Report to Congressional Requesters

United States Government Accountability Office

GAO 

NONPRESCRIPTION 

DRUGS 

Considerations 

Regarding a 

Behind-the-Counter 

Drug Class 

February 2009 

GAO-09-245 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

February 2009

NONPRESCRIPTION DRUGS 

Considerations Regarding a Behind-the-Counter Drug

Class

Highlights of GAO-09-245, a report to 

congressional requesters 

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. 

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. 

To view the full product, including the scope 

and methodology, click on GAO-09-245.

For more information, contact Marcia Crosse 

at (202) 512-7114 or crossem@gao.gov. 
Contents 

Letter 1

Results in Brief 4

Background 6

Arguments Made Supporting and Opposing a BTC Drug Class 

Reflect Disagreement on Its Impact on Health Care and Health

Care Costs 10 

All Study Countries Have Increased Nonprescription Drug 

Availability, but the Impact of Restricted Nonprescription Drug 

Classes on Availability Is Unclear 17 

Pharmacist-, Infrastructure-, and Cost-Related Issues Would Be 

Important Considerations if a BTC Drug Class Were Established 24 

Agency Comments and Our Evaluation 35 

Appendix I Objectives, Scope, and Methodology 37 

Appendix II Description of Drug Classification Systems 

in the Five Study Countries and the European 

Union 41 

Appendix III Classification of 86 Drugs in Australia, Italy, 

the Netherlands, the United Kingdom, and the 

United States 48 

Appendix IV Comments from the Department of Health and 

Human Services 51 

Appendix V GAO Contact and Staff Acknowledgments 54 

Tables 

Table 1: Drug Classes Used in the Study Countries, 2008 19 

Table 2: Number of 86 Selected Drugs Assigned to Each Drug Class 

in the Study Countries 21 

Page i GAO-09-245 Behind-the-Counter Drug Class
Table 3: Drugs with OTC Status in the United States but a More 

Restrictive Status in All Other Study Countries 22 

Table 4: Drugs with Prescription Status in the United States but 

Nonprescription Status in All Other Study Countries 23 

Table 5: Drugs with Prescription Status in Countries without a BTC 

Drug Class but Nonprescription Status in Countries with a 

BTC Drug Class 24 

Figures 

Figure 1: Definitions and Relative Levels of Restriction for Drug 

Classes Used in This Report 9 

Figure 2: Definitions and Relative Levels of Restriction for Drug 

Classes Used in This Report 41 

Abbreviations 

AIDS acquired immunodeficiency syndrome 

BTC behind-the-counter 

CMS Centers for Medicare & Medicaid Services 

EU European Union 

FDA Food and Drug Administration 

HHS Department of Health and Human Services 

IHS Indian Health Service 

MHRA Medicines and Healthcare products Regulatory 

 Agency (United Kingdom) 

MMA Medicare Prescription Drug, Improvement, and 

 Modernization Act of 2003 

MTM medication therapy management 

OBRA ’90 Omnibus Budget Reconciliation Act of 1990 

OTC over-the-counter 

VA Department of Veterans Affairs 

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately. 

Page ii GAO-09-245 Behind-the-Counter Drug Class
United States Government Accountability Office

Washington, DC 20548 

 

February 20, 2009 

The Honorable Henry A. Waxman 

Chairman 

The Honorable John D. Dingell 

Chairman Emeritus 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Henry A. Waxman 

Chairman 

The Honorable John D. Dingell 

Chairman Emeritus 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Bart Stupak 

Chairman 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Bart Stupak 

Chairman 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

The United States has a two-tier system for the classification of drugs: 

prescription and nonprescription. Prescription drugs can be dispensed 

only with written or oral orders (i.e., a prescription) from a licensed 

prescriber—such as a doctor, nurse practitioner, or physician’s assistant—

to a pharmacist or other licensed dispenser. Most nonprescription drugs 

are available for sale over the counter (OTC) by self-service in pharmacies 

and in nonpharmacy outlets such as grocery stores, mass merchandisers, 

and gas stations. The two-tier system in the United States is distinct from 

other countries that have more or different categories of nonprescription 

drugs. In other countries, levels of restriction on where and by whom a 

nonprescription drug can be sold vary. For example, certain

nonprescription drugs may be sold only under the supervision of a 

pharmacist. 

