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Harder to Get Than You Think: Levonorgestrel Emergency Contraception Access in West Virginia Community Pharmacies

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Objectives Emergency contraception (EC) is the only noninvasive form of contraception available after risk exposure and is an important tool for preventing unintended pregnancy resulting from unprotected sex, sexual assault, or contraceptive failure. The U.S. Food and Drug Administration (FDA) removed age restrictions on levonorgestrel EC and made it available over-the-counter to everyone in 2013. Despite improved availability and accessibility since the change in FDA regulations, community pharmacies have not uniformly embraced the policy. West Virginia is a rural state with high rates of poverty and teen pregnancy. Design The investigators called community pharmacies in West Virginia to assess the availability and accessibility of levonorgestrel EC in addition to the pharmacy staff’s knowledge of effectiveness for this cross-sectional study. Setting and participants The study sample consisted of 509 community pharmacies throughout the state. Outcome measures A structured script was employed to conduct phone calls to community pharmacies with items assessing availability, accessibility, and knowledge of effectiveness. Results At the time of the phone calls, levonorgestrel EC was reported to be available in 48.9% of the community pharmacies in West Virginia. Chain pharmacies were more likely to report EC as being in stock (0.76) than independent pharmacies (0.15.). Other measures of accessibility also favored chain pharmacies versus independent pharmacies. The overall accessibility of EC at West Virginia community pharmacies was derived from a binary composite variable of “completely accessible” or “not completely accessible” by combining 5 predetermined items. Overall, EC was completely accessible to callers in 0.27 of all pharmacies with significant differences by pharmacy type (0.47 of chain pharmacies as compared with 0.03 of independent pharmacies). Conclusion Accessible EC could reduce unintended pregnancy and help break the state’s generational cycle of poverty and poor educational, social, and health outcomes. Pharmacists will be instrumental in expanding access to EC.
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RESEARCH
Harder to get than you think: Levonorgestrel emergency
contraception access in West Virginia community pharmacies
Amie M. Ashcraft
*
, Sara Farjo, Charles D. Ponte, Sarah Dotson, Usha Sambamoorthi,
Pamela J. Murray
article info
Article history:
Received 29 May 2020
Accepted 25 July 2020
Available online 21 August 2020
abstract
Objectives: Emergency contraception (EC) is the only noninvasive form of contraception
available after risk exposure and is an important tool for preventing unintended pregnancy
resulting from unprotected sex, sexual assault, or contraceptive failure. The U.S. Food and Drug
Administration (FDA) removed age restrictions on levonorgestrel EC and made it available
over-the-counter to everyone in 2013. Despite improved availability and accessibility since the
change in FDA regulations, community pharmacies have not uniformly embraced the policy.
West Virginia is a rural state with high rates of poverty and teen pregnancy.
Design: The investigators called community pharmacies in West Virginia to assess the avail-
ability and accessibility of levonorgestrel EC in addition to the pharmacy staffs knowledge of
effectiveness for this cross-sectional study.
Setting and participants: The study sample consisted of 509 community pharmacies
throughout the state.
Outcome measures: A structured script was employed to conduct phone calls to community
pharmacies with items assessing availability, accessibility, and knowledge of effectiveness.
Results: At the time of the phone calls, levonorgestrel EC was reported to be available in 48.9% of
the community pharmacies in West Virginia. Chain pharmacies were more likely to report EC as
being in stock (0.76) than independent pharmacies (0.15.). Other measures of accessibility also
favored chain pharmacies versus independent pharmacies. The overallaccessibility of ECat West
Virginia community pharmacies was derived from a binary composite variable of completely
accessibleor not completely accessibleby combining 5 predetermined items. Overall, EC was
completely accessible to callers in 0.27 of all pharmacies with signicant differences by phar-
macy type (0.47 of chain pharmacies as compared with 0.03 of independent pharmacies).
Conclusion: Accessible EC could reduce unintended pregnancy and help break the states
generational cycle of poverty and poor educational, social, and health outcomes. Pharmacists
will be instrumental in expanding access to EC.
©2020 American Pharmacists Association
®
. Published by Elsevier Inc. All rights reserved.
Background
Althoughteen pregnancies in the United States have declined
0.60 since 2007, notable disparities persist.
1,2
Provisional data for
2019 indicate that West Virginia, for example, had a teen birth
rate of 25.4 births per 1000 womendaratethatdecreasedvery
little from 2018 and remains one of the highest in the United
States with an overall rate of 16.6 births per 1000 women.
1,2
Rates of unintended pregnancy reect a similar pattern.
3
In ru-
ral and impoverished parts of the country such as West Virginia
and the larger Appalachian region, socioeconomic factors such
as lack of health insurance, long distances to travel for medical
care, and lack of transportation limit contraception access and
increase the risk for unintended pregnancy.
4-7
Although these
factors are not unique to rural areas, they are particularly pro-
nounced among rural populations.
Higher rates of teen and unintended pregnancies in poor,
rural regions of the United States. result in disproportionately
Disclosure: The authors declare no relevant conicts of interest or nancial
relationships.
Previous presentation: Portions of this work have been presented at Ada-
gios Transforming Womens Health Symposium in September 24, 2019 at and
North American Society for Pediatric and Adolescent Gynecology in April 3,
2020.
*Correspondence: Amie M. Ashcraft, PhD, MPH, Department of Family
Medicine, School of Medicine, West Virginia University, 1 Medical Center Dr.,
Box 9152, Morgantown, WV 26506.
E-mail address: amashcraft@hsc.wvu.edu (A.M. Ashcraft).
