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NPWomensHealthcare.com September 2018 • Volume 6 • Number 3 Healthcare Womens The official journal of A clinical journal for NPs’

CONTINUING EDUCATION Managing women’s health issues across a lifespan

Challenges of preconception Developing and implementing NPWH POSITION STATEMENT and interconception care: PrEP at your local health center Men with breast conditions: Environmental toxic exposures The role of the WHNP specializing in breast care

A Publication

STAFF Group Publisher Gregory P. Osborne Director, Marketing & Program Mgmt. Tyra London NPWH CEO EDITOR-IN-CHIEF Gay Johnson Beth Kelsey, EdD, APRN, WHNP-BC, FAANP Assistant Professor Editor-in-Chief School of Nursing Beth Kelsey, EdD, APRN, WHNP-BC, FAANP Ball State University Managing Editor Muncie, Indiana Dory Greene Art Director Michael F. Higgins EDITORIAL ADVISORY BOARD Lorraine Byrnes, PhD, FNP-BC, PMHNP-BC, CNM, FAANP Production Director Associate Professor/Associate Dean Undergraduate Nursing Programs Christian Evans Gartley Hunter College of the City University of New York New York, New York PUBLISHED BY Helen A. Carcio, MS, MEd, ANP-BC HealthCom Media Director, Health & Continence Institute of New England 259 Veterans Lane, Doylestown, PA 18901 South Deerfield, Massachusetts Telephone: 215/489-7000 Facsimile: 215/230-6931 Melanie Deal, MSN, WHNP-BC, FNP-BC Clinical Practice, University Health Services Chief Executive Officer University of California, Berkeley Gregory P. Osborne Barb Dehn, RN, MS, NP, FAANP, NCMP Executive Vice President, Sales & Operations Women’s Health Nurse Practitioner Melissa Warner El Camino Women’s Medical Group Mountain View, California Vice President of Publishing & Sales Sofia Goller Linda Dominguez, WHNP Clinician/Consultant Account Managers Southwest Women’s Health John Travaline, Meg Celmayster, Albuquerque, New Mexico Mary Chris Schueren Brooke Faught, MSN, WHNP-BC, IF Senior Project Manager Nurse Practitioner/Clinical Director John McInerney Women’s Institute for Sexual Health, A Division of Urology Associates Nashville, Tennessee Digital Design Manager Wendy Grube, PhD, CRNP, FAAN Michelle Welliver Practice Associate Professor Digital Project Assistant Director, Women’s Health Gender-Related Nurse Practitioner Program Abigail L. Snyder University of Pennsylvania School of Nursing Philadelphia, Pennsylvania Finance Director MaryAnn Fosbenner Caroline M. Hewitt, DNS, WHNP-BC, ANP-BC Assistant Professor & DNP Program Coordinator Business Manager Hunter College of the City University of New York Jennifer Felzer School of Nursing New York, New York Women’s Healthcare: A Clinical Journal for NPs (ISSN 2331-0944) is published by HealthCom Media, Aimee Holland, DNP, WHNP-BC, FNP-C, RD, FAANP 259 Veterans Lane, Doylestown, PA 18901. Printed in the USA. Associate Professor Copyright © 2018 by HealthCom Media. All rights reserved. No DNP Program Director part of this publication may be reproduced, stored, or trans- The University of Alabama at Birmingham School of Nursing mitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and Gay Johnson, BA retrieval system, without permission in writing from the copy- Chief Executive Officer right holder. Send communication to HealthCom Media, 259 National Association of Nurse Practitioners in Women’s Health Veterans Lane, Doylestown, PA 18901. Washington, DC The opinions expressed in the editorial and advertising material in this issue are those of the authors and advertisers and do not Susan Kendig, JD, MSN, WHNP-BC, FAANP necessarily reflect the opinions or recommendations of the Na- Teaching Professor and WHNP Emphasis Area Coordinator tional Association of Nurse Practitioners in Women’s Health; the University of Missouri-St. Louis Editorial Advisory Board members; or the Publisher, Editors, and Consultant, Health Policy Advantage, LLC the staff of Women’s Healthcare St. Louis, Missouri . Editorial Mission: Women’s Healthcare, the official journal of Amy Levi, CNM, WHNP-BC, PhD, FACNM, FAAN the National Association of Nurse Practitioners in Women’s Leah L. Albers Professor of Midwifery Health, provides NPs and other advanced practice nurses University of New Mexico providing healthcare to women with comprehensive, timely, Albuquerque, New Mexico useful, evidence-based information to empower them to set a new standard for women’s healthcare throughout the Susan Rawlins, RN, MS, WHNP continuum of a patient’s life; to maximize their educational Director of Education foundation of best practices; and to assist them in the ad- National Association of Nurse Practitioners in Women’s Health vancement of their professional practice and career. Washington, DC Women’s Healthcare is indexed in CINAHL. Suzanne L Reiter, MM, MSN, WHNP-BC, FAANP The peer-reviewed content of the journal consists of articles Advanced Nurse Practitioner Specialist written by experts in their fields. This content is presented in Mid-County Health Center cutting-edge digital turn-page format deployed electronically to Largo, Florida members every quarter. Mary M. Rubin RNC, PhD, CRNP, FAANP The publication attempts to select authors who are knowledge- Associate Clinical Professor, Research Coordinator for Gyn Oncology able in their fields; however, it does not warrant the expertise of any author, nor is it responsible for any statements made by any Gyn/Anal Dysplasia Clinic, UCSF Helen Diller Family Comprehensive Cancer Center author. Certain statements about the use, dosage, efficacy, and San Francisco, California characteristic of some drugs mentioned here reflect the opinions Kathryn Trotter, DNP, CNM, FNP, FAANP, FAAN or investigational experience of the author. Any procedures, Associate Professor medications, or other courses of diagnosis or treatment dis- Duke University School of Nursing cussed or suggested by authors should not be used by clinicians without evaluations of their patients’ conditions and possible Durham, North Carolina contraindications or danger in use, review of any applicable manufacturer’s prescribing information, and comparison with the recommendations of other authorities. 2 September 2018 Women’s Healthcare NPWomensHealthcare.com NPWomensHealthcare.com September 2018 • Volume 6 • Number 3

features 12 Continuing Education: Managing women’s health issues across a lifespan:

NPWH 2017-2018 regional meetings page 12 By Beth Kelsey, EdD, APRN, WHNP-BC, FAANP Clinical scenarios on the topics of contraception, osteoporosis, bacterial vaginosis, and hypoactive sexual desire disorder illustrate the interactive learning strategy used by presenters at NPWH regional meetings. 26 Developing and implementing PrEP at your local health center By Brenda A. Wolfe, MSN, APN, ACRN; Elizabeth Higgins, MSN, WHNP; Michelle Vos, MA; and Amy Whitaker, MD The authors describe the logistics of developing and implementing a pre-exposure prophylaxis program at multiple Planned Parenthood of Illinois health centers. page 26 35 Challenges of preconception and interconception care: Environmental toxic exposures By Diane Schadewald, DNP, MSN, RN, FNP-BC, WHNP-BC and Ursula A. Pritham, PhD, WHNP-BC, FNP-BC, SANE This article offers healthcare providers up-to-date information about the impact of a variety of potentially toxic environmental exposures on reproductive health, specifically with respect to preconception and interconception care. page 35 51 NPWH 2017 conference abstracts We proudly share abstracts of the podium presenters and the first- and second-place poster award winners from last year’s NPWH conference. departments 8 Editor-in-chief’s message page 51 A message from editor-in-chief Beth Kelsey, EdD, APRN, WHNP-BC, FAANP 11 NPWH news & updates News from Gay Johnson, CEO of NPWH 23 NPWH Position Statement Men with breast conditions: The role of the WHNP specializing in breast care 40 Clinical resources Effects of environmental toxins on reproductive health and pregnancy, by Diane Schadewald, DNP, MSN, RN, FNP-BC, WHNP-BC and Ursula A. Pritham, PhD, page 42 WHNP-BC, FNP-BC, SANE 42 DNP projects: Spotlight on practice Educational interventions to increase Tdap vaccination rates among pregnant women, by Cari McAlister, DNP, MSN, WHNP-BC; Ginny Moore Wurttemberg, DNP, MSN, CNM; Donna Dunn, PhD, CNM, FNP-BC; and Tedra Smith, DNP, CPNP-PC, CNE

45 Policy & practice points page 45 Health policy and the female caregiver: The impact on women’s health, by Diana M. Drake, DNP, MSN, APRN, WHNP-BC 48 Commentary WHNPs in specialty positions: My experience in breast surgical oncology, by Caitlyn E. Hull, MS, APRN-CNP, WHNP-BC and Randee L. Masciola, DNP, APRN-CNP, WHNP-BC 55 Focus on sexual health Pessary use for pelvic organ prolapse in sexually active women, page 55 by Brooke M. Faught, MSN, WHNP-BC, IF

NPWomensHealthcare.com September 2018 Women’s Healthcare 3 NEXPLANON — 1 ARM IMPLANT provides up to 3 years of pregnancy prevention* (Actual implant shown; actual implant size is 4cm)

>99% effective† Placed subdermally in the inner upper arm just under the skin

*NEXPLANON must be removed by the end of the third year and may be replaced by another NEXPLANON at the time of removal, if continued contraceptive protection is desired.

Model †Less than 1 pregnancy per 100 women who used NEXPLANON for 1 year.

NEXPLANON is indicated for use by women to prevent pregnancy. SELECTED SAFETY INFORMATION (continued) • Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, SELECTED SAFETY INFORMATION NEXPLANON should not be used prior to 21 days postpartum. Who is not appropriate for NEXPLANON • Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. • NEXPLANON should not be used in women who have known or suspected pregnancy; current or past Consider removing the NEXPLANON implant in case of long-term immobilization due to surgery or illness. history of thrombosis or thromboembolic disorders; liver tumors, benign or malignant, or active liver disease; undiagnosed abnormal genital bleeding; known or suspected breast cancer, personal history of breast cancer, Counsel her about changes in bleeding patterns or other progestin-sensitive cancer, now or in the past; and/or allergic reaction to any of the components of • Women are likely to have changes in their menstrual bleeding pattern with NEXPLANON, including changes NEXPLANON. in frequency, intensity, or duration. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. In clinical studies of the non-radiopaque etonogestrel implant, changes in bleeding WARNINGS and PRECAUTIONS pattern were the most common reason reported for stopping treatment (11.1%). Counsel women regarding Complications of insertion and removal potential changes they may experience. • NEXPLANON should be inserted subdermally and be palpable after insertion. Palpate immediately after Be aware of other serious complications, adverse reactions, and drug interactions insertion to ensure proper placement. Undetected failure to insert the implant may lead to unintended pregnancy. Failure to remove the implant may result in continued effects of etonogestrel, such as • Remove NEXPLANON if jaundice occurs. compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event. • Remove NEXPLANON if blood pressure rises significantly and becomes uncontrolled. • Insertion and removal-related complications may include pain, paresthesias, bleeding, hematoma, scarring, • Prediabetic and diabetic women using NEXPLANON should be carefully monitored. or infection. If NEXPLANON is inserted too deeply (intramuscular or in the fascia), neural or vascular injury • Carefully observe women with a history of depressed mood. Consider removing NEXPLANON in patients who may occur. Implant removal may be difficult or impossible if the implant is not inserted correctly, inserted too become significantly depressed. deeply, not palpable, encased in fibrous tissue, or has migrated. If at any time the implant cannot be palpated, • The most common adverse reactions (≥10%) reported in clinical trials were headache (24.9%), vaginitis it should be localized and removal is recommended. (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis • There have been postmarketing reports of implants located within the vessels of the arm and the pulmonary (10.5%). artery, which may be related to deep insertions or intravascular insertion. Endovascular or surgical procedures • Drugs or herbal products that induce enzymes, including CYP3A4, may decrease the effectiveness of may be needed for removal. NEXPLANON or increase breakthrough bleeding. NEXPLANON and pregnancy • The efficacy of NEXPLANON in women weighing more than 130% of their ideal body weight has not been studied. Serum concentrations of • Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or etonogestrel are inversely related to body weight and decrease with time complain of lower abdominal pain. after implant insertion. Therefore, NEXPLANON may be less effective in • Rule out pregnancy before inserting NEXPLANON. overweight women. • Counsel women to contact their health care provider immediately if, at any Educate her about the risk of serious vascular events time, they are unable to palpate the implant. • The use of combination hormonal contraceptives increases the risk of vascular events, including arterial • NEXPLANON does not protect against HIV or other STDs. events [stroke and myocardial infarction (MI)] or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis (DVT), retinal vein thrombosis, and pulmonary embolism). Women with risk factors Please read the adjacent Brief Summary of the Prescribing Information known to increase the risk of these events should be carefully assessed. Postmarketing reports in women using the nonradiopaque etonogestrel implant have included pulmonary emboli (some fatal), DVT, MI, and stroke. NEXPLANON should be removed if thrombosis occurs.

Copyright © 2017 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. All rights reserved. WOMN-1233494-0000 10/17 NEXPLANON — 1 ARM IMPLANT provides up to 3 years of pregnancy prevention* (Actual implant shown; actual implant size is 4cm)

>99% effective† Placed subdermally in the inner upper arm just under the skin

*NEXPLANON must be removed by the end of the third year and may be replaced by another NEXPLANON at the time of removal, if continued contraceptive protection is desired.

Model †Less than 1 pregnancy per 100 women who used NEXPLANON for 1 year.

