Contraception - Chemical Methods / Hormonal Contraception / Emergency / Morning After Pill

EC Does Not Reduce Pregnancy Rates: Commentary & JAMA Study (1/05)

“…this study should be interpreted as telling us that emergency contraception [EC/MAP] is not of any benefit when given in advance for patients to have on hand, or when easily available from a pharmacist, compared to having to obtain a prescription to use it.  That is ALL this study can tell us.  And that, I’m sure, is not what the authors wanted to tell us.”…

“In fact, they tried to tell us a lot more in their conclusion…”

Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs: A Randomized Controlled Trial  JAMA. 2005; 293:54-62

[Comment: this is a new article in 1/05  JAMA by the strong proponents of OTC EC which shows that, in fact, EC does NOT reduce unwanted pregnancies (reducing unwanted pregnancies is, in fact, the only reason to consider making it OTC).  Comments by AAPLOG member Dr Nate Hoeldtke.]

COMMENTARY

Dr Nate Hoeldtke: “Below I’ve included the abstract and the accompanying editorial. There are several things to note:
 — Randomized study with three groups of 15-24 yr olds:
1) pharmacy access to obtain EC (access from a pharmacist–closer to
an over-the-counter model)
2) given advance supplies of EC (this is what ACOG has recommended all ob/gyns do)
3) clinic access only (need to come in for prescription)
 
“They looked to see if there was any difference in pregnancy rates or
sexually transmitted diseases in the three groups. With advance
supplies the women were twice as likely to use EC as the other two
groups. Interestingly, those who had access to get it from a
pharmacist were not more likely to use it than those had to get a
prescription. But here’s the real kicker: They didn’t show any
difference in pregnancy rates among the three groups.
 
“Here is their first conclusion: While removing the requirement to go
through pharmacists or clinics to obtain EC increases use, the public
health impact may be negligible because of high rates of unprotected
intercourse and relative underutilization of the method.
 
“Here’s their second conclusion: Given that there is clear evidence
that neither pharmacy access nor advance provision compromises
contraceptive or sexual behavior, it seems unreasonable to restrict
access to EC to clinics.
 
“In effect, here is what they are saying: WE DIDN’T SHOW ANY BENEFIT TO MAKING EMERGENCY CONTRACEPTION EASILY AVAILABLE, BUT THERE DIDN’T SEEM TO BE ANY HARM RELATIVE TO THE GROUP THAT HAD TO GET A PRESCRIPTION, SO THEREFORE IT SEEMS UNREASONABLE TO RESTRICT ACCESS. …HUH??
 
“They are so desperate to put out a good spin that they don’t even seem to notice that all the prior hyperbolic claims about how it will
reduce unintended pregnancy by half and all the rest were not
demonstrated in the least in their study.

“In fact, in the  ‘Context’ part of their abstract they state: “It is estimated that half of unintended pregnancies could be averted if emergency contraception (EC) were easily accessible and used.” In the accompanying editorial (included below the abstract) it is noted that perhaps the study period wasn’t long enough to detect a difference in pregnancy rates.

“Well, wait a minute. If that is true, then the same can, and should,
be said regarding any potential negative differences in behavior
regarding use of regular contraception, number of STDs etc–which also weren’t shown to be different between the groups in this study.
 
“If anything, in the strictest construction, this study should be
interpreted as telling us that emergency contraception is not of any
benefit when given in advance for patients to have on hand, or when
easily available from a pharmacist, compared to having to obtain a
prescription to use it. That is ALL this study can tell us.  And that,
I’m sure, is not what the authors wanted to tell us. In fact, they
tried to tell us a lot more in their conclusion.
 
“P.S. Someone forgot to coach the editorial author on the politically
correct way to speak about the mechanism(s) of emergency
contraception. Here is what she says: ‘Women without access to
effective contraception were enthusiastic about the discovery that
certain formulations of contraceptive hormones or hormone receptor
inhibitors could prevent implantation of a fertilized ovum.’
 