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association
journal homepage: www.japha.org
https://doi.org/10.1016/j.japh.2020.07.027
1544-3191/©2020 American Pharmacists Association
®
. Published by Elsevier Inc. All rights reserved.
Journal of the American Pharmacists Association 60 (2020) 969e977
SCIENCE AND PRACTICE
more negative behavioral, health, and education outcomes for
children; increased negative health outcomes and decreased
education and employment opportunities for mothers; and
higher costs for health care, social services, and education for
everyone.
8-12
Given these disparities and their impact on
public health, child welfare, and the economy, prioritizing
pregnancy prevention is critical.
Comprehensive pregnancy prevention efforts include
providing medically accurate information on the full range of
options for safer sex practices and all forms of contraception,
including a comparison of various forms of contraception and
their effectiveness.
13,14
Emergency contraception (EC) is the
only form of contraception available after risk exposure and is
thus an important tool for preventing unintended pregnancy
after unprotected sex, sexual assault, or suspected contracep-
tive failure.
14-16
In 2013, the U.S. Food and Drug Administration (FDA)
removed age restrictions on levonorgestrel (LNG) EC and made
it available over-the-counter (OTC) to everyone, thus
improving availability (i.e., whether it is in stock) and acces-
sibility (i.e., whether there are barriers, such as age or identi-
cation [ID] requirements).
17,18
The advantages of OTC LNG EC
are that it eliminates many barriers associated with obtaining
EC by prescription from a clinician, such as contacting a
provider, scheduling an appointment, securing transportation,
time delays, and feeling shame and embarrassment.
18,19
EC is most used by female teens aged 15-19 years after
unprotected or inadequately protected sex.
13,20
Approximately
0.22 of women aged 15-44 years report having used EC at least
once.
13
However, many community pharmacies have not made
OTC LNG EC readily available. Some pharmacists cite lack of
training, low product demand, and short shelf-life as barriers
to stocking EC; for others, politics and personal morals inter-
fere.
18,21-24
As a result, many adolescents and adults have dif-
culty obtaining EC in their local community pharmacies.
A recent review of studies published from 2003 to 2016
examined availability and accessibility of LNG EC and found
lack of availability in nearly one-third of reviewed studies.
18
Multiple studies have documented variability in pharmacy
staff knowledge of EC regulations and effectiveness, creating
barriers to access.
15,25,26
Obstacles mentioned include age re-
strictions, ID requirements, locked boxes or shelves, placement
behind the pharmacy counter, limited pharmacy hours, high
prices, misinformation about timing, adverse effects, and
effectiveness, low rates of stocking in lower income areas, lack
of transportation, shame and embarrassment, unpredictable
degrees of condentiality, and the lack of available non-English
language consultation.
15,18,25,27-29
Numerous studies have also
found statistically I hasignicant differences between chain
and independent pharmacies in availability and accessibility,
with chain pharmacies more likely to stock LNG EC and less
likely to impose barriers to obtaining LNG EC.
28,30-32
Objectives
Given the importance of EC for pregnancy prevention, the
stark health disparities of poor rural women, and the variable
availability and accessibility seen in other studies on EC, we set
out to examine these constructs in West Virginia community
pharmacies. The state has the fourth highest poverty rate and
the sixth highest teen pregnancy rate in the United States.
33,34
We hypothesized that availability and accessibility are limited,
particularly in the independent community pharmacies of
West Virginia.
Methods
Design
We called community pharmacies in West Virginia to
assess the availability and accessibility of LNG EC as well as the
pharmacy staffs knowledge regarding effectiveness and
proper use of LNG EC using a cross-sectional study design.
Setting and participants
We selected pharmacies for inclusion by purchasing a list
of licensed pharmacies from the state board of pharmacy
then removed sites that were not community pharmacies
(e.g., in-patient hospital pharmacies, nuclear pharmacies,
dental facilities.). We categorized the remaining community
pharmacies into 2 types: independent (pharmacies with 5
West Virginia sites or fewer) and chain pharmacies (e.g., CVS
Health, Kroger, Walmart). A total of 511 pharmacies were
Key Points
Background:
The U.S. Food and Drug Administration removed age
restrictions on levonorgestrel emergency contra-
ception (EC) and made it available over-the-counter
(OTC) to everyone in 2013.
The advantages of OTC EC are that it eliminates
many barriers associated with obtaining EC by pre-
scription from a clinician, such as scheduling an
appointment, securing transportation, and feeling
shame and embarrassment.
Many community pharmacies have not made OTC
EC readily accessible. Some pharmacists cite lack of
training, low product demand, and short shelf-life as
barriers to stocking, whereas for others, politics and
personal morals interfere.
Findings:
In the first statewide comparison of levonorgestrel
EC availability in West Virginia community pharma-
cies, we found that fewer than half reported having it
in stock.
The 4 most urban counties (with a combined popu-
lation of 497,230) were not significantly different than
the 4 most rural counties (combined population of
27,036) in reported EC stocking rates.
Pharmacists could be instrumental in expanding ac-
cess EC by ensuring that it is in stock and that phar-
macy staff are prepared to give accurate and
nonjudgmental information to customers.
A.M. Ashcraft et al. / Journal of the American Pharmacists Association 60 (2020) 969e97 7
SCIENCE AND PRACTICE
970
called with 2 pharmacies declining to participate in the study.
Therefore, the nal study sample consisted of 509 community
pharmacies throughout all 55 counties in the state.
Data collection training
Training for data collection consisted of a 2-hour session in
which data collectors learned the script, made practice calls,
entered test cases into the online database, and agreed on
standardized responses to possible questions (e.g., how to
respond to I dont knowor personal questions about their
identity or motives). Practice calls were made to pharmacies
outside of the sample.
