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Abstract

Oral contraceptives are commonly chosen methods whose contraceptive effectiveness is very user-dependent. Approaches to significantly improving oral contraceptive continuation have been largely unsuccessful. Long-acting reversible methods are the most highly effective reversible contraceptives, with the highest continuation rates, and should be the first-line methods offered to reproductive-aged women.

Keywords

adherence combined oral contraceptives contraception contraceptive implant discontinuation hormonal contraception intrauterine device long-acting reversible contraception oral contraceptives

Women use contraception to prevent pregnancy, to optimize pregnancy spacing, to complete their education or job training, or to attain financial stability [1]. Additional noncontraceptive health benefits of hormonal contraceptive methods include prevention of endometrial and ovarian cancers and management of menstrual symptoms [2]. Contraceptive use of modern methods is widespread with a worldwide prevalence of 56% among women of a reproductive age who are married or in a union [101]. Oral contraceptive (OC) use varies by region; it is by far the most commonly used contraceptive in the USA [3], but worldwide it is second to the intrauterine device (IUD) [101]. The highest OC prevalence, by region, is in Europe (21%), and the lowest is in Asia (6%); OC prevalence in the USA is 16% [101]. Correct and consistent contraceptive use helps avoid mistimed births and the need for abortions. This, in turn, positively affects the maternal mortality rate, resulting in at least 270,000 fewer maternal deaths worldwide. In the USA that means 800–3000 fewer maternal deaths per year [4]. Maximizing effective contraceptive use, then, has wide-reaching implications for both public health and the health of women and their families. We propose a shift in thinking about the optimal contraception for most women: rather than OCs, longer acting methods should be considered as the first-line choice.

Retrospective survey data indicate that 85% of sexually active women of reproductive age who do not use a contraceptive method will experience a pregnancy in a year. All contraceptives, however, do not work equally to prevent pregnancies. Of women with typical use of a combined hormonal method, 9% will become pregnant each year, likely due to incorrect or inconsistent use [5]. Failure rates for OCs are even higher in younger women [6]. The failure rate decreases to ≤0.8% for users of the contraceptive implant and IUDs, largely due to lower dependence on the user for contraceptive success [5]. A prospective cohort study of 7486 US women further demonstrated how much more effective IUDs and implants are at preventing unintended pregnancy. Users of combined hormonal methods were 22-times more likely to suffer a contraceptive failure than their IUD or implant using counterparts; once again, this failure rate was even higher for women under the age of 21 years [7].

Continuation is key to contraceptive success. Method continuation is higher for the long-acting reversible contraceptive (LARC) methods (defined as IUDs and implant in the USA [8]). In a prospective cohort study by Peipert et al. of 4167 US women, 86% of LARC users were still using the method at 12 months, compared with only 55% of other hormonal contraceptive users [9]. Similarly, in an analysis of 15 countries, 1-year continuation rates were higher for IUD (59–90%) users than for OC (36–66%) and injectable (25–71%) users [10]. Contraceptive continuation is lowest in younger women [11 –14].

Why do women discontinue OCs?

While studies of OC use report discontinuation of the method, not all report the reasons for discontinuation in great detail. In the prospective cohort study by Peipert et al., satisfaction mirrored continuation, with 84% of LARC users expressing satisfaction with the method at 1 year, versus 43% of other hormonal contraceptive users [9]. Dissatisfaction may reflect other cited reasons for discontinuation, including changes in fertility intentions, side effects and logistical reasons (difficulty using, obtaining or paying for OCs).

Women who discontinue OC use can be categorized in one of two ways: true discontinuers, who no longer need, dislike or discontinue the method due to fear; and misusers, who like the method, but are unable to comply with the rigors of daily use.

True discontinuers

Women who discontinue OCs may experience changes in need; they may want to become pregnant, or may no longer be sexually active. These fertility-related reasons for discontinuation do not require immediate intervention to help a woman plan against an unwanted pregnancy. A woman on OCs is likely to discontinue on her own, without first consulting her clinician. Thus, discussing future discontinuation with an OC user may be an excellent (and perhaps the only) opportunity to impact preconception use of folic acid and encourage other healthy behaviors while trying to conceive.

