Hailey Stokes- Birth Control and Adolescents

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1 Birth Control and Adolescents Birth Control and Adolescents: The Effect of Over the Counter Birth Control Access on Unwanted Pregnancy Rates in Adolescents Hailey Stokes University of Kentucky

2 Birth Control and Adolescents Abstract Birth control options are wider now than ever before. The recent FDA approval of a current birth control option, a progesterone only pill, in an over the counter format will allow for women to obtain birth control prescription free. This may have implications for women, especially those who deal with varying factors of access. Specially, adolescents may have a change in birth control usage if there is an option that is easier to access in their community. The same could potentially be said for those in contraceptive deserts than have a harder time with accessibility. However, there has been no over the counter pharmaceutical option offered before in the United States. Due to the novelty of this, research dealing with an over the counter birth control is not available in a non-hypothetical format. In an attempt to bridge this knowledge gap as the FDA approval occurs, observation of the unwanted pregnancy rate in adolescents before and after the over the counter method is introduced would provide actual data for the United States. A total of three counties will be observed, all noted to be contraceptive deserts, where high school juniors will be surveyed before and after the FDA approval. It is hypothesized that the rate of unwanted pregnancies will decrease due to the additional accessible option. The findings of this study may benefit research into better providing birth control options to adolescents and simultaneously reducing unwanted pregnancy rates.

3 Birth Control and Adolescents Birth Control and Adolescents: The Effect of Over the Counter Birth Control Access on Unwanted Pregnancy Rates in Adolescents Birth control methods have varied widely throughout the years, and the introduction to hormone-based contraception has been revolutionary. In the US, the most common form of reversible birth control are pills (Long et al. 2023). The FDA is approving a birth control pill that is progesterone only called Opill (Long et al. 2023). This contraceptive method works for users by thickening cervical mucus, preventing sperm from contact with an egg (Mayo Clinic 2023). It often prevents ovulation in about half of users (Mayo Clinic 2023). The pregnancy rate with use is as low as 1 in 100 users with perfect use, with the most being 9 out of 100 getting pregnant within the first year of use (Mayo Clinic 2023). A downside to a contraceptive pill is that it relies on users to take it at the same time every day with no gaps in usage, and this can lead to a higher rate of user error. It is essential to study the effect of higher accessibility to an over the counter birth control option on unwanted pregnancy rates as it is introduced as an option, specifically for adolescents. The rate of unwanted pregnancies is highest for this age group and further research would work to understand the effect this newly approved drug would have on the rate of unwanted pregnancies, if any. Literature Review Accessibility and Unwanted Pregnancy Rates Accessibility is related to factors such as cost, transportation, and location. For some, cost determines whether they can afford the medication itself. For others, being able to get to a healthcare facility so a prescription can be obtained is a struggle. For many people desiring contraceptives, both factors limit options and contribute to a higher unwanted pregnancy rate.

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4 Birth Control and Adolescents Cost Per Birth Control Pack and its Effect on Contraceptive Use Frost et al. (2007) conducted a qualitative study where 1,978 adult women at risk of unintended pregnancy were surveyed. Sample size was collected through a random digit dial generation, allowing for a sample size that included women across the nation (Frost et al. 2007). 23% of these women surveyed had gaps in contraception use, and 5% of these women cited the expense of the birth control as the reason (Frost et al. 2007). Additionally, in a study by Grindlay and Grossman, a cross section survey was done using 2,026 women nationwide through a KnowledgePanel (2007). The goal of this panel was to determine the interest in a progestin-only pill for sexually active women ages 15-44 (Grindlay and Grossman 2007). This study found that the price adults were willing to pay for birth control out of pocket per month was $15 and teenagers reported a willingness to pay $10 (Grindlay and Grossman 2007). It is also found that 39% of adults and 29% of teens would consider using a progestin-only pill, and coverage by insurance was associated with a more willingness to use this contraceptive (Grindlay and Grossman 2007). Overall, both of these studies found that expense was a factor in contraceptive use. The second study had a wider, more accurate sample size due to the use of KnowledgePanel, but both had nation-wide coverage of the United States. This has many implications regarding an over the counter birth control that can have a higher variation in price. Low-income Accessibility in Relation to Ability to Visit Providers Most birth control options require a prescription. However, accessibility to a provider in order to obtain this prescription can be challenging. Transportation, copays, and time off of work are jut a few of the factors that affect how often patients can visit their providers. From the previously mentioned qualitative survey by Frost et al., there were also key findings that out of