Between September 2019 and February 2020, we trained 14
female undergraduate and graduate students from West Vir-
ginia University to call pharmacies and inquire about LNG.
Immediately after the phone call, data collectors entered in-
formation from the call into an online database.
Procedures and call script
We used a structured script to conduct phone calls to
community pharmacies (Figure 1) with items assessing avail-
ability, accessibility, and knowledge of effectiveness. This
script is 1 of 2 from a larger study using a mystery caller
approach to assess outcomes of interest. Each pharmacy
received 2 separate, scripted phone calls from our team at least
1 week apart in a random order: (1) a transparent researcher
phone call in which the caller introduced herself and
explained that she was calling as part of a study and (2) a
mystery callercall in which a member of our research team
pretended to be a 16-year-old seeking LNG EC for herself.
Procedures and data presented in this manuscript are from the
researcher-scripted call to each site.
According to the call script, if LNG EC was not available that
day, follow-up questions assessed whether it could be ordered
and how long the order would take to arrive. If the pharmacy
staff members responded, I dont knowto any question, the
scripted response was Can you help me nd someone who
knows?
All calls were made on weekdays between 9 AM and 5
PM when pharmacies were ostensibly fully staffed. Data
collectors recorded the date, time, and success of each call in
a call log spreadsheet. Calls were considered successful if the
pharmacy staff responded to the question, Do you have
emergency contraception available today?If the pharmacy
staff asked data collectors to call back (e.g., after lunch,
during a less busy time, or when the regular pharmacist
returned), it was noted in the call log and those sites were
called again at their preferred time period. To mimic
customer experience, callers put on hold for 5 minutes hung
up and attempted the call a second time. If callers were left
on hold for 5 minutes a second time, the site was classied
Figure 1. Research script for data collectors. Abbreviations used: WVU, West Virginia University; IRB, institutional review board; ID, identication.
Levonorgestrel access in West Virginia community pharmacies
SCIENCE AND PRACTICE
971
as not having LNG EC available today. If the pharmacy staff
hung up on the caller, they noted it in the call log and the
call was attempted once more at least 1 week later so as to
minimize any potential perception of harassment by the
pharmacy staff. The sites that hung up on callers a second
time were classied as not having LNG EC available.
Whereas other similar studies have ended contact attempts
after 1 hang-up to mimic customer experience, we chose a
more conservative approach of ending attempts after 2
hang-ups to reduce the likelihood of misclassifying LNG EC
as unavailable at a given pharmacy location.
Outcome measures
We assessed 3 primary outcomes: availability, accessi-
bility, and staff knowledge of effectiveness. To assess
whether LNG EC was available, the callers asked if they could
obtain it today. To assess how accessible LNG EC was at
pharmacy sites, we asked a series of questions about po-
tential barriers that may exist, including whether a 16-year-
old could obtain it, if a prescription was required, if ID was
required, whether parents needed to know, and whether the
caller could get LNG EC without staff assistance, such as
having to ask for a locked container or shelf to be opened or
having to ask for LNG EC to be retrieved from behind the
pharmacy counter before purchasing. To determine the
pharmacy staffs knowledge about LNG EC effectiveness, the
callers asked, Whens the latest it can be taken?In our
analyses, we considered within 3 daysor within 72
hoursto be the most correct response.
To determine the overall accessibility of LNG EC at West
Virginia community pharmacies, we created a binary com-
posite variable of completely accessibleby combining 6
items (from Uysal et al.
26
). LNG EC was considered completely
accessible at a site if it was in stock at the time of the call; there
was no age restriction, no ID required, and no prescription
required; parents did not need to know; and it could be ob-
tained without staff assistance. The pharmacy staff answers of
I dont knowwere combined with noto create binary
items.
In addition to the primary outcomes of availability,
accessibility, and staff knowledge of effectiveness, we
assessed a number of secondary outcomes including whether
the pharmacy staff stated that they did not stock LNG EC
because of personal or moral reasons, aspects of the phone
call experience (staff asking personal questions, transfers,
holds, and hang-ups), pharmacy hours, and the cost of LNG
EC.
This study was given expedited approval by the institu-
tional review board (IRB) at West Virginia University.
Statistical analysis
Data from caller surveys were entered manually by the
callers into an online database and analyzed in SPSS (IBM Corp,
Armonk, NY) using the Pearson chi-square test and the inde-
pendent samples ttest. We conducted analyses on our primary
outcomes of availability, accessibility, and knowledge of
effectiveness. We also conducted secondary analyses on caller
experience, pharmacy hours, and cost. Pvalues less than 0.05
were considered statistically signicant.
Results
Primary outcomes
Availability
At the time of this study, LNG EC was reported to be
available in 0.49 of the community pharmacies sampled in
West Virginia (Table 1). There was a signicant difference in
reported availability between chain and independent phar-
macies, P<0.001, with chain pharmacies more likely to
report LNG EC as being in stock (0.76) than independent
pharmacies (0.15) (Figure 2). Among the pharmacies that
reported not having LNG EC in stock, there were no signi-
cant differences between chain and independent pharmacies
in terms of their willingness to order it (P¼0.42) or in the
estimated length of the wait time for the order to arrive
(P¼0.43).
Accessibility
There were signicant differences between chain and in-
dependent pharmacies with respect to all barriers assessed to
obtaining LNG EC (Table 2 and Figure 3). Chain pharmacies
were signicantly more likely to report that LNG EC could be
obtained by 16-year-olds (0.76) than independent pharmacies
(0.31), P<0.001. Chain pharmacies were signicantly more
likely to correctly report that a prescription is not required
(0.79) than independent (0.35), P<0.001. In addition, chain
pharmacies were signicantly more likely to correctly report
that an identication was not required (0.67) and that LNG EC
could be obtained without parents knowing (0.82) than in-
dependent pharmacies (0.26 and 0.41, respectively), P<0.001.
