Author Archives: Brian Jones

Increasing access to care through pharmacy provision of hormonal contraceptives: A nursing perspective

Approximately 40% of all pregnancies in the United States are unplanned, and about 50% of all unintended pregnancies occur in women who are not using contraception. In this article, the authors discuss state-based initiatives to increase access and decrease barriers to care by promoting pharmacy-provided hormonal contraceptives. The authors describe their experience in participating on a legislative commission to craft legislation to expand access. Continue reading »

Position Statement: Expanding Access to Hormonal Contraception

The National Association of Nurse Practitioners in Women’s Health (NPWH) affirms the right of each individual or couple who desire to use contraception to be able to do so. Barriers to obtaining and successfully using contraception must be eliminated, particularly for the most vulnerable individuals and populations. NPWH advocates for federal- and state-level policies that remove barriers and increase access to affordable, safe, and effective contraceptive methods for all reproductive-aged individuals. Multiple strategies involving legislation, regulations, consumer education, and innovation are necessary. Over-the-counter (OTC) access to hormonal contraceptives (HCs) and pharmacist-provided HCs are two specific strategies that can lower barriers to obtaining safe, effective contraception.

NPWH will provide leadership through policy advocacy, consumer and healthcare provider (HCP) education, and support of research on outcomes related to innovative strategies to expand access to HCs. NPWH supports the right of all individuals to access comprehensive sexual and reproductive health services and to make choices that meet their own needs.

Background

The concepts of desiring/not desiring a pregnancy and intended/unintended pregnancy are complex, especially when ambivalence about pregnancy, power inequities in relationships, family pressures, belief that one cannot become pregnant, and cultural and religious norms are taken into account. However, for purposes of data collection and analysis in demography and public health studies, the term unintended pregnancy is defined as pregnancy that is mistimed or unwanted.1 Although unintended pregnancy rates declined overall from 51% in 2008 to 45% in 2011,2 disparities persist. Unintended pregnancy rates are highest among women who are poor and/or low-income, members of minorities, younger than 25 years, less educated, and/or cohabiting with their sexual partner.2 Approximately 60% of women with unintended pregnancies were not using contraception during the month that they became pregnant.3

Reproductive-aged, sexually active individuals who do not want to become pregnant but who do not use effective contraception off er a variety of reasons for not doing so. Some of the reasons cited for not using HCs in particular include lack of access to and/or inconveniences associated with healthcare appointments needed to obtain prescriptions for HCs, the assumption that a pelvic examination is required to obtain HCs, the high cost, and concerns about safety and side effects.3-6 In addition, adolescents’ concerns about confidentiality may deter them from seeking highly effective contraceptive methods.3-7 OTC access to HCs and pharmacist-provided HCs might eliminate some, albeit not all, of these barriers.

Establishing OTC access to HCs requires action at the federal level through the FDA. When a company submits an application to the FDA to change the status of a product from prescription to OTC, reviewers of the application determine whether the medication has an established high safety profile and low potential for misuse or abuse, and whether labeling exists or could be developed so that consumers would be able to use the medication safely, without HCP intervention.8 To date, only one company, based in France, has initiated an FDA application to change its HC product, a progestin-only pill (POP), from prescription to OTC status.9 This process may be streamlined because the FDA has already approved OTC status for emergency-contraceptive POPs and because POPs have few contraindications. Nevertheless, the process is still complex and may take up to 3-4 years to complete.9 In addition, major concerns persist regarding the potential for federal regulatory policies to limit HC access for adolescents or to fail to guarantee insurance coverage for OTC HCs.10 Expanding access at the state level, although still posing some restrictive challenges, has thus far proved less time consuming and less cumbersome than going through the relabeling process with the FDA.

As of 2016, 47 states and the District of Columbia (DC) have statutes allowing creation of collaborative practice agreements (CPAs) for qualified pharmacists, which enable them to initiate, modify, and/or discontinue drug therapy for a variety of conditions. A CPA for this purpose is an agreement between a pharmacist and one or more prescribing HCPs that permits the pharmacist to work within the context of a defined protocol and assume professional responsibility for certain aspects of medication management. Although statutory language and additional requirements such as training and continuing education vary from state to state, none include restrictions about which specific health conditions approved CPAs may address. Therefore, use of CPAs for pharmacist provision of HCs is a possibility in each of these states and DC.11

To date, 12 states and DC have passed or proposed legislation to expand access to HCs through pharmacist provision—without the prospective HC user being required to be seen first by an HCP to obtain a prescription.12 Types of HCs (e.g., oral, transdermal, vaginal ring, injection), age restrictions, training requirements, specifics of protocols, and insurance coverage vary from state to state.12,13

The establishment of CPAs, standing orders, or other types of written agreements, along with training and the use of standardized protocols to screen for contraindications/risks and provide education about a chosen HC method, allow pharmacists to provide HCs safely. Box 1 presents an example protocol.14 For persons without pre-existing risk factors or conditions, the overall health risk of using HCs is very low.15,16 Studies have found that women are able to self-screen reliably for these pre-existing risk factors or conditions.17-19 A study in Washington State supported pharmacists’ ability to identify individuals with/ without contraindications to HCs by using a screening checklist and measuring blood pressure.20

