A Universal Medication Schedule to Promote Patient Understanding and Use (Text Version)

On September 15, 2009, Michael Wolf made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (1.8 MB).

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A Universal Medication Schedule to promote patient understanding and use

Michael Wolf, PhD MPH
Northwestern University

Terry Davis, PhD
Louisiana State University Health Sciences Center-Shreveport

Ruth Parker, MD
Emory University

Will Shrank, MD
Harvard Medical School

Slide 2

 

Acknowledgements

• Primary Support: R01 HS017687 (AHRQ; Enhanced drug label design to improve patient understanding and use; PI: Wolf)
• Disclosure: Target Corporation Research Grant
• Partners: Alastair Wood, MD; JoAnn Knox, MSW
• Research Staff: Anjali Pandit, MPH; Ashley Bergeron, BA; Pear Moraras, BA

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Overview

• Health Literacy & Drug Labeling: a 60-second review.
• An Evidence-based, Patient-Centered Label Design
• Field Test Results
• The 'UMS Trial'—Methods & Rationale
• Next Steps

 

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Health Literacy & Drug Labeling

 

Slide 5

 

An image of a person is shown.

 

Slide 6

 

Image: Two people are shown. The left image is labeled MD/RN.

 

Slide 7

 

An image of a person and a prescription are shown.

 

Slide 8

 

An image of a person and an image of pharmacy counter are shown.

 

Slide 9

 

An image of a person and an image of barcode label are shown.

 

Slide 10

 

An image of a person and an image of medication bottle are shown.

 

Slide 11

 

An image of a person and an image of labels on medication bottle are shown.

 

Slide 12

 

An image of a person and an image of Wellitol are shown.

 

Slide 13

 

An image of a person and an image of FDA Web site are shown.

 

Slide 14

 

An image of a person and an image of the physician's desk reference are shown.

 

Slide 15

 

An image of a person and an image of the AARP guide to pills are shown.

 

Slide 16

 

Images of a person and of people talking are shown.

 

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Image: A person with preceding concepts encircling him/her is shown.

 

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Value of Rx Labels

Image: A person with preceding concepts encircling him/her is shown.

• Tangible
• Brief
• Repeatedly used
• Only source for many

 

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Value of Rx Labels

Image: A person with preceding concepts encircling him/her is shown.

• Tangible
• Brief
• Repeatedly used
• Only source for many

 

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Value of Rx Labels

Image: A person with preceding concepts encircling him/her is shown.

• Tangible
• Brief
• Repeatedly used
• Only source for many

 

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Value of Rx Labels

Image: A person with preceding concepts encircling him/her is shown.

• Tangible
• Brief
• Repeatedly used
• Only source for many

<10% read them

Source: Wolf, et al. Am J Health Sys Pharm, 2006

 

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Evidence Available.

• Group label content
• Emphasize patient info (Rx name, patient name, directions, indication*)
• Write instructions using explicit time intervals (UMS)
• Use numeric vs. alpha characters for dose, frequency
• Separate times with virtual 'carriage returns'
• Provide a visual aid to reinforce the 'sig' instruction

Value in Standardization!

 

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An Enhanced Label and 'UMS'

Image: Sample label for patient Michael Wolf, containing UMS dosage directions.

 

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Efficacy Trial

• Comprehension testing
• 4 clinics in two sites (Chicago, Shreveport); 1 academic, 1 FQHC
• Sample = 500 primary care patients >18 years of age
• Sequential assignment to standard, UMS, UMS + graphic
• Outcome: Functional understanding of 3 hypothetical regimens

 

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Study Arms

Standard	UMS	UMS + Graphic Aid
Take one tablet by mouth daily.	Take 1 tablet at bedtime.	Image shows table with 4 sections, morning, noon, evening, and bedtime. Morning, noon, evening are blacked out; there is a "1" under bedtime.
Take one tablet by mouth three times daily.	Take 1 tablet in the morning 1 tablet at noon 1 tablet in the evening	Image shows table with 4 sections, morning, noon, evening, and bedtime. There is a "1" under the morning, noon, evening sections; bedtime is blacked out.
Take two tablet by mouth twice daily.	Take 2 tablets in the morning, And 2 tablets at bedtime	Image shows table with 4 sections, morning, noon, evening, and bedtime. Noon and evening are blacked out; there is a "2" under the morning and bedtime sections.

 

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Findings.

• 91% of patients correctly interpreted UMS instructions
• Benefit strongest with more complex regimens (%):
• GEE Model: greater comprehension of UMS instructions vs. standard label instructions (ARR 1.33, 95% CI 1.25-1.41; p<0.001)
• Addition of Graphic Aid of limited value for single drug review (ARR 0.93, 95% CI 0.89-0.97; p<0.001)
• Improvement for 2 or 3x daily schedules (40% of US prescriptions)

 

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Findings (cont.)

• Impact of limited literacy mitigated (REALM—low (n=101): ARR 0.95, 95% CI 0.86—1.04; p=0.25)
• Significant interactions found—Patients w/ low literacy had greatest benefit from the UMS (ARR 1.39, 95% CI 1.14-1.68, p<0.001)
• Regimen complexity and UMS—greater complexity, greater benefit (ARR 2.00, 95% CI 1.44-2.42, p<0.001)

 

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Present Study—the 'UMS' trial

Objective: to test the effectiveness of the evidence-based, enhanced prescription drug container label design to improve patients' understanding of instructions for use.

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Methods.

• Actual Use Assessment
• 11 Safety Net Clinics, 1 Central-Fill Pharmacy (Va.)
• Sample = 960 Diabetic/Hypertensive Patients, > 30 years of age
• Random Assignment to Enhanced vs. Standard Label (all meds)
• Assessment: Baseline, 3 months, 1 Year
• Outcomes:
  • Functional Understanding
  • Adherence (self-report, pill count, refill data)
  • HBA1C/Blood Pressure

 

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In Progress.

• 5 clinics activated.
• 335 patients identified, 131 recruited to study. Response rate 67%.
• Lessons learned:
  • Patients navigating multiple pharmacies for meds
  • Current pharmacy software (PDX) has significant limitations
    • I) Hard coding of 'sig' font and size
    • Ii) Position of sig, indication, etc.
    • Iii) Emphasis options
    • Iv) Auxiliary warnings
• Broader issues (evidence for warnings, other label elements, ethics)

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PRN.

• Current study emphasis 1) solid pill-form, 2) non-PRN
• UMS graphic blocked out for PRN drugs.
• Best practice?

Take 1-2 tablets by mouth every 4-6 hours as needed for pain.

Take: 1 or 2 pills for pain. Wait at least 4 hours before you take it again. Do NOT take more than 8 pills in a day.

 

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Next Steps

• 3 month interviews (w/ adherence outcomes) have begun
• Remaining clinics to be engaged in systematic manner
• Orient, teach use of the UMS (and graphic aid) to patients?
• Need repeatedly identified for language concordant services
  • Supplement in California Endowment grant
• Work with others (i.e. USP) on...
  1. Auxiliary instructions
  2. Standard label content
  3. Required format (i.e. PDX issue)

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Contact Information:

Michael S. Wolf, PhD MPH
Associate Professor, Medicine & Learning Sciences
Associate Division Chief—Research
Division of General Internal Medicine
Northwestern University
Feinberg School of Medicine
750 N. Lake Shore Drive, 10th Floor
Chicago, IL 60611
(312) 503—5592
mswolf@northwestern.edu