The United States has a two-tier system for the classification of drugs: 

prescription and nonprescription. Prescription drugs can be dispensed 

only with written or oral orders (i.e., a prescription) from a licensed 

prescriber—such as a doctor, nurse practitioner, or physician’s assistant—

to a pharmacist or other licensed dispenser. Most nonprescription drugs 

are available for sale over the counter (OTC) by self-service in pharmacies 

and in nonpharmacy outlets such as grocery stores, mass merchandisers, 

and gas stations. The two-tier system in the United States is distinct from 

other countries that have more or different categories of nonprescription 

drugs. In other countries, levels of restriction on where and by whom a 

nonprescription drug can be sold vary. For example, certain

nonprescription drugs may be sold only under the supervision of a 

pharmacist. 

Pharmacists, academics, and other experts have suggested that an 

additional class of nonprescription drugs could increase drug availability, 

because more drugs could be made available without the need to obtain a 

prescription. In the United States, the Food and Drug Administration 

(FDA), an agency within the Department of Health and Human Services 

(HHS), has authority to approve drugs prior to their marketing, to ensure 

that they are safe and effective, and to determine their prescription or 

nonprescription status. Although FDA has not developed a specific 

proposal, in November 2007, it held a public meeting to explore the public

health implications of behind-the-counter (BTC) availability of certain 

Pharmacists, academics, and other experts have suggested that an 

additional class of nonprescription drugs could increase drug availability, 

because more drugs could be made available without the need to obtain a 

prescription. In the United States, the Food and Drug Administration 

(FDA), an agency within the Department of Health and Human Services 

(HHS), has authority to approve drugs prior to their marketing, to ensure 

that they are safe and effective, and to determine their prescription or 

nonprescription status. Although FDA has not developed a specific 

proposal, in November 2007, it held a public meeting to explore the public

health implications of behind-the-counter (BTC) availability of certain 

Page 1 GAO-09-245 Behind-the-Counter Drug Class
 

drugs.1 BTC drugs would be held behind a pharmacy counter and available 

without a prescription, but dispensed only after intervention by a 

pharmacist. The primary purpose of a BTC class would be to increase 

access to drugs to promote public health by making drugs available 

without a prescription when intervention by a pharmacist or other means 

can help ensure the safe and effective use of such drugs. Similar proposals 

have been considered in the past and, in 1995, GAO issued a report titled 

Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet

to Be Demonstrated (GAO/PEMD-95-12).2

 In that report, we stated that 

there was little evidence to support the establishment of a BTC or similar 

class of drugs in the United States. The evidence at the time tended to 

show that countries with a BTC or similar drug class were not obtaining 

major benefits from that class. 

In light of the FDA hearing on BTC drugs and the fundamental change that 

a BTC drug class would represent in the U.S. drug classification system, 

you asked us to update 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 countries3

 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. 

To describe the arguments that have been made supporting and opposing 

a BTC drug class in the United States, we reviewed published literature, 

reports, and meeting minutes of FDA hearings on prescription-to-OTC 

switches,4

 and the transcript of and docket submissions for the November 

2007 FDA meeting on BTC drugs.5

 We interviewed officials at FDA, 

pharmacy associations, drug manufacturers, consumer groups, and 

 1

A transcript of this meeting, Behind the Counter Availability of Certain Drugs: Public

Meeting, is available at http://www.fda.gov/oc/op/btc/transcripts11_14_07.html. 

2

GAO, Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be 

Demonstrated, GAO/PEMD-95-12 (Washington, D.C.: Aug. 24, 1995). 

3

In addition to the United States, the study countries are Australia, Italy, the Netherlands, 

and the United Kingdom. We also describe drug classification in the European Union (EU). 

4

The reclassification of drugs from one class to another is referred to as switching. 

5

One issue that has been raised, but is beyond the scope of this report, is whether FDA has

authority to create such a class without a legislative change. 