Copyright © 2017 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. All rights reserved. WOMN-1233494-0000 10/17 Table 2: Bleeding Patterns Using the Non-Radiopaque Etonogestrel Implant (IMPLANON) During the First 2 Years of Use* Bleeding Patterns Definitions %† BRIEF SUMMARY (For full Prescribing Information, see package insert.) Infrequent Less than three bleeding and/or spotting episodes in 33.6 Women should be informed that this product does not protect against HIV infection (the virus 90 days (excluding amenorrhea) 14. Fluid Retention Substances increasing the plasma concentrations of HCs: Co-administration of certain HCs and that causes AIDS) or other sexually transmitted diseases. Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit Amenorrhea No bleeding and/or spotting in 90 days 22.2 INDICATION AND USAGE with caution, and only with careful monitoring, in patients with conditions which might be juice, or ketoconazole may increase the serum concentrations of progestins, including etonogestrel. NEXPLANON is indicated for use by women to prevent pregnancy. Prolonged Any bleeding and/or spotting episode lasting more than 17.7 aggravated by fluid retention. It is unknown if NEXPLANON causes fluid retention. Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non- 15. Contact Lenses DOSAGE AND ADMINISTRATION 14 days in 90 days nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the Contact lens wearers who develop visual changes or changes in lens tolerance should be plasma concentrations of progestin have been noted in cases of co-administration with HIV protease The efficacy of NEXPLANON does not depend on daily, weekly or monthly administration. All healthcare Frequent More than 5 bleeding and/or spotting episodes in 90 days 6.7 assessed by an ophthalmologist. providers should receive instruction and training prior to performing insertion and/or removal of NEXPLANON. inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ A single NEXPLANON implant is inserted subdermally in the upper arm. To reduce the risk of neural * Based on 3315 recording periods of 90 days duration in 780 women, excluding the first 90 days 16. In Situ Broken or Bent Implant ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease or vascular injury, the implant should be inserted at the inner side of the non-dominant upper arm after implant insertion There have been reports of broken or bent implants while in the patient’s arm. Based on in inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase data, when an implant is broken or bent, the release rate of etonogestrel may be slightly about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. The implant should be † % = Percentage of 90-day intervals with this pattern vitro inhibitors (decrease [e.g., nevirapine, efavirenz] or increase [e.g., etravirene]). These changes may be increased. When an implant is removed, it is important to remove it in its entirety inserted subdermally just under the skin, avoiding the sulcus (groove) between the biceps and triceps [see Dosage clinically relevant in some cases. Consult the prescribing information of anti-viral and anti-retroviral In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures and Administration]. concomitant medications to identify potential interactions. muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper should be conducted to rule out malignancy. in the subcutaneous tissues. An implant inserted more deeply than subdermally (deep insertion) 17. Monitoring Effects of Hormonal Contraceptives on Other Drugs 3. Ectopic Pregnancies A woman who is using NEXPLANON should have a yearly visit with her healthcare provider for may not be palpable and the localization and/or removal can be difficult or impossible[see Dosage Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma As with all progestin-only contraceptive products, be alert to the possibility of an ectopic a blood pressure check and for other indicated health care. and Administration and Warnings and Precautions]. NEXPLANON must be inserted by the expiration concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine). date stated on the packaging. NEXPLANON is a long-acting (up to 3 years), reversible, hormonal pregnancy among women using NEXPLANON who become pregnant or complain of 18. Drug-Laboratory Test Interactions Consult the labeling of all concurrently-used drugs to obtain further information about interactions contraceptive method. The implant must be removed by the end of the third year and may be replaced lower abdominal pain. Although ectopic pregnancies are uncommon among women using Sex hormone-binding globulin concentrations may be decreased for the first six months after with hormonal contraceptives or the potential for enzyme alterations. by a new implant at the time of removal, if continued contraceptive protection is desired. NEXPLANON, a pregnancy that occurs in a woman using NEXPLANON may be more likely to NEXPLANON insertion followed by gradual recovery. Thyroxine concentrations may initially be be ectopic than a pregnancy occurring in a woman using no contraception. slightly decreased followed by gradual recovery to baseline. USE IN SPECIFIC POPULATIONS CONTRAINDICATIONS 1. Pregnancy 4. Thrombotic and Other Vascular Events NEXPLANON should not be used in women who have ADVERSE REACTIONS Ri sk Summary • Known or suspected pregnancy The use of combination hormonal contraceptives (progestin plus estrogen) increases the In clinical trials involving 942 women who were evaluated for safety, change in menstrual bleeding NEXPLANON is contraindicated during pregnancy because there is no need for pregnancy • Current or past history of thrombosis or thromboembolic disorders risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep patterns (irregular menses) was the most common adverse reaction causing discontinuation of use prevention in a woman who is already pregnant [see Contraindications]. Epidemiologic studies ® • Liver tumors, benign or malignant, or active liver disease venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein of the non-radiopaque etonogestrel implant (IMPLANON [etonogestrel implant]) (11.1% of women). and meta-analyses have not shown an increased risk of genital or non-genital birth defects • Undiagnosed abnormal genital bleeding thrombosis, and pulmonary embolism). NEXPLANON is a progestin-only contraceptive. It is Adverse reactions that resulted in a rate of discontinuation of ≥1% are shown in Table 3. (including cardiac anomalies and limb-reduction defects) following maternal exposure to • Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive unknown whether this increased risk is applicable to etonogestrel alone. It is recommended, low dose CHCs prior to conception or during early pregnancy. No adverse development however, that women with risk factors known to increase the risk of venous and arterial Table 3: Adverse Reactions Leading to Discontinuation of Treatment in 1% or More cancer, now or in the past of Subjects in Clinical Trials of the Non-Radiopaque Etonogestrel Implant (IMPLANON) outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel • Allergic reaction to any of the components of NEXPLANON [see Adverse Reactions] thromboembolism be carefully assessed. There have been postmarketing reports of serious during organogenesis at doses of 315 or 781 times the anticipated human dose (60 μg/day). arterial and venous thromboembolic events, including cases of pulmonary emboli (some Adverse Reactions All Studies NEXPLANON should be removed if maintaining a pregnancy. WARNINGS AND PRECAUTIONS fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel N = 942 The following information is based on experience with the etonogestrel implants (IMPLANON® 2. Nursing Mothers implants. NEXPLANON should be removed in the event of a thrombosis. Bleeding Irregularities* 11.1% [etonogestrel implant] and/or NEXPLANON), other progestin-only contraceptives, or Lactation experience with combination (estrogen plus progestin) oral contraceptives. Due to the risk of thromboembolism associated with pregnancy and immediately following Emotional Lability† 2.3% Risk Summary 1. Complications of Insertion and Removal delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present Weight Increase 2.3% NEXPLANON should be inserted subdermally so that it is palpable after insertion, and this should be thromboembolic disorders should be made aware of the possibility of a recurrence. Evaluate for in human milk. No significant adverse effects have been observed in the production or quality confirmed by palpation immediately after insertion. Failure to insert NEXPLANON properly may go retinal vein thrombosis immediately if there is unexplained loss of vision, proptosis, diplopia, Headache 1.6% of breast milk, or on the physical and psychomotor development of breastfed infants. Hormonal unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant papilledema, or retinal vascular lesions. Consider removal of the NEXPLANON implant in case contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. may lead to an unintended pregnancy. Complications related to insertion and removal procedures, of long-term immobilization due to surgery or illness. Acne 1.3% This is less likely to occur once breastfeeding is well-established; however, it can occur at such as pain, paresthesias, bleeding, hematoma, scarring or infection, may occur. 5. Ovarian Cysts Depression‡ 1.0% any time in some women. When possible, advise the nursing mother about both hormonal and If NEXPLANON is inserted deeply (intramuscular or in the fascia), neural or vascular injury If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle non-hormonal contraceptive options, as steroids may not be the initial choice for these patients. * Includes “frequent”, “heavy”, “prolonged”, “spotting”, and other patterns of bleeding irregularity. may occur. To reduce the risk of neural or vascular injury, NEXPLANON should be inserted at may continue to grow beyond the size it would attain in a normal cycle. Generally, these The developmental and health benefits of breastfeeding should be considered along with the † Among US subjects (N=330), 6.1% experienced emotional lability that led to discontinuation. the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial enlarged follicles disappear spontaneously. On rare occasion, surgery may be required. ‡ mother’s clinical need for NEXPLANON and any potential adverse effects on the breastfed child epicondyle of the humerus. NEXPLANON should be inserted subdermally just under the skin Among US subjects (N=330), 2.4% experienced depression that led to discontinuation. from NEXPLANON or from the underlying maternal condition. 6. Carcinoma of the Breast and Reproductive Organs avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels Women who currently have or have had breast cancer should not use hormonal contraception Other adverse reactions that were reported by at least 5% of subjects in the non-radiopaque 3. Pediatric Use and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissues. Deep etonogestrel implant clinical trials are listed in Table 4. because breast cancer may be hormonally sensitive [see Contraindications]. Some studies Safety and efficacy of NEXPLANON have been established in women of reproductive age. insertions of NEXPLANON have been associated with paraesthesia (due to neural injury), Safety and efficacy of NEXPLANON are expected to be the same for postpubertal adolescents. migration of the implant (due to intramuscular or fascial insertion), and intravascular insertion. suggest that the use of combination hormonal contraceptives might increase the incidence of Table 4: Common Adverse Reactions Reported by ≥5% of Subjects in Clinical Trials breast cancer; however, other studies have not confirmed such findings. Some studies suggest With the Non-Radiopaque Etonogestrel Implant (IMPLANON) However, no clinical studies have been conducted in women less than 18 years of age. Use of If infection develops at the insertion site, start suitable treatment. If the infection persists, the this product before menarche is not indicated. that the use of combination hormonal contraceptives is associated with an increase in the risk implant should be removed. Incomplete insertions or infections may lead to expulsion. All Studies of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to Adverse Reactions 4. Geriatric Use Implant removal may be difficult or impossible if the implant is not inserted correctly, is N = 942 This product has not been studied in women over 65 years of age and is not indicated in this population. inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. which these findings are due to differences in sexual behavior and other factors. Women with a Headache 24.9% 5. Hepatic Impairment There have been reports of migration of the implant within the arm from the insertion site, family history of breast cancer or who develop breast nodules should be carefully monitored. Vaginitis 14.5% No studies were conducted to evaluate the effect of hepatic disease on the disposition of which may be related to deep insertion. There also have been postmarketing reports of 7. Liver Disease NEXPLANON. The use of NEXPLANON in women with active liver disease is contraindicated implants located within the vessels of the arm and the pulmonary artery, which may be related Disturbances of liver function may necessitate the discontinuation of hormonal contraceptive use Weight increase 13.7% [see Contraindications]. to deep insertions or intravascular insertion. In cases where the implant has migrated to the until markers of liver function return to normal. Remove NEXPLANON if jaundice develops. Hepatic Acne 13.5% 6. Overweight Women pulmonary artery, endovascular or surgical procedures may be needed for removal. adenomas are associated with combination hormonal contraceptives use. An estimate of the Breast pain 12.8% The effectiveness of the etonogestrel implant in women who weighed more than 130% If at any time the implant cannot be palpated, it should be localized and removal is recommended. attributable risk is 3.3 cases per 100,000 for combination hormonal contraceptives users. It is not Abdominal pain 10.9% of their ideal body weight has not been defined because such women were not studied in Exploratory surgery without knowledge of the exact location of the implant is strongly known whether a similar risk exists with progestin-only methods like NEXPLANON. The progestin clinical trials. Serum concentrations of etonogestrel are inversely related to body weight and discouraged. Removal of deeply inserted implants should be conducted with caution in order in NEXPLANON may be poorly metabolized in women with liver impairment. Use of NEXPLANON in Pharyngitis 10.5% decrease with time after implant insertion. It is therefore possible that NEXPLANON may be to prevent injury to deeper neural or vascular structures in the arm and be performed by women with active liver disease or liver cancer is contraindicated [see Contraindications]. Leukorrhea 9.6% less effective in overweight women, especially in the presence of other factors that decrease healthcare providers familiar with the anatomy of the arm. If the implant is located in the 8. Weight Gain Influenza-like symptoms 7.6% serum etonogestrel concentrations such as concomitant use of hepatic enzyme inducers. chest, healthcare providers familiar with the anatomy of the chest should be consulted. Failure In clinical studies, mean weight gain in U.S. non-radiopaque etonogestrel implant (IMPLANON) to remove the implant may result in continued effects of etonogestrel, such as compromised Dizziness 7.2% OVERDOSAGE users was 2.8 pounds after one year and 3.7 pounds after two years. How much of the weight gain Overdosage may result if more than one implant is inserted. In case of suspected overdose, the fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event. Dysmenorrhea 7.2% was related to the non-radiopaque etonogestrel implant is unknown. In studies, 2.3% of the users implant should be removed. 2. Changes in Menstrual Bleeding Patterns reported weight gain as the reason for having the non-radiopaque etonogestrel implant removed. Back pain 6.8% After starting NEXPLANON, women are likely to have a change from their normal menstrual NONCLINICAL TOXICOLOGY bleeding pattern. These may include changes in bleeding frequency (absent, less, more 9. Elevated Blood Pressure Emotional lability 6.5% In a 24-month carcinogenicity study in rats with subdermal implants releasing 10 and 20 mcg frequent or continuous), intensity (reduced or increased) or duration. In clinical trials of the Women with a history of hypertension-related diseases or renal disease should be discouraged Nausea 6.4% etonogestrel per day (equal to approximately 1.8-3.6 times the systemic steady state exposure in non-radiopaque etonogestrel implant (IMPLANON), bleeding patterns ranged from amenorrhea from using hormonal contraception. For women with well-controlled hypertension, use of women using NEXPLANON), no drug-related carcinogenic potential was observed. Etonogestrel was Pain 5.6% (1 in 5 women) to frequent and/or prolonged bleeding (1 in 5 women). The bleeding pattern NEXPLANON can be considered. Women with hypertension using NEXPLANON should be not genotoxic in the in vitro Ames/Salmonella reverse mutation assay, the chromosomal aberration experienced during the first three months of NEXPLANON use is broadly predictive of the future closely monitored. If sustained hypertension develops during the use of NEXPLANON, or if Nervousness 5.6% assay in Chinese hamster ovary cells or in the in vivo mouse micronucleus test. Fertility in rats bleeding pattern for many women. Women should be counseled regarding the bleeding pattern a significant increase in blood pressure does not respond adequately to antihypertensive Depression 5.5% returned after withdrawal from treatment. changes they may experience so that they know what to expect. Abnormal bleeding should be therapy, NEXPLANON should be removed. Hypersensitivity 5.4% PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling. evaluated as needed to exclude pathologic conditions or pregnancy. 10. Gallbladder Disease • Counsel women about the insertion and removal procedure of the NEXPLANON implant. Provide the In clinical studies of the non-radiopaque etonogestrel implant, reports of changes in bleeding Studies suggest a small increased relative risk of developing gallbladder disease among Insertion site pain 5.2% woman with a copy of the Patient Labeling and ensure that she understands the information in the pattern were the most common reason for stopping treatment (11.1%). Irregular bleeding (10.8%) combination hormonal contraceptive users. It is not known whether a similar risk exists with Patient Labeling before insertion and removal. A USER CARD and consent form are included in the was the single most common reason women stopped treatment, while amenorrhea (0.3%) was progestin-only methods like NEXPLANON. In a clinical trial of NEXPLANON, in which investigators were asked to examine the implant site after packaging. Have the woman complete a consent form and retain it in your records. The USER CARD cited less frequently. In these studies, women had an average of 17.7 days of bleeding or spotting insertion, implant site reactions were reported in 8.6% of women. Erythema was the most frequent should be filled out and given to the woman after insertion of the NEXPLANON implant so that she every 90 days (based on 3,315 intervals of 90 days recorded by 780 patients). The percentages 11. Carbohydrate and Lipid Metabolic Effects Use of NEXPLANON may induce mild insulin resistance and small changes in glucose implant site complication, reported during and/or shortly after insertion, occurring in 3.3% of subjects. will have a record of the location of the implant in the upper arm and when it should be removed. of patients having 0, 1-7, 8-21, or >21 days of spotting or bleeding over a 90-day interval while Additionally, hematoma (3.0%), bruising (2.0%), pain (1.0%), and swelling (0.7%) were reported. • Counsel women to contact their healthcare provider immediately if, at any time, they are unable to using the non-radiopaque etonogestrel implant are shown in Table 1. concentrations of unknown clinical significance. Carefully monitor prediabetic and diabetic women using NEXPLANON. Women who are being treated for hyperlipidemia should be Effects of Other Drugs on Hormonal Contraceptives palpate the implant. Table 1: Percentages of Patients With 0, 1-7, 8-21, or >21 Days of Spotting or Bleeding Over followed closely if they elect to use NEXPLANON. Some progestins may elevate LDL levels and Substances decreasing the plasma concentrations of hormonal contraceptives (HCs) and • Counsel women that NEXPLANON does not protect against HIV or other STDs. • Counsel women that the use of NEXPLANON may be associated with changes in their normal a 90-Day Interval While Using the Non-Radiopaque Etonogestrel Implant (IMPLANON) may render the control of hyperlipidemia more difficult. potentially diminishing the efficacy of HCs: Drugs or herbal products that induce certain enzymes, menstrual bleeding patterns so that they know what to expect. Total Days of Percentage of Patients 12. Depressed Mood including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of HCs and Spotting or Bleeding Treatment Days Treatment Days Treatment Days Women with a history of depressed mood should be carefully observed. Consideration should potentially diminish the effectiveness of HCs or ncrease breakthrough bleeding. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of 91-180 271-360 631-720 be given to removing NEXPLANON in patients who become significantly depressed. Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. (N = 745) (N = 657) (N = 547) 13. Return to Ovulation rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between HCs 0 Days 19% 24% 17% In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use For more detailed information, please read the Prescribing Information. 1-7 Days 15% 13% 12% levels in blood decreased below sensitivity of the assay by one week after removal of the an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are USPI-MK8415-IPTX-1705r019 8-21 Days 30% 30% 37% implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Revised: 05/17 used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the >21 Days 35% 33% 35% Therefore, a woman should re-start contraception immediately after removal of the implant if enzyme inducer to ensure contraceptive reliability. Copyright © 2017 Merck Sharp & Dohme B.V., continued contraceptive protection is desired. Bleeding patterns observed with use of the non-radiopaque etonogestrel implant for up to 2 years, and a subsidiary of Merck & Co., Inc. All rights reserved. the proportion of 90-day intervals with these bleeding patterns, are summarized in Table 2. WOMN-1233494-0000 10/17 Table 2: Bleeding Patterns Using the Non-Radiopaque Etonogestrel Implant (IMPLANON) During the First 2 Years of Use* Bleeding Patterns Definitions %† BRIEF SUMMARY (For full Prescribing Information, see package insert.) BRIEF SUMMARY (For full Prescribing Information, see package insert.) InfrequentInfrequent Less than three bleeding and/or spotting episodes in 33.6 Women should be informed that this product does not protect against HIV infection (the virus 90 days (excluding amenorrhea) 14. Fluid Retention Substances increasing the plasma concentrations of HCs: Co-administration of certain HCs and that causes AIDS) or other sexually transmitted diseases. Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit Amenorrhea No bleeding and/or spotting in 90 days 22.2 INDICATION AND USAGE with caution, and only with careful monitoring, in patients with conditions which might be juice,juice, oror ketoconazoleketoconazole maymay increaseincrease thethe serumserum concentrationsconcentrations ofof progestins,progestins, includingincluding etonogestrel.etonogestrel. NEXPLANON is indicated for use by women to prevent pregnancy. Prolonged Any bleeding and/or spotting episode lasting more than 17.7 aggravated by fluid retention. It is unknown if NEXPLANON causes fluid retention. Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non- 15. Contact Lenses DOSAGE AND ADMINISTRATION 14 days in 90 days nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the Contact lens wearers who develop visual changes or changes in lens tolerance should be The efficacy of NEXPLANON does not depend on daily, weekly or monthly administration. All healthcare Frequent More than 5 bleeding and/or spotting episodes in 90 days 6.7 plasma concentrations of progestin have been noted in cases of co-administration with HIV protease The efficacy of NEXPLANON does not depend on daily, weekly or monthly administration. All healthcare Frequent More than 5 bleeding and/or spotting episodes in 90 days 6.7 assessed by an ophthalmologist. providers should receive instruction and training prior to performing insertion and/or removal of NEXPLANON. inhibitorsinhibitors (decrease(decrease [e.g.,[e.g., nelfinavir,nelfinavir, ritonavir,ritonavir, darunavir/ritonavir,darunavir/ritonavir, (fos)amprenavir/ritonavir,(fos)amprenavir/ritonavir, lopinavir/lopinavir/ * 16. Broken or Bent Implant A single NEXPLANON implant is inserted subdermally in the upper arm. To reduce the risk of neural * Based on 3315 recording periods of 90 days duration in 780 women, excluding the first 90 days 16. In Situ Broken or Bent Implant ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease There have been reports of broken or bent implants while in the patient’s arm. Based on or vascular injury, the implant should be inserted at the inner side of the non-dominant upper arm after implant insertion There have been reports of broken or bent implants while in the patient’s arm. Based on inin inhibitorsinhibitors (decrease(decrease [e.g.,[e.g., boceprevirboceprevir andand telaprevir])telaprevir]) oror withwith non-nucleosidenon-nucleoside reversereverse transcriptasetranscriptase vitro data, when an implant is broken or bent, the release rate of etonogestrel may be slightly about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. The implant should be † % = Percentage of 90-day intervals with this pattern vitro inhibitorsinhibitors (decrease(decrease [e.g.,[e.g., nevirapine,nevirapine, efavirenz]efavirenz] oror increaseincrease [e.g.,[e.g., etravirene]).etravirene]). TheseThese changeschanges maymay bebe increased.increased. WhenWhen anan implantimplant isis removed,removed, itit isis importantimportant toto removeremove itit inin itsits entiretyentirety [see Dosage clinically relevant in some cases. Consult the prescribing information of anti-viral and anti-retroviral insertedinserted subdermallysubdermally justjust underunder thethe skin,skin, avoidingavoiding thethe sulcussulcus (groove)(groove) betweenbetween thethe bicepsbiceps andand tricepstriceps In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures and Administration]. concomitant medications to identify potential interactions. muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper should be conducted to rule out malignancy. inin thethe subcutaneoussubcutaneous tissues.tissues. AnAn implantimplant insertedinserted moremore deeplydeeply thanthan subdermallysubdermally (deep(deep insertion)insertion) 17. Monitoring Effects of Hormonal Contraceptives on Other Drugs 3. Ectopic Pregnancies A woman who is using NEXPLANON should have a yearly visit with her healthcare provider for may not be palpable and the localization and/or removal can be difficult or impossible[see Dosage Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma As with all progestin-only contraceptive products, be alert to the possibility of an ectopic a blood pressure check and for other indicated health care. and Administration and Warnings and Precautions]. NEXPLANON must be inserted by the expiration concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine). pregnancy among women using NEXPLANON who become pregnant or complain of date stated on the packaging. NEXPLANON is a long-acting (up to 3 years), reversible, hormonal pregnancy among women using NEXPLANON who become pregnant or complain of 18. Drug-Laboratory Test Interactions Consult the labeling of all concurrently-used drugs to obtain further information about interactions lower abdominal pain. Although ectopic pregnancies are uncommon among women using contraceptive method. The implant must be removed by the end of the third year and may be replaced lower abdominal pain. Although ectopic pregnancies are uncommon among women using Sex hormone-binding globulin concentrations may be decreased for the first six months after with hormonal contraceptives or the potential for enzyme alterations. NEXPLANON, a pregnancy that occurs in a woman using NEXPLANON may be more likely to NEXPLANON insertion followed by gradual recovery. Thyroxine concentrations may initially be by a new implant at the time of removal, if continued contraceptive protection is desired. USE IN SPECIFIC POPULATIONS be ectopic than a pregnancy occurring in a woman using no contraception. slightly decreased followed by gradual recovery to baseline. USE IN SPECIFIC POPULATIONS CONTRAINDICATIONS 1. Pregnancy 4. Thrombotic and Other Vascular Events NEXPLANON should not be used in women who have ADVERSE REACTIONS Ri sk Summary The use of combination hormonal contraceptives (progestin plus estrogen) increases the • Known or suspected pregnancy The use of combination hormonal contraceptives (progestin plus estrogen) increases the InIn clinicalclinical trialstrials involvinginvolving 942942 womenwomen whowho werewere evaluatedevaluated forfor safety,safety, changechange inin menstrualmenstrual bleedingbleeding NEXPLANON is contraindicated during pregnancy because there is no need for pregnancy risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep • Current or past history of thrombosis or thromboembolic disorders risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep patterns (irregular menses) was the most common adverse reaction causing discontinuation of use prevention in a woman who is already pregnant [see Contraindications]. Epidemiologic studies ® • Liver tumors, benign or malignant, or active liver disease venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein of the non-radiopaque etonogestrel implant (IMPLANON [etonogestrel implant]) (11.1% of women). and meta-analyses have not shown an increased risk of genital or non-genital birth defects • Undiagnosed abnormal genital bleeding thrombosis, and pulmonary embolism). NEXPLANON is a progestin-only contraceptive. It is Adverse reactions that resulted in a rate of discontinuation of ≥1% are shown in Table 3. (including cardiac anomalies and limb-reduction defects) following maternal exposure to unknown whether this increased risk is applicable to etonogestrel alone. It is recommended, • Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive Table 3: Adverse Reactions Leading to Discontinuation of Treatment in 1% or More lowlow dosedose CHCsCHCs priorprior toto conceptionconception oror duringduring earlyearly pregnancy.pregnancy. NoNo adverseadverse developmentdevelopment however, that women with risk factors known to increase the risk of venous and arterial Table 3: Adverse Reactions Leading to Discontinuation of Treatment in 1% or More cancer, now or in the past of Subjects in Clinical Trials of the Non-Radiopaque Etonogestrel Implant (IMPLANON) outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel • Allergic reaction to any of the components of NEXPLANON [see Adverse Reactions] thromboembolism be carefully assessed. There have been postmarketing reports of serious during organogenesis at doses of 315 or 781 times the anticipated human dose (60 μg/day). arterial and venous thromboembolic events, including cases of pulmonary emboli (some Adverse Reactions All Studies NEXPLANON should be removed if maintaining a pregnancy. WARNINGS AND PRECAUTIONS NEXPLANON should be removed if maintaining a pregnancy. WARNINGS AND PRECAUTIONS fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel N = 942 The following information is based on experience with the etonogestrel implants (IMPLANON® 2. Nursing Mothers implants.implants. NEXPLANONNEXPLANON shouldshould bebe removedremoved inin thethe eventevent ofof aa thrombosis.thrombosis. Bleeding Irregularities* 11.1% [etonogestrel implant] and/or NEXPLANON), other progestin-only contraceptives, or Lactation Due to the risk of thromboembolism associated with pregnancy and immediately following experience with combination (estrogen plus progestin) oral contraceptives. Due to the risk of thromboembolism associated with pregnancy and immediately following Emotional Lability† 2.3% Riskisk SummarySummary 1. Complications of Insertion and Removal delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present Weight Increase 2.3% NEXPLANON should be inserted subdermally so that it is palpable after insertion, and this should be thromboembolic disorders should be made aware of the possibility of a recurrence. Evaluate for inin humanhuman milk.milk. NoNo significantsignificant adverseadverse effectseffects havehave beenbeen observedobserved inin thethe productionproduction oror qualityquality confirmed by palpation immediately after insertion. Failure to insert NEXPLANON properly may go retinal vein thrombosis immediately if there is unexplained loss of vision, proptosis, diplopia, Headache 1.6% of breast milk, or on the physical and psychomotor development of breastfed infants. Hormonal unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant papilledema, or retinal vascular lesions. Consider removal of the NEXPLANON implant in case contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. Acne 1.3% may lead to an unintended pregnancy. Complications related to insertion and removal procedures, of long-term immobilization due to surgery or illness. Acne 1.3% This is less likely to occur once breastfeeding is well-established; however, it can occur at such as pain, paresthesias, bleeding, hematoma, scarring or infection, may occur. 5. Ovarian Cysts Depression‡ 1.0% any time in some women. When possible, advise the nursing mother about both hormonal and If If NEXPLANONNEXPLANON isis insertedinserted deeplydeeply (intramuscular(intramuscular oror inin thethe fascia),fascia), neuralneural oror vascularvascular injuryinjury If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle non-hormonal contraceptive options, as steroids may not be the initial choice for these patients. If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle * Includes “frequent”, “heavy”, “prolonged”, “spotting”, and other patterns of bleeding irregularity. may occur. To reduce the risk of neural or vascular injury, NEXPLANON should be inserted at may continue to grow beyond the size it would attain in a normal cycle. Generally, these * Includes “frequent”, “heavy”, “prolonged”, “spotting”, and other patterns of bleeding irregularity. The developmental and health benefits of breastfeeding should be considered along with the may continue to grow beyond the size it would attain in a normal cycle. Generally, these † Among US subjects (N=330), 6.1% experienced emotional lability that led to discontinuation. the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial Among US subjects (N=330), 6.1% experienced emotional lability that led to discontinuation. mother’s clinical need for NEXPLANON and any potential adverse effects on the breastfed child enlarged follicles disappear spontaneously. On rare occasion, surgery may be required. ‡ Among US subjects (N=330), 2.4% experienced depression that led to discontinuation. epicondyle of the humerus. NEXPLANON should be inserted subdermally just under the skin Among US subjects (N=330), 2.4% experienced depression that led to discontinuation. from NEXPLANON or from the underlying maternal condition. 6. Carcinoma of the Breast and Reproductive Organs avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels Other adverse reactions that were reported by at least 5% of subjects in the non-radiopaque 3. Pediatric Use Women who currently have or have had breast cancer should not use hormonal contraception Other adverse reactions that were reported by at least 5% of subjects in the non-radiopaque 3. Pediatric Use and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissues. Deep etonogestrel implant clinical trials are listed in Table 4. Safety and efficacy of NEXPLANON have been established in women of reproductive age. because breast cancer may be hormonally sensitive [see Contraindications]. Some studies Safety and efficacy of NEXPLANON have been established in women of reproductive age. insertionsinsertions ofof NEXPLANONNEXPLANON havehave beenbeen associatedassociated withwith paraesthesiaparaesthesia (due(due toto neuralneural injury),injury), Safety and efficacy of NEXPLANON are expected to be the same for postpubertal adolescents. suggest that the use of combination hormonal contraceptives might increase the incidence of Table 4: Common Adverse Reactions Reported by ≥5% of Subjects in Clinical Trials Safety and efficacy of NEXPLANON are expected to be the same for postpubertal adolescents. migration of the implant (due to intramuscular or fascial insertion), and intravascular insertion. However, no clinical studies have been conducted in women less than 18 years of age. Use of breast cancer; however, other studies have not confirmed such findings. Some studies suggest With the Non-Radiopaque Etonogestrel Implant (IMPLANON) However, no clinical studies have been conducted in women less than 18 years of age. Use of IfIf infectioninfection developsdevelops atat thethe insertioninsertion site,site, startstart suitablesuitable treatment.treatment. IfIf thethe infectioninfection persists,persists, thethe this product before menarche is not indicated. implant should be removed. Incomplete insertions or infections may lead to expulsion. that the use of combination hormonal contraceptives is associated with an increase in the risk implant should be removed. Incomplete insertions or infections may lead to expulsion. All Studies 4. Geriatric Use of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to Adverse Reactions 4. Geriatric Use Implant Implant removalremoval maymay bebe difficultdifficult oror impossibleimpossible ifif thethe implantimplant isis notnot insertedinserted correctly,correctly, isis N = 942 Thisis productproduct hashas notnot beenbeen studiedstudied inin womenwomen overover 6565 yearsyears ofof ageage andand isis notnot indicatedindicated inin thisthis population.population. insertedinserted tootoo deeply,deeply, notnot palpable,palpable, encasedencased inin fibrousfibrous tissue,tissue, oror hashas migrated.migrated. which these findings are due to differences in sexual behavior and other factors. Women with a family history of breast cancer or who develop breast nodules should be carefully monitored. Headache 24.9% 5. Hepatic Impairment There have been reports of migration of the implant within the arm from the insertion site, No studies were conducted to evaluate the effect of hepatic disease on the disposition of 7. Liver Disease Vaginitis 14.5% which may be related to deep insertion. There also have been postmarketing reports of 7. Liver Disease NEXPLANON. The use of NEXPLANON in women with active liver disease is contraindicated implants located within the vessels of the arm and the pulmonary artery, which may be related Disturbances of liver function may necessitate the discontinuation of hormonal contraceptive use Weight increase 13.7% implants located within the vessels of the arm and the pulmonary artery, which may be related Disturbances of liver function may necessitate the discontinuation of hormonal contraceptive use Weight increase 13.7% [see Contraindications]. to deep insertions or intravascular insertion. In cases where the implant has migrated to the until markers of liver function return to normal. Remove NEXPLANON if jaundice develops. Hepatic Acne 13.5% 6. Overweight Women pulmonary artery, endovascular or surgical procedures may be needed for removal. adenomas are associated with combination hormonal contraceptives use. An estimate of the Breast pain 12.8% The effectiveness of the etonogestrel implant in women who weighed more than 130% If If atat anyany timetime thethe implantimplant cannotcannot bebe palpated,palpated, itit shouldshould bebe localizedlocalized andand removalremoval isis recommended.recommended. attributable risk is 3.3 cases per 100,000 for combination hormonal contraceptives users. It is not of their ideal body weight has not been defined because such women were not studied in Abdominal pain 10.9% of their ideal body weight has not been defined because such women were not studied in Exploratory surgery without knowledge of the exact location of the implant is strongly known whether a similar risk exists with progestin-only methods like NEXPLANON. The progestin clinical trials. Serum concentrations of etonogestrel are inversely related to body weight and discouraged. Removal of deeply inserted implants should be conducted with caution in order inin NEXPLANONNEXPLANON maymay bebe poorlypoorly metabolizedmetabolized inin womenwomen withwith liverliver impairment.impairment. UseUse ofof NEXPLANONNEXPLANON inin Pharyngitis 10.5% decrease with time after implant insertion. It is therefore possible that NEXPLANON may be to prevent injury to deeper neural or vascular structures in the arm and be performed by women with active liver disease or liver cancer is contraindicated [see Contraindications]. Leukorrhea 9.6% lessless effectiveeffective inin overweightoverweight women,women, especiallyespecially inin thethe presencepresence ofof otherother factorsfactors thatthat decreasedecrease healthcare providers familiar with the anatomy of the arm. If the implant is located in the 8. Weight Gain Influenza-likeInfluenza-like symptomssymptoms 7.6% serum etonogestrel concentrations such as concomitant use of hepatic enzyme inducers. chest, healthcare providers familiar with the anatomy of the chest should be consulted. Failure In In clinicalclinical studies,studies, meanmean weightweight gaingain inin U.S.U.S. non-radiopaquenon-radiopaque etonogestreletonogestrel implantimplant (IMPLANON)(IMPLANON) to remove the implant may result in continued effects of etonogestrel, such as compromised Dizziness 7.2% OVERDOSAGE users was 2.8 pounds after one year and 3.7 pounds after two years. How much of the weight gain Overdosage may result if more than one implant is inserted. In case of suspected overdose, the fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event. Dysmenorrhea 7.2% was related to the non-radiopaque etonogestrel implant is unknown. In studies, 2.3% of the users implantimplant shouldshould bebe removed.removed. 2. Changes in Menstrual Bleeding Patterns reported weight gain as the reason for having the non-radiopaque etonogestrel implant removed. Back pain 6.8% After starting NEXPLANON, women are likely to have a change from their normal menstrual NONCLINICAL TOXICOLOGY bleeding pattern. These may include changes in bleeding frequency (absent, less, more 9. Elevated Blood Pressure Emotional lability 6.5% InIn aa 24-month24-month carcinogenicitycarcinogenicity studystudy inin ratsrats withwith subdermalsubdermal implantsimplants releasingreleasing 1010 andand 2020 mcgmcg Women with a history of hypertension-related diseases or renal disease should be discouraged frequent or continuous), intensity (reduced or increased) or duration. In clinical trials of the Women with a history of hypertension-related diseases or renal disease should be discouraged Nausea 6.4% etonogestrel per day (equal to approximately 1.8-3.6 times the systemic steady state exposure in non-radiopaque etonogestrel implant (IMPLANON), bleeding patterns ranged from amenorrhea from using hormonal contraception. For women with well-controlled hypertension, use of women using NEXPLANON), no drug-related carcinogenic potential was observed. Etonogestrel was Pain 5.6% (1 in 5 women) to frequent and/or prolonged bleeding (1 in 5 women). The bleeding pattern NEXPLANON can be considered. Women with hypertension using NEXPLANON should be not genotoxic in the inin vitrovitro Ames/Salmonella reverse mutation assay, the chromosomal aberration experienced during the first three months of NEXPLANON use is broadly predictive of the future closely monitored. If sustained hypertension develops during the use of NEXPLANON, or if Nervousness 5.6% assay in Chinese hamster ovary cells or in the inin vivovivo mouse micronucleus test. Fertility in rats bleeding pattern for many women. Women should be counseled regarding the bleeding pattern a significant increase in blood pressure does not respond adequately to antihypertensive Depression 5.5% returned after withdrawal from treatment. changes they may experience so that they know what to expect. Abnormal bleeding should be therapy, NEXPLANON should be removed. Hypersensitivity 5.4% PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling. evaluated as needed to exclude pathologic conditions or pregnancy. 10. Gallbladder Disease • Counsel women about the insertion and removal procedure of the NEXPLANON implant. Provide the In In clinicalclinical studiesstudies ofof thethe non-radiopaquenon-radiopaque etonogestreletonogestrel implant,implant, reportsreports ofof changeschanges inin bleedingbleeding Studies suggest a small increased relative risk of developing gallbladder disease among InsertionInsertion sitesite painpain 5.2% woman with a copy of the Patient Labeling and ensure that she understands the information in the pattern were the most common reason for stopping treatment (11.1%). Irregular bleeding (10.8%) combination hormonal contraceptive users. It is not known whether a similar risk exists with Patient Labeling before insertion and removal. A USER CARD and consent form are included in the was the single most common reason women stopped treatment, while amenorrhea (0.3%) was was the single most common reason women stopped treatment, while amenorrhea (0.3%) was progestin-only methods like NEXPLANON. InIn aa clinicalclinical trialtrial ofof NEXPLANON,NEXPLANON, inin whichwhich investigatorsinvestigators werewere askedasked toto examineexamine thethe implantimplant sitesite afterafter packaging. Have the woman complete a consent form and retain it in your records. The USER CARD cited less frequently. In these studies, women had an average of 17.7 days of bleeding or spotting cited less frequently. In these studies, women had an average of 17.7 days of bleeding or spotting insertion,insertion, implantimplant sitesite reactionsreactions werewere reportedreported inin 8.6%8.6% ofof women.women. ErythemaErythema waswas thethe mostmost frequentfrequent should be filled out and given to the woman after insertion of the NEXPLANON implant so that she every 90 days (based on 3,315 intervals of 90 days recorded by 780 patients). The percentages 11. Carbohydrate and Lipid Metabolic Effects every 90 days (based on 3,315 intervals of 90 days recorded by 780 patients). The percentages implantimplant sitesite complication,complication, reportedreported duringduring and/orand/or shortlyshortly afterafter insertion,insertion, occurringoccurring inin 3.3%3.3% ofof subjects.subjects. will have a record of the location of the implant in the upper arm and when it should be removed. of patients having 0, 1-7, 8-21, or >21 days of spotting or bleeding over a 90-day interval while Use of NEXPLANON may induce mild insulin resistance and small changes in glucose concentrations of unknown clinical significance. Carefully monitor prediabetic and diabetic Additionally, hematoma (3.0%), bruising (2.0%), pain (1.0%), and swelling (0.7%) were reported. • Counsel women to contact their healthcare provider immediately if, at any time, they are unable to using the non-radiopaque etonogestrel implant are shown in Table 1. palpate the implant. women using NEXPLANON. Women who are being treated for hyperlipidemia should be Effects of Other Drugs on Hormonal Contraceptives palpate the implant. Table 1: Percentages of Patients With 0, 1-7, 8-21, or >21 Days of Spotting or Bleeding Over • Counsel women that NEXPLANON does not protect against HIV or other STDs. Table 1: Percentages of Patients With 0, 1-7, 8-21, or >21 Days of Spotting or Bleeding Over followed closely if they elect to use NEXPLANON. Some progestins may elevate LDL levels and Substances decreasing the plasma concentrations of hormonal contraceptives (HCs) and • Counsel women that NEXPLANON does not protect against HIV or other STDs. a 90-Day Interval While Using the Non-Radiopaque Etonogestrel Implant (IMPLANON) • Counsel women that the use of NEXPLANON may be associated with changes in their normal a 90-Day Interval While Using the Non-Radiopaque Etonogestrel Implant (IMPLANON) may render the control of hyperlipidemia more difficult. potentially diminishing the efficacy of HCs: Drugs or herbal products that induce certain enzymes, menstrual bleeding patterns so that they know what to expect. Total Days of Percentage of Patients 12. Depressed Mood includingincluding cytochromecytochrome P450P450 3A43A4 (CYP3A4),(CYP3A4), maymay decreasedecrease thethe plasmaplasma concentrationsconcentrations ofof HCsHCs andand potentially diminish the effectiveness of HCs or ncrease breakthrough bleeding. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Spotting or Bleeding Treatment Days Treatment Days Treatment Days Women with a history of depressed mood should be carefully observed. Consideration should potentially diminish the effectiveness of HCs or ncrease breakthrough bleeding. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of 91-180 271-360 631-720 be given to removing NEXPLANON in patients who become significantly depressed. Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, (N = 745) (N = 657) (N = 547) barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. (N = 745) (N = 657) (N = 547) 13. Return to Ovulation rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between HCs 0 Days 19% 24% 17% In In clinicalclinical trialstrials withwith thethe non-radiopaquenon-radiopaque etonogestreletonogestrel implantimplant (IMPLANON),(IMPLANON), thethe etonogestreletonogestrel and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use For more detailed information, please read the Prescribing Information. 1-7 Days 15% 13% 12% levelslevels inin bloodblood decreaseddecreased belowbelow sensitivitysensitivity ofof thethe assayassay byby oneone weekweek afterafter removalremoval ofof thethe USPI-MK8415-IPTX-1705r019 an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are USPI-MK8415-IPTX-1705r019 8-21 Days 30% 30% 37% implant.implant. InIn addition,addition, pregnanciespregnancies werewere observedobserved toto occuroccur asas earlyearly asas 77 toto 1414 daysdays afterafter removal.removal. Revised: 05/17 used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the >21 Days 35% 33% 35% Therefore, a woman should re-start contraception immediately after removal of the implant if enzyme inducer to ensure contraceptive reliability. Copyright © 2017 Merck Sharp & Dohme B.V., continued contraceptive protection is desired. Bleeding patterns observed with use of the non-radiopaque etonogestrel implant for up to 2 years, and a subsidiary of Merck & Co., Inc. All rights reserved. the proportion of 90-day intervals with these bleeding patterns, are summarized in Table 2. WOMN-1233494-0000 10/17 Editor-in-chief’s message

