Burden of Changes in Generic Pill Appearance
Authors: Kathleen Uhl, John R. Peters
Journal: Annals of Internal Medicine (2014)

Letters2 December 2014Burden of Changes in Generic Pill AppearanceKathleen Uhl, MD and John R. Peters, MDKathleen Uhl, MDFrom Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.Search for more papers by this author and John R. Peters, MDFrom Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L14-5028 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:There are many reasons for patient nonadherence to a prescribed therapeutic regimen. Kesselheim and colleagues (1) identify an important contributor: variability in the appearance (for example, shape, color, and size) of tablets. We realize that changes in pill appearance and packaging can contribute to patient nonadherence, and the U.S. Food and Drug Administration (FDA) has published draft guidance addressing certain aspects of these concerns (2–4).Because generic drugs currently represent nearly 85% of prescriptions dispensed, patients will continue to experience changes in pill appearance as economic forces lead to product turnover in pharmacies and mail-order houses. These ...References1. Kesselheim AS, Bykov K, Avorn J, Tong A, Doherty M, Choudhry NK. Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case–control studies. Ann Intern Med. 2014;161:96-103. [PMID: 25023248] doi:10.7326/M13-2381 LinkGoogle Scholar2. U.S. Food and Drug Administration. Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules: Draft Guidance. Silver Spring, MD: U.S. Food and Drug Administration; 2013. Accessed at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377938.pdf on 28 October 2014. Google Scholar3. U.S. Food and Drug Administration. Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors: Draft Guidance. Silver Spring, MD: U.S. Food and Drug Administration; 2012. Accessed at www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm331808.htm on 28 October 2014. Google Scholar4. U.S. Food and Drug Administration. Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Draft Guidance. Silver Spring, MD: U.S. Food and Drug Administration; 2013. Accessed at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdf on 28 October 2014. Google Scholar5. Greene JA, Kesselheim AS. Why do the same drugs look different? Pills, trade dress, and public health. N Engl J Med. 2011;365:83-9. [PMID: 21732842] doi:10.1056/NEJMhle1101722 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L14-0452. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoBurden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction Aaron S. Kesselheim , Katsiaryna Bykov , Jerry Avorn , Angela Tong , Michael Doherty , and Niteesh K. Choudhry Burden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction Aaron S. Kesselheim , Katsiaryna Bykov , Jerry Avorn , Angela Tong , Michael Doherty , and Niteesh K. Choudhry Burden of Changes in Generic Pill Appearance Stephen Pauker Burden of Changes in Generic Pill Appearance Aaron S. Kesselheim , Niteesh K. Choudhry , and Jerry Avorn Burden of Changes in Generic Pill Appearance Stephen Pauker Burden of Changes in Generic Pill Appearance Aaron S. Kesselheim , Niteesh K. Choudhry , and Jerry Avorn Metrics 2 December 2014Volume 161, Issue 11Page: 839-839KeywordsConflicts of interestDisclosureDrugsEpileptic seizuresPharmacistsPrevention, policy, and public health ePublished: 2 December 2014 Issue Published: 2 December 2014 CopyrightCopyright © 2014 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...