Counseling for Emergency Contraception

James L. Lindon, PharmD, PhD, JD

Disclosures

February 24, 2016

Question

While personal information is not required to purchase emergency contraception, what counseling should be offered about its proper use?

Response from James L. Lindon, PharmD, PhD, JD
Director, Pharmacy Law and Intellectual Property, Lindon & Lindon, LLC

A Controversial History

Contraception has a long history of controversy; for example, the marketing of condoms for contraception was once illegal in the United States.[1] The progestin levonorgestrel (Plan B One-Step® [Teva Pharmaceuticals]; generically Take Action® [Teva Pharmaceuticals], Next Choice One Dose® [Actavis Pharmaceuticals], My Way® [Gavis Pharmaceuticals], levonorgestrel [Perrigo])—the so-called morning after pill—has a similar history of controversy.

In December 2011, US Department of Health and Human Services Secretary Kathleen Sebelius blocked the US Food and Drug Administration's (FDA's) plan to approve the over-the-counter (OTC) sale of Plan B without age restrictions, an action that was supported by President Barack Obama. In a ruling on April 4, 2013, Judge Edward Korman of the Eastern District of New York held that Sebelius's decision on Plan B was "arbitrary, capricious, and unreasonable" and that it was "politically motivated, scientifically unjustified, and contrary to agency precedent....:[2] As a result, Plan B became available without a prescription and without age restrictions.

The FDA subsequently approved the sale of generic versions of levonorgestrel without age restrictions. Levonorgestrel emergency contraception products can be sold in pharmacies, grocery stores, and other stores that sell family planning products to women and men of any age. Even though the package directions for generic products may say that the product is intended for use by women aged 17 years and older, these products do not have age, sex, or point-of-sale restrictions.[2,3]

Ulipristal (ella® [Afaxys Pharmaceuticals]) is a progesterone receptor antagonist and is indicated for the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. The product is available by prescription only in the United States, but it is available as a nonprescription product in Europe. Like that of levonorgestrel, the package label does not include age restrictions.[4]

Mechanism of Action and Clinical Use

Both levonorgestrel and ulipristal exert an anticontraceptive effect by inhibiting or delaying ovulation. Levonorgestrel slows development of egg follicles, and ulipristal inhibits follicular rupture. Neither drug prevents egg fertilization or fertilized egg implantation. Neither drug interrupts an established pregnancy or has an adverse effect on pregnancy or a developing embryo.[3,5,6,7]

Levonorgestrel and ulipristal are sometimes erroneously associated with medical abortion, which uses such drugs as mifepristone (Mifeprex®) and misoprostol (Cytotec®) to terminate a pregnancy.

Neither a clinical examination nor pregnancy testing is required before the use of emergency contraception. The indication for emergency contraceptive products is prevention of unwanted pregnancy following unprotected or inadequately protected sexual intercourse.

Unlike daily oral contraceptives, emergency contraceptives should not be used as routine birth control. It is somewhat ironic that lower-dose daily oral contraceptives currently require a practitioner's prescription, while there is no legal barrier to prevent emergency contraceptives from being used as often as desired.

Economic barriers may limit access. Under the Affordable Care Act, oral contraceptives, as well as emergency contraceptives, are a covered treatment when prescribed by a practitioner; however, OTC emergency contraception may not be covered by some states and insurance plans.[8]

Counseling Patients

The pharmacist is not required to elicit personal details from a person purchasing nonprescription emergency oral contraception. Identification of the purchaser or the person who will use the product is not required. Obtaining the age of the intended patient is no longer legally required. Similarly, a person buying condoms or other forms of OTC contraception is not questioned about the identity or age of the intended user.

Women who are victims of sexual assault should be offered emergency contraception as well as referred for medical care.

Purchasers of levonorgestrel or ulipristal for emergency contraception should be counseled on proper use.[4,9]

  • Explain that emergency contraception will not terminate an existing pregnancy.

  • Emergency contraception should not be used in known or suspected pregnancy.

  • Levonorgestrel should be taken as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.

  • Ulipristal should be taken as soon as possible and not more than 120 hours after unprotected intercourse or a known or suspected contraceptive failure.

  • Patients should contact a healthcare provider to discuss whether to take another tablet if vomiting occurs within 2 to 3 hours of administration.

  • Emphasize the need for medical attention for severe lower abdominal pain 3 to 5 weeks after taking emergency contraception to be evaluated for an ectopic pregnancy.

  • Advise patients to contact a healthcare provider and consider the possibility of pregnancy if the menstrual period is delayed by more than 1 week beyond the expected date after taking emergency contraception.

  • Explain that emergency contraceptive products should not be used as routine contraception or used repeatedly in the same menstrual cycle.

  • Educate that emergency contraception does not protect against HIV/AIDS and other sexually transmitted diseases.

Comments

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