Using the Readability Assessment Instrument to Evaluate Patient Medication Leaflets

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0092-8615/99 Copyright 0 1999 Drug Information Association Inc.

USING THE READABILITY ASSESSMENT INSTRUMENT TO EVALUATE PATIENT MEDICATION LEAFLETS MARYANN F. KIRKPATRICK,PHD Assistant Professor

CHERRIP. MOHLER,BS Department of Pharmacy & Pharmaceutics, Virginia Commonwealth University, Richmond. Virginia

Seven phenytoin information leaflets were evaluated f o r their readability using the Singh Readability Assessment Instrument (RAIN). These evaluations were performed to ascertain if the variable criteria of the RAIN, developed to assess the readability of patient information brochures, were appropriate for evaluating the readability of medication information leaflets. Leaflets were scored in terms of eight variables identifed by reading researchers as facilitating comprehension: global coherence, local coherence, unitypaudience appropriateness, adjunct questions, writing style, illustrations, and typography. A scoring criterion of 80% adherence on most variables was considered acceptable. The American Association of Retired Persons leaflet was found to be acceptable. Five of the leaflets failed to meet RAIN criteria for audience appropriateness, adjunct questions, illustrations, and typography. Results support the RAIN as a useful tool for evaluating and optimizing the readability of medication information leaflets. Key Words: Medication; Readability; Information; RAIN; Evaluation

INTRODUCTION THE UNITED STATES Food and Drug Administration (FDA) and other health organizations have been concerned for many years with a perceived lack of information being provided to patients receiving medications (1). To begin addressing these problems, the Omnibus Reconciliation Act of 1990 was passed, requiring the offer of patient counseling by pharmacists when new prescriptions were filled for Medicaid recipients. Most states expanded these regulations to require written andor oral counseling for all patients receiving new prescriptions (2). Reprint address: Mary Ann F. Kirkpatrick, Box 980533, Virginia Commonwealth University, Richmond, VA 232984533.

In the August 24, 1995 Federal Register, the FDA reported that approximately 50% of patients do not receive information when obtaining their medications and that there is great variability in the quality and usefulness of the information provided. In keeping with the Healthy People 2000 initiative developed by the United States Department of Health and Human Services' Public Health Services (3), the FDA proposed that the private sector accept the challenge of providing useful (accurate, thorough, and understandable) information to 75% of individuals receiving new prescriptions by the year 2000 and 95% of individuals receiving new prescriptions by the year 2006. Organizations such as the United States Pharmacopeial Convention have accepted this challenge and are currently supporting research to determine

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Mary Ann F. Kirkpatrick and Cherri P. Mohler

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where and by whom medication information is