TON July/August 2014

JULY/AUGUST 2014

www.TheOncologyNurse.com

Vol 7, No 4

The Whole Patient

Cancer Center Profile

Sequoia Regional Cancer Center

Fertility Preservation Options for Patients With Cancer Alice Goodman

O The staff at the Sequoia Regional Cancer Center (left to right): Sylvia Dominguez, Nurse Practitioner; Katrina Lomeli, RN; Delsie Grover-Denevi, Pharmacy Tech; Stephanie McCall, RN; Ellen Woods, RN; Anna Bernardo, RN; Senovia Banuelos, RN; Grace Pagh, RN; and Melissa Garcia, RN.

T

he Sequoia Regional Cancer Center is part of the Kaweah Delta Health Care District. Located in Visalia, in the heart of California’s San Joaquin Valley, the cancer center offers a multidisciplinary approach to cancer care with a team of specialists who collaborate on helping patients navigate their cancer journey through diagnosis, treatment, and recovery. The combined efforts of the multidisciplinary team allow for the treatment of cancer utilizing all oncology specialties, ensuring that the best care possible is available for each patient.

Continued on page 8

Oncology Pharmacy Safety

Chemotherapy: Current and Emerging Issues in Safe Handling of Antineoplastic and Other Hazardous Drugs Christine Roussel, PharmD, BCOP Clinical Pharmacy Manager, Doylestown Hospital Pharmacy Thomas H. Connor, PhD Research Biologist, National Institute for Occupational Safety and Health

T

he toxic effects and safe handling of hazardous drugs are issues of major concern to healthcare professionals. In previous articles, Roussel and Connor have covered the adverse health effects of hazardous drugs, contamination of the workplace, and biomarkers of effect and exposure.1-3 This article addresses

several emerging issues that healthcare providers will need to be aware of, including hazardous drug assessment, use of antineoplastic drugs in nononcology settings, oral chemotherapy, decontamination/cleaning, state legislative activities, and US Pharmacopeial Convention (USP) Chapter 800.4

f the 14 million cancer survivors in the United States, some have not yet had children but wish to plan a family, and some wish to have more children. Oncology nurses should be aware of the various options for fertility preservation prior to cancer treatment so that they can have discussions with their patients and refer them to fertility specialists when necessary.

“Oncology nurses can play a significant role in guiding patients interested in parenthood after cancer treatment. A

systematic approach can be helpful in communicating about fertility and family building,” stated Joanne Frankel Kelvin, RN, MSN, AOCN, clinical nurse specialist at Memorial Sloan Kettering Cancer Center in New York City. Kelvin spoke at the recent Oncology Nursing Society 39th Annual Congress.

Although clinicians recognize that discussions with cancer patients about fertility are important, there are many barriers, including lack of knowledge, time, and resources; concerns about the cost of ferContinued on page 11

Empowering Patients and Survivors

Survivor’s Guilt—Let Me Count the Ways Angela Long

“Guilt is to the spirit what pain is to the body.”

Edgar Bednar

W

hile there is growing attention paid to our experiences as cancer survivors, there is little acknowledgment of survivor’s guilt. It is neither well understood nor adequately discussed. Survivors who express feelings of guilt often find that our feelings are either minimized or dismissed. Well-

meaning listeners often counsel that we “shouldn’t feel that way,” a response that tells survivors we are better off keeping our feelings to ourselves.

Survivor guilt is very real, and, on closer analysis, we see that surviving cancer offers very fertile conditions for feelings of guilt. Survivor’s guilt is defined as deep guilt “experienced by those who have survived a catastrophe that took the lives of many Continued on page 9

inside Financial Issues. . . . . . . . . . . . . .

Financial Distress Unexpected by 40% of Cancer Patients

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Best Practices. . . . . . . . . . . . . . .

Caregivers Benefit From Immediate Versus Delayed Palliative Support

8

Nutrition in Focus . . . . . . . . .

Early Nutrition Intervention Improves Outcomes and Treatment Tolerance in Patients With Esophageal Cancer

Continued on page 14 ©2014 Green Hill Healthcare Communications, LLC

10

Genetic Counseling. . . . . . . .

What Is “Next-Gen?”

20

The Whole Patient. . . . . . . . .

Exercise for Cancer Survivors

23

VOTE NOW The 2014

ONE Award Make Your Choice at www.TheOncologyNurse.com/award See Our 4 Finalists on Pages 18 and 19

Now enrolling: MURANO study Investigating the Selective BCL-2 Inhibitor GDC-0199/ABT-199 in Chronic Lymphocytic Leukemia GDC-0199/ABT-199 is an investigational agent that has not been approved by regulatory agencies.

A Phase III Study of GDC-0199/ABT-199 Plus Rituximab Compared With Bendamustine Plus Rituximab in Patients With Relapsed or Resistant Chronic Lymphocytic Leukemia (CLL)

GDC-0199/ABT-199 + rituximab

Phase III Relapsed or resistant CLL (N=370)

GDC-0199/ABT-199 continued for 2 years or until disease progression

Bendamustine + rituximab Randomize Primary Endpoint

Secondary Endpoints

• Investigator-assessed progression-free survival, defined as time from randomization until disease progression or death from any cause

• Overall response rate • Incidence of adverse events

Key Inclusion Criteria

Key Exclusion Criteria

• Adult patients ≥18 years of age • Diagnosis of CLL per diagnostic criteria and relapsed or refractory CLL per the iwCLL guidelines • Previously treated with 1-3 lines of therapy (eg, completed ≥2 treatment cycles per therapy), including ≥1 standard chemotherapy-containing regimen • Previously treated with bendamustine, only if duration of response was ≥24 months • ECOG performance status of 0-1 • Adequate bone marrow function • Adequate renal and hepatic function

• Transformation of CLL to aggressive non-Hodgkin lymphoma or CNS involvement by CLL • Undergone an allogenic stem-cell transplant • A history of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease • Hepatitis B, hepatitis C, or known HIV-positive • Receiving warfarin treatment • Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of study drug • Received any anticancer or investigational therapy within 14 days prior to the first dose of study drug or has not recovered from previous therapy • Received CYP3A4 inhibitors (such as fluconazole, ketoconazole and clarithromycin) or inducers (such as rifampin, carbamezapine, phenytoin, St John’s Wort) within 7 days prior to the first dose of GDC-0199/ABT-199 • Prior GDC-0199/ABT-199 treatment

To learn more about this study, please visit www.ClinicalTrials.gov (NCT02005471, GO28667) or call the Trial Information Support Line at 1-888-662-6728.

GDC-0199/ABT-199 is being codeveloped by AbbVie and Genentech, a member of the Roche Group.

© 2014 Genentech USA, Inc. All rights reserved. BIO0002506000 Printed in USA.

Reference: ClinicalTrials.gov, as of 5/2014.

A2396579

Editorial Board EDITOR-IN-CHIEF

Beth Faiman,

PhD(c), MSN, APRNBC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Catherine Bishop, DNP, NP, AOCNP

Shannon Hazen,

Melinda Oberleitner, RN,

Karla Wilson,

College of Nursing and Allied Health Professions University of Louisiana Lafayette, LA

City of Hope National Medical Center Duarte, CA

Patricia Irouer Hughes, RN, MSN,

Jayshree Shah, RN, APN-C, AOCNP, MSN, BSN, BS

Pharmacy John F. Aforismo, RJ Health Systems International, LLC Wethersfield, CT

RN, BSN, OCN Novant Health Presbyterian Cancer Center Charlotte, NC

DNS, APRN, CNS

Johns Hopkins Kimmel Cancer Center/Sibley Infusion Washington, DC

BSN, OCN

Piedmont Healthcare Rex, GA

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Deena Damsky Dell, MSN, RN-BC,

Taline Khoukaz,

Gary Shelton,

NP, MSN, ACNP-C

Fox Chase Cancer Center Philadelphia, PA

University of Southern California Norris Cancer Center & Hospital Los Angeles, CA

Wendy DiSalvo,

Sandra E. Kurtin,

AOCN, LNC

DNP, APRN, AOCN Genentech New London, NH

Denice Economou,

RN, MN, CNS, AOCN City of Hope National Medical Center Duarte, CA

RN, MS, AOCN, ANP-C

MSN, NP, ANP-BC, AOCNP NYU Clinical Cancer Center New York, NY

Lori Stover, RN, BSN

Arizona Cancer Center Tucson, AZ

Western Pennsylvania Cancer Institute Pittsburgh, PA

Ann McNeill,

Joseph D. Tariman,

MSN, RN, NP-C, OCN John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

PhD, ANP-BC DePaul University Chicago, IL

Kena C. Miller,

Jacqueline Marie Toia, RN, MS,

The CHE Consulting Group, Inc. Mt. Kisco, NY

Millennium Pharmaceuticals, Inc Boston, MA

Northwestern University Myeloma Program Chicago, IL

Amy Ford, RN,

Patricia Molinelli,

Pamela Hallquist Viale, RN, MS,

MS, CNS, OCN

BSN, OCN Biodesix, Inc. Dallas, TX

MS, RN, APN-C, AOCNS

Somerset Medical Center Somerville, NJ

BSc Pharm, RPh, FASCP

Nutrition Karen Connelly, RD, CSO

Somerset Medical Center Somerville, NJ

Patient Advocacy Peg Ford

Ovarian Cancer Alliance San Diego, CA

Social Work Carolyn Messner, DSW, MSW, LCSW-R, BCD CancerCare New York, NY

Constance Engelking, RN,

RN, MSN, ARNP-BC

RN, MSN, FNP-C, CPON

DNP

CS, ANP, AOCN Saratoga, CA

Genetic Counseling Cristi Radford, MS, CGC Invitae Atlanta, GA

Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS

Onco360/OncoMed New York, NY

Sharon S. Gentry, RN, MSN, AOCN, CBCN

Ellen A. Neylon, MSN, FNP-BC, CCRP, OCN

Novant Health Derrick L. Davis Cancer Center Winston-Salem, NC

Columbia University Medical Center Center for Lymphoid Malignancies New York, NY

Cassandra J. Hammond, RN,

Dolores “Jeff” Nordquist, RN, MS,

Avid Education Partners, LLC Sharpsburg, MD

Mayo Clinic Rochester, MN

MSN, CRNP

www.TheOncologyNurse.com

CS, FNP

Connie Visovsky,

PhD, RN, ACNP-BC University of South Florida College of Nursing Tampa, FL

Rita Wickham,

PhD, RN, AOCN Northern Michigan University Independent Oncology & Palliative Care Consultant Marquette, MI

Isabell Castellano, RN

Bristol-Myers Squibb Children’s Hospital Robert Wood Johnson University Hospital New Brunswick, NJ

Jeanne Westphal, RN

Meeker County Memorial Hospital Litchfield, MN

July/August 2014 I VOL 7, NO 4

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From The Editor PUBLISHING STAFF Senior Vice President, Sales & Marketing Philip Pawelko ppawelko@the-lynx-group.com Group Director, Sales & Marketing

John W. Hennessy jhennessy2@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Publisher Russell Hennessy rhennessy@the-lynx-group.com Editorial Director Kristin Siyahian ksiyahian@the-lynx-group.com Managing Editor Kristen Olafson kolafson@the-lynx-group.com Copy Editors Mollie Friedman Peggy Roeske Editorial Assistant Jennifer Brandt Production Manager Cara Nicolini

The Lynx Group

I

n this month’s issue of The Oncology Nurse-APN/PA (TON), we continue our coverage of the news from the recent Oncology Nursing Society (ONS) 39th Annual Congress and the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO). Unsurprisingly, both conferences presented invaluable information to oncology professionals.

Beth Faiman, PhD(c), At ONS, Joanne Frankel MSN, APRN-BC, AOCN Editor-in-Chief Kelvin, RN, MSN, AOCN, a clinical nurse specialist at Memorial Sloan Kettering Cancer Center, discussed fertility preservation options for both male and female patients with cancer. Some of the 14 million cancer survivors in the United States may wish to plan a family or have more children—these people need to know what options may be available to them prior to starting treatment for cancer. Joanne hopes that the information she presented at ONS inspires nurses to address fertility issues with patients. Fertility preservation is the

Reader Poll

President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz

Do you talk to your patients about options for fertility preservation? o Yes o No

Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Manager Jini Gopalaswamy Project Coordinators Mike Kodada Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Administrative Coordinator Stephanie Ramadan Office Coordinator Robert Sorensen

Green Hill Healthcare Communications, LLC 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-656-7935 • fax: 732-656-7938

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July/August 2014 I VOL 7, NO 4

topic of this month’s reader poll. Please read the article about Joanne’s ONS presentation and then go to www.

TheOncologyNurse.com to participate in the poll and tell us how you discuss fertility preservation options with your patients.

Our continuing ASCO coverage includes information about the financial distress that many patients with cancer experience. As oncology professionals, we all know how much financial issues can affect our patients.

Researchers who conducted a study of 300 patients at Duke University noted that financial distress related to cancer care often has many consequences, which can range from nonadherence to treatment to bankruptcy. The researchers next plan to examine possible risk factors for financial distress and how to monitor for these factors.

Stay tuned for more news from ONS and ASCO, along with other information important to your daily practice. In the meantime, please visit our website, www.TheOncologyNurse.com. Be sure to tell us what topics you want to see covered in TON. Let us know if you would be interested in writing an article for TON. We want to hear from you, and we appreciate your feedback—positive and negative—about what you see in print and on the website. l

©iStockphoto.com/ValuaVitaly

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t the recent Oncology Nursing Society 39th Annual Congress, Joanne Frankel Kelvin, RN, MSN, AOCN, noted that “Oncology nurses can play a significant role in guiding patients interested in parenthood after cancer treatment.”

Do patients ask you about fertility issues? Do you talk to your patients about the various options for fertility preservation prior to cancer treatment?

Why or why not? If you do, how do you approach the topic?

Go to www.TheOncologyNurse.com to answer the question and add your comments.

The Oncology Nurse-APN/PA®, ISSN 1944-9798 (print); ISSN 1944-9801 (online) is published 6 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2014 by Green Hill Health­care Com­munications, LLC. All rights reserved. The Oncology Nurse-APN/PA® logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, The Oncology Nurse-APN/PA®, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: editorial@greenhillhc.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues, $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in The Oncology Nurse-APN/PA® do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mentioned in The Oncology Nurse-APN/PA® should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications.

It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director.

www.TheOncologyNurse.com

Established treatment, demonstrated results Single-agent TREANDA® (bendamustine HCl) for Injection provided durable responses that lasted a median of 9 months

Median DR

9.2 months (95% CI: 7.1, 10.8)

All responders (n=74) Patients who achieved a CR/CRu

10.4 months (95% CI: 9.3, 13.6)

1

8.3 months (95% CI: 6.3, 10.8)

Patients who achieved a PR

1

0

2

4

6

Months

8

10

12

The efficacy of TREANDA was evaluated in a single-arm study of 100 patients with indolent B-cell NHL that had progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

TREANDA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Important Safety Information Contraindication: TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.

Myelosuppression: TREANDA caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppressionrelated adverse reactions. If myelosuppression occurs, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.

Infections: Infection, including pneumonia, sepsis, septic shock, and death have occurred. Patients with myelosuppression following treatment with TREANDA are more susceptible to infections.

Anaphylaxis and Infusion Reactions: Infusion reactions to TREANDA have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.

Tumor Lysis Syndrome: Tumor lysis syndrome associated with TREANDA treatment has occurred. The onset tends to be within the first treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. There may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly.

Skin Reactions: Skin reactions have been reported with TREANDA treatment and include rash, toxic skin reactions, and bullous exanthema. In a study of TREANDA (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab. Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue TREANDA. Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with TREANDA therapy has not been determined.

Extravasation Injury: TREANDA extravasations have been reported in postmarketing resulting in hospitalizations from erythema, marked swelling, and pain. Ensure good venous access prior to starting TREANDA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of TREANDA. Embryo-fetal Toxicity: TREANDA can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using TREANDA. Most Common Adverse Reactions: The most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis. The most common hematologic abnormalities (frequency ≥ 15%) are lymphopenia, leukopenia, anemia, neutropenia, and thrombocytopenia.

