that would be available without a prescription. To assess the merits of these arguments, GAO reviewed the pertinent literature and interviewed or requested information from national and state government health officials, representatives of professional and consumer associations, academics, and pharmacists in the United States, the European Union, Australia, Canada, Denmark, France, Germany, Italy, the Netherlands, Sweden, Switzerland, and the United Kingdom.

Results in Brief

Little evidence supports the establishment of a pharmacy or pharmacist
class of drugs in the United States at this time, as either a fixed or a
transition class. The evidence that is available tends to undermine the
contention that major benefits are being obtained in the countries that
have such a class. This conclusion is substantiated by six points.

(1) Reliable and valid studies that examine the effect of different drug
distribution systems on overall health and health care system costs do not
exist. (2) While a pharmacy or pharmacist class exists in all 10 countries, it
is not used with any frequency in any of them to facilitate the movement of
drugs to sale outside specialized drug outlets. (3) The European Union has
decided not to impose any particular drug distribution system on its
member countries because it has found no evidence of the superiority of
one system over another. (4) There is no clear pattern of increased or
decreased access to drugs as nonprescription products where a
pharmacist or pharmacy class exists. (5) While a pharmacy or pharmacist
class is assumed by some to improve safeguards against drug misuse and
abuse, in the 10 countries these safeguards are easily circumvented, and
studies show that pharmacist counseling is infrequent and incomplete.
(6) Experience in Florida with a class of drugs similar to a pharmacist
class has not been successful; pharmacists have not regularly prescribed
these drugs, and recordkeeping requirements have not been followed.

GAO's Analysis

Extant Studies

No systematic evidence supports the superiority of one drug distribution system over another. Studies have not attempted to link different systems with differences between countries in health care costs, adverse drug reactions, and quality of care. No studies show that problems or benefits arise from either restricting the sale of nonprescription drugs to pharmacies or allowing them to be sold outside pharmacies.

Executive Summary

Drug Distribution Systems

All 10 countries restrict the sale of some or all nonprescription products. France, Italy, and the Netherlands restrict the sale of all nonprescription drugs to specialized drug outlets, while the 7 other countries allow the sale of only some nonprescription drugs outside these outlets. No country limits nonprescription drugs to sale by pharmacists or in pharmacies in order to assess their suitability for sale outside pharmacies. Instead, drugs are placed in the pharmacy or pharmacist class with no assurances that they will eventually be assessed for more general sale.

The European Union has set criteria for distinguishing prescription from nonprescription products. However, since EU officials could find no evidence showing the superiority of a particular drug distribution system, each country will decide the nature and number of its own drug distribution classes.

Access to Nonprescription
Drugs

The Role of Pharmacists

There is no consistent pattern across the 10 countries and the United States on the accessibility of 14 selected drugs. The United States allows the sale of some of the drugs without a prescription that most of the other countries restrict to prescription sale. Conversely, the United States restricts some drugs to prescription sale that most of the other countries allow to be sold in a pharmacist or pharmacy class.

The United States has fewer community pharmacies per capita than 6 of the 10 countries, so that restricting the sale of some nonprescription drugs to community pharmacies in the United States would appear to be somewhat of a greater inconvenience. However, this could be partially or completely offset if other outlets such as managed-care and mail-order pharmacies also sold these products or if new pharmacies opened.

Access could be reduced in the United States if consumers had to request these drugs from a pharmacist or an employee, as is generally the case in the other countries. However, even if self-selection were not allowed, if the intermediate class were used to move drugs out of prescription status that would not otherwise have been reclassified, access to the drugs would increase since a prescription would no longer be needed.

Only in Australia (and only for some drugs in some states) do
requirements that pharmacists counsel customers on nonprescription drug
use explicitly state what information should be discussed. In 3 countries,
pharmacists are expected to provide sufficient information for the proper

use of nonprescription drugs, but there are no detailed counseling requirements. Other countries typically require that a pharmacist be aware of sales, be on the premises when a sale is made, or promote proper drug use. However, counseling and other pharmacist interventions with customers often do not occur. Although counseling by pharmacists on the use of nonprescription drugs has improved, it is often infrequent and incomplete.

Only in some states in Australia and only for some drugs are pharmacists required to maintain records on nonprescription drug use. In none of the countries are pharmacists required to report adverse drug reactions. In Italy and the United Kingdom, such reports from pharmacists are not accepted, while in the others pharmacists rarely report these reactions.

Pharmacist associations in the United States and other countries advocate "pharmaceutical care," a concept that seeks to expand pharmacy practice from only dispensing drugs to being more involved in monitoring drug therapy (for instance, checking for adverse drug reactions). Pharmaceutical care is being implemented in some community pharmacies, but even if its value there can be documented, there will still be reason for debate on the need for an intermediate class.

The U.S. Experience

Recommendations

Agency Comments

The Florida Pharmacist Self-Care Consultant Law allows pharmacists to prescribe specific medications without the supervision of a physician. However, they rarely use this authority and, when they do, seldom follow the law's recordkeeping requirements. As in the 10 countries, Florida pharmacists often gather incomplete information and spend little time in assessing and responding to their patients' medical complaints.

GAO is making no recommendations in this report.

Officials from the Food and Drug Administration reviewed a draft of this report and provided written comments (see appendix VI). Their comments were brief and stated that the report does not address all the changes that would be necessary for the United States to adopt an intermediate class of drugs. A comprehensive assessment of all such changes was beyond the Scope of GAO's work.