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1Kennedy CE, et al. BMJ Global Health 2019;4:e001402. doi:10.1136/bmjgh-2019-001402
Should oral contraceptive pills be available without a prescription? A systematic review of over-the-counter and pharmacy access availability
Caitlin E Kennedy,1 Ping Teresa Yeh, 1 Lianne Gonsalves,2 Hussain Jafri,3 Mary Eluned Gaffield,2 James Kiarie,2 Manjulaa L Narasimhan2
Research
To cite: Kennedy CE, Yeh PT, Gonsalves L, et al. Should oral contraceptive pills be available without a prescription? A systematic review of over-the-counter and pharmacy access availability. BMJ Global Health 2019;4:e001402. doi:10.1136/bmjgh-2019-001402
Handling editor Soumyadeep Bhaumik
Received 8 January 2019Revised 7 June 2019Accepted 8 June 2019
1Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA2Department of Reproductive Health and Research, Organisation mondiale de la Santé, Genève, Switzerland3WHO Patients for Patients Safety Program, Organisation mondiale de la Sante, Geneve, Switzerland
Correspondence toDr Manjulaa L Narasimhan; narasimhanm@ who. int
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Key questions
What is already known? ► Making oral contraceptives (OC) available over the counter (OTC) may increase access.
What are the new findings? ► A systematic review of the literature identified four studies using comparative designs to examine the effect of OTC availability of OCs and 23 studies ex-amining values and preferences of patients and pro-viders, mostly from the USA and Mexico.
► The more recent and rigorous studies suggested OTC users had higher rates of OC continuation over time; there was some indication that OTC users had lower rates of side effects but slightly higher rates of use of OCs despite contraindications.
► Values and preferences suggested general sup-port for OTC availability or pharmacy access, with more support among women and pharmacists than among physicians.
What do the new findings imply? ► Making OCs available OTC, perhaps with progesto-gen-only pills that have fewer contraindications to use, may be an approach to increasing access to and use of this effective contraceptive option.
AbsTrACTIntroduction Making oral contraceptives (OC) available over the counter (OTC) could reduce barriers to use. To inform WHO guidelines on self-care interventions, we conducted a systematic review of OTC availability of OCs.Methods We reviewed data on both effectiveness and values and preferences surrounding OTC availability of OCs. For the effectiveness review, peer-reviewed articles were included if they compared either full OTC availability or pharmacist-prescribing (behind-the-counter availability) to prescription-only availability of OCs and measured an outcome of interest. For the values and preferences review, we included peer-reviewed articles that presented primary data (qualitative or quantitative) examining people’s preferences regarding OTC access to OCs. We searched PubMed, CINAHL, LILACS and EMBASE through November 2018 and extracted data in duplicate.results The effectiveness review included four studies with 5197 total participants. Two studies from the 2000s compared women who obtained OCs OTC in Mexico to women who obtained OCs from providers in either Mexico or the USA. OTC users had higher OC continuation rates over 9 months of follow-up (adjusted HR: 1.58, 95 % CI 1.11 to 2.26). One study found OTC users were more likely to report at least one WHO category 3 contraindication (13.4% vs 8.6%, p=0.006), but not category 4 contraindications; the other study found no differences in contraindicated use. One study found lower side effects among OTC users and high patient satisfaction with both OTC and prescription access. Two cross-sectional studies from the 1970s in Colombia and Mexico found no major differences in OC continuation, but some indication of slightly higher side effects with OTC access. In 23 values and preference studies, women generally favoured OTC availability. Providers showed more modest support, with pharmacists expressing greater support than physicians. Support was generally higher for progestogen-only pills compared with combination OCs.Conclusion A small evidence base suggests women who obtain OCs OTC may have higher continuation rates and limited contraindicated use. Patients and providers generally support OTC availability. OTC availability may increase access to this effective contraceptive option and reduce unintended pregnancies.
systematic review (PrOsPErO) registration number CRD42019119406.
InTrOduCTIOnEnsuring access to contraceptive methods, including for vulnerable populations and young people, is essential for the well-being and autonomy of women and girls. Oral contraceptives (OC), both combined oral contraceptives (COC) and progestogen-only pills (POP), are widely used effective methods of birth control. However, access to OCs varies globally—in some countries, OCs are available over the counter (OTC), while other
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BMJ Global Health
countries restrict access to OCs either by requiring eligi-bility screening by trained pharmacy staff before dispen-sation (pharmacy access, or behind-the-counter availa-bility), or by requiring a healthcare provider’s prescrip-tion. A 2015 review of OC access across 147 countries found that 35 countries had OCs legally available OTC, 11 countries had OCs available without a prescription but only after eligibility screening by trained pharmacy staff, 56 countries had OCs available informally without a prescription and 45 countries required a prescription to obtain OCs.1 Given the persistently high proportion of unintended pregnancies globally—44% according to some estimates2—making OCs available OTC in more settings has the potential to reduce barriers to access, thereby increasing use of this effective contraceptive option and reducing unintended pregnancies.
While different regulatory criteria are needed in different countries to make a specific medication avail-able OTC or with eligibility screening by pharmacy staff, the WHO is responsible to provide overall guidance to critical questions of whether interventions should be recommended or not. We conducted this systematic review in the context of developing WHO normative guidance on self-care interventions for sexual and repro-ductive health and rights. We included both a review of effectiveness data and a review of data on values and preferences.
METHOdsEffectiveness review: PICO question and inclusion criteriaWe sought to answer the following question: should contraceptive pill/oral contraceptives be made available over the counter without a prescription?
Our effectiveness review followed the PICO question format:
PopulationIndividuals using contraceptive pill/oral contraceptives.
InterventionAvailability of contraceptive pill/oral contraceptives OTC (without a prescription) or behind the counter (phar-macy access, including dispensing from trained pharmacy personnel and pharmacist prescribing of hormonal birth control).
ComparisonAvailability of contraceptive pill/oral contraceptives by prescription only.
Outcomes1. Uptake of OCs (initial use).2. Continuation of OCs (or, conversely, discontinuation).3. Adherence to OCs (correct use).4. Comprehension of instructions (product label).5. Health impacts (unintended pregnancy, side effects,
adverse events or use of OCs despite contraindica-tions).
6. Social harms (eg, coercion, violence (including inti-mate partner violence, violence from family members or community members, and so on), psychosocial harm, self-harm, and so on), and whether these harms were corrected/had redress available.
7. Client satisfaction.To be included in the effectiveness review, a study had
to meet the following criteria:1. Employ a study design comparing OTC availability of
OCs (with or without pharmacist dispensation) to pre-scription-only availability of OCs.
2. Measured one or more of the outcomes listed above.3. Published in a peer-reviewed journal.
We focused on daily contraceptive pill/oral contra-ceptives for routine pregnancy prevention and did not include studies examining pills specifically for emergency contraception.
Where data were available, we stratified all analyses by the following subcategories:
► Behind-the-counter (pharmacy access) versus OTC availability without a prescription.
► COCs versus POPs. ► Point of access (eg, stores, pharmacies, and so on). ► Prior use of contraception. ► Age: adolescent girls and young women (aged 10–14,
15–19 and 15–24) and adult women (aged 25+). ► Vulnerabilities (ie, poverty, disability, religion). ► High-income versus low/middle-income countries. ► Literacy/educational level.Study inclusion was not restricted by location of the inter-
vention or language of the article. We planned to translate articles in languages other than English if identified. The complete protocol was registered and is available in PROS-PERO (CRD42019119406).
Values and preferences review: inclusion criteriaThe same search strategy was used to search and screen for study inclusion in a complementary review of values and preferences related to OTC access to OCs (including phar-macy access). We included studies in the values and pref-erences review if they presented primary data (qualitative or quantitative) examining people’s preferences regarding OTC access to OCs. We included studies examining the values and preferences of both people who have used or potentially would use OCs themselves as well as providers (including pharmacists) and other stakeholders, such as male partners, policymakers and insurance providers.
search strategyThe same search strategy was used for both the effectiveness review and the values and preferences review. We searched four electronic databases (PubMed, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Latin American and Caribbean Health Sciences Literature (LILACS) and Embase) through the search date of 30 November 2018. The following search strategy was devel-oped for PubMed and adapted for entry into all computer databases; a full list of search terms for all databases is avail-able from the authors on request.
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BMJ Global Health
Figure 1 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart showing disposition of citations through the search and screening process.
(‘Contraceptives, Oral’ [Mesh] OR ‘oral contraceptive pill’ [tiab] OR ‘oral contraceptive pills’ [tiab] OR ‘birth control pill’ [tiab] OR ‘birth control pills’ [tiab] OR ‘oral contraceptives’ [tiab] OR ‘oral contraception’ [tiab] OR ‘hormonal birth control’ [tiab] OR ‘hormonal contracep-tion’ [tiab] OR ‘the pill’ [tiab]) AND (‘Nonprescription Drugs’ [Mesh] OR ‘nonprescription’ [tiab] OR ‘over the counter’ [tiab] OR ‘over-the-counter’ [tiab] OR ‘without a prescription’ [tiab] OR ‘pharmacist-prescribed’ [tiab] OR ‘pharmacy access’ [tiab] OR ‘clinician-prescribed’ [tiab] OR ‘physician-prescribed’ [tiab] OR ‘without prescription’ [tiab] OR ‘community pharmacy services’ [Mesh] OR ‘community center’ [tiab] OR ‘community centre’ [tiab] OR store [tiab] OR online [tiab] OR mobile [tiab] OR tele-health [tiab])
To identify articles that may have been missed through online database searching, we used several complemen-tary approaches. We reviewed the resources section of the OCs OTC working group website,3 which gathers scien-tific articles and reviews on this topic, and reviewed the citations included in several related recent reviews.1 4 5 Secondary reference searching was also conducted on all studies included in the review. We searched for ongoing trials through ClinicalTrials. gov, the WHO International Clinical Trials Registry Platform, the Pan African Clinical Trials Registry, and the Australian New Zealand Clinical Trials Registry. Finally, selected experts in the field were presented with our list of included articles and asked to share any additional article we had missed.