Please see accompanying brief summary of Full Prescribing Information on following pages.

Learn more at TREANDAHCP.com.

Reference: 1. Data on file. Teva Pharmaceuticals. ©2013 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. TRE-40313 December 2013.

www.TheOncologyNurse.com

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Financial Issues

Financial Distress Unexpected by 40% of Cancer Patients Caroline Helwick

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early 40% of cancer patients experienced a higher financial burden than they expected, but the duration of their chemotherapy did not correlate with financial distress, according to a Duke University study

of 300 patients with cancer. The study results were presented at the American Society of Clinical Oncology 2014 annual meeting.

There was no evidence of a correlation between subjective financial distress

and the amount of time that a patient received treatment (P = .8931), according to Lena Van Nimwegen, a third-year medical student at Duke. The senior author was S. Yousuf Zafar, MD, MHS. Van Nimwegen noted that while

Brief Summary of Prescribing Information for Indolent B-cell Non-Hodgkin’s Lymphoma That Has Progressed 1 INDICATIONS AND USAGE TREANDA® is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

2 DOSAGE AND ADMINISTRATION 2.2 Dosing Instructions for NHL Recommended Dosage: The recommended dose is 120 mg/m2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.

Dose Delays, Dose Modifications and Reinitiation of Therapy for NHL: TREANDA administration should be delayed in the event of a Grade 4 hematologic toxicity or clinically significant ≥ Grade 2 non-hematologic toxicity.

Once non-hematologic toxicity has recovered to ≤ Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 109/L, platelets ≥ 75 x 109/L], TREANDA can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted. [See Warnings and Precautions (5.1)] Dose modifications for hematologic toxicity: for Grade 4 toxicity, reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle; if Grade 4 toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.

Dose modifications for non-hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.

2.3 Reconstitution/Preparation for Intravenous Administration Aseptically reconstitute each TREANDA vial as follows: • 25 mg TREANDA vial: Add 5 mL of only Sterile Water for Injection, USP. • 100 mg TREANDA vial: Add 20 mL of only Sterile Water for Injection, USP. Shake well to yield a clear, colorless to a pale yellow solution with a bendamustine HCl concentration of 5 mg/mL. The lyophilized powder should completely dissolve in 5 minutes. If particulate matter is observed, the reconstituted product should not be used. Aseptically withdraw the volume needed for the required dose (based on 5 mg/mL concentration) and immediately transfer to a 500 mL infusion bag of 0.9% Sodium Chloride Injection, USP (normal saline). As an alternative to 0.9% Sodium Chloride Injection, USP (normal saline), a 500 mL infusion bag of 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, may be considered. The resulting final concentration of bendamustine HCl in the infusion bag should be within 0.2–0.6 mg/mL. The reconstituted solution must be transferred to the infusion bag within 30 minutes of reconstitution.

After transferring, thoroughly mix the contents of the infusion bag. The admixture should be a clear and colorless to slightly yellow solution. Use Sterile Water for Injection, USP, for reconstitution and then either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, for dilution, as outlined above. No other diluents have been shown to be compatible. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any unused solution should be discarded according to institutional procedures for antineoplastics.

2.4 Admixture Stability TREANDA contains no antimicrobial preservative. The admixture should be prepared as close as possible to the time of patient administration. Once diluted with either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, the final admixture is stable for 24 hours when stored refrigerated (2-8°C or 36-47°F) or for 3 hours when stored at room temperature (15-30°C or 59-86°F) and room light.

Administration of TREANDA must be completed within this period.

3 DOSAGE FORMS AND STRENGTHS TREANDA for Injection single-use vial containing either 25 mg or 100 mg of bendamustine HCl as white to off-white lyophilized powder.

4 CONTRAINDICATIONS TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. [See Warnings and Precautions (5.3)] 5 WARNINGS AND PRECAUTIONS 5.1 Myelosuppression TREANDA caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies (see Table 2). Three patients (2%) died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with Grade 3 thrombocytopenia, and pneumonia from an opportunistic infection (CMV). In the event of treatmentrelated myelosuppression, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. In the clinical trials, blood counts were monitored every week initially. Hematologic nadirs were observed predominantly in the third week of therapy. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle. Prior to the initiation of the next cycle of therapy, the ANC should be ≥ 1 x 109/L and the platelet count should be ≥ 75 x 109/L. [See Dosage and Administration (2.2)]

727-38225

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July/August 2014 I VOL 7, NO 4

PI-Pg1

DIGITAL

objective financial burden is known to correlate with treatment course, less is known about whether patients’ subjective reports of financial distress follow similar trends during the course of treatment.

“Finding a trend in patients’ financial

5.2 Infections Infection, including pneumonia, sepsis, septic shock, and death have occurred in adult and pediatric patients in clinical trials and in postmarketing reports.

Patients with myelosuppression following treatment with TREANDA are more susceptible to infections. Advise patients with myelosuppression following TREANDA treatment to contact a physician if they have symptoms or signs of infection.

5.3 Anaphylaxis and Infusion Reactions Infusion reactions to TREANDA have occurred commonly in clinical trials.

Symptoms include fever, chills, pruritus and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Patients who experience Grade 3 or worse allergic-type reactions should not be rechallenged. Consider measures to prevent severe reactions, including antihistamines, antipyretics and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions. Discontinue TREANDA for patients with Grade 4 infusion reactions. Consider discontinuation for Grade 3 infusion reactions as clinically appropriate considering individual benefits, risks, and supportive care.

5.4 Tumor Lysis Syndrome Tumor lysis syndrome associated with TREANDA treatment has occurred in patients in clinical trials and in postmarketing reports. The onset tends to be within the first treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. Allopurinol has also been used during the beginning of TREANDA therapy. However, there may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly [see Warnings and Precautions (5.5)].

5.5 Skin Reactions Skin reactions have been reported with TREANDA treatment in clinical trials and postmarketing safety reports, including rash, toxic skin reactions and bullous exanthema. Some events occurred when TREANDA was given in combination with other anticancer agents. In a study of TREANDA (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab (see rituximab package insert). Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. The relationship to TREANDA cannot be determined. Where skin reactions occur, they may be progressive and increase in severity with further treatment.

Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue TREANDA. 5.6 Other Malignancies There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia and bronchial carcinoma. The association with TREANDA therapy has not been determined.

5.7 Extravasation Injury TREANDA extravasations have been reported in postmarketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting TREANDA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of TREANDA. 5.8 Embryo-fetal toxicity TREANDA can cause fetal harm when administered to a pregnant woman.

Single intraperitoneal doses of bendamustine in mice and rats administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations, and decreased fetal body weights.

6 ADVERSE REACTIONS The following serious adverse reactions have been associated with TREANDA in clinical trials and are discussed in greater detail in other sections [See Warnings and Precautions] of the label: Myelosuppression (5.1); Infections (5.2); Infusion Reactions and Anaphylaxis (5.3); Tumor Lysis Syndrome (5.4); Skin Reactions (5.5); Other Malignancies (5.6). The data described below reflect exposure to TREANDA in 176 patients who participated in two singlearm trials for the treatment of indolent B-cell NHL. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

6.2 Clinical Trials Experience in NHL The data described below reflect exposure to TREANDA in 176 patients with indolent B-cell NHL treated in two single-arm studies. The population was 31-84 years of age, 60% male, and 40% female. The race distribution was 89% White, 7% Black, 3% Hispanic, 1% other, and <1% Asian. These patients received TREANDA at a dose of 120 mg/m2 intravenously on Days 1 and 2 for up to eight 21-day cycles. The adverse reactions occurring in at least 5% of the NHL patients, regardless of severity, are shown in Table 1. The most common non-hematologic adverse reactions (≥ 30%) were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%) and pyrexia (34%). The most common non-hematologic Grade 3 or 4 adverse reactions (≥ 5%) were fatigue

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Financial Issues

distress could help providers implement timely interventions to provide aid and relieve distress,” Van Nimwegen said.

Financial distress related to cancer care often has far-ranging consequences, including nonadherence to treatment,

use of savings to pay for care, bankruptcy, and decreased spending on food, clothing, and leisure activities, she noted.

Cross-sectional Study of 300 Adults Van Nimwegen led a cross-sectional study

(11%), febrile neutropenia (6%), and pneumonia, hypokalemia and dehydration, each reported in 5% of patients.

Table 1: Non-Hematologic Adverse Reactions Occurring in at Least 5% of NHL Patients Treated with TREANDA by System Organ Class and Preferred Term (N=176) Number (%) of patients* System organ class Preferred term All Grades Grade 3/4 Total number of patients with at least 1 adverse reaction 176 (100) 94 (53) Cardiac disorders 0 Tachycardia 13 (7) Gastrointestinal disorders 7 (4) Nausea 132 (75) 5 (3) Vomiting 71 (40) 6 (3) Diarrhea 65 (37) 1 (<1) Constipation 51 (29) 1 (<1) Stomatitis 27 (15) 2 (1) Abdominal pain 22 (13) 0 Dyspepsia 20 (11) 0 Gastroesophageal reflux disease 18 (10) 1 (<1) Dry mouth 15 (9) 0 Abdominal pain upper 8 (5) 0 Abdominal distension 8 (5) General disorders and administration site conditions 19 (11) Fatigue 101 (57) 3 (2) Pyrexia 59 (34) 0 Chills 24 (14) 1 (<1) Edema peripheral 23 (13) 4 (2) Asthenia 19 (11) 1 (<1) Chest pain 11 (6) 0 Infusion site pain 11 (6) 0 Pain 10 (6) 0 Catheter site pain 8 (5) Infections and infestations 5 (3) Herpes zoster 18 (10) 0 Upper respiratory tract infection 18 (10) 4 (2) Urinary tract infection 17 (10) 0 Sinusitis 15 (9) 9 (5) Pneumonia 14 (8) 11 (6) Febrile neutropenia 11 (6) 2 (1) Oral candidiasis 11 (6) 0 Nasopharyngitis 11 (6) Investigations 3 (2) Weight decreased 31 (18) Metabolism and nutrition disorders 3 (2) Anorexia 40 (23) 8 (5) Dehydration 24 (14) 1 (<1) Decreased appetite 22 (13) 9 (5) Hypokalemia 15 (9) Musculoskeletal and connective tissue disorders 5 (3) Back pain 25 (14) 0 Arthralgia 11 (6) 2 (1) Pain in extremity 8 (5) 0 Bone pain 8 (5) Nervous system disorders 0 Headache 36 (21) 0 Dizziness 25 (14) 0 Dysgeusia 13 (7) Psychiatric disorders 0 Insomnia 23 (13) 1 (<1) Anxiety 14 (8) 0 Depression 10 (6) Respiratory, thoracic and mediastinal disorders Cough 1 (<1) 38 (22) Dyspnea 3 (2) 28 (16) Pharyngolaryngeal pain 1 (<1) 14 (8) Wheezing 0 8 (5) Nasal congestion 0 8 (5) Skin and subcutaneous tissue disorders Rash 1 (<1) 28 (16) Pruritus 0 11 (6) Dry skin 0 9 (5) Night sweats 0 9 (5) Hyperhidrosis 0 8 (5) Vascular disorders Hypotension 2 (1) 10 (6) *Patients may have reported more than 1 adverse reaction.

NOTE: Patients counted only once in each preferred term category and once in each system organ class category.

of insured adults with solid tumors receiving treatment for at least 1 month. Using a validated measure of financial distress, the researchers surveyed 300 patients, mostly with incurable disease, at a referral center and 3 rural oncology clinics. They

Hematologic toxicities, based on laboratory values and CTC grade, in NHL patients treated in both single arm studies combined are described in Table 2.

Clinically important chemistry laboratory values that were new or worsened from baseline and occurred in >1% of patients at Grade 3 or 4, in NHL patients treated in both single arm studies combined were hyperglycemia (3%), elevated creatinine (2%), hyponatremia (2%), and hypocalcemia (2%).

Table 2: Incidence of Hematology Laboratory Abnormalities in Patients Who Received TREANDA in the NHL Studies Percent of patients Hematology variable All Grades Grades 3/4 Lymphocytes Decreased 99 94 Leukocytes Decreased 94 56 Hemoglobin Decreased 88 11 Neutrophils Decreased 86 60 Platelets Decreased 86 25 In both studies, serious adverse reactions, regardless of causality, were reported in 37% of patients receiving TREANDA. The most common serious adverse reactions occurring in ≥ 5% of patients were febrile neutropenia and pneumonia. Other important serious adverse reactions reported in clinical trials and/or postmarketing experience were acute renal failure, cardiac failure, hypersensitivity, skin reactions, pulmonary fibrosis, and myelodysplastic syndrome. Serious drug-related adverse reactions reported in clinical trials included myelosuppression, infection, pneumonia, tumor lysis syndrome, and infusion reactions [see Warnings and Precautions (5)]. Adverse reactions occurring less frequently but possibly related to TREANDA treatment were hemolysis, dysgeusia/taste disorder, atypical pneumonia, sepsis, herpes zoster, erythema, dermatitis, and skin necrosis.

6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of TREANDA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylaxis; and injection or infusion site reactions including phlebitis, pruritus, irritation, pain, and swelling; pneumocystis jiroveci pneumonia and pneumonitis. Skin reactions including SJS and TEN have occurred when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. [See Warnings and Precautions (5.5)] 10 OVERDOSAGE The intravenous LD50 of bendamustine HCl is 240 mg/m2 in the mouse and rat. Toxicities included sedation, tremor, ataxia, convulsions and respiratory distress. Across all clinical experience, the reported maximum single dose received was 280 mg/m2. Three of four patients treated at this dose showed ECG changes considered dose-limiting at 7 and 21 days post-dosing. These changes included QT prolongation (one patient), sinus tachycardia (one patient), ST and T wave deviations (two patients), and left anterior fascicular block (one patient). Cardiac enzymes and ejection fractions remained normal in all patients. No specific antidote for TREANDA overdose is known.

Management of overdosage should include general supportive measures, including monitoring of hematologic parameters and ECGs. 15 REFERENCES 1. OSHA Hazardous Drugs. OSHA. [Accessed on June 19, 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html] 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Safe Handling and Disposal As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of solutions prepared from TREANDA. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If a solution of TREANDA contacts the skin, wash the skin immediately and thoroughly with soap and water. If TREANDA contacts the mucous membranes, flush thoroughly with water. TREANDA is an antineoplastic product. Follow special handling and disposal procedures1.

16.2 How Supplied TREANDA (bendamustine hydrochloride) for Injection is supplied in individual cartons as follows: NDC 63459-390-08 TREANDA (bendamustine hydrochloride) for Injection, 25 mg in 8 mL amber single-use vial and NDC 63459-391-20 TREANDA (bendamustine hydrochloride) for Injection, 100 mg in 20 mL amber single-use vial.

16.3 Storage TREANDA may be stored up to 25°C (77°F) with excursions permitted up to 30°C (86°F) (see USP Controlled Room Temperature). Retain in original package until time of use to protect from light.

Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 TREANDA is a trademark of Cephalon, Inc. or its affiliates. ©2008-2013 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd or its affiliates. All rights reserved.

8/2013 (Label Code: 00016287.06) TRE-40155 This brief summary is based on TRE-008 TREANDA full Prescribing Information.

also asked about out-of-pocket expenses, and used disease and treatment information extracted from medical records.

Upon study enrollment, all patients (median age 60 years) were insured (though 40% were underinsured), and 97% had prescription drug coverage.

Median household income was $60,000 a year.

The patients’ time on treatment ranged from 1 month to more than 13 years. All participants were receiving chemotherapy or hormonal therapy at the time of the survey; 72% were on intravenous chemotherapy, 5% were on oral drugs, and 22% were on both.

Financial distress related to cancer care often has far-ranging consequences.

Most Patients Reported “Moderate” Financial Distress The patients’ median monthly out-ofpocket cost was $592 for a median time on treatment of 4.6 months. Their median financial distress score was 7.4 (out of 10), corresponding to moderate distress, she reported.

