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

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

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; 2004. Available at www.iom.edu/healthliteracy.html. 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;51:267-275. Williams MV, Baker DW, Honig EG, Lee TM, Nowlan A. Inadequate literacy is a barrier to asthma knowledge and self-care. Chest. 1998; 114:1008-15. 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;66:1809-1816.

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;87:1027-1030. 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;21:806-812. 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. 2006;21:1215-1221. 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;887-894.

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: 1503-1509.

“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.

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)

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.

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

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.

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

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

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

Data analysis SPSS Version 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

Questions relating to Health Literacy Spearman Correlation with REALM scores Are medical forms difficult to fill out? -0.157 p<0.001 n=1332 Are medical booklets or leaflets difficult to understand? -0.151 p<0.001 n=1336 Are instructions on tablets from the chemist hard to understand? -0.059 p<0.05 n=1338 Do you ever need help to read information or filling in forms from doctors , nurses or hospital? -0.245 p<0.001 n=1336 How often do you read a book? 0.305 p<0.001 n=1339

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

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

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

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

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%

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”

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 22.5% Caffeine Pregnancy Inflammatory Attack Arthritis Diabetes Kidney Nutrition Hepatitis Hormones Menopause Antibiotics Herpes 18.5% Appendix Diagnosis Seizure Abnormal Potassium 20% Bowel Syphilis 22.5% Anaemia 20% 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)

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

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

3. s-TOFHLA - Comprehension Section 1% 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

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

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

Correlations REALM versus s-TOFHLA – “as the REALM score increases, does s-TOFHLA score increase also?” + 0.536 (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: -0.471 (Spearman correlation co-efficient) Negative Medium value Average score obtained in each test REALM: -0.272 (Spearman co-efficient) Negative Low value

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.

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

Thank you!...

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.

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

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.

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

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)

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]

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

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...

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

Correct Interpretation by Label Type

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.

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).

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

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.

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

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