CONTINUING EDUCATION

THIS ACTIVITY IS SUPPORTED BY AN EDUCATIONAL GRANT FROM PERRIGO.

From Prescription Pad to Pharmacy Shelf:

Unveiling the Future of Contraception

FACULTY PHARMACIST EDUCATIONAL OBJECTIVES

Rachel Selinger, PharmD, BCACP, CPP, CDCES
Pharmacy Manager At the completion of this activity, the participant will be able to:
MAHEC Community Pharmacy • Analyze the public health impact of unintended pregnancy in the United States
Asheville, North Carolina • Identify social, economic, and regulatory barriers that limit access to contraception
(including OTC options) for different patient populations
Adjunct Assistant Professor of Clinical • Differentiate OTC birth control pill options including progestin-only and combination
Education pills, considering factors such as efficacy, adverse effects, and patient suitability
Department of Practice Advancement and
• Examine counseling on the proper use of and adherence to OTC birth control pills,
Clinical Education
including strategies for identifying and addressing potential adherence challenges
UNC Eshelman School of Pharmacy
Chapel Hill and Asheville, North Carolina
PHARMACY TECHNICIAN EDUCATIONAL OBJECTIVES
DISCLOSURES At the completion of this activity, the participant will be able to:
The following contributors have no relevant
• Analyze the public health impact of unintended pregnancy in the United States
financial relationships with commercial interests
• Identify social, economic, and regulatory barriers that limit access to contraception
to disclose:
(including OTC options) for different patient populations
FACULTY • Differentiate OTC birth control pill options including progestin-only and combination
Rachel Selinger, PharmD, BCACP, CPP, CDCES pills, considering factors such as efficacy, adverse effects, and patient suitability
• Explore the role of the pharmacy technician when communicating with patients
PHARMACY TIMES CONTINUING EDUCATION™ about OTC birth control pills
PLANNING STAFF
TARGET AUDIENCE: Community pharmacists and pharmacy technicians
Jim Palatine, RPh, MBA; Maryjo Dixon, RPh,
MBA; Dipti Desai, PharmD, MBA, CHCP; Krishani ACTIVITY TYPE: Application
Rajapaksa; Susan Pordon; Brianna Winters; RELEASE DATE: July 30, 2024
Chloe Taccetta; and Rebecca Green EXPIRATION DATE: July 30, 2025
ESTIMATED TIME TO COMPLETE ACTIVITY: 2.0 hours
PHARMACY TIMES ® EDITORIAL STAFF LEARNER LEVEL: Foundational
Aislinn Antrim FEE: This lesson is offered for free at www.pharmacytimes.org.

An anonymous peer reviewer was part of the

content validation and conflict resolution and
has no relevant financial relationships with Introduction: Overview of cies in the United States remains higher
commercial interests to disclose.
Unintended Pregnancies and than in other wealthy nations, leading to
Contraception Use significant economic, social, and health
One of the greatest public health concerns care costs to the affected individuals
affecting women of reproductive age is and society at large.1
the prevention of unintended pregnancies. While the issue of unintended preg-
Unplanned and unintended pregnancies nancy tends to exact higher tolls on some
may include pregnancies that are mistimed women based on socioeconomic status,
due to life events or pregnancies in women it has the potential to affect a majority
who do not want a child or additional of women. Sexually active heterosexual
children. The rate of unplanned pregnan- couples who do not use any method of
*Please note that the issue of unintended pregnancy is one that affects all individuals with female
reproductive organs and the potential to be pregnant, regardless of their gender identity or expression,
including transgender men and nonbinary and gender diverse individuals. For simplification, the terms
woman or women in this article refer to all such individuals across the gender identity spectrum for
whom pregnancy is a biological possibility.

Pharmacy Times Continuing Education™ is accredited by the

Accreditation Council for Pharmacy Education (ACPE) as a provider
of continuing pharmacy education. This activity is approved for 2.0
contact hours (0.20 CEU) under the ACPE universal activity numbers
0290-0000-24-216-H01-P and 0290-0000-24-217-H01-T. The activity is
available for CE credit through July 30, 2025.

