Decades of research show that a majority of adolescents initiate
sex before the age of 18 and that earlier use of contraception reduces
the risk of teen pregnancy.
After reviewing decades of published studies, a team of pediatric,
adolescent and women's health experts concludes that regulatory,
behavioral and scientific evidence supports switching oral
contraceptives from prescription-only status to over-the-counter (OTC)
‘Giving teens easier access to various contraceptives would result in fewer unwanted pregnancies.’
Moreover, the experts say, the evidence also supports OTC access for
teens and adult women, citing studies showing that teens are capable of
safely and properly using "the pill" to prevent unwanted pregnancies.
A report on the literature review was published in the Journal of Adolescent Health
"Our review strongly suggests that giving
teens easier access to various contraceptives will not lead to more sex
but would result in fewer unwanted pregnancies," says Krishna Upadhya,
assistant professor of pediatrics at the Johns Hopkins
University School of Medicine and the paper's lead author.
The review by Upadhya and her colleagues comes as reproductive
health service providers and federal policymakers continue to debate
moving oral contraceptives to OTC status, particularly for teenagers.
Additionally, a partnership between HRA Pharma and Ibis Reproductive
Health to begin an application for an OTC oral contraceptive to the Food
and Drug Administration was recently announced.
For the review, the Johns Hopkins-led team looked for teen-specific
data related to the safety and effectiveness of oral contraceptives,
pregnancy risk associated with typical use of various forms of
contraception, teen ability to use oral contraceptives correctly and
consistently, the impact of OTC access on sexual behaviors, and concerns
that OTC access might reduce clinician counseling opportunities with
The pill is already the most commonly used hormonal method of birth
control by teens and other women of reproductive age in the U.S.,
according to the 2011-2013 National Survey of Family Growth. That survey
estimates that 54% of female ages 15 to 19 have used it.
Proponents of OTC status say easier, wider access to the pill will
further increase contraceptive use, further lowering teen pregnancy
rates and abortion. The Centers for Disease Control and Prevention (CDC)
recently reported that births to teens in the U.S. reached a historic low of 22.3 live births per 1,000 women ages 15 to 19 in 2015. A recent analysis
by one of the paper's authors found that the decline in pregnancy risk
among U.S. teens between 2007 and 2012 was entirely attributable to
increased use of contraception. Critics of OTC status say they fear
wider access would lead to more teen sex, sexually transmitted disease
and the safety concerns of long-term use.
Under FDA laws and regulations, prescription drugs should only be
switched to OTC status if they are safe for self-administration,
effective when self-administered, treat a condition or address a concern
that is self-diagnosable, and can carry labels that are easily
understood and tailored for self-administration. The FDA has previously
established the safety and effectiveness of oral contraceptive pills for
all females post-menarche.
In their review, which included the CDC's
Medical Eligibility Criteria for Contraceptive Use, the research team
found that medical conditions that could increase the risk of serious
side effects among pill users are rare among teens. Oral contraceptives
containing progesterone alone, rather than combined estrogen and
progesterone, are safe for virtually all women. Upadhya also notes that
the risk of blood clots that can cause serious complications like heart
attacks and stroke are up to four times greater during pregnancy than
with use of combined oral contraceptives.
The research team also reviewed existing research regarding teens'
ability to use oral contraceptives consistently and correctly. Upadhya
says studies of adolescent development suggest that most teens have the
reasoning skills to make informed decisions about oral contraceptives.
Because the use of oral contraceptives is a daily behavior not tied to
specific or imminent sexual or emotional pressures - as is the case
with condom use - teens may actually be more likely to use them
consistently. According to Upadhya, the research suggests that factors
like having routines and feeling in control of the decision are more
important to consistent use of pills than age.
In addition, Upadhya says, studies comparing the contraceptive
failure rate in teens versus young women showed no significant
differences, and one study that gauged teens' ability to answer
questions about correct use of oral contraceptives found that 90 percent
answered them correctly.
The team reviewed the impact of FDA action in 2012 making the
hormonal emergency contraceptive marketed as "Plan B" available OTC for
teens. Upadhya and colleagues found that teen use of Plan B increased
from 8% in 2002 to 22% in 2011 to 2013. Increased use
after reduced restrictions demonstrated a need for improved access for
teens, not increased sexual behaviors, posture the researchers, who
assume the same if oral contraceptives were to gain OTC status.
Finally, the researchers considered the potential of OTC status to
negatively impact clinicians' opportunities to counsel teens and provide
additional sexual and reproductive health care. The team found that the
percentage of teens who get recommended annual preventive visits is
already low. According to one study of 14- to 17-year-olds from 2000 to
2004, only 38% received the recommended annual visit, and of
those who did receive a visit, only 40% reported having private
discussions with their clinician. Upadhya says the results suggest that
providing alternative access points outside of clinics, when possible,
is critical to ensuring that all teens in need can use effective
contraceptives. Because not all methods can be self-administered,
however, Upadhya stresses the importance of continued efforts to ensure
that teens have contraceptive visits with clinicians.
"Oral contraceptives are popular, safe and effective methods of
pregnancy prevention for women and teens. Our review emphasizes that any
future over-the-counter pill has the potential to benefit teens, and
there is no scientific rationale to restrict access based on age,"