Finally, chain pharmacies were signicantly more likely to
report that LNG EC could be obtained for purchase without
asking for staff assistance (0,66) than independent pharmacies
(0,08), P<0.001.
Knowledge of effectiveness
With respect to the staff knowledge of effectiveness, there
was a signicant difference in correct responses between
chain and independent pharmacies, P<0.001. The staff
answering the phone at chain pharmacies were more likely to
provide the correct answer (0.66) than staff at independent
pharmacies (0.40) (Table 3). The staff at chain pharmacies
were less likely to respond that they did not know the correct
timing of when LNG EC could be taken (0.13) than the staff at
independent pharmacies (0.32).
Secondary outcomes
Conscientious objection
Chain pharmacy staff were signicantly less likely to
state that they did not stock LNG EC for personal or moral
reasons (0.0 0) than the staff at independent pharmacies
(0.02 or n ¼4), P<0.01.
Call experience
Chain pharmacies were signicantly less likely to transfer
callers to another staff member (0.23) than independent
pharmacies (0.30), P<0.05. There were no signicant differ-
ences between chain and independent pharmacies in whether
callers were asked personal questions, such as their name or
A.M. Ashcraft et al. / Journal of the American Pharmacists Association 60 (2020) 969e97 7
SCIENCE AND PRACTICE
972
relationship status (0.03 vs. 0.05, respectively, P¼0.293); put
on hold (0.64 vs. 0.54, P¼0.073); or the length of wait time
while on hold (0.37 vs. 0.32 waited on hold 1 minute or less,
whereas 0.27 vs. 0.20 were on hold more than 1 minute,
P¼0.29). With respect to wait time on hold, 0.04 of chain
pharmacies and 0.02 of independent pharmacies kept callers
on hold for 4 minutes; 0.03 of chain pharmacies and 0.04 of
independent pharmacies left callers on hold for 5 minutes on at
least one of the call attempts. There was also no signicant
difference in whether callers were hung up on between chain
and independent pharmacies, (0.07 for both, P¼0.98).
A total of 7 pharmacies (2 chain and 5 independent) were
classied as not having LNG EC owing to nonresponse either
through holds or hang-upsdthese made up 0.03 of the phar-
macies that did not have LNG EC available. Two of the phar-
macies (both independent) left callers on hold for 5 minutes
on both call attempts and were classied as not having LNG EC
available 0.01 of the pharmacies that did not have LNG EC
available). Five of the pharmacies (2 chain and 3 independent)
hung up on callers on both call attempts and were classied as
not having LNG EC available (0.02 of the pharmacies that did
not have LNG EC available).
Pharmacy hours
Chain pharmacies were signicantly more likely to have
evening hours after 5 PM (0.84) than independent pharmacies
(0.59), P<0.001. Independent pharmacies, by contrast, were
signicantly more likely to have weekend hours (0.70) than
chain pharmacies (0.58), P<0.01. Across all pharmacies in
West Virginia, 0.29 did not have evening hours, and 0.35 were
closed on Saturday and Sunday.
Cost
There was a signicant difference between chain and in-
dependent pharmacies for the cost of name-brand Plan B,
P¼0.001. Chain pharmacies reported a higher mean (±SE)
shelf cost of Plan B ($49.82 ±$0.30) than independent phar-
macies ($46.93 ±$1.07). Chain pharmacies also reported a
higher mean (±SD) shelf cost of generic LNG ($37.25 ±$0.57)
than independent pharmacies ($28.14 ±$2.09).
Conclusion
In the rst statewide comparison on LNG EC availability in
West Virginia community pharmacies, we found thatfewer than
half reported having it in stock. In comparisonwith other recent
studies assessing LNG EC availability, West Virginias rate of 0.49
was low. For example, a study of 165 pharmacies around Kansas
City, KS found that 0.78 reported having LNG EC in stock,
whereas a study of 184 pharmacies across 26 U.S. states found
that 0.60 had it in stock.
17,32
Ditmars et al.
35
called community
pharmacies in San Diego and San Francisco and found that LNG
EC was available at 0.88 of the pharmacies. Wilkinson et al.
29
called 993 pharmacies in 5 U.S. cities (Austin, Cleveland, Nash-
ville, Philadelphia, and Portland) and found that approximately
0.80 reported having LNG EC in stock. Uysal et al.
26
called 1475
randomly selected pharmacies in Arizona, California, New
Table 1
LNG EC availability by pharmacy type
Outcome All West Virginia
pharmacies (N ¼509)
Chain pharmacies
(n ¼283)
Independent
pharmacies (n¼226)
Chi-square, P
n% n% n%
Available today?
Yes 249 48.9 216 76.3 33 14.6
c
2
(2) ¼212.08
No 226 44.4 49 17.3 177 78.3 P<0.001
a
Dont know 14 2.8 13 4.6 1 0.4
No Answer/missing 20 3.9 5 1.8 15 6.6
Abbreviations used: LNG, levonorgestrel; EC, emergency contraception.
a
P<0.001.
0 20 40 60 80 100 120
Independent
Chain
All
Available today?
Availability of LNG EC by Pharmacy Type
Yes No Don't Know
0
20
40
60
80
100
12
I
d
e
p
e
d
e
t
C
a
i
n
A
ll
A
va
i
l
a
b
l
e
t
o
d
a
y?
