In a retrospective cohort study, a higher incidence of venous thromboembolism (VTE) was observed in patients treated with cisplatin-based chemotherapy compared with other forms of chemotherapy.

Patients who had received chemotherapy between November 2010 and October 2012 were retrospectively identified from the registry at Aga Khan University Hospital in Karachi, Pakistan. This included 200 patients identified as the "exposed group" and 200 patients who had received 1 of approximately 12 non-cisplatin—based chemotherapy treatments, identified as the "nonexposed group." Patients were followed for development of VTE throughout the entire duration of therapy plus 1 month.

Overall, 31 patients in the exposed group and 11 patients in the nonexposed cohort experienced VTEs. The most common VTE event, the study notes, was deep vein thrombosis: 18 in the exposed group, 7 in the nonexposed group. Among those who experienced a VTE event, 4 patients in the exposed group died, while 1 patient in the nonexposed group died.

The crude relative risk of VTE in the exposed group was 2.8 times higher than in the non- exposed group. When the investigators adjusted for gender, ECOG status, granulocytecolony stimulating factor, presence of a central venous catheter, and Khorana risk score, the adjusted relative risk was 3.32 times higher in the exposed group than in the nonexposed group.

The study also considered the dose of cisplatin in the exposed group. Of the patients in this group, 31 VTE events occurred when the mean cumulative dose of cisplatin was 471 mg/m

. In the same group, VTE events did not occur when the mean cumulative dose of cisplatin was 322 mg/m

The study concludes that until focus is turned onto the discovery of newer and safer chemotherapeutic agents, prophylaxis against VTE with antiplatelets or anticoagulants should be given to patients receiving cisplatin-based chemotherapy.

Zahir MN, Shaikh Q, Shabbir-Moosajee M, Jabbar AA. Incidence of venous thromboembolism in cancer patients treated with cisplatin-based chemotherapy—a cohort study. BMC Cancer. 2017;17(1):57. doi: 10.1186/s12885-016-3032-4.

Articles

Adverse Events Report

Patients treated with cisplatin-based chemotherapy had a higher risk of venous thromboembolism.

Higher VTE Incidence With Cisplatin Chemotherapy

Last summer, the Center for Medicare & Medicaid Services unveiled a performance-based Oncology Care Model (OCM) and selected 190 practices across the country to participate in the ambitious 5-year pilot, which, if successful, could become a model for the delivery of cancer care in the future.

What does this innovative payment model portend for the oncology nurse? As the OCM pilot moves into its second year, Oncology Nursing News spoke with nurses who work at some of these OCM participating practices.

They see many benefits of the mod- el and agree that care coordination, facilitated by a navigator, stands at its core. In fact, communication and collaboration is 1 of the 4 major domains of the OCM, along with a focus on the patient and caregiver experience, clinical quality of care, and patient safety. These, of course, are principles oncology nursing professionals already embrace in the clinic every day.

A focus on patient safety underpins this month’s Fast Facts for the Frontline on preventing falls. As clinical nurse specialist Melissa Grier reminds us, an otherwise successful patient experience can be upended when a patient falls, and consciously working to prevent such events is the business of everyone on the inpatient floor.

May is Oncology Nursing Month, and again this year, we showcase an outstanding oncology nurse. As always, there are so many to choose from! In this issue, we spotlight Seattle Cancer Care Alliance’s Rosemary Ford, recently retired after 4 decades, most spent in oncology nursing. Ford worked alongside Nobel Prize—winning Donnell Thomas, MD, a trailblazer in the development of bone marrow transplant to treat blood cancers. Thomas described nurses as his “secret weapon,” and who could disagree with that?

Nurses may sometimes wonder when explaining anticancer therapies to patients and their caregivers, do they actually understand the instructions? Clinicians at the Smilow Cancer Hospital at Yale-New Haven took on this challenge and developed a competency assessment using live simulations of these interactions; the results are impressive.

Our editors were on hand to cover the 42nd Annual Oncology Nursing Society Congress held May 4-7 in Denver. We’ll have full coverage in our June issue and online at OncNursingNews.com.

In the meantime, and as always, thank you for reading.

From the Chairman

Coordination of care, facilitated by a navigator, is central to the Oncology Care Model.


A New Payment Model With a Focus on Patient Centered Care

Adverse reactions occurring at an overall incidence of <10% of patients receiv- ing palbociclib plus letrozole in Study 1 included alanine aminotransferase in- creased (9.9%), aspartate aminotransferase increased (9.7%), epistaxis (9.2%), lacrimation increased (5.6%), dry eye (4.1%), vision blurred (3.6%), and febrile neutropenia (2.5%).