professional role so that we can realize this vision. In particular, I ask you to consider participating in the 2018 NPWH WHNP Workforce Demographics and Compensa- tion Survey. To assist you in deciding whether to participate in this survey, I have answered some questions you might have.

How is this survey being conducted? ear Colleagues, This survey is being conducted by NPWH. The National D Certification Corporation (NCC) is providing assistance in The National Association of Nurse Practitioners in Wom- distributing the survey to all nationally certified WHNPs. en’s Health (NPWH) strives to continuously improve the NPWH is the national organization representing WHNPs. accessibility and quality of healthcare for women. This NCC is the national certification body for WHNPs. improvement is accomplished by promoting innovation and excellence in continuing education and professional Why is this survey important to WHNPs? development; leadership in policy, practice, and research NPWH strives to support and advocate for WHNPs so that areas; and support and services for our members. Achiev- their role is fully appreciated and that it thrives into the ing all these goals is our organization’s vision. future. Having detailed demographic information is espe- If you are a women’s health nurse practitioner (WHNP), cially important to fully understand who today’s WHNPs I urge you to help NPWH learn more about you and your are, where these WHNPs work, what they do, and which (continued on page 10)

A survey focused on WHNPs would allow for better representation and a more complete picture of the demographics and employment characteristics of this important group of NPs.

8 September 2018 Women’s Healthcare NPWomensHealthcare.com

(continued from page 8) populations they serve. It is also crucial for the future of (AANP) 2017 national NP survey overview, it was re- the WHNP role to have information about compensation/ ported that there are more than 222,000 licensed NPs in benefits and employment/role satisfaction specific to the United States, with the majority certified as family WHNPs so that NPWH can advocate for both fair com- nurse practitioners (FNPs).1 A random sample of 47,540 pensation and favorable working environments. Finally, NPs was used for the AANP survey. Among the 6,784 we seek information about the role of the WHNP as a pre- respondents, 60.6% were FNPs. Data were presented on ceptor for future generations of WHNPs. compensation and benefits for respondents working full- time. Of the 4,344 full-time primary care NP respondents, Why should I participate in this survey? 2,964 (68.2%) were FNPs and 957 (22.0%) were adult or Success of this survey depends on a high response rate adult-gerontology NPs. Of those 4,344 full-time primary from WHNPs so that we can gather as much information as care NP respondents, only 137 (2.7%) were WHNPs.1 Be- possible in order to draw as many conclusions as possible cause the WHNP participation rate was quite small, it may and to make as many reasonable recommendations as not have been representative. A survey focused on WHNPs possible. At the beginning of the survey, you will be asked would allow for better representation and a more complete a few preliminary questions to see if you qualify to com- picture of the demographics and employment characteris- plete the entire survey. Once you have completed the pre- tics of this important group of NPs. liminary questions, if you qualify, you will have access to the remainder of the survey. The survey is fully voluntary; Who will see the information I provide there is no penalty for not participating and no penalty for on the survey? opting to skip answering any specific questions. First, the survey is anonymous. No individual identifying information will be collected. All responses will be How does this workforce survey differ reported only at the aggregate level. NPWH will use the from other NP workforce surveys? data internally to guide development of support and In the American Association of Nurse Practitioners services for WHNPs. The data also will be shared through a variety of venues with other stakeholders to include our membership, faculty and directors for WHNP programs, current WHNP students, prospective WHNP students, NCC, other NP organizations, and relevant policy makers. NPWH hopes to have a robust response to the survey to make the data meaningful and useful—for all of us. All certified WHNPs should receive an email from NCC Therapeutic Devices, Inc. with an invitation and link to the NPWH WHNP Workforce Demographics and Compensation Survey by the end of September. If you do not receive your invitation by Vaginal Dilators & Sexual Health Products September 30, 2018, please contact Julia Knox at jknox@ npwh.org so that she can send it to you. Thank you in advance for your participation in this important survey.

Beth Kelsey, EdD, APRN, WHNP-BC, FAANP www.SoulSource.com Reference 1. American Association of Nurse Practitioners. 2017 Na- 888-325-5870 tional Nurse Practitioner Sample Survey: An Overview. Committed to helping women Austin, TX: American Association of Nurse Practitioners; regain and maintain their sexual health March 2018.

10 September 2018 Women’s Healthcare NPWomensHealthcare.com NPWH news & updates

Gay Johnson, CEO Message from the CEO

ome of you may know about NPWH’s WellS Woman Visit Mobile App and have downloaded it already, but other readers may not be familiar with it. Several years ago, we decided to develop this app as a helpful tool for the well woman visit. The app is designed for healthcare providers (HCPs) to facilitate and guide the evaluation and treatment of patients. First, the HCP enters the patient’s age. This information then generates age-appropriate avenues of investigation in the following categories: sexual history taking, physical exam, STD screening, immunizations, preventative health screening, and anticipatory guidance. After the initial launch of the app, we added several new categories, including cardiovascular assessment, irritable bowel syndrome, and menopause. And because toms of Alzheimer’s and other dementias. They want our app is always evolving and expanding, we are now help starting the conversation about brain health with developing another new category that will be extremely their patients, and they want and need greater access to helpful in assessing a patient’s brain health, which should diagnostic tools. As the number of U.S. women aged 65+ be an integral component of the well woman visit. The years with Alzheimer’s continues to grow (this number brain health portion of the app will include a definition now stands at more than 3.3 million), the assessment of a healthy brain and then cover cognitive impairment, of memory and brain health belongs at the forefront of symptoms, diagnosis, treatment, special considerations, women’s healthcare. caregiver resources, and web resources. We believe that this new portion of our Well Woman In 2017, NPWH released the findings of a joint survey Visit Mobile App will become the “go to” for HCPs seeking of more than 1,000 nurse practitioners that we con- more information and guidance on brain health. Watch ducted with the organization Women Against Alzhei- for the release of this new iteration of our mobile app, mer’s. Our goal was to determine whether NPs have the which should be available in late September. Until then, information and tools they need to evaluate patients at download the app now for other valuable guidance. This risk for Alzheimer’s disease and other dementias, to make free app is available for download from NPWH or the Ap- timely diagnoses of these diseases, to manage these dis- ple Store. eases, and to counsel patients and their families once the risk or actual disease is identified. The survey results sug- – Gay Johnson gested that NPs want more information about the symp- Chief Executive Officer, NPWH

NPWomensHealthcare.com September 2018 Women’s Healthcare 11 Continuing Education Managing women’s health issues across a lifespan: NPWH 2017-2018 regional meetings By Beth Kelsey, EdD, APRN, WHNP-BC, FAANP

Faculty: 3. Discuss assessment and management of postmenopausal Beth Kelsey, EdD, APRN, WHNP-BC, FAANP is Assistant HSDD. Professor at Ball State University School of Nursing in Muncie, 4. Describe assessment and management of postmenopausal Indiana. osteoporosis. Intended audience: This continuing education (CE) activity Accreditation statement: This activity has been evalu- has been designed to meet the educational needs of nurse prac- ated and approved by the Continuing Education Approval titioners who provide care for women across the lifespan. Program of the National Association of Nurse Practitioners CE approval period: Now through September 30, 2019 in Women’s Health (NPWH), and has been approved for 1.0 contact hour of CE credit. Estimated time to complete this activity: 1 hour Faculty disclosures: NPWH policy requires all faculty to CE approval hours: 1.0 contact hour of CE credit disclose any affiliation or relationship with a commercial inter- Goal statement: To use current evidence and guidelines in est that may cause a potential, real, or apparent conflict of in- shared decision making with women to develop treatment/ terest with the content of a CE program. NPWH does not imply management plans for unscheduled bleeding with hormonal that the affiliation or relationship will affect the content of the contraception, recurrent bacterial vaginitis (BV), postmeno- CE program. Disclosure provides participants with information .

A pausal hypoactive sexual desire disorder (HSDD), and post- that may be important to their evaluation of an activity. Fac- menopausal osteoporosis—according to each woman's needs, ulty are also asked to identify any unlabeled/unapproved uses here desires, and preferences. of drugs or devices made in their presentation. Needs assessment: This activity for Women’s Healthcare is Beth Kelsey, EdD, APRN, WHNP-BC, FAANP, has no based on a CE presentation developed by the NPWH Education actual or potential conflicts of interest in relation to this pre- Committee and presented at the four NPWH regional meetings sentation. in 2017-2018. In this article, the author used clinical scenarios to Disclosure of unlabeled use: NPWH policy requires describe current recommendations/guidelines for management authors to disclose to participants when they are presenting of unscheduled bleeding with hormonal contraception, recur- information about unlabeled use of a commercial product or rent BV, postmenopausal HSDD, and postmenopausal osteopo- device or an investigational use of a drug or device not yet rosis. The author used data shared at the NPWH regional meet- approved for any use. ings in which the presenters provided updates on issues related to contraception, BV, HSDD, and osteoporosis. Disclaimer: Participating faculty members determine the editorial content of the CE activity; this content does not Educational objectives: At the conclusion of this educa- necessarily represent the views of NPWH. This content has tional activity, participants should be able to: undergone a blinded peer review process for validation of 1. Describe potential causes of and management options for clinical content. Although every effort has been made to unscheduled bleeding associated with hormonal contracep- ensure that the information is accurate, clinicians are respon- tion use. sible for evaluating this information in relation to generally accepted standards in their own communities and integrat- 2. Describe potential causes of and management options for ing the information in this activity with that of established recurrent BV. recommendations of other authorities, national guidelines, To participate in this CE program, click To FDA-approved package inserts, and individual patient characteristics.

12 September 2018 Women’s Healthcare NPWomensHealthcare.com Successful completion of the activity: Successful com- 4. Complete the post-test and evaluation. You must earn a pletion of this activity, J-18-03, requires participants to: score of 70% or better on the post-test to receive CE credit. 1. Log on to npwh.org/courses/home/details/1155 and 5. Print out the CE certificate if successfully completed. “Sign In” at the top right-hand corner of the page if you have an NPWH account. You must be signed in to receive *If you are an NPWH member, were once a member, or have taken credit for this course. If you do not remember your user- CE activities with NPWH in the past, you have a username and pass- name or password, please follow the “Forgot Password” word in our system. Please do not create a new account. Creation of multiple accounts could result in loss of CE credits as well as other link and instructions on the sign-in page. If you do not NPWH services. If you do not remember your username or password, have an account, please click on “Create an Account.”* please either click on the “Forgot Username” or “Forgot Password” 2. Read the learning objectives, disclosures, and disclaimers link or call the NPWH office at (202) 543-9693, ext. 1. on the previous page. Commercial support: The content for this article was 3. Study the material in the learning activity during the ap- supported by educational grants from Lupin Pharmaceuti- proval period (now through September 30, 2019). cals; Merck & Co., Inc.; Radius Health, Inc.; and Valeant Phar- maceuticals North America, LLC.

A Scenario #1: Before reading the article, click here to take the pretest. Contraception Long-acting reversible contracep- ver the past year, NPWH sponsored four regional meetings tives (LARC), the most effective of highlighting updates on the management of women’s all reversible contraceptives, are becoming more widely used by health issues across a lifespan. The meetings were O reproductive-aged women and presented to live audiences using an interactive learning strategy, adolescents. LARC include intrauter- with several clinical scenarios illustrating issues within four topic ine contraceptives (IUCs) and the areas: contraception, bacterial vaginosis, hypoactive sexual desire etonogestrel (ENG) implant. Fewer disorder, and postmenopausal osteoporosis. The author of this than 1% of LARC users become pregnant, and their continuation article has chosen one scenario for each topic to demonstrate how rates at 1 year are significantly this learning strategy can cover important health areas in a way that higher than those of short-acting intrigues and challenges, in this case, our readers. birth-control method users (86% vs. 55%).1 LARC have a good safety profile, with very few contraindications; most women are eligible for either IUCs or the ENG implant.2 In fact, for women with conditions that might make pregnancy an unac- ceptable health risk, LARC might be the best choice to avoid unintended pregnancy. Likewise, LARC might be the best choice for women taking teratogenic drugs for a health condition. The American College of Obstetricians and Gynecologists recommends that LARC be offered as first-line contraceptives and encouraged as options for most females, including adolescents and nullipa- rous women.1,3 Scenario #1 depicts assessment and management of unscheduled bleeding associated with use of the ENG implant. Ava is 17 years old. She is brought to the clinic by her mother, who just

NPWomensHealthcare.com September 2018 Women’s Healthcare 13 learned that her daughter is sex- Are laboratory tests or a physical tion oral contraceptive [COC], oral ually active. Ava has never been examination needed? conjugated estrogen 1.25 mg, or pregnant. Her last menstrual pe- Another possible cause of Ava’s oral estradiol 2 mg) if medically eli- riod started 3 days ago. The nurse irregular bleeding is infection with gible. Although several studies have practitioner (NP) reviews contra- Chlamydia, especially because she shown that treatment with NSAIDs ceptive methods with Ava, who has a new sex partner who does not or estrogen controls bleeding asso- decides she would like an implant, use a condom. A urine sample is col- ciated with various progestin-only which is placed at that visit. Ten lected for a Chlamydia test. Because contraceptives, these results are not weeks later, Ava calls the clinic to Ava uses a highly effective contra- consistently sustained. Moreover, report that she has been bleeding ceptive, the NP is reasonably certain these studies evaluated different or spotting every day. She tells the that she is not pregnant. Unsched- NSAIDs and different lengths of NP, I am sick of the bleeding and I uled bleeding is not indicative of time on estrogen, making it difficult want this thing out. The NP recom- decreased efficacy of the method.6 to draw firm conclusions.6 mends that Ava come to the clinic A pregnancy test could be done if After the NP and Ava discuss for evaluation of her bleeding and there is concern. A pelvic exam is the options and their possible to discuss how to proceed from not needed. but uncertain effectiveness, Ava there. decides to try the COC. The NP Unscheduled bleeding is a What options are available to prescribes a low-dose COC for 21 common side effect of all the manage Ava’s bleeding? days. Two months after treatment, progestin-only methods (i.e., pro- The etiology of unscheduled bleed- Ava remains without bleeding or gestin-only pills, depot medroxy- ing with use of progestin-only con- spotting. She does have a posi- progesterone acetate, ENG implant, traceptives is not fully understood. tive Chlamydia test result and is levonorgestrel [LNG] IUCs). Two re- The bleeding may be due in part to treated along with her partner. cent studies have shown that unpre- rapid endometrial thinning initially. Nurse practitioners providing dictable or irregular bleeding is one With sustained use, the endome- care for reproductive-aged women of the most common reasons cited trium may become more fragile and can help them choose contracep- for early discontinuation of these prone to bleed.6 Studies of various tives that fit their individual lifestyles methods.4,5 therapies to decrease bleeding have and preferences. Evidence-based shown mixed results. guidelines such as the U.S. Medical What else would be helpful for The U.S. Selected Practice Eligibility Criteria for Contracep- the NP to know? Recommendations for Contracep- tive Use, 2016C and the SPR can Ava tells the NP that she has a new tive Use, 2016B (SPR) provides an assist in appropriate assessment boyfriend. They had sex 6 weeks algorithm to guide management and management for safe and effec- ago and again 2 weeks ago, without of bleeding irregularities in women tive contraception.2,7 Strategies to using a condom. She has no pain using hormonal contraceptives.7 reduce barriers and promote con- with sex or abnormal vaginal dis- Options to manage bothersome sistent contraceptive use should be charge. She describes her bleeding bleeding associated with an im- individually tailored, and should pro- as lighter than a period (Some- plant include a 5- to 7-day course vide women with knowledge and times it is only spotting) that has of a nonsteroidal anti-inflammatory tools that empower them to prevent occurred on most days since the drug (NSAID) or a 10- to 20-day unintended pregnancies. implant was placed. course of estrogen (via a combina-

