Warnings and Precautions added: keratitis

Keratitis reported in 0.7% (n = 6) of 833 patients treated with osimertinib in clinical trials.

Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist.

Adverse Reactions updated: AURA3 clinical trial experience:

Serious adverse reactions were reported in 18% of patients treated with osimertinib and 26% in the chemotherapy group.

No single serious adverse reaction was reported in 2% or more patients treated with osimertinib. One patient (0.4%) treated with osimertinib experienced a fatal adverse reaction (interstitial lung disease/pneumonitis).

AURA3 was not designed to demonstrate a statistically significant reduction in adverse reaction rates for osimertinib.

Warnings and Precautions added: benzyl alcohol preservative

Serious and fatal adverse reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including blinatumomab (with preservative).

Gasping syndrome is characterized by central nervous syndrome depression, metabolic acidosis, and gasping respirations.

When prescribing blinatumomab (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources.

Blinatumomab (with preservative) contains 7.4 mg of benzyl alcohol per mL. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

Warnings and Precautions added: respiratory disorders

Interstitial pneumonia/pneumonitis, interstitial lung disease, and acute respiratory distress syndrome have been reported and may be associated with fatal outcome.

Patients with underlying lung disease may be at higher risk for these events.

Acute respiratory distress syndrome may occur in the setting of infection.

Interrupt cabazitaxel if new or worsening pulmonary symptoms develop.

Patient Information added: lung or breathing problems

Patients should be advised that lung or breathing problems may develop with cabazitaxel and may lead to death.

People who have lung disease before receiving cabazitaxel may have a higher risk for developing lung or breathing problems with cabazitaxel treatment.

Warnings and Precautions expanded and updated

Pembrolizumab can cause severe or life-threatening infusion-related

reactions, including hypersensitivity and anaphylaxis, which have been reported in 6 (0.2%) of 2799 patients receiving pembrolizumab.

Pembrolizumab can cause immune-mediated pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, type I diabetes mellitus, nephritis, and thyroiditis

Other clinically important immune-mediated reactions may involve any organ system.

Articles

Adverse Events Report

An update on the labeling changes from the FDA.

August Adverse Events Report: FDA Labeling Changes

The phase III ATLANTIS trial is testing the investigational synthetic analogue lurbinectedin in combination with doxorubicin for use in patients with recurrent small cell lung cancer (SCLC) in the hopes of providing a superior option to the current standard-of-care second-line chemotherapy. SCLC accounts for between 15% and 20% of the 1.6 million annual new cases of lung cancer worldwide.

Although chemotherapy combinations are a mainstay of treatment for patients with SCLC, recurrence rates after platinum-based first-line therapy are high. Effective second-line options are limited.

“SCLC is a disease in which the outcomes have not improved in the past 30 years of treating patients,” said principal investigator Anna F. Farago, MD, PhD, an attending physician in the Center for Thoracic Cancers at Massachusetts General Hospital and an instructor in medicine at Harvard Medical School. “We haven’t seen any regimen superior to topotecan in the second-line setting, although several have been investigated.”

Doxorubicin has shown some activity in SCLC, according to Farago, and it is part of several combination therapies, including vincristine/ cyclophosphamide/doxorubicin (CAV), which is administered in later lines of treatment. However, there has not been a head-to-head comparison of lurbinectedin plus doxorubicin versus standard-of-care chemotherapy, so the design of the ATLANTIS trial aims to define whether the novel combination is superior to other secondline options.

Lurbinectedin, which is administered intravenously, is a synthetic compound that is structurally related to trabectedin (Yondelis), a marine-derived agent that is FDA-approved for patients with metastatic liposarcoma or leiomyosarcoma. In the ATLANTIS trial, participants will be randomized either to the experimental arm of lurbinectedin plus doxorubicin or to 1 of 2 control arms consisting of either topotecan or CAV. The primary endpoint of the trial is progression-free survival.

The most notable adverse events (AEs) in a phase I dose escalation study of the lurbinectedin/ doxorubicin combination in a variety of solid tumor types were neutropenia and febrile neutropenia. Grade 3/4 neutropenia occurred in 96% of patients whereas the rate of febrile neutropenia was 24% for grade 3 and 5% for grade 4. After those AEs were noted in the first cohort of patients, investigators began administering granulocyte colony-stimulating factor (G-CSF) to all participants, Farago said. The phase III study requires that patients on all arms of the ATLANTIS trial receive G-CSF support prophylactically.

