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Changes in pill appearance led to nonpersistence to generic drugs after MI
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Patients recovering from MI were less likely to persist with their generic medication regimens if the color or shape of the pill changed during treatment, according to study data.
Researchers studied whether nonpersistent use of generic beta-blockers, ACE inhibitors, angiotensin II receptor blockers or statins prescribed after MI was associated with changes in the appearance of the medications.
“Generic drugs may be therapeutically interchangeable, but they are not required to look the same as their brand-name counterparts or other generic versions of the same product, in part for historical reasons,” Aaron S. Kesselheim, MD, JD, MPH, and colleagues wrote. “Yet, pill appearance can be an important driver of patients’ health care experience. Pill color mediates patients’ clinical response to medication, and changes in pill appearance contribute to patient confusion and medical error. Changes in the appearance of medications used to treat chronic conditions may lead to nonadherence and negative health outcomes.”
Using medical and pharmacy data from the UnitedHealth research database, Kesselheim and colleagues analyzed the medications of patients discharged after hospitalization for MI between July 2006 and June 2011 (n=11,513). All patients were followed for 1 year. The researchers performed a nested case-control study matching cases, who discontinued their index medication for at least 1 month, with controls who continued treatment. Matches were made according to therapeutic class, the number of dispensings before nonpersistence, sex and age.
They calculated the rates of changes in pill color and shape during the year after MI and evaluated pill color and shape of two refills prior to nonpersistence to determine whether the appearance of the pill had changed.
Kesselheim, of the division of pharmacoepidemiology and pharmacoeconomics at Brigham & Women’s Hospital, and colleagues found that 29% of patients experienced a change in pill shape or color during the study period. Among the evaluated medication classes, statins had the most changes in pill appearance and beta-blockers the fewest, they found.
The researchers matched 4,573 episodes of nonpersistence to 19,881 control episodes and found that the odds of nonpersistence increased among case patients after a change in pill color (adjusted OR=1.34; 95% CI, 1.12-1.59 vs. controls) or shape (adjusted OR=1.66; 95% CI, 1.43-1.94).
Although the study did not address clinical outcomes, the association between changes in pill appearance and nonpersistence “has important implications for public health,” Kesselheim and colleagues wrote. Stopping essential medications after MI “will increase morbidity and mortality and health care spending overall because of preventable complications and disease recurrence. The associations revealed in our study explain a substantial part of suboptimal outcomes after MI.”
Therefore, they wrote, “cardiologists and other prescribers of [CV] medications should proactively warn patients about the potential for these changes and their lack of clinical import, especially in light of the growing prevalence of the use of generic drugs.”
Disclosure: See the full study for a list of relevant financial disclosures.
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