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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(1):54–62. doi:10.1001/jama.293.1.54
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.
It is estimated that half of the 3.5 million unintended pregnancies
that occur each year in the United States could be averted if emergency contraception
(EC) were easily accessible and used.1 This
figure has been extrapolated from efficacy trials that demonstrate that the
risk of pregnancy after a single act of unprotected intercourse is reduced
by 75% with use of combined EC (the “Yuzpe” regimen).2
In efforts to increase access to EC, to date 6 states (Alaska, California,
Hawaii, Maine, New Mexico, and Washington) have implemented pharmacy access
legislation whereby women can obtain EC directly from pharmacists without
having to see a clinician or obtain a prescription first. Although women in
Washington State have had increased access to EC through direct pharmacy access
since 1997, an outcome evaluation is not available, and it is not clear if
reductions in pregnancy and abortion rates in Washington State over the same
time period can be attributed to this increased access.3
While several investigators have demonstrated that women who receive
EC before they need to use it (“advance provision”) are more likely
to use it if unprotected intercourse occurs, there have been no trials in
the United States evaluating the impact of pharmacy access on key reproductive
health outcomes.4-6 Glasier
and Baird demonstrated that Scottish women who had an advance supply of EC
on hand were almost twice as likely to use the medication if needed; however,
the sample size was small and the difference in pregnancy rates between access
groups was not statistically significant, making it difficult to draw conclusions
about the effect of advance provision on unintended pregnancy rates.7
An important element in policy debates over making EC more widely available
is a concern that it will increase risk taking. There is a concern that women
who have easy access to a postcoital form of contraception may in fact have
more unprotected intercourse and abandon more effective forms of regular contraception.
Studies have also shown that clinicians—as well as pharmacists—and
users are concerned about the impact of increased access to EC on sexual risk-taking
behaviors and sexually transmitted infections (STIs).8-10 Recent
research in the field of STI and human immunodeficiency virus (HIV) prevention
has shown that sexual risk-taking behaviors and unprotected intercourse in
men have increased after the introduction of highly active antiretroviral
therapy.11,12 No study has yet
tested whether increased access to EC might increase STI risk by affecting
sexual behavior, including frequency of intercourse and number of partners.
While we do have data from several small studies showing that advance provision
of EC is not associated with increases in unprotected intercourse or decreases
in condom use, these self-report data have not been correlated with outcome
data, particularly biological markers.4-6,13,14
We conducted a randomized controlled trial to evaluate the effect of
access to EC through pharmacies on pregnancy and STIs. A secondary objective
was to test the null hypothesis that level of access does not have an effect
on contraceptive and sexual behavior. Since few states have direct pharmacy
access and small numbers of providers give women advance provisions, we considered
access through clinics the standard of care. We also evaluated EC use and
reproductive health outcomes with advance provision relative to clinic access.
Since pharmacies have more flexible hours, including evenings and weekends,
and do not require appointments, we hypothesized that women with direct access
through pharmacies (and women with advance provision) would use EC more than
women with standard access through clinics and that women with increased access
to EC would experience lower unintended pregnancy rates. We also hypothesized
that access affects EC use, not risk behavior, and thus STI rates would not
The study was conducted from July 2001 to June 2003 at 4 clinics located
in San Francisco and Daly City, Calif, that provide family planning services
and supplies to young women. One site, a college health center, also provides
primary preventive health services. Enrollment was initiated at 2 of the sites
(New Generation Health Center/University of California-San Francisco [UCSF]
and Planned Parenthood, San Francisco) in July 2001 and the other 2 sites
(City College of San Francisco Student Health Center and Planned Parenthood,
Daly City) in October 2001. The study protocol, informed consent, and questionnaires
were reviewed and approved by the Committee on Human Research at UCSF, and
the Planned Parenthood Federation of America.
We included women who were 15 to 24 years old, spoke English or Spanish,
and had had sexual intercourse in the previous 6 months. Women who were pregnant
or wished to become pregnant in the next 6 months and women who were using
the contraceptive transdermal patch and vaginal ring (not approved by the
Food and Drug Administration [FDA] in July 2001) or longer-acting methods
(injectables, the intrauterine device, or implants) were excluded from participation.
