Novartis Issues Voluntary Nationwide Recall of One Lot of Cyclosporine Oral Solution
On September 11, 2023, the U.S. Food and Drug Administration announced Novartis’s voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of observations of crystals in some bottles that could result in incorrect dosing. No other cyclosporine oral solution formulations are affected.
Moral Injury and Trauma in Nursing
When Ethan was 15 years old, he was diagnosed with osteogenic sarcoma. He underwent chemotherapy and was deemed cancer free for nearly 10 years. Maria, an advanced oncology certified nurse, worked closely with Ethan’s healthcare team throughout his treatment. She got to know Ethan, his sense of humor, and his dreams of becoming a child psychologist.
ONS Education Supports Oncology Nurses Through Every Season Transition
When summer ends in the northern hemisphere and the autumnal equinox ushers in fall on September 23, 2023, the earth begins to tilt away from the sun, making the nights grow longer and days shorter until the winter solstice. Those of us working 12-hour shifts especially notice the decrease in daylight, coming to and leaving our workplaces in darkness.
U.S. Congress Members Call for Overdue Review, Enforcement of E-Cigarettes Still on Market
U.S. Representatives Diana DeGette (D-CO) and Debbie Wasserman Schultz (D-FL), along with more than 50 members of the U.S. Congress, wrote a letter in June 2023 calling on the U.S. Food and Drug Administration (FDA) to abide by a court-ordered deadline to review outstanding Premarket Tobacco Product Applications for e-cigarette products that remain on the market without approval. The call comes after FDA failed to meet the initial deadline of September 9, 2021, to complete its review of all pending e-cigarette applications.
FDA Takes Action on Youth E-Cigarette Usage With Warning Letters to Retailers
In a record number of outreaches, the U.S. Food and Drug Administration issued warning letters in June 2023 to 189 retailers for selling unauthorized tobacco products. Two notable brands included in the warning, Elf Bar and Esco Bars, sell disposable e-cigarettes that come in flavors that appeal to youth, such as bubblegum and cotton candy.
U.S. Sales of E-Cigarettes Climbed Almost 50% From 2020–2022
As overall monthly unit sales of e-cigarettes increased by 46.6% from January 2020–December 2022, according to June 2023 data from the Centers for Disease Control and Prevention, tobacco cessation advocates continue to fight an uphill battle. Purchases grew from 15.5 million units to 22.7 million units in the study period.
Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps and IQ Infusion Systems With Dose IQ Safety Software, Issues Corrected Software
On August 1, 2023, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s June 15, 2023, recall of SIGMA Spectrum infusion pumps with master drug library (version 8) and Spectrum IQ infusion systems with dose IQ safety software (version 9) because of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01, respectively. 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.
A growing literature base supports the use of medical cannabis in cancer care and symptom management, and as of April 2023, 42 states, including 3 territories and the District of Columbia, allow for medical use. As more patients use or seek to use medical cannabis during their cancer trajectory, oncology nurses are looking to the latest research behind medical cannabis, how cannabis can impact their patients’ treatment plans and symptom management, and legislation in the state in which they practice.
Nurses Report Significant Experiences and Perceptions of Discrimination
Nearly 80% of nurses have witnessed or been victims of racism or discrimination from patients—and nearly 60% from colleagues—according to a May 2023 Robert Wood Johnson Foundation report published in partnership with the National Opinion Research Center at the University of Chicago.
The Harvard Drug Group, LLC, Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg, and Ziprasidone Hydrochloride Capsules, 20 mg, Because of Label Mix-Up
On June 14, 2023, the U.S. Food and Drug Administration reported that the Harvard Drug Group, LLC, conducting business as Major Pharmaceuticals and Rugby Laboratories, issued a voluntary recall of a single lot of dronabinol capsules, USP, 2.5 mg, and ziprasidone hydrochloride capsules, 20 mg, after receiving a report that some unit dose cartons labeled as ziprasidone hydrochloride capsules, 20 mg, contained blister packages labeled as and containing dronabinol capsules, USP, 2.5 mg.
