The U.S. two-class system is divided into prescription and nonprescription, or over-the-counter (OTC), medicines. The advantage is that OTC medicines are conveniently sold in a number of retail outlets so that medicines are available when consumers need them.
In recent years, a few of the world’s pharmacy-only national systems have recognized the growing need for greater access to safe and effective medications. Japan, the Netherlands, Denmark, the United Kingdom, Italy, and Argentina all have been part of this trend toward granting consumers increased access to medicines in more outlets.
The drug distribution system in the U.S. is highly regulated by the U.S. Food and Drug Administration (FDA) to ensure only those medications that have a wide enough safety margin and that can be safely and effectively used without the help of a health care professional are available without a prescription.
The somewhat controversial notion of adding a third class of drugs to the U.S. system has been panned by experts and regulators including the AMA and FDA. They say creating a third transition class of drugs would create another health care-disadvantaged population -- those without easy access to a pharmacist at convenient times.