Practice Updates

We are Title X

As providers of women’s healthcare and sexual and reproductive health (SRH) services, we must stay up to date and vigilant about the ongoing attacks that are eroding access and rights to essential healthcare services. Policy changes at the federal and state levels are threatening the very core of the comprehensive, evidence-based reproductive health and family planning services delivered through the Title X program in the United States. At the same time, severe restriction of abortion services has rendered the procedure virtually inaccessible in many states. The consequences of these trends are particularly dire for individuals who are most vulnerable, including those who are low income, uninsured/underinsured, and/or adolescents. Historically, Title X-funded clinics have also been a key source of training and employment for women’s health nurse practitioners (WHNPs). Reducing funding for this program not only threatens our livelihood and the pipeline for preparing future providers of women’s healthcare and SRH care but also, in our view, undermines the health of our patients. Continue reading »

My career as a nurse advocate

When I was 6 years old, I knew I wanted to be a nurse. I followed through on this aspiration and pursued nursing throughout my adult career. At the same time, I’ve always considered myself artsy. I collect art—there are no bare walls in my house—and I have done a lot of needlework and have even won some awards. But my mission, my passion, which I developed early in my nursing career, is patient advocacy and access to care for women and newborns. Continue reading »

Health policy and the female caregiver: The impact on women’s health

As healthcare providers (HCPs), we are aware of the demographic shift and increased longevity that have resulted in a rise of the aging population in the United States and in many other countries around the world.These changes have increased the need for “informal” caregivers, usually partners or relatives, to provide assistance to individuals at varying levels of healthcare need. Unpaid caregiving by partners, family members, or even friends remains the main source of long-term care for older persons worldwide.This caregiving, usually provided by women, can have an adverse impact on caregivers’ health, quality of life, economic stability, and longevity.2,3 Continue reading »

Cultivating your inner Wonder Woman: Policy advocacy

By Diana M. Drake, DNP, MSN, APRN, WHNP-BC

The movie Wonder Woman is said to be, in essence, two solid hours of female empowerment. At the start of 2018, while flying to Salvador, Brazil, to lead a practicum entitled Women’s Health in the Context of Environment, Race, Culture and Policy, I was able to watch this blockbuster film. While doing so, I realized that, in the Brazil practicum, I would be asking my NP students to find their own inner Wonder Woman and become powerful advocates and ambassadors for change within an international context. Continue reading »

Policy and preventive healthcare services: Women living longer, living well

By Diana M. Drake, DNP, MSN, APRN, WHNP-BC

From the perspective of women’s healthcare providers (HCPs) in the United States, one of the major shifts in their field over the past decade has been a female patient population that is growing older, with an increasing mix of midlife and senior-life patients. Continue reading »

New evidence-based guideline for accurate HPV testing in head and neck cancers

The College of American Pathologists has released its newest evidence-based practice guideline, “Human Papillomavirus Testing in Head and Neck Carcinomas,” now available in Archives of Pathology and Laboratory Medicine. The guideline recommends accurate assessments of a patient’s high-risk HPV status, directly or by surrogate markers. Read more.

From practice to policy: The WHNP as advocate

As most of our readers know, the National Association of Nurse Practitioners in Women’s Health (NPWH) and the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) released the 7th edition of the Women’s Health Nurse Practitioner: Guidelines for Practice and Education in December 2014. Many women’s health nurse practitioners (WHNPs) use this document to outline their clinical competencies, and faculty use it as a framework in developing WHNP program curricula. But the guidelines go beyond describing clinical practice components and educational requirements; they also include policy and advocacy competencies. In particular, the guidelines enumerate participating in legislative/policy-making activities that influence women’s health and serving as “a consultant and trusted source of information on women’s health for healthcare systems and policy-makers” as key WHNP leadership competencies.1

As core WHNP competencies, policy and advocacy align well with NPWH’s mission and values. NPWH’s mission is to “ensure the provision of quality primary and specialty healthcare to women of all ages by women’s health and women’s health-focused nurse practitioners.” This mission includes protecting and promoting a woman’s right to make her own choices regarding her health within the context of her personal, religious, cultural, and family beliefs. As a professional membership organization, NPWH strives to continuously improve access and quality of healthcare for women through excellence and innovation in continuing education and professional development; to demonstrate leadership in policy, practice, and research; and to provide support and services for our members. These policy-related values are key to achieving our mission:

  • To advocate for healthcare policies that support women and advanced practice registered nurses (APRNs) who care for them; and,
  • To collaborate with strategic partners to enhance the effectiveness and timeliness of our efforts in the policy arena.2

How do these competencies affect clinical practice?

So, what does all of this mean in the real world of clinical practice? As most of our readers witness every day, policy decisions related to everything from reimbursement for healthcare service delivery to state-based APRN scope of practice regulations to decisions regarding availability of services, medications, or new technologies can affect women’s health—and the realization of NPWH’s mission. The following discussion provides just a few examples.

The Patient Protection and Affordable Care Act seeks to increase access to affordable health insurance, with the ultimate goal of increasing access to healthcare. One way that it does this is by providing a mechanism for federally supported Medicaid expansion to cover most low-income adults (i.e., those earning up to 138% of the federal poverty level). Yet, to date, approximately 20 states have not expanded Medicaid to this level of coverage.3 Most states provide Medicaid coverage during pregnancy; however, in non–Medicaid-expansion states, this coverage stops shortly after delivery. Although coverage of prenatal care facilitates a favorable pregnancy outcome, lack of coverage for care needed before and between pregnancies can have devastating effects on women and their children.

Consider the reproductive-aged woman with type 1 diabetes mellitus (T1DM). Diabetes in pregnancy can adversely affect both maternal and infant outcomes. Women with T1DM have higher rates of maternal mortality and morbidity, including increased rates of pre-eclampsia and cesarean section. Likewise, maternal T1DM increases the risks for fetal and neonatal loss, congenital anomalies, macrosomia, and a host of other neonatal complications. A patient with T1DM who qualifies for Medicaid during pregnancy but loses coverage soon after delivery will not have access to care for her chronic disease prior to her next pregnancy. This gap in care can allow her T1DM to spiral out of control, contributing to increased maternal and infant health problems or even death during subsequent pregnancies.4

In June 2015, the House Labor, Health and Human Services (LHHS) Subcommittee marked up its fiscal year 2016 spending bill, which contained a complete elimination of Title X. The following week, the Senate released a funding bill proposing $257.8 million for Title X, a decrease from the prior year’s $286.5 million budget.5 By the time this article goes to press, we should know how the Title X program fares in the 2016 budget. It is estimated that publicly funded healthcare providers, such as those funded through Title X, met an estimated 42% of the need for publicly supported contraceptive services and supplies in 2013.6 Cuts to, or elimination of, the Title X program would effectively bar many of these women from accessing similar services in the future. In the case of the patient with T1DM discussed earlier who has already lost access to care for her chronic disease, she will also lose family planning services, which may contribute to a shortened pregnancy interval and may increase the potential for a poor pregnancy outcome. Furthermore, because Title X clinics are staffed primarily by NPs, cuts to Title X could decrease women’s access to quality care by WHNPs and other NPs who provide family planning services.

Professional competencies plus organizational values in action

Although many of our readers in clinical practice may have little time to “participate in legislative and policy-making activities that influence women’s health” in the traditional sense, they are our greatest asset in terms of bringing women’s stories to the forefront. NPWH staff keep our fingers on the pulses of policy-makers with power to make decisions about how, where, and from whom each woman can access care that is “within the context of her personal, religious, cultural, and family beliefs,” but our organization’s members provide the stories that give life to the policy. It is through our organization’s members that we at NPWH learn about the challenges that women face in accessing woman-centric care to meet their needs, as well as the barriers faced by WHNPs in attempting to provide that care.

Conclusion

In keeping with the NPWH/AWHONN guidelines, WHNPs possess the leadership competencies to serve as trusted sources of information on women’s health. As NPWH Policy Director, I invite all of our readers to collaborate with NPWH as “strategic partners to enhance the effectiveness and timeliness of our efforts in the policy arena.” Please contact me at skendig@npwh.org to share your stories about policy issues affecting your practice and your patient population at the local, state, or national level. In this way, we can work together to become a collective voice for the women we serve in moving the policy needle to a place that supports women’s full access to the care that they need delivered by the providers they choose.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH).

References

  1. National Association of Nurse Practitioners in Women’s Health/Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.
  2. NPWH. Mission, Vision, and Values. Mission. 2015. https://www.npwh.org/pages/about
  3. Kaiser Family Foundation. Current Status of State Medicaid Expansion Decisions. July 20, 2015. http://kff.org/health-reform/slide/current-status-of-the-medicaid-expansion-decision/
  4. Negrato CA, Mattar R, Gomes MB. Adverse pregnancy outcomes in women with diabetes. Diabetol Metab Syndr. 2012;4(1):41.
  5. National Family Planning & Reproductive Health Association. Title X: Budget & Appropriations. http://www.nationalfamilyplanning.org/title-x_budget-appropriations
  6. Frost JJ, Frohwirth L, Zolna MR. Contraceptive Needs and Services, 2013 Update. Washington, DC: Guttmacher Institute; July 2015. www.guttmacher.org/pubs/win/contraceptive-needs-2013.pdf

Not your mother’s WHNP guidelines

In the past, and even continuing into the present day, low-income women and children have encountered barriers in accessing healthcare. Fifty years ago, to help overcome these barriers, Loretta Ford, RN, and Henry Silver, MD, created the first nurse practitioner (NP) program at the University of Colorado; it was there, in 1965, that the NP role first emerged. This certificate education program, which built on the knowledge and skills of the public health nurse, prepared pediatric NPs (PNPs) to work in collaboration with physicians to care for underserved low-income pediatric populations.1

Inspired by the success of the PNP role, innovative nurses and physicians expanded the registered nurse role to include provision of care to underserved pregnant women. The evolution of the obstetric/gynecologic (OB/GYN) nurse’s role from maternity care to women’s healthcare throughout the lifespan, in what would become an advanced practice role, drove the need for uniform standards for education and practice.

To serve this need, the first guidelines, Obstetric-Gynecologic Women’s Health Nurse Practitioner: Role Definition, Role Description, and Guidelines for Educational Development, were published in 1979. These guidelines, updated in 1984 and 1990, remained in effect until 1996. Reflecting the spirit of cooperation inherent in women’s healthcare, the National Association of Nurse Practitioners in Women’s Health (NPWH) and the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) collaborated to develop and publish Women’s Health Nurse Practitioner: Guidelines for Practice and Education (hereafter called the Guidelines) in 1996. This 4th edition and two subsequent editions have delineated the emerging skills and competencies necessary for WHNPs to meet women’s healthcare needs.

