1. Patient-Centered Prescription Labels: Academic Perspective
Clark Kebodeaux, Pharm.D., BCACP

2. Background St. Louis College of Pharmacy
Center for Patient Education and Health Literacy
University of Kentucky College of Pharmacy
USP-NF General Chapter <17>
Prescription Container Labeling
Community/Ambulatory Care Pharmacy Experience

3. Goals
Evaluate the quality of prescription container labels and measure the adherence to USP Chapter 17
Use the output to identify opportunities for change through state-level regulation and within pharmacies/health-systems
Increase awareness of the importance of labeling within the pharmacy community

4. Patients Focus Groups Major Themes
Thematic analysis of patients in the state of Missouri
Confirm patient-perceived prescription content and formatting expectations for prescription container labeling consistency with USP Chapter 17
Major Themes
Importance of drug name, dose, and directions
Lack of side effects on the label
Improved organization and larger font size
Using the color red
Lack of familiarity with auxiliary labels
The importance of pharmacy information
Kebodeaux, Clark D., et al. "Patient-perceived content and formatting expectations for prescription container labeling." Journal of the American Pharmacists Association 56.3 (2016):

5. Stakeholders Community Pharmacists Previous Research State of Missouri
Chain (>4 locations)
Independent
Grocery
Mass Merchandizer
Academicians
Health literacy
Pharmacy
Previous Research
The variability and quality of medication container labels. Archives of internal medicine (2007)
State of Missouri
One state used for consistency of regulations
Missouri has not adopted patient- centered prescription regulations
Shrank, W. H., Agnew-Blais, J., Choudhry, N. K., Wolf, M. S., Kesselheim, A. S., Avorn, J., & Shekelle, P. (2007). The variability and quality of medication container labels. Archives of internal medicine, 167(16),

6. Prescription Evaluation
USP Chapter 17 Parameters Present among 80 Label Sample Set
Patient name at top
Spell out full brand name
Spell out full generic name
List strength
No jargon/medication abbreviation
Separate dose and timing
Avoid use of hours in the SIG (instructions)
Use numbers rather than alphabet characters
Include purpose for use
Team identified 22 measureable items from the USP Chapter 17
18 were used in final analysis

7. Prescription Evaluation
USP Chapter 17 Parameters Present among 80 Label Sample Set
High contrast (black ink on white label)
Sentence case (including initial capital and period)
Font size > 11 for drug name, patient name, SIG
Font size no less than 10 for other content
No vertical text
No more than 2 colors of highlights
Font readability (Arial/Times New Roman)
Adequate white space
No “bad bolding” (other than patient/refill)
Team identified 22 measureable items from the USP Chapter 17
18 were used in final analysis

8. Prescriptions

9. Results High Performing Measurements
Kebodeaux C, Peters GL, Kindermann H, Hurd P and Berry T. Prescription Labels: Adherence to USP Chapter 17 Standards. J Am Pharm Assoc. 2017;Presentend at the APhA Annual Meeting; San Francisco, CA.

10. Results Low Performing Measurements
Kebodeaux C, Peters GL, Kindermann H, Hurd P and Berry T. Prescription Labels: Adherence to USP Chapter 17 Standards. J Am Pharm Assoc. 2017;Presentend at the APhA Annual Meeting; San Francisco, CA.

11. Results Measurements by Pharmacy Type
Kebodeaux C, Peters GL, Kindermann H, Hurd P and Berry T. Prescription Labels: Adherence to USP Chapter 17 Standards. J Am Pharm Assoc. 2017;Presentend at the APhA Annual Meeting; San Francisco, CA.

12. Prescriptions 1 2 3 4

13. Results Measurements by Prescription Differences
Kebodeaux C, Peters GL, Kindermann H, Hurd P and Berry T. Prescription Labels: Adherence to USP Chapter 17 Standards. J Am Pharm Assoc. 2017;Presentend at the APhA Annual Meeting; San Francisco, CA.

14. Outcomes System Level Changes Expected Outcomes Unexpected Outcomes
Pharmacy Systems/Technology
Pharmacists
Prescribers
Regulators
Expected Outcomes
Unexpected Outcomes
Successes/Challenges/Recommendations

15. Questions?