1. Enhanced Prescription Label Design - Does this improve Patients’ Understanding of their Medication?
Dr Suzanne McCarthy and Dr Laura Sahm,
Lecturers in Clinical Pharmacy,

2. Overview Introduction
Health Literacy in an Irish setting using the REALM tool
Use of enhanced prescription labels in an Irish setting
Conclusions
Future work

3. Introduction
Direct link between individual health literacy and health outcomes3
less health knowledge4
worse self-management skills5
lower use of preventative services6
higher hospitalisation rates7
Institute of Medicine. Health Literacy: A Prescription to End Confusion. Washington, DC: National Academies Press; Available at Accessed on 13/01/09.
Gazmararian JA, Williams MV, Peel J, Baker DW. Health literacy and knowledge of chronic disease. Patient Education and Counselling. 2003;51:
Williams MV, Baker DW, Honig EG, Lee TM, Nowlan A. Inadequate literacy is a barrier to asthma knowledge and self-care. Chest. 1998; 114:
Miller Jr. DP, Brownlee CD, McCoy TP, Pignone MP. The effect of health literacy on the knowledge and receipt of colorectal cancer screening: A survey study. BMC Family Practice. 2007;8:16.
Cho YI, Lee SD, Arozullah AM, Krittenden KS. Effect of health literacy on health status and health service utilisation amongst the elderly. Social science and Medicine. 2008;66:

4. Introduction worse self-rated health8 higher rates of mortality9
poorer medication adherence10
difficulty understanding prescription drug labels11
Baker DW, Parker RM, Williams MV, Clark WS, Nurss J. The relationship of patient reading ability to self-reported health and use of health services. Am J Public Health. 1997;87:
Sudore RL, Yaffe K, Satterfield S, Harris TB, Mehta KM, Simonsick EM, Newman AB, Rosano C, Rooks R, Rubin SM, Ayonayon HN, Schillinger D. Limited literacy and mortality in the elderly: The health, aging and body composition Study. J Gen Intern Med. 2006;21:
Gazmararian JA, Kripalani S, Miller MJ, Echt KV, Ren J, Rask K. Factors associated with medication refill adherence in cardiovascular-related diseases: A focus on health literacy. J Gen Intern Med ;21:
Davis TC, Wolf MS, Bass III PF, Thompson JA, Tilson HH, Neuberger M, Parker RM. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006;145;

5. Literacy and Mortality Risk.
STRONGER INDICATOR OF MORTALITY RISK
THAN YEARS OF SCHOOLING
Baker DW, Wolf MS, Feinglass J, Gazmararian JA, Thompson JA. Arch Intern Med 2007; 167:

6. “Take one tablet on Monday, one tablet on Tuesday, and skip Wednesday”
Health Literacy – The Story of Jimmy!
“Take one tablet on Monday, one tablet on Tuesday, and skip Wednesday”
Wednesday…
Monday…
Tuesday…
1 in 5 Irish people are not confident that they understand all the information which their health professional gives to them
43% would only sometimes ask for information to be explained more clearly
1 in 10 people admitted to taking the wrong dose of medication because they didn’t understand the instructions given.

7. However
The Republic of Ireland results revealed that one in four working age adults have problems with even the simplest of literacy tasks (IALS 1997)
(Compare 3% Sweden, 5% Germany)

8. Today
OECD report:
The report ranked the reading ability of Irish 15-year-olds in 17th place out of 39 countries, compared to 5th place in 2000.

9. Use of the Rapid Estimate of Adult Literacy in Medicine (REALM) in an Irish Population

10. Aim To estimate the Health Literacy of an Irish Population Objectives:
To determine the prevalence of low health literacy in this population sample.
To investigate the relationship between demographics and health literacy levels.

11. Methods
Ethical approval from the Clinical Research Ethics Committee (CREC) of the Cork teaching hospitals
Study setting:
OPDs of two urban teaching hospitals and five community pharmacies in the Cork area.
Data collection period January-August 2009
Inclusion criteria:
Adults aged 18 years and older
Exclusion Criteria:
sight impairment
hearing impairment
patients who did not have English as their first language

12. Methods
Patient demographics; age category, gender, age leaving full time education.
Questions relating to difficulty with health- related material
REALM scores

13. REALM Sixty-six medical terms Three columns with 22 words per column
Words are arranged in order of increasing number of syllables and level of difficulty
Scores based on the number of words correctly pronounced
Assesses reading comprehension
Score Range (0-66):
< 60 = inadequate health literacy
> 61 = adequate health literacy