The 7th edition of the Guidelines

The evolving national healthcare scene, the changing policies/guidelines affecting NP education and practice, and multiple emerging population health concerns have driven the need for periodic comprehensive reviews and revisions of the Guidelines. The 7th edition of the Guidelines provides a clarification of the WHNP role, without expanding the role.1 This edition articulates and differentiates the women’s health population focus by:

• Strengthening language regarding the WHNP’s role in primary care, and;
• Describing key areas of specialty practice consistent with WHNP education and identified competencies, including high-risk pregnancy, infertility, urogynecology, gynecologic oncology, menopause, and gynecologic office-based procedures.

The revision process for the Guidelines

In April 2013, a joint NPWH/AWHONN task force of WHNPs, with equal representation from the two associations, was convened to revise the Guidelines under the leadership of a chairperson with dual NPWH/AWHONN membership. Task force members were selected for their knowledge and experience in women’s health, nursing education, and clinical practice. In addition, the National Certification Corporation (NCC), the only nationally recognized certifying body for WHNPs, was invited to name a representative to participate on the task force.

Over the course of 18 months, the task force took steps to ensure that the updated document would reflect not only current WHNP practice but also the an­ticipated WHNP role of the future. First, the task force reviewed key documents guiding NP practice and education, as well as women’s healthcare, to ensure alignment. Upon completion of the draft document, key WHNP stakeholders were asked to review the document and provide comments to strengthen it. Following this review, NPs in other population foci, along with representatives from the American Association of Nurse Practitioners, the Gerontological Advanced Practice Nurses Association, the National Association of Pediatric Nurse Practitioners, and the National Organization of Nurse Practitioner Faculties (NONPF), participated in a second review. The second review hinged on these questions:

• Do these Guidelines align with key NP guidance documents regarding NP practice and education?
• When, and for what services, would you refer to a WHNP?
• Is the reason that you would refer to a WHNP adequately reflected in the Guidelines document?

All comments were reviewed by the task force and incorporated into the document.

During development of the Guidelines, all NCC-certified WHNPs were invited to complete a survey regarding their current practice, including work setting, skills utilized in practice, content learned in WHNP programs, and content and skill building in the workplace. Survey results indicated that approximately 82% of WHNPs practice in primary care settings, including OB/GYN and family practice offices, family planning clinics, governmental health departments, college health departments, sexually transmitted disease clinics, and prenatal care clinics.2 The other respondents reported working in specialty and sub­specialty practices such as gynecologic oncology, urogynecology, infertility, and maternal–fetal medicine. The survey results, combined with input from non-WHNP colleagues, underscored the broad reach of WHNP practice.

Revisions include alignment with Licensure, Accreditation, Certification & Education (LACE), NONPF NP Core Competencies, American Association of Colleges of Nursing MSN and DNP Essentials, other NP population focus guidelines, and the Institute of Medicine’s (IOM’s) The Future of Nursing: Leading Change, Advancing Health, as well as key documents pertaining to women’s health.

Key differences from prior editions

The 7th edition of the Guidelines represents a comprehensive view of WHNP practice today, emphasizing a lifespan approach to care extending from menarche through senescence. Written within the framework of the LACE consensus model for advanced practice nursing and consistent with the IOM’s groundbreaking report on the future of nursing, the Guidelines, compared with earlier editions, reflect a broader description of WHNP assessment, diagnostic, and treatment activities within the context of general competencies, gynecology, male sexual and reproductive healthcare (SRH), nongynecologic primary care, and obstetrics. WHNP education concepts reflect the practice competencies necessary to partner with women to meet their healthcare needs. The Guidelines elaborate on the WHNP role in male SRH, take a gender-focused approach to women’s health concerns, and recognize WHNPs’ expertise in performing selected office-based procedures. In further clarifying the components of WHNP practice, the Guidelines reflect WHNPs’ expertise and value as care providers, leaders, and consultants in the areas of women’s health and male SRH.

Conclusion

The writing team and reviewers for the Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition spent countless hours bringing this final document to fruition. Guideline development and publication by NPWH and AWHONN included a review of interdisciplinary documents and input from family NP, adult-gerontology NP, PNP, and faculty colleagues in addition to a team of WHNPs. This multifaceted approach exemplifies the collaborative nature of women’s healthcare providers as partners with their female patients in promoting health, preventing disease, and optimizing health outcomes.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at skendig@npwh.org.

References
1. National Association of Nurse Practitioners in Women’s Health/ Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.

2. Kelsey B and the National Association of Nurse Practitioners in Women’s Health. NPWH Women’s Health NP Role and Competencies Survey. 2013. Unpublished data.

Women’s health: More than an annual event*

As I write this column in mid-May, we are  week past Mother’s Day, and Women’s Health Week has just ended. During the 5th month of the year, healthcare providers (HCPs) and healthcare consumers are bombarded with messaging focused on the importance of women’s health. But then these messages go virtually silent until October—Breast Cancer Awareness Month. During the 10th month of the year, media attention will be drawn to breast cancer, the most frequently diagnosed cancer among women. By the end of October, the women’s health voice will once again be stilled until new messaging emerges during February, designated as American Heart Month, when we are encouraged to wear red to symbolize our solidarity in the fight against cardiovascular disease, the No. 1 cause of premature death among women. And so it goes.

On an individual level, as each woman makes her yearly appointment to see her HCP, she also tends to think of her health as an “annual event.” Most women perceive of this annual visit as the time to be screened for breast and cervical cancers and to address their family planning needs, menopausal symptoms, and/or other gynecologic health problems and concerns. But for HCPs who care for female patients, as well as for the patients themselves, women’s health is more than just an annual event.

Reproductive and maternal–child health

National and global statistics underscore the importance of women’s health status in affecting birth outcomes. The United States ranks 31st out of 178 countries on Save the Children’s Mothers’ Index.1 This ranking is based on a composite of five indicators related to maternal well-being: risk of maternal death, under 5-mortality rate (the probability per 1,000 live births that a newborn will die before reaching his or her 5th birthday), expected number of years of formal schooling, gross national income per capita, and women’s participation in national government.

Although the U.S. has placed in the top 10 on the Mothers’ Index as recently as 2006, next to Cyprus, our country has fallen farthest from the top. Of the 30 countries now ahead of the U.S. on this index, all but the Republic of Korea have a higher percentage of seats held by women in national government. When women have a voice in policy, issues important to women and children are more likely to emerge as national priorities.1 Worldwide, prematurity is the leading cause of newborn death (birth to 4 weeks) and the second leading cause of death in children younger than 5 years. The U.S. ranks 37th of 165 countries in the number of deaths due to prematurity, placing 6th among the top 10 countries responsible for 60% of the world’s premature births.1,2

The burden of perinatal morbidity and mortality extends to mothers as well. Since 1990, maternal mortality in this country has nearly doubled. Of approximately 4 million U.S. women each year who give birth, about 52,000 experience severe complications and 500-600 die of these complications. Of these maternal deaths, approximately one-half are preventable. Leading causes of these maternal deaths include thromboemboli, obstetric hemorrhage, and severe hypertension or preeclampsia.3,4

Of the 6.6 million pregnancies that occur in the U.S. each year, 3.4 million (51%) are unintended, occurring disproportionately in non-Hispanic black women, unmarried women, and women with less education and financial stability.5,6 Intendedness of pregnancy and birth spacing of approximately 2 years are linked to improved pregnancy outcomes. Care before, during, and between pregnancies—including reproductive life planning, optimization of nutrition and exercise, folic acid supplementation, screening for and management of chronic diseases, immunizations, management of infectious diseases, and attention to psychological and behavioral health—contributes to more favorable maternal and child outcomes.2

Sexual/gynecologic health

Sexually transmitted infections (STIs), when untreated, can increase the risk for contracting other STIs, including HIV infection, and lead to other reproductive health problems such as cervical cancer and infertility. STI rates are highest among individuals younger than 25 years, with more than 70% of gonorrhea and chlamydia cases occurring in women in this age group. Gynecologic problems are among the most common health-related complaints for reproductive-aged women. Of the top 10 sites of cancer occurrence in the U.S. population, 3 are woman specific. Lung and bronchial cancers are the leading cause of cancer death among women aged 34-85 years, but breast cancer is more commonly diagnosed and ranks as the second leading cause of cancer death. Recommended screenings can help detect infections that compromise reproductive health, as well as breast, cervical, colorectal, and other cancers, at earlier, more treatable stages.7

Women’s health across the lifespan

Both male and female life expectancies have increased over the years, with women now living approximately 4.8 years longer than men. However, female mortality rates have increased in more than 40% of U.S. counties, as compared with an increase in male mortality in only 3.4% of U.S. counties.7 Although women’s longevity outpaces that of men in all age groups, the most impoverished 40% of women, relative to the previous generation of women, are seeing life expectancy decline.8

While women live longer than men, they are not necessarily healthier.9Women are more likely than men to report activity limitations, with 70% of women older than 65 years reporting such limitations. The most commonly reported causes of activity limitations include back and neck problems, arthritis, depression, anxiety or emotional health problems, bone injuries, and weight problems. Overall, heart disease, cancer, and stroke are the leading causes of death in women, followed by chronic lower respiratory disease and Alzheimer’s disease. Overweight and obesity are key contributors to increased risk for chronic disease, including hypertension, type 2 diabetes mellitus, cardiovascular disease, liver disease, arthritis, cancer, and reproductive health disorders. In addition to chronic disease, women experience higher rates of mental illness than do men,10 with suicide recognized as one of the top 10 causes of death in women aged 18-64 years. Physical, behavioral, and mental health problems affecting women require recognition of gender-related differences in symptoms, diagnostic considerations, and treatment decisions.

More than one-third of women have experienced physical violence at the hands of an intimate partner, and 20% of homicides are directly related to intimate partner violence (IPV). IPV, the most common cause of violence-related deaths among 40- to 44-year-olds, is associated with long-term effects on physical, emotional, and sexual health.11 Despite increased attention on the effects of violence against women in their homes, their communities, within the military, and on college campuses, effective screening for such violence remains uneven in healthcare settings. Major HCP organizations, including the National Association of Nurse Practitioners in Women’s Health (NPWH), support universal screening for IPV and other forms of violence against women.

Importance of the well-woman visit

Although the snapshot of women’s health presented in this column may be somewhat disturbing, we can take this opportunity to sharpen our focus and improve the picture now. The well-woman visit (WWV) is designed to make a difference by helping patients identify their personal health risks, access healthcare appropriate to their own needs, and receive support in achieving their goal to be as healthy as possible. The WWV gives women a chance to partner with their HCP in order to do the following:

Access recommended health screenings and assessments;

Recognize and address emerging personal and/or family risk factors that may have direct impact on their present and future health status;

Attend to physical, emotional, behavioral, and environmental factors that affect health and well-being; and

Identify personal health goals and the strategies to achieve these goals.