14 September 2018 Women’s Healthcare NPWomensHealthcare.com Scenario #2: Recurrent bacterial vaginosis Factors that alter the vaginal microbiome increase the risk for bacterial vaginosis (BV) by causing a shift in the vaginal microbiota from lacto- bacillus-dominated bacteria to a variable mixture of anaerobic and facultative bacteria.8,9 These factors include, but are not limited to, sexual behaviors (e.g., frequent vaginal intercourse, multiple male or female sex partners, new sex partner, lack of condom use), hormonal fluc- tuations, smoking, douching, and antibiotic use. Protective factors may include having a male partner who is circumcised and use of hormonal contraceptives.8-10 Recent studies have detected a polymicrobial biofilm in the vaginal epithelial cells of some women with BV that aids in bacterial persistence and enhances resistance to host de- What additional information are noted. Vaginal pH is >5.0 and a fense mechanisms and antibiotics.8,9 would be helpful for the NP to wet prep shows clue cells, no yeast This biofilm also may inhibit normal obtain? buds/hyphae, no trichomonads, and shedding of vaginal epithelial cells Bea tells the NP that she has been no lactobacilli. A potassium hydrox- needed to provide glycogen as a nu- treated for BV 3 times in the past ide (KOH) whiff test result is positive. trient source of lactobacilli, further year, each time with oral metroni- A diagnosis of BV is made based on disrupting the healthy vaginal mi- dazole for 7 days. Her symptoms the presence of at least three Amsel’s crobiota. The trigger for the change resolve for a month and then recur criteria: homogeneous thin gray/ in the vaginal microbiota and the when she has a period. The odor is white discharge, positive whiff test development of the biofilm remains worse after sex. Bea is married and result with 10% KOH, vaginal pH elusive, but it may contribute to in a monogamous relationship with >4.5, and clue cells on microscopy.11 persistent or recurrent BV.8,9 BV is her husband of 10 years and knows A confirmatory test is not needed. typically defined as recurrent if three that BV is not a sexually transmitted Diagnosis based on identification or more episodes occur per year. infection (STI), but she wonders of Gardnerella vaginalis on vaginal Scenario #2 portrays assessment whether he should be treated. Bea culture is insufficient; G. vaginalis is and management of a woman with admits to douching after sex some- detected in up to 55% of healthy recurrent BV. times to try to eliminate the odor. asymptomatic women.12 Based on Bea, a 35-year-old woman, pre- She is in good health overall, is of Bea’s history and exam findings, the sents at the clinic as a new patient normal weight, does not smoke, and NP does not order any STI tests. with a complaint of bad smelling is on no medications. She has had vaginal discharge again. She states no abnormal Pap test results and What is the recommended that she just wants a cure that lasts. has never had an STI. Her husband treatment plan? She tells the NP that she has been had a vasectomy 3 years ago. They The NP acknowledges Bea’s frustra- treated countless times for BV over do not use condoms. tion with her recurring symptoms. the past several years, with tem- A pelvic exam reveals a mal- The NP explains that although data porary relief before the odor and odorous thin gray discharge at the on treatment for recurrent BV are discharge return. vaginal introitus and adhering to the not conclusive, several options vaginal walls. No erythema or lesions have been cited in the literature

NPWomensHealthcare.com September 2018 Women’s Healthcare 15 based on limited studies. The NP daily for 5 days, or clindamycin 300 Several interventions to reduce and Bea develop a treatment plan mg orally twice daily for 7 days. or eradicate bacteria associated with but agree that they will consider Secnidazole, a single-dose granule BV and to restore and maintain a other options as needed. The plan formulation with no warning to normal vaginal microbiome have is to treat the current BV infection avoid alcohol consumption, was ap- been proposed based on limited with metronidazole 500 mg orally proved by the FDA in 2017 for treat- and sometimes conflicting studies. twice daily for 7 days, followed by ment of BV and is not yet included Among these interventions are the 0.75% metronidazole gel intravag- in the CDC recommendations.13 The use of biofilm-disruptive agents such inally twice weekly for 4 months to granules are mixed with soft food as intravaginal boric acid; probiotics reduce the risk for recurrence, with such as applesauce, yogurt, or pudding to boost favorable lactobacilli spe- cessation of vaginal douching. and then consumed within 30 min- cies; hormonal contraception to im- In addition to oral metronidazole, utes. prove the genital microenvironment the CDC recommends intravaginal Limited studies support the use through increased glycogen produc- metronidazole gel 0.75% once daily of 0.75% metronidazole gel twice tion in vaginal epithelial cells, pro- for 5 days or intravaginal clindamy- weekly for 4-6 months after com- moting lactobacilli species growth cin cream 2% at bedtime for 7 days pletion of treatment for the current as well as reduction of menstrual to treat BV.11 Alternative regimens infection to reduce recurrences. The bleeding; male and female partner are tinidazole 2 g orally once daily benefit may not persist after discon- treatment; condom use; and suppres- for 2 days, tinidazole 1 g orally once tinuation.9,11 sive antimicrobial therapy.8-11,14

their sexual relationship. She notes that Ellen is understanding but also sometimes frustrated with her recent lack of interest in sex. Both women have fast-paced, time-consuming jobs that have recently required them to work on weekends, which had always been time for them to relax, reconnect, and share intimacy.

What additional information would be helpful for the NP to obtain? Cass is 8 years postmenopausal. She was on oral estrogen-progestogen therapy to manage hot flashes until last year, when she stopped treatment at the recommendation of her previous healthcare provider. Scenario #3: Hypoactive Cass, a 58-year-old female, pre- The hot flashes recurred, so about sexual desire disorder sents at the office as a new patient 6 months ago, she started the se- Whether called low libido, hypoactive with concerns about low libido that lective serotonin reuptake inhibitor sexual desire disorder (HSDD), or fe- she first noticed a year ago. She tells (SSRI) paroxetine 7.5 mg, which has male sexual interest/arousal disorder, the NP that she worries about its been helpful. However, she has no- this condition is common across the effect on her relationship with her ticed vaginal dryness that has made adult lifespan. Scenario #3 illustrates partner. She and Ellen have been penetrative sex play painful. Cass has assessment and management of in a monogamous relationship for suffered from severe arthritis in her HSDD in a postmenopausal woman. 20 years and have always enjoyed hips for the past few years, causing

16 September 2018 Women’s Healthcare NPWomensHealthcare.com certain sex positions to be uncom- and if results will affect treatment specific relationship between SSRI fortable. In this context, the vaginal decisions. Measurement of various use and sexual dysfunction is not dryness and pain with penetration hormone levels may be considered known but appears to be dose de- are even more distressing. Cass has in specific circumstances by clini- pendent.18 Cass is taking the SSRI to had a recent normal Pap test result, cians well versed in the use of results help relieve hot flashes, not for de- and she has had no urinary tract to guide therapy.16 The NP deter- pression. She can decrease the SSRI problems. She has never been preg- mines from Cass’s assessment that dosage to see if hot flashes are still nant or had any pelvic surgery. She no other lab tests are indicated. relieved or consider nonpharmaco- denies any current or past history of logic management strategies. physical, emotional, or sexual abuse; What is an appropriate Control of arthritis pain may in- depression; or substance abuse. management strategy for Cass? clude physical therapy (PT), applica- The NP uses the Female Sexual Cass’s assessment indicates that she tion of heat or cold, and use of OTC Function IndexD questionnaire has HSDD. Contributing factors to analgesics. Other strategies include to guide further assessment of six this diagnosis include genitourinary planning sexual activity for times of domains of sexual health: desire, syndrome of menopause (GSM), day when pain severity is typically arousal, lubrication, orgasm, satisfac- which can lead to dyspareunia (or low, taking an analgesic about 30 tion, and pain.15 She confirms that pain with any vaginal penetration); minutes in advance, judicious use Cass’s main concerns are related to the potential dampening effect of of pillows for positioning and joint decreased desire and pain with pen- an SSRI on sexual desire and arousal; support, and incorporating a warm etrative sex. Cass is able to achieve positioning discomfort related to shower or bath.19 arousal and orgasm with a vibrator hip arthritis; and a change in work The NP and Cass discuss these and oral sex, but it takes longer now. schedules that has decreased time approaches. Cass considers local Use of an over-the-counter (OTC) for Cass and her partner to share re- vaginal estrogen and discontin- vaginal lubricant is minimally helpful. laxation and intimacy. uation of paroxetine, along with A physical exam reveals bilateral OTC lubricants have been only nondrug management of her hot hip range-of-motion limitation con- minimally helpful. Three FDA-ap- flashes. She also plans to discuss sistent with osteoarthritis. The NP proved medications are available to what she has learned at this visit conducts a systematic vulvovaginal/ treat GSM-related dyspareunia: local with Ellen. She believes that the pelvic exam to determine the loca- vaginal estrogen, ospemifene, and two of them can be creative in tion of Cass’s pain and to evaluate prasterone.17 Ospemifene, a selective planning time for relaxation and skin/tissue integrity and vaginal/ estrogen reuptake modulator, has an intimacy if they work on it together. pelvic floor muscle (PFM) strength. estrogen agonist effect on vaginal tis- She agrees to a referral to PT to Inspection and palpation of vulvar sue. However, hot flashes are a com- start exercises for mobility and structures reveal no lesions or ten- mon side effect, making it a less than strength building. She also asks if derness. The vaginal walls are pale optimal choice for Cass. Prasterone any medication is available specifi- and dry with decreased rugae. PFM is an intravaginal DHEA converted cally to treat HSDD. The NP explains strength is moderate, and no pelvic locally inside vaginal cells into active that one medication, flibanserin, organ prolapse is noted. Vaginal pH is estrogens and androgens.17 is FDA approved for treatment of >5.0 and a wet prep shows presence SSRIs are among the most com- HSDD in premenopausal women. of parabasal cells and no lactobacilli. mon medications linked to low This agent acts on the central ner- Other lab tests are performed libido, decreased arousal, and or- vous system to improve sexual de- only when a clinical indication exists gasmic dysfunction in women. The sire and satisfying sexual events.16

NPWomensHealthcare.com September 2018 Women’s Healthcare 17 sustained a hip fracture at age 72 as the result of a fall. Given this information, the NP wants to assess Dot for osteoporosis and other bone fractures risks. Dot reached menopause at age 50 and has never used hormonal treatment to manage menopause symptoms. She does not smoke or drink alcohol and admits she gets very little exercise. She does not consume dairy products because she is lactose intolerant. She occasionally takes a multivita- min but is not on any prescription medications. She is 5’6” tall and weighs 140 lb. Lab tests show normal results for her urinalysis, complete blood cell count, and metabolic panel. The only abnormal lab test result is a low 25-hydroxyvitamin D (25[OH] D) level. A spinal radiograph shows Scenario #4: spine. FRAX uses 10 risk factors to a T12 wedge compression fracture Postmenopausal calculate the 10-year risk of a major “age indeterminate” and mild de- osteoporosis osteoporotic fracture. An algorithm generative changes in the L2-L5 The American Association of Clinical based on FRAX score places an indi- area. DXA shows T-scores of –2.3 at Endocrinologists and the American vidual at low, moderate, or high risk L1-L4 and –1.9 at the left femoral College of Endocrinology list four for fracture.21 Scenario #4 reflects neck. Her FRAX score is 17% for ma- criteria, any one of which indicates assessment and management of a jor osteoporotic fracture and 2.2% a diagnosis of osteoporosis in post- woman with postmenopausal oste- for hip fracture in the next 10 years, menopausal women20: oporosis. placing her at moderate risk. • a T-score of –2.5 or lower in the Dot, a 63-year-old female, pre- lumbar spine, femoral neck, total, sents at the office with a complaint Does Dot have a diagnosis of and/or one-third of radius; of mid-back pain that started 2 osteopenia or osteoporosis? • low-trauma spine or hip fracture, weeks ago. Acetaminophen has Dot is diagnosed with osteoporosis regardless of bone mineral den- helped, but the pain remains. based on her BMD scores (indicating sity (BMD); osteopenia) and her history of a fra- • osteopenia/low bone mass What additional information will gility fracture of the distal forearm. (T-score, –1 to –2.5) with a fragility be helpful for the NP to obtain? The most common areas of fragility fracture of the proximal humerus, Dot tells the NP that the current fractures are the wrist, hip, and pelvis, or possibly distal forearm; back pain started after strenuous spine; in women, more than 50% of or gardening and it worsens when these fractures occur in those with • osteopenia/low bone mass and she takes a deep breath and with T-scores in the osteopenia range.20 high fracture probability based certain movements. She has no on a Fracture Risk Assessment urinary tract signs or symptoms. What is the best treatment plan Tool (FRAX) score and coun- In reviewing Dot’s health history, for Dot? try-specific thresholds. the NP learns that she suffered a Recommended initial pharmaco- wrist fracture 3 years ago when she therapy for postmenopausal osteo- BMD is measured most com- slipped on her bathroom floor and porosis in women at moderate risk monly with dual-energy x-ray ab- stretched out her arm to brace the for fracture includes medications in sorptiometry (DXA) of the hip and fall. Dot tells the NP that her mother the antiresorptive drug class. These

18 September 2018 Women’s Healthcare NPWomensHealthcare.com medications slow or suppress os- appropriate as initial treatment for When are anabolic medications teoclast-mediated bone resorption, postmenopausal women at high considered? resulting in increased BMD. Drugs fracture risk, those who cannot tol- Two anabolic medications, teri- in this class that have been shown erate oral agents, those with lower paratide and abaloparatide, are ap- to reduce the risk for hip, nonver- gastrointestinal problems that may proved for treatment of osteoporo- tebral, and spine fractures include inhibit absorption, and those who sis in postmenopausal women who bisphosphonates (BPs) such as alen- have difficulty remembering to take are at high risk for fracture or have dronate, risedronate, and zoledronic or adhering to instructions for oral failed or been intolerant of treat- acid and the RANK ligand inhibitor medications.20 ment with antiresorptive drugs.23,24 denosumab.20,22 Two other drugs in Attention is given to Dot’s defi- These parathyroid analogs are the antiresorptive class, the BP iban- ciency in vitamin D, which is essen- self-administered subcutaneously dronate and the estrogen agonist/ tial for efficient intestinal absorp- daily and work by increasing new antagonist raloxifene, have been tion of calcium and may enhance bone formation through stimulation shown to reduce vertebral fracture response to BP therapy. In Dot’s of osteoblastic activity.22 Their use is risk but not that of nonvertebral or case, the likely cause of the vitamin not recommended beyond 2 years’ hip fracture.20 D deficiency is lack of dietary vita- duration. Unlike BPs, anabolic med- The NP and Dot discuss the impli- min D and age-related decline in ications do not accumulate in bone; cations of her test results and her risk cutaneous production.22 Pharmaco- BMD declines quickly after discon- for future fractures. Dot says that the logic management options include tinuation. Use of an antiresorptive fall and wrist fracture scared her, and 50,000 IU of vitamin D2 or D3 once drug following discontinuation may that she does not want to endure a weekly or 5,000 IU of vitamin D2 or prevent this loss and further in- hip fracture as her mother did. Her D3 daily for 8-12 weeks to achieve crease BMD. Research is ongoing to main treatment goals are to improve a blood 25(OH)D level >30 ng/mL. determine when combination ther- and/or stabilize her T-scores and to Maintenance therapy is 1,000-2,000 apies might be beneficial and which decrease her fracture risk. She agrees IU of vitamin D3 daily or an appropri- treatment sequence is optimal for to start an oral BP. ate dose to maintain a blood 25(OH)D patients with osteoporosis.25 = Oral BPs are taken on a daily, level ≥30 ng/mL.20,22 weekly, or monthly basis. These Other components of an osteo- References medications may cause dysphagia, porosis treatment and fracture pre- 1. ACOG Practice Bulletin No. esophagitis, and esophageal ulcers. vention program for Dot include ade- 186: Long-acting reversible contraception: implants and intra- Patients with esophageal abnor- quate calcium intake (recommenda- uterine devices. Obstet Gynecol. malities that delay esophageal tion for women aged 50+ years, 1,200 2017;130(5):e251-e269. emptying or who cannot stand or mg/day), including supplements as 2. CDC. U.S. Medical Eligibility Criteria sit upright for at least 30-60 min- needed, an exercise program to infor Contraceptive Use, 2016. MMWR utes after ingesting medication clude weight-bearing activities as well Recomm Rep. 2016;65(3):1-103. should not use oral BPs. Hypocal- as strength and balance training, and 3. ACOG Committee Opinion No. cemia is a possible adverse effect. fall prevention strategies.20,22 735: Adolescents and long-acting Serum calcium and serum creati- reversible contraception: implants nine should be measured before What follow-up is important for Dot? and intrauterine devices. Obstet Gynecol. 2018;131(5):e130-e139. beginning treatment; BPs should Dot should undergo BMD testing ev- not be used in individuals with ery 1-2 years, with stable or increas- 4. Grunloh DS, Casner T, Secura GM, et al. Characteristics associated renal impairment. Rare but serious ing T-scores indicating a satisfactory with discontinuation of long-acting adverse effects with long-term and response. If she has no new fractures reversible contraception within the high-dose BP therapy include os- during 5 years on oral BPs, a drug first 6 months of use. Obstet Gyne- teonecrosis of the jaw and atypical holiday can be considered. BPs ac- col. 2013;122(6):1214-1221. femur fracture.20,22 cumulate in bone and continue to 5. Diedrich JT, Zhao Q, Madden T, et Zoledronic acid is a BP given by have a protective effect. Optimal al. Three-year continuation of re- intravenous infusion once yearly duration of therapy and length of versible contraception. Am J Obstet Gynecol. 2015;213(5):662.e1-e8. and denosumab is given by subcu- a holiday are not established and taneous injection every 6 months. should be based on ongoing assess- 6. Zigler R, McNicholas C. Unsched- uled vaginal bleeding with proges- Either of these two drugs may be ment for fracture risk.20,22 tin-only contraceptive use. Am J

NPWomensHealthcare.com September 2018 Women’s Healthcare 19 Obstet Gynecol. 2017;26(5):443-450. 2000;26(2):191-208. 23. Eli Lilly and Company. Forteo 7. CDC. U.S. Selected Practice Rec- 16. Faught B. Alterations in sexual (teriparatide) Prescribing Informa- ommendations for Contraceptive function. In: Schuiling KD, Likis tion. March 2017. uspl.lilly.com/ Use, 2016. MMWR Recomm Rep. FE, eds. Women’s Gynecologic forteo/forteo.html#pi 2016;65(4):1-66. Health. 2nd ed. Burlington, 24. Radius Health Inc. Tymlos (ab- 8. Nasioudis D, Linhares IM, Ledger MA: Jones & Bartlett Learning; aloparatide) p Prescribing Infor- WJ, Witkin SS. Bacterial vaginosis: 2017:379-395. mation. 2017. radiuspharm.com/ a critical analysis of current knowl- 17. Hoffstetter S. Managing postmeno- wp-content/uploads/tymlos/ edge. BJOG. 2017;124(1):61-69. pausal dyspareunia: an update. tymlos-prescribing-information.pdf 9. Unemo M, Bradshaw CS, Hocking Womens Healthcare. 2018;6(2):6-12. 25. Cosman F, Nieves J, Dempster D. JS, et al. Sexually transmitted in- 18. Rappek NA, Sidi H, Kumar J, et al. Treatment sequence matters: an- fections: challenges ahead. Lancet Serotonin selective reuptake in- abolic and antiresorptive therapy Infect Dis. 2017;17(8):e235-e279. hibitors (SSRIs) and female sexual for osteoporosis. J Bone Miner Res. 2017;32(2):198-202. 10. Lewis FM, Bernstein KT, Aral dysfunction (FSD): hypothesis on its association and options of treat- SO. Vaginal microbiome and its Acknowledgment relationship to behavior, sexual ment. Curr Drug Targets. 2016. health, and sexually transmit- Epub ahead of print. The author recognizes and thanks ted infections. Obstet Gynecol. 19. American College of Rheumatol- the regional meeting presenters: 2017;129(4):643-654. ogy. Sex and Arthritis. 2017. Brooke M. Faught, MSN, WHNP-BC, 11. CDC. Sexually transmitted diseases rheumatology.org/I-Am-A/Patient- IF (Current Management Strate- treatment guidelines, 2015. MMWR Caregiver/Diseases-Conditions/Liv- gies and Updates in Diagnosis and ing-Well-with-Rheumatic-Disease/ Recomm Report. 2015;64(RR-03):1-137. Treatment for Bacterial Vaginosis; Sex-Arthritis 12. Stockdale CK. A positive culture Updates in the Diagnosis and result for Gardnerella is not diag- 20. Camacho PM, Petak SM, Binkley N, et al. American Association Management of HSDD); Suzanne L. nostic of bacterial vaginosis. J Low Reiter, MSN, MM, WHNP-BC, FAANP Genit Tract Dis. 2016;20(4):281-282. of Clinical Endocrinologists and American College of Endocrinol- (Contraception: No More Excuses); 13. Lupin Pharmaceuticals Inc. Secnida- ogy Clinical Practice Guidelines and Lisa D. Wright, DNP, ANP-C, zole Prescribing Information. 2017. for the Diagnosis and Treatment CPHQ (Updates in the Management solosechcp.com/?msclkid=44485ac- of Postmenopausal Osteoporosis - of Postmenopausal Osteoporosis). dad2e1452dc5b01f3f5ab3f12 2016. Endocr Pract. 2016;22(suppl 14. Bradshaw CS, Brotman RM. Mak- 4):1-42. Web resources ing inroads into improving treat- 21. Kanis JA, Hans D, Cooper C, et al; A. npwh.org/courses/home/details/1155 ment of bacterial vaginosis – striv- Task Force of the FRAX Initiative. B. cdc.gov/mmwr/volumes/65/rr/ ing for long-term cure. BMC Infect Interpretation and use of FRAX in rr6504a1.htm Dis. 2015;15(292):1-12. clinical practice. Osteoporos Int. C. cdc.gov/mmwr/volumes/65/rr/ rr6503a1.htm?s_cid=rr6503a1_w 15. Rosen R, Brown C, Heiman J, et 2011;22(9):2395-2411. D. fsfi-questionnaire.com al. The Female Sexual Function 22. Cosman F, de Beur SJ, LeBoff MF, Index (FSFI): a multidimen- et al. Clinician’s guide to prevention sional self-report instrument for and treatment of osteoporosis. Os- the assessment of female sex- teoporos Int. 2014;25(10):2359-2381. ual function. J Sex Marital Ther.

