| Characteristics of container labeling in a sample of commonly prescribed children's oral medications. | |
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MedLine Citation:
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PMID: 21111385 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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BACKGROUND: Time constraints often limit the amount of instruction pharmacists can provide to patients regarding accurate prescription medication use. OBJECTIVES: To assess the content, text point size, and reading difficulty of medication container labels and auxiliary warning labels (stickers) of 2 commonly prescribed children's medications (prednisolone and amoxicillin) dispensed by 20 US pharmacies. Secondly, to examine variability of pharmacy interpretations of electronically generated physician instructions (signatures [sigs]). METHODS: All medication container labels were evaluated on the following: presence and rank order of 7 Food and Drug Administration (FDA)-required label items, presence of additional label content (eg, fill date), and whether each label content item was emphasized in some way (eg, highlighting). Presence, placement, content, and color of auxiliary warning labels (stickers) were also assessed. Text point size of pharmacy name, instructions, medication name, and instructional/warning stickers was measured to the nearest centimeter. Reading grade level (RGL) of medication label instructions and auxiliary warning labels was estimated using the Lexile Analyzer (available via the Internet [http://www.lexile.com]). Amount and timing of medication administration of pharmacy interpretations of sigs were examined. RESULTS: All containers included the 7 FDA-required label items. Text point sizes varied widely (pharmacy name [mean ± standard deviation [SD] = 12.0 ± 3.9] versus auxiliary warning labels [mean ± SD = 6.8 ± 1.1]). Four (10%) containers did not include any additional type of warnings related to the medication, beyond the dosage amount and administration frequency. Mean Lexile score of warning stickers was 488.3 ± 316.3 (approximately third to fourth RGL), whereas that of pharmacy-generated instructions was 648.3 ± 215.9 (approximately fifth to sixth RGL). Prednisolone sig instructions were presented in 14 distinct ways by the pharmacies, whereas amoxicillin sig instructions were interpreted in 16 different ways. CONCLUSIONS: Although all prescriptions reviewed met the minimum FDA-required labeling standards, pharmacy characteristics were more likely to be prominently emphasized on the labels than were medication instructions and patient information. Systematic initiatives to standardize and call attention to key medication instructions and warnings should be considered. |
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Authors:
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Lorraine S Wallace; Amy J Keenum; Jennifer E DeVoe |
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Publication Detail:
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Type: Journal Article Date: 2009-12-07 |
Journal Detail:
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Title: Research in social & administrative pharmacy : RSAP Volume: 6 ISSN: 1934-8150 ISO Abbreviation: Res Social Adm Pharm Publication Date: 2010 Dec |
Date Detail:
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Created Date: 2010-11-29 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101231974 Medline TA: Res Social Adm Pharm Country: United States |
Other Details:
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Languages: eng Pagination: 272-9 Citation Subset: IM |
Copyright Information:
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Copyright © 2010 Elsevier Inc. All rights reserved. |
Affiliation:
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Department of Family Medicine, University of Tennessee Graduate School of Medicine, 1924 Alcoa Highway, Knoxville, TN 37920, USA. lwallace@mc.utmck.edu |
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Comment In:
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Res Social Adm Pharm. 2010 Dec;6(4):269-71
[PMID:
21111384
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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