Titles, abstracts, citation information and descriptor terms of citations identified through the search strategy were initially screened by a member of the study staff. Remaining citations were then screened in duplicate by two reviewers (CEK and PTY) with differences resolved through consensus. Final inclusion was determined after full-text review.
data extraction and analysisFor each included article, data were extracted inde-pendently by two reviewers using standardised data extraction forms. Differences in data extraction were resolved through consensus.
For the effectiveness review, data extraction forms covered the following categories:
► Study identification: author(s); type of citation; year of publication, funding source.
► Study description: study objectives; location; popu-lation characteristics; type of oral contraceptives; description of OTC access; description of any addi-tional intervention components (eg, any education, training, support provided); study design; sample size; follow-up periods and loss to follow-up.
► Outcomes: analytical approach; outcome measures; comparison groups; effect sizes; CIs; significance levels; conclusions; limitations.
► Risk of bias: assessed for randomised controlled trials with the Cochrane Collaboration’s tool for assessing risk of bias,6 and for non-randomised trials but
comparative studies with the Evidence Project risk of bias tool.7
For the values and preferences review, data extraction forms included sections on study location, population, study design and key findings.
We did not conduct meta-analysis due to the small number and heterogeneous nature of included studies. Instead, we report findings based on the coding catego-ries and outcomes.
Patient and public involvementSeveral of the authors are current or past OC users. HJ, chair of the advisory group for the WHO Patients for Patients Safety Program, was involved as a community representative starting with the phase of protocol devel-opment. He commented on the overall study design and protocol, including patient-relevant outcomes, interpreta-tion of results and writing/editing the document for reada-bility and accuracy. Patients were involved in a global survey of values and preferences and in focus group discussions with vulnerable communities conducted to inform the WHO guideline on self-care interventions8; they thus play a significant role in the overall recommendation informed by this review.
rEsulTssearch resultsFigure 1 presents a flow chart showing study selection for both the effectiveness and values and preferences reviews. The initial database search yielded 929 records, with 15 records identified through other sources; 782 remained after removing duplicates. After the initial title/abstract review, 68 articles were retained for full-text screening. Ultimately, six articles reporting data from
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Table 1 Descriptions of studies included in the effectiveness review
Study Location Population Sampling Study design
2006–2008 Border Contraceptive Access Study10
12 13
El Paso, Texas, USA
1046°C users aged 18–44 who obtained OCs either OTC from a Mexican pharmacy (n=532) or from a family planning clinic in El Paso (n=514)
Convenience sampling Cohort study following both groups of women in four surveys over 9 months
2000 Mexican National Health Survey analysis14
Nationally representative sample from Mexico
1195°C users aged 20–49 who obtained OCs either OTC from a pharmacy (n=501) or from a health clinic of some sort (n=694)
Four-stage probability proportionate to size sampling
Cross-sectional study design
1979 Mexico National Fertility and Mortality Study9
Nationally representative sample from Mexico
2063°C users aged 15–49 who (when they first used contraception) obtained OCs either OTC from a pharmacy or store (39%) from a private physician or private clinic (17%), or from the national family planning programme (44%)
Stratified probability sample Cross-sectional study design
1974 Colombian Fertility and Contraceptive Use Survey11
Bogotá, Colombia
893°C users aged 15–49 who (when they first used contraception) obtained OCs either OTC from a drugstore or similar commercial outlet without a medical prescription and without the advice of a physician or an organised family planning programme (n=298) or chose OCs as her first contraceptive method through a physician or family planning programme (n=595)
Three-stage probability sample
Cross-sectional study design
OC, oral contraceptive; OTC, over the counter.
four studies met the inclusion criteria and were included in the effectiveness review.9–14 An additional 24 articles from 23 studies were included in the values and prefer-ences review.13 15–37
One study was considered for the effectiveness review but ultimately judged to not meet the inclusion criteria.38 In Kuwait, where OCs are available OTC, the study compared women who consulted with a physician and those who did not. We excluded the study because it was not clear whether women received OCs from these physicians or not. However, we note that the study found no difference across groups in OC continuation, dura-tion of first OC use, method failure and reasons for discontinuation.
Effectiveness reviewTable 1 shows the characteristics of the four studies included in the effectiveness review.9–14 The first study, the Border Contraceptive Access Study, was a longitu-dinal cohort study conducted among women living in El Paso, Texas, USA, from 2006 to 2008 with results reported in a number of articles.10 12 13 The study used conveni-ence sampling to enrol 1046°C users who obtained OCs either OTC from a Mexican pharmacy (n=532) or from a family planning clinic in El Paso (n=514). These women were interviewed at baseline and then followed in three additional surveys over 9 months. The second study, an analysis of data from the 2000 Mexican National Health Survey14 by an overlapping group of researchers, was
a cross-sectional comparison of women who reported obtaining OCs OTC to women who reported obtaining them from a healthcare provider. The third and fourth studies were significantly older, drawing on data from the 1970s. They presented cross-sectional comparisons of women whose initial contraceptive method was OCs, obtained OTC from a pharmacy/drugstore, from a private provider/clinician or the national family plan-ning programme: one analysed data from the 1979 Mexico National Fertility and Mortality Study among 2063 women9 and the other was a 1974 Fertility and Contraceptive Use survey in Bogotá, Colombia, among 893 women.11 All studies included mainly women using COCs, rather than POPs, although pill formulations likely differed by time.
As all studies were observational, table 2 shows the risk of bias assessments using the Evidence Project tool. The Border Contraceptive Access and Mexican National Health Survey studies found that women who obtained their OCs OTC were different in at least some sociode-mographic characteristics than those who obtained them from clinics; however, both studies employed analyses that adjusted for confounders to address this discrep-ancy.10 12–14 The Mexico National Fertility and Mortality Study and Colombian Fertility and Contraceptive Use Survey said there were only minor sociodemographic differences between groups but did not present actual statistics to support these statements; neither study
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Tab
le 2
E
vid
ence
Pro
ject
ris
k of
bia
s as
sess
men
t7 for
stud
ies
incl
uded
in t
he e
ffect
iven
ess
revi
ew
Stu
dy
Stu
dy
des
ign
incl
udes
p
re/p
ost
in
terv
enti
on
dat
a
Stu
dy
des
ign
incl
udes
co
ntro
l or
com
par
iso
n g
roup
Stu
dy
des
ign
incl
udes
co
hort
Co
mp
aris
on
gro
ups
equi
vale
nt
at b
asel
ine
on
soci
od
emo
gra
phi
cs
Co
mp
aris
on
gro
ups
equi
vale
nt
at b
asel
ine
on
out
com
e m
easu
res
Par
tici
pan
ts
rand
om
ly
sele
cted
fo
r as
sess
men
t
Par
tici
pan
ts
rand
om
ly
allo
cate
d
to t
he
inte
rven
tio
n
Co
ntro
l fo
r p
ote
ntia
l co
nfo
und
ers
Follo
w-u
p
rate
>=
75%
2006
–200
8 Th
e B
ord
er C
ontr
acep
tive
Acc
ess
Stu
dy10
12
13N
oYe
sYe
sN
oYe
sN
oN
oYe
sYe
s
2000
Mex
ican
Nat
iona
l Hea
lth S
urve
y an
alys
is14
No
Yes
No
No
N/A
Yes*
No
Yes
N/A
1979
Mex
ico
Nat
iona
l Fer
tility
and
M
orta
lity
Stu
dy9
No
Yes
No
NR
†N
/AYe
sN
oN
oN
/A
1974
Col
omb
ian
Fert
ility
and
C
ontr
acep
tive
Use
Sur
vey11
No
Yes
No
NR
†N
/AYe
s‡N
oN
oN
/A
*Fou
r-st
age
pro
bab
ility
pro
por
tiona
te t
o si
ze s
amp
ling.
†Aut
hors
sta
te t
hat
the
com
par
ison
gro
ups
wer
e si
mila
r, b
ut n
o co
mp
arat
ive
dat
a p
rovi
ded
to
asse
ss t
his.
‡Thr
ee-s
tage
pro
bab
ility
sam
plin
g.N
/A, n
ot a
pp
licab
le; N
R, n
ot r
epor
ted
.
adjusted for confounders.9 11 The Border Contraceptive Access Study relied on convenience sampling, but was strengthened by its longitudinal design.10 12 13 Conversely, while the other three studies were cross sectional in nature, they were strengthened by their multistage sampling strategies.9 11 14
The included studies reported on three of the PICO outcomes: continuation of OCs, health impacts (specif-ically, use of OCs despite contraindications and side effects) and client satisfaction. For the other PICO outcomes, we found no studies. Results from each study are presented in table 3 and described below.
Continuation of OCsThe Border Contraceptive Access Study reported the proportion of women who continued OC use over the 9-month study period.12 Overall, 25.1% of clinic users discontinued by the end of the study period compared with 20.8% of OTC users (p=0.12). In an unadjusted Cox proportional hazards model, OTC users were more likely to continue OC use than clinic users (unadjusted HR: 1.48, 95% CI 1.07 to 2.04); this estimate changed only slightly in the adjusted model and remained statistically significant (adjusted HR: 1.58, 95% CI 1.11 to 2.26).
The two studies from the 1970s also examined contin-uation. The Mexico National Fertility and Mortality Study presented continuation rates at 12 months per 100 women who accepted OCs as their first contraceptive method.9 No difference by OC source was found: 59% of private physician or clinic users, 57% of government family planning programme users and 60% of OTC users remained on OCs after 12 months. The Colombian Fertility and Contraceptive Use Survey presented first contraceptive method continuation rates for women who chose OCs at 12 and 24 months.11 Though a validation survey found that the continuation rates were overesti-mated by approximately 10%–15%, the study found that at both 12 and 24 months, OC continuation was approxi-mately 5% higher for clinic users than OTC users.
Use of OCs despite contraindicationsThe two studies from the 2000s reported on the use of OCs despite contraindications.
