The Unintended Pregnancy Problem

Unintended pregnancy remains a major public health concern, as half of all pregnancies in the United States are unintended (American College of Obstetricians and Gynecologists 2012; Finer and Zolna 2011). An unintended pregnancy is one that is not planned. Unintended pregnancy can be categorized as mistimed, meaning the pregnancy occurred earlier than desired, or unwanted, meaning the pregnancy occurred when no children, or no more children, were desired. While some such unintended pregnancies surely become wonderful surprises, others remain unwanted. In 2011, 42 percent of unintended pregnanciesFootnote 1 ended in abortion, and 58 percent ended in birth (Finer and Zolna 2016).

Significant demographic disparities exist in terms of who unintended pregnancies affect. Such pregnancies are highest among 18–24-year-old women, low income women, cohabiting women, minority women, and women without high school degrees (Finer and Zolna 2016).

The leading cause of unintended pregnancy is inconsistent contraceptive use or lack of contraceptive use, as opposed to contraceptive failure (Jones, Daroch, and Henshaw 2002). One of the barriers that lead to inconsistent use, or no use of contraceptives, is the need for a prescription in order to obtain hormonal contraceptives (Foster et al. 2012; Biggs, Karasek, and Foster 2012). Traditionally, obtaining a prescription for contraceptives requires a doctor’s visit. However, this visit is viewed as burdensome.

Women may have practical obstacles that cause them to delay or avoid seeking care, such as difficulties obtaining transportation to a doctor’s appointment (18 percent), lack of child care (13 percent), or limited time off work (18 percent), and these barriers are especially substantial among women who are young, low-income, or uninsured (Kaiser Family Foundation 2011).

Other issues of access include challenges obtaining an appointment or contacting the doctor’s office and office hours not being convenient or being a hassle (Grindlay and Grossmann 2016). For those who are uninsured, the office visit fee may dissuade them from seeking medical care (Grindlay and Grossman 2016). Further, many women are uncomfortable getting a pelvic exam, and while a pelvic exam is not medically necessary before prescribing hormonal contraceptives, almost one-third of clinicians in the U.S. still require it (Henderson et al. 2010; Grindlay and Grossman 2016). Thus, a doctor’s visit is for many women costly, uncomfortable, inconvenient, and time-consuming.

Removing the barrier of the doctor’s visit in order to obtain contraceptives would theoretically facilitate the continuity of use and reduce the high rate of unintended pregnancies. In addition, it may encourage women who are not currently using hormonal contraceptives or are relying exclusively on condoms to obtain hormonal contraceptives.

Many countries have made oral contraceptive pills available without a prescription in order to improve access (Grindlay, Burns and Grossman 2013). While the U.S., Canada, and most of Western Europe require a prescription for contraceptives, 88 percent of countries surveyed by Grindlay, Burns and Grossman did not require a prescription for contraceptives.

There is interest in having similar access to hormonal contraceptives in the U.S. (Grossman, Burns and Grossman 2013). Hormonal contraceptives are, after all, among the safest, easiest, and most effective options available to women seeking to avoid unintended pregnancies. While there is an increased risk of venous thromboembolism with combined hormonal contraceptives the risk is extremely low, and there is no significant effect on venous thromboembolism for progestin-only contraceptives (Food and Drug Administration 2011, 2012; Gorenoi et al. 2007).

There are, however, important contraindications for women seeking contraceptives, such as pre-existing cardiovascular disease, hypertension, deep vein thrombosis/pulmonary embolism, aged 35 or older and smoking, diabetes, certain disorders of the liver, those who have migraines with aura, etc., because these would place the woman at increased risk of complications—even death.

To better understand such risk and the effectiveness of risk mitigation strategies, several studies have investigated whether women can accurately use a checklist to identify contraindications and related risks, and results are positive. When comparing women’s self-assessment of contraindications with clinical assessment, studies have found 98 percent or greater agreement between respondent and clinician (Shotorbani et al. 2006; Grossman et al. 2008). When discrepancies arose, women were more likely to report contraindications than health care providers; they were thus more cautious in their self-assessment (Shotorbani et al. 2006; Grossman et al. 2008). These and other studies indicate that women are capable of self-assessing contraindications for hormonal contraceptives. Based on these studies and others, the American College of Obstetricians and Gynecologists (ACOG) issued a recommendation in 2012 to make oral contraceptive pills available over-the-counter and reaffirmed the recommendation in 2014 and 2016 (American College of Obstetricians and Gynecologists 2016).

