Introduction

Since the first emergency contraceptive (EC) pills were approved by the Food and Drug Administration (FDA) in the 1990s, advancements have led to several methods that are currently available to prevent pregnancy after unprotected or inadequately protected sexual intercourse. Despite this, 45% of pregnancies in the United States remain unintended.¹ This is primarily due to barriers to access and lack of awareness among women about their own risk of unintended pregnancy as well as safe and effective use of contraception.²

Levonorgestrel (Plan B^®, My Choice^®, Take Action^TM, etc.) is the only EC that is available over the counter to anyone regardless of age or gender and without parental consent. Ulipristal acetate (Ella^®), copper intrauterine device (Cu-IUD, ParaGard^®), and combined oral estrogen-progestin regimen (the Yuzpe method) are all EC methods that require a prescription.^2,3,4Additionally, the Cu-IUD requires insertion by a trained healthcare professional. Both levonorgestrel and ulipristal have been shown to be less effective in patients who are overweight or obese, a concern considering more than 60% of adult patients in the US are overweight or obese.⁴ All EC options can be used within five days of unprotected intercourse; however, levonorgestrel efficacy may decrease after 72 hours.

Prescription-only EC methods create major barriers to access as it delays care and can be a time consuming and expensive process. Pharmacies across the nation who have elected to prohibit dispensing of ECs or allow their pharmacists to refuse to dispense pose another barrier. From an ethical standpoint, it is important for healthcare professionals to understand the underlying mechanism of action of the EC methods so it is not confused with medical abortion methods. EC is effective in preventing pregnancy only before implantation phase, which means EC would not terminate an existing pregnancy.²

Use of EC products can be especially beneficial in specific circumstances, such as in the case of missed dose(s) or drug-drug interaction where oral contraceptive efficacy is compromised. However, use of EC products as a primary contraceptive method is not recommended.⁵ Consistent use of EC as a primary method of contraception is not as effective as combined oral contraceptives (COC), can cause increased menstrual irregularities, and is often more expensive. Further, despite its availability during the past 20 years, there is limited data to show that EC availability has decreased pregnancy rates.² Twenty-five percent of women who are at risk for unintended pregnancy in the US experience challenges in obtaining a primary contraceptive method (e.g., difficulty obtaining a visit with a physician, inconvenient clinic hours or not desiring a pelvic exam).⁶

As of 2019, six states allow pharmacists to prescribe oral contraceptives, and more states are working on legislation.^7,8 Pharmacists must be prepared with adequate knowledge of necessary patient-assessment processes; differences between pharmacotherapy products’ efficacy, safety, side effects, and drug interactions; and rules and regulations surrounding their prescribing activities. The US Medical Eligibility Criteria (MEC) and Selected Practice Recommendations (SPR) published by the CDC guide appropriate selection of contraception products for patients seeking contraception based on comorbidities, efficacy, and other factors.^9,10

Case (part 1)

CC: “My boyfriend and I had sex last night and didn’t use a condom. Do you have that pill I can take?”

Patient: RG is a 19-year-old college sophomore that has been coming to your pharmacy for the last year and a half for her sumatriptan and levothyroxine. Today, she presents looking a little pale and uncomfortable. She waits for the line at the pharmacy counter to die down before coming up to speak to you.

HPI: RG has been dating her current boyfriend for two years and they began having consensual monogamous sexual intercourse a few months prior. They have used condoms in the past but ran out and hadn’t stopped at the pharmacy to pick up more. RG reports this was her first time having unprotected sex.

PMH: hypothyroidism (2 years); headaches (1-2/month)

FH:

• Mother: alive (55 years), HTN and hypothyroidism
• Father: alive (58 years), HTN

SH:

• Current sophomore studying electrical engineering at a public university
• Drinks socially 3-4 drinks every other weekend
• Denies use of nicotine, illicit substances, and non-prescribed medications.

SDH: Uninsured. Works part time at the campus bookstore. Lives in campus housing. Does not have a car on campus. Current PCP is located 6 hours away.

Medications:

• Sumatriptan 100 mg by mouth at onset of headache (may repeat if headache persists after 2 hours)
• Levothyroxine 88 mcg by mouth daily

Allergies: NKDA

Labs:

• BP 124/82 mmHg
• HR 68 bpm

Case Questions

1. One of the largest barriers to contraceptive care is the ability to access medications. How might RG struggle to access contraception? How might current laws and ethical principles factor into access to care?

