Plan B and Teens
Editor's Note:
On December 7, Kathleen Sebelius, Secretary of the Department of Health and Human Services, announced that she was overriding the recommendations of the US Food and Drug Administration and would not allow Plan B One-Step® (Teva Women's Health, Inc; Woodcliff Lake, New Jersey), an agent used for emergency contraception (EC), to be sold over the counter to women under the age of 17 years. This decision sparked an immediate reaction from a number of groups, including the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists (ACOG), and the Society for Adolescent Health and Medicine (SAHM) which issued a joint statement denouncing the decision. Medscape spoke with Cora Collette Breuner, MD, MPH, a member of the Division of Adolescent Medicine at Seattle Children's Hospital, Professor of Pediatrics at the University Of Washington School of Medicine, and a member of the AAP's National Committee on Adolescence, about the implications of this decision for pediatric providers. Dr. Breuner is the lead author of the upcoming revised policy statement from AAP on EC, which is scheduled to be released in 2012.
Medscape: In her statement, Secretary Sebelius cited concerns that research has not demonstrated the safety of Plan B in the youngest group of teens and preteens. Can you speak to this specific issue?
Dr. Breuner: Noting that some girls begin menstruating at age 11 years, Secretary Sibelius cited concerns that Plan B was not studied in that age group and, therefore, shouldn't be available to them. However, this concern does not address the true issue, which is the teen birth rate of 39.1 per 1000 in the 15- to 19-year age group. While it is certainly less than that in the 11- to 12-year-old group, I don't think that attention should be spent on whether or not this medication has been effectively studied in these young girls. The key is that it has been studied in adolescents, as have birth control pills in general.
The biggest issue is that this is an extremely effective means of preventing unintended pregnancy, which in our country is at least twice -- if not 3 times -- what it is in most other developed countries in the world.
Medscape: The joint statement from your organization noted a recent study from the Centers for Disease Control and Prevention concluding that adolescent pregnancy rates hit a record low in 2010, with the numbers declining over the last 3 years. Is it known whether, and how much, Plan B has contributed to this decline?
Dr. Breuner: That's unknown. The live birth rate has decreased from 61.8/1000 15- to 19-year-old teenagers in the early 1990s to a rate of 39.1/1000 in 2009. However, that is still a number that is unacceptable. In Canada, the teen birth rate is 14/1000. In Germany, it is less than that, about 10/1000, and even lower in Italy where it is 7/1000.That it has gone down is wonderful. Determining credit for it depends on one's perspective.
Some of it is that kids are less sexually active now than they used to be. The percentage of teens that are sexually active by the time they hit their senior year of high school has decreased from over 51.1% in 1988 to 42.6%, according to data from the period between 2006 and 2010, a rate that varies by race and ethnicity. So that's part of it.
That is certainly not the only reason why the numbers have gone down. I think the other reasons do include use of contraception, which includes condoms and hormones. While abortion may be a factor, I don't think it's as available or as accessible to kids as it used to be. So I don't think that's the reason.
Addressing the fact that EC is a very effective means of preventing an unintended pregnancy, reducing risk by 75%-85%, is extremely important, recognizing that probably 10%-15% of all teenagers that do have sex before the age of 19 years have intercourse that is nonconsensual. Not necessarily rape, per se, but it's definitely not something that the teen wants. This is extremely important but is rarely discussed. One out of 10-15 young women are having sex without desiring it. If that sex was unprotected, there is risk for an unintended pregnancy that occurred by nonconsensual means.
Medscape: Plan B has been and will continue to be available for use in younger women by prescription. How widely used is this agent in this population?
Dr. Breuner: The data are hard to really track down. In the 2005 AAP Policy Statement on Emergency Contraception, it was noted that only 52% of teens were even aware that EC existed.
A 2010 study examined use of EC in teenagers that had nonconsensual penetration and concluded that many of these young women did not even realize that they can use EC if they have had nonconsensual sexual intercourse.
So the first thing that adolescent medicine providers are trying to do is to make kids aware that EC exists and that use of this method up to 5 days from nonconsensual and/or unprotected sexual activity can prevent unintended pregnancy. It should be kept in mind, though, that the product is most effective if used within the first 24-48 hours.
That is the big problem here. EC is only available by prescription to girls under 17 years, an age that was decreased from 18 years by the Obama administration in 2009. Older teens or young adult women who might need it have to go to the pharmacist and ask for it. It is not available anywhere out on the shelves. Men cannot purchase it over the counter until they are over 18 years. That is a real barrier to use.
A final caveat, which is extremely important to be aware of, is the expense of EC, which is in the range of $40-$50 per prescription. One of the things that is not addressed by Secretary Sebelius' comment is this issue. While her statement voices concern that 11- or 12-year-olds should not have access to EC, it seems improbable that most girls this age will have $50 to spend on something like this.