The ATLANTIS trial (NCT02566993) is seeking to enroll 600 patients with SCLC whose disease has progressed following 1 prior platinum-containing regimen and who have had a chemotherapy-free interval ≥30 days from the time of their last dose of first-line chemotherapy to progressive disease.

If successful, the lurbinectedin/doxorubicin combination could offer a strategy for improving survival, which would be a breakthrough for patients with SCLC. “The median survival from the time of diagnosis is 9 to 11 months for patients diagnosed with metastatic disease, even when patients are treated with the most aggressive therapies. The 5-year [overall survival] is less than 5%. There is a great need for improved therapies,” Farago said.

PharmaMar, a company based in Madrid, Spain, is also developing lurbinectedin for use in platinum-resistant ovarian cancer and other solid tumor types.

Clinical Trials in Progress

The phase III ATLANTIS trial is testing the investigational synthetic analogue lurbinectedin in combination with doxoubicin for use in patients with recurrent small cel lung cancer (SCLC).

Marine-Derived Drug Anchors Chemo Regimen in Phase III Lung Cancer Trial

My journey started 2 years ago when I lost my beloved dog Darla. She was 16 years old and pretty robust for an old girl until her last few months when old age reared its ugly head, and she died on her own terms when I was away. I think she knew how difficult her loss would be for me and did not want me there when she died.

Needless to say, I was devastated. I knew I wanted to provide a forever home for a new dog. It was just a matter of finding the right dog, and it had to be a rescue dog. I was looking for a specific breed and gender (female Border collie or Border collie mix), and my goal was to train her to be a certified therapy dog. I knew how much comfort and love my dogs have brought to me throughout my life, and I wanted to pay it forward by having her visit the cancer center where I work as a nurse navigator.

It was not long after Darla died that I was set to adopt a new dog. I was so excited that I found a new addition to the family, only to be rejected 3 days before I was to pick up my new dog, Sally.

I believe in karma and 3 days later I found an email concerning a dog I had inquired about. I was doing an adoption via the internet, and after careful screening and a lot of discussion specifically related to being a therapy dog, the adoption was approved. My new dog was rescued from a kill shelter in Georgia and was being fostered by a wonderful woman close to the shelter. She came north on the canine transport bus with several other dogs who were traveling to their new forever homes. She was named Darla by the rescue. Talk about coincidence! I think this match was made in heaven.

Darla and I trained for more than a year. We did basic obedience classes and certified therapy dog training. We spent a lot of time practicing to ensure we got it right. She was trained amid noise, with people, with other dogs, and with what she would be in contact with in a medical setting. She did great and passed her test on the first try. I knew I had a smart girl!

I had spoken with my director and our integrative navigator many times throughout our training about starting a therapy program for patients and staff. As oncology providers, we deal with a lot of stress and are so giving to others that we often forget to care for ourselves.

The administration approved our program: “De-stress with Darla Days.” Now, she comes to work with me once or twice a week to provide therapy to anyone who needs some extra love. When she has her ID and red bandana on, she is in her work mode, brightening everyone’s day and providing lots of laughs.

The changes she brings about in people are amazing. When she arrives in the morning, she goes to every staff member’s office to check on all her "herd." One of my colleagues found out she had a death in her family while at work one day. Darla sensed her loss and immediately went into see her and just sat with her.

Our administrator was not a huge fan of dogs at the start of the program but has been charmed by Darla. The two are now best friends. Darla visits her several times a day, and she has taken multiple selfies with her. She constantly asks when she is coming to work because Darla helps her unwind.

One of our big events occurred when our clinics were doubling in size. Need- less to say, moving clinic space, patients, and providers all at the same time to new locations was a massive task. We held a "De-stress With Darla" week, where she was available for staff and patients to decompress and spend some time away from all the craziness. We had giveaways, food, and just a quiet space where people could unwind. Darla was the main attraction, and the feedback we received from the staff and patients told us having her as part of the team helped everyone feel better during the change. 

Darla makes clinic rounds to see patients in the waiting areas to provide support and love, helping patients to share their feelings and cope with a stressful time. Many of our patients live far away and have to leave their pets behind, so Darla reminds them of home. She also has provided bereavement therapy to several patients who recently lost a pet. Darla is a very good listener. Nurses never know where an idea will end up, so don’t be afraid to think outside the box. That is what we do best as oncology nurse navigators.

