IntegraDose Compounding Services Issues Voluntary Nationwide Recall of Cefazolin Injection Products Because of a Lack of Sterility Assurance
On September 21, 2021, the U.S. Food and Drug Administration (FDA) reported IntegraDose Compounding Services’ voluntary recall of nine lots of cefazolin 2 g in 20 ml syringe for injection and two lots of cefazolin 3 g in 100 ml 0.9% sodium chloride bag for injection because of a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.
Pfizer Expands Recall to Include All Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content
On September 17, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of all lots of varenicline 0.5 mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, at or above the FDA interim acceptable intake limit. FDA said that while Pfizer is undertaking the precautionary measure, alternative suppliers have been approved in the United States.
FDA Reprimands Tobacco Company for Not Meeting Premarketing Filing Requirements
On August 9, 2021, the U.S. Food and Drug Administration issued a refuse-to-file letter (RTF) to JD Nova Group, notifying the company that their premarket tobacco product applications associated with approximately 4.5 million of their products do not meet the filing requirements for a new tobacco product seeking a marketing order.
The Case of the Swift Sepsis Response
Simon is a 72-year-old patient diagnosed with myelodysplastic syndrome and acute myeloid leukemia. He underwent an HLA-identical sibling peripheral blood stem cell transplantation with fludarabine and melphalan as conditioning chemotherapies before the procedure. Simon is now more than 12 days posttransplant but still neutropenic with an absolute neutrophil count of 0. He has no signs of engraftment, is on total parenteral nutrition, and requires multiple blood transfusions and electrolytes through his central line catheter daily.
FDA Grants Full Approval for First COVID-19 Vaccine
On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 coronavirus infection in individuals aged 16 years and older. The vaccine is still under emergency use authorization (EUA) for individuals aged 12–15 years and as a third dose in certain immunocompromised individuals.
FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma
On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk for recurrence after undergoing radical resection.
FDA Expands Recall to Include Four Additional Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content
On August 16, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of an additional four lots of varenicline 0.5mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. To date, Pfizer has not received any reports of adverse events that have been related to the recall. FDA reported Pfizer’s recall of 12 lots of varenicline tablets because of N-nitroso varenicline content on July 19, 2021.
Overall Youth Tobacco Use Declines, but E-Cigarette Use Climbs, According to National Survey Results
American youth reported a decline in using any tobacco product in 2020 compared to 2019 but no significant decrease in the use of cigarettes, hookah, pipe tobacco, or heated tobacco products, according to 2020 U.S. Food and Drug Administration (FDA) survey findings on youth tobacco use. Despite the decline, FDA said that the data shows “disturbingly high rates of frequent and daily e-cigarette use” and strong nicotine dependence among youth.
Baxter Healthcare Recalls Dose IQ Software Version 9.0.x Because of Software Defect
On August 12, 2021, the U.S Food and Drug Administration (FDA) reported Baxter Healthcare’s recall of the Dose IQ Safety Software used with the Spectrum IQ Infusion System because a software defect may lead to mismatched drug information in drug libraries that were created using version 9.0.x of the computer-based software. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
FDA Announces Recall for SterRX, LLC, Sodium Bicarbonate in 5% Dextrose Injection Because of Microbial Contamination
On August 10, 2021, the U.S. Food and Drug Administration (FDA) reported SterRx, LLC’s, voluntary recall of three lots of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 ml due to waterborne microbial contamination.
Nursing Informaticists Are the Backbone of Technology-Driven Care
Emerging healthcare technologies require a significant investment in time, money, and training. It starts with ensuring that quality improvement efforts are consistent to support positive clinical and patient outcomes, which is why clinical and information technology (IT) representation is critical in making decisions and exploring solutions. Nursing informatics bridges that gap.
FDA Announces Recall for 12 Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content
On July 19, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of two lots of varenicline 0.5 mg tablets, two lots of varenicline 1 mg tablets, and eight lots of a varenicline kit of 9.5 mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. Varenicline is a treatment to help patients quit smoking and is intended for short-term use. To date, Pfizer has not received any reports of adverse events that have been related to the recall.