5 Birth Control and Adolescents the 23% of women who reported a gap in contraceptive use, 5% reported it was related to not having the time to get a medical visit required for being prescribed a method of contraception (2007). This survey also looked at the demographics of the women who had a gap in contraceptive use and found that more women who were above 100% of the federal poverty level were more likely to have a gap in contraceptive use than those who were below (Frost et al. 2007). Additionally, in a study called the Border Contraceptive Access Study by Potter et al., convenience sampling was used to determine the rates of continuation of oral contraceptive pills for women who receive contraception over the counter in Mexico versus from family planning clinics in the United States (2013). 1,046 women participated in this survey, with the only criteria being that they must be oral contraceptive users, obtain their contraceptive from a family planning clinic in El Paso or from a pharmacy in Mexico, an El Paso resident, and ages 18-44 (Potter et al. 2013). Key results from this study include that there was more discontinuation of use associated with women who obtained their contraceptive from El Paso clinics (Potter et al. 2013). There was also an association between number of pill packs and discontinuation rates, where women who received only 1-5 pill packs from the clinic compared to those who received six or more pill packs from the clinic and those with a contraceptive obtained from Mexico (Potter et al. 2013). This study highlights that when a prescription is required, as well as frequency of doctor visits, less adherence to contraceptive use is likely. Both studies mention that it would lead to increased continuation of contraceptive use if a medical visit was not required for obtaining an oral contraceptive. Both focus on United States citizens, however the study by Frost et al. is qualitative and has a high risk of recall bias in answers. It also relied on telephone usage, so it may not include women who do not have access

6 Birth Control and Adolescents to a phone or are not around their phone often. The Border Contraceptive Access Study was quantitative and had less of a recall bias, but a smaller sample size that was limited to a town close enough to the United States-Mexico border than travel between the countries was feasible for residents. Unwanted Pregnancy Rates for Low-income Areas An important aspect to cover is unwanted pregnancy rates. Specifically, this over the counter birth control may have a larger effect in low income areas. Finer and Zolna had the goal of calculating the pregnancy rates in 2008 and 2011 and categorizing these rates based on intentions and outcomes (2016). The data used for these calculations came from the National Survey of Family Growth, National Center for Health Statistics, and other nationwide surveys on abortion, pregnancy rates, birth count, miscarriages (Finer & Zolna 2016). The results of this study relevant to unwanted pregnancy rates was that the rates of those below the federal poverty were higher, two to three times above the national average (Finer & Zolna 2016). Foster et al. (2015) also successfully predicted the effect of non-prescription oral contraceptive pills on usage, unintended pregnancy rate, and pregnancy associated costs for low income women through models. These figures have data representing the nation and predicts two scenarios estimating a high and low amount of over the counter contraceptive use (Foster et al. 2015). Importantly, this study takes into consideration the out of pocket cost and varies this to represent the likelihood women would use the contraceptive for different price ranges (Foster et al. 2015). This prediction found that the rate of unintended pregnancies could be reduced in the low model at notable rates: 11%, 15%, or 7% reduction in unintended pregnancy rates depending on if the over the counter contraceptive pill has no change in the rate of birth control failure, reduces the failure rate, or increases the failure rate, for each percentage in respectively (Foster et