Pharmacist provision of HCs offers the advantages of convenient locations, extended hours of operation, and walk-in access without appointments. However, for this service to succeed, several potential barriers must be addressed. Barriers for pharmacists include the time required for training, already demanding workloads, and, most notably, lack of insurance reimbursement for time spent on assessment and counseling. Legislation in some states has addressed the lattermost barrier by expanding pharmacists’ scope of practice to enable direct billing for time spent providing the service.21 For individuals desiring contraceptives, a major barrier involves lack of knowledge about the availability of pharmacist-provided HCs—a service that would obviate the need for a prior HCP visit and prescription in most cases. Individuals without insurance that covers HCs may not be able to afford the fee for the pharmacist’s time and the cost of the HCs. Still, several studies indicate that most women at risk for unintended pregnancy believe HCs should be available without prescription and would use pharmacy access themselves.22-25

In 2016, NPWH signed onto a statement of purpose published by the Oral Contraceptives (OCs) OTC Working Group, a coalition of reproductive health, rights, and justice organizations; nonprofit research and advocacy groups; university-based researchers; and prominent clinicians committed to providing easier access to safe, effective, acceptable, and affordable contraceptives to all reproductive-aged individuals.26 The Working Group focuses on the potential to reduce disparities in reproductive healthcare access and outcomes among low-income, poor, and young women through OTC access to OCs. Activities of the group include engaging in public education and discussion, building consensus on key issues, and conducting research to maximize benefits and minimize risks regarding OTC OCs. The Working Group supports policies that expand coverage of OTC OCs in all public and private insurance plans and that ensure adolescents have full access to OTC contraceptives. Other professional HCP organizations that have signed on to the statement are listed in Box 2.26

Implications for women’s healthcare and WHNP practice

WHNPs are experts in helping individuals and couples choose and use contraceptive methods that are safe and effective and that meet their personal needs and preferences. As such, WHNPs should be in the forefront of designing, implementing, and evaluating new models of care to increase access to safe and effective contraception. WHNPs can seek out opportunities to lead in terms of writing protocols, creating self-screening forms, and developing education materials that can be used by pharmacists when providing HCs. Legislators need to hear from all NPs who practice evidence-based reproductive healthcare and who have witnessed the impact of disparities in access to contraceptives.

Over-the-counter or pharmacist-provided HCs cannot address all barriers to access and use of safe and effective contraceptives. In states with age restrictions for OTC/ pharmacist-provided HCs, persons younger than the minimum allowable age will still not be able to gain access to them. Individuals whose health insurance does not cover OTC or pharmacist-provided HCs may not be able to afford them. Finally, expanded access to HCs, either through OTC availability or through pharmacist provision of them, does not pertain to highly effective long-acting reversible contraceptive methods that may be desired—because these methods require an HCP visit.

Regardless of whether they can obtain HCs without a prescription, many individuals will continue to seek sexual and reproductive healthcare. NPs who provide this care must continue to fi nd ways to make it accessible, affordable, and acceptable for everyone and to address the needs of vulnerable populations in a thoughtful manner. NPWH will provide leadership to ensure that:

  • federal legislators have evidence-based information regarding policies needed to improve contraception access that reduces disparities in individuals’ and couples’ abilities to prevent unintended pregnancies.
  • policies support public and private insurance coverage that encompasses prescription, pharmacist-provided, and OTC contraceptives.
  • policies do not impose age restrictions on access to prescription, pharmacist-provided, or OTC contraceptives.
  • NPs have the resources needed to advocate for access to safe, effective, acceptable, and affordable contraceptives at state and federal levels.
  • continuing education programs and resources are available for NPs to lead and contribute meaningfully to developing and evaluating state-level protocols for pharmacy access to HCs.
  • research on outcomes related to OTC and pharmacist-provided HCs is encouraged and supported.

References

1. Guttmacher Institute. Fact Sheet: Unintended Pregnancy in the United States. September 2016. guttmacher.org/ sites/default/fi les/factsheet/fb-unintended-pregnancy-us.pdf

2. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. New Engl J Med. 2016;374(9):843-852.

3. Mosher WJ, Jones J, Abma J. Nonuse of contraception among women at risk of unintended pregnancy in the United States. Contraception. 2015;92(2):170-176.

4. Grindlay K, Grossman D. Prescription birth control access among U.S. women at risk of unintended pregnancy. J Womens Health. 2016;25(3):249-254.

5. Clare C, Squire MB, Alvarez K, et al. Barriers to adolescent contraception use and adherence. Int J Adolesc Med Health. 2018;30(4):1-8.

6. Chernick LS, Schnall R, Higgins T, et al. Barriers to and enablers of contraceptive use among adolescent females and their interest in an emergency department based intervention. Contraception. 2015;91(3):217-225.

7. Williams RL, Meredith AH, Ott MA. Expanding adolescent access to hormonal contraception: an update on over-the-counter, pharmacist prescribing, and web-based telehealth approaches. Curr Opin Obstet Gynecol. 2018;30(6):458-464.

