Nonprescription Drugs

The drug classification system in the United States, under which drug are classified as eight prescription or nonprescription, is unique. Other countries have a class of drugs that is available without a prescription but can be obtained only at a pharmacy and sometimes can be dispensed only by a pharmacist. This report reviews the drug distribution systems in 10 countries and the European Union. GAO also reviews the practice of pharmacy focusing on pharmacists counseling of patients on the use of non prescription drugs. GAO found that little evidence exists to support the establishment of a pharmacy or a pharmacist class of drugs in the United States at this time, either as a fixed or a transition class. Available evidence tends to undermine the argument that countries with such a class obtain major benefits. This report discusses in detail the facts supporting this conclusion.

GAO found that: (1) available evidence shows that there are no major benefits from establishing a class of pharmacist-controlled nonprescription drugs; (2) studies have not attempted to link different drug distribution systems with differences between the countries' health care costs, adverse drug reactions, and quality of care; (3) the two-tier system in the United States is unique, since all other countries have at least one intermediate class of drugs; (4) although all 10 countries restrict some or all sales of nonprescription drugs, they do not use the pharmacy or pharmacist drug class to assess the drugs' suitability for sale outside of pharmacies; (5) the European Union has decided not to impose any particular drug distribution system on its members, since no system has proved to be superior; (6) there is no clear pattern of increased or decreased access to nonprescription drugs where an intermediate class of drugs exists; (7) the countries' safeguards to prevent drug misuse and abuse are easily circumvented and pharmacist counseling is infrequent and incomplete; (8) pharmacists are rarely required to keep records on drug use and none are required to report adverse reactions; and (9) Florida's unsuccessful experience with a similar class of drugs was due to pharmacists' failure to regularly prescribe these drugs, give patients adequate counseling, or follow recordkeeping requirements.