Additional adverse reactions occurring at an overall incidence of less than 10.0% of patients receiving palbociclib plus fulvestrant in Study 2 included as- thenia (7.5%), aspartate aminotransferase increased (7.5%), dysgeusia (6.7%), epistaxis (6.7%), lacrimation increased (6.4%), dry skin (6.1%), alanine amino- transferase increased (5.8%), vision blurred (5.8%), dry eye (3.8%), and febrile neutropenia (0.9%).

Based on animal studies, IBRANCE can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a pregnancy test prior to starting treatment with IBRANCE.

Colitis and gastrointestinal perforation, including fatal outcomes, have been re- ported in patients taking MEKINIST as a single-agent and when administered with dabrafenib.

Across clinical trials of trametinib administered as a single agent (N = 329) and with dabrafenib (N = 559), colitis occurred in 0.6% of patients and gastrointesti- nal perforation occurred in 0.3% of patients.

​Monitor patients closely for colitis and gastrointestinal perforations.

Patients receiving trametinib are advised tocontact their healthcare provider immediately if they experience diarrhea, stomach or abdominal pain, fever, or nausea

A Pregnancy Safety Surveillance Study has been established to collect informa- tion about pregnancies in women who have received ipilimumab.

Healthcare providers are encouraged to enroll patients or have their patients en- roll directly by calling (844)-593-7869.

Lactation—it is not known whether ipilimumab is present in human milk.

Healthcare providers should review steps for appropriate administration of filgrastim-sndz with prefilled syringe with patients and caregivers, particularly if the entire prefilled dosage will not be used

Patients who self-administer prefilled syringes should receive instructions about the dangers of reusing needles and syringes, the importance of proper disposal, and importance of informing healthcare provider if difficulty occurs when mea- suring or administering partial contents of prefilled syringe.

Recent changes to FDA labels regarding adverse events.

May Adverse Events Report: FDA Labeling Changes

Napabucasin (BBI-608), the most advanced cancer stemness inhibitor in development, is being evaluated in combination with FOLFIRI chemotherapy in patients with previously treated metastatic colorectal cancer (mCRC) ub a karge phase III trial (NCT02753127) that aims to test a long-pursued theory about overcoming resistance to cytotoxic therapy.

Napabucasin is an orally administered small molecule that inhibits the phosphorylation of STAT3. Overactivated STAT3 may drive tumor development by helping to maintain the ability of cancer stem cells to renew and differentiate. Previous studies have shown positive results for napabucasin. In a phase Ib/II study, results confirmed that napabucasin can be safely combined with FOLFIRI, with or without bevacizumab, in patients with advanced CRC who have received an average of >2 prior lines of therapy. In a phase III study, napabucasin monotherapy improved overall survival (OS) versus placebo for patients with pretreated advanced CRC whose tumors tested positive for phosphorylated STAT3.

The international CanStem303C trial is seeking to randomize 1250 patients in a 1:1 ratio to twice-daily napabucasin (240 mg) plus FOLFIRI or to FOLFIRI alone. Bevacizumab can be added in both arms at the investigator’s discretion. The trial’s primary endpoint is an improvement in median OS. Secondary endpoints include OS in biomarker-positive patients, defined as positivity for expression of nuclear beta-catenin, another cancer stemness signaling protein, and/ or phosphorylated STAT3.

To date, the most common adverse event (AE) observed with napabucasin therapy has been diarrhea. “We recommend, in the protocol, very aggressive and preemptive management of diarrhea, so that when the patients start the drug, they have been supplied with antidiarrheal agents, and have been educated that they need to hydrate themselves,” explained lead investigator Axel Grothey, MD, a medical oncologist with Mayo Clinic in Rochester, Minnesota. The other main AE investigators expect to see is fatigue, which is linked to the diarrhea. Other AEs are mild and include nausea, anorexia, and loss of appetite, Grothey said, but there is little to no concern of major toxicity in terms of blood counts, fevers, or high risk of infections. “It gets confounded, of course, by the toxicity of the underlying chemotherapy, the FOLFIRI backbone. It’s something we’ll closely monitor.”

Patients with metastatic CRC and an ECOG status of 0 or 1 who have failed prior first-line combination therapy containing oxaliplatin and a fluoropyrimidine with or without bevacizumab are eligible for the trial. The trial is open to patients regardless of biomarker status. The CanStem303C trial is among nearly a dozen clinical trials testing napabucasin in a range of tumor types that drug developer Boston Biomedical, Inc, is sponsoring. Phase III studies are ongoing in gastric/gastroesophageal junction adenocarcinoma (NCT02178956), pancreatic cancer (NCT02993731), and non-squamous non—small cell lung cancer (NCT02826161).