Almost 40% of patients reported experiencing a higher financial burden than they had expected, and 16% reported “high or overwhelming” financial distress.

In the multivariate analysis, the main predictor of experiencing high financial distress was early stage of disease (ie, potentially curable cancer), which carried an odds ratio (OR) of 2.56 (P = .02). Factors associated with not reporting financial distress included the following: • Increasing age: OR = 0.77 (P = .01) • Employed versus unemployed: OR = 0.36 (P = .03) • Married versus unmarried: OR = 0.23 (P = .01) • Prescription drug coverage: OR = 0.11 (P = .03) The research group’s next steps will be to further examine various risk factors for financial distress during treatment and to find a way to monitor this “to ensure timely intervention,” she said. l Reference

Van Nimwegen L, Rushing C, Ladd Chino F, et al.

Does cancer treatment-related financial distress worsen over time? Presented at: 50th Annual Meeting of the American Society of Clinical Oncology; May 30-June 3, 2014; Chicago, IL. Abstract 6559.

727-38225

PI-Pg2

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DIGITAL

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7

Cancer center profile

Sequoia Regional Cancer Center The Oncology Nurse-APN/PA spoke with Ellen Woods, BSN, PHN, RN, OCN, RN-BC, about her role as clinical educator for oncology at the Sequoia Regional Cancer Center. Although she is responsible for educating the staff of both the inpatient and outpatient facilities, the interview focused on her role in the outpatient setting.

Describe your role as clinical nurse educator in the outpatient clinic.

Ellen Woods (EW): I am responsible for coordinating education activities for all of the patient care staff at the cancer center.

I provide education support to 4 radiation oncology nurses, 10 medical oncology nurses who deliver chemotherapy, radiation therapists, and medical assistants who mix the chemotherapy, and office staff.

What are the biggest rewards of your job?

EW: My biggest reward is seeing the staff become independent and able to care for patients, becoming a resource for patients during this stressful time in their lives. I get great satisfaction watching them become competent and engage in this intimate relationship with patients.

Some patients live for many years, and

Continued from cover

the oncology nurse becomes like part of the family.

What are some of the challenges of your job?

EW: I work within a complex medical system. It can be difficult to know whom to talk to about certain issues. I find that bringing together all the stakeholders to discuss certain issues takes time, effort, and coordination, at the same time that I am doing my regular job as educator.

Ellen Woods, BSN, PHN, RN, OCN, RN-BC

Some issues we might need to discuss include new policies, changes in regulations, and providing education about errors that have occurred or can occur and how to avoid the same mistakes in the future.

What are you excited about right now in the field of oncology?

EW: The biotherapies, which are enabling patients to live longer. Over my 36-year career I have seen many changes. When I first started, children with leukemia had a 20% 5-year survival rate, and now more than 90% live 5 years or longer. I am excited about the Genome Project and the promise of making therapy unique for each patient’s cancer. Also, some of the biotherapies have had exciting results for off-label applications. For example, Herceptin— originally developed for HER2-positive breast cancer—may be effective in other solid tumors that express HER2, and that is now being studied.

Has the role of the oncology nurse changed over the past decade?

EW: Yes, it has changed a lot, mainly due to the complexity of cancer treatment.

Schedules are more complex with newer protocols. This is challenging. Learning

oncology-specific information takes a longer time than it used to. Oncology nurses have to make a greater investment in time and effort to learn new information and quickly adapt the concepts into their work flow. The only constant in healthcare is change, and cancer care is evolving daily.

What inspired you to be an oncology nurse?

EW: Cancer patients are the patients who need you the most. I wanted to be able to make an impact at this scary time of life. It is rewarding to gain patients’ trust and be able to help them.

What advice would you give to a nurse who wanted to become a certified oncology nurse?

EW: Be sure you have the heart for this job. It is a unique opportunity to make an impact on patients’ lives. You also need brain power. The learning never stops.

You have to acquire a lot of knowledge and at the same time know how to hold someone’s hand when they get bad news.

What would you do if you won the lottery?

EW: I would volunteer to work with cancer patients. l

Best Practices

Caregivers Benefit From Immediate Versus Delayed Palliative Support Alice Goodman

I

ntroducing palliative care services early for caregivers of patients with advanced cancer improves their ability to cope with the caregiving experience, according to results of a study presented at the American Society of Clinical Oncology (ASCO) 2014 annual meeting. The study, called Educate, Nurture, Advise, Before Life Ends (ENABLE) III, showed that a palliative care, phone-based support program designed for caregivers was able to reduce depression and stress, and improve quality of life for caregivers if given early rather than later. This is the first randomized trial to evaluate the optimal timing of palliative oncology care, said the authors.

“Unfortunately, the full range of palliative care services is rarely taken advantage of, because palliative care is often introduced too late in the course of cancer treatment. Patients and caregivers should understand that the palliative care is not end-of-life care, but

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Marie Bakitas, DNSc

Photo by © ASCO/Scott Morgan 2014.

rather an extra layer of support to be offered along with curative medical treatments,” said senior study author Marie Bakitas, DNSc, the Marie L. O’Koren Endowed Chair and Professor at the University of Alabama School of Nursing in Birmingham.

Family caregivers are a crucial part of the patient care team. The well-being of patients affects the well-being of care-

givers, and vice versa, she continued.

“Our study showed that when caregivers begin to receive palliative care support around the time of a diagnosis of advanced cancer, they experienced less depression, perceived themselves to be less burdened by performing caregiver tasks, and had better quality of life.”

The federally funded study enrolled 207 patients with recurrent or metastatic cancer and 122 family caregivers.

The patient and caregiver palliative care intervention was given in parallel and consisted of palliative care support via telephone. One group of patients and caregivers received the intervention within 2 weeks of diagnosis (immediate group) and the other started 12 weeks later (delayed group). The analysis Bakitas presented was confined to caregiver results.

Intervention Details After an in-person assessment, advanced practice palliative care nurses deliv-

ered a phone-based curriculum called Charting Your Course and provided monthly phone-based supportive care follow-up to both patients and caregivers. The Charting Your Course curriculum covers problem solving, using creativity, optimism, planning, and expert information; self-care, including diet, exercise, and relaxation; how to partner with patients in symptom management; building a support network; and decision making, decision support, and advanced care planning. The curriculum was developed for research purposes and is now publicly available.

Results showed that caregivers who got immediate palliative services intervention had significantly improved Caregiver Quality of Life Index-Cancer scores (mean decrease of 7.2 points, P = .02) and significantly less depression as measured by the Center for Epidemiologic Study-Depression Scale (mean decrease of 6.9 points, P = .006).

Continued on page 9

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Empowering Patients and Survivors

Survivor’s Guilt—Let Me Count the Ways others.” As a result, survivors may feel that we did not do enough to save the others. We may then feel unworthy relative to those who died. Although this is the dictionary version of survivor’s guilt, those of us who experience it know that survivor’s guilt manifests itself in various ways throughout our lives and journeys.

One of the biggest misconceptions is the spectrum of emotions that fit under the label of survivor’s guilt. Survivor’s guilt is often understood to be a very specific emotional response to the specific act of out-surviving others. In reality, cancer survivors experience guilt for reasons that extend far beyond simply surviving cancer when others have not. Cancer survivors can experience guilt in a variety of ways: Loss of a fellow cancer survivor is the most discussed type of survivor’s guilt we cancer survivors experience. Many of us eventually experience the loss of a friend or acquaintance who succumbs to the disease that we are surviving. My first experience with this was the loss of a friend and fellow mother with children the same age as mine and in class with my children. At the last stage of her life, I was there as she mustered up the energy to attend the class parties, field trips, and school activities.

Now as I attend our school functions, there is a constant pang in my heart that we refer to as guilt, knowing that she is not there to share in those moments with her children.

News of recurrence in a fellow survivor can create feelings of guilt for cancer survivors with NED (no evidence of disease).

Having a diagnosis at an earlier stage than our peers and not having to undergo as much treatment is a very common type of survivor’s guilt. This kind of guilt can deter early-stage survivors from seeking out support in groups. They may feel they do not have the “right” to “complain”

about their own situation since they have it “easier” than others.

Having an easier time with treatment or experiencing fewer side effects from treatment than our fellow survivors can also be a source of guilt for some, even with the same stage diagnosis as their peers. This can be especially difficult for those who have befriended another survivor during their treatment or are mentoring a survivor on their journey.

Passing on our genes to our children can be an extreme form of guilt for those of us who learn we have an inherited genetic mutation that may have led to our cancer.

Although knowledge is power, knowledge of a genetic mutation that raises the risk can cause stress for our family members and cause us to feel tremendous guilt.

Angela Long

Impacting the lives of others during treatment and thereafter is another form of guilt that can show up in many facets of a survivor’s life. Whether it is the burden of our care, missed time from work, or the financial strain that our cancer has caused on the family, it can all weigh heavily on a cancer survivor’s shoulders. Our personal changes can also have an impact on others—our change in attitude, our perspective, or even our sexuality can play an enormous role in our relationships.

After his battle with prostate cancer, Will

Continued from cover

Grant said, “My guilt comes in the form of my sexuality or better stated, in the loss of my sexuality as defined by our culture.

I felt I was no longer able to be the sexual partner my beloved wife and soul mate deserved.”

Not doing cancer “well” was a form of guilt I had not considered until attending a talk by psychotherapist Julie Larson, LCSW. Survivors who struggle to maintain a “positive” attitude or who aren’t handling their diagnosis the way they think they “should” may judge themselves harshly and experience guilt over what they perceive to be their failures.

Not being enough of a survivor may be a struggle for those who just want to get back to their own life. These survivors may be feeling pressure to wear their cancer ribbon, fundraise, advocate, and so on, when what they really want is to just put it all behind them.

Not having a life-changing experience relates to the 2 types of guilt discussed above. Survivors may experience guilt over not having a spiritual epiphany, or not feeling as if cancer was the best thing that ever happened because it “woke me up” to life. Survivors might feel guilty for not transforming into more health-minded, enlightened, cancer-fighting gurus.

Feeling a lifelong responsibility to be there for those who were there for them can be a daunting form of guilt for those who experience it. This is especially difficult as we learn about hardships our former supporters face. Tiffany Gould said she felt guilt when she learned that her friend had passed from cancer after 6 months in remission. “I cried for days because I felt so terrible that I had no idea she was fighting for her life again and I wasn’t there for her like she was for me. I felt like I should have somehow KNOWN and should have been there to DO something.”

Although I have listed several forms

of survivor’s guilt, these are just the most common. With such a broad spectrum of emotions categorized under the one label, Larson advises that redefining survivor’s guilt as specific emotions can help us to cope and more fully heal. Larson explains that survivor’s guilt can most often be decoded as empathy, sadness, anger, grief, anxiety, pressure, or posttraumatic stress disorder (PTSD), an anxiety disorder associated with serious traumatic events.

Our first step in addressing survivor’s guilt is to identify the emotion we are dealing with so that we can then take steps to process those feelings. The following are some self-care tips for addressing specific emotions associated with survivor’s guilt: Empathy as experienced by cancer survivors is a new and heightened sensitivity toward others and their struggles. As an advocate, I know how heavily empathy can weigh on us. We recognize and respond to another’s pain in relation to our own experience. As we empathize with another, we sometimes experience a confusion of emotions that span from sadness for another, to relief, gratitude, and hope for ourselves.

Sadness is an emotion that needs to be felt in order to release it. Find the people, places, and comforts that allow you to feel safe enough to feel your sadness. Larson highly recommends “shower therapy,” saying that many find the shower a safe and soothing place to release tears. It is equally important to identify thoughts or activities that help to pull you out of your sadness and to turn off your tears, such as doing tasks, listening to upbeat music, taking care of responsibilities, counting your blessings, and so on.

Anger is an energy that needs an action to be expressed. These actions can be done in private or just mentally. Try to identify people in your life that you can Continued on page 11

Best Practices

Caregivers Benefit…

Continued from page 8

“The key message here is that starting palliative care earlier achieved statistically better outcomes in quality of life, depression, and stress burden for caregivers.”

Marie Bakitas, DNSc

Those in the immediate group also experienced less caregiver burden as measured by the Montgomery Borgatta Caregiver

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Burden Scale, but this difference did not reach statistical significance. Betweengroup differences in caregiver experience

were maintained at 24 months.

Results on overall quality of life and caregiver burden also favored immediate palliative services.

“Subjective outcomes of caregivers were improved by doing the intervention immediately as opposed to waiting until 3 months after the diagnosis of advanced cancer. The key message here is that starting palliative care earlier achieved statistically better outcomes in quality of life, depression, and stress burden for caregivers,” Bakitas stated.

An online family care navigator tool is available on the website of the Family

Caregiver Alliance’s National Center on Caregiving.

At the ASCO annual meeting, patient outcomes from the ENABLE III study were presented separately and showed improved survival in patients who received immediate versus delayed palliative care services. l Reference

Dionne-Odom JN, Azuero A, Lyons K, et al. Benefits of immediate versus delayed palliative care to informal family caregivers of persons with advanced cancers: outcomes from the ENABLE III randomized clinical trial. Presented at: 50th Annual Meeting of the American Society of Clinical Oncology; May 30-June 3, 2014; Chicago, IL. Abstract LBA9513.

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nutrition in focus

Early Nutrition Intervention Improves Outcomes and Treatment Tolerance in Patients With Esophageal Cancer Abby C. Sauer, MPH, RD Abbott Nutrition

Abby C. Sauer, MPH, RD

P

atients with head and neck cancer, including esophageal cancer, are at high risk for nutritional issues, including difficulty eating, weight loss, and malnutrition. Often at diagnosis, patients with esophageal cancer experience dysphagia, or difficulty swallowing, and are subsequently malnourished.1 Treatment for esophageal cancer often involves surgery, chemotherapy, and/or radiation, all of which can lead to further nutritional adverse effects, including poor appetite and esophagitis, and increased nutritional risk. A 2014 study of malnutrition prevalence in cancer patients found that, overall, 39% were malnourished, and for those with esophageal or stomach cancer, 60.2% were malnourished.2 Weight loss and malnutrition in patients with cancer results in negative outcomes, including decreased treatment tolerance and response, decreased quality of life, increased hospital length of stay (LOS) and readmissions, and increased healthcare costs.3 However, research has demonstrated that early and targeted nutrition screening, assessment, education, and intervention can improve outcomes in patients with esophageal cancer.1,4-6 Poulsen and colleagues found that individual dietary counseling (and an optional oral nutritional supplement) was associated with better weight maintenance and protein and energy intake in patients with cancer, including esophageal cancer.4 Enteral nutrition has also been shown to result in positive outcomes in patients with esophageal cancer after esophagectomy, including improved nutritional status, improved immune function, faster recovery, and decreased costs.5,6 Xiao-Bo and colleagues examined the effect of enteral versus parenteral nutrition in patients with esophageal cancer undergoing esophagectomy. The authors reported that patients

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receiving enteral nutrition had significantly higher albumin and prealbumin levels than did those receiving parenteral nutrition.5 In addition, nitrogen balance was better, there were no severe complications associated with the enteral nutrition, and the cost of nutritional support was significantly less in the enteral nutrition group.5 Furthermore, Zhao and colleagues showed that early enteral nutrition (initiated soon after surgery) can promote recovery of gastrointestinal function and improve nutritional and immune function, therefore leading to faster postoperative recovery in patients with esophageal cancer.6 Odelli and colleagues developed a targeted nutrition pathway involving early and periodic nutrition assessment of all patients presenting to a multidisciplinary esophageal clinic for chemoradiation treatment.1 The nutrition pathway promoted a proactive approach to nutrition intervention, ensuring that early and aggressive nutrition assessment and intervention was undertaken for all patients.

It also provided guidelines for the initiation and maintenance of nutrition support throughout the treatment course.