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7 Birth Control and Adolescents al. 2015). For the high model, results were estimated to be even higher, with a 18% reduction in pregnancy number with no change to the failure rate, 25% if the introduction reduced the failure rate of the contraceptive by half, and 12% if it increases by half (Foster et al. 2015). It is important to note in both of these scenarios, these models were based on a zero dollar copay (Foster et al. 2015). Both of these studies found that unwanted pregnancy rates for lower income levels are higher than the national average. Notedly, the study by Foster et al. (2015) choses this as a point of focus for the model to determine how these rates may be altered by this new introduction of an over the counter contraceptive pill. Adolescents and Unwanted Pregnancy Rates For adolescents, even more factors come into play. The lack of contraceptives can lead to unwanted pregnancies, which are extremely hard on adolescents physically, mentally, financially, and emotionally. This age group has high unwanted pregnancy rates, and accessibility to contraceptives may be more difficult to obtain due to a variety of factors. In the previously mentioned study by Finer and Zolna, there was also important data in regard to unwanted pregnancy, where there was decline in all age groups in the number of unwanted pregnancies (Finer & Zolna 2016). However, adolescents have the largest percentage of unintended pregnancies, at a staggering 91% of total pregnancies being unintended in 008 and 72% in 2011 for age group 15-17 years (Finer & Zolna 2016). Kost et al. created their estimates on pregnancy, birth, and abortion by looking at a variety of national and state level sources and took into account that CDC has fluctuations in reports from the state level by using a base year and a maximum amount of 4% change between the years to eliminate any inaccuracies (2017). These estimates found that women 17 years and

8 Birth Control and Adolescents younger are most likely to have an unwanted pregnancy, and 68% of these pregnancies measured were unintended. Additionally, even if it was reported as intended, another 68% of these women were unsure if they wanted the baby (Kost et al. 2017). Both of these studies report that adolescents were most likely to have an unwanted pregnancy. While neither discuss the factors that lead to these high rates accessibility, sexual education, and contraceptive failure rates may play a part. While overall pregnancy rates are lowered, it does not address that a high percentage of these pregnancies are still unintended. Financial Implications for Both Healthcare Systems and Patients With the introduction of an over the counter birth control options, many question about cost have been brought up. The financial implications of an over the counter birth control options vary, but at present the healthcare system and women who have an unexpected pregnancy are often financially burdened. Potential to Save Healthcare Systems Money In order to keep a birth control method available, it must make keep both the manufacturer and the healthcare system of America in a good financial position. In a study by Osterman et al. for the National Vital Statistics Reports, the goal was to report the birth trends and categorize and interpret them due to the factor related to the births (2022). Methodology for this study included tabulating data of 3.61 million births, 100% of those in the United States and DC (Osterman et al. 2022). For any data that did not meet the NCHS standards of reliability, the Clopper-Pearson methos was applied to those who had fewer than twenty births (Osterman et al. 2022). Results indicate that compared to other age groups, women under 20 had the largest percentage of women where primary payment of delivery was through Medicaid, at 78.4% (Osterman et al. 2022).

9 Birth Control and Adolescents In reference to the previously mentioned study by Foster et al. with the goal to predict the effect of non-prescription oral contraceptive pills on usage, unintended pregnancy rate, and pregnancy associated costs for low income women, there were also important findings related to healthcare system costs when the out of pocket price was at zero dollars (2015). The model based on low usage of the over the counter oral contraceptive noted savings of less than 1% (rate of contraceptive failure is unchanged), 4% (rate of contraceptive failure is reduced by half), and increase in cost by 3% (rate of contraceptive failure is increased by half) (Foster et al. 2015). For the model based on high usage of the over the counter oral contraceptive noted savings of less than 6% (rate of contraceptive failure is unchanged), 12% (rate of contraceptive failure is reduced by half), and less than 1% (rate of contraceptive failure is increased by half) (Foster et al. 2015). Overall, the first study indicated that younger mothers required more financial assistance from the government, which often puts more of a financial burden to the healthcare system. Building on the data presented in the first study, the second study applies this thought into a theoretical model that indicates healthcare systems could potentially save money by introducing this contraceptive. Both indicate that the introduction of a new contraceptive option would be economically beneficial. Potential to Save Contraceptive Users Money Additionally, a birth control method will not be feasibly if it is not within the budge of the target audience. In the study by Trussell et al. the goal was to determine cost effectiveness of contraceptives using a Markov model and sensitivity analysis based on published data (2013). Key findings were that all measured measures of contraception, including the contraceptive pill, were cost effective when compared to no method of contraceptive (Trussell et al. 2013). This is

