FDA Reports Recall of Custom Convenience Kits Because of Prefilled Syringe Plunger Defect
On November 9, 2021, the U.S. Food and Drug Administration (FDA) reported Aligned Medical Solutions’ recall of its custom convenience kits because of the potential for the plunger of the Cardinal Health monoject flush prefilled syringe (0.9% sodium chloride) to draw back after the air has been expelled and reintroduce air back into the syringe. FDA identified the recall as a class I recall, the most serious type of recall.
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APRNs Can Lead by Example When Integrating Palliative Care in Practice
Early and regular integration of palliative care (PC) improves patient and caregiver outcomes in symptom management, quality of life, psychosocial health, communication, shared decision-making, overall satisfaction—and even survival. Health systems also benefit through reduced emergency department visits, hospitalizations, and intensive care stays; increased completion of advanced directives; and improved quality of end-of-life care. Both the Centers for Medicare and Medicaid Services’ (CMS’s) Oncology Care Model and many oncology organizations, including ONS, support the approach for patients with cancer.
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New Radiopharmaceutical Improves Survival in Advanced Prostate Cancer
Among patients with metastatic, castration-resistant prostate cancer, treatment with the experimental 177Lu-PSMA-617 radiopharmaceutical, along with other standard treatments, improved survival by four months over treatment with standard therapies alone, researchers reported in the New England Journal of Medicine. The therapy targets the PMSA protein and may one day be an option when other treatments have failed.
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Cultural Humility Is a Nursing Clinical Competency
To confront the disparities that minority populations face in health care, organizations across the United States are recognizing that cultural humility is a clinical competency. Implicit and explicit bias are part of human nature, but prioritizing cultural humility as a foundation, diversifying the workforce, and engaging in education and training can help providers overcome those tendencies and achieve patient-centered care.
ONS Board Holds First In-Person Meeting Since 2019
During a crisp fall week on September 22–24, 2021, the ONS Board of Directors met in person for the first time since 2019. Dynamics are different when everyone is in the same room, and the Board embraced the energy it infused into its work. Here are some of the important topics they discussed, and ONS members can read the complete minutes from the three-day meeting at ons.org/board-minutes.
Genetic Disorder Reference Sheet: Familial Adenomatous Polyposis
Individuals with 10–100+ polyps may have a germline pathogenic variant in the APC gene, placing them at higher risk for developing colorectal, gastrointestinal, and other cancers. The condition is known as familial adenosis polyposis (FAP), and loss of function in the APC gene is the first step in the adenoma-to-carcinoma sequence. Some people have an attenuated form (aFAP), with delayed polyp growth and fewer polyps (see sidebar). As many as 20% are de novo, meaning that they are the first in their family to have an identified pathogenic variant.
Clinical Full-Body Skin Examination Identifies Twice the Number of Cancers
A dermatologist-performed total-body skin examination (TBSE) identifies more than two times the number of skin cancers than patients or other providers discovered, researchers reported in the International Journal of Women’s Dermatology. The cancers may otherwise have gone undiagnosed, leading to later-stage disease and poorer outcomes.
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Genetic Counselors Help Patients and Providers Understand Biomarker Testing Goals and Results
Genetic counselors have a unique ability to explain complex genetic information to patients, providers, and our healthcare colleagues and to empower patients to take an active role in their healthcare decisions. We review biosignature data points and help explain the difference between variants that were acquired (somatic) versus those that may have a germline component, or possibly inherited from a parent. By working with oncology teams, genetic counselors provide guidance on potential next steps to evaluate variation occurrences and how providers, patients, and their families can use the information to guide their care.
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Bringing Biosignatures to the Bedside
With the growth of genomics and targeted therapy, nurse scientists are gaining deeper understanding the vast facets of patients’ symptom experience, and biosignatures could be the key to unlocking the next frontier in symptom science research.
FDA Approves Asciminib for Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib (Scemblix®) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who were previously treated with two or more tyrosine kinase inhibitors (TKIs). FDA also approved asciminib for adult patients with Ph+ CML in CP with the T315I variation.