Page 2 GAO-09-245 Behind-the-Counter Drug Class
 

industry associations in the United States. We also interviewed academics 

and other officials knowledgeable about pharmaceutical practice. 

To determine the impact of restricted nonprescription drug classes on 

drug availability, we interviewed experts to ask them to help us identify 

countries that had evaluated drug classification since our 1995 report. 

Based on this information, we selected 5 of the 11 countries covered in our 

previous report.6

 We also examined drug classification in the European 

Union (EU), because it affects drug availability in three of our study 

countries. We reviewed published literature, reports, and agency 

documents on drug classification and prescription-to-nonprescription 

switches in our study countries. We also interviewed agency officials, 

industry representatives, and others knowledgeable about pharmaceutical 

practices in the United States and the other study countries. We examined 

changes since 1995 in the drug classification systems in two study 

countries (Italy and the Netherlands) that changed the number or type of

nonprescription drug classes in use. We also determined the number of 

drugs switched from one drug class to another (e.g., prescription to BTC) 

between 1995 and 2008 for the three study countries (Australia, the United 

Kingdom, and the United States) that maintained the same number and 

type of nonprescription drug classes during that time. Additionally, we 

determined the classification of selected drugs in our study countries. We 

chose a sample of drugs using World Self-Medication Industry data on the 

classification of more than 200 drugs in 36 countries and identified 86 of 

these drugs as available in all five study countries.7

 We examined the 

survey format used to collect information on drug classification and 

response rates from the most recent survey, and determined that the data

were sufficiently reliable for our purposes. We then used drug

classification documents published by the regulatory agencies in each of

the study countries and information from agency officials to determine 

how each of the 86 drugs was classified in each country. The data in these 

 6

In addition to the United States, in our previous report we examined the drug 

classification systems in Australia, Canada, Denmark, France, Germany, Italy, the

Netherlands, Sweden, Switzerland, the United Kingdom, and the EU (GAO/PEMD-95-12, 

pp. 85-10). In this report, the study countries are Australia, Italy, the Netherlands, the 

United Kingdom, and the United States. 

7

The World Self-Medication Industry is a federation of more than 50 member associations

representing manufacturers and distributors of nonprescription medicines. Methodology 

adapted from A. Gilbert, D. Rao, and N. Quintrell, “A Review of Pharmaceutical Scheduling 

Processes in Six Countries and the Effect on Consumer Access to Medicines,” 

International Journal of Pharmacy Practice, vol. 14, no. 2 (2006). 

Page 3 GAO-09-245 Behind-the-Counter Drug Class
 

reference documents are standard data sources published by each 

country’s regulatory authority and were sufficiently reliable for our 

purposes. 

To identify issues that would be important to the establishment of a BTC 

drug class in the United States, we reviewed published literature and 

reports. We interviewed officials at FDA, the Centers for Medicare & 

Medicaid Services (CMS), the Department of Veterans Affairs (VA), the 

Indian Health Service (IHS), pharmacy associations, drug manufacturers, 

consumer groups, industry associations, and drug regulatory agencies in

other countries. We also interviewed academics and other experts—

including individuals who have testified before FDA on the possible 

creation of a BTC drug class in the United States—knowledgeable about 

pharmacists’ prescribing authority. Appendix I provides a more detailed

explanation of the scope and methodology for this report. We conducted 

our work from March 2008 through February 2009 in accordance with all 

sections of GAO’s quality assurance framework that are relevant to our 

objectives. The framework requires that we plan and perform the 

engagement to obtain sufficient and appropriate evidence to meet our 

stated objectives and to discuss any limitations in our work. We believe 

that the information and data obtained, and the analysis conducted, 

provide a reasonable basis for any findings and conclusions. 

Arguments supporting and opposing a BTC drug class in the United States 

have been based on public health and health care cost considerations, and 

these arguments reflect general disagreement on the likely consequences

of the establishment of such a class. Some who support a BTC drug class 

suggest that such a class would lead to improved public health through 

increased availability of nonprescription drugs. For example, a BTC class 

might allow more drugs to be switched out of the prescription class, 

providing increased access to these drugs for consumers. Additionally, 

proponents argue that pharmacists have extensive knowledge of drug use 

and drug interactions and could help consumers to assess their medical 

needs and determine whether a physician’s visit would be appropriate. 

