1. IOM 20 06 ACPF 200 6/2 007 VA NCPS 200 7 NABP 200 8/20 09 USP 200 8/20 09 CA Senate Bill 472 AFB 200 8 Rx# Patient Name Patient-Centered VA Prescription Label Project VA National Center for Patient Safety (10X) Keith W. Trettin, RPh, MBA and Erin Y.N. Narus, PharmD, RPh PROJECT DESCRIPTION Use an evidence-based, patient- centric evaluation model to determine preference for a standardized national VA prescription label which enhances Veteran comprehension and satisfaction over current VA prescription labels. Patient Name Rx# Patient Name Rx# Patient Name

2. NCPS Database 644 Cases involving Rx + label 2000-2011 DOD 2659 Cases of OP Mislabeling Event Reports. FY09-Sept 11. “Glyburide 5mg tablets take two tablets by mouth twice a day ( half an hour before a meal )”. Prescription written for glyburide 10mg BID AC. Patient misunderstood directions and was taking his glyburide before every meal three times a day resulting in hypoglycemia. Label changed to read twice a day half an hour before breakfast and dinner. "Take one tablet by mouth every day for heart give x 2 doses only (start 8 hours after the initial 250mcg now dose is given). Asked pt how he was taking his digoxin and pt reported "twice daily just as the label says". 1229 Cases involving ½ tablet incidents 2005-2009 “Take one half tablet daily for blood pressure”. Pt called the pharmacy stating he would run out of lisinopril before the refill date. The prescription was for lisinopril 10mg tablet, In talking to the pt it was found he had been taking a whole tablet instead of splitting the tablet and taking only one half daily. The pt was instructed to take just half of the tablet for each dose.

3. Health Literacy, and Prescription labels, Why should we be concerned? 12% of adults have proficient health literacy and can interpret a Rx label correctly! AHRQ Pharmacy Health Literacy Center 30% of patients inadequate health literacy were able to state how many pills of a prescription should be taken. * 54% of patients can interpret primary label Wolf, et al. Ann Intern Med 2006 75% of patients with inadequate health literacy were able to correctly state how to take a medication four times a day!* * Williams MV, Parker RM, Baker DW, et al. Inadequate functional health literacy among patients at two public hospitals. JAMA. 1995; 274:1677- 1682

4. Others have Identified a need for a patient centric label American College of Physicians Foundation (ACPF) 2007“ Improving Prescription Drug Container labeling in the United States” http://www.acpfoundation.org/files/medlabel/acpfwhitepaper.pdf http://www.acpfoundation.org/files/medlabel/acpfwhitepaper.pdf NABP “Report of the Task Force on Uniform Prescription Labeling Requirements.” Dec 2008 http://www.nabp.net/ftpfiles/NABP01/08TF_Uniform_Presc_Labeling_Req.pdf USP,”Standardizing Medication Label, Confusing Patients Less” 2008 http://www.nap.edu/catalog.php?record_id=12077 NABP Model State Act, Aug 2009 http://www.nabp.net/index.html?target=/annualmeeting/CTFR.asp&

5. Others have Identified a need for a patient centric label California State Board of Pharmacy CA Senate Bill 472 required Board to promulgate regulations for a standardized, patient-centered Rx label. To be implemented by 2011. http://www.pharmacy.ca.gov/meetings/agendas/2009/09_jul_bd_pubed.pdf http://www.pharmacy.ca.gov/meetings/agendas/2009/09_jul_bd_pubed.pdf American Federation for the Blind Use light background such as pale yellow Don’t use all CAPS Use bold type face for most important information http://www.afb.org/Section.asp?SectionID=3&TopicID=329&DocumentID=406 Medication Safety for Veterans: Revising the Drug Container Label, A White Paper Prepared for the Amarillo Texas Veterans Affairs Medical Center and the Veterans Affairs National Center for Patient Safety Cynthia L. Raehl, Pharm.D., FASHP, FCCP

6. Adherence With Medications Associated with Improved Outcomes STATINSsACEIBeta blockers P. Michael Ho, et al. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease American Heart Journal Vol. 155, Issue 4, Pages 772-779et al. Ho et al; Am Heart J 2008 ACEI BETA BLOCKERS

7. Nonadherence causes $100 Billion in annual wasteful health care spending* *National Priorities Partnership April 2011

8. Test Your Knowledge HOW MANY PRESCRIPTIONS DOES THE VA FILL DAILY?  3,727  37,270  372,700  3,727,000  Too many to count. VA 372,700 DOD 365,196 *VHA Statistics EOY FY 20010

9. What we know! (FY 2010) 21 Million Veterans, 4.6 Million used the VA Pharmacy 3%/yr growth DOD 7.1 Million 136 Million RXs were filled by VA Pharmacies 4%/yr DOD 133 Million $3,284 Million spent by VA on drugs. 4%/yr CMOPs filled 77% of all Rxs DOD8% 7,276 Pharmacist and 4,149 Pharmacy Techs are employed by VA. VA Rx labels are not standardized.