These key components of the WWV directly address the many factors affecting women’s reproductive, gynecologic, and sexual health; maternal–child health outcomes; and overall health status from menarche through older adulthood. Under the Affordable Care Act, basic women’s preventive healthcare is covered with no cost-sharing (e.g., copayments, co-insurance, deductible costs) to the woman. The well-woman preventive care visit is defined as occurring “annually for adult women to obtain the recommended preventive services that are age and developmentally appropriate, including preconception and prenatal care….”12 In general, the WWV occurs once a year, although the U.S. Department of Health and Human Services recognizes that, depending on a woman’s health status, health needs, and other risk factors, several visits may be needed within a year to obtain all necessary recommended preventive services.12 The Table lists examples of the types of services that are available as part of the WWV without co-pays, co-insurance, or deductible costs to the woman.12,13

Conclusion

A woman’s physical and emotional health is influenced by biologic, psychosocial, behavioral, and environmental factors. In addition, the impact of gender differences on the manifestations of chronic disease and mental illness cannot be overlooked. Although events such as Mother’s Day, Women’s Health Week, Breast Cancer Awareness Month, American Heart Month, and other awareness campaigns serve to remind us of the importance of attention to women’s health, they cannot be the sole driver of our focus. Like the components of the WWV, women’s health is addressed and improved in a variety of steps, over time. In order to improve women’s health, regardless of life stage, women’s issues must be a key consideration in every policy decision—education, economics, and, of course, healthcare. In crafting policy related specifically to women’s health issues, one must consider how such policies…

Affect the overall health status of women;

Affect women’s access to and acquisition of high-quality primary and specialty healthcare through the life span—care that is delivered by women’s health-focused HCPs within the context of their patients’ personal, religious, cultural, and family beliefs14; and

Leverage the expertise of multiple types of gender-focused HCPs, including OB/GYN physicians, women’s health nurse practitioners, certified nurse-midwives and certified midwives, women’s health and perinatal clinical nurse specialists, and other HCPs working in women’s health by convening more comprehensive task forces, commissions, and other panels assembled to inform policy. =

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis, a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri, and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at sue@healthpolicyadvantage.com.

References

  1. Save the Children. State of the World’s Mothers 2014. Westport, CT: Save the Children; 2014.

2. Partnership for Maternal, Newborn & Child Health. Born Too Soon: The Global Action Report on Preterm Birth. Geneva, Switzerland: World Health Organization; 2012.

3. UNFPA. Trends in Maternal Mortality:1990-2010. Geneva, Switzerland: WHO; 2012.

4. The National Maternal Health Initiative. The Burden of Maternal Mortality and Morbidity in the United States.

Rockville, MD: HRSA Maternal Child Health Bureau; 2014.

5. Mosher WD, Jones J, Abma JC. Intended and unintended births in the United States: 1982-2010. Natl Health Stat Rep. 2013;24(55):1-28.

6. Guttmacher Institute. Unintended Pregnancy in the United States. December 2013. www.guttmacher.org/pubs/FB-Unintended-Pregnancy-US.html

7. U.S. Department of Health and Human Services. Health Resources and Services Administration. HRSA Maternal Child Health Bureau. Women’s Health USA 2013. http://mchb.hrsa.gov/whusa13/dl/pdf/hs.pdf

8. Bosworth BP, Burke K. Differential Mortality and Retirement Benefits in the Health and Retirement Study. April 8, 2014. www.brookings.edu/research/papers/2014/04/differential-mortality-retirement-benefits-bosworth

9. Kaiser Family Foundation. The role of Medicaid and Medicare in women’s health care. JAMA. 2013;309(19):1984. http://jama.jamanetwork.com/article.aspx?articleid=1687586

10. Substance Abuse and Mental Health Services Administration. Results From the 2010 Survey on Drug Use and Health: Mental Health Findings. 2011. www.samhsa.gov/data/NSDUH/2k10NSDUH/2k10Results.htm

11. Office of the Assistant Secretary for Planning and Evaluation. Screening for Domestic Violence in Health Care Settings. Washington, DC: USDHSS; 2013.

12. U.S. Department of Health and Human Services. Health Resources and Services Administration. Women’s Preventive Services Guidelines. www.hrsa.gov/womensguidelines/

13. Institute of Medicine. Clinical Services for Women: Closing the Gaps. Washington, DC: National Academies Press; 2011.

14. National Association of Nurse Practitioners in Women’s Health (NPWH). Mission Statement. 2014. www.npwh.org/i4a/pages/index.cfm?pageid=3333

 

Will the first medication to treat low sexual desire in women be approved?

Female sexual dysfunction (FSD) affects an estimated 43% of women in the United States.1  FSDs include impaired sexual interest/arousal disorder, sexual pain disorder, and orgasmic disorder. But the most common FSD by far is hypoactive sexual desire disorder (HSDD), reported by as many as 1 in 10 women. 2 HSDD can be definitively diagnosed with reliable and validated screening tools. 3 Women’s healthcare providers are on the front line in terms of caring for women with HSDD, but we lack FDA-approved options to provide relief for them.

But now there is hope. As the August 2015 issue of Women’s Healthcare: A Clinical Journal for NPs goes to press, the FDA will have made its decision regarding whether to approve flibanserin for the treatment of HSDD in premenopausal women. Flibanserin, a non-hormonal drug, is thought to work by correcting an imbalance in the levels of neurotransmitters in the brain that affect sexual desire. 4 More specifically, flibanserin increases dopamine and norepinephrine, both of which drive sexual excitement, and transiently decreases serotonin, which drives sexual safety/inhibition.

Two months ago, an FDA advisory committee voted to recommend approval of flibanserin to treat HSDD in premenopausal women. Although the FDA is not required to accept the advisory committee’s recommendation, the agency agreed to consider it as part of the new drug application review. Readers can check www.npwh.org for the latest information on the FDA decision.

During the open comment portion of the hearing prior to this vote, Gay Johnson, CEO of NPWH, spoke on behalf of the association and in support of both women with HSDD and the providers who struggle to treat these women every day.  In her statement, Ms. Johnson said, “Women’s sexual health is complex and multidimensional and often overlooked in primary care because of many factors, including cultural conditioning of women and providers. Historically, women’s sexuality has been viewed as something tied to the obligation to have sexual relations for reproduction, but not the desire to have sexual relations to achieve personal pleasure. Thankfully, now, in the 21st century, women’s sexual health is seen as a valid component of overall wellness. Women’s sexual dysfunction is now recognized as a real health condition, of real women, that decreases quality of life and negatively impacts relationships.”

Ms. Johnson clarified that NPWH is not advocating for the approval of any specific drug. She stated, “Each HSDD medical treatment option should receive fair consideration and the side effect/adverse event profile evaluated while considering the significant impact of the condition.  Women are intelligent, insightful decision makers and can be trusted the risks of side effects/adverse events and the benefits of any treatment according to the impact of HSDD on their personal lives and relationships.”

In both its educational and advocacy endeavors, NPWH supports nurse practitioners in providing high-quality healthcare for women, which includes addressing their sexual concerns. Our Women’s Sexual Health Course for NPs, offered for the first time in June 2014 and again in June 2015, has been extremely well received, filling to capacity several weeks ahead of time and garnering positive feedback from participants. Women’s Healthcare, our journal, includes a Focus on Sexual Health department article in each issue, and our annual conference always includes course on sexual health topics. Our advocacy work is ever-present as we actively support evidence-based treatments for all FSDs. As such, we applaud the FDA’s recognition of HSDD as a health problem that merits pharmacologic treatment and we encourage the FDA to consider approval of medications that have demonstrated efficacy and safety in treating women’s most common sexual complaint.

Susan Rawlins is Director of Education for the National Association of Nurse Practitioners in Women’s Health and a women’s health nurse practitioner at the Greater Texoma Health Clinic in Denison, Texas.  The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

  1. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281(6):537-544.
  2. Parish SJ, Rubio-Aurioles E. Education in sexual medicine: proceedings from the International Consultation in Sexual Medicine, 2009. J Sex Med. 20100;7(10):3305-3314.
  3. Kingsberg SA, Woodard T. Female sexual dysfunction: focus on low desire. Obstet Gynecol. 2015;125(2):477-486.
  4. Sprout Pharmaceuticals, Inc. FDA Advisory Committee Recommends Approval for Sprout Pharmaceuticals’ ADDYI TM (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women. June 5, 2015. http://www.sproutpharma.com/news-center/

After Hobby Lobby: Where do women’s rights fit in?

The Affordable Care Act (ACA) seeks to improve population health outcomes by making preventive health services affordable and accessible. To achieve this aim, the ACA requires health plans to cover preventive services that have strong scientific evidence of their health benefits, with no cost sharing by patients (i.e., no co-payment, co-insurance, or deductible) when these services are delivered by a network provider. With limited exceptions, all FDA approved contraceptive methods are covered under the Women’s Preventive Services Guidelines. 1

However, on June 30, 2014, the U.S. Supreme Court issued one of its most highly anticipated rulings regarding women’s health. In a 5-to-4 ruling in Burwell v. Hobby Lobby Stores,2 the Court stated that “closely held” corporations do have religious rights and, as such, should be permitted an exemption from compliance with the contraceptive mandate issued by the U.S. Department of Health and Human Services (HHS).

How did we get here?

In accordance with the ACA, required preventive services, to be covered with no cost sharing on the patient’s part, include (1) evidence-based services that have received a U.S. Preventive Services Task Force (USPSTF) rating of “A” or “B”; (2) immunizations recommended by the CDC’s Advisory Committee on  Immunization Practices; (3) evidence-informed screenings and guidelines for infants, children, adolescents, and women supported by the Health Resources and Services Administration (HRSA, a division of HHS); and (4) USPSTF breast cancer screening, mammography, and prevention recommendations considered the most current other than those issued in or around November 2009.3

The Institute of Medicine (IOM) was then charged with convening an expert committee to review which preventive services are necessary for women’s health and should be considered in the development of comprehensive guidelines for preventive services for women, as well as with identifying any gaps in the USPSTF’s A- and B-rated preventive services for women.4 The IOM panel included recommendations for women that met the following criteria:

The condition to be prevented affects a broad population;

The condition to be prevented has a large potential impact on health and well-being; and

The quality and strength of the evidence is supportive of the recommendation.

Within this framework, the IOM panel recommended that preventive services for women that are to be provided without cost sharing include the “full range of FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity.” 4In making this recommendation, the IOM panel cited systematic evidence reviews and other peer-reviewed studies pointing to the efficacy of these interventions in reducing the number of unintended pregnancies, as well as their favorable effect on women’s health and pregnancy outcomes.4 (pp102-110) Based on the IOM recommendation, HRSA issued regulations requiring inclusion of all FDA-approved contraceptive methods as a preventive health benefit.