The Border Contraceptive Access Study reported use of OCs despite contraindications using the WHO Medical Eligibility Criteria (MEC) (third edition) relative (cate-gory 3) and absolute (category 4) contraindications.10 At the baseline survey, at least one category 3 or 4 contra-indication was reported by 21.4% of OTC users and 13.8% of clinic users (p=0.002). OTC users were more likely to have any category 3 contraindication (13.4% vs 8.6%, p=0.006), but there was no difference in category 4 contraindications (7.4% vs 5.3%, p=0.162). The study also provided a list of specific contraindications. For most contraindications there was no significant difference for OTC and clinic users; however, OTC users were signifi-cantly more likely than clinic users to have category 3 hypertension (140–159/90–99) (8.4% vs 4.5%, p=0.036)
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BMJ Global Health
Tab
le 3
O
utco
mes
of s
tud
ies
incl
uded
in t
he e
ffect
iven
ess
revi
ew
Cit
atio
nR
esul
ts
2006
–200
8 Th
e B
ord
er
Con
trac
eptiv
e A
cces
s S
tud
y10
12 1
3
Co
ntin
uati
on
of
OC
sD
isco
ntin
uatio
n of
OC
s ov
er 9
mon
ths:
OTC
: 20.
8% (9
7/46
6), c
linic
: 25.
1% (1
19/4
74),
p=
0.12
Una
dju
sted
Cox
pro
por
tiona
l haz
ard
s m
odel
, clin
ic v
ersu
s O
TC: u
nad
just
ed H
R: 1
.48
(95%
CI 1
.07
to 2
.04)
, ad
just
ed H
R: 1
.58
(95%
CI
1.11
to
2.26
)Li
fe t
able
est
imat
es o
f con
tinua
tion
at 9
mon
ths
wer
e 5%
hig
her
for
OTC
use
rs t
han
clin
ic u
sers
(p<
0.01
).H
ealt
h im
pac
ts: u
se o
f O
Cs
des
pit
e co
ntra
ind
icat
ions
Una
dju
sted
reg
ress
ion
mod
el fo
r at
leas
t on
e ca
tego
ry 3
or
4 co
ntra
ind
icat
ion,
OTC
ver
sus
clin
ic: u
nad
just
ed O
R: 1
.69
(95%
CI 1
.22
to
2.36
), ad
just
ed O
R: 1
.59
(95%
CI 1
.11
to 2
.29)
, p=
0.01
2
Hyp
erte
nsio
n
Any
hyp
erte
nsio
n (1
40/9
0 m
m H
g or
mor
e)
Hyp
erte
nsio
n 14
0–15
9/90
–99
mm
Hg
H
yper
tens
ion
160/
100
mm
Hg
or m
ore
S
mok
ing
and
age
35
year
s or
old
er
Sm
okes
less
tha
n 15
cig
aret
tes
per
day
S
mok
es 1
5 or
mor
e ci
gare
ttes
per
day
M
igra
ine
head
ache
s w
ith a
ura
C
urre
nt g
all b
lad
der
dis
ease
H
igh
chol
este
rol a
nd u
sing
med
icat
ion
D
iab
etes
with
com
plic
atio
ns
Cur
rent
live
r d
isea
se o
r hi
stor
y of
live
r ca
ncer
H
isto
ry o
f or
curr
ent
hear
t d
isea
se
Pre
viou
s he
art
atta
ck o
r st
roke
H
isto
ry o
f thr
omb
osis
or
pul
mon
ary
emb
olis
m
Cur
rent
use
of m
edic
atio
ns fo
r tu
ber
culo
sis
or
seiz
ure
H
isto
ry o
f or
curr
ent
bre
ast
canc
er
Cla
ssifi
catio
n of
ass
esse
d c
ontr
aind
icat
ions
A
ny c
ateg
ory
3 co
ntra
ind
icat
ion
A
ny c
ateg
ory
4 co
ntra
ind
icat
ion
A
ny c
ateg
ory
3 or
4 c
ontr
aind
icat
ion
Clin
ic u
sers
n (%
)29
(5.6
)23
(4.5
)6
(1.2
)16
(3.1
)0
(0.0
)21
(4.1
)5
(1.0
)2
(0.4
)2
(0.4
)0
(0.0
)1
(0.2
)0
(0.0
)1
(0.2
)1
(0.2
)0
(0.0
)44
(8.6
)27
(5.3
)71
(13.
8)
OT
C u
sers
n (%
)49
(9.8
)42
(8.4
)7
(1.4
)32
(6.4
)2
(0.4
)21
(4.2
)8
(1.6
)3
(0.6
)1
(0.2
)3
(0.6
)1
(0.2
)2
(0.4
)1
(0.2
)1
(0.2
)1
(0.2
)70
(13.
4)37
(7.4
)10
7 (2
1.4)
P v
alue
0.01
30.
036
0.01
70.
932
0.37
70.
633
0.57
80.
079
0.98
60.
152
0.98
60.
986
0.31
10.
006
0.16
20.
002
H
ealt
h im
pac
ts: s
ide
effe
cts
R
epor
ted
sid
e ef
fect
s: O
TC: 2
2.3%
(104
/466
), cl
inic
: 30.
4% (1
44/4
74),
p<
0.01
C
lient
sat
isfa
ctio
n
3/4
of c
linic
use
rs a
nd >
70%
of p
harm
acy
user
s sa
id t
hey
wer
e ve
ry s
atis
fied
with
the
ir so
urce
. Onl
y ab
out
4% o
f eac
h gr
oup
sai
d t
hey
wer
e ei
ther
som
ewha
t or
ver
y un
satis
fied
with
the
ir so
urce
.
Con
tinue
d
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BMJ Global Health
Cit
atio
nR
esul
ts
2000
Mex
ican
Nat
iona
l Hea
lth
Sur
vey
anal
ysis
14H
ealt
h im
pac
ts: u
se o
f O
Cs
des
pit
e co
ntra
ind
icat
ions
Clin
ic u
sers
(%)
OT
C u
sers
(%)
All
p v
alue
s no
n-si
gnifi
cant
Hyp
erte
nsio
n (≥
160/
100
mm
Hg)
1.8
1.7
A
ge <
351.
11.
2
A
ge ≥
354.
23.
1
Sm
okin
g an
d a
ge ≥
357.
59.
4
Any
con
trai
ndic
atio
n3.
64.
5
A
ge ≥
351.
11.
2
A
ge ≥
3511
.612
.8
1979
Mex
ico
Nat
iona
l Fer
tility
an
d M
orta
lity
Stu
dy9
Co
ntin
uati
on
of
OC
sFi
rst
met
hod
con
tinua
tion
rate
s p
er 1
00 w
omen
who
acc
epte
d O
Cs
as t
heir
first
met
hod
, by
initi
al s
ourc
e of
sup
ply
(197
4–19
79)
Pri
vate
phy
sici
an/c
linic
us
ers
Go
vern
men
t p
rog
ram
me
user
sO
TC
use
rs
Tota
l at
12 m
onth
s59
5760
A
ge <
2557
5655
A
ge 2
5+61
5866
Tab
le 3
C
ontin
ued
Con
tinue
d
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BMJ Global Health
Cit
atio
nR
esul
ts
1974
Col
omb
ian
Fert
ility
and
C
ontr
acep
tive
Use
Sur
vey11
Co
ntin
uati
on
of
OC
s
Firs
t m
etho
d c
ontin
uatio
n of
OC
s ov
er 1
2 m
onth
s: O
TC: 7
9.2
per
100
wom
en (u
nwei
ghte
d n
umb
er o
f use
rs c
omp
letin
g p
erio
d n
=19
1),
clin
ic: 8
4.2
per
100
wom
en (n
=40
0)Fi
rst
met
hod
con
tinua
tion
of O
Cs
over
24
mon
ths:
OTC
: 68.
8 p
er 1
00 w
omen
(n=
131)
, clin
ic: 7
4.3
per
100
wom
en (n
=26
9)N
ote:
A J
anua
ry 1
975
valid
atio
n su
rvey
ind
icat
ed t
hat
first
-seg
men
t O
C c
ontin
uatio
n ra
tes
wer
e ov
eres
timat
ed b
y ap
pro
xim
atel
y 10
%–1
5%.
Life
tab
le e
stim
ates
of O
C c
ontin
uatio
n at
12
and
24
mon
ths
wer
e ap
pro
xim
atel
y 5%
hig
her
for
clin
ic u
sers
tha
n O
TC u
sers
.
Hea
lth
imp
acts
: sid
e ef
fect
s
Clin
ic u
sers
(%) n
=58
7O
TC
use
rs (%
) n=
295
Rep
orte
d a
ny s
ide
effe
cts
whi
le u
sing
OC
s44
.451
Rep
orte
d t
hrom
bop
hleb
itis
00
Rep
orte
d t
hrom
boe
mb
olis
m0
0
Rep
orte
d w
eigh
t ch
ange
s7.
24.
9
Rep
orte
d v
aric
es4.
53.
4
Rep
orte
d h
ead
ache
27.4
25.1
Rep
orte
d n
ervo
usne
ss10
.715
.3
Rep
orte
d s
kin
pro
ble
ms
6.2
14.7
Rep
orte
d p
ain
2.8
10.1
Rep
orte
d b
leed
ing
pro
ble
ms
3.7
5.2
Rep
orte
d v
ario
us o
ther
sid
e ef
fect
s (n
ot s
pec
ified
)37
.521
.2
OC
, ora
l con
trac
eptiv
e; O
TC, o
ver
the
coun
ter.
Tab
le 3
C
ontin
ued
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BMJ Global Health
or to both smoke (<15 cigarettes per day) and be 35 years or older (6.4% vs 3.1%, p=0.017).
The 2000 Mexican National Health Survey analysis reported use of OCs despite category 3 contraindica-tions using the WHO MEC Criteria from 1996 based on hypertension and smoking at or over age 35.14 Overall, the study found no significant differences in contraindi-cations between OC users who obtained their pills OTC versus those who obtained them at a clinic (table 3). This finding held true when comparing OTC to clinic users on contraindications related to hypertension (≥160/100) (1.7% vs 1.8%), smoking and age 35 or older (9.4% vs 7.5%), and both contraindications combined (4.5% vs 3.6%).
