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Message from the CEO

As I am sure many of you know, NPWH always strives to provide you with tools and information that you can use to further your professional development and your education. I am proud to announce that NPWH has developed the Women’s Health Nurse Practitioner Certification Exam Review Course and Women’s Health Update! This 22-module package provides a comprehensive review course that will help new WHNP graduates prepare for the National Certification Corporation (NCC) WHNP certification examination. In addition, the review course package includes a module on test-taking strategies, with more than 200 review questions that are presented in the NCC question format.

This course is designed to meet the needs of not only new WHNP graduates but also students and practicing NPs. In addition, current WHNP students can use selected modules to supplement course content as they progress through their academic program. The added benefit of this review course is that WHNPs will earn continuing education credit and pharmacology hours for each module.

These modules have been created and presented by 15 NCC-certified WHNPs who are experts in women’s health. All presenters of the modules either currently teach or have taught in WHNP programs and were chosen specifically because they specialize in the topic. Exposure to multiple WHNP experts enables participants to experience a variety of presenting styles that will keep them engaged throughout the course.

As a final important note, each module was reviewed by two external NPs with a range of experience, from recent graduates to veteran WHNPs.

For more information on how to purchase the entire review course or selected modules, please visit www.npwh.org and click on E-Learning and then Curriculum.

We hope to see you in New Orleans for our 19th Annual PremierWomen’s Healthcare Conference, which will be held from September 28 through October 1, 2016. This conference promises to be an exciting event in a fabulous location! Visit our website for more information.

– Gay Johnson

Chief Executive Officer, NPWH

Message from the CEO

In case you haven’t noticed, NPWH is striving to provide more and more educational offerings for nurse practitioners. We just completed our complimentary continuing education (CE) 1-day regional course, Managing Women’s Health Issues Across a Lifespan, in Pasadena, California. I am pleased to report that the attendees found the content very informative and the expert faculty highly inspiring. They felt it was worthwhile to give up a Saturday in order to learn more about long-acting reversible contraceptives, endometriosis, genitourinary syndrome of menopause, and obesity, and to earn free CE credits. We are working toward providing more of these regional courses covering additional hot topics in women’s health next year.

Another update: We are building out our Well Woman Visit mobile app to include assessment and treatment options for irritable bowel syndrome. Stay tuned for the announcement indicating that this updated app is available to download. For those of you who haven’t already downloaded our mobile app, please visit npwh.org or go to the Apple Store and download it for free. The app is available for both Apple’s iOS and Google’s Android operating systems. We have received praise from members of organizations such as the American Association of Nurse Practitioners, who recognize that our WWV app is easy to use, is scientifically sound, and serves as a handy and immediate reference during a patient visit.

And here’s more good news: Registration is still open for the Women’s Sexual Health Course for NPs, which will be held on June 23-26, 2016, in San Diego, California. This is the only post-graduation educational offering on women’s sexual health for nurse practitioners. You will receive not only CEs but also a Certificate of Completion, which documents that you have gained knowledge in the area of women’s sexual health.

And, finally, the 19th Annual NPWH Premier Women’s Healthcare Conference, our national clinical conference, is almost here! This year, our conference takes place in the vibrant city of New Orleans on September 28-October 1, 2016. The conference program guide, which appears on pages 23-26 of this issue, reveals the variety of leading-edge topics we are offering this year, along with courses covering essential primary skills to incorporate into your practice. You’ll want to register early to take advantage of the discount; the complete program guide, including the registration form, is available at npwh.org. As always, NPWH takes great pride in offering up-to-date women’s health content imparted by experts in their fields so that you can gain the knowledge and skills you need to provide high-quality healthcare to women of all ages.

Gay Johnson

Chief Executive Officer, NPWH

Editor-in-chief‘s message

Dear Colleagues,

I am excited to now serve as Publication Coordinator for NPWH along with my continuing role as Editor-in-Chief of the journal. In the role of Publication Coordinator, I work with the Board of Directors (BOD), our Chief Executive Officer (CEO) Gay Johnson, and our staff to expand the benefits NPWH brings to its members. It is my pleasure to share with you some of the activities with which I am engaged.

One of the responsibilities of my new role is to coordinate the development of position statements for NPWH. Position statements provide an explanation, justification, or recommendation for a course of action that reflects the organization’s stance regarding a specific issue or concern. Position statements can be used to facilitate development and advocacy for health policies, direct educational activities, promote evidence-based practice, support research, and/or encourage collaboration with other agencies and organizations. In keeping with the mission of NPWH, position statements for the organization always advocate for women’s health and the practice of WHNPs and other nurse practitioners who provide women’s healthcare.

With input from the membership, the NPWH BOD and professional staff are charged with identifying priority issues and concerns. The process for writing position statements is inclusive, and requires active involvement of NPWH members—from identifying issues, to participating as a writing group member, to reviewing and providing feedback on drafts.