However, opponents are concerned about the potential for a BTC class to 

become a default class for all drugs switching from prescription to 

nonprescription status even when the additional restrictions of BTC 

classification are not necessary for safe use of all such drugs; BTC 

classification would reduce consumers’ access to drugs if those drugs 

would otherwise have switched to OTC status. Opponents also note that

pharmacists are not trained in clinical diagnosis, generally do not have 

access to relevant patient information (such as laboratory results), and 

Results in Brief 

Page 4 GAO-09-245 Behind-the-Counter Drug Class
 

lack the time to provide counseling to patients. Health care cost arguments 

in favor of a BTC drug class center on possible reduced costs through a 

decrease in the number of physician visits and a decline in drug prices that

might result from nonprescription status. However, opponents argue that

out-of-pocket costs for many consumers could rise if prescription drugs 

currently covered by insurance are switched to BTC status and third-party 

payers elect not to cover BTC drugs. Additional costs to consumers could 

result if pharmacists require a fee in order to provide counseling. 

All five study countries have increased nonprescription drug availability 

since 1995; however, the impact of restricted nonprescription drug classes 

on drug availability is unclear. The five study countries—selected because

they evaluated drug classification in their countries since 1995—have 

increased drug availability in two ways: by changing nonprescription drug 

classes or by switching some drugs into less restrictive classes. Italy—in 

2006—and the Netherlands—in 2007—changed their nonprescription drug 

classes by making some or all of their nonprescription drugs available for

OTC sale at nonpharmacy outlets, such as grocery stores. Previously, the 

Netherlands restricted drug sales to drugstores (operated by a licensed

druggist and allowed to sell certain nonprescription drugs) or pharmacies 

(operated by a pharmacist and allowed to sell all prescription and 

nonprescription drugs); Italy also previously limited the sale of all drugs to

pharmacies. Since 1995, Australia, the United Kingdom, and the United 

States have switched a number of drugs from more restrictive to less 

restrictive drug classes, again resulting in an overall increase in drug 

availability. When we examined the classification of 86 selected drugs in 

the five study countries, we found that the impact of restricted 

nonprescription drug classes on availability is unclear. 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 also classified more of the drugs from our sample as 

OTC—the option that provides greatest access to these drugs for 

consumers—than all four of the other study countries. Additionally, we 

did not find an association between the restrictions placed on the 

availability of particular drugs in our sample by the study countries and 

the presence of a BTC drug class. The United States gave more restrictive 

classification to some drugs and less restrictive classification to other 

drugs when compared to the other four 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. The roles and responsibilities of pharmacists in a BTC drug class 

that would need to be considered include defining pharmacist 

Page 5 GAO-09-245 Behind-the-Counter Drug Class
 

responsibilities for dispensing BTC drugs, ensuring that pharmacists 

provide the necessary BTC counseling, and determining whether 

additional training would be needed for pharmacists and pharmacy staff. 

In addition, whether or not there is a sufficient pharmacist workforce to 

make such a class viable would need to be determined, and pharmacists’ 

new role would need to be communicated to the public. Ensuring that 

pharmacies have the data infrastructure necessary to provide pharmacists 

with patient information and the physical infrastructure to protect 

consumer privacy would also be important. Additionally, several cost 

issues would be important to the implementation of a BTC drug class. For 

example, the availability of third-party coverage for BTC drugs would 

affect consumers’ out-of-pocket expenditures. If BTC drugs were more 

expensive than prescription or OTC alternatives, it could discourage 

consumer use of BTC drugs. Also, pharmacists’ compensation for 

providing BTC services would need to be considered. The level of 

pharmacist compensation might influence pharmacists’ willingness to 

engage in activities required for dispensing BTC drugs, such as providing 

counseling, and therefore could affect their participation in a BTC drug 

class. Other cost issues might also affect the viability of a BTC drug class. 