August 2024 pharmacytimes.org 53

contraception have an 85% chance of experiencing a preg- likely to breastfeed, and their children are at increased risk of
nancy over the course of 1 year, and by the age of 45, more experiencing physical and mental health problems.7
than half of all women in the US will have experienced an
unintended pregnancy.2,3 Landscape of Contraceptive Use in the US
The most recent data from the CDC indicate that in 2019, The CDC named contraception one of the 10 great public
the rate of unintended pregnancies in women aged 15 to 44 health achievements of the 20th century. Benefits include
years in the US was 41.6%, which was a decrease from 43.3% improved health and well-being of women and children,
in 2010.4 Decreasing unintended pregnancies is a national reduced global maternal mortality, benefits of pregnancy
health priority in the US.4 Included in the 359 core objectives spacing for maternal and child health, female engagement
of Healthy People 2030 is the goal of decreasing that rate to in the work force, and economic self-sufficiency for women.1
36.5%.5 Related Healthy People 2030 goals include reducing Rates of ever using contraception among US women who
preterm birth, increasing the proportion of adolescent females have been sexually active are high, with 99% reporting
who used effective birth control the last time they had sex, having used at least 1 form of contraception in their lifetime.
increasing depression screening in pregnancy, and reducing Nearly 88% of those women reported using a highly effective
interpersonal violence.3,6 reversible method.1
One large meta-analysis found distinct associations In a survey of contraception use among women in 2016,
between poor maternal-child health outcomes and unintended rates were lowest among 15-24-year-olds (83%) and highest
pregnancies. Included were increased rates of maternal among 25-34-year-olds.9 To achieve the average number of
depression, maternal experiences of interpersonal violence, children that, when surveyed, US adults think is ideal (2.7),
and preterm birth and infant low birth weight.6 sexually active women must use contraceptives for approxi-
Disparities in the rates of unintended pregnancies exist, mately 3 decades on average.2 The use of contraception is
with higher rates in women living below the national also affected by the cost of that use, with increased insurance
poverty level, women with lower education levels, and Black coverage correlated with increased use of effective forms of
and Hispanic women. Additionally, rates of unintended contraception. In one study among sexually active women not
pregnancy are 4-fold higher in unmarried women who cohabi- seeking pregnancy, 81% of uninsured individuals used contra-
tate than in married women.7 Lower educational and economic ception, compared with 87% of those covered by Medicaid
attainment are also effects seen in women who experience and 90% of those covered by private health insurance.2
unintended pregnancies at a young age, with fewer than 50% In addition to cost barriers, the use of contraception among
of women who give birth in their teens receiving a high school women varies for many other reasons, including income,
diploma by age 22 vs 90% of women who do not give birth socioeconomic status, ethnicity, geographic location, and
during adolescence.3 their relationship status.9 One study found that reducing or
eliminating costs associated with birth control led to birth
Associated Risks, Costs, and Disparities in rate reduction, particularly among individuals belonging to
Unintended Pregnancies lower income groups who may be more sensitive to the cost
The costs of unintended pregnancy are high, resulting in of contraception and may therefore benefit from expanded
US government health care expenditures of $21 billion in access to effective birth control methods being available
2010.8 It is estimated that each dollar spent on publicly without a prescription.10
funded contraceptive services in the US saves the health Among the barriers to obtaining effective contraception
care system $6.1 Noneconomic costs are also important methods in women of childbearing age, cost plays a key role
to consider, especially in the US, where rates of infant and in dictating which methods an individual chooses or does not
maternal mortality are consistently above those in all other choose. In the US, 1 of 5 women would use a form of contra-
high-income countries.1 ception (or a different form) if cost were not a consideration,
Women with unintended pregnancies are more likely to and financial concerns lead to larger differences between
either delay the start of prenatal care or to receive inadequate preferred and used contraceptive methods among women with
prenatal care, use alcohol or smoke during pregnancy, and are lower socioeconomic status.11 One study found that nearly
more likely to have infants with low birth weight. After birth, 40% of low-income nonusers of contraception would prefer
women whose pregnancies were unintended are also less to use a method if cost were not a factor.12

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FIGURE 1. PERCENT DISTRIBUTION OF WOMEN AGED 15-49, BY CURRENT CONTRACEPTIVE STATUS: UNITED STATES, 2017-201915

100
Never had sexual intercourse or did not have
34.7% of 16.8
sex in past 3 months
women not
currently using
80 contraception 7.8 Pregnant, postpartum, or seeking pregnancy

7.0 Nonuser who had sexual intercourse in past 3 months

3.0 All other nonusers

60
18.1 Female sterilization
Percent

5.6 Male sterilization

40 65.3% of
women 14.0 Oral contraceptive pill
currently using
contraception
8.4 Male condom
20
Long-acting reversible contraceptives
10.4
Depot medroxyprogesterone acetate injection,
3.1 contraceptive ring, or patch
5.7 All other contraceptive methods
0
Current contraceptive status

Note: Percentages may not add to 100 due to rounding. Women currently using more than 1 method are classified according to the most effective method they
are using. Long-acting reversible contraceptives include contraceptive implants and intrauterine devices.

With the inception of the Affordable Care Act in 2012, or ethnic minority groups.13 Approximately half of unintended
all FDA-approved contraceptive methods, sterilization pregnancies in the US are among women who became preg-
procedures, and patient contraceptive education and coun- nant despite reported use of contraception, demonstrating
seling are covered for women without cost sharing by all an area where pharmacist interventions, counseling, and
non-excluded health plans, including all women enrolled in education can improve women’s reproductive autonomy and
Medicaid expansion programs. While this policy has served as improve reproductive planning.8
a significant advantage for some women, many health insur-
ance plans have now been exempted from these requirements. Need and Expansion of Contraceptive
Uninsured people, such as unauthorized immigrant women Methods for Women
or financially disadvantaged women in states that have not Structural barriers to reproductive health care, such as
enacted Medicaid expansion, have not been able to benefit transportation difficulties, childcare challenges, insurance
from this expanded coverage.1 coverage, and appointment availability affect both access to
Additional regulatory challenges also restrict access to and use of contraception in one-third of women in the US
contraception for some women in the US. Some states have who have ever tried to obtain prescription contraception.14
disallowed minors to consent to contraceptive services without From the National Survey of Family Growth, which included
parental consent, and other states have allowed employers women aged 15 to 49 years between 2017 and 2019, approxi-
to exclude contraceptive services from coverage under their mately 65% were using a form of contraception, with the most
employee health insurance plans.1 common being female sterilization (18.1%), oral contracep-
In addition to challenges related to obtaining contraception, tive pills (14%), long-acting reversible contraceptives such as
the incorrect or inconsistent use of contraception also contrib- intrauterine devices (IUDs) or implants (10.4%), and the male
utes to higher rates of unintended pregnancy that dispropor- condom (8.4%) (see FIGURE 115).15 The use rate of condoms
tionately affect low-income women and those from racial and/ was unrelated to education level, while the rates of the other

August 2024 pharmacytimes.org 55

 FIGURE 2. PERCENTAGE OF ALL WOMEN AGED 15-49 WHO WERE CURRENTLY USING FEMALE STERILIZATION, ORAL
CONTRACEPTIVE PILLS, THE MALE CONDOM, OR LONG-ACTING REVERSIBLE CONTRACEPTIVES, BY AGE GROUP: UNITED STATES,
2017-201915

50
15-19 20-29 30-39 40-49

40 39.1

30
Percent

21.2 21.6
19.5
20

13.7
12.7
10.9 10.4
9.7
10
6.5 6.5 5.8 6.6
5.1
2.9

0
Female sterilizationa Pilla Male condomb Long-acting reversible
contraceptivesb

a
Significant linear trend.
b
Percentages for age groups 20-29 and 30-39 were higher than percentages for age groups 15-19 and 40-49. Differences between percentages for other age
groups were not statistically significant.
Note: Women currently using more than 1 method are classified according to the most effective method they are using. Long-acting reversible contraceptives
include contraceptive implants and intrauterine devices.