Clinical Trials in Progress

An ongoing phase III trial is evaluating the combination of napabucasin, a stemness inhibitor, and FOLFIRI chemotherapy in patients with metastatic colorectal cancer.

Novel Drug Targets Cancer Stem Cell Pathway in Metastatic CRC Trial

Staging is considered the universal language that describes the extent to which a cancer has developed or spread. The TNM system, which assigns a letter and number to describe a Tumor, Nodal involvement, and presence or absence of Metastases, has been used for decades to stage the majority of cancer types. Although this system is primarily an anatomic approach, it is used throughout the world to guide cancer treatment and predict prognosis.

Technological advances in cancer detection and identification have made biologic markers, such as genomic profiles and molecular targets, increasingly important in the understanding of how different types of cancer present themselves and respond to treatment. These advances have spawned “prognostic staging,” which incorporates and supersedes anatomic staging. It is anticipated that starting next year, the prognostic stage of a cancer will be the primary stage that is recorded in cancer registries in the United States.

The forthcoming 8th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual (which will be effective for all cases diagnosed as of January 1, 2018, and onward) includes cancer staging changes that incorporate biologic information. For example, the prognostic staging of breast cancer will include TNM staging and grade along with HER2, estrogen receptor (ER), and progesterone receptor (PR) status.

When appropriate, it also will include genomic profiles, such as Oncotype DX and MammaPrint results. Information from multigene panels is incorporated for patients with T1-2N0M0, ER-positive, HER2-negative tumors.

With these 8 variables (tumor, nodal involvement, metastases, grade, ER, PR, HER-2, and multigene panel score), the complexity of staging has increased. The result is the creation of several hundred possible combinations of variables.

Other noteworthy changes include the elimination of lobular carcinoma in situ as a breast cancer diagnosis. It is estimated that with the new AJCC staging system there will be more cases of stage I disease diagnosed in the United States and fewer cases of stage IIA, IIB, and IIIA breast cancer.

All disease sites in the updated staging manual will incorporate nonanatomic prognostic factors when relevant and include prognostic risk-calculating models for cancers of the breast, colon, prostate, lung, and head and neck; melanoma; soft tissue sarcoma; and select hematolymphoid malignancies.

Oropharyngeal cancer staging systems will include human papillomavirus status; there is a separate staging system for patients receiving neoadjuvant therapy for various cancers, and the staging system for bone and soft tissue sarcomas is further delineated.

The updated AJCC staging system includes the anatomy- and histology-based original TNM staging system and uses the addition of various biomarkers to refine prognostic information. The ultimate goal is better treatment and improved treatment outcomes. For example, using the new staging system, it is now possible to identify women with invasive breast cancer with a prognosis so favorable that they may forgo systemic chemotherapy. This ability to predict benefit from or resistance to specific treatments is of major clinical relevance.

The new staging system creates a bridge between a population-based approach to cancer staging and a more personalized approach. The system will continue to be refined and updated as new information on the biology and genomics of different types of cancer emerges.

Giuliano AE, Connolly JL, Edge SB, et al. Breast cancer—major changes in the American Joint Committee on Cancer eighth edition cancer staging manual [published online ahead of print March 14, 2017]. CA Cancer J Clin. 2017. doi: 10.3322/caac.21393.s.

Nurse's Notes

Following on dramatic advances in the understanding of tumor biology, experts have revised the classification of cancers to emphasize prognostic staging.

Get Ready for Changes in Cancer Staging

In 2013, Yousuf Zafar, MD, and a colleague introduced the term "financial toxicity" in a 2-part article addressing the burdensome cost of cancer care. They discovered that for patients, even those with insurance, not only did chemotherapy have a physically toxic effect, but a financial one as well. An aging demographic, rising drug costs, higher insurance premiums, and skyrocketing deductibles were seen as largely to blame for dramatically increased out-of-pocket costs of care.

For many patients, the researchers found, the effects of financial toxicity were life changing— from canceling vacations to coming up with money for food and clothing. At the time, the medical community had no way to describe the impact this burden placed on patients. Zafar diagnosed the problem and gave it the name "financial toxicity" as a way to both identify and address it for what it truly was.

