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Evaluation of Written Prescription Information Provided in Community Pharmacies: A National Study

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Evaluation of Written Prescription Information Provided in Community ... Shopper mailed materials to shopper firm Firm removed pharmacy/pharmacist ... – PowerPoint PPT presentation

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Title: Evaluation of Written Prescription Information Provided in Community Pharmacies: A National Study


1
Evaluation of Written Prescription Information
Provided in Community Pharmacies A National
Study
  • Bonnie L. Svarstad, Ph.D.
  • Jeanine K. Mount, Ph.D. and R.Ph.
  • University of Wisconsin - Madison

2
Study done in cooperation with...
  • FDA
  • National Association of Boards of Pharmacy
  • National expert panel

3
National Expert Panel
  • 16 experts
  • Nominated by seven pharmacy organizations
  • Pharmacy practitioners and experts in
    pharmacotherapy and communications
  • Faculty at 9 pharmacy colleges and universities

4
Panelists
  • Mary Amato
  • Heidi Anderson-Harper
  • Robert Beardsley
  • C. A. Bond
  • Marie Gardner
  • Betty Dong
  • Carole Kimberlin
  • Duane Kirking
  • Sharlea Leatherwood
  • Matt Osterhaus
  • Anthony Provenzano
  • Mary Pubentz
  • Betsy Sleath
  • Jenene Spencer
  • Judith Sommers Hanson
  • Gayle Dichter
  • Bonnie Svarstad, Chair

5
Past Studies
  • Distribution of patient information increased
    from 16 in 1982 to 74 in 1998
  • 1999 study in 8 states found 87 given
    information but quality was variable Svarstad
    Bultman, 1999

6
How does this study differ?
  • Pharmacies sampled from national list
  • Professional shoppers visited pharmacies
  • Experts and consumers rated information
  • Additional analyses performed

7
Primary Aims of Study
  • What percent of patients are given written
    prescription information?
  • How do experts rate this information?
  • How do consumers rate this information?
  • How well does information adhere to criteria for
    useful medication information?

8
Secondary Aims of Study
  • How do expert/consumer ratings compare?
  • Do ratings vary by consumer background?
  • Do ratings vary by pharmacy type?
  • Do ratings vary by leaflet characteristics?

9
Objectives for Today
  • Review study design and procedures
  • Review evaluation criteria and forms
  • Present results - Leaflet distribution and
    ratings - Factors that might influence ratings

10
Study Design
  • Shoppers acting as patients presented four
    prescriptions at each pharmacy
  • Patient information leaflets mailed to UW
  • Expert panelists rated leaflets
  • Consumer panelists rated leaflets
  • Rating forms mailed to UW for analysis

11
Sampling of Pharmacies
  • Excluded hospital, clinic, LTC, mail order, IV
    infusion, dispensing physician, government
    settings, Alaska, Hawaii, Puerto Rico, states
    prohibiting filling of prescriptions for research
  • Selected from 57,157 community pharmacies
  • Simple random sample of 384 pharmacies
  • 35 independent, 65 chain
  • Data collected in 44 states

12
Observer Protocol
  • Shoppers hired by professional shopper firm
  • 72 of visits by females
  • 66 of visits by persons 45 years or older
  • Mean age 50

13
Standard Scenario
  • Presented new prescriptions for atenolol,
    glyburide, atorvastatin, nitroglycerin SL
  • Did not ask questions or initiate talk
  • If asked, patient-observer reported - new
    diagnoses heart disease, diabetes - no prior use
    of study drugs

14
Observer Protocol (cont.)
  • Shopper mailed materials to shopper firm
  • Firm removed pharmacy/pharmacist names
  • All leaflets, brochures, other information items
    mailed to researchers
  • All items referred to as leaflets

15
Expert Evaluation Forms
  • Each form included 8 general criteria and 62-63
    sub-criteria
  • Eight criteria from 1996 Action Plan for useful
    information
  • Sub-criteria based on approved labeling
  • Forms revised until all panelists approved