3 most common forms of contraception varied by educational the number of months of contraception that may be obtained
attainment (see FIGURE 215).15 at one time to 3 months or even 1 month at a time.
One national survey of nearly 1400 women demonstrated
STAR*
the difficulties many women face in obtaining a contracep-
What are some barriers revolving around contraceptive
tive method.16 While 68% of surveyed women had ever tried
access and use that patients may face?
to obtain a prescription for contraception, 29% of them had
*S = Stop; T = Think; A = Assess; R = Review
experienced challenges in receiving either the initial prescrip-
tion or refills of the product. The most common issues cited
Barriers to Contraceptive Access by these women included cost barriers or lack of insurance
Medical barriers to contraceptive use continue to exist coverage (14%), difficulties getting a clinic appointment or
despite evidence that they are not required, such as some traveling to a clinic (13%), the requirement of the health care
providers requiring unnecessary screening tests or physical provider that the patient come in for a visit or a screening
examinations before initiation (eg, pelvic examinations or test such as a pelvic exam or Pap smear (13%), not having a
Papanicolaou tests [Pap smears]), an inability to receive the regular provider or clinic where they generally receive their
method on the same day as the visit (due to waiting for results health care (10%), difficulty getting to a pharmacy (4%), or
of unnecessary exams or being asked to wait until the begin- other reasons (4%).16
ning of the individual’s next menstrual cycle before initiating Knowledge deficits among the public are another barrier
use), or challenges in receiving continued contraceptive to the use of effective forms of contraceptive methods,
supplies (such as limits on the number of oral contraceptive particularly as they relate to unawareness of all available
pill packs dispensed at one time).8 Most insurance plans limit methods, misperceptions of contraceptive methods and their

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mechanisms of action, and exaggerated concerns related to the First OTC Progestin-Only Pill
safety of contraceptive use. It is important to note that none of Norgestrel is a progestin with a long history of data demon-
the FDA-approved contraceptive methods are abortifacients; strating both its efficacy and safety since its original approval
none of them interfere with a pregnancy; and none are effective by the FDA in 1973. The progestin-only pill (POP) containing
after a fertilized egg has successfully implanted in the uterus.1 norgestrel 0.075 mg was discontinued in 2005 for business
Health care providers may also lack sufficient knowledge reasons, not due to concerns related to its safety or efficacy;
about the full spectrum of contraceptive methods to provide norgestrel itself has still been available in combination
comprehensive contraceptive counseling and options to with ethinyl estradiol.20 Levonorgestrel is one of the most
their patients. Improving the knowledge of both providers common progestins included in some combined hormonal
and patients about contraceptive methods is an impor- contraceptive products and is the levo-enantiomer of
tant way to improve access to contraception and improve norgestrel that is responsible for its activity.3
its appropriate use.1 To be eligible for nonprescription status according to 503(b)
Pharmacist refusals to fill contraceptive prescriptions due to of the Federal Food, Drug, and Cosmetic Act, a drug must
conscientious objection or their choice to not stock contracep- be determined by the FDA to be both safe and effective for
tion are other barriers to women obtaining their method of its purported uses and should not require the supervision of a
choice, particularly in rural areas where accessing other phar- health care provider. Additionally, the need for use should be
macies may prove to be too difficult. It is common for rural self-diagnosable and patients should be able to use the label to
communities to have just 1 community pharmacy, although adequately self-treat or self-manage the condition. Finally, the
pharmacy closures in these areas are an increasing concern. In drug must have a low risk of misuse and abuse and the bene-
a review from 2018, more than 600 rural communities in the fits of the increased accessibility of OTC availability must
US went from having at least 1 pharmacy to having no pharma- outweigh the risks.3 The FDA approved the norgestrel POP for
cies within their community.17 For this reason, the American OTC use in July 2023 and the product has been available on
Pharmacists Association supports ensuring patient access to pharmacy shelves since March 2024.21 Like other progestins,
contraception following a pharmacist’s refusal to provide it.1 norgestrel works by causing thickening of the cervical mucus,
To overcome some of the barriers to contraception access which prevents sperm from passing through the cervix and by
that exist, there has been a large national movement to allow suppressing ovulation.
pharmacists the legal ability to prescribe and directly dispense Adverse effects (AEs) were relatively rare in clinical studies
some forms of contraception at the pharmacy for patients who of norgestrel. Some cases of ovarian cysts were reported and
qualify based on their past medical history. This “pharmacy bleeding changes, such as irregular bleeding or spotting,
access” or “behind-the-counter” access to contraception typi- amenorrhea, or prolonged bleeding, were the most common
cally consists of completing a questionnaire, consulting with AEs experienced by participants. AEs that were reported in
a pharmacist, and having a blood pressure measurement.16 at least 5% of trial participants included headache; dizzi-
While California and Oregon were the first states to allow ness; nausea; increased appetite; abdominal pain, cramps, or
this pharmacist-prescribed contraception as early as 2016, as bloating; fatigue; vaginal discharge; dysmenorrhea; nervous-
of August 31, 2023, 28 states and the District of Columbia ness; backache; breast discomfort; and acne.22
all have their own policies to allow pharmacists to prescribe Compared with combined oral contraceptive pills (COCs),
hormonal contraception through a statewide protocol, which contain both a progestin and estrogen, POPs such as
standing order, or collaborative practice agreement. Twelve norgestrel have fewer contraindications and fewer significant
of these states require that patients receiving this service are risks with use, especially related to venous thromboembolism
at least 18 years of age.18,19 While eliminating the barriers (VTE), a risk associated with estrogen use. While the risk of
of an additional visit with a provider before obtaining the VTE is higher with estrogen-containing contraceptives than
product at the pharmacy, there are still issues. The need for with progestin-only forms, it is important to note that the risk
transportation to the pharmacy, the fact that not all pharma- of VTE is higher in pregnancy than with either progestin-only
cies and pharmacists in states that have allowed this expanded or estrogen-containing contraceptives.20 The US Medical
access have enacted it, and a lack of insurance coverage of Eligibility Criteria for Contraceptive Use (US MEC) is the
the pharmacist’s consultation continue to limit access to this CDC’s resource for determining the safety of using a specific
service by some patients. form of contraception in combination with comorbidities.