 Do you have a navigation story to share with your colleagues? Email 

Nurse Navigators

A navigator's simple idea to bring her therapy dog to the cancer clinic reaped enormous benefits for patients and her colleagues.

De-stress With Darla

Today’s disruptive healthcare environment has set the stage for nurses to step up as leaders and use their skills and expertise to address the many challenges the industry faces. As the largest practitioner group in the healthcare team, nurses are taking the lead to ensure delivery of care is safe, efficient, and cost-effective and meets the needs of the individual patient regardless of the setting.

I recently had the honor of meeting a nurse who seized the opportunity to demonstrate her skills and expertise in leading one of the most prestigious healthcare systems in the country. I first learned about Regina Cunningham, PhD, RN, NEA-BC, FAAN, as I was scanning my Facebook page. The post that caught my attention read: “Oncology Nurse, Regina Cunningham has been named Chief Executive Officer of the Hospital of the University of Pennsylvania (HUP).”

As a native of Philadelphia, the headline made me stop, click on the link, and read further. HUP is one of the premier hospitals in the Philadelphia area and nationally, so I wanted to learn more about the oncology nurse who was appointed its chief executive officer.

I read the press release and found it interesting but wanted to know more. I was granted an interview with Cunningham. We had an interesting conversation that lasted over an hour, and I have listened to the interview several times since—each time discovering insights from her career journey that can help guide all nurses working to reach their full potential in today’s complex and exciting healthcare system.

Cunningham started her career in the surgical intensive care unit before moving into an area where she always wanted to work: medical oncology. She worked at Memorial Sloan Kettering Cancer Center (MSK) for several years, honing her clinical skills. It was at MSK that she became very interested in the way nursing services were organized and delivered, as well as the impact nursing models have on clinical outcomes.

When Cunningham enrolled in her master’s degree program, she focused on nursing administration because she wanted to influence the practice environment. Her resume is impressive and shows how she advanced over the years into leadership positions. Through each move, she learned more, took on new challenges, and, importantly, had fun.

Cunningham said that many leadership opportunities emerged at times when she was not looking for a new role, but she seized the moment. On each occasion, she learned more that added to the value she brought to the organizations she worked for, both clinically and academically.

When she assumed the position of chief nursing officer of a small cancer center, it enabled her to understand more about how cancer centers work, their funding mechanisms, how research priorities are set, and the importance of research to clinical care and advancing the delivery of care.

The CEO position came to Cunningham at a time when she was happy in her current post as the chief nursing executive and senior vice president at the University of Pennsylvania Health System, with responsibility for the whole system, not just the hospital. The chief nursing role was challenging and gave her the opportunity to work with other talented people. When the then HUP CEO announced his retirement, he asked Cunningham to think about taking on the role.

The promotion was not something Cunningham was looking for, but as she thought about the opportunity, she realized this was the perfect time for a nurse to assume this role. Nurses understand quality, how to drive value, and recognize waste in the system. Nurses understand care coordination, how to collaborate, and how to manage transition of care as patients move from one setting to another. Nurses recognize the importance of educating patients, so they can understand their conditions, the plan of care, and be active participants in their care.

Cunningham’s decision was made when she realized what an incredible opportunity taking on the role of CEO presented; she could represent patients, their families, and all employees as strategic directions were discussed and decided.

Another tip Cunningham shared was the need for mentors and having good people to help guide you along the way. An important part of her career included active participation in the Oncology Nursing Society, which helped to fuel her professional development and allowed her to network with fellow nursing leaders. She participated at the national level to help drive standards of practice and standards of care to advance cancer nursing. She advises all nurses to join a professional organization and be an active member. Doing so will allow you to grow and advance yourself personally and professionally.

Cunningham spoke candidly about how she stayed in touch with her clinical roots as she advanced in her career. She shared that even though she has moved away from the clinical side, she continues to read and keep up-to-date with research that impacts her field. She believes this is critical because as nurses, our clinical knowledge distinguishes us in any leadership position we assume. It is an extra skillset and knowledge base that nurses bring to the table that many in the upper levels of administration do not have.

