Plan B Nonprescription Use: Implications for the Pharmacist

Plan B emergency contraception has been available as a prescription medication since July 1999.¹ After much deliberation, the FDA approved Plan B on August 24, 2006, for OTC purchase by women 18 years and older.² Plan B will remain a prescription-only product for girls aged 17 and younger.² The OTC drug is expected to hit retail pharmacies by the end of 2006.³

Plan B prevents pregnancy from occurring by inhibiting ovulation and, alternatively, by preventing implantation in the uterine wall (Table 1^4,5). Plan B will not work once implantation has begun, and it cannot be used to terminate a preexisting pregnancy.⁴

Plan B consists of 2 tablets (each tablet containing 0.75 mg of levonorgestrel).⁴ The first tablet should be taken within 72 hours of unprotected intercourse or contraceptive failure, and the second tablet 12 hours later.⁴ Plan B is ~95% effective when initiated within 24 hours and 74% effective when used within 72 hours.⁶ The drug is considered extremely time-sensitive and should be initiated as early as possible for maximum effectiveness. Although there is evidence that both tablets can be taken at once, this dosing regimen is not FDA-approved and should not be routinely recommended.¹

Plan B Packaging

Plan B has a unique marketing approval based on a dual-label concept. The drug will be packaged the same way to satisfy both the Rx and the OTC labeling requirements.^7,8 Plan B will be available for OTC sales for patients 18 years of age and older with proper age identification (ID). There will be a space for the pharmacist to apply the prescription label before dispensing it to girls 17 and younger with a prescription.⁷ The package will be labeled "Prescription only for age 17 and younger," and it must remain behind the pharmacy counter.⁷ A licensed pharmacist must be on duty when Plan B is sold without a prescription.^3,7

Additionally, Plan B will be available at health clinics and other areas with health care professionals. It will not be sold in convenience stores, gas stations, or other locations where a health care professional or pharmacist is not present.^1,3,7,9

Implications for the Pharmacist

Requesting emergency contraception can be an emotional situation for women¹⁰?go to www.pharmacytimes. com to read some illuminating first person perspectives. Regardless, pharmacists should counsel patients that the side effects of Plan B are similar to those of oral contraceptives?such as nausea, vomiting, stomach pain, and breast tenderness. Plan B should be taken with food to minimize any gastrointestinal complaints. Patients who vomit within 1 hour of taking a dose should repeat the dose. Antinausea medications such as dimenhydrinate (Dramamine) or meclizine hydrochloride (Bonine) can be taken 1 hour before each dose if needed.¹ Any serious or unexpected adverse reactions to Plan B should be reported to the FDA via the MedWatch reporting program.

Plan B OTC will allow immediate access to emergency contraception at pharmacies, because physician visits can result in financial and time constraints.^11,12 Pharmacies have extended and weekend hours often not available at physician offices and will offer great convenience for patients.^11,13 Pharmacists can help ensure that patients receive the full benefits of Plan B, since efficacy is based on the time frame in which therapy is initiated.^10,11,13

Concerns may arise because there is no gender restriction or limit to the quantity of Plan B that can be purchased by an individual.³ Ultimately, this lack of restriction can lead to overuse, a rise in sexually transmitted diseases, and delayed care by a gynecologist if Plan B fails.^11,12 Pharmacists should be aware of these concerns. Also, once Plan B OTC is purchased, the ultimate user may not always be the purchaser. Thus there may be increased use among teenagers or a lack of appropriate counseling.⁹

In addition, some pharmacists may object conscientiously to selling Plan B.^1,14 Pharmacists who object to Plan B should direct patients to another pharmacist or to a nearby pharmacy where pharmacists are willing to sell the drug.^1,14

The issue of insurance reimbursement for Plan B is uncertain. Traditionally, once a drug makes the switch from Rx to OTC, insurance coverage terminates.¹ It is expected, however, that some insurance companies will continue to cover Plan B.

Table 2 lists counseling pearls for the pharmacist.^15,16

CARE Program

An integral part of the OTC access to Plan B is the CARE (Convenient Access, Responsible Education) Program.^2,8 This program was created by Barr's Duramed, the sponsor of Plan B. The program was developed to help ensure that Plan B will be used responsibly and appropriately.⁸ CARE consists of 4 key elements: (1) Labeling/Packaging/Informational Toll Free Hotline, (2) Education, (3) Distribution, and (4) Monitoring.^7,8

For the educational element of CARE, Barr plans to promote awareness of Plan B to consumers and health care professionals.^2,8 The company will target physicians, physician assistants, pharmacists, and nurse practitioners.⁸ Programs will include continuing education by certified professionals and educational materials that can be accessed easily and at any time.⁸ Furthermore, consumers targeted will be between the ages of 18 and 44. Barr has stated that audiences aged 17 years and younger will not be targeted by the media.⁸

Distribution is another key element of CARE.⁸ Once a drug is available for nonprescription use, sales generally are unregulated with regard to location and quantity.⁸

Barr will monitor trends involving emergency contraception?including pregnancy and abortion rates, Plan B usage, and spread of sexually transmitted diseases?and make appropriate adjustments as necessary.⁸ Barr also will survey health care professionals and consumers, collecting demographic information and assessing risk factor behavior.⁸

Moreover, Barr will oversee compliance with the prescription age requirement by conducting a Point-of-Purchase Monitoring Program.⁸ The purpose of this program is to track how Plan B is being sold at the time of purchase.⁸ Anonymous shoppers will visit pharmacies and health clinics in various regions of the United States where Plan B is available and purchase the product.⁸ This program will evaluate whether the prescription age requirement is being followed and identify areas in need of further education.⁸ Health professionals who fail to check for proper ID may be reported to the respective state Board of Pharmacy or the FDA.^7,8

Dr. Fass is a drug information resident and Dr. Matthew Seamon is an assistant professor at the College of Pharmacy, Nova Southeastern University, Fort Lauderdale, Fla. Dr. Erica Seamon is a clinical research associate based in Cambridge, Mass.

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Rybovic, Pharmacy Times, Ascend Media Healthcare, 103 College Road East, Princeton, NJ 08540; or send an e-mail request to: arybovic@ascendmedia.com.