August 2024 pharmacytimes.org 57

There are 16 medical conditions rated as category 4 (or pregnancies possible with an OTC norgestrel contraceptive
contraindications) to COC use in the MEC and just 1 contra- outweighed the risks.20
indication (current breast cancer) for POP use.23 The final OTC drug facts label for the norgestrel POP
Because norgestrel is the first POP available without a includes warnings against use for women who22:
prescription, significant attention was paid to ensure that • Have currently or have had a history of breast cancer
consumers were able to understand, determine if they • Are already pregnant or think they may be pregnant
were eligible to use, and adhere to the labeled instruc- • Have unexplained vaginal bleeding between periods
tions on the OTC packaging. The OTC labeling for the • Are allergic to the product or any of its ingredients,
norgestrel POP was developed over a 7-year period including including tartrazine (FD&C yellow 5)
14 consumer studies and incorporating multiple rounds of
FDA feedback.3 The label also includes instructions for women to discuss
The Adherence with Continuous-dose Oral Contracep- their use of the product with their health care provider if
tive: Evaluation of Self-Selection and Use (ACCESS, they have liver problems. However, it is widely accepted
NCT04112095) was a single-arm, nonrandomized, open- that the use of POPs is preferred over COCs in liver disease
label, multicenter, 24-week prospective study to assess and that low-dose progestins, such as norgestrel 0.075 mg,
participant use of the norgestrel POP in an OTC-like are not hepatotoxic.22
environment to determine if consumers were eligible to use the The contraindication to the use of POPs in women with a
product and if they could use it correctly based on the labeling history of breast cancer is based on a theory that exogenous
instructions.3 The study enrolled participants aged at least reproductive hormones may increase the risk of or the speed
11 years who were interested in using an OTC oral contracep- of recurrence of hormone-sensitive cancers, namely breast
tive pill. From this study, it was determined that few people cancer. Limited recent data have not confirmed an increased
were likely to experience significant consequences if they risk of progression or recurrence of breast cancer in women
inappropriately self-selected to use the norgestrel POP due to using hormonal contraceptives.3 In the self-selection study
not reading or misunderstanding the OTC directions for use.3 undertaken to determine if the public could appropriately
Ninety-nine percent of participants were able to correctly self- determine if they were good candidates for the use of OTC
select for OTC POP use in the ACCESS study, whereas 84.5% contraceptive pills, 95% of the 206 individuals with a history
of participants who were not appropriate users correctly did of or current breast cancer correctly identified that they should
not select the product. Importantly, the ability to self-select not use the product.20
remained consistent across the subgroups of participants,
STA R
including in those with low health literacy and in adolescents
How might an individual be counseled on decreasing
younger than 18 years.3 the risk of unintended pregnancy while they are using
Multiple concerns regarding the ACCESS trial were OTC norgestrel tablets?
addressed in a final memorandum from the FDA before
the approval of the OTC POP. One such issue was related The dose, formulation, and instructions remained the same
to “improbable dosing,” in which 39% of ACCESS trial for the norgestrel POP from the prescription to the OTC
participants reported taking more than 1 tablet on at least 1 version; women of childbearing age should take 1 tablet by
day of the study, and some participants reported taking up to mouth every day at the same time each day to prevent preg-
5 tablets in a single day. The likeliest reason for this aberra- nancy. Women may start taking their first norgestrel tablet on
tion in expected data is pervasive overreporting, perhaps due any day of the month and at any time during their menstrual
to design flaws in the eDiary used to track adherence, incen- cycle. As with prescription POPs, a barrier method such as
tives for overreporting, or overprompting of participants for condoms should also be used for at least the first 2 days of
adherence data. This flaw in the data skews the outcomes of using POPs, if a dose is more than 3 hours late, or if 1 or
the study relating to whether individuals would take the OTC more doses are missed. Also, as with prescription POPs,
tablet every day at the same time each day as directed, which tablets are available in 28-day packs in which every tablet
optimizes the contraceptive efficacy of the product. Despite in the pack is the same; there are no placebo or inactive
this concern, the FDA’s Advisory Committee voted unani- tablets in POP packets, so women should continue to take 1
mously that the overall benefit of a reduction in unintended tablet every day at the same time, even if they are currently