Cunningham always understood the importance of staying close to the frontline workforce. To make decisions effectively, nurse leaders need to understand what is happening on the frontline and the perspectives of those who work there.

Today, many people think the powerful roles in healthcare are the higher-level roles in administration. But those in the most powerful roles are the people at the bedside, because they are the ones who make decisions every day that drive any organization’s outcomes.

Even as the chief nursing executive, Cunningham often made rounds on the floors and says she will continue to do this as CEO. She wants the staff to know her, to feel comfortable enough to ask questions, and to use their voice.

Nurse managers hold one of the most important roles as the liaison between staff, patients, and leadership—translating an organization’s mission and values to the frontlines. With so much information coming at these managers from all directions, Cunningham feels it is her role as the CEO to help them and others to differentiate the priorities from all the noise coming at them.

She does not want staff paying attention to issues that are not going to make a difference; she wants everyone to pay attention to those that impact quality and patient safety as that will make all the difference. By being visible and in touch, she can help focus other leaders on what matters most and ensure all stay on track.

Ensuring today’s nurses and other healthcare team members are prepared to meet the demands of the healthcare system is essential, Cunningham stresses. “We need to make sure that people have the knowledge to drive quality and to drive safety. When I think about quality and safety, I think about high reliability—doing the right thing for every patient every single time.”

To achieve high-reliability work settings includes first ensuring the staff is knowledgeable and knows what needs to be done at every turn. Second, staff must understand best practices and how to access the best clinical evidence available and put that evidence into practice, armed with the knowledge and skills to drive quality and ensure they are following best practices for each patient all of the time.

Another critical point is to comprehend data and know how to use predictive analytics. Doing so enables us to see who is going to be at risk for what and employ strategies to prevent setbacks. Thus, either in the prevention or in the intervention stage of care, you need to make sure that people are following the best evidence to drive the quality of care. Nurses, at the point of service, are best positioned to do this. They are the ones who care for patients, day in day out, shift after shift, and have a huge impact on patient outcomes. It is the job of senior leadership to make sure nurses have the resources and the knowledge to perform their roles consistently.

A strong proponent of education for nurses, Cunningham shared that with the complexity of today’s healthcare system, advanced education is part of our professional development. Healthcare is extremely multifaceted, and a lot of what nurses need to know today about managing populations and illnesses over a trajectory requires a high level of knowledge. Education does not always have to be formal, however. It can be a combination of both formal and continuing education. As nurses, we commit to lifelong learning because everything changes. To be responsible and responsive to our patients, we need to commit to lifelong learning, so we are prepared for the highly complex management our patients demand.

Finally, I asked Cunningham how she was going to take care of herself as she moves into one of the most challenging roles of her career. She said she has thought about this and realizes that to be effective, she must take care of herself. She referred to Steven Covey’s Book; The Seven Habits of Highly Effective People. The seventh habit is referred to as “sharpening the saw," and through it, Covey talks about the importance of people taking the time to preserve and enhance their greatest asset—themselves.

Sharpening the saw means having a balanced program for self-renewal in 4 areas of your life: physical, social/emotional, mental, and spiritual. Cunningham knows she will need to make time to exercise, eat well, and get restful sleep. She realizes that a good work—life balance depends on this, and that to be successful, she will lean on the team of talented people who surround her. She also plans to celebrate her husband’s 59th birthday by taking a much-anticipated vacation this year.

I hope this article inspires you to seize the day! Be the best that you can be, and lend your expertise in making the healthcare system safe and caring for all who use it.

Cover Story

Regina Cunningham discusses her path from oncology nurse to hospital system CEO and shares insights on how nurses can leverage their unique skills to assume leadership roles.

Serving Up Inspiration: Nurse Brings Bedside Expertise to the Boardroom

Melissa Kalarchian is associate dean for Research and Professor at the 

Obesity, defined as excess adiposity, is a chronic disease affecting more than 1 in 3 adults in the United States.

 It affects some groups more than others, including women, older adults, an individuals from certain racial/ethnic minority groups. Obesity increases the risk for cardiovascular disease, type 2 diabetes, sleep apnea, and even cancer.

In 2003, the American Cancer Society released a landmark study linking obesity to cancer death among US adults.

