1. Promoting Safe & Appropriate Drug Use a health literacy perspective Michael S. Wolf, PhD MPH Associate Professor, Medicine & Learning Sciences Associate Division Chief, General Internal Medicine Feinberg School of Medicine Northwestern University Chicago, IL, USA 2 nd Annual Julia Berg Memorial Lecture – University of Minnesota Department of Pediatrics

2. 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

3. A Prescription for Confusion. Mother Master’s degree health educator Father General internist Daughter 6 years old with diagnosis of H1N1 influenza (‘swine flu’)

5. September 22, 2009

6. ¾ teaspoon dose: 5 ml (volume of teaspoon) x.75 x 12 mg per ml Tamiflu suspension = 45 mg on syringe September 22, 2009

7. 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

8. 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?

9. 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)

10. 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 annually 2 1 in 6 children taking an Rx drug will experience a medication dosing error 1 Institute of Medicine, Preventing Medication Error, 2006 2 Cohen, Budnitz, Weidenbach, et al. J Ped 2008

11. 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?

12. 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

13. 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

14. 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

15. 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

16. 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

17. Health Literacy Simplified Model of Health Learning Wolf, Wilson et al. Pediatrics 2009 Reading and Beyond

18. 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

19. The Impact of Limited Health Literacy $106 -230 billion per year - Friedland, 2002, Vernon et al. 2007

20. Understanding Primary Rx Label Instructions: “Take Two Tablets by Mouth Twice Daily” Wolf et al, Annals of Internal Medicine, 2006 1:51:32:3

21. individual abilities vary…

22. yet messages are often unclear

25. The Goal for Public Health & Medicine. Find Ways to Match Healthcare to Average User Ability CLOSE THE GAP

26. Contextualize the Problem.

28. Health Literacy Targets. Individual skills – improve learning & retention Health materials – examine modality, improve design Clinician skills – consider communication strategies Health system design – human factors

29. 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!

30. An Abundance of Low-Hanging Fruit.

31. 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.

32. 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.

33. 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

36. Goal: Reduce Cognitive Load. Provide plain language directions Be concise, explicit Sequence information w/ consumer perspective Use meaningful visual aids only!

37. 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

38. Unnecessary Complexity

39. Michael Wolf 04/29/71 Glyburide 5mg Take for Diabetes Take: 2 pills in the morning 2 pills in the evening Noon 11-1 PM Evening 4-6 PM Bedtime 9-11 PM 22 Morning 7-9 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 R x Label.

40. Standardize Dosage Devices. Pediatric Dosing Instruction Sheets Yin, Dreyer, van Schieck, Arch Pediatr Adol Med 2008

41. Provider Communication Skills. Three common strategies: ‘Teach Back’ (Current recommended standard) Teach-to-Goal (Learning Mastery) Guided Imagery (Implementation Intention)

42. Provider Communication Skills. Three common strategies: ‘Teach Back’ (Current recommended standard) Teach-to-Goal (Learning Mastery) Guided Imagery (Implementation Intention)

43. Provider Communication Skills. Three common strategies: ‘Teach Back’ (Current recommended standard) Teach-to-Goal (Learning Mastery) Guided Imagery (Implementation Intention)

44. Provider Communication Skills. Three common strategies: ‘Teach Back’ (Current recommended standard) Teach-to-Goal (Learning Mastery) Guided Imagery (Implementation Intention)

45. 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

46. 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 visit Telephone call follow-up Clinic visit OR telephone call follow-up Carve-In vs. Carve-Out?

47. 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

48. 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!

49. September 30, 2009 Change can happen…

50. 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, 10 th Floor Chicago, IL 60611 (312) 503 – 5592 mswolf@northwestern.edu mswolf@northwestern.edu