Women may also discontinue OCs due to dislike of the method or due to side effects. Research reflects the varying frequency in which ‘side effects’ is given as a common or the main reason for discontinuation. Side effects may be asked about in an open-ended fashion, or more specifically from a list; these methods may yield differing results.

Rosenberg et al. conducted a prospective study of a convenience sample of 6676 women in five European countries. Women who reported at least one side effect (51%) had a higher risk of OC early discontinuation (26%). The more side effects a woman reported, the higher her risk of discontinuation: 33% of those reporting two side effects discontinued, and 43% of those with three side effects discontinued OC use [15].

Kalmuss et al. reported on 687 women who restarted OC use and who provided a main reason for their prior discontinuation; 17% reported that side effects were the main reason. The women who reported side effects reported the most negative experiences with the method; in addition, OC continuation at the 3-month follow-up was lowest among those who had previously discontinued owing to side effects [16].

Westhoff et al. randomized 1716 women to immediate or traditional start of OCs. Participants chose from a list of symptoms (weight or vision changes, headaches, sexual satisfaction and moodiness) and also included menstrual changes, acne, hair changes and “I didn't like it” as reasons for OC discontinuation. Side effects were the second most common reason (34%) for OC discontinuation [17].

In addition to being predictors of discontinuation [18,19], side effects are associated with switching from one OC to another, or to less effective methods [13,20 –23]. Other studies, however, have found that discontinuation for side effects is not as common, with discontinuation rates for this reason ranging from 4 to 9% [24,25].

While some women with side effects will attribute these symptoms to their OC [20], some may do so even when the effects reported are not traditionally associated with OC use. Westhoff et al. found that while women who discontinued OC use within 6 months of initiation were more likely to report negative physical changes in that interval, they were no more likely to report that those changes were caused by the OC than by other factors [17]. These data challenge a straightforward interpretation of women's reports that side effects were their main reason for contraceptive discontinuation.

Fear of unwanted effects from OCs may be a contributing factor in discontinuation. In interviews with 398 women, reported side effects of hormonal contraceptive use contributed to a generalized fear of the side effects even among women who have never used such methods [26]. Cheung and Free found that decision-making around hormonal contraception reflected not only the experience of side effects, but women's underlying beliefs about the nature of hormones in contraception [27]. When unwanted effects were experienced, women with no concerns about the nature of hormones tended to switch to other highly effective hormonal contraceptives. Those with underlying concerns regarding the nature of hormones returned to (inconsistent) condom use or stopped using contraception altogether [27]. Kallmuss et al., in contrast, found that <1% of women cited fear of OCs as a reason for discontinuation [16]. Westhoff et al., also found that fear of side effects is not often given as a reason for discontinuation [17].

Fear of nuisance side effects, however, may be different from fear of a serious adverse event or even death. After reports published in 1995 – 1996 suggested a higher risk of venous thromboembolism (VTE) in users of OCs with the third-generation progestins desogestrel and gestodene, many women worldwide abruptly stopped taking their OCs [28,29]. Induced abortion rates increased [28,29] with no subsequent decrease in VTE rates [30]. Recently, observational studies that investigated a possible increased risk of VTE in users of OCs containing the fourth-generation progestin drospirenone led to a labeling change by the US FDA [102]. Despite the subsequent proliferation of lawsuits against the manufacturers of these hormonal formulations alleging increased VTEs, there are no data yet on the impact on initiation or continuation of OCs containing drospirenone.

Misusers

Clinical trials are not real-world settings. Studies often offer free contraception, give clear instructions about how to take pills, request a written record of medication adherence and have a research coordinator calling participants, reminding them about OC use and offering to replace lost packs. These situations remove or mask the access issues that many women face in trying to use OCs in daily life. In studies that assess these reasons, logistical and access reasons are frequently the most common reasons for OC discontinuation [16,17].

Multiple reasons can be categorized as logistical or access reasons:

Getting pregnant before starting pills;

Prematurely discontinuing pills (e.g., a relationship restarts before pill use does);

Not being able to afford pills (insurance lapse or lack of insurance coverage for contraception);

Not understanding how to use pills properly (e.g., how to make up missed pills and stopping pills while bleeding);

Forgetting to take pills;

Running out of pills.

