Aaron S. Kesselheim, MD, JD, MPH; Katsiaryna Bykov, PharmD, MS; Jerry Avorn, MD; Angela Tong, MS; Michael Doherty, MS; Niteesh K. Choudhry, MD, PhD
Financial Support: Dr. Kesselheim was supported by a career development award from the Agency for Healthcare Research and Quality (K08HS18465-01), the Greenwall Faculty Scholars Program in Bioethics, the Harvard Program in Therapeutic Science, and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research. Dr. Kesselheim and Dr. Avorn receive research support from the FDA Office of Generic Drugs. Dr. Choudhry was supported by unrestricted research grants from CVS Caremark, Aetna, The Commonwealth Fund, and the Robert Wood Johnson Foundation.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2381.
Reproducible Research Statement:Study protocol: Available from Dr. Kesselheim (e-mail, email@example.com). Statistical code: Not available. Data set: Available to approved persons through written agreements with the authors and data partner.
Requests for Single Reprints: Aaron S. Kesselheim, MD, JD, MPH, Division of Pharmacoepidemiology and Pharmacoeconomics, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Kesselheim, Bykov, Avorn, and Choudhry; Ms. Tong; and Mr. Doherty: Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 1620 Tremont Street, Suite 3030, Boston, MA 02120.
Author Contributions: Conception and design: A.S. Kesselheim, K. Bykov, J. Avorn, N.K. Choudhry.
Analysis and interpretation of the data: A.S. Kesselheim, K. Bykov, J. Avorn, M. Doherty, N.K. Choudhry.
Drafting of the article: A.S. Kesselheim, K. Bykov.
Critical revision of the article for important intellectual content: A.S. Kesselheim, J. Avorn, N.K. Choudhry.
Final approval of the article: A.S. Kesselheim, K. Bykov, J. Avorn, M. Doherty, N.K. Choudhry.
Provision of study materials or patients: J. Avorn.
Statistical expertise: K. Bykov, N.K. Choudhry.
Obtaining of funding: A.S. Kesselheim.
Administrative, technical, or logistic support: K. Bykov, J. Avorn, A. Tong.
Collection and assembly of data: A.S. Kesselheim, K. Bykov, M. Doherty.
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. doi: 10.7326/M13-2381
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Published: Ann Intern Med. 2014;161(2):96-103.
Generic prescription drugs made by different manufacturers may vary in color or shape, and switching among these drug products may interrupt medication use.
To determine whether nonpersistent use of generic drugs among patients with cardiovascular disease after myocardial infarction (MI) is associated with inconsistent appearance of their medications.
Cohort and nested case–control studies.
Claims from a commercial health insurance database in the United States.
Patients discharged after hospitalization for MI between 2006 and 2011 who initiated treatment with a generic β-blocker, angiotensin-converting enzyme inhibitor, angiotensin II–receptor blocker, or statin. Case patients discontinued their index medication for at least 1 month; control patients continued treatment. Control patients were matched to case patients on therapeutic class, number of dispensings before nonpersistence, sex, and age.
Rates of changes in pill color and shape during the year after MI were calculated. Next, 2 refills preceding nonpersistence were evaluated to determine whether pill color or shape had changed. Odds of discordance among case and control patients were compared using conditional logistic regression.
A total of 29% of patients (3286 of 11 513) had a change in pill shape or color during the study. Statins had the most changes in appearance, whereas β-blockers had the fewest. A total of 4573 episodes of nonpersistence was matched to 19 881 control episodes. The odds of nonpersistence in case patients increased by 34% after a change in pill color (adjusted odds ratio, 1.34 [95% CI, 1.12 to 1.59]) and 66% after a change in pill shape (adjusted odds ratio, 1.66 [CI, 1.43 to 1.94]).
Only 3 categories of drugs indicated after MI were evaluated, and clinical outcomes were not addressed.
Variation in the appearance of generic pills is associated with nonpersistent use of these essential drugs after MI among patients with cardiovascular disease.
Agency for Healthcare Research and Quality and the Harvard Program in Therapeutic Science.
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Cardiology, Emergency Medicine, Acute Coronary Syndromes, Coronary Heart Disease.
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