For Sara Sargente, RN, OCN, it was the middle of the night when she heard her calling to be an oncology nurse. From a young age, she had known she would be a nurse as she watched her grandmother leave for work in her starched white uniform and cap. But it was another moment that clarified oncology nursing as her calling.

Sargente was only 13 when her grandfather was sent home on hospice for his final days after being diagnosed with colon cancer. She and her mother, an EMT, were caring for him, answering the tiny bell they had given him to ring for care.

“I was sleeping downstairs one night, when I heard the bell,” she recalled. “My mom didn’t wake, so I went to help him by myself.” Sargente had no fear that night, she said, nor was she afraid when he died a few days later. Instead, she experienced a comfortable feeling as the family played his favorite songs and he closed his eyes for the last time.

While caring for him that night, Sargente said she knew that her career in nursing would be as an oncology nurse, a vision she did not relinquish, even when everyone in nursing school told her she would have to do a few years of other, more basic care before going on to oncology. Indeed, her first job was as a floor nurse in a general surgery unit. After only a few months, however, she applied for an oncology position at another hospital across town. It was a longer drive, but she knew it was where she belonged.

Sargente worked in radiation for a few years, when a mentor tapped her to apply for a position as a nurse navigator for patients with head and neck cancer at the Orange Regional Medical Center, in Middletown, New York. “They go through so much with this cancer,” she explained. “It is so very difficult, and their quality of life is affected. They can’t go out to eat with their family and enjoy the simplest things that we take for granted.”

Often, she goes to see patients at home, relieving them of the lengthy drive many of them must take to get to treatment. She facilitates a support group through the organization Support for People with Oral, Head and Neck Cancer, and she became certified in blood management to respond to the needs of Jehovah’s Witness community members who do not allow the use of any blood products during surgery. This year, she is beginning her second term as president of her local ONS chapter, which she helped found to provide a closer group for area nurses.

“We have a core group of nurses here who are so loving and compassionate. They are not worried about themselves but keep asking what we can do for the patients,” she said. Sara oversaw a fundraiser that brought in $10,000 the first year the chapter was in operation. The group established a fund called Acts of Kindness, and any patient could apply. Last year they raised $15,000.

“Instead of giving it to nurses, we all decided we wanted to support the patients with $100 gift cards for gas or prescriptions or whatever they needed,” said Sargente. “For example, one woman who had a mastectomy needed a button-up-the-front shirt. We have patients who are so poor, they cannot buy their medicine.”

Sargente is supported not only by the hospital but also by her family, her husband, and 4 children. The third-generation healer in her family, she is watching the fourth generation prepare that role as her daughter trains to be a radiation therapist—in oncology, of course.

Articles

Cover Story

Sara Sargente found her calling at age 13, caring for her grandfather who had cancer. This oncology nurse navigator and winner of CURE® magazine's 2017 Extraordinary Healer® Award has never looked back.


Oncology Found Her: Going the Extra Mile for Patients With Head and Neck Cancer

BGB-3111, a second-generation Bruton tyrosine kinase (BTK) inhibitor, is being tested in patients with refractory B-cell lymphoid malignancies in an effort to determine whether the novel oral small molecule is a viable therapeutic option and to better understand its pharmacologic properties. Investigators also are seek- ing to differentiate BGB-3111 from ibrutinib (Imbruvica), the first and thus far only FDA-approved BTK inhibitor.

BGB-3111 is a potent, irreversible, and highly selective BTK inhibitor that blocks the signaling that leads to growth inhibition and cell death in malignant B cells. “The mechanism is the same as ibrutinib, but with less off-target kinase activity,” explained the study’s principal investigator Constantine S. Tam, MBBS, MD, a hematologist at the Peter MacCallum Cancer Centre in Melbourne, Australia. He added that investigators are targeting “the diseases known to be sensitive to ibrutinib, such as chronic lymphocytic leukemia [CLL], follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenström macroglobulinemia, and activated B-cell like— diffuse large B-cell lymphoma.”

If successful, BGB-3111 could fulfill a need for a more concentrated therapy to treat patients with chemotherapy-refractory B-cell malignancies and patients in frontline settings who are not good candidates for chemotherapy, according to Tam, with early studies of the agent suggesting that BGB-3111 appears to be associated with less toxicity, compared with ibrutinib.

The phase I study (NCT02343120) features a dose escalation component followed by an expansion stage in which patients will be assigned to different cohorts based on the histology of their cancer.