Side effectsTwo studies reported on side effects related to OC use. The Border Contraceptive Access Study found that, at baseline, 22.3% (104/466) of OTC users reported side effects compared with 30.4% (144/474) of clinic users (p<0.01).12 The Colombian Fertility and Contraceptive Use Survey found that 51% of OTC users and 44.4% of clinic users reported any side effect from initial OC use.11 Neither group reported the most important complications of OC use (thrombophlebitis and throm-boembolism), and similar proportions reported the most common side effect (headache). OTC users were more likely to mention nervousness, skin problems, pain and bleeding problems, while clinic users were more likely to complain of weight changes, varices and other side effects (not specified).
SatisfactionOne study—the Border Contraceptive Access Study—reported client satisfaction but did not present exact results. They stated, ‘three quarters of clinic users and more than 70% of pharmacy users said they were very satisfied with their source (results not shown). Only about 4% of each group said they were either somewhat or very unsatisfied with their source.’13
Values and preferences reviewWe identified 24 articles from 23 studies that met the inclusion criteria for the values and preferences review. Of these, 13 articles focused on the perspec-tives of female OC users, potential users, or women in general,13 15 16 18 19 21–24 29–31 37 9 focused on the perspec-tives of healthcare providers (particularly physicians) and pharmacists17 25 26 28 32–36 38 39 and 1 focused on the general public;27 one article included both women and healthcare providers.20 Almost all studies were conducted in the USA, except for one each in Canada,32 France17 and Ireland15; one publication from the Border Contra-ceptive Access Study included in the values and prefer-ences review included women residing in El Paso, Texas, who accessed OCs in both the USA and Mexico.13 Studies used both quantitative and qualitative methodologies.
Studies covered both OTC and pharmacy access. While most studies of women asked about hypothetical values and preferences around OTC availability, a few studies reported the perspectives of women who had actually used OTC or pharmacy access services.13 20 Most studies distinguished between pharmacy access and OTC availability, although a few were less clear about which approach they were studying, using terms such as ‘access to oral contraceptives without a prescription,’ which we assumed to be OTC availability. Using our best assessment of which model studies were examining, we present data for the values and preferences studies sepa-rated by true OTC access (table 4) and pharmacy access (table 5), and present results accordingly below. Two studies examined perspectives on both OTC and phar-macy access, so are presented in both tables 4 and 5. One cross-sectional survey among young women aged 14–17 in the USA found slightly higher support for dispensa-tion in pharmacies compared with full OTC availability (79% vs 73%), but slightly higher potential use of full OTC availability compared with pharmacy access (61% vs 57%).30 Another cross-sectional survey among healthcare providers in the USA found much higher rates of support for pharmacy access (74%) compared with full OTC access (28%), although this study combined the pill, patch and ring together in one question about hormonal contraceptives.35
OTC accessAcross studies using both quantitative and qualitative methods, women generally expressed high interest in hypothetical OTC availability of OCs. In quantitative studies, support for OTC availability of OCs ranged from a third of female students in two US colleges/univer-sities19 31 to 89% of current OC users aged 18–50 in Ireland.15 However, most quantitative surveys of potential OC users found that a majority of participants supported OTC availability.15 18 21 24 30 Slightly lower but still sizeable proportions of women said they would obtain OCs OTC if available.23 24 30 Ease of access, convenience, privacy and time saved from clinician visits for prescriptions were the main benefits women anticipated from OTC availa-bility.13 16 18 30 However, across studies, participants noted concerns about cost, continued use of other preventive screening options (eg, for Pap smears, pelvic exams, clin-ical breast exams and sexually transmitted infections) and the safety of such access, particularly for young people, first-time pill users and women with medical conditions.13 16 18 19 23 30 31
Healthcare professionals from France and the USA, particularly medical doctors, voiced moderate to low support for OTC availability of OCs, often citing safety concerns, OC efficacy, concerns about correct OC use or missed examinations for medical contraindications.17 28 35 Providers generally supported making POPs available OTC more than they supported making COCs available OTC.26
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lob Health: first published as 10.1136/bm
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nloaded from
10 Kennedy CE, et al. BMJ Global Health 2019;4:e001402. doi:10.1136/bmjgh-2019-001402
BMJ Global Health
Tab
le 4
S
tud
y d
escr
iptio
ns a
nd k
ey fi
ndin
gs o
f stu
die
s in
clud
ed in
the
val
ues
and
pre
fere
nces
rev
iew
exa
min
ing
OTC
acc
ess
Stu
dy
auth
ors
and
yea
rC
oun
try
Po
pul
atio
nS
tud
y d
esig
nK
ey fi
ndin
gs
Pot
entia
l OC
use
rs
Bar
lass
ina,
201
515Ire
land
OC
use
rs a
ged
18–
50C
ross
-sec
tiona
l sur
vey
(n=
488)
88%
(429
/488
) of p
artic
ipan
ts w
ere
in fa
vour
of O
Cs
bei
ng a
vaila
ble
with
out
pre
scrip
tion.
92%
(448
/488
) sai
d t
hey
wer
e lik
ely
to o
bta
in O
Cs
with
out
pre
scrip
tion
if av
aila
ble
. Con
veni
ence
and
eas
e of
acc
ess
wer
e th
e m
ain
adva
ntag
es o
f OTC
ava
ilab
ility
, whi
le s
afet
y w
as t
he b
igge
st c
once
rn.
Bau
m e
t al
, 201
616U
SA
Wom
en a
ged
13–
45 w
ho id
entifi
ed
with
at
leas
t on
e p
riorit
y p
opul
atio
n:
Bla
ck/A
fric
an-A
mer
ican
, Asi
an/P
acifi
c Is
land
er, L
atin
a, a
nd/o
r ag
ed 1
3–24
Qua
litat
ive
stud
y us
ing
focu
s gr
oup
sW
omen
rep
orte
d p
oten
tial b
enefi
ts o
f OTC
acc
ess,
incl
udin
g co
nven
ienc
e an
d
priv
acy.
Man
y b
elie
ved
OTC
ava
ilab
ility
of O
Cs
wou
ld h
elp
red
uce
unin
tend
ed
pre
gnan
cy a
nd h
elp
des
tigm
atis
e b
irth
cont
rol.
Par
ticip
ants
exp
ress
ed c
once
rns
abou
t O
TC a
cces
s, s
uch
as w
orry
tha
t fir
st-t
ime
user
s an
d y
oung
ad
oles
cent
s w
ould
not
hav
e en
ough
info
rmat
ion
to u
se t
he p
ill s
afel
y an
d e
ffect
ivel
y, a
s w
ell
as c
once
rns
abou
t w
heth
er w
omen
wou
ld s
till o
bta
in p
reve
ntiv
e sc
reen
ings
. W
omen
wer
e al
so w
orrie
d t
hat
OTC
OC
s w
ould
cos
t m
ore
if no
long
er c
over
ed
by
insu
ranc
e.
Den
nis
and
Gro
ssm
an,
2012
18U
SA
Low
-inc
ome
wom
enQ
ualit
ativ
e st
udy
usin
g fo
cus
grou
ps
and
in-d
epth
in
terv
iew
s
Mos
t p
artic
ipan
ts s
upp
orte
d O
TC a
cces
s to
OC
s. P
artic
ipan
ts e
xpec
ted
tha
t O
TC a
vaila
bili
ty w
ould
sav
e w
omen
tim
e in
clin
icia
n vi
sits
for
pre
scrip
tions
and
in
crea
se t
he c
onve
nien
ce o
f the
met
hod
. How
ever
, the
y ra
ised
con
cern
s ab
out
cost
, con
tinue
d u
se o
f oth
er p
reve
ntiv
e sc
reen
ing
optio
ns a
nd t
he s
afet
y of
suc
h ac
cess
for
min
ors,
firs
t-tim
e us
ers
and
wom
en w
ith m
edic
al c
ond
ition
s.
Form
an e
t al
, 199
719U
SA
Und
ergr
adua
te s
tud
ents
at
an u
rban
w
omen
's li
ber
al a
rts
colle
geC
ross
-sec
tiona
l sur
vey
(n=
290)
65%
of a
ll re
spon
den
ts fe
lt O
Cs
shou
ld n
ot b
e av
aila
ble
with
out
pre
scrip
tion.
Th
e tw
o m
ost
com
mon
ly c
ited
rea
sons
for
not
wan
ting
OC
s to
be
avai
lab
le
OTC
wer
e: (1
) sid
e ef
fect
mig
ht o
ccur
tha
t a
heal
thca
re p
rovi
der
cou
ld h
ave
pre
vent
ed (5
9%) a
nd (2
) peo
ple
wou
ld n
ot g
o to
the
ir p
rovi
der
s fo
r re
gula
r ch
eck-
ups
(56%
). Th
e m
ost
com
mon
ly c
ited
rea
son
for
wan
ting
OC
s to
be
avai
lab
le O
TC w
as t
here
wou
ld b
e fe
wer
unw
ante
d p
regn
anci
es. R
ace,
pre
viou
s O
C u
se, p
revi
ous
sexu
al a
ctiv
ity a
nd p
erce
ived
ris
k of
pre
gnan
cy w
ere
not
sign
ifica
nt p
red
icto
rs o
f bel
ievi
ng O
Cs
shou
ld b
e av
aila
ble
OTC
. Hav
ing
had
a
pre
viou
s p
regn
ancy
was
a s
igni
fican
t p
red
icto
r of
bel
ievi
ng O
Cs
shou
ld b
e av
aila
ble
OTC
(p=
0.04
7). T
hose
who
bel
ieve
d O
Cs
shou
ld b
e av
aila
ble
onl
y w
ith
a p
resc
riptio
n w
ere
will
ing
to p
ay m
ore
for
OC
Ps
(p=
0.03
3). L
ogis
tic r
egre
ssio
n co
ntro
lling
for
race
rev
eale
d t
hat
bot
h yo
unge
r ag
e (p
=0.
030)
and
pre
viou
s p
regn
ancy
(p=
0.00
2) w
ere
ind
epen
den
t p
red
icto
rs o
f bel
ievi
ng O
Cs
shou
ld b
e av
aila
ble
OTC
.