The probability that sexually active girls in that age group are having nonconsensual sex is probably quite high, making parental and healthcare provider support and involvement essential.
Medscape: Has use of EC spread to general pediatric practices or is it more commonly prescribed in adolescent clinics, emergency departments, and women's health settings?
Dr. Breuner: We don't have that data. We know that the awareness of EC in pediatric and family medicine providers was quite low in the 1990s. It is much higher now in the teens themselves and is likely higher for professionals also. However, I am unaware of any study that examined the knowledge base of primary care providers, although I think primary care providers, including family medicine physicians and pediatricians, are not as aware of EC as are obstetrician/gynecologists. The media is an important resource in informing the public who, in turn, are asking their practitioners about EC.
Medscape: Some experts advocate providing EC to all sexually active adolescents, even those prescribed alternative contraceptive methods. This group is often nonadherent to contraceptive methods, particularly daily oral contraceptives, and is also likely to engage in spontaneous intercourse. The argument for this practice is that the teen will then have this method available should it be needed and thus will not have to wait for an appointment with a healthcare professional, which may preclude administration within 24-48 hours of unprotected intercourse when use is most effective and may even make administration within 120 hours, the upper limit of administration, difficult. This practice is described in the AAP policy statement. Are there caveats?
Dr. Breuner: One of the questions raised by opponents of EC is whether advanced provision might lead to increased unprotected sex or increased sex in general. The answer to that question is no.
The other question is, does advanced provision lead to more or less unintended pregnancy? That question has not been definitively answered. Many factors can intervene. Teens may lose the medication. Adult women might too. It is an ethical dilemma. There are pharmacists that refuse to provide it, even if you write a prescription for it. A 2003 study of pharmacists' attitudes towards EC use in adolescents found that 57% of pharmacists were unsure of how to use EC. Younger pharmacists, those under 45 years of age, are more comfortable and more aware of prescribing practices. While several states allow pharmacists to prescribe EC, the older pharmacists in this paper were less likely than their younger counterparts to prescribe EC.
Many people think that EC is only effective if administered within 72-96 hours of unprotected intercourse, though it can be administered up to 120 hours later. While not as effective, it does prevent pregnancy up to 5 days after intercourse.
Medscape: The Internet abounds with suggestions for “make your own” emergency contraceptives using common oral contraceptives in place of Plan B. The policy statement provides specific information about types of oral contraceptives that may be used as emergency contraceptives, including dosing. However, AAP's Healthy Children site discusses emergency contraception but does not provide information about this option. This might be interpreted as tacit recognition that input from a healthcare professional is needed. Are there any caveats to use of EC in kids without input from a healthcare professional?
Dr. Breuner: The use of combined oral contraceptives, birth control pills, for EC is from the original Yuzpe method that began in 1974. It is associated with significant nausea and vomiting. While information about this option was included in the 2005 policy statement, the problem with its use is that it is very difficult because of the nausea. It is also fairly complicated, requiring girls to take 2-5 pills at the start and again 12 hours later, leaving providers uncertain as to whether or not the young woman actually takes the pills. Vomiting is also an issue. When the pills are vomited, should they be repeated? It is difficult for the patient to make that decision. If I get a call from a teen who has had unprotected sex and cannot get to a pharmacy but has birth control pills at home, I would say that, yes, they can use this method. But I am certain to tell her she's going to become very nauseated and may vomit.
Plan B is much less likely to cause this problem. Additionally, there are concerns with taking the amount of estrogen that is contained in multiple pills of a combined oral contraceptive. We would prefer that Plan B or a levonorgestrel-only method be used. However, certainly a woman can use this alternative method.
Medscape: Do you have any concluding advice for our readers?
Dr. Breuner: Clinicians must be knowledgeable about the mechanism of action of Plan B. Hormonal EC, including combined and progesterone-only methods, inhibits ovulation, disrupts follicular development, and interferes with the maturation of corpus luteum. These are the same methods by which other hormonal methods of contraception prevent pregnancy. Results of studies evaluating the effect of hormonal EC on the endometrium are conflicting, which means some studies suggest that endometrial, histologic, or biochemical alterations occur after EC when endometrial receptivity of the implantation of a fertilized egg is impaired. Other studies demonstrate little to no effect on the endometrium.
It should be noted that the issue of over-the-counter EC does not include ulipristal acetate (ella®; Watson Pharmaceuticals; Parsippany, New Jersey) which is considered primarily to inhibit or delay ovulation and requires a negative pregnancy test before a prescription should be written. It is important that providers recognize the difference between these agents.
