Expanding Emergency Contraceptive Access: An Exploration of the Pros, Cons and Current Conversation on a U.S. and Global Scale

BY RYAN SUTHERLAND, FRANCESCA MAVIGLIA, ALEJANDRA MONCAYO, JULIA SPINNENWEBER

Emergency contraception (EC) is a key tool for women to avert unintended pregnancy in a safe and effective manner shortly after having unprotected sex. EC is designed to be used in cases of non-use or inconsistent use of other contraception, and there are two categories of U.S. Food and Drug Administration (FDA) approved options as of 2018: i) orally administered pills, which includes progestin-based pills and ulipristal acetate, or ii) a copper intrauterine device (IUD) marketed under the name ParaGard. This paper will focus on the access and availability of oral EC, as the requirement of a prescription for these pills has varied over time in the U.S., across adolescent versus adult recipients, and globally. Brand and generic progestin-based EC versions are currently available over the counter (OTC) without a prescription to women of all ages, but access varies substantially across countries. Fewer than 19 countries including the U.S. allow OTC EC access, while 75 countries have EC available behind the counter (BTC) of the pharmacy only, and over 54 countries dispense EC solely by prescription.¹

This paper analyzes each side of the debate surrounding the expansion of EC availability to OTC across countries, and concerning the discontinuation of age restrictions on OTC access, supported by i) relevant background and history, ii) an analysis of the current state of affairs. iii) the “pros” arguing for OTC EC access, iiv) the “cons” against expanded OTC access.

History of EC Options, Approval & Access: Domestic

         The availability of EC options has expanded throughout the past 50 years, though the only modern option available sans prescription in the U.S. is progestin-based pills. Clinical administration of emergency contraception began in the mid-1960s and evolved into modern options at the close of the century. In the ‘60’s, high doses of estrogen were used to prevent unintended pregnancy exclusively as part of the treatment of rape victims, which proved efficacious but came with harsh side effects. In the 1970’s, a combination hormone formula called the Yuzpe regimen replaced the high-dose estrogen method. Combination pills are no longer recommended due to lower efficacy and more severe side effects than other modern methods. In the late 1970’s, the copper IUD, branded as ParaGard, gained FDA approval for EC use and remains the only non-pill, non-hormonal option currently recommended. ParaGard IUD is implantable in a clinical setting only and is thus not available OTC. ²

         Following a request for new drug applications for EC pills, the FDA approved Plan B as the first oral EC product for use in the U.S. in 1999.  Plan B is the branded version of the generic levonorgestrel, a progestin-based pill, and was available via prescription only until it became accessible OTC for men and women aged 18 or older in 2006. The switch from Plan B’s prescription to nonprescription status was a highly contentious and multi-year process involving Barr Laboratories, Plan B’s original manufacturer, and the FDA. Barr Laboratories initially requested an OTC switch without age restrictions in 2003, the FDA responded with concerns about the OTC impact on teen health and sexual behavior, despite studies indicating the availability of Plan B did not alter female use of other contraception methods or affect their sexual choices. Barr revised their request to seek OTC status only for women aged 16 and older, and FDA delayed their decision-making amid heavy criticism of the agency until 2006. The agency approved sales of Plan B OTC to men and women age 18 and older only, still requiring a prescription for users under 18. OTC access was expanded to men and women 17 and older as of 2009, the same year the single dose version of the pill, Plan B One-Step, replaced the original version and the first generic version, Next Choice, came to market.³

         In 2010, the FDA approved ulipristal acetate, marketed under the brand name “ella”, which remains the only other oral EC option. Ella has been sold exclusively via prescription in the U.S. since its approval and is considered the most effective pill option. Ella has straight-line efficacy over a 120-hour period following unprotected sex, while progestin-based pills are most useful within 72 hours and have diminishing efficacy over time.⁴