We have collaborated with Sigma Theta Tau International Honor Society of Nursing to establish collections in both the “Nursing Organizations—Events” and the “Nursing Organizations—Resource Papers” communities on the Virginia Henderson Global Nursing e-Repository. The NPWH events collection will enable our conference research and innovative clinical project poster and podium presenters to have abstracts posted in the e-Repository, making their work available to nurses around the globe. The resource papers collection will provide another avenue for NPWH to reach nurses and other constituents with our position statements, guidelines, and other important documents to promote women’s health. Watch for our entries in both of these collections later this summer.

We have been hard at work on the online NPWH Certification Review Course for WHNPs and are pleased to let you know that it will be available early this summer. The course will have 21 modules covering the topics outlined in the NCC WHNP certification examination guide, with review questions at the end of each module. Continuing education credit will be provided.

I am looking forward to continuing to work enthusiastically with the NPWH BOD, our CEO, our staff, and our members to support our organization’s mission and goals.

Beth Kelsey, EdD, APRN, WHNP-BC

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.

Message from the CEO

February may have been the shortest month of the year, but all of us at NPWH made the most of it by preparing for a busy and productive year. We welcome a new board chair, Jacki Witt, who is from Kansas City, Missouri, and three new board members: Diana Drake, from Minneapolis, Minnesota; Shelagh Larson, from Fort Worth, Texas; and Jordan Vaughan, from Nashville, Tennessee. We are also pleased to announce that Beth Kelsey, Editor-in-Chief of this journal, has added a new role: NPWH Publication Coordinator. Congratulations to all!

In January, we launched “Women’s Health Wisdom,” NPWH’s own blog! The purpose of the blog is to share thoughts, updates, and new information and opportunities related to women’s health policy, primary care, sexual health, pregnancy, pre-conception, postpartum concerns, heart health, mental health, overactive bladder, and many other topics. You can access the new blog by clicking here or by logging on to the NPWH website.

In April, we are offering a new regional CE course, Managing Women’s Health Issues Across a Lifespan. This live, interactive, 1-day meeting will be held at the Sheraton Pasadena Hotel in Pasadena, California. The course will include topics such as LARC, endometriosis, obesity, and genitourinary syndrome of menopause. You can register for this course here. See the back cover of this issue for much more information. And we proudly present the third annual Women’s Sexual Health Course for NPs on June 23-26, 2016, at the Sheraton Mission Valley San Diego Hotel in San Diego, California. New to the sexual health course this year will be a post-conference session for hands-on vulvoscopy training. The program guide for the Women’s Sexual Health Course for NPs appears on pages 8-12 in the journal; registration is available at npwh.org.

Make the most of this exciting year of 2016 by joining NPWH! You won’t want to miss out on all the exciting activities we have planned. And you will want to take advantage of the membership discounts and value-added features that we provide throughout the year.

– Gay Johnson

Chief Executive Officer, NPWH

Editor-in-chief’s message

Dear Colleagues,

I hope you’re all enjoying a happy and healthy new year and looking forward to the upcoming spring season!

Women’s Healthcare: A Clinical Journal for NPs is now entering its third year of publication! We are looking forward to providing you, our readers, with another year of up-to-date, useful information as you continue your important work of providing high-quality healthcare to women.

We have many excellent feature-length articles, as well as a large number of shorter articles (in our departments), coming up in 2016. You’ve likely noticed that we’ve expanded our journal departments in response to your request for shorter articles that still provide timely and relevant information to meet your clinical and professional needs. Our departments now include Assessment & Management, On the Case, Clinical Resources, Professional Development, Patient Education, DNP Projects: Spotlight on Practice, Policy & Practice Points, Commentary, and Focus on Sexual Health.

I hope that you will help us keep the momentum going by submitting a manuscript in one of the multiple formats we offer. We are especially interested in the shorter articles for our journal departments. As always, we welcome feature-length manuscript submissions as well.

Click here to visit our journal website to access the complete Guidelines for Authors. In case you need inspiration, please consider writing about topics such as abnormal uterine bleeding, adolescent health, cancer in women, coding for ob/gyn diagnoses, contraception for women with chronic health conditions, human trafficking, male reproductive health, older women’s health, or pregnancy complications. We welcome query letters about any topic and article format you are considering; you can reach us at bkelsey@healthcommedia.com and dgreene@healthcommedia.com. Even if you’re not quite ready to write for us, please let us know if you have a particular topic that you want to see covered in the journal.

In this first journal issue of 2016, I extend a special thank-you to the individuals who peer-reviewed manuscripts for us in 2015:

Kelly Ackerson, Cynthia Adams, Ivy Alexander, Carola Bruflat, Lorraine Byrnes, Joyce Cappiello, Helen Carcio, Janie Daddario, Melanie Deal, Brenda Deeser, Linda Dominguez, Caroline Hewitt, Susan Hoffstetter, Amy Levi, Patrice Malena, Anne Moore, Suzy Reiter, Michelle Schramm, Beth Steinfeld, Carolyn Sutton, and Jordan Vaughan.

In the November 2015 issue, I wrote about the opportunity to become a peer reviewer for our journal. I was happy to hear from many of you. Please click here for an application form to join this fine cadre of nurse practitioners and nurse midwives who have helped to make the articles we publish the very best!

Beth Kelsey, EdD, APRN, WHNP-BC