Pharmacists’ liability risk could increase as a result of their expanded role

in a BTC drug class and thus deter pharmacists from participating in a 

BTC drug class. 

In commenting on a draft of this report, HHS agreed that cost-related 

issues would have to be addressed before implementing a BTC drug class 

and also provided technical comments. VA also reviewed the report and 

provided technical comments. We have incorporated HHS and VA 

technical comments as appropriate. 

In the United States, although drugs are classified as prescription or 

nonprescription at the federal level by FDA, the practice of pharmacy is 

typically regulated by states. For example, states license pharmacists and 

enforce pharmacists’ continuing education requirements. 

Background 

The 1951 Durham-Humphrey Amendments to the Federal Food, Drug, and 

Cosmetic Act provided the statutory basis for the two-tier drug 

classification system that currently exists in the United States.

8

 Since that 

time, there have been a number of proposals to introduce a third category 

 8

Pub. L. No. 82-215, 65 Stat. 648 (1951). 

Page 6 GAO-09-245 Behind-the-Counter Drug Class
 

of drugs in the United States. This category has been called by a number of 

names, including pharmacist-legend, pharmacist-only, third class of drugs, 

and BTC. Although there is some variation between proposals, the basic 

idea is the same: a class of drugs would be established that would be 

available without a prescription, but only in pharmacies. 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.9

Use of a BTC Drug Class There are two general views on how a BTC class of drugs would be used in 

the United States. The first is that BTC would be a permanent class. It 

would be similar to the current prescription and OTC classes, in that drugs 

would be placed in the BTC class with no expectation that they would 

eventually switch to the prescription or OTC class. Drugs in the BTC class 

would be those determined by FDA to be nonprescription but would 

require the intervention of a pharmacist. Drugs in the BTC class could 

come from the current prescription and OTC classes or new drugs could 

be classified as BTC, although proposals for a BTC drug class generally

seek to increase access to medications by switching drugs out of the 

prescription class. 

The second view is that the BTC drug class could function as a transition 

class for some drugs and a permanent class for others. A drug being 

switched from prescription to nonprescription would spend time in the 

transition class, during which the suitability of the drug for OTC status 

could be assessed. In addition to studies specifically designed for such an 

assessment, consumer use of the drug as a prescription drug and as a BTC 

 9

Since FDA has not issued a detailed BTC proposal, it is unknown if mail-order or Internet 

pharmacies would be permitted to dispense BTC drugs. At the November 2007 public 

meeting, one FDA official stated that the specific role of the pharmacist would need to be 

determined. See FDA, Behind the Counter Availability of Certain Drugs: Public Meeting, 

p. 1. A pharmacist’s intervention with a consumer might include reviewing drug

interactions and reading and interpreting laboratory results. 

Page 7 GAO-09-245 Behind-the-Counter Drug Class
 

drug could be examined.10 The argument is that this would provide a better

picture of how the drug would be used by the public if it were available as 

an OTC product. Information that could be gathered while the drug was in 

the transition class includes types and levels of misuse among the general 

public, incidents of adverse drug reactions, and interactions with other 

medications. At some point after the product has been BTC, a decision 

might be made based on the available data to switch the drug to OTC, 

return the drug to prescription status, keep the drug in the BTC class for 

future study, or keep the drug in the BTC class with no expectation that it

would eventually be switched to the prescription or OTC class. 

FDA has not indicated which drugs might be classified as BTC in the 

United States. However, among the drugs suggested by some proponents 

are certain drugs that treat chronic conditions such as high cholesterol, 

asthma, high blood pressure, diabetes, urinary incontinence, and 

osteoporosis. Vaccines; the epinephrine auto-injector used in emergency 

situations following insect bites, stings, or exposure to other allergens; and 

oseltamivir—which is used to treat influenza and might be effective in the 

event of an influenza pandemic—have also been suggested as possible 

BTC products. More generally, drugs that are subject to abuse and drugs 

that are to be sold only to consumers of a minimum age have been 

mentioned as possible candidates for a BTC class. 

