Plan B available at more drugstores without Rx

With all of the hoopla in the lay press surrounding the Food & Drug Administration's refusal to approve Barr Pharmaceuticals' application for over-the-counter status of its emergency contraceptive (EC) Plan B (levonorgestrel), Barr held a press briefing in New York City to deliver a message.

EC is available by prescription as well as through pharmacy access without a prescription in eight states: Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, and Washington.

Carole S. Ben-Maimon, M.D., president/COO of Barr Research, said, "We hope over time that more states will make it available if the federal government is unwilling to make that decision."

Edward S. Linn, M.D., chairman, department of obstetrics and gynecology, and director of Women's Health Services, at Rush North Shore Medical Center, Chicago, was also on hand at the press briefing.

Noting that EC is available in more than 100 countries and that in more than 30 countries a prescription is not required for EC, Linn said Plan B is a safe and effective method of pregnancy prevention after a contraceptive failure or after unprotected intercourse.

Linn cautioned that Plan B is not a substitute for routine birth control, and it should not be confused with RU-486 (Mifeprex, mifepristone, Danco), which he said is marketed as a drug that "will interrupt pregnancy." He also advised that Plan B does not protect against AIDS and other sexually transmitted diseases (STDs). "The sooner a woman takes Plan B, the more effective it will be, and a 72-hour window has been established in which these products are effective," he said. "If a woman is already pregnant, this product will not alter the pregnancy."

Linn also provided the following statistics:

Finally, Linn concluded, "If appropriate, advanced prescriptions for Plan B should be given to prevent pregnancy in emergency situations."

Another panelist, Kathleen Hill-Besinque, Pharm.D., associate professor of clinical pharmacy at University of Southern California School of Pharmacy, said that in her home state of California, where pharmacy access began in 2002, about 21% of pharmacies offer EC and about 3,000 pharmacists have completed EC training. She advised women who live in states that offer pharmacy access to contact hotlines to find out which pharmacies provide EC and to call the pharmacies to find out the hours they are open.

Yet another panelist, Amy Niemann, VP of marketing, proprietary products, Duramed Research, a subsidiary of Barr Pharmaceuticals, said the company conducted focus groups around the country and found that women had a limited understanding of Plan B but they acknowledged that there is a need for a "second-chance contraceptive."

Duramed is launching an ad campaign, which carries the theme, "When things don't go as planned," to reinforce the message that Plan B shouldn't be a woman's primary method of birth control and that it doesn't protect against STDs.