         In 2013, the FDA approved the OTC sale of Plan B One-Step with no age restrictions, after a years-long process that involved Teva Pharmaceuticals, the new manufacturer of the pill, and the U.S. courts system urging the FDA to approve the application. In 2014, the generic single pill alternatives Next Choice One Dose and My Way were also granted OTC status without age restrictions, with additional labeling requirements. As of 2018, additional generic versions are also available OTC in the U.S.³

Current state of the conversation: EC access around the world

On a global level, EC access policies have varied significantly over time and across countries. Policies regarding the availability of the aforementioned oral EC options, levonorgestrel (LNG) pills and ulipristal acetate (UPA) pills, range from full OTC access for both to unavailability of either. Global policy supports wide accessibility to oral EC, with the pills included on the World Health Organization (WHO)’s Essential Medicines list.⁵

     For countries in the European Union (EU), access has changed significantly to both oral options in the past decade. Before late 2014, women in 22 countries could purchase LNG pills in pharmacies without a prescription,  with expanded access to convenience stores in the Netherlands and Sweden. In four countries – Croatia, Germany, Italy and Hungary – women could only access LNG pills via prescription, and in Malta, EC was unavailable. From 2009 to 2014, UPA pills were available in all but two countries via prescription only. The European Medicines Agency (EMA) recommended a reclassification to non-prescription status for UPA pills as of 2014, implemented by the European Commission. Twenty-three countries implemented full non-prescription access for UPA pills following the decision, with three countries including age restrictions and five countries exhibiting prescription-only or no access policies.⁶

     In the rest of the world, EC access is more variable. Different levels of access include: no EC product officially registered for sale; EC available by doctor prescription only; at least one EC product available from a pharmacist without a prescription by a physician (“behind the counter”, BTC, access); at least one EC product available over the counter (OTC), with age restrictions; and at least one EC product available over the counter without age restrictions. As of 2016, at least one brand of EC pills is registered in 148 countries, but 47 have no registered EC products.^{6, 7} A study of accessibility in low resource countries found that, in the public sector, only 23 of 42 countries offered EC; the public sector is a significant point of access for women who are poor, disadvantaged or rape victims.⁵

No registered EC

According to the International Consortium for Emergency Contraception, no EC product is registered in 47 countries worldwide. Most of the countries with no registered EC are concentrated in Central America, East and West Africa, the MENA region, and South-East Asia.⁸ Lack of registration includes countries that may only offer EC importation through special license, have inconsistent supply, too small a market to support sales or too unstable a political structure to import EC.

It is important to note that access may vary significantly depending on whether no EC product is registered because of bans and direct opposition, or due to a small population that does not represent an attractive market for distributors. Many small states such as Fiji, Monaco, Sao Tome, Maldives, or Tonga, as well some larger states facing political instability and conflict such as Syria, the West Bank and Gaza, and Afghanistan, rely on imports of EC products from other countries, so a limited supply is available. With respect to the countries that do not appear to import EC products, in some countries such as Costa Rica, Honduras, Jordan, and the Philippines, EC products have faced active opposition; others such as Libya, East Timor, and Sudan are currently being affected by conflicts; and others such as Brunei, Cape Verde, and Samoa have a very small population. Finally, a number of Gulf countries (Bahrain, Oman, Qatar, and the United Arab Emirates) do not currently import EC products, but it is unclear whether there has been active opposition to them.⁹

EC only by prescription

         54 countries worldwide offer EC access by prescription of a physician only. These include countries in South America; Central and Southern Africa; Eastern Europe; the MENA region; Central, East, and Southeast Asia. Depending on the country and specific context, users might be able to obtain a prescription from family doctors, hospital staff, and healthcare professionals at a family planning clinic.¹⁰

Behind the counter (BTC) access

75 countries worldwide offer at least one brand of EC with behind the counter (BTC) access, including parts of South and Central America; East and West Africa; Central, East and South-East Asia; Oceania; and Europe. BTC access is defined as the ability to purchase EC from a pharmacist without a physician’s prescription; some countries might have one type of EC available BTC but require a prescription for other brands or types. In general, LNG EC pills are more easily available without a prescription, while UPA EC pills are often by prescription only; very few countries require a prescription for LNG EC while allowing BTC access to UPA EC. LNG EC is generally more widespread, with several countries only having LNG products registered.¹¹