Nonprescription Drug 

Classes in Other Countries 

Figure 1 defines the terms we use to describe the drug classes in the 

United States and other countries and how the levels of restriction vary 

among classes based on the conditions under which drugs are sold. As 

discussed in our previous report, varying levels of restriction on 

nonprescription drugs already exist in other countries.11 Among the 

 10Currently, label comprehension, self-selection, and actual use studies are conducted to

help support a request to switch a drug from prescription to OTC status. For some drugs,

clinical safety and efficacy trials are also needed. Label comprehension studies are used to 

determine whether the label clearly communicates the uses, directions, and warnings to 

diverse populations and enables the consumer to make appropriate judgments about selfselection. Self-selection studies are used to evaluate whether consumers can appropriately 

select a product based on the product label and their unique medical histories. Actual use 

studies are clinical studies designed to simulate the OTC use of a drug. They are meant to 

assess drug selection, compliance with labeling, and safe use of the drug. 

11In addition to the United States, in our previous report we examined the drug 

classification systems in Australia, Canada, Denmark, France, Germany, Italy, the

Netherlands, Sweden, Switzerland, the United Kingdom, and the EU. GAO/PEMD-95-12, 

85-103. 

Page 8 GAO-09-245 Behind-the-Counter Drug Class
 

criteria foreign countries have used for switching a drug from prescription 

to a less restrictive nonprescription drug class are: (1) the symptoms or 

circumstances for use of the drug are suitable for self-medication, 

including self-diagnosis, with the intervention of a pharmacist; and (2) the 

drug has a low potential for side effects or overdose, and intervention by a 

pharmacist could minimize these risks. In contrast, nonprescription drugs 

in the United States generally have these characteristics: (1) their benefits

outweigh their risks; (2) consumers can use them for self-diagnosed 

conditions; (3) they can be adequately labeled for self-medication; and 

(4) a prescription by a licensed prescriber is not needed for the consumer 

to safely and effectively use the drug and the conditions or symptoms are 

generally self-limiting. Appendix II provides details on the drug 

classification systems in each study country and the European Union 

(EU). 

Figure 1: Definitions and Relative Levels of Restriction for Drug Classes Used in

This Report 

Source: GAO analysis of agency documents from the study countries.

Term used in the report

Prescription drugs

 Prescription

Nonprescription drugs

 BTC

 Pharmacy

 Drugstore

 OTC/pharmacist

 OTC

Definition

Available only from a pharmacist 

or other licensed dispenser upon 

submission of a prescription

Available only in pharmacies; 

contact with pharmacist required

Available only in pharmacies; 

contact with pharmacist not required

Available only in pharmacies or 

drugstores; contact with pharmacist 

not requireda

Available for self-selection in pharmacies and other retail outlets, but 

a pharmacist must be present

Available for self-selection in pharmacies and other retail outlets, including 

those without pharmacists or druggists

Levels of restriction

Most restrictive

Least restrictive

a

In the Netherlands, a distinction is made between pharmacies (run by pharmacists and able to sell all 

prescription and nonprescription drugs) and drugstores (run by druggists with less training than 

pharmacists and able to sell only some nonprescription drugs). 

Page 9 GAO-09-245 Behind-the-Counter Drug Class
 

While Figure 1 indicates how the levels of restriction for prescription and 

nonprescription drug classes affect drug availability, there are other 

factors that can also affect availability including cost, patient participation 

in health decisions, and purchase site convenience. For example, the 

number of pharmacies in a country affects the availability of BTC drugs. 

The more pharmacies there are, the greater the availability of BTC drugs 

and the smaller the difference in availability between BTC and OTC drugs. 

Also, the distribution of pharmacies can affect availability. Areas without a 

local pharmacy but with outlets that sell OTC drugs, would be more 

affected by not having drugs available OTC than would areas with nearby 

pharmacies. 

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. Many of the arguments are concerned with how a BTC drug 

class might affect consumers’ access to medications, pharmacist 

involvement in selecting drugs, the costs of drugs, and payment policies.

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.12 Proponents of a BTC drug class argue that such a 

class would increase access because drugs that might not otherwise be 

suitable for general OTC use could be available without a prescription. 

The switching of a drug