Women using other methods (oral contraceptives, condoms, other spermicides
or barriers, and none) were included. Women who had had unprotected intercourse
in the previous 3 days, or who were requesting EC at the time of their visit,
were excluded. Participants were required to live in the San Francisco Bay
Area and be available for a follow-up visit 6 months after enrollment.
We used a computer-generated randomization sequence to assign participants
to 1 of 3 treatment groups: pharmacy access, advance provision, or clinic
access (control). The sequence at each site was restricted so that each consecutive
block of 9 boxes randomized 3 participants to each group. Allocation concealment
was implemented using sealed, sequentially numbered boxes that were identical
in appearance for the 3 treatment groups. The Department of Epidemiology and
Biostatistics at UCSF, which was not involved in any other study procedures
or analyses, created the randomization sequence and filled and labeled the
In January 2002, California implemented pharmacy access legislation
allowing women to obtain EC from pharmacies without consulting a physician.
To minimize contamination of the control group and avoid the possibility of
placing women in the control group at a disadvantage relative to other treatment
groups, we eliminated the clinic access group after December 2001. At the
end of December 2001, the Department of Epidemiology and Biostatistics generated
a new randomization sequence with 2 study groups (using randomization blocks
of size 8 within location) and relabeled the remaining unused study boxes.
Research assistants administered an eligibility-screening questionnaire
to all women attending the clinic sites who met the age criteria. Eligible
participants provided a urine specimen to test for pregnancy (Clearview One
Step, Unipath Diagnostics, Waltham, Mass, or equivalent) and chlamydia (BD ProbeTec, Becton Dickinson & Co, Sparks, Md).
Research assistants obtained a fingerstick sample of whole blood to test for
antibodies to herpes simplex virus type 2 (HSV-2) (POCkit HSV-2 Rapid Test,
Diagnology Inc, Dublin, Ireland). All women who tested positive for chlamydia
at enrollment were referred to the clinic site for treatment and partner management
per clinic protocol. Women testing positive for HSV-2 antibodies were informed,
and counseled on HSV-2 antibody results if requested. Participants provided
consent to allow study staff to verify that all positive chlamydia cases were
treated through the clinic sites.
All participants were given information about EC, including its effectiveness
compared with regular methods, how to use it, and the need to use condoms
to prevent STIs. Research assistants interviewed each subject using a questionnaire
on demographics, including self-reported race/ethnicity, sexual activity,
EC use, current contraceptive method and patterns of use, condom use, and
unprotected intercourse. We collected information on race/ethnicity to describe
the study population and because previous studies indicate contraceptive behavior
may vary by race/ethnicity.
Research assistants then assigned each subject to one of the study groups
by giving her a sequentially numbered treatment box labeled with a study identification
number. Participants were instructed to open their box after leaving the clinic
to ensure blinding of research staff. Participants randomized to the pharmacy
access group received a box containing a card with instructions for obtaining
levonorgestrel (Plan B EC, Women’s Capital Corp, Washington, DC) directly
from a pharmacist without a prescription. The cards were in English and Spanish
and listed 13 Walgreens pharmacies (including two 24-hour stores) that were
located in close proximity to the clinic sites, from which participants could
obtain EC at no cost. Thirty-eight pharmacists from the 13 stores participated
in a 3-hour training session conducted by the principal investigators (T.R.R,
C.C.H.) on counseling women about EC, contraceptive options, and prevention
of STIs. To simulate Washington pharmacy access programs, EC was dispensed
to women requesting EC who verbally identified themselves as study participants,
and pharmacists provided handouts on contraception and STIs with the EC.
Participants randomized to the advance provision group received a box
that contained 3 packets of EC. The regimen contains two 0.75-mg levonorgestrel
pills to be taken in 2 doses, 12 hours apart, within 72 hours of unprotected
intercourse. Participants randomized to the clinic access group received a
box that contained a card with instructions to return to the clinic for EC,
if needed. Women who returned to the clinics for EC were treated according
to standard clinic protocol, ie, appointments or triage per availability and
EC at no cost for the vast majority of women. At the 2 Planned Parenthood
sites, a small proportion of women (10% at the San Francisco site and 5% at
the Daly City site) are not eligible for coverage under Medical or the State
Family Planning Insurance Program (SOFP) and receive services on a sliding
payment scale based on income. Therefore, some study participants may have
had to pay all or some of the cost of obtaining EC at the clinic per standard
clinic protocol. All women from the 2 remaining sites receive SOFP coverage
and did not have to pay for EC at the clinics.