Over the counter (OTC) access

19 countries worldwide offer at least one brand of EC with over the counter (OTC) access, most of which are concentrated in North America; Southern Africa; Europe; and South Asia. OTC access is defined as the ability to purchase EC without any gatekeeping from a healthcare professional. At present, no country allows for OTC sale of UPA EC.¹¹

In Bulgaria, EC is only available OTC to individual over 16 years old, while in the Czech Republic OTC sale requires a minimum age of 17.^{12, 13} The following countries allow OTC sale with no age restrictions: Bangladesh, some provinces of Canada (while others only allow BTC access); Denmark; Estonia; France; India; Laos; Netherlands; Norway; Portugal; Romania; Slovakia; Sweden; the United States. No data on age restrictions is available for Malawi, South Africa, and Uzbekistan.¹¹ 

Usage and knowledge

Usage and knowledge of EC are also extremely variable by country. According to the International Consortium for Emergency Contraception, out of the 62 countries for which information is available, the highest percentage of ever use among women of reproductive age is found in the United Kingdom (61%), followed by Sweden (59%), Bulgaria (38%), France (22%), Estonia and the Netherlands (21% each), Denmark (20%), Austria (18%), Spain (14.7%) Germany (13%), the Congo (12%), Peru (11.7%), and the United States (11%). In all other countries, percentage of ever use falls below 10%, and in many cases it is lower than 1%. EC knowledge among women of reproductive age ranges from 98.7% in Spain to 3.2% in East Timor.¹⁴

It is important to note that data on usage and knowledge is not available for more than two thirds of countries worldwide, and in particular it is missing for several countries with more restrictive legislations, making is challenging to paint a complete picture of EC use and knowledge and examine the impact on access of different policies.

Advocating for the Over-the-Counter Access to EC: Pros

According to U.S. Medical Eligibility Criteria for Contraceptive Use (US MEC), the benefits of EC pills made available OTC far outweigh the risks.¹⁵ The OTC use of the EC pill is endorsed by The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American Medical Association, the American Public Health Association, and the International Planned Parenthood Federation. Furthermore, OTC access is supported without age-restriction for use among adolescents by the American Academy of Pediatrics and the Society for Adolescent Medicine.¹⁶ 

Self-administration of OTC EC is safe and effective

OTC EC can reduce rates of unintended pregnancies or abortions resulting from inconsistent birth control use, contraceptive failure, or in cases of sexual assault involving unprotected sex. The use of levonorgestrel pills is safe and effective when self-administered for preventing unintended pregnancy.¹⁶  Its use can serve as an additional barrier to prevent unwanted pregnancy — studies have shown that use of EC pills within 72 hours of sexual intercourse reduced the likelihood of insemination by 75-88%.¹⁷ According to Seetharaman et al, “among 15- to 19-year-olds globally, complications secondary to pregnancy, childbirth, and unsafe abortions are the second-leading cause of mortality.”¹⁸ Considering the fact that 16 million worldwide births (18% of all births) occur among young mothers under the age of 20 years old — 95% of these births occur in low- and middle-income countries (LMIC) and many are unwanted — increased knowledge and accessibility of emergency contraception could potentially reduce the risk of birth complications and unsafe abortions globally among these youth.¹⁹ Furthermore, 45% of pregnancies for adult women in the United States are unintended and emergency contraception can play a role in averting unintended pregnancy and reducing rates of abortion.² Over 50% of unintended pregnancies end in abortion in the United States, and more widespread access to EC could reduce this amount by 700,000 procedures annually and decrease costs associated with Medicaid resource utilization.²⁰ Therefore, widespread international efforts to reduce barriers to access EC by making them accessible OTC and advertising them widely can facilitate a reduction in unplanned pregnancies and could have a pronounced economic effect on government health care spending.