Pharmacists Prescribing Contraceptives?

It is perhaps then no surprise that the demand for increased access to birth control has reached a point where the doctor’s visit is seen as an obstacle to obtaining contraceptives. There are currently two ways to eliminate this obstacle and improve access to contraceptives that are being considered.

On a federal level, certain contraceptives could be made available over-the-counter, as recommended in part by ACOG. Under federal law, there are two classes of drugs: those that require a prescription and those that are over-the-counter. A prescription drug is defined in 21 US § 353(b) as one that is “because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug”. Prescription drugs may only be dispensed on the order of a licensed practitioner, whereas over-the-counter drugs can be purchased without such an order. Currently, hormonal contraceptives require a prescription nationwide.

On a state level, the prescriptive authority for pharmacists could be expanded to include hormonal contraceptives. Accordingly, while the federal government regulates which drugs require a prescription, as opposed to those that are available over-the-counter, states have the flexibility to determine who can prescribe medications.

Some states have taken advantage of this flexibility in order to increase access to contraceptives. Recently, Oregon signed bills (HB2879 in 2015, and HB2527 in 2017) expanding the prescriptive authority of pharmacists to include oral contraceptive pills and contraceptive patches and injectable hormonal contraceptives, respectively. California passed a similar, but somewhat broader law (SB493) in 2013, which authorized pharmacists to prescribe self-administered hormonal contraceptives, nicotine replacement products, and certain prescription medications recommended for international travelers. Colorado, Hawaii, Maryland, and New Mexico have recently followed suit, and other states including Illinois, Minnesota, Missouri, and New Hampshire are considering legislation that would make hormonal contraceptives available from the pharmacy, and at the time of this writing, are in various stages of the legislative process.

In brief, these bills allow pharmacists to prescribe hormonal contraceptivesFootnote 2 directly to women. Pharmacies have widespread geographic distribution and convenient hours of operation, making them a convenient option for many women. In order to determine which, if any, method is safe and appropriate, the woman must complete a one-page self-screening risk assessment tool, which ensures that contraceptives do not interfere with other prescribed medications or existing health conditions. The goal of increasing access to contraceptives, while minimizing harm seems fulfilled.

The Access Paradox

Increasing access to contraceptives by making them available through a pharmacist is in theory a positive move. To be sure, improving access to contraceptives will theoretically increase their use and decrease discontinuity for access-related reasons. This increased access should reduce the rate of unplanned pregnancies. Nevertheless, while the outcome of expanded prescriptive authority for pharmacists may have a positive effect on the rate of unplanned pregnancies, the effects on women’s health are potentially far-reaching.

Studies consistently show that the OB-GYN is a significant care provider identified by young female patients. For all women (18+ years of age), 10 percent consider their OB-GYN their provider of routine care, whereas 14 percent of women of child bearing age (18–44 years of age) identify their OB-GYN as their provider of routine care (Kaiser Family Foundation 2011). Another study specifically examined young, low-income women, and found as many as 38 percent of them use OB-GYNs as their primary care provider (Scholle and Kelleher 2003). Compared to women not using OB-GYNs for primary care, women who used an OB-GYN for primary care were younger, had less education, and more frequently had small children (Scholle and Kelleher 2003).

And yet, trends in OB-GYN visits indicate that the percentage of women who see an OB-GYN annually has been steadily declining since 2000 (Simon and Uddin 2017). Simon and Uddin found that women 18 years of age and older who had seen an OB-GYN in the past 12 months declined from 44.7 percent in 2000 to 38.4 percent in 2015. “The difference may seem small but… we estimate that nearly 7.9 million women would have seen an ob-gyn in 2015 if the percentages were at the levels observed in year 2000” (Simon and Uddin 2017, p. 681). Noteworthy is the fact that the overall percentage of women having seen a general physician did not increase in the same time period, suggesting that the decline in having seen an OB-GYN was not merely a substitution of physician types (Simon and Uddin 2017). These results are troubling because they show that fewer women are accessing preventive services, regardless of health care provider type.

Recent changes to recommended frequency of cervical cancer screening may have contributed to this decrease. One study found that getting a Pap smear (70.2 percent), getting a prescription refill (43.8 percent), and discussing birth control (10.7 percent) were among the main reasons women attend a well woman visit (Becker, Longacre, and Harper 2004). Since cervical cancer screening frequency has been reduced (U.S. Preventive Services Task Force 2018), and certain hormonal contraceptives are being made available from the pharmacist in many states, women may feel that the annual well woman visit is unnecessary. And yet, the provision of preventive services is critical to women’s health.