When faced with these barriers, women may stop taking OCs altogether, or miss multiple pills in a row or over the course of a cycle [12,20,31 –33]. Smith and Oakley examined diary cards to analyze 141 OC users' reasons for missing active pills. More than 12 reasons were spontaneously reported by participants, ranging from being away from home, to illness, to sleep disturbances and side effects [33]. One study found that inconsistent pill use was more likely among women who experienced side effects such as nausea, bleeding problems, breast tenderness and hair growth. Women experiencing such side effects were almost twice as likely to discontinue OCs than were women not reporting the same side effect [15].

Reasons for missing occasional pills may be different than the reasons why the method is stopped altogether. There may be a spectrum of misused pills, from missing one pill to missing multiple pills to missing enough that the woman decides to stop using the method. Discontinuation may not always be a deliberate act, but the outcome of extended incorrect OC use. Women who frequently miss pills may not consider themselves to be discontinuing the method, but may not be protected against pregnancy, depending on the number and timing of the missed pills.

Approaches to improving continuation

Counseling & education

Early approaches to improving OC continuation focused on provider counseling and explicit instruction about proper method use [15,34]. These approaches focused on the user's adherence to OCs and included instruction in the correct use of the specific OC package prescribed, provision of easy-to-understand verbal and written missed pill instructions, and use of follow-up contact or phone inquiries by patients as an opportunity to evaluate consistency of use. We have found no evidence that such counseling improves either pill taking compliance or method adherence. While counseling about usage is an important component of prescribing any medication, counseling alone has not been shown to meaningfully improve OC continuation rates [35 –37].

Halpern et al. conducted a meta-analysis to determine the effectiveness of ancillary techniques to improve adherence to, and continuation rates of, hormonal methods of contraception [35]. The review included six randomized controlled trials (RCTs) of an intensive counseling technique or client-provider intervention versus routine family planning counseling, though only two trials specifically assessed counseling regarding OC use [36,37]. Outcome measures reviewed were discontinuation, reasons for discontinuation, number of missed pills and on-time injections, and pregnancy. Only one study – assessing injectable contraceptive continuation – found a significant benefit to the structured counseling intervention [38]. The studies were hampered by small sample sizes, sometimes high loss to follow-up rates, and a wide variety of intensity and type of interventions. The authors concluded that little evidence from RCTs supports the hypothesis that enhanced counseling improves contraceptive use [35].

Side-effect management

We found only one reference that directly discussed management of OC side effects [39]. The author recommends changes in OCs according to the side effect:

Acne and hirsutism – change to low androgenic preparations of OCs;

Breakthrough bleeding – change from a very low-dose OC (≤20 μg ethinyl estradiol) or one with a less androgenic progestin;

Headache: change the formulation with no specific recommendation;

Menstrual symptoms (e.g., headache): extend the duration of active pills (with newer formulations such as 24/4 and 84/7 packs);

Nausea and breast tenderness: change to a very low-dose OC.

We found no studies, however, that assess the effectiveness of such recommendations, with the exception of studies that examine bleeding patterns among different OC formulations.

Several Cochrane reviews address comparisons of different formulations of combined OCs [40 –42]. Gallo et al. reviewed studies that compared OCs with ≤20 μg ethinyl estradiol to those with >20 μg ethinyl estradiol. Compared with the higher estrogen OCs, several OCs containing 20 μg ethinyl estradiol resulted in higher rates of early trial discontinuation (overall and due to side effects such as irregular bleeding). Low-dose estrogen OCs also resulted in higher rates of bleeding pattern disruptions. Most trials, however, compared OCs containing different progestin types, and changes in bleeding patterns could be related to progestin type as well as estrogen dose [40].

Lawrie et al. reviewed studies that compared OC formulations with different progestins. They found that women using OCs containing second-generation progestins (gonanes including levonorgestrel, norethisterone and norgestrel) were less likely to discontinue than those using OCs containing first-generation progestins (estranes including norethindrone, norethynodrel, norethindrone acetate and ethynodiol diacetate). Based on one small double-blind trial, third-generation progestins (gonanes including desogestrel, gestodene and norgestimate) may be preferable to second-generation preparations with regard to bleeding patterns, but further evidence is needed. Overall, however, comparisons between the various ‘generations’ of progestins used in OCs cannot be made without blinding as to treatment group [41].

