On May 29, 2024, the U.S. Food and Drug Administration (FDA) announced that Sagent Pharmaceuticals issued voluntary nationwide recall of two lots of docetaxel injection, USP (80 mg per 8 ml multidose vials and 160 mg per 16 ml multidose vials), because of the potential presence of particulate matter from the stopper in the drug product.

Remote verification methods through virtual care nurse models and telehealth technologies have merit, but the evidence is inadequate to determine safety or efficacy, according to the latest findings from a team of ONS members and staff that were published in the Clinical Journal of Oncology Nursing.

Switching from heparin to normal saline (NS) as the preferred flushing solution for central venous catheter (CVC) lines in adult ambulatory patients with cancer saved one institution nearly $30,000 without affecting quality of care, researchers reported in the Clinical Journal of Oncology Nursing. The change also increased patient safety by reducing risk of heparin-induced thrombocytopenia or allergic reactions, the authors said. 

In its annual report to the U.S. Congress on drug shortages, the U.S. Food and Drug Administration cited the COVID-19 pandemic, supply chain problems, and approval processes as reasons for the shortages during the 2022 calendar year.

Join ONS member Ashley Barill, BSN, OCN®, nurse supervisor at WVU Medicine in Morgantown, WV, as she explains how she and her team train using mock code simulations in an outpatient infusion center in this video. Mock code simulations can help oncology nurses and other healthcare professionals prepare for emergencies, and Barill’s tips and resources are helpful tools when conducting those simulations. 

To increase access to and coverage for innovative tests that can detect multiple types of cancer, U.S. Senators Mike Crapo (R-ID), Michael Bennet (D-CO), Tim Scott (R-SC), and Ben Cardin (D-MD) reintroduced the Medicare Multicancer Early Detection Screening Coverage Act. Bipartisan companion legislation was also introduced in the U.S. House of Representatives.  

Veterans and active service members of the U.S. armed forces have dedicated their lives to the safety and freedom of their country. However, that honorable service may place them at risk for post-traumatic stress disorder, anxiety, depression, and cancer.

Ushering in a new field of study called tobacco regulatory research, the U.S. Food and Drug Administration’s Tobacco Regulatory Science Program (TRSP) funded its first 14 Tobacco Centers of Regulatory Science in 2013. Ten years later, David M. Murray, PhD, associate director of the National Institutes of Health’s Office of Disease Prevention, highlighted TRSP’s decade of research discoveries—but reinforced the need for continued research and advocacy on tobacco use.

Unsupervised machine learning can assign older adult patients to low, moderate, or high prediagnosis symptom severity categories, allowing healthcare providers to identify patients at risk for hospitalization or death even before initiating treatment, researchers reported in JAMA Network Open.

Nearly 60% of patients with cancer turn to herbal supplements for symptom relief, but patient-physician communication about that use remains inadequate. Unsupervised herbal use can lead to adverse events and herb-drug interactions for patients during active treatment. Many physicians and providers also lack sufficient knowledge about herbal supplements to help patients make informed decisions.

An “acute state of confusion resulting from organic brain dysfunction,” delirium is a medical emergency that can be highly distressing to both patients and caregivers. Approximately 2.6 million older adults experience delirium each year.

Rates of hate incidents against the Asian American/Pacific Islander community have tripled since the COVID-19 pandemic began, and it’s taking a toll on the population’s mental well-being. Researchers have linked pandemic-related discrimination to increased anxiety, depression, and sleep disturbances among members of the AAPI community, yet they are much less likely to seek or accept mental health services than any other racial group.

For nearly 2,500 years, nonmaleficence, or “do no harm,” has been a fundamental tenet of medical ethics. Yet none of today’s U.S. breast, cervical, colorectal, lung, or prostate cancer screening guidelines report all of the harms associated with screening tests, researchers said in study results published in Annals of Internal Medicine.

Across disciplines, all healthcare providers take a practice oath that supports the principle of nonmaleficence (“first, do no harm”)—and so does the Centers for Medicare and Medicaid Services (CMS), several agency leaders wrote in a March 2023 blog post. The authors called for increased awareness of patient safety and highlighted ways CMS is taking action.

Direct-to-consumer genomic testing is a patient-initiated type of testing that is marketed to the general public in advertisements on all media. The tests can be purchased online or in stores without requiring a healthcare professional order or third-party payer authorization. Customers send a saliva sample to the company and view their test results on a secure website, but the results are not included in their electronic health record unless they specifically request it.

Anger is a common emotion for both patients and their partners when facing cancer, but in almost a quarter of relationships, that anger turns psychologically or physically violent. According to the results of a new study published in Supportive Care in Cancer, both genders report acts of abuse from their partners during the cancer journey.

On February 2, 2023, the U.S. Food and Drug Administration reported Smiths Medical’s recall of its CADD™ infusion system administration sets and cassette reservoirs because of tubing occlusions that may under- or not deliver medication and false no disposable attached alarms that may prevent pump use. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.

On January 26, 2023 the U.S. Food and Drug Administration removed its emergency use authorization of tixagevimab/cilgavimab (Evushield) for the prevention of SARS-CoV-2 infection after exposure to the virus. FDA said it made the decision because the agent is not effective in preventing infections from the current variants that are responsible for 90% of today’s infections and because the risks of the drug’s side effects do not outweigh the benefits.

Long-term use of vaping products can significantly impair the body’s blood vessel functioning, increasing a person’s risk for cardiovascular disease, researchers for two studies supported by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, reported in October 2022. The researchers also found that combined use of e- and regular cigarettes may increase that risk even further than use of either product alone.

Giving providers the latest evidence to inform the safe use and management of opioid prescriptions for cancer-related and other types of short- and long-term pain, the Centers for Disease Control and Prevention updated and expanded its recommendations in November 2022. The updated information was published in the CDC Clinical Practice Guideline for Prescribing Opioids for Pain, which replaces the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.

On December 22, 2022, the U.S. Food and Drug Administration (FDA) reported Accord Healthcare, Inc.’s, voluntarily recall of a single lot of daptomycin for injection 500 mg and 350 mg vials at the consumer level because vials labeled as “daptomycin for injection 500 mg/vial” were found in cartons labeled “daptomycin for injection 350 mg/vial.”

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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 announced. HHS 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.

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.

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.