Article Review: Effective Ways to Deliver Health Information to Patients

HyungMin Lee University of Pittsburgh

FDA Rotation

October 26th, 2015

Objectives

Discuss significance of Health Literacy

Identify what composes patient preferred patient label

Discuss why certain formats increase patient label comprehension

Demonstrate the lessons I’ve learned from the project

A Looming Epidemics

2030 Health Literacy Prediction (Parker et al. ) Blue: National Adults Literacy Survey in 1992

Red: Literacy projection for 2030 • 54% of people will have most basic literacy skill in 2030, compared to 43% in 1992

Declining Literacy

• Failures in Education System – Stagnant H.S. grad rates

• Shifting Demographics – New, larger immigrant population

• Changing Economy – Growth in knowledge-intensive jobs

Inadequate Health Literacy and Mortality

Age-adjusted survival rate with adequate, marginal and inadequate health literacy. N=3260 (Baker et al. 2007)

Patient Communication

• Consumer Rx materials written 10-11th grade level (Wolf et al., 2012)

• Less than one third routinely review (Wolf et al., 2006)

• Physicians, pharmacists missing opportunities to counsel patients (Metlay et al., 2005)

Patient Information

Layouts

• Patients preferred Bubble format( 2-column, segmented design) 3,4

Layout

• Avoid visual clutter2

Employ list formats2 Maximize white space2,4 Chunk information into manageable pieces 2

• Use horizontal text only5

• Most common improvement suggestions for prescription auxiliary labels8

– Do not prefer white background (99.2%)

– Larger label size needed (85%)

– Prefer a picture (58.3%)

– Prefer a red, yellow, or green background (31.7%)

Layouts

• Comprehension was significantly greater for all three prototypes 1

• Health literacy form (simple table format) had the most improved patient comprehension1

Typography

• Use clear and simple font2

• Use larger, Sans Serif font5

– Sans (French) = without

– Serif (German) = line

• Preferred Arial font to Times New Roman3 – Arial font is “bigger and bolder” than Times New Roman font

Content

• Patient preferred information 6 – Indication for use5,6

– Expected benefits

– Duration of therapy

– Potential adverse effects

– Information identifies the drug’s name

– Directions for use

– Warnings

Topamax 200 mg

round, peach, imprinted with TOPAMAX, 200

© Cerner Multum

Content

• Misleading and confusing information3

– Death related sentences • “some people have died from these infections”

• One third of respondents indicated such warning discourage them from taking drug.

– Separation between “Call Your Doctor” and “Common Side Effects”

• Call Your Doctor: ‘pain, chest discomfort, bleeding, swelling… all these things are scary’

• Common Side Effects: Not informative

Content

• Examples of poor interpretation of auxiliary labels 8

Avoid Sunlight (23.3%)

Keep medication away from sun

Do not chew or crush (14%)

Don’t chew but crush

Take at bedtime Crush medication before taking

Don’t take medication when it’s hot outside

Don’t swallow medication whole

There are strong drugs; stay away from

Sometimes can crush or bite

Don’t leave in sun or throw in sun

Dissolve medication in liquid

Avoid exercise Take medication right away to get in blood stream

Be out in sun

Preference of Content Order3

– For patients with immune disorders and chronic disease, and respondents 50 to 69 years of age,

– For general population, and respondents younger than 50 years and those 70 years of age or older

Content Order

Directions for Use

Important Warning

Language - Encouraged

• Use concrete2, explicit, active4 , simple 4,8 , and concise8 language

• Stick to positive wording 2,4.

– Negation in statement can hinder memorization

– Older readers are more likely to misremember negatively worded health guidelines

• Use numeric 5

– Drug dose, concentration, and frequency

• Six-grade reading level 8

• Avoid medical jargon5

Medication Information Distribution Pathways

• In pharmacy in paper and electronic formats

• Online via email or other electronic method (QR code)

• Sent to patient in electronic health record

Pearsall, Bryon. “Patient Medication Information.” Exploring the Promise of Patient Medication Information. The Brooking Institute. Washington, DC. July 1st, 2014. Presentation

Near Field Communication (NFC)

• “NFC-Enabled Cellphones Shipments to Soar Fourfold in Next Five Years” – IHS 2014

• https://www.youtube.com/watch?v=EdyIP7yqWJY

– 18.2% in 2013 64.0% in 2015

lisinopril

Thank You

References 1. Wolf et al. Comparative Effectiveness of Patient-centered Strategies to

Improve FDA Medication Guides. Medical Care; 2014; 52:781-789

2. Wilson et al. Working memory and the design of health materials: A cognitive

factors perspective. Patient Education and Counseling 74 (2009) 318–322

3. Kish-Doto et al. Preferences for Patient Medication Information: What Do

Patients Want? Journal of health communication, 19(sup2), 77-88.

4. Boudewyns et al. Influence of patient medication information format on

comprehension and application of medication information: A randomized,

controlled experiment. Patient Education and Counseling (2015)

5. Bailey et al. Advancing best practice for prescription drug labeling: an updated

literature review. Annals of Pharmacotherapy 1-15, 2015

6. Bosworth et al., Medication Adherence: A call for action; review article. Am

Heart J 2011; 162:412-24.

7. Lindquist et al. Unnecessary complexity of home medication regimens among

seniors. Patient Education and Counseling 96 (2014) 93-97

8. Locke et al. Improving prescription auxillary labels to increase patient

understanding. J Am Pharm Assoc. 2014; 54:267–274.

9. Yin et al. Unit of Measurement Used and Parent Medication Dosing Errors.

Pediatrics Vol 134, No. 2: e354-361; Aug 2014.

10. Smith et al. Reducing drug self-injection errors: A randomized trial comparing

a "standard" versus "plain language" version of Patient Instructions for Use.

Research in Social and Administrative Pharmacy. 9, 621-625.