Moving Oral Contraceptives Over-the-Counter:

Frequently asked questions

Click here for the glossary of terms

Why make the birth control pill available OTC?
Unintended pregnancy is a major public health concern in the United States, with more than half of all pregnancies unwanted or mistimed [1]. There is evidence that the current prescription status for hormonal contraception serves as a barrier to access for some women, and that an OTC switch for the pill may lead to higher rates of initiation [2, 3] and continuation [4].

In a representative survey of US women at risk of unintended pregnancy, 29% who had ever tried to get a prescription for hormonal contraception reported ever having problems obtaining a prescription or refills [5]. Difficulties included cost barriers or lack of insurance (14%), challenges obtaining an appointment or getting to a clinic (13%), the clinician requiring a clinic visit, exam, or Pap smear (13%), not having a regular doctor/clinic (10%), difficulty accessing a pharmacy (4%), and other reasons (4%) [5].

In another national survey of US women, 23% of women at risk of unintended pregnancy had a gap in contraceptive method use in the prior year that put them at high risk of pregnancy [6]. Of these women, 5% said their non-use was due to a lack of time for medical visits to get a method, and 5% reported difficulties paying for a method [6]. In a study on women’s interest in pharmacy access to hormonal contraception, 20% reported that the cost of a doctor’s visit was an obstacle to obtaining a prescription contraceptive [3]. Running out of pills and not having a pill pack on hand were found in another study to be common reasons why women miss pills [7]. Some of these problems with access would likely be alleviated if the pill were available OTC. Sales of emergency contraception doubled in the year after Plan B became available OTC [8], despite the high cost that may prevent some women from accessing it. Keeping these access and cost barriers in mind, these data suggest that more women might use the pill product if they could access it OTC at an affordable price.

In addition to pregnancy prevention, there are also numerous health benefits associated with pill use that support the need for wider availability through OTC access, including reductions in: pain and heavy bleeding during menstruation, acne, ectopic pregnancy, iron-deficiency anemia, pelvic inflammatory disease requiring hospitalization, ovarian and endometrial cancers, and benign breast disease, among others [9]. An editorial in the highly respected medical journal The Lancet argued that the pill should be made more widely available through OTC access because they are the only proven ovarian cancer prevention strategy; the editorial cites data showing that in the last 50 years 200,000 cases of ovarian cancer and 100,000 deaths from the disease worldwide have been prevented through the use of the pill [10]. A 2013 meta-analysis of 55 oral contraceptive use studies revealed a significant decrease in the incidence of ovarian cancer in the US population as a result of pill use [11]. Results of a 2015 review of 36 endometrial cancer studies suggest that the benefits of using the pill persist for over 30 years after a woman stops using them. The longer a woman continues to use the pill, the greater the reduction in risk of endometrial cancer [12].

An OTC switch would remove the unnecessary burden of requiring women to visit a clinician in order to obtain the pill. Research shows that even when performed by a clinician, screening for conditions that might put a woman at risk for complications while using the pill is not always perfect [13], and that women themselves are able use a simple checklist to self-screen for health conditions that could make use harmful (“contraindications”) [14, 15]. A systematic review of health outcomes among women who received STI, HIV, cervical cytology, lipid, glucose, or liver enzyme screening before starting to use oral contraception found no significant difference between their health outcomes and those of women who did not receive the same screening prior to initiation [16] (click here for more information on whether women would safely be able to use OTC pills). Pelvic exams and other screening tests performed during oral contraception prescribing visits are not medically required before starting the pill, and there has been a growing movement to unbundle these services in the US [17] (click here to learn more about whether pelvic exams are required to obtain the pill). It is critical for women to have the opportunity to make informed choices regarding their reproductive health, and to avoid the significant health burden that unintended pregnancy presents. To best achieve this, women should be able to obtain highly effective contraceptive methods like the pill in the most accessible, affordable, and convenient manner possible.

The substantial literature on oral contraception indicates that they meet the US Food and Drug Administration’s (FDA) criteria for OTC status: complications are rare, and the drug’s benefits outweigh the risks for most women; the potential for misuse or abuse is low; a consumer can easily self-diagnose the condition for which the pills are indicated; and directions for use are straightforward.

Because progestin-only pills (POPs) are very safe and have even fewer contraindications than combined oral contraceptive pills (COCs), it is likely that the first OTC pill will be a POP [18]. Additionally, levonorgestrel emergency contraception, another progestin-only formulation, has already been approved by the FDA for OTC sale [18]. Click here for more information on POPs, including their safety and effectiveness.
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What do women think about OTC access to the pill?
Research suggests that US women from a range of racial and ethnic backgrounds and income groups are interested in obtaining the pill OTC [2, 19, 20]. Many women not using a hormonal method say they would begin using one if they could access the method without a prescription. Convenience is one of the main reasons for women’s interest in OTC access and also drives their choice of current method of use. The data come from numerous studies, described in more detail below.

A nationally representative survey conducted in November–December 2011 with 2,046 women aged 18 to 44 years who were at risk for unintended pregnancy (i.e., they were sexually active with a male partner in the past year, not pregnant or trying to become pregnant, did not give birth in the two months before the survey, and were not sterilized or with a sterilized partner) found that 62% reported being in favor of the pill being available OTC, and 37% were likely to use an OTC pill if it were available. This translates to a potential market of 11 million adult women in the United States. Characteristics of women who reported they were likely to use an OTC pill included younger age, being divorced, widowed, or separated, being unmarried and living with a partner, having private insurance or no insurance at all, and living in the southern United States. There were no differences in interest by race/ethnicity or educational level. Women currently using the pill were much more likely to report they would use an OTC pill compared to women using another hormonal method or an IUD. Additionally, participants who were using a less effective birth control method or no method at all were more likely to say they were likely to use an OTC pill. One-third of women currently using a less effective birth control method (like condoms alone) and 28% using no method said they were likely to start using the pill if it were available OTC [2].

A 2004 national survey of 811 US women aged 18-44 explored women’s interest in pharmacy access to hormonal contraceptive methods. In this survey, 68% of women reported they would start the pill, patch, or vaginal ring if it were available directly in a pharmacy. African American/Black and Latina women were more than twice as likely as White women to express interest in pharmacy access. Interest was also higher among low-income women and uninsured women. In addition, almost half of women not using contraception, including uninsured and low-income women, said they would begin using a hormonal method if it were available from pharmacies without a prescription [3]. Women said that cost, convenience, and simplicity were their highest considerations when choosing a contraceptive. Sixty-five percent of African American/Black women said they chose their current method because it did not require a prescription, compared to 51% of White women and 54% of Latinas [3].

