Ruth M. Parker, MD Professor of Medicine, Pediatrics, and Public Health Emory University

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1 Ruth M. Parker, MD Professor of Medicine, Pediatrics, and Public Health Emory University

2 Medication Labels Common We take a lot of Rx meds $$$ Confusing puzzling Frustrating Could be better

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4 Patients

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6

7 One capsule twice daily One tablet by mouth twice a day for 3 days One tablet two times a day One tablet by mouth twice a day Tomar 1tab XLA boca vezdia X7 dias luego do XLA boca X7 dias Take one by mouth 3? Times a day Take as directed

8 OTC Drug Facts

9 A Broken System of Patient R x Information Rx Labeling

10 Prescribers

11 Prescription Examples of Take 1 Tablet Daily

12 Same Physician Uses Different Sig for Once Daily Medicine

13 Pharmacists/Pharmacies

14 Pharmacist Transcription Variability For Take 1 Tablet Daily

15 What Constitutes the Label? 1) Container Label 3) Package Insert 2) Consumer Medication Information (CMI) 4) Medication Guide William H. Shrank, MD, MSHS, Nov. 2006

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17 Research

18 Variability in the Sig 53 Different Ways to See Take one Tablet a Day Bailey, et al., Annals of Pharmacotherapy, 2009 And the Translations Lipitor 10 mg tabs Take one tab QD Dispense #30 Indication: for high cholesterol No refills Fosamax 5 mg tabs Take one tab QD Dispense #30 Indication: osteoporosis prevention Do not lie down for at least 30 minutes Wolf, et al., Medical Care, "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." - 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.

19 Bottom Lines Labels simple. not clear Mistakes are common Ability to read label does not mean correct interpretation Mistakes more likely the more meds patients take Variability of dosing instructions is source of confusion

20 Biggest lesson from the field Patients/consumers are the real experts partner with them

21 Health Literacy Framework (Parker) Skills/Ability Demands/Complexity

22 A Need to Consolidate Wolf et al Arch Intern Med 2011

23 Reprogram the R x Label 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 Michael Wolf 04/29/71 Glyburide 5mg Take for Diabetes Take: Morning 7 9 AM 2 pills in the morning 2 pills in the evening Noon 11 1 PM Evening 4 6 PM 2 2 Bedtime 9 11 PM Rx #: /8/2009 You have 11 refills 180 pills Discard after 9/8/2010 Provider: RUTH PARKER, MD Emory Medical Center (414) Pharmacy: NoVA ScriptsCentral Sunset Blvd. Reston, VA (713) NDC #

24 Reduce Cognitive Load plain language Sequence w/ consumer perspective ONLY meaningful visual aids

25 Reprogram-- Default Sigs Epic EHR view

26 Pediatric Liquid Medication Errors Dosing instruments? Concentrations Units ml/cc/tsp/tbsp

27 September 22, 2009

28

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

30 September 30, 2009

31 Timing Focus on Quality

32 Come to AHRQ tell us about health literacy and patient safety And now go make some links

33 A Matter of Patient Safety Patients taking more (3 Bil Rx written/yr; adult fills 12 Rx/yr) Elderly fill 30Rx/year, from 8 docs Hospitalization and death increased 9 fold ( ) due to outpatient med errors Medication error and adverse events cost $50 B/yr Need systems approach

34 Health Literacy and Quality Health literacy linked to selfmanagement as cross cutting priority (2003)

35

36 collaboratives

37 At intersection of health literacy and patient safety Members: Carolyn Clancy, AHRQ Frank Frederico, IHI Charles Ganley, FDA Will Shrank, Harvard Scott Smith, AHRQ Roger Williams, USP Albert Wu, Hopkins Alaister Wood, Symphony Capital Ruth Parker, Emory Co chair Mike Wolf, Northwestern Co chair

38

39 Those links Influencers

40 Influencers included HHS AHRQ, FDA, HRSA, CDC, ODPHP, NLM Legislators federal & state; new CA law Advocacy Latino Coalition for Healthy CA, National Consumers League, others Standard setting bodies USP, NCPCP Prof Societies AMA, ACPF, AAP, AAFP, ASHP, AACP, APAF, others Pharmaceutical Manufacturers several Media

41 Health Literacy Exposure Television and Radio

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43 WARNING LABELS: A NATIONAL CONCERN New York Times (October 25, 2005) CBS Early Morning News (October 28, 2005) CBS/ABC Evening News (currently aired locally) Forbes Magazine (to be released)

44 PARTNERSHIPS IN HEALTH Steering Committee on Health Literacy Nation s leading experts in health literacy and policy define the scope and objectives of program Members include: Terry Davis, PhD Nicole Lurie, MD, MSPH Scott Ratzan, MD, MPH Bruce A. Scott, MD Reed Tuckson, MD Julie Gazmararian, PhD, MPH Ruth Parker, MD (Chair) J. Sanford Schwartz, MD, MBA Stephen A. Somers, MD Barry Weiss, MD

45 Healthy People /11/2014 Linda Lloyd, HRSA Center for Quality 45

46 a wall between us and the people we were trying to serve Dr. Richard Carmona, U.S. Surgeon General, mentioned health literacy in 200 of last 260 speeches

47 IOM

48 Efforts to improve quality, to reduce costs and to reduce disparities cannot proceed without simultaneous improvements in health literacy.

49 So by 2007 Skills/Ability Demands/Complexity

50 Using lesson of health literacy to build patientcentered outcomes for safe use Roundtable workshop,2010

51

52 We envisage a society in which people have the skills they need to obtain, interpret, and use health information effectively and within which a wide variety of health systems and institutions take responsibility for providing clear communication and adequate support to facilitate health promoting actions.

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