In an interview with Oncology Nursing News, Zafar discussed ways the OCM aims to reduce the cost of care and the opportunity that nurses have to impact patient outcomes while adapting to changes in practice resulting from the model. "Improving the patient experience, as the OCM intends to do," Zafar said, "can happen only when the cost of care is included as an integral part of cancer care moving forward."

For this to happen, he said, "the entire care team—particularly oncologists and nurses&mdash; plays a role...Among the providers patients prefer to talk to about their cost of care, the nurse ranks high, if not highest, on the list. If nurses are not asking patients about their ability to pay for treatment, then it is possible nobody else is either." Only after financial toxicity is recognized, can patients be linked with appropriate resources, such as financial assistance programs, drug coupons, and other options that exist. This is important, because even when patients receive value-based care, they still face high out-of-pocket costs. By linking value and quality with reimbursement, the OCM provides incentives to practices that focus on evidence-based care by reconsidering the use of high-cost, experimental drugs with uncertain or limited efficacy.

Although it is too early to tell how the OCM initiatives will impact the patient experience in the long-term, Zafar acknowledged that the goals of the model make sense, at least in theory: Attacking the problem of financial toxicity is a step in the right direction, and it begins by talking about it with as much concern and as routinely as the effects of cancer-killing drugs.

 Zafar SY, Abernethy AP. Financial toxicity, Part I: a new name for a growing problem. Oncology. 2013;27(2):80-81.

Cover Story

The Oncology Care Model (OCM) aims to reduce the cost of care and nurses can have an impact on patient outcomes while adapting to changes in practice resulting from the model.

Sticker Shock: How the OCM Hopes to Tackle Financial Toxicity

Last summer, nearly 200 oncology practices and 16 health insurance providers embarked on a collaborative new mission to transform the business of cancer care in the United States. Selected by the Centers for Medicare & Medicaid Services (CMS) to participate in a new Oncology Care Model (OCM), they will implement innovative methods of service delivery, care coordination, and financial accountability.

Simply stated, the model's goals are to improve quality and reduce cost. Achieving these goals, however, will require a commitment to, and compliance with, a complex process. The 5-year model is slated to run through June 2021, but its focus on providing accountable, patient-centered care is already a reality for nurses and other healthcare professionals practicing in oncology.

The OCM was released in February 2015 by the CMS Innovation Center to improve the access, appropriateness, and coordination of care for Medicare patients receiving chemotherapy through the alignment of financial incentives with practice. The 190 physician groups selected for inclusion were announced on June 29, 2016.

Dawn Hershman, MD, a medical oncologist and leader of the Breast Cancer Program at the Herbert Irving Comprehensive Cancer Center, Columbia University, explained some of the program essentials, including its 6 practice requirements in an interview with 

. For each 6-month episode of care, participating practices, which must be Medicare-enrolled and provide chemotherapy, will receive fee-for-services payments in addition to enhanced oncology services payments of $160 monthly.1 Episodes of care are triggered by initiation of chemotherapy and may be repeated as necessary throughout the program term. Performance-based payments will also be awarded according to quality improvement criteria and are intended to guide efficient, effective, and patient-centered collaborative practice.

24/7 patient access to qualified clinician

Comprehensive care planning incorporating the 13 components of the Institute of Medicine Care Management Plan

Treatment therapies compliant with nationally recognized guidelines

Use of certified electronic health record technology

Data-driven continuous quality improvement

OCM payment models are complicated and not the focus of this article, but it is important to note that financial incentives are not profit-enhancing; they are designed to reward practices that reduce the cost of care while maintaining and/or improving the quality of care delivered.

Participants in the model must demonstrate improvements and are required to report their efforts and results on a quarterly basis throughout the 5 years of the pilot performance reports to the practices outlining achievement measures according to benchmarking standards.

Hershman, although optimistic about the OCM, understands the challenges associated with providing high-value care: “Better quality does not always equate to lower cost.”

Practices may need to add members to the care team, such as patient/financial navigators, and IT and financial experts, thereby increasing existing costs, which may not be completely offset

by monthly service payments. Nonetheless, practices that, “significantly reduce per beneficiary total cost of care will see the largest rewards under the OCM.”

Although the OCM’s requirements are nonnegotiable, practices are encouraged to optimize the opportunity to receive performance-based incentives through innovation. The biggest

challenge may be meeting the requirements of the model without overspending.

Both oncology practice and payer interest in improving the efficiency and value of cancer care through this initiative surpassed expectations, according to the US Department of

Health and Human Services, which reported it received more than twice the expected number of practice applications. More than 3200 oncologists are now included in the project, covering

Program participants, including commercial payers, are listed on the OCM website.