Van Vleit et al. reviewed studies that compared quadriphasic and monophasic OC formulations and found only one RCT, that included dienogest with estradiol valerate. Contraceptive effectiveness, intracyclic bleeding and discontinuation due to side effects were similar for quadriphasic and monophasic OCs. The number of women experiencing withdrawal bleeding was higher in the monophasic group compared with the quadriphasic group. Owing to the different formulations of OCs being compared, however, the authors found that there was not enough evidence to draw conclusions [42].

Van Vleit et al. also conducted a review of triphasic and monophasic formulations. This review included 23 trials; no differences were found in the 19 trials that examined effectiveness. Approximately one-half of the included trials reported favorable bleeding patterns in triphasic versus monophasic OC users. However, a meta-analysis was not possible due to differences in measuring and reporting the cycle disturbance data and in progestin type and hormone dosages. No differences were found in the numbers of women who discontinued due to medical reasons, cycle disturbances, intermenstrual bleeding or adverse events [43].

Based on published studies, therefore, there are few evidence-based changes to OC regimens that can be done to improve side effects. A provider can change a woman's OC if she requests a switch, but there is no solid evidence, from appropriately randomized trials or cohort studies, that changing OC formulations or progestins will change the incidence of side effects. A discussion of the transient nature of most side effects for women starting OCs may be helpful [15,34].

Concept of nocebos

Discrepancies in reporting (and experiencing) side effects and in attributing discontinuation reasons to side effects have led researchers to seek alternate explanations for symptoms women may experience while on OCs. Interestingly, women in randomized contraceptive trials report similar side effects whether they are randomized to pills containing hormones or to placebos [44]. The concept of nocebo (‘I will harm’ in Latin) is a framework that may explain this phenomenon. An underlying tenet of the nocebo phenomenon is the power of suggestion. Negative and adverse symptoms sometimes develop only because of an expectation that they will [44,45]. Another underlying tenet is that the side effects cannot be explained by the pharmacology of the medication [45]. The nocebo phenomenon considers whether other mechanisms might better explain high rates of reported side effects. One mechanism involves attributing existing symptoms to a medication [45]. For example, headaches and nausea are reported by people without illnesses and not on medications [46], but are also often attributed to contraceptive hormone effects [13,15,19,24,26,34]. Similarly, common medication side effects (e.g., headaches and nausea) are not unique to OC users. Another nocebo mechanism involves coincident development of symptoms with OC use, symptoms that would have occurred without OC use.

Until interventions to address the nocebo phenomenon in contraceptive users have been studied, perhaps the best approach to side-effect management in an OC user is the management of the nocebo effect. Given the key role played by suggestion, one approach would be to counsel a new OC user with a positive outlook, not setting up expectations of negative symptoms they may experience [44]; a provider then needs to be available for reassurance and encouragement should symptoms occur. Another approach is to assess symptoms a woman may have had with OCs in the past and discuss the nocebo phenomenon directly. Yet another is to await symptoms, offer reassurance of their transient nature and suggest ways to manage them until they resolve [45].

Elimination of system or logistical barriers

Logistical and access barriers to OC continuation may be the easiest to overcome. These suggested approaches recognize both the logistical hurdles and systemic barriers that exist to method continuation. The emphasis here is not on ‘compliance’, and on a woman's behavior, but on what the healthcare system can do to support her use. These interventions are not operating on an individual level, but on a systems level.

Start pills now (Quick Start)

Some providers continue to counsel a patient beginning OCs to wait for her next menstrual period. Given the availability of quick, highly sensitive pregnancy tests, and the lack of teratogenicity if OCs are inadvertently used in early pregnancy [47], such delay is unwarranted. Women who do not begin OCs directly after counseling may become confused about starting instructions, lose motivation or become pregnant while waiting to start OCs.

Westhoff et al. randomized 1716 women to immediate (Quick Start) or conventional (delayed) start of pills at the time of OC initiation or restart [48]. Women could Quick Start their OC at any point in their cycle; they were instructed to use back-up contraception for 1 week. Women who took the first pill in the clinic were more likely to continue to the second pack of OCs (odds ratio: 1.5, 95% CI: 1.0–2.1.) though the Quick Start approach did not improve OC continuation rates at 3 and 6 months. Those assigned to Quick Start were slightly less likely to become pregnant within 6 months from the time they started their OC (hazard ratio: 0.90, 95% CI: 0.64–1.25). Most women (81%) rated the Quick Start approach as acceptable or preferable to waiting. Rates of serious adverse events were low and similar in the two groups [48].