Six months after enrollment, research assistants conducted follow-up
visits with participants at one of the clinic sites or the home of the participant.
A follow-up questionnaire assessing behaviors and study outcomes including
self-report of EC use, pregnancies, and STIs (chlamydia, gonorrhea, HSV-2,
genital warts, Trichomonasvaginalis, and pelvic inflammatory disease) was administered. A urine specimen
for pregnancy and chlamydia testing and fingerstick blood for HSV-2 testing
was collected. Participants who were not available for a follow-up visit completed
the questionnaire by telephone. Bilingual research assistants conducted study
procedures with Spanish-speaking participants using translated questionnaires.
Subjects received $10 for completing enrollment procedures and $20 for the
follow-up visit. We also obtained consent from study participants to review
their medical charts at the study sites for positive test results indicating
interim pregnancies or chlamydial, gonococcal, or HSV-2 infections.
Pregnancies and Contraceptive Use. The study
questionnaire was developed using previously tested questions and was pretested
on a small sample of women from the study sites to assess clarity of the questions
and time required to administer the questionnaire.4,15 The
primary outcome measure was pregnancy, determined by positive urine pregnancy
test at follow-up, self-report over the study period, or positive test on
medical chart review. Pregnancies documented by more than 1 measure were counted
only once. Information was collected on the number of times EC was used over
the study period as well as why it was used and how it was obtained at last
use. Unprotected intercourse was categorized by reported frequency of intercourse
without contraception or condoms as never, some of the time, most of the time,
or every time a participant had intercourse. Among women using oral contraceptive
pills, we assessed the reported number of pills missed per pack over the study
period. We created a variable to assess changes in contraceptive method at
enrollment compared with follow-up. Participants who used no method at enrollment
and adopted any method were categorized as adopting contraception; those who
changed from any method to no method were categorized as abandoning contraception.
Subjects who changed methods were categorized as either women who changed
from oral contraceptive pills to condoms or other nonhormonal methods, or
as women who changed from condoms or other nonhormonal methods to any hormonal
method (oral contraceptives, injectables, or the contraceptive transdermal
patch or vaginal ring, which became available to women in 2002).
STIs, Risk Behavior, and Condom Use. Sexually
transmitted infection measures included the following: (1) chlamydia, based
on positive test at follow-up; (2) new HSV-2 infections based on positive
test at follow-up after a negative test at enrollment; (3) self-report of
STIs (chlamydia, gonorrhea, HSV-2, genital warts, T vaginalis, and pelvic inflammatory disease) during the follow-up period; and
(4) medical chart review for positive chlamydia, gonorrhea, or HSV-2 tests
during the follow-up period. The variable “any STI” was defined
as a positive chlamydia or HSV-2 test at follow-up or any additional infection
identified by self-report or medical chart review; more than 1 type of STI
in a participant was counted only once. To examine risk behavior, we measured
frequency of intercourse (>once per week, once per week, 1-3 times per month, <once
per month), number of sex partners, and length of time with main partner for
women who reported having a main partner. We examined frequency of condom
use (every time, most of the time, sometimes, never) and condom use at last
intercourse (yes, no). Consistent condom use was defined as women who reported
using condoms every time they had intercourse both at enrollment and at follow-up.
