Nonprescription Drugs:

Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated

PEMD-95-12: Published: Aug 24, 1995. Publicly Released: Aug 24, 1995.

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Pursuant to a congressional request, GAO reviewed the creation of a drug class that would be available only through pharmacies, but would not require a physician's prescription, focusing on: (1) studies and reports on the development, operation, and consequences of different drug distribution systems; (2) the drug distribution systems in 10 selected countries; (3) how access to nonprescription drugs varies between the selected countries and the United States; (4) how pharmacists ensure the proper use of nonprescription drugs; and (5) the U.S. experience with pharmacists dispensing drugs without a prescription.

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.

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