Worsening Immigration Backlogs Delay One Strategy for U.S. Nursing Shortage
A battalion of trained nurse reinforcements is waiting just outside the U.S. borders, eager to help alleviate the nursing shortage, but the system that lets international nurses enter and work in the United States is heavily congested. And according to the U.S. State Department’s June 2023 Visa Bulletin, the backlog is only worsening.
ICU Medical Recalls Replacement Batteries for Plum Infusion Systems Because Diminished Battery Life Can Affect Infusion Delivery
On May 22, 2023, the U.S. Food and Drug Administration (FDA) reported ICU Medical’s recall of replacement batteries for its Plum 360™, Plum A+™, and Plum A+3 infusion systems because of a manufacturing defect that can substantially diminish how long the batteries can run the system. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.
FDA Files Complaints Against Four E-Cigarette Product Manufacturers
In an attempt to strongly regulate the e-cigarettes and vapes industry, the U.S. Food and Drug Administration filed civil money penalty complaints against four tobacco product manufacturers for manufacturing and selling e-liquid products without authorization. The action marks the first time FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic Act’s premarket review requirements for new tobacco products.
Teva Pharmaceuticals USA, Inc., Issues Voluntary Nationwide Recall of Specific Lots of Fentanyl Buccal Tablets CII Because of Labeling Error
On April 27, 2023, the U.S. Food and Drug Administration reported that Teva Pharmaceuticals USA, Inc., issued a voluntary recall of certain lots of fentanyl buccal tablets, a schedule II substance, to the consumer level because safety updates were omitted in the lots’ product insert/medication guide. Teva Pharmaceuticals USA, Inc., manufactured and labeled the product lots exclusively for Mayne Pharma, Inc.
Public Health Emergency Funding Ends, HHS Provides Transition
With the anticipated end of the public health emergency looming after three years of being consumed by the COVID-19 pandemic, Xavier Becerra, secretary of the U.S. Health and Human Services, wrote a letter to state governors praising their efforts in the pandemic, offering a supportive hand, and highlighting the Biden-Harris administration’s accomplishments in combating COVID-19.
Continue the Conversation With ONS Congress® Key Speakers
Coming to you from Congress, we're speaking with some of the key speakers presenting at the the 48th annual conference. Here, Tamryn Gray, PhD, RN, MPH, Chris Snyder, and Lauren Ghazal, PhD, FNP-BC, talk about their sessions and ways you can learn more about important topics like caregivers, safety and violence in health care, and nursing sustainability.
It’s Time to Stop E-Cigarette Manufacturers From Blowing Smoke About Youth Tobacco Use
Joe Camel, the Marlboro Man, and the women who’ve “come a long way, baby” with Virginia Slims are marketing mascots that created an image of smoking as cool, chic, and classy—a concept that’s still cemented in the minds of many Americans today. For the past 30 years, public awareness campaigns have battled that belief among young people to dramatically curtail underage smoking, finally reaching a real reduction in youth tobacco use.
FDA Recommends Stopping Use of Certain Owens and Minor Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks Because of Risk of Protection Failure
On April 12, 2023, the U.S. Food and Drug Administration issued a safety communication to healthcare providers, institutions, and consumers recommending that they do not use certain surgical N95 respirators manufactured by Owens and Minor Halyard and that they use certain surgical masks and pediatric face masks from Owens and Minor Halyard with caution. The recommendation comes after the masks failed fluid resistance performance tests.
FDA Proposes Guidelines and Restrictions for Blood Donations
Taking into consideration the history of HIV/AIDS and upholding COVID-19–related guidelines, the U.S. Food and Drug Administration proposed adjusting blood donor eligibility from time-based deferrals to assessing donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.
NIH Researchers Make Progress Toward a Possible HIV Vaccine
An experimental HIV vaccine increased participants’ broadly neutralizing antibody (bnAb) precursor B cells that enable the body to develop bnAb-producing B cells and fight HIV, researchers reported in study results published in December 2022. The progress comes more than a decade after researchers at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases Vaccine Research Center first discovered the rare class of antibodies.
