For anyone taking oral anti-cancer medications, sticking with a prescribed treatment regimen is critical to ensure the drugs work as well as possible to keep the illness in check.

MORE FROM THE LAB: Subscribe to our weekly newsletter

Missed or irregularly timed doses, or stopping or restarting the medications, can seriously compromise the effectiveness of oral chemotherapy agents, also called oral oncolytics. These drugs — taken at home in pill or liquid form instead of as intravenous infusions at infusion clinics or centers — are often long-term therapies that work by continually targeting the genetic irregularities that cause cancer cells to grow.

But up to 30 percent of people taking these oral cancer treatments had less-than-optimal adherence to their treatment regimens, according to a new study of patients across practices involved with the Michigan Oncology Quality Consortium (MOQC), a statewide effort supported by Blue Cross Blue Shield of Michigan and coordinated through the University of Michigan Comprehensive Cancer Center.

The primary reason: Patients identified difficulties in managing the drugs' side effects.

The findings point to a pressing need for oncology practices to develop new systems of monitoring and supporting individuals taking oral oncolytics, the researchers say. With the shift to at-home chemo, patients bear much of the responsibility for diligently following treatment plans, self-managing side effects and reporting back to their physician or clinic.

Those are responsibilities that, in the more traditional form of IV chemotherapy delivery, are handled by nurses at a central infusion center where dosing, treatment response and any adverse reactions can be closely supervised.

The relative ease of intake can, in fact, complicate the process.

"With oral chemotherapies, we've moved to a system with multiple caregivers, multiple sites of care, as well as different expectations for outcomes," says Emily Mackler, Pharm.D., a clinical pharmacist with MOQC and one of the study's co-authors.

"Meanwhile, patients and their families have had to take on a much more active and complex role in managing cancer treatment within this constantly changing delivery environment. This is a major shift of responsibilities that used to lie with the health system."

Changes in cancer treatment settings

Oral anti-cancer medications, which have been prescribed since the early 2000s, are now one of the fastest-growing areas of cancer treatment, comprising more than 25 percent of anti-cancer therapies in development by pharmaceutical companies.

SEE ALSO: Text Message Alerts Help Patients Remember to Take Meds

Because oral oncolytics are self-administered at home, much like treatments for any other chronic illness, these drugs offer greater convenience than IV chemotherapy that must be administered at an infusion center. 

With patients more removed from the clinic setting, however, providers are less equipped to monitor medication adherence, and have fewer face-to-face opportunities to evaluate patients and help them manage treatment-related symptoms such as fatigue, nausea and diarrhea that interfere with taking medication as directed.

"We saw that the symptom burden that patients experience was the primary reason for nonadherence to oral chemotherapy," says Karen Farris, Ph.D., the Charles R. Walgreen III Professor of Pharmacy Administration at the University of Michigan and the study's senior author. "We need to make sure that each patient is well-prepared to self-manage symptoms at home."

Still, "that's going to take a large effort to be able to change how patients are cared for in their oncology practices," she adds.

Enhancing care as treatment landscape evolves

How can oncology practices help improve the quality of care delivered to patients on oral chemotherapy, while better preparing patients to take greater ownership of their own treatment?

For one, the study's authors call for the creation of new workflows within oncology clinics to enhance self-care management ability and adherence for patients taking oral oncolytics. This first requires assessing current workflows to determine which professionals would carry out these interventions, and what their roles and tasks would be for each patient.

"We need to understand how clinics can get data prior to a visit or in between visits, particularly after a new start of a medication, so we can understand what's happening with that patient at home," says Farris, who is also a member of the Institute for Healthcare Policy & Innovation (IHPI). "That will help inform how to use that information at the next clinic visit or perhaps intervene in the interim because the therapy is not going well."

Building on their current work in this publication, MOQC, in partnership with St. Joseph Mercy Hospital, is currently piloting a brief questionnaire to help practices better understand how their patients are managing their oral oncolytic regimens. They hope to use the data to better respond to safety concerns, make modifications to treatment plans, provide re-education about symptom management and develop other care enhancements.

The team is working with a number of MOQC-affiliated practices to refine the tool, which is based on patient-reported outcomes. The tool is also intended to help practices document quality measures to comply with national quality metrics in cancer care — metrics that are increasingly including oral oncolytics.

"MOQC is acutely aware of the challenges medical providers face in prescribing oral chemotherapy to their patients," says consortium director Jennifer Griggs, M.D., M.P.H., also an IPHI member. "At the same time, we also understand the importance of managing side effects in the lives of our patients."

"A multidisciplinary approach that incorporates and acknowledges the many demands on medical providers and patients alike is the only way to deliver the best care to our patients while seamlessly integrating patient-centered care into a busy clinical practice," she adds.