Editor's Note:
On December 7, Kathleen Sebelius, Secretary of the Department of Health and Human Services, announced that she was overriding the recommendations of the US Food and Drug Administration and would not allow Plan B One-Step® (Teva Women's Health, Inc; Woodcliff Lake, New Jersey), an agent used for emergency contraception (EC), to be sold over the counter to women under the age of 17 years. This decision sparked an immediate reaction from a number of groups, including the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists (ACOG), and the Society for Adolescent Health and Medicine (SAHM) which issued a joint statement denouncing the decision. Medscape spoke with Cora Collette Breuner, MD, MPH, a member of the Division of Adolescent Medicine at Seattle Children's Hospital, Professor of Pediatrics at the University Of Washington School of Medicine, and a member of the AAP's National Committee on Adolescence, about the implications of this decision for pediatric providers. Dr. Breuner is the lead author of the upcoming revised policy statement from AAP on EC, which is scheduled to be released in 2012.
Medscape: In her statement, Secretary Sebelius cited concerns that research has not demonstrated the safety of Plan B in the youngest group of teens and preteens. Can you speak to this specific issue?
Dr. Breuner: Noting that some girls begin menstruating at age 11 years, Secretary Sibelius cited concerns that Plan B was not studied in that age group and, therefore, shouldn't be available to them. However, this concern does not address the true issue, which is the teen birth rate of 39.1 per 1000 in the 15- to 19-year age group. While it is certainly less than that in the 11- to 12-year-old group, I don't think that attention should be spent on whether or not this medication has been effectively studied in these young girls. The key is that it has been studied in adolescents, as have birth control pills in general.
The biggest issue is that this is an extremely effective means of preventing unintended pregnancy, which in our country is at least twice -- if not 3 times -- what it is in most other developed countries in the world.
Medscape: The joint statement from your organization noted a recent study from the Centers for Disease Control and Prevention concluding that adolescent pregnancy rates hit a record low in 2010, with the numbers declining over the last 3 years. Is it known whether, and how much, Plan B has contributed to this decline?
Dr. Breuner: That's unknown. The live birth rate has decreased from 61.8/1000 15- to 19-year-old teenagers in the early 1990s to a rate of 39.1/1000 in 2009. However, that is still a number that is unacceptable. In Canada, the teen birth rate is 14/1000. In Germany, it is less than that, about 10/1000, and even lower in Italy where it is 7/1000.That it has gone down is wonderful. Determining credit for it depends on one's perspective.
Some of it is that kids are less sexually active now than they used to be. The percentage of teens that are sexually active by the time they hit their senior year of high school has decreased from over 51.1% in 1988 to 42.6%, according to data from the period between 2006 and 2010, a rate that varies by race and ethnicity. So that's part of it.
That is certainly not the only reason why the numbers have gone down. I think the other reasons do include use of contraception, which includes condoms and hormones. While abortion may be a factor, I don't think it's as available or as accessible to kids as it used to be. So I don't think that's the reason.
Addressing the fact that EC is a very effective means of preventing an unintended pregnancy, reducing risk by 75%-85%, is extremely important, recognizing that probably 10%-15% of all teenagers that do have sex before the age of 19 years have intercourse that is nonconsensual. Not necessarily rape, per se, but it's definitely not something that the teen wants. This is extremely important but is rarely discussed. One out of 10-15 young women are having sex without desiring it. If that sex was unprotected, there is risk for an unintended pregnancy that occurred by nonconsensual means.
Medscape: Plan B has been and will continue to be available for use in younger women by prescription. How widely used is this agent in this population?
Dr. Breuner: The data are hard to really track down. In the 2005 AAP Policy Statement on Emergency Contraception, it was noted that only 52% of teens were even aware that EC existed.
A 2010 study examined use of EC in teenagers that had nonconsensual penetration and concluded that many of these young women did not even realize that they can use EC if they have had nonconsensual sexual intercourse.
So the first thing that adolescent medicine providers are trying to do is to make kids aware that EC exists and that use of this method up to 5 days from nonconsensual and/or unprotected sexual activity can prevent unintended pregnancy. It should be kept in mind, though, that the product is most effective if used within the first 24-48 hours.
That is the big problem here. EC is only available by prescription to girls under 17 years, an age that was decreased from 18 years by the Obama administration in 2009. Older teens or young adult women who might need it have to go to the pharmacist and ask for it. It is not available anywhere out on the shelves. Men cannot purchase it over the counter until they are over 18 years. That is a real barrier to use.
A final caveat, which is extremely important to be aware of, is the expense of EC, which is in the range of $40-$50 per prescription. One of the things that is not addressed by Secretary Sebelius' comment is this issue. While her statement voices concern that 11- or 12-year-olds should not have access to EC, it seems improbable that most girls this age will have $50 to spend on something like this.