20 September 2018 Women’s Healthcare NPWomensHealthcare.com

Position Statement

Men with breast conditions: The role of the WHNP specializing in breast care

Risk factors An individual may present to a breast specialist not because of signs or symptoms that could indicate breast cancer but, rather, because of an identified potentially he National Association of Nurse Practi- increased risk for breast cancer. For men, well-established Ttioners in Women’s Health (NPWH) affirms the role of the breast cancer risk factors include family history and women’s health nurse practitioner (WHNP), as a member BRCA1/2 mutations, primarily those of BRCA2. In fact, 5%- of a multidisciplinary breast care specialty team, in pro- 10% of men with BRCA2 mutations eventually develop viding specialized breast care for women and men. Fur- breast cancer.3,4 In addition, conditions that alter the thermore, NPWH supports the removal of any restrictions estrogen-to-androgen ratio (e.g., Klinefelter syndrome, to the provision of male breast care that are based on the obesity, cirrhosis, history of prostate cancer treated with WHNP credential. estrogen) are associated with an increased risk of breast WHNPs are educationally prepared to provide care for cancer in men.3,5,6 Although some of these risk factors both women and men with benign and malignant breast apply only to men, the principles of risk assessment and conditions. The WHNP program curriculum includes counseling are the same for women and men. The Na- breast pathophysiology, genomics/genetics, assessment tional Comprehensive Cancer Network provides detailed and management of breast disorders, and risk assess- guidelines for risk assessment, criteria for offering genetic ment for hereditary breast cancers—all applicable to counseling and testing, and recommendations for sur- men as well as women.1 The national WHNP certification veillance of individuals identified as being at increased examination through the National Certification Corpora- risk for breast cancer.7 tion (NCC) includes content on breast cancer and other breast disorders.2 WHNPs choosing to specialize in breast Incidence care may expand their knowledge and skills in this area The American Cancer Society predicts that 2,550 men will through on-the-job training in the clinical setting and develop breast cancer in 2018.3 By comparison, an esti- through continuing education (CE) programs. mated 266,120 new cases of breast cancer in women are As of now, some states and healthcare institutions re- expected in 2018.8 Consistent with these statistics, male strict WHNPs from providing care for male patients with breast cancer comprises fewer than 1% of all breast can- breast cancer or other breast conditions. Given that the cer cases, as well as fewer than 1% of overall male cancer diagnostic procedures and treatment are the same for cases. Although these numbers and percentages in men women and men, this restriction is unwarranted. WHNPs are small compared with those in women, many men specializing in breast care are qualified to provide this care with breast disease will present to a breast care center at for all individuals. some point during diagnosis and treatment.

Background Diagnosis The majority of individuals who develop breast cancer Diagnostic tests used when an individual presents with are women. Nevertheless, breast cancer is not exclusively a breast mass or other breast changes that may indicate a female disease. Current knowledge concerning breast a malignancy are the same for women and men. These cancer risks, statistics, diagnosis, and treatment in men tests include clinical breast examination; imaging modal- provides a background to understand the role of the ities such as mammography, ultrasound, and magnetic WHNP specializing in breast care as it applies to male resonance imaging, as indicated; and biopsy of the patients. Although the background information in this mass.5,9 The most common type of breast cancer diag- section focuses on breast cancer, it is important to keep nosed in men (80%-90% of cases) is infiltrating ductal in mind that specialized breast care encompasses both carcinoma. This breast cancer type is also the most com- malignant and benign breast conditions. mon type in women (80%). About 10% of breast cancers

NPWomensHealthcare.com September 2018 Women’s Healthcare 23 in men are ductal carcinoma in situ. Fewer than 2% of rience side effects similar to those in women, including male breast cancers are lobular carcinomas, primarily hot flashes, weight gain, and sexual dysfunction. In fact, because most men have minimal lobular tissue.3 Estro- approximately one in four men discontinues therapy gen-, progesterone-, and HER2-receptor testing of breast prematurely because of bothersome symptoms.6,14 cancer cells is part of the evaluation for both women and Although management of breast cancer treatment- men. Many breast cancers in men demonstrate receptors related side effects in men is less well studied than that for the hormones estrogen and progesterone.3,10,11 in women, similar lifestyle and medication approaches are used.14 Staging Because any type of cancer, as well as its treatment, Histologic staging of breast cancer is the same for can affect sexual functioning in men and women, WHNPs women and men. Staging is defined according to tumor should ask patients about their sexual health at follow-up size, nodal involvement, metastasis, and pathologic char- visits and refer them to specialists when needed.14-17 The acteristics of the cancer, including receptor status and WHNP curriculum includes specific content on male sex- tumor grade.3,6,9,12 The pathophysiology of breast cancer ual health that prepares WHNPs to assess sexual health metastasis is the same in women and men.3 Studies do conditions, to address psychosocial factors and condi- suggest that men, compared with women, are diagnosed tions that affect sexual health, and to collaborate or refer with higher-stage tumors and have a poorer prognosis appropriately for male sexual dysfunction treatment.1 overall. The poorer prognosis correlates with delay in The NCC WHNP certification examination includes con- diagnosis and treatment—thought to occur in part be- tent on male sexuality and sexual dysfunction.2 cause of lack of awareness of breast cancer in men.5,6,10 Both men and women with a diagnosis of breast cancer may experience body image disruption, anxiety, Treatment and depression.14,15 Although similarities between male Four modalities are used either as single therapies or in and female breast cancer survivors exist in terms of combination for the treatment of breast cancer in both psychological and quality-of-life (QOL) concerns, certain women and men. These modalities are surgery, radiation, concerns are more likely to affect men. For example, chemotherapy, and hormone therapy.3,6,12 In the ab- some men may feel stigmatized by having a diagnosis sence of randomized controlled trials of the treatment of so strongly associated with women.6,14,15 They may feel breast cancer in men, current guidelines are based for the embarrassed to talk with their healthcare provider and most part on treatment of breast cancer in women.13 feel isolated because they cannot find other male breast cancer survivors to whom then can relate.14,15 WHNPs Follow-up care and concerns are prepared in educational and clinical environments The care provided by healthcare professionals special- that emphasize attention to psychological, social, and izing in breast cancer goes beyond initial diagnosis and cultural factors that influence healthcare and health treatment. The needs of both male and female breast outcomes. This holistic and individualized care extends cancer survivors are multifaceted and ongoing. Genetic across genders. counseling/testing, as appropriate, is one component of this care (if not done prior to treatment). Just as for Gaps in knowledge females, genetic testing for male breast cancer survivors More research is needed regarding all aspects of male can provide information relevant to their surveillance breast cancer. Biological differences between male breast needs and those of their family members.6,7,12,14 Sur- cancers and female breast cancers may have implications veillance recommendations for both male and female for treatment strategies.11,12,14 Men with breast cancer breast cancer survivors include clinical breast/chest wall should have an opportunity to participate in clinical examination twice yearly for the first 5 years and then an- trials and/or be added to a tumor registry to provide nually thereafter.13,14 Although only limited data support data on the care and outcomes of a rare disease. Studies the use of breast imaging as part of surveillance for male conducted to better understand psychological and QOL breast cancer survivors, it may be offered.14 problems for men with breast cancer could lead to im- Care for both male and female breast cancer survi- proved care. All healthcare professionals specializing in vors also includes management of side effects of treat- breast cancer care for women and men are expected to ment. Men treated with hormone therapies may expe- stay current on evidence for best practice.

24 September 2018 Women’s Healthcare NPWomensHealthcare.com Implications for WHNP practice 5. National Cancer Institute Physician Data Query (PDQ). Male WHNPs who choose to specialize in breast care have Breast Cancer Treatment. 2017. cancer.gov/cancertopics/ a strong foundation to prepare them for this role. The pdq/treatment/malebreast/healthprofessional WHNP curriculum and the WHNP certification examina- 6. Ruddy KJ, Wine EP. Male breast cancer: risk factors, biology, diagnosis, treatment and survivorship. Ann On- tion reflect the knowledge base needed to provide care col. 2013;24(6):1434-1443. in this specialty area, which includes benign and malig- 7. National Comprehensive Cancer Network. Genetic/ nant breast conditions in women and men. On-the-job Familial High-Risk Assessment: High-Risk Assessment: training and CE programs further expand the knowledge Breast and Ovarian Cancer. 2017. nccn.org/profession- and skills appropriate to providing this care. als/physician_gls/pdf/genetics_screening.pdf Principles of breast cancer risk assessment and coun- 8. American Cancer Society. Breast Cancer. 2018. cancer. seling are the same for women and men. Diagnostic org/cancer/breast-cancer.html. testing, hormone-receptor evaluation, and staging for 9. National Comprehensive Cancer Network. Clinical Prac- breast cancer are the same. Treatment modalities are the tice Guidelines in Oncology: Breast Cancer Screening same. Management for treatment-related side effects and Diagnosis. 2017. nccn.org/professionals/physician_ gls/pdf/breast-screening.pdf and surveillance strategies for breast cancer survivors are 10. Uslukaya O, Gümüs M, Gümüs H, et al. The manage- similar for women and men. Holistic and individualized ment and outcomes of male breast cancer. J Breast care is a cornerstone for all WHNPs. And those WHNPs Health. 2016;12(4):165-170. who specialize in breast care are qualified to provide care 11. Nilsson C, Homlqvist M, Bergkvist L, et al. Similar- for women and men. ities and differences in the characteristics and primary treatment of breast cancer in men and women NPWH will: – a population based study (Sweden). Acta Oncol. 2011;50(7):1083-1088. • Educate employers and state boards of nursing as needed concerning the qualifications of WHNPs to spe- 12. Shahidsales S, Ersi MF. Male breast cancer: a review of the literature. Rev Clin Med. 2017;4(2):69-72. cialize in breast care; and • Advocate for removal of any current restrictions to 13. National Comprehensive Cancer Network. Clinical Prac- tice Guidelines in Oncology: Breast Cancer. 2018. nccn. WHNPs providing breast care for men. = org/professionals/physician_gls/pdf/breast.pdf 14. Ferzoco RM, Ruddy KJ. Optimal delivery of male breast References cancer follow-up care: improving outcomes. Breast 1. NPWH/AWHONN. Women’s Health Nurse Practitioner: Cancer (Dove Med Press). 2015;7:371-379. Guidelines For Practice and Education. 7th ed. Wash- 15. Kipling M, Ralph J, Callanan K. Psychological impact of ington DC: NPWH/AWHONN; 2014. male breast disorders: literature review and survey re- 2. National Certification Corporation. 2018 Candidate sults. Breast Care. 2014;9(1):29-33. Guide Women’s Health Nurse Practitioner. Chicago, IL: 16. National Cancer Institute. Sexual Health Issues in National Certification Corporation; 2018. Women with Cancer. 2017. cancer.gov/about-cancer/ 3. American Cancer Society. Breast Cancer in Men. 2016. treatment/side-effects/sexuality-women cancer.org/cancer/breast-cancer-in-men/about.html 17. National Cancer Institute. Sexual Health Issues in Men 4. Pritzlaff M, Summerour P, McFarland R, et al. Male with Cancer. 2017. cancer.gov/about-cancer/treatment/ breast cancer in a multi-gene panel testing cohort: inside-effects/sexuality-men sights and unexpected results. Breast Cancer Res Treat. 2016;161(3):575-586. Approved by the NPWH Board of Directors: May 2018

NPWomensHealthcare.com September 2018 Women’s Healthcare 25 Developing and implementing PrEP at your local health center

By Brenda A. Wolfe, MSN, APN, ACRN; Elizabeth Higgins, MSN, re-exposure prophylaxis WHNP; Michelle Vos, MA; and Amy Whitaker, MD (PrEP) is the use of an- tiretroviral medication by Pre-exposure prophylaxis (PrEP) is an effective tool in the PHIV-negative individuals to reduce their risk of acquiring HIV. Emtricit- prevention of HIV acquisition. Advanced practice registered abine/tenofovir disoproxil fumarate nurses are ideally positioned to introduce and prescribe PrEP, (ETDF), the only FDA-approved but some may not know how to integrate it into their practice. In medication for PrEP, is more than 92% effective in preventing HIV this article, the authors describe the logistics of developing and acquisition when taken as directed.1 implementing a PrEP program at multiple Planned Parenthood of Information about PrEP should Illinois (PPIL) health centers. They also discuss the training and be offered to suitable candidates, support offered to PPIL clinicians during implementation of the as described in the CDC’s Clinical Practice Guideline, Preexposure program, the evaluation process, and the results. The process from Prophylaxis for the Prevention development to implementation and evaluation can be easily of HIV Infection in the United A 2 adapted to other clinical settings. States . Advanced practice registered nurses (APRNs) working in Key words: Pre-exposure prophylaxis, PrEP, women, HIV reproductive health clinics, sexually prevention, outpatient health services, reproductive health transmitted infection clinics, obstetrics and gynecology (Ob/Gyn) practices, and other primary healthcare settings are particularly well positioned to discuss PrEP with their patients and prescribe the medication when indicated. Many clinicians are reluctant to implement PrEP in their practices—for a variety of reasons. A major concern is the time needed to obtain sexual histories, provide counseling, and complete required paperwork for patients needing financial assistance (mainly for medication provision). Clinical concerns related to prescribing PrEP include drug side effects, a potential lack of adher-

26 September 2018 Women’s Healthcare NPWomensHealthcare.com ence to the regimen by patients, and and numerous details regarding its use when ordering PrEP in order the possibility that patients might implementation must be addressed. to make the evaluation process engage in riskier sexual behavior3 Based on their experience at PPIL, easier). because, by taking PrEP, they may the authors recommend these steps • Create standing orders for labora- feel less vulnerable to harm. for developing and implementing a tory tests and medications. Even though ETDF has proved to PrEP program: • Configure standing laboratory be highly effective in preventing HIV • Ensure that top administrators test and medication orders into acquisition, clinicians working in cer- (e.g., CEO, county commissioners, electronic health records (EHRs). tain types of practices are unlikely to board of directors) are well versed • Create educational phrases in the prescribe it. For example, according about PrEP. EHR for efficient comprehensive to a PrEP utilization review, only 3% • Obtain support from the senior documentation. of PrEP regimens prescribed be- leadership team. • Include PrEP services in marketing tween 2013 and 2016 were provided • Determine whether clinicians per- materials and messages, including in Ob/Gyn offices.4 According to this ceive that PrEP is an appropriate those on social media. same review, most women accessed intervention and whether they • Inform stakeholders and commu- PrEP through family medicine and have concerns about the screen- nity agencies about available PrEP emergency department providers, ing process or the PrEP protocol services. whereas most men accessed it itself. Provide information and ad- • Pre-populate and print patient through family medicine and inter- dress concerns as needed. medication assistance forms and nal medicine providers.4 • Train and support clinicians on co-pay cards for efficient appli- With the hope of encouraging how to provide PrEP. cation processing. The Gilead APRNs to be more proactive in • Create a PrEP algorithm for Advancing Access®programB prescribing PrEP and, even more, screening and prescribing. provides information for clinicians helping them set up a PrEP program • Train medical assistant staff to and patients to help ensure access in their own practice venue—the screen for and educate about PrEP. to medication. authors share their experience in de- • Inform support staff, schedulers, • Add your clinic and/or clinicians veloping and implementing a PrEP educators, and administrative staff to the PrEP Locator National program at 16 affiliates of Planned about PrEP services. DirectoryC. Parenthood of Illinois (PPIL). They • Include PrEP education in the • Evaluate the effectiveness of pro- describe the training and support new-hire orientation program. gram implementation. provided to the PPIL clinicians • Designate a champion to provide • Address concerns recognized during implementation of the pro- support and on-call assistance. during the evaluation process. gram and discuss the evaluation (A clinician can become a PrEP process and results. champion via continuing educa- PrEP training and support tion, experience in prescribing for clinicians Developing and PrEP, or both.) Written protocols are an important implementing a PrEP • Determine whether rapid HIV test- resource for training and supporting program ing will be performed onsite or clinicians as they implement a new Integrating a new service into a outsourced. service within their practice setting. private or multispecialty practice • Identify patient visit and labora- Examples of available resources requires planning. One of the first tory test costs. for PrEP protocols and checklists steps is to anticipate barriers that • Ascertain whether ETDF will be are provided in the Box. Planned may (1) prevent administrators, clini- stocked in-house and/or acquired Parenthood’s Medical Standards cians, and staff members from fully by patients from offsite pharmacies. and Guidelines (MS&Gs) include embracing the program or (2) deter • Identify appropriate diagnostic comprehensive PrEP protocols and patients from returning for services. codes for PrEP services to ensure algorithms that were used for this The next step is figuring out how to optimal reimbursement and purpose at PPIL. avoid or overcome these barriers as ability to track visits for program As part of the training at PPIL, the the program is designed and then evaluation (at PPIL, the PrEP pro- clinicians were asked to review these launched. A host of other decisions gram developers gave clinicians MS&Gs and attend a 90-minute pre- about the program must be made one specific diagnostic code to (continued on page 31)

NPWomensHealthcare.com September 2018 Women’s Healthcare 27 For your patients with moderate to severe dyspareunia due to menopause, IT’S WHAT’S INSIDE THAT COUNTS Only INTRAROSA® converts to androgens and estrogens in a woman’s body with no restrictions on duration of use1*

Help give women with moderate to severe dyspareunia due to menopause the chance

TRAROS to embrace the next third of their lives. IN A

E s

s n t r e o g g 1,2 ro en d • First and only FDA-approved, vaginal non–estrogen-baseds An therapy • Demonstrated efficacy1-3 TRARO • Once-daily treatment at bedtime 1 IN SA

Prasterone* is an inactive precursor that is converted into active androgens s s t n and estrogens. The mechanism of action is not fully established. r e o g g e ro n d s An Order samples and learn more at IntrarosaHCP.com.

Indication INTRAROSA is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Important Safety Information INTRAROSA is contraindicated in women with undiagnosed abnormal genital bleeding. Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer. In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥2 percent were vaginal discharge and abnormal Pap smear. Please see the following page for a Brief Summary of full Prescribing Information.

References: 1. lntrarosa [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; 2018. 2. Archer DF, Labrie F, Bouchard C, et al. Menopause. 2015;22(9):950-963. 3. Labrie F, Archer DF, Koltun W, et al. Menopause. 2016;23(3):243-256.

INSPIRED BY HER BODY For your patients with moderate to severe dyspareunia due to menopause, IT’S WHAT’S INSIDE THAT COUNTS Only INTRAROSA® converts to androgens and estrogens in a woman’s body with no restrictions on duration of use1*

Help give women with moderate to severe dyspareunia due to menopause the chance

TRAROS to embrace the next third of their lives. IN A

E s

s n t r e o g g 1,2 ro en d • First and only FDA-approved, vaginal non–estrogen-baseds An therapy • Demonstrated efficacy1-3 TRARO • Once-daily treatment at bedtime 1 IN SA

INSPIRED BY HER BODY INTRAROSA® (prasterone) vaginal inserts Brief Summary: Consult full Prescribing Information for complete product information. INDICATION INTRAROSA is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

CONTRAINDICATIONS Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA.

WARNINGS AND PRECAUTIONS Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.

ADVERSE REACTIONS Clinical Trials Experience 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. In four (4) placebo-controlled, 12-week clinical trials [91% - White Caucasian non-Hispanic women, 7% - Black or African American women, and 2% - “Other” women, average age 58.8 years of age (range 40 to 80 years of age)], vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group. There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group. In a 52-week non-comparative clinical trial [92% - White Caucasian non-Hispanic women, 6% - Black or African American women, and 2% - “Other” women, average age 57.9 years of age (range 43 to 75 years of age)], vaginal discharge and abnormal Pap smear at 52 weeks were the most frequently reported treatment-emergent adverse reaction in women receiving INTRAROSA with an incidence of ≥ 2 percent. There were 74 cases of vaginal discharge (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in 521 participating postmenopausal women. The eleven (11) cases of abnormal Pap smear at 52 weeks include one (1) case of low-grade squamous intraepithelial lesion (LSIL), and ten (10) cases of atypical squamous cells of undetermined significance (ASCUS).

Manufactured for: Endoceutics, Inc., Quebec City, Canada, G1V 4M7. Distributed by: AMAG Pharmaceuticals, Inc., Waltham, MA 02451 PP-INR-US-00250 (continued from page 27) Box. PrEP resources sentation on PrEP. The presentation was provided by PPIL’s PrEP cham- New York State Department of Health AIDS Institute. Clinical Guidelines Program. pion. The presentation included PREP FOR HIV PREVENTION a case study with multiple-choice • Purpose of this guideline: https://www.hivguidelines.org/prep-for- questions that generated discussion prevention/prep-to-prevent-hiv/#tab_0 and allowed the clinicians to apply • Updates to this guideline: https://www.hivguidelines.org/prep-for- information from the protocols prevention/prep-to-prevent-hiv/#tab_1 and algorithms. PrEP education • PrEP efficacy: https://www.hivguidelines.org/prep-for-prevention/prep- included identifying candidates for to-prevent-hiv/#tab_2 PrEP, counseling, prescribing, and re- • Candidates for PrEP: https://www.hivguidelines.org/prep-for-prevention/ quired follow-up. Information about prep-to-prevent-hiv/#tab_3 PrEP-Ception, the utilization of PrEP • Pre-prescription counseling and assessment: https://www.hivguidelines.org/ for HIV sero-discordant couples prep-for-prevention/prep-to-prevent-hiv/#tab_5 wanting to conceive, was included • Prescribing PrEP: https://www.hivguidelines.org/prep-for-prevention/ in the training. prep-to-prevent-hiv/#tab_7 The clinicians were reminded that • PrEP follow-up: https://www.hivguidelines.org/prep-for-prevention/prep- most patients are unaware of PrEP; to-prevent-hiv/#tab_8 as clinicians, they are responsible for discussing PrEP as part of a comprehensive HIV prevention strategy. tion about and screening for PrEP • Which drugs can potentially interact Clinicians involved in reproductive was encouraged. However, the with PrEP? healthcare practices are already ex- clinicians exercised their own judg- perienced in taking sexual histories ment and comfort level in terms of Evaluation process and and discussing safer sex practices. whether they chose to prescribe results Adding PrEP to the conversation PrEP themselves or refer patients to Short- and long-term evaluations simply expands the prevention another PPIL provider to do so. The are important components of a suc- messages and options for patient PrEP champion was always available cessful change in practice. Barriers protection. to answer questions and provide can be identified and addressed, Statistics on HIV prevalence support. Most questions posed to lessons can be learned and shared within the communities in which the champion concerned laboratory to improve processes, and factors the clinicians practice were provided tests, co-morbidities, and potential needed to sustain the change can during the presentation as well. drug interactions, and were typified be assessed. Each clinical setting The clinicians were encouraged to by the following: implementing PrEP services can share this information with their pa- • When monitoring kidney function, decide how best to implement the tients—a strategy aimed at increas- which test panel or test (complete evaluation component. However, ing patients’ awareness of the level metabolic profile, basic metabolic having an evaluation plan in place of risk of acquiring HIV based on its profile, blood urea nitrogen, or creati- from the beginning will help ensure prevalence within their community. nine) is the most cost effective? that it occurs. Too often, patients perceive PrEP • How should I proceed if a patient has PPIL implemented evaluations at candidates as persons who have en- a slightly low or high creatinine level? 4, 12, and 18 months using EHR data, gaged in promiscuous or dangerous • How often should a hepatitis B anti- one-on-one meetings between the behavior. Clinicians’ emphasis on HIV gen be drawn on a patient who wants clinicians and the PrEP champion, prevalence in the community—as to restart PrEP? and clinician surveys. Along the way, opposed to certain behaviors—as • Can PrEP be started in a patient with a these evaluations provided valuable being a factor in acquiring HIV can positive syphilis test result? insights. Early on, some clinicians reduce the stigma. • Can use of PrEP be affected by the needed and were provided with Upon completion of the PrEP presence of certain health conditions? more information about the PrEP presentation, the clinicians were • Can PrEP be prescribed prior to the return protocol, as well as guidance on ini- free to implement PrEP into their of baseline lab test results in a patient tiating the conversation about PrEP practice. Providing routine educa- with a negative rapid HIV test result? with patients who might not con-