Preventive services, such as those offered during the annual well woman visit, are an effective tool in improving health and well-being (Maciosek et al. 2010; Institute of Medicine 2011). Nearly half of all deaths in the U.S. are caused by modifiable health behaviors (McGinnis and Foege 1993; Institute of Medicine 2011), but only about half of all persons receive recommended preventive care (McGlynn et al. 2003). Prevalence rates of chronic disease and mental health conditions are rising among women of reproductive age (Center for Disease Control 2016; Kaiser Family Foundation 2005, 2014, Farr et al. 2011; Hayes et al. 2011; Ko et al. 2012). One in ten women of reproductive age report having a chronic disease, such as hypertension, high cholesterol, asthma etc., and rates are higher among women who are poor and belonging to a racial/ethnic minority (Center for Disease Control 2016; Kaiser Family Foundation 2005, 2014, Farr et al. 2011; Hayes et al. 2011; Ko et al. 2012). The Institute of Medicine estimates that improving access to, and use of, preventive care could save more than 2 million life years annually (2011).

While the OB-GYN visit may be viewed as an obstacle to some patients, it offers significant benefits in the form of regular contact with a care provider and routine screening. Most obvious, the well woman visit will provide services related to reproductive and sexual health: STI testing, Pap smears, breast exams, etc. But the visit also offers a wide variety of other important health services and screenings, including but certainly not limited to, alcohol abuse, mental health, hypertension, thyroid function, psychosocial issues, and cardiovascular risk factors or disease (ACOG 2016), and there is evidence supporting both the effectiveness and cost-benefit of these interventions (U.S. Preventive Services Task Force 2014; Masiosek et al. 2010).

For women of reproductive age (18–44 years of age), seeing both a generalist and an OB-GYN is significantly associated with receiving more—albeit not all—of the recommended preventive screening and counseling services as compared to seeing a generalist only (Henderson, Weisman, and Grason 2002). Henderson, Weisman, and Grason’s findings suggest that women of childbearing age who see a generalist alone may receive substandard care, as they “do not receive significantly more preventive services than women who have no regular physician” (2002, p. 146). Further, these findings suggest that OB-GYNs may be “especially sensitive to women’s health care needs, including nonreproductive health issues”, such as heart disease (Henderson, Weisman, and Grason 2002, p. 146).

Women of reproductive age (18–44 years of age) who used an OB-GYN as their primary care provider reported receiving significantly more preventive counseling (13 topics) as compared to women seeing a generalist only (6.3 topics). The difference in number of preventive topics discussed is not solely accounted for by discussion of sexual and/or reproductive health by OB-GYN’s (3.4 versus 1.3 topics) but reflects an overall increase in preventive topics discussed—general medical (3.2 versus 3.0 topics), injury prevention (1.2 versus 0.5 topics), and family/behavioral health (5.2 versus 1.4 topics). Patients also scored OB-GYN’s higher than generalists on accessibility, ongoing care management, coordination, community orientation, and cultural competence (Scholle and Kelleher 2003).

The use of OB-GYNs as primary care or routine providers is unquestionable. The value OB-GYNs provide, equally so. But, how can prescriptive authority affect this dynamic? It is difficult to predict what we can expect from expanded prescriptive authority. Will women continue to go to the OB-GYN for preventive services, despite getting their contraceptives from the pharmacist? Research in this area is much needed, but one study by Hopkins et al. comparing reproductive health preventive screening for U.S. resident women near the Mexico border may provide some insight (2012). Hopkins et al. compared U.S. resident women who obtained contraceptives from U.S. clinics with U.S. resident women who obtained contraceptives over-the-counter in Mexico. They found that over-the-counter contraceptive users were less likely than clinic users to: (1) have received a Pap smear in the last three years; (2) have ever had a pelvic exam; (3) have ever had a clinical breast exam; and (4) have ever been screened for a sexually transmitted infection (STI) (Hopkins et al. 2012). This data suggests that not all women will access routine well woman services unless required to do so in order to obtain a prescription for contraceptives. Thus, improving access to contraceptives may have the paradoxical effect of a practical reduction in health care access for many women

Such possible loss in health care access may have detrimental effects, as women risk losing important screenings, medical advice, and counseling, as well as the benefits of a potential long-standing physician–patient relationship. The physician–patient relationship is almost entirely dependent on trust and its foundation is a holistic view of the patient. Such whole-person focus rests on the physician’s knowledge of the patient and her family, community, values, preferences, etc. In this physician–patient relationship, the physician cares for the patient’s health problems in a compassionate, attentive, and empathetic manner, either directly or through collaboration with others, regardless of the nature, origin, or organ system involved. Further, the physician tailors treatment to the patient’s goals, expectations, and values (Leopold, Cooper, and Clancey 1996).