The outcomes studied included weight status, percentage of planned treatment delivered, number of unplanned hospital admissions, and hospital LOS during treatment. Each patient’s nutrition risk was assessed and defined as low, moderate, or severe. Appropriate nutrition interventions were provided based on nutrition risk level. Interventions included: • Preventive advice for low-risk patients • Oral nutritional supplements for moderate-risk patients Table

• Enteral feeding for severe-risk patients The study compared outcomes between 2 groups of patients—the control group (n = 24), who received nutrition support in a reactive manner (referred to the dietitian only as problems arose, which resulted in delayed initiation of nutrition support); and the treatment group (n = 24), who received nutrition support proactively at the initial clinic visit (automatically interviewed by a dietitian) and began the nutrition pathway based on their risk level. The study demonstrated that approximately 80% of the patients

ance during chemoradiation in patients with esophageal cancer. Implementation of this nutrition pathway was associated with improved clinical outcomes, including decreased weight loss, number of unplanned hospital admissions, and a higher tolerance of planned treatment.1 In the environment of a multidisciplinary clinic, the nutrition pathway and proactive nutrition support were easy to adopt and were readily accepted by the patients, as all members of the healthcare team repeatedly reinforced the role of nutrition during the treatment course. l

In the environment of a multidisciplinary clinic, the nutrition pathway and proactive nutrition support were easy to adopt.

were at moderate to severe nutritional risk.1 Patients receiving the nutrition pathway in the treatment group had significantly better outcomes than those in the control group.1 Patients who received the nutrition pathway experienced less weight loss, fewer chemotherapy dose reductions, higher rates of radiation completion, fewer unplanned hospital admissions, and shorter hospital LOS with admissions (Table).1 This study showed that early nutrition assessment and intervention delivered according to a nutrition pathway had a significant positive effect on the nutritional status and treatment toler-

References

1. Odelli C, Burgess D, Bateman L, et al. Nutrition support improves patient outcomes, treatment tolerance and admission characteristics in oesophageal cancer.

Clin Oncol (R Coll Radiol). 2005;17(8):639-645.

2. Hébuterne X, Lemarié E, Michallet M, et al.

Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014;38(2):196-204.

3. Marin Caro MM, Laviano A, Pichard C. Nutritional intervention and quality of life in adult oncology patients. Clin Nutr. 2007;26(3):289-301.

4. Poulsen GM, Pedersen LL, Osterlind K, et al.

Randomized trial of the effects of individual nutritional counseling in cancer patients [published online ahead of print November 8, 2013]. Clin Nutr. doi: 10.1016/j. clnu.2013.10.019.

5. Xiao-Bo Y, Qiang L, Xiong Q, et al. Efficacy of early postoperative enteral nutrition in supporting patients after esophagectomy. Minerva Chir. 2014;69(1):37-46.

6. Zhao G, Cao S, Zhang K, et al. Effect of early enteral nutrition on immune response and clinical outcomes after esophageal cancer surgery. Zhonghua Wei Chang Wai Ke Za Zhi. 2014;17(4):356-360.

Summary of Study Results1

Control Group (n = 24)

Treatment Group (n = 24)

P Value

3.6 ± 3.0

−0.31 ± 2.8

.001

Weight change during treatment, kg

−8.9 ± 5.9

−4.2 ± 6.4

.03

Patients who had a chemotherapy dose reduction, %

42 (n = 10)

29 (n = 7)

.34

Patients who completed radiation, %

50 (n = 12)

92 (n = 22)

.001

95

100

.004

Patients who had an unplanned hospital admission, %

75 (n = 18)

46 (n = 11)

.04

Total length of stay for all unplanned hospital admissions, d

13.5 ± 14.1

3.2 ± 5.4

.002

Enteral nutrition started, wk

Planned radiation dose delivered, median, %

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Empowering Patients and Survivors

Survivor’s Guilt—Let Me Count the Ways vent to and who will listen and respond in a supportive way. It is also important for survivors to learn to identify the triggers for anger.

Grief is a common response to any type of loss. We can neither bypass nor avoid grief. We have to go right through the middle of grief in order to eventually move beyond it. As survivors, we may be experiencing grief if we show such signs as unexpected crying, lack of energy, feelings of uncertainty, changes in sleeping or eating habits, feeling withdrawn or unmotivated, irritability, hyperactivity or fear of slowing down, trouble concentrating, avoidance of others, and fear of being alone. The grieving process is highly individual. There is no prescribed timetable or way of experiencing grief. We must be patient with ourselves as we work through our grief in whatever ways come most natural to us.

Anxiety is a strong feeling that commonly triggers reactions in the body.

Anxiety is often caused by what Larson describes as “the dirty little habits of our thoughts.” Making assumptions, over-generalizing, making unfavorable

comparisons between ourselves and others, taking things personally, dwelling on the negative and disqualifying the positive, and “catastrophizing” can all be ways in which our thoughts wreak havoc on our mental state. Recognizing when our thoughts are destructive or distorted can help us to stop them when they start and to redirect our thoughts in more constructive ways. Thinking positive, reaffirming thoughts, asking for compliments from others, and surrounding ourselves with people who lift our spirits and encourage us are helpful ways of reducing anxiety.

Pressure is feeling the strong need to give back or pay it forward. It is not uncommon to feel this sort of pressure, and many great things can come from this emotion. Pressure can help survivors to identify the good and find meaning in survival. Larson coaches her clients to: • Identify your skills and sources of joy in helping others.

• Join in and support a cause or create your own.

• Consider how the emotional impact of giving back will affect you and how you will take care of yourself as a result.

Continued from page 9

Larson offers these general tips for selfcare when dealing with survivor’s guilt: • Be gentle with yourself and honor your emotions.

• Understand that your feelings will change from day to day.

• Try not to ignore the need to share your worries, fears, and questions.

• Talk with others about your concerns or uncertainties.

• Try not to put on a happy face if you are not feeling happy. Being honest about your feelings is more helpful to everyone.

Knowing that survivor’s guilt is not only real, but it exists in many emotional forms is the first step in overcoming it.

Find the people in your life with whom you can express your emotions without feeling dismissed. Find your audience, whether it be good friends with strong listening skills, support groups, or a therapist who can help you to better understand your feelings, accept support, and guide you through your process. As stated by a sister survivor in my Empowering Patients and Survivors focus group, “I don’t feel pressure to be there or that I owe anyone

anything. I think surviving, and then thriving, is the best gift I can give.” l Angela Long is looking for male and female survivors of all cancer types who are willing to share their perspective in an effort to help oncology nurses better understand the cancer patient’s journey. If you know a cancer survivor who would like to join in the discussion about Empowering Patients and Survivors, he or she can join a private focus group at www. facebook.com/groups/empoweringpa tientsandsurvivors.

Julie Larson, LCSW, can be reached through her website at www.julielar sonlcsw.com.

Angela Long is the founder and creator of Breast Investigators. Breast Investigators serves as a comprehensive resource guide to help those affected by breast cancer readily gain access to quality information, care, assistance, and support. Visit www.

BreastInvestigators.com.

The Whole Patient

Fertility Preservation Options for Patients With Cancer tility options; and not knowing where to refer patients.

For males and females treated with chemotherapy, the most gonadotoxic agents are alkylating agents, followed in descending order by platinum analogs and anthracyclines. The long-term effects of targeted therapies on fertility are not known.

Radiation also carries some risk of infertility, depending on the extent of the radiation field and the cumulative dose to reproductive organs.

Surgery may compromise fertility as well. Bilateral orchiectomy or bilateral oophorectomy can deplete the sperm and ovarian reserves, respectively. In addition, treatment that damages the pituitary gland can disrupt hormonal regulation of reproduction.

Fertility Preservation for Males Approaches to fertility for postpubertal males include sperm collection/preservation techniques such as semen cryopreservation (sperm banking), electroejaculation, and testicular sperm extraction (TESE) from testicular tissue. None of these options can be offered to prepubertal males who do not have mature sperm. These techniques to preserve sperm must be completed before treatment is initiated, Kelvin said.

www.TheOncologyNurse.com

Steps can also be taken to reduce the gonadotoxicity of radiation, including testicular shielding during pelvic/inguinal field radiation and intensity-modulated radiation therapy.

Fertility Preservation for Females Many treatments are gonadotoxic for females, depleting the pool of available ovarian follicles (also called ovarian reserve). If all the eggs are destroyed by cancer treatment, the patient goes into premature menopause. Even some of those patients with oocytes left after treatment will have premature menopause.

“Female cancer patients are at risk for premature ovarian failure and menopause at a young age,” Kelvin stated.

It is difficult to predict the full effects of cancer treatment on females. Many women will have diminished ovarian reserve but can become pregnant with the help of assisted reproductive technology, while other women will have a narrowed window of opportunity, she explained.

The 2 basic approaches for preserving fertility in females are cryopreservation of eggs or fertilized embryos and strategies to reduce treatment-related toxicity.

As with sperm banking, cryopreservation for females must be completed before the

initiation of cancer treatment.

Embryo cryopreservation entails egg retrieval under anesthesia, followed by in vitro fertilization with male sperm; embryos that are thus produced are then cryopreserved.

“Until recently, you couldn’t freeze eggs, but the latest technology allows cryopreservation of eggs. However, this technique is much more successful in younger women than in older women,” Kelvin noted.

Cryopreservation of embryos takes time and can delay cancer treatment, so expedited referral is needed for patients who choose this option. There is some concern that females with estrogen receptor–sensitive breast cancer who are treated with hormonal therapy to stimulate the ovaries prior to egg retrieval may be at increased risk, and these women are sometimes also given an aromatase inhibitor to lower estrogen levels. However, many oncologists are not comfortable using hormonal therapies for patients with breast cancer who require neoadjuvant chemotherapy due to bulky disease and lymph node involvement.

Patients need to know that egg retrieval carries risks of bleeding, thrombocytopenia, liver dysfunction, accidental puncturing of vascular pelvic mass,

Continued from cover

infection, and risks associated with anesthesia.

Cryopreservation of ovarian tissue is an experimental procedure that may be used in pre- and postpubertal females who cannot delay cancer treatment and thus do not have time for cryopreservation of eggs or embryos. This technique should be used only in patients who are at high risk of infertility from cancer treatment. Reimplantation of ovarian tissue is available at selected centers, but there is concern that the ovarian tissue may harbor occult cancer cells.

Some clinicians offer ovarian function suppression with a GnRH agonist 2 weeks prior to starting chemotherapy to protect ovarian follicles from treatment-related effects, but this is considered experimental, she said.

Message to Patients “I hope this information inspires you to address fertility with your cancer patients before they start treatment. It can be helpful to use the phrase parenthood after cancer,” Kelvin said. l

Reference

Kelvin J. Clinical lecture—parenthood after cancer treatment: discussing fertility with your patients.

Presented at: Oncology Nursing Society 39th Annual Congress; May 1-4, 2014; Anaheim, CA.

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5

YE AR A N N IV E R S A RY

FIFTH ANNUAL

Navigation and Survivorship Conference September 18-21, 2014 • Walt Disney World Dolphin Hotel • Orlando, FL AONN+ LEADERSHIP PROGRAM DIRECTOR

TARGET AUDIENCE

This educational initiative is directed toward oncology nurse navigators, patient navigators, case managers, care managers, administrators, and social workers whose focus is on cancer care and survivorship.

STATEMENT OF NEED/PROGRAM OVERVIEW

Lillie D. Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, The Johns Hopkins Breast Center Administrative Director, Johns Hopkins Cancer Survivorship Programs Associate Professor, JHU School of Medicine Departments of Surgery, Oncology & Gynecology and Obstetrics Associate Professor, JHU School of Nursing Baltimore, MD

AONN+’s Fifth Annual Conference will continue to advance the navigation profession by expanding the scope of educational sessions, networking opportunities, and poster presentations. In addition, this year’s conference will address the evolving challenges of program improvement, the role of personalized medicine, and implementing best practices in navigation, survivorship, and psychosocial care for cancer patients.

EDUCATIONAL OBJECTIVES

After completing this activity, the participant should be better able to: • Describe the evolution of the role of navigation in healthcare • Interpret strategies for navigating diverse patient populations by cancer type and environmental factors • Define methods for providing patient support and guidance in the age of personalized cancer care • Explain how to evaluate best practices regarding survivorship and psychosocial care

NURSING CONTINUING EDUCATION

Global Education Group is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s COA. This educational activity for 15.75 contact hours is provided by Global Education Group.

Nurses should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN CASE MANAGEMENT ASSOCIATION

Application for certification of ACMA hours has been applied for and is pending decision.

Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

This activity is co-provided by Global Education Group and Center of Excellence Media, LLC.

NATIONAL ASSOCIATION OF SOCIAL WORKERS

This program has been submitted and is pending approval by the National Association of Social Workers for continuing education contact hours.

DISCLOSURE OF CONFLICTS OF INTEREST

Global Education Group (Global) requires instructors, planners, managers, and other individuals and their spouse/life partner who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

AMERICANS WITH DISABILITIES ACT

Event staff will be glad to assist you with any special needs (ie, physical, dietary, etc).

Please contact Patrice Melluso prior to the live event at pmelluso@the-lynx-group.com and 516-835-6529.

12

REGISTER TODAY! www.regonline.com/AONN2014

July/August 2014 I VOL 7, NO 4

www.TheOncologyNurse.com

AGENDA

*

Thursday, September 18 12:30 pm - 1:30 pm 3:30 pm - 4:30 pm 5:30 pm - 8:00 pm

Start a Subcommittee Meeting (non–CE-certified activity) Start an AONN Chapter Meeting (non–CE-certified activity) Welcome Reception and Keynote Session (non–CE-certified activity)

4:45 pm - 5:45 pm

Friday, September 19 Navigators Exploring Xtra Tracks (N.E.X.T.) Day

Breakfast/Session 1 sponsored by Celgene Corporation (non–CE-certified activity) 8:15 am - 9:15 am Session 2 sponsored by Lilly Oncology (non–CE-certified activity) 9:30 am - 10:30 am Session 3 sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (non–CE-certified activity) 10:45 am - 11:45 am Session 4 (non–CE-certified activity) 12:00 pm - 1:00 pm Lunch/Session 5 sponsored by Millennium: The Takeda Oncology Company (non–CE-certified activity) 1:15 pm - 2:15 pm Session 6 (non–CE-certified activity) 2:30 pm - 3:30 pm Session 7 (non–CE-certified activity) 3:45 pm - 4:45 pm Session 8 (non–CE-certified activity) 4:45 pm - 6:15 pm Poster Question and Answer Session in the Exhibit Hall (non–CE-certified activity) 6:30 pm - 9:30 pm Heroes of Hope AONN+ Family Event at Epcot Center Extra registration fee required for this event. (non–CE-certified activity) 7:00 am - 8:00 am

TM

Saturday, September 20

Meet the Experts Breakfast in the Exhibit Hall (non–CE-certified activity) 8:00 am - 8:15 am Welcome, Introductions & Business Update (non-CE-certified activity) - Lillie D. Shockney, RN, BS, MAS; Sharon Gentry, RN, MSN, AOCN, CBCN 8:00 am - 9:00 am General Session 1: Finding Humor Where You Least Expect It: An Oncology Nurse Navigator’s Experiences with Breast Cancer - Lillie D. Shockney, RN, BS, MAS 9:00 am - 10:00 am General Session 2: Sex, Chemo, and Rock & Roll Penny Daugherty, RN, MS, OCN 10:00 am - 11:00 am General Session 3: Navigation and Survivorship Standards —Are You Ready for Your Commission on Cancer Accreditation? - Virginia Vaitones, MSW, OSW-C 11:00 am - 12:00 pm General Session 4: Multiorgan Site Navigation - Libby F. Daniels, RN, OCN 12:00 pm - 1:15 pm Poster Award Winner Announcements, Presentations, and Luncheon in the Exhibit Hall (non–CE-certified activity) 1:15 pm - 2:15 pm General Session 5: Pediatric Oncology Navigation and Survivorship - Kathy Ruble, RN, CRNP, PhD 2:15 pm - 3:15 pm General Session 6: Medical Home and Quality Accreditations Update - Maureen Lowry, RN, BSN, OCN; John Sprandio, MD 3:15 pm - 5:30 pm Exhibit Hall Open 3:15 pm - 3:30 pm Break in the Exhibit Hall (non–CE-certified activity) 3:30 pm - 4:30 pm Breakout Session 1 (Choose one of the following sessions) • Basic Navigation (0-2 years) - Britta Newcomer, RN 7:00 am - 8:00 am

www.TheOncologyNurse.com

6:00 pm - 10:00 pm

• Intermediate Navigation (3-5 years) - Lucy Gansauer, RN, MSN, CPSO, OCN - Elaine Sein, RN, BSN, OCN, CBCN • Advanced Navigation (5+ years) - Sharon Gentry, RN, MSN, AOCN, CBCN • Administrators - Lisa Shalkowski, RN, BSN, MSHA Breakout Session 2 (Choose one of the following sessions) • Breast Cancer Navigation and Survivorship • Hematologic Malignancies Navigation and Survivorship - Peg Rummel, RN, MHA, OCN • Head, Neck, and Neurologic Cancers Navigation and Survivorship - Tamara Bowen, RN, BSN, MHA • Gynecologic Cancers Navigation and Survivorship - Carol Cherry, MSN, RN, AOCNS, APNG Heroes of Hope AONN+ 2nd Annual Gala Extra registration fee required for this event. (non–CE-certified activity) TM