14. Data analysis
SPSS Version 15

15. Health Literacy Data from Irish Sample
Total Number of Participants
1339
Gender (n,%)
Male
521 (38.9)
Female
818 (61.1)
Age Category in years (n,%)
18 – 30
283 (21.1)
31 – 45
401 (29.9)
46 – 60
369 (27.6)
61 – 70
209 (15.6) 70
77 (5.8)
Age leaving full-time education in years* (mean, SD)
18.6 (4.8)
REALM Score (mean, SD)
62.2 (6.8)
“Inadequate” Health Literacy (n,%)
247 (22.6)
“Inadequate” Health Literacy by gender (n,%)
Males
121 (49)
Females
126 (51)
* Data based on 1322 participants

16. Questions relating to Health Literacy
Spearman Correlation with REALM scores
Are medical forms difficult to fill out?
p< n=1332
Are medical booklets or leaflets difficult to understand?
p< n=1336
Are instructions on tablets from the chemist hard to understand?
p< n=1338
Do you ever need help to read information or filling in forms from doctors , nurses or hospital?
p< n=1336
How often do you read a book?
p< n=1339

17. Conclusions Health literacy is a serious problem in Ireland today
REALM is a quick and clinically meaningful screening tool for the clinical setting
Further research on health literacy is needed in the Irish setting
prevalence of inadequate health literacy in the general population must be investigated
risk factors for low health literacy and groups at risk of inadequate health literacy must be identified

18. s-TOFHLA and REALM in an OPD Population
Michelle O’Driscoll
Supervisor: Dr. Laura Sahm

19. s-TOFHLA and REALM in an OPD Population
short Test Of Functional Health Literacy in Adults Vs
Rapid Estimate of Adult Literacy in Medicine
Out Patient Department

20. Out Patient Department
251 people approached
Exclusion Criteria
14 people declined
17 = Visual impairment
1. Data Sheet
Ethnicity
Gender
D.O.B.
Age leaving full time education
Level of education attained
Occupation
Experiences of the healthcare system
Questions about the amount of reading they do
4 = Hearing impairment
23 were ineligible
0 = Under 18
2 = English not first language
14 were called away
N = 200

21. Data Sheet Statistics Gender Age Category 24% 16% Male 35% Female 65%
18-30
31-45
46-60
61-70
>70 N
Minimum
Maximum
Mean
Std. Deviation
Age
200 18 81
51.02
13.746
24%
16%

22. 2. Rapid Estimate of Adult Literacy in Medicine (REALM)
List 1
List 2
List 3
Fat
Fatigue
Allergic
Flu
Pelvic
Menstrual
Pill
Jaundice
Testicle
Dose
Infection
Colitis
Eye
Exercise
Emergency
Stress
Behaviour
Medication
Smear
Prescription
Occupation
Nerves
Notify
Sexuality
Germs
Gallbladder
Alcoholism
Meals
Calories
Irritation
Disease
Depression
Constipation
Cancer
Miscarriage
Gonorrhea
Caffeine
Pregnancy
Inflammatory
Attack
Arthritis
Diabetes
Kidney
Nutrition
Hepatitis
Hormones
Menopause
Antibiotics
Herpes
Appendix
Diagnosis
Seizure
Abnormal
Potassium
Bowel
Syphilis
Anaemia
Asthma
Haemorrhoids38
Obesity
Rectal
Nausea
Osteoporosis
Incest
Directed
Impetigo
2. Rapid Estimate of Adult Literacy in Medicine (REALM)
66 words
increasing difficulty
+1 for correct pronunciation
0 for incorrect pronunciation
Categorised:
61 – 66 = “non case”
60 or below = “case”

23. 2. Rapid Estimate of Adult Literacy in Medicine (REALM)
List 1
List 2
List 3
Fat
Fatigue
Allergic
Flu
Pelvic
Menstrual
Pill
Jaundice
Testicle
Dose
Infection
Colitis
Eye
Exercise
Emergency
Stress
Behaviour
Medication
Smear
Prescription
Occupation
Nerves
Notify
Sexuality
Germs
Gallbladder
Alcoholism
Meals
Calories
Irritation
Disease
Depression
Constipation
Cancer
Miscarriage
Gonorrhea %
Caffeine
Pregnancy
Inflammatory
Attack
Arthritis
Diabetes
Kidney
Nutrition
Hepatitis
Hormones
Menopause
Antibiotics
Herpes %
Appendix
Diagnosis
Seizure
Abnormal
Potassium 20%
Bowel
Syphilis %
Anaemia %
Asthma
Haemorrhoids 19%
Obesity
Rectal
Nausea
Osteoporosis
Incest
Directed
Impetigo
2. Rapid Estimate of Adult Literacy in Medicine (REALM)
Min. score: 17
Max. score: 66
Average score: 62
Cronbach’s alpha: 0.938
Case 22.5%
Non case 77.5%
Fat dose and cancer right for all people and the other six in red were the most commonly mispronounced items ( of which 3 were STIs)