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10 Birth Control and Adolescents due to the high cost of pregnancy and childcare on a family, making annual expense much higher when having to account for an abortion or future childcare costs compared to a contraceptive method. On a slightly different note, the Kaiser Family Foundation (KFF) conduct an annual Women’s Health Survey, and one of the objectives of the survey was to determine general interest in an over the counter contraceptive pill (Long et al. 2022). It is generated through online and telephone using a tool called Opinion Panel and includes additional data from KnowledgePanel to include those that are unlikely to have access to a phone or other device (Long et al. 2022). It was a qualitative assessment, using a probability based panel and data was weighed to represent adults ages 18 to 64 (Long et al. 2022). Results from this survey indicated that some women would use an over the counter contraceptive pill because they believe an over the counter birth contraceptive pill would save them money, specifically 16% of uninsured women and 5% of privately insured women (Long et al. 2022). The difference in uninsured and insured rates are likely due to the higher out of pocket cost to get an appointment to get a birth control prescribed, plus an overall higher out of pocket cost for birth control. Both studies focus on contraceptive costs and how it would save users money. When an unintended pregnancy occurs, there is an immediate financial burden put on women in the form of abortion or appointments with prenatal care, delivery, and postnatal care. Trussell et al. had more of this financial focus for their research. However, in the KFF report, the focus was rather on how women felt switching contraceptive care would save them costs, rather than a comparison of contraceptive cost versus unintended pregnancy costs. Overall, both studies agree that contraceptive care and innovation in this field helps to save money for consumers. Critique of Existing Literature

11 Birth Control and Adolescents When comparing the previous literature, it is clear that this would be the first study of this kind in the United States, as FDA. A study has not been done in the United States before, and this would help determine what effect an over the counter birth control pills has. Again, it is essential to study the effect of higher accessibility to an over the counter birth control option on unwanted pregnancy rates as it is introduced as an option, specifically for adolescents. The rate of unwanted pregnancies is highest for this age group and further research would work to understand the difference this newly approved drug would have, if any. Regarding the strengths of the current studies are that the rates of current birth control usage have been addressed, and the link between accessibility to healthcare providers and birth control usage has been established. It is well known that accessibility does play a role into how often women partake in birth control. Many of these studies have the advantage of large sample sizes that have data that spans nationwide. However, the overall weakness of the studies at hand, as Michael J. Rosenberg and Michael S. Waugh mention in their research, is that the reason for birth control discontinuation in adolescents is often not clear (1998). The suggested study would help eliminate some of this question, as it would help determine to what extent cost and accessibility play in discontinuation. Also, the Border Contraceptive Access Study had the disadvantage of trying to collect data from two different countries, where exact information about contraceptive from Mexico was hard to obtain. As a general review, all the studies so far lack any actual data based on the effect of an over the counter contraceptive pill for the United States. This is not due to a lack of interest; obtaining data has not been feasible until FDA approval arrives. The current studies can only gauge the interest of people through qualitative means to determine whether or not people are

12 Birth Control and Adolescents likely to be affected by this change in legislation or compare to other countries. There is no current data for the United States that has determined by looking at one community with both an over the counter and prescription option for oral contraceptive and effect on unwanted pregnancy rates. The next step would be to run a study to get actual data for the United States for before and after the over the counter oral contraceptive becomes available to compare how birth control usage and unwanted pregnancy rates vary. I hypothesize that after Opill is available over the counter, this higher accessibility will result in a decrease in the unwanted pregnancy rates for low income adolescents. Methods Participants Those participants studied would be low income female adolescents ages 14-17 in America. Participants will be recruited by going to all local schools and having the survey provided for all females in a health class. All students would be juniors in high school of varying ages. Consent forms will be provided due to the sensitive subject matter and age restrictions. Anonymity would be assured, and no responses without a consent form will be used. Eligibility criteria will be that an adolescent conceived a child, had an abortion, or miscarried. An additional survey question will then narrow down whether this pregnancy was wanted or unwanted, but any adolescent who has had a pregnancy in the last 12 months is the target population. Cluster sampling will be used, with three low income areas being surveyed and unwanted pregnancy rates compared. Liberty County, Texas; Hardin County, Kentucky; and Hamilton County, Indiana were all selected due to the high poverty rates and contraceptive deserts. These rates were all above the national average for both categories, indicating these areas would be satisfactory for