Grin
dla
y et
al,
2014
21U
SA
Wom
en a
ged
15–
46 s
eeki
ng a
bor
tion
serv
ices
Cro
ss-s
ectio
nal s
urve
y (n
=65
1)81
% o
f res
pon
den
ts s
upp
orte
d O
TC a
cces
s to
OC
s. W
hile
42%
of w
omen
p
lann
ed t
o us
e th
e p
ill a
fter
the
ir ab
ortio
n, 6
1% s
aid
the
y w
ould
like
ly u
se
this
met
hod
if it
wer
e av
aila
ble
OTC
. 33%
of w
omen
who
pla
nned
to
use
no
cont
race
ptiv
e fo
llow
ing
thei
r ab
ortio
n sa
id t
hey
wou
ld u
se a
n O
TC p
ill, a
s d
id
38%
who
pla
nned
to
use
cond
oms
afte
rwar
d. I
n m
ultiv
aria
ble
ana
lysi
s, s
ever
al
sub
grou
ps
had
incr
ease
d o
dd
s of
like
ly O
TC u
se: w
omen
old
er t
han
19 (O
R: 1
.8
for
ages
20–
29 a
nd 1
.6 fo
r ag
es 3
0–46
), un
insu
red
(OR
: 1.5
), p
revi
ous
pill
use
rs
(OR
: 1.4
), ha
d d
ifficu
lty o
bta
inin
g a
pre
scrip
tion
refil
l for
hor
mon
al c
ontr
acep
tives
(O
R: 2
.7) o
r p
lann
ed p
osta
bor
tion
pill
use
(OR
: 13.
0). N
on-W
hite
wom
en w
ere
less
like
ly t
o sa
y th
ey w
ould
use
OTC
OC
s (O
Rs
rang
ed fr
om 0
.4 t
o 0.
7).
Con
tinue
d
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BMJ Global Health
Stu
dy
auth
ors
and
yea
rC
oun
try
Po
pul
atio
nS
tud
y d
esig
nK
ey fi
ndin
gs
Grin
dla
y an
d
Gro
ssm
an,2
01823
US
AS
exua
lly a
ctiv
e ad
ult
wom
en a
ged
18–
44 n
ot c
urre
ntly
des
iring
pre
gnan
cy
and
fem
ale
teen
s ag
ed 1
5–17
Cro
ss-s
ectio
nal s
urve
y (n
=25
39: 2
026
adul
t, 5
13
teen
s)
39%
of a
dul
ts a
nd 2
9% o
f tee
ns r
epor
ted
like
ly u
se o
f OTC
PO
Ps,
with
a g
reat
er
likel
ihoo
d if
cov
ered
by
insu
ranc
e. A
mon
g ad
ults
, wom
en w
ho w
ere
neve
r m
arrie
d o
r liv
ing
alon
e (v
s m
arrie
d),
unin
sure
d (v
s p
rivat
ely
insu
red
), cu
rren
t p
ill o
r le
ss e
ffect
ive
met
hod
use
rs (v
s rin
g, p
atch
, inj
ecta
ble
or
intr
aute
rine
dev
ice)
, trie
d t
o ge
t a
birt
h co
ntro
l pre
scrip
tion
in t
he p
ast
year
, or
ever
use
d
a co
ntra
cep
tive
pill
/ora
l con
trac
eptiv
e or
PO
P h
ad h
ighe
r od
ds
of li
kely
use
. A
mon
g te
ens,
Sp
anis
h sp
eake
rs a
nd t
hose
who
eve
r ha
d s
ex h
ad h
ighe
r od
ds
of li
kely
use
; Bla
ck t
eens
(vs
Whi
te) h
ad lo
wer
od
ds.
Grin
dla
y an
d G
ross
man
, 20
1522
US
AW
omen
age
d 1
8–44
at
risk
of
unin
tend
ed p
regn
ancy
Cro
ss-s
ectio
nal s
urve
y (n
=20
46)
26%
of r
esp
ond
ents
sup
por
ted
an
age
rest
rictio
n fo
r an
OTC
OC
; 28%
wer
e ag
ains
t an
age
res
tric
tion;
and
46%
wer
e un
sure
. In
mul
tivar
iab
le a
naly
sis,
w
omen
wer
e m
ore
likel
y to
sup
por
t an
age
res
tric
tion
for
an O
TC O
C if
the
y ha
d le
ss t
han
a hi
gh s
choo
l deg
ree
(OR
: 2.5
), a
high
sch
ool d
egre
e (O
R: 1
.6) o
r so
me
colle
ge (O
R: 1
.6) c
omp
ared
with
a c
olle
ge d
egre
e; if
the
y w
ere
mar
ried
co
mp
ared
with
nev
er m
arrie
d (O
R: 2
.1);
and
if t
hey
lived
in t
he M
idw
est
(OR
: 2.1
) or
Sou
th (O
R: 2
.1) c
omp
ared
with
the
Wes
t.
Gro
ssm
an e
t al
, 201
32462
.2%
of r
esp
ond
ents
wer
e st
rong
ly (3
1.4%
) or
som
ewha
t (3
0.9%
) in
favo
ur o
f O
Cs
bei
ng a
vaila
ble
OTC
. 37.
1% r
epor
ted
bei
ng li
kely
to
use
OC
s if
avai
lab
le
OTC
, inc
lud
ing
58.7
% o
f cur
rent
use
rs, 2
8.0%
usi
ng n
o m
etho
d a
nd 3
2.7%
us
ing
a le
ss e
ffect
ive
met
hod
. Cov
aria
tes
asso
ciat
ed w
ith a
hig
her
odd
s of
re
por
ting
inte
rest
in u
sing
OTC
OC
s w
ere
youn
ger
age;
bei
ng d
ivor
ced
, bei
ng
sep
arat
ed o
r liv
ing
with
a p
artn
er (v
s m
arrie
d);
bei
ng u
nins
ured
or
havi
ng p
rivat
e in
sura
nce
(vs
pub
lic in
sura
nce)
; liv
ing
in t
he S
outh
(vs
Nor
th-E
ast);
and
cur
rent
us
e of
OC
s or
less
effe
ctiv
e m
etho
ds,
or
non-
use
of c
ontr
acep
tion
(vs
use
of
anot
her
horm
onal
met
hod
or
intr
aute
rine
dev
ice)
.
Land
au e
t al
, 200
629U
SA
Wom
en a
ged
18–
44 y
ears
at
risk
of
unin
tend
ed p
regn
ancy
Cro
ss-s
ectio
nal s
urve
y (n
=81
1)W
omen
wer
e m
ore
likel
y to
be
pot
entia
l OTC
use
rs o
f OC
s if
they
had
pro
ble
ms
with
ob
tain
ing
pre
scrip
tion
cont
race
ptio
n (O
R: 2
.55)
, wer
e un
insu
red
(OR
: 2.3
1),
wer
e lo
w in
com
e (O
R: 1
.53)
, had
an
unin
tend
ed p
regn
ancy
or
pre
gnan
cy s
care
(O
R: 1
.82)
, or
wer
e A
fric
an-A
mer
ican
(OR
: 1.5
9) o
r La
tina
(OR
: 1.9
0).
Man
ski a
nd K
ottk
e,
2015
30U
SA
Youn
g w
omen
age
d 1
4–17
Cro
ss-s
ectio
nal s
urve
y (n
=34
8)73
% o
f par
ticip
ants
sup
por
ted
OTC
acc
ess
to O
Cs,
and
61%
rep
orte
d t
hey
wou
ld b
e lik
ely
to u
se O
Cs
avai
lab
le O
TC. 7
9% o
f par
ticip
ants
sup
por
ted
p
harm
acy
acce
ss t
o O
Cs,
and
57%
rep
orte
d t
hey
wou
ld b
e lik
ely
to u
se O
Cs
avai
lab
le t
hrou
gh p
harm
acy
acce
ss. F
ew s
ubgr
oup
diff
eren
ces
wer
e no
ted
, ex
cep
t th
at s
exua
lly e
xper
ienc
ed p
artic
ipan
ts w
ere
mor
e lik
ely
to b
oth
sup
por
t O
TC a
cces
s an
d b
e lik
ely
to u
se it
. Sub
urb
an t
eena
gers
wer
e m
ore
likel
y to
su
pp
ort
pha
rmac
y ac
cess
tha
n th
ose
from
rur
al a
nd u
rban
are
as. T
he m
ost
com
mon
ly c
ited
ad
vant
age
to O
TC a
cces
s w
as fe
wer
tee
nage
pre
gnan
cies
(4
5%).
Oth
er c
omm
on r
esp
onse
s w
ere
that
it w
ould
be
easi
er fo
r te
enag
ers
to
get
birt
h co
ntro
l (22
%) a
nd it
wou
ld b
e m
ore
confi
den
tial (
14%
). D
isad
vant
ages
ci
ted
incl
uded
tee
nage
rs n
ot u
sing
con
dom
s to
pro
tect
aga
inst
STI
s (2
2%),
need
ing
a d
octo
r d
ecid
e if
OC
s ar
e sa
fe fo
r th
em (1
9%),
mig
ht h
ave
sex
at a
yo
unge
r ag
e (1
8%) a
nd m
ight
use
OC
s in
corr
ectly
(18%
).
Tab
le 4
C
ontin
ued
Con
tinue
d
on July 1, 2020 by guest. Protected by copyright.
http://gh.bmj.com
/B
MJ G
lob Health: first published as 10.1136/bm
jgh-2019-001402 on 25 June 2019. Dow
nloaded from
12 Kennedy CE, et al. BMJ Global Health 2019;4:e001402. doi:10.1136/bmjgh-2019-001402
BMJ Global Health
Stu
dy
auth
ors
and
yea
rC
oun
try
Po
pul
atio
nS
tud
y d
esig
nK
ey fi
ndin
gs
Nay
ak e
t al
, 200
531U
SA
Uni
vers
ity w
omen
Cro
ss-s
ectio
nal s
urve
y (n
=50
0)37
% o
f par
ticip
ants
favo
ured
the
acq
uisi
tion
of O
Cs
with
out
a p
resc
riptio
n.
Wom
en a
ssoc
iate
d O
TC a
cces
s to
OC
s w
ith in
crea
sed
like
lihoo
d o
f ad
vers
e m
edic
al c
onse
que
nces
and
the
pre
scrip
tion-
only
sys
tem
with
an
incr
ease
d
likel
ihoo
d o
f pre
gnan
cy a
void
ance
. Wom
en w
ho p
refe
rred
OTC
ava
ilab
ility
re
por
ted
mor
e fa
vour
able
att
itud
es t
owar
ds
OC
use
and
str
onge
r in
tent
ions
to
buy
OC
s w
ithou
t a
pre
scrip
tion.