RG may have limited access to transportation to care, especially to see her current PCP for initiation of long-term treatment, ulipristal acetate, or Cu-IUD which are prescription only. Levonorgestrel-containing EC is available now to patients of all ages OTC since 2013. Previously, this was limited by age restrictions. Having access to OTC EC at pharmacies which may be located much closer to patients can improve patient access. However, just because it is available OTC does not mean all pharmacies must carry EC products. While some states contain “duty-to-dispense” rules, some states may allow pharmacies to choose not to stock or dispense EC based on religious or moral beliefs.^a Corporate policies may also dictate how pharmacists respond. It is recommended that any pharmacist morally conflicted about dispensing emergency contraception, recommend another colleague.

In addition to access, cost may be a barrier for RG as she is uninsured and will have to pay cash price. EC may be paid for under insurance. Under the Patient Protection and Affordable Care Act, insurance companies must cover contraception methods and counseling for all women provided by a healthcare provider. Exempt insurance plans include those provided by a religious employer or non-profit religious organization.^b

2. RG does not have insurance and cannot afford the cost of Plan B? What options are available to help minimize costs?

Typical costs of OTC EC range around $40-50. Some products may offer coupons to help with product costs. In addition, patients may be able to get a prescription for a COC available on the $4 list (not actually $4, but lower cost). The COC can be used for emergency contraception following the Yuzpe method to get to 100 mcg ethinyl estradiol and 0.5 mg levonorgestrel taken once and then again 12 hours later.^c-e This may minimize cost; however, rates of nausea are higher.

3. RG mentions she has heard some emergency contraception can cause an abortion. How would you respond to this?

None of the available EC products can cause an abortion. The levonorgestrel, combined oral contraception Yuzpe method products, and ulipristal acetate all work by delaying the release of the egg, a process known as ovulation. As such, these work best if given within 72 hours of unprotected sex. As ulipristal acetate, a progesterone receptor modulator, has a direct inhibitory effect on follicular rupture, it may have similar efficacy for up to 120 hours. The copper IUD works by causing an inflammatory response that impairs sperm motility, function and viability. In addition, it may have effects in minimizing implantation.^e Studies have not shown increased fetal malformations in those who have used oral contraceptives or emergency contraception in early pregnancy.^c,f

4. Based on access, cost and patient concerns, what would be an appropriate recommendation for RG?

As RG is at the community pharmacy and within 72 hours from unprotected intercourse, the OTC levonorgestrel would be appropriate. She can use the coupon card to limit cost. Additionally, generic or store brand options are available at lower costs. RG should be reminded that emergency contraception does not provide coverage for sexually transmitted infections and she still should be screened by a healthcare provider (MD, DO, NP, PA). For longer term contraception options, services may be available on campus or at the local health department for a small fee.

Case (part 2)

RG returns to the community pharmacy to initiate a hormonal contraceptive after seeking her third course of EC in three months. She just finished her menstrual cycle and has not had unprotected sex since she last saw you for her EC. RG has one sexual partner and is in a committed relationship. She has never taken an oral contraceptive due to cost as she is uninsured and due to fears that it would make her gain weight.

Many of her friends who started OCs when she was a teenager told her they made them gain 15-20 lbs. She reports using EC is becoming expensive and her boyfriend doesn’t like using condoms. RG wants to know if there is an affordable oral contraceptive she can start – she heard that pharmacists can now prescribe contraceptives.

RG has never taken any daily medications and is worried that she may struggle to remember taking a pill but doesn’t think she would like the ring product. She reports that her menstrual cycle is fairly heavy and some of her friends told her their oral contraceptive shortens their period to every few months. RG would like to use one of these products to help alleviate symptoms of her menstrual cycle but wonders if there are any health risks associated with that.

Case Questions

5. What family history and/or past medical history would be significant to collect in your assessment for RG? Why?

For RG, the most significant PMH impacting decision for contraceptive method is her history of headaches. It is important to collect more information as to whether her migraine is with or without aura. If without aura (includes menstrual headaches) there is no restriction to any contraceptive method, though initiating combined hormonal contraception (COC) falls under category 2 because COC may decrease or increase migraines. If with aura, initiating COC is unacceptable because studies have demonstrated a higher risk of stroke in women with history of migraines with aura compared to women with a history of simple migraines.^g,h

6. What factors should be considered when assisting RG in choosing an appropriate contraceptive method?

Other important characteristics to collect and assess include age, weight, social history (e.g., smoking status), and vitals. In the case of RG these factors do not restrict any contraceptive method. However, it is imperative to consider patient preferences, social factors and lifestyle. RG is looking for something affordable (recall she does not have health insurance), worried about weight gain, and not sure she would like the ring product. An important preference is her heavy menstrual bleeding (she asks about a product that could reduce her menstrual cycle to every few months).

7. If RG had a PMH of VTE instead of migraines, how would her contraception selection and health risks from contraceptives change?