The study seeks to recruit 235 patients and is open to those aged ≥18 years with most B-cell malignancies who have relapsed after 1 or more lines of therapy and have not had prior BTK inhibitor therapy. Patients with Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphomare not eligible. It is currently enrolling patients at The University of Texas MD Anderson Cancer Center in Houston and at centers in Australia, New Zealand, and South Korea.

The research is being sponsored by BeiGene, a biopharmaceutical company with a clinical headquarters in Fort Lee, New Jersey, and a research and development center in Beijing, China.

Clinical Trials in Progress

Emerging BTK Inhibitor Tested in B-Cell Malignancies

Embryo-fetal toxicity: Advise females of reproductive potential to use effective contraceptive measures to prevent pregnancy while being treated with bosutinib and for at least 30 days after the final dose.

Skin and subcutaneous tissue disorders (postmarketing experience): Stevens-Johnson syndrome

Musculoskeletal and connective tissue disorders (postmarketing experience): musculoskeletal pain upon treatment discontinuation, including myalgia, pain in extremities, arthralgia, bone pain.

Infections (postmarketing experience): hepatitis B virus reactivation

Acute lymphoblastic leukemia: Superficial edema was a common finding in all studies and was described primarily as periorbital or lower limb edemas. These edemas were reported as grade 3/4 events in 6.3% of the patients and may be managed with diuretics, other supportive measures or, in some patients, by reducing the dose of imatinib.

Skin and subcutaneous tissue disorders: nail disorders including paronychia; severe cutaneous adverse skin reactions, including Stevens-Johnson syndrome and toxic epidural necrolysis.

Cardiac disorders: ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolongation.

Severe skin reactions: lapatinib may cause severe skin reactions. Advise patients to inform their healthcare provider immediately if symptoms develop, including skin rash; red skin; blistering of the lips, eyes, or mouth; peeling of the skin; fever; or any combination of these.

CYP3A4 inhibitors: Vemurafenib is a substrate of CYP3A4; therefore, coadministration of strong CYP3A4 inhibitors may increase vemurafenib plasma concentrations and may lead to increased toxicity.

CYP3A4 inducers: Coadministration of vemurafenib with rifampin, a strong CYP-3A4 inducer, decreased vemurafenib plasma concentrations and may result in decreased efficacy. Avoid coadministration of vemurafenib with strong CYP3A4 in- ducers (eg, phenytoin, carbamazepine, rifampin), and replace these drugs with alternative drugs when possible. If coadministration of a strong CYP3A4 inducer is unavoidable, increase the dose of vemurafenib by 240 mg (1 tablet) as tolerated.

Females of reproductive potential: Based on its mechanism of action, vemurafenib can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with vemurafenib and for 2 weeks after the final dose.

Risk summary: There are no available data on the use of vemurafenib in pregnant women to determine the drug-associated risk; however, placental transfer of vemurafenib to a fetus has been reported.

Adverse Events Report

FDA labeling changes reflecting adverse events.

June Adverse Events Report: FDA Labeling Changes

We in the subspecialty of oncology nurse navigation assiduously work to authenticate and substantiate our role. We use many metrics, competencies, and benchmarks that validate what we do for our patients, but let us never forget the inestimable emotional significance we can bring to our patients as we guide them through the grueling journey of their cancer experience and treatment.

One of my patients with ovarian cancer was a professor of English literature. We will call her “Elsa.” If this conjures up the title character in the animated film, Frozen, it would crystallize her persona quite accurately. During one of her increasingly frequent admissions, she laughingly characterized her possibility of a cure by saying it was as likely as seeing flying pigs.

That day I went to our hospital gift shop and, lo and behold, found a beautiful, soft, and cuddly flying pig. The woman at the shop is well aware of my eccentricities, so she and I both laughed at my delight in finding a stuffed flying pig as we wrapped it to give to Elsa— who laughed so hard that tears came to her eyes. The next day Elsa went to the GI lab for a procedure, and when she came back to her room, her flying pig was gone. Needless to say, she was very disappointed. But being the kind soul she was, she said that maybe someone took it to give to their child. As always, I was astounded at Elsa’s lemons-to-lemonade thought processes.

Sadly, not too many months later, Elsa was readmitted with anasarca and nausea; in ovarian cancer, this is a profound and moribund development. Having known this beautiful woman since her diagnosis, I went home that day in tears. My husband (another lemons-to-lemonade personality) sat down at the computer and ordered 2 beautiful Webkinz flying pigs from Amazon and had them to us the next day. I brought them to Elsa—who had toddler-aged twins&mdash;and she laughingly shared her plans for the stories and wonderful scenarios to be experienced with the twins and their new flying pigs.