In a survey of 561 women aged 15-46 who were seeking abortion care at six urban clinics in the US, 81% of respondents supported OTC access to the pill, and while 42% of women planned to use the pill after their abortion, 61% said they would likely use this method if it were available OTC. One-third of women who reported that they were otherwise not planning to use any contraceptive method after their abortion said they would if they could obtain the pill OTC. Of women who planned to use condoms after their abortion, 38% said they would use an OTC pill [21].

The Border Contraceptive Access Study has explored several topics related to women’s interest in and use of OTC birth control pills. In a 2006 survey of 601 unsterilized women (91% Latina) in El Paso, Texas, who were not currently using hormonal contraception or the IUD, 60% said they would be more likely to use the pill if it were available OTC in the US [22]. Other data from this study show that women who cross the border to obtain the pill OTC from Mexican pharmacies do so because of cost and convenience and are satisfied with their method for obtaining contraception. Researchers surveyed 532 women who obtain pills at El Paso clinics and 514 El Paso residents who obtain pills OTC at Mexican pharmacies about their choices and motivations for their oral contraceptive source (this sample was 98% Latina). They found that older women and women born and educated in Mexico were more likely to take advantage of the OTC option. For those who opted to obtain their birth control pills OTC in Mexico, motivating factors included lower cost (40%), no requirement for a doctor’s visit (27%), and convenience of friends or family members being able to pick up the pills on the participant’s behalf (18%) [23].

In collaboration with community organizations, researchers conducted a series of focus groups in 2011-2012 in order to better understand attitudes about OTC access to the pill among young women, African American women, and Asian American women [19]. In total, 138 women participated in these focus groups and shared their opinions about the anticipated benefits and potential barriers to OTC availability of the pill. Improved convenience and increased privacy were identified as the most important potential benefits of accessing the pill OTC. Women felt that increasing the availability of the pill in this way could help to reduce unintended pregnancy and could normalize pill use, thereby reducing stigma. Focus group participants also shared reservations about OTC access, including that cost would increase if the pill were available OTC. Although they felt that their own practices in visiting a health care provider would not change, many women also believed that OTC availability of the pill might make others less likely to visit clinicians for screenings or preventive care [19].

In focus group discussions and in-depth interviews with low-income women that took place in Boston in 2007-2009, the majority of participants reported they would expect to experience an increase in convenience and access to the pill if it were OTC. If the pill were OTC, participants speculated, convenience and general accessibility would increase for many reasons, including the ability to purchase multiple months of the pill at one time, because other people (such as partners or parents) could pick up their birth control for them, and because they would no longer have to wait in long lines at pharmacy counters to obtain their contraception. They also said that they would like being able to access the pill at any time from multiple locations across the country. In particular, participants using dual methods, such as the pill in combination with condoms, said that it would be easier for them to obtain multiple methods if they were available in one accessible location, such as a grocery store. A minority of participants did not think OTC access would increase the convenience of obtaining the pill because of the relative ease they already experience in obtaining their contraception [20].

In the Boston focus group discussions and in-depth interviews, the majority of participants reported that they perceived the pill as safe enough for themselves to access OTC. However, many participants were concerned about “other” women’s abilities to use the pill safely and correctly without a clinician’s advice, particularly minors, women with pre-existing health conditions, and first-time pill users. They also expressed concern about whether women offered an OTC pill option would continue to obtain other preventive health care services, such as Pap smears. See the FAQ, Would women miss out on other health benefits gained by an appointment with their health care provider to get a prescription?, for more information. Overall, however, participants thought they themselves would continue to seek reproductive health advice from a clinician and continue to obtain preventive health care services. Participants also emphasized the need for readily available information about contraception in an OTC environment; many reflected that they already seek out this information from clinicians, pharmacists, websites, friends, family, contraceptive instruction inserts, and help hotlines, and that they would continue to do so if given an OTC option [20]. Their feedback shows the diversity of information sources beyond the doctor’s office that women seek independently when making decisions about birth control methods.

Areas for further research: Research is needed on women in rural areas and areas with fewer family planning providers, where the benefits of OTC access may be larger than in settings where contraception is readily available from multiple sources. Pharmaceutical companies also have their own methodology for projecting market share for a potential OTC product, and it is important that advocates have a voice in making sure the populations surveyed are representative. An actual use study, required by the FDA during an OTC-switch application, will provide more data about women’s perceptions and opinions related to OTC access to the pill.
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What do providers think about OTC access to the pill?
There is strong support for a switch from professional associations representing obstetricians and gynecologists (Ob/Gyns), family medicine physicians, and others. Significant demonstration of physician support for an OTC switch came in November 2012 when the American College of Obstetricians and Gynecologists (ACOG) released a Committee Opinion giving full support for OTC access to the pill. ACOG reviewed much of the published evidence documenting the safety and effectiveness of OTC access to the pill, and after weighing the risks and benefits, concluded that the pill should be available OTC [24, 25]. The American Academy of Family Physicians (AAFP) has also endorsed OTC access to the pill, and supports insurance coverage of oral contraceptives regardless of prescription status in all insurance plans [26]. In addition, in July 2013 the American Medical Association (AMA) announced a resolution in support of OTC availability of the pill, recommending that manufacturers of oral contraceptives be encouraged to submit the required application and supporting evidence for the US Food and Drug Administration to consider approving a switch in status from prescription to over-the-counter for such products [27]. Finally, more than 50 organizations have signed onto the Oral Contraceptives Over-the-Counter Working Group’s statement of purpose.