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13 Birth Control and Adolescents measuring a low income population of adolescents that would potentially have higher access to birth control upon introduction of an over the counter contraceptive. Procedure For this study, the proposed procedure is conducted through a survey. This survey will be done with the control group in the respective counties before the FDA approves the new contraceptive method. After the over the counter method is an available option in these communities at local pharmacies for 12 months, the survey will be conducted again in these communities. This is not a longitudinal study due to the difficulty of tracking down participants. The same survey will be given in the health classes to the female juniors, and then aggregated rates of unwanted pregnancies would be compared. This will ensure that if there is a change in the rate of unwanted pregnancies, it will be noted in the change between the control and the same population after. The survey will be conducted through these communities online. To get a wide variety of responses from this community, the survey will be online through SQL Server Reporting Services (SSRS) Opinion Panel. To account for those in communities with no internet access, an additional measure of invitation will be on paper in the health classrooms. The survey itself will be designed using feedback from SSRS to ensure clarity. The survey will be a modified version of the Kaiser Family Foundation Women’s Health Survey, with additional questions to account for the new over the counter birth control option and if the pregnancy was planned. To ensure the intended population is being measured, additional survey questions will ask for household income level and level of transportation access. Measures

14 Birth Control and Adolescents The variables being studied are access to over the counter birth control and effect on unwanted pregnancy rates. The conceptual definition of access to over the counter birth control is that there is an ability to purchase and use this birth control method. The conceptual definition of an unwanted pregnancy is a woman became pregnant or conceived a child that was not planned at the time of conception or beforehand. Access to the over the counter birth control will be measured by looking at income, location, transportation, and legality of over the counter birth control starting once the FDA approves the drug for use using the survey items. Unwanted pregnancy rate will be determined by survey, asking whether or not a woman had a pregnancy and then a secondary question of if this pregnancy was planned and wanted. The survey reliability itself will be measured to have a Cronbach’s alpha value of 0.70 or greater. Internal validity will be measured by asking questions in multiple ways to ensure the responses are consistent. Data Analysis Data analysists will use an independent samples t -test. This will measure the mean difference in the communities between the rate of unwanted pregnancies before the introduction of the over the counter birth control and after. It will also allow for conclusions to be drawn about accessibility rates and if this changes with the additional birth control option. Discussion/Conclusion Potential results of this study would be a significant decrease in unwanted pregnancy rates with the introduction of the over the counter birth control option. Ideally, this result along with the demographic information would give insight into how close the location to purchase this option must be to have an optimal decrease in birth control rates. This research could be

15 Birth Control and Adolescents implemented in more communities to provide more adolescents with the opportunity to avoid an unwanted pregnancy in communities that have lower accessibility rates. This study has several limitations. Since it was done with juniors in high school, there is a larger concentration of females in the 15-17 range, so there may not as applicable to a wider age range of adolescents. Another limitation is the lack of uniformity among states and what states offer coverage for this over the counter birth control. The states without inclusion of this new drug in their formulary list may have lower rates of use due to price differences in options. This may lead to less users in certain states. Since the survey is self-reported, numbers may be reported at a lower rate that actual unwanted pregnancies due to the sensitive nature of the survey. The need for parental consent to take the survey may also affect the population of adolescents that are able to take the survey. Additionally, this new birth control option may not be carried in every pharmacy in the community or may be out of stock due to high demand. This is beyond the control of the study and would affect usage rates. For future research, further comparison of how this over the counter method affects larger populations. These three counties may not reflect the diversity of the United States, so research with larger populations would be beneficial. Additionally, this study is not longitudinal, and habits of the adolescents may change over time. More research to see if the over the counter option is used for a longer period of time would help expand the information on the drug use by adolescents. While there are many ways to expand, this research serves as a starting point for baseline information on adolescents and birth control usage for future research. Overall, there is a need for research on the over the counter option. Many factors come into play when it comes to choosing a method of contraceptive, especially for adolescents. Accessibility is a huge part of healthcare research and important to understand in order to best