Exempt from this contraceptive mandate were religious employers; non-profit entities, including churches, their integrated auxiliaries, and conventions or associations of churches; and the exclusively religious activities of any religious order.1,5 In addition, HHS rules issued in June 2013 provided an accommodation for other non-profit religious organizations that object to the contraceptive mandate. The accommodation permitted religious organizations that met certain requirements to self-certify as non-profit religious organizations. Such organizations could then avoid contracting, paying for, or otherwise making available contraceptive coverage by notifying their health insurance issuer of their self-certified status as a religious organization.6

Understanding Hobby Lobby

Burwell v. Hobby Lobby Stores arose from cases brought by three closely held, for-profit corporations. 2 These companies sued HHS, seeking to prohibit application of the contraceptive mandate in – sofar as it required them to provide coverage for four “objectionable” contraceptive methods. In particular, Conestoga Wood Companies, a woodworking company owned by the Hahn family, sought to prohibit application of the contraceptive mandate with regard to two forms of emergency contraception and two types of intra uterine devices. The Hahns, devout Mennonites, believed that because these contraceptive methods may operate after fertilization of the egg, these products are “against their moral conviction to be involved in the termination of human life.”2(p12)

Likewise, Hobby Lobby, a chain of arts and craft stores, and Mardel, an affiliated business that operates 35 Christian bookstores, brought suit to stop application of the contraceptive mandate with regard to the same four contraceptives that the Hahns found objectionable.2 Hobby Lobby is owned by David Green and family and Mardel by one of Davi Green’s sons. Like the Hahns, the Greens believe that life begins at conception. Therefore, providing access to contraceptives with potential to operate after fertilization of the ovum would violate their religious beliefs. The owners of Conestoga, Hobby Lobby, and Mardel do not object to the other FDA-approved methods of birth control.2 (p14) The decisions by lower courts in this matter differed, resulting in the matter being brought to the Supreme Court.

In a narrow 5-4 opinion, the Court held that the HHS contraceptive mandate, as it applies to closely held corporations, violates the Religious Freedom Restoration Act (RFRA). The RFRA prohibits the federal government from taking any  action that substantially burdens a person’s exercise of religion, unless that action constitutes the “least restrictive means” of serving a “compelling government interest.” 7Although the RFRA does not define the term “person,” the Court here applied the definition under the Dictionary Act, which defines “person” to include “corporations, companies, associations, firms … as well as individuals.”8Although the Court acknowledged that the contraceptive mandate may serve a compelling government interest, requiring these closely held companies to arrange for coverage of the objectionable contraceptive methods or to suffer penalties if they refuse to do so, it also posed a “substantial burden” on their free exercise of religion.2

In an eloquent dissent, Justice Ruth Bader Ginsburg challenged the majority’s assertion that the ruling was narrow in scope, and referred to the Court’s holding as a decision of “startling breadth” that would allow commercial entities to “opt out of any law (save tax laws) they judge incompatible with their sincerely held beliefs.”9The dissent argued against the interpretation of the word “person” to include a for-profit corporation in this instance. In addition, Justice Ginsburg pointed out that the decision to claim contraceptive health benefits is a woman’s decision, and that women with beliefs similar to those of the Hahns and Greens would not be compelled by the plan to access the objectionable methods. In closing, Justice Ginsburg accused the Court of “stepping onto a minefield … by its immoderate reading of the RFRA.”9

Where are we now?

Following the Hobby Lobby decision, Senators Patty Murray (D-WA) and Mark Udall (D-CO) introduced the Protect Women’s Health from Corporate Interference Act.10 This bill was intended to restore the ACA’s contraceptive coverage requirement and protect coverage of other health services from being denied based on an employer’s beliefs by prohibiting employers from refusing to provide health coverage guaranteed to employees under Federal law. The procedural vote to take up the bill narrowly failed in the Senate, by a vote of 56-43, just 4 votes short of the 60 votes needed to move the bill forward.11

In the wake of Hobby Lobby, various executive departments have issued guidance and fact sheets, and have proposed rules regarding ACA implementation with regard to contraceptive coverage. In July 2014, the U.S. Department of Labor issued a Frequently Asked Questions (FAQ) response regarding health plans’ disclosure of changes to contraceptive coverage.12 According to the FAQ, a plan subject to the provisions of the Employee Retirement Income Security Act (ERISA) must disclose information relevant to coverage of preventive services. The Department of Labor regulations require that the summary plan description include an explanation of preventive services, including contraception, covered by the plan. Expedited disclosure requirements are in place for plans that reduce or eliminate aspects of preventive services coverage after having provided the services.13

In August 2014, HHS issued a proposed rule in response to the Hobby Lobby decision in an attempt to help ensure that women whose contraceptive coverage is being threatened continue to receive the coverage to which they are entitled under the ACA.14 The proposed rule expands the availability of the accommodation for non-profit religious organizations to avoid contracting, arranging, paying, or referring for contraceptive services to include a closely held, for-profit entity that has a religious objection to providing coverage for some or all contraceptive services. Under the proposed rule, the closely held, for profit entity may not be publicly traded and must be owned by a limited number of persons or have a minimum percentage of ownership concentrated among a smaller group of people. The comment period for the proposed rule is scheduled to close prior to publication of this article.

Summary

The Supreme Court’s Hobby Lobby decision has the potential to undermine the ACA’s provision establishing a federal guarantee of coverage for a full range of FDA-approved contraceptive methods as a key preventive health service for women.1 By limiting the ability of some women to choose among all FDA-approved contraceptive methods, based on their employer’s values and belief system, this decision may create uneven access to evidence-based healthcare services shown to have a profound impact on women’s overall health and well-being. =

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at skendig@npwh.org.

References

1. Health Resources and Services Administration website. Women’s Preventive Services Guidelines. 2012.

http://www.hrsa.gov/womensguidelines/

2. Burwell v. Hobby Lobby Stores. 13-354, s.l. : U.S. Supreme Court, June 30, 2014.

3. 42 USC § 300gg-13 (a)(1)-(5). 2010. Coverage of preventive health services.

4. Institute of Medicine. Clinical Preventative Services for Women: Closing the Gap. Washington, DC: National Academies Press; 2011.

5. 26 USC § 6033(a)(3(A)(1)(3). Returns by exempt organizations.

6. U.S. Department of Health and Human Services. Coverage of Certain Preventive Health Services under the Affordable Care Act – Final Rules. 78 Fed. Reg. 39870-39899. July 2, 2013.

7. Religious Freedom Restoration Act (RFRA). 42 USC § 2000bb-1(a)(b).

8. Dictionary Act. 1 USC § 1.

9. Ginsburg RB. Burnwell v. Hobby Lobby (dissent). 13-354 and 13-356 , s.l. : U.S. Supreme Court, 2014.

10. Murray/Udall. Protect Women’s Health from Corporate Interference Act. s.l. : 113th Congress, 2014.

11. Cunningham PW. Democratic bid to reverse Hobby Lobby fails. July 16, 2014. http://dyn.politico.com/printstory.cfm?uuid=74A8B33D-2EF4-4C9B-ADBE-19F7D09DA6BA

12. U.S. Department of Labor. FAQs about Affordable Care Act implementation (Part XX). July 17, 2014. http://www.dol.gov/ebsa/faqs/faq-aca20.html

13. Centers for Medicare and Medicaid Services website. Center for Consumer Information & Insurance Oversight. Women’s Preventive Services Coverage and Non-Profit Religious Organizations. Fact Sheet: Women’s Preventive Services Coverage, Non-Profit Religious Organizations, and Closely-Held For-Profit Entities.  CMS-CCIIO. August 22, 2014. http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/womens-preven-02012013.html

14. U.S. Department of Health and Human Services. Coverage of Certain Preventive Services Under the Affordable Care Act. 79 Fed. Reg. 51118. August 27, 2014.

Maternal Mental Health: Perinatal Depression and Anxiety Patient Safety Bundle

In 2015, the Council on Patient Safety in Women’s Health Care convened an interdisciplinary workgroup to develop an evidence-based patient safety bundle addressing maternal mental health. The 13-member workgroup was co-chaired by NPWH Director of Policy Susan Kendig, JD, MSN, WHNP-BC, FAANP, and American Congress of Obstetricians and Gynecologists representative John P. Keats, MD. The workgroup collaborated over several months, reaching consensus and approval of the Maternal Mental Health: Perinatal Depression and Anxiety Patient Safety Bundle in 2016.

The bundle has four key components: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning (Box). Rather than introducing new guidance, the bundle summarizes existing recommendations and matches them with specific resources to facilitate the implementation of best practices in all maternity care settings. The bundle is designed to be applicable in any setting where prenatal and/or postpartum care is provided. It can be adapted for implementation in preconception/interconception care as well.

Why is a maternal mental health bundle important?

First, healthcare providers (HCPs) need to know what is meant by the term bundle as it applies to healthcare. A bundle is a small set of evidence-based interventions that combines medical and improvement science to achieve improved outcomes. When care processes are grouped into simple bundles, HCPs are more likely to implement them by making fundamental changes in how the work is done. When the care processes are evidence based, subsequent outcomes will improve. Bundled interventions encourage interdisciplinary teams to organize work, adapt the delivery system, and deliver all of the bundle components. An emphasis is placed on improving process reliability. The endpoint is improvement of clinical outcomes.1 

Second, HCPs need to recognize the scope of maternal mental health safety issues. Perinatal mood and anxiety disorders are among the most common complications of pregnancy. Perinatal depression affects one in seven women.2,3 Anxiety disorders affect 13%-21% of women during pregnancy and 11%-17% postpartum.4 When unrecognized or untreated, these conditions can have a devastating effect on women, their infants, and their families. The spectrum of adverse effects includes poor adherence to healthcare recommendations, smoking, substance abuse, loss of financial and interpersonal resources, and a potential adverse effect on maternal–infant bonding/attachment. Depressive psychosis, an extreme form of perinatal depression, can lead to maternal suicide and/or infanticide. In fact, maternal suicide within a year of delivery is emerging as a major cause of maternal mortality and is probably underreported. Because perinatal mood and anxiety disorders are associated with increased risks for maternal and infant morbidity and mortality, they represent a vital patient safety issue.5

Where can HCPs find information about the bundle?

A commentary, Consensus Bundle on Maternal Mental Health: Perinatal Depression and Anxiety, published in the March 2017 issue of the journal Obstetrics and Gynecology, provides information to assist with bundle implementation. This commentary includes a discussion concerning each item within the four key bundle components. In addition, it provides a table listing useful patient/provider educational resources and the websites where these resources can be obtained. Because NPWH provided leadership both in the development of the bundle and in the writing of the commentary (Susan Kendig is the lead author), we at Women’s Healthcare are able to provide you with a link to the full article in Obstetrics and Gynecology.

What is the Council on Patient Safety in Women’s Health Care?