Sunday, September 21

Breakfast in the Exhibit Hall (non–CE-certified activity) 7:45 am - 8:00 am Welcome - Lillie D. Shockney, RN, BS, MAS; Sharon Gentry, RN, MSN, AOCN, CBCN 8:00 am - 8:45 am General Session 6: Sharing Best Practices - Mandi Pratt-Chapman, MA 8:45 am - 9:30 am General Session 7: Lay Navigation - Jean B. Sellers, RN, MSN 9:30 am - 10:45 am General Session 8: Utilizing EPIC to Successfully Navigate Patients - Lisa DelPizzo, RN, MSN, CCM, CBPN-IC; Danielle Guillama, RN, BSN, OCN 10:45 am - 12:00 pm Exhibit Hall Open 10:45 am - 11:00 am Break in the Exhibit Hall (non–CE-certified activity) 11:00 am - 12:15 pm Breakout Session 3 (Choose one of the following sessions) • Lung Cancer Navigation and Survivorship - Caryn M. Vadseth, RN, BSN, OCN • Prostate Cancer Navigation and Survivorship - Frank dela Rama, RN, MS, AOCNS • Gastrointestinal/Colorectal Cancer Navigation and Survivorship - Allyson Foor; Gail Sullivan, RN, BS • Melanoma Navigation and Survivorship - Krista M. Rubin, MS, RN, FNP-C 12:15 pm - 1:30 pm Lunch/General Session 9: Cancer Support Community/UF Health Cancer Center Pilot Program - Linda House, RN, BSN, MSN; Diane Robinson, PhD 1:30 pm - 2:30 pm General Session 10: Sexuality and Intimacy - Michael L. Krychman, MD, FACOG 2:30 pm - 3:30 pm General Session 11: Doctor, Doctor Lend Me Your Ear - Marisa C. Weiss, MD 3:30 pm - 3:45 pm Closing Remarks - Lillie D. Shockney, RN, BS, MAS; Sharon Gentry, RN, MSN, AOCN, CBCN 7:00 am - 7:45 am

*Agenda subject to change.

Complete agenda and faculty information available on our website at AONNonline.org

*

Blackout Times

†

Thursday, September 18 Friday, September 19

8:00 am - 8:00 pm 6:30 am - 8:00 pm

Saturday, September 20 Sunday, September 21

6:30 am - 8:00 pm 6:30 am - 8:00 pm

Please note that organizations may not hold functions during the defined “blackout” times unless approved by AONN+. AONN+ will strictly enforce the blackout times. Failure to have approval to hold any event in these established time frames may result in a fine and exclusion from all AONN+ events.

†

AONN2014ConfAd Ksize_60914

July/August 2014 I VOL 7, NO 4

13

Oncology Pharmacy Safety

Chemotherapy: Current and Emerging Issues…

The clinical utility of hazardous drugs is expanding rapidly, and new challenges are arising for their safe use and handling. Occupational safety and health organizations and healthcare professionals are working hard to create safety guidance documents that keep pace with the changing environment. The growing use of hazardous drugs in nononcology practices and the increased utilization of oral hazardous drugs require the scope of safe handling practices to extend beyond traditional settings. The promulgation of new legislation related to safe handling of hazardous drugs by several states has forever changed the climate in which safe handling guidelines have been perceived.

With the revamped USP Chapter 800 for hazardous drug compounding, oncology pharmacists’ and nurses’ unique skill sets should be shared beyond their disciplines.

Historically, safe handling guidance documents have been recommendations that are only followed on a voluntary basis. Occupational Safety and Health Administration (OSHA) inspections are infrequent and generally conducted only in response to reports of violations. However, states like Washington,5 California,6 and North Carolina7 are leading the charge in establishing state laws for the safe handling of hazardous drugs with consequences for when they are not followed. With guidance from OSHA,8 the National Institute for Occupational Safety and Health (NIOSH),9 the American Society of Health-System Pharmacists,10 the Oncology Nursing Society,11 and USP,12 it is important for senior management in hospitals and private oncology practices, and for owners and managers of retail pharmacies, to perceive this information as mandatory requirements to ensure employee protection. While implementation of medical surveillance may meet with greater resistance, proper policies for the identificaTable 1

tion and labeling of hazardous drugs, as well as adequate facilities, equipment, and personal protective equipment (PPE), should be clear in standard operating procedures. The hope is that this article challenges the oncology community to reach out to other practice sites where hazardous drugs are handled and share the safety practices that have evolved over the past few decades.

include inhalation (breathing contaminated aerosols and vapors), ingestion via hand-to-mouth contact (eating, drinking, gum chewing) in areas where hazardous drugs are stored or compounded, and injection (finger sticks, vial breakage).15 Of greater concern than the presence of hazardous drugs in the work environment is documentation that the drugs and their metabolites have been found in

The promulgation of new legislation related to safe handling of hazardous drugs by several states has forever changed the climate in which safe handling guidelines have been perceived.

The Risk of Hazardous Drugs The healthcare setting has the largest and most diverse mix of chemicals that are hazardous to humans—more than any other occupational setting—ranging from drugs with acute effects to those linked to reproductive toxicity and cancer.13 Surface contamination with hazardous drugs in pharmacies and nursing administration areas has been extensively documented.2 Considering that the existing literature has only evaluated the presence of less than 5% of the known hazardous drugs found in the healthcare workplace, the incidence and magnitude of surface contamination are likely higher. The main vector of exposure is dermal contact directly with drugs and drug packaging (documented to be as high as 100% contaminated when leaving the manufacturer) and through indirect contact by touching surfaces that have been contaminated.14 Additional routes of exposure

the urine of exposed healthcare workers.3 Similarly, studies of worker exposure have only been conducted on a small percentage of hazardous drugs, and positive urine samples have been detected in pharmacists, pharmacy technicians, and nurses, including those not directly involved in compounding.3 Some investigations into biomarkers of effect have shown associations between surface contamination and the presence of drugs in the urine,16-18 while others have demonstrated significant associations between exposure and biomarkers of genotoxicity in exposed healthcare workers.3 Hazardous Drug Identification and Hazard Assessment The first step in any safe handling program is the identification and risk assessment of hazardous drugs in any given workplace.

It is recommended to start the process by examining NIOSH’s Hazardous Drug

H azardous Drugs in Many Practice Settings: “It’s Not Just Oncology Anymore”

Specialty

Drug

Rheumatology

Cyclophosphamide, azathioprine, rituximab, abatacept, tacrolimus, methotrexate

Transplant

Cyclosporine, tacrolimus, sirolimus, mycophenolate

Infectious diseases

Ganciclovir

Obstetrics/gynecology

Methotrexate

Urology

Mitomycin, bacillus Calmette-Guérin (BCG), valrubicin

Surgery

Mitomycin: ocular, bladder, tracheal stricture

Emergency department

Methotrexate

Ophthalmology

Mitomycin

Community pharmacy

All of the above in solid dosage forms

14

July/August 2014 I VOL 7, NO 4

Continued from cover

List, but institutions can and should create their own facility-specific list based on their current drug usage. The NIOSH list was last updated in June 2012,13 and the proposed changes for the 2014 update include the addition of several oral agents (eg, erlotinib, fluconazole, spironolactone, topiramate, warfarin).19 Institutions in which hazardous drugs are present should have a mechanism for updating their list as new drugs come into the facility.

There are many variations for further categorizing hazardous drugs, with some institutions separating antineoplastic drugs from hazardous drugs with precautions similar to those for the antineoplastic drugs and grouping together teratogens, reproductive toxins, and hormones.20-22 Some facilities further separate risk levels by formulation, using different precautions and PPE when handling hazardous intravenous drugs compared with hazardous oral drugs, and even determining which drugs should be counted or manipulated within a biological safety cabinet (BSC) versus oral drugs that have been classified as safe to be handled in the general environment as long as the dosage form is not altered.

Both USP Chapter 8004 and OSHA’s Technical Manual8 acknowledge that dispensing nonantineoplastic hazardous drugs in unit-dose and unit-of-use dosage forms that are not altered (cut, crushed, etc) likely does not impart significant risk to the employee. To better address these and other issues, NIOSH has proposed listing hazardous drugs in 3 categories: (1) antineoplastic drugs (based on American Hospital Formulary Service classification 10:00), (2) nonantineoplastic drugs, and (3) drugs primarily with reproductive risks. Along with these changes, NIOSH will also provide additional guidance on engineering controls and PPE.19 In hospitals and cancer centers, pharmacists can provide knowledge about pharmacology, dosage formulation, and compounding, while nurses can address administration concerns and patient-specific issues that have required process and administration changes at the bedside. A team approach can enhance the ability to evaluate all aspects of a drug and its potential risks, from receiving to preparation, administration, disposal, and patient excretion. The risk stratification approach to hazardous drug handling may increase compliance by targeting the medications and situations most likely to cause the greatest exposure and risk to the employee.

Use of Antineoplastic Drugs in Nononcology Settings Cancer patients are not the only patients being treated with antineoplastic drugs.23,24 Many drugs that have typically been considered just for the treatment

www.TheOncologyNurse.com

Oncology Pharmacy Safety of cancer are now being used in other specialties (Table 1). As Polovich and Giesker noted in 2011, “Oncology units where patients with cancer receive chemotherapy are not the only settings where hazardous drugs are found. Because of the increased use of antineoplastic agents for nononcology indications, nurses’ risk for occupational exposure is distributed more widely than in the past.”23 Often, healthcare professionals who are administering antineoplastic drugs in other settings may not be aware of their potential occupational hazards and/or may not be adequately trained in their use and disposal. General inpatient units in hospitals, as well as procedural areas such as the surgery department and interventional radiology, may manage hazardous drugs as only a small percentage of total patient care activities; thus, these handling activities may be associated with less robust procedures and staff education as well as decreased access to appropriate equipment or supplies for safe handling and disposal. Oncology pharmacists and nurses have valuable insight and can help inpatient and procedural areas perform a gap analysis, develop standardized processes, and share knowledge gained from experience. Sharing up-to-date regulatory documents and employing face-to-face collaborative approaches to reviewing existing policies related to the safe handling and administration of hazardous drugs are hugely beneficial for institutions as a whole.

With the increased prescribing of hazardous drugs for nononcology conditions, retail pharmacies often carry many solid dosage forms of NIOSH-listed drugs, some of which are uncoated pressed-powder tablets that easily liberate hazardous drug powder onto the work surface or into the air. Retail pharmacies often purchase large stock bottles of medications, and the dust liberated in production and transportation accumulates in the bottom of the bottles. Inverting a stock bottle of uncoated tablets to get them out often leads to spilling powder and sending it into the air. The range of hazardous drugs in retail chains is increasing as a result of expanding their scope of services in an effort to increase revenue and remain competitive, including special ordering medications to help loyal customers. While few retail pharmacies may believe they carry many hazardous drugs, about 10% of the top 100 drugs in the United States either by sales or number of units dispensed from 2013 to 2014 are listed as hazardous by NIOSH.13,14,25 Prefilled syringes of hormonal-modulating and immunotherapy agents as well as injectable vials of methotrexate can be found on the shelves of retail pharmacies.

In the busy retail pharmacy environment, staffs traditionally wear minimal to no PPE, and the positions of retail pharmacy

www.TheOncologyNurse.com

Christine Roussel, PharmD, BCOP

Table 2

“Counting coated tablets and capsules does not require a C-PEC [containment primary engineering control], as long as they are not altered or broken.”4 The oral route of administration for hazardous drugs has become increasingly more common, with 25% of the oncology drug pipeline intended for oral self-administration.27 Retail pharmacies, specialty pharmacies, and physician practices with in-house dispensaries must think about safe handling from a different perspective.

Recently, several documents have been published with a focus on oral chemotherapy.28-34 While standards of practice dictate that nurses administering intrave-

Thomas H. Connor, PhD

Summary of State Bills on Hazardous Drugs

State/Bill

Year

Comments

Washington—Senate Bill 5594

2011

Does not include medical surveillance

California—Assembly Bill 1202

2013

Applies only to antineoplastic drugs

North Carolina—House Bill 664

2013

Currently in Senate

Maryland—Regulations proposed by Maryland Occupational Safety and Health

2013

Currently in committee

technicians are predominantly staffed by a younger workforce with a relatively high turnover rate. This reinforces the fact that it is crucial for all healthcare settings and pharmacies to identify and label hazardous drugs and to properly educate staff.

Oral Chemotherapy/Nonliquid Hazardous Drugs The guidelines from several organizations8-12 state that hazardous drugs in solid dosage forms pose a health risk to employees. The level of risk varies depending on the formulation. The highest-risk formulation is uncoated pressed-powder tablets that liberate dust particles, causing surface contamination and creating airborne drug dust that can be directly inhaled by employees and can contaminate the work area.8 Capsules and coated tablets are unlikely to produce dust unless broken in handling or if they are crushed or cut, which can pose a risk for surface contamination.

OSHA’s Technical Manual states: The handling of nonliquid forms of HD’s [hazardous drugs] requires special precautions as well. Tablets which may produce dust or potential exposure to the handler should be counted in a BSC. Capsules, i.e., gel-caps or coated tablets, are unlikely to produce dust unless broken in handling. These are counted in a BSC on equipment designated for HD’s only, because even manual counting devices may be covered with dust from the drugs handled. Automated counting machines should not be used unless an enclosed process isolates the hazard from the employee(s).8

While many retail pharmacies have separate counting trays for penicillin and other β-lactam drugs, many pharmacies do not have separate counting trays for hazardous oral drugs, let alone have negative pressure rooms with externally vented BSCs. Common examples of hazardous drugs dispensed in most pharmacies in uncoated pressed β-powder formulation include generic cyclophosphamide, methotrexate, melphalan, 6-mercaptopurine, and others.26 When finalized, USP Chapter 800 will provide additional information detailing the dispensing of hazardous drug dosage forms not requiring alteration: HDs in unit-dose or unit-of-dose packaging that do not require any further alteration before delivery to the patient or the patient’s caregiver may be dispensed without any further requirements for containment unless required by the manufacturer.