Elsa died 2 weeks later, but her husband told me how much fun she had with the twins as she shared not only flying pig stories, but essential cuddling time with her children. Me, I have a crystallized and beautiful memory of Elsa, intermingled with the quantifiable medical aspects of her care.

Another story involves a very genteel man, “Lance” (quite the naturally aristocratic and elegant individual). A nurse colleague and friend asked me to see him as he was her neighbor. Lance had pancreatic and lung cancer and was not doing well at all. I went to his room and spoke with him, which was quite difficult as he had a nasogastric tube in place, oxygen via a rebreather device, and a massive amount of ascites, making it difficult for him to breathe and speak clearly. Nevertheless, he managed to have a short conversation with me.

Profoundly saddened by Lance’s obvious struggle, I came away from his room and pondered how to approach a second visit. Once again, I went to the hospital gift shop—more to compose myself than any other reason&mdash;and there was a large, cuddly, funny-looking, stuffed beaver, complete with a big, flat beaver tail. When I got home, my husband asked me what I’d bought at the gift shop (he knows those blue bags well) and my reply was, “Do you want to see my stuffed beaver? His reaction to me&mdash;(

The next morning I went to Lance’s room where this time his wife was with him. We chatted as I held the stuffed beaver behind my back, and it seemed that discharge planning was in progress for Lance to go to a rehab facility (somewhat of a misnomer for his condition). Understandably, neither Lance nor his wife was very cheerful.

I finally said that from our visit the day before, he seemed to me to have a quirky sense of humor and I thought he would appreciate a stuffed beaver. He and his wife both grinned as I went on to say that I’d shown it to my husband the previous evening, but I could not repeat what my husband said when I asked if he wanted to see my stuffed beaver. Lance and his wife both laughed for quite some time. I left, feeling like I’d at least created a happy moment for this couple. Lance’s wife called me to thank me for that moment, saying it had been many months since they had shared a laugh such as they did, because of that stuffed beaver from the hospital’s gift shop.

Although through quality indices and metrics, we can validate the return on investment we can effect as navigators, imperative to the ever dynamic development and evolution of our role is the ability to connect the dots of shared love, laughter, and tenderness, as we support and assist our patients and their caregivers, enabling them to create memories of joy (however fleeting) to take forward into their future, whatever that might hold for them.

Penny Daugherty is an oncology nurse navigator specializing in gynecologic oncology and multiple myeloma at the Northside Hospital Cancer Institute in Atlanta.

Nurse Navigators

Metrics and benchmarks are a vital part of the value proposition behind navigation, but these vignettes illustrate how even the smallest gesture can make a big difference for our patients.


Forging an Emotional Connection With Our Patients

Summer is just around the corner, which means trips to the beach, lake, swimming pool, and other sunny locales. Although having fun and enjoying time with friends and family are at the forefront of these outings, sun safety and skin cancer prevention should also top the list.

Oncology nurses have the unique opportunity to educate patients and their loved ones about the dangers of excess sun exposure. We can provide this education at the bedside and through our own positive example when we're out and about under the sun.

Unrepaired damage to DNA in our skin caused by too much exposure to ultraviolet radiation (ie, sunshine and tanning beds) can lead to genetic mutation and rapid growth of abnormal cells, ultimately resulting in malignancy.

Abnormal skin lesions are classified as “precancerous” and “cancerous.” The precancerous variety includes actinic keratosis and dysplastic nevi (atypical moles). The presence of either of these places a person at higher risk for developing skin cancer.

Basal cell carcinoma, the most commonly occurring form of skin cancer, originates in the deepest layer of the epidermis. These cancerous lesions are the result of cumulative or occasional intense sun exposure. Squamous cell carcinoma is the second most common skin cancer and results from cumulative sun exposure over the course of a lifetime. Melanoma is the most dangerous type of skin cancer. It originates in melanocytes, the pigment-producing cells within the basal layer of the epidermis. When detected early, melanoma is typically curable. However, when undetected, it can metastasize to other parts of the body and becomes more difficult to treat and cure. Merkel cell carcinoma is a very rare and aggressive form of skin cancer that typically affects fair-skinned individuals over the age of 50.

Sun protection and skin cancer prevention techniques may seem obvious to us as healthcare professionals, but our patients may never have received this education. The basics should include seeking shade between 10 am and 4 pm.