Y
e
s
N
o
D
o
n
'
t
K
o
wMissing
Figure 2. Comparison of availability of LNG EC by pharmacy type. Abbreviations used: LNG, levonorgestrel; EC, emergency contraception. The difference in availability
of LNG EC is signicant at P<0.001. The bar representing availability across all pharmacies is slightly greater than 100% owing to rounding error.
Levonorgestrel access in West Virginia community pharmacies
SCIENCE AND PRACTICE
973
Mexico and Utah and found LNG EC in stock at nearly 0.81 of
them.
Whereas many studies on LNG EC availability have not
explicitly assessed differences between rural and urban phar-
macies, those studies that have assessed the differences found
no signicant difference between their reported stocking
rates.
26,30,36-38
We conducted secondary analyses to examine
the reported availability in our data using West Virginias4
most urban counties as compared with its 4 most rural
counties (on the basis of 2019 population size).
34
The 4 most
urban counties (with a combined population of 497,230) were
not signicantly different than the 4 most rural counties
(combined population of 27,036) in reported LNG EC stocking
rates.
Differences are consistently found, however, in the re-
ported stocking rates between chain and independent phar-
macies on par with the magnitude of the difference in our
study.
17,26,28,30,31
In our sample, 0.44 of the pharmacies were
independent pharmacies. In 30 of the 55 West Virginia
counties 0.55, independent pharmacies make up 0.50 or more
of the pharmacies in that county. Four counties had only in-
dependent pharmacies.
Overall, we found numerous barriers and much misinfor-
mation that limit the accessibility of LNG EC, a nding
consistent with aggregated research ndings since 2000.
30,39
The signicant differences in cost of name-brand and generic
LNG EC between chain and independent pharmacies are
consistent with rates reported in other studies.
40,41
This rela-
tively high cost may be a barrier, especially at chain pharma-
cies, but the trade-off of paying a higher price in exchange for
obtaining LNG EC with relative anonymity and fewer hassles
may be worth it for those who can afford it.
Inventory management in community pharmacies is deter-
mined by a number of factors,
42
and we speculate as others
have
28
several possible reasons for the wide differences
observed between chain and independent pharmacies. These
differences may be explained partly by LNG EC policy set at a
corporate level at chain pharmacies, whereas independent
pharmacies have more variability in their policies and proced-
ures and may be less current in their knowledge of LNG EC re-
strictions or place a lower priority on such information.
Independent pharmacies may also be physically smaller and
have less shelf space for LNG EC. In addition, West Virginias
population tends to be older adults with high rates of obesity,
smoking, and related comorbid conditions, so the already
limited shelf space in West Virginias independent pharmacies
may be disproportionately stocked with medications to treat
those conditions instead of LNG EC. Additional research is
needed to determine how much of the variability in both chain
and independent pharmacies is due to a lack of knowledge of
FDA regulations or to an implementation issue (e.g., low de-
mand, short shelf-life, shoplifting). Further research exploring
these possibilities will inform the design of future interventions.
LNG has decreasing efcacy with time after unprotected
sex and is labeled for use up to 72 hours. However, studies
have shown it is still moderately effective when the rst
dose is taken up to 5 days after sexual intercourse.
20
We
conducted additional secondary analyses using 120 hours
as the correct answer to see how this would affect the
accuracy of responses. Few pharmacy staff gave an answer
that was more than 72 hours (0.03 of chain pharmacy staff
and 0.01 of independent pharmacy staff). Those who got it
wrong were more likely to give an answer that was less
than 72 hours. There were far more Idontknowanswers
Table 2
LNG EC accessibility by pharmacy type
Barrier All West Virginia
pharmacies
(N ¼509)
Chain
pharmacies
(n ¼283)
Independent
pharmacies
(n¼226)
Chi-square, P
n% n% n%
Can a 16-year-old get it?
c
2
¼113.36, P<0.001
a
Yes 284 55.8 214 75.6 70 31.0
No 84 16.5 39 13.8 45 19.9
No answer/missing 141 27.8 30 10.6 111 21.8
Can you get it without a prescription?
c
2
(2) ¼111.41, P<0.001
a
Yes 302 59.3 223 78.8 79 35.0
No 57 11.2 25 8.8 32 14.2
Dont know 10 2.0 5 1.8 5 2.2
No answer/missing 140 27.5 30 10.6 110 21.6
Can you get it without showing ID?
c
2
(2) ¼119.32, P<0.001
a
Yes 248 48.7 190 67.1 58 25.7
No 117 23.0 61 21.6 56 24.8
Dont know 12 2.4 4 1.4 8 3.5
No answer/missing 132 25.9 28 9.9 104 46.0
Can you get it without parents knowing?
c
2
(2) ¼76.65, P<0.001
a
Yes 324 63.7 232 82.0 92 40.7
No 38 7.5 13 4.6 25 11.1
Dont know 15 2.9 6 2.1 9 4.0
No answer/missing 132 25.9 32 11.3 100 44.2
Can you get it without staff assistance?
c
2
(2) ¼196.55, P<0.001
a
Yes 203 39.9 186 65.7 17 7.5
No 161 31.6 65 23.0 96 42.5
Dont know 3 0.6 0 0 3 1.3
No answer/missing 142 27.9 32 11.3 110 48.7
Abbreviations used: LNG, levonorgestrel; EC, emergency contraception; ID, identication.
a
P<0.001.
A.M. Ashcraft et al. / Journal of the American Pharmacists Association 60 (2020) 969e97 7
SCIENCE AND PRACTICE
974
(0.14 and 0.40 of chain and independent pharmacies,
respectively). Therefore, using 5 days as the benchmark for
a correct answer would not have substantially changed our
nding.
