# Presentation: 734609

## Consumer Usage Patterns in OTC Settings

**Bernard P. Schachtel, M.D.**
**Department of Epidemiology ****and Public Health****Yale University School of Medicine**

## Consumer Use Program: Objectives

- Do consumers understand the proposed Prilosec 1 label?
- How do consumers use Prilosec 1 under actual conditions of use?
- Is Prilosec 1 safe under actual conditions of use?
- Is Prilosec 1 effective under actual conditions of use?

## Consumer Use Program: Overview

**Consumer Use Program: Overview**

**Label Comprehension (Study 3358)****	****n****	****=****	****504**
**Usage Patterns**
- Study 003: General Population (20mg)	n	=	825
- Study 014: General Population  (20mg)	n	=	939
- Study 022: General Population (10mg)	n	=	489
- Study 067: Adolescents (20mg)	n	=	92
***Total******	******n******	******= ******	******2,849***

## Label Comprehension Study: Design

- Consumers recruited from 10 malls across the US 		(n=504)
- Four cohorts
- Consumers with heartburn		(n=197)
- Consumers without heartburn	(n=104)
- Low-Literacy consumers with and without heartburn 		(n=155)
- Contraindicated Populations		(n=117)

## Label Comprehension Study: Results

- Use for relief or prevention 	**99%**
- How to use for prevention of heartburn 	******80%**
- How to use for relief of heartburn 	**95% **
- When not to use/Ask a health 	******81%**professional
- When to stop using and ask a doctor 	******84% **
- Not to take more than 1 tablet per day 	******80%**
- What to do in case of overdose	**94%**

## Consumer Usage Studies: Design

- 4 studies at 75 centers among 2,345 consumers
- 3 general population studiesrecruited in malls/shopping centers
- 1 adolescent study (12–17 yr. olds)recruited in medical offices
- Consumers self-selected after examining label; minimal safety screening

## Consumer Usage Studies: Design

***2437 Consumers Interviewed***

- 1764 (72%) Consumers
- Self-Selected to Use

- 673 (28%) Consumers
- Selected _**Not**_ to Use

- 347 (14%): Appropriate, but not want to participate
- 126 (  5%): Don’t get heartburn/ heartburn not bad
-   39 (  2%): Happy with current heartburn medication
-   56 (  2%): Not try new medications without doctor’s approval
-   42 (  2%): Contraindicated medication/condition
-     5 (<1%): Pregnant/nursing

*Data from Studies 003 and 022, General Population Actual Use Trials.*

## Consumer Usage Studies: Design

- 4-week at-home usage
- Daily diary

## Consumer Demographics

| Characteristic | Mean (range) |
| --- | --- |
| Gender (% Female) | 62 |
| Race (% Caucasian) | 86 |
| Age (yrs)
Over 65 (17%) | 44 (12–87) |
| Education (% HS Grad or lower)* | 42 |
| Occupation (% Not Manager/Admin or Professional/Technical)* | 63 |

**** Studies 022/003 Only (n=1,314)***

## Clinical Characteristics:  Studies 003 & 022

| Characteristic | Mean |
| --- | --- |
| Reported History of Episodic Heartburn 	(% greater than 5 yrs) | 75 |
| Frequency of Heartburn	Daytime (% 2 or more times/wk) | 62 |
| Frequency of Heartburn	Night (% 2 or more times/wk) | 52 |
| Use of Prescription Heartburn Meds 	(%) | 18 |
| Use of OTC Heartburn Meds 	(%) | 78 |

***(n=1,314)***

## Consumer Usage Studies: Use Patterns

**Consumer Usage Studies: ****Use Patterns**

***Predominant Use (n=2,291, 4 studies)***

- No Predominant Use: **16%**

- Prevention: **28%**

- Relief: **56%**

## Label Directions: Percent of Dosing Occasions with No More Than One Tablet Taken

- Study:

- 003

- 014

- 022

- 067

***(24,802 dosing occasions among 2,291 consumers)***

## Label Directions: Percent of Dosing Days with No More Than One Dose Taken

- Study:

- 003

- 014

- 022

- 067

**>**

***(24,071 dosing days among 2291 consumers.)***

## Label Directions: Percent of Consumers Dosing 10 or Fewer Consecutive Days

***(n=2,287 consumers)***
**** Includes consumers with physician/medical interaction (003 estimated, 022 actual)***

- Study:

- 003*

- 014

- 022*

- 067

## 10-Day Compliance Results:  Study 022 (N=488)

**10-Day Compliance Results:  Study 022 (N=488)**

- Dosed for <10 consecutive days	383 (78%)
- Dosed for 10 consec. days _*but*_:
-     Spoke to physician/health prof. about HB    and/or Prilosec 1 during study	12 (  2%)
-     Told by physician to take that way	3 (  1%)
-     Under physician care and given Rx
-     for PPI/H2RA during the last year 	45 (  9%)
-     Physician consult about HB in past yr.	16 (  3%)
***Total ******	******443 (94%)***
***    ***

## Consumer Usage Studies:Most Common Adverse Events

| Adverse Event  | Ome-Mg n=2,355 |
| --- | --- |
| Headache | 13% |
| Infection | 4% |
| Diarrhea
Abdominal Pain | 3%
3% |
| Pain | 2% |
| Flatulence | 2% |
|  |  |

## Consumer Usage Studies:OTC Effectiveness — 1st & All Doses

**Consumer Usage Studies:****OTC Effectiveness — 1****st**** & All Doses**

***“******Did the Medication Work for Your Heartburn?”***

- Study:

- 003

- 022

- 067

- First Dose	All Doses

## Consumer Usage Studies:OTC Effectiveness

**Consumer Usage Studies:****OTC Effectiveness**

*Percent of subjects (n=1,406) with Good/Very Good/Excellent rating*

***“******Overall, How Would You Rate the Medication?”***

- Study:

- 003

- 022

***Excellent***

***Very Good***

***Good***

***Excellent***

***Very Good***

***Good***

## Consumer Usage Studies: Conclusions

- Consumers understand the Prilosec 1 label
- Under actual conditions of use, consumers complied with each dosing instruction
- Under actual conditions of use, consumers:
- Used Prilosec 1 safely
- Rated Prilosec 1 effective