8. FAQs About Rx-to-OTC Switch. Consumer Healthcare Products Association. 2019. chpa.org/faqsswitchpp.aspx

9. Kaiser Family Foundation. Fact Sheet: Oral Contraceptive Pills. August 2017. files.kff.org/attachment/factsheet-oral-contraceptive-pills.

10. Barot S. Moving oral contraceptives to over-the-counter status: policy versus politics. Guttmacher Pol Rev 2015;18(4):85-91.

11. Hill JD, Hill JM, Gentile NJ. A review of state pharmacist collaborative practice laws. Am J Health Syst Pharm. 2016;73(18):1467-1472.

12. Ibis Reproductive Health. Free the Pill: What’s the Law in Your State? Updated August 2018. freethepill.org/ statepolicies/

13. Kaiser Family Foundation. State Requirements for Insurance Coverage of Contraceptives. July 2018. kff.org/ other/state-indicator/state-requirements-for-insurance-coverage-of-contraceptives/?currentTimeframe= 0&sortModel=%7B%22colId%22:%22Location%22,%22 sort%22:%22asc%22%7D

14. Oregon Pharmacists Prescribing of Contraceptive Therapy. oregon.gov/pharmacy/Pages/ContraceptivePrescribing.aspx#Tool-Kit_Resources.

15. Shulman LP. The state of hormonal contraception today: benefi ts and risks of hormonal contraceptives: combined estrogen and progestin contraceptives. Am J Obstet Gynecol. 2011;205(4):S9-S13.

16. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1-103.

17. Grossman D, Fernandez L, Hopkins K, et al. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol. 2008;112(3):572-578.

18. Shotorbani S, Miller L, Blough DK, Gardner J. Agreement between women’s and providers’ assessment of hormonal contraception risk factors. Contraception. 2006;73(5):501-506.

19. Doshi JS, French RS, Evans HE, Wilkinson CL. Feasibility of a self-completed history questionnaire in women requesting repeat hormonal contraception. J Fam Plann Reprod Health Care. 2008;34(1):51-54.

20. Gardner JS, Miller L, Downing DF, et al. Pharmacist prescribing of hormonal contraceptives: results of the Direct Access study. J Am Pharm Assoc. 2008;48(2):212-221.

21. American Pharmacists Association. More states address pharmacists’ provider status recognition. April 1, 2015. pharmacist.com/more-states-address-pharmacists-provider-status-recognition

22. Landau SC, Tapias MP, McGhee BT. Birth control within reach: a national survey on women’s attitudes toward an interest in pharmacy access to hormonal contraception. Contraception. 2006;74(6):463-470.

23. Grossman D, Grindlay K, Li R, et al. Interest in over-the-counter access to oral contraceptives among women in the U.S. Contraception. 2013;88(4):544-552.

24. Grindlay K, Grossman D. Interest in over-the-counter access to a progestin-only pill among women in the United States. Womens Health Issues. 2018;28(2):144151.

25. Manski R, Kottke M. A survey of teenagers’ attitudes toward moving oral contraceptives over the counter. Perspect Sex Reprod Health, 2015;47(3):123-129.

26. OCs OTC Working Group. Statement of Purpose. 2019. ocsotc.org/statement-of-purpose/

Approved by the NPWH Board of Directors: March 25, 2019

DNP projects: Spotlight on practice

A QI project to assess the feasibility of using One Key Question® in retail health clinics

One goal of Healthy People 2020 is improving pregnancy planning, increasing spacing between pregnancies, and decreasing unintended pregnancy.1 As the situation stands now, almost half of all pregnancies in the United States are unintended.2 Only 14% of ambulatory care encounters with women of reproductive age include provision of contraception and preconception services,3 which, if offered on a broader basis, would go a long way toward reducing the rate of unintended pregnancies and improving women’s health and pregnancy outcomes.

In 2006, the CDC recommended reproductive life planning (RLP) as an approach that could be introduced at healthcare visits.4 RLP is a process in which healthcare providers (HCPs) and female patients or couples engage in discussions that serve to identify their family planning goals and then make healthcare plans collaboratively in order to safely and realistically meet those goals.5 Key components of RLP include consideration of the desire for children, number of children desired, spacing of children, and timing of children. Preconception and contraceptive counseling are provided as appropriate, and referrals are made as needed.5

One Key Question® (OKQ) is an evidence-based intervention used to help initiate the discussion between HCPs and female patients concerning reproductive desires and goals.6 Developed by the Oregon Foundation for Reproductive Health, OKQ uses a simple prompt— Would you like to become pregnant in the next year?—in order to move the health visit conversation toward these goals. The ensuing conversation then focuses on patients’ desire for pregnancy rather than their specific plans. The OKQ algorithm includes three response categories: yes, no, and I’m not sure or I’m okay either way (Algorithm). This non-confrontational approach focuses on each woman’s desire for pregnancy, with the aim of opening the RLP dialogue with the HCP, which will then, under ideal circumstances, connect the woman to the most appropriate healthcare services.7 The OKQ screening tool has been piloted in multiple settings in Oregon and one setting in Missouri. Three clinical trials are now under way to study the impact of screening and the service delivery patterns for preventive reproductive healthcare (i.e., contraception and preconception care).8

Finding non-traditional avenues for HCPs and women to engage in RLP discussions is important, particularly in terms of reaching women who do not regularly see a primary care or ob/gyn provider for reproductive healthcare. Retail health clinics (RHCs) commonly used for episodic acute care may provide such an avenue. RHCs offer convenience, including accessible locations, walk-in service, and ease of obtaining appointments for morning, evening, and weekend hours. HCPs at RHCs conduct comprehensive health assessments, make diagnoses, and develop care plans that include education and referrals as needed. These HCPs have an ideal opportunity to screen reproductive-aged women for pregnancy intention and to increase awareness about contraception options and healthful preconception behaviors. Folic acid supplements can be recommended or prescribed on site. Appropriate referrals can be made to primary care and ob/gyn providers in the community to meet reproductive healthcare needs.

