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Plan B®: Does Over the Counter Availability of Emergency Contraception Increase the Incidence of Risky Adolescent Behavior?

By Stephanie Crews

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Image from http://www.go2planb.com

 

Background

What is Plan B®  

How does it work?

Research on emergency contraception and adolescents

Conclusion

References

 

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Background                                                          

 

As of August 2006, the United States Food and Drug Administration (FDA) finally allowed the sales of  Plan B®, an emergency contraceptive (EC),  without a prescription for women 18 years and older. Nonetheless, it is only a partial solution that leaves young women without equal access to healthcare. The compromise was unnecessarily long and complicated, made so by some FDA officials playing politics when they should have been serving science.

It all began in 2003 when the FDA held a meeting with a panel of medical and scientific experts in response to receiving an application from Barr Pharmaceuticals, the manufacturer of Plan B® (Food and Drug Administration, 2004). Barr wanted to switch the drug from prescription to nonprescription status as a way to speed up the process of obtaining and taking the medicine, a crucial part of its effectiveness. At the conclusion of this meeting, the FDA went against the advice of its own scientific experts and blocked the application for non-prescription sales of Plan B® (FDA, 2004). The decision was controversial; the FDA was accused of making its decision based on moral concerns that played into the hands of a small, but very vocal, contingency who wished to impose their brand of righteousness on society rather than on scientific grounds. Debates about making the drug over the counter have not centered on the safety of the drug itself, but on the harmful effects some people claim it will have on women’s behavior, particularly adolescents. Opponents claim that the over the counter accessibility will encourage unprotected sex, increase abuse of emergency contraception, undermine the use of more reliable methods of contraception, and lead to increased promiscuity and pregnancy among adolescents (FDA, 2006). Despite the concern that access to EC may encourage sexual risk-taking, data from several studies supports the position that there is no justification to withhold Plan B® from adolescents.

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What is Plan B

 

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Plan B® a backup method to birth control. It contains a synthetic form of the hormone progesterone in the form of two levonorgestrel pills that are taken by mouth after another form of contraception fails (Women's Capital Corporation, 2006). For example, it is ideal when:  a condom breaks, after unprotected sex, or if someone is raped (U.S. Department of Health and Human Services, 2005). Levonorgestrel is not a hormone that is exclusive to Plan B®, or EC in particular; many popular brands of oral contraceptives (the pill) contain this hormone. Plan B can

reduce the chances of a woman becoming pregnant when taken within 72 hours of unprotected sex. As expected, the quicker it is taken, the more effective it will be; hence, the heated debates over making the drug more accessible. Prior to this action, Plan B was available only by prescription. So if a female does not have a primary caregiver or access to programs such as Planned Parenthood, she is more likely to have an abortion or become another teen statistic. Many young women have not had a chance to establish a good relationship with a provider, and although such a connection needs to be formed, a woman should not be kept from treatment if she does not have a clinician to prescribe her the pill. More importantly, since there is a window of time that the pill must be taken, and the sooner it gets in the system the more effective it will be, it is very crucial for a women to not have to go around trying to figure out where she can go to get EC or schedule an appointment in a doctor’s office.

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How does it work?

 

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Besides the argument that easy access will lead to risky behaviors, many of the attempts to restrict access to the drug are based on the view that taking EC is comparable to an abortion, but that is a misunderstanding of how the drug works. EC is simply a higher, one-time dose of the hormone progestin that is found in standard contraceptive methods that many women already regularly take including the pill, the patch, injections, and the implantable ring. Thus, it works the same way birth control does: doses of hormones, prevent the ovaries from producing an egg, or prevent implantation of an already fertilized egg (FDA, 2006). To the extent that it works by blocking implantation, it is not an abortion because it does not terminate an already established pregnancy. An established pregnancy, medically speaking, begins when the egg implants itself in the uterus (FDA, 2006).

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Research on emergency contraception and adolescents

 

Although critics claim that over the counter accessibility of  Plan B® will encourage unprotected sex, increase abuse of emergency contraception, undermine the use of more reliable methods of contraception, and lead to increased promiscuity and pregnancy among adolescents, research seeks to address these concerns from a scientific standpoint. The first study of interest sought to “evaluate the effect of direct access to EC through pharmacies and advance provision on reproductive health outcomes” (Raine, Harper, Rocca, Fischer, Padian, Klausner, & Darney, 2005, p. 54). Researchers at the University of California at San Francisco sought to better understand the impact of increased access to emergency contraception on important reproductive health outcomes, including STDs. The study was designed specifically to determine whether providing emergency contraception in advance or directly at a pharmacy would affect EC use or rates of STD infection or pregnancy among young adults and teens (Raine, et al., 2005, p. 55). The study also analyzed whether advance provision and pharmacy access affected use of contraception and condoms as well as sexual behaviors. The “randomized, single-blind, controlled trial” provided participants “ages 15-24 years, attending 4 California clinics” with three different ways of obtaining EC:  direct, non-prescription access from a pharmacy, an advance supply of 3 packets of Plan B®, or clinical access (the control) (Raine et al,. 2005, p. 54). Participants were interviewed, tested for pregnancy and STDs, and given information about EC as well as using condoms to protect against STDs at the time of enrollment; six months later, researchers administered questionnaires, did a second round of tests, and reviewed medical charts (Raine, et al., p. 56). They “screened 4,361 women” and “enrolled and randomized 2,117”, but “167 were lost to follow-up”, making the total results reflecting “1950 women” (Raine et al., 2005, p. 58).