Our study was powered to detect significant differences in pregnancy
rates in comparisons between the control group, clinic access, and either
of the 2 treatment groups. A final sample size of 620 women per treatment
group would allow us to reject a null hypothesis that there is no difference
in pregnancy rates in (1) women with direct pharmacy access compared with
women with clinic access to EC and (2) women with advance provision compared
with women with clinic access to EC with 90% power in a 2-sided test with
an α of.05 if the true reduction was 50% or greater. Our effect size
was based on prior estimates that use of combined EC has the potential to
reduce unintended pregnancy rates in half.1 Based
on prior research, we assumed a 6-month pregnancy rate of 10% in the clinic
access group, and thus a 5% pregnancy rate in the pharmacy access and advance
We used a “modified” intent-to-treat analysis: all participants
who completed follow-up were analyzed as a part of the group to which they
were randomized. Contingency tables and χ2 statistics were
used for significance tests with categorical variables and t tests for continuous variables. We compared the pharmacy access group
with the clinic access group and the advance provision group with the clinic
access group; we present P values for both comparisons.
The number and percentage of pregnancies that occurred in each study group
over the follow-up period are presented. Since women who report unprotected
intercourse, women who experience method failures, and women who use less
effective contraceptive methods represent different risk groups, pregnancy
rates are also presented by frequency of unprotected intercourse and contraceptive
Multiple logistic regression analysis was used to estimate the odds
of pregnancy during the study by treatment arm (odds ratios [ORs] are presented
with 95% confidence intervals). Variables known to influence pregnancy risk
from previous research were included in the model.16,17 The
final model included the following baseline variables: clinic site, age (measured
continuously), race/ethnicity (Latina, black, white, Asian, multiracial/other),
pregnancy history, attitude about pregnancy in the next year (very happy,
somewhat happy, don’t know, somewhat unhappy, very unhappy), frequency
of unprotected intercourse, and contraceptive method (oral contraceptive pills,
condoms, other, none). After analyzing main effects, we assessed interactions
between various predictor variables and treatment group. For example, we tested
whether there were interactions between contraceptive method at baseline and
either of the treatment groups. None of the interactions tested were significant;
therefore, we present a main effects model. The number and percentage of participants
who were positive for any STIs by study group are presented, and we also used
multiple logistic regression to estimate the odds of acquiring an STI during
the study. There were no significant interactions between treatment group
and predictor variables; the final STI model included main effects only, including
the following baseline variables: clinic site, age, race/ethnicity, history
of STIs (ever), number of sex partners in past 6 months (1, 2, or ≥3),
and frequency of condom use.
Since we found baseline differences in race/ethnicity and clinic site
by treatment group, we also conducted multivariate analyses to control for
these variables on outcomes including EC use, unprotected intercourse, contraceptive
method change, frequency of condom use, and condom use at last intercourse.
We constructed separate models with each of these outcomes as the dependent
variable and assessed whether treatment arm was a significant predictor after
controlling for race/ethnicity and clinic site. All analyses were also performed
using Bonferroni corrections; we present results from analyses in which no
corrections were made for multiple comparisons since the findings were consistent.
Data were analyzed using Stata 8.0 (Stata Corporation, College Station, Tex).
An interim analysis of the 1020 participants recruited through December
2001 was conducted in July 2002 by an outside consultant. The investigators
and research staff were not informed of the results of the analysis until
after the completion of the study. The investigators would have been notified
of the results prior to completion of the study only if a difference in pregnancy
rates or STI rates with a critical P value of less
than or equal to.001 was observed between either the pharmacy access group
or the advance provision group compared with the clinic access group. As a
result of this interim analysis, we reduced the P value
in our current analysis of the data from.050 to.049, as determined by the
sequential design criteria of Fleming et al.18 After
the completion of the study, we also performed an analysis of the subsample,
women who were enrolled prior to January 2002, to verify that these results
were consistent with the full study sample. In addition, to assess whether
there was an independent study effect on pregnancy rates by time period of
recruitment into the study (before and after December 31, 2001), we included
a time period variable in the multiple logistic regression analysis of the
full study sample and found no effect.
We screened 4361 women and enrolled and randomized 2117 at the 4 study
sites (Figure). Of 2244 women excluded,
2231 did not meet eligibility criteria. In total, 167 women were lost to follow-up,
and 1950 (92%) women were included in the follow-up analyses. Only 3.7% of
participants who completed follow-up were not available for a visit and completed
the questionnaire by telephone and thus did not complete chlamydia or HSV-2
infection testing at follow-up. Our final group sizes were 814, 826, and 310
in the pharmacy access, advance provision, and clinic access groups, respectively.
