FDA and DOJ File Permanent Injunctions Against Six E-Cigarette Manufacturers
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions against six e-cigarette manufacturers in October 2022. It was the first time FDA initiated injunction proceedings to enforce review requirements for new tobacco products.
More Than a Shot in the Arm, Policymakers and Providers Must Support a Sustained Case for Vaccinations
One hundred twenty years ago, the U.S. Congress initiated the country’s first steps “to regulate the sale of virus, serum, toxin, and analogous products,” passing the 1902 Biologics Control Act to codify, oversee, and regulate a burgeoning field. By 1906, the legislation expanded to the Food and Drug Act, which formally established the U.S. Food and Drug Administration.
Exela Pharma Sciences, LLC, Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection Because of Vial Breakage
On October 13, 2022, the U.S. Food and Drug Administration reported Exela Pharma Sciences, LLC’s, voluntary recall of 49 lots of sodium bicarbonate injection, USP, 8.4%, 50 mEq/50 ml vial, 20-count carton, to the consumer level because of potential vial breakage and flying glass when pressurized while preparing for administration.
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.
Workforce Violence Requires Legislative Support
Health care is a hazardous professional industry. As a calling more than a career, providers understand the risks associated with patient interactions. Florence Nightingale’s environmental theory of nursing calls for nurses to tailor a patient’s surroundings to their treatment plan, and that includes creating a safe space for patients and providers alike.
Help Caregivers Control the Chronic Stress of Cancer Care and Manage PTSD
Post-traumatic stress disorder can develop after individuals experience an event that goes beyond their usual stressors, affecting a broad range of people. It is associated with exposure to death or threatened death, including a sudden, catastrophic event due to a medical incident. A cancer diagnosis’s significant psychological stressors can affect not only patients, but their caregivers as well.
New HHS Office Will Fight Environmental Injustices That Affect Health
To address and protect the health of communities disproportionally affected by pollution and other environmental problems, the Biden-Harris administration created a new U.S. Department of Health and Human Services (HHS) office in May 2022.
Critical Care Nurse Receives Presidential Medal of Freedom, America’s Highest Civilian Honor
Reinforcing the public perception of nursing as the most trusted profession, President Joe Biden awarded Sandra Lindsay, DHSc, MS, MBA, RN, CCRN-K, NE-BC, a critical care nurse, a Presidential Medal of Freedom in July 2022 for her work in the COVID-19 pandemic.
FDA Orders JUUL to Stop Selling All of Its Products
Under its authority to regulate vaping and e-cigarettes, the U.S. Food and Drug Administration (FDA) ordered JUUL Labs Inc. to stop selling and remove all of its current products from the market after the company’s applications failed to provide sufficient evidence about the products’ toxicologic profiles.
Biden-Harris Administration Launches Initiative to Protect People’s Health From Climate Events
The well-established connection between climate change and health is back in the spotlight, and the U.S. Department of Health and Human Services’ (HHS’s) Office of Climate Change and Health Equity launched a new observational initiative in May to identify strategies to protect the public.
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.
CMS, HHS Issue Emergency Regulation Requiring COVID-19 Vaccination for Healthcare Workers
In an effort to protect patients and control the COVID-19 coronavirus pandemic, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) have issued an interim final rule requiring all staff at certain Medicare- and Medicaid-certified healthcare facilities to be vaccinated against COVID-19.
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
On September 22, 2021, the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for use as a single booster dose administered at least six months after completion of the primary series in individuals aged 65 and older, individuals aged 18–64 at high risk for severe COVID-19, and individuals aged 18–64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk for serious complications of COVID-19 or severe COVID-19.
ONS Response to Mandated COVID-19 Vaccinations for Nurses and All Healthcare Professionals
On July 26, 2021, the American Nurses Association (ANA) signed onto a statement released by a large group of healthcare systems and other associations in support of healthcare employers mandating nurses and all healthcare personnel be vaccinated against the COVID-19 coronavirus. This is in response to increasing circulation of COVID-19 variants and lagging vaccination rates. Although ONS was not listed on the statement as a supporting organization because of a late request, ONS agrees that vaccinations are critical for healthcare providers, particularly those caring for immunocompromised patients.
OSHA Issues Emergency Temporary Standard to Protect Healthcare Workers From COVID-19
“Frontline healthcare workers have a nearly 12-times higher risk of testing positive for COVID-19 compared with individuals in the general community,” according to the results of a 2020 study. Although U.S. vaccination rates continue to increase and infection rates continue to decrease, national government entities such as the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) are releasing new guidelines to help protect those who are putting themselves at risk for transmission so they can care for others.
Share These Resources to Increase COVID-19 Vaccination Rates
President Joe Biden committed to getting at least 70% of U.S. adults their first dose of the COVID-19 coronavirus vaccine and achieve 160 million fully vaccinated American adults by July 4, 2021. However, one in five Americans reported that they aren’t planning to get vaccinated. To dispel public fear and increase understanding, several U.S. health agencies provided multiple resources to educate patients and providers on vaccine distribution and efficacy.