FDA Announces Recall of One Lot of Topotecan Injection Because of Presence of Particulate Matter
On July 1, 2021, the U.S. Food and Drug Administration (FDA) reported Teva Pharmaceuticals’ June 30, 2021, voluntary recall of lot 31328962B of topotecan injection 4 mg/4 ml. The recall was based on a report that a single vial contained a glass particle, a grey silicone particle, and a translucent, colorless cotton fiber.
Oncology Dietitians Tackle Nutritional Barriers and Dispel Misinformation
Because they often face nutrition challenges—such as nausea, taste alterations, difficulty swallowing, and altered gastrointestinal function—that develop during their journey and hinder their nutrition stability, patients with cancer have increased nutrient needs. Oncology dietitians are experts at guiding patients and caregivers through the nutritional process and developing solutions.
Food for Thought: Prevent and Screen for Malnutrition in Patients With Cancer
Malnutrition affects 30%–85% of all patients with cancer, making it one of the most common symptoms for oncology nurses to manage. To help patients achieve the best outcomes, clinicians must understand how and when to screen for malnutrition and how nutritional status affects treatment outcomes and patients’ quality of life.
FDA Announces Several New Recalls of BD Alaris Pump Module Model 8100 Because of Key and Bezel Problems
On April 16, 2021, the U.S. Food and Drug Administration (FDA) reported Care Fusion 303, Inc.’s, recall of the BD Alaris Pump Module 8100 because the device may experience stuck or unresponsive keys during operation. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
FDA Makes Strides in Premarket Review of Tobacco Product Applications
The U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products has aggressively fought to obtain tighter tobacco product regulations to protect adolescent lungs. One of those ways is through premarket review, where e-cigarettes and other new tobacco products that were available as of August 8, 2016, were required to submitted applications to FDA for approval by Sept. 9, 2020.
Zydus Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection
On March 25, 2021, the U.S. Food and Drug Administration shared Zydus Pharmaceuticals Inc.’s notice of its voluntary recall of four lots of acyclovir sodium injection 50 mg/ml, supplied in 10 ml and 20 ml vials, after receiving reports of crystallization in the product.
Infection Prevention for Oncology Nurses
Regardless of care setting, oncology nurses must be vigilant about creating a safe environment for and educating patients about the importance of infection prevention. Patients with cancer are at increased risk for viral, bacterial, and fungal infections, but the extent depends on cancer type and treatment.
FDA Advises Healthcare Professionals Not to Use BD’s ChloraPrep™ 3 ml Applicators
On March 19, 2021, the U.S. Food and Drug Administration (FDA) issued an advisory to healthcare professionals not to use ChloraPrep 3 ml applicators manufactured by BD (Becton, Dickinson and Company) because of the risk of microbial contamination. The product was distributed globally and is labeled with “CareFusion, El Paso, TX.”
Should Patients With Cancer Receive COVID-19 Vaccines? Here’s What Oncology Nurses Need to Know
Patients with cancer who are infected with COVID-19 coronavirus have an overall 21.2% increased mortality rate, compared to 8.7% for those without cancer—and for those with a smoking history, mortality increases to 31.1%. With statistics like those, should patients with cancer get COVID-19 vaccination as soon as possible?
Sunstar Americas, Inc., Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, for Microbial Contamination
On December 28, 2020, the U.S. Food and Drug Administration announced that Sunstar Americas, Inc., expanded its October 27, 2020, voluntary recall of Paroex® chlorhexidine gluconate oral Rinse USP, 0.12%, because of possible contaminated with the bacteria Burkholderia lata.
FDA Issues Emergency Use Authorization for First COVID-19 Vaccine
On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for a vaccine to prevent the COVID-19 coronavirus caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United States.
FDA Warns Against Wearing Face Masks With Metal During MRI Exams
The U.S. Food and Drug Administration (FDA) issued an alert on December 7, 2020, informing patients and healthcare providers that patients may be injured if they wear face masks with metal parts and coatings during magnetic resonance imaging (MRI) exams. Metal parts (e.g., nose pieces, nanoparticles, or antimicrobial coatings that may contain metal such as silver or copper) may become hot and burn patients during MRIs.