 Over a decade later, obesity has been associated with the risk for numerous cancers, including endometrial cancer, esophageal adenocarcinoma, gastric cardia cancer, liver cancer, kidney cancer, multiple myeloma, meningioma, pancreatic cancer, colorectal cancer, gallbladder cancer, breast cancer, ovarian cancer, and thyroid cancer.

 Obesity has also been linked to childhood leukemia.

In 2014, the American Society of Clinical Oncology (ASCO) identified obesity as overtaking smoking as the leading preventable cause of cancer.

 One recent study documented that 3.6% of all new cancer cases worldwide were attributable to excess adiposity.

 This equates to hundreds of thousands of cancer cases that could potentially be avoided —particularly colorectal, pancreatic, and breast cancer.

The mechanisms underlying the relationship between cancer and obesity are not fully understood. These mechanisms may include insulin resistance and chronic hyperinsulinemia, increased bioavailability of steroid hormones, and localized inflammation.

 More recent data suggest that microbes that live in the gastrointestinal tract may also play a role. A better understanding of these pathways may lead to the development of targeted interventions.

The Obesity Society recommends that adults and children maintain reasonable weight for their height and age for multiple health benefits, including decreasing their risk of cancer.

 Lifestyle modification, including diet and exercise, is the foundation for weight management. However, caloric restriction may lead to biological adaptations which undermine the long-term effectiveness of lifestyle modification.

Indeed, results of behavioral treatment of obesity have been relatively modest, and maintenance of weight loss is challenging. Adjunct interventions include pharmacotherapy and bariatric surgery. Nonetheless, many providers do not address obesity due to barriers such as lack of information about treatment options, as well as limited time and resources.

Bariatric surgery, recommended for individuals with clinically severe obesity, has been associated with the greatest weight loss and maintenance. A meta-analysis showed that bariatric surgery reduced cancer risk and mortality in formerly obese patients, particularly women.

 However, more research is needed before definitive conclusions can be drawn.

Among patients diagnosed with cancer, obesity has been linked to poor prognosis including surgical complications, cancer recurrence, and even cancer mortality.

 Additionally, cancer treatment can contribute to excess adiposity. Chemotherapy and steroid medication are often associated with weight gain among patients. Causes for treatment-related weight gain may include changes in appetite, reduced activity, fluid retention, or other factors.

Evidence-based interventions to support adoption of a healthier lifestyle among patients with cancer are limited. Weight loss interventions for women with breast cancer have been shown to feasible and safe11 with beneficial effects on body weight and cancer biomarkers.

More work is needed to develop and evaluate weight management interventions to meet the unique needs of different groups of patients.

The ASCO Obesity Initiative has identified priority areas related to obesity and cancer, raised awareness, and distributed toolkits for patients and providers.

 Current efforts are focused on collaborating with groups working on obesity-related initiatives, both within and outside of the field of cancer.

Weight management is important for the general poulation and for patients with cancer. Ongoing interdisciplinary care is key to optimizing health and well-being for all patients.

National Institute of Diabetes and Digestive and Kidney Diseases. Overweight & obesity statistics. 2012. 

www.niddk.nih.gov/health-information/health-statistics/overweight-obesity

. Published October 2012. Accessed June 23, 2017.

Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. 

. 2003;348(17):1625-1638. doi: 10.1056/NEJMoa021423.

NIH National Cancer Institute. Obesity and Cancer. 

www.cancer.gov/about-cancer/causes-prevention/risk/obesity/obesity-fact-sheet

. Reviewed January 17, 2017. Accessed June 23, 2017.

Oeffinger KC, Mertens AC, Sklar CA, et al. Obesity in adult survivors of childhood acute lymphoblastic leukemia: A report from the Childhood Cancer Survivor Study. 

 2003;21(7):1359-1365. doi: 10.1200/JCO.2003.06.131

Ligibel JA, Alfano CM, Courneya KS, et al. American Society of Clinical Oncology position statement on obesity and cancer. 

. 2014;32(31):3568-3574. doi: 10.1200/JCO.2014.58.4680.

Arnold M, Pandeya N, Byrnes G, et al. Global burden of cancer attributable to high body-mass index in 2012: A population-based study. 

. 2015;16(1):36-46. doi: 10.1016/S1470-2045(14)71123-4. 

Calle EE, Kaaks R. Overweight, obesity and cancer: Epidemiological evidence and proposed mechanisms. 

