FDA Reports BD’s Recall of Intraosseous Products
On June 22, 2022, the U.S. Food and Drug Administration (FDA) reported Becton, Dickinson and Company’s (BD’s) voluntary recall of its intraosseous needle set kits, manual driver kits, and powered drivers. Use of the products could lead to needlestick injuries or delays in care because of limited or non-functioning intraosseous access.
FDA Reports Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
On June 21, 2022, the U.S. Food and Drug Administration (FDA) reported Vi-Jon, LLC’s, voluntarily recall of one lot of CVS magnesium citrate saline laxative oral solution lemon flavor, 10 fl oz (296 ml), after testing revealed the product contains the bacteria Gluconacetobacter liquefaciens.
FDA Reports Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
On June 8, 2022, the U.S. Food and Drug Administration (FDA) reported Plastikon Healthcare's voluntarily recall of one lot of Milk of Magnesia 2,400 mg/10 ml oral suspension, one lot of Milk of Magnesia 2,400 mg/30 ml oral suspension, 11 lots of magnesium hydroxide 1,200 mg/aluminum hydroxide 1,200 mg/simethicone 120 mg per 30 ml oral suspension, and two lots of magnesium hydroxide 2,400 mg/aluminum hydroxide 2,400 mg/simethicone 240 mg per 30 ml oral suspension to the consumer level because of microbial contamination.
FDA Reports Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks
On June 2, 2022, the U.S. Food and Drug Administration (FDA) reported a cybersecurity vulnerability that affects software in the Illumina NextSeq 550Dx, MiSeqDx, NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq next generation sequencing instruments. The devices are used in diagnostic (Dx), research-use only (RUO), or dual boot (either Dx or RUO) modes.
COVID-19 Contributes to Climbing Costs of Cancer Care
Cancer is one of the top five most expensive healthcare conditions to treat, costing the United States more than $157 billion annually. The payout from patients’ pockets may be even greater, with the cost of cancer medications alone standing at $895 billion per year. But paying for cancer during a pandemic? Even financially secure patients with healthcare coverage are struggling.
FDA Reports Safety Announcement for Spectrum V8 and Spectrum IQ Infusion Pumps
On February 18, 2022, the U.S. Food and Drug Administration (FDA) reported Baxter International’s urgent safety communication to reinforce safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps.
E-Cigarettes Affect Adults and Kids Differently, FDA Center for Tobacco Products Director Says
Balancing the benefits of e-cigarettes for adults with the harms makes regulating e-cigarette marketing particularly challenging, U.S. Food and Drug Administration (FDA) Center for Tobacco Products Director Mitch Zeller, JD, said in a January 2022 interview with the National Cancer Institute (NCI). FDA continuously evaluates e-cigarettes and tobacco companies’ marketing strategies, and Zeller says it’s up to tobacco companies to make those differences clear in their advertising.
FDA Reports Nationwide Recall of Senna Syrup 8.8 mg/5 ml Because of Microbial Contamination
On January 12, 2022, the U.S. Food and Drug Administration (FDA) reported Lohxa’s voluntary recall of one lot of senna syrup 8.8 mg/5 ml unit-dose cups to the consumer level because of microbial contamination.
Make Subcutaneous Administration More Comfortable for Your Patients
Much of oncology nursing education focuses on IV administration of systemic therapies because for years, that was the only route. Until 2004, only two cancer therapies were approved for subcutaneous (SC) administration, and just nine others were added through 2012. However, as more familiar IV therapies get SC counterparts, including the more recent approvals of four high-volume monoclonal antibodies (mAbs), infusion nurses are using them more regularly in practice.
HHS Secretary Becerra Announces New Overdose Prevention Strategy
Preventing overdoses—from any substance, but particularly opioids—is an urgent need during the U.S. opioid epidemic that involves a four-step process: prevention, harm reduction, treatment, and recovery, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra announcedHHS released a new overdose prevention strategy in October 2021 to increase access to services for patients and their families who use substances that can put them at risk for overdose.
Black Patients at Higher Risk for Infection, Poor Outcomes From COVID-19 During Cancer
Patients with cancer are more likely to contract the COVID-19 coronavirus and experience complications from the infection—and the risk is highest for Black patients, study findings show. Researchers published the report in JAMA Oncology.
FDA Reports Teligent Pharma’s Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4%
On December 7, 2021, the U.S. Food and Drug Administration (FDA) reported Teligent Pharma’s voluntary recall of two lots of lidocaine HCl topical solution 4% in a 50 ml screw cap glass bottle to the user level. The manufacturer’s testing found that the product is super potent based on an out-of-specification result at the 9-month (lot 16345) and 18-month (lot 15594) stability timepoint.
FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind
Under the authority given in the Family Smoking Prevention and Tobacco Control Act, in October 2021 the U.S. Food and Drug Administration (FDA) authorized the marketing of three new electronic nicotine delivery system (ENDS) products, “marking the first set of ENDS products ever to be authorized by FDA through the Premarket Tobacco Product Application pathway.” The agency made the announcement it continues its review of thousands of tobacco and e-cigarette products.
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.
Many Popular Online Cancer Articles Contain Misleading Information, NCI Says
With a plethora of information available online, patients with cancer and their families have access to plenty of resources to learn more about their diagnosis and treatment options. However, one-third of the online articles about cancer circulating on social media contain incorrect information, according to findings from a 2021 study published in the Journal of the National Cancer Institute.
FDA Amends EUAs With Booster Doses for COVID-19 Vaccines
On October 20, 2021, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for the Moderna and Janssen (Johnson and Johnson) COVID-19 vaccines to allow for the use of a single booster dose for certain populations.
FDA Reports Worldwide Recall of Lidocaine HCl Topical Solution 4% Because of Super Potency
On October 13, 2021, the U.S. Food and Drug Administration (FDA) reported Teligent Pharma’s voluntary recall of five lots of lidocaine HCl topical solution 4% in a 50 ml screw cap glass bottle to the user level because the firm’s testing found it to be super potent based on an out-of-specification result obtained at the 18-month stability timepoint.
FDA Issues Marketing Denial Orders for 55,000 Flavored E-Cigarette Products
In August 2021, the U.S. Food and Drug Administration (FDA) denied about 55,000 flavored e-cigarette products’ marketing applications for failing to provide evidence that they appropriately protect public health.
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.”
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 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.