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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

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  1. 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# One Label One Mission One VA 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 • 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 • 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 ACEI BETA BLOCKERS STATINSs ACEI Beta blockers Ho et al; Am Heart J 2008 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 772-779

  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 RxsDOD8% • 7,276 Pharmacist and 4,149 Pharmacy Techs are employed by VA. • VA Rx labels are not standardized.

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

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

  12. If you said “1” you and42% of Veterans Answered Correctly

  13. The words we use make a difference to the Veteran!

  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. * Flesh-Kincaid Grade Level as determined by Microsoft Word® Version 2007

  18. More words do not always increase understanding. * Flesh-Kincaid Grade Level as determined by Microsoft Word® Version 2007

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

  20. Demographics of Veteran Participants

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

  22. Vets Don’t read the Rx label Everytime

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

  24. 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?

  25. 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

  26. California State Board of Pharmacy Survey

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

  28. 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.

  29. USABILITYLast 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.

  30. USABILITYLarger font is preferred

  31. USABILITYVeterans prefer bolded sig:

  32. USABILITY Vets prefer selective highlights

  33. California State Board of Pharmacy Survey

  34. USABILITYWhen 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.

  35. 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% .

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

  37. 8 Million ½ Tab Prescriptions • 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? 18,414

  38. 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

  39. 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”

  40. 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

  41. 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

  42. What does meals mean?

  43. Veterans had no preference Pharmacy staff preferred A

  44. Veterans & Rx staff prefer Vet name at top of label

  45. Veterans & Rx staff prefer Vet name at top of label

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

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

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