Wisconsin Health Literacy Conference Keith W. Trettin R Wisconsin Health Literacy Conference Keith W. Trettin R.Ph;, MBA Program Manager (Retired) VA National Center for Patient Safety 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. Rx# Patient Name Patient Name Rx# One Label One Mission One VA Rx# Patient Name IOM 2006 ACPF 2006/2007 VA NCPS 2007 NABP 2008/2009 USP CA Senate Bill 472 AFB 2008

644 Cases involving Rx + label 2000-2011 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.

VA Rx Benefit! 24 Million Vets in 2013, 4.87 Million users of the RX benefit. DOD 7.1 M 136 Million RXs were filled by VA Pharmacies 4%/yr 60M in 1995.DOD 133 M 142,986,291 OP Rx filled in FY13 at a cost of $3.3 Billion 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.

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

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

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!

% VETERAN IMPORTANCE OF LABEL INFORMATION Not Important 2 3 4 Very Important Dosage instructions 1 9 88 Drug name 10 85 Veteran’s name 6 7 83 Fill number (2 of 3) 16 72 Number of refills left 18 71 Rx number 11 Quantity of pills 21 63 Filled date 20 62 VAMC phone number 61 Discard date 12 55 Written warnings (take w/food, etc.) 5 15 22 54 Doctor’s name 52 Description of pills (shape, color) 8 14 50 VAMC facility name 13 46 Pictures (relating to take w/food, etc.) 17 37

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

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

Vets Don’t read the Rx label Everytime VETERANS REFERENCED INFORMATION ON THE PRESCRIPTION LABEL Never Once Sometimes Every time Drug name 1% 10% 17% 72% Instructions 27% 55% Veteran’s name 4% 25% 15% 56% Doctor’s name 8% 28% 29% 35%

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

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

If you said “1” you and 42% of Veterans Answered Correctly NUMBER OF PILLS IN 1 Day % of respondents One 42% Two 3% Three 38% Depends on how many meals I eat 13% Don’t know 4%

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”

The words we use make a difference to the Veteran! NUMBER OF PILLS % of respondents One 42% Two 3% Three 38% Depends on how many meals I eat 13% Don’t know 4% NUMBER OF PILLS % of respondents One 81% Two 8% Four 4% Don’t know 7%

MEALS WITH WHICH TO TAKE THE MEDICATION What does meals mean? MEALS WITH WHICH TO TAKE THE MEDICATION Veteran % Rx % With 2 meals Breakfast and supper 68% 88% Breakfast and bedtime snack 6% 2% Lunch and supper 5% 1% Breakfast and lunch 4% With 1 meal Breakfast only 1% (2Rx,2T) Supper only 3% Lunch only Bedtime snack only With 3 or 4 meals Breakfast, lunch and supper 3% (5Rx,12T) Breakfast, lunch, supper and bedtime 3% (7Rx, 10T) Don’t know

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

USABILITY Larger font is preferred PREFERRED LABEL FOR INSTRUCTIONS % of respondents A much easier 69% A a little easier 10% A and B are equal 12% B a little easier 4% B much easier 5%

USABILITY Veterans prefer bolded sig: PREFERRED LABEL FOR INSTRUCTIONS % of respondents A much easier 14% A a little easier 7% A and B are equal 31% B a little easier 16% B much easier 32%

USABILITY Vets prefer selective highlights preferred label for instructions % of respondents A much easier than B 29% A little easier than B 12% A and B are equal 33% B a little easier than A 10% B much easier than A 16%

How we ask a Veteran to take ½ tablet makes a difference How we ask a Veteran to take ½ tablet makes a difference! 8 Million Rxs/Yr 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% .

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

Highlighting & bolding of patient centered info VA PATIENT CENTRIC PRESCRIPTION LABEL, PREFERRED BY VETS AND 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

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

Questions? Keith W. Trettin, RPh Keith.Trettin2268@att.net 419-865-2915