 Practice participants range from solo oncologists to multiprovider systems located in rural, suburban, and urban settings throughout the United States. Annmarie Flannery, RN, the nurse manager of the OCM program at Montefiore Medical Center in New York City, said that the OCM “shines a spotlight on the notion of change and the importance of evolving the practice of care delivery.” Although practice at Montefiore was aligned with many OCM requirements prior to acceptance into the program, Flannery acknowledges that further improvements, such as adding OCM-specific social workers and enhanced IT data mining, will add to the center’s existing level of high-quality care.

Part of the performance-based payment methodology relates to quality, which in the OCM, focuses on 12 measures divided into 4 domains: (1) Communication and Care Coordination; (2)

Person- and Caregiver-Centered Experience and Outcomes; (3) Clinical Quality of Care, and (4) Patient Safety.

It is within these domains that oncology nurses do their best and most important work and where innovation finds opportunity.

Diane Baldwin, RN, of Mitchell Cancer Institute, and Anne Marie Rainey, RN, MSN, CHC, of Clearview Cancer Institute, whose centers are both located in Alabama, each have seen how

these measures promote high-value care. The communication/care coordination domain, for example, addresses unnecessary hospital and emergency department (ED) admissions. Baldwin

explained how preemptive interventions by oncology nurse clinical care coordinators make a difference and improve the patient experience.

“Prior to the OCM, we had lay navigators—specially trained individuals from various backgrounds, such as social work, education, or counseling&mdash;who helped patients with social support, advanced care directives, transportation, etc. Since then, we have added clinical care coordinators as part of a collaborative effort, and they manage the clinical aspect of care&mdash;managing symptoms, triaging patients at home, and arranging same day appointments for hydration or other needs.”

Rainey, who is an OCM project lead, concurs on the important role of care coordinators, but adds that meeting the requirements of the model can be challenging, due in part to added documentation. One positive outcome, said Rainey, pertains to screening for depression, which is 1 of the measures within the person/caregiver—centered experience and outcomes domain.

Prior to the OCM, depression screening happened, “most of the time,” but implementation of the model enhanced awareness. Now they make a concerted effort to routinely screen all

chemotherapy patients, even those who are not eligible for Medicare.

“We make sure we are addressing whatever nuances of their healthcare are important to them,” Rainey explained. Some clinical staff responded to the additional screening mandates by questioning the change. Explaining that not only is depression screening required, but also why—to provide better care&mdash;encouraged staff buy-in and helped them to fully engage with the work being done.

The remaining domains (clinical quality of care and patient safety) focus on appropriate chemotherapy regimens for various types and stages of prostate, colon, and breast cancer and

accurate documentation in the medical record of the patients’ current medications.

Baldwin and Rainey agree that although it is still too early in the model to determine how the cost-reduction aspect of the model will work in the long term, they do know that by reducing

unnecessary hospital and ED admissions with early and proactive intervention, they are able to rein in those costs and provide more effective care management for their patients.

Rainey also praises supportive efforts offered by OCM project leaders geared to help facilities as they progress through the model. Participating in focus groups and reviewing released case

studies have been very beneficial for providers in knowing what other practices have found works or does not work well. In this sense, collaboration is more than an OCM requirement; it

As the OCM pilot continues to evolve and practices find and share their successes, nonparticipating cancer centers, and the care community in general, can benefit from following

their journey, becoming familiar with the model’s key components, and scrutinizing their own delivery of services. Much remains to be learned and gained through creativity, collaboration, and commitment to excellence.  As Flannery stressed, “The Oncology Care Model gives us direction with our care and helps us focus on practicing our calling.” 

Center for Medicare & Medicaid Services. Oncology Care Model. Fact Sheet. go.cms.gov/29cD7az. Accessed April 26, 2017.

The Advisory Board Company. CMMI’s Oncology Care Model. Published June 20, 2016. bit.ly/2pmB8XH. Accessed April 26, 2017.

The ASCO Post. HHS Announces Physician Groups Selected For An Initiative Promoting Better Cancer Care. 2016. bit.ly/2p4KUgm. Accessed April 3, 2017.

Center for Medicare & Medicaid Services. Oncology Care Model. innovation.cms.gov/initiatives/Oncology-Care. Accessed April 26, 2017.

Center for Medicare & Medicaid Services. OCM Performance-Based Payment Methodology. innovation. cms.gov/Files/x/ocm-methodology.pdf. Published December

Institute of Medicine. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. bit.ly/2qfEPeT. Accessed April 26, 2017.