Little data exist documenting what individual physicians and other clinicians think about OTC oral contraceptives. Several opinion pieces from 2008-2009 showed concern from providers that women might either ignore label warnings or not read them, or that they might not be able to self-diagnose contraindications; that women might be less compliant with consistent pill use if they do not receive counseling; that they might avoid annual exams and screening for STIs and cervical cancer; and that they may not be able to access long-acting methods (like IUDs and implants) if the doctor visit is no longer required [28-31]. Similar concerns were voiced by physicians, advanced practice clinicians, and registered nurses in a 2009 survey (19.3% response rate) of provider attitudes toward pharmacist prescribing and OTC access to the pill. Although 74% supported pharmacist-prescribing of the pill, only 28% supported OTC availability [32]. Participants reported concerns that OTC oral contraceptives could reduce patient attendance at preventive screenings, negatively impact the patient-provider relationship, and reduce practice revenue. Results from an electronic survey with Ob/Gyn and Family Medicine residents found that the majority of respondents were against an OTC switch for both combined oral contraceptives (COCs) and progestin-only pills (POPs), although respondents had more favorable views about OTC POPs [33]. For those against moving a COC or POP over the counter, the majority stated the main reason for their opposition was safety concerns. Despite the low response rate (4%), the survey gives some idea of the negative perceptions that some physicians in training have about OTC pills and identifies areas of misinformation among physicians regarding the safety of the pill used without a prescription. It is possible that these concerns have been alleviated in light of the ACOG, AAFP, and AMA organizational support.

In 2011 the Women’s Health Practice and Research Network of the American College of Clinical Pharmacy released an opinion statement in favor of moving oral contraceptives OTC, under the conditions that they be sold where a pharmacist is available for consultation and that an OTC pill would be covered by Medicaid [34].

It is important to note that in practice clinician screening for contraindications to the pill use does not always take place, and an analysis from the United States found that at least 6% of current pill users are actually contraindicated for use of the pill [13]. Furthermore, as mentioned in the FAQs, Would women miss out on other health benefits gained by an appointment with their health care provider to get a prescription?, and Are pelvic exams required to obtain the pill?, annual exams, STI screenings, and Pap smears are not necessary prior to prescribing the pill, and making the pill available without a prescription would not eliminate the option of clinician consultation for any of these services or for accessing long-acting contraceptive methods.

Areas for further research: More outreach is needed to better understand the opinions of individual providers so that the OCs OTC Working Group can address potential concerns and hopefully secure their support.
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Would women have enough information to know if the pill is safe for them to use?
Women who have certain conditions or take certain medications are considered contraindicated to use of the pill, either because the condition (or drug) may make the pill more risky or may reduce its efficacy. Contraindications to progestin-only pills (POPs) are rarer than contraindications to combined oral contraceptives (COCs). In one study of women aged 18-49, 39% had at least one contraindication to COCs, while less than 2% had a contraindication to POPs [35]. However, other research suggests that COC contraindications are rarer among women seeking contraception [36].

Research from Mexico, where the pill is available without a prescription, found that women obtaining the pill OTC at pharmacies in Mexico without visiting a clinician were no more likely to have a contraindication than those who did visit a clinician [37, 38]. On the other hand, the Border Contraceptive Access Study found that women who live along the US-Mexico border in El Paso, TX, who obtain the pill in Mexican pharmacies were more likely to have contraindications than women who get the pill from a clinic in El Paso (who were also found to have contraindications) [39]. Specifically, 13.4% of OTC users, compared to 8.6% of clinic users, were found to have at least one relative contraindication (that is, a condition that makes use of the pill risky, though benefits of use might outweigh these risks). In terms of absolute contraindications, or conditions under which the pill should not at all be used, there was no significant difference in prevalence between OTC and clinic users (7.4% and 5.3%, respectively). The most common contraindications identified in these studies are contraindications to COC pills, which contain estrogen, and not to POPs. Only about 1% of women obtaining the pill OTC in pharmacies or in clinics in the Border Contraceptive Access Study had a contraindication to POPs [35].

Hypertension is a relative contraindication for COCs, but is not a contraindication for POPs [40]. Limited evidence suggests that for women who have hypertension, there may be increased risk of poor health outcomes were they to receive COCs without blood pressure pre-screening. In a 2013 review of the research on blood pressure measurement before COC initiation, five out of six studies found that women who did not receive pre-screening were at higher risk for acute myocardial infarction and stroke than those who received blood pressure screening before initiation of a COC pill. One study found no significant difference in risk between women who receive blood pressure screening and those that did not [41]. Because of their relative safety, POPs are often prescribed for women with hypertension who cannot take COCs [42]; this is one of the reasons why POPs are the most likely pill to be introduced OTC first [18]. See the FAQ, What about POPs? What do the data say about use, safety, and effectiveness?, for more information on the safety of POPs. It is important to recognize that if COCs became available OTC, women could determine whether they had hypertension by measuring their blood pressure at a pharmacy or grocery store or by having been evaluated by a doctor or nurse in the recent past.

One way for women to determine if the pill is safe for them may be through the use of a simple checklist. Two studies in the United States demonstrated that women were able to accurately self-identify contraindications to oral contraceptive use using a checklist [14, 15], although older women were more likely to have unrecognized hypertension [14]. One study in El Paso, TX, surveyed a sample of 1,271 English- or Spanish-speaking women aged 18-49 and asked them to use a simple 15-item checklist to self-screen for contraindications to COC use. Immediately after completing the checklist, participants had their blood pressure checked and were evaluated by a nurse practitioner to determine if they were medically eligible to take COCs. The women in the sample were, on average, in their early 30s and 92% were Latina. The women in the study were slightly more likely to think that they were ineligible when it was actually safe for them to use the pill than to miss a medical reason and incorrectly deem the pill safe for their use. Only 6.6% of women incorrectly thought they were appropriate for the pill when they were not, largely due to unrecognized hypertension. Younger and more educated women as well as Spanish speakers were more accurate at self-screening than other women [14].

In a 2004 national survey of 811 US women aged 18-44, some women expressed concerns about safety of OTC pills due to a belief that the nonprescription version of hormonal contraception would not be as good as the prescription version [3]. However, other research has found that consumers generally think OTC drugs are safe [43], which might contribute to an improved perception about the safety of the pill in an OTC environment. It is also important to note that while the pill is contraindicated for certain conditions, unintended pregnancy may present a greater threat to many women with contraindications to the pill [44].

