rx to otc switch of antihistamines
The pharmacy community seems to be solidly behind the move to switch Claritin (loratadine, Schering-Plough), Allegra (fexofenadine, Aventis), and Zyrtec (cetirizine, Pfizer) from Rx to OTC, following votes by two Food & Drug Administration advisory committees attesting to their potential safety.
"The public has demonstrated for decades that it can self-medicate with antihistamines, decongestants, and cough suppressants and can follow the package labeling without significant problems. If these nonsedating prescription antihistamines are what the manufacturers claimwhich is very effective and safer than OTC versions of antihistamineswhy not give the public more options?" suggested Tim Covington, Pharm.D., M.S., Bruno professor of pharmacy, McWhorter School of Pharmacy, Samford University, and executive director of the Managed Care Institute in Birmingham, Ala.
Covington said if the Rx medications become OTC, it doesn't mean physicians can't still prescribe them. "It just means the patients may also be able to make some management decisions themselves, working in concert with their pharmacist as well as their physician," he said.
To critics who argue that it may be risky for some consumers to take the products without first being diagnosed by a physician, Covington said, "I would assume that if the OTC versions of these nonsedating antihistamines were available, the labeling would be adequate."
Covington believes that if the medications are switched to OTC, manufacturers will enjoy excellent margins. He thinks the products will command premium prices because of their wide exposure through direct-to-consumer advertising. But in order for the drugs to gain broad consumer acceptance, he contended, the prices will have to come down.
Covington doesn't see pharmacists enjoying a huge increase in sales if the products go OTC. Instead, he foresees customers moving from the OTCs available now to the nonsedating antihistamines. But he does think an OTC switch will result in a lot more questions for pharmacists. "This gives the pharmacist the opportunity to practice pharmaceutical care in a new domain," he said. "This will absolutely result in better public health."
At the FDA's open public hearing, Daniel Hussar, professor of pharmacy at the Philadelphia College of Pharmacy, presented to the committees testimony in favor of a switch. He said the biggest benefit for consumers is that drugs like Claritin and Allegra are safer than the current nonprescription antihistamines, which contain diphenhydramine and chlorpheniramine. Those ingredients, he said, have sedative effects that result in drowsiness and fatigue and often cause people to fall asleep behind the wheel.
According to Hussar, it is estimated that there are 600 deaths and 47,000 injuries each year in the United States as a result of motor vehicle accidents related to the use of sedating antihistamines. He said he believes that the number of deaths and injuries could be reduced if consumers were allowed to purchase safer antihistamines without a prescription.
To opponents of the switch, who contend that people will be paying more to purchase these products if their insurance plans don't cover OTCs, Hussar said he expects the price of the OTCs to decrease because of the increased competition that exists in the OTC market.
Will patients who self-diagnose and use these OTCs be at risk of going undiagnosed for a more serious ailment? Hussar responded, "Even if these products stay on prescription, there are still going to be many individuals who for one reason or another will not take the initiative to go to a physician. They are at least initially going to try to treat the symptoms themselves. I don't see that the availability of three more antihistamines without an Rx will result in hundreds or thousands more people not going to the physician for allergy or asthma symptoms."
Janet Engle, Pharm.D., associate dean for academic affairs, clinical associate professor of pharmacy practice, University of Illinois at Chicago College of Pharmacy, believes pharmacists have an important role to play in "making sure the people buying these products are the appropriate patients. We should do that now, anyway. It's important for consumers to understand that for certain things, this is not the answer. If they are going to take these medications long-term, they definitely need to get advice. It's one thing to have a few allergies and take [the medication] three to five days unsupervised. If it's long-term, however, you want to make sure there's not some other disease state," she said.
Engle said that if the allergy drugs were to go OTC, patients would have more access to antihistamines that have fewer side effects. The only negative she cited is that patients, whose insurance offered low copayments for the Rx medications, might incur more out-of-pocket expenses for the OTCs. "It could get rather expensive, even if they come down in price a quarter of what they cost now," she said.
Sandra Levy. Many R.Ph.s support switching antihistamines from Rx to OTC.