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FIGURE 3. EFFICACY RATES FOR CONTRACEPTIVE METHODS24

experiencing bleeding or spotting, to continue to prevent effective. In the setting of prescription oral contraceptives,
unintended pregnancy.22 efficacy with typical or real-world use of oral contraceptives
While COC tablets are typically packaged in 28-day packs is estimated to be 93%, meaning that 7%, or 7 of 100 women
like POPs, COC packets only contain 21 or 24 days of active may experience an unintended pregnancy during the first year
tablets and 7 or 4 days of placebo or very low-dose hormone of typical use.24 In clinical studies of the norgestrel POP, where
tablets, respectively, when scheduled bleeding can gener- appropriate use tends to be highest, rates of pregnancy were
ally be expected to occur. Some COCs also come in 91-day found to be 2 in 100 woman-years.3 The ability to access the
packs with just 1 section of inactive tablets or very low-dose norgestrel POP over the counter makes it the only contracep-
hormones of 4- to 7-day duration. tive method that is currently available without a prescription
Efficacy data for contraceptive methods are based on considered to be moderately effective.
failure rates and are generally separated into 3 categories:
most effective/highly effective, which include sterilization STA R
and long-acting reversible contraception such as IUDs and Under what circumstances might you recommend a
patient reach out to their regular health care provider
implants; moderately effective, including oral contracep- before initiating the use of OTC norgestrel tablets?
tion (POPs and COCs), patches, injections, and vaginal
rings; and least effective, including such methods as male
and female condoms and the fertility awareness/rhythm Role of the Pharmacy Staff and
method (see FIGURE 324).24 Counseling Points
Efficacy data for the norgestrel POP are similar to those of Pharmacies are often seen as the first place to go with many
other POPs and COCs, which are considered to be moderately health-related problems or questions, and pharmacists are the

August 2024 pharmacytimes.org 59

most accessible health care providers in the US. Data show allergic to aspirin. Symptoms of this allergy may include
that patients visit their community pharmacists almost twice hives, facial swelling, wheezing, shock, skin reddening,
as often as their primary care providers or other health care rash, or blisters, and medical help should be sought
providers.25 Pharmacy technicians are often the first point immediately if an allergic reaction is suspected.
of contact between the public and the pharmacy. They are
generally the initial person that a patient will speak with at Before starting self-treatment with the OTC norgestrel POP,
the pharmacy, either in person or on the phone, and they can individuals with irregular bleeding between periods should
be an excellent source of counseling referrals for pharmacists discuss their symptoms with their provider. Patients with liver
as a result of these interactions. For example, if a patient disease or liver tumors and anyone who has ever had any type
presents requesting emergency contraceptives, a technician of cancer also need to contact their provider.
may alert the pharmacist to come speak with the patient In any consultation with a patient, drug interactions should
regarding emergency contraception (EC) use as well as the also be ruled out based on an inventory of the patient’s current
additional option of effective, ongoing contraception with the medication list. Some prescription and nonprescription medi-
use of the norgestrel OTC contraceptive. cations may decrease the efficacy of norgestrel as a contra-
If counseling a patient about contraception, best prac- ceptive, including some antiseizure medications (barbiturates,
tice for pharmacists is to assess the individual’s needs, carbamazepine, oxcarbazepine, phenytoin, topiramate, and
preferences, and goals for the use of the contraceptive and primidone), anti-tuberculosis drugs (rifampin, rifabutin), the
help them find the form of contraception that will work blood pressure medication bosentan, efavirenz used to treat
best for them. Pharmacists’ knowledge of the range of HIV/AIDS, and St John’s wort or any other herbal product
contraception types available can aid in providing the most containing hypericum perforatum.24
comprehensive counseling for patients unsure of what they Once it is clear that the patient is a good candidate for
want or what will best meet their needs. using the OTC POP, proper use and the importance of adher-
In some cases, conversations with patients about contra- ence should be explained, as should information regarding
ception may require a pharmacist to refer the patient to efficacy and ways to further decrease the risk of unintended
their primary care provider or a clinic, especially for forms pregnancy. Patients should be encouraged to take their POP
of contraception that require either a prescription or place- tablet every day at the same time each day, perhaps by tying
ment by a health care provider, such as IUDs or implants. it to an already habitual action such as brushing teeth in the
Alternately, targeted counseling can be used when a patient morning or, if consistent throughout the week, the eating of a
presents with specific questions or is already sure of the form meal that is generally eaten at the same time each day. Phar-
of contraception they would like to use, such as the OTC POP. macists can play an important role in helping patients deter-
Tailoring the conversation to the patient’s needs and prefer- mine ways that will work for them to adhere to the daily use
ences is essential to a successful contraceptive consult, as is of the OTC POP; cell phone alarms, calendar alerts, Post-it
the use of clear and concise patient-friendly language. notes on bathroom mirrors, or other reminders may be helpful
Counseling points for patients who are interested in for different patients.
beginning the OTC POP should include the most important It is also important to ensure that patients are aware that
information from the product labeling and include the teach- POPs do not in any way prevent any sexually transmitted
back method to ensure understanding by the patient. While diseases (STDs) such as HIV/AIDS, and that the appropriate
patients may purchase this product without seeking pharma- and consistent use of barrier methods is the only way to
cist counseling, if counseling is requested, pharmacists should prevent STDs. In addition to using them for STD prevention,
first determine that there are no contraindications to use of barrier methods such as condoms should be worn for every
the product such as26: act of intercourse for at least 48 hours after initiating the
• History of or currently active breast cancer OTC POP tablets, following a tablet that is at least 3 hours
• Known current or suspected current pregnancy late or any missed doses, and if a patient vomits or has
• Concurrent use of other forms of hormonal contracep- diarrhea within 4 hours of taking a tablet.22
tion or the copper IUD If a patient has previously used prescription COCs, they
• Allergies to any components of the product such as may be surprised to see that all of the tablets in the packet
tartrazine, which may be more likely in individuals of POPs are the same with no inactive tablets. Therefore,