“Then this conclusion by the editorialist: ‘The task remains to improve
access to EC by expanding the number and types of facilities where it
can be obtained.’ 

“Based on this study, what rationale can there be to do this since there was no diffence in the studied outcomes? Why waste
precious resources?  She even admits that despite the availability
through pharmacists of EC in many states ‘the effects of this
availability on clinical outcomes and rates of use have not yet been
evaluated.’ This is not evidence based medicine. This is blind
ideology…” 
  
 

STUDY
Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs

A Randomized Controlled Trial

Tina R. Raine, MD, MPH; Cynthia C. Harper, PhD; Corinne H. Rocca, MPH; Richard Fischer, MD; Nancy Padian, PhD; Jeffrey D. Klausner, MD, MPH; Philip D. Darney, MD, MSc

JAMA. 2005;293:54-62.

Context  It is estimated that half of unintended pregnancies could be
averted if emergency contraception (EC) were easily accessible and used.

Objective  To evaluate the effect of direct access to EC through
pharmacies and advance provision on reproductive health outcomes.

Design, Setting, and Participants  A randomized, single-blind,
controlled trial (July 2001-June 2003) of 2117 women, ages 15 to 24
years, attending 4 California clinics providing family planning
services, who were not desiring pregnancy, using long-term hormonal
contraception or requesting EC.

Intervention  Participants were assigned to 1 of the following groups:
(1) pharmacy access to EC; (2) advance provision of 3 packs of
levonorgestrel EC; or (3) clinic access (control).

Main Outcome Measures  Primary outcomes were use of EC, pregnancies, and sexually transmitted infections (STIs) assessed at 6 months; secondary outcomes were changes in contraceptive and condom use and sexual behavior.

Results  Women in the pharmacy access group were no more likely to use EC (24.2%) than controls (21.0%) (P = .25). Women in the advance provision group (37.4%) were almost twice as likely to use EC than controls (21.0%) (P<.001) even though the frequency of unprotected intercourse was similar (39.8% vs 41.0%, respectively, P = .46).

Only half (46.7%) of study participants who had unprotected intercourse used EC over the study period. Eight percent of participants became pregnant and 12% acquired an STI; compared with controls, women in the pharmacy access and advance provision groups did not experience a significant reduction in pregnancy rate (pharmacy access group:
adjusted odds ratio [OR], 0.98; 95% confidence interval [CI],
0.58-1.64; P = .93; advance provision group: OR, 1.10; 95% CI,
0.66-1.84, P = .71) or increase in STIs (pharmacy access group:
adjusted OR, 1.08, 95% CI, 0.71-1.63, P = .73; advance provision
group: OR, 0.94, 95% CI, 0.62-1.44, P = .79). There were no
differences in patterns of contraceptive or condom use or sexual
behaviors by study group.

Conclusions:  While removing the requirement to go through
pharmacists or clinics to obtain EC increases use, the public health impact may be negligible because of high rates of unprotected intercourse and
relative underutilization of the method. Given that there is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to EC to clinics.

Author Affiliations: Center for Reproductive Health Research and
Policy, Department of Obstetrics, Gynecology, and Reproductive
Sciences, University of California, San Francisco (Drs Raine, Harper,
Padian, and Darney and Ms Rocca); Planned Parenthood Mar Monte, San Jose, Calif (Dr Fischer); and San Francisco Department of Public
Health, San Francisco, Calif (Dr Klausner).

—————————————

Placing Emergency Contraception in the Hands of Women

Iris F. Litt, MD

JAMA. 2005;293:98-99.

For more than 50 years, since the successful synthesis of estrogens
and progestins, safe and effective pregnancy prevention has been
possible. Nonetheless, in the United States an estimated 3.5 million
unwanted pregnancies occur annually, one third of which involve
teenagers.1

Among the many possible explanations for this paradox,
barriers to health care figure prominently. For instance, lack of
health insurance, an issue for more than 44 million Americans, creates
a formidable barrier to access. Religious beliefs, concerns about
contraceptive safety, and psychological barriers also contribute.
Contraception may not be sought, especially by teens and other women for whom a physician visit and discussion of sexual behavior may prove embarrassing.