The medical charts of 1613 study participants (1562 who completed follow-up
and 51 who were lost to follow-up) were available for review.
Equal proportions of women were lost to follow-up from the 3 treatment
groups and the 4 study sites. The mean age of participants who were lost to
follow-up was 20.0 years compared with 19.9 years for those who completed
follow-up. An analysis of study attrition showed no significant differences
in other baseline demographic traits, history of pregnancy or STIs, or contraceptive
Baseline characteristics of the study sample are shown in Table 1. Since enrollment was initiated earlier at 2 of the sites
and elimination of the clinic access group occurred simultaneously at all
4 sites, there was a smaller proportion of participants assigned to the clinic
access group at the 2 sites that initiated recruitment later (P<.001). There was also a slightly higher proportion of blacks in
the clinic access group (P = .045). Half
of study participants were adolescents: 483 (25%) were 15 to 17 years old
and 481 (25%) were 18 to 19 years old. About half of the sample used oral
contraceptives, with or without condoms, and the other half of the sample
relied on condoms as their contraceptive method; however, only 27% of women
reported condom use at every intercourse. The study sample was moderately
high-risk for negative reproductive health outcomes in that 27% of these young
women had had an abortion, and 11% tested positive for chlamydia or HSV-2
antibodies at baseline.
The mean follow-up time was 6.9 months (SD, 1.3 months). Overall, 29%
of women used EC during the study, and there were significant differences
by study group (Table 2). Women in the
pharmacy access group were no more likely to use EC than women in the clinic
access group (P = .25). As expected, women
in the advance provision group (37%) were significantly more likely than women
in the clinic access group to report having used EC 1 or more times (P<.001). Only 6.8% of women used EC 2 times, and 4.1%
used it 3 or more times over the study period. Women in the advance provision
group (15.1%) were significantly more likely than the clinic access group
(5.8%) to use EC 2 or more times (P<.001); however,
women in the pharmacy access group (8.5%) were not more likely than women
in the clinic access group to use EC 2 or more times (P = .29).
There were no significant differences in frequency of unprotected intercourse
by study group; 37.5% of study participants reported having unprotected intercourse
(Table 2). Only half (46.7%) of study
participants who had unprotected sex reported using EC 1 or more times over
the study period; 54.9% of women who had unprotected intercourse in the advance
provision group used EC. There were no significant differences in patterns
of oral contraceptive use or the proportion of women switching their regular
contraceptive method by study group (Table 2).
Sexual risk behaviors, including frequency of intercourse or number of partners,
were also the same across study groups (Table
3). While a significantly lower proportion of participants in the
advance provision group (47%) reported condom use at last intercourse than
in the clinic access group (54%), this difference was not significant after
adjusting for race/ethnicity and clinic site (OR , 0.79; 95% CI,
0.60-1.04, P = .09). There were no differences
in frequency of condom use or proportion of women who reported consistent
condom use across study groups (Table 3).
Over the 6-month follow-up period, 151 (7.7%) of participants became
pregnant; there were no significant differences by study group. Seventy-one
pregnancies (3.6%) were identified by a positive test at follow-up, 76 pregnancies
(3.9%) were identified by self-report, and 4 pregnancies (0.2%) were identified
by a positive test on chart review. The pregnancy rate correlated with self-reported
measures of risk; the pregnancy rate increased as the reported frequency of
unprotected intercourse increased. The risk of pregnancy over the study period
was also lower for women who used hormonal contraceptives (adjusted OR, 0.63;
95% CI, 0.40-1.00, P = .05). Twelve percent
of women acquired an STI over the study period. One hundred eighteen infections
(6.0%) were identified by a positive test at follow-up, 107 (5.5%) by self-report,
and 9 (0.5%) by a positive test on chart review. There were no differences
in positive chlamydia or HSV-2 tests across study groups (Table 3) or STI risk after adjusting for variables known to influence
STI rates (Table 4).
Additional multivariate analyses were performed to adjust for group
differences in race/ethnicity and clinic site at enrollment; there were no
differences from the unadjusted results except that the difference between
the study groups in condom use at last intercourse was no longer significant.
