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 14,5). 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
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: firstname.lastname@example.org.