Lopez et al. reviewed five studies of the Quick Start method; only two studies were OC only. Method discontinuation was similar between groups in all trials; reassuringly, bleeding patterns and side effects were similar in trials that compared immediate with conventional start [49]. While Quick Start of OCs may not be sufficient to increase continuation, it is a safe technique for encouraging immediate OC initiation and helps to relay the message that OCs are safe to use.

Increase pill supply

A prevalent approach to OC initiation or restart in the USA is to supply pills for 3 months or less, whether in actual packages given or via a prescription for refills. Dispensing or prescribing a greater amount of cycles eliminates the necessity to return to the provider to simply get more packs. There may also be a reduction in risk of a delayed start of the next pack, and thus a lapse in contraception, when a woman has a greater OC supply on hand. In addition to reducing these logistical barriers to continuation, there may be a psychological benefit to an increased OC supply. Being given a longer, even 1 year, supply or prescription may communicate the acceptability and safety of the method, whereas fewer packs may suggest that the woman is likely to experience side effects or adverse events, and should reconsider use of the method at each visit [50].

White and Westhoff conducted a randomized trial (n = 700) of a greater number of OC cycles dispensed at the time of initiation (seven vs three cycles). Women who received more pill packs had higher 6-month OC continuation rates (51 vs 35%; p < 0.001). Similarly, women who received a prescription for more packs had higher continuation rates (42 vs 21%; p < 0.01). The treatment effect was greater among participants less than 18 years of age (49 vs 12%; p < 0.001) than among those 18 years and older (52 vs 40%; p = 0.018). Adverse events in the study were rare and not associated with receiving more OC packs [14].

Foster et al. used paid claims data for 82,319 women regarding OC dispensing from the Family Planning, Access, Care and Treatment Program in California, USA [51]. Women who received a greater number of OC cycles had higher method continuation and were less likely to experience a gap in supply coverage than women who received fewer cycles [51]. The same research group linked 84,401 women who received OCs through the Family Planning, Access, Care and Treatment program to pregnancy events and births conceived in the same year. Dispensing a 1-year supply of OC was associated with a 30% reduction in the odds of conceiving a pregnancy in the subsequent year and a 46% reduction in the odds of an abortion [50].

Remind them to take pills

Another approach to eliminating logistical barriers addresses women who forget to take their OC. The ideal reminder system would be low cost and could be distributed widely. Providers often counsel OC users to incorporate their pill-taking into their daily routine (e.g., coupling it with a routine activity such as brushing their teeth). One pharmaceutical company created a ‘starter kit’ that included a toothbrush and a reminder card containing a microchip timer [52]. The effect of this timer on contraceptive continuation was never formally evaluated.

Text message interventions have been successful in a few RCTs for medical indications; they improve smoking cessation [53,54] and adherence to antiretroviral treatment [55], and increase influenza vaccination rates [56]. However, a 3-month text message intervention coupled with an electronic pill tracking device to improve OC adherence and decrease the number of missed pills was unsuccessful [31].

Noting the rise in reliance on cell phones by our reproductive-aged women, Castaño et al. designed a study to test a text message intervention to increase OC continuation. A survey of 2521 women aged 13–83 years from New York City (NY, USA) confirmed that most patients in an urban, disadvantaged population have cell phones with text messaging capability. Participants indicated that text message medication reminders would be desirable to them [57]. In an RCT to assess the effectiveness of a daily educational text message for 6 months on OC continuation (n = 962), the participants who were assigned to the text message arm had continuation rates 10% higher than those receiving routine clinical care (64 vs 54%; p = 0.005). The effect was limited to the time period of receiving the messages, and did not persist long beyond 6 months [12].