The Council on Patient Safety in Women’s Health Care is a broad consortium of organizations across the spectrum of women’s health established for the promotion of safe healthcare for every woman. The council has a mission to “continually improve patient safety in women’s healthcare through multidisciplinary collaboration that drives culture change” and a vision of “safe healthcare for every woman.” The council membership comprises 19 organizations, including NPWH, as well as patient advocates. NPWH participates in a number of workgroups convened by the council.

One of the major accomplishments of the council has been the development and dissemination of evidence-based patient safety bundles to support ongoing improvement of clinical care and patient outcomes. The council website provides access to live and archived webinars on a variety of topics relevant to promoting a culture of safety in women’s healthcare. The website also provides information on all of the patient safety bundles along with safety resources and tools.

Recommendations

I strongly encourage you to read the commentary, Consensus Bundle on Maternal Mental Health: Perinatal Depression and Anxiety, and to share the information with colleagues who provide prenatal, postpartum, and pre/interconception care. If you provide this care in your own clinical setting, consider using the bundle to facilitate a standardized process to ensure that maternal mental health is always addressed. The bundle is not intended to dictate practice. It is, as described previously, a set of evidence-based interventions that combines medical and improvement science to achieve improved outcomes. The interventions can be adapted in consideration of local resources, but standardization within an institution is important for consistent and safe care.

If you have implemented the bundle in your healthcare setting, please consider writing a short commentary for our journal on the process and outcomes thus far. You can submit your commentaries to me at bkelsey@healthcommedia.com. By sharing our experiences, we can strengthen the resolve to make sure that maternal mental health is always regarded as a safety issue and that it is addressed in an evidence-based manner.

Beth Kelsey is Assistant Professor and DNP Program Director at the School of Nursing, Ball State University, in Muncie, Indiana. She is editor-in-chief of Women’s Healthcare: A Clinical Journal for NPs and NPWH Director of Publications. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

  1. Reser R, Pronovost P, Haraden C, et al. Using a bundle approach to improve ventilator care processes and reduce ventilator-associated pneumonia. Jt Comm J Qual Patient Saf. 2005;31(5):243-248.
  2. Gaynes BN, Gavin N, Meltzer-Brody S, et al. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005;(119):1-8.
  3. Wisner KL, Sit DK, McShea MC, et al. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013;70(5):490-498.
  4. Fairbrother N, Young AH, Janssen P, et al. Depression and anxiety during the perinatal period. BMC Psychiatry. 2015;15:206.
  5. Kendig S, Keats JP, Hoffman MC, et al. Consensus bundle on maternal mental health: perinatal depression and anxiety. Obstet Gynecol. 2017;129(3):422-430.

Updated contraception resources from the CDC

The U.S. Medical Eligibility Criteria for Contraceptive Use, 2016 (MEC)1 and the U.S. Selected Practice Recommendations for Contraceptive Use, 2016 (SPR)2 were both released to the public on July 29, 2016. The MEC provides guidance to healthcare providers (HCPs) regarding safe use of contraceptive methods by individuals with certain personal characteristics (e.g., age, smoking status, postpartum status) or medical conditions (e.g., hypertension, diabetes, headaches). The SPR, a companion document to the MEC, provides guidance for common contraceptive management topics such as how to be reasonably certain that a woman is not pregnant, when to start contraception, which exams and tests are medically indicated prior to starting a contraceptive method, what type of follow-up is needed, and how problems should be managed.

The first edition of the MEC was published in 20103 and the first edition of the SPR, in 2013.4 The 2016 updates were made after a thorough review of the scientific evidence and consultation with national experts. A summary of the MEC changes since 2010 is provided in Appendix A of the 2016 edition and a summary of the SPR changes since 2013 appears on page 2 of the 2016 SPR.1, 2

MEC updates

The 2016 MEC provides more than 1,800 recommendations for more than 60 personal characteristics and medical conditions.1 As in the 2010 edition, the 2016 MEC continues to use four categories of medical eligibility to help HCPs assess the safety of a particular contraceptive method for persons with specific personal characteristics or medical conditions (Box). HCPs are reminded that although the MEC recommendations provide guidance, individual circumstances should always be considered in contraceptive method counseling and decisions. Take-home messages in the 2016 MEC remain the same as those in the 2010 edition:

Most women can safely use most contraceptives.

Women with medical conditions associated with an increased risk for adverse health events as a result of pregnancy need highly effective contraception for reproductive life planning.

Women, men, and couples should be informed of  the full range of methods to decide what will be best for them.

Use of the MEC can help HCPs decrease barriers to choosing safe and effective contraceptive methods.

New recommendations

New to the 2016 MEC are recommendations for women with multiple sclerosis (MS) or cystic fibrosis (CF) and for women taking selective serotonin reuptake inhibitors (SSRIs) or St. John’s wort. Ulipristal acetate (UPA) has been added to the recommendations on emergency contraception (EC).

Multiple sclerosis

HCPs should check the MS subsection of the Neurologic Conditions section of each appendix. In Appendix C, Classifications for Progestin-Only Contraceptives (POCs), depot medroxyprogesterone acetate (DMPA) is listed in category 2 for women with MS, with the comment that these women’s bone health may be compromised due to disease- related immobility and use of corticosteroids. Use of DMPA, which has been associated with small changes in BMD, might be of concern in this patient population. The other POCs, the subdermal implant and progestin-only pills (POPs), are listed in category 1 for women with MS. In Appendix D, Classifications for Combined Hormonal Contraceptives (CHCs), CHCs are listed in category 3 for women with MS who have prolonged immobility and in category 1 for women with MS who do not have prolonged immobility. Of note, although no data suggest an increased risk for venous thromboembolism (VTE) in women with MS using CHCs, these women are at overall higher risk than unaffected women for VTE.

Cystic fibrosis

HCPs should check the CF subsection of the Respiratory Conditions section of each appendix. CF is described as a condition associated with an increased risk for adverse health events as a result of pregnancy. Certain drugs used to treat CF (e.g., lumacaftor) might reduce the effectiveness of hormonal contraceptives, including oral, injectable, transdermal, and implantable contraceptives. In Appendix C, Classifications for POCs, DMPA is listed in category 2 for women with CF, with the comment that these women have a higher prevalence of osteopenia, osteoporosis, and fragility fractures than the general population. Use of DMPA, which has been associated with small changes in BMD, might be of concern in this patient population. The other POCs in women with CF are listed in category 1.

Selective serotonin reuptake inhibitors 

HCPs should check the Drug Interactions section in each appendix for specific information about this drugclass. In Appendix A, SSRIs are listed in category 1 for all contraceptives. Available data, albeit limited, show no decrease in the effectiveness of hormonal contraceptives in SSRI users. Likewise, available data show no difference in the effectiveness or in the adverse effects of SSRIs in women using hormonal contraceptives versus those not using them. The comments sections of Appendix C and Appendix D note that drugs that are inhibitors of CYP3A4 or CYP2C9 have the potential, at least in theory, to raise levels of contraceptive steroids, which might increase adverse events. The SSRI fluvoxamine is known to be a moderate inhibitor of both CYP3A4 and CYP2C9; however, no clinical or pharmacokinetic studies were identified to explore these potential drug–drug interactions.

St. John’s wort

HCPs should check the Drug Interactions section in each appendix for information about this herbal product. In Appendix A, St. John’s wort is listed in category 1 for intrauterine devices (IUDs) and DMPA, and in category 2 for the implant, POPs, and CHCs. With regard to the implant, POPs, and CHCs, as noted in Appendix C and Appendix D, limited available data raise concern that St. John’s wort might decrease the effectiveness of hormonal contraceptives by increasing the metabolism of estrogen and progestins. Interactions may be dependent on the dose of St. John’s wort. Also, the concentration of active ingredients in St. John’s wort products may vary. Any potential impact of this herbal product on the contraceptive effectiveness of DMPA is less likely than with the other POCs because of the higher dose of progestin.

Ulipristal acetate

HCPs should check Appendix J, Classifications for  Emergency Contraception, for more information about UPA, which has been added to the EC appendix. Like levonorgestrel (LNG) and combined oral contraceptives (COCs) used for EC, UPA is listed in category 2 for women with a history of severe cardiovascular disease, severe liver disease, or obesity, and in those who use a CYP3A4 inducer (e.g., bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate, efavirenz, lumacaftor). Of note, for women who are obese or who use strong CYP3A4 inducers, UPA, LNG, and COCs used for EC are listed in category 2 because of possibly reduced effectiveness. There are no personal characteristics or medical conditions that place UPA, LNG, or COCs used for EC in category 3 or 4.

Women who are breastfeeding and have taken UPA are advised to express and discard breast milk for 24 hours after taking the medication. This recommendation has been made because UPA is excreted in breast milk, with highest concentrations in the first 24 hours.

Other MEC revisions

Revisions to recommendations have been made for postpartum and breastfeeding women, as well as for several medical conditions. The revisions to recommendations for postpartum and breastfeeding women include those presented in the 2011 CDC revised recommendations for these populations related to use of the IUD, POCs, and CHCs.5 Appendix B, Classifications for IUDs, includes changes for women with gestational trophoblastic disease, HIV infection, and certain factors related to sexually transmitted infections. Appendix D, Classifications for CHCs, includes changes for women with migraines, superficial venous disease, or known dyslipidemias, and for women on antiretroviral therapy.

SPR updates

As in the 2013 edition, the 2016 SPR provides information organized by contraceptive method.2 Charts and algorithms are included in appendices that summarize guidance across all methods for when to start, examinations and tests that are needed, routine followup, and management of bleeding irregularities. SPR updates are consistent with changes in the 2016 MEC. Take-home messages in the 2016 SPR remain the same as in the 2013 edition:

Most women can start most methods anytime.

Few, if any, exams or tests are needed.

Routine follow-up is generally not required.

Regular contraception should be started after emergency contraception.

Anticipatory counseling for potential contraceptive-related bleeding changes and proper management are important.

Use of the SPR can help HCPs decrease medical barriers to accessing and using contraception.

New recommendation: use of medications to ease IUD insertion

Misoprostol is not recommended for routine use before IUD insertion but might be helpful in some circumstances—for example, in a woman with a recent failed insertion. A paracervical block with lidocaine might reduce pain during IUD insertion.

Updated recommendation: when to start regular contraception after taking UPA

Under ideal circumstances, women should start or resume a hormonal contraceptive method no sooner than 5 days after taking UPA because of a risk that hormonal contraceptives might decrease the effectiveness of UPA. However, if the chosen hormonal method would require an additional visit to an HCP (e.g., DMPA, implant, IUD), the risk of reduced effectiveness needs to be weighed against the risk that a regular contraceptive method might not be started. Women who have taken UPA should abstain from sexual intercourse or use a barrier method for 7 days after starting or resuming regular contraception or until the next menses, whichever comes first. Any nonhormonal contraceptive method can be started immediately after taking UPA.