Timely and accessible distribution of OTC EC

No evidence exists showing that OTC sale of this medication would harm users, as EC has minimal side effects.²¹ Physicians and medical associations in the United States have long called for the OTC sale of EC, citing its benefits to women’s reproductive health and have since continued to advocate for its distribution OTC without a prescription, imploring the FDA to repeal previous legislation that imposed point-of-sale and age-limitations. Additional barriers to seeking EC — such as setting up an appointment to see a physician— might delay use of this drug which could hinder its effectiveness.²² A Lancet study found that EC taken within 12 hours resulted in a pregnancy rate of approximately 0.5%, tripling after 24 hours.^{23, 24}

 A nationwide survey indicated that 65% of women preferred to purchase EC directly from pharmacists, citing appointment timeliness and costs as a concern.²⁴ Since pharmacies often are open on weekends and stay open longer than private clinics, OTC EC available at pharmacies increase opportunities for users to purchase this medication — and considering the short window of action of Levonorgestrel emergency contraception pills, timeliness of access is key.²⁵ 

OTC access to EC decreases perceived and real barriers to access

OTC EC is of particular significance to women who lack insurance, minorities, and women of lower socioeconomic statuses.² Furthermore, barriers to access could disproportionately affect youth in their ability to access EC: stigma (perceived or real) that accompanies doctor visits to procure prescriptions for this medication could augment rates of unwanted pregnancies, increase negative birth outcomes, and result in an uptick of unsafe abortions among this underage subgroup.²⁶ Therefore, offering EC OTC and without age limitations or point-of-sale restrictions is important for its timely distribution and use among all women, particularly among these disadvantaged groups, due to these concerns regarding costs, timeliness, and stigma.”

Risks of EC are minimal 

OTC EC is non-addictive, non-toxic, non-teratogenic, and isn’t dose specific. Further supporting continuation of the sale of OTC EC, the prescription for levonorgestrel pills is not prescribed according to medical need but is prescribed to patients who do not wish to become pregnant after unprotected sex or contraceptive malfunction (i.e. electively, not medically). Moreover, EC dosage does not need to be adjusted before being prescribed and therefore doesn’t require the need for dose calibration via consultation with a medical professional.¹⁶ The risks of taking EC are much lower than taking a once-daily birth control pill, and even among those contraindicated for this drug, EC poses almost no risk — contraindications may make the pill pharmacologically less effective but do not induce significant side effects.^{27, 28} Side effects are minor and include nausea and vomiting. Menstrual cycle disruption can occur rarely after prolonged successive use of EC.²⁸ Furthermore, taking the EC pill successively within a short time period does not diminish its effectiveness.²⁹ Although this medication is contraindicated for women who are pregnant — it is not effective at terminating a pregnancy — levonorgestrel will not cause harm to a developing fetus (non-teratogenic).³⁰ Lastly, although myriad myths attempts to equilibrate EC with abortion-inducing drugs, these pills are not the same as mifepristone or misoprostol that induce abortions: ECPs delay ovulation, preventing the timely union of the sperm and an egg and implantation into the uterine wall.³¹

Overall, this medication is effective for all women of childbearing age, doesn’t interact with other drugs, and doesn’t result in an overdose if too many pills are taken.¹⁶ Furthermore, as stated previously, it doesn’t cause birth defects in children born to mothers who were using this medication during pregnancy. The aforementioned criteria permit its sale OTC, according to the U.S. Medical Eligibility Criteria for Contraceptive Use (US MEC). Therefore, its minimal side effects, effectiveness after repeated use, and lack of interactions with other drugs make it an attractive method of preventing pregnancy.