Nearly 200 practices across the United States are piloting an ambitious new mmodel that focuses squarely on delivering high-quality, lower-cost, patient-centered care.

Delivering Quality: What Nurses Can Learn From the Oncology Care Model

Lisa Barbarotta is an oncology patient education specialist.

At Smilow Cancer Hospital, a National Cancer Institute—designated comprehensive cancer center that includes a hospital and 10 community sites, the Oncology Practice and Education Department annually assesses the competency of all nurses who administer systemic cancer treatments. Competencies include order verification, safe handling, and managing emergencies. These assessments are done in a simulation center.

Historically, patient education has not been assessed as a mandatory competency. Clinical observations from educators noted variations in messages delivered and inadequate assessment of patient understanding. Effective communication, however, can impact patient outcomes, including adherence, resource utilization, and patient satisfaction. The patient perspective is critical in assessing these professional communication skills.

Our goal for 2016 was to engage patients and caregivers in competency assessments related to patient education through live simulation of patient education interactions with nurses. We also aimed to promote the utility of teach-back (a method used to confirm that a patient understands what is explained) in assessing comprehension.

Patient and family adviser participation was voluntary and recruited through our Oncology Patient and Family Advisory committee. Twelve advisers underwent a 2-hour training session to prepare them for the competency assessments. Standard adviser expectations and evaluation tools were developed and reviewed during training, and participants were instructed to respond naturally in the scenarios. Six primary domains were assessed: professionalism, assessment of baseline knowledge, organization of information, use of lay terminology, allowing time for questions, and use of teach-back.

Prior to the first day of assessments, the nurses were given an outline of what to expect, scenarios, and an article on the basics of patient education. A sample scenario was: “Today is cycle 1, day 1 of treatment with dose-dense Adriamycin and Cytoxan. Your patient just finished treatment, and you are reviewing the antiemetic schedule at home which includes dexamethasone 8 mg daily on days 2, 3, and 4. The prescription is written so that the patient will receive 24 tablets. Please review how to take these medications with your patient.”

Each nurse was asked to provide 5 minutes of focused patient education to an adviser based on 1 of the 4 scenarios while an educator evaluated from an observation room. Upon completion of the education, the adviser and the educator provided verbal and written feedback. If the nurse failed to assess the patient’s understanding using teach-back, this was role-modeled by the educator and reinforced in their evaluation.

More than 270 nurses were evaluated over 8 days, and the results were collated and analyzed. Adviser and educator evaluations of staff were resoundingly congruent. The majority of staff received high marks in the domains of professionalism, organization of information, and allowing time for questions. Two areas of improvement were identified: performing a baseline assessment of what a patient understands and teach-back when education is provided. Both nurses and advisers gave positive evaluations to the experience. Eighty-six percent of nurses strongly agreed that the simulation tested their knowledge and skills, and over 80% felt strongly that having an adviser was useful in helping them enhance their skills and improved the value of the learning experience.

Most advisers felt that by participating in this initiative, they were contributing positively to the development of oncology nurses. As 1 adviser commented, “This training is an invaluable tool for the nursing staff. Overall the nurses I encountered were well trained and very caring...This was a very enriching experience for me."

Patients and caregivers can provide important insight into the effectiveness of our communication. This exercise provided a unique opportunity for staff to receive direct feedback from patients and caregivers with specific recommendations for improvement. The strategy facilitated a thorough assessment of nurse competency in specific patient education domains, enabling us to target future staff education efforts based on common deficits that included lack of initial assessment of patient knowledge and a need to gauge patient understanding after receiving the focused education.

Additionally, the exercise provided the opportunity to identify inconsistencies in nursing practice and messaging across our network. For example, we identified variations in what body temperature readings patients were advised should trigger a call to their clinician. These differences were tracked over the 8 days of evaluations and will be used to guide future educational activities.

A combination of both professional and patient evaluation provides a comprehensive assessment of staff skill. The use of patient and family advisers to assess competency is feasible and viewed favorably by both nurses and advisers. In the future, this approach may be considered for other communication-based competencies.

Partner Perspectives

Effective communication can impact patient outcomes, and the patient perspective is critical in assessing these professional communicational skills.

Message Delivered? Assessing the Effectiveness of Patient Education Interactions

The use of chemotherapy and other hazardous drugs (HD) is increasing each year. With an estimated 1.68 million individuals in the US diagnosed with cancer in 2016,

 the number of patients who are likely to be treated with chemotherapy is quite high. Add the multiple uses of chemotherapy for nononcology indications and the over 100 nonantineoplastic HDs in common use, and HDs can be present anywhere in healthcare settings

Most oncology nurses are knowledgeable about exposure; however, results from a study of nurses’ use of safe handling precautions for HD handling found that 15% of those nurses did not know that HDs left behind on surfaces can be a source of exposure.