Pot
ter
et a
l, 20
1013
US
A/M
exic
oO
C u
sers
age
d 1
8–44
Coh
ort
stud
y fo
llow
ing
1046
°C u
sers
who
ob
tain
ed
OC
s ei
ther
OTC
from
a
Mex
ican
pha
rmac
y (n
=51
4) o
r fr
om a
fam
ily p
lann
ing
clin
ic in
E
l Pas
o (n
=51
4)
Cos
t of
pill
s w
as t
he m
ain
mot
ivat
ion
for
choo
sing
the
ir so
urce
for
40%
of
pha
rmac
y us
ers
and
23%
of c
linic
use
rs. T
he m
ain
adva
ntag
e ci
ted
by
49%
of
clin
ic u
sers
was
ava
ilab
ility
of o
ther
hea
lth s
ervi
ces.
Byp
assi
ng t
he r
equi
rem
ent
to o
bta
in a
doc
tor’s
pre
scrip
tion
was
mos
t im
por
tant
for
27%
of p
harm
acy
user
s.
Pro
vid
ers
Bill
ebea
u et
al,
2016
17Fr
ance
Hea
lth p
rofe
ssio
nals
con
cern
ed w
ith
cont
race
ptio
n (in
tern
al m
edic
ine,
ob
stet
ricia
ns, m
edic
al g
ynae
colo
gist
s an
d m
idw
ives
)
Cro
ss-s
ectio
nal s
urve
y (n
=95
6)53
.4%
of r
esp
ond
ents
wer
e in
favo
ur o
f OTC
acc
ess
to p
roge
stin
-onl
y co
ntra
cep
tive
pill
/ora
l con
trac
eptiv
es. C
omp
ared
with
oth
er p
rofe
ssio
nal
cate
gorie
s, m
edic
al g
ynae
colo
gist
s w
ere
the
leas
t lik
ely
to b
e su
pp
ortiv
e (a
OR
: 0.6
3, 9
5% C
I 0.4
6 to
0.8
7). 1
9.3%
of r
esp
ond
ents
sup
por
ted
OTC
ac
cess
to
com
bin
ed o
ral c
ontr
acep
tives
. Mis
sed
exa
min
atio
n fo
r m
edic
al
cont
rain
dic
atio
ns w
as t
he m
ain
obst
acle
tha
t re
spon
den
ts s
aw t
o fr
ee O
C
acce
ss.
How
ard
et
al, 2
01326
US
AP
hysi
cian
s (p
rimar
ily r
esid
ents
tra
inin
g in
ob
stet
rics
and
gyn
aeco
logy
and
fa
mily
pra
ctic
e)
Cro
ss-s
ectio
nal s
urve
y (n
=63
8)M
ost
phy
sici
ans
(71%
) wer
e ag
ains
t a
switc
h to
OTC
ava
ilab
ility
for
com
bin
ed
oral
con
trac
eptiv
es. O
f tho
se o
pp
osed
, saf
ety
(92%
) was
cite
d a
s th
e p
rimar
y co
ncer
n. R
esp
ond
ents
wer
e fa
irly
even
ly d
ivid
ed o
n m
akin
g p
roge
stin
-onl
y p
ills
avai
lab
le O
TC—
52%
wer
e ag
ains
t an
d 4
8% w
ere
in fa
vour
. Of t
hose
op
pos
ed
to P
OP
s, 7
3% c
ited
saf
ety
as t
heir
prim
ary
conc
ern.
Geo
grap
hic
loca
tion
was
no
t as
soci
ated
with
att
itud
e, b
ut fe
mal
e p
hysi
cian
s w
ere
mor
e lik
ely
to fa
vour
O
TC a
vaila
bili
ty fo
r P
OP
s th
an t
heir
mal
e co
unte
rpar
ts.
Rafi
e et
al,
2016
35U
SA
Rep
rod
uctiv
e he
alth
care
pro
vid
ers
(phy
sici
ans
(mos
tly g
ynae
colo
gist
s),
nurs
e p
ract
ition
ers,
cer
tified
nur
se-
mid
wiv
es, p
hysi
cian
ass
ista
nts
and
re
gist
ered
nur
ses)
Cro
ss-s
ectio
nal s
urve
y (n
=48
2)O
vera
ll, 2
8% o
f pro
vid
ers
sup
por
ted
com
ple
te O
TC a
cces
s to
hor
mon
al
cont
race
ptiv
es (O
Cs,
pat
ch a
nd r
ing)
. Phy
sici
ans
wer
e so
mew
hat
mor
e su
pp
ortiv
e of
exp
and
ing
cont
race
ptiv
e ac
cess
tha
n m
id-l
evel
pro
vid
ers,
but
the
d
iffer
ence
s w
ere
not
sign
ifica
nt.
OC
, ora
l con
trac
eptiv
e; O
CP,
Ora
l Con
trac
eptiv
e P
ill; O
TC, o
ver
the
coun
ter;
PO
P, p
roge
stog
en-o
nly
pill
; STI
, sex
ually
tra
nsm
itted
infe
ctio
n; a
OR
, ad
just
ed O
R.
Tab
le 4
C
ontin
ued
on July 1, 2020 by guest. Protected by copyright.
http://gh.bmj.com
/B
MJ G
lob Health: first published as 10.1136/bm
jgh-2019-001402 on 25 June 2019. Dow
nloaded from
Kennedy CE, et al. BMJ Global Health 2019;4:e001402. doi:10.1136/bmjgh-2019-001402 13
BMJ Global Health
Tab
le 5
S
tud
y d
escr
iptio
ns a
nd k
ey fi
ndin
gs o
f stu
die
s in
clud
ed in
the
val
ues
and
pre
fere
nces
rev
iew
exa
min
ing
pha
rmac
y ac
cess
Stu
dy
auth
ors
and
yea
rC
oun
try
Po
pul
atio
nS
tud
y d
esig
nK
ey fi
ndin
gs
Pot
entia
l OC
use
rs
Gar
dne
r et
al,
2008
20U
SA
Wom
en (a
nd c
omm
unity
p
harm
acis
ts—
see
bel
ow)
Tim
e se
ries
inte
rven
tion
stud
y (n
=21
4 w
omen
)B
oth
wom
en a
nd p
harm
acis
ts w
ere
satis
fied
with
the
exp
erie
nce
of p
harm
acis
t-le
d
inte
rven
tions
for
oral
con
trac
eptiv
es, c
ontr
acep
tive
pat
ches
or
the
cont
race
ptiv
e va
gina
l rin
g.
Nea
rly a
ll re
spon
den
ts e
xpre
ssed
will
ingn
ess
to c
ontin
ue t
o se
e p
harm
acis
t p
resc
riber
s an
d
rece
ive
thei
r se
rvic
es fr
om t
hem
.
Land
au e
t al
, 200
629U
SA
Wom
en a
ged
18–
44 y
ears
at
risk
of u
nint
end
ed p
regn
ancy
Cro
ss-s
ectio
nal s
urve
y (n
=81
1)68
% o
f wom
en s
aid
the
y w
ould
use
pha
rmac
y ac
cess
for
horm
onal
con
trac
eptiv
es if
av
aila
ble
. 41%
of w
omen
who
wer
e no
t us
ing
any
cont
race
ptio
n sa
id t
hey
wou
ld b
egin
usi
ng
a ho
rmon
al c
ontr
acep
tive
if p
harm
acy
acce
ss w
ere
avai
lab
le; t
his
was
47%
for
unin
sure
d
wom
en a
nd 4
0% fo
r lo
w-i
ncom
e w
omen
. 66%
of c
urre
nt h
orm
onal
con
trac
eptiv
e us
ers
said
th
ey w
ould
like
to
obta
in t
heir
met
hod
thr
ough
pha
rmac
y ac
cess
. 63%
agr
eed
tha
t ho
rmon
al
cont
race
ptiv
es s
houl
d b
e av
aila
ble
with
out
a p
resc
riptio
n if
a p
harm
acis
t sc
reen
s a
wom
an
first
. Sup
por
t d
eclin
ed t
o 43
% w
hen
pha
rmac
ist
scre
enin
g w
as n
ot m
entio
ned
. Am
ong
thos
e no
t su
pp
ortin
g p
harm
acy
acce
ss, c
once
rns
focu
sed
on
a p
oten
tial l
ack
of s
cree
ning
or
info
rmat
ion.
Man
ski e
t al
, 201
530U
SA
Youn
g w
omen
age
d 1
4–17
Cro
ss-s
ectio
nal s
urve
y (n
=34
8)79
% o
f par
ticip
ants
sup
por
ted
pha
rmac
y ac
cess
to
OC
s, a
nd 5
7% r
epor
ted
the
y w
ould
be
likel
y to
use
OC
s av
aila
ble
thr
ough
pha
rmac
y ac
cess
. Few
sub
grou
p d
iffer
ence
s w
ere
note
d,
exce
pt
that
sex
ually
exp
erie
nced
par
ticip
ants
wer
e m
ore
likel
y to
bot
h su
pp
ort
OTC
acc
ess
and
be
likel
y to
use
it. S
ubur
ban
tee
nage
rs w
ere
mor
e lik
ely
to s
upp
ort
pha
rmac
y ac
cess
tha
n th
ose
from
rur
al a
nd u
rban
are
as. T
he m
ost
com
mon
ly c
ited
ad
vant
age
to O
TC a
cces
s w
as
few
er t
eena
ge p
regn
anci
es (4
5%).
Oth
er c
omm
on r
esp
onse
s w
ere
that
it w
ould
be
easi
er fo
r te
enag
ers
to g
et b
irth
cont
rol (
22%
) and
it w
ould
be
mor
e co
nfid
entia
l (14
%).
Dis
adva
ntag
es
cite
d in
clud
ed t
eena
gers
not
usi
ng c
ond
oms
to p
rote
ct a
gain
st S
TIs
(22%
), ne
edin
g a
doc
tor
dec
ide
if O
Cs
are
safe
for
them
(19%
), m
ight
hav
e se
x at
a y
oung
er a
ge (1
8%) a
nd m
ight
use
O
Cs
inco
rrec
tly (1
8%).
Wilk
inso
n et
al,
2018
37U
SA
Youn
g w
omen
age
d 1
8–19
Qua
litat
ive
stud
y us
ing
in-d
epth
inte
rvie
ws
Nea
rly a
ll p
artic
ipan
ts w
ere
sup
por
tive
of C
alifo
rnia
’s n
ew la
w a
llow
ing
pha
rmac
ist’s
p
resc
riptio
n of
con
trac
eptio
n. W
hile
par
ticip
ants
wer
e sa
tisfie
d w
ith t
rad
ition
al s
ervi
ce
pro
vid
ers
and
val
ued
tho
se r
elat
ions
hip
s, t
hey
app
reci
ated
the
ben
efit
of in
crea
sed
acc
ess
and
con
veni
ence
of g
oing
dire
ctly
to
a p
harm
acy.
Par
ticip
ants
exp
ecte
d in
crea
sed
acc
ess
to c
ontr
acep
tion
in p
harm
acie
s w
ould
lead
to
bot
h p
erso
nal a
nd s
ocie
tal b
enefi
ts. T
hey
exp
ress
ed c
once
rns
rega
rdin
g p
aren
tal i
nvol
vem
ent,
as
wel
l as
confi
den
tialit
y in
the
p
harm
acy
envi
ronm
ent
and
with
insu
ranc
e d
iscl
osur
es.
Pro
vid
ers
Gar
dne
r et
al,
2008
20U
SA
Com
mun
ity p
harm
acis
ts (a
nd
wom
en—
see
abov
e)Ti
me
serie
s in
terv
entio
n st
udy
(n=
26
pha
rmac
ists
)
Bot
h w
omen
and
pha
rmac
ists
wer
e sa
tisfie
d w
ith t
he e
xper
ienc
e of
pha
rmac
ist-
led
in
terv
entio
ns fo
r or
al c
ontr
acep
tives
, con
trac
eptiv
e p
atch
es o
r th
e co
ntra
cep
tive
vagi
nal r
ing.
Hilv
erd
ing
et a
l, 20
1725
US
ALi
cens
ed p
harm
acis
tsC
ross
-sec
tiona
l sur
vey
(n=
138)
Mos
t p
harm
acis
ts in
dic
ated
tha
t or
al a
nd t
rans
der
mal
con
trac
eptiv
e m
etho
ds
shou
ld b
e p
harm
acis
t in
itiat
ed (5
7% a
nd 5
4%, r
esp
ectiv
ely)
thr
ough
a c
olla
bor
ativ
e p
ract
ice
agre
emen
t or
sta
te-w
ide
pro
toco
l. In
crea
sed
acc
ess
to c
are
and
con
veni
ence
for
pat
ient
s w
ere
the
mos
t fr
eque
ntly
iden
tified
pot
entia
l ben
efits
. Tim
e co
nstr
aint
s an
d c
once
rns
abou
t in
crea
sed
lia
bili
ty w
ere
iden
tified
as
bar
riers
. Pha
rmac
ists
sai
d t
hey
need
ed c
linic
al g
uid
elin
es,
cont
inui
ng p
rofe
ssio
nal e
duc
atio
n an
d p
atie
nt e
duc
atio
n m
ater
ials
to
succ
essf
ully
initi
ate
cont
race
ptiv
e th
erap
y re
gim
ens.
Con
tinue
d
on July 1, 2020 by guest. Protected by copyright.
http://gh.bmj.com
/B
MJ G
lob Health: first published as 10.1136/bm
jgh-2019-001402 on 25 June 2019. Dow
nloaded from
14 Kennedy CE, et al. BMJ Global Health 2019;4:e001402. doi:10.1136/bmjgh-2019-001402
BMJ Global Health
Stu
dy
auth
ors
and
yea
rC
oun
try
Po
pul
atio
nS
tud
y d
esig
nK
ey fi
ndin
gs
Land
au e
t al
, 200
928U
SA
Pha
rmac
ists
Cro
ss-s
ectio
nal s
urve
y (n
=27
25)
The
maj
ority
of p
harm
acis
ts w
ere
com
fort
able
and
inte
rest
ed in
pro
vid
ing
dire
ct a
cces
s to
hor
mon
al c
ontr
acep
tion
in t
he p
harm
acy.
Per
ceiv
ed b
arrie
rs in
clud
ed la
ck o
f tim
e, n
o m
echa
nism
of r
eim
bur
sem
ent
for
the
serv
ice
and
pos
sib
le r
esis
tanc
e fr
om p
hysi
cian
s.
Nor
man
et
al, 2
01532
Can
ada
Pha
rmac
ists
Cro
ss-s
ectio
nal s
urve
y (n
=14
6) fo
llow
ed b
y an
op
tiona
l qua
litat
ive
inte
rvie
w
Ove
r 80
% o
f par
ticip
atin
g p
harm
acis
ts in
dic
ated
will
ingn
ess
to p
resc
ribe
horm
onal
co
ntra
cep
tives
. Fac
tors
ass
ocia
ted
with
will
ingn
ess
to p
resc
ribe
incl
uded
com
fort
usi
ng a
p
roto
col t
o ac
cess
sex
ual h
isto
ry, c
onfid
ence
ab
out
staf
f ava
ilab
ility
and
pub
lic a
ccep
tab
ility
, an
d fe
wer
yea
rs in
pra
ctic
e. P
harm
acis
ts r
eque
sted
tra
inin
g in
ass
essm
ent
pro
toco
ls a
nd
liab
ility
issu
es p
rior
to im
ple
men
tatio
n.
Rafi
e et
al,
2011
33U
SA
Stu
den
t p
harm
acis
tsC
ross
-sec
tiona
l sur
vey
(n=
502)
96%
of s
tud
ent
pha
rmac
ists
wer
e in
tere
sted
in p
rovi
din
g ho
rmon
al c
ontr
acep
tion
serv
ices
to
eith
er b
oth
min
ors
and
ad
ults
(53%
), ad
ults
(41%
), or
min
ors
(6%
). S
tud
ents
felt
that
pat
ient
s w
ould
ben
efit
from
imp
rove
d a
cces
s an
d a
dvi
ce (9
4.0%
). In
adeq
uate
pha
rmac
ist
time
was
an
imp
orta
nt b
arrie
r in
det
erm
inin
g w
heth
er p
harm
acis
ts c
ould
effi
cien
tly a
nd e
ffect
ivel
y p
rovi
de
OC
ser
vice
s, fo
llow
ed b
y la
ck o
f priv
ate
coun
selli
ng a
rea
in t
he p
harm
acy,
inad
equa
te p
atie
nt
heal
th in
form
atio
n an
d la
ck o
f ap
pro
pria
te in
cent
ive
stru
ctur
e.
Rafi
e et
al,
2012
34U
SA
Rep
rod
uctiv
e he
alth
care
p
rovi
der
s, in
clud
ing
phy
sici
ans
and
ad
vanc
ed
pra
ctic
e cl
inic
ians
Qua
litat
ive
stud
y us
ing
stru
ctur
ed in
terv
iew
sM
ost
resp
ond
ents
con
sid
ered
the
cur
rent
pre
scrip
tion-
only
mod
el o
f acc
ess
to h
orm
onal
co
ntra
cep
tion
to b
e to
o re
stric
tive.
Som
e re
por
ted
a p
refe
renc
e fo
r a
pha
rmac
y ac
cess
mod
el
whe
re w
omen
cou
ld o
bta
in c
ontr
acep
tives
dire
ctly
from
a p
harm
acis
t, b
ypas
sing
the
clin
ic
visi
t. M
any
pro
vid
ers
bel
ieve
d t
hat
met
hod
con
tinua
tion
and
com
plia
nce
wou
ld im
pro
ve w
ith
pha
rmac
y ac
cess
to
cont
race
ptio
n. T
he m
ost
com
mon
con
cern
rep
orte
d w
as p
harm
acis
t’s
refu
sal t
o p
rovi
de
serv
ices
.
Rafi
e et
al,
2016
35U
SA
Rep
rod
uctiv
e he
alth
care
p
rovi
der
s (p
hysi
cian
s (m
ostly
gyn
aeco
logi
sts)
, nu
rse
pra
ctiti
oner
s, c
ertifi
ed
nurs
e-m
idw
ives
, phy
sici
an
assi
stan
ts a
nd r
egis
tere
d
nurs
es)
Cro
ss-s
ectio
nal s
urve
y (n
=48
2)O
vera
ll, 7
4% o
f pro
vid
ers
sup
por
ted
pha
rmac
ist-
initi
ated
acc
ess
to h
orm
onal
con
trac
eptiv
es
(OC
s, p
atch
and
rin
g), w
hile
45%
sup
por
ted
beh
ind
-the
-cou
nter
acc
ess
(whe
re a
ny p
harm
acy
per
sonn
el c
an e
nsur
e re
stric
tions
are
met
and
pro
vid
e co
ntra
cep
tives
). P
hysi
cian
s w
ere
som
ewha
t m
ore
sup
por
tive
of e
xpan
din
g co
ntra
cep
tive
acce
ss t
han
mid
-lev
el p
rovi
der
s, b
ut
the
diff
eren
ces
wer
e no
t si
gnifi
cant
.
Vu e
t al
, 201
736U
SA
Pha
rmac
ists
Cro
ss-s
ectio
nal s
urve
y (n
=12
1)Fo
llow
ing
a ne
w la
w e
xpan
din
g p
harm
acis
ts’ s
cop
e of
pra
ctic
e to
incl
ude
dire
ctly
pro
vid
ing
self-
adm
inis
tere
d h
orm
onal
con
trac
eptio
n to
pat
ient
s p
ursu
ant
to a
sta
te-w
ide
pro
toco
l, th
e m
ajor
ity (7
3%) o
f pha
rmac
ist
resp
ond
ents
sai
d t
hey
wou
ld li
kely
pro
vid
e th
is n
ew s
ervi
ce.
Res
pon
den
ts r
epor
ted
bei
ng c
omfo
rtab
le e
duc
atin
g p
atie
nts
on s
hort
-act
ing
(94%
) and
long
-ac
ting
reve
rsib
le c
ontr
acep
tion
(82%
), as
wel
l as
iden
tifyi
ng d
rug
inte
ract
ions
with
hor
mon
al
cont
race
ptio
n (9
7%).
Res
pon
den
ts in
dic
ated
tim
e co
nstr
aint
s (7
4%),
lack
of r
eim
bur
sem
ent
(64%
) and
liab
ility
con
cern
s (6
2%) a
s b
arrie
rs t
o p
resc
ribin
g ho
rmon
al c
ontr
acep
tion.
Oth
er s
take
hold
ers
Irw
in e
t al
, 201
827U
SA
Gen
eral
pub
lic c
omm
entin
g in
on
line
soci
al d
isco
urse
Ret
rosp
ectiv
e, c
ross
-se
ctio
nal,
mix
ed
met
hod
s an
alys
is o
f p
ublic
com
men
ts p
oste
d
in r
esp
onse
to
artic
les
pub
lishe
d b
y m
ajor
m
edia
out
lets
on
OTC
av
aila
bili
ty o
f OC
s
Com
men
ters
wer
e ge
nera
lly p
ositi
ve t
owar
ds
pha
rmac
ist-
pre
scrib
ed s
elf-
adm
inis
tere
d n
on-
emer
genc
y ho
rmon
al c
ontr
acep
tion
and
cite
d s
ever
al b
enefi
ts, s
uch
as in
crea
sing
acc
ess
to
heal
thca
re, r
educ
ing
unin
tend
ed p
regn
anci
es a
nd s
upp
ortin
g in
div
idua
l aut
onom
y. H
owev
er,
it w
as a
ckno
wle
dge
d t
hat
thes
e b
enefi
ts w
ould
nee
d t
o b
e b
alan
ced
with
pot
entia
l saf
ety
conc
erns
and
logi
stic
al is
sues
ass
ocia
ted
with
del
iver
ing
clin
ical
ser
vice
s in
a c
omm
unity
p
harm
acy
sett
ing.
OC
, ora
l con
trac
eptiv
e; O
TC, o
ver
the
coun
ter;
STI
, sex
ually
tra
nsm
itted
infe
ctio
n.
Tab
le 5
C
ontin
ued
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Kennedy CE, et al. BMJ Global Health 2019;4:e001402. doi:10.1136/bmjgh-2019-001402 15
BMJ Global Health
Pharmacy accessAmong potential or current OC users, most women were in favour of pharmacy access, and substantial proportions said they would obtain OCs through pharmacy access if it were available.29 30 37 Some women currently not using any contraception said they would begin using a hormonal contraceptive if pharmacy access were available.29 One study found that women (and pharmacists) were satis-fied with pharmacist-led OC use and expressed willing-ness to continue seeing pharmacist prescribers.20 While young women appreciated their traditional healthcare providers, they liked the increased access and conveni-ence of obtaining OCs directly from a pharmacy.37
In studies among healthcare providers, pharmacists were generally very supportive of pharmacy access to OCs, while physicians tended to be more moderately supportive.20 25 28 32–36 Increased access to care, preventing unintended pregnancies and convenience for patients were the most frequently identified potential bene-fits.25 33–35 Safety, time constraints, lack of private space in the pharmacy, increased liability and reimbursement were identified as potential barriers.25 28 33 36 There was also concern from pharmacists about physician’s resis-tance to making OCs available at pharmacies28 and concern from physicians about pharmacist’s refusal to provide services.34
Finally, in a study of digital comments on online media articles about pharmacy access to OCs in the USA, commentators were generally positive and cited benefits including increasing access to healthcare, reducing unin-tended pregnancies and supporting individual autonomy, but noted these must be balanced with potential safety and logistical concerns.27
dIsCussIOnIn this systematic review, we identified four studies using comparative designs to examine the impact of OTC availability of OCs. Two studies conducted in the 2000s examined women who obtained OCs OTC in Mexico and compared them with women who obtained OCs from providers in either Mexico or the USA. The other two studies were significantly older (from the 1970s) and compared first contraceptive method users who either obtained OCs OTC from a pharmacy or drugstore or through a provider or family planning programme; the OC formulations in these studies were likely different, and women 45 years ago potentially differ from women today in terms of desired fertility, decision-making around contraceptive methods and perception/tolerance of and tendency to report side effects. While the more recent studies suggested OTC users had higher rates of OC continuation over time and fewer side effects, there was some indication that OTC users had slightly higher rates of use of OCs despite contraindications. Contraindica-tions are an important concern; however, research has indicated that women can self-screen for contraindica-tions fairly well using a simple checklist.40 41 Despite the
strengths of the studies included in the review, the small evidence base provides limited guidance for countries considering OTC availability of OCs.
We identified a much larger evidence base on the values and preferences of potential users, providers and the public. However, this evidence was also limited, since almost all studies were conducted in the USA. Women were generally in favour of OTC availability; healthcare providers were as well, with pharmacists expressing higher support than physicians for pharmacy access. Among both women and providers, support was gener-ally higher for dispensation in pharmacies compared with full OTC availability, and for OTC access to POPs rather than COCs. Given the near-universal use of COCs at the times and locations where the studies included in the main review were conducted, we had no comparative effectiveness data on POPs. This is unfortunate, as POPs have been suggested as a good option for initial OTC availability, given that they have fewer contraindications to use.
An additional concern about OTC availability is that the concomitant reduced visits to clinicians may also translate to a reduction in routine preventive screening (including for Pap smears, pelvic exams, clinical breast exams and screening for sexually transmitted infections). This was not one of our prespecified PICO outcomes since such exams are not required to receive OCs per the WHO’s Selected Practice Recommendations for Contra-ceptive Use.42 However, the Border Contraceptive Access Study did report on preventive screening; while women who obtained their OCs from a clinic reported slightly higher rates of some screenings, both groups (OTC and clinic users) had high overall rates of reported screenings with relatively minimal differences between groups.43 One values and preferences study also found that US women said they would continue to get screened if OCs were made available OTC,23 although clinicians were afraid they would not.35 These findings offer some indi-cation that OTC access for OCs may not necessarily result in reduced use of other preventive services.
OTC availability is only one way to increase access to OCs. A previous systematic review found that increasing the number of OC pill packs dispensed or prescribed increased OC continuation, although it also resulted in increased pill wastage.44 There are also internet-based platforms for ordering OCs, which comply with clini-cian prescriptions or pharmacist screening, but conduct all screenings online.45 A modelling study found that making out-of-pocket pill pack costs low or free would increase OC use.46 Finally, increased insurance coverage for OCs should also reduce access barriers to OC use, regardless of access point. Although moving OCs to OTC status should lead to fewer clinician visits for women, thus decreasing costs related to travel, time and other medical expenses associated with those visits, OTC access could potentially increase the cost of OCs if insurance does not cover OTC purchases, or if women are unaware that they can use insurance in OTC purchases. Insurance
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/B
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lob Health: first published as 10.1136/bm
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BMJ Global Health
considerations should be explicitly considered in policy discussions of OTC availability, as insurance coverage will be particularly important for some of the most vulner-able groups, such as low-income women and girls.
Our review has several strengths, including our broad search strategy and our inclusion of both effectiveness and values and preferences studies. However, conclu-sions from our review are limited by the small evidence base in this area. We identified four observational studies in our main effectiveness review, from the same global region, and there may have been residual confounding in comparing OTC and clinic OC users despite some analyses being adjusted. Although there were more studies in the values and preferences review, they were also geographi-cally limited, and many relied on participants’ responses to hypothetical questions about OTC availability. While it is challenging to conduct randomised trials of what is fundamentally a policy intervention, researchers should be encouraged to take advantage of natural experiments such as the Border Contraceptive Access Study or to study changes to policies such as those recently allowing pharmacy access to OCs in the US states of Oregon and California. Further, many countries already allow OTC availability of OCs, so policy decisions can also take into consideration the wide range of country experience in this area.
Despite the limitations of the evidence base, this review provides important information to guide policy decisions around OTC availability of OCs. This evidence has been used to inform the development of WHO recommenda-tions for self-care interventions for sexual and reproduc-tive health and rights in relation to OTC availability of OCs. The benefits and harms of OTC availability of OCs and the values and preferences of patients and providers found in the present review, along with a separate survey of community values and preferences and consideration of resource use, human rights and feasibility, will shape the recommendation. Additional research into outcomes critical to decision-makers where little comparative data currently exist should be done to address the gaps identified.
Acknowledgements We thank Laura Ferguson and Nandi Siegfried for their comments on the review protocol. We also thank Johns Hopkins research assistants Rui (Renee) Ling, Kaitlyn Atkins, Priyanka Mysore, Molly Petersen and Anita Dam for help with screening the initial database search results, conducting hand searching and secondary reference searching, and duplicate data extraction. Finally, we thank Daniel Grossman and Sara Yeatman for their timely and thorough responses to questions about their studies, and the excellent comments from the anonymous reviewers who really helped improve the manuscript.
Contributors MN conceptualised the study. CEK and PTY designed the protocol with input from JK, MLG, LG, HJ and MLN. PTY ran the search and oversaw screening, data extraction and assessment of bias. CEK drafted the manuscript, while all authors reviewed the draft and provided critical feedback. All authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. All authors read and approved the final manuscript. The corresponding author, as guarantor, accepts full responsibility for the finished article, has access to any data and controlled the decision to publish.
Funding This study received financial support from the UNDP-UNFPA-Unicef-WHO-World Bank Special Programme of Research, Development and Research
Training in Human Reproduction (HRP) and the Children's Investment Fund Foundation (CIFF). HRP was involved in the study design.
disclaimer The funders played no part in the decision to submit the article for publication, nor in the collection, analysis and interpretation of data.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
data availability statement All data come from published journal articles. Extracted data are available on request to the corresponding author.
Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
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2. Bearak J, Popinchalk A, Alkema L, et al. Global, regional, and subregional trends in unintended pregnancy and its outcomes from 1990 to 2014: estimates from a Bayesian hierarchical model. Lancet Glob Health 2018;6:e380–9.
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