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16 Birth Control and Adolescents serve the population of the United States. This research serves to further the knowledge we have in all of these topics in an effort for a better healthcare system.

17 Birth Control and Adolescents References Finer, L. B., & Zolna, M. R. (2016). Declines in unintended pregnancy in the United States, 2008–2011. New England Journal of Medicine , 374 (9), 843–852. https://doi.org/10.1056/nejmsa1506575 Foster, D. G., Biggs, M. A., Phillips, K. A., Grindlay, K., & Grossman, D. (2015). Potential public sector cost-savings from over-the-counter access to oral contraceptives. Contraception , 91 (5), 373–379. https://doi.org/10.1016/j.contraception.2015.01.010 Frost, J. J., Singh, S., & Finer, L. B. (2007). U.S. women’s one-year contraceptive use patterns, 2004. Perspectives on Sexual and Reproductive Health , 39 (1), 48–55. https://doi.org/10.1363/3904807 Grindlay, K., & Grossman, D. (2018). Interest in over-the-counter access to a progestin-only pill among women in the United States. Women’s Health Issues , 28 (2), 144–151. https://doi.org/10.1016/j.whi.2017.11.006 Kost, K., Maddow-Zimet, I., & Arpaia, A. (2023, January 18). Pregnancies, births and abortions among adolescents and young women in the United States, 2013: National and State Trends by age, race and ethnicity . Guttmacher Institute. https://www.guttmacher.org/report/us-adolescent-pregnancy-trends-2013 Long, M., Diep, K., Sobel, L., & Salganicoff, A. (2023, September 14). Over-the-counter oral contraceptive pills . Kaiser Family Foundation. https://www.kff.org/womens-health- policy/issue-brief/over-the-counter-oral-contraceptive-pills/ Long, M., Frederiksen, B., Ranji, U., & Salganicoff, A. (2022, November 03). Interest in using over-the-counter oral contraceptive pills: Findings from the 2022 KFF Women’s Health Survey . Kaiser Family Foundation. https://www.kff.org/womens-health-policy/issue- brief/interest-using-over-the-counter-oral-contraceptive-pills-findings-2022-kff-womens- health-survey/ Mayo Clinic. (2023, January 13). Minipill (progestin-only birth control pill) . https://www.mayoclinic.org/tests-procedures/minipill/about/pac-20388306 Osterman, M. J. K., Hamilton, B. E., Martin, J. A., Driscoll, A. K., & Valenzuela, C. P. (2022, February 7). National Vital Statistics reports . CDC. https://www.cdc.gov/nchs/data/nvsr/nvsr70/nvsr70-17.pdf Potter, J. E., McKinnon, S., Hopkins, K., Amastae, J., Shedlin, M. G., Powers, D. A., & Grossman, D. (2011). Continuation of prescribed compared with over-the-counter oral contraceptives. Obstetrics & Gynecology , 117 (3), 551–557. https://doi.org/10.1097/aog.0b013e31820afc46

18 Birth Control and Adolescents Rosenberg, M. J., & Waugh, M. S. (1998). Oral contraceptive discontinuation: A prospective evaluation of frequency and reasons. American Journal of Obstetrics and Gynecology , 179 (3), 577–582. https://doi.org/10.1016/s0002-9378(98)70047-x Trussell, J., Lalla, A. M., Doan, Q. V., Reyes, E., Pinto, L., & Gricar, J. (2009). Cost effectiveness of contraceptives in the United States. Contraception , 79 (1), 5–14. https://doi.org/10.1016/j.contraception.2008.08.003

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