10. Tell what this picture means. Chew before swallowing Do not refrigerate. Dissolve in full glass of water. Avoid the sun while taking this medicine. Test Your Knowledge Veterans rated pictures as the LEAST Understood & LEAST Important part of the Rx label.

11. Test Your Knowledge How many do you take in a day?

12. If you said “1” you and 42% of Veterans Answered Correctly NUMBER OF PILLS IN 1 DAY % of respondents One42% Two3% Three38% Depends on how many meals I eat13% Don’t know4%

13. The words we use make a difference to the Veteran! NUMBER OF PILLS % of respondents One81% Two8% Four4% Don’t know7% NUMBER OF PILLS % of respondents One42% Two3% Three38% Depends on how many meals I eat13% Don’t know4%

14. Aren’t VA Labels Clear Already?

15. Aren’t VA Labels Clear Already?(7.8)

16. Aren’t VA Labels Clear Already?(6.5)

17. More words do not always increase understanding. Prescription label Grade level to understand* Take one capsule by mouth three times a day for pain. 1.5 Take one capsule by mouth three times a day for pain and spasticity. 4.9 Take one capsule by mouth three times a day for pain and spasticity. (Approved by Chief of staff) 6.5 Take one tablet by mouth at bedtime and take one tablet at bedtime as needed. 5.9 Take one tablet by mouth at bedtime and take one tablet at bedtime as needed for depression & mood. 7.8 * Flesh-Kincaid Grade Level as determined by Microsoft Word® Version 2007

18. More words do not always increase understanding. Auxiliary label Grade level to understand* May cause drowsiness. 5.2 Warning: May cause drowsiness. Alcohol may intensify this effect. USE CARE when driving or when operating dangerous machinery 10.3 Warning: This medicine may be taken with or without food. 6 th Grade but is it necessary? * Flesh-Kincaid Grade Level as determined by Microsoft Word® Version 2007

19. 446 Veterans at 11 Survey Sites & 697 Pharmacist/ Technician Participated

21. Demographics of Veteran Participants VA Rx Users Study Participants Age50% > 65 Yr49%>60 yr Gender93% Male84% Male High School +77.7%97% Ethnicity80% White 13% Black 3% Hispanic <1% Asian 45% White 34% Black 14% Hispanic (50% spoke Spanish as their primarily language at home.) 2% Asian 6% American Indian/Alaska Native 93% of the respondents were Veterans; 7% were their caregivers.

22. Prescriber TYPICAL VA Prescription Label Patient name Directions for use Drug name “Use by” Date Pharmacy name & phone # “Fill Date” Rx # Drug Qty # Refills Product Description Fed/State Cautions Refill number 66% of respondents were satisfied with their current label! Aux Info

23. Vets Don’t read the Rx label Everytime REFERENCE TO INFORMATION ON THE LABEL NeverOnceSometimesEvery time Drug name1%10%17%72% Instructions1%17%27%55% Veteran’s name4%25%15%56% Doctor’s name8%28%29%35%

24. WHAT VETERANS IDENTIFIED AS MOST IMPORTANT Patient name Directions for use Drug name “Use by” Date Pharmacy name & phone # Prescriber “Fill Date” Rx # Drug Qty # Refills Product Description Fed/State Cautions Aux Info Refill number

25. % VETERAN IMPORTANCE OF LABEL INFORMATION N= 446 Not Important 234 Very Important Dosage instructions111988 Drug name1131085 Veteran’s name226783 Fill number (2 of 3)3361672 Number of refills left2361871 Rx number7471171 Quantity of pills23112163 Filled date44102062 VAMC phone number6691861 Discard date710121655 Written warnings (take w/food, etc.)45152254 Doctor’s name56162152 Description of pills (shape, color)78142150 VAMC facility name1112131846 Pictures (relating to take w/food, etc.)1712181637

26. Sub Analysis Satisfied with current label Ethnicity White, Black, Spanish and Native Americans Spanish as the primarily language at home Education Age Gender Color Blind Need corrective devices to read? Do you need help to complete forms?