. 2004;4(8):579-591.  doi:10.1038/nrc1408.

www.obesity.org/obesity/resources/facts-about-obesity/cancer-obesity

. Updated January 2015. Accessed June 23, 2017.

Ochner CN, Tsai AG, Kushner RF, Wadden TA. Treating obesity seriously: when recommendations for lifestyle change confront biological adaptations. 

. 2015;3(4):232-234. doi: 10.1016/S2213-8587(15)00009-1. 

Tee MC, Cao Y, Warnock GL, Hu FB, Chavarro JE. Effect of bariatric surgery on oncologic outcomes: A systematic review and meta-analysis. 

. 2013;27(12):4449-4456. doi: 10.1007/s00464-013-3127-9. 

Reeves MM, Terranova CO, Eakin EG, Demark-Wahnefried W. Weight loss intervention trials in women with breast cancer: A systematic review. 

. 2014;15(9):749-768. doi: 10.1111/obr.12190.

Harrigan M, Cartmel B, Loftfield E, et al. Randomized trial comparing telephone versus in-person weight loss counseling on body composition and circulating biomarkers in women treated for breast cancer: The Lifestyle, Exercise, and Nutrition (LEAN) study. 

. 2016;34(7):669-676. doi: 10.1200/JCO.2015.61.6375. 

Ligibel JA, Wollins D. American Society of Clinical Oncology obesity initiative: Rationale, progress, and future directions. 

Obesity and Cancer: A Guide for Oncology Providers.

www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/documents/obesity-provider-guide.pdf

Partner Perspectives

Obesity has overtaken smoking as the leading preventable cause of cancer. Among patients diagnosed with cancer, obesity has been linked to poor prognosis.

Obesity and Cancer: An Interdisciplinary Approach to Weight Management

Despite increased awareness of the dangers of sun exposure and a multibillion—dollar sunscreen industry, melanoma rates have tripled over the past 30 years. Sunscreen is recommended to protect the skin from harmful ultraviolet A (UVA) and ultraviolet B (UVB) rays. Did you know that half of the sunscreens sold in the United States do not provide enough UVA protection to be sold in Europe? Europe sets a higher bar, requiring UVA protection to rise in proportion with sun protection factor (SPF), which provides only UVB protection. UVA rays penetrate the skin more deeply than UVB rays and damage keratinocytes in the basal layer of the epidermis, which is where most skin cancers occur.

UVA rays are emitted by the sun and sunlamps used in tanning salons, the latter emitting doses as much as 12 times that of the sun. The Skin Cancer Foundation notes that use of tanning beds by teenagers and young adults increases their risk of melanoma by 75%.

With so many products available in the United States, which ones are safe and effective? People choose sunscreen based on its SPF and often assume that higher numbers of SPF confer better protection from damaging rays. However, higher SPF ratings do not necessarily offer greater protection from UV-related skin damage.

In 2017, the Environmental Working Group (EWG), a nonprofit, nonpartisan organization dedicated to protecting human health and the environment, issued its 11th annual Sunscreen Guide (available at ewg.org/sunscreen).

• One in 5 Americans will develop skin cancer in their lifetime

• More people develop skin cancer because of tanning than develop lung cancer due to smoking

• On average, a person’s risk for melanoma doubles if he/she has had more than 5 sunburns

The EWG evaluated 880 beach and sport sunscreens, 480 moisturizers, and 120 lip products sold in the United States and found that 75% of the products contained less than the labeled SPF. Some also contained ingredients such as oxybenzone, a hormone disruptor, and retinyl palmitate, a form of vitamin A that actually may be harmful to the skin.

In 2011, the FDA determined that high SPF claims may be inherently misleading, and proposed to join most industrialized nations in capping SPF values at 50+. The ruling has not been finalized as of this year, so manufacturers continue their production of sunscreens with very high SPF ratings. The concern is that consumers may misuse the sunscreens with a higher SPF label by staying out in the sun longer. They assume an SPF 100 gives them twice as much protection as an SPF 50, but that is not the case. In 2007, only 10 sunscreens evaluated by the EWG claimed an SPF of 70 and higher. Ten years later, 69 products make this claim, with 13 advertised as having SPFs of 100 or higher.

