Home-Based Anticancer Therapy Without Oncologist Oversight is Not Safe

With the arrival of COVID-19, related travel restrictions and the growing emotional toll of the pandemic, the uptake of home-based chemotherapy has grown. And while there may be a positive impact on patients, this approach may only be feasible for a select group of patients. But not everyone agrees.

For example, earlier this year, the Community Oncology Alliance (COA) issued a statement in which the organization stated that it was fundamentally opposed [to] home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns. [1]

A spokesperson for the organization said that (oncology) nurses who deliver infusions to cancer patients in the infusion centers are highly skilled and most of these nurses are nationally certified to care for these patients, confirming that “it is crucial to deliver multidrug anticancer regimens in the correct order.”

In their statement COA further explains that many of the side effects caused by cancer treatment can have a rapid and unpredictable onset and could potentially be life-threatening to a patient.  And while this may also be the case when antivancer drugs are administered in a dedicated infusion center, one of the biggest concerns is those home infusions may not always be administered by a trained oncology nurse. Furthermore, unlike administration in the clinic, there is not a team of knowledgeable and skilled clinicians on standby if something goes wrong.

However, in their COVID-19 related toolkit, the National Comprehensive Cancer Network (NCCN) cautiously endorsed the home infusion.  The organization stated that a number of chemotherapies could potentially be administered in an at-home setting.[2]

But based on ongoing studies, experts at the American Society of Clinical Oncology (ASCO), one of the nation’s leading cancer organizations, concluded that home infusion of anticancer chemotherapy is currently not a safe alternative to outpatient treatment.

ASCO recently published a guide to cancer care delivery during the COVID-19 pandemic and, previously, standards on the safe handling of hazardous drugs.

In a position statement, the organization raises concerns about home-infusion of anticancer therapy and the Centers for Medicare & Medicaid Services (CMS) regulations regarding the practice.

“We understand that COVID-19 has resulted in treatment challenges in some cases, and that home infusion services have been utilized as an alternative to treatment in outpatient facilities, but it is still unclear if the benefits outweigh the risks of this approach,” said ASCO President Lori J. Pierce, MD, FASTRO, FASCO.

“During and beyond this pandemic, patient safety must continue to be the first priority, and the decision to administer anticancer therapy in a home setting should be made only if both the treating physician and patient agree it’s in the patient’s best interest,” Pierce added.

Cancer therapy
Home infusion of anticancer therapy differs from traditional outpatient therapy in that instead of going to an oncology facility for treatment, a qualified member of the care team, typically a nurse comes to the patient’s home to administer the treatment.

While this, no doubt, reduces some hurdles for the patient, home infusion adds a number of risks for both patients and care team members.  These risks may include the safe handling of anticancer therapy in the home and the potential lack of coordination with the treating oncologist. Furthermore, adverse events and side effects from anticancer therapy may quickly escalate and become life-threatening emergencies that may not be able to be adequately resolved in the patient’s home.

21st Century Cures Act
A provision in the 21st Century Cures Act, signed into law on December 13, 2016, prompted Centers for Medicare & Medicaid Services to finalize a rule in 2019 to create a benefit for home infusion therapy services that will be implemented beginning in 2021.

However, as the COVID-19 crisis evolved into a pandemic, CMS also released numerous regulatory flexibilities to assist health care professionals and patients, including one that allows care to be delivered in the setting most appropriate and safest for an individual patient’s circumstances. This could lead to increases in the use of home infusion for anticancer therapy.

Safety standards
In 2016, the American Society of Clinical Oncology and the Oncology Nursing Society (ONS) published updated chemotherapy administration safety standards designed to minimize the risk of errors in chemotherapy ordering, preparation, and administration.

ASCO’s 2019 standards focus on the safe handling of hazardous oncology drugs in the workplace, and the ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic provides pandemic-specific guidance to oncology practices on the immediate and short-term steps that could be taken to help protect the safety of patients and health care staff before resuming more routine care operations during the COVID-19 public health crisis.

There is very little evidence directly comparing the safety of anticancer therapy infusions in the home versus outpatient settings. Many established standards and precautions may be difficult, if not impossible, to meet during home infusion.

“Our safety principles, for example, emphasize using more than one practitioner to verify and document dosage and infusion volume, safeguards that are designed to minimize errors and prevent patient harm,” Pierce observed.

“In oncology practice, additional trained staff is available to do this, but that is not the case in a home infusion setting,” she added.

The position statement states that the decision to administer anticancer therapy in a home setting should be made by the treating physician in consultation with the patient.  And the decision to go-ahead should, according to the experts, only be made after consideration of all available and necessary precautions to protect medical staff, patients, and caregivers during infusion and disposal.

Reference
[1] Position statement on home infusion. Community Oncology Alliance. Online. April 9, 2020. Last accessed on July 29, 2020.
[2] NCCN Best Practices CommitteeInfusion Efficiency WorkgroupToolkit: Providing Oncology Treatments in the Outpatient Setting (Revised: 03/31/2020). Online. Last accessed on July 29, 2020.
[3] Neuss MN, Gilmore TR, Belderson KM, et al. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology [published correction appears in J Oncol Pract. 2017 Feb;13(2):144]. J Oncol Pract. 2016;12(12):1262-1271. doi:10.1200/JOP.2016.017905 [Article]

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