NPWomensHealthcare.com September 2018 Women’s Healthcare 31 sider themselves vulnerable to HIV. clinicians prescribing PrEP for an work and dedication of the clinicians; One year after implementing PrEP increased number of patients. Staff support from reproductive health services, the clinicians reported that continue to look at strategies to re- assistants who were invaluable in they had received appropriate train- move barriers to medication adher- screening and counseling patients; ing but that they gained complete ence crucial to PrEP efficacy and to and support from the leadership confidence in themselves and the better facilitate PrEP follow-up visits. team, health center managers, and process only after seeing a patient for staff at Planned Parenthood of Illinois. whom they prescribed PrEP. They re- Clinical implications A special acknowledgment goes to ported that the more times they pre- According to the CDC, a total of the technical team for their assistance scribed PrEP, the easier it became to 1,232,000 persons in the U.S. would in capturing the metrics that allowed do so. During the first year, 18 (75%) benefit from PrEP.1 Among this for evaluation, quality improvement, of the 24 PPIL clinicians reported group are 492,000 men who have and sharing of the data. prescribing PrEP and all 24 expressed sex with men, 115,000 adults who interest in prescribing PrEP. inject drugs, and 624,000 hetero- References The PrEP champion used informa- sexually active adults, of whom 1. Smith DK, Handel MV, Wolitski RJ, tion from one-on-one meetings with 468,000 are women.1 Information et al. Vital signs: estimated percentages and numbers of adults the clinicians, as well as the 4-month about PrEP should be included with indications for preexposure and 1-year evaluations, to provide routinely when APRNs caring for prophylaxis to prevent HIV ac- a second presentation on PrEP that women are discussing reproduc- quisition — United States, 2015. was focused on common questions tive and sexual health. Women MMWR Morb Mortal Wkly Rep. about abnormal lab test results should be informed if they reside 2015;64(46):1291-1295. and drug interactions, strategies in areas with high HIV prevalence 2. CDC. Preexposure Prophylaxis for for increasing PrEP use specifically and should be helped in identifying the Prevention of HIV Infection in the United States—2017 Update: for women at risk for HIV acquisi- their own individual risk factors. A Clinical Practice Guideline. cdc/ tion, PrEP use during pregnancy APRNs caring for women should gov/hiv/pdf/risk/prep/cdc-hiv- and breastfeeding, use of PrEP for consider implementing PrEP ser- prep-guidelines-2017.pdf patients with co-morbidities, and vices as an HIV prevention strategy. 3. Monthly Prescribing Reference. use of an iPhone app, NefroCalcD, The steps described by the authors Why are Clinicians Reluctant to for easy calculation of estimated for developing, implementing, and Prescribe PrEP to High-Risk Pa- creatinine clearance. A chart audit evaluating PrEP services at PPIL pro- tients? April 6, 2015. empr.com/ conducted at 18 months post-im- vide guidance that can be adapted news/why-are-clinicians-reluctant- to-prescribe-prep-to-high-risk-pa- plementation (4 months after the to a variety of clinical settings. = tients/article/407448/ second presentation) identified a 4. Truvada for PrEP Utilization by significant increase in the number of Brenda A. Wolfe is Director of Clin- Gender and Provider Specialty. new patients receiving PrEP, demon- ical Initiatives and Education, Eliz- November 2016. Email communi- strating the importance of ongoing abeth Higgins is Associate Medical cation with Staci Bush. education and discussion with staff Director, Michelle Vos is Business when implementing a new program. Intelligence Manager, and Amy Web resources A. cdc.gov/hiv/pdf/risk/prep/cdc-hiv- Whitaker is Medical Director, all at prep-guidelines-2017.pdf Summary Planned Parenthood of Illinois in B. gileadadvancingaccess.com/hcp At PPIL, PrEP services were imple- Chicago. Brenda A. Wolfe reports C. preplocator.org/about-us/ mented immediately following an that she serves on the Gilead HIV D. download.cnet.com/NefroCalc/ 3000-2129_4-75598175.html initial educational presentation. A Speaker Bureau. The other au- system-wide approach to imple- thors state that they do not have mentation was utilized rather than a financial interest in or other executing the service one health relationship with any commercial center at a time. Clinicians did not product named in this article. find screening and prescribing PrEP during routine visits problematic. Acknowledgments Ongoing education, support, eval- Implementation of PrEP would not uation, and dialogue resulted in have succeeded without the hard

32 September 2018 Women’s Healthcare NPWomensHealthcare.com

Challenges of preconception and interconception care: Environmental toxic major focus of preconception care (PC) and exposures A interconception care (IC) is identification and mitigation/ By Diane Schadewald, DNP, MSN, RN, FNP-BC, WHNP-BC and management of risk factors to im- Ursula A. Pritham, PhD, WHNP-BC, FNP-BC, SANE prove health outcomes for women, newborns, and children.1 The im- This article provides healthcare providers with up-to-date portance of providing information about environmental toxins, as information about the impact of a variety of potentially toxic part of PC/IC to decrease risks of environmental exposures on reproductive health, specifically with exposure, was recently highlighted respect to preconception care (PC) and interconception care (IC). by the International Federation of Gynecology and Obstetrics (FIGO).2 PC/IC should include education regarding environmental risks The American College of Obstetri- and a discussion about ways to minimize a woman’s exposure cians and Gynecologists (ACOG) to environmental toxins in order to optimize both pregnancy and includes information about environmental risks in its Good Health Be- infant outcomes. fore Pregnancy: Preconception Care patient guide.3 In this article, the au- Key words: preconception care, interconception care, thors describe what is known about environmental toxic exposures, reproductive health some common environmental toxins and recommend strategies that healthcare providers (HCPs) can implement to help patients mitigate their risks of exposure. Nearly all HCPs are aware of the dangers of smoking and drinking alcoholic beverages both prior to conception and during pregnancy, and counsel patients to avoid these practices. Also, before and after pregnancy is achieved, nearly all HCPs review patients’ medications to identify any potential teratogens and make adjustments as needed. Most HCPs advise pregnant patients to avoid eating fish high in mercury (e.g., shark, tilefish, swordfish, king mackerel).4 It also is common knowledge to

NPWomensHealthcare.com September 2018 Women’s Healthcare 35 Figure. Effects of endocrine disruptors on cells Agricultural runoff from pesticides, herbicides, and fertilizers seeps into ground water. Exposure to the herbicide atrazine has been associated with reduced fetal growth.9 Nitrates in groundwater coming from fertilizers, manure, and human sewage have been associated with methemoglobinemia When absorbed in the body, an endocrine disruptor can decrease or increase normal hormone (blue baby syndrome) in infants and levels (left), mimic the body’s natural hormones (middle), or alter the natural production of hor- thyroid dysfunction in pregnant mones (right). 9 Source: NIH, National Institute of Environmental Health Sciences. niehs.nih.gov/health/topics/agents/endocrine/index.cfm women. Although public water systems are tested for these contam- recommend against consumption malformations, neurologic/cognitive inants and must meet safety stan- of soft cheeses and deli meats to developmental disruptions, preterm dards, individuals who get drinking decrease risk of exposure to listeria, birth, and increased future cancer water from wells should be advised and to remind patients to avoid ex- risk.2,4,6-8 Many different categories of to have the water tested. Likewise, posure to toxins such as radiation, substances in the environment can individuals whose drinking water radon, and lead. Therefore, this arti- serve as endocrine disruptors. comes from a public water system cle focuses on environmental risks should ask for the latest test results about which HCPs may be less well Pesticides/herbicides/ for these substances.9 If test results informed.5 fertilizers are positive, home water filtration Environmental toxins are found in Certain pesticides and herbicides and/or reverse osmosis systems are the air, in water, and in animals and may adversely affect fertility or recommended. plants that are consumed as food, as they may have teratogenic effects if well as in products and furnishings in conception does occur. In addition, Personal care products/ people’s homes. Adverse effects of ex- exposure to detectable amounts of cleaning products/paints posure to high concentrations of such pesticides has been linked to child- Many personal care products such as toxins in humans have been reported. hood leukemia and to neurologic fragrances, cosmetics, soaps, lotions, It remains unclear, however, whether and cardiovascular abnormalities in and deodorants contain phthalates, the lower concentrations of such offspring.7 For example, exposure to which can act as endocrine disrup- toxins in the surrounding environ- organophosphate pesticides such as tors.5,7 Phthalate exposure both ment can potentially have the same chlorpyrifos and diazinon has been prior to and during pregnancy has adverse effects as do higher concen- associated with abnormal cognitive been linked to a risk for preterm trations that are ingested or inhaled development in offspring.2,4,8 birth and to neurodevelopmental directly and on a regular basis.6 Consuming organically grown and executive function problems produce may limit one’s exposure to in offspring.2,4 Males are more Endocrine disruptors organophosphates used to control likely than females to be adversely Many of these environmental toxins weeds and pests.7 Some non-or- affected by prenatal exposure to can act as endocrine disruptors; that ganically grown produce is safer to phthalates.4 In particular, male re- is, they can interfere with endocrine consume than others. Readers are productive development abnormal- system function at multiple levels advised to check the Environmen- ities have been noted from in utero and in multiple ways (Figure). During tal Working Group’s (EWG’s) exposure to these compounds.4,10 highly sensitive stages of human de- Shopper’s Guide to Pesticides in Best practice is to check the labels velopment, even small disturbances ProduceA, which has information on personal care products and use in endocrine function can have on non-organic fruits and vegeta- only those that are phthalate free. profound effects. With regard to the bles with low or high residues of Triclosan, parabens, and triclocar- reproductive system and pregnancy organophosphates. Of note, residue bans, which are added to personal outcomes, potential effects of endo- from these organophosphates be- care products to provide antibacte- crine disruption include fertility prob- comes embedded in the skin of the rial and antifungal effects, have been lems for both females and males, produce and/or penetrates into the identified as endocrine disruptors fetal growth restriction, physical produce and cannot be washed off. (continued on page 38)

36 September 2018 Women’s Healthcare NPWomensHealthcare.com Ferretts® Iron I like because it likes me. Gentle and Effective, Feel the Difference Chewable, Tablet or Liquid Better Tolerated = Better Results Available at your local Pharmacy Ask the Pharmacist

High Quality Nutritional Products for a Healthy Need samples 800-456-4138 or www.IronSamples.com and Balanced Lifestyle (continued from page 36) that have been associated with tics containing phthalates and pose were replaced by the flame retar- preterm birth and low birth weight the same risks as do personal care dant tris(1,3-dichloro-2-propyl)phos- (LBW). In addition, exposure to tri- products containing phthalates.11 phate (TDCPP), which also disrupts closan may have thyrotoxic effects Perfluorochemicals (PFCs) are endocrine function and has carcino- on the mother, which would have an used to make fluoropolymer coat- genic properties. TDCPP was volun- adverse impact on the fetus.10 The ings and products that resist heat, tarily withdrawn from the market EWG’s web page on Consumer oil, stains, grease, and water. Fluo- in 2015. However, both products— ProductsB is a good resource for in- ropolymer coatings can be used in PBDE and TDCPP—were widely used formation on high- and low-risk per- products such as clothing, furniture, in the foam of upholstered furniture, sonal care and cleaning products. adhesives, food packaging, heat-re- as well as in other foam cushion Some organic compounds are sistant non-stick cooking surfaces, products (e.g., foam mattresses, not tightly chemically bound to the and the insulation of electrical wire. pillows, bumper pads, automobile products containing them and can PFCs have been voluntarily elimi- seats) and electronics. These chem- be released into the atmosphere nated from the market. However, icals are unstable in the foam and in a process called off-gassing. Off- because of their long half-lives, are released into the atmosphere gassed compounds can be inhaled they persist in the environment and via off-gassing, enabling them to be directly from the atmosphere, but in wildlife and humans previously inhaled. In addition, these gases set- they also may settle on surfaces and exposed to them. PFCs have been tle into household dust and create be absorbed through the dermis linked to thyroid problems and to pathways for accumulation in the by contact with such contaminated adverse pregnancy outcomes re- body through dermal absorption. surfaces, or they may be ingested by lated to prenatal exposure, although TDCPP is included in California hand-to-mouth transfer. This phe- study results are inconsistent.9 As a Proposition 65’s list of carcinogenic nomenon is a concern when using health advisory, the Environmental products. Good hand washing can latex-based paints and enamels. Protection Agency has recom- decrease exposure to this com- Exposure to these volatile organic mended that drinking water be pound.14,15 Another recommended compounds (VOCs) has been asso- evaluated for presence of perfluoro- practice is to check the tag on up- ciated with increased allergy-related alkyl substances (PFASs), including holstered furniture to determine conditions in offspring such as rhi- PFCs such as perfluorooctanoic acid whether it meets California TB117 fire nitis, asthma, and eczema.7 Use of and perfluorooctanesulfonic acid.12 safety standards and then avoid such low VOC-containing paints—recog- These PFASs can be removed from furniture to limit exposure to these nizable by labels indicating this sta- drinking water by carbon filtration flame retardants.16,17 Finally, if pos- tus—is recommended. and/or reverse osmosis.12 sible, polyurethane foam should be Additive flame retardants such avoided in favor of products that use Housewares/furnishings/ as polybrominated diphenyl ethers polyester fiber filling for cushioning. flame retardants (PBDEs), widely used in furniture Polyester fiber fillings are not treated Many hard plastic containers contain starting in the 1960s and 1970s, have with flame-retardant chemicals. bisphenol A (BPA), which acts as an been linked to endocrine disruption, endocrine disruptor and which has impaired neurodevelopment, and Polycyclic aromatic been associated with LBW in new- increased risk for papillary thyroid hydrocarbons and borns and persistent wheezing, be- cancer.2,7 Exposure to organophos- particulate matter havioral problems, and neurodevel- phate flame retardants (PFRs), as Living near a highway, which in- opmental abnormalities, including quantified by urinary concentration creases one’s exposure to polycyclic problems with executive function, in of PFR metabolites in a study sample aromatic hydrocarbons (byproducts offspring.2,4,7 Heating may increase of 211 women, was shown to signifi- of fuel burning) and high levels of release of BPA from these containers. cantly impede the success of in vitro particulate matter (PM), is associated Best practice is to not use these hard fertilization.13 Because of PBDEs’ long with increased risk for preterm labor plastic containers or at least not use half-lives, any accumulation remains and the development of autism them to heat food in a microwave in the body for years.14 spectrum disorder (ASD) and other oven. Containers marked with a PBDEs were banned in Europe cognitive problems in offspring.4,7,18 triangle containing the number 3 or and voluntarily taken off the market Preterm labor and ASD have also the number 7 are made of soft plas- in the United States in 2004. They been associated with spending a lot

38 September 2018 Women’s Healthcare NPWomensHealthcare.com Box. Preconception care and interconception care: Resources regarding environmental toxic exposures of time driving in internal combus- tion engine-powered vehicles, with • CDC. Planning for Pregnancy: cdc.gov/preconception/planning.html resultant higher exposure to exhaust • Wisconsin Association for Perinatal Care. Resources for Parents and Consumers: containing benzene and other vola- perinatalweb.org/for-parents-and-consumers/other-resourses tile gases such as polycyclic aromatic • Wisconsin Environmental Health Network. Prenatal Environmental Health: hydrocarbons.4,7,18 Traffic-related WEHNonline.org/prenatal exposure to nitrogen dioxide and • Wisconsin Association for Perinatal Care. Planning for a Healthy Future. Algorithm for Providers Caring for Women of Childbearing Age: beforeandbeyond.org/ to PM <2.5 micrometers in diameter uploads/wapc_pcc_algorithm.pdf (PM ) and <10 micrometers in di- 2.5 • Environmental Working Group website: ewg.org/ ameter (PM ) is also associated with 10 • Duke University Foam Project: foam.pratt.duke.edu/ ASD development.18 The risk related • Preconception Health + Healthcare Initiative: Before, Between & Beyond Pregnancy: to long commutes or an occupation beforeandbeyond.org/ involving driving an internal com- bustion engine-powered vehicle can be mitigated by having a good filtra- Potential emerging als, and children’s health advocates tion system in the vehicle.7 environmental risks joined together in Project TENDR: Exposure to ozone and fine PM Concern exists regarding the possibility Targeting Environmental Neuro-

(PM2.5 and PM10) in the air also is that banned substances such as poly- Developmental Risks. Project TENDR associated with preterm delivery chlorinated biphenyls (PCBs), which developed a consensus statement and risk for pregnancy-related hy- have been associated with adverse neu- supporting assessment, monitoring, pertension.7 Therefore, paying at- rodevelopmental effects, may increase and reduction of exposures to envi- tention to low-quality air alerts and again in the environment.9 The return ronmental toxins in order to promote staying indoors in a setting with a of PCBs is related to melting of the polar health for children in the U.S.20 The good filtration system for cooling ice caps in which they may be trapped. seriousness of the risks to the current and heating systems is a prudent Information is also emerging about generation and the potential inter- practice for every woman of child- possible harms from electromagnetic generational risks related to possible bearing age, not just those with radiation exposures, nanoparticles, and epigenetic changes associated with chronic respiratory conditions. genetically modified organisms.7 These toxic environmental exposures make risks need further study before inclusion providing information to patients Solvents in PC/IC recommendations. about these risks imperative. = In its Good Health Before Pregnancy: Preconception Care patient guide, Resources and Diane Schadewald is Clinical As- ACOG advises women to check with recommendations sociate Professor at the University their employers about potential Preconception care and intercon- of Wisconsin-Milwaukee College exposure to solvents.3 Prenatal ex- ception care should include the pro- of Nursing. Ursula A. Pritham is posure to solvents such as toluene vision to patients of evidence-based Associate Professor at Georgia Southern University School of has long been known to be harmful information on potential environ- Nursing in Statesboro. The au- to offspring. Exposure to chlorinated mental toxins and how to reduce thors state that they do not have solvents has been associated with risks of exposure. In today’s often a financial interest in or other 18 increased risk for ASD. Presence time-limited visits, HCPs may have relationship with any commercial in drinking water of a product used difficulty covering everything im- product named in this article. in dry cleaning, tetrachoroethylene portant in PC/IC. Written materials (perchlorethylene or PERC), has been such as ACOG’s Good Health Before A complete list of references linked to neurologic problems and Pregnancy: Preconception Care and cited in this article is available the development of neurodegener- websites such as those listed in the at npwomenshealthcare. ative disorders such as Parkinson’s Box can be helpful. com/?p=6706. disease later in life.4 Although many Healthcare providers are encour- dry cleaners are replacing PERC with aged by FIGO to engage in advocacy Web resources safer chemicals, long-term exposure to decrease the widespread use of A. ewg.org/foodnews/ remains a concern and is associated identified environmental toxins.2 In B. ewg.org/key-issues/consumer-products#.WX9RrYTyuJA with adverse pregnancy outcomes.7,19 2015, scientists, health profession-

NPWomensHealthcare.com September 2018 Women’s Healthcare 39 Clinical resources

Effects of environmental toxins on reproductive health and pregnancy* By Diane Schadewald, DNP, MSN, RN, FNP-BC, WHNP-BC and Ursula A. Pritham, PhD, WHNP-BC, FNP-BC, SANE

Women who want to become pregnant or who are already pregnant need to be aware of toxins (poisons) in the environment. These toxins may be in their homes, their neighborhoods, their workplaces, or in their world at large. The toxins may affect their fertility (their ability to become pregnant) or they may harm the women and/or the baby growing inside them. This chart lists agents (that is, the toxins or poisons) that may be harmful in this way. It explains the type of damage the agents can cause, lists the sources of these agents, and suggests how to avoid exposure to these agents.

*Readers are invited to photocopy this table for their own use and/or for their patients' use.

Agent Risk to woman/offspring Source Suggestions

Tobacco • Infertility Smoking, chewing tobacco, secondhand Quit use of tobacco prior to and during pregnancy. • Fetal growth restriction smoke • Placental previa (a condition in which the placenta partly or fully covers the cervix) or insufficiency Alcohol Fetal alcohol spectrum disorders Drinking alcoholic beverages Avoid all alcoholic beverages if you could become pregnant and during pregnancy.

Mercury Irreversible brain and nerve damage, • Large fish such as shark, tilefish, Limit exposure. Avoid consumption of large fish listed on (high exposure) hearing loss, poor vision in offspring swordfish, king mackerel, white or this chart and limit intake of tuna to one 6-oz serving per albacore tuna week. • Thimerosal, a topical disinfectant and preservative used in some vaccines • Household items such as fluorescent lightbulbs, batteries, items that glow

Lead Harmful effects on developing brain, • Paint in homes built before 1978 Have home and water inspected and tested for lead. If the leading to lower intelligence quotient (IQ) • Tap water from old lead pipes, test result is positive, have lead paint removed and get and behavior problems in offspring well-water home water filtration or reverse osmosis system that filters for lead.

Radiation (ionizing; Cell damage, contributing to early preg- X-rays, computed tomography (CT) scan, Compare risks and benefits of such imaging tests. Use large doses) nancy loss or increased risk for childhood positron emission tomography (PET) scan proper shielding when dental X-rays are done. Undergo leukemia screening mammograms as recommended by your healthcare provider (they pose little risk).

Radon Birth defects Igneous rock and soil (radon may seep Test your house for radon. If present, do proper into house through cracks in concrete remediation. basement floors or slabs, floor drains, sump pumps, construction joints, or cracks/pores in hollow-block walls)

Air pollutants • Preterm labor/delivery, pregnancy- • Exhaust from cars, trucks, power plants, When possible, avoid going outdoors when local air quality induced hypertension in mother wildfires, wood-burning stoves index report is poor or smog/haze is visible. Use a high-fil- • Autism spectrum disorders in offspring • Traffic-related exposure to nitrogen tration filter in your heating and air conditioning system for dioxide from long commutes or an your home and vehicle. occupation involving driving

Solvents • Adverse pregnancy outcomes (long- • Prenatal exposure to toluene (found in Avoid known exposures. Make sure your nail polish or nail term exposure) nail polish) polish remover does not contain toluene. Look for dry • Neurologic problems, autism spectrum • Tetrachloroethylene or perchloreth- cleaners who use newer, more environmentally friendly disorders (chlorinated solvent expo- ylene (PERC) used in dry cleaning (green) solvents. sure) in offspring • Neurodegenerative disorders (e.g., Parkinson’s disease) later in life

40 September 2018 Women’s Healthcare NPWomensHealthcare.com Agent Risk to woman/offspring Source Suggestions

All of the following environmental toxins are in a category of endocrine disruptors. The endocrine system is a collection of glands that secrete hormones. Pesticides and • Infertility • Organophosphate pesticides and herbi- When possible, buy organic fruits and vegetables to limit herbicides • Thyroid dysfunction in pregnancy cides on food and in groundwater exposure to organophosphates. See Environmental • Fetal growth restriction • Atrazine pesticide (fetal growth Working Group websiteA for nonorganic fruits and • Birth defects, childhood leukemia, restriction) vegetables with low and high residues. Check public water neurologic and cardiovascular defects, • Nitrates from fertilizers, manure, and reports or well-water for contaminants; if result is positive, blue baby syndrome in offspring human sewage (thyroid dysfunction get home water filtration or reverse osmosis system. in pregnancy, blue baby syndrome in infants)

Personal care and • Preterm birth, neurodevelopmental Fragrances, cosmetics, soaps, lotions, Check labels on products and avoid those with phthalates, cleaning products with and executive function problems and deodorants (some products contain triclosan, parabens, or triclocarbans. See Environmental phthalates, triclosan, • Males more adversely affected by in phthalates) Working Group websiteB for product safety ratings. parabens, or triclocar- utero exposure, with potential repro- bans ductive development abnormalities Latex-based paints or Allergy-related conditions (rhinitis, asth- Organic compounds in some latex-based Use paints/enamels with low VOCs. Such products are enamels with volatile ma, and eczema) in offspring paints/enamels (can seep from the prod- labeled as low VOC. organic compounds uct, a process known as off-gassing) (VOCs)

Plastic containers with Low birth weight, wheezing, behav- • Hard plastic containers (many contain Avoid use of plastic containers to heat food in the micro- bisphenol A (BPA) ioral problems, neurodevelopmental BPA; heating increases release of BPA wave. Soft plastic containers marked with #3 or #7 in a abnormalities from container) triangle contain phthalates (see information above on • Soft plastics (may contain phthalates; phthalates). see information above on phthalates)

Perfluorochemicals Thyroid problems Stain-resistant treatments, carpet Removed from market, but PFCs persist in the environment (PFCs) cleaning solutions, non-stick cookware, and in those previously exposed. Check drinking water. If some food-contact packaging (especially PFCs are present, remove them by carbon filtration and/or microwave popcorn bags) reverse osmosis system.