Misuse is rare

Instructions for OTC EC are easy to follow among women of various ages and educational backgrounds. Subsequently, women are generally capable of deciding themselves if this pill is right for them and following treatment regimens without provider instruction.³² Clinical appointments were shown to be no more effective at guaranteeing that women with contraindications were appropriately screened and prevented from accessing this medication than consultations with pharmacists, and consultations were shown not to affect comprehensibility of treatment or use.³³ A comprehensibility study including adolescent women and women with low literacy levels showed that the majority of women regardless of literacy level or age understood how to appropriately use OTC EC.³⁴ And as pill regimens for EC are simple — Plan B One Step requires women to take only one pill — instructions for taking this medication are easy to follow for users.³⁵ According to Dr. James Trussel, Princeton University researcher in reproductive health, emergency contraception pills “are extraordinarily safe drugs. No deaths have been linked to using emergency contraceptive pills. And the benefits of being able to prevent pregnancy after sex outweigh any possible risks of taking the pills.”³⁶ Therefore, providing EC in OTC settings without requiring a prescription from medical professionals is safe, easy, and effective for the prevention of unwanted pregnancies.²⁸

OTC EC use doesn’t increase sexual risk behaviors among users

Lastly, no scientific evidence exists that providing EC to women would increase sexual risk behaviors or that making this medication OTC would disrupt prior birth control or contraception use patterns.³⁷ In several studies, women who received advanced provision EC (i.e. in advance of sexual encounter necessitating its use) were not more likely to engage in higher rates of unprotected sex or have sex with a greater number of sexual partners, did not change their pattern of use for birth control or adopt less effective contraception methods, and did not experience higher infection rates of sexually transmitted infections.³⁸ Furthermore, making this product available OTC did not increase individual utilization — Raymond et al showed that only 1.5% of study participants utilized OTC EC more than once over the study’s three month investigative time frame.³⁹

Arguments against Expanded EC Access: Cons

While clinicians, public health advocates and other professionals are strongly in favor of expanded OTC access to EC across age groups, critiques remain concerning the medication’s impact on adolescent behavior, risks of inappropriate use and unintended consequences among adolescents, and long-term health effects. 

Easy EC access may be a negative influence on teen sexual behavior 

Adolescents may lack the maturity and cognition to make safe sexual decisions, and OTC access to EC could encourage risky choices accordingly. The FDA’s Center for Drug Evaluation and Research (CDER) Acting Director denied Plan B’s switch from prescription to OTC in 2004 with the critique that young adolescents may exhibit “impulsive behavior, without the cognitive ability to understand the etiology of their behavior”.⁴⁰ With the knowledge that a post-coital solution to unprotected sex exists and is readily available at every pharmacy OTC, teens may engage in unsafe sexual behaviors like sex without a condom or with multiple partners due to easy EC access and their lack of cognitive maturity.⁴⁰ If expanded EC use is associated with teens having more sexual partners, this could increase STI incidence. Research has found STI prevalence is higher for individuals reporting more sexual partners; in 2009, females aged 14-19 with more than three sexual partners exhibited an STI prevalence of 53.3% compared to 19.2% for those with one sexual partner.⁴¹ Furthermore, as argued by the 2004 CDER Acting Director, data demonstrating lack of harmful behavioral consequences of EC use among older adolescents may not be rightfully extrapolated to younger adolescents.⁴²

EC is not as effective as regular contraception 

Although research has found that increased EC access does not reduce ongoing contraceptive use, EC is scientifically less effective in preventing pregnancy compared to regular contraceptive options. One study found that if an average woman used progestin-only EC each time she had sex in one year, her pregnancy risk would be 20% compared with 8% risk if she used regular oral contraception or <1% if she used an IUD or implant.⁴³ Young, inexperienced or uneducated users may not understand that EC is less effective than regular birth control, which critics can argue could negatively impact their contraceptive and sexual choices. 

EC does not reduce population-level rates of unintended pregnancy 

EC has also been criticized for failing as a public health tool, as data has shown access to EC does not positively impact unintended pregnancy rates in populations in which it is available. While the reason for the lack of association between EC access and unintended pregnancy rates is unknown, one explanation may be that women do not use EC in cases of highest risk unprotected sexual events often enough to cause a measurable effect on the population level.⁴³ This research suggests that public health professionals should encourage the use of regular contraception and sexual education that better prevents unwanted pregnancy to better impact these rates. 