Useful tools for HCPs

The CDC provides a variety of useful tools and aids to facilitate use of the MEC and SPR in clinical practice. The summary MEC chart has been updated, as has the MEC and SPR Smartphone app. Printable PDF versions of When to Start Contraceptive Methods and Routine Follow-up and What to Do If Late, Missed, or Delayed CHC are available. 

Beth Kelsey is Assistant Professor and DNP Program Director at the School of Nursing, Ball State University, in Muncie, Indiana. She is editor-in-chief of Women’s Healthcare: A Clinical Journal for NPs and Publication Coordinator for NPWH. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Centers for Disease Control and Prevention (CDC). U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. July 29, 2016.

2. CDC. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. July 29, 2016.

3. CDC. U.S. medical eligibility criteria for contraceptive use, 2010. June 18, 2010.

4. CDC. U.S. selected practice recommendations for contraceptive use, 2013. MMWR. 2013;62(RR-5):1-46.

5. CDC. Update to CDC’s U.S. medical eligibility criteria for the use of contraceptive methods, 2010: revised recommendations for the use of contraceptive methods during the postpartum period. MMWR. 2011;60(26):878-883.

Collaboration in practice: A framework for team-based care

Since passage of the Affordable Care Act in 2010, alternate care delivery models such as patient- centered health homes and accountable care organizations have emerged as tools for payment and healthcare delivery system reform. The intent of such clinical integration models is to drive improvement in individual and population health outcomes and in the quality and efficiency of healthcare service delivery.Although these models hold promise in moving our healthcare system from a disjointed paradigm to a seamless, value-driven standard, fragmentation persists at all levels of the healthcare continuum. Establishment of a well-functioning team is one mechanism by which healthcare providers (HCPs) can achieve the goal of patient-centric, well-coordinated, safe, and responsive healthcare.2

Healthcare providers have been challenged to respond to an evolving health policy landscape that demands movement to coordinated, value-driven care models in the face of HCP shortages and shrinking resources. In response to this changing landscape, and, reflective of his own commitment to a team approach to care, John Jennings, ACOG’s 2014 President, chose—as the priority issue of his presidential year—revision of ACOG’s Guidelines for Implementing Collaborative Practice (1995) to better reflect the demands of today’s healthcare system. To meet this charge, ACOG convened an interdisciplinary task force comprising delegates from nine different organizations representing physicians, nurse practitioners, midwives, physician assistants, clinical pharmacists, and consumers. The resulting Collaboration in Practice: Implementing Team-Based Care represents a paradigm shift for healthcare service delivery in which patients are integral participants; all team members are valued equally; and all HCPs are supported in practicing to the full extent of their education, certification, and experience and accept accountability for their practice. To date, this document has been endorsed or supported by 21 national organizations, including NPWH and our sister NP organizations AANP, GAPNA, NAPNAP, and NONPF.3 The Executive Summary of this document is available here.

Team-based care and collaboration

In crafting this document, the writing team worked with the following definitions. Team-based care is defined as the “provision of health services to individuals, families, and/or their communities by at least two healthcare providers who work collaboratively with patients and their families…to accomplish shared goals…”Effective implementation of team-based care requires interprofessional collaborationdefined as “a process involving mutually beneficial participation between autonomous individuals whose relationships are governed by shared norms and visions.”3

The terms team-based care and collaboration have sometimes been used in regulatory policies in a way that places barriers to qualified HCPs’ ability to practice to the full extent of their education, certification, and experience. However, implementing team-based care delivery models does not require team-based licensure or integrated regulatory frameworks. In some cases, linked licensure and restrictive regulations may inhibit the flexibility and innovation required for team-based, patient-centered care. Of note, the ACOG document uses the terms team-based care and collaboration in their truest forms, denoting an equitable practice environment wherein each team member’s knowledge and skills are valued contributions to the team’s work. As such, the terms team-based care and collaboration should not be construed as recommended policy constructs within the context of this document.

Core concepts: Application to women’s health practice

Collaboration in Practice identifies six principles as core components guiding team-based care, all of which are relevant to women’s healthcare and WHNP practice. First and foremost, successful team-based care recognizes the patient and family as central, actively engaged members of the healthcare team.4 In 2008, the National Priorities Partnership identified patient and family engagement as one of six priorities with the most potential to reduce harm, eliminate disparities, decrease disease burden, and remove inefficiencies in healthcare delivery.4 Given the disparities in maternal/child and women’s health outcomes across the lifespan,5 a team-based approach that supports active patient engagement and shared decision making holds merit as one strategy to improve women’s health outcomes.

The second, third, and fourth guiding principles recognize the importance of shared vision, role clarity, and accountability, respectively, as important components of team-based care. These principles underscore the value of mutual respect that recognizes the expertise of each team member. Likewise, there exists an expectation of professional accountability to one’s own practice and to the team. Maintaining competencies through continuous learning is an expectation within an accountable practice. Although regulation of scope of practice resides within the purview of each state, the document urges professional organizations to continue to provide guidance for clinical practice and promote uniform educational requirements and standards of care and conduct. The Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th edition (2014), available hereprovides a population-focused framework for WHNPs.

Communication, the fifth guiding principle, underscores the need for clear transfer of information regarding patient status and team tasks. The document recognizes the fluid nature of teams and appreciates evolving trends in healthcare. Teams range from a typical model wherein care is provided at a discrete location by a selected team of HCPs to virtual teams wherein care is provided by multiple HCPs across a variety of settings in disparate locations—in some instances using telehealth as a tool to expand access.The sixth guiding principle recognizes the fluid and dynamic nature of patient-centered care. Team leadership is described as being situational and dynamic. Within this principle, team leadership is determined in response to patient need at any given moment in time, rather than ownership by a specific role or discipline.

Women’s healthcare providers practicing in the maternal/child healthcare field may recognize parallels between team-based care and perinatal regionalization, a concept supported by the maternal/child healthcare community for more than two decades. Perinatal regionalization, which seeks to assure that high-risk pregnant women and/or infants receive the appropriate level of care at the appropriate time in order to optimize patient outcomes in high-risk situations, can be viewed as a key example of a virtual model for team-based care. In this model, communication to facilitate seamless transitions in care among community-based HCPs and perinatal care providers must be established to achieve optimal pregnancy outcomes. In-person or virtual consultation, education, and skill building help support open communication, professional accountability, and fluid team leadership. Just as the team-based care model recognizes the important role of each member, perinatal regionalization recognizes the important role of the community-based team, the perinatal center team, and wraparound service providers, all of whom contribute to an optimal outcome.7,8 Although perinatal regionalization serves as one example of the breadth of a team-based care model, the concept is transferable across a variety of healthcare settings and specialties, within a traditional or a virtual setting.

Conclusion

Women’s healthcare has always been a team-based endeavor recognizing the important role of access to gender-focused care throughout the lifespan, with attention to the realities of women’s lives outside the hospital and clinic walls. In this regard, it is especially fitting that women’s healthcare providers led the way in bringing together a diverse group of HCPs to chart a path applicable across specialties and disciplines. Furthermore, the collaborative process used in developing this document mirrored the equitable, collaborative approach recommended as a pathway to successful implementation of team-based care. NPWH was proud to be part of the working group that helped shape the concepts put forth in this document.

The aforementioned Executive Summary of the Collaboration in Practice document provides an overview of the process and key points. All of the essential elements of the work, including recommendations for implementing an equitable, accessible, reimbursable, patient-centric model of care, are elaborated in the full report. The Collaboration in Practice team invites you to consider how the full report can be used to enhance your practice and improve patient outcomes.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri- St. Louis; a consultant at Health Policy Advantage,LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She served as the NPWH delegate to ACOG’s Collaborative Practice Task Force. She can be reached at 314-629-2372 or at skendig@npwh.org.

References

1. Guterman S, Drake H. Developing innovative payment approaches: finding the path to high performanceThe Commonwealth Fund. May 2010.

2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.

3. Executive Summary: Collaboration in Practice: Implementing Team-Based Care. Report of the American College of Obstetricians and Gynecologists’ Task Force on Collaborative Practice. Obstet Gynecol. 2016;127(3):612-617.

4. National Priorities Partnership. National Priorities and Goals: Aligning Our Efforts to Transform America’s HealthcareWashington, DC: National Quality Forum; 2008.

5. Kendig S. Women’s health: more than an annual event. Womens Healthcare. 2014;2(3):36-39.

6. ACOG Task Force on Collaborative Practice. Collaboration in Practice: Implementing Team-Based CareWashington, DC: ACOG; 2016.

7. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care, 7th edition. Elk Grove Village, IL: AAP; Washington, DC: ACOG; 2012.

8. Obstetric Care Consensus No. 2: Levels of Maternal Care. Obstet Gynecol. 2015;125(2):502-515.

Women in clinical trials: FDA Office of Women’s Health efforts

During the fall of 2015, NPWH CEO Gay Johnson and I attended an FDA Office of Women’s Health (FDA OWH) meeting regarding the exciting work being done to foster inclusion of diverse populations of women in clinical trials. The FDA OWH campaign, to be launched in 2016, aims to encourage women to make a difference for themselves and others through participation in clinical trials.1

Why do we need more women in clinical trials?

Although the drug development process routinely includes an analysis of sex differences in terms of drug safety and efficacy, this was not always the case. Prior to 1993, male physiology was presumed to be the norm for scientific research. For the most part, restrictive FDA guidelines excluded women of childbearing potential from the early phases of clinical trials—except in situations involving life-threatening conditions.

In 1992, the General Accounting Office (GAO) issued a report stating that women were indeed under-represented in drug development trials and that there was a need for increased study of gender differences in prescription drug testing.2 The GAO report was followed by development of a Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (Gender Guideline), which set the stage for the creation of the FDA OWH.3 After the Gender Guideline was issued, women’s participation in clinical trials improved. A 2001 GAO report showed that women comprised a majority—52%—of the clinical trial participants in studies conducted for the 36 new drug applications approved between August 1998 and December 2000.A 2013 FDA report showed that women were adequately represented in most of the clinical trials used as the basis for safety and effectiveness decisions about FDA-approved products.5

Women’s participation in clinical trials is important because the same dose of the same drug may have different pharmacokinetics and/or pharmacodynamics in women versus men. Such differences in drug disposition can manifest as differences in drug safety and efficacy.6 For example, women are almost twice as likely as men to experience an adverse drug reaction. Sex differences have been reported across all phases of drug disposition, and may be related to body weight, body makeup, interactions with endogenous sex steroid hormones, physiologic changes in pregnancy, and other factors. The FDA OWH plays an important role in increasing understanding of sex differences in therapeutic interventions, which can in turn lead to more precise dosing regimens, greater efficacy, decreased side effects, and fewer adverse drug events for both women and men.6

A refresher on the FDA OWH

The FDA OWH was created in 1994 to provide leadership and policy direction for the FDA with regard to women’s health issues. The Office’s purpose is to protect and advance the health of women through policy, science, and outreach; advocate for inclusion of women in clinical trials; and foster appropriate analysis of sex and gender effects.3 Since its inception, the FDA OWH has established a science program for women’s health research to inform sound policy and regulation development, and has provided support for multiple women’s health research studies covering a broad range of topics that affect women throughout the lifespan.