24. How does Level of Education affect REALM Category?
Degree/Postgrad
100% non case
Primary School
50:50

25. 3. s-TOFHLA - Numeracy Section
e.g. Prompt 1:
18%
wrong
Take one tablet by mouth every 6 hours as needed
ORAL QUESTION: If you take your first tablet at 7:00am, when should you take the next one?
CORRECT ANSWER: “1:00pm”
4 prompts, 7 marks each = 28 marks

26. 3. s-TOFHLA - Comprehension Section1%
0.5%
X-ray 1%
2.5%
11%
0.5%
1.5%
16% didn’t attempt
1.5%
36 blanks, 2 marks each = 72 marks

27. LEVEL OF FUNCTIONAL HEALTH LITERACY
Categorised
SCORE
LEVEL OF FUNCTIONAL HEALTH LITERACY
MEANING
0-53
Inadequate
Unable to successfully complete basic reading and numeracy tasks required to function adequately in the health care setting
54-66
Marginal
Some difficulty with completing basic reading and numeracy tasks required to function adequately in the health care setting
67-100
Adequate
Able to successfully complete basic reading and numeracy tasks required to function adequately in the health care setting
Min. score: 22
Max. score: 100
Average score: 83
Inadequate
Marginal
Adequate 83.5%
16.5%
Cronbach’s alpha: 0.909

28. How does Occupation affect s-TOFHLA Category?
Professional
Healthcare worker
Student
Semiskilled
100% non case
Retired
42% case

29. Correlations
REALM versus s-TOFHLA – “as the REALM score increases, does s-TOFHLA score increase also?”
(Spearman correlation co-efficient)
positive value
high value
Test Score versus Age – “as a person’s Age increases, what happens their Test Scores?”
S-TOFHLA:
(Spearman correlation co-efficient)
Negative
Medium value
Average score
obtained in each test
REALM:
(Spearman co-efficient)
Negative
Low value

30. Comparing REALM to s-TOFHLA (gold standard)
Sensitivity of REALM vs s-TOFHLA = 0.7 Specificity of REALM versus s-TOFHLA = 0.84 Negative predicted value of REALM = 0.94 Positive predicted value of REALM = 0.51 Accuracy of REALM vs. s-TOFHLA = 0.84 False positives with REALM = 0.13 False negatives with REALM = 0.3
If REALM says the person is OK, it’s probably true!
If REALM says the person has inadequate health literacy its only 51% likely to be true.
BUT
REALM tends to err on the side of caution, and over – diagnose cases of inadequate health literacy.

31. “The main problem with Communication
is the assumption that it has occurred.”
– George Bernard Shaw

32. Thank you!...

33. Background
Patient misunderstanding of instructions on prescription drug labels is a medication safety and health literacy concern1–3.
The 2006 Institute of Medicine Report, Preventing Medication Errors, cited poor patient comprehension and subsequent unintentional misuse of prescription drugs as a root cause of medication error, poor adherence, and worse health outcomes3.
1. Institute of Medicine. In: Kohn L, Corrigan J, Donaldson M, eds. To err is human: Building a safer health system. Washington, D.C.: National Academy Press; 2000.
2. Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, et al. Adverse drug events in ambulatory care. N Engl J Med.
2003;348:1556–64.
3. Institute of Medicine. In: Aspden P, Wolcott J, Bootman L, Cronenwett LR, eds. Preventing Medication Errors. Washington D.C.: National Academy Press; 2006.

34. Background
Improving Patient Understanding of Prescription Drug Label Instructions.
Metformin, 1000 mg
[Time periods] Take 2 pills by mouth every day. Take 1 with breakfast and 1 with supper.
[Specific times] Take 2 pills by mouth every day. Take 1 at 8 A.M. and 1 at 5 P.M.
[Times per day] Take one tablet by mouth twice daily.
[Hourly intervals] Take 1 pill by mouth every 12 hours.
Davis et al, J Gen Intern Med. 2009; 24(1): 57–62

35. Aims
To evaluate the effectiveness of standardized, patient-centered label (PCL) instructions to improve comprehension of prescription drug use compared to typical instructions in an Irish outpatient setting.