The routes of occupational exposure to HDs are absorption, inhalation, ingestion, and injection (Figure). Initially, inhalation was thought to be the main source of occupational exposure to HDs. Aerosols are generated when drugs are withdrawn from vials, which led to the use of biosafety cabinets (BSCs) in the 1980s. Dermal absorption is a common exposure route and is possible during any HD handling activity. The purpose of personal protective equipment (PPE) is to provide barrier protection from HDs.

Figure. Exposure to Hazardous Drugs in Occupational Settings

			Hand-to-mouth transfer from contaminated items/surfaces

			Release of drug vapor in the environment

Puncture injury with drug-contaminated needles or other sharps

 the presence of cyclophosphamide residue was first identified on surfaces in pharmacies and chemotherapy administration areas. The presence of environmental contamination was recognized as a source of exposure for healthcare workers who might absorb HD residue when touching workplace surfaces.

Residue can be transferred to other items and surfaces, resulting in exposure of individuals who are not personally involved in HD handling. In a recent study, researchers swabbed workers’ hands and found that a volunteer, oncologist, dietician, and aide who worked in a unit where chemotherapy is administered had exposure that was equal to that of the nurses who directly handled the drugs.

HD residue has been recovered from surfaces inside BSCs, floors in drug preparation, and administration areas, countertops, sinks, computer terminals, telephones, and elevator buttons. At least 15 studies have demonstrated HD residue on the external surfaces of drug vials when delivered from manufacturers. Handling vials without gloves is a source of skin exposure. If vials are not decontaminated before bringing them into the BSC, drug residue can be transferred to other surfaces.

BSCs capture HD aerosols, but do not prevent the generation of contamination. Drug droplets or aerosols produced during the compounding process can contaminate the outside of IV bags and syringes. Crushing tablets, opening capsules, and other drug manipulation outside of a controlled environment cause contamination of the environment with HD residue. PPE used for HD handling can be a vector for transferring drug residue to other surfaces.

Traditional needle-and-syringe techniques often result in leaking. IV tubing and connectors that are not closed systems can result in HD contamination of numerous surfaces in infusion centers, including IV pumps, IV poles, tables, infusion chair arms, and the floor. Small drops of HDs, if not identified and cleaned, are a source of exposure. Closed system transfer devices (CSTDs) are pieces of equipment that contain HDs when they are transferred from one container to another (eg, from vial to syringe or IV container). Ample evidence exists that CSTDs are effective in reducing environmental contamination.

Oncology nurses may consider their work environment free of HD contamination in the absence of a known spill. The evidence does not support that. In the last 24 years, over 100 studies have documented contamination of many surfaces with chemotherapy.

 The frequency and magnitude of contamination vary from one study to another; however, every published study to date has found HD surface contamination when testing for it.

Because surface contamination is invisible, laboratory testing is required to identify it. Documenting contamination, using surface wipe samples, is usually performed in the context of research, but can be an eye-opening exercise in clinical settings. The US Pharmacopeial Convention (USP) in its General Chapter <800>— Hazardous Drugs Handling in Healthcare Settings,

 recommends baseline and periodic sur- face wipe sampling for environmental contamination with HDs. Positive wipe samples not only identify areas of contamination, but also can be used to determine sources of exposure. Follow-up sampling can measure the effectiveness of practices aimed at decreasing contamination.

Some of the challenges related to implementing routine surface wipe sampling for evaluating environmental HD contamination include: limited laboratories that can perform the analysis; the high cost of the assays; the lack of standards for the level of contamination that might be considered “acceptable,” and the level of contamination that requires action. For these reasons, such monitoring is not yet considered routine.

Several strategies exist for reducing nurses’ risk of HD exposure:

Implement CSTDs for all HD administration

Check the security of all infusion equipment connections

Avoid crushing tablets and other manipulation of HDs outside of a containment device

Do not touch items with HD-contaminated gloves. Consider all used PPE contaminated and discard it

Protect surfaces where HD containers are placed with absorbent pads

Institute a thorough process for cleaning and decontamination of areas where HDs are handled

Environmental contamination with HDs is now considered the most likely source of HD exposure for healthcare workers. It is not necessary to wait for laboratory evidence of workplace contamination. The chances are high that HD residue exists wherever the drugs are present. It is time to address the problem of HD residue on work surfaces to minimize nurses’ exposure.