A known limitation of this study was our inability to ask
the staff member(s) who answered the phone to tell us their
job title. On the basis of IRB restrictions, we could only record
that information if it was volunteered. Therefore, we often did
not know the position of the person to whom we were
speaking. Staff members other than the pharmacist
answering the phone may have less accurate knowledge of
pharmacy stock, LNG EC regulations, and window of effec-
tiveness. Although this is a limitation to internal validity, it is
more realistic (and externally valid) because it is common
practice for staff members other than the pharmacist to
answer the phone.
Figure 3. Comparison of accessibility of LNG EC by pharmacy type. Abbreviations used: LNG, levonorgestrel; EC, emergency contraception; ID, identication. All
outcomes displayed in the chart represent statistically signicant differences between independent and chain pharmacies, P<0.001.
Table 3
Knowledge of LNG EC effectiveness by pharmacy type
Barrier All West
Virginia
pharmacies
(N ¼509)
Chain
pharmacies
(n ¼283)
Independent
pharmacies
(n ¼226)
Chi-square, P
n% n% n%
Whens the latest it can be taken for it to work?
c
2
(2) ¼38.90, P<0.001
Accurate answer 277 54.4 186 65.7 91 40.3
Inaccurate answer 60 11.8 43 15.2 17 7.5
Dont know 110 21.6 38 13.4 72 31.9
No answer/missing 62 12.2 16 5.7 46 20.4
Abbreviations used: LNG, levonorgestrel; EC, emergency contraception.
Levonorgestrel access in West Virginia community pharmacies
SCIENCE AND PRACTICE
975
Another limitation of our study was our reliance on self-
report from the pharmacy staff as to whether LNG EC was in
stock. We did not verify the accuracy of the responses. A
further limitation of this study was that the pharmacy staff
knew they were on the phone with a research team member,
and this may have biased them toward increased reports of
same-day LNG EC availability. If anything, our nding of 0.49
availability is likely an overestimate. The data comparing
availability, accessibility, and pharmacy staff knowledge of
effectiveness by caller type (researcher vs. mystery caller) will
be shared in a future manuscript.
Family planning remains a high priority area for the United
States, with goals to increase the proportion of pregnancies
that are intended, to reduce pregnancy rates among adoles-
cents, and to increase contraceptive use prioritized in the
Healthy People 2020 objectives and in the Centers for Disease
Control and Prevention s (CDC) list of winnable battles.
23,43
Although birth rates are affected by a number of factors, a few
studies suggest that the ability to purchase LNG EC in a com-
munity pharmacy may be one of those factors.
44-47
Easily
accessible LNG EC could play an important role in reducing
teen and unintended pregnancies in West Virginia and help
break the states generational cycle of poverty; unintended
pregnancy; and poor educational, social, and health outcomes.
According to CDC, 67.6% of women in West Virginia aged 18-49
years are at risk for unintended pregnancy, and of those
women, 22.3% are not using any form of contraception.
48
West Virginia is moving in the right direction. In June 2019,
the state passed House Bill 2583dknown as The Family
Planning Actdto allow pharmacists to dispense self-
administered oral contraception estrogen and progesterone
for up to 1 year without a prescription or provider visit.
Although the new law is a positive step, it has its limits. The
policy is opt-in for all pharmacists, and those who feel un-
comfortable doing so will not have to prescribe oral contra-
ception. Furthermore, pharmacists will have to pay for their
own training on the various types of contraceptives, the
different brands, and potential risks associated with them.
49
Pharmacists could be instrumental in expanding access to
and the proper use of LNG EC by ensuring that it is in stock;
preparing pharmacy staff to give accurate and nonjudgmental
information to customers; and encouraging purchasing in
advance in locations where pharmacy hours are limited. In-
terventions with pharmacy staff may focus, in part, on what
LNG EC is and how it works in addition to providing ongoing
training and education about FDAs permissive guidance
regarding the sale of nonprescription LNG EC.
Acknowledgments
The authors thank Paula Tavrow, Tracey Wilkinson, and El
Chiccarelli for their gracious advice and information-sharing
during the design of this study. The authors are grateful to
our research assistants and data collectors for their time and
enthusiasm for this project, including Nicole Matthews,
Rebecca Kroeze, Lanita Kim, Christiane Messerli, Sarah Eaglen,
Emma Platt, Natalie Dixon, Cassidy Pinion, Josephine Lo,
Rebecca Romano, Marvina Jones, Varsha Rajkumar, Riley
Fisher, Negheen Dorost, and Chris Feghali. The authors are also
indebted to Tatiana Solovieva and Eleni Padden for their
critical roles in project development, support, and oversight
and to Elena Wojcik for her assistance preparing this manu-
script for publication.
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Amie M. Ashcraft, PhD, MPH, Research Assistant Professor, Director of Research,
Department of Family Medicine, School of Medicine, West Virginia University,
Morgantown, WV
Sara Farjo, DO, Assistant Professor, Department of Emergency Medicine,
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Pamela J. Murray, MD, MHP, Professor, Department of Pediatrics, West Virginia
University, Morgantown, WV
Levonorgestrel access in West Virginia community pharmacies
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... Nevertheless, high immediate availability of UPA preparations is to be welcomed due to their generally greater efficacy and longer window of effect [6,7]. The basically quite high immediate availability of both UPA and LNG preparations can be explained by an above-average demand due to the metropolitan character and the world-famous party scene [93] of the study site Berlin, whereas most international SPM studies-with few exceptions [16]-have not identified significant differences between rural and urban CPs [15,47,49,54]. However, the physical contact restrictions in place during the mystery calls due to the COVID-19 pandemic especially for the young population considered as the main users of oral EC [22] might have biased the results in different directions (lower demand or lower orders of CPs at wholesale). ...