Areas for further research: As part of an application to switch an oral contraceptive product OTC, the FDA would require an actual use study that demonstrates that a specified population of users can accurately screen themselves for contraindications using the information on the proposed product labeling. Although likely not required by the FDA, research that demonstrates the linguistic and cultural competency of the product labeling and other patient education materials (in English and other languages) will also be critical to demonstrate that women of diverse backgrounds have the necessary information to determine if the product is appropriate for them. More research is also needed to better understand how women would like to be given information about pill use in an OTC environment, including the use of the internet, smart phones, hotlines, and other resources.
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Would women know how to use the pill correctly and consistently if they did not get it from a health care provider?
While it may be safe to use the pill without obtaining a prescription, some may worry that women will not use the method correctly if they do not visit a clinician. However, correct pill use is not complicated: you take one every day. Still, even when women are required to visit a clinic, compliance with pill use is not perfect [45]. This suggests that strategies other than clinician visits may be helpful to improve consistent use. Research has not demonstrated that contraceptive counseling in a clinical setting significantly reduces unintended pregnancy [46], though many women do value the information and counseling they receive from health care providers [20, 23].

Continuation is an important measure of how long women take the pill after starting it. Continuation is influenced by many factors, including whether women have adequate information about how to manage common side effects or what to do if they miss a pill, as well as whether they can continue to access the method. Two studies have specifically looked at continuation of the pill in an OTC setting. The pill is available OTC in Kuwait, and research there found that continuation was no different between women who consulted with a physician and those who did not [47]. In the Border Contraceptive Access Study, pill users were followed for nine months, and women who obtained the pill OTC in Mexico were found to have a significantly lower discontinuation rate than those who obtained pills in US clinics. When clinic users were supplied with six or more packs (cycles) of pills, the continuation rates became more similar, suggesting that both OTC access and additional packs in hand contribute to better method continuation [4].

Other data also suggest that when women have better access to the pill, they stay on it longer. Data from California showed that women given 13 pill packs at the time of initiation continued the method significantly longer compared to those given only one or three packs [48, 49]. Additionally, women given a one-year supply of the pill are less likely to experience unintended pregnancy or obtain abortions, when compared to women given one or three packs [48, 49]. A systematic review of studies investigating the impact of the number of prescribed pill packs on women’s rates of continued use found that in three out of four studies, continuation rates were higher when women were provided with more packs of pills. In the remaining study, one group of women were provided with three pill packs after the completion of their first pack, while women in another group received a total of four pill packs at once. There was no difference in continuation rates between the two groups. Overall, the reviewers found that dispensing more pill packs at once were associated with fewer pregnancies and pregnancy tests and lowered costs [25]. Another study found that women who were prescribed the pill had significantly higher six-month continuation rates when seven packs were provided at once, compared to women who were given three packs—this effect was especially notable among adolescents under the age of 18. The study also compared women who were given their pill packs directly with those who received a prescription to refill at the pharmacy. Women who were given a prescription for refills had lower continuation, suggesting the convenience of having pill packs readily available promotes method continuation [50]. Other research on barriers to pill continuation has found that travel away from home and running out of pill packs were frequent reasons women missed pills [7], a common cause of method failure.

It is important to remember that in an OTC environment access to clinicians would not be restricted, and women who wanted to see a physician or nurse to help determine which pill was right for them or how to use the method would still be able to do so. Research from Mexico shows that women move between provision sources, sometimes obtaining pills from a clinician and sometimes getting them from a pharmacy without a prescription [38]. There is limited evidence about what, if any, impact follow-up contact with a clinician has on women’s continuation of contraceptive methods. In a 2013 systematic review of the literature to date, two studies evaluating the continuation rates of a range of contraceptive methods were included. These studies evaluated the impact of follow-up calls on adolescents’ use of contraception. There was no significant difference in rates of continued use of contraception among those adolescents who did receive follow-up calls and those who did not [51].

Areas for further research: An actual use study would be designed to follow women using the pill obtained in a simulated OTC setting to see how effectively and for how long women used the method compared to those who obtain pills from a clinician. A label comprehension study, also required by the FDA, would also demonstrate that women understand pill use instructions in an OTC label. In addition, research is needed to understand where women would obtain information in an OTC environment, especially if they had a question or problem.
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Should there be an age restriction for an OTC pill?
Ultimately, the FDA decides whether there would be an age restriction for an OTC pill. Age restrictions for OTC products are unusual and almost unheard of. However, when Plan B emergency contraception first became available OTC, it had an age restriction that was later removed [52]. Evidence so far does not indicate a compelling reason for there to be an age restriction for the pill if available over the counter. The pill is safe, and the prevalence of contraindications (i.e., conditions that could make pill use harmful) to combined oral contraceptive (COC) pills is lower among younger compared to older women [14] and is low among women of all ages for a progestin-only pill (POP) [35]. Additionally, adolescents face unique age-related barriers to contraception access, including concerns related to disclosure of confidential information and their ability to access services without the consent of a parent or guardian [53], which could be lessened with OTC access to the pill.

A 2011 nationally representative survey revealed that most women do not support an age restriction for the pill. In fact, only a quarter of women were in favor of an age restriction [54]. Teenagers themselves also support OTC access for the pill. A 2014 survey of teens between the ages of 14 and 17 years old found that three-quarters (73%) supported over-the-counter access to the pill [55]. A 2011 survey conducted among women seeking abortion at six US clinics also found high interest among teens. Nearly half of respondents (47%) aged 15-17 and 62% aged 18-19 reported being likely to use an OTC pill if it were available [21].
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What would the likely impact be of making the pill available OTC?
Making the pill available OTC would make it easier for women to access it, and could save them time and money. In addition to appointment costs, there can also be other costs related to a clinic visit, like for travel and child care. Moving a pill over the counter could also keep women from having gaps in their birth control use since they wouldn’t need to schedule a medical visit to get or refill a prescription.

An OTC pill also has the potential to help women switch from using less effective methods of contraception or no contraception at all to a more effective method. Research shows roughly one in three women currently using a less effective birth control method (like condoms alone) or using no method report that they would start using the pill if it were available OTC [2, 21]. In a 2015 study of the potential impact of OTC pill access on usage among low-income women at risk for unintended pregnancy, 21% of women reported they were likely to use an OTC pill. If there were no out-of-pocket costs for the pill, an additional 11-21% of low-income women would likely use it. Thus, making the pill available OTC with no out-of-pocket cost has the potential to help even more women change from less effective methods of contraception or no contraception at all to a more effective method. Modeling shows that removing prescription and financial barriers to pill access could have a significant impact on unintended pregnancy among low-income women as well, decreasing the number of unintended pregnancies by as much as 25% [56]. Without addressing cost, however, moving the pill over the counter could still leave some of the most at-risk women without access to them [18, 42].

