Pharmacists Comply with Plan B's Requirements

The results from the ConvenientAccess, Responsible Education(CARE) program indicate that theemergency contraception (EC) dual-labelPlan B (levonorgestrel) requirements arebeing followed by pharmacists. Plan B,known as the morning-after pill, wasapproved OTC for individuals aged 18and older by the FDA on August 24, 2006.Plan B still requires a prescription forindividuals 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 ensurethat Plan B is used responsibly and correctlyand that the restrictions of thedual-label product are understood andfollowed at the pharmacy level, accordingto Joe Carrado, MSc, RPh, vice presidentof global regulatory affairs forDuramed. The CARE program includes 4elements:

• Packaging and labeling that conformsto the OTC and prescriptionrequirements while providing informationto individuals in an understandableformat
• Restricting distribution of Plan B tolicensed drug wholesalers, retailoperations with pharmacy services,and clinics with licensed health carepractitioners
• Implementing an extensive educationalcampaign with health careproviders on the appropriate use ofprescription and OTC Plan B, includingan informational toll-free numberand easy-to-understand educationalmaterial for health care professionalsto distribute to patients
• Monitoring the effectiveness of theage restriction and the safe distributionof OTC Plan B to patients 18 andabove and Rx Plan B to patientsunder 18

CARE Results

The effectiveness of CARE was monitoredthrough a point-of-purchase programconducted from November 2006to April 2007. The FDA requires reportsevery 6 months, said Carrado. Chain andindependent pharmacies in 10 stateswere identified for monitoring based onprior Plan B Rx sales and geographicregion. The states included California,Texas, New York, Florida, Illinois,Washington, Minnesota, Kansas, NewMexico, and Maine. Of the 10 statesmonitored, California, Maine, NewMexico, and Washington are PharmacyAccess states, in which certified pharmacistscan write a script for EC for individualswho request it, regardless of age.

Pharmacies were monitored usingtrained, anonymous secret shoppersaged 15 to 17 who were enlisted to visitassigned pharmacies and ask to buyPlan B. If identification or a prescriptionwas requested, the shopper was told toexplain that she did not have it with herand ask that Plan B be sold to herregardless.

All pharmacies surveyed kept Plan Bbehind the counter. Carrado said thatoverall compliance, meaning checkingthe shopper's identification and dispensingOTC Plan B only if the individual was18 or older, was >95% for chain pharmaciesand 91% for independent pharmacies.If a pharmacy was noncompliantand the product was dispensed to asecret shopper, Carrado explained thatthe pharmacy was notified, remedial educationwas provided, and the pharmacywas remonitored. For pharmacies thatdid not have Plan B in stock at the time,the visit did not take place. If a pharmacywas found to be a multiple offenderregarding the requirements for dispensingOTC Plan B, a report was sent to thatpharmacy's state board of pharmacy.

The results "speak to the fact thateducation does work and pharmacistsdo get it," he said. Carrado added thatoverall, the availability of Plan B is still anissue, and pharmacy educational effortswill continue.

Patient Request Card

Another aspect of Plan B education isthe patient request card (PRC), which isnot part of the CARE program. The cardoffers women a discreet way to receivePlan B, by handing the card directly tothe pharmacy staff person, withouthaving to ask for it out loud. It includesimportant facts about EC and the needto bring government-issued proof ofage. The card also outlines several scenariosthat women can check off, suchas wanting to purchase Plan B or talkingwith a pharmacist about Plan B privately.

The card can be downloaded fromPlan B's Web site www.go2planb.com.The PRC also is given to college studentsvia health fairs and health centers. Todate, the PRC program has been wellreceived by pharmacists and individualsalike, especially college-age groups,according to Heather Ioset, Plan Baccount manager at CommunicationsStrategies Inc.

"Going forward, we plan to build uponthis momentum and continue educatingphysicians and pharmacists, while alsomaking consumers aware that access toPlan B is now easier with the PatientRequest Card," she said.