Four RHCs identified in Maricopa County, Arizona, were not currently screening for pregnancy intention. The authors determined that the absence of such screening in these clinics offered them an opportunity to pilot the use of the OKQ screening tool/algorithm in the clinics.

Purpose

The purpose of this quality improvement (QI) project was to assess the feasibility of implementing the OKQ screening tool/algorithm at four RHCs. Desired QI project outcomes included the following: (1) 75% of all eligible women aged 18-50 years who visited one of the RHCs, regardless of their visit reason, would be screened; (2) 90% of women who answered yes to the OKQ, indicating a desire for pregnancy in the next year, would be referred to an ob/gyn provider; (3) folic acid would be prescribed or recommended to 100% of all screened women, regardless of their answer to OKQ; (4) 100% of patients whose answer was no or I am not sure/I’m okay either way would be assessed for current contraception use and referred to a primary care or ob/gyn provider, if desired, for comprehensive birth control counseling, including being provided with information about long-acting reversible contraceptives; and (5) feasibility of use of the OKQ screening tool/algorithm in RHCs would be assessed.

Methods

The DNP project is a QI project and, as such, does not meet the definition of human subjects research as defined by the Common Rule and the Federal Policy for Protection of Human Subjects. Therefore, Institutional Review Board (IRB) approval was not needed, which is a reflection of more contemporary definitions of research (language about IRB approval per Duke DNP program guidelines).

Six family nurse practitioners (FNPs) working at the aforementioned four clinic sites were recruited to participate in the project. Women aged 18-50 years who visited one of the sites during the project were eligible for OKQ screening, regardless of the reason for their visit to the clinic. Women who indicated that they had undergone permanent sterilization or a hysterectomy were excluded from screening.

An in-service was conducted with all participating FNPs as a group so that consistent education and messaging about the project were delivered. A paper screening tool was provided to allow for tracking algorithm use. Anonymity was maintained by not including any identifying information on the form. After the education/ messaging session was completed, implementation of OKQ screening at the project sites began.

During the 6-week project period, the FNPs screened eligible women for pregnancy intention and implemented educational interventions based on the algorithm. When obtaining a current sexual history, FNPs asked eligible women, Would you like to become pregnant in the next year? as well as the date of their last menstrual period. For a woman who answered yes to the OKQ, the FNP recommended folic acid supplements and smoking/ alcohol cessation as indicated. The FNP encouraged the woman to follow up with an ob/gyn provider for a preconception visit. For women who indicated they did not desire a pregnancy or were unsure/okay either way, the FNP asked about current contraception use and satisfaction with the method, with encouragement to follow-up with a primary care or ob/gyn provider as needed. The FNPs did not provide any written information about contraceptives because of restrictions from the RHCs where the pilot study was performed. Following the 6-week project period, the primary author led a focus group meeting with the FNPs to assess their perceptions about the feasibility of using the OKQ screening tool/algorithm in an RHC setting.

Outcomes

A total of 275 women seen at the RHCs during the 6-week project period were eligible for pregnancy intention screening. Among them, 194 (71%) were screened using the OKQ tool. For the 8 women who answered yes, all (100%) were referred to primary care or ob/gyn providers to discuss preconception care. For the 186 women who answered no or I am not sure/I’m okay either way, all (100%) were assessed for current contraception use and/or referred to primary care or ob/gyn providers for further discussion and provision of contraception. Folic acid was prescribed or recommended to all 194 screened women (100%).

Six FNPs participated in the project and attended the focus group. The FNPs agreed that the OKQ screening tool/algorithm was helpful and allowed for provision of better care for reproductive-aged women. They felt that an RHC setting was appropriate for use of this screening tool/algorithm for patient awareness purposes, with referrals provided when indicated. They noted that use of the screening tool/algorithm helped fill a gap for women who might not otherwise receive reproductive health information if they did not regularly see a primary care provider. Stated barriers to use of the screening tool/ algorithm included not enough time and not being able to prescribe and manage contraception in the RHC setting. The FNPs did recommend that the screening tool/ algorithm be incorporated in the electronic health record (EHR) rather than using a paper format.

Limitations

Limitations included the short time interval for the project and small number of providers participating in the project. Also, providers did not have adequate time in busy daily schedules to follow up on referrals made for reproductive healthcare.

Implications for women’s health

The project fell just short of meeting the desired outcome to screen 75% of eligible women and to assess and refer them as needed for contraception. All other desired outcomes were met. Overall, the FNPs felt that use of the screening tool/algorithm was feasible and positive for increasing women’s awareness concerning reproductive health and resources within the community.