Teens that were given three doses of EC in advance were almost twice as likely to use it at least once, compared to the control group of women who had to return to the clinic for it (Raine, et al., 2005, p. 58). At the same time, women who were given detailed instructions on how to obtain EC directly from a pharmacy were no more likely than the control group to use back-up birth control – indicating that requiring women to go to either a pharmacy or a clinic remains a barrier to EC use. Only a small fraction of women in either the advance provision or pharmacy access group used EC more than once. Upon completion of the trial, it was concluded that “given that there is clear evidence that neither pharmacy access nor advanced provision compromises contraceptive or sexual behavior, it seems unreasonable restrict access to EC through clinics” (Raine et al., 2005, p. 62). There were also no significant differences in patterns of birth control or condom use or sexual behaviors by study group. Teens who had EC on hand or who had instructions on how to get it directly from a pharmacy were no more likely to miss a pill, switch birth control methods, or forego using a condom than women in the clinic access group (Raine, et al., 2005, p. 58-59) . Frequency of intercourse, amount of unprotected sex, and number of sexual partners were also roughly equivalent among women in the advance provision, pharmacy access, and clinic control groups.

The second study of interest literally took the previous study and went one step further. Their goal was to “analyze data on young adolescents with increased access to emergency contraception” (Harper, Cheong, Rocca, Darney, & Raine, 2005, p. 483). Thus, instead of detecting the significant differences in behavior between participants in the pharmacy group, advanced provision, and control group, this research group “examined the influence of young age on use of emergency contraception and sexual risk-taking” (Harper et al. 2005, p. 484). By doing so, Harper and her colleagues were directly addressing the concerns brought up by critics as to why Plan B® was not fit to be over the counter sales. Of the 964 adolescents, 90 of whom were aged younger that 16 years, all were far more likely than adults to rely on condom use, equally capable of taking the drug correctly, and their behavior did not become riskier (Harper et al., 2005, p. 489-90). While it is noted that enhanced access increased its use, it did not increase rates of unprotected intercourse, STDs, or pregnancy (Harper et al., 2005, p. 490). Studies of EC use among young women show increased access to emergency contraception among adolescents does not result in inappropriate use of Plan B®  as a routine form of contraception, nor an increase in number of sexual partners, nor an increase in frequency of unprotected intercourse, nor an increase in the frequency of sexually transmitted diseases (Harper et al., 2005, p. 489). The implications of this study is that “adolescents aged younger than 16 years behaved no differently in response to increased access to emergency contraception (EC) from other age groups” (Harper et al., 2005 p. 483). The bigger picture is that not providing emergency contraception to adolescents in advance does not increase rates of abstinence or postponement of sexual activity. If adolescents perceive obstacles to obtaining contraception and condoms, they are more likely to experience negative outcomes to sexual activity.

These are just two of many recent studies pertaining to EC and adolescents. A study from Mexico showed that use of emergency contraceptives was significantly associated with an increased probability of condom use at last sexual intercourse among adolescents (Walker, D.M., Torres, P., Gutierrez, J.P., Flemming, K., & Bertozzi, S.M., 2004 p.329). Here they showed that easier access to and more information concerning EC does not decrease the likelihood that adolescents will disregard more reliable forms of contraception, particularly the condom (Walker, et al., 2004 p.329).

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Conclusion

 

            While antagonists contend that enhanced access to the emergency contraceptive, Plan B® will increase the risky behavior of adolescents, the studies mentioned above provide no evidence to support these arguments. It is important to note that these studies have limitations and to date are small in number. Nonetheless, they still have important policy implication; these studies add to the growing body of literature that demonstrates that there are no negative behavioral or health ramifications to making EC available outside the confines of a health care visit. The main lesson that can be learned from these studies is that teenagers under the age of 18 should not be excluded from having up-front, easy access to Plan B® . There is no evidence from these studies to suggest that providing Plan B® over the counter causes adolescents to have more unprotected intercourse or less consistent contraceptive use. It is true that Plan B® remains difficult to access in a timely manner from health care providers and is not always readily available from pharmacies. This data supports the recommendation that if Plan B® is provided in advance; the likelihood that it will be taken during the most effective time frame without having an adverse effect on sexual or contraceptive risk-taking behavior increases. Expanding access to emergency contraception impacts women's ability to use the product – period.

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References

 

Food and Drug Administration. (2004).Retrieved on September 16, 2006, from http://www.fda.         gov/cder /drug/infopage/planB/planB_NALetter.pdf

… (2006) Retrived on September 16, 2006, from http://www.fda.gov/cder/drug/infopage/ /planBQandA.htm

Harper, C.C., Cheong, M., Rocca, C.H., Darney, P.D., & Raine T.R. (2005). The Effect of Increased Access to Emergency Contraception Among Young Adolescents. Obstetrics and Gynecology, 106, 483-491.

Marston, C., Meltzer, H., & Majeed, A. (2005). Impact on Contraceptive Practice of Making Emergency Hormonal Contraception Available Over the Counter in Great Britain: Repeated Cross Sectional Surveys. BMJ.

NARAL Pro-Choice New York. Retrieved September 15, 2006 from      http://backupyourbirthcontrol.org/materials/link.htm

Raine, T.R., Harper, C.C., Rocca, C.H., Fischer, R., Padian, N., Klausner, J.D., & Darney, P.D. (2005). Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs: A Randomized Clinical Trial. The Journal of the American Medical Association, 293, 54-62.

United States Department of Health and Human Services.(2005). Retrieved September 16, 2006, from http://www.4woman.gov/faq/econtracep.htm#a

Walker, D.M., Torres, P., Gutierrez, J.P., Flemming, K., & Bertozzi, S.M. (2004). Emergency contraception Use is Correlated with Increased Condom Use among Adolescents: Results from Mexico. Journal of Adolescent Health, 35, 329-334.

Women's Capital Corporation. (2006). Retrieved September 15, 2006 from      http://www.go2planb.com

 

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