Daily use of a broad-spectrum (Ultra Violet A&B) sunscreen with an SPF of at least 15 should be recommended for the areas of skin that are most frequently exposed to the sun (face, ears, neck, etc). During extended, intense exposure, an SPF of 30 or higher is recommended 30 minutes prior to sun exposure. Reapplication should occur every 2 hours or immediately after swimming or excessive sweating. Sunscreen should be used on infants over 6 months old; newborns should be protected from sun exposure. Protective clothing, such as lightweight long-sleeved shirts, wide-brimmed hats, and sunglasses with UVA/UVB protection should also be encouraged. Finally, a monthly skin self-exam and a yearly visit to a physician or dermatologist for a thorough skin assessment are recommended.

Photosensitivity or sunburn occurring after minimal sun exposure, is a known side effect associated with certain types of certain anticancer therapies. High-soder methotrxate, dacarbazine, 5-Flourouracil, trans retinoic acid, and vinblastine are chemotherapy agents known to cause photosensitivity. Cetuximab, panitumumab, vandetanib, and vemurafenibare biotherapy agents and targeted therapies associated with photosensitivity. Patients receiving active treatment with any of these agents should receive education about sun protection prior to starting treatment, with follow-up education provided periodically throughout the treatment regimen.

FROM EVIDENCE TO REALITY: “POOL COOL” IN KANSAS

In 2014, an oncologist at the University of Kansas Cancer Center approached Ashley Adorante, outreach coordinator for the Midwest Cancer Alliance, about implementing Pool Cool, a research-tested program that teaches children, their parents, and aquatics staff at local pools about sun safety.

The program is based on research published by the University of Pennsylvania in 2002. Aquatics instructors working at community pools receive training through a “train-the-trainer” model, which also helps them implement the preventive measures in their own lives. A series of eight 5-minute lessons are then taught by the aquatics instructors prior to swimming lessons. Along with the lessons, sun protection resources are offered at pools participating in the program—including large jugs of sunscreen, Pool Cool signs, shade areas, and other promo- tional items.

Adorante took the oncologist’s request to the Kansas City Metro Aquatics Council and got the program rolling. In its first year, Pool Cool was implemented at 21 pools in the Kansas City area. By 2015, a total of 33 pools across the state were participating. Last year, approximately 40 pools joined, and the goal for 2017 is to bring Pool Cool to another 50 community pools across Kansas.

Adorante says the program has now been implemented in western Kansas, a sparsely populated region with many small rural communities. In communities without public pools, lunch and learn programs about sun safety have been provided to city workers who spend the day working outdoors.

The Kansas Pool Cool program receives its funding from the Midwest Cancer Alliance, Kansas Cancer Partnership, and Outpacing Melanoma. For more information about implementing Pool Cool in your community and state, email Ashley Adorante at aadorante@kumc.edu.

More information about skin cancer, prevention, and treatment is available through the Skin Cancer Foundation at skincancer.org.

Fast Facts for the Frontline

Increasing awareness of the dangers of sun exposure involves not only patient and caregiver education, but also nurses setting a positive example themselves.


Fast Facts for the Front Line: Skin Cancer and Sun Protection

Oncology nurses have a unique opportunity to attend “summer school” in August, earn 10.25 Contact Hours, and learn the latest information about new treatments and side effects across the full range of tumor types from nationally recognized experts at the 1st Annual School of Nursing Oncology

The SONO conference, to be held August 5 to 6, 2017, in Nashville, Tennessee, is a CME/ CE-certified activity sponsored by Physicians’ Education Resource

 SONO program co-chair Laura S. Wood, RN, MSN, OCN, explained that one of the attractions of this meeting for the practicing oncology nurse is its broad coverage of cancer and treatment options. “So much is changing for our patients and for ourselves as clinicians—the meeting offers a great opportunity to get a comprehensive update.”

“The treatment options and the diagnosis and management of cancer from early to advanced disease and survivorship is constantly evolving,” continued Wood, who is the renal cancer research coordinator at Cleveland Clinic Taussig Cancer Institute. She added that it’s especially helpful that the conference will cover all of the solid tumor malignancies as well as hematologic cancers, in one, 2-day conference.

At the conference, Wood will be giving 2 presentations, 1 focused on genitourinary cancers, where she said the biggest change has been in bladder cancer where patients have many more treatment options than they did even 1 year ago.

Immunotherapies have expanded rapidly in the clinic, following on recent FDA approvals across many tumor types; thus, not surprisingly, information to help nurses educate and manage patients on these therapies will be a focus of the SONO meeting that will include a session dedicated to clinical applications in the management of toxicities associated with immunotherapy.

Nurses are very good at managing chemotherapy and educating patients and families on chemotherapy and chemotherapy-related side effects,” said Wood.

