FDA Recommends Reusing Tracheostomy Tubes or Switching to Appropriate Alternatives Because of Shortage
On October 31, 2022, the U.S. Food and Drug Administration alerted patients, caregivers, and healthcare providers of a tracheostomy tube shortage, including Bivona tracheostomy tubes manufactured by ICU Medical, because of difficulty obtaining required raw materials. FDA said it is working with manufacturers and other stakeholders to help resolve supply challenges and support the devices’ availability.
FDA Recommends Healthcare Providers Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Because of Shortage
On October 31, 2022, the U.S. Food and Drug Administration recommended that healthcare providers discuss alternative options for magnetic resonance imaging–guided breast biopsy procedures with patients if a facility is unable to perform it because of a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables.
Eugia US, LLC, Recalls AuroMedics Acyclovir Sodium Injection Because of Particulate Matter
On September 27, 2022, the U.S. Food and Drug Administration reported Eugia US, LLC’s, voluntary recall of AuroMedics acyclovir sodium injection 500 mg per 10 ml (50 mg/ml) single-dose vial to the consumer level because of reported presence of a dark red, brown, and black particulate inside the vial.
Post-Flooding Natural Disaster Cancer Considerations and Patient Education Points
Natural disasters present unique challenges to patients with cancer and the healthcare systems that must stand ready to keep them healthy. Exposure to floodwater places patients at risk for infectious diseases, chemical hazards, and injury, and anything in the water’s path, including medical equipment, medications, homes, and vehicles, can be severely damaged or destroyed. Patients with cancer who are immunocompromised are a highly vulnerable post-flooding population and need special guidance.
FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death
On September 22, 2022, to help achieve its priority of expanding the availability of overdose reversal products, the U.S. Food and Drug Administration issued the Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency industry guidance.
Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set With Duovent Because of Leaks That Risk Exposure to Toxic Substances
On September 15, 2022, the U.S. Food and Drug Administration reported Baxter Healthcare Corporation’s recall of Clearlink basic solution set with Duovent because of reports of leaks. FDA identified it as a class I recall, the most serious type of recall, where use of the set may cause serious injuries or death.
FDA Reports Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Breast Implants
On September 8, 2022, the U.S. Food and Drug Administration reported that cancers, including squamous cell carcinoma and various lymphomas, may develop in the capsule that forms around breast implants.
Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Because of Faster-Than-Expected Flow Rates
On August 29, 2022, the U.S. Food and Drug Administration reported Intera Oncology’s recall of the Intera 3000 hepatic artery infusion pump because of reports that the devices were delivering medications faster than expected. FDA identified it as a class I recall, the most serious type of recall, where use of the device may cause serious injuries or death.
Truth Initiative Asks for Removal of Unauthorized E-Cigarettes
The U.S. Food and Drug Administration must pull all unauthorized synthetic nicotine products from the market, Robin Koval, CEO and president of Truth Initiative, said in a July 2022 statement.
Can Patients Use Continuous Glucose Monitors During Radiation Therapy for Cancer?
Sally is a 65-year-old patient with T3N1M0 human papillomavirus–negative cancer of the supraglottic larynx who is beginning treatment with radiation and chemotherapy. She has a history of type 1 diabetes mellitus, diabetic retinopathy, diabetic nephropathy, and hospital admissions for diabetic ketoacidosis. She has been using a continuous glucose monitor and insulin pump to help her effectively manage her diabetes. She is concerned that her chemotherapy regimen will involve taking dexamethasone, which will affect her hard-to-control diabetes. Sally tells you she wants to wear her CGM and IP during treatment.
Monkeypox Fact Sheet and Implications for Patients With Cancer
In May 2022, the Centers for Disease Control and Prevention began tracking cases of monkeypox in the United States, a disease caused by infection with the monkeypox virus. As of August 2022, 48 U.S states have reported at least some level of monkeypox diagnoses, and the World Health Organization declared the virus a global public health emergency.
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.
Baxter Healthcare Corporation Recalls Abacus Software for Risk of Medication Label Errors
On July 25, 2022, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s recall of the Abacus order entry and calculation software because of a printing error that could cause final bag labels for compounded mixtures to be incorrect. FDA identified it as a class I recall, the most serious type of recall, where use of the software may cause serious injuries or death.
Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Malfunctions That Can Affect Infusion Delivery
On July 20, 2022, the U.S. Food and Drug Administration (FDA) reported Smiths Medical’s recall of its Medfusion 3500 and 4000 syringe infusion pumps because of software malfunctions. 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.
Females Are More Likely to Have Severe Cancer Side Effects Than Males
Broad-based sex differences exist in the severity of side effects from cancer and its treatment, with female patients at an overall 34% higher risk for severe symptoms than male patients—and the risk jumps to nearly 50% for immunotherapies, researchers reported in the Journal of Clinical Oncology.
Legislation Funds FDA Programs to Support Safety, Lower Costs, and Spur Innovation
To improve safety and regulation for drugs and devices, U.S. Senators Patty Murray (D-WA) and Richard Burr (R-NC) introduced the Safety and Landmark Advancements (FDASLA) Act in May 2022. The act reauthorizes and builds on the U.S. Food and Drug Administration’s (FDA’s) prescription drug, generic drug, biosimilar, and medical device user fee agreements.
FDA Reports Recall of Morphine Sulfate Extended-Release Tablets Because of Label Mix-Up
On June 28, 2022, the U.S. Food and Drug Administration (FDA) reported Bryant Ranch Prepack Inc.’s voluntarily recall of one lot of morphine sulfate 30 mg extended-release tablets and one lot of morphine sulfate 60 mg extended-release tablets because the products are incorrectly labeled. Bottles labeled as 60 mg tablets may contain 30 mg tablets and bottles labeled as 30 mg may have 60 mg tablets.
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 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.