Sandra Levy is Managing Editor-Projects. She covers self care, chains and business, home care, over-the-counter medicines and Rx-to-OTC switches. She joined <i>Drug Topics</i> in 1998.
The pharmacy community seems to be solidly behind the Food & Drug Administration's move to switch Duramed Pharmaceuticals' Plan B (levonorgestrel) emergency contraception to over-the-counter status. In giving the green light, the FDA granted OTC status for consumers 18 years of age and older, while maintaining the prescription status for girls 17 and younger.
"I'm glad Plan B is now available without a prescription for women 18 and older," said Jack Fincham, Ph.D., R.Ph., A.W. Jowdy Professor of Pharmacy Care, University of Georgia College of Pharmacy. This approval has the potential to decrease unwanted pregnancies and lower the number of abortions that occur. It makes sense that Plan B be as available as possible." He said that since pharmacists will be responsible for providing Plan B, they will need to have a process in place to ensure that the women purchasing Plan B are at least 18 years old. He thinks pharmacists have an important role to play in counseling the women. He added that it is crucial that "this [conversation] be done in a private atmosphere-where they both can feel comfortable exchanging information."
Pointing out that OTC Plan B will be sold only in pharmacies and in health clinics, Paul Doering, M.S., Distinguished Service Professor of pharmacy practice, University of Florida College of Pharmacy, said, "This is one of the times the FDA has publicly acknowledged that there can be or needs to be a third class of drugs. It's a de facto third class of drugs because you can't get Plan B in a convenience store or a supermarket or vending machine."
Doering is skeptical about whether women under 18 will be prevented from obtaining OTC Plan B. "There are no pill police out there to enforce things. It's voluntary enforcement on the part of pharmacists. Someone may present false identification. If you don't believe these things are hard to enforce, just read an article on underage drinking. The intent is good, but the so-called closed system is going to be more like a sieve with leaks."
Jill Johnson, Pharm.D., assistant professor of pharmacy practice at the University of Arkansas for Medical Sciences College of Pharmacy, gave a thumbs-up to the switch. She also expressed the opinion that Plan B should not be placed behind the counter. "It makes work for the pharmacist, and I don't see the point in creating a barrier to young girls. This seems like a responsible way to react after unprotected sex has occurred."