Counseling for nonprescription products is infrequent and sometimes inappropriate, and they argue that this would not change with the establishment of an intermediate class of drugs. 4. How does access to nonprescription drugs vary between the study countries and the United States? How do pharmacists ensure the proper use of nonprescription drugs? What is the U.S. experience with dispensing drugs without a physician’s prescription but only by pharmacists? (2) The experiences of other countries and the European Union with a pharmacist or pharmacy class, including its use to move a drug to a general sale class, its usefulness in preventing drug abuse, and its effect on drug expenditures. Literature Review

We conducted computerized literature searches on the following topics: (1) drug distribution systems in the study countries, (2) the behavior of pharmacists, (3) the classification of the 14 drugs, (4) the advantages and disadvantages of an intermediate class of drugs, and (5) assessments of the health and economic effects of different drug distribution systems. What conclusions can be drawn from studies or reports on the development, operation, and consequences of different drug distribution systems? 3. 6. 7. Similarly, no studies have attempted to link the type of drug distribution system in a country to the frequency of adverse drug reactions or have attempted to relate different drug distribution systems to the quality of health care. As table 2.1 shows, the two-tier system in the United States is unique. However, the European Union has decided not to impose a particular drug distribution system on the member countries. The difference would be that a prescription would not be required. An assessment of the relative openness of the current drug distribution system in the United States compared to the other countries studied depends on one’s definition of “access.” If access is defined by the availability of drugs for general sale, the United States appears to have the most open system, since more of the 14 drugs are available for sale outside pharmacies than in any of the other countries. 5. There are no national counseling requirements in Canada. Thus, the experiences of the 10 other countries do not allow us to assess the benefits from or costs of requiring pharmacists to report adverse drug reactions. Under the law, pharmacists are not required to perform the prescribing role. These countries restrict the sale of at least some nonprescription drugs to pharmacies or personal sale by a pharmacist. However, it should also be clear that there is no evidence that systems that do this are necessarily inferior to drug distribution systems that allow some or all nonprescription drugs to be sold outside pharmacies.
Why GAO Did This Study

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.

What GAO Found

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.