Promoting Safe & Appropriate Drug Use

a health literacy perspective

Michael S. Wolf, PhD MPHAssociate Professor, Medicine & Learning SciencesAssociate Division Chief, General Internal Medicine

Feinberg School of MedicineNorthwestern University

Chicago, IL, USA

2nd Annual Julia Berg Memorial Lecture – University of Minnesota Department of Pediatrics

Disclosures. National Cancer Institute (NCI) Foundation for Informed Medical

Decision Making (FIMDM)

National Institute on Aging (NIA) McNeil Consumer Healthcare

National Insitute for Nursing Research (NINR)

Abbott Labs

National Heart, Lung, and Blood Institute (NHLBI)

Pfizer Pharmaceuticals

Agency for Healthcare Research and Quality (AHRQ)

The California Endowment

Centers for Disease Control (CDC) Earthbound

A Prescription for Confusion.

Mother Master’s degree health educator

Father General internist

Daughter 6 years old with diagnosis of H1N1 influenza (‘swine flu’)

September 22, 2009

¾ teaspoon dose:

5 ml (volume of teaspoon) x .75 x 12 mg per ml Tamiflu suspension =

45 mg on syringe

September 22, 2009

A Glance at Patient Compliance.

• 60% of asthmatic adults don’t properly use inhalers

• 54% of U.S. adults don’t get annual flu shots

• 50% of diabetic patients are non-adherent to Rx regimens

• 49% of eligible adults have not received CRC screening

• 40% of adults don’t know signs of a heart attack

• 40% of hypertensive patients can’t identify their medicine

A Glance at Patient Compliance.

• 60% of asthmatic adults don’t properly use inhalers

• 54% of U.S. adults don’t get annual flu shots

• 50% of diabetic patients are non-adherent to Rx regimens

• 49% of eligible adults have not received CRC screening

• 40% of adults don’t know signs of a heart attack

• 40% of hypertensive patients can’t identify their medicine

Do Patients Understand their Role?

A Problem from the Beginning.• 55% of children under-use preventive asthma medicine

• 50% of young adults w/ chronic conditions do not successfully transition from pediatric to internal medicine

• 33% of young adults lack knowledge of meningitis risk and symptoms

• 20% of teens 15-19 years old report not using contraception during last intercourse episode

• 17% of children taking Rx drugs will experience a dosing error (leading to 250,000 adverse events annually)

Medication Error.• Most common form of medical error.

• > 500,000 preventable adverse drug events (ADEs) occur in ambulatory care annually.1

• Cost: > $1 Billion/year

• Majority of studies among adults

• Recent surveillance (2001): 250,000 ADEs occur in children and adolescents in outpatient settings annually2

• 1 in 6 children taking an Rx drug will experience a medication dosing error

1Institute of Medicine, Preventing Medication Error, 2006

2Cohen, Budnitz, Weidenbach, et al. J Ped 2008

Root Cause – Misunderstanding.• IOM 2006/2008 reports identifies unintentional misuse a

leading root cause

• In outpatient care, patients and their families assume quality control, NOT physicians

• MEPS Data (1996-2003) shows increasing trend – patients of all ages taking more Rx drugs

Do patients and families

have the necessary skills?

Understanding and Promoting Health Literacy

Help patients and families:

Understand their health & healthcare

Translate knowledge to recommended actions

Apply problem-solving skills to new situations

Foster ongoing health learning opportunities

Instill health-promoting attitudes

Understanding and Promoting Health Literacy

Help patients and families:

Understand their health & healthcare

Translate knowledge to recommended actions

Apply problem-solving skills to new situations

Foster ongoing health learning opportunities

Instill health-promoting attitudes

Understanding and Promoting Health Literacy

Help patients and families:

Understand their health & healthcare

Translate knowledge to recommended actions

Apply problem-solving skills to new situations

Foster ongoing health learning opportunities

Instill health-promoting attitudes

Understanding and Promoting Health Literacy

Help patients and families:

Understand their health & healthcare

Translate knowledge to recommended actions

Apply problem-solving skills to new situations

Foster ongoing health learning opportunities

Instill health-promoting attitudes

Understanding and Promoting Health Literacy

Help patients and families:

Understand their health & healthcare

Translate knowledge to recommended actions

Apply problem-solving skills to new situations

Foster ongoing health learning opportunities

Instill health-promoting attitudes

Health Literacy

Simplified Model of Health LearningWolf, Wilson et al. Pediatrics 2009

Reading and Beyond

Health Literacy: What We Know• Use of preventive services

• Delayed diagnoses

• Understanding of medical condition

• Adherence to medical instructions

• Self-management skills

• Risk of hospitalization

• Physical and mental health

• Mortality risk

The Impact of Limited Health Literacy

$106 -230 billion per year

- Friedland, 2002, Vernon et al. 2007

Understanding Primary Rx Label Instructions: “Take Two Tablets by Mouth Twice Daily”

AdequateMarginalLow

Patient Literacy Level

100.00

80.00

60.00

40.00

20.00

0.00

Corr

ect (%

)

80.2

62.8

34.7

89.484.1

70.7

Demonstration of LabelInstructions

Understanding of LabelInstructions

Wolf et al, Annals of Internal Medicine, 2006

1:51:32:3

individual abilities vary…

yet messages are often unclear

The Goal for Public Health & Medicine.

Find Ways to Match Healthcare to Average User Ability

CLOSE THE GAP

Contextualize the Problem.

Health Literacy Targets.

• Individual skills – improve learning & retention

• Health materials – examine modality, improve design

• Clinician skills – consider communication strategies

• Health system design – human factors

Health Literacy Targets.

• Individual skills – improve learning & retention

• Health materials – examine modality, improve design

• Clinician skills – consider communication strategies

• Health system design – human factors

Comprehensive Strategies Needed!

An Abundance of Low-Hanging Fruit.

Preeclampsia (prē-i-klam(p)sē-ә\): a serious condition developing in late pregnancy that is characterized by a sudden rise in blood pressure, excessive weight gain, generalized edema, proteinuria, severe headache, and visual disturbances and that may result in eclampsia if untreated.

Variability in the Message…Lipitor 10 mg tabs

Take one tab QD

Dispense #30

Indication: for high cholesterol

No refills

- "Take one tablet daily.“- "Take 1 tablet by mouth for high cholesterol.“- "Take one (1) tablet(s) by mouth once a day.“- “Take one tablet by mouth every day for high cholesterol."

Fosamax 5 mg tabs

Take one tab QD

Dispense #30

Indication: osteoporosis prevention

Do not lie down for at least 30 minutes

- “Take 1 tablet by mouth daily.“- "Take one tablet by mouth every day for osteoporosis prevention. Do not lie

down for at least 30 minutes after taking.“- "Take 1 tablet every day, 30 minutes before breakfast with a glass of water.

Do not lie down.“- “Take one tablet every day.”

Bactrim DS tabs

Take one tab BID

Dispense #6

Indication: UTI

No refills

- "Take one tablet by mouth twice daily for UTI“- "Take one tablet by mouth twice daily for urinary tract infection.“- "Take 1 tablet by mouth 2 times a day.“- "Take 1 tablet twice daily for 3 days."

Ibuprofen 200 mg tabs

Take 1-2 tabs TID PRN pain

Dispense #30

No refills

- "Take 1 to 2 tablets by mouth as needed for pain.“- "Take 1 to 2 tablets by mouth three times daily as needed for pain.“- "Take 1 to 2 tablets by mouth as needed for pain ** Not to exceed 4 times a

day“- "Take 1 to 2 tablets 3 times a day as needed for pain."Bailey, et al., Annals of Pharmacotherapy, 2009

53 Different Ways to Say ‘Take 1 Tablet a Day’

Take one tablet by mouth once daily.

Take 1 tablet one time each day.

Take one pill by mouth at bedtime.

Take one tablet for cholesterol.

Take one pill by mouth once each day.

Take one tablet orally once every day.

Take 1 tablet by mouth every morning.

Take 1 tablet 1 time daily.

Variability in the Interpretation...Lipitor 10 mg tabs

Take one tab QD

Dispense #30

Indication: for high cholesterol

No refills

- "Take one tablet daily.“- "Take 1 tablet by mouth for high cholesterol.“- "Take one (1) tablet(s) by mouth once a day.“- “Take one tablet by mouth every day for high cholesterol."

Fosamax 5 mg tabs

Take one tab QD

Dispense #30

Indication: osteoporosis prevention

Do not lie down for at least 30 minutes

- “Take 1 tablet by mouth daily.“- "Take one tablet by mouth every day for osteoporosis prevention. Do not lie

down for at least 30 minutes after taking.“- "Take 1 tablet every day, 30 minutes before breakfast with a glass of water.

Do not lie down.“- “Take one tablet every day.”