COCs should be avoided as this method may increase risk of VTE. Estrogens increase hepatic production of factor VII, factor X and fibrinogen in the clotting cascade thereby increasing the risk of VTE.^g,h Drospirenone-containing contraceptives may be associated with a higher risk of VTE than COCs containing other progestins and COC’s containing > 50 mcg ethinyl estradiol (EE). Risk is greatest during 1^st year of COC use or after ≥ 4 weeks of a pill-free interval. VTE risk factors include smoking, obesity, family history of VTE, and age ≥ 35.

8. How could RG’s cultural or religious beliefs impact her contraception preference, use, and adherence?

Teens who live in rural areas have increased barriers to contraception access and are less likely to use contraception despite increased sexual activity, partially due to stigma and affordability issues.ⁱ Different cultures, ethnicities, and religious faiths will have varying beliefs about acceptability of contraception that the pharmacist must investigate and make recommendations that are congruent with their beliefs.

References:

a. Yang YT, Sawicki NN. Pharmacies’ Duty to Dispense Emergency Contraception: A Discussion of Religious Liberty. Obstet Gynecol. 2017 Mar;129(3):551-553.

b. U.S. Centers for Medicare & Medicaid Services. Health Benefits and Coverage: Birth control benefits. Available at: https://www.healthcare.gov/coverage/birth-control-benefits/. Accessed Nov 21, 2018.

c. Trussell J, Raymond E, Cleland K. 2017. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy.

d. Gemzell-Danielsson K1, Berger C, PGLL. Emergency contraception — mechanisms of action. Contraception. 2013 Mar;87(3):300-8.

e. Yuzpe AA, Thurlow HJ, Ramzy I, Leyshon JI. Post coital contraception—a pilot study. J Reprod Med. 1974;13(2):53-58.

f. Shen J, Che Y, Showell E, et al. Interventions for emergency contraception. Cochrane Database Syst Rev. 2017;8:CD001324.

g. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical criteria for contraceptive use, 2016. MMWR Recomm Rep. 2016;65(4):1-66.

h. Shrader SP, Ragucci KR. Contraception. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e New York, NY: McGraw-Hill https://accesspharmacy.mhmedical.com/book.aspx?bookID=1861. Accessed November 28, 2018.

i. Geske S, Quevillion R, Struckman-Johnson C, et al. Comparisons of contraceptive use between rural and urban teens. J Pediatr Adolesc Gynecol. 2016;29(1):33-41.

Author Commentary

The development of safe, effective contraception is widely considered to be one of the greatest public health achievements of the 20^th century.¹¹ There are an increasing number of safe and effective choices for contraceptive methods to reduce the risk for an unintended pregnancy, however with this comes an increasing need for healthcare providers’ knowledge of evidence-based guidance to offer quality family planning care. This includes choosing the most appropriate contraceptive method, counseling on appropriate and consistent use of the contraceptive, and identification and resolution of adverse effect and adherence challenges. In addition to tolerability, accessibility and affordability of contraception should be ensured. Contraception recommendations by family medicine physicians were found to be inconsistent with CDC guidelines 23% of the time for oral contraceptives and 40% of the time for intrauterine devices (IUDs). The Direct Access study was the first study to evaluate the use of a collaborative drug therapy protocol by pharmacists for contraception prescribing.¹² It demonstrated that community pharmacists have the knowledge and skill to adequately screen female patients seeking contraception and select the most appropriate product to meet individualized patient needs.^12,13

EC is an effective option for those who do not desire pregnancy if taken up to 120 hours from unprotected or inadequately protected sexual intercourse. The CDC US MEC for contraceptive use (2010) includes no medical conditions in which the risks of EC outweigh the benefits.^9,10 Thus, all women should be offered or made available EC when requested and should not be delayed waiting for pregnancy testing. Pharmacists can dispense and counsel patients on appropriate use of these products as well as improve access through knowledge of the laws and ethical considerations pertaining to these products. Pharmacists should make an effort to minimize barriers to dispensing of ECs and refer the patient to a colleague if morally conflicted.

Patient Approaches and Opportunities

Pharmacists working in community and ambulatory care settings can and should screen all female patients for contraception use and access. Pharmacists should be aware of US MEC and SPR guidance published by the CDC. Using these and other resources available, females should be provided with an appropriate contraceptive method that is safe, effective, and affordable. They should also be well educated on what to do in the setting of missed doses, adverse effects (e.g., breakthrough bleeding), and drug-drug interactions. Pharmacists have the knowledge and opportunity to provide education and counseling on EC and non-contraceptive risks and benefits.

In addition to decreasing the risk of unintended pregnancy, many contraceptive methods reduce the risk of endometrial and ovarian cancers, are therapeutic agents for menstrual-related disorders and have other benefits.^14,15 Women should be empowered with the necessary education and counseling to make a shared decision in which method, if any, to use to prevent pregnancy and/or to ameliorate or treat symptoms related to their menses.