Additional analyses performed using Bonferroni corrections were consistent
with analyses performed without corrections for multiple comparisons.
To increase use of EC, 6 states have emulated the Washington State model
allowing women to obtain EC directly from a pharmacist; however, in our study
population, direct pharmacy access did not appear to be any more useful than
access through clinics. While study participants had a choice of 13 pharmacies,
they could have been reluctant to go to a pharmacy or experienced difficulty
getting to a pharmacy or finding a pharmacist on duty who was trained to dispense
EC. The requirement to go through pharmacists or clinics to obtain EC appears
to be a barrier that limits use. Even though rates of unprotected intercourse
were similar across study groups, women in the advance provision group were
still almost twice as likely to use EC than women in the clinic access group.
Furthermore, contrary to concerns that increased access to EC will entice
women to use EC repeatedly, only a small fraction of women in the pharmacy
access and advance provision groups used EC more than once over the 6-month
period, even though EC was supplied at no cost. Recently, the FDA rejected
an application to switch levonorgestrel EC to over-the-counter status, leaving
in place many of the barriers associated with pharmacy or clinic access. These
data support the previous scientific literature that indicates that among
young sexually active women, unprotected intercourse leads to EC use, not
We did not observe a difference in pregnancy rates in women with either
pharmacy access or advance provision; the adjusted risk of pregnancy for both
treatment groups was not significantly less than 1. Previous studies also
failed to show significant differences in pregnancy or abortion rates among
women with advance provisions of EC.6,7,19 It
is possible that the effect of increased access on pregnancy rates is truly
negligible because EC is not as effective as found in the single-use clinical
trials, or because women at highest risk do not use EC frequently enough or
at all. Indeed, almost half of women in the advance provision group who reported
having unprotected sex did not use EC. Thus, it is not surprising that the
vast majority of pregnancies (73%) occurred in the women who reported having
unprotected intercourse rather than in women experiencing method failures.
We would not expect the pregnancy rate to be lower in the pharmacy access
group given the similar EC use rate as the control group; however, EC use
was increased in the advance provision group. An alternative explanation for
the lack of observed difference in pregnancy rates is that women in the advance
provision group used EC more because they were using it “unnecessarily,”
ie, as a backup to a regular method. We think this is unlikely since the proportion
of women reporting using EC because of condom mishaps or using no birth control
method the last time they used EC was similar for women in the advance provision
group and the control group (94.9% vs 96.9%, P = .74).
Our sample size calculations were based on equally sized groups; however,
with our unequal group sizes, we had an 80% power to detect a 50% difference
in pregnancy rates. It is possible that with a larger sample or widespread
increased public access that a smaller, yet meaningful reduction in pregnancy
rates would be observed. While we set out to demonstrate a large reduction
in pregnancy rates, even a 10% or 20% reduction in unintended pregnancy rates
would be a significant and desirable public health achievement.
Access to EC did not have a detrimental effect on contraceptive use
or sexual behavior. While women who used condoms or other less effective forms
of contraception were more likely to become pregnant than women who used hormonal
contraception, women with advance provision or pharmacy access were not more
likely to abandon contraception or switch to less effective methods. Given
this finding, it is unlikely that increased access to EC would lead to higher
pregnancy rates, even though our risk estimates indicate that the true effect
may also be greater than 1. Our study supports the hypothesis that behavior
is not influenced by access to EC and that women who have increased access
to EC do not have more unprotected intercourse. There were no significant
differences in self-reported frequency of unprotected intercourse. One might
argue that self-report is not an accurate measure of actual behavior, ie,
there is underreporting. Pregnancy is an outcome that is less susceptible
to recall bias and was assessed by several measures in our study, including
biological markers. We demonstrate that baseline self-report of unprotected
intercourse, as well as contraceptive method, correlated directly with pregnancy
rates at follow-up, adding validity to our self-report measures.