Although RHCs provide an opportunity to improve access to care, they may have an adverse impact on continuity of care and on the use of preventive healthcare services.9 However, using a simple screening tool can help support both continuity of care and prevention through appropriate referral, as demonstrated with this project. The next step to help strengthen this continuity would be to ascertain whether patients do, in fact, seek the referral. Future plans include presenting the data to RHC companies and working to include this screening tool/algorithm into the EHR, which would make the information part of the permanent record. Interventions can then be billed and recorded so that quality metrics can be obtained.

Rachel E. Curry is a Family Nurse Practitioner (FNP) and Retail Health Clinic (RHC) provider; Anne L. Derouin is Associate Professor at Duke University School of Nursing in Durham, North Carolina; Katherine Kenny is Associate Dean of Academic Affairs at Arizona State University College of Nursing and Health Innovation in Phoenix; Debra Goulding is an FNP and RHC provider; and Julie A. Thompson is Statistical Consultant and Eleanor L. Stevenson is Associate Professor, both at Duke University School of Nursing in Durham, North Carolina.

References

1. U.S. Department of Health and Human Services. Family Planning. Site last updated April 11, 2019. healthypeople. gov/2020/topics-objectives/topic/family-planning ?topicid=13

2. CDC. Reproductive Health. Page last reviewed January 30, 2019. cdc.gov/reproductivehealth/index.html

3. Bello JK, Rao G, Stulberg DB. Trends in contraceptive and preconception care in United States ambulatory practices. Fam Med. 2015;47(4):264-271.

4. Johnson K, Posner SF, Biermann J, et al. Recommendation to improve preconception health and health care—United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006;55 (RR6):1-23.

5. Edmonds SW, Ayres L. Evolutionary concept analysis of reproductive life planning. J Obstet Gynecol Neonatal Nurs. 2017;46(1):78-90.

6. Oregon Foundation for Reproductive Health. One Key Question® Implementation Manual. 2015.

7. Allen D, Hunter MS, Wood S, et al. One Key Question®: first things first in reproductive health. Matern Child Health J. 2017;21(3):387-392.

8. Oregon Foundation for Reproductive Health. One Key Question®. July 10, 2017.

9. Villasenor S, Krouse HJ. Can the use of urgent care clinics improve access to care without undermining continuity in primary care? J Am Assoc Nurse Pract. 2016;28(6):335-341.

Continuing Education: Insomnia across the lifespan

Faculty: Wendy L. Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP, is owner of Wright & Associates Family Healthcare @ Amherst and @ Concord and is the owner of Partners in Healthcare Education, a medical education company.

Intended audience: This continuing education (CE) activity has been designed to meet the educational needs of women’s health nurse practitioners (NPs), adult NPs, family NPs, certifi ed nurse midwives (CNMs), and other healthcare providers (HCPs) who care for women.

CE approval period: Now through June 30, 2021

Estimated time to complete this activity: 1 hour

CE approval hours: 1.0 contact hour of CE credit, including 1.0 contact hour of pharmacology content

Goal statement: HCPs will increase their clinical skills in the evaluation and nonpharmacologic and pharmacologic management of patients presenting with sleep problems.

Needs assessment: Among adults in the United States, about 30% have symptoms of insomnia on occasion and 6%-10% have chronic insomnia meeting DSM-V criteria, including the all-important element of dissatisfaction with one’s sleep. HCPs who provide primary care to women need to inquire about sleep problems and understand the many treatment options available to women with impaired sleep.

Educational objectives: At the conclusion of this educational activity, participants should be able to:

  1. discuss the incidence and prevalence of insomnia across the lifespan;
  2. identify the appropriate work-up of the individual with insomnia; and
  3. describe nonpharmacologic and pharmacologic treatment options for the patient with insomnia.

Accreditation statement: This activity has been evaluated and approved by the Continuing Education Approval Program of the National Association of Nurse Practitioners in Women’s Health (NPWH), and has been approved for 1.0 contact hour of CE credit, including 1.0 contact hour of pharmacology content.

Faculty disclosures: NPWH policy requires all faculty to disclose any affiliation or relationship with a commercial interest that may cause a potential, real, or apparent conflict of interest with the content of a CE program. NPWH does not imply that the affiliation or relationship will affect the content of the CE program. Disclosure provides participants with information that may be important to their evaluation of an activity. Faculty are also asked to identify any unlabeled/unapproved uses of drugs or devices made in their presentation. Wendy L. Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP, receives consulting fees from Merck, Pfizer, and Sanofi – vaccines.

Disclosure of unlabeled use: NPWH policy requires authors to disclose to participants when they are presenting information about unlabeled use of a commercial product or device or an investigational use of a drug or device not yet approved for any use.

Disclaimer: Participating faculty members determine the editorial content of the CE activity; this content does not necessarily represent the views of NPWH. This content has undergone blinded peer review for validation of clinical content. Although every effort has been made to ensure that the information is accurate, HCPs are responsible for evaluating this information in relation to generally accepted standards in their own communities and integrating the information in this activity with that of established recommendations of other authorities, national guidelines, FDA-approved package inserts, and individual patient characteristics.

