# Presentation: 316929

## Prescription for Confusion: Health Literacy & Drug Warning Labels

**Michael S. Wolf, PhD MPH**
- Northwestern University
**Terry C. Davis, PhD**
- Louisiana State University Health Sciences Center
**Ruth M. Parker, MD**
- Emory University

## DO PATIENTS UNDERSTAND HOW TO SAFELY TAKE THEIR PRESCRIPTION DRUGS?

**DO PATIENTS UNDERSTAND HOW TO SAFELY TAKE THEIR PRESCRIPTION DRUGS?**

## Health Literacy

- The capacity to obtain, process, and
- understand basic information and
- services needed to make appropriate
- health decisions

- UNDERSTAND and USE health information

## A Matter of Patient Safety

- 90 million U.S. adults have trouble understanding and acting on health information (Institute of Medicine,2004)
- Unfamiliar/complex text such as medication labelsmost difficult to read and understand

## A Matter of Patient Safety

- Patient responsibility has increased for medication self-management
- More meds - average U.S. adult fills _**9**_ prescriptions a year
- Elderly fill an average of _**20**_ prescriptions per year
**Where do patients get information on how to safely administer all of these drugs?**

## Consumer Medication Information: Warning Labels

- Physician and Pharmacist: Time Limited
- Patient Information Forms: Industry-generated, not standardized, not used (?)
- Warning Labels (a.k.a. Auxillary or Secondary Labels)

## The Value of Warning Labels

- Display warnings or special instructions on how to administer drug
- Placed directly on drug container
- Use of icons, color
- Minimal text compared to information sheets

**BUT ARE THEY **_**USEFUL**_** TO PATIENTS?**

**WARNING LABELS: A NATIONAL CONCERN**
- New York Times (October 25, 2005)
- CBS Early Morning News (October 28, 2005)
- CBS/ABC Evening News (currently aired locally)
- Forbes Magazine (to be released)

## Our Investigations

- LSUHCS – Northwestern – Emory Partnership
- Conducted interviews with 500+ primary care patients in 3 states
- Tested patient comprehension of
- 		- warning label messages
- 		- icon meaning
- 		- label color

## Lessons Learned

- Text too difficult
- Too many steps per label
- Icons are confusing
- Random use of color
- Poor message clarity

** **Patient comprehension of warning labels is poor
-  Average comprehension rate for warning labels is **47%**
-  The Problem...

## The Big Picture

- Hundreds of warning labels created by several companies, pharmacy chains
- No universal set of warning labels
- No standards or regulations to guide warning label development
- No consumer involvement in development to date
- Language concordance?
- Assurances that best evidence drives warning labels?

## Slide 12

## Roadmap for Policy, Practice

**Standardize, Regulate Label Development**
- 		- Message text should be < 6th grade level
- 		- Simplify steps
- 		- Give meaning to color
- 		- **Pilot test among consumers!**
**Universal Icons**
**Language Concordance**
**Train health professionals on literacy and medication risk communication **

## For More Information:

| Michael Wolf, PhD MPH		
Feinberg School of Medicine
Northwestern University
(312) 695 – 0459
mswolf@northwestern.edu |
| --- |
| Terry Davis, PhD
Louisiana State University Health Sciences Center – Shreveport
(318) 675 – 8694
tdavis1@lsuhsc.edu |
| Ruth Parker, MD
Emory University
(404) 778 – 1639
rpark01@emory.edu |