Polybrominated diphen- Impaired neurodevelopment, increased Additive flame retardants used in furni- Removed from market in U.S. in 2004. However, PBDE accu- yl ethers (PBDEs) risk for thyroid cancer ture starting in 1960s mulation remains in bodies of those exposed for years.

Tris(1,3-dichloro-2-pro- Cancer-causing properties • Flame retardant used in foam uphol- Removed in 2015. Decrease exposure by good hand wash- pyl) phosphate (TDCPP) stered furniture, foam mattresses, ing. Avoid upholstered furniture flame retardants. Buy prod- pillows, bumper pads, automobile seats, ucts that use polyester fiber filling for cushioning, which is electronics not treated with flame retardants. If desired, submit a small • TDCPP releases into atmosphere, sample of the foam for analysis to the Duke University allowing it to be inhaled and settle into Foam ProjectC. household dust and absorbed through skin

Web resources A. ewg.org/foodnews/ B. ewg.org/key-issues/consumer-products#.WX9RrYTyuJA C. foam.pratt.duke.edu/

NPWomensHealthcare.com September 2018 Women’s Healthcare 41 DNP projects: Spotlight on practice

Educational interventions to increase Tdap vaccination rates among pregnant women By Cari McAlister, DNP, MSN, WHNP-BC; Ginny Moore Wurttemberg, DNP, MSN, CNM; Donna Dunn, PhD, CNM, FNP-BC; and Tedra Smith, DNP, CPNP-PC, CNE

he highly contagious respiratory infection Tpertussis remains a public health problem for the United States.1 Infants have the highest morbidity and mortality rates from pertussis because of a lack of immunity at dence-based educational intervention to increase knowl- birth and an immature immune system. In 2015, a total edge about the importance of Tdap vaccination during of 20,762 cases of pertussis were reported in the U.S., pregnancy and provide information about the vaccine’s with infants accounting for 1,960 cases (9.5% of the total safety. The goal was to increase Tdap vaccination rates cases).2 among pregnant women seen for care at two obstetrics In 2013, the CDC and the American Congress of Obste- settings. tricians and Gynecologists recommended that pregnant women receive the tetanus/diphtheria/acellular pertussis Method (Tdap) vaccination at 27-36 weeks’ gestation during each The university’s institutional review board approved the pregnancy.1 Tdap vaccine given to women at this point in project. Criteria to participate in the project included pregnancy provides passive immunity to infants until 6 being pregnant, having the ability to speak English or months of age, by which time most will have completed Spanish, and being 19-44 years old. The educational the recommended three-dose vaccination series.3 intervention included the CDC’s Tdap vaccination hand- Despite this evidence-based recommendation, the out, a 5-minute educational video created by the project rate of gestational Tdap vaccination remains low.3 Ac- directors (PDs), and a PD-led patient education session. cording to obstetricians surveyed, a major barrier to Each educational intervention was available in English recommending the vaccination is lack of patient inter- and Spanish. Information provided in the handout, video, est.4 Many pregnant women do not view pertussis as and education session was identical and included the an infection they can acquire and pass to their infants.5 purpose, importance, and safety of Tdap vaccination Some women choose not to obtain the Tdap vaccine during pregnancy and current recommendations in this during pregnancy because of misinformation about regard. vaccine safety.6 Lack of knowledge about the impor- The PDs conducted education at their respective tance of Tdap vaccination during pregnancy and lack of practice locations (Clinic A and Clinic B) during a 12-week healthcare provider (HCP) recommendation are reasons period. All three educational interventions were imple- pregnant women have noted for not receiving the vac- mented with each participant. Education took place at cine.7 Nitsch-Osuch et al1 reported that 80% of women the first obstetric visit or at the 1-hour glucose-tolerance would be willing to receive the Tdap vaccine if their HCP test appointment. Review of the CDC handout, viewing recommended it. of the video, and the education session took approximately 10 minutes altogether. Purpose Each participant received an evaluation form to com- The purpose of the project was to implement an evi- plete after watching the video. Completion of this form,

42 September 2018 Women’s Healthcare NPWomensHealthcare.com which addressed participants’ understanding of the Clinic B’s population was composed of mainly under- video and its impact on their vaccination decision, was served Hispanic women without health insurance. Clinic optional. The form was completed by all participants staff did not routinely administer vaccines because of in Clinic A but by only 38% of those in Clinic B, mainly cost, nor did they provide any education on Tdap vacci- because of time constraints and literacy barriers. If par- nation to pregnant women prior to this project. No Tdap ticipants chose not to obtain the Tdap vaccine, the PDs vaccinations were given in the year before the interven- asked in a non-judgmental manner about factors that tion. The authors received a grant from the CDC, which affected their decision. provided vaccines for Clinic B. Prior to the grant, patients at this clinic needed to go to the local health department or primary care clinic to obtain the vaccine. Cultural awareness Forty-four women in Clinic B participated in the Tdap educational intervention. Of this group, 33 (75%) re- and acknowledging the ceived the vaccine. Eleven participants did not receive the vaccine because they believed that everything would importance of be fine. Data from these participants’ completed evaluation forms indicated two factors affecting vaccination education in the rates in a culturally diverse population: (1) The participants understood more clearly the importance of the participants’ primary language Tdap vaccination after viewing the educational video in their native language and (2) the participants desired are keys to increasing family input with regard to the decision for maternal Tdap vaccination. Although the conversations with the HCP were helpful, these participants indicated a greater Tdap vaccination understanding after watching the video. Family members rates in pregnancy. were allowed to view the video with participants, thereby clarifying any additional concerns.

Outcomes Limitations A total of 75 pregnant women participated in the edu- Limitations included the short time interval and the inabil- cational intervention in Clinic A or Clinic B. Each partici- ity to see all women meeting inclusion criteria. PDs were pant’s chart included documentation of the decision to not able to follow up with all participants who were un- obtain or decline the Tdap vaccination on the problem decided about receiving the Tdap vaccine because of the list and the medication list. short time frame and the inability to make contact with Because Clinic A’s population comprised patients every participant between 27 and 36 weeks’ gestation. with private insurance or Medicaid, the clinic was able to receive reimbursement for vaccinations. Prior to this Implications for practice intervention, Clinic A provided education, albeit not In this project, 66 (81%) of 75 participants received the consistently, in the form of handouts and HCP conversa- Tdap vaccination. The vaccination rate remained higher tion. A retrospective chart audit showed that among 468 in Clinic A than in Clinic B. Participants in Clinic A, more pregnant women seen in the clinic, 186 (40%) received so than those in Clinic B, were willing to receive the Tdap the Tdap vaccination in the year before the intervention. vaccination after HCP discussion prior to viewing the Thirty-one women in Clinic A participated in the Tdap video. At Clinic B, the language barrier was an obstacle educational intervention. Of these women, 28 (90%) for HCPs in explaining the importance of Tdap vaccina- received the vaccine. Of the 3 who refused the vaccine, tion during pregnancy. This obstacle was overcome using 2 stated that they did not feel that pertussis was a threat an educational video in Spanish. Cultural awareness and and 1 was concerned about vaccine safety. Data from the acknowledging the importance of education in the par- Clinic A participants' completed evaluation forms indi- ticipants’ primary language are keys to increasing Tdap cated that HCP conversations superseded the need for an vaccination rates in pregnancy. educational video about the importance of Tdap vaccina- Understanding specific barriers to and concerns about tion during pregnancy. vaccination within an HCP’s particular patient popula-

NPWomensHealthcare.com September 2018 Women’s Healthcare 43 tion is important. Vaccination rates can be improved by 2. CDC. 2015 Final Pertussis Surveillance Report. cdc.gov/ having a protocol in place to ensure that education is pertussis/downloads/pertuss-surv-report-2015.pdf provided, vaccination recommendation is made, and the 3. Skoff TH, Kenyon C, Cocoros N, et al. Sources of in- vaccine is available in the clinical setting. = fant pertussis infection in the United States. Pediatrics. 2015;136(4):635-641. Cari McAlister is a nurse practitioner at Anniston 4. Jones KM, Carroll S, Hawks D, et al. Efforts to improve immunization coverage during pregnancy among ob- OB/GYN in Anniston, Alabama. Ginny Moore Wurt- gyns. Infect Dis Obstet Gynecol. 2016;2016:6120701. temberg is a Clinical Specialist for Labor and Deliv- 5. Moniz MH, Beigi RH. Maternal immunization. Clinical ery at Northside Hospital in Atlanta, Georgia. Donna experiences, challenges, and opportunities in vaccine Dunn is Assistant Professor and Tedra Smith is Assis- acceptance. Hum Vaccin Immunother. 2014;10(9):2562- tant Professor and Faculty Mentor at the University 2570. of Alabama at Birmingham School of Nursing. This 6. Chamberlain AT, Seib K, Ault KA, et al. Factors asso- project was supported by a grant from the American ciated with intention to receive influenza and tetanus, Association of Colleges for Nursing (AACN) – Aca- diphtheria, and acellular pertussis (Tdap) vaccines demic Partners to Improve Health. during pregnancy: a focus on vaccine hesitancy and perceptions of disease severity and vaccine safety. PLoS Curr. 2015 Feb 25;7. References 7. Donaldson B, Jain P, Holder BS, et al. What determines 1. Nitsch-Osuch A, Korzeniewski K, Gawlak M, et al. Epi- uptake of pertussis vaccine in pregnancy? A cross sec- demiological and clinical reasons for vaccination against tional survey in an ethnically diverse population of preg- pertussis and influenza in pregnant women. Adv Exp nant women in London. Vaccine. 2015;33(43):5822-5828. Med Biol. 2014;849:11-21.

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44 September 2018 Women’s Healthcare NPWomensHealthcare.com Policy & practice points

members, or even friends remains the main source of long-term care for older persons worldwide.1 This caregiving, usually provided by women, can have an adverse impact on caregivers’ health, quality of life, economic stability, and longevity.2,3

Diana M. Drake Rising need for caregivers Increasing longevity, the aging of the large Baby Boomer generation, and a decline in fertility and subsequent family sizes of younger generations have all contributed to Health policy and the female the rising need for informal caregivers amidst a shrinking pool of prospective younger caregivers. The 65-and-older caregiver: The impact on women’s population in the U.S. is projected to nearly double over the next three decades, ballooning from 48 million to health 88 million by 2050.1 Declining fertility levels have been one of the main propellers of a demographic shift to an By Diana M. Drake, DNP, MSN, APRN, WHNP-BC older population; the global fertility rate is near or below the 2.1 replacement level in all world regions except Africa.1 In 2030, the first wave of Baby Boomers will turn 85, an age when people are twice as likely as those even a decade younger to need help getting through the day. s healthcare providers (HCPs), we However, because of shrinking family sizes over the past Aare aware of the demographic shift and increased lon- few decades, fewer young or even middle-aged adults gevity that have resulted in a rise of the aging population will be available to care for their older relatives in the in the United States and in many other countries around years ahead.1 the world.1 These changes have increased the need for “informal” caregivers, usually partners or relatives, to Caregiver role as a policy concern provide assistance to individuals at varying levels of The caregiver role has become a significant public pol- healthcare need. Unpaid caregiving by partners, family icy issue that affects healthcare costs, personal losses of wages and benefits, and stability of the workforce. Of note: • Women provide the majority of informal care to spouses, parents, parents-in-law, friends, and neigh- bors, and they play many roles while caregiving: hands-on care provider, care manager, friend, compan- ion, surrogate decision-maker, and advocate.4 • Sixty-five percent of care recipients are female, with an average age of 69.4 years.4 • The typical caregiver is a woman who works outside the home and provides 20 hours per week of unpaid care to her mother.2 • Although men do provide assistance in this regard, female caregivers may spend as much as 50% more time than their male counterparts do in providing care.5 • Nearly 60% of today’s family members perform tasks that were previously handled by nurses, including giving injections, providing wound care, and operating special medical equipment. These individuals spend an average of $7,000 a year of their own money.2 • Family caregivers aged 50+ years who leave the workforce to care for a parent lose, on average, nearly

NPWomensHealthcare.com September 2018 Women’s Healthcare 45 $304,000 in wages and benefits over their lifetime. For National Women’s Law Center President & CEO Fatima women, this amount—$324,044—is even higher.2 Goss Graves, whose organization administers the TIME’S • Family caregivers have been described as America’s UP Legal Defense Fund, and Rep. Raul Ruiz, MD (CA-36). other Social Security. The nation’s healthcare system Samantha Abrams, Executive Director of the March on would go broke if it had to pay for their work, valued at Washington Film Festival, served as summit emcee. In $470 billion a year in free care.2 addition to lead sponsor Hadassah, the Women’s Zionist • Workers with eldercare responsibilities comprise all Organization of America, Inc., the American Heart racial and ethnic groups, including African Association and Women Against Alzheimer’s Americans (21%), Hispanics (20%), whites were key in focusing attention on policy (17%), and Asians (14%).2 briefings, scientific advances, financial • Compared with other demographic implications of disease, and the di- groups, low-income workers, mi- rect impact of policy and advocacy norities, and women are more work. likely to reduce their work hours As a participating organization or leave the workforce because of on the steering committee for the their caregiving role.2 summit, NPWH helped organize a speaker panel, Caregiving Across Impact on women’s health the Lifespan: the Disparate Impact Female caregivers are more likely than of Caregiving on Women and Oppor- male caregivers to report poor health, tunities for Change. Panel members dis- especially when they perceive their roles as cussed the burden and opportunities pre- difficult or life changing.6 Female caregivers are less sented by caregiving and legislation that would likely than male caregivers to see HCPs for their own pre- require the government to develop strategies to recog- ventive healthcare needs. According to the U.S. Depart- nize and support family caregivers. As a panel member ment of Health and Human Services, female caregivers representing NPWH, I was honored to speak as both a are at increased risk for7: women’s health nurse practitioner who provides health- • depression and anxiety; care to many informal caregivers and a daughter of two • a weak immune system; 96-year-old parents living in partially assisted care. As • obesity; an NPWH member, I was able to speak directly to the • chronic disease; impact on the female caregiver, the invisibility of the • problems with short-term memory or paying attention; issue, and the gap in our healthcare system to recognize and and assess the caregiver status of patients, as well as the • heart disease. impact that being a caregiver has on women’s health. The importance of advocating for our patients who are NPWH leadership and policy work: caregivers to practice self-care and disease prevention Caring for the female caregiver was stressed. All women who serve as caregivers were NPWH is providing leadership by participating in two encouraged to describe their caregiver roles to their coalitions in Washington, DC, that aim to increase aware- HCPs at health visits. ness of the impact of the female caregiver role: the Coali- This event was streamed live on Facebook and gen- tion for Women’s Health Equity8 and Healthy at Any Age: erated a lot of Twitter activity among the organizations Women’s Health over 50. (#HealthEquity4Her and #NWHW). More information about the other speakers and the summit itself is avail- Coalition for Women’s Health Equity able hereA. As a key member of this coalition, which comprises about 20 organizations, NPWH participated on the steering Healthy at Any Age: Women’s Health over 50 committee for its 2nd Annual Women’s Health Empower- Coalition ment Summit. On May 16, 2018, more than 300 women Gay Johnson, CEO of NPWH, described the second from across the country met in Washington, DC, to Healthy at Any Age summit in her messageB in the June highlight actionable steps to address inequities that en- 2018 issue of Women’s Healthcare. The Healthy at Any danger women’s health and safety. The summit featured Age: Women’s Health over 50 Coalition takes a broad

46 September 2018 Women’s Healthcare NPWomensHealthcare.com In 2030, the first wave • Encourage maintaining regular healthcare visits and preventive screenings. will • Utilize patient education tools and community re- of Baby Boomers sources: • Family Caregiver Alliance: caregiver.org turn 85, an age when people • Office on Women’s Health. Caregiver Stress fact sheet: womenshealth.gov/files/documents/car- are twice as likely as egiver-fact-sheet.pdf • American Heart Association. Caregivers: Be Realis- those even a decade younger tic, Think Positive: heart.org/HEARTORG/Sup- port/Caregivers-Be-Realistic-Think-Positive_ to need help getting UCM_301771_Article.jsp#.Wz1k0S2ZNhF through the day. 3) Increase your knowledge of health policy and the role of caregivers. view of women’s health issues as they age, and is launch- • Become familiar with the Concentrating on High- ing the National Older Women’s Health Agenda. This Value Alzheimer’s Needs to Get to an End (CHANGE) agenda includes health issues related to women as care- Act of 2018, which, if passed, would address the care givers and the adverse impact of caregivers’ long-term needs of patients and their caretakers, including neglect of their own health.9 Caregiver-related topics of creating a coverage and payment model that offers pay, respite care, mental and physical health, and medi- family caregivers evidence-based training and certification management are considered opportunities for im- cation specific to dementia care. proving healthcare for older women. NPWH will lead the • Learn about the newly enacted Recognize, Assist, coalition’s communications and meetings and will recruit Include, Support and Engage (RAISE) Family Caregiv- select public, private, and nonprofit organizations to join ers Act, which provides a framework for public and the founders. The ongoing journey of the coalition is to private sector stakeholders to develop and execute a unite diverse sectors, share resources, and create strate- national caregiving strategic action plan. gies that advance the health and well-being of older U.S. • As family caregiver advocates for 40 years, the women for decades to come. Family Caregiver Alliance recognizes passage of the federal RAISE Family Caregivers Act as critical Taking steps from policy to action to the creation of a strategy to acknowledge and Healthcare providers are encouraged to bring the care- aid unpaid family caregivers on a national level. giver role into the health assessment visit with a few • The RAISE Act is an important step toward more fully simple steps: recognizing the impending crisis in caregiving as the aging population continues to grow. As improved 1) Ask questions. Listen to their stories. guidelines and policies develop from the legislation, • During health exams, ask women about their caregiver funding will be required to relieve the 2015 AARP role and its effects on their physical and mental health. estimate of $470 billion in unpaid care and the 2016 • Be aware of the known increased health risks for AARP estimate of $7,000 in out-of-pocket expenses caregivers. provided annually by family caregivers. • Inquire about the number of hours per week that • Understand that better federal coordination across they spend in caregiving. agencies and initiatives can further the recognition • Assess their stress level and quality of life. and support of unpaid family caregivers and has the • Assess their support system. possibility of large-scale change in payment and ser- • Be aware that caregiving does not necessarily exert vice delivery systems. an adverse impact on every caregiver’s life. Conclusion 2) Promote and support caregivers’ self-care. Research and public discourse on the caregiver role • Teach self-care practices and the signs of caregiver and its specific impact on women must remain a focus burnout. of national and local community attention. Women’s (continued on page 50)

NPWomensHealthcare.com September 2018 Women’s Healthcare 47 Commentary

The growing number of breast cancer survivors, whose healthcare needs become even more complex as they age, has presented an opportunity for WHNPs to play a more important role in their care. Physicians who work in the field of breast oncology have perceived an increased need to deliver survivorship care to their patients Caitlyn E. Hull Randee L. Masciola and are increasingly looking to NPs to address these specialized needs.3 During our initial interview, the surgeon who would WHNPs in specialty positions: become my primary collaborating physician said that, for him, working with a WHNP would enhance his ability to both run his practice and provide quality care to his My experience in breast patients. Because he needs to spend so much time in the operating room, the surgeon said that he, not to mention surgical oncology his patients, could benefit from having a WHNP work in By Caitlyn E. Hull, MS, APRN-CNP, WHNP-BC and the clinic, seeing patients either in collaboration with him Randee L. Masciola, DNP, APRN-CNP, WHNP-BC or independently. In addition, he emphasized the meaningful provider–patient relationships that would evolve from caring for patients through their cancer journeys. He felt that a WHNP was particularly well equipped, by virtue of this provider’s educational background, experience, and nursing philosophy, to fill this role and achieve these goals.

hen I, Caitlyn E. Hull, sought to Wbecome a women’s health nurse practitioner (WHNP), I had not considered the variety of roles that might be available. I had imagined myself working as a generalist in an obstetrics/gynecology (Ob/Gyn) private practice or federally funded clinic like many of my professors and preceptors, and I was thrilled with the possibilities that lay ahead of me in this field. When I was offered a position as a WHNP in surgical oncology at the Stefanie Spielman Comprehensive Breast Center (Photograph), which is affiliated with The Ohio State University Com- prehensive Cancer Center – Arthur G. James Cancer Hospital (The James) and Richard J. Solove Research Institute, I had several questions and hesitations. I was I acknowledge that my entrance into breast oncology as curious about how my education and training would be a novice NP posed a steep learning curve. My entrance was utilized in breast oncology, particularly as a new NP. facilitated by my orientation at the Stefanie Spielman Com- Excluding non-melanoma skin cancers, breast cancer prehensive Breast Center, which was structured to expose me is the most common cancer in women in the United to the evidence-based multidisciplinary team approach that States; as of January 2018, more than 3.1 million U.S. is highly regarded within most healthcare delivery systems women are breast cancer survivors.1 Owing to advances to improve patient outcomes. This orientation included ob- in the field of breast oncology over the past several servation experiences in the operating room and exposure decades, overall outcomes are much better today. The to the various departments comprising the multidisciplinary decreasing breast cancer mortality rate combined with a team: reconstructive surgery, radiation oncology, medical demographic shift toward an aging population has led to oncology, radiology, and physical therapy. I spent a good deal a large increase in the number of breast cancer survivors. of time reviewing breast pathology, as well as the National In fact, these women represent 41% of all female cancer Comprehensive Cancer Network breast cancer guidelines survivors.2 that are the standard of care for practice in breast oncology.