Successful completion of the activity: Successful completion of this activity, J-19-02, requires participants to:

  1. Log on to npwh.org/courses/home/details/1266 and “Sign In” at the top right-hand corner of the page if you have any NPWH account. You must be signed in to receive credit for this course. If you do not remember your username or password, please follow the “Forgot Password” link and instructions on the sign-in page. If you do not have an account, please click on “Create an Account.”*
  2. Read the learning objectives, disclosures, and disclaimers on the next page
  3. Study the material in the learning activity during the approval period (now through June 30, 2021).
  4. Complete the post-test and evaluation. You must earn a score of 70% or better on the post-test to receive CE credit.
  5. Print out the CE certificate if successfully completed.

*If you are an NPWH member, were once a member, or have taken CE activities with NPWH in the past, you have a username and password in our system. Please do not create a new account. Creation of multiple accounts could result in loss of CE credits as well as other NPWH services. If you do not remember your username or password, please either click on the “Forgot Username” or “Forgot Password” link above or call the NPWH office at (202) 543-9693, ext. 1.

Commercial support: This activity is supported by an educational grant from Merck.

Healthcare providers (HCPs) caring for women of any age will find that a substantial proportion of them have difficulty falling and/or staying asleep. When insomnia interferes with their daily life and causes distress, they may seek professional help. This article provides background information about sleep, and offers HCPs useful and up-to-date information regarding the evaluation of patients presenting with sleep problems and the wide variety of treatments that are available.

The American Academy of Sleep Medicine (AASM) defines insomnia as a complaint of trouble initiating/ maintaining sleep that is associated with daytime consequences and that is not attributable to environmental circumstances or an inadequate opportunity to sleep.1 According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), insomnia is characterized by difficulty initiating and/or maintaining sleep and/or waking earlier than desired, occurring at least 3 nights per week for at least 3 months, and causing dissatisfaction with sleep.2 Unlike in days past, when insomnia was classified as a condition secondary to another diagnosis, it is now considered an entity of its own.

The DSM-V lists insomnia among 10 other sleep–wake disorders.2 Healthcare providers (HCPs) may need to rule out other sleep–wake disorders (e.g., obstructive sleep apnea, circadian rhythm sleep–wake disorder, restless leg syndrome [RLS]) before making a definitive diagnosis of insomnia in a given patient.

Prevalence and adverse consequences

Among adults in the United States, about 30% have symptoms of insomnia on occasion and 6%-10% have chronic insomnia meeting DSM-V criteria, including the all-important element of dissatisfaction with one’s sleep.3,4 Insomnia is more common in women than in men, in older adults than in younger adults, and in persons affected by co-morbid physical or mental health conditions than in persons in the general population.1,4

Chronic insomnia, defined as insomnia lasting longer than 3 months, has many adverse effects on daily functioning, health, and quality of life.1 It is linked to increased rates of work absenteeism and occupational and motor vehicle accidents, and it has been identified as a major risk factor for developing psychiatric disorders, especially mood disorders; for relapse among persons with depression or alcoholism; for adverse effects in persons with chronic health conditions; and for development of hypertension and cardiovascular disease.1

Background information about sleep

The typical adult falls asleep within 30 minutes of going to bed. If she awakens in the middle of the night, it generally takes 30 minutes or less for her to fall back to sleep. A full night’s sleep lasts 7-8 hours. Her sleep efficiency—the amount of time asleep relative to the amount of time spent in bed—is about 85%.

The sleep-wake cycle

Wakefulness and sleep are under the control of highly complex neural circuitry consisting of neuronal populations, neurotransmitters, and pathways that form orchestrated wake- or sleep-promoting networks.5 Neurotransmitters involved in wakefulness include dopamine, norepinephrine, serotonin, acetylcholine, histamine, and orexin,6 the lattermost of which was identified in 1998 and has been found to play a critical role in maintaining wakefulness.7 Neurotransmitters involved in sleep promotion include adenosine, GABA, melatonin, and galanin.6 The role of these neurotransmitters is particularly relevant in that the medications used to treat insomnia either activate sleep-promoting neurotransmitters or suppress wakefulness-promoting neurotransmitters.

Effect of life stage on sleep

Life stages in women, including pregnancy, menopause, and older age, can have major effects on sleep quality, duration, and efficiency.

Pregnancy

Increased rhinorrhea, low back discomfort, need for an altered sleep position, fetal movements, heartburn, RLS-type symptoms, and shortness of breath can disturb sleep during pregnancy.8,9

Menopause

According to The North American Menopause Society, sleep disturbances occur mainly in women bothered by nighttime hot flashes, although a firm cause-and-effect relationship has not been established.10 Other contributors to insomnia during this life stage include general aging effects, stress, negative mood, and hormonal changes.10

Aging

Alterations in sleep architecture that occur as a part of normal aging, including a decrease in total sleep time and increases in arousals and awakenings secondary to lighter and more fragmented sleep, contribute to sleep problems such as insomnia in older persons.11 Other factors contributing to insomnia in older adults include co-morbid physical and mental health conditions and the medications used to treat them, changes in lifestyle and schedule, and altered circadian rhythm. Insomnia in older adults is typically characterized by difficulty sleeping through the night or waking up too early, as opposed to difficulty falling asleep.4

Screening

Unless HCPs specifically ask a patient about her sleep habits during a wellwoman visit or a patient broaches the topic herself—perhaps as she is about to leave the exam room— they may not learn about any sleep problems she is having. But a sleep problem such as insomnia, especially if chronic and distressful, merits a workup and treatment in many cases.