Text messaging uptake continues to rise and is a low-cost approach to reaching patients on a large scale. Nearly one-quarter (24%) of US households no longer have a telephone landline [58]. Most (84%) Americans own a cell phone and 73% text; they send and receive an average of 42 messages daily. Black and Hispanic women under the age of 30 years with lower income and lower educational attainment text the most [103]. Free text message contraception reminder systems are available for online registration in the USA [e.g., birth control reminders and appointment reminders [104 –106]) and despite lack of formal evaluation of these specific systems, there is no reason not to recommend these to OC users or initiators who fear forgetting their daily dose. Another related technology available for medication reminders is mobile applications. A way of incorporating these technologies in the clinical setting would be integration of text message reminder systems into electronic health records. All of these approaches need to be evaluated on a large scale.

Make pills available over-the-counter

OCs are safer than some existing over-the-counter (OTC) medications, and are already available OTC – formally or informally – in the majority of countries around the world [59]. OCs share the characteristics of other OTC medications [107]:

Their benefits outweigh their risks;

The potential for misuse and abuse is low;

Consumers can use them for self-diagnosed conditions;

They can be adequately labeled;

Health practitioners are not needed for the safe and effective use of the product.

Self-screening for contraindications to OCs using a medical checklist is relatively accurate [60]. Giving OCs OTC status would especially help women who are at risk of gaps in their contraceptive coverage, from life events or disruptions such as moving, changing jobs, temporary absence of health insurance, loss of packs or rapid changes in relationship status [61]. Easier access to OCs, however, would likely benefit all women. In the RCT of a greater supply of OCs dispensed at the time of initiation, participants who received a prescription were less likely to continue OC use than those who received packs (45 vs 31%; p = 0.061) [14]. A study of 1046 women living on the USA–Mexico border found that OC discontinuation was higher for women who obtained OCs in Texas (TX, USA) clinics compared with those who obtained their OCs without a prescription in Mexico (hazard ratio: 1.6, 95% CI: 1.1–2.3) [62].

One clear barrier to consistent OC use in the USA is the requirement for a prescription. The Oral Contraceptives Over-the-Counter Working Group is a coalition of reproductive health, rights and justice organizations, nonprofit research and advocacy groups, university-based researchers, and prominent clinicians exploring the potential of OTC access to OCs in the USA to reduce disparities in reproductive healthcare access and outcomes, and to increase opportunities for women to access a safe, effective method of contraception, free of unnecessary barriers [108]. A change in medical opinion is already underway; the American College of Obstetricians and Gynecologists recently published an opinion that OCs be made available OTC [63].

Do not give out pills (to everyone)

Many patients and providers think of OCs as the first-line contraceptive for women who are choosing a new method. Although over 80% of women who use contraception in the USA will use OCs at some point [3], there is no medical or logistical reason that OCs need to be the ‘gateway’ contraceptive. And while multiple modalities to improve OC continuation have been tested, none have improved continuation to acceptable levels. Many women will choose to use OCs, for a short time or intermittently throughout their reproductive years. However, too few will use OCs consistently and correctly for this method to always be considered the first or preferred method. Women who have demonstrated the ability to take OCs consistently over time may represent a relative minority; all other women may simply not be ideal candidates.

Stop thinking about OCs as the first-line contraceptive method

The act of daily pill taking is intrinsically difficult. Adherence to a daily regimen of medication for a chronic condition is poor for many populations, not simply young women [109]. The motivation to take a pill when one is feeling well, for prevention of a future unwanted outcome, is different from the motivation to take a medication when one is not feeling well. Given that pill taking itself has been shown to be so challenging, there is likely a ceiling of OC consistency that can be achieved no matter what interventions we enact.

In the USA, LARC methods include IUDs and contraceptive implants [8]. These methods require little if any daily effort on the part of the user for optimum adherence to the method, and therefore have much greater efficacy than methods that require more user involvement. LARC methods have relatively few contraindications compared with combined hormonal contraceptive methods [64], but do require insertion via a minimally invasive procedure by a skilled provider. Despite higher upfront costs, these methods have higher cost–effectiveness when measured over multiple years of use. In an economic analysis of US contraceptive methods, the copper-T and levonorgestrel IUDs were among the three least expensive contraceptive methods over a 5-year period [65].

