FDA Could Move More Drugs OTC

Pharmacists could soon play an even bigger role in consumer healthcare, opening the door for expanded sales of a variety of pharmaceuticals. The US Food and Drug Administration is considering a new model for approving more drugs for over-the-counter (OTC) sales, which could put pharmacists front and center. The proposal would reclassify certain prescription drugs to OTC products, as long as certain conditions are met.

That last part -- as long as certain conditions are met -- is where the pharmacist would play an expanded role. Since the prescription drugs being considered by the FDA for OTC with a conditional-use status may need more instruction and intervention than usual OTC drugs, a consumer may need interaction with a pharmacist before buying the drug.

"We may be able to help screen and assess a patient that already has a diagnosis for a particular issue," says Marcie Bough, senior director of government affairs for the American Pharmacists Association. A pharmacist could redirect patients who may need greater assistance to a doctor and back into the healthcare system, she said, adding, "It's that team-based approach to capture the many number of under-treated patients. We're not taking away what medicine does. We're supplementing and providing another access point for patients."

Some of the drugs that could be reclassified as OTC -- with special conditions -- are those used to treat high cholesterol, migraines, high blood pressure, diabetes, and asthma. Others include certain allergy medicines for bee stings, anti-viral medications, burn ointments, and steroid nasal sprays.

"The FDA has decided that there are some products that makes sense to have as over the counter status, with a condition of safe use, where certain things could be assured before the patient had access to that product," says Ronna Hauser, vice president of policy and regulatory affairs for the National Community Pharmacists Association.

Some typical OTC drugs that used to be prescription-only include Aleve, manufactured by Bayer HealthCare, a subsidiary of the Bayer Group (FWB: BAYN), GlaxoSmithKline's (NYSE: GSK) Nicorette and Zantac, Merck's (NYSE: MRK) Claritin, and Sanofi-aventis's (NYSE: SNY) Allegra. These drugs have no conditional use. People can buy them right off the shelf. With the new proposal, the FDA doesn't appear to want to create another class of drugs. Rather, it just wants to broaden the existing OTC class.

Some drugs could even have dual status -- prescription and OTC, which would allow the drugs to continue to be covered by insurance. "There are different nuances of how insurance covers non prescription drugs vs. prescription," Bough says.

Some of the new tasks pharmacists might take on include helping patients decide if a medication is suitable, based on the results of screening. Potentially, pharmacists could be armed with iPads and could walk consumers through simple screenings. Technology companies are already working on products that could aid pharmacists. There could even be self-diagnosing kiosks that consumers could use by themselves.

Pharmacists could also monitor the effects of the drug on a person, document the effects and consult with the patient at intervals on the drug's effectiveness, and remind people of refills. Pharmacists are apparently ready to take on this larger role. "A lot of times we already see these patients more than their physicians," Hauser said, adding that pharmacists could easily modify systems already in place to track prescription drug use to also track OTC drugs.

In the past decade, retail healthcare has been ramping up, filling in the hole that's not covered by the traditional healthcare system. Retailers have been rolling out in-store health clinics, which do light healthcare such as immunizations, pregnancy tests, strep throat treatment, and blood pressure checks. CVS Caremark Corp. (NYSE: CVS), for example, has in-store MinuteClinics.

More OTC drugs on the market, along with some paid services associated with those drugs, could be a boon for drugstores, grocery chains, and retailers with pharmacies, such as The Kroger Co. (NYSE: KR), Walgreen Co. (NYSE: WAG), Wal-Mart Stores Inc. (NYSE: WMT), and Target Corp. (NYSE: TGT).

As healthcare costs soar, this new model of moving more drugs to OTC is part of healthcare's migration toward preventive care -- getting people treated earlier to head off more serious, and costly, health problems. Reclassifying a prescription drug as OTC makes the drug more accessible, especially for people without health insurance. The more accessible a drug is, the more likely it will be used. In theory, preventive healthcare leads to healthier people and lower healthcare costs.

A Booz & Co. study recently measured the value of OTC drugs. The study says 240 million people in the US spent $23 billion on OTC drugs in 2010. The study also says healthcare costs would be even higher without access to OTC drugs, which save trips to the emergency room by people on Medicaid and uninsured patients.

The FDA's consideration of shifting more drugs to OTC status is also a response to a consumer who is more perceptive about health and nutrition. That increased awareness has triggered a rise in the use of remedies and therapies as an alternative or a complement to traditional healthcare, including vitamins, natural products, alternative medicines, such as homeopathy, and other complementary therapies, such as acupuncture and hypnosis.

The National Center for Complementary and Alternative Medicine says alternative therapies are used by nearly 40% of adults in the US with a reported $34 billion worth spent in 2007, out-of-pocket, for alternative remedies, according to a National Health Interview Survey. With more OTC drugs on the market, retail pharmacies and drug makers -- and those who invest in them -- could potentially benefit if more people opt for OTC drugs instead of alternative treatments.

Pharmacists say talk of broadening the OTC class of drugs isn't just pie in the sky. But it's not something that will happen tomorrow. Details such as safe-use processes and labeling need to be hashed out. It also needs drug manufacturer buy-in. The FDA doesn't dictate what category a drug should be in, Bough says. Manufacturers find the concept interesting, but they haven't weighed in yet, she says.

The FDA held hearings on broadening the OTC class in March and is accepting public comments until May 7.