If the entity’s SOPs [standard operating procedures] permit, non-antineoplastic HDs that require only transfer from the manufacturer’s package to a prescription container may be dispensed without any further requirements for containment unless required by the manufacturer. Counting of HDs should be done carefully, and clean equipment should be dedicated for use with these drugs.4 The finalized USP Chapter 800 will state that tablet and capsule forms of HDs shall not be placed in automated counting machines, as mechanical stress may damage the dosage form and introduce powdered contaminants into the work area.

nous chemotherapy should have specific qualifications (such as additional training, passing facility-specific competencies, and preferably the Oncology Nursing Society Chemotherapy Biotherapy Certificate), currently no additional requirements are recommended for nurses administering oral hazardous drugs.27 Patients and caregivers must also be educated about the safe handling of hazardous drugs while self-administering in the home, such as wearing gloves during administration of drugs, handling patient waste and changing diapers, proper storage of drugs, and disposal of waste materials. Parents who may be administering liquid formulations of hazardous drugs to their children (potentially for years) must be educated about how to protect themselves and other members of the household. In addition to safety recommendations for oral chemotherapy, both for patient education and healthcare practitioners, Goodin and colleagues30 made recommendations to drug manufacturers. To reduce the possibility of exposure for healthcare personnel and family members or other caregivers, the authors recommended either dispensing oral hazardous drugs in more appropriately sized packages to better approximate treatment cycles or considering unit-dose packaging with the goal of minimizing product manipulation during dispensing.

Special consideration should also be paid to mail order pharmacies and other facilities that use automated dispensing machines for both nonhazardous and hazContinued on page 16

July/August 2014 I VOL 7, NO 4

15

Oncology Pharmacy Safety

Chemotherapy: Current and Emerging Issues… ardous drugs in pill form, as these tend to produce dust, which can be inhaled by workers and contaminate surfaces, which can lead to dermal uptake.35-37 Decontamination and Cleaning of Surfaces Contaminated With Hazardous Drug Residues USP Chapter 79712 defines decontamination as “inactivation, neutralization, or removal of hazardous drugs, usually by chemical means,” whereas deactivation is the “treatment of a hazardous drug with another chemical, heat, ultraviolet lights, or other agent to create a less

Table 3

sulfate as a neutralizer for the second step; HDClean is a proprietary blend of quaternary ammonium compounds. It should be noted that using isopropyl alcohol to disinfect a BSC will not decontaminate any hazardous drugs, but rather could put the drug into solution, and the wiping process may result in the spread of contamination.10 Decontamination procedures are vital safety measures in any facility that handles hazardous drugs. While the process and frequency were previously not well defined in US documents,8,9 USP Chapter 800 provides more detailed guidance, and

ashington State’s Hazardous Drugs Control Program W Mandatory Elements

A written inventory of hazardous drugs in the workplace A current hazard assessment for the hazardous drugs Hazardous drugs policies and procedures that cover, but are not limited to: Engineering controls (equipment use and maintenance) Personal protective equipment Safe handling practices (receiving and storage, labeling, preparing, administering, and disposing of hazardous drugs) Cleaning, housekeeping, and waste handling Spill control Personnel issues (eg, exposure of pregnant workers) Training hazardous agent.” Cleaning is described as “the removal of soil (e.g., organic and inorganic material) from objects and surfaces normally accomplished manually or mechanically using water with detergents or enzymatic products.” Often these terms are used interchangeably and incorrectly.

Given the large number of hazardous drugs in use and the wide variation in their chemical nature and makeup, no single agent will successfully decontaminate or clean surfaces after exposure to most of these drugs.38-45 Sodium hypochlorite (bleach) is probably used most often for decontamination. Bleach is a strong oxidizer shown to deactivate some hazardous drugs. The availability of commercial products such as Surface Safe (Hospira Healthcare Corporation, SaintLaurent, Quebec, Canada; http://www. hospira.ca/english/surfacesafe.aspx) and HDClean (ChemoGLO, LLC, Chapel Hill, North Carolina; http://www.che moglo.com/WhatIsHDClean.aspx) has increased convenience, but they have only been validated with a small number of drugs and may be cost prohibitive in some facilities. The 2-part Surface Safe decontamination product contains bleach as the first step and sodium thio-

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it is expected that more information will be released within the next few years as the data documenting surface contamination continue to accumulate.

Important considerations for decontamination of BSCs include donning full PPE and ensuring proper ventilation.

While it is ideal for the sash of the BSC to remain down during decontamination, often it is necessary to lift the sash of the BSC; thus, employees must wear a respirator such as an N-95 (not a surgical mask). USP Chapter 800 mentions the importance of performing cleaning in areas that are sufficiently ventilated, but does not provide further detail. Because there is a risk of hazardous vapors generated by liberating hazardous drugs or from cleaning agents, the exhaust fan and blower of the BSC must always remain on during the decontamination process to maintain exhaust.8 A BSC should be decontaminated at least weekly, as well as prior to environmental maintenance and certification, after a chemotherapy spill or if contamination is suspected, and after any interruption in ventilation occurs.

Cleaning with water and an alkaline detergent, followed by thorough rinsing, is also an acceptable method when the

Continued from page 15

physical situation permits, as hazardous residue would be liberated and then rinsed away.8 All waste material generated during decontamination is considered hazardous and should be discarded in appropriate waste containers. Using spray bottles inside BSCs should be avoided, owing to effects on HEPA filters and the production of aerosols. The final step before compounding is to wipe down the BSC with alcohol to reestablish sterility. Cleaning and disinfection of the hood should be conducted per USP 797.12 Surface decontamination is also appropriate for pharmacy counters with hazardous drug traffic as well as nursing areas where chemotherapy is administered.

State Legislative Activities Related to Hazardous Drugs In response to the growing concern about healthcare workers being exposed to hazardous drugs during the course of their working life and the wealth of new information being published internationally in the literature, several states have enacted, or are in the process of enacting, legislation aimed at protecting workers from the adverse effects of antineoplastic and other hazardous drugs. Most legislation is based on the guidelines published by NIOSH in 2004.9 Table 2 summarizes the current activities at the state level.

Washington State In 2011, the Washington State legislature passed a bill requiring the Department of Labor & Industries to adopt rules for the safe handling of hazardous drugs.5 The legislation stated the following: Pursuant to RCW 49.17.465, the department is required to ‘adopt by rule requirements for the handling of antineoplastic and other hazardous drugs in health care facilities regardless of the setting.’ The statute requires the department’s rules ‘be consistent with and not exceed provisions adopted by the National Institute for Occupational Safety and Health’s (NIOSH) 2004 alert on preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings as updated in 2010.’…The legislature also directed the department to consider input from hospitals, organizations representing health care personnel, other stakeholders in adopting the rules.46 Adopted on January 3, 2012, the hazardous drugs rule requires employers to develop and implement a written hazardous drugs control program to protect workers if there is a reasonably anticipated occupational exposure to one or more hazardous drugs. Washington State adopted the NIOSH definition of hazardous drugs and the NIOSH Hazardous Drug List for its documents. The program is being implemented in stages, and as of the start of 2015, employers must have completed and implemented a written hazardous drugs control program.

Employee training must be implemented

by July 2015, and, finally, appropriate ventilated cabinets must be installed by January 2016.

All healthcare facilities where employees face occupational exposure must comply, including hospitals, clinics, nursing homes, laboratories, offices, veterinary medicine clinics, retail pharmacies, home healthcare agencies, and research laboratories where a healthcare provider offers healthcare to patients. The rule allows for alternative precautions when the hazard assessment determines a low occupational exposure risk while preparing hazardous drugs other than chemotherapy agents, for example, from crushing and splitting tablets or drawing drug into a syringe. These alternatives could include temporarily designating a space as the preparation area, using appropriate PPE, and instituting specific cleaning procedures. The Washington State Division of Occupational Safety & Health has created a Hazardous Drugs Advisory Committee to aid employers in implementation of the requirements by discussing new NIOSH recommendations, scientific and technological developments, and other issues related to implementing this rule, via live meetings, a hazardous drugs webpage for resources, and a hazardous drugs email listserv.47 Washington State’s hazardous drugs rule does not include medical surveillance in the final document, as the topic was removed from the proposed rule because of concerns that NIOSH was updating its statements on the topic during the drafting process. Washington State’s written hazardous drugs control program specifies a list of elements that must be addressed and must include worker input during the creation process (Table 3).

Healthcare and other workers potentially impacted by the Washington State rule include all those who work in areas where hazardous drugs are handled (Table 4).

California The Cal/OSHA Occupational Exposure to Antineoplastic Drugs Advisory Meeting in June 2014 discussed implementation of Assembly Bill (AB) 1202 and Labor Section 144.8 regarding occupational safety and health standards: hazardous drugs. The California bill refers only to antineoplastic drugs and not all hazardous drugs.6,48 The language noted: It is the intent of the Legislature to require the Occupational Safety and Health Standards Board to adopt standards consistent with the NIOSH alert regardless of setting in order to protect health care personnel from hazardous exposure to these drugs.

The board shall adopt an occupational safety and health standard for the handling of antineoplastic drugs in health care facilities

www.TheOncologyNurse.com

Oncology Pharmacy Safety regardless of the setting. In developing the standard, the board shall consider input from hospitals, practicing physicians from impacted specialties, including oncology, organizations representing health care personnel, including registered nurses and pharmacists, and other stakeholders, and shall determine a reasonable time for facilities to implement new requirements imposed by the adopted standard. The standard, to the extent feasible, shall be consistent with and not exceed recommendations in the NIOSH 2004 alert entitled ‘Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings,’ as updated in 2010. The standard may incorporate applicable updates and changes to NIOSH guidelines.

North Carolina The state of North Carolina is currently debating the bill in the Senate, after being passed by the House in 2013.7 Whereas, in this alert, the NIOSH presents a standard precautions or universal precautions approach to handling hazardous drugs safely, meaning that it recommends that all hazardous drugs be handled as outlined in the alert; Now, therefore, The General Assembly of North Carolina enacts: The General Assembly finds that health care personnel who work with or near hazardous drugs in health care settings may be exposed to these agents in the air, on work surfaces, clothing, and medical equipment or through patient contact. It is the intent of the General Assembly to require health care facilities to follow rules requiring compliance with all aspects of alerts from the National Institute for Occupational Safety and Health regardless of the setting in order to protect health care personnel in this State from hazardous exposure to such drugs.

USP Chapter 800 An important new development related to the safe handling of hazardous drugs is the new USP chapter, Hazardous Drugs—Handling in Healthcare Settings, which was recently available for public comment. Chapter 8004 will supersede the hazardous drug section in USP Chapter 7979 (http://www.usp.org/usp-nf/ notices/compounding-notice). Because Chapter 800 will be enforced by some state boards of pharmacy, it will have an impact on the preparation/compounding of hazardous drugs.

Summary With new challenges to both employees and employers to ensure a safe working environment when antineoplastic and other hazardous drugs are present, it will be imperative that all parties are aware of new recommendations and regulations that will affect their work practices.

Washington State and California already have legislation focused on the safe handling of hazardous drugs, and other states

www.TheOncologyNurse.com

are following close behind with their own legislation or regulations. As NIOSH, USP, and other organizations move forward on activities aimed at protecting workers from hazardous drugs, healthcare workers everywhere will benefit from safer working conditions in their endeavors to treat seriously ill patients with an everexpanding armament of drugs. l References

1. Roussel C, Connor TH. Chemotherapy and pharmacy: a toxic mix? Oncol Pharmacist. 2013;6(2):1, 32-33.

2. Roussel C, Connor TH. Chemotherapy: every step you take, every move you make…. Oncol Pharmacist.

2013;6(4):1, 8-12.

3. Roussel C, Connor TH. Chemotherapy: biomarkers of exposure, effect, reproductive hazards and cancer.

Oncol Pharmacist. 2014;7(1):1, 10-13, 18.

4. US Pharmacopeial Convention. General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. http://www.usp.org/usp-nf/notices/compound ing-notice. Accessed June 20, 2014.

5. Washington State Senate Bill 5594. 62nd Leg, 2011 Regular Session. http://apps.leg.wa.gov/documents/ billdocs/2011-12/Pdf/Bills/Senate%20Bills/5594.pdf.

Accessed June 20, 2014.

6. California Assembly Bill 1202. 2013-2014 Regular Session. http://openstates.org/ca/bills/20132014/AB1 202/. Accessed June 20, 2014.

7. North Carolina House Bill 644. 2013-2014 Regular Session. http://www.ncleg.net/gascripts/BillLookUp/ BillLookUp.pl?Session=2013&BillID=h644. Accessed June 20, 2014.

8. Occupational Safety and Health Administration.

Controlling occupational exposure to hazardous drugs. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2. html. Published January 20, 1999. Accessed June 20, 2014.

9. Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health.

Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. www.cdc. gov/niosh/docs/2004-165/. Published September 2004.

Accessed June 20, 2014.

10. American Society of Health-System Pharmacists.

ASHP guidelines on handling hazardous drugs. Am J Health Syst Pharm. 2006;63:1172-1193.

11. Polovich M, Bolton DL, Eisenberg S, et al, eds. Safe Handling of Hazardous Drugs. 2nd ed. Pittsburgh, PA: Oncology Nursing Society; 2011.

12. US Pharmacopeial Convention. Revised Chapter <797> Pharmaceutical Compounding—Sterile Preparations. http://www.pbm.va.gov/linksotherresourc es/docs/USP797PharmaceuticalCompoundingSterile Compounding.pdf. Accessed July 15, 2014.

13. Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health.

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012. DHHS (NIOSH) Publication No. 2012-150. http://www.cdc.gov/niosh/ docs/2012-150/. Published June 2012. Accessed June 20, 2014.

14. Connor TH, Sessink PJ, Harrison BR, et al. Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: results of three studies. Am J Health Syst Pharm. 2005;62:475-484.

15. Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Personal Protective Equipment for Health Care Workers Who Work With Hazardous Drugs. DHHS (NIOSH) Publication No. 2009-106. http://www.cdc.gov/niosh/docs/wp-solu tions/2009-106/pdfs/2009-106.pdf. Published October 2008. Accessed June 20, 2014.

16. Pethran A, Schierl R, Hauff K, et al. Uptake of antineoplastic agents in pharmacy and hospital personnel.

Part I: monitoring of urinary concentrations. Int Arch Occup Environ Health. 2003;76(1):5-10.

17. Connor TH, DeBord G, Pretty JR, et al. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. J Occup Environ Med. 2010;52:1019-1027.

18. Villarini M, Dominici L, Piccinini R, et al.

Assessment of primary, oxidative and excision repaired DNA damage in hospital personnel handling antineoplastic drugs. Mutagenesis. 2011;26(3):359-369.

19. Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health.

NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014. DHHS (NIOSH) Publication No. 2014-xxx [In preparation]. http://www. cdc.gov/niosh/topics/hazdrug/. Accessed July 15, 2014.

20. Chaffee BW, Armistead JA, Benjamin BE, et al.

Guidelines for the safe handling of hazardous drugs: consensus recommendations. Am J Health Syst Pharm.

2010;67(18):1545-1546.

21. Badry N, Fabbro J, de Lemos ML. Hazards in determining whether a drug is hazardous [published online ahead of print August 20, 2013]. J Oncol Pharm Pract.

Table 4 Potentially Affected Workers Identified by Washington State

Pharmacists and pharmacy technicians Physicians and physician assistants Nurses and nursing assistants Patient care assistants, such as healthcare assistants or nursing assistants Surgical personnel Home healthcare workers Veterinarians and veterinary technicians Environmental services employees in healthcare facilities (including workers involved with housekeeping, laundry, or waste disposal) Employees in healthcare facilities who ship or receive hazardous drugs from the manufacturer or distributor doi:10.1177/1078155213496675.

22. Kaestli L-Z, Fonzo-Christe C, Bonfillon C, et al.

Development of a standardised method to recommend protective measures to handle hazardous drugs in hospitals. Eur J Hosp Pharm. 2013;20(2):100-105.

23. Polovich M, Giesker KE. Occupational hazardous drug exposure among non-oncology nurses. Medsurg Nurs. 2011;20(2):79-85, 97.

24. Menonna-Quinn D. Safe handling of chemotherapeutic agents in the treatment of nonmalignant diseases.

J Infus Nurs. 2013;36(3):198-204.

25. Drugs.com. U.S. pharmaceutical sales - Q4 2013. http://www.drugs.com/stats/top100/sales. Updated February 2014. Accessed July 15, 2014.

26. Drug Information Handbook. 23rd ed. Hudson, OH: Lexi-Comp, Inc; 2014.

27. Neuss MN, Polovich M, McNiff K, et al. 2013 updated American Society of Clinical Oncology/ Oncology Nursing Society chemotherapy safety standards including standards for the safe administration and management of oral chemotherapy. J Oncol Pract.