Research funded by the FDA OWH focuses on topics or issues with regulatory impact, thereby providing a mechanism for science to inform policy. Funding mechanisms include intramural grants to support research within the FDA targeting gaps in knowledge, special funding initiatives to support FDA scientists in studying pressing women’s health needs, and extramural contracts providing an avenue to convene with outside experts to answer regulatory research questions.3 These examples demonstrate how FDA OWH funded research has contributed to knowledge regarding the effects of sex differences on disease presentation and response to interventions, and its subsequent effect on health policy and regulation:

• Shaping policy regarding inclusion of women in clinical trials is a core FDA OWH commitment. Following release of the 1993 Gender Guideline, the newly created FDA OWH further clarified the effect of the Gender Guideline by funding a study reviewing protocol criteria for sex-based exclusions. Since this time, the FDA OWH has continued to monitor trends related to gender analysis and inclusion of women in clinical trials.

• The FDA OWH science and policy planning function has contributed significantly to improved understanding of gender differences in clinical presentation and therapeutic interventions. Early research supported by the FDA OWH elucidated (1) the effect of longer corrected QT intervals in women, (2) the effect of sex hormones on this phenomenon, and (3) the risks to women’s health that are related to the effect of certain drugs on women’s QT intervals. This information has led to regulatory requirements regarding relevant black box warnings, re-labeling of approved drugs, and development of draft guidance to protect women’s health.3

• Drug/dietary supplement interactions can lead to altered drug or hormone metabolism. FDA-funded studies have suggested a relationship between the use of the over-the-counter dietary supplement St. John’s wort and decreased efficacy of oral contraceptives. Similarly, FDA-funded studies have shown the effect of Echinacea in compromising the safety and efficacy of drugs such as warfarin that have narrow therapeutic windows.3

FDA OWH and FDA resources for providers and patients

Healthcare providers (HCPs) can access the FDA OWH website for basic information and links to additional resources. To help HCPs understand sex and gender differences with regard to disease conditions and therapeutic interventions, the FDA OWH and the NIH offer a three-course series on sex- and gender-related differences. The series provides information regarding physiologic differences and their influence on health and disease; behavior; and disease manifestation, treatment, and outcome. On the FDA’s Women in Clinical Trials page, patients can find links to a fact sheet, videos, and other resources designed to help them understand the role of clinical trials in protecting and promoting women’s health. And on the FDA’s For Women page, patients can find various gender-focused patient information tools related to chronic disease conditions and other women’s health issues.

Conclusion

Women’s health research provides valuable insights as to how sex differences can affect women’s health outcomes. Likewise, inclusion of more diverse populations of women in clinical trials will better inform HCPs as to the potential of the effect of ethnicity overlaid with gender in the efficacy of therapeutic interventions. During 2016, the FDA OWH and NIH Office of Research on Women’s Health are focused on inclusion of diverse population of women in clinical trials. The links provided in this column can help nurse practitioners working in women’s health to better inform their patients about opportunities for participation in studies that can “Make a Difference” in finding optimal, targeted assessment and intervention strategies to promote and protect the health of all women.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri- St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at skendig@npwh.org.

References

1. U.S. Food and Drug Administration. Women in Clinical Trials. November 25, 2015.

2. U.S. Government Accountability Office. Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drugs Testing. HRD-93-17. October 29, 1992.

3. Obias-Mannos D, Scott PE, Kaczmarczyk J, et al. The Food and Drug Administration Office of Women’s Health: impact of science on regulatory policy. J Womens Health (Larchmt). 2007;16(6):807-817.

4. U.S. Government Accountability Office. Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement. GAO-01-754. July 6, 2001.

5. U.S. Food and Drug Administration. FDA Report. Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products. August 2013.

6. Fadiran EO, Zhang L. Chapter 2: Effects of sex differences in the pharmacokinetics of drugs and their impact on the safety of medicines in women. In: Harrison-Woolrych M, ed. Medicines for Women. Switzerland: Springer International Publishing; 2015.

From practice to policy: The WHNP as advocate

PDF 50

By Susan Kendig, JD, MSN, WHNP-BC, FAANP

As most of our readers know, the National Association of Nurse Practitioners in Women’s Health (NPWH) and the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) released the 7th edition of the Women’s Health Nurse Practitioner: Guidelines for Practice and Education in December 2014. Many women’s health nurse practitioners (WHNPs) use this document to outline their clinical competencies, and faculty use it as a framework in developing WHNP program curricula. But the guidelines go beyond describing clinical practice components and educational requirements; they also include policy and advocacy competencies. In particular, the guidelines enumerate participating in legislative/policy-making activities that influence women’s health and serving as “a consultant and trusted source of information on women’s health for healthcare systems and policy-makers” as key WHNP leadership competencies.1

As core WHNP competencies, policy and advocacy align well with NPWH’s mission and values. NPWH’s mission is to “ensure the provision of quality primary and specialty healthcare to women of all ages by women’s health and women’s health-focused nurse practitioners.” This mission includes protecting and promoting a woman’s right to make her own choices regarding her health within the context of her personal, religious, cultural, and family beliefs. As a professional membership organization, NPWH strives to continuously improve access and quality of healthcare for women through excellence and innovation in continuing education and professional development; to demonstrate leadership in policy, practice, and research; and to provide support and services for our members. These policy-related values are key to achieving our mission:

  • To advocate for healthcare policies that support women and advanced practice registered nurses (APRNs) who care for them; and,
  • To collaborate with strategic partners to enhance the effectiveness and timeliness of our efforts in the policy arena.2

How do these competencies affect clinical practice?

So, what does all of this mean in the real world of clinical practice? As most of our readers witness every day, policy decisions related to everything from reimbursement for healthcare service delivery to state-based APRN scope of practice regulations to decisions regarding availability of services, medications, or new technologies can affect women’s health—and the realization of NPWH’s mission. The following discussion provides just a few examples.

The Patient Protection and Affordable Care Act seeks to increase access to affordable health insurance, with the ultimate goal of increasing access to healthcare. One way that it does this is by providing a mechanism for federally supported Medicaid expansion to cover most low-income adults (i.e., those earning up to 138% of the federal poverty level). Yet, to date, approximately 20 states have not expanded Medicaid to this level of coverage.3 Most states provide Medicaid coverage during pregnancy; however, in non–Medicaid-expansion states, this coverage stops shortly after delivery. Although coverage of prenatal care facilitates a favorable pregnancy outcome, lack of coverage for care needed before and between pregnancies can have devastating effects on women and their children.

Consider the reproductive-aged woman with type 1 diabetes mellitus (T1DM). Diabetes in pregnancy can adversely affect both maternal and infant outcomes. Women with T1DM have higher rates of maternal mortality and morbidity, including increased rates of pre-eclampsia and cesarean section. Likewise, maternal T1DM increases the risks for fetal and neonatal loss, congenital anomalies, macrosomia, and a host of other neonatal complications. A patient with T1DM who qualifies for Medicaid during pregnancy but loses coverage soon after delivery will not have access to care for her chronic disease prior to her next pregnancy. This gap in care can allow her T1DM to spiral out of control, contributing to increased maternal and infant health problems or even death during subsequent pregnancies.4

In June 2015, the House Labor, Health and Human Services (LHHS) Subcommittee marked up its fiscal year 2016 spending bill, which contained a complete elimination of Title X. The following week, the Senate released a funding bill proposing $257.8 million for Title X, a decrease from the prior year’s $286.5 million budget.5 By the time this article goes to press, we should know how the Title X program fares in the 2016 budget. It is estimated that publicly funded healthcare providers, such as those funded through Title X, met an estimated 42% of the need for publicly supported contraceptive services and supplies in 2013.6 Cuts to, or elimination of, the Title X program would effectively bar many of these women from accessing similar services in the future. In the case of the patient with T1DM discussed earlier who has already lost access to care for her chronic disease, she will also lose family planning services, which may contribute to a shortened pregnancy interval and may increase the potential for a poor pregnancy outcome. Furthermore, because Title X clinics are staffed primarily by NPs, cuts to Title X could decrease women’s access to quality care by WHNPs and other NPs who provide family planning services.

Professional competencies plus organizational values in action

Although many of our readers in clinical practice may have little time to “participate in legislative and policy-making activities that influence women’s health” in the traditional sense, they are our greatest asset in terms of bringing women’s stories to the forefront. NPWH staff keep our fingers on the pulses of policy-makers with power to make decisions about how, where, and from whom each woman can access care that is “within the context of her personal, religious, cultural, and family beliefs,” but our organization’s members provide the stories that give life to the policy. It is through our organization’s members that we at NPWH learn about the challenges that women face in accessing woman-centric care to meet their needs, as well as the barriers faced by WHNPs in attempting to provide that care.

Conclusion

In keeping with the NPWH/AWHONN guidelines, WHNPs possess the leadership competencies to serve as trusted sources of information on women’s health. As NPWH Policy Director, I invite all of our readers to collaborate with NPWH as “strategic partners to enhance the effectiveness and timeliness of our efforts in the policy arena.” Please contact me at skendig@npwh.org to share your stories about policy issues affecting your practice and your patient population at the local, state, or national level. In this way, we can work together to become a collective voice for the women we serve in moving the policy needle to a place that supports women’s full access to the care that they need delivered by the providers they choose.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH).

References

  1. National Association of Nurse Practitioners in Women’s Health/Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.
  2. NPWH. Mission, Vision, and Values. Mission. 2015. https://www.npwh.org/pages/about
  3. Kaiser Family Foundation. Current Status of State Medicaid Expansion Decisions. July 20, 2015. http://kff.org/health-reform/slide/current-status-of-the-medicaid-expansion-decision/
  4. Negrato CA, Mattar R, Gomes MB. Adverse pregnancy outcomes in women with diabetes. Diabetol Metab Syndr. 2012;4(1):41.
  5. National Family Planning & Reproductive Health Association. Title X: Budget & Appropriations. http://www.nationalfamilyplanning.org/title-x_budget-appropriations
  6. Frost JJ, Frohwirth L, Zolna MR. Contraceptive Needs and Services, 2013 Update. Washington, DC: Guttmacher Institute; July 2015. www.guttmacher.org/pubs/win/contraceptive-needs-2013.pdf

Will the first medication to treat low sexual desire in women be approved?