Across all measures, we also found similar rates of sexual risk behaviors
in all study groups. The finding of similar STI acquisition rates among study
groups seems plausible given the lack of difference in self-reported measures
of risk. Using the combined STI variable including test results, self-report,
and medical chart review, we had 90% power to detect an increase in STIs from
12% to 18%. It is possible that we failed to detect a smaller yet clinically
meaningful increase in STIs; however, given our increased power to detect
small differences in self-reported measures of risk, like number of sex partners,
this seems less plausible. The FDA’s decision to reject over-the-counter
sale of EC was based on concerns that increased access to EC could lead to
unsafe sexual practices and the spread of STIs and HIV/AIDS, a notion that
is contrary to the findings of our current study and the published literature.4-7,13,20-22
Our study has limitations. There was cross over of treatment groups
as participants could obtain EC through any of the 3 methods. The majority
of participants (67%) reported obtaining EC at last use consistent with the
study group to which they were assigned. Thirty percent of women in the pharmacy
access group and 26% of women in the advance provision group reported obtaining
EC through clinics and 12% of women in the clinic access group reported obtaining
EC directly from pharmacies without speaking with a provider. This cross over
may have diminished our ability to demonstrate a difference in reproductive
health outcomes in treatment groups.
This was not a strict intent-to-treat analysis as some study participants
were lost to follow-up. Follow-up rates were equal across study groups, but
if all participants lost to follow-up in the advance provision group became
pregnant or acquired an STI and no one in the clinic access group did, study
results would have changed. This is an unlikely scenario, as attrition analysis
showed no difference in characteristics of women lost to follow-up, and chart
review of women lost to follow-up revealed that only 1 of 14 women in the
advance provision group lost to follow-up tested positive for chlamydia and
1 of 10 women in the advance provision group tested positive for pregnancy.
Another limitation of the study is that EC use in the clinic access
group was relatively high compared with previous studies.4,6 High
use rates in the control group may explain why we did not observe a difference
compared with the pharmacy access group. Pharmacy access might be more useful
for women who do not have a source of care. The study was conducted in a clinic
population and all women received education on EC; results may not be generalizable
to other women. While this is an urban clinic population, the women were young
and mostly uninsured, low-income representing an important at-risk population.
Despite these limitations, our study has important public health implications.
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 through clinics.
Corresponding Author: Tina R. Raine, MD,
MPH, Department of Obstetrics, Gynecology, and Reproductive Sciences, San
Francisco General Hospital—6D, 1001 Potrero Ave, San Francisco, CA 94110
Author Contributions: As principal investigators,
Drs Raine and Harper had full access to all of the data in the study and take
responsibility for the integrity of the data and the accuracy of the data
Study concept and design: Raine, Harper, Rocca,
Padian, Klausner, Darney.
Acquisition of data: Raine, Harper, Rocca,
Analysis and interpretation of data: Raine,
Harper, Rocca, Padian, Klausner, Darney.
Drafting of the manuscript: Raine, Harper,
Critical revision of the manuscript for important
intellectual content: Raine, Harper, Fischer, Padian, Klausner, Darney.
Statistical analysis: Harper, Klausner.
Obtained funding: Raine, Harper, Rocca, Klausner,
Administrative, technical, or material support:
Raine, Rocca, Fischer, Padian, Klausner, Darney.
Study supervision: Raine, Harper, Rocca, Fischer,
Funding/Support: This research was supported
by grants from the Compton Foundation, Inc, the Open Society Institute, the
Walter Alexander Gerbode Foundation, and the William and Flora Hewlett Foundation.
The Women’s Capital Corporation, distributor of Plan B, donated the
emergency contraception for use in the trial.
Role of the Sponsors: The funding organizations
played no role in the design and conduct of the study; in the collection,
management, analysis, and interpretation of the data; and in the preparation,
review, or approval of the manuscript for submission.
Disclaimer: The opinions in this article do
not necessarily reflect those of the funding organizations or the Planned
Parenthood Federation of America, Inc.
Acknowledgment: The San Francisco Department
of Public Health and Diagnology LTD donated the tests for the sexually transmitted
infections. We are indebted to the staffs of the New Generation Health Center/UCSF,
the Planned Parenthood Golden Gate Affiliate clinics in San Francisco and
Daly City, and the City College of San Francisco Student Health Center for
allowing us to conduct the studies at their sites.
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