Further, although 30% of sunscreens are available as sprays, they may not provide a thick-enough even coating on the skin and pose an inhalation risk. In 2011, the FDA indicated it would ban spray sunscreens unless their manufacturers submitted evidence that they protect the skin and pose no safety hazards. Until this happens, the EWG cautions people to avoid sunscreen sprays.

Also in 2011, the FDA set new sunscreen rules that removed false marketing claims, such as use of the words “waterproof” and “sweat-proof” from product labels. The FDA now requires that sunscreen labels include warnings about the risk of skin cancer and the skin aging effects of sun exposure.

The 2014 Sunscreen Innovation Act, which amended the US Food, Drug, and Cosmetic Act of 1938, expedites the FDA’s review of new sunscreen ingredients. The law gave the FDA 1 year to respond to its backlog of sunscreen ingredient approval requests, and 18 months to reply to any future applications, with the goal of accelerating the review and approval of effective sunscreen ingredients that have been available in Europe for the past decade.

The EWG’s Sunscreen Guide is available at no cost online and provides a comprehensive overview of sunscreen product safety and efficacy. Oncology nurses can use this resource to not only educate our patients, but to educate people in our communities as well.

Confusion about sunscreen options and ingredients can lead to inadequate sun protection and increased skin cancer risk. The Environmental Working Group has resources to help. 

Sunscreens: What You Need to Know

Central line-associated bloodstream infection (CLABSI) is one of the hottest topics in healthcare. What are the best prevention methods? How can we reduce associated costs? More and more products are being created to combat this seemingly undefeatable foe. Although the innovations are helpful in many settings, there are some basic interventions that have been proven effective as well.

Sometimes the simplest intervention is the most effective. Take a moment and mindfully reflect on your hand-hygiene practice.Do you routinely foam in when entering a patient room and foam out as you’re leaving? Do you perform hand hygiene prior to applying gloves when you’re getting ready to access a central line? It’s easy to rush past this imperative task. Increase mindfulness regarding your hand-hygiene habits and you can rest assured that you’re decreasing your patients’ risk for CLABSI.

Prior to accessing a central line lumen or port, scrub it with your facility’s approved device cleansing swab. The lumen or port should be cleaned every time you’re preparing to access. For example, when administering an antiemetic, 

, connect a saline flush to assess patency, 

, and connect another normal saline flush to clear the line.

If your facility uses heparin or sodium citrate to “lock” lumens between uses, scrub the hub again before connecting that syringe. Yes, you’re going to be doing a lot of scrubbing. Use the time to chat with your patient about all the ways you can work together to prevent infection.

The duration of scrubbing varies depending on the product being used. Because the product won't be effective if you don't scrub long enough, read the instructions for use to ensure that the product is being used according to the manufacturer’s recommendations. Generally, 10 to 15 seconds of scrubbing is recommended when using alcohol swabs. Device swabs containing chlorhexidine gluconate may decrease the scrub time to 5 seconds.

Patency is very important for central line functionality, but it also plays a major role in preventing infection. When a line isn’t flushed well after being used, the particulate matter left behind (especially from blood products and total parenteral nutrition) becomes a breeding ground for microbial growth. The average person may not develop a CLABSI, but patients with compromised immune systems are highly susceptible to infection and subsequent sepsis related to microbial growth within a central line. Follow your facility’s policy regarding the frequency of flushing central lines. Ensure that scheduled and additional flushes as needed are ordered and administered from the time the line is initially placed until the line is discontinued.

As you’re performing central line care, explain the rationale for your actions. Explain when patients and their caregivers will be responsible for central line maintenance outside of the acute care setting. Also, teach them about the importance of hand hygiene, scrubbing the hub, flushing the line, and maintaining the integrity of the dressing.

Despite our best efforts, sometimes CLABSIs will occur. Review signs and symptoms of infection with your patient and their caregivers. Discuss the process for seeking immediate intervention and make sure they have contact information for a resource to address any concerns they have after hours.

We often fall in to the trap of leaving a central line in place “just in case” the patient needs it. Though the intention is good, the risk is definitely greater than the benefit. When the line is no longer indicated, it needs to come out.

Fast Facts for the Frontline

Preventing central line–associated bloodstream infections is a top priority for healthcare practitioners, and following basic safety protocols, such as handwashing and line flushing, is essential to the effort.