Women without access to effective contraception were enthusiastic
about the discovery that certain formulations of contraceptive
hormones or hormone receptor inhibitors could prevent implantation of
a fertilized ovum. “Morning after” or “emergency contraception” (EC)
provided these women a second chance to prevent an unwanted pregnancy.

When taken within 72 hours of an episode of unprotected intercourse,
the “Yuzpe” regimen (consisting of 2 doses of combined oral
contraceptive pills, with the first taken within 72 hours of
unprotected intercourse and the second, 12 hours later [a total of
100-120 mg of estrogen and 1.0-1.2 mg of progestin, depending on the
formulation of the oral contraceptive pill]) is effective in
preventing pregnancy in 75% of cases.2

As with regular contraception, however, use of these agents has been less frequent than anticipated, and several other factors appear to restrict EC use. For example, patient knowledge of these agents is limited and some physicians are reluctant to prescribe them citing fears that their availability will lead to increased risk-taking behavior, especially among teens.

Some countries, including the United Kingdom, have removed some real
and potential barriers to EC use by making these drugs available
over-the-counter. This approach precludes the need for insurance,
offers timely access, and eliminates the need for a physician visit
for women who would find seeking EC embarrassing or otherwise
difficult to accomplish. Indeed, studies have demonstrated that the
rate of EC use is doubled when it is provided in advance of need.3 In
the United States, 6 states (Washington and Maine, with pilot programs in Alaska, California, New Mexico, and Hawaii) have legislatively sanctioned pharmacy access to EC without needing a physician’s prescription,4-5 but the effects of this availability on clinical outcomes and rates of use have not yet been evaluated.

In this issue of JAMA, Raine and colleagues6 report important data on
the effect of access to EC on clinical outcomes. In their study, 2117
young women 15 to 24 years of age were randomly assigned to pharmacy access without a prescription, advance provision, or usual care that required a clinic visit to obtain EC. The authors assessed the effects of increased access on pregnancy rates, acquisition of new sexually transmitted infections (STIs), contraceptive use, and sexual
behaviors. Strengths of this study include the large number of women
enrolled and the use of biomarkers, rather than self-report, for most
of the outcome measures, including tests for diagnosis of Chlamydia
trachomatis and herpes simplex virus type 2 and pregnancy tests.

After 6 months of follow-up, the authors documented a near doubling of EC use in the advance access group (37.4%) relative to usual care
(21.0%) and comparable rates of use for pharmacy access and usual care (24.2% and 21.0%, respectively). Pregnancy rates were comparable in all groups as was the incidence of new STIs. Easier access to EC did not compromise regular contraceptive use or lead to an increase in risky sexual behaviors.

Limitations of the study include self-reported use of EC rather than
performance of bioassays of hormone metabolites to verify use.
Moreover, the women appear to have self-selected by presenting for
care at clinics that provide family planning services. Although women
requesting EC were excluded, the authors do not report whether
contraception was the reason for their visit. That notwithstanding,
the very fact these women sought health care suggests that they are
more sophisticated than many young women in need of pregnancy
protection. Accordingly, the findings of this study cannot be
generalized to a nonselected group of young women or to youth in
states with more restrictive provision of contraception to minors.

Another limitation of the study is the loss to follow-up of almost 10%
of the inception cohort. This raises questions of differential
outcomes in what is likely to have been a higher risk group of
patients. Moreover, the short, 6-month follow-up may not have been
sufficient to detect a reduction in pregnancies, a limitation
acknowledged by the researchers. An unexplained result is less use of
EC during the study than reported lifetime use, despite the
facilitated access provided in the study.

