# Presentation: 181791

## Pivotal Label Comprehension StudyMevacorTM OTC

- Capt. Laura Shay, RN, MS, C-ANP
- Division of Over-the-Counter Drug Products

**Center for Drug Evaluation and Research**** **

## Overview

- Purpose of a label comprehension (LC) study
- MevacorTM OTC LC study design
- Summary of the study results

## Purpose of a Label Comprehension Study

- To evaluate whether or not consumers can comprehend important communication objectives on the label
- Literate and low literate populations
- Diverse population: Representative of the U.S. population

## Purpose of a Label Comprehension Study (cont.)

- Generally performed prior to the behavioral (actual use) study
- Low comprehension may be predictive of poor results in the actual use setting
- High comprehension does not necessarily guarantee success in the actual use setting

## Primary Objective Of the Mevacor OTC LC study

- 	To evaluate consumer comprehension of the label used in the CUSTOM actual use study

## Secondary Objectives

- Determine how well respondents correctly respond to questions designed to try to measure self-selection
- Evaluate low literacy respondents
- Evaluate non-Caucasian respondents

## Key Communication Objectives

- Provided in your FDA background package
- 		(Tab 6, page 1)
- Summary of Results

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

- 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.

## Assessment of Comprehension 

**Clinical Significance**

- 0%

- 100%

## Slide 10

## Slide 11

## Study Design

## Recruitment

- 	Subjects were selected if they were found to be “cholesterol-concerned respondents”

**Paid $20-25 for participating**

## 25 sites (shopping malls) across the country

**25 sites (shopping malls) across the country**

## Study Cohorts

- 696 	Total representative sample
- 203 	Total low-literacy sample
- ( _<_ 8th grade reading level)
- 493 	Non low-literate sample
- 207 	Non-Caucasian sample
- 489 	Caucasian sample

## Gender

- 44% male
- 51% _>_ age 45
- 56% female
- 35% _>_ age 55

## Questionnaire 

- Tested one label
- Structured interviews
- Refer to the label throughout the study
- Primarily multiple choice
- Scenarios were used to:
- test key communication objectives
- test decision making ability based on information found on the label

## Scenario forUnexplained Muscle Pain 

- 	_Diane_ has been taking MEVACORTMOTC for several weeks.  She didn’t do any unusual physical activity and isn’t feeling sick but she has started to feel pain in her leg muscles

## Slide 19

## Answer Definitions 

- Correct:
- 		If a respondent’s answer adhered to the label
- Acceptable:
- 		If a respondent’s answer did not 	specifically adhere to the label
- 	 	“but would not pose a safety risk”

## Answer Options for the Unexplained Muscle Pain Scenario

- Stop using Mevacor OTC.  Must talk to a doctor (**C**)
- Continue to use Mevacor OTC but must talk to a doctor (**A**)
- Stop using Mevacor OTC.  Does not need to talk to doctor (**A**)
- Continue to use Mevacor OTC and does not need to talk to a doctor (**I**)
- Don’t know (**I**)

## Results of the Unexplained Muscle Pain Scenario:

| Cohorts | Correct | Correct plus Acceptable |
| --- | --- | --- |
| Total  | 79% | 98% |
| Caucasian  | 81% | 98% |
| Non-Caucasian  | 74% | 99% |
| Non-Low Literacy | 79% | 99% |
| Low Literacy | 79% | 97% |

## Scenario for Liver Disease

-               Barbara has liver disease:

## Slide 24

## Answer Options for the Liver Disease Scenario

- This person should not use at all (**C**)
- Before using, this person needs to talk to a doctor (**A**)
- This person could start using right away (**I**)
- Don’t know (**I**)

## Results of the Liver Disease Scenario:

| Cohorts | Correct | Correct plus Acceptable |
| --- | --- | --- |
| Total  | 69 % | 99 % |
| Caucasian  | 68 % | 99 % |
| Non-Caucasian  | 71 % | 99 % |
| Non-Low Literacy | 70 % | 99 % |
| Low Literacy | 65 % | 100 % |

## Study Results

- Based on % of _Correct_ Answers from the Total Representative Sample
- (answers adhered to the label)

## % Correct Answers: Dosing, Other Info:

- 99% What the product is used for
- 99% Dosage and dosing information
- 95% Need to consult with health care professional prior
-              to use if on a Rx drug
- 92% Active ingredient
- 87% Time frame for cholesterol testing
- 86% Prerequisite of diet and exercise before taking the
-              medication
- 82% Evening best time of day for dosing
- 78% Need to fast for cholesterol testing
- 59% Cholesterol will go up if MevacorTM OTC is stopped

## % Correct Answers for Scenarios that Indicate the Need to Stop MevacorTM OTC:

- 47%-90%
- 79% Unexplained muscle pain

## % Correct Answers: Self-selection Scenarios

- 37-81%
- 54%:  average correct answers
- 72%:  allergy to lovastatin_ _
- 42%:  prior Hx of muscle pain on a cholesterol-lowering 	        medicine

## % Correct Answers: Listed Under the “Do Not Use If”

- 74% pregnant
- 77% breast feeding
- 69% liver disease

## % Correct Answers: False Positives

|  | Correct | Correct plus Acceptable |
| --- | --- | --- |
| Developed a Cold | 66% | 98% |
| Tums for Indigestion | 72% | 96% |
| Poison Ivy | 64% | 94% |
| Gas from Food | 69% | 95% |
| Constipation | 64% | 95% |

## Self-Selection

- 	Respondents were asked if they could start MevacorTM OTC today.  This answer was compared to the self-reported medical history questions and demographic data in order to validate if the response was correct

## Self-selection

- 696 Total Representative Sample
- 461 respondents reported they “could _not_ start Mevacor OTC today”
- 209 respondents reported they “could start Mevacor OTC today”
- 26 respondents reported they “Did not know”

## Self-selection Results

- 461 (100%) out of the 461 Respondents who reported they “_could not start_ Mevacor OTC today” self-selected correctly according to label criteria
- 3 (1%) out of the 209 Respondents who reported they “_could start_ Mevacor OTC today” self-selected correctly according to label criteria
- 464 (67%) out of the 696 total Respondents self–selected correctly according to label criteria

## Summary: Study Design

- Well designed study
- Diverse population
- Non-Caucasian and low-literate
- Non-leading well constructed Questions
- Study was able to distinguish varied levels of comprehension

## Summary: Clinically Significant Communication Objectives

**Clinical Significance**

- 0%

- 100%

- 20%

- 40%

- 80%

- 60%

## Summary: Self-Selection

- Total number who self-selected correctly according to the label
- 464** **out of 696** (67%)**
- “Could start Mevacor TM OTC today”
- 3 out of 209 **(1%)**

## Summary: Correct vs. Acceptable

- “acceptable” answers increased most scores >90%
- Some “acceptable responses” could be correct:
- Do Not Use-Ask a doctor or pharmacist or
- Do Not Use unless directed by your doctor
- The “acceptable” answers often contained “ask a doctor” even when not indicated to do so on the label
- Respondents often had a _>_ 50% (3 out of 5) chance of selecting either a correct or “acceptable” answer