2013;9(suppl 2):S5-S13.

28. Griffin E. Safety considerations and safe handling of oral chemotherapy agents. Clin J Oncol Nurs.

2003;7(suppl 6):25-29.

29. Simmons CC. Oral chemotherapeutic drugs: handle with care. Nursing. 2010;40(7):44-47.

30. Goodin S, Griffith N, Chen B, et al. Safe handling of oral chemotherapeutic agents in clinical practice: recommendations from an international pharmacy panel.

J Oncol Pract. 2011;7(1):7-12.

31. Meier K, Griffith N, Chen B, et al. Safe handling of oral chemotherapeutic agents: a European perspective.

Eur J Oncol Pharm. 2011;5(2):4-10.

32. McLauchlan R. Safe dispensing of oral chemotherapy. Safety Considerations Oncol Pharm. Fall 2011 (special ed).

33. Wakui N, Ookubo T, Iwasaki Y, et al. Development of a closed drug preparation method for oral anticancer drugs. J Oncol Pharm Pract. 2013;19(4):315-320.

34. Si P, Chan A. Common toxicities of oral anticancer agents: an overview. Safety Considerations Oncol Pharm.

Fall 2011 (special ed).

35. Fent KW, Durgam S, Aristeguieta C, et al; Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Health Hazard Evaluation Report: Exposures to Pharmaceutical Dust at a Mail Order Pharmacy—Illinois. http://www.cdc.gov/ niosh/hhe/reports/pdfs/2010-0026-3150.pdf. NIOSH HETA no. 2010-0026-3150. Published December 2011.

Accessed June 20, 2014.

36. Fent KW, Tapp L, Wiegand D; Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Health Hazard Evaluation Program: Evaluation of Safety Climate, Health Concerns, and Pharmaceutical Dust Exposures at a Mail Order Pharmacy. Report no. 2012-0044-3199. http:// www.cdc.gov/niosh/hhe/reports/pdfs/2012-0044-3199. pdf. Published December 2013. Accessed June 20, 2014.

37. Fent KW, Durgam S, Methner M; Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Health Hazard Evaluation Program: Evaluation of Pharmaceutical Dust Exposures at an Outpatient Pharmacy. Report no. 20100078-3177. http://www.cdc.gov/niosh/hhe/reports/ pdfs/2010-0078-3177.pdf. Published April 2013.

Accessed June 20, 2014.

38. Chu WC, Hon CY, Danyluk Q, et al. Pilot assessment of the antineoplastic drug contamination levels in British Columbia hospitals pre- and post-cleaning.

J Oncol Pharm Pract. 2012;18(1):46-51.

39. Hon CY, Chua PP, Danyluk Q, et al. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study. J Oncol Pharm Pract. 2014;20(3):210-216.

40. Queruau Lamerie T, Nussbaumer S, Décaudin B, et al. Evaluation of decontamination efficiency of cleaning solutions on stainless steel and glass surfaces contaminated by 10 antineoplastic agents. Ann Occup Hyg. 2013;57(4):456-469.

41. Lé LM, Jolivot PA, Sadou Yaye H, et al. Effectiveness of cleaning of workplace cytotoxic surface. Int Arch Occup Environ Health. 2013;86(3):333-341.

42. Lee S-G, Ambados F, Tkaczuk M, et al. Paclitaxel exposure and its effective decontamination. J Pharm Pract Res. 2009;39(3):181-185.

43. Roberts S, Khammo N, McDonnell G, et al. Studies on the decontamination of surfaces exposed to cytotoxic drugs in chemotherapy workstations. J Oncol Pharm Pract. 2006;12(2):95-104.

44. Touzin K, Bussières JF, Langlois E, et al. Pilot study comparing the efficacy of two cleaning techniques in reducing environmental contamination with cyclophosphamide. Ann Occup Hyg. 2010;54(3):351-359.

45. BC Cancer Agency. BC cancer agency pharmacy practice standards for hazardous drugs. Module 1: safe handling of hazardous drugs. http://www.bccancer. bc.ca/NR/rdonlyres/2F1E0F82-D308-4E94-ABC0-1BF 1CCCE2FC3/59972/2Module1.pdf. Published January 2012. Updated April 3, 2014. Accessed June 20, 2014.

46. Washington State Dept of Labor & Industries.

Concise explanatory statement: hazard drugs. Adopted January 2012; effective January 2014. http://www.lni. wa.gov/rules/AO11/10/1110CES.pdf. Accessed June 20, 2014.

47. Washington State Dept of Labor & Industries.

Questions & answers about the new hazardous drugs rule. http://www.lni.wa.gov/Safety/Topics/AtoZ/Hazar dousDrugs/qna.asp. Accessed June 20, 2014.

48. State of California Dept of Industrial Relations.

Ca.gov. Web site. Cal/OSHA: Occupational exposure to neoplastic drugs advisory meeting. http://www.dir. ca.gov/dosh/doshreg/Antineoplastic-Drugs/. Accessed June 20, 2014.

Disclaimers The findings and conclusions of this presentation have not been formally disseminated by NIOSH and should not be construed to represent any agency determination or policy.

Mention of company names or products does not constitute endorsement by the National Institute for Occupational Safety and Health.

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Oncology Nurse Excellence Award Finalists Vote Now for Your Choice at www.TheOncologyNurse.com/award It was a difficult process, but we have selected 4 finalists from among the peers you nominated for the Fourth Annual Oncology Nurse Excellence (ONE) Award. All the nominees were outstanding, but these 4 individuals stood out for their display of leadership and compassion and for their commitment to evidence-based practices. Now it’s your turn. After you read about each finalist, please go to www.TheOncologyNurse.com/award and tell us your pick for the ONE Award. We will announce the readers’ choice at the Fifth Annual Academy of Oncology Nurse and Patient Navigators Meeting on September 20, 2014, in Orlando, Florida (www.aonnonline.org).

Deborah K. Walker, DNP, CRNP, AOCN An Innovative Solution to a Gap in Care eborah K. Walker, DNP, CRNP, AOCN, University of Alabama at Birmingham, School of Nursing, was nominated for her outstanding contribution in practice solutions in the field of oncology. “Dr Walker recognized a gap in the clinical practice setting and did something about it,” according to the person who nominated her. “Over the past 2 years she has led a team in developing a cancer resource app for her community and the 4 surrounding counties.”

Debbie has worked in the field of oncology for the past 15 years and knew from very early on that she wanted to be part of the medical field. She received her bachelor’s degree from Troy University, Alabama, and quickly found her niche. She returned to school to

D

Deborah K. Walker, DNP, CRNP, AOCN

University of Alabama at Birmingham, School of Nursing

get her master’s degree in nursing and decided to become a nurse practitioner to do more for patients. “I started off as a nurse practitioner in oncology so that’s what I have always done, and I wouldn’t do anything else,” she said. “I love it.”

Debbie first got the idea for the mobile application (app) during a community survey she conducted in the northern part of the state in 2011. During the interview process, she realized that the majority of patients, families, and caregivers did not ask their providers for information about community resources. “As a nurse practitioner I want my patients to come to me for any questions they may have about the resources that they need,” she explained. The app is designed to complement the National Comprehensive Cancer Network dis-

tress thermometer by providing community resources for patients, providers, and caregivers. Resources ranging from transportation services to wig shops and support groups are included in this app, comprising more than 500 resources. The app was designed to be user friendly and includes the ability to text and email as well as the ability to locate resources by county or type of service.

Google maps is available so patients can easily find the resource. She is currently working to expand this service to other areas in the state of Alabama and beyond.

Debbie is very passionate about her work and also educates others about the oncology subspecialty. “Nursing is a lifelong learning experience,” she added, urging nurses to take advantage of every opportunity and learn from them.

Jana Floersheim, RN, OCN Caring for Patients Close to Home ana Floersheim, RN, OCN, is being recognized as one of the finalists for the ONE Award because of her outstanding contribution to patient care.

Jana decided to go to nursing school at the age of 35 and began her career at Miners’ Colfax Medical Center in Raton, New Mexico, where she still works today. She worked a full year on the medical-surgical floor before she specialized in oncology. Jana was a parttime oncology nurse and within 2 years of the time she started working, the staff she originally worked with, which included 2 full-time oncology nurses and a secretary, left the center; Jana became the sole oncology nurse on staff. “I have been quite busy,” she stated modestly,

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Jana Floersheim, RN, OCN Miners’ Colfax Medical Center Raton, New Mexico

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adding that for the last 21 years she has been the only oncology nurse serving an area of more than 110 square miles. “It is really a huge workload for one person,” she added. Jana noted it is also important to be part of a group that can give you feedback and provide support when issues arise to offer the best care possible for the patient.

Because she lives in the same town that she grew up in, Jana finds herself treating family and friends. “Most patients I see, I have known my entire life,” she explained. “It is difficult when you treat your classmates.” In this setting, it is hard not to get attached to patients, she continued. One of the challenges to patient care includes finding ways to help patients pay for their treatment. Jana works closely

with patients who cannot easily afford treatment, including those looking into patient assistance programs for drugs that have them. In addition, she finds ways to address other challenges in patient care, including patient adherence to medication, especially now with oral chemotherapy drugs. “If patients are not compliant with their medication, there is a chance for overdose or underdose,” she explained. To that end, Jana assists patients by providing them with ways to keep track of what they need to take and when to take them. She also calls them to make sure that they are compliant.

Jana is considering retiring at the end of the year. If she wins this award, she plans to donate the proceeds to the Raton Humane Society.

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the

ONE Award

Jessica M. Engel, DNP, RN, FNP-BC, AOCNP An Environment Conducive to Research essica M. Engel, DNP, RN, FNP-BC, AOCNP, Marshfield Clinic, Stevens Point, Wisconsin, was nominated for her outstanding contribution to research in oncology. “She is an exceptional oncology nurse practitioner,” according to her colleague. “Dr Engel also consistently receives excellent patient satisfaction reviews and goes to great lengths to ensure optimal care for her patients. Dr Engel’s significant oncology research contributions make her a distinguished and deserving candidate.”

Jessica became interested in nursing during her freshman year in college, after she was diagnosed with Hodgkin lymphoma. “That really made me think about a lot of different things,” she said. “Going through this experience, the contact with healthcare profession-

J

als, made me think about where I was headed and what I wanted to give back.”

After graduating from college, Jessica received her bachelor’s and master’s degrees in nursing from the University of Wisconsin (UW), Milwaukee, and then went on to become a nurse practitioner; she currently practices in a small community oncology clinic. In addition, Jessica recently took a position teaching the graduate program at the University of Wisconsin at Oshkosh. Research, patient care, working in the clinic, and most recently, teaching are aspects of the work as a nurse practitioner that Jessica appreciates the most.

For the past 8 years, Jessica has been actively involved in research, coauthoring more than 35 peerreviewed publications and providing a unique and vital perspective to each study she undertakes. Early on, Jessica worked closely with a physician

on staff who was able to direct her research interests and involve her in his research projects. She was recently the recipient of the UW-Stevens Point Geographic Information Systems Center Outstanding Partner Award for her work in mammography utilization in a largely rural region. Furthermore, Jessica is a member of the Marshfield Clinic Institutional Review Board, as well as the editorial board of the Journal of Clinical Medicine & Research, and regularly reviews for the Oncology Nursing Forum and the Clinical Journal of Oncology Nursing. She is now also a grant reviewer for the Patient-Centered Outcomes Research Institute.

“Nurse involvement and representation in research is lacking,” she explained. “I have been lucky in that I have been able to try my hand at different things that I want to be involved in.”

Jessica M. Engel, DNP, RN, FNP-BC, AOCNP Marshfield Clinic Stevens Point, Wisconsin

Kathryn Shine, RN, BSN, OCN Reaching for Excellence athryn Shine, RN, BSN, OCN, Providence Portland Medical Center, Oregon, was chosen as one of the finalists for the ONE Award because of her outstanding contribution to education. “Katie is passionate about patient care and advocates for her patients and colleagues to have the highest level of information and care,” according to the colleague who nominated her. “She is an asset to us and we benefit so much from her support and encouragement as well as example of excellent patient care.”

Katie has been an oncology nurse for 7 years. A rotation during her senior year of nursing school drove her to pursue a career as an oncology nurse; she is going back to school this fall to get her nurse practitioner’s license. “The more you

K

take care of the oncology population, the more you grow as a nurse,” according to Katie. “The way you interact with people in the world changes, and evolves over time.”

Patient advocacy is an important aspect of Katie’s work, including keeping patients informed with what is happening, going through the plan for their care, and making sure everyone is on the same page in terms of treatment goals. “It is all about the person who is going through this traumatic experience,” she explained. Katie is involved in fall prevention and is part of her unit committee on standardizing care.

Katie has also done international volunteering, including a recent trip to Bhutan where she educated oncology nurses at the National Hospital.

Altogether, the hospital has a staff of 6 nurses, and during her time there, Katie worked with the staff to review and standardize processes of care. “It was really interesting to get to work with them and provide basic education on safe chemotherapy handling and how to prevent errors,” she explained. It was a rewarding experience, and she had the opportunity to learn from the nurses there as well. For example, she worked on an extravasation process, which came to good use when she went back home after her trip.

“It is about giving our patients some control in what is seemingly so uncontrollable in their diagnosis,” she added. Katie said the greatest asset that patients can have is to be knowledgeable about their disease so they can ask questions during the process.

Kathryn Shine, RN, BSN, OCN

Providence Portland Medical Center Providence, Oregon

Sponsored by

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Genetic Counseling

What Is “Next-Gen?” Cristi Radford, MS, CGC, Invitae

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NGS platforms require platform-specific adapters. Thus, when the specimen arrives at the laboratory, genomic DNA must be isolated and then prepared for the NGS platform being utilized. Preparation for a multigene cancer test involves a target enrichment step. This step “targets”

5

involve bar coding and fragmentation of DNA. Each of these nuances allows room for variation.

After a specimen is prepared, sequencing takes place on the designated platform. The final quality and accuracy of the data can be affected by the platform

the genes of interest included on a particular panel. Different platforms use various sequence enrichment methods and, thus, have different benefits and limitations.

All platforms have the ability to sequence millions of DNA fragments in parallel.5 Additionally, sample preparation may

FIFTH ANNUAL

Y EAR ANNIVER SARY

Navigation and 5 Survivorship Conference YEA R

A NNI V E RS A RY

September 18-21, 2014 Walt Disney World Dolphin Hotel • Orlando, Florida

TO DATE, THE CONFERENCE HAS HAD MORE THAN:

1,700

98

Total Attendees

Thank you again for a wonderful conference (only missed your first year). I submit a report on the conference to my administration each year to help me get funding for the following year and so far...so good. I attend various national conferences throughout the year and stand amazed at your ability to continue

Expert Speakers

55

60

to provide new and motivating presentations.

– 2013 Conference Attendee

93%

108

Abstracts

Abstracts Submitted

“N

ext-gen” is short for next-generation sequencing (NGS). It is a type of sequencing technology or a method to determine the order of nucleotides in a particular specimen, such as a DNA molecule. Sometimes the technology is referred to as second-generation sequencing, as it is the newer sequencing technology. Sanger sequencing, which was first described in 1975

by Frederick Sanger,1 is considered first-generation sequencing and is still widely used in clinical testing. It is extremely accurate and is considered the gold standard. However, a major limitation of Sanger sequencing is its throughput. Throughput is the amount of DNA sequence that can be read with each sequencing reaction. It is estimated that sequencing an entire genome with Sanger-based methods on one machine would take approximately 60 years and cost up to $30 million.2 Thus, Sangerbased technology is not practical for analyzing large amounts of data and has limited research and clinical applications. As a result, newer technologies were needed. Such technology emerged in the mid 2000s in the form of NGS.3 Over the last 5 years, this technology has transitioned from the research to the clinical setting and is routinely used for noninvasive prenatal testing, multigene panels, and exome analysis.4 NGS is a term used to refer to the various high-throughput DNA sequencing platforms available that are capable of sequencing large numbers of different DNA sequences in parallel. Thus, NGS is also referred to as massively parallel sequencing. Massively parallel sequencing results in a much higher throughput than Sanger sequencing, and, as a result, multiple genes can be analyzed more quickly and for a lower cost. Additionally, bar coding allows for pooling of patient samples.5 Technological advances, coupled with the US Supreme Court ruling in June 2013 that genes cannot be patented,6 changed the landscape of inherited cancer testing and has resulted in multiple entities offering multigene testing options. Such tests may be targeted for a particular disease type, such as breast or colon cancer, or may encompass a variety of genes with or without overlapping phenotypes. Because of the variety of options available, clinicians may find it helpful to have a basic understanding of the various steps involved in NGS and how variations in each can affect the final product—the patient’s clinical report.