... Giving advice was overall-as in international MC studies with comparable counseling items in the USA [28,30,34,39,41,46,49,50,56,58], with few exceptions [55]below average. While the Berlin CPs were still giving quite frequent advice on the correct different window of effect of UPA and LNG preparations, the giving advice on taking oral EC as soon as possible and about its use after vomiting were much less frequently. ...
Article
Full-text available
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Importance Nearly half of US states have restricted abortion access. Policy makers are exploring pathways to increase access to abortion and reproductive health care more broadly. Since 2016, California pharmacists could prescribe hormonal birth control, providing an opportunity to learn about the implementation of pharmacist-provided reproductive health care. Objective To explore the feasibility of broadening pharmacist scope of practice to include prescribing medication abortion. Design, Setting, and Participants A cross-sectional online survey was conducted from October 11 to December 20, 2022, among a convenience sample of California licensed community pharmacists to examine their attitudes toward, knowledge of, and confidence in prescribing hormonal birth control and reports of pharmacy-level practices. Main Outcomes and Measures Descriptive analyses and log-binomial regression models were used to compare medication abortion and contraceptive provision attitudes by pharmacist and pharmacy characteristics. Results Among the 316 pharmacists included in the analysis who worked at community pharmacies across California (mean [SD] age, 40.9 [12.0] years; 169 of 285 [59.3%] cisgender women; and 159 of 272 [58.5%] non-Hispanic Asian individuals), most (193 of 280 [68.9%]) indicated willingness to prescribe medication abortion to pharmacy clients if allowed by law. However, less than half were confident in their knowledge of medication abortion (139 of 288 [48.3%]) or their ability to prescribe it (115 of 285 [40.4%]). Pharmacists who indicated that providing access to hormonal birth control as a prescribing provider was important (263 of 289 [91.0%]) and were confident in their ability to prescribe it (207 of 290 [71.4%]) were 3.96 (95% CI, 1.80-8.73) times and 2.44 (95% CI, 1.56-3.82) times more likely to be willing to prescribe medication abortion and to express confidence in doing so, respectively. Although most pharmacists held favorable attitudes toward hormonal birth control, less than half (144 of 308 [46.8%]) worked in a pharmacy that provided prescriptions for hormonal birth control, and 149 who did not reported barriers such as lack of knowledge or training (65 [43.6%]), insufficient staff or time to add new services (58 [38.9%]), and lack of coverage for services (50 [33.6%]). Conclusions and Relevance The findings of this cross-sectional survey study of California pharmacists suggest that most pharmacists were willing to prescribe medication abortion. However, future efforts to expand pharmacists’ scope of practice should include training to increase knowledge and confidence in prescribing medication abortion. Pharmacy-level barriers to hormonal birth control prescription, such as insurance coverage for pharmacist effort, should also be addressed, as they may serve as barriers to medication abortion access.
Article
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Ensuring access to and promoting use of effective contraception have been identified as important strategies for preventing unintended pregnancy (1). The importance of ensuring resources to prevent unintended pregnancy in the context of public health emergencies was highlighted during the 2016 Zika virus outbreak when Zika virus infection during pregnancy was identified as a cause of serious birth defects (2). Accordingly, CDC outlined strategies for state, local, and territorial jurisdictions to consider implementing to ensure access to contraception (3). To update previously published contraceptive use estimates* among women at risk for unintended pregnancy† and to estimate the number of women with ongoing or potential need for contraceptive services,§,¶ data on contraceptive use were collected during September-December 2016 through the Behavioral Risk Factor Surveillance System (BRFSS). Results from 21 jurisdictions indicated that most women aged 18-49 years were at risk for unintended pregnancy (range across jurisdictions = 57.4%-76.8%). Estimates of the number of women with ongoing or potential need for contraceptive services ranged from 368 to 617 per 1,000 women aged 18-49 years. The percentage of women at risk for unintended pregnancy using a most or moderately effective contraceptive method** ranged from 26.1% to 65.7%. Jurisdictions can use this information to estimate the number of women who might seek contraceptive services and to plan and evaluate efforts to increase contraceptive use. This information is particularly important in the context of public health emergencies, such as the recent Zika virus outbreak, which have been associated with increased risk for adverse maternal-infant outcomes (2,4-6) and have highlighted the importance of providing women and their partners with resources to prevent unintended pregnancy.
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INTRODUCTION For emergency contraception (EC) to be effective, it has to be readily available. Thus, in 2013 the FDA approved EC Levonorgestrel (LNG) for sale over-the-counter (OTC) without a prescription or age limit. Although requiring a prescription, Ulipristal acetate (UPA) approved in 2010 for EC may be more effective than LNG in certain circumstances. We sought to determine the accessibility of these EC medications at pharmacies in the Lehigh Valley Area of Pennsylvania (population 850,000). METHODS Phone surveys were conducted of Corporate and Independent pharmacies. Only the pharmacist or pharmacy tech provided information about availability, age requirements and accessibility of EC. Corporate and Independent pharmacies were compared using chi squared test with appropriate correction. RESULTS The EC survey included 104 Corporate (CorP) and 26 Independent pharmacies (IndP) in the prescribed area. EC was in stock in 95/104 (91%) of CorP and 14/26 (54%) of IndP (p<.001). UPA was in stock at 12/104 (11%) of CorP and none of the IndP (p=.15). Age restriction was noted in 24/104 (23%) of CorP and 8/26 (31%) of IndP (p=.58). LNG over the counter location was found in 75/104 (72%) of CorP and 2/26 (8%) of IndP (p<.001). CONCLUSION Although regional differences may apply, the availability/accessibly of EC is not ideal. Although the corporate pharmacies appear better than independents, the lack of UPA is a concern. Physicians should be aware of the availability of EC in their area.