Even in a busy office setting, HCPs can start with a two-question screen: Do you experience difficulty sleeping? If so, do you have difficulty falling or staying asleep? To elicit more information, HCPs can then ask: Are you dissatisfied with your sleep? Do you suffer daytime fatigue? Affirmative answers to any or all of these questions suggest a diagnosis of insomnia, and may determine the type of treatment needed.

Another screening option is the BEARS Sleep Assessment Tool.12 Initial letters of the acronym stand for Bedtime problems (e.g., Does the patient have difficulty falling asleep?); Excessive daytime drowsiness; Awakenings during the night (e.g., Is the patient making frequent trips to the bathroom? Is she being interrupted by a crying baby or a sick child?); Regularity and duration of sleep; and Sleep-disordered breathing (e.g., Does the patient have obstructive sleep apnea?).

Workup: Taking a targeted history

For a patient whose screening responses suggest she may have a sleep disorder, HCPs should ask these questions (if not posed during initial screening): Do you suffer from daytime fatigue? Do you snore or have episodes where you stop breathing when you sleep (based on the report of someone sharing your bedroom or your bed)? How many hours are you in bed each night? How many hours do you sleep each night? Do you feel refreshed upon awakening and throughout the next day? Do you have restless leg symptoms? Do you ever sleepwalk or have vivid dreams?

In addition, HCPs should ask the patient about alcohol or illicit drug use, which can have profound effects on sleep. HCPs should also consider aspects of her current health that may be affecting her sleep; common offenders include overactive bladder, chronic pain, mental health disorders, fibromyalgia, hyperthyroidism, perimenopause, and RLS. In patients complaining of RLS-type symptoms, HCPs should consider checking a ferritin level. RLS can be associated with iron-deficiency anemia and ferritin levels below 50 ng/mL.13

If a patient does have ongoing health problems, HCPs should inquire about the over-the-counter (OTC) and prescription medications she is using to treat them. Commonly used medications that can disturb sleep include selective serotonin reuptake inhibitors, dopamine agonists, amphetamines, anticonvulsants, decongestants, corticosteroids, beta agonists, theophylline, antihypertensives, diuretics, and appetite suppressants.14 In addition, HCPs should ask the patient which treatments, including alcohol, marijuana, OTC preparations, and prescription drugs, she has tried to help her sleep.

Some patients may have sleepstate misperception; they believe that they are awake much of the night but are actually asleep for a normal period of time. They think that it takes them an abnormally long time to fall asleep (even though it does not) and/or they underestimate how long they remain asleep. To identify this misperception, or to better understand the nature of any patient’s sleep problem, HCPs can recommend a home sleep study.

Home sleep study

This study, conducted primarily to check for obstructive sleep apnea (OSA) with a small, portable monitor, measures oxygen saturation, heart rate, airflow, and movement in the chest and abdomen, and records time spent snoring and sleep position. The AASM recommends its use for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms indicating an increased risk of OSA.15 HCPs can incorporate the use of home sleep studies into their own practices.16

Sleep apnea affects 6%-17% of the general population—and not just men, obese persons, or older persons, although these are the strongest risk factors.17 One sign of OSA with which HCPs may not be aware is recurrent uvulitis. A patient who presents with frequent sore throats not ascribed to other causes and a beefy-looking uvula may in fact have OSA.18 Of note, a home sleep study does not replace polysomnography performed in a sleep laboratory. The latter is preferred if HCPs suspect that a patient has severe OSA or another type of sleep abnormality or disorder that needs to be identified.

Non-medication approaches to therapy

For a patient who meets criteria for insomnia and who wants to improve her sleep, the first step is to treat any co-morbid condition(s) that may be causing or contributing to her insomnia. At the same time, HCPs should consider the medications that the patient is already taking, including OTC/prescription medications and alcohol, to determine whether any of them may be causing or exacerbating her problem.

The next step is to evaluate the patient’s sleep hygiene and, if less than optimal, advise her to make changes. Good sleep hygiene entails19:

  • being consistent—that is, going to bed at the same time each night and getting up at the same time each morning, including on weekends;
  • making sure one’s bedroom environment is quiet, dark, cool, and relaxing;
  • removing electronic devices from the bedroom;
  • avoiding large meals, caffeine, and alcohol before bedtime;
  • getting some exercise on most days; and
  • receiving daily exposure to sunlight (if possible) and keeping lights on until bedtime.