NGS consists of 3 main steps. These are sample preparation, sequencing, and data analysis.5 For a multigene cancer test, the typical specimen is blood or saliva. Most

93% of 2013 conference attendees said they intended to change their practice as a result of participating in the AONN+ Conference

50 40 30 20

20 10 0

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2011

2012

2013

Year of Submission

“WOW! I am so impressed with the growth of AONN. Lillie, Sharon, and their team are awesome. The speakers were knowledgeable about their subject matter and all the presentations were relevant to my practice. I will use the pearls of wisdom shared by the speakers to my team at

97%

97% of 2013 conference attendees rated the AONN+ Conference as Above Average or Excellent when compared with other continuing education activities

home. I arrived feeling we have a pretty good program and I am leaving with ideas to share to make it even better!”

– Donna Moore Wilson, BSN, RN, CBCN Oncology Nurse Navigator Bon Secours Cancer Institute Richmond, Virginia

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REGISTER TODAY

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Genetic Counseling

chosen for the task at hand, as each platform differs in its sequence capacity, sequence read length, and run time.5 This step also relies heavily on bioinformatics support, as massive amounts of data are produced.

The sequenced data must then be analyzed. The various bases must be called, and reads must be correctly aligned to the reference sequence. Each base has various short reads that align to it. The number of reads that overlap a particular location is referred to as coverage. The variants (differences in DNA being analyzed compared with the reference sequence) must then be called and annotated. Sufficient coverage is essential for accurate identification and annotation of variants.7 In areas with inadequate coverage, Sanger sequencing is often utilized to ensure accuracy. This information must then be translated into the clinical report. Again, each of these steps allows room for variation.

Compiling and analyzing the massive amount of data produced by NGS require extensive bioinformatics and computing power. The ability to shorten turnaround time and automate steps in analysis is dependent on advances in bioinformatics and computing power. As technology continues to improve, knowledge of gene functions increases, and more variants are characterized, whole exome and genome sequencing are anticipated to replace targeted panels.

NGS cancer panels have been clinically available only since 2012 and have included BRCA since 2013. In this short time period, the impact on diagnosing inherited cancer syndromes has been demonstrated. No longer must a clinician rely on a sequential testing strategy; rather he or she can utilize a concurrent approach via a multigene test. For example, historically, a woman diagnosed with breast cancer at age 34 might have BRCA1/2 testing, and, if the result was negative, TP53 analysis might then occur. Depending on the family history, other genes might be in the differential diagnosis. Assuming that TP53 was negative, these additional genes might then be analyzed.

However, such an approach is often not realistic when a woman and her healthcare team are relying on this information for surgical decision making, and, even when time is not an issue, such an approach is often cost prohibitive. NGS has helped lessen these barriers via the creation of targeted panels. Additionally, through these targeted panels the phenotypic knowledge of cancer syndromes has begun expanding, and there have been increased diagnoses in syndromes previously thought to be rare.4,8,9 NGS

www.TheOncologyNurse.com

and genetics are in their infancy, and the clinical utility of testing will continue to expand. l References

1. Sanger F, Nicklen S, Coulson AR. DNA sequencing with chain-terminating inhibitors. Proc Natl Acad Sci U S A. 1977;74(12):5463-5467.

2. Rizzo JM, Buck MJ. Key principles and clinical applications of “next-generation” DNA sequencing. Cancer Prev Res. 2012;5(7):887-900.

3. Pilgrim SM, Pain SJ, Tischkowitz MD. Opportunities and challenges of next-generation DNA sequencing for breast units. Br J Surg. 2014;101(8):889-898.

4. Laduca H, Stuenkel AJ, Dolinsky JS, et al. Utilization of multigene panels in hereditary cancer predisposition testing: analysis of more than 2,000 patients [published online ahead of print April 24, 2014]. Genet Med. doi:10.1038/gim.2014.40.

5. Rehm HL, Bale SJ, Bayrak-Toydemir P, et al; Working Group of the American College of Medical Genetics and Genomics Laboratory Quality Assurance Committee.

ACMG clinical laboratory standards for next-generation sequencing. Genet Med. 2013;15(9):733-747.

6. American Civil Liberties Union. BRCA FAQs.

https://aclu.org/free-speech/brca-faqs. Accessed June 23, 2014.

7. Zhang J, Chiodini R, Badr A, et al. The impact of next-generation sequencing on genomics. J Genet Genomics. 2011;38(3):95-109.

8. Walsh T, Casadei S, Lee MK, et al. Mutations in 12 genes for inherited ovarian, fallopian tube, and peritoneal carcinoma identified by massively parallel sequencing.

Proc Natl Acad Sci U S A. 2011;108(44):18032-18037.

9. Cragun D, Radford C, Dolinsky JS, et al. Panel-based testing for inherited colorectal cancer: a descriptive study of clinical testing performed by a US laboratory [published online ahead of print February 9, 2014]. Clin Genet. doi:10.1111/cge.12359.

Noteworthy Numbers

Health Literacy As originally defined by researchers with the National Library of Medicine in 2000, health literacy is “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”1 In advance of the October observance of Health Literacy Month, here is additional information regarding this important issue.

In 2003, more than 19,000 Americans aged 16 years and older participated in the National Assessment of Adult Literacy, which included, for the first time, a health literacy component. Health literacy was reported using 4 performance levels: Below Basic, Basic, Intermediate, and Proficient. Rates reported were2:

6. I ncrease basic research and the development, implementation, and evaluation of practices and interventions to improve health literacy.

• Intermediate 53% • Basic 22% • Below Basic 14% • Proficient 11%

On its Health Literacy website, the Centers for Disease Control and Prevention lists health literacy activities for 20 states.4

In 2010, the US Department of Health and Human Services released the National Action Plan to Improve Health Literacy, which includes 7 goals3: 1. D evelop and disseminate health and safety information that is accurate, accessible, and actionable.

2. P romote changes in the healthcare system that improve health information, communication, informed decision making, and access to health services.

3. I ncorporate accurate, standards-based, and developmentally appropriate health and science information and curricula in child care and education through the university level.

4. S upport and expand local efforts to provide adult education, English language instruction, and culturally and linguistically appropriate health information services in the community.

5. Build partnerships, develop guidance, and change policies.

7. I ncrease the dissemination and use of evidence-based health literacy practices and interventions.

From July 1, 2009, through June 30, 2012, Rutgers University School of Nursing and the Ironbound Community Corporation (ICC) collaborated on health literacy classes for non–English-speaking Latino immigrants in a Newark, New Jersey, neighborhood. The ICC held 6 sessions of Spanish-language health literacy classes, each lasting between 8 and 12 weeks. A total of 64 participants attended at least 80% of the classes, and most participants reported increased ability to access needed health services. About one-third of the agency’s staff were trained to identify and support clients with low health literacy, and the university updated its curriculum to include health literacy.5 In a recent small study of 65 patients and 30 nurses, results demonstrated that nurses were 6 times as likely to overestimate rather than underestimate patients’ health literacy.6 Sources 1. www.nlm.nih.gov/archive//20061214/pubs/cbm/hliteracy.html.

2. http://nces.ed.gov/pubsearch/pubsinfo.asp?pubid=2006483.

3. http://www.health.gov/communication/hlactionplan/.

4. http://www.cdc.gov/healthliteracy/statedata/index.html.

5. http://www.rwjf.org/en/research-publications/find-rwjf-research/2014/05/healthliteracy-101-in-newark--n-j-.html.

6. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3814908/.

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Conference News: AVBCC

Prospects for Personalization of Medicine Lie in Evidence Thresholds Wayne Kuznar

A

lthough targeted drug development and testing are clearly transforming medicine, resistance to greater uptake of personalized medicine includes a shift in the evidence threshold in personalized testing and drawbacks to the delivery system, including the cost of tests, said Peter B. Bach, MD, director of the Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York City, at the Fourth Annual Conference of the Association for Value-Based Cancer Care.

There are many obstacles to actualizing the value of personalized medicine, according to Bach. The question is, how far and how soon could we get there?

“Can we target tumors more precisely?” he asked. “Can we turn the immune system into our ally? Can we shut off critical mechanisms in cancer cell cycles in a way that has limited toxicity? Can we become more precise?”

Molecular Testing Is Changing The traditional cancer treatment has an established taxonomy, with the treatment based on an established test and disease characteristics (eg, HER2 amplification and breast cancer). Insurers then work around the lack of specific coding for the test. In the case of breast cancer, for example, UnitedHealthcare instituted a program whereby the results of HER2

The paradigm for cancer drug development, approval, and labeling may eventually change from one based on the organ site of the cancer, the cancer stage, and the cell type to mutation status or biologic pathway.

testing had to be communicated before trastuzumab treatment would be covered.

The payment action on the test was stopped until the test results were known, not before the test was performed, said Bach. “That matters, and it also matters as we move toward this place where the tests themselves will be expensive. If you put the barricade after the test, then it’s going to have a different effect on utilization than if you do it before.”

The paradigm for cancer drug development, approval by the US Food and Drug Administration (FDA), and labeling may eventually change from one based on the site of the cancer, the cancer stage, and the cell type to mutation status or biologic pathway. “As we move forward, the FDA has been heavy-handed about saying that we’re going to live in a new age of paired diagnostics,” he said. Crizotinib was the prototype for this model, with the test

Figure. Pricing Trends: Monthly and Median Costs of Cancer Drugs, 1965-2014

Individual Drugs Median Monthly Price (per 5-year period)

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codeveloped with the drug manufacturer within the context of a clinical trial.

According to Bach, however, the age of paired diagnostics may already be over, as the number of required tests and tissue samples becomes cumbersome. “We’re going to rapidly need to do too many assays and look for too many different mutations in any particular organ type for us to stick with a paired paradigm,” he said. “I think testing for multiple mutations at the same time in the tumor is where we’re going to end up.”

Building of Evidence An evidence shift is taking place around personalized testing. The first trend is an evolution in recognizing that not all tests are equivalent. HER2 testing errors occur in approximately 20% of samples, resulting in misclassification of patients.

In addition, there are many flavors of alterations with similar biologic activity (ie, base pair substitutions, deletions, copy number alterations), not simply the alteration that was studied. It is also clear that there is no gold standard in test development.

The targets and compounds number in the hundreds. Tests themselves are becoming a cost center, sometimes running into the thousands of dollars. “Payers are noticing the costs of these tests, and they’re trying to figure out what the standard should be for them,” said Bach.

The tests are opening up a Pandora’s box in treatment: any mutation found anywhere could become justification for a trial of treatment. “There is a fear that it’s going to lead to wild experimentation without the capture of data, and I think that’s a legitimate one,” he said.

Payers also have operational challenges, he said. Insurers generally cover tests under fairly simple rules that can be administered, such as obtaining a HER2 assay in a patient with breast cancer. But the new multigene tests themselves are complex, as are the clinical scenarios (ie, first, second, or third line of therapy; the indication for the agent being considered; the results of other tests). It is not

clear that oncologists will know how to respond to the coming barrage of information.

The appropriate evidence standard remains open, said Bach. Moving from a test result to improved outcome should be one standard, he argued. The evidence for off-label uses of agents should go beyond supposition, but randomized controlled trials are not feasible for every possibility.

“We’re probably headed for a case series kind of approach,” he said.

The FDA often accelerates drug approval based on single-arm studies with surrogate end points—essentially case series. Imatinib, for example, was approved with evidence of cytogenetic changes on sequential case series, and ceritinib was approved on the basis of response rate in a single-arm trial. Disease registries such as those used by Medicare

Tests themselves are becoming a cost center, sometimes running into the thousands of dollars. for coverage under evidence development are also fundamentally case series, he said.

“The essential features of [case series/ registries] are that they are sequential,” said Bach. “There’s no cherry picking; they enroll all comers.” They capture high-quality data with deep follow-up, with no bias introduced from loss to follow-up or end-point evaluation triggered by clinical events. Outcomes otherwise must be known from historical data.

Until evidence is built correctly, the default stance will be very conservative.

“We have shown ourselves to be somewhat aggressive about pushing the envelope for using expensive therapies when they are not indicated, so the default is the resistance of 2 opposing forces,” he said.

Pricing trends are also a problem, with monthly and median costs of cancer drugs at the time of FDA approval increasing exponentially over the years (Figure).

“Any issue we have with off-label use of drugs that are targeted is going to get worse as the prices go higher,” said Bach. l Reference

Bach PB. Prospects and promise for personalization.

Presented at: 4th Annual Conference of the Association for Value-Based Cancer Care; May 6-9, 2014; Los Angeles, CA.

www.TheOncologyNurse.com

The Whole Patient

Exercise for Cancer Survivors Alice Goodman

D

espite the well-known benefits of physical activity for general health and for cancer survivors, only about 1 in 10 of all cancer survivors are doing enough exercise to gain benefits, according to a study reported

by Yale investigators at the American

Association for Cancer Research 2014 annual meeting.

The level of physical activity recommended for cancer survivors by the US Department of Health and Human Services is 150 minutes of moderateintensity physical exercise, or 75 minutes

of vigorous exercise, and 2 sessions of strength training every week. In a large US study of cancer survivors, only 10% met the recommended level of physical activity.

Interestingly, survivors who did exercise at the recommended level reported

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The Academy of Oncology Nurse & Patient Navigators (AONN+) invites you to share your story of how cancer has affected you or a loved one. These stories will serve as a forum to build awareness and be a source of inspiration and reassurance to others. Select stories will be featured on the AONN+ website and in future issues of the Journal of Oncology Navigation & Survivorship®.

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“The finding that only 10% of cancer survivors meet physical activity guidelines is very concerning. We know that exercise not only improves multiple aspects of quality of life, but other studies have shown that it is also associated with lower risk of recurrence and mortality,” Irwin said. “The 10% rate is what we see in the general healthy adult population, so we need to make huge efforts to increase physical activity for everyone.”

Senior author of the study, Anees Chagpar, MD, director of the Breast Center at Smilow Cancer Hospital at Yale-New Haven, said that exercise should be a priority for patients and physicians. “Perhaps we as oncologists should be writing more prescriptions for physical activity,” she stated. l Reference

AONNFacesofHopeAsize_53014

Share Your StorY With uS!

“We know that exercise not only improves multiple aspects of quality of life, but other studies have shown that it is also associated with lower risk of recurrence and mortality.”

Melinda Irwin, PhD

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improved quality of life, with less fatigue, improved mental and physical health, and increased satisfaction in social activities and relationships compared with those who did not exercise.

One of the study investigators, Melinda Irwin, PhD, codirector of the Cancer Prevention and Control Research Program at Yale Cancer Center and associate professor at the Yale School of Public Health in New Haven, Connecticut, said most studies of exercise and cancer are in breast cancer survivors. The present study was based on the 2010 National Health Interview Survey that included a large sample of more than 19 million cancer survivors with more than 10 different types of cancer.

Tewari A, Irwin M, Chagpar A. Physical activity is associated with improved quality of life in cancer survivors: a population-based analysis. Presented at: 2014 Annual Meeting of the American Association for Cancer Research; April 5-9, 2014; San Diego, CA. Abstract 5039.

See the TON May/June issue for the article ONS Exercise Campaign Aims to Improve Outcomes.

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