OTC access removes potential for educational gatekeeping 

OTC EC expansion to adolescents eliminates the important barrier of requiring that adolescents interact with a trained healthcare provider prior to receiving the contraceptive option, which is implicit in BTC and prescription-based access to EC. A physician, nurse or pharmacist would be able to educate and ensure complete understanding of the product. Critics can argue that requiring clinician-adolescent interaction is necessary because EC has substantial short-term side effects, and because teens in the U.S. school system receive inadequate and varied sexual education. EC has noticeable side effects, including nausea or vomiting, headache, bleeding between menstrual cycles and cramping. The pill also has risks that younger or inexperienced users may not educate themselves on by reading the product’s labeling alone, including potential allergies or drug interactions that reduce EC’s effectiveness.²⁸ While providing contraindication questions at point-of-sale in pharmacies has been found to be as effective as conversations with providers, this practice may not be implemented in a standardized manner across pharmacies and risks could remain.⁴⁴ Lastly, school age adolescents receive highly variable sexual health education in the U.S. Only 24 states mandate sex education, and programs include disparate content and implementation ranging from abstinence-only to full evidence-based information.⁴⁴ Given this variability, it is reasonable to assert that adolescents may not understand contraceptive options well enough to access EC without clinician discussions. 

Religious objections that EC approximates abortion

Some religious groups frame EC in the context of the abortion debate, arguing that the drug may have an abortifacient effect. Religiously affiliated opponents claim that the product may work to prevent a fertilized egg from implantation up to roughly a week following conception, which they equate with abortion. The labeling on progestin-based EC products cites implantation prevention as a mechanism used by the pharmaceutical product, suggesting that these critiques are well-founded for groups which identify as anti-abortion.⁴⁵

Lack of causal efficacy data and post-market data concerning adolescents 

Although the FDA has concluded that EC is safe and effective for adolescent and adult populations, there has never been a placebo-controlled trial of EC efficacy.⁴³ The full mechanisms of action for how EC works are also unknown by clinicians.⁴⁵ This lack of data could be used as a criticism of expanded EC access since there are still unknown elements about the product. The enduring impact of EC on adolescent user health may also not be fully known due to a lack of long-term post-market clinical data. The FDA approved expanded OTC EC use for females aged 17 or older in 2009, meaning there is less than a decade of post-market surveillance data available on how this additional access may have affected adolescents clinically or behaviorally. Publicly available research is strongly skewed towards the positive attributes of expanded EC access, and studies which take a critical lens towards EC use may be underfunded and unable to reach the popular media due to public consensus being favorable for the product. More unbiased research questions and data could be necessary to fully understand its long-term consequences on younger users. 

Conclusion 

Overall, the positive results of making emergency contraception available over-the-counter are myriad and outweigh criticisms.² Not only can timely over-the-counter access to emergency contraception reduce unintended pregnancies in instances of contraceptive failure or inconsistent birth control use, unprotected sex, or sexual assault, but its ease of use and relative safety can reduce rates of unsafe abortions and negative birth outcomes for all women of reproductive age, it can have a pronounced economic influence on the government and consumer health care spending, and it can reduce stigma and other barriers to access particularly among the uninsured, minorities, and youth.² According to Cecile Richard, President of the Planned Parenthood Federation of America stated, the FDA’s decision to make emergency contraception available over-the-counter was “a strong statement to American women that their health comes before politics. And that’s the way it should be…. This will help reduce the number of unintended pregnancies and protect the health and safety of all women.”⁴⁶

Ryan Sutherland is a first-year graduate student at the Yale School of Public Health (YSPH). Francesca Maviglia is a first-year graduate student at YSPH. Julia Spinnenwebte is a second-year graduate student at YSPH and the Yale School of Management. Alejandra Moncayo is a second-year graduate student at YSPH. All authors contributed equally to the article. Ryan can be contacted at ryan.sutherland@yale.edu. 

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