Bactrim DS tabs

Take one tab BID

Dispense #6

Indication: UTI

No refills

- "Take one tablet by mouth twice daily for UTI“- "Take one tablet by mouth twice daily for urinary tract infection.“- "Take 1 tablet by mouth 2 times a day.“- "Take 1 tablet twice daily for 3 days."

Ibuprofen 200 mg tabs

Take 1-2 tabs TID PRN pain

Dispense #30

No refills

- "Take 1 to 2 tablets by mouth as needed for pain.“- "Take 1 to 2 tablets by mouth three times daily as needed for pain.“- "Take 1 to 2 tablets by mouth as needed for pain ** Not to exceed 4 times a

day“- "Take 1 to 2 tablets 3 times a day as needed for pain."Wolf, et al., Medical Care, 2009

Goal: Reduce Cognitive Load.

• Provide plain language directions

• Be concise, explicit

• Sequence information w/ consumer perspective

• Use meaningful visual aids only!

Goal: Reduce Cognitive Load.

• Provide plain language directions

• Be concise, explicit

• Sequence information w/ consumer perspective

• Use meaningful visual aids only!

Do not use if - you are pregnant- think you are pregnant- breastfeeding

Unnecessary Complexity

Michael Wolf04/29/71

Glyburide 5mg

Take for Diabetes

Take: 2 pills in the morning 2 pills in the evening

Noon11-1 PM

Evening 4-6 PM

Bedtime 9-11 PM

2 2

Morning7-9 AM

Do not drink alcoholic beverages while taking this medicine

Carry or wear medical identification stating you are taking this medicine

You should avoid prolonged or excessive exposure to direct and/or artificial sunlight while taking this medicine

Rx #: 1234567 9/8/2009

You have 11 refills

180 pills

Discard after 9/8/2010

Provider: RUTH PARKER, MD Emory Medical Center (414) 123-4567

Pharmacy: NoVA ScriptsCentral 11445 Sunset Blvd. Reston, VA (713) 123-4567

NDC # 1234567

Reprogramming the Rx Label.

Standardize Dosage Devices.Pediatric Dosing Instruction Sheets

Yin, Dreyer, van Schieck, Arch Pediatr Adol Med 2008

Provider Communication Skills.

Three common strategies:

• ‘Teach Back’ (Current recommended standard)

• Teach-to-Goal (Learning Mastery)

• Guided Imagery (Implementation Intention)

Provider Communication Skills.

Three common strategies:

• ‘Teach Back’ (Current recommended standard)

• Teach-to-Goal (Learning Mastery)

• Guided Imagery (Implementation Intention)

Provider Communication Skills.

Three common strategies:

• ‘Teach Back’ (Current recommended standard)

• Teach-to-Goal (Learning Mastery)

• Guided Imagery (Implementation Intention)

Provider Communication Skills.

Three common strategies:

• ‘Teach Back’ (Current recommended standard)

• Teach-to-Goal (Learning Mastery)

• Guided Imagery (Implementation Intention)Guided Imagery (Implementation Intention)

Action-Oriented Self Care.

ACP Guide: a Low literacy, print self-care tool

• Brief, plain language messages

• Supportive pictures, graphics

• Patient narratives

• Chunked information

• Non-linear approach

Education is not a One-Time Endeavor!

• Follow-up necessary to move patients forward. • Front load activities. • ACP Guide – min. 6 follow-up calls or in-person

encounters

0 1 2 3 4 5 6 7 8 9 10 11 12

Baseline clinic visitTelephone call follow-upClinic visit OR telephone call follow-up

Carve-In vs. Carve-Out?

Standards Needed.

• Health materials

• Communication training (“universal precautions”)

• Coordination of care processes

• Measurement/evaluation indicators

Set Policy, Health Provider Incentives

• Medicare Part D: Medication Therapy Management

• KP Plan: Stanford Patient Self-Management

Teach Roles & Responsibilities.• Use schools to familiarize youth

with health system

• Identify roles by age group

• Train children and teens on specific health skills

• Opportunities for family education

• The value of anticipatory guidance!

September 30, 2009

Change can happen…

Contact Information:

Michael S. Wolf, PhD MPHAssociate Professor, Medicine & Learning SciencesAssociate Division Chief – ResearchDivision of General Internal MedicineNorthwestern University Feinberg School of Medicine750 N. Lake Shore Drive, 10th FloorChicago, IL 60611(312) 503 – 5592mswolf@northwestern.edu