • Muscle Warning LCS • Summary

  6. OTC 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

  7. OTC Mevacor Consumer 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)

  8. Overview • Label comprehension (LC) study • OTC Mevacor Label Development • CUSTOM LCS • SELECT LCS • Muscle Warning LCS • Summary

  9. CUSTOM Label 2004

  10. CUSTOM Label 2004

  11. CUSTOM Results: Selection Criteria Communication Objectives Comprehension 0% 100% 20% 80% 40% 60% Risk Factor: MI (37%) LDL/HDL (54-59%) Correct Age (57%)

  12. Woman <55 (55%) unexplained muscle pain (79%) liver disease (69%) breast feeding (77%) pregnant (74%) allergy to lovastatin (72%) CUSTOM Results: Safety Communication Objectives Comprehension 0% 20% 40% 60% 100% 80%

  13. CUSTOM 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)

  14. Deficiencies Listed in the February 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

  15. Overview • Label comprehension (LC) study • OTC Mevacor Label Development • CUSTOM LCS • SELECT LCS • Muscle Warning LCS • Summary

  16. SELECT-LDL Label 2007

  17. SELECT-LDL Label 2007 Back of the Box

  18. SELECT-LDL Label 2007 Inside Flap

  19. SELECT-LDL Label 2007

  20. SELECT-LDL Label 2007 Bottom of Box

  21. LDL-Label vs. Total Cholesterol-Label SELECT Label Paradigms

  22. LDL 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

  23. SELECT Label Comprehension Study 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

  24. Study Design • Parallel two group design • Random assignment • LDL label (LDL-C) • T. Chol. label (Total-C)

  25. Sample • 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

  26. LDL Label Rep. Sample=307 Total Chol. Label Rep. Sample=303 Sample Size Sample Total n=816 • Low Literate=155* • Low Literate=160* * Augmented

  27. 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?”

  28. Data 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

  29. SELECT Labels Results:Selection Criteria Communication Objectives Comprehension 0% 20% 80% 60% 40% 100% Risk Factor MI: (29%-44%) Overall Scores T. chol LDL/HDL (64%-78%) T.Chol/HDL (70%-86%) Correct Age: both labels (86-92%)

  30. SELECT Results (Both Labels): Safety Communication Objectives Comprehension 40% 80% 100% 20% 60% 0% Liver Disease (84-94%) Woman <55/Female Subjects (92%) Allergy to lovastatin (91-99%) Pregnant (94-98%) Breast Feeding (94-97%) Unexplained Muscle Pain (96-98%)

  31. Key Communication Objectives CUSTOM LCS VS.SELECT LCS

  32. Results CUSTOM vs. SELECT Selection Criteria Communication Objectives SELECT CUSTOM 0% 20% 60% 80% 40% 100% • Age • LDL/HDL • T. Cholesterol/HDL 54-59% 64-92% ~80%

  33. Results CUSTOM vs. SELECT Selection Criteria Communication Objectives 0% 20% 40% 60% 80% 100% Risk Factor (MI) 29-44%

  34. Results CUSTOM vs. SELECT Safety Communication Objectives SELECT CUSTOM 40% 80% 100% 20% 60% 0% • Liver Disease • Woman <55/Female Subjects • Pregnant/Breast Feeding • Unexplained Muscle Pain • Allergy to lovastatin 84-99% 55-79%

  35. CUSTOM vs. SELECT • Follow-Up Lipid Testing • What to do if LDL has not reached goal

  36. CUSTOM : When to RetestLipids

  37. SELECT: When to RetestLipids

  38. Question: 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

  39. CUSTOM: What to do if LDL has not reached goal

  40. SELECT: What to do if LDL/T.C. has not reached goal Bottom of Box

  41. Question: What to do if LDL has not reached 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

  42. Overview • Label comprehension (LC) study • OTC Mevacor Label Development • CUSTOM LCS • SELECT LCS • Muscle Warning LCS • Summary

  43. Purpose 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

  44. Muscle LCS Label 2007

  45. Muscle LCS Label 2007

  46. Muscle LCS Label 2007 Quick Start Guide

  47. Muscle LCS Label 2007 Package Insert/Brochure

  48. Muscle LCS Label 2007 Magnet

  49. Study Design • One group (LDL label) • Sample Size: • Rep. Sample=316 • Low literacy=104 • Cholesterol interested individuals/malls • Inclusion/Exclusion

  50. Data Collection • Trained interviewer/scripted questionnaire • Questionnaire • Scenario • Open-ended • Closed-ended • All questions not focused on muscle warning

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