Protect Patients With Cancer During Flu Season With Recommended Vaccinations
Patients with cancer are at increased risk for complications from the common flu. Plus, ensuring they receive recommended influenza vaccinations will reduce flu-related healthcare demands and decrease stress on the United States’ healthcare system, which is crucial as the nation approaches 10 million COVID-19 coronavirus cases. In response, the Centers for Disease Control and Prevention (CDC) isn’t waiting until National Influenza Vaccination Week, December 6–12, 2020, to promote vaccinations to high-risk populations.
Manage Malnutrition’s Monstrous Consequences in Patients With Cancer
Nutritional status is one aspect of cancer care that may often be overlooked. Patients, particularly those with esophageal, gastric, pancreatic, and non-small cell lung cancers, have increased nutritional requirements because of their high resting energy expenditure. Treatment side effects further hinder a patient’s desire and ability to eat, creating a wider gap between energy intake and energy needs and placing patients with cancer at high risk for malnutrition.
Annual Survey Shows Youth Vaping Is Still a National Epidemic
In 2020, the number of middle and high school students who use e-cigarettes decreased by 1.8 million compared to 2019, the Centers for Disease Control and Prevention and U.S. Food and Drug Administration reported in the results of the 2020 National Youth Tobacco Survey. However, the results also showed that youth tobacco use is still an epidemic in the United States.
Opioids Can Be Used Safely for Cancer-Related Pain
During the current opioid epidemic, a safe, balanced approach to pain management is imperative. In an ONS Bridge presentation, Jeannine M. Brant, PhD, APRN, AOCN®, FAAN, discussed the use of opioids in patients with cancer.
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 Case of the Major Malnutrition Concerns
Max, a 60-year-old patient with head and neck cancer, is receiving chemoradiation. Since his initial consult, he’s experienced a 12% weight loss from baseline, impaired swallowing, pain, anorexia, and dysgeusia. He has financial challenges, limited social support, poor health literacy, and a history of alcohol abuse. He has a feeding tube, but you suspect he is not using it. You reinforce prior education about malnutrition, and although Max refuses to be admitted to the hospital, he promises to do better.
When Function Becomes Malfunction
Malfunctioning medical products can pose safety risks to both patients and nurses and waste valuable time and resources. All medical devices and equipment used in the United States must pass specific manufacturing requirements before they can be approved for sale. But every product, regardless of performance, is subject to malfunction. A challenge for nurses is determining whether an issue is a rare failure or if the product is legitimately problematic.
Antibody-Drug Conjugates Join the Best of Two Worlds Into One New Treatment
A new class of drugs, antibody-drug conjugates (ADCs), combines the specificity of targeted therapy with the cytotoxicity of chemotherapy for a powerhouse effect against certain types of cancer variants. Here’s what you need to know about this novel treatment modality.
Virtual Care for Patients With Cancer in New Jersey During COVID-19
The COVID-19 coronavirus pandemic is unchartered territory with many unknowns, especially a new reality that nurses may be experiencing for the first time: virtual patient care. Even at a distance, the team at Jefferson Health New Jersey Sidney Kimmel Cancer Center in Sewell wanted to ensure we offered the same level of care and encouragement to patients in all phases of the cancer continuum, so here’s what we found worked for us.
Oncology Drug Reference Sheet: Capecitabine
Capecitabine (Xeloda®) was approved by the U.S. Food and Drug Administration (FDA) in 1998 as a nucleoside metabolic inhibitor with antineoplastic activity indicated for adjuvant colon cancer, metastatic colorectal cancer, and metastatic breast cancer.
COVID-19 Talking Points for Patients With Cancer, Caregivers, and Family Members
To keep our communities safe and the most vulnerable people healthy, everyone needs to stay at home as much as possible. But patients with cancer and survivors must take extra steps to help maintain their health and safety. These patient education talking points can help people with cancer, as well as their family members and caregivers, stay well while staying at home.
