The Oncology Nursing Society’s (ONS’s) new Recognize It; Report It campaign encourages oncology nurses to document and report adverse events to the U.S. Food and Drug Administration’s (FDA’s) MedWatch program to increase the breadth of knowledge associated with drugs given expedited approval.
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(April 19, 2018)—As groundbreaking treatments come to market, patients with cancer have more options than ever before. For example, immunotherapies are providing a new line of hope for patients who’ve previously exhausted all other options. Although the novel treatments are changing the way healthcare professionals treat cancer, these newly approved drugs can still lead to severe adverse events and dangerous reactions for patients. The Oncology Nursing Society’s (ONS’s) new Recognize It; Report It campaign encourages oncology nurses to recognize adverse events experienced by their patients and communicate with the healthcare team to decide if a higher level of awareness is necessary. If appropriate, they are encouraged to report adverse events to the U.S. Food and Drug Administration’s (FDA’s) MedWatch program to increase the breadth of knowledge associated with drugs given expedited approval.
MedWatch program is designed specifically for healthcare professionals to report side effects, adverse events, administration issues, and other considerations found in newly approved medications. Recently, a number of immunotherapy agents received the FDA’s fast-track approval, moving them out of the final phases of clinical trials and delivering them to patients. Fast-track approvals, although advantageous for drug accessibility, limit data collection and the information available related to expected and unexpected adverse events. By using MedWatch to report adverse events, oncology nurses can ensure a comprehensive repository of drug-related data and timely communication for adverse events.
“New approvals are arriving at historic rates. Clinical trials for these agents study the drug activity and adverse events in very controlled patient populations, but when we administer these agents outside of the trial setting, we need to be vigilant about recognizing and reporting adverse events, both immediate and longer-term,” Michele Galioto, RN, MSN, ONS’s assistant chief clinical officer, said. “To report adverse events, nurses don’t need to confirm a cause-and-effect relationship. If something unexpected occurs, it should be escalated to the entire healthcare team and then reported, if necessary. Unexpected isn’t defined by life-threatening alone. It’s important for oncology nurses to recognize when something is out of the ordinary and report what occurred. Without that data, we will never fully understand the effects of these agents.”