Most importantly, an over-the-counter pill would improve people’s autonomy and control over their reproductive health.
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What about POPs? What do the data say about use, safety, and effectiveness?
Progestin-only pills (POPs) have fewer contraindications and thus may have a better safety profile than combined oral contraceptives (COCs), which makes POPs a likely candidate as the first OTC pill in the US. POPs lack the estrogen that is in COCs, and therefore have a lower risk of complications such as stroke, heart attack, or blood clots (pulmonary embolus or deep venous thrombosis). In terms of contraceptive effectiveness, while some research has suggested that the timing of ingestion may be more important for POPs than COCs, a Cochrane review published in November 2013 concluded that there are insufficient data to compare efficacy of progestin-only and combined oral contraceptive pills [57, 58]. POPs are associated with more days of bleeding or spotting than COCs, but this bleeding is almost never medically dangerous [59].

Research from the Border Contraceptive Access Study examined the prevalence of contraindications to POPs among a sample of 1,267 reproductive-aged women, and among 1,046 current pill users (including women who obtained the pill OTC in Mexico) [35]. The study found that just 1.6% of all women had one or more contraindication to POPs, such as taking medication for seizures or tuberculosis, or having a history of liver disease or breast cancer. Furthermore, when women were asked to fill out a self-assessment checklist for contraindications to POPs, only five women (0.4% of the sample) failed to self-identify a contraindication to POP use when a nurse practitioner found such a contraindication. Seven women self-reported a contraindication when they actually did not have a true contraindication to POPs. Among current pill users, 0.6% of the total sample had any contraindication to POPs; for women who accessed their pills OTC in Mexico, 1.0% was contraindicated compared to 0.2% of women who obtained their pills through US clinics. The difference in contraindication prevalence between OTC users and clinic users was not statistically significant. These data suggest that not only is there a very low prevalence of contraindications for POP use, but also that a screening checklist can be accurately used by women to self-identify contraindications without undergoing a medical assessment.

In the United States, POPs are much less commonly used than COCs, accounting for only about 4% of all pill users [60]. In Europe, however, they are one of the most popular methods that women use [60], and it is possible that a POP could gain traction in the US as well, particularly given its greater safety profile compared to COCs. POPs are commonly recommended for use by women who are breastfeeding, as estrogen in COCs may reduce milk production. POPs are also sometimes used by women with health conditions like hypertension or older women who smoke, who are contraindicated to using COCs. In line with this, data from a nationally representative sample of pill users in the US indicate that women who received postpartum care in the past year and women with hypertension were more likely to use POPs than COCs. Other characteristics the study found to be associated with increased likelihood of POP use were residing in the West (versus the South) and older age (31-50 years versus 13-30 years). No other demographic features such as race, ethnicity, or income differed between POP and COC users [60].

Areas for further research: Additional research about the acceptability of POPs in diverse populations—especially related to side effects such as menstrual bleeding changes—is needed.
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Would women miss out on other health benefits gained by an appointment with their health care provider to get a prescription?
Some people worry that women would miss out on other preventive services, such as Pap smears or screening for sexually transmitted infections, if they were not required to visit a clinician for the pill. However, these screening tests are not medically required before prescribing the pill, and there has been a growing movement to unbundle these services in the US [17] (for more information on this topic see the FAQ, Are pelvic exams required to obtain the pill?). Holding women’s contraception “hostage” to cervical cancer screening and other unrelated services does not help to solve the problem of health disparities; requiring a clinician visit in order to obtain the pill could be seen as coercive and punitive to women who face barriers in accessing health services. It is also important to note that guidelines regarding the frequency of cervical cancer screening have changed; depending on a woman’s age and history and the use of other testing modalities, screening is recommended every three to five years [61].

Moreover, research suggests that women continue to see their health care provider whether or not they are using a prescription contraceptive method. A 2004 national survey found that among women not currently using contraception, 88% had undergone Pap screening in the prior 24 months [3]. Results from the Border Contraceptive Access Study show that a very high proportion of women who obtain pills OTC in Mexico also obtain Pap smears (90.8%) and STI testing (71.7%), as well as other preventive screening such as pelvic and breast examinations (88.5% and 88.9%, respectively). Although a slightly higher proportion of clinic users obtained these preventive services, the proportion of OTC users who reported having had these tests was higher than national averages [62].

Some women may choose to obtain their pills OTC because they do not have access to the US health care system, which likely contributes to their slightly lower use of preventive screening. The Border Contraceptive Access Study found that over one in five pharmacy users obtained their last Pap smear in Mexico, where such services are often free of charge in the public sector. Under the Affordable Care Act, insurance plans are required to cover well-woman visits without cost sharing [63], which should improve women’s access to preventive services and screening, but is not a reason in itself to require a clinician visit before a woman may obtain contraception.

Areas for further research: The actual use study that is required by the FDA will provide information about whether women continue to obtain necessary preventive screening while obtaining pills in a simulated OTC environment. Efforts to move the pill OTC should include education and awareness-raising about the importance of seeking preventive screening services on a regular basis consistent with evidence-based guidelines.
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Are pelvic exams required to obtain the pill?
A pelvic exam is neither medically necessary nor required prior to beginning oral contraception. Sometimes clinicians perform other testing, such as screening for cervical cancer or sexually transmitted infections, at the time of the pelvic exam. While these tests are important for some women (depending on their age, the results of prior screening tests, and other risk factors), they are not mandatory before starting hormonal birth control. The World Health Organization, US Food and Drug Administration, and the American College of Obstetricians and Gynecologists state that oral contraceptives can be safely and effectively prescribed without a pelvic examination [64-66]. Research demonstrates that providing breast exams or pelvic exams before prescribing a contraceptive method does not significantly reduce a woman’s risk of STIs or abnormal Pap smears and has no impact on health outcomes [67]. In fact, a pelvic exam does not identify any recognized contraindication to the use of hormonal birth control [40]. For combined oral contraceptives with both estrogen and progestin, contraindications are identified by measuring blood pressure and taking a targeted medical history; for progestin-only pills, health history alone is required [40].