“Immunotherapies represent a paradigm shift, and we have found in our clinical practice, that how patients with a given disease tolerate a therapy varies.” Wood stressed that for patients to stay on these therapies, communication with their healthcare team is crucial.

“Patients need to know what to watch for, and they need to clearly understand the importance of early and ongoing communication. That goes for the patient and the healthcare team.”

In her presentation, program co-chair Grace Cherry, RN, MSN, NP, will focus on melanoma, the setting where immunotherapies were first deployed. Cherry, an oncology nurse practitioner with the UCLA Melanoma Program, will focus on the mechanism of action with melanoma therapies, as well as melanoma staging.

“It’s an opportunity to show how melanoma is an immunogenic tumor,” Cherry said, adding that with immunotherapies being seen more and more in practice, helping nurses understand the agents’ significant clinical experience thus far in the melanoma setting can be very useful to the oncology nurse in the clinic.

Wood is also giving a presentation on best practices for communicating with patients about adhering to their treatment regimens. Although adherence to oral oncolytics garners a lot of attention, she will also stress the importance of patients adhering to their supportive therapies. She explained that if patients don’t understand the importance of following guidance on antidiarrheal regimens or steroids, for example, “they’re going to experience side effects that will interfere with their treatment, their quality of life, and their overall wellness.”

“If the healthcare provider isn’t well-versed on tracking that and questioning that, they’re going to miss an important piece of the overall management of that patient...Are patients taking the right dose, the right formulation, at the right time?”

Such careful monitoring and communication certainly applies to one of the more prevalent side effects that patients experience—chemotherapy-induced nausea and vomiting (CINV).

This will be the focus of a presentation by program co-chair Beth Eaby-Sandy, MSN, CRNP, OCN, thoracic oncology nurse practitioner at the Abramson Cancer Center at the Hospital of the University of Pennsylvania.

“CINV is probably the most rapidly changed supportive care topic in oncology in the past 2 years,” said Eaby-Sandy. “Several new drugs have been approved with new routes of administration with a longer half-life.

To learn more about the 1st Annual School of Nursing OncologyTM, view the agenda, and to register, visit 

. The meeting will be held at the Loews Vanderbilt Hotel in Nashville. Physicians’ Education Resource®, LLC is approved by the California Board of Registered Nursing, Provider #16669 for 10.25 Contact Hours. Program content is reviewed by the Oncology Nursing Certification Corporation (ONCC) and is acceptable for recertification points.

“The most important thing for oncology nurses is knowing which drugs cause what level of CINV and also, the newer treatment options and how to individually tailor antiemesis prophylaxis to each patient.”

Eaby-Sandy also will be presenting on side effect management in another growing class of cancer drugs: targeted agents for lung cancer. She plans to review both the MASCC and NCCN guidelines for managing toxicities associated with these agents, in particular, rash, along with some of the less common but concerning ones.

The SONO conference will have an interactive component, Cherry noted, adding that she is really looking forward to collaborating with other practitioners at the meeting:

“Our goal is to provide practical and meaningful information nurses can immediately deploy back home in their clinics...We hope nurses will leave here more confident in their interactions with patients and family members."

Feature Story

In August, Physician's Education Resource®, LLC will be sponsoring the 1st Annual School of Nursing OncologyTM (SONO) where nurses can earn 10.25 Contact Hours. 

School of Nursing Oncology to Offer Comprehensive Update on New Treatments in One Meeting

Chemotherapy is most often administered intravenously (IV) by trained oncology nurses in a clinical setting. However, the continued development and FDA approval of oral oncolytic agents (OOA) has brought about a paradigm shift in cancer treatment. With about 30% of chemotherapy in the development pipeline and being prescribed, many medications are moving from the clinical setting to the patient’s home.

This shift in setting also brings about a shift in responsibility, from the clinician to the patient. When being prescribed OOA, patients are now required to self-manage medications and symptoms, more so than when receiving IV chemotherapy. This requires clinicians to provide a higher standard strategies to empower patients and caregivers to be utilize successful in managing and adhering to medication regimens.

For patients with solid tumors, an OOA prescription is typically the result of disease progression, whereas for patients with hematologic malignancies, an OOA may be prescribed for a new diagnosis as a first line of treatment.

 Some patients may not have insurance, or their insurance may not cover specific OOAs. This may require connecting patients with care management or social work in order to provide them with resources to pay for medications.

