Background
Health literacy (HL) is defined as ¿the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions¿(1). This study aimed to; (i) assess the level of inadequate health literacy (HL) among a cohort of patients and (ii) determine the impact of enhanced prescription label design on patient understanding of their medication.Local Ethics committee approval was granted for this study.
Method
The study was carried in the outpatient department of the Mercy University Hospital and in a Cork-based care centre for the elderly from 11th-29th January 2010. All patients were approached and the nature of the study explained. Where verbal consent was obtained, patient demographics were collected eligibility determined. Exclusion criteria (i) aged less than 18 years, (ii) severely impaired vision, (iii) hearing disabilities, (iv) MMSE score less than 18, or (iv) if they did not speak English fluently. Part 1: Patients¿ HL was screened using the Rapid Estimate of Adult Literacy in Medicine (REALM) (2). Part 2: Patients were randomised into one of three groups, to receive either Regimen A, Regimen B or Regimen C prescription labels. Each regimen was composed of standard and enhanced labels so each patient received at least one standard, one patient-centered label (PCL) and one PCL + Graphic label. The order in which patients received the labels varied between each Regimen, to prevent information carryover. Patients were asked two questions that assessed their interpretation of each instruction. 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?¿ Responses to the first question were independently rated as either correct or incorrect by two clinical pharmacists. Patients had to respond correctly to both questions in order to be classified as having correctly interpreted a prescription instruction. Data were analysed using the SPSS Version 15. Chi squared tests were used to determine any association between correct interpretation and label type. A p value <0.05 was deemed statistically significant.
Results
Part 1: Of the 198 participants, 23.2% were found to possess inadequate literacy levels. Part 2 (n=119): rates of correct interpretation of the prescription label instructions varied among regimens A, B and C (65%, 40% and 67% respectively). PCL labels were more likely to be interpreted correctly compared with standard and PCL + graphic labels (65.5%, 57.14% and 50.4% respectively) although this finding was not statistically significant. There was no statistical significant association between patients¿ literacy levels and their ability to understand prescription medication labels.
Conclusion
Patients of all literacy levels had improved understanding of PCL prescription labels. Interestingly the PCL+Graphic label appeared to make information less clear, which may be due to the unfamiliarity of this presentation. Further research is needed to elucidate this further. Prescription label design can influence understanding of medication instructions and thus should be optimized.
References
1. Smith Pecukonis E. Health literacy: A prescription to end confusion. Social Work in Health Care. 2008; 46(4):101-4.
2. Davis TC, Crouch MA, Long SW, Jackson RH, Bates P, George RB, et al. Rapid assessment of literacy levels of adult primary care patients. Fam Med. 1991 Aug; 23(6):433-5