Evidence suggests that there are significant benefits to a long-standing physician–patient relationship. One study by Stewart et al. found lower blood pressure, less frequent physician visits, higher patient and physician satisfaction, and higher likelihood of the patient following physician advice or prescribed therapy as outcomes of strong physician–patient relationship visits as compared to weak physician–patient relationship visits (Stewart 1995). Leopold, Cooper, and Clancey found similar beneficial outcomes of sustained physician–patient relationship (1996). Short term outcomes included patient satisfaction, knowledge, reduced levels of anxiety, and intent to adhere to medical advice; long term outcomes included physiologic, functional, and behavioral health improvements, symptom resolution, disease prevention, and improved quality of life (Leopold, Cooper, and Clancey 1996). Overall, the benefits of a trusting physician–patient relationship included fewer patient visits, lower cost, and better patient health (Leopold, Cooper, and Clancey 1996). Other studies found similar results, especially in terms of medication compliance (see, e.g., Schneider et al. 2004; Kerse et al. 2004) and efforts to prevent or reduce the impact of disease by modifying lifestyle behaviors (Ettner 1999).

The potential loss of, or damage to, the physician–patient relationship which provides long-term, whole-person focused, comprehensive and coordinated care is problematic, and must be anticipated as a likely consequence of expanded prescriptive authority of pharmacists.

Before we look too quickly to countries that have successfully made contraceptives available without a prescription for inspiration to our own issues of access, it is worth noting that the 88 percent of countries that do not require a prescription for contraceptives are low- or middle-income countries with limited health care resources (Grindlay, Burns and Grossman 2013). For each country, the decision to increase access to contraceptives by making them available without a prescription is based on a complex risk–benefit analysis that involves evaluation of infrastructure and available resources. Some countries are willing to accept a drug’s health risk because its use outweighs harms associated with non-use, such as maternal morbidity and mortality, reduced earnings potential, and poor educational performance (Greene and Merrick 2015). In other countries, it is simply unfeasible to enforce prescription regulations, either because resources to do so are non-existent, or because there is no other way for patients to get needed drugs due to lack of health care providers or clinics (Peltzman 1987). Subsequently, while these low- and middle- income countries have correctly identified a problem with access to contraceptives, their root cause of the problem of access is vastly different from that of the United States. In the United States, the problem is not that there are few clinics or physicians to prescribe contraceptives, nor is it that our rates of maternal morbidity and mortality are much higher than other developed countries. Issues of access in the United States revolve around convenience, cost, and time. Since the root cause of the problem of access is so vastly different from that of these other countries, a different approach to solve the issue may be needed, and surely, the effects of new interventions will be different as well.

To be sure, I do not wish to ignore or downplay the successful effects of current efforts to improve access to health care. Implementing urgent care clinics and clinics in pharmacies as part of our health care delivery system, for instance, has had beneficial effects by precisely targeting a need—access to quick and convenient care for minor health concerns.

Similarly, I do not wish to suggest that the bills expanding pharmacists’ prescriptive authority should not pass, nor that physicians should hold contraceptives hostage, only that the care OB-GYNs provide is invaluable and that there are consequences to all decisions we make. The need for easy and affordable access to contraceptives is real; but the risk of losing the physician–patient relationship and the benefits it provides must also be considered.

By failing to address why women are experiencing a barrier to care, we have, in effect, sidestepped the real problem and instead merely implemented a quick fix solution. The issue is not merely how to increase access to contraceptives, but how we can address the reasons why women report having trouble accessing health services in the first place. When practical issues such as child care, time off work, or transportation stand in the way of obtaining health care, it signifies a disturbing societal trend—making time for ourselves and our health is low on our list of priorities.

This larger societal issue is much harder to address than mere contraceptive access, but it is also much more important and impactful. Expanding prescriptive authority obscures the true problem—it is not just access to contraceptives, but access to care that is needed.