Fast Facts for the Front Line: Central Line-Associated Bloodstream Infection

For patients with cancer, moving through the phases of diagnosis, treatment, and survivorship can be more than a little daunting. The process can seem like a different world, with a whole new language. Personalized treatments, molecular profiling, and immunotherapies have led to advances in treatment, but they also add a layer of complexity at a time when patients and their loved ones are feeling terrified and overwhelmed.

Enter the nurse navigator, a certified RN with navigation training tailored to a specific type of cancer. The nurse navigator’s role is to empower patients and families by eliminating barriers to care, providing education about their specific cancer, available treatments and clinical trials, as well informing them how to find support, such as physical and psychosocial therapy and financial and transportation resources.

Sarah Cannon, the Cancer Institute of HCA Healthcare, has built a flagship navigation program to serve its cancer programs across the nation. The program has seen tremendous growth—from just 5 nurse navigators in 2011 to 200 today. The number one goal of the navigation program, explained Crystal Dugger, MBA, MSN, RN, assistant vice president of clinical operations at Sarah Cannon, “is to help patients stay compliant with the treatment plan.”

“Nurse navigators are the point person for the patient throughout the entire continuum of care,” she continued. And, nurse navigators are not there just for the patients. At Sarah Cannon, navigators also coordinate office visits, streamline communication among other members of the healthcare team, and organize multidisciplinary team conferences. With a process that has as many moving parts as cancer care, the nurse navigator can function as a conductor, ensuring that all departments know how to work with one another in the most efficient and effective way.

“Nurse navigators are the point person for the patient throughout the entire continuum of care.”

The impact of the program can be seen in many ways, but especially in the patient experience. As just 1 example, Dugger mentioned a patient who had been diagnosed with breast cancer 8 years ago, before the navigation program was in place. Recently, that same patient had a recurrence and was given a nurse navigator. “She could not stop talking about the difference in the experience that she had from the first time compared to the second time,” Dugger said.

Dugger attributes much of the success of Sarah Cannon’s navigation program to the creation of oncology pathways— guided by physicians and based on tumor type and stage&mdash;that help ensure seamless care across the cancer journey for both patients and providers. These pathways help to standardize the training and role of the nurse navigator, with an eye toward achieving critical quality metrics and optimal patient outcomes throughout the health system.

The Sarah Cannon program assigns a nurse navigator to the patient at the time of diagnosis. In turn, the navigator walks with the patient through every step of the cancer journey: diagnosis, genetic testing, treatment, palliative, and/or supportive care.

Nurse navigators at Sarah Cannon also keep the patient’s own specific goals in mind. “The navigator’s job is to ensure that the voice [of the patient] is heard in our multidisciplinary conferences, when providers are creating the treatment options for the patient.” Dugger recalled a patient who was a concert pianist, but the standard chemotherapy was likely to cause neuropathy, or severe numbness in the fingertips, a side effect that would have a tremendously negative impact on that patient’s livelihood. Survival statistics were not quite as good with another chemotherapy option, but that therapy offered a lower neuropathy risk, an option the patient preferred. Without the nurse navigator advocating on the patient’s behalf, this risk may have been missed.

For other institutions seeking to start or improve their own navigation programs, Dugger urges starting with a vision: “What are you trying to accomplish? What is the goal you’re trying to reach?” It is also necessary to have other programs and departments fully on board: “You need to make sure you have physician and administrative alignment.”

Successful navigation programs ultimately depend on a workable business model. “We have to make sure that we’re being impactful within the budget,” Dugger stressed. For Sarah Cannon, this meant measuring patient satisfaction and retention at the facility. Although nurses can sometimes be uneasy focusing on financial aspects, they’re important for creating a sustainable program.

To facilitate demonstration of the navigation program’s value, Sarah Cannon’s proprietary iNavigate data collection software captures key metrics such as timeliness to first treatment, patient satisfaction, and navigator retention, which generates a scorecard that captures all data into one report.

“At the end of the day, our goal is to help more patients. You’re going to do that by showing a good business model, so you can get resources, grow your program, and show improvement.”

For nurses who are unfamiliar with quality and financial metrics or may be uncomfortable with this line of thinking, Dugger urges them to get more involved with leadership. “Nurses have to start talking from the perspective of both sides of the business. We have to get nurses thinking that way,” she said.

Nurse navigators at Sarah Cannon use oncology pathways to help ensure patient access to seamless care across the cancer continuum.

August 2017