If making improvements in sleep hygiene proves inadequate, a patient can try a course of psychotherapy such as cognitive-behavioral therapy for insomnia (CBT-I). CBT-I addresses sleep-disruptive beliefs, maladaptive habits, and physiologic factors and incorporates elements of cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation.4,20 A systematic review and meta-analysis demonstrated that CBT-I is effective for adults with chronic insomnia.20 Two possible downsides of CBT-I, as delivered by an HCP, are that it may be difficult to access and it may be expensive. As an alternative, online CBT-I options are available and have been reported to be effective.21,22

Non-medication approaches may be particularly useful for pregnant women with insomnia because many, if not most, medications used to treat insomnia can have a potentially adverse impact on the developing fetus. A recent study of pregnant women with insomnia showed that CBT-I was preferred over drug therapy or acupuncture.8 CBT-I is also recommended as first-line treatment in healthy midlife women with insomnia and moderately bothersome vasomotor symptoms.23

Nonprescription medication options

For patients still experiencing troublesome insomnia after non-medication interventions have been tried, several OTC medications are available. Although not included in the Table, the most common nonprescription “medication” used to treat insomnia is alcohol.24 An alcoholic drink may facilitate sleep onset, but it can also cause insomnia, manifested by multiple nighttime awakenings, increased urination, and difficulty falling back to sleep.

Melatonin, valerian root, and diphenhydramine are three nonprescription medications commonly used to treat insomnia. The Table provides information about their mechanisms of action, indication(s), dosing (in most cases, women and older patients should receive only the lowest dose), appropriateness of use in pregnancy/lactation, and precautions. The Table also includes recommendations from the AASM and from the American Geriatrics Society (AGS), specifically with regard to the AGS Beers Criteria, which lists medications that can cause side effects in older adults related to the physiologic changes of aging.25

Prescription medication options

Three general categories of prescription medication options for treatment of insomnia are the benzodiazepine (BZ) hypnotics, non-BZ hypnotics, and miscellaneous hypnotics. The Table provides the same categories of information for these prescription medications as for the nonprescription medications. Again, in most cases, women and older adults should receive only the lowest dose of a given medication.

Benzodiazepine hypnotics

Five BZ receptor agonists, all Schedule IV drugs, have been approved by the FDA for short-term treatment of insomnia.26 Two drugs in this class—temazepam and triazolam— are listed in the Table; the others, which are similar to temazepam and triazolam, are estazolam, quazepam, and flurazepam. Their mechanism of action entails binding to a modulatory site on the GABAA receptor and enhancing GABA activity.27

The prescribing information for drugs in this class includes a boxed warning about administering them concurrently with an opioid, which could result in profound sedation, respiratory depression, coma, and even death. BZ hypnotics can cause complex sleep behaviors (e.g., sleep-driving, having sex or eating while asleep and having no memory of it afterward).28,29 Based on the Beers Criteria, these agents should be avoided in older adults.25 Patients who take BZ hypnotics for a prolonged period (despite the fact that they are indicated only for short-term use) and who wish to discontinue them should taper them gradually, as opposed to stopping them abruptly, to avoid withdrawal symptoms.

Nonbenzodiazepine hypnotics

These Schedule IV drugs, eszopiclone, zaleplon, and zolpidem (Table), are known as the “Z” drugs because their generic name or their predecessor’s generic name starts with “Z” (eszopiclone is the active stereoisomer of zopiclone, which is available in Japan, Brazil, and some European countries). Or perhaps these drugs are so nicknamed because they help people get their zzz’s.

Non-BZ hypnotics act through the BZ binding sites associated with GABAA receptors.30 Their effects may be slowed if they are ingested with or shortly after a meal.31-34 They should be taken only if patients can be assured of getting a full night’s sleep.31-34 Based on the Beers Criteria, these drugs should be avoided in older adults.25 Doses should be as low as possible in patients with mild to moderate hepatic impairment; in those with severe hepatic impairment, these drugs should be used at the lowest possible dose, with great caution, or avoided.31-34

Other concerns regarding the “Z” drugs include short-term effects such as complex sleep behaviors, next-day sedation, and long-term effects such as amnesia, dementia, and rebound insomnia after the drug is stopped.31-34 If these drugs are to be halted after prolonged use, they should be slowly tapered to avoid withdrawal symptoms.31-34

Miscellaneous hypnotics

These agents include ramelteon, a prescription-strength melatonin agonist; three antidepressants; and suvorexant, which inhibits the action of orexin, a neurotransmitter involved in wakefulness (Table).35-40

Follow-up care

Patients and HCPs should not expect to find an effective solution for insomnia in one visit. Patients receiving any type of medication for insomnia should return for follow-up after 4-8 weeks for evaluation of efficacy, safety, and the need for ongoing treatment. The American College of Physicians guidelines suggest that patients who require medication for longer than 4-5 weeks be assessed regularly for the need to continue it.4

Conclusion

Insomnia affects millions of individuals in the U.S. Because many patients with insomnia do not mention their sleep problem at HCP visits, they should be screened for insomnia on a regular basis. Numerous treatment options, both nonpharmacologic and pharmacologic, exist. In most cases, HCPs should proceed in step-wise fashion, starting with behavioral approaches and advancing to OTC or prescription medication; the choice of medication depends on a patient’s age, health status, particular form of insomnia (problem with sleep onset, sleep maintenance, or both), and other considerations (e.g., a need to avoid drugs with addictive potential). Regardless of therapeutic choice, HCPs should follow patients with insomnia on a regular basis to ensure that treatment is effective, well tolerated, and still needed.

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