27. Importance of label information African Americans were more likely than people of other races to rate the following information as very important: VAMC facility name (53% vs. 40%) P=.030 Discard date (69% vs. 47%)P=.001 Quantity of pills (71% vs. 58%)P=.05 Pictures relating to written warnings (48% vs. 30%)P=.005 Doctor’s name (61% vs. 47%)P=.006

28. California State Board of Pharmacy Survey

29. WHAT PHARMACY STAFF IDENTIFIED AS MOST IMPORTANT Patient name Directions for use Drug name “Use by” Date Pharmacy name & phone # Prescriber “Fill Date” Rx # Drug Qty # Refills Product Description Fed/State Cautions Aux Info Refill number

30. % PHARMACY STAFF IMPORTANCE OF LABEL INFORMATION N=697 Not Important 234 Very Important Patient name212392 Drug name112591 Dosage instructions122491 Quantity of pills1151479 Rx number44131663 Doctor’s name54132058 Filled date47132551 Description of pills (shape, color)47172250 Written warnings (take w/food, etc.)77172049 Fill number (2 of 3)69192739 Number of refills left10 192536 VAMC phone number2116141336 Pictures (relating to take w/food, etc.)1514211832 VAMC facility name1619171632 Discard date1416192031

31. USABILITY # Of Refills Remaining 58/59% of Veterans respectively could identify one refill was remaining 64% of the Veterans said they prefer Label B. 37% of Pharmacy Staff felt Label A was confusing to themselves/Vet 76% of Pharmacy Staff prefer Label B.

32. USABILITY Last Date to Order Refills 67/71% of Veterans respectively could identify correct date Two-thirds (65%) of the Veterans said they prefer Label B. 75% of Pharmacy Staff prefer Label B.

33. USABILITY Larger font is preferred PREFERRED LABEL FOR INSTRUCTIONS % of respondents A much easier69% A a little easier10% A and B are equal12% B a little easier4% B much easier5%

34. USABILITY Veterans prefer bolded sig: PREFERRED LABEL FOR INSTRUCTIONS % of respondents A much easier14% A a little easier7% A and B are equal31% B a little easier16% B much easier32%

35. USABILITY Vets prefer selective highlights PREFERRED LABEL FOR INSTRUCTIONS % of respondents A much easier than B29% A little easier than B12% A and B are equal33% B a little easier than A10% B much easier than A16%

36. California State Board of Pharmacy Survey

37. USABILITY When medication should be discarded 77/76% of Veterans respectively could identify correct date 65% of the Veterans said they prefer Label A. 69% of Pharmacy Staff prefer Label A.

38. How we ask a Vet to take ½ tablet makes a difference! TAKE ½ (ONE-HALF) TABLET BY MOUTH… 88% gave the correct response. TAKE ONE-HALF TABLET BY MOUTH… 86% TAKE ONE-HALF (12.5 MG) TABLET… 82% TAKE ½ TABLET BY MOUTH … 80%.

39. Test Your Knowledge HOW MANY ½ TABLET PRESCRIPTIONS DID THE VA FILL IN FY 2011? 8,068,401 *VHA Statistics EOY FY 2011

40. 8 Million ½ Tab Prescriptions 18,414  2.9 Million Veterans  59.2% of all Veterans  VAMC Variance 25-75%  Many different ½ tablet Sig codes  TAKE 1/2 TO 1 TABLET BY MOUTH AS DIRECTED TAKE ONE TABLET IN AM ONLY IF NEEDED AND ONE AND ONE/HALF TABLETS AT BEDTIME ONLY WHEN NEEDED FOR ANXIETY/SLEEP- DO NOT EXCEED PERSCRIBED DOSE. DECREASE AS TOLERATED;DO NOT STOP SUDDENLY.  TAKE 2 AND A HALF OR 3 TABLETS BY MOUTH AT BEDTIME  TAKE ONE AND ONE-HALF TABLETS BY DISSOLVING UNDER THE TONGUE EVERY DAY APPROVED FOR WINDOW PICK-UP 4-6-11; COVERS 4-6-11 TO 4-11  TAKE ONE AND ONE-HALF TABLETS BY MOUTH AT BEDTIME -MAY CAUSE DROWSINESS -DO NOT DRINK ALCOHOL -TAKE WITH FOOD FOR INSOMNIA--MAY TAKE LESS THAN ONE AND ONE-HALF TABLETS TEST Your Knowledge: How many ½ tablet Sig Codes were used in FY11?