While Raine et al have provided new and important information on the
use of EC in this population of high-risk young women, it is
unfortunate that the study population was not stratified by age and
ethnic group. For example, matching on age, rather than analyzing age
as a continuous variable, might have provided important information
about the effect of the intervention on younger adolescents who are at highest risk of unprotected intercourse and unwanted pregnancy.
Analyses that controlled for past use of EC also would have been of
interest. It is possible that prior experience with EC may have
influenced compliance as well as perceived adverse effects. Further,
experience with adverse effects may have influenced use across the
entire study, and exploration of this variable may have added
important information to what is already known about the frequency of
nausea and vomiting in patients using EC.7

Despite these limitations, the report by Raine et al makes an
important contribution to current knowledge of EC use and should help
dispel concerns that easier access to EC increases the risk of STIs or
leads to abandonment of regular contraception. The finding that women who were provided EC at a clinic visit prior to the time of need were almost twice as likely to use EC than women in the clinic access
control group is critically important, even though a reduction in
pregnancy was not demonstrated. Several explanations for this finding,
which could not be assessed within the context of the study, include
timing of unprotected intercourse in relationship to ovulation, as
well as the timing and accuracy of use of EC. The fact remains that
women are more likely to use EC if it is readily available. It is
similarly significant that no apparent downside of EC was demonstrated
in the study. There was no evidence of
a decrement in use of other
methods of contraception such as oral contraceptives or condoms.
Equally important, to counter the frequent argument tha
t provision of
EC will increase high-risk behavior, this study demonstrated no
increase in STIs or reports of unprotected intercourse.

The task remains to improve access to EC by expanding the number and types of facilities where it can be obtained. Education about EC for both physicians and the public should be improved, especially now that other agents (including RU-486 [mifepristone]) have been shown to be effective in preventing unwanted pregnancy after an episode of
unprotected intercourse.4 Importantly, physicians may wish to
reconsider their position on EC in relation to other contraceptive
methods; as this study suggests, regular contraception and EC are not
in conflict. Sexually active women who do not desire to become
pregnant should be counseled about regular methods of birth control,
but they can be assured that EC is available if they are concerned
their regular method may not have protected them from the possibility
of an unwanted pregnancy.

AUTHOR INFORMATION

Corresponding Author: Iris F. Litt, MD, Division of Adolescent
Medicine, Stanford University School of Medicine, 750 Welch Rd, Suite
325, Palo Alto, CA 94304 ([email protected]).

Editorials represent the opinions of the authors and THE JOURNAL and
not those of the American Medical Association.

Author Affiliation: Division of Adolescent Medicine, Stanford
University School of Medicine, Palo Alto, Calif.

REFERENCES

1. Centers for Disease Control and Prevention. National and
state-specific pregnancy rates among states, 1995-1997. MMWR Morb
Mortal Wkly Rep. 2000;49:605-611. MEDLINE
2. World Health Organization. Randomised controlled trial of
levonorgestrel versus the Yuzpe regimen of combined oral
contraceptives for emergency contraception. Lancet. 1998;352:428-433.
CrossRef | ISI | MEDLINE
3. Bissell P, Anderson C. Supplying emergency contraception via
community pharmacies in the UK: reflections on the experience of users
and providers. Soc Sci Med. 2003;57:2367-2378. CrossRef | ISI | MEDLINE
4. Gardner JS, Hutchings J, Fuller TS, Downing D. Increasing access to
emergency contraception through community pharmacies: lessons from
Washington State. Fam Plann Perspect. 2001;33:172-175. ISI | MEDLINE
5. Pharmacy Access Partnership. EC Over-the-Counter (OTC) Status.
Available at: http://www.pharmacyaccess.org/ECOTCStatus.htm. Accessed
November 30, 2004.
6. Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency
contraception through pharmacies and effect on unintended pregnancy
and STIs: a randomized controlled trial. JAMA. 2005;293:54-62.
ABSTRACT/FULL TEXT
7. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology.
New York, NY: Ardent Media Inc; 2004.