1. Readability Characteristics of Patient Instructions for Pulmonary Inhalation Devices
Steven E. Roskos, M.D., Assistant Professor
Lorraine S. Wallace, Ph.D., Associate Professor
University of TN Graduate School of Medicine
Department of Family Medicine

2. Background Together, asthma and COPD affect over 20 million Americans.
Despite the availability of effective medications for long-term management of asthma and COPD, morbidity for these conditions remains high.
Successful control of asthma and COPD relies heavily on patient adherence to prescribed inhalation therapies.

3. Background Many patients do not use inhalers correctly.
These patients do not reap the full therapeutic benefits.

4. Background
Health professionals are often unfamiliar with the correct method for using inhalers
Patients must rely on Consumer Medication Information (CMI) (The Package Insert)

5. Asthma Patients’ Misunderstanding Regarding Medications
Patients who believe asthma medications have
no side effects.
Almost half of Americans have limited or marginal reading ability.
Williams et al. (1998). Chest.

6. Proper Use of Asthma Inhaler
Reading ability is the strongest predictor of proper inhaler use among high-risk patients. Patients at greatest risk for Asthma and COPD (elderly, low socioeconomic status, limited education) are at higher risk for limited health literacy.
Williams et al. (1998). Chest.

7. Purpose
Other patient information related to asthma has been found to exceed the literacy abilities of most American adults
No studies have examined the reading difficulty of the instructions for patients included in the Consumer Medication Information (CMI) that accompanies prescription inhalers.

8. Purpose
We assessed the readability and related characteristics of the CMI for all prescription pulmonary inhalation devices currently available in the United States.

9. Methods
Identified all Rx pulmonary inhalers available in the United States
Epocrates Rx Pro (version 7.02) to identify all brand-name (n=18)
Micromedex to identify all generic (n=2)

10. Methods
English language CMI was obtained from pharmaceutical manufacturers of each identified product.

11. Methods
The CMI from these products was then evaluated for readability characteristics:
Grade level (Fry formula)
Text point size
Dimensions (length and width)
Diagrams
Directions

12. Results Mean readability: Grade Level 8.2±1.5 (range=5-11)
Above the recommended 5th Grade level.
Mean text point size: 9.2±2.2 (range=6-12)
Smaller than the recommended 12-point size.
Above the recommended fifth grade level.

13. Results: Dimensions Mean Length: 33.7±21.5 cm Mean Width: 12.9±9.5 cm.
Two smallest CMI’s:
4.5 cm long x 16.4 cm wide
15.2 cm long x 5.8 cm wide
Smaller than the size of a candy bar wrapper.
Two largest CMI’s:
56.2 cm long x 16.0 cm wide
nearly the size of a computer keyboard.

14. Results: Illustrations
Average 6.2 ± 3.6 (range=2-12)
illustrations per CMI
14 (70%) included a device overview diagram
11 (55%) included detailed step-by-step diagrams

15. *These leaflets contained only one illustration.
Diagrams
*These leaflets contained only one illustration.

16. Step-by Step Diagrams *These illustrations were from a single patient
information leaflet. They show a sequence of steps.

17. Results Steps and Sequence
14 CMIs included step-by-step directions in chronological order.
6 CMIs presented steps in an out-of-order sequence.

18. Example of Out of Order Instructions
Shake the inhaler system before each inhalation.
Before each use, remove cap and inspect mouthpiece for foreign objects.
Replace the cap after each use.
Breathe out as completely as possible.
Hold the inhaler system upright and put plastic mouthpiece in your mouth, being sure to close
your lips tightly around the mouthpiece.

19. Comparison of Total Steps to the Number of Generally Accepted Steps
We formulated a standard set of steps for pressurized and dry powder inhalers.

20. Conclusions
Most CMI for prescription inhalers is presented in a reading difficulty level, text size, and with diagrams and instructions that make it suboptimal for patient education.

21. Conclusions
These suboptimal patient instructions may contribute to the large number of patients who use inhalers incorrectly.

22. Conclusions
Manufacturers of inhalers should consider revising their CMI to comply with generally accepted guidelines for patient education information.

23. Questions?
SDG