Surveys Show PPE Is Still in Short Supply
A perhaps unexpected phenomenon the COVID-19 coronavirus pandemic created around the world was countless supply shortages. Most at worst were inconvenient (e.g., yeast shortages from pandemic breadmaking) or humorous (e.g., toilet paper memes), but one that oncology nurses experienced far too close to home was downright deadly: lack of proper personal protective equipment (PPE) supplies for handling hazardous drugs.
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.
How Nurses Can ‘Curb the Spread’ and Support Themselves
As the United States reopens and social distancing moves into different phases, concerns remain about containing the COVID-19 coronavirus. Anxiety and stress are high as nurses and other healthcare professionals who are caring for COVID-19 positive patients are worried about their own health and the health of their families. A paramount fear is inadvertently spreading the virus to ourselves or our loved ones.
Share Your Comments About Hazardous Drugs With NIOSH
As part of the update process for the List of Hazardous Drugs in Healthcare Settings, the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention, in the Department of Health and Human Services, is seeking public comments on the draft documents through June 30, 2020.
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.
'Lost on the Front Lines'; Physicians Campaign Congress; Policymakers on COVID-19
Healthcare workers in the United States accounted for 20% of all deaths caused by the COVID-19 coronavirus pandemic to date. The Guardian and Kaiser Health News partnered to document every healthcare worker who’s died from COVID-19 in response to the absence of a reliable nationwide database.
Fear on the Front Lines of COVID-19 in the United States
As oncology nurses in Chicago, IL, on the front lines of the COVID-19 coronavirus pandemic in the United States, fear, anxiety, anger, and frustration are just some of the emotions that have been festering in me and my coworkers since the beginning of 2020. It seems like an endless era, and I’m scared: for my patients, coworkers, and family.
Democrats Draft Fourth COVID-Response Bill; Trump Extends Social Distancing; Some Legislation Perpetuates Nursing Shortage
On March 30, 2020, Democrats in the U.S. House of Representatives began drafting a fourth COVID-19 coronavirus relief package to include substantial infrastructure investments, said Speaker Nancy Pelosi. Pelosi said the legislation could be ready for a vote by late April.
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.
CDC Releases Healthcare Professional Preparedness Checklist for COVID-19
Although many federal health agencies are involved in the COVID-19 coronavirus pandemic, central to every discussion has been the Centers for Disease Control and Prevention (CDC). Charged with the safety of the American public’s health, CDC is spearheading the United States’ epidemiologic approach, including how healthcare workers should recognize, test for, report, and respond to the coronavirus.
FDA Requires New Health Warnings for Cigarette Packages, Advertisements
Change at the federal level takes time and perseverance. Thanks to great effort from the smoking cessation community—including ONS—the federal government is updating package and advertising warning for tobacco products for the first time since 1984. Advocates have been calling on agencies to exercise authority over tobacco products along with their marketing and distribution, and on March 17, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule requiring new health warning labels for cigarette packages and advertisements.
HHS Changes Regulatory Action During COVID-19 Pandemic
The alarmingly quick spread of the COVID-19 coronavirus has put a strain on the U.S. healthcare system, including the availability of personal protective equipment and other safety resources. The speed at which the virus spreads requires an even swifter response from federal agencies, government officials, and public health experts to combat the disease. To cut the red tape and accelerate data collection, the Department of Health and Human Services (HHS) has used statutory authority under the Paperwork Reduction Act to survey Health Resources and Services Administration healthcare institutions to understand the current COVID-19 response, challenges institutions are facing, and ways to help.
ONS Meets With Trump; COVID-19 and Patients With Cancer; Senators Weigh COVID-19 Action
Alongside 11 other national nursing organizations, ONS Chief Executive Officer Brenda Nevidjon, MSN, RN, FAAN, participated in a meeting with President Trump, Vice President Pence, and other leaders from the administration at the White House on March 18, 2020, to discuss the nursing community’s needs and response to the COVID-19 novel coronavirus pandemic. Administrators from the Centers for Medicare and Medicaid Services, Centers for Disease Control and Prevention, and Coronavirus Task Force also attended.
Proper PPE Procedures for COVID-19
Although many oncology nurses are well versed in donning and doffing (removal) of personal protective equipment (PPE) for administering hazardous drugs, but not infection control. Additionally, nursing colleagues in other specialties may not wear PPE as part of their daily practice. As the COVID-19 novel coronavirus pandemic changes that, oncology nurses should understand PPE use for infection control to promote safety for nurses and patients.
Emotional Coping Strategies for COVID-19
The COVID-19 novel coronavirus pandemic is turning the world, inside and outside of the hospital, upside down. Not only are oncology nurses seeing high demands at work, but changes and restrictions are being instated at home as well.
Prescription Drug Proposal; COVID-19 Safety Legislation; Drug Costs Outpace Inflation
Drug pricing is a top legislative issue for Congress, and amid rising COVID-19 concerns, health policy topics are more pressing than ever. On March 5, Senator Martha McSally (R-AZ) introduced the Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020, which would allow Medicare to negotiate prices after a drug’s patent expires as well as cap out-of-pocket prescription spending for seniors at $3,100 per year.
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.