Unfortunately, despite these guidelines and the medical evidence, many clinicians require pelvic exams before prescribing or refilling the pill. A 2008-2009 survey of Ob/Gyns, Family Medicine physicians, and advanced practice nurses specializing in Obstetrics and Gynecology and Women’s Health or Family Medicine found that one-third of clinicians required pelvic examinations before providing the pill [68]. Unnecessary pelvic exams can be a barrier to contraceptive access for some women. If your provider requires you to have a pelvic exam before prescribing or refilling hormonal contraception, we encourage you to discuss these medical guidelines with her or him.
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What is the impact of health care reform on women’s contraceptive access?
Contraceptive access has improved under health care reform (also known as the Affordable Care Act, ACA, and ‘Obamacare’). Many insurance plans are now required to cover certain women’s preventive health services without cost sharing, meaning no co-payment (or “co-pay”), coinsurance, or deductibles. These preventive services include well-woman visits and “all Food and Drug Administration [FDA]-approved contraceptive methods, sterilization procedures, and patient education and counseling” [69].

Plans and issuers must cover without cost sharing at least one form of contraception in each of the methods (currently 18) that the FDA has identified for women in its current Birth Control Guide [70, 71]. The contraceptive methods for women currently identified by the FDA include: (1) sterilization surgery for women; (2) surgical sterilization implant for women; (3) implantable rod; (4) IUD copper; (5) IUD with progestin; (6) shot/injection; (7) oral contraceptives (combined pill); (8) oral contraceptives (progestin only); (9) oral contraceptives extended/continuous use; (10) patch; (11) vaginal contraceptive ring; (12) diaphragm; (13) sponge; (14) cervical cap; (15) female condom; (16) spermicide; (17) emergency contraception (Plan B/Plan B One Step/Next Choice); and (18) emergency contraception (Ella) [70].

Further guidance from the Department of Health and Human Services has clarified that insurers must cover OTC contraceptive methods used by women (currently the sponge, female condoms, emergency contraception (Plan B/Plan B One Step/Next Choice), and spermicide); however, a woman may need to get a prescription from a health care provider in order to use her insurance for OTC contraception [63]. (Male condoms are not covered because men are not included in the women’s preventive services guidelines.)

Women who are insured by religious employers will have contraceptive coverage with no cost sharing provided directly through their insurance company rather than through the employer health plan (such employers will need to request this “accommodation”). Houses of worship are exempt from covering contraception all together [72].

Most women on Medicaid already had access to contraception without cost sharing. However, the ACA also expands the group of people who are eligible for Medicaid in some states and requires that this new group of Medicaid enrollees have access to the preventive health services insurers are required to cover, including the full range of contraceptive coverage, without co-pays [73].

Several studies have explored the impact of health care reform on contraceptive access. A 2014 analysis of the impact of the ACA on the cost of common contraceptive methods found a significant reduction in out-of-pocket costs for many women. Among 892 adult women who used private insurance to obtain the pill between late 2012 and early 2014, the proportion of women with no out-of-pocket cost increased from 15% in 2012 to 67% in 2014. The average amount paid by women out-of-pocket costs decreased from $14.35 in 2012 to $6.48 in 2014 [74]. A 2015 comparison of 2011, 2012, and 2013 claims for contraceptives in a commercial health insurance database also found significant reductions in out-of-pocket costs for women aged 15-44 who used their private health insurance to obtain contraception [75]. Across the study period, the annual mean out-of-pocket costs for the pill dropped from $86 to $26. During the same period, the mean cost for annual pill co-pays was reduced from $66 to $19 per woman. The average per claim copay for the pill went from $14 in 2011 to just $4 in 2013, showing significant savings for women able to use their commercial health insurance to obtain the pill [75]. Similar savings have been found for other methods of hormonal contraception [76]. In this same period, the proportion of women with a $0 out-of-pocket cost for any contraceptive method under their commercial insurance plan increased from 10% to 70% [75].

Additional studies have looked specifically at the impact of health reform on overall rates of insurance coverage. Two national surveys of 8,000 women aged 18-39 conducted in 2012 and 2015 were compared in order to determine whether any significant changes in insurance coverage or health care access resulted from ACA implementation [77]. Data show that nearly 40% fewer women reported being uninsured in 2015 than in 2012. Among low-income women, the overall impact was even greater, with the rate of those uninsured dropping from 40% in 2012 to 25% in 2015. Among low-income women in states with Medicaid expansion, the proportion of those uninsured dropped from 38% to 15% largely as a result of increased Medicaid coverage [77]. The number of respondents reporting continuous periods of coverage also increased, and those who experienced a coverage gap reported a reduction in the length time they experienced a lack of coverage. Improvements in coverage were not shown in all groups, and results of both surveys failed to show an increase in coverage among Latinas. This suggests that the benefits of the ACA may not extend to all groups of women, and OTC availability of the pill could be particularly important for women unable to obtain them through a health insurance benefit [77].

Studies that examined the impact of health care reform in Massachusetts (passed in 2006) on contraceptive access for low-income women and young adults provide some additional insights [78-83]. Through systematic reviews of the health care plans available to low-income women and young adults, focus group discussions with low-income women and young adults, and in-depth interviews and surveys with the health care providers that serve these populations, the studies identified benefits of reform as well as barriers to reproductive health services that emerged as well as remained under reform. Benefits included more women being able to access health services and prescription medications at low or reduced costs. Barriers included complex eligibility guidelines and enrollment procedures, low health insurance literacy, difficulty understanding how to use prescriptions among women who previously received contraception directly from a provider, limited access to confidential services for young adults on a parent’s health care plan, and increased administrative burdens for health care providers. These challenges led to women frequently being pushed on and off of their health care plans, leaving them without consistent access to prescription medications. The research also identified particular challenges in access to health care and prescriptions for certain populations such as those going through life changes like marriage, moving, or motherhood; those living in non-urban areas; minors; and young adults.

In addition, other groups of women, such as recent and undocumented immigrants, have been left out of health care reform. For groups of women who are not eligible for health insurance plans in the state exchanges (online insurance marketplaces) under the ACA, for those experiencing problems enrolling in or maintaining their insurance status, and for those experiencing challenges in getting an appointment with a health care provider in order to obtain a prescription for contraception, OTC oral contraception may serve as a stopgap to help ensure that women can continually access contraception without health insurance coverage [18, 77-83].