COVID-19 Public Health Emergency Will End in Late Spring 2023
After more than two years of heightening response and awareness in every corner of U.S. society, the COVID-19 pandemic public health emergency (PHE) and national emergency is sticking around a few months longer. Originally set to expire on March 1 and April 11, respectively, both will finally come to an end on May 11, 2023, the Biden-Harris administration announced in January.
Nearly 25% of Patients With Cancer Are Victims of Intimate Partner Violence
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.
How Nurses and Administrators Can Respond to the Prevalence of Violence in Health Care
As a clinician in inpatient cardiovascular and acute care nursing and as a healthcare administrator, like many of my colleagues across the nation, I have encountered many violent situations in the workplace. Healthcare workers account for 73% of all violence-related nonfatal workplace injuries and illnesses, and nurses bear the brunt of that statistic, with 44% reporting physical violence and 68% reporting verbal. In fact, in 2022, more than two nurses were assaulted every hour. The rate of violence-related injuries is higher in health care than in all other occupational settings. But data often reflects reported incidents of violence. Its true prevalence is likely much higher because workers may believe that violence is part of the job and don’t report events, and not all events cause an injury.
Violence in Nursing
Across all nursing specialties and settings, 60% of nurses reported experiencing an incident of workplace bullying and incivility and 29% confronted at least one incident of violence in 2022, according to the American Nurses Foundation 2022 Workplace Survey report. And it’s escalating—violence against hospital employees and healthcare professionals has increased since the onset of the COVID-19 pandemic in early 2020, with 44% of nurses reporting having experienced physical violence and 67% verbal abuse between February and June 2020 alone.
CMS Releases Memo on Workplace Violence Requirements for Hospitals
To combat the increasing incidence of healthcare workplace violence, hospitals must “identify patients at risk for intentional harm to self or others, identify environmental safety risks for such patients, and provide education and training for staff and volunteers” so that workers can deliver care in a safe setting, the Centers for Medicaid and Medicare Services’ (CMS) Quality, Safety, and Oversight Group (QSOG) and Survey and Operations Group (SOG) said in a November 2022 memo.
Smiths Medical Issues Urgent Medical Device Correction Letter About Potential Issues With CADD™ Infusion Sets
On January 5, 2022, the U.S. Food and Drug Administration reported that Smiths Medical issued a December 12, 2022, urgent medical device correction letter to notify customers of two potential issues with CADD infusion system infusion sets because of potential under or no delivery and false no-disposable-attached alarms.
Spectrum Laboratory Products, Inc., Issues Voluntary Recall of Epinephrine USP, Bulk API, Because of Product Discoloration
On January 9, 2022, the U.S. Food and Drug Administration reported that Spectrum Laboratory Products, Inc., issued a voluntarily recall of three lots of epinephrine (l-adrenaline), USP, used to manufacture or compound prescription products, at the user level because of customer reports that the product is discolored.
Hospira, Inc., Issues Voluntary Nationwide Recall for One Lot of Vancomycin Hydrochloride Injection, USP 1.5 g
On December 22, 2022, the U.S. Food and Drug Administration reported that Hospira, Inc., a Pfizer company, issued a voluntarily recall of one lot of vancomycin hydrochloride injection, USP, 1.5 g, single-dose flip-top vial, at the consumer level. Hospira, Inc., issued the recall because a report of two glass particulates observed in a single vial.
Oncology APRNs Are Change Agents for Tobacco Cessation
Whether by cigarette, pipe, cigar, or vaping device, tobacco use is a major risk factor for the development of many cancers; increases cancer mortality, risk of recurrence, and second primary cancers; adversely affects treatment outcomes for surgery, radiation, and chemotherapy; and affects other chronic health conditions. Initiating smoking cessation at the time of a lung cancer diagnosis improves overall survival by 30%–40%, yet 40%–50% of smokers continue to use tobacco after diagnosis.
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.