The process of transferring prescription (Rx) drugs to nonprescription, over-the-counter (OTC) status, known as "Rx-to-OTC switch," expands the range of conditions that can be treated with OTC medicines, empowering consumers who want to take a more active role in their own health care. Consumers have indicated a strong interest in new OTC products.

Switch also reduces health care costs by expanding the most inexpensive form of health care, self-medication with OTC medicines. A 1997 study conducted by Kline & Company found American consumers saved almost $13 billion a year by using OTC medicines switched from prescription-only availability. According to Kline, Rx-to-OTC switched products and products formulated with switched ingredients accounted for 63 percent of total U.S. OTC sales in 1996 (roughly $10.2 billion).

For example, an American can save as much as $80 by using switched OTC vaginal anti-fungal products for previously diagnosed recurring yeast infections, according to the American Pharmacists Association (APhA). While an OTC medication can be obtained for less than $20, patients can spend close to $100 for a doctor's visit and prescription-only vaginal anti-fungal medicine, APhA reported. Savings can be even higher when travel costs and lost time from work are considered.

A study published in the Journal of Managed Care Pharmacy (May/June 1996) found that a managed care organization saved "approximately 25 percent of the cost of caring for patients with nonsevere heartburn or nonulcer dyspepsia" by using a nonprescription acid reducer. These savings equate to roughly $6 million over a five-year period for the managed care organization.

Another survey found that consumers benefit by up to $750 million a year as a result of OTC cough-cold medicines that were once available only by prescription. The same study found that doctor visits for the common cold fell by 110,000 a year between 1976 and 1989 thanks to FDA's policy of switching cold medicines to OTC status during that time.

Over 90 ingredients or dosage strengths have made the switch from Rx to OTC or have been newly approved since 1976. More than 700 OTC products on the market today use ingredients or dosages available only by prescription 25 years ago. A few of the more recent switches include polyethylene glycol 3350 (laxative), ketotifen (antihistamine eye drops), orlistat (weight loss aid), and cetirizine HCI (antihistamine).

Note: The switch process also works in reverse. If FDA acquires evidence of a significant safety problem with a product or ingredient, the Agency can transfer it back to prescription-only status or remove it from the market all together, e.g., antimicrobial hexachlorophene in 1977, the antihistamine methapyrilene in 1979 and the laxative danthron in 1987.