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 DESCRIPTIONUse 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#

Rx#Patient Name

One LabelOne Mission

One VA

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.

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

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 2008http://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 2009http://www.nabp.net/index.html?target=/annualmeeting/CTFR.asp&

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 BlindUse 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

Adherence With Medications Associated with Improved Outcomes

STATINSs ACEI Beta 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 772-779

Ho et al; Am Heart J 2008

ACEI BETA BLOCKERS

Nonadherence causes $100 Billion in annual wasteful health care spending*

*National Priorities Partnership April 2011

Test Your Knowledge

• HOW MANY PRESCRIPTIONS DOES THE VA FILL DAILY?3,72737,270372,7003,727,000Too many to count.

VA 372,700 DOD 365,196*VHA Statistics EOY FY 20010

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.

Tell what this picture means.

Tell what this picture means.

Tell what this picture means.

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.

Test Your KnowledgeHow many do you take in a day?

If you said “1” you and42% 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%

The words we use make a difference to the Veteran!

NUMBER OF PILLS

% of respondents

One 81%

Two 8%

Four 4%

Don’t know 7%

NUMBER OF PILLS % of

respondentsOne 42%Two 3%

Three 38%Depends on how many meals I eat 13%

Don’t know 4%

Aren’t VA Labels Clear Already?

Aren’t VA Labels Clear Already?(7.8)

Aren’t VA Labels Clear Already?(6.5)

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

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.

6th Grade but is it necessary?

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

446 Veterans at 11 Survey Sites & 697 Pharmacist/ Technician

Participated

Demographics of Veteran Participants

VA Rx Users Study Participants

Age 50% > 65 Yr 49%>60 yr

Gender 93% Male 84% Male

High School + 77.7% 97%

Ethnicity 80% White13% Black3% Hispanic

<1% Asian

45% White34% Black14% Hispanic (50% spoke Spanish as their primarily language at home.)

2% Asian6% American Indian/Alaska Native

93% of the respondents were Veterans; 7% were their caregivers.

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

Vets Don’t read the Rx label Everytime

REFERENCE TO INFORMATION ON THE LABEL

Never Once Sometimes Every time

Drug name 1% 10% 17% 72%

Instructions 1% 17% 27% 55%

Veteran’s name 4% 25% 15% 56%

Doctor’s name 8% 28% 29% 35%

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

% VETERAN IMPORTANCE OF LABEL INFORMATION N= 446

Not Important

2 3 4Very

Important

Dosage instructions 1 1 1 9 88

Drug name 1 1 3 10 85

Veteran’s name 2 2 6 7 83

Fill number (2 of 3) 3 3 6 16 72

Number of refills left 2 3 6 18 71

Rx number 7 4 7 11 71

Quantity of pills 2 3 11 21 63

Filled date 4 4 10 20 62

VAMC phone number 6 6 9 18 61

Discard date 7 10 12 16 55

Written warnings (take w/food, etc.) 4 5 15 22 54

Doctor’s name 5 6 16 21 52

Description of pills (shape, color) 7 8 14 21 50

VAMC facility name 11 12 13 18 46

Pictures (relating to take w/food, etc.) 17 12 18 16 37

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?

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

California State Board of Pharmacy Survey

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

# RefillsProduct Description

Fed/State Cautions

Aux Info

Refill number

% PHARMACY STAFF IMPORTANCE OF LABEL INFORMATION

 N=697Not

Important2 3 4

Very Important

Patient name 2 1 2 3 92

Drug name 1 1 2 5 91

Dosage instructions 1 2 2 4 91

Quantity of pills 1 1 5 14 79

Rx number 4 4 13 16 63

Doctor’s name 5 4 13 20 58

Filled date 4 7 13 25 51

Description of pills (shape, color) 4 7 17 22 50

Written warnings (take w/food, etc.) 7 7 17 20 49

Fill number (2 of 3) 6 9 19 27 39

Number of refills left 10 10 19 25 36

VAMC phone number 21 16 14 13 36

Pictures (relating to take w/food, etc.) 15 14 21 18 32

VAMC facility name 16 19 17 16 32

Discard date 14 16 19 20 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.

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.

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%

California State Board of Pharmacy Survey

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.

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% .

Test Your Knowledge

• HOW MANY ½ TABLET PRESCRIPTIONS DID THE VA FILL IN FY 2011?

8,068,401

*VHA Statistics EOY FY 2011

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?

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

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”

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

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

What does meals mean?

MEALS WITH WHICH TO TAKE THE MEDICATIONVeteran % Rx %

With 2 mealsBreakfast and supper 68% 88%

Breakfast and bedtime snack 6% 2%Lunch and supper 5% 1%

Breakfast and lunch 4% 1%With 1 meal

Breakfast only 5% 1% (2Rx,2T)Supper only 3%Lunch only 3%

Bedtime snack only 1% 1%With 3 or 4 meals

Breakfast, lunch and supper 3% 3% (5Rx,12T)Breakfast, lunch, supper and bedtime 1% 3% (7Rx, 10T)

Don’t know 1%

VETERANS PREFERENCE% of respondents

A much better 34%A a little better 8%

A and B are equal 13%B a little better 12%B much better 34%

Veterans had no preference Pharmacy staff preferred A

PHARMACY PREFERENCE% of respondents

A much better 44%A a little better 10%

A and B are equal 3%B a little better 19%B much better 24%

Veterans & Rx staff prefer Vet name at top of label

VETERAN PREFERRED LABEL % of respondents

A much better 26%A a little better 10%

A and B are equal 12%B a little better 16%B much better 36%

PHARMACY PREFERRED LABEL –% of respondents

A much better 30%A a little better 8%

A and B are equal 2%B a little better 21%B much better 39%

Veterans & Rx staff prefer Vet name at top of label

VETERAN PREFERRED LABEL % of respondents

A much better 46%A little better 8%

A and B are equal 16%B a little better 9%B much better 21%

PHARMACY STAFF PREFERRED LABEL% of respondents

A much better 53%A a little better 16%

A and B are equal 3%A a little better 13%B much better 15%

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

The VA is not the first to adopt a Patient-Centric Prescription label.

Let us not be the last!

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.

Questions?