41. ½ Tab Education Differences People with educations of some college or more were more likely than those with educations of high school or less to respond correctly to these questions: Take ½ (one half) tablet by mouth in the morning and the evening (92% vs. 78%) P=.001 Take one-half tablet by mouth in the morning and in the evening (93% vs. 74%) P=.001 Take one-half (12.5MG) tablet by mouth in the morning and in the evening (88% vs. 71%) P=.001 Take ½ tablet by mouth in the morning and in the evening (86% vs. 66%) P=.001

42. Numeracy Number of pills in one day TAKE 1 TABLET BY MOUTH IN THE MORNING AND EVENING 89% TAKE 1 TABLET BY MOUTH TWICE DAILY – 89% TAKE 1 TABLET BY MOUTH TWICE DAILY WITH FOOD – 85% TAKE 1 TABLET BY MOUTH ONCE DAILY WITH FOOD – 81% TAKE 1 TABLET BY MOUTH ONCE DAILY WITH MEALS - 75% TAKE 1 TABLET BY MOUTH TWICE DAILY WITH MEALS 75% TAKE ONE TABLET BY MOUTH DAILY WITH MEALS – 42% 70% of Rx staff preferred using “food”

43. General Numeracy Caregivers are more likely to be correct. P=.0239 More formal education the more likely to be correct. P=.0331 White and non-hispanic are more likely to be correct. P=.0288 Older Vets are more likely to be incorrect. P=.0004

44. TAKE ONE TABLET BY MOUTH DAILY WITH MEALS 42% Spanish ethnicity answered correctly 59% vs 40% P=.013 Spanish speaking at home answered correctly 60% vs 41% by English speaking P=.042

45. What does meals mean? MEALS WITH WHICH TO TAKE THE MEDICATION Veteran %Rx % With 2 meals Breakfast and supper68%88% Breakfast and bedtime snack6%2% Lunch and supper5%1% Breakfast and lunch4%1% With 1 meal Breakfast only5%1% (2Rx,2T) Supper only3% Lunch only3% Bedtime snack only1% With 3 or 4 meals Breakfast, lunch and supper3%3% (5Rx,12T) Breakfast, lunch, supper and bedtime1%3% (7Rx, 10T) Don’t know 1%

46. VETERANS PREFERENCE % of respondents A much better34% A a little better8% A and B are equal13% B a little better12% B much better34% Veterans had no preference Pharmacy staff preferred A PHARMACY PREFERENCE % of respondents A much better44% A a little better10% A and B are equal3% B a little better19% B much better24%

47. Veterans & Rx staff prefer Vet name at top of label VETERAN PREFERRED LABEL % of respondents A much better26% A a little better10% A and B are equal12% B a little better16% B much better36% PHARMACY PREFERRED LABEL – % of respondents A much better30% A a little better8% A and B are equal2% B a little better21% B much better39%

48. Veterans & Rx staff prefer Vet name at top of label VETERAN PREFERRED LABEL % of respondents A much better46% A little better8% A and B are equal16% B a little better9% B much better21% PHARMACY STAFF PREFERRED LABEL % of respondents A much better53% A a little better16% A and B are equal3% A a little better13% B much better15%

49. VA PATIENT CENTRIC PRESCRIPTION LABEL, PREFERRED BY 64% OF VETS AND 62% OF PHARMACY STAFF Patient name Directions for use Drug name “Use by” Date Pharmacy name & phone # Prescriber “Fill Date” Rx # Drug Qty # Refills Product Description Aux Info Fed/State Cautions Use ½ (one half) Highlighting & bolding of patient centered info Avoid jargon Sans serif, min. 12 pt font

50. The VA is not the first to adopt a Patient-Centric Prescription label. Let us not be the last!

51. Next Steps Trial Advisory Group Established Eliminate jargon now! Trial at Charleston CMOP and VISNs 6, 7, 8- June 4 start. ScriptPro Reps will contact VAMC to setup exact date. VAMC Pharmacy to specify POC. Scriptpro and Optifill label format setup. Veteran Education Letter. Veteran Monitor.

52. Questions?