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there is no definitive period of time to expect the onset of the act of unprotected intercourse, although up to 5 days
regular vaginal bleeding. after intercourse is allowable. A woman can start or reini-
Pharmacists should be sure to discuss menstrual bleeding tiate therapy with POPs, either prescription or OTC, imme-
disturbances, which are some of the most frequent AEs of diately following use of the levonorgestrel EC tablet, even
POPs. Women need to know that their periods may be similar on the same day. Any time a woman starts POPs or resumes
to how they were before taking the POPs regarding length following a late or missed dose, a backup barrier method
and frequency or they may be lighter, shorter, longer, or more such as condoms should be used for at least 48 hours after
frequent. In general, menstruation tends to become lighter and resuming or starting the POP.16
shorter with continued use of progestin-only contraceptives The other oral form of EC, ulipristal acetate, requires
such as POPs, which may be a welcome AE for some women a waiting period before resuming or starting a regular
with heavy and painful periods.27 Some women even experi- hormonal contraceptive such as the OTC POP. A woman
ence amenorrhea as a result of taking POPs; this is an impor- should wait 5 days following the use of ulipristal acetate to
tant counseling point, as some may be alarmed by an absence initiate or resume daily POP therapy, and a barrier method
of menstrual bleeding, and the OTC POP label recommends such as condoms should be used with every act of inter-
having a pregnancy test if a user has missed more than 2 course until the next menstrual period. Failing to wait the
consecutive periods.26,27 Spotting or breakthrough bleeding 5 days after ulipristal acetate use can decrease the efficacy
throughout the month can also be AEs of POPs that can be of both the regular hormonal contraception and the EC, so
disturbing to some users and should be included in counseling. appropriate counseling about this interaction is essential for
Both amenorrhea and breakthrough bleeding are common pharmacists’ patients.16
reasons for POP users to stop treatment; in clinical trials of The cost of the OTC POP may vary by retailer, but the
the original prescription version of the norgestrel POP, 6.4% general cost can range from $19.99 for a pack of 28 tablets to
of participants discontinued due to breakthrough bleeding and $49.99 for an 84-pill pack, which may be a consideration for
2.7% discontinued due to amenorrhea.3 Proper counseling can some patients. Surveys of patients interested in using the OTC
help patients know what to expect and improve adherence. POP showed that just about 34% of those surveyed would be
One concern that is common among women considering, willing to pay up to $20 per month for it, while 39% would
initiating, or continuing hormonal contraception is the poten- be willing to pay between $1 and $10 per month, 16% would
tial for weight gain or the effect of overweight or obesity be willing to pay more than $20 per month, and 11% were
based on a high body mass index (BMI) on the efficacy of not willing to pay anything for the tablets. Insurance coverage
their preferred form of contraception. Regarding the OTC of OTC products varies widely and can be burdensome to
POP, there are no data supporting weight gain related to the obtain for both patients and pharmacists. Insurance coverage
use of POPs. Additionally, because POPs do not contain is dependent on the type of insurance held by the patient
estrogen and therefore have a significantly lower VTE risk (private health plans or state-funded Medicaid) and
associated with them than COCs, and because overweight varies by state.29
and obesity are themselves factors that increase risk of VTE The manufacturer of the OTC norgestrel POP created a
and cardiovascular disease, POPs are often considered some pregnancy impact model to estimate the potential benefit of
of the safest forms of contraception for women with elevated the increased availability of an OTC POP. Even using conser-
BMI. Finally, regarding efficacy in women with overweight vative assumptions, the model found a potential reduction
or obesity, studies have not demonstrated an increased risk of of unintended pregnancies of 10% to up to 80% if patients
method failure with the use of POPs.28 switched from using either no method of contraception or
Because some women will be looking to initiate OTC POP one of the other contraceptive options available over the
therapy following the use of EC, pharmacists should know counter to the OTC POP. In addition, patients included in the
about proper counseling for women who are planning to or ACCESS trial who were currently using either no method or
have recently used EC and when to start or restart regular an OTC method of contraception attested to being willing to
hormonal contraception. The levonorgestrel 1.5 mg EC pill pay out of pocket for OTC access for a more effective contra-
is available OTC and should be taken as soon as possible ceptive such as the OTC POP, demonstrating the potential
after unprotected intercourse if a woman is not on a regular individual and public health benefits of the prescription-to-
form of contraception. Best results are within 72 hours of OTC switch of the norgestrel POP.3

August 2024 pharmacytimes.org 61

Conclusion 1729. doi:10.1001/jama.2022.19097

In purely practical terms, the accessibility of an OTC POP 7. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N

will remove many barriers for patients related to the require- Engl J Med. 2016;374(9):843-852. doi:10.1056/NEJMsa1506575

ment of a provider’s visit and a prescription. Research has 8. Centers for Disease Control and Prevention. CDC Contraceptive Guidance for Health Care

demonstrated that OTC access to a daily contraceptive Providers. US Selected Practice Recommendations for Contraceptive Use, 2016 (US SPR).

could save some women time spent in travel, at the clini- Updated May 2021. Accessed June 1, 2024. www.cdc.gov/reproductivehealth/contraception/

cian’s office, and missing work. The prescription-to-OTC mmwr/spr/summary.html

switch may particularly help those patients who have histori- 9. Kavanaugh ML, Pliskin E. Use of contraception among reproductive-aged women in the

cally had the most difficulty accessing reliable forms of United States, 2014 and 2016. F S Rep. 2020;1(2):83-93. doi:10.1016/j.xfre.2020.06.006

contraception, including young adults and adolescents, the 10. Dalton VK, Moniz MH, Bailey MJ, et al. Trends in birth rates after elimination of cost

uninsured, and patients living in areas where access to clinics sharing for contraception by the Patient Protection and Affordable Care Act. JAMA Netw Open.