The superior effectiveness of LARC methods cannot be disputed. Of women with typical use of an implant or IUD, ≤0.8% will have an unintended pregnancy in 1 year, compared with 6–9% for other hormonal methods [5]. Developed countries with higher IUD prevalence have lower unintended pregnancy rates than the USA [66,67]. A decrease has been seen in repeat pregnancy at 1 year in young users with immediate postpartum implant initiation compared with those who planned to start any contraceptive method later [68]. In prospective studies, LARC continuation at 1 year is higher [9] than the best 6-month OC continuation rate we have been able to achieve [12]. Satisfaction is higher among users of long-acting methods than with other methods [9]. For these reasons, the American College of Obstetricians and Gynecologists recommends LARC methods as first-line contraception, regardless of age [69].

We are not suggesting that providers abandon use of OCs and similar hormonal contraceptives. OCs will still have a place in the contraceptive menu of options. OCs remain an excellent choice for short-term use of a method that is able to be discontinued by the user without a provider visit. Women already happy with and successful on daily OC regimens need not be encouraged to change a method that is working for them. OCs or other combined hormonal contraceptive methods may be the best options for women who have absolute contraindications to the LARC methods (i.e., active or recent pelvic infection, gestational trophoblastic disease, cervical or endometrial cancer, or a distorted uterine cavity) [64]. Finally, OCs will also continue to offer health benefits, such as acne control or ovarian cancer risk reduction [2], that may provide extra incentive for consistent use for some women.

A frame-shift from offering OCs as a first-line method to LARC as a first-line method should not be accompanied by rejecting OCs. Contraceptive users who discontinue a method often switch to a less effective method [21,34]. LARC discontinuers only have less-effective reversible contraceptive methods to switch to. Providers are obligated to ensure a balance between encouraging LARC use and not disparaging other contraceptive options. The best way may be to present the facts of benefits of LARC use over the other methods and the scenarios where OC use may be more beneficial, while keeping in mind that the nocebo effect seen in OC users can also present with LARC users. A woman considering LARC use needs to have appropriate expectations about intended length of use and lack of ease of discontinuation. LARC methods are so effective partly because they are not easy to discontinue without consulting a provider. Perhaps while a symptomatic LARC user awaits evaluation by her clinician, the symptoms she may attribute, appropriately or inappropriately, to LARC may resolve. Future studies may explore if nocebo symptoms are better tolerated by LARC users given this inherent delay in removal.

LARC methods are not universally available to women in the USA due to the higher upfront cost and need for provider training in insertion and removal. Insurance plans, too, have not all chosen to provide LARC method coverage as a benefit. The future of truly improving contraceptive continuation, then, may be found in improving access to LARC methods and removing barriers to their use. Beginning in August 2012, the US Affordable Care Act gives women free access to all FDA-approved contraceptive methods, sterilization procedures and patient education and counseling without a copay or cost sharing [110]. Many uninsured women will still have out-of-pocket costs since the new rules only apply to people currently enrolled in health insurance plans. Moreover, the Affordable Care Act exempts most plans that existed on 23 March 2010 (the day the law was enacted) from some of the law's consumer protections, including contraceptive counseling and methods [111]. Considering that poor and younger women are disproportionately affected by unintended pregnancy [70], it is imperative that these women get the access and coverage for these most effective methods. A recent prospective cohort study has shown that when all methods, including LARC, are made available at no cost, abortion rates, repeat abortion rates and teenage birth rates are lower [71].

Expanded access will be utilized only by women who consider LARC methods to be an acceptable choice for them. We greatly need improved consumer education regarding the advantages and safety of LARC methods. Misconceptions about IUD use and its risks persist despite the abundance of research attesting to their safety [112].

Misconceptions about patient suitability for LARC methods are not only held by patients, but by providers as well [72,73]. Healthcare providers need ongoing education about the benefits and safety of LARC methods to not restrict their use. Providers need to reframe their approach to contraceptive counseling, to not fall back on the convenience and ease of an OC prescription, but to consider offering LARC methods as the first-line contraceptive for most women. Ideally, education should extend to all healthcare providers, be they physicians, nurse practitioners or nurse midwives, and of all specialties, including internists, family medicine physicians and pediatricians. Such providers may not be skilled or comfortable in placing LARC methods, but can provide additional sources of information for patients as well as confirmation of the methods' advantages and safety.