Areas for further research: More research is needed to document how national health reform impacts contraceptive uptake and use for women who have access to coverage under reform, as well as for those who do not. Monitoring of insurance plans’ implementation of the contraceptive coverage rule, including coverage of OTC contraception, and of the accommodation for religious employers is also necessary.
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Will insurance cover an OTC birth control pill?
Under the health care law (also known as the Affordable Care Act, ACA, and ‘Obamacare’), most private insurers are required to cover “all Food and Drug Administration [FDA] approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity” without cost sharing (i.e., co-pays, co-insurance, or deductibles) [69]. For more information on this topic see the FAQ, What is the impact of health care reform on women’s contraceptive access?.

As part of this, the health care law requires insurers to cover OTC contraceptive methods used by women (which currently includes the sponge, female condoms, emergency contraception (Plan B/Plan B One Step/Next Choice), and spermicide) if the method is “prescribed for a woman by her health care provider.” Male condoms are not covered because men are not included in the women’s preventive services guidelines [63]. In other words, OTC birth control for women must be covered, but a woman usually has to obtain a prescription for them first. Private insurers may choose to cover OTC contraception without a prescription, but they are not required to do so.

Some state Medicaid programs don’t require women to get a prescription to get OTC birth control (like EC or condoms) covered, but most of them do. Most state Medicaid programs cover OTC EC if women have a prescription [5, 84, 85]. In 2013, the Assistant Secretary of Defense issued a memorandum requiring all branches of the military to cover OTC Plan B One-Step for women of all ages without a prescription and without cost sharing [86]. And then in September 2013, the Indian Health Service issued a verbal directive ordering its facilities to provide free of charge OTC emergency contraception without a prescription for Native American women age 17 or older [87]. In October 2015, the Indian Health Service added a chapter on Emergency Contraceptives to the Indian Health Manual, making EC pills available to all females of all ages without requiring a prescription [88]. Several private insurers have also started covering OTC EC without requiring a prescription. These examples of public and private insurers covering OTC contraception without requiring a prescription provide models that other federal, state, and private programs could follow.
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Would women’s out-of-pocket expenses for the pill increase if it were available OTC?
Women with insurance subject to health care reform (also known as the Affordable Care Act, ACA, and ‘Obamacare’) and women with Medicaid or other public insurance plans should not lose coverage for the pill if one or more formulation becomes available OTC. Under the Affordable Care Act, many health insurance plans are now required to cover all FDA-approved contraceptive methods for women without cost sharing [69], and OTC contraceptive methods for women must also be covered without cost-sharing as long as the woman has a prescription. (For more information on this topic see the FAQs, Will insurance cover an OTC birth control pill? and What is the impact of health care reform on women’s contraceptive access?)

Additionally, if a progestin-only pill (POP) becomes available OTC, other oral contraceptives, including all combined oral contraceptives (COCs), would likely remain on prescription. Due to the difference in formulation, women with insurance coverage for prescription-only COCs should continue to have coverage for these drugs. While plans may use “reasonable medical management” to control costs (for example, covering a generic drug without cost sharing, but imposing cost sharing on the brand name), plans must have a waiver process so that a woman is able to obtain the method her health care provider determines is best for her [63].

It is difficult to predict how an OTC switch would affect the cost of an oral contraceptive pill. The price of EC increased after going OTC, and women reported that cost was a barrier to having timely access [85]. One analysis of several prescription-to-OTC switches in the United States found that in most cases consumers’ out-of-pocket costs increased [89]. However, other research found that out-of-pocket costs decreased in the United States after an OTC switch for antihistamines and gastritis medications [90]. For people who are still required to pay for family planning office visits and contraceptive pills, including those without insurance or with insurance plans that are not required to implement the preventive services rule, OTC access would save them considerable costs. Even for women for whom the cost of the office visit and pack of pills may be covered, other costs must still be considered such as the time lost from work and child care. Increased convenience, less waiting, and not having to pay for appointments might make up for the possible additional out-of-pocket costs.

Areas for further research: Continued efforts to ensure public and private insurance coverage of OTC contraceptive products are critical. Monitoring costs after a pill is available OTC will also be necessary.
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Given the new no-cost sharing benefit for contraception under health care reform, is there still a need to make the pill available OTC?
Under health care reform (also known as the Affordable Care Act, ACA, and ‘Obamacare’), in order for a woman to obtain OTC contraception without cost-sharing, it may need to be prescribed to her by a health care provider [63]. While the elimination of cost-sharing is an important step towards improving contraceptive access and affordability, the costs and burdens associated with visiting a clinician to obtain a prescription must still be considered, such as time lost from work or school, child care costs, transportation to/from the health care provider, and the limited hours for care. Furthermore, not all people will benefit from the new health care law, and some may still experience barriers even with it in place. For groups of people who are not eligible for health insurance plans in the state exchanges (online insurance marketplaces) that will be created under the ACA; for people insured by houses of worship that are exempt from the contraceptive coverage rule; for undocumented immigrants, who have been left out of health care reform; for people with grandfathered insurance plans that are not required to implement the preventive services rule; for those experiencing problems enrolling in or maintaining their insurance status; and for those experiencing challenges in getting an appointment with a health care provider, OTC access may help ensure that people can continually access contraception without health insurance coverage or access to a provider [78-83]. An OTC pill may also appeal to people who have insurance that covers contraception with no cost-sharing, but prefer the convenience of obtaining it on their own without a prescription. An OTC pill may also be an important stopgap for those who forget to bring their prescription pills on a trip or who are between insurance plans.
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Could pharmacy provision of the pill improve access to effective contraception?
Although not true OTC provision, ‘pharmacy provision’ or ‘pharmacy access,’ where a trained pharmacist screens a woman for contraindications and provides contraceptive methods and counseling, is another way women can access the pill without a prescription. Laws implemented in California and Oregon in 2016, for example, allow pharmacists to prescribe (or furnish) hormonal contraceptives, expanding access for millions of women [91]. California’s law has no age restriction, but the Oregon law requires that people under age 18 must have had a prior prescription for the method [91]. In both states, pharmacists screen women using a brief medical history questionnaire, and the contraceptives are covered by insurance (if the woman has insurance). Similar legislation is being considered in other states [91].