How to Prevent Opioid Misuse While Effectively Managing Cancer Pain
Opioid misuse is prevalent among the U.S. population—so much so that President Trump declared it a public health emergency in 2017. At the same time, research shows that 20%–50% of patients with cancer and 80% of those with advanced-stage disease report experiencing moderate to severe pain. Balancing the dichotomies is difficult, but oncology nurses and other cancer care providers have a responsibility to provide comprehensive pain management for patients with cancer.
How COVID-19 Is Affecting Oncology Practice in South Korea
Oncology nurses around the world are seeing the effects of the COVID-19 coronavirus pandemic in their practices. At my facility in South Korea, nurses’ daily routines have changed and institution-wide shifts have affected patients with cancer, too.
FDA Announces Leucovorin Drug Shortage
On April 9, 2020, the U.S. Food and Drug Administration (FDA) announced that supplies of leucovorin calcium lyophilized powder for injection manufactured by Sagent Pharmaceuticals are currently in shortage. On April 21, the agency expanded the shortage to include supplies manufactured by Fresenius Kabi USA and Teva Pharmaceuticals.
State Governors Lead U.S. Response to COVID-19
Although the United States federal government is coordinating the nation’s public health campaign against the COVID-19 coronavirus pandemic, the states—and the governors in particular—are coordinating across the country and party lines to implement containment plans using all the public and private tools at their disposal.
Oncology Drug Reference Sheet: Panitumumab
Approved in 2006 as monotherapy for the treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC) after disease progression following treatment, panitumumab has been a mainstay metastatic disease for more than a decade. In 2014, it received additional indication as first-line therapy for the treatment of patients with EGFR-expressing mCRC in combination with FOLFOX, but in 2017, use was narrowed to wild-type RAS (not mutated RAS).
Telehealth Visits During COVID-19
With the Centers for Disease Control and Prevention’s recommendations for practicing social distancing to slow the national risk of transmission of COVID-19 novel coronavirus, oncology nurses must take increased precautions with patients with cancer who are at increased risk for contracting or experiencing poorer outcomes from COVID-19. Patients require communication and education in these uncertain times.
COVID-19 Fact Sheet and Implications for Patients With Cancer
COVID-19 is a novel coronavirus (a large family of viruses that can cause cold-like illnesses) first identified in Wuhan, China, in December 2019. It is a respiratory illness and can be spread from person to person, possibly through respiratory droplets during close contact. The first case of COVID-19 in the United States was reported on January 21, 2020.
Staffing Levels in Ambulatory Oncology Nursing
Convenience. Flexibility. Normalcy. Ambulatory oncology clinics deliver on those three crucially important aspects of treatment to many patients with cancer, offering expert care without a hospital stay or traveling far from home.
ONS Members Help Drive the Ambulatory Staffing Discussion
With evolving treatments and novel approaches to care, outpatient oncology practice has grown exponentially during the past two decades. As a vital stop on the cancer journey for many patients, ambulatory clinics have seen a boom in acuity, patient needs, and staffing demands. ONS has been actively researching the growing staffing dilemma in ambulatory oncology nursing to help institutions understand and address nurse-patient staffing and which best practices can accommodate the varied challenges.
The Case of the Candy-Coated (Mis)Conception
P.G. is a 54-year-old woman who presents to the infusion center to receive her second cycle of chemotherapy for breast cancer. As her oncology nurse, you check the chemotherapy orders and patient history and are concerned to see that her weight has dropped by 10% from baseline, necessitating a change in dosing.
Nurses Can Protect Patients From Neurotoxicity During Lumbar Puncture Procedures
When cleaning patients’ skin in preparation for lumbar puncture procedures, oncology nurses must consider side effects from use of various germicide solutions. Chlorhexidine gluconate (CHG) solution has been considered the broad-spectrum germicide effective against most nosocomial yeasts and gram-positive and -negative bacteria. It’s available as 2% or 5% CHG in 70% isopropyl alcohol and is used as an antiseptic for skin preparation and central venous catheter dressings.