The results from the Convenient Access, Responsible Education (CARE) program indicate that the emergency contraception (EC) dual-label Plan B (levonorgestrel) requirements are being followed by pharmacists. Plan B, known as the morning-after pill, was approved OTC for individuals aged 18 and older by the FDA on August 24, 2006. Plan B still requires a prescription for individuals 17 and younger.

CARE Program

As part of the approval process, Duramed Pharmaceuticals Inc, the sponsor, developed and implemented CARE. The purpose of the program is to ensure that Plan B is used responsibly and correctly and that the restrictions of the dual-label product are understood and followed at the pharmacy level, according to Joe Carrado, MSc, RPh, vice president of global regulatory affairs for Duramed. The CARE program includes 4 elements:

• Packaging and labeling that conforms to the OTC and prescription requirements while providing information to individuals in an understandable format
• Restricting distribution of Plan B to licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed health care practitioners
• Implementing an extensive educational campaign with health care providers on the appropriate use of prescription and OTC Plan B, including an informational toll-free number and easy-to-understand educational material for health care professionals to distribute to patients
• Monitoring the effectiveness of the age restriction and the safe distribution of OTC Plan B to patients 18 and above and Rx Plan B to patients under 18

CARE Results

The effectiveness of CARE was monitored through a point-of-purchase program conducted from November 2006 to April 2007. The FDA requires reports every 6 months, said Carrado. Chain and independent pharmacies in 10 states were identified for monitoring based on prior Plan B Rx sales and geographic region. The states included California, Texas, New York, Florida, Illinois, Washington, Minnesota, Kansas, New Mexico, and Maine. Of the 10 states monitored, California, Maine, New Mexico, and Washington are Pharmacy Access states, in which certified pharmacists can write a script for EC for individuals who request it, regardless of age.

Pharmacies were monitored using trained, anonymous secret shoppers aged 15 to 17 who were enlisted to visit assigned pharmacies and ask to buy Plan B. If identification or a prescription was requested, the shopper was told to explain that she did not have it with her and ask that Plan B be sold to her regardless.

All pharmacies surveyed kept Plan B behind the counter. Carrado said that overall compliance, meaning checking the shopper's identification and dispensing OTC Plan B only if the individual was 18 or older, was >95% for chain pharmacies and 91% for independent pharmacies. If a pharmacy was noncompliant and the product was dispensed to a secret shopper, Carrado explained that the pharmacy was notified, remedial education was provided, and the pharmacy was remonitored. For pharmacies that did not have Plan B in stock at the time, the visit did not take place. If a pharmacy was found to be a multiple offender regarding the requirements for dispensing OTC Plan B, a report was sent to that pharmacy's state board of pharmacy.

The results "speak to the fact that education does work and pharmacists do get it," he said. Carrado added that overall, the availability of Plan B is still an issue, and pharmacy educational efforts will continue.

Patient Request Card

Another aspect of Plan B education is the patient request card (PRC), which is not part of the CARE program. The card offers women a discreet way to receive Plan B, by handing the card directly to the pharmacy staff person, without having to ask for it out loud. It includes important facts about EC and the need to bring government-issued proof of age. The card also outlines several scenarios that women can check off, such as wanting to purchase Plan B or talking with a pharmacist about Plan B privately.

The card can be downloaded from Plan B's Web site www.go2planb.com. The PRC also is given to college students via health fairs and health centers. To date, the PRC program has been well received by pharmacists and individuals alike, especially college-age groups, according to Heather Ioset, Plan B account manager at Communications Strategies Inc.

"Going forward, we plan to build upon this momentum and continue educating physicians and pharmacists, while also making consumers aware that access to Plan B is now easier with the Patient Request Card," she said.