The BTC idea  that FDA sought comment on would require that these drugs be sold only  in pharmacies, and that a pharmacist’s intervention with a consumer occur  before the drug could be dispensed. Drugs in the BTC class  would be those determined by FDA to be nonprescription but would  require the intervention of a pharmacist. For example, the  number of pharmacies in a country affects the availability of BTC drugs. Arguments Made Supporting and Opposing a BTC Drug Class Reflect Disagreement on Its Impact on Health Care and Health Care Costs

Arguments that have been made supporting and opposing a BTC drug  class are generally based on public health or cost considerations and  reflect disagreement on the likely consequences of the establishment of  such a class. Some Proponents of a BTC Drug Class Argue It Will Improve Public Health

Some of those who support a BTC drug class, including representatives of  pharmacist associations and some academics, suggest that such a class  would lead to improved public health through increased availability of  nonprescription drugs. Opponents also raise concerns about the potential harm that might be  done to consumers if pharmacists are not able to provide high-quality,  reliable BTC services. Cost savings could also result from a decrease in the number of  physicians’ visits. For instance, because insurers  do not typically reimburse consumers for OTC drugs and thus might not  provide coverage for BTC drugs, out-of-pocket expenses for consumers  could increase if prescription drugs were switched to a BTC drug class  and if the cost of the BTC product were greater than the previous copay. All Study Countries Have Increased Nonprescription Drug Availability, but the Impact of Restricted Nonprescription Drug Classes on Availability Is Unclear

All five study countries have increased nonprescription drug availability  since 1995; however, the impact of restricted nonprescription drug classes  on availability is unclear. Italy and the  Netherlands established new OTC classes by making some or all  nonprescription drugs available for sale at nonpharmacy outlets, while  Australia, the United Kingdom, and the United States switched a number  of drugs from more restrictive to less restrictive drug classes. The United States required a prescription  for more of the selected drugs than did the two study countries (Australia  and the United Kingdom) with a BTC drug class but also had more of these  drugs classified as OTC—the option that provides greatest availability— than the other four study countries. Australia, the United Kingdom, and the United States have increased drug  availability since 1995 by switching certain drugs from more restrictive to  less restrictive drug classes. The classification of drugs in other countries and the existence of other  classes provide little insight into the likely effect of a BTC drug class on  nonprescription drug availability in the United States. Pharmacist-, Infrastructure-, and Cost-Related Issues Would Be Important Considerations if a BTC Drug Class Were Established

Pharmacist-, infrastructure-, and cost-related issues would have to be  addressed before a BTC drug class could be established in the United  States. If third-party payers do not  reimburse consumers for drugs that were switched from prescription to  BTC, consumers’ out-of-pocket expenditures could increase. Third-party payers might also be willing to cover pharmacist services. Agency Comments and Our Evaluation

HHS provided comments on a draft of this report. In its comments HHS agreed that cost-related  issues would have to be addressed before implementing a BTC drug class. In addition, HHS and VA provided technical comments on the report draft,  which we have incorporated as appropriate. GAO staff who made major contributions to this report are  listed in appendix V.

Appendix I: Objectives, Scope, and Methodology

	Objectives

In light of the November 2007 Food and Drug Administration (FDA) public  meeting to explore the public health implications of behind-the-counter  (BTC) availability of certain drugs in the United States and the  fundamental change that BTC availability would represent in the U.S. drug  classification system, we are updating information we first presented in  our 1995 report. Specifically, we are reporting on (1) the arguments that  have been made supporting and opposing the creation of a BTC drug class  in the United States; (2) changes in drug availability in our five study  countries since 1995 and the impact of restricted nonprescription drug  classes on drug availability; and (3) issues that would be important to the  establishment of a BTC drug class.
Why GAO Did This Study

In the United States, most nonprescription drugs are available over-the-counter (OTC) in pharmacies and other stores. Experts have suggested that drug availability could be increased by establishing an additional class of nonprescription drugs that would be held behind the counter (BTC) but would require the intervention of a pharmacist before being dispensed; a similar class of drugs exists in many other countries. Although the Food and Drug Administration (FDA) has not developed a detailed proposal for a BTC drug class, it held a public meeting in 2007 to explore the public health implications of BTC drug availability. GAO was asked to update its 1995 report, Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated (GAO/PEMD-95-12). Specifically, GAO is reporting on (1) arguments supporting and opposing a U.S. BTC drug class, (2) changes in drug availability in five countries since 1995 and the impact of restricted nonprescription classes on availability, and (3) issues important to the establishment of a BTC drug class. GAO reviewed documents and consulted with pharmaceutical experts. To examine drug availability across countries, GAO studied five countries it had reported on in 1995 (Australia, Italy, the Netherlands, the United Kingdom, and the United States) and determined how 86 drugs available in all five countries were classified in each country.

What GAO Found

Arguments supporting and opposing a BTC drug class in the United States have been based on public health and health care cost considerations, and reflect general disagreement on the likely consequences of establishing such a class. Proponents of a BTC drug class suggest it would lead to improved public health through increased availability of nonprescription drugs and greater use of pharmacists' expertise. Opponents are concerned that a BTC drug class might become the default for drugs switching from prescription to nonprescription status, thus reducing consumers' access to drugs that would otherwise have become available OTC, and argue that pharmacists might not be able to provide high quality BTC services. Proponents of a BTC drug class point to potentially reduced costs through a decrease in the number of physician visits and a decline in drug prices that might result from switches of drugs from prescription to nonprescription status. However, opponents argue that out-of-pocket costs for many consumers could rise if third-party payers elect not to cover BTC drugs. All five countries GAO studied have increased nonprescription drug availability since 1995 by altering nonprescription classes or reclassifying some drugs into less restrictive classes. Italy and the Netherlands, which previously allowed nonprescription drugs to be sold only at specialized drug outlets, made some or all of these drugs available for OTC sale. Australia, the United Kingdom, and the United States switched certain drugs from more restrictive to less restrictive drug classes, increasing these drugs' availability. However, the impact of restricted nonprescription drug classes on availability is unclear. When we examined the classification of 86 selected drugs in the five countries, we found that the United States required a prescription for more of those drugs than did Australia or the United Kingdom--the study countries using a BTC drug class. However, the United States classified more of the 86 drugs as OTC--the option that provides greatest access to these drugs for consumers--than all four of the other study countries. Pharmacist-, infrastructure-, and cost-related issues would have to be addressed before a BTC drug class could be established in the United States. For example, ensuring that pharmacists provide BTC counseling and that pharmacies have the infrastructure to protect consumer privacy would be important. Issues related to the cost of BTC drugs would also require consideration. For example, the availability of third-party coverage for BTC drugs would affect consumers' out-of-pocket expenditures and pharmacists' compensation for providing BTC services would need to be examined. In commenting on a draft of this report, the Department of Health and Human Services (HHS) agreed that cost-related issues would have to be addressed before implementing a BTC drug class and also provided technical comments. The Department of Veterans Affairs (VA) also reviewed the report and provided technical comments. We have incorporated HHS and VA technical comments as appropriate.