ORAL ONCOLYTICS PATIENT COUNSELING POINTS

The following topics are just a few of the primary education components that should be discussed with patients who are prescribed oral oncolytic agents (OOA):

  ✓ Regimen complexity (eg, continuous vs cycling dosing schedules)

  ✓ Management of side effects, including supportive drugs (eg, antiemetics) Food and drug interactions

This shift in setting also brings about a shift in responsibility, from the clinician to the patient. When being prescribed OOA, patients are now required to self-manage medications and symptoms, more so than when receiving IV chemotherapy. This requires clinicians to provide a higher standard strategies to empower patients and caregivers to be utilize successful in managing and adhering to medication regimens.2

At the initial oncology visit, when patients with cancer are newly prescribed OOA, they receive a substantial amount of education. However, due to the nature of the situation, it can be extremely stressful and difficult for them to fully comprehend all the information given. For these reasons, clinicians—especially oncology nurses&mdash;should be providing continued and sustained patient education at each clinic visit (Box).

With more of the responsibility for medication and symptom management placed on patients, it is the responsibility of the oncology nurse to educate and provide strategies to effectively self-manage OOA regimens. We want them to be successful, and that begins with discussing the importance of adherence. Patients need to maintain a certain level of adherence for the medications to be efficacious, but a myriad of barriers exist.

 Regimen complexity may have a substantial impact on adherence, for example.

 Regimens may be as simple as 1 pill once per day, or multiple medications with 1 being taken every day, while the other being taken 21 days on, 7 days off.

“Among the potential barriers to adherence are regimen complexity, cost, side effects, and possible drug—drug interactions.”

Oral oncolytics also can be extremely expensive, makin it difficult for patients to afford and access them.

 Some patients may not have insurance, or their insurance may not cover specific OAs. This may require connecting patients with care management or social work in order to provide them with resources to pay for medication.

Unlike most medications, an OOA prescription cannot be simply filled at the local pharmacy. Specialty pharmacies or mail order pharmacies are needed to access these medications. It is important to discuss these special circumstances with patients at the time of the initial prescription and throughout their cancer care.

Once patients are able to access their medications, nurses can deploy strategies and share important information to help them be successful with their oral regimens. Importantly, patients need to take certain steps to properly handle OOAs in order to keep themselves and their families safe. Tips for safe handling of OOAs include

Patients should administer theirown medications, but if a caregiver or loved one is doing so, they should wear gloves

These agents should not be chewed, crushed, or dissolved

Avoid spread of bodily fluids, especially urine or saliva.

Much like IV chemotherapy, OOAs can bring about severe adverse events. It is important to talk with patients about common side effects associated with their OOA, such as fatigue, nausea, vomiting, diarrhea, and skin reactions, and provide strategies for self-management of symptoms or when patients should contact a provider.

Most patients not only take their OOAs, but also supportive care drugs or medications for other chronic conditions.

 Educating patients on the importance of possible drug—drug interactions, or which foods/liquids to avoid, can aid in making sure OOA drug levels are not increased or decreased and for decreasing possible toxicities.

Patients newly prescribed OOA are in a particularly vulnerable situation. Oncology nurses are at the front line for patient education. Nurses play a critical role in making sure patients understand the information being discussed with them when OOA therapy is initiated, but also at subsequent visits. Open communication and reinforced education are the keys to success in patients managing OOA regimens, and oncology nurses are the perfect facilitators to make this happen.

1. Bassan F, Peter F, Houbre B, et al. Adherence to oral antineoplastic agents by cancer patients: definition and literature review. 

2. Arber A, Odelius A, Williams P, et al. Do patients on oral chemotherapy have sufficient knowledge for optimal adherence? A mixed methods study. 

3. Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. 

4. Hall AE, Paul C, Bryant J, et al. To adhere or not to adhere: Rates and reasons of medication adherence in hematological cancer patients. 

5. Accordino MK, Hershman DL. Disparities and challenges in adherence to oral antineoplastic agents. 

6. Verbrugghe M, Duprez V, Beeckman D, et al. Factors influencing adherence in cancer patients taking oral tyrosine kinase inhibitors: a qualitative study. 

7. George J, Phun YT, Bailey MJ, et al. Development and validation of the medication regimen complexity index. 

8. Lee C, Grigorian M, Nolan R, et al. A retrospective study of direct cost to patients associated with the use of oral oncology medications for the treatment of multiple myeloma. 

9. Esper P. Identifying Strategies to Optimize Care With Oral Cancer Therapy. Clinical journal of oncology nursing. 2013;17:629-36.

