Black Box Warnings Guide Oncologic Emergencies in Acute Care and Outpatient Settings
The transition of chemotherapy and immunotherapy delivery from the acute care and clinic settings to the home setting has created a need for innovative strategies to keep patients safe. Today, with decreased face-to-face interactions, the need for those strategies and tools is even greater in a system reliant on multiple facilities and disciplines to collaborate care in a time when resources are sometimes scarce or minimal, Mary Jo Sarver, ARNP, AOCN®, CRNI, VA-BC, LNC, said in an on-demand session for the inaugural ONS Bridge™ virtual conference.
“The shift in care setting and patient self-administration of cytotoxic and immunologic therapy poses challenges related to medication exposure and to patient comprehension and ability to follow instructions,” Sarver said.
One strategy the U.S. Food and Drug Administration uses to meet those challenges is black box warnings to identify potential treatment-related outcomes and monitoring strategies. Black box warnings are required if a medication can cause undesirable effects so that physicians and patients can decide if the potential benefit of a drug is worth the risk and prevent, reduce in frequency, or reduce in severity any serious adverse events that may occur.
Tumor Lysis Syndrome
A common adverse effect for cancer treatment is tumor lysis syndrome, an oncologic emergency caused by massive tumor cell lysis and the release of large quantities of potassium, phosphate, and nucleic acid into the systemic circulation. The use of black box warnings has opened the opportunity to take a proactive—not reactive—approach to treatment.
“With prescribing of home therapies that have black box warnings related to occurrence, prophylactic treatment is on the radar,” Sarver said. “Now, we have drugs other than allopurinol with rapid onset considerations to usage, such as distance from medical treatment, ability to obtain labs rapidly, patients’ ability to self-monitor for side effects, cost savings by prevention of hospitalization, and prevention of kidney damage.”
Progressive Multifocal Leukoencephalopathy
A differential diagnosis for a patient with cancer can become a complex challenge when treatment is administered at home. For example, progressive multifocal leukoencephalopathy (PML) is a rare but often fatal viral disease that damages or inflames multiple areas of white matter in the brain and can often have symptoms similar to other conditions. PML is a black box warning for many new immunotherapy treatments in cancer care.
“Symptoms for PML can mimic cerebrovascular syndromes like stroke or thrombosis and often have insidious onsets that are overlooked or contributed to chemobrain, anemia, or fatigue,” Sarver said. “This makes patient recognition and reporting, along with education and continual assessment, paramount to evading potential adverse outcomes.”
Sarver emphasized the importance of considering the fine line between frightening a patient and minimizing potential life-threatening complications. With any new medication, knowing what questions to ask via telephone or video follow-up can lead to positive outcomes.
Home administration of oral medications and continuous infusions creates new challenges in maintaining patient safety and proper administration schedules. Combined therapy and interventional procedures increase this complexity, requiring oncology nurses to develop concise instructions and pathways for patient reporting of adverse effects to avoid life-threatening outcomes, Sarver said.