OTC is big savings for pharmacies, but consumer knowledge is lacking

Pharmacists concerned about self-medicating, lack of consumer education

The potential switch from prescription to over-the-counter (OTC) status of several popular drugs may be a boon for hospital pharmacy budgets, but it also brings its share of concerns.

"The big concern is that when anything goes over the counter, people can buy it anywhere, at a gas station or at a retail outlet, with no pharmacist around. You can see the real danger that we have," says Nicholas Popovich, PhD, professor of pharmacy administration at the University of Illinois-Chicago College of Pharmacy.

Consumers are also not as careful about taking OTC medications as they are about prescription drugs, he says. Consumers, having heard about adverse drug reactions and deaths from inappropriately prescribed prescription medications, sometimes even take less of the medication than prescribed. Surveys, however, have shown that consumers are more casual about the risks of OTC drugs.

Several OTC possibilities

Several blockbuster drugs are currently working toward OTC status, including:

Loratadine (Claritin). Schering-Plough filed a supplemental new drug application with the Food and Drug Administration (FDA) to switch all of loratadine’s formulations to OTC status. The company expects the agency to act on its application this month. In April, an FDA advisory committee found that loratadine’s data were sufficient to support a prescription to OTC switch for chronic idiopathic urticaria, but not for general urticaria.

Schering-Plough didn’t have many options. Blue Cross of California petitioned for three second-generation antihistamines (loratadine, fexofenadine [Allegra] and cetirizine [Zyrtec]) to be moved from prescription to OTC status. Then Johnson & Johnson and Wyeth told the FDA that as soon as loratadine’s patent expires in December, they want to sell OTC versions of the drug. Schering-Plough isn’t having much success fighting the introduction of a generic loratadine. In August, a U.S. District Court Judge found that certain claims of a patent protecting against generic versions and expiring in 2004 were not valid. Schering-Plough said it would appeal.

Omeprazole (Prilosec). Procter & Gamble (P&G) received FDA approval and expects to begin commercial non-prescription sales of the proton pump inhibitor in the first half of next year. Before the drug can be approved in OTC form, however, the FDA said P&G must conduct a study showing that consumers understand the drug’s labeling, according to a company spokesman. P&G says Prilosec will be sold OTC in 14-dose packages.

Lovastatin (Mevacor). In 2000, an FDA advisory committee recommended against switching the cholesterol-lowering drugs lovastatin and pravastatin (Pravachol) to OTC status, because of concerns that consumers would not understand the labels. The companies won’t stop trying, though. Representatives from Johnson & Johnson and Merck say recent talks with the FDA about the possibility of switching lovastatin to OTC status have been "positive."

Reimbursement will change significantly

Once prescription drugs go to OTC status, few insurance plans will pay for them. So the switch to OTC for drugs commonly prescribed and stocked in hospitals will have a major impact on the pharmacy budget. The cost of the OTC version is usually a fraction of the prescription price. For example, a month’s supply for loratadine currently costs about $100. A month’s supply of the OTC version, on the other hand, might cost one-tenth of that, according to some financial analysts.

Community pharmacists, however, may find they are spending the same amount to stock the drug on the shelves as they did to keep it behind the counter.

"What you lose on the Rx side, you usually pick up on the OTC side," says Stephen J. Clement, RPh, chairman of the board of the Illinois Pharmacists Association in Springfield and owner of the Copper Bend Pharmacy in Belleville.

Anticipating that the end of its loratadine patent is inevitable, Schering-Plough encourages health care providers to switch to its second-generation, non-sedating antihistamine, desloratadine (Clarinex). Many, however, don’t see much difference between the two. In fact, executives of several insurers have told The Wall Street Journal that they may not reimburse patients seeking desloratadine prescriptions once loratadine goes OTC.

WellPoint Health Networks in Thousand Oaks, CA, has already implemented new guidelines for prescriptions of cetirizine, fexofenadine, and desloratadine to encourage patients to use OTC loratadine once it’s available. WellPoint has placed the prescription drugs in the highest co-pay tier and will require special physician approval to obtain them. Health insurers Humana, Sierra Health Networks, and UnitedHealth Group say they will follow WellPoint’s lead, according to Reuters Business.

The cost benefits don’t detract from worries about consumers medicating themselves.

"I see a problem when patients self-diagnose and try an OTC that may not be correct for them," Clement says. "If it doesn’t work, then they try something else that may or may not work, ultimately prolonging their proper treatment and subsequent healing."

Popovich is worried that people may treat themselves for heartburn with OTC omeprazole when they should be diagnosed by a doctor. "You don’t want anything more serious happening and have them treating themselves for the wrong reason."

Advertisements promoting the drugs contribute to the problem, Popovich adds. "People help themselves because the advertisement gives them the impression that they can take care of it themselves. They can, but they have to do it intelligently."

When consumers go to the pharmacy, therefore, they need to read the label carefully and ask questions. "They may be taking other drugs that might conflict with it and cause a drug interaction," he adds.

By checking with a pharmacist about medication usage, consumers might find out, for example, that a first-generation drug might work better — and be more cost-effective — than loratadine. "We are hoping that pharmacists will use their professional expertise to help people find a less costly alternative," Popovich says.

Overall, he says, pharmacists should try to help consumers make the right choices about OTC drugs and help them decide whether they really need the medications or whether they should see their doctor first.

"It’s an opportunity for pharmacists to play a bigger role and interact more with their patients and their doctors," Clement says.