10. Bettencourt E. Oral chemotherapy—What Your Patients Need to Know. Association of Community Cancer Centers. 2014. 

https://www.accc-cancer.org/oncology_issues/articles/ND14/ND14-Oral-Chemotherapy-What-Your-Patients-Need-to-Know.pdf

11. Williams GR, Mackenzie A, Magnuson A, et al. Comorbidity in older adults with cancer. 

12. Given BA, Spoelstra SL, Grant M. The challenges of oral agents as antineoplastic treatments. 

Partner Perspectives

Open communication and reinforced education are the keys to success in helping patients to manage their oral oncolytic regimens.


Educating Patients About Oral Oncolytic Agents

The new standards from the US Pharmacopeoal (USP) Convention address the importance of informing healthcare workers (HCWs) about the adverse reproductive outcomes from exposure hazardous drugs (HDs).

 The standard appears in the USP Chapter <800> section on Hazard Communication and states that all personnel who are capable of reproduction must acknowledge in writing that they have received information and that they understand the risks associated with HD handling.

This is an important step forward in safety for HD handlers, which has implications for every organization where HDs are present, as implementation may require several changes in policy and practice.

Many drugs are hazardous to reproductive function in women, men, or both, affecting their ability to conceive and bear healthy children. Such effects may occur as a result of changes in ovarian function, sperm production, or hormonal changes. Some drugs have a direct effect on an embryo or fetus, such as antineoplastic agents that damage rapidly proliferating cells in the same way that they destroy cancer cells. Two criteria for drugs to be labeled as hazardous are teratogenicity (structural defects in a fetus) and reproductive toxicity.2 (

HDs are identified as reproductive toxins based on:

Animal or human studies during drug development (eg, Black Box Warnings in prescribing information)

Postmarketing reports of adverse outcomes (eg, thalidomide)

Evidence of reproductive harm from epidemiologic studies (eg, increased miscarriages in Nurses' Health Study II)

Infertility has occurred in patients treated with antineoplastic drugs and has also been reported in nurses from occupational HD exposure. In one study, exposed nurses took longer to conceive than nonexposed nurses.

 In others, infertility occurred up to 1.5 times more frequently in exposed nurses.

Few studies have had sufficient numbers of participants to clearly document birth defects in HD-exposed healthcare workers. One recent study, in which “exposure” was defined as chemotherapy handling, reported an increase in miscarriages, with higher occurrence in exposed nurses during their first pregnancy

The National Institute for Occupational Safety and Health (NIOSH) has compiled a list of drugs that should be handled as hazardous. The NIOSH list is divided into 3 separate tables: (1) Antineoplastic drugs; (2) Non-antineoplastic hazardous drugs; (3) Drugs with primarily reproductive effects. Drugs in table 3 need only be considered harmful “to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, and women who are breastfeeding.”

 Drugs in tables 1 and 2 may have adverse reproductive effects as well as being carcinogens, mutagens, and organ toxins.

HD safe handling precautions are necessary for all personnel because healthcare settings should be safe for everyone. The recommendations from the American Society of Health System Pharmacists, NIOSH, the Occupational Safety and Health Administration, the Oncology Nursing Society (ONS), and USP agree that the use of engineering controls, administrative controls, and personal protective equipment (PPE) will reduce exposure. Evidence suggests, however, that current work practices cannot completely eliminate exposure.

Known spills and environmental contamination are sources of exposure that workers cannot necessarily avoid if they are involved in HD preparation, administration, or handling of contaminated excreta, illustrating the need for other practices that provide additional protection for workers who are vulnerable to reproductive harm because of their life situation.

One recommendation for nurses or other HCWs who are actively trying to conceive, pregnant, or breastfeeding is to refrain from HD handling activities. This is referred to as alternative duty or temporary reassignment and is a “recognized risk management strategy.”

This involves identifying job tasks that do not include HD handling that the HCW can safely perform. In order for such a program to be implemented, all employees must be aware of the risks of exposure around pregnancy, the availability of alternative duty, and the process for requesting such duty.

Information about the risks of HD exposure must be provided as a part of a hazard communication program. Employees may not be aware of the need to avoid HD exposure around pregnancy and should be provided with specific information during initial education and training.

The USP standard for acknowledging receipt of information in writing is a good way to document the initial education. HCWs should be retrained about the risks in annual updates, since their life situation may have changed.

Organizations must develop a policy that addresses alternative duty. Current recommendations from ONS and the American Nurses Association support alternative duty that does include HD handling when an employee requests it.

 Policies should be written instead of implied, so that there is a formal mechanism to protect nurses when making patient care assignments.

The formal process should include who the employee should contact to request alternative duty and how that request is made. HCWs should notify their manager or supervisor when they want to refrain from handling HDs so that appropriate levels of staffing can be provided.