FDA Grants Accelerated Approval to Nivolumab and Ipilimumab Combination for Hepatocellular Carcinoma
On March 10, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab and ipilimumab (Opdivo® and Yervoy®) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
BD Issues Class I Recall of Alaris System Infusion Pumps
On February 4, 2020, BD announced a recall of all lots of affected models of its Alaris System pump modules because of multiple system errors, software errors, and use-related errors. On March 6, 2020, the U.S. Food and Drug Administration identified it as a class I recall, its most serious level of recalls, because of the possibility of serious injuries or death.
Educational Framework Offers Guidance for Oral Chemo Safety at Home
One aspect that ambulatory oncology nurses must consider in the greater staffing conversation is the time spent on educating patients and caregivers about oral chemotherapy safety in the home setting. Developing an educational framework to guide those conversations not only ensures that all critical information is covered but also that it’s delivered in a standard and efficient process.
Supreme Court ACA Case; Cancer Moonshot; COVID-19 Outbreak
As part of its focus to dismantle the 2010 healthcare law, the GOP repealed the Affordable Care Act individual mandate in 2017. Republican state attorneys general then challenged the law’s constitutionality in a series of lower court cases, and the most recent has been lingering in federal courts for more than a year. On March 2, the Supreme Court agreed to take up the issue, marking the third time the law will be heard at the highest court in the country.
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 December 2019. It is a respiratory illness and can be spread from person to person through respiratory droplets during close contact. The first case of COVID-19 in the United States was reported on January 21, 2020.
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.
B. Braun Recalls Certain Lots of Blood Administration Sets
Because of the potential for leakage at the joint between the blood filters and tubing, B. Braun issued a voluntary recall of 22 lots of its y-type blood administration sets in November 2019. The recalled sets are used to deliver blood from a container to a patient's vascular system through an IV catheter inserted into a vein or central venous catheter.
Should You Wear a Gown to Disconnect Chemo?
The short answer is yes—guidelines from ONS, National Institute of Occupational Safety and Health, Occupational Safety and Health Administration, and U.S. Pharmacopia all call for nurses to always wear appropriate personal protective equipment (PPE) when at risk for exposure, including disconnecting a patient’s chemotherapy. Wearing a gown and other PPE isn’t just good practice—it protects nurses at one of many touchpoints during chemotherapy administration and patient care where healthcare providers are at risk for exposure to hazardous drugs.
What the Research Says About Drug Interactions and Medical Cannabis
Despite medical cannabis’s legalization for medical use throughout 31 different jurisdictions in the United States, practicing providers have little research and few guidelines for patient care. To address the gap, in 2018 the National Council of State Boards of Nursing published Nursing Guidelines for Medical Marijuana, which provides general nursing education and guidance—yet doesn’t discuss drug interactions, specifically. To understand how medical cannabis affects concomitant pharmaceuticals, nurses must have a basic knowledge of the endocannabinoid system (ECS).
FDA Warns of Rare Lung Inflammation With Certain CDK 4/6 Inhibitors
Palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs, the U.S. Food and Drug Administration (FDA) announced on September 13, 2019. It approved new warnings about the risk on the prescribing information and package insert for the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. However, “the overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed,” the agency noted.
Company Recalls TPN Bags Because of Leak and Infection Risk
Bags used to store and administer total parenteral nutrition (TPN) are being recalled because of leaks near the divider rod and channel when the rod is removed, the Metrix Company of Dubuque, IA, announced on September 9, 2019.
Why Aren’t Nurses Adhering to PPE Requirements?
Oncology nurses are dedicated to providing the best, safest cancer care to their patients—protecting them from medical harm and prolonging life. But when it comes to protecting themselves, nurses sometimes take shortcuts in wearing personal protective equipment (PPE) that guards them against exposure to hazardous drugs.
Evidence Supports Strategies for Better Safe Handling Practice
The evidence is clear: for more than 40 years, reports have confirmed that hazardous drug exposure poses significant safety risks to providers who handle many agents related to cancer treatments. Healthcare professionals experience several substantial health threats, including reproductive problems, airway and skin irritation, and cancers. Despite the potential health risks, the data are also clear: nurses routinely do not wear personal protective equipment as recommended when handling hazardous drugs.
Health Care in Campaigns; Respiratory Illness From Vaping; Drug Importation Politics
Chicago ONS Chapter member Janice Phillips, RN, CENP, PhD, FAAN, said it all in her op-ed published on Morning Consult. The entire Democratic field of presidential candidates has declared some form of healthcare overhaul, albeit to varying degrees of change. With expanded access and reduced costs for patients and families as a priority, the centerpiece to most presidential hopefuls’ domestic policy program is redesigning a struggling system.
USP <800> Brings Change, Collaboration to Pharmacy and Nursing
U.S. Pharmacopeia (USP) chapter <800> provides safety measures for all healthcare workers in any setting where hazardous drugs (HDs) are used in the health system. For situations from the initial delivery of the drug to the institution through administration and disposal, USP <800> provides a vast number of safety measures intended to minimize risk and potential exposure to HDs. To meet the new requirements, medical institutions and pharmacies have had to make significant changes in various systems.