Document Detail

Variations in pill appearance of antiepileptic drugs and the risk of nonadherence.
MedLine Citation:
PMID:  23277164     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Generic prescription drugs are bioequivalent to brand-name versions but may not have consistent color or shape, which can cause confusion and lead to interruptions in medication use. We sought to determine whether switching among different-appearing antiepileptic drugs (AEDs) is associated with increased rates of medication nonpersistence, which can have serious medical, financial, and social consequences.
METHODS: We designed a nested case-control study of commercially insured patients in the United States who initiated an AED. Cases were patients who became nonpersistent, defined as failure to fill a prescription within 5 days of the elapsed days supplied. Controls had no delay in refilling and were matched by sex, age, number of refills, and the presence of a seizure disorder diagnosis. We evaluated the 2 refills preceding nonpersistence and determined whether pill color and/or shape matched ("concordant") or did not match ("discordant"). We compared the odds of discordance among cases and controls using multivariate conditional logistic regression, adjusting for baseline characteristics, and drug type. We repeated our analysis among patients with a seizure diagnosis.
RESULTS: The AEDs dispensed had 37 colors and 4 shapes. A total of 11,472 patients with nonpersistence were linked to 50,050 controls. Color discordance preceded 136 cases (1.20%) but only 480 controls (0.97%) (adjusted odds ratio [OR], 1.27 [95% CI, 1.04-1.55]). Shape discordance preceded 18 cases (0.16%) and 54 controls (0.11%) (OR, 1.47 [95% CI, 0.85-2.54]). Within the seizure disorder diagnosis subgroup, the risk of nonpersistence after changes in pill color was also significantly elevated (OR, 1.53 [95%, CI 1.07-2.18]).
CONCLUSIONS: Changes in pill color significantly increase the odds of nonpersistence; this may have important clinical implications. Our study supports a reconsideration of current regulatory policy that permits wide variation in the appearance of bioequivalent drugs.
Aaron S Kesselheim; Alexander S Misono; William H Shrank; Jeremy A Greene; Michael Doherty; Jerry Avorn; Niteesh K Choudhry
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  JAMA internal medicine     Volume:  173     ISSN:  2168-6114     ISO Abbreviation:  JAMA Intern Med     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-20     Completed Date:  2013-04-08     Revised Date:  2013-08-09    
Medline Journal Info:
Nlm Unique ID:  101589534     Medline TA:  JAMA Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  202-8     Citation Subset:  AIM; IM    
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA.
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MeSH Terms
Anticonvulsants / administration & dosage,  standards*
Case-Control Studies
Dosage Forms
Medication Adherence / statistics & numerical data*
Middle Aged
Multivariate Analysis
Grant Support
K08HS18465-01/HS/AHRQ HHS
Reg. No./Substance:
0/Anticonvulsants; 0/Dosage Forms
Comment In:
Fortschr Neurol Psychiatr. 2013 Jun;81(6):301
JAMA Intern Med. 2013 Feb 11;173(3):208-9   [PMID:  23277345 ]
JAMA Intern Med. 2013 Feb 11;173(3):209   [PMID:  23277310 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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