American Cancer Society. Cancer Facts & Figures 2016. 

https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2016.html

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

Polovich M, Clark PC. Factors influencing oncology nurses' use of hazardous drug safe-handling precautions. 

McDevitt JJ, Lees PS, McDiarmid MA. Exposure of hospital pharmacists and nurses to antineoplastic agents. 

Hon CY, Teschke K, Demers PA, Venners S. Antineoplastic drug contamination on the hands of employees working throughout the hospital medication system. 

Sessink PJ, Trahan J, Coyne CW. Reduction in surface contamination with cyclophosphamide in 30 US hospital pharmacies following implementation of a closed-system drug transfer device. 

Shult P. Reducing workplace cytotoxic surface contamination using a closed-system drug transfer device. 

Sessink PJ, Connor TH, Jorgenson JA, Tyler TG. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed-system drug transfer device. 

Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health. Occupational Exposure to Antineoplastic Agents and Other Hazardous Drugs: Recent Publications, Guidelines, Review Articles, and Surveys. 

https://www.cdc.gov/niosh/topics/antineoplastic/pubs.html

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

http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

Feature Story

The chances are high that hazardous drug residue exists wherever the drugs are present. What can nurses do to reduce their risks?


Eye-Opener: Understanding Invisible Hazardous Drug Exposure

Those of us who are klutzy realize that tripping, stumbling, and face-planting are part of everyday life. We pick ourselves up, dust off, and keep on moving. However, when our patient experience falls, they may not bounce back as quickly. Fractures, internal bleeding, and other injuries can add days or weeks to a hospitalization — not to mention the countless other negative implications associated with preventable falls. So, what can nurses do to help?

If you have worked in healthcare for any amount of time, you can probably talk about fall prevention in your sleep. But how often do we really talk to our patients about fall prevention? Is a pamphlet or a patient education leaflet the extent of what we provide? How can we make sure they get the message?

Making fall prevention part of your initial conversation with a patient and continuing to talk about it throughout treatment is the key. Although it may seem obvious that we need to prevent falls, it’s not high on the list of the things patients are worrying about. Tailor information about fall prevention to each patient's specific situation. Stress the importance of asking for help, especially when they’re in an unfamiliar setting (ie, in the hospital, connected to an IV pump or oxygen).

Encouraging your patients to call for help, however, means getting there quickly when they need you. A 5-minute wait while you finish adding a note to the chart may not seem like a long time to you, but it can seem like an eternity to your patient. Keep in mind that the same risk for falls (eg, pain, fatigue, dizziness, weakness) are the same things that make it difficult for them to sit on a toilet or commode for an extended period. If they’re kept waiting long enough, they’ll try to remedy the situation themselves, which is when a substantial number of falls with severe injury occur.

While we’re on the subject of toileting, let’s address the elephant in the room: protecting patient privacy. That’s what we think we’re doing when we leave a patient unattended for a few minutes while they use the restroom. The problem is, however, a few minutes can turn into 10 or 20. Patients may also experience an unforeseen complication that requires immediate attention. (Use your imagination. Anything that can happen will happen while your patient is on the toilet). If you're right there to address the situation, the likelihood of patient harm decreases significantly. Again, talk to your patient about why you're staying right there. Chances are they won't have a problem with your company. 

There’s nothing more frustrating than running your tail off to keep your patients safe and coming back for your next shift to find out that one of them fell. Fall prevention can’t be the responsibility of 5 or 6 people on a large team of healthcare providers. It must be a priority for every person on your unit—even those who aren’t responsible for direct patient care. Volunteers, unit secretaries, and other ancillary staff may not be trained to assist patients with ambulation, but they can help by retrieving a personal item that’s out of reach or by providing reassurance until trained staff arrives.

Each time you enter a patient’s room, take a moment to look around. What environmental hazards might place them at risk while you’re out of the room? Cords running across the floor, small spills, and trash that missed the wastebasket are just a few things that can be quickly corrected. If you work in a clinic or an infusion center, consider the layout of each patient care area. Is there enough room to navigate with a walker or an oxygen tank? Are chairs locked and tray tables out of the way? Be mindful about the minutiae; overlooking something small may have a tremendous impact on your patient’s well-being.

Fast Facts for the Frontline

Some cancer treatments, as well as aging, increase the risk of patient falls. Making these basic steps a routine part of patient care can go a long way in preventing this often life-limiting complication.


May 2017