Conclusion

Unplanned pregnancy is a major public health problem, particularly in the USA, where half of all pregnancies are mistimed or unwanted. Such pregnancies impose appreciable medical, emotional, social and financial burden on women, their families and society. The only way to avoid unplanned pregnancy is to use contraception consistently. We owe it to our patients to offer them the best ways that we know to control their fertility, to optimize their pregnancies and to improve the health of themselves and their families.

Future perspective

We do not need development of new OCs. Different formulations of estrogens and progestins are not likely to lead to expanded patient profiles or improved noncontraceptive benefits; we are not going to see a ‘side-effect free’ OC. We will likely see a reduction in OC variety, with fewer new brands brought to market. We also anticipate an increase in generic formulations that will be more cost effective. OCs will continue to remain a good option for some women, especially for the noncontraceptive benefits.

A new generation of healthcare providers is training in a pro-LARC environment. Provider hesitancy to offer LARC to all of their patients will decrease, and more providers will be trained in placement. As experience with the methods (and their overwhelming effectiveness) expands, we anticipate increased eagerness among providers to utilize these methods for their patients as well.

Women, too, will more widely ask for LARC methods, particularly in the USA. With use of IUD already doubling from 2007 to 2009 [74], mostly driven by use in parous women, we expect IUD use to continue to increase, particularly in subgroups such a nulliparous women and adolescents.

Financial barriers to LARC methods, we hope, will continue to fall, with full implementation of the Affordable Care Act in the USA. Commercial insurers will also offer increased coverage for LARC, as the economic analysis proves the cost–effectiveness of the devices. Similarly, we expect to see increased placement of LARC at the time of other procedures – immediately postpartum [75] and postabortion [76,77] – to eliminate the necessity of an additional office visit. Uptake of LARC may be increased by additional planned LARC products.

Executive summary

Background

Contraceptive use is widespread worldwide, with oral contraception (OC) and intrauterine devices chosen most frequently.

Beyond pregnancy prevention, contraceptives include noncontraceptive benefits for a woman and her family.

A decrease in unintended pregnancies improves maternal mortality.

OCs are less effective, and users have higher discontinuation rates and lower satisfaction rates when compared with users of long-acting reversible contraception (LARC) methods.

Why do women discontinue OCs?

True discontinuers discontinue OCs because of changes in need, dislike of a method or side effects.

Widely publicized warnings in the past about OC risks, even though unfounded, resulted in mass OC discontinuation and increased abortions.

Logistical and access reasons are real-world barriers that prevent correct and consistent OC use.

Approaches to improving OC continuation

There is little evidence that contraceptive counseling or side-effect management will improve continuation.

Side effects perceived by an OC user may be unrelated and misattributed to OC use.

Immediate OC initiation does not appear to increase side effects and is safe.

Advance provision of greater OC supply increases 6-month continuation and decreases unintended pregnancies.

Text message reminders improve OC continuation at 6 months.

Over-the-counter OC access would increase continuation.

OCs should no longer be the preferred contraceptive method.

Stop thinking about OCs as the first-line contraceptive method

Researchers have maximized efforts to improve OC continuation.

LARC methods are recommended first-line contraceptive agents because of high user satisfaction, excellent continuation rates and high effectiveness at preventing unplanned pregnancy.

OCs continue to be a good contraceptive option for established users, short-term users and those who receive noncontraceptive health benefits from OC use.

Access to LARC needs to increase to ensure greater LARC uptake by the women who need it most.

Patient and provider education is key to continuing to increase LARC uptake.

Conclusion

Encouraging LARC use bolsters public health efforts to reduce unplanned pregnancies.

Footnotes

PM Castaño serves as a scientific advisor for Bayer HealthCare Pharmaceuticals and as a preceptor for Conceptus and Merck. KO White is a consultant for Teva Women's Health. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

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Should we Do more to Improve Oral Contraceptive Continuation?

Abstract

Keywords

Why do women discontinue OCs?

True discontinuers

Misusers

Approaches to improving continuation

Counseling & education

Side-effect management

Concept of nocebos

Elimination of system or logistical barriers

Start pills now (Quick Start)

Increase pill supply

Remind them to take pills

Do not give out pills (to everyone)

Stop thinking about OCs as the first-line contraceptive method

Conclusion

Future perspective

Footnotes

References