48 September 2018 Women’s Healthcare NPWomensHealthcare.com My role in the surgical oncology clinic began by serv- to the appropriate care teams for treatment and support. ing as an “extension” of the breast surgeon. During his Because male breast cancer is far less common than fe- three clinic days each week, I joined him in seeing both male breast cancer, I strongly encourage WHNPs to seek women with newly diagnosed breast cancer and breast out continuing education (CE) resources to support their cancer survivors coming in for follow-up visits. My main knowledge base and clinical experience in male breast responsibility entailed performing a history and physical cancer. In 2017, as an expert in our healthcare system examination in women needing a breast biopsy or breast because of my education and training, I organized a CE surgery. I also ordered and managed pre-operative labo- event for our advanced practice providers and registered ratory testing and imaging, making referrals as needed, nursing staff members that featured a journal club on the and I prepared patients for their breast procedures. topic of male breast cancer to improve our awareness as an institution about caring for men with this disease. The decreasing breast cancer Since I started in my position in 2012, the number of NPs in our organization has soared. We now have 23 NPs, combined including 7 WHNPs, caring for patients at the Stefanie mortality rate Spielman Comprehensive Breast Center. The role that we play in caring for patients with breast cancer has with a demographic expanded too. We now perform both independent and shared visits. In addition, the growing number of long- shift toward an aging term breast cancer survivors has created a demand for WHNP-driven follow-up clinics to provide surveillance population has led to a large and to address the long-term physical and emotional sequelae of breast cancer treatments, as well as the in- increase in the number of creased need for survivorship care. Furthermore, WHNPs lead benign breast disease and high-risk breast disease breast cancer survivors. clinics within the breast center. In addition to the advancement of WHNPs within the Over time, I have become even more deeply involved breast center since I started in 2012, I have witnessed the in the coordination of care of our patients, managing implementation and accreditation of The James Oncol- their treatment trajectory and seeing them in clinic for ogy Advanced Practice Provider fellowship program. This acute problems, most commonly postoperative compli- 12-month, highly competitive program, initiated in 2013, of- cations, breast infections, and new breast lumps. In addi- fers NPs, including WHNPs, an opportunity to rotate within tion, I return patients’ phone calls; notify them of test re- mentored subspecialty clinical experiences. These clinical sults, including the pathology reports from biopsies and experiences are supplemented by weekly educational surgeries; and manage follow-up and case management sessions and training in evidence-based practice (EBP). This problems as they arise. yearlong fellowship serves as a gateway for new WHNPs to Of note, our institution and physician colleagues, in enter the field of oncology at The James. WHNPs who have addition to supporting WHNPs in their role in providing completed this program are now successfully caring for pa- care for women with breast cancer, support WHNPs’ pro- tients within the multiple specialty disciplines at The James, vision of care for men with benign and malignant breast including gynecology/oncology, breast surgical/oncology, conditions. Our standard-of-care arrangement states that medical/oncology, and radiation/oncology. we can care for men with breast diseases or conditions Beyond the fellowship, The James offers its own ver- warranting our specialty expertise. Although breast sion of a clinical ladder program to continue to enhance cancer in men represents only 1% of all breast cancers, WHNPs’ professional development. This yearly opportu- many of these men present at a more advanced stage of nity allows all advanced practice providers to create five disease than do women.4 In 2018, approximately 2,500 goals within the categories of leadership, education, clin- men in the U.S. will be diagnosed with breast cancer ical practice, EBP, and community service. Since its incep- and 500 will die of it.4 Utilization of WHNPs to see males tion, this project has encouraged WHNPs to participate in with breast conditions enables us to differentiate benign numerous activities, including joining action committees, breast conditions such as gynecomastia or breast abscess implementing unit improvement projects, presenting from breast cancer and expedite those with a malignancy research projects, and providing women’s health services

NPWomensHealthcare.com September 2018 Women’s Healthcare 49 to underserved members of the community. This pro- gether as WHNPs. Whether we work in a general Ob/Gyn gram has enriched my career by affording me the oppor- practice or a breast cancer clinic, at the end of the day, tunity to guest-lecture on the WHNP role in survivorship caring for our patients is what we all have in common care. My lectures are presented to graduate students in and why we keep doing what we do. = women’s health and nurse midwifery at our affiliated Col- lege of Nursing at The Ohio State University. Caitlyn E. Hull is a women’s health nurse practitioner When I started my WHNP education, I did not imagine specialist at the Stefanie Spielman Comprehensive myself as a WHNP in breast oncology; now I am very proud Breast Center and Randee L. Masciola is an Assistant Pro- to serve in this capacity. My WHNP education—particu- fessor at The Ohio State University, College of Nursing, larly my training in breast pathophysiology, breast health and an actively practicing women’s health nurse prac- assessment and risk assessment, management of breast titioner, both in Columbus, Ohio. The authors state that disorders, pharmacology, EBP, and patient-centered they do not have a financial interest in or other relation- care—provided the foundation I needed to navigate this ship with any commercial product named in this article. specialty role. I have learned so much, both personally and professionally, since I started in my position, and I am hum- References bled by the fact that I have a lot of learning left to do in this 1. Breastcancer.org website. U.S. Breast Cancer Statistics. fast-paced, information-exploding specialty. 2018. breastcancer.org/symptoms/understand_bc/statistics I admit that working in oncology can sometimes be emo- 2. Ganz PA, Goodwin PJ. Breast cancer survivorship: where tionally taxing. However, the privilege of being a part of my are we today? Adv Exp Med Biol. 2015;862:1-8. patients’ journeys and helping them through some of the 3. Friese C, Hawley S, Griggs J, et al. Employment of nurse toughest moments of their lives is what makes my job so re- practitioners and physician assistants in breast cancer warding. I am passionate about taking care of these patients care. J Oncol Pract. 2010;6(6):312-316. and I cherish the relationships I have built with them. 4. Giordano S. Breast cancer in men. N Engl J Med. These connections are the threads that tie all of us to- 2018;378(24):2311-2320.

(continued from page 47) healthcare providers can increase the visibility of the 3. Roth DL Fredman L, Haley WE. Informal caregiving issue through comprehensive assessment in health ex- and its impact on health: a reappraisal from popula- ams, promotion of education, and provision of support tion-based studies. Gerontologist. 2015;55(2):309-319. resources for their caregiving patients, as well as increase 4. Family Caregiver Alliance. Caregiver Statistics: Demo- public policy awareness and action. = graphics. 2016. caregiver.org/caregiver-statistics- demographics 5. Family Caregiver Alliance. Online Resources for More Diana M. Drake is Clinical Associate Professor and Information. caregiver.org/online-resources-more- Specialty Coordinator of the DNP WHNP Program at information the University of Minnesota School of Nursing and 6. American Heart Association/American Stroke Associ- Program Director for Integrative Women’s Health at ation. newsroom.heart.org/news/wednesday-news- the Women’s Health Specialists Clinic, both in Min- tips-2826602 neapolis. She is Chair of the NPWH Policy Commit- 7. U.S. Department of Health and Human Services. Office tee and Chair Elect of the NPWH Board of Directors. on Women’s Health. womenshealth.gov/a-z-topics/caregiver-stress 8. Coalition for Women’s Health Equity website. hadassah. References org/advocate/coalition-for-womens-health.html 1. United States Census Bureau. U.S. Population Aging Slower than Other Countries, Census Bureau Reports. 9. American Heart Association. Caregivers: Be Realistic, March 28, 2016. census.gov/newsroom/press- Think Positive. Last reviewed June 2017. heart.org/ releases/2016/cb16-54.html HEARTORG/Support/Caregivers-Be-Realistic-Think- Positive_UCM_301771_Article.jsp#.WzlnWi2ZNhE 2. AARP Public Policy Institute. Understanding the Impact of Family Caregiving on Work. October 2012. Web resources aarp.org/content/dam/aarp/research/public_policy_ A. hadassah.org/advocate/womens-health-empowerment-2018.html institute/ltc/2012/understanding-impact-family- B. npwomenshealthcare.com/wp-content/uploads/2018/06/ WHNP0618_NPWH_News.pdf caregiving-work-AARP-ppi-ltc.pdf

50 September 2018 Women’s Healthcare NPWomensHealthcare.com NPWH 2017 Conference Abstracts This issue of Women’s Healthcare: A Clinical Journal for NPs features abstracts presented at the 20th annual NPWH conference in Seattle in October 2017. These abstracts include those of the podium presenters and the first- and second-place poster award winners. My heartiest congratulations to all! Each year, the NPWH conference is enriched by these podium presentations and the poster sessions. Please take time to review the abstracts that provide state- of-the-science information about women’s health, and please consider submitting your work for 2019!

Lorraine Byrnes, PhD, CNM, FNP-BC, PMHNP-BC, FAANP 2017 NPWH Research Committee Chair

Counseling patients on medication use during pregnancy: Why you need to be talking about pregnancy exposure registries

By Robin D. Johnson, Public Health Advisor, and Kimberly A. Thomas, MPH

Objectives: and opinions about medication cation had heard of a pregnancy 1. To provide pregnant women’s use during pregnancy and par- exposure registry prior to the top five preferred sources of in- ticipation in pregnancy exposure group. However, they were open formation on medication use dur- registries. The aim of the project to participating in order to help ing pregnancy and methods for was to better understand women’s other women have more infor- teaching patients how to assess attitudes about registries to help mation on drug effects. Based on the credibility of these sources. improve FDA resources for pa- these findings, OWH conducted 2. To provide four tips to help preg- tient–provider counseling. an outreach campaign targeting nant women learn more about patients and health professionals. how prescription and over-the Summary: Four 90-minute focus Phase I of the campaign included counter medicines might affect group sessions were conducted in distribution of new Medicine and them and their babies. Chicago, Miami, and the Washing- Pregnancy factsheets for patient 3. To describe how to use the FDA ton, DC, area. Twenty-six partici- counseling and a digital ad cam- pregnancy exposure registries’ pants ranged in age from 21 to 41 paign to raise awareness about website to identify a registry and years. Among the participants, 92% pregnancy registries. The cam- how pregnancy registries can help took prescription medications or re- paign reached more than 1 million improve product safety informa- ceived a vaccine during pregnancy. individuals throughout the United tion and labeling. Participants engaged in a guided States, including Puerto Rico. group discussion and completed a Purpose: Fifty percent of preg- verbal and written review of FDA Implications for women’s nant women report taking at least medicine and pregnancy materials. healthcare: Enrolling patients in one medication. First-trimester a pregnancy exposure registry can use of prescription medications Outcomes: Participants viewed help improve safety information for increased by more than 60% the healthcare provider (HCP) as medicines used during pregnancy. between 1976 and 2008. Preg- the primary information source. The focus groups demonstrated nancy exposure registries gather Decisions about medication use that HCPs are important informa- information about drug effects were also influenced by online tion sources about registries and on a pregnant woman and her searches via social media, preg- that discussions about registries developing fetus. In 2015, the nancy websites, and hospital or and online pregnancy resources FDA Office of Women's Health health insurance websites. None should be added to patient coun- (OWH) conducted focus groups to of the participants, including those seling about medication choices learn about women’s knowledge currently pregnant and on medi- during pregnancy. =

NPWomensHealthcare.com September 2018 Women’s Healthcare 51 An examination of three Indiana ethnically and racially diverse populations’ knowledge and perceptions of human papillomavirus infection and HPV prevention, screening, and vaccination

By Juanita M. Brand, EdD, MSN, RN, WHNPc; Sam Colbert, BS; Millicent Fleming Moran, PhD; Anita Ohmit, MPH; and Virginia A. Caine, MD Juanita M. Brand

Objectives: health, understanding of HPV, more than 80% would encourage 1. To describe study participants’ HPV vaccination uptake, and teen participation in HPV immuni- knowledge of HPV infection and access/confidence in healthcare. zation and information events. their understanding of HPV pre- Interviews were conducted, re- Regarding access to care, 75% vention through vaccination. corded, and transcribed verbatim of participants had regular care 2. To summarize participants’ per- in Spanish or English. access, and a similar proportion sonal and cultural beliefs regard- reported good-to-excellent health, ing HPV vaccination uptake in Results: The three groups gen- whereas 24.7% reported very children and young adults. erally self-identified racially/ethni- poor or fair health status. NAs 3. To identify community members’ cally as singular AA, Hispanic, or and Hispanics (27%-30%) were support of HPV vaccination for NA (90%+ for each group). More more likely than AAs to report fair- the medically recommended than 80% of the participants were poor health. Twenty-one percent populations in the communities female. Mean age overall was reported financial barriers to care, identified. 45 years, with Hispanics being and 31% had difficulty paying for an average of 10 years younger prescription medications (no sig- Purpose: This qualitative study than the other groups (AAs, 51 nificant differences by racial/ethnic examined three Indiana ethni- years; NAs, 46 years; Hispanics, group). cally/racially diverse populations’ 38.3 years). Three key themes knowledge of HPV infection and emerged: level of trust in health- Implications for women’s their perceptions of HPV preven- care, vaccine beliefs, and access health: HCPs should be aware tion, screening, and vaccination. to care. Although most partici- that trust and access concerns pants trusted healthcare providers may influence racial/ethnic com- Methodology: A study group of (HCPs), some mistrusted messag- munities’ acceptance of HPV 90 men and women was selected ing regarding vaccination uptake vaccination. Crafting culturally by purposeful sampling among and outcomes. Vaccination beliefs relevant healthcare messaging persons who self-identified as Afri- were not consistent. Some partic- and respect for cultural beliefs can American (AA; n = 30) Native ipants related “anecdotal” stories concerning HPV vaccine safety American (NA)/Alaska Native (n heard regarding injury, steriliza- and acceptance among young = 30), or Hispanic/Latino (n = 30). tion, post-vaccination increase persons are key elements for Recruitment occurred at statewide in sexual activity (in youth), and HCPs in caring for culturally di- Indiana Minority Health Coalition dire vaccination outcomes. Other verse populations. = sites and powwows from May participants reported or perceived 2016 through November 2016. no difficulties with vaccination or Twenty-minute open-ended in- its uptake. Overall, 77% viewed terviews covered demographics, vaccination opportunities as “valu- self-identity, cultural influences, able” at community events and

52 September 2018 Women’s Healthcare NPWomensHealthcare.com FIRST-PLACE POSTER AWARD WINNER Improving quality of care during gynecologic examinations by reducing anxiety and discomfort

By Kristen Leigh Ransone, DNP, APRN, FNP-C

Objectives: 1. To describe the evidence underlying the project development. 2. To identify two interventions effective at decreasing anxiety and discomfort during gynecologic examinations. 3. To discuss implications of the outcomes for women’s health and patient-centered care.

Purpose: The purpose of this poster presentation was to describe the development, implementation, and outcomes of a quality improvement project undertaken to address anxiety and discomfort felt by women during gynecologic exams.

Summary: This project was con- discomfort, 1.47 (1 = no discomfort Implications ducted in a single-setting military to 5 = complete discomfort), (2) for women’s healthcare: family practice clinic over a period sense of vulnerability, 1.41 (1 = Many women of all ages and of 2 months. All the women who no vulnerability to 5 = completely backgrounds feel anxiety and presented for a routine gyneco- vulnerable), (3) sense of control, discomfort during gynecologic logic exam were offered a choice 1.35 (1 = fully in control to 5 = exams, which can lead to delays of music to be played throughout total lack of control), (4) sense of in screening and treatment of their visits and their pelvic exams anxiety, 1.58 (1 = no anxiety to 5 disease. This clinical project suc- were conducted without the use of = highly anxious), and (5) overall cessfully demonstrated how sim- stirrups. At the end of the visit, they quality of care, 1.17 (1 = excellent ple interventions can be applied completed an 8-question survey to 5 = poor). Ninety-four percent to the gynecologic visit to improve about the experience. of the women reported that this a patient’s experience and overall experience made them more likely quality of patient-centered care. Outcomes: The following results to return for a wellness exam in the By having a more positive experi- were collected from 17 women, future. Open-ended survey com- ence, women may be more likely who used a Likert-type survey tool. ments supported that the experi- to return for future routine screen- Average scores were (1) physical ence was extremely positive. ing and disease treatment. =

NPWomensHealthcare.com September 2018 Women’s Healthcare 53 SECOND-PLACE POSTER AWARD WINNER Implementation of a universal screening program to increase identification and treatment of perinatal mood and anxiety disorders among pregnant and postpartum women* Laura Bartlett Terrie H. Platt

By Laura Bartlett, DNP, RN, WHNP-BC and Terrie H. Platt, DNP, RN, WHNP-BC, NCMP

Purpose: The purpose of this Data, including EPDS scores and Implications for women's project was to evaluate whether ICD-10 codes, were extracted health: Standardized, universal consistent implementation of a from the electronic health re- screening for perinatal mood and valid and reliable screening tool for cord to determine the number of anxiety disorders improves the de- perinatal mood and anxiety disor- women with symptoms of perina- tection rate. Screening for perinatal ders in the clinic setting, as well as tal mood and anxiety disorders mood and anxiety disorders during follow-up care, would result in bet- identified by the clinician. pregnancy, especially at the initial ter identification and treatment. prenatal visit, can result in earlier Outcomes: Of 836 women who identification. Earlier identification Summary: From January 2017 met eligibility criteria, 619 were of women with perinatal mood to May 2017, clinicians at the Ob/ included in the QI project. A 494% and anxiety disorders can result in Gyn clinic implemented use of the increase in identification of women more prompt intervention and man- Edinburgh Postnatal Depression with perinatal mood and anxiety agement of symptoms. Screening Scale (EPDS) to screen patients disorders was seen with implemen- with the EPDS in the Ob/Gyn for perinatal mood and anxiety tation of the screening protocol. clinic is cost effective, efficacious, disorders at the initial obstetric More than 87.4% of women with and easily reproducible. Although visit, the 24-week visit, the 36- EPDS scores ≥10 were given ed- screening is important, ensuring week visit, the 2-week postpartum ucation about perinatal mood and adequate behavioral health fol- visit (if applicable), and the 6-week anxiety disorders and were offered low-up is crucial in the manage- postpartum visit. For women with behavioral referrals and local re- ment of women with perinatal EPDS scores ≥10, the clinician sources. More than 65% of partici- mood and anxiety disorders. = performed risk assessment and pants with perinatal mood and anx- referred them to a local perinatal iety disorders were provided with *The initial abstract for this study was submitted while the project was still in process. mental health clinic if indicated. To referrals to behavioral health; 42% This updated version of the abstract, which assess for overall effectiveness of of them completed an appointment has all of the results and outcomes of the the project, chart reviews of all eli- with a behavioral health specialist project, was submitted to NPWH following gible participants were performed. to address symptoms. its completion.

54 September 2018 Women’s Healthcare NPWomensHealthcare.com Focus on sexual health

Brooke M. Faught

Pessary use for pelvic organ prolapse in sexually active women By Brooke M. Faught, MSN, WHNP-BC, IF

Pelvic organ prolapse (POP), a common condition in women, increases in prevalence with advancing age. Treatment for POP may include pelvic floor exercises, surgery, and/or use of pessaries. Pessaries offer women a nonsurgical, cost-effective, low-risk option for treating symptomatic prolapse. This col- umn focuses on what healthcare providers need to know when caring for sexually active women with POP who choose to use a pessary. benefit from a nonsurgical treatment that is effective and that poses minimal risk: a pessary.3 A pessary is a soft-yet-firm, medical-grade silicone device that comes in various sizes and shapes and that is placed in the vagina to support the prolapsed area. Up to 90% of women with POP can be successfully fitted for a pessary.5 The pessary pproximately 3% of women in shape recommended for an individual woman depends Athe United States have pelvic organ prolapse (POP).1 on the type, location, and severity of prolapse, as well as POP prevalence in U.S. women is projected to reach 5% the presence or absence of stress urinary incontinence. by 2050 because of changing demographics.2 POP may The most frequently used pessary shapes for women with involve the bladder (cystocele), rectum (rectocele), small POP are the ring, oval, donut, Shaatz, and dish. Less com- bowel (enterocele), urethra (urethrocele), and/or uterus monly used shapes for this indication are the Gehrung, (uterovaginal prolapse). Although many women with Mar-Land, Hodge, and cube. POP remain asymptomatic, some report vaginal pressure, sensation of a vaginal bulge, vulvovaginal irritation, Special considerations for sexually active bowel or bladder dysfunction, and/or a disruption in women sexual functioning. Healthcare providers (HCPs) should When HCPs consider prescribing a pessary for a sexually perform a pelvic examination on all patients with known active woman, they need to ascertain the types and or suspected prolapse and document the type and stage frequency of sexual activity in which the woman is en- of prolapse.3 The POP quantification system (POP-Q) is gaging. Most pessaries must be removed before penetra- commonly used to stage the condition.4 tive sex play (e.g., intercourse, use of sexual aids or toys inserted within the vagina); HCPs should know that the A nonsurgical alternative ring, oval, and Shaatz pessaries are easiest for a patient to Not all women with POP are surgical candidates. And self-manage. At the time of the pessary fitting, the HCP even among those who are candidates, many prefer to should teach the patient how to remove and replace the avoid surgery for a variety of reasons. These women may pessary so that it does not interfere with sex play. At this

NPWomensHealthcare.com September 2018 Women’s Healthcare 55 same visit, the patient should demonstrate to her HCP of the International Society for the Study of Wom- that she has learned the proper techniques. A woman en’s Sexual Health (ISSWSH). The author states that who finds that she is not capable of pessary self-mainte- she serves as a speaker and an advisory board mem- nance may opt for nonpenetrative sex play or have her ber for AMAG and as an advisory board member for partner learn to remove and replace the pessary. Another Symbiomix, Duchesnay, and AMAG. option is for the HCP to remove the pessary before a planned penetrative event (e.g., during a trip or vacation). References The woman may then return at a later date for pessary 1. Wu JM, Vaughan CP, Goode PS, et al. Prevalence and replacement. This option is particularly suitable for a trends of symptomatic pelvic floor disorders in U.S. woman with mild prolapse who infrequently partakes in women. Obstet Gynecol. 2014;123(1):141-148. penetrative sex play. 2. Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting Many postmenopausal women experience urogenital the prevalence of pelvic floor disorders in U.S.women: tissue changes related to vulvovaginal atrophy (VVA).6 If 2010 to 2050. Obstet Gynecol. 2009;114(6):1278-1283. VVA is suspected during a pessary fitting, HCPs should 3. Alas AN, Bresee C, Eilber K, et al. Measuring the quality consider prescribing treatment with local vaginal estro- of care provided to women with pelvic organ prolapse. gen or other FDA-approved products for VVA symptoms. Am J Obstet Gynecol. 2015;212(4):471-e1-471e9. This treatment may prevent vaginal tissue breakdown 4. Persu C, Chapple CR, Cauni V, et al. Pelvic Organ Pro- while the pessary is being worn, as well as potentially lapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011;4(1):75-81. improve other manifestations of VVA, including dyspareunia and vaginal dryness.7-11 All pessary users, but 5. Nygaard IE, Heit M. Stress urinary incontinence. Obstet Gynecol. 2004;104(3):607-620. particularly those with VVA, should be encouraged to use 6. Kingsberg SA, Wysocki S, Magnus L, Krychman ML. a water-based, glycerin-free lubricant with removal and Vulvar and vaginal atrophy in postmenopausal women: replacement of the pessary. findings from the REVIVE (REal Women’s VIews of Some women may complain of vaginal odor and dis- Treatment Options for Menopausal Vaginal ChangEs) charge with prolonged pessary use. Presence of ejaculate survey. J Sex Med. 2013;10(7):1790-1799. in the vagina may increase the potential for a temporary 7. Goldstein SW, Winter AG, Goldstein I. Improvements shift in vaginal pH. Women who engage in sexual activity to the vulva, vestibule, urethral meatus, and vagina in that involves internal ejaculation may want to douche women treated with ospemifene for moderate to severe with a diluted hydrogen peroxide solution before replac- dyspareunia: a prospective vulvoscopic pilot study. Sex Med. 2018;6(2):154-161. ing the pessary. Although postcoital douching is not nec- 8. The North American Menopause Society. The 2017 hor- essary, many women report that this practice diminishes mone therapy position statement of The North American vaginal discharge and odor. Over-the-counter, prepared Menopause Society. Menopause. 2017;24(7):728-753. douche solutions are not advised because of the pres- 9. Parish SJ, Nappi RE, Kingsberg S. Perspectives on coun- ence of harsh ingredients that may disrupt the normal seling patients about menopausal hormone therapy: vaginal ecosystem. strategies in a complex data environment. Menopause. March 5, 2018. Epub ahead of print. Conclusion 10. Simon JA, Archer DF, Kagan R, et al. Visual improve- Pessaries are a suitable alternative to more invasive and ments in vaginal mucosa correlate with symptoms of expensive treatments for symptomatic POP. HCPs should VVA: data from a double-blind, placebo-controlled trial. Menopause. 2017;24(9):1003-1010. assess women’s sexual health history at the time of the pessary fitting in order to preserve their desired type and 11. Traish AM, Vignozzi L, Simon JA, et al. Role of androgens in female genitourinary tissue structure and function: im- frequency of sexual activity. Additional thoughts when plications in the genitourinary syndrome of menopause. considering a pessary include the presence of bowel and Sex Med Rev. April 6, 2018. Epub ahead of print. bladder dysfunction, VVA, and tendency for vaginal discharge and odor. =

Brooke M. Faught is a women's health nurse practitioner and the Clinical Director of the Women’s Insti- tute for Sexual Health (WISH), A Division of Urology Associates, in Nashville, Tennessee. She is a Fellow

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