36. Methods Study Design Study Participants Cross-sectional design
Outpatient department in Cork teaching hospital & Day Care Centre for the elderly
Study Participants
Exclusion Criteria:
age > 18 years
hearing impairment
visual impairment
cognitive impairment
english as first language

37. Structured Interview
A trained RA collected sociodemographic information, then presented patients, one at a time, with three prescription pill bottle containers with either standard, PCL, or PCL + Graphic drug labels.
Once patients provided their interpretations, the RA administered the Rapid Estimate of Adult Literacy in Medicine (REALM)

38. Drug label instructions
1 od
[Standard] Take one tablet once a day
[PCL] Take 1 tablet at bedtime
[PCL + Graphic]
Drug 2
1 tds
[Standard] Take one tablet three times a day
[PCL] Take 1 tablet at breakfast, 1 tablet at lunchtime and 1 tablet at dinner
[PCL + Graphic]
[Standard] Take two tablets twice a day
Drug 3
2 bd
[PCL] Take 2 tablets in the morning and 2 tablets at bedtime
[PCL + Graphic]

39. Regimen A Regimen B Regimen C
Standard
Drug1
Take one tablet once daily
Dissolve or mix with water before taking
Drug 3
Take two tablets twice daily
To be sucked or chewed
Drug 2
Take one tablet three times daily
Take with or after food
PCL
Take 1 tablet at breakfast,
1 tablet at lunch, and
1 tablet at dinner
Drug 1   
Take 1 tablet at bedtime
Take 2 tablets in the morning and 2 tablets at bedtime.
PCL + Graphic
Take 2 tablets in the morning and
2 tablets at bedtime
Morning
Noon
Evening
Bedtime 2
Morning
Noon
Evening
Bedtime 1
Morning
Noon
Evening
Bedtime 1

40. Patient-Centered labels (PCL) were devised, where numbers instead of words are used to indicate how many tablets are to be taken at how many intervals and also the exact time of day is stated, for example, “Take 1 tablet at bedtime”. “PCL + Graphic” labels were also devised which included a graphical depiction of what time of day the medication should be taken.
Each patient was presented with three medicine bottles depending on which study group they were randomly assigned. For each medicine bottle, participants were asked “In your own words, how would you take this medicine?” and “How many tablets would you take of this medicine in one day?” Patients had to respond correctly to both questions in order to be classified as having correctly interpreted a prescription instruction.
Answers were recorded by means of a Dictaphone.
Interrater Reliability...Kappa Measure of Agreement...>0.8...

41. Outcome Measures
Correct interpretation of the three prescription drug label instructions was evaluated by
1) subjects’ verbatim response to the RA asking “In your own words, how would you take this medicine?”, and
2) subjects’ demonstration of understanding by a second question: “How many pills would you take of this medicine in one day?”
Patients had to respond correctly to both questions in order to be classified as having correctly interpreted a prescription instruction

43. Correct Interpretation by Label Type

44. Results from interaction models
Significant interaction between instruction type and literacy (p=0.008). i.e. correct interpretation of the standard vs PCL labels depends on literacy level
No interaction between literacy and use of graphic, literacy and regimen complexity, or literacy and age group. Also no interaction between regimen complexity and instruction type or use of graphic.

45. Discussion
Rates of understanding PCL instructions were close to and exceeded 90 percent in this diverse sample of patients.
The PCL format was particularly useful for patients with low literacy skills and when regimens displayed some level of complexity (i.e. > one pill a day).

46. Discussion
The inclusion of a graphic aid to support comprehension provided no additional benefit and may even impair comprehension.
It is possible the graphic aid was redundant, causing confusion as subjects tried to interpret and mentally resolve both presentations

47. Discussion
Our study did not examine the association between misinterpretation of prescription instructions and actual error in taking real medications.
Patients’ motivation, concentration and comprehension might have been greater if they were reporting on their own medicine given by their physician for conditions they actually had.

48. Future Work Refinement of the PCL format
Strategies must be developed to address instructions for prescription drugs that are to be taken only as needed, for non-pill form medications, medications with tapered doses, and for complex regimens that include auxiliary warnings and precautions that would affect how a patient administers a drug (i.e. with food, not to lie down after taking)
Discussions with pharmacy software companies regarding implementation in the clinical setting

49. Acknowledgements Dr Michael S. Wolf, MPH, Laura Curtis, Stacey Bailey
Feinberg School of Medicine
Northwestern University
Chicago, IL, USA
Zoe Mannix, Odhran O’Donoghue, Susan Spillane, Hilary Gallwey, Peter Mc Nally, Michelle O’Driscoll
School of Pharmacy, University College Cork