Real World Testing May Help Better Understand Inconsistent Medicine Adherence in Clinical Trials


Dawn L. Hershman, MD, MS, Columbia University Medical Center, New York, NY, presents her findings at the 2022 San Antonio Breast Cancer Symposium.

Pharmacy Times is joined by Hershman, who discusses some of the reasons why participants may not adhere to their medication during clinical trials. She considers pill counting to be a good, but often unattainable, solution in the current clinical setting.

PT Staff: How can pharmacists assist with medication adherence?

Dawn Hershman, MD, MS: So, pharmacists play a key role. And both the studies that we've done at our institution, or that we're on going in terms of ongoing recruitment and prior studies, have shown that pharmacists can make a really big difference in terms of explaining to patients what to look out for, what to expect, how to take their medication, why they're taking their medication, and then alerting providers when there's a problem—like when a patient doesn't come.

Pharmacists focus on medicines in a way that are different than an oncologist (or a primary care provider) might, because they're looking at all of their medications at once. And so thinking about ways to increase access between patients and pharmacists, and pharmacists and practices, I think will improve over the overall care of the patients who are getting.

PT Staff: How do 24-hour recall and refill history measures compare with pill counting?

Dawn Hershman, MD, MS: The24-hour recall is usually, I mean, pill diaries are usually pretty awful in general. And in terms of pill counting, that's probably the best that you can do. Most trials don't have the capacity to do that. And we certainly don't do that in practice. So it's not entirely realistic.

I think we have a pretty good sense of when patients discontinued their medicines. But there are lots of different ways of measuring adherence. None of them is perfect. So, you can try to use some of the patient reported outcomes to get a sense of patient whether patients are skipping or missing their medicines.

You can use Micro-Electro-Mechanical Systems (MEMS) devices to try to understand at least if patients are opening them. You can use digital medicines to get a sense of when patients have consumed them if that consumption is really important, but the problem is that [it] doesn't translate into the real world. So we're better off understanding and testing scenarios that are closer to what people do in the real world.

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