The probability that sexually active girls in that age group are having nonconsensual sex is probably quite high, making parental and healthcare provider support and involvement essential.
Medscape: Has use of EC spread to general pediatric practices or is it more commonly prescribed in adolescent clinics, emergency departments, and women's health settings?
Dr. Breuner: We don't have that data. We know that the awareness of EC in pediatric and family medicine providers was quite low in the 1990s. It is much higher now in the teens themselves and is likely higher for professionals also. However, I am unaware of any study that examined the knowledge base of primary care providers, although I think primary care providers, including family medicine physicians and pediatricians, are not as aware of EC as are obstetrician/gynecologists. The media is an important resource in informing the public who, in turn, are asking their practitioners about EC.
Medscape: Some experts advocate providing EC to all sexually active adolescents, even those prescribed alternative contraceptive methods. This group is often nonadherent to contraceptive methods, particularly daily oral contraceptives, and is also likely to engage in spontaneous intercourse. The argument for this practice is that the teen will then have this method available should it be needed and thus will not have to wait for an appointment with a healthcare professional, which may preclude administration within 24-48 hours of unprotected intercourse when use is most effective and may even make administration within 120 hours, the upper limit of administration, difficult. This practice is described in the AAP policy statement. Are there caveats?
Dr. Breuner: One of the questions raised by opponents of EC is whether advanced provision might lead to increased unprotected sex or increased sex in general. The answer to that question is no.
The other question is, does advanced provision lead to more or less unintended pregnancy? That question has not been definitively answered. Many factors can intervene. Teens may lose the medication. Adult women might too. It is an ethical dilemma. There are pharmacists that refuse to provide it, even if you write a prescription for it. A 2003 study of pharmacists' attitudes towards EC use in adolescents found that 57% of pharmacists were unsure of how to use EC. Younger pharmacists, those under 45 years of age, are more comfortable and more aware of prescribing practices. While several states allow pharmacists to prescribe EC, the older pharmacists in this paper were less likely than their younger counterparts to prescribe EC.
Many people think that EC is only effective if administered within 72-96 hours of unprotected intercourse, though it can be administered up to 120 hours later. While not as effective, it does prevent pregnancy up to 5 days after intercourse.
Medscape: The Internet abounds with suggestions for “make your own” emergency contraceptives using common oral contraceptives in place of Plan B. The policy statement provides specific information about types of oral contraceptives that may be used as emergency contraceptives, including dosing. However, AAP's Healthy Children site discusses emergency contraception but does not provide information about this option. This might be interpreted as tacit recognition that input from a healthcare professional is needed. Are there any caveats to use of EC in kids without input from a healthcare professional?
Dr. Breuner: The use of combined oral contraceptives, birth control pills, for EC is from the original Yuzpe method that began in 1974. It is associated with significant nausea and vomiting. While information about this option was included in the 2005 policy statement, the problem with its use is that it is very difficult because of the nausea. It is also fairly complicated, requiring girls to take 2-5 pills at the start and again 12 hours later, leaving providers uncertain as to whether or not the young woman actually takes the pills. Vomiting is also an issue. When the pills are vomited, should they be repeated? It is difficult for the patient to make that decision. If I get a call from a teen who has had unprotected sex and cannot get to a pharmacy but has birth control pills at home, I would say that, yes, they can use this method. But I am certain to tell her she's going to become very nauseated and may vomit.
Plan B is much less likely to cause this problem. Additionally, there are concerns with taking the amount of estrogen that is contained in multiple pills of a combined oral contraceptive. We would prefer that Plan B or a levonorgestrel-only method be used. However, certainly a woman can use this alternative method.
Medscape: Do you have any concluding advice for our readers?
Dr. Breuner: Clinicians must be knowledgeable about the mechanism of action of Plan B. Hormonal EC, including combined and progesterone-only methods, inhibits ovulation, disrupts follicular development, and interferes with the maturation of corpus luteum. These are the same methods by which other hormonal methods of contraception prevent pregnancy. Results of studies evaluating the effect of hormonal EC on the endometrium are conflicting, which means some studies suggest that endometrial, histologic, or biochemical alterations occur after EC when endometrial receptivity of the implantation of a fertilized egg is impaired. Other studies demonstrate little to no effect on the endometrium.
It should be noted that the issue of over-the-counter EC does not include ulipristal acetate (ella®; Watson Pharmaceuticals; Parsippany, New Jersey) which is considered primarily to inhibit or delay ovulation and requires a negative pregnancy test before a prescription should be written. It is important that providers recognize the difference between these agents.