16
Eight Criteria from 1996 Action Plan for Useful
Information
1. Drug names and indications 2.
Contraindications and what to do before using 3.
Specific directions about how to use,
monitor, get most benefit 4. Specific precautions
and how to avoid harm
17
Eight Criteria from 1996 Action Plan for Useful
Information
5. Serious and frequent adverse reactions, what
to do 6. General information, encouraged to ask
questions 7. Scientifically accurate, unbiased,
up-to-date 8. Readily comprehensible and legible
18
Scoring Method for Expert Forms
  • Each criterion rated by 4-10 sub-criteria
  • Each sub-criterion rated by adherence level
    full (2), partial (1), no adherence (0)
  • Computer calculated points obtained
  • Scale ranged from 0 to 100 (best)

19
Scoring Categories
Level of Adherence Point Range
5 80-100 4 60-79 3 40-59 2 20-39
1 0-19
20
Inter-rater Reliability
  • Experts assigned to one of four drug groups
  • Independently rated same sub-set of leaflets
  • Good inter-rater reliability obtained
  • Pearson r for overall adherence 0.90-0.97

21
Expert Rating Process
  • Each expert assigned to one of four drugs
  • Each leaflet rated by one expert
  • Experts rated 1,367 pharmacy-generated leaflets
    and 31 manufacturer-generated leaflets (mean 87
    per expert)

22
Consumer Evaluation Form
  • 1-page form with 12 items
  • Based on 1996 Action Plan and Krass et al
  • Items scored 1 (poor) to 5 (good)
  • Overall scale ranged from 0 - 100 (best)

23
Scoring Categories for Consumer Form
Level of Adherence Point Range
5 80-100 4 60-79 3 40-59 2 20-39
1 0-19
24
Three Legibility Items
  • Poor-good print size
  • Poor-good print quality
  • Poor-good spacing between lines

25
Six Comprehensibility Items
  • Poorly-well organized
  • Poor-good length
  • Unclear-clear
  • Unhelpful-helpful
  • Incomplete-complete
  • Hard-easy to find important information

26
Three Summary Items
  • Hard-easy to read
  • Hard-easy to understand
  • Not useful-useful

27
Test-Retest Reliability
  • Nine consumers independently rated 18 leaflets at
    two sessions
  • Good test-retest reliability obtained
  • Pearson r for overall score 0.82

28
Consumer Rating Process
  • Recruited 154 consumer raters in 11 states
  • Recruited at senior centers, clinics, work and
    social organizations
  • Facilitator met with 8-15 raters per session
  • Each rater independently rated 10 leaflets

29
Rater Characteristics
  • Mean age 61 yrs (20-89 yrs)
  • 68 female, 89 white
  • 77 used medication daily
  • 8 not completed high school, 38 completed high
    school, 54 beyond h.s.

30
Patient-Observers Given Any Written Information
atenolol 89.6 glyburide 88.8 atorvastatin 89
.3 nitroglycerin 88.3
31
Expert Ratings, All Criteria (n1,367 leaflets)
32
Expert Ratings by Criterion
  • Low Ratings 5 ADRs, what to do 6 general
    information
  • Lowest Ratings 2 contraindications 4
    precautions 8 legibility/comprehens.
  • Highest Ratings 7 accuracy, unbiased
  • Moderate Ratings 1 names, indication 3
    directions

33
Highest Expert Ratings - Criterion 7
Scientifically Accurate, Unbiased, Up-to-date
lt1
lt1
34
Moderate Expert Ratings - Criteria 1 3
35
Low Expert Ratings - Criteria 5 6
36
Lowest Expert Ratings - Criteria 2 4
37
Lowest Expert Ratings - Criterion
8Legibility/Comprehensibility
38
Consumer Ratings, All Items ()
39
Consumer Scores by Item
  • Scores varied by item
  • Lowest scores print size, print quality,
    spacing, overall readability
  • Moderate-high scores easy to understand, useful
  • 36 of leaflets given low ratings on readability

40
Consumer Scores on Readability
Understandability Items
41
Consumer Scores on Usefulness Item
42
Expert Versus Consumer Ratings
  • Low correlation between total scores
  • Expert rating of usefulness was related to
    consumer usefulness item
  • Expert rating of usefulness was unrelated to
    consumer readability item

43
Expert Rating of Usefulness by Consumer Rating of
Usefulness Item (n339 atenolol leaflets)
Consumer Score Mean expert () 1
(poor) 40.3 2 46.3 3 50.0 4 55.0 5
(good) 55.0 (plt.001)
44
Conclusions -- Part I
  • 89 given some information
  • Ratings varied by criterion
  • Experts most critical of information on
    contraindications and precautions and
    legibility/comprehensibility
  • Consumers most critical of readability

45
Results -- Part IIWhat factors might influence
leaflet ratings?
  • Consumer characteristics?
  • Pharmacy type?
  • Leaflet characteristics?
  • Changes made by pharmacy organization or pharmacy
    integrator?