1. US Pharmacopeial Convention Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings. 

2. National Institute for Occupational Safety and Health. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. 

https://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf

3. Fransman W, Roeleveld N, Peelen S, et al., Nurses with dermal exposure to antineoplastic drugs: reproductive outcomes. 

4. Martin S. Chemotherapy handling and effects among nurses and their offspring (Abstract). 

5. Valanis B, Vollmer W, Labuhn K, Glass A, et al. Occupational exposure to antineoplastic agents and self-reported infertility among nurses and pharmacists. 

6. Lawson CC, Rocheleau CM, Whelan EA, et al. Occupational exposures among nurses and risk of spontaneous abortion. 

7. American Nurses Association. Reproductive Rights of Registered Nurses Handling Hazardous Drugs. 

http://www.nursingworld.org/MainMenuCategories/WorkplaceSafety/Healthy-Work-Environment/reproductive-rights-of-rns-handling-hazardous-drugs.pdf

8. Oncology Nursing Society. Ensuring healthcare worker safety when handling hazardous drugs. 

https://www.ons.org/advocacy-policy/positions/practice/hazardous-drugs

Nurses may not be aware of the reproductive risks of exposure to hazardous drugs, but the new USP Chapter  requires a formal notification process.


Hazardous Drugs and Reproductive Effects: Understanding the Risks

Years ago, I administered chemotherapy to a young patient who was convinced that drinking milk from a cow that had just given birth would boost his immune system. It seemed logical to him, since antibody levels in this milky fluid, called colostrum, are in fact higher than those found in regular cow’s milk.

Thus, when the FDA issued warning letters on April 25, 2017, I was not surprised to see colostrum capsules on the list of 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer.

It’s an interesting list, with several unproven (and potentially harmful) products falling into the vitamins and herbs category. Some have straightforward names, such as asparagus extract, garlic, and milk thistle. Others include scientific terms, presumably to make these products sound more legitimate (eg, liposomal curcumin, astragalus glycerite). A few have names that illustrate marketing to a vulnerable population at its best, such as the World’s Finest Vitamin C powder, Healthy Prostate & Ovary, and Super Liposomal Plus. There is also a "natural salve" on the list, labeled as a skin cancer treatment with the notation that it "gets the roots out."

These unproven products have been around for a long time, and people being treated for cancer learned about them primarily by word of mouth. Thanks to the Internet, these products became commercially available and were marketed and sold without FDA approval, most commonly on websites and social media platforms. It’s unknown just how many people purchased these unproven products, but it’s likely that enough did purchase them for these companies to stay in business and for additional companies to emerge.

Individuals seeking these products should of course consult with their healthcare providers prior to purchasing these unprovenproducts. However, I suspect that few do. It’s likely that some people being treated for cancer may believe that these products cannot be harmful, since they have names that often include words such as natural and organic. Thinking that "it can’t hurt" and may even help is an understandable thought process that people with cancer may have.

It is a violation of the Federal Food, Drug, and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate, or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. I’m hoping that the FDA follows through to ensure that the companies that were sent warning letters stop producing, marketing, and selling these products. However, as the FDA notes, companies marketing fraudulent products, primarily or exclusively online, attempt to subvert compliance and enforcement efforts by changing the names of their products, their companies, and/or their websites frequently.

So what happens next? Each of the companies on the FDA’s list has 15 working days from the date the letters were issued to respond with a compliance plan. The FDA has authority to take further action, including criminal prosecutions, product seizures, and injunctions. Companies that fail to come into compliance after receiving a warning letter can face criminal prosecution and court-ordered decrees that require them to recall products and get written permission from FDA before resuming operations. The violations identified in the warning letters, if not corrected, are punishable by up to 1 year in federal prison, 5 years’ probation, and a fine of either $100,000 or twice the gain from the offense.

The take-home message for healthcare providers is to ask about use of vitamins, herbs, and topical products when conducting new patient assessments and medication reconciliation. Although the FDA has requested media exposure regarding its list, healthcare providers on the frontline of care also can publicize the list by posting or distributing information about the 65 products deemed by the FDA to be unproven — and potentially harmful &mdash; cancer treatments.

US Food and Drug Administration (FDA). Illegally Sold Cancer Treatments. 

www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/ucm533465.htm

. Updated April 25, 2017. Accessed May 12, 2017.

Nurse's Notes

The Internet provides easy access to companies marketing products that claim to prevent, diagnose, treat, or cure cancer. Healthcare practitioners and patients need to be vigilant.


June 2017