TY - JOUR
T1 - Variations in pill appearance of antiepileptic drugs and the risk of nonadherence
AU - Kesselheim, Aaron S.
AU - Misono, Alexander S.
AU - Shrank, William H.
AU - Greene, Jeremy A.
AU - Doherty, Michael
AU - Avorn, Jerry
AU - Choudhry, Niteesh K.
N1 - Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2013/1/11
Y1 - 2013/1/11
N2 - 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:Wedesigned 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.Weevaluated 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.
AB - 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:Wedesigned 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.Weevaluated 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.
UR - http://www.scopus.com/inward/record.url?scp=84874074498&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84874074498&partnerID=8YFLogxK
U2 - 10.1001/2013.jamainternmed.997
DO - 10.1001/2013.jamainternmed.997
M3 - Article
C2 - 23277164
AN - SCOPUS:84874074498
SN - 2168-6106
VL - 173
SP - 202
EP - 208
JO - JAMA internal medicine
JF - JAMA internal medicine
IS - 3
ER -