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Objectives: To assess levonorgestrel (LNG) and ulipristal acetate (UPA) availability in pharmacies in a metropolitan area. Methods: A cross-sectional survey was conducted of all identified pharmacies within 25 miles of an urban medical center in Kansas City, KS. We categorized the pharmacies as dedicated commercial (national chains), store-associated (affiliated with a general merchandise or grocery store), or independent. We assessed LNG and UPA availability or time to availability if not currently stocked. Results: We contacted 165 pharmacies. Of the 165 pharmacies, few stocked UPA (12/165, 7%) whereas the majority stocked oral LNG (128/165, 78%). Dedicated commercial pharmacies were more likely to carry UPA than store-associated and independent pharmacies (11/84 [13%] vs. 1/61 [1%] vs. 0/20, respectively; P = 0.016). Most pharmacies that did not stock UPA reported that they could obtain it within 24 hours (94/153, 62%). Dedicated commercial pharmacies were most likely report the ability to obtain UPA in 24 hours (P = 0.016). Conclusion: Few pharmacies stock UPA, the most effective form of oral emergency contraception. Enhanced communication between medical providers and pharmacists within current laws and regulations could enhance patient access to UPA.
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Purpose: To evaluate the availability and accessibility of emergency contraception (EC) to adolescents in U.S. pharmacies across four Southwestern states, 3 years after the federal Food and Drug Administration (FDA) removed age restrictions for over-the-counter sales of levonorgestrel-only pills. Methods: Using a mystery-caller approach, we trained male and female data collectors to phone pharmacies posing as 16-year-olds who wanted to prevent a pregnancy after recent unprotected sex. From April to May 2016, they called 1,475 randomly selected retail pharmacies in Arizona, California, New Mexico, and Utah and completed an online survey about their experience. Caller data were analyzed by state and pharmacy type (i.e., national chains, regional outlets, and individually owned outlets). Results: Of pharmacies contacted, 80.6% had EC available at the time of the call. Availability of EC varied by state (p < .01) and pharmacy type (p < .01), but not by rural/urban location. Even where EC was available, pharmacy personnel often hindered youths' access to EC by mentioning incorrect point-of-sale restrictions, keeping EC in restrictive store locations, or asking personal questions. Individually owned outlets presented significantly more barriers than larger chains. Overall, EC was completely accessible to an adolescent caller in only 28% of pharmacies. Lower EC accessibility was found in states with higher teen pregnancy rates. Conclusions: This study found that EC is still not sufficiently available or accessible to adolescents in Southwestern states. Differences in accessibility vary significantly by state and pharmacy type and may be a contributor to teen pregnancy rates.
Article
Federal regulations governing access to levonorgestrel (LNG) emergency contraception (EC) have evolved since its introduction in the 1990s. LNG EC was initially available by prescription only, but is now available over-the-counter to consumers of all ages. Nonetheless, consumers seeking EC in their communities may face ongoing barriers to access including low stock and inaccurate information provided by pharmacy staff. We conducted a review of LNG EC secret shopper studies to describe changes in EC access and barriers over time. EC access was compared across all applicable studies, which were published during 2003–2016. When possible, reasons for EC unavailability, helpfulness of pharmacy staff when EC was not in stock, and accuracy of EC information provided by pharmacy staff were described. Overall, access to EC appeared to be improving. However, EC was unavailable during 31% of encounters. Pharmacy staff attributed this to “low demand” (30%) or EC being “out of stock” (21%). Personal objections (9%) and store policy (10%) were also cited in studies from earlier years. Inaccurate information provided by pharmacy staff persists regarding federal EC regulations, mechanism of action, and drug administration. Pharmacy staff should remain informed about EC and its regulations in order to reduce remaining access barriers.
Article
Purpose: Since restrictions on nonprescription sales were removed in 2013, levonorgestrel emergency contraception (EC) should be available without a prescription at pharmacies for consumers of all genders and ages. Using mystery callers, we assessed variations in availability of and access to EC. Methods: In 2015-2016, three sets of mystery callers (two female physicians, two adolescent females, and two adolescent males) each called all licensed retail pharmacies in five U.S. cities using standardized call scripts. Scripts assessed same-day availability and subsequent access to EC for 17-year-olds. Data on various characteristics of calls were collected and compared by caller type. Results: Among the 993 pharmacies called, same-day availability for EC was approximately 80%, with no differences by caller types (p = .34). However, 10.7% of calls made by the adolescent male caller and 8.3% made by the adolescent female caller resulted in incorrectly being told they could not obtain EC based on age, compared to only 1.6% of calls made by the physician (p < .01). Pharmacy staff stated correctly that EC was available over-the-counter more often to adolescent male callers (62.0%) than adolescent females (51.6%) or female physicians (57%) (p < .01). Physicians were more likely to be placed on hold, talk to a pharmacist, or be transferred to a pharmacist (p < .01) than adolescents. Conclusions: Persistent barriers to accessing EC exist for adolescents despite regulatory changes to make EC available over-the-counter, especially for females. Additional work to remove these barriers is needed to assure timely access for those who require effective pregnancy prevention.
Article
Emergency contraception refers to contraceptive methods used to prevent pregnancy in the first few days after unprotected intercourse, sexual assault, or contraceptive failure. Although the U.S. Food and Drug Administration approved the first dedicated product for emergency contraception in 1998, numerous barriers to emergency contraception remain. The purpose of this Committee Opinion is to examine barriers to the use of emergency contraception, emphasize the importance of increasing access, and review new methods of emergency contraception and limitations in efficacy in special populations.