46
Leaflet Ratings by Consumer Characteristics
  • Ratings unrelated to gender, age, education,
    current drug use
  • White raters gave higher scores than non-white
    raters for nitroglycerin leaflets
  • Race unrelated to other ratings

47
Leaflet Distribution and Ratings by Pharmacy Type
Plt.001 all tests
48
Expert Ratings by Leaflet Length
Plt.001 all tests
49
Consumer Ratings by Leaflet Length
Plt.001 all tests

50
Consumer Ratings by Font Size
Plt.001 all tests

51
Consumer Ratings of Readability by Font Size
Plt.001 all tests

52
Data Vendors Examined
  • Vendor - not ascertainable 13.5 (46)
  • Vendor 1 - partial message 5.0 (17)
  • Vendor 1 - full message 81.5 (277)
  • Vendor 2 (comparison leaflets,institutional)

53
Leaflet Length by Vendor
Vendor leaflets lt5.6 inches Vendor - not
ascertainable 82.6 Vendor 1- partial
message 94.1 Vendor 1- full message 27.1 Vendor
2 0.0
Plt.001
54
Results By Data Vendor
  • Substantial variability by data vendor
  • Highest Vendor 1 and Vendor 2
  • Lowest Partial messages and unidentified
    vendors

55
Expert Ratings by Vendor
Plt.001 all tests
56
Ratings of Atenolol Leaflets by Vendor
Plt.001 all tests
.
57
Ratings of Atenolol Leaflets by Vendor
Plt.001 all tests except Criterion 7 (pgt.05)
58
Consumer Ratings by Vendor
Plt.001 all tests
59
Consumer Ratings of Atenolol Leaflets by Vendor
Plt.001 all tests
60
Data Vendor by Pharmacy Type
Plt.001
61
Analysis of Vendor 1 Leaflets
  • Analyzed full leaflets used by 16 organizations
  • 5 organizations used Version 1 (33 leaflets)
  • 5 organizations used Version 2 (50 leaflets)
  • 6 organizations used Version 3 (72 leaflets)
  • Compared leaflets with prototypes

62
Results
  • Ratings varied by leaflet version
  • No prototype fully met criteria
  • Some organizations added and deleted information
    from prototype

63
Expert Ratings by Leaflet Version
Plt.001 all tests
64
Expert Ratings by Leaflet Version
Plt.001 for all criteria

65
Additions/Deletions from Prototypes
  • V1 One organization deleted publisher and
    disclaimer information two used leafletlabel
  • V2 One deleted additional information and added
    label
  • V3 Five deleted warning box and overdose
    sections four deleted drug names and notes five
    added disclaimer 1 added publisher section

66
Ratings of Distributed Versus Prototype Leaflets
-- Atenolol Version 1
67
Ratings of Distributed Versus Prototype Leaflets
-- Atenolol Version 2
68
Ratings of Distributed Versus Prototype Leaflets
-- Atenolol Version 3
69
Conclusions (1)
  • Highest ratings for scientific accuracy and being
    nonpromotional
  • Lowest ratings for contraindications and
    precautions

70
Conclusions (2)
  • Lowest ratings for leaflets - lt 5.5 inches
    long or - font size lt 10 point
  • Lowest ratings for leaflets from -
    independent pharmacies - unidentified vendors

71
Conclusions (3)
  • No prototype fully met criteria
  • Experts, consumers both critical of legibility
  • Pharmacy organizations can influence ratings by
  • selecting vendor and leaflet version
  • modifying leaflets themselves

72
Examples
  • Leaflets with low versus high ratings
  • Leaflets from different vendors
  • Changes made by pharmacy organizations or
    integrators
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