Investigating the Impact of Patient-centred Labels on Comprehension of Medication Dosing: a Randomised Controlled Trial

Overview

Journal BMJ Open

Specialty General Medicine

Date 2021 Nov 19

PMID 34794998

Authors

Ahsan Saleem

Gemma Woodruff

Kathryn Steadman

Adam La Caze

Affiliations

Soon will be listed here.

Abstract

Objective: This study aims to implement a version of patient-centred labels (PCL) consistent with current labelling practice in Australia; assess the effectiveness of PCL in relation to the proportion of participants that correctly comprehend dosing instructions, and explore the proportion of correct comprehension of PCL in participants with both low and high health literacy.

Design: Randomised controlled trial.

Setting: A large tertiary care hospital in Brisbane, Queensland, Australia.

Participants: 121 participants with a majority born in Australia (65.3%), New Zealand (14.0%), the UK (6.6%) and Ireland (2.5%).

Intervention: Participants were randomly assigned to either a panel of three PCL (n=61) or three standard labels (n=60) and asked to comprehend their assigned panel of labels.

Outcome Measures: Difference in the proportion of participants that correctly comprehend dosing instructions provided on PCL compared with standard labels. The two-proportion test was used to measure the impact of PCL on the proportion of participants correctly comprehending dosing instructions.

Results: A greater proportion of participants were able to accurately comprehend PCL compared with standard labels. The proportion of participants who were able to correctly comprehend dose instructions provided on all three labels was significantly higher in the group that received PCL; 23.3% standard vs 83.6% PCL, p<0.001. The effect was observed in both low and high health literacy participants. The proportion of participants with accurate label comprehension was higher in participants with low Newest Vital Signs scores (8.3% standard vs 85.7% PCL, p<0.001) and low Rapid Estimate of Adult Literacy in Medicine scores (10.5% standard vs 96.0% PCL, p<0.001) who received PCL.

Conclusion: This study supports the use of PCL in Australian pharmacy practice. PCL provide simple, clear and explicit dosing instructions to patients. Implementing PCL may reduce the risk of misinterpreting dosing instructions by patients and improve quality use of medicines.

Trial Registration Number: ACTRN12621000083897; Results.

Citing Articles

Evidence-Based Design of Prescription Medication Information: An Updated Scoping Review.

Russell A, Lovett R, Vogeley A, Nunes D, McKelvie C, Middleton W Drug Saf. 2025; .

PMID: 40075034 DOI: 10.1007/s40264-025-01527-8.

References

Collins S, Currie L, Bakken S, Vawdrey D, Stone P . Health literacy screening instruments for eHealth applications: a systematic review. J Biomed Inform. 2012; 45(3):598-607. PMC: 3371171. DOI: 10.1016/j.jbi.2012.04.001. View

Kripalani S, Schmotzer B, Jacobson T . Improving Medication Adherence through Graphically Enhanced Interventions in Coronary Heart Disease (IMAGE-CHD): a randomized controlled trial. J Gen Intern Med. 2012; 27(12):1609-17. PMC: 3509298. DOI: 10.1007/s11606-012-2136-z. View

Davis T, Wolf M, Bass 3rd P, Thompson J, Tilson H, Neuberger M . Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006; 145(12):887-94. DOI: 10.7326/0003-4819-145-12-200612190-00144. View

Wolf M, Davis T, Curtis L, Webb J, Bailey S, Shrank W . Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use. Med Care. 2010; 49(1):96-100. PMC: 3845798. DOI: 10.1097/MLR.0b013e3181f38174. View

Wolf M, Davis T, Shrank W, Rapp D, Bass P, Connor U . To err is human: patient misinterpretations of prescription drug label instructions. Patient Educ Couns. 2007; 67(3):293-300. DOI: 10.1016/j.pec.2007.03.024. View

Borgsteede S, Heringa M . Nature and frequency of dosing instructions on prescription labels in primary care. Pharmacoepidemiol Drug Saf. 2019; 28(8):1060-1066. DOI: 10.1002/pds.4796. View

Weiss B, Mays M, Martz W, Castro K, DeWalt D, Pignone M . Quick assessment of literacy in primary care: the newest vital sign. Ann Fam Med. 2005; 3(6):514-22. PMC: 1466931. DOI: 10.1370/afm.405. View

Tai B, Bae Y, LaRue C, Law A . Putting words into action: A simple focused education improves prescription label comprehension and functional health literacy. J Am Pharm Assoc (2003). 2016; 56(2):145-2.e3. DOI: 10.1016/j.japh.2015.12.010. View

Nutbeam D . Defining and measuring health literacy: what can we learn from literacy studies?. Int J Public Health. 2009; 54(5):303-5. DOI: 10.1007/s00038-009-0050-x. View

10.

Davis T, Wolf M, Bass 3rd P, Middlebrooks M, Kennen E, Baker D . Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med. 2006; 21(8):847-51. PMC: 1831578. DOI: 10.1111/j.1525-1497.2006.00529.x. View

11.

Shrank W, Avorn J, Rolon C, Shekelle P . Effect of content and format of prescription drug labels on readability, understanding, and medication use: a systematic review. Ann Pharmacother. 2007; 41(5):783-801. DOI: 10.1345/aph.1H582. View

12.

Sentell T . Implications for reform: survey of California adults suggests low health literacy predicts likelihood of being uninsured. Health Aff (Millwood). 2012; 31(5):1039-48. DOI: 10.1377/hlthaff.2011.0954. View

13.

Sahm L, Wolf M, Curtis L, Behan R, Brennan M, Gallwey H . What's in a label? An exploratory study of patient-centered drug instructions. Eur J Clin Pharmacol. 2011; 68(5):777-82. DOI: 10.1007/s00228-011-1169-2. View

14.

Davis T, Federman A, Bass 3rd P, Jackson R, Middlebrooks M, Parker R . Improving patient understanding of prescription drug label instructions. J Gen Intern Med. 2008; 24(1):57-62. PMC: 2607498. DOI: 10.1007/s11606-008-0833-4. View

15.

Bailey S, Navaratnam P, Black H, Russell A, Wolf M . Advancing Best Practices for Prescription Drug Labeling. Ann Pharmacother. 2015; 49(11):1222-36. DOI: 10.1177/1060028015602272. View

16.

Dowse R, Ehlers M . Medicine labels incorporating pictograms: do they influence understanding and adherence?. Patient Educ Couns. 2005; 58(1):63-70. DOI: 10.1016/j.pec.2004.06.012. View

17.

McManus E, McCarthy S, Carson R, Sahm L . Impact of a Universal Medication Schedule on rationalising and understanding of medication; a randomised controlled trial. Res Social Adm Pharm. 2018; 14(9):831-838. DOI: 10.1016/j.sapharm.2018.02.001. View

18.

Davis T, Long S, Jackson R, Mayeaux E, George R, Murphy P . Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med. 1993; 25(6):391-5. View

19.

Murray M, Young J, Hoke S, Tu W, Weiner M, Morrow D . Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007; 146(10):714-25. DOI: 10.7326/0003-4819-146-10-200705150-00005. View

20.

Bailey S, Sarkar U, Chen A, Schillinger D, Wolf M . Evaluation of language concordant, patient-centered drug label instructions. J Gen Intern Med. 2012; 27(12):1707-13. PMC: 3509294. DOI: 10.1007/s11606-012-2035-3. View