Research demonstrates significant support for this model of contraceptive provision among clinicians. A 2009 survey (19% response rate) of reproductive health care providers found that the majority supported pharmacist prescribing of hormonal contraceptives. Three-quarters (74%) of the 482 providers surveyed indicated support for this model of pharmacist provision and 65% reported support for behind-the-counter access to oral contraceptive pills. Although many of these providers also expressed concern that women’s attendance at preventive reproductive health care screenings might decrease, this did not appear to significantly reduce their support for expanding access to hormonal contraceptives through pharmacy provision [32].

A study published in 2009 surveying pharmacists (19% response rate) across the country indicated that the large majority (85%) of respondents were interested in providing hormonal contraceptive methods, such as the pill, directly to pharmacy customers [92]. Some of the services pharmacists were most interested in providing included helping women switch to a different hormonal method, adjusting dosages, and helping women start a hormonal method for the first time. Among those who showed interest in pharmacy access to hormonal contraception, there was near-unanimous agreement that it was an important public health concern (98%) and that having one-on-one patient contact was desirable (97%). Participating pharmacists also identified a number of training needs, such as helping people choose the best hormonal method, identifying people for whom hormonal contraception would not be appropriate, and informing people of other preventive services such as sexually transmitted infection and cancer screenings.

A model involving pharmacists to provide hormonal contraception after appropriate screening was evaluated in Washington State, where it was found to be safe, effective, and acceptable to women [93]. In the Direct Access Study, 26 community pharmacists who had collaborative practice agreements with physicians were trained to provide hormonal contraception using the World Health Organization Medical Eligibility Criteria for contraceptive use. Among the 175 women who received hormonal contraceptives from these pharmacists, 98% reported being satisfied or very satisfied with the experience, and a similar proportion said they would recommend the pharmacist to a friend. Eighty percent of participants reported that they were using a hormonal contraceptive six months after the initial contact with a pharmacist, and 70% were using a hormonal contraceptive at 12 months (although not all were still using the same method they were initially provided). More than 85% of women seeking contraception paid for the screening and prescribing consultation out of pocket, as no third-party insurance payer agreed to reimburse pharmacists for these services. The program did not continue on a large scale after this pilot project, largely due to the lack of insurance reimbursement to the pharmacist.

In addition to the training needs and improved reimbursement mechanisms, it is also critical for pharmacists and drugstore staff to be fully informed about the availability of the pill in the pharmacy environment in order to prevent miscommunication and additional barriers for women. In a study published in 2012, 943 pharmacies across the United States were called by research assistants posing as 17-year-old adolescent women in need of EC or as physicians seeking EC for a patient of the same age [94]. Nearly one in five pharmacies incorrectly told the adolescent caller she could not obtain EC at all, and over 40% of pharmacies could not correctly inform the adolescent caller of the age threshold for non-prescription access to EC, which at the time was 17. Although experiences with pharmacy provision of EC and the pill may not be directly comparable, similar challenges may emerge if a pharmacy access model for the pill is available to women, particularly if there is an age restriction on OTC access.
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Is there anywhere in the world where the pill is already available OTC?
Yes! Many countries in the world have OTC access to the pill, either by law (i.e., no prescription requirement exists) or informally in practice (i.e., technically a prescription is required, but people commonly can get the pill without one). Ibis Reproductive Health conducted a global survey of countries’ prescription requirements and informal commercial availability of the pill. Of approximately 150 countries surveyed, the vast majority—more than 100 countries—reported formal or informal OTC availability of the pill.

You can view a world map displaying the OTC availability of the pill HERE.
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What are the FDA criteria for OTC drugs, and does the pill meet them?
The pill meets the FDA’s criteria for over-the-counter sale [95]:
1. They have no toxicity in the event of an overdose.
2. They are not addictive.
3. People can determine on their own if use of the pill is appropriate for them (i.e., they know if they are at risk of unintended pregnancy).
4. A person can take the medication as indicated without a doctor’s explanation. (The instructions are simple: take one every day.)
5. A person can take the pill safely without a provider’s screening. (Research suggests that people can use a simple checklist to determine if they have any medical conditions that would make using the pill unsafe.)
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How would a birth control pill move over the counter, and how long would it take?
There are several ways that a birth control pill could become available over the counter. The most likely process is for a pharmaceutical company to submit an application to change one pill product that is already registered as a prescription product to be an over-the-counter product. There are hundreds of formulations of the pill, and all others would remain as prescription-only. The following things need to happen, and some of them can happen at the same time:
• Research must establish the safety of the pill product as a prescription product. This includes a review of post-marketing safety data, and it typically takes 6-18 months.
• Research must show that potential users can understand the labeling for the OTC pill. This is called a label comprehension study, and it typically takes 6-19 months.
• Research must also show that potential users can use the OTC label to determine whether the product is appropriate for them. This is called a self-selection study and is usually done in conjunction with the label comprehension.
• Research must demonstrate that women can use the product correctly in a simulated OTC environment. This is called an actual use study, and it typically takes 18-26 months.
• Once these data are all collected, the FDA staff review the findings in consultation with an advisory committee. This typically takes 6 months.

Altogether, it will probably take 3-4 years from the time a drug company begins an application process until a successful pill is available on the shelf.

Glossary of terms
ACA: The Patient Protection and Affordable Care Act, the US health care law enacted by President Barack Obama in 2010 that will require all legally residing US residents to have health insurance, enacts reforms in insurance industry, and expands Medicaid, among other changes
COC: Combined oral contraceptive pill; an oral contraceptive pill that contains both progestin and
Contraindication: A health condition that could make drug use harmful
EC: Emergency contraception, a birth control method that, if taken after sexual intercourse, may prevent pregnancy
FDA: United States Food and Drug Administration, an agency of the United States Department of Health and Human Services that is responsible for protecting and promoting public health through food and drug related regulations
OC: Oral contraceptive, or “the pill”
OOP: Out of pocket
OTC: Over the counter; OTC medications are drugs that may be sold directly to a consumer without a
prescription from a health care professional, as compared to prescription drugs, which may be sold only to consumers who have a prescription
Pharmacy provision: A model of service delivery wherein a trained pharmacist screens a potential user for health conditions that would make use of a drug harmful—contraindications—and provides medications and counseling
POP: Progestin-only pill, or “mini pill;” an oral contraceptive pill that does not contain estrogen
STI: Sexually transmitted infection

These FAQs were prepared by Ibis Reproductive Health with feedback from members of the Oral Contraceptives Over-the-Counter Working Group.

Updated April 2016.
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