PDF 50
By Susan Rawlins, RN, MS, WHNP-BC

Female sexual dysfunction (FSD) affects an estimated 43% of women in the United States.1 FSDs include impaired sexual interest/arousal disorder, sexual pain disorder, and orgasmic disorder. But the most common FSD by far is hypoactive sexual desire disorder (HSDD), reported by as many as 1 in 10 women.2 HSDD can be definitively diagnosed with reliable and validated screening tools.3 Women’s healthcare providers are on the front line in terms of caring for women with HSDD, but we lack FDA-approved options to provide relief for them.

But now there is hope. As the August 2015 issue of Women’s Healthcare: A Clinical Journal for NPs goes to press, the FDA will have made its decision regarding whether to approve flibanserin for the treatment of HSDD in premenopausal women. Flibanserin, a non-hormonal drug, is thought to work by correcting an imbalance in the levels of neurotransmitters in the brain that affect sexual desire.4 More specifically, flibanserin increases dopamine and norepinephrine, both of which drive sexual excitement, and transiently decreases serotonin, which drives sexual satiety/inhibition.

Two months ago, an FDA advisory committee voted to recommend approval of flibanserin to treat HSDD in premenopausal women. Although the FDA is not required to accept the advisory committee’s recommendation, the agency agreed to consider it as part of the new drug application review. Readers can check www.npwh.org for the latest information on the FDA decision.

During the open comment portion of the hearing prior to this vote, Gay Johnson, CEO of NPWH, spoke on behalf of the association and in support of both women with HSDD and the providers who struggle to treat these women every day. In her statement, Ms. Johnson said, “Women’s sexual health is complex and multidimensional and often overlooked in primary care because of many factors, including cultural conditioning of women and providers. Historically, women’s sexuality has been viewed as something tied to the obligation to have sexual relations for reproduction, but not the desire to have sexual relations to achieve personal pleasure. Thankfully, now, in the 21st century, women’s sexual health is seen as a valid component of overall wellness. Women’s sexual dysfunction is now recognized as a real health condition, of real women, that decreases quality of life and negatively impacts relationships.”

Ms. Johnson clarified that NPWH is not advocating for the approval of any specific drug. She stated, “Each HSDD medical treatment option should receive fair consideration and the side effect/adverse event profile evaluated while considering the significant impact of the condition. Women are intelligent, insightful decision makers and can be trusted to evaluate the risks of side effects/adverse events and the benefits of any treatment according to the impact of HSDD on their personal lives and relationships.”

In both its educational and advocacy endeavors, NPWH supports nurse practitioners in providing high-quality healthcare for women, which includes addressing their sexual health concerns. Our Women’s Sexual Health Course for NPs, offered for the first time in June 2014 and again in June 2015, has been extremely well received, filling to capacity several weeks ahead of time and garnering positive feedback from participants. Women’s Healthcare, our journal, includes a Focus on Sexual Health department article in each issue, and our annual conference always includes courses on sexual health topics. Our advocacy work is ever-present as we actively support evidence-based treatments for all FSDs.

As such, we applaud the FDA’s recognition of HSDD as a health problem that merits pharmacologic treatment and we encourage the FDA to consider approval of medications that have demonstrated efficacy and safety in treating women’s most common sexual complaint.

Susan Rawlins is Director of Education for the National Association of Nurse Practitioners in Women’s Health and a women’s health nurse practitioner at the Greater Texoma Health Clinic in Denison, Texas. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281(6):537-544.

2. Parish SJ, Rubio-Aurioles E. Education in sexual medicine: proceedings from the International Consultation in Sexual Medicine, 2009. J Sex Med. 2010;7(10):3305-3314.

3. Kingsberg SA, Woodard T. Female sexual dysfunction: focus on low desire. Obstet Gynecol. 2015;125(2):477-486.

4. Sprout Pharmaceuticals, Inc. FDA Advisory Committee Recommends Approval for Sprout Pharmaceuticals’ ADDYI™ (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women. June 5, 2015. http://www.sproutpharma.com/news-center/

Not your mother’s WHNP guidelines

PDF 50

By Susan Kendig, JD, MSN, WHNP-BC, FAANP

In the past, and even continuing into the present day, low-income women and children have encountered barriers in accessing healthcare. Fifty years ago, to help overcome these barriers, Loretta Ford, RN, and Henry Silver, MD, created the first nurse practitioner (NP) program at the University of Colorado; it was there, in 1965, that the NP role first emerged. This certificate education program, which built on the knowledge and skills of the public health nurse, prepared pediatric NPs (PNPs) to work in collaboration with physicians to care for underserved low-income pediatric populations.1

Inspired by the success of the PNP role, innovative nurses and physicians expanded the registered nurse role to include provision of care to underserved pregnant women. The evolution of the obstetric/gynecologic (OB/GYN) nurse’s role from maternity care to women’s healthcare throughout the lifespan, in what would become an advanced practice role, drove the need for uniform standards for education and practice.

To serve this need, the first guidelines, Obstetric-Gynecologic Women’s Health Nurse Practitioner: Role Definition, Role Description, and Guidelines for Educational Development, were published in 1979. These guidelines, updated in 1984 and 1990, remained in effect until 1996. Reflecting the spirit of cooperation inherent in women’s healthcare, the National Association of Nurse Practitioners in Women’s Health (NPWH) and the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) collaborated to develop and publish Women’s Health Nurse Practitioner: Guidelines for Practice and Education (hereafter called the Guidelines) in 1996. This 4th edition and two subsequent editions have delineated the emerging skills and competencies necessary for WHNPs to meet women’s healthcare needs.

The 7th edition of the Guidelines

The evolving national healthcare scene, the changing policies/guidelines affecting NP education and practice, and multiple emerging population health concerns have driven the need for periodic comprehensive reviews and revisions of the Guidelines. The 7th edition of the Guidelines provides a clarification of the WHNP role, without expanding the role.1 This edition articulates and differentiates the women’s health population focus by:

• Strengthening language regarding the WHNP’s role in primary care, and;
• Describing key areas of specialty practice consistent with WHNP education and identified competencies, including high-risk pregnancy, infertility, urogynecology, gynecologic oncology, menopause, and gynecologic office-based procedures.

The revision process for the Guidelines

In April 2013, a joint NPWH/AWHONN task force of WHNPs, with equal representation from the two associations, was convened to revise the Guidelines under the leadership of a chairperson with dual NPWH/AWHONN membership. Task force members were selected for their knowledge and experience in women’s health, nursing education, and clinical practice. In addition, the National Certification Corporation (NCC), the only nationally recognized certifying body for WHNPs, was invited to name a representative to participate on the task force.

Over the course of 18 months, the task force took steps to ensure that the updated document would reflect not only current WHNP practice but also the an­ticipated WHNP role of the future. First, the task force reviewed key documents guiding NP practice and education, as well as women’s healthcare, to ensure alignment. Upon completion of the draft document, key WHNP stakeholders were asked to review the document and provide comments to strengthen it. Following this review, NPs in other population foci, along with representatives from the American Association of Nurse Practitioners, the Gerontological Advanced Practice Nurses Association, the National Association of Pediatric Nurse Practitioners, and the National Organization of Nurse Practitioner Faculties (NONPF), participated in a second review. The second review hinged on these questions:

• Do these Guidelines align with key NP guidance documents regarding NP practice and education?
• When, and for what services, would you refer to a WHNP?
• Is the reason that you would refer to a WHNP adequately reflected in the Guidelines document?

All comments were reviewed by the task force and incorporated into the document.

During development of the Guidelines, all NCC-certified WHNPs were invited to complete a survey regarding their current practice, including work setting, skills utilized in practice, content learned in WHNP programs, and content and skill building in the workplace. Survey results indicated that approximately 82% of WHNPs practice in primary care settings, including OB/GYN and family practice offices, family planning clinics, governmental health departments, college health departments, sexually transmitted disease clinics, and prenatal care clinics.2 The other respondents reported working in specialty and sub­specialty practices such as gynecologic oncology, urogynecology, infertility, and maternal–fetal medicine. The survey results, combined with input from non-WHNP colleagues, underscored the broad reach of WHNP practice.

Revisions include alignment with Licensure, Accreditation, Certification & Education (LACE), NONPF NP Core Competencies, American Association of Colleges of Nursing MSN and DNP Essentials, other NP population focus guidelines, and the Institute of Medicine’s (IOM’s) The Future of Nursing: Leading Change, Advancing Health, as well as key documents pertaining to women’s health.

Key differences from prior editions

The 7th edition of the Guidelines represents a comprehensive view of WHNP practice today, emphasizing a lifespan approach to care extending from menarche through senescence. Written within the framework of the LACE consensus model for advanced practice nursing and consistent with the IOM’s groundbreaking report on the future of nursing, the Guidelines, compared with earlier editions, reflect a broader description of WHNP assessment, diagnostic, and treatment activities within the context of general competencies, gynecology, male sexual and reproductive healthcare (SRH), nongynecologic primary care, and obstetrics. WHNP education concepts reflect the practice competencies necessary to partner with women to meet their healthcare needs. The Guidelines elaborate on the WHNP role in male SRH, take a gender-focused approach to women’s health concerns, and recognize WHNPs’ expertise in performing selected office-based procedures. In further clarifying the components of WHNP practice, the Guidelines reflect WHNPs’ expertise and value as care providers, leaders, and consultants in the areas of women’s health and male SRH.

Conclusion

The writing team and reviewers for the Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition spent countless hours bringing this final document to fruition. Guideline development and publication by NPWH and AWHONN included a review of interdisciplinary documents and input from family NP, adult-gerontology NP, PNP, and faculty colleagues in addition to a team of WHNPs. This multifaceted approach exemplifies the collaborative nature of women’s healthcare providers as partners with their female patients in promoting health, preventing disease, and optimizing health outcomes.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at skendig@npwh.org.

References
1. National Association of Nurse Practitioners in Women’s Health/ Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.

2. Kelsey B and the National Association of Nurse Practitioners in Women’s Health. NPWH Women’s Health NP Role and Competencies Survey. 2013. Unpublished data.

After Hobby Lobby: Where do women’s rights fit in?

By Susan Kendig, JD, MSN, WHNP-BC, FAANP

The Affordable Care Act (ACA) seeks to improve population health outcomes by making preventive health services affordable and accessible. To achieve this aim, the ACA requires health plans to cover preventive services that have strong scientific evidence of their health benefits, with no cost sharing by patients Continue reading »

Women’s health: More than an annual event

By Susan Kendig, JD, MSN, WHNP-BC, FAANP

As I write this column in mid-May, we are a week past Mother’s Day, and Wo­men’s Health Week has just ended. During the 5th month of the year, healthcare providers (HCPs) and healthcare consumers are bombarded with messaging focused on the importance of women’s health. Continue reading »

Policy & practice points

The Patient Protection and Affordable Care Act
By Susan Kendig, JD, MSN, WHNP-BC, FAANP

Since passage of the Patient Protection and Affordable Care Act (PPACA) on March 23, 2010, there has been an ever-present news cycle focused on implementation of various aspects of the law Continue reading »