providing the full spectrum of contraceptive methods is limited 2020;3(11):e2024398. doi:10.1001/jamanetworkopen.2020.24398

or nonexistent.30 In time, perhaps the lowering of barriers to 11. Prol B, Klein S, Rennie C, Andelija S. Respondent demographics and contracep-

accessing effective contraception will result in diminishing tive use patterns in the United States: a national survey of family growth analysis. Cureus.

rates of unintended pregnancy and improving women’s repro- 2024;16(1):e53121. doi:10.7759/cureus.53121

ductive autonomy and well-being. 12. Kavanaugh ML, Pliskin E, Hussain R. Associations between unfulfilled contraceptive pref-

erences due to cost and low-income patients’ access to and experiences of contraceptive care in

R EF ERE N C ES the United States, 2015-2019. Contracept X. 2022;4:100076. doi:10.1016/j.conx.2022.100076

1. American College of Obstetricians and Gynecologists. Committee on Health Care for Under- 13. Walsh-Buhi ER, Helmy HL. Trends in long-acting reversible contraception (LARC) use,

served Women, number 615. Access to contraception. Published January 2015. Accessed June LARC use predictors, and dual-method use among a national sample of college women. J Am

24, 2024. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/01/ Coll Health. 2018;66(4):225-236. https://doi.org/10.1080/07448481.2017.1399397

access-to-contraception 14. Frohwirth L, Mueller J, Anderson R, et al. Understanding contraceptive failure: an analysis

2. Guttmacher Institute. Contraceptive use in the United States by demographics. Published May of qualitative narratives. Womens Reprod Health (Phila). 2023;10(2):280-302. doi:10.1080

2021. Accessed June 1, 2024. www.guttmacher.org/fact-sheet/contraceptive-use-united-states /23293691.2022.2090304

3. HRA Pharma. Opill (norgestrel 0.075 mg tablets) for Rx-to-OTC switch. Joint Meeting 15. Daniels K, Abma JC. Current contraceptive status among women aged 15–49: United States,

of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and 2017–2019. NCHS Data Brief, no 388. National Center for Health Statistics. Published October

Urologic Drugs Advisory Committee. May 9-10, 2023. Accessed June 16, 2024. www.fda.gov/ 2020. Accessed June 24, 2024. www.cdc.gov/nchs/data/databriefs/db388-H.pdf

media/167893/download 16. American College of Obstetricians and Gynecologists. FAQs: Emergency contraception.

4. Rossen LM, Hamilton BE, Abma JC, et al. Updated methodology to estimate overall FAQ114. Published August 2019. Updated November 2021. Accessed June 17, 2024. https://

and unintended pregnancy rates in the United States. National Center for Health Statistics. www.acog.org/womens-health/faqs/emergency-contraception

Vital and Health Statistics Series. April 12, 2023. Accessed June 25, 2024. https://dx.doi. 17. Salako A, Ullrich F, Mueller KJ. Update: Independently owned pharmacy closures in rural

org/10.15620/cdc:124395 America, 2003-2018. RUPRI Center for Rural Health Policy Analysis. Brief No. 2018-2.

5. US Department of Health and Human Services. Office of Disease Prevention and Published July 2018. Accessed July 9, 2024. https://rupri.public-health.uiowa.edu/publications/

Health Promotion. Healthy People 2030. Reduce the proportion of unintended pregnan- policybriefs/2018/2018%20Pharmacy%20Closures.pdf

cies—FP‑01 Accessed July 15, 2024. https://health.gov/healthypeople/objectives-and-data/ 18. Guttmacher Institute. State laws and policies. Pharmacist-prescribed contraceptives.

browse-objectives/family-planning/reduce-proportion-unintended-pregnancies-fp-01 Published August 31, 2023. Accessed June 16, 2024. https://www.guttmacher.org/state-policy/

6. Nelson HD, Darney BG, Ahrens K, et al. Associations of unintended pregnancy with maternal explore/pharmacist-prescribed-contraceptives

and infant health outcomes: a systematic review and meta-analysis. JAMA. 2022;328(17):1714- 19. Jones KB. Advancing contraception access in states through expanded pharmacist

ADDITIONAL RESOURCES

Organization Website
US SPR & CDC MEC Contraception app https://www.cdc.gov/reproductive-health/hcp/contraception-guidance/app.html
Managing Contraception https://store.managingcontraception.com/managing-contraception-16th-edition/
Contraceptive Technology https://contraceptivetechnology.org/
Planned Parenthood https://www.plannedparenthood.org/learn/birth-control

62 pharmacytimes.org August 2024

 www.pharmacytimes.org

prescribing. American Progress.org. Published January 31, 2023. Accessed June 1, 2024. 25. Valliant SN, Burbage SC, Pathak S, Urick BY. Pharmacists as accessible health care

https://www.americanprogress.org/article/advancing-contraception-access-in-states-through- providers: quantifying the opportunity. J Manag Care Spec Pharm. 2022;28(1):85-90. https://

expanded-pharmacist-prescribing/ doi.org/10.18553/jmcp.2022.28.1.85

20. Murry KM. Decisional memorandum, New Drug Application 17031 Supplement 41, Appli- 26. Horn PJ. Opill packaging. Published March 11, 2024. Accessed July 9, 2024. https://www.

cation for full prescription-to-nonprescription switch of norgestrel tablets 0.075 mg. Published accessdata.fda.gov/drugsatfda_docs/label/2024/017031Orig1s042,%20s043lbl.pdf

July 13, 2023. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/ 27. American College of Obstetricians and Gynecologists. FAQs: Progestin-only hormonal birth

nda/2023/017031Orig1s041SumR.pdf control: pill and injection. Published January 2023. Updated May 2024. Accessed July 9, 2024. https://

21. American College of Obstetricians and Gynecologists. First over-the-counter www.acog.org/womens-health/faqs/progestin-only-hormonal-birth-control-pill-and-injection

daily contraceptive pill released. Published March 2024. Accessed July 9, 2024. 28. Mody SK, Han M. Obesity and contraception. Clin Obstet Gynecol. 2014;57(3):501-507.

https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2024/03/ doi:10.1097/GRF.0000000000000047

first-over-the-counter-daily-contraceptive-pill-released 29. Kaiser Family Foundation. 3 Charts: the cost and coverage of Opill—the first FDA-

22. Opill. Prescribing information. Laboratoire HRA Pharma; 2017. Accessed June 25, 2024. approved over-the-counter daily oral contraceptive pill in the United States. Published March 5,

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf 2024. Accessed June 17, 2024. https://www.kff.org/health-costs/press-release/three-charts-the-

23. CDC. US Medical Eligibility Criteria for Contraceptive Use, 2016 (US MEC). Updated cost-and-coverage-of-opill-the-first-fda-approved-over-the-counter-daily-oral-contraceptive-

March 27, 2023. Accessed July 16. 2024. https://www.cdc.gov/reproductivehealth/contracep- pill-in-the-united-states/

tion/mmwr/mec/summary.html 30. Diep K, Long M, Salganicoff A. Oral contraceptive pills: access and availability. KFF.

24. Office of the California Surgeon General. Let’s talk birth control (contraception). Accessed Published March 20, 2024. Accessed June 17, 2024. https://www.kff.org/womens-health-policy/

June 17, 2024. www.osg.ca.gov/contraception issue-brief/oral-contraceptive-pills-access-and-availability/

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August 2024 pharmacytimes.org 63

 PHARMACIST POSTTEST QUESTIONS*

1. Recent rates of unintended pregnancies in the US 6. Which of the following is a characteristic of

have been estimated to be ___, and the Healthy progestin-only hormonal contraceptive pills (POPs)?
People 2030 goal is to get that number to below ___. A. They come in packs with 21 or 24 active tablets and
A. 40%, 35% 7 or 4 inactive or low-dose pills.
B. 41.6%, 36.5% B. They often can result in irregular spotting or
C. 51.2%, 39.5% bleeding between periods.
D. 59%, 45% C. There is an elevated risk of venous
thromboembolism with their use.
2. Which poor maternal-child health outcome is D. They have been found to be less effective in women
associated with unintended pregnancies? with overweight or obesity.
A. Decreased rates of maternal depression
B. Increased rates of maternal substance use disorder 7. Based on available data, which form of contraception
C. Decreased maternal experiences of interpersonal is less effective in real-world use than POPs?
violence A. Female condoms
D. Preterm birth and low infant birth weight B. IUDs
C. Combined hormonal contraceptive pills (COCs)
3. Which option is a barrier to contraception use for D. The contraceptive injection (depot
women in the US? medroxyprogesterone)
A. The advent of telehealth options to obtain
contraceptive prescriptions Please use the following case to answer questions 8-10.
B. Lack of effective contraceptive options in the
marketplace You are a community pharmacist and KB is a 26-year-
C. Exaggerated concerns about the safety of old woman who you know well because of her chronic
contraceptive methods approved by the FDA asthma. For the past several years, she comes to the
pharmacy monthly for controller inhaler refills as well
D. Cost of contraception for individuals covered by an
as occasional albuterol inhaler prescriptions. She
Affordable Care Act insurance plan
approaches you at the pharmacy counter today to pick
up her inhaler refill and also to purchase a package of
4. According to available data, which form of reversible OTC norgestrel tablets.
contraception is the most commonly used?
A. Male condoms
8. Which is one of the most important things to discuss
B. Long-acting reversible contraceptives (intrauterine with her?
devices [IUDs], implants) A. OTC POPs are 100% effective at preventing
C. Oral contraceptive pills pregnancy if taken appropriately and consistently.
D. Patch B. OTC POPs prevent sexually transmitted disease
(STD) transmission.
5. Which option is one of the ways that pharmacists are C. Review potential changes to her menstrual cycle that
able to prescribe contraception in states that allow
may occur during POP use.
“behind-the-counter” access to contraception?
D. Caution her about use of OTC POPs if she has any
A. Permission from the governor
history of kidney disease.
B. Legislative decree
C. Standing order
9. Under what circumstances would you recommend
D. Verbal agreement with a community physician
that KB reach out to her regular provider before
initiating treatment with an OTC POP?
A. If she has never used contraception before
B. If she is overdue for a Pap smear
C. If she is currently undergoing testing to determine if
she has a rare form of breast cancer
D. If she recently received a prescription for oral
antibiotics to treat an STD

64 pharmacytimes.org August 2024

 www.pharmacytimes.org

PHARMACIST POSTTEST QUESTIONS* (continued)

10. At checkout, KB confides that she had unprotected

sex last night and so is eager to start the POP right
away. Which of the following is the most appropriate
advice?
A. Start the POP today and use a condom for the first
2 days.
B. Take an OTC levonorgestrel emergency
contraceptive today, then start taking the POP today
in addition to using a condom for at least 48 hours
after starting the POP.
C. She should see her provider to rule out pregnancy
before initiating the OTC POP.
D. Start the POP today and take it at the same time
every day.

*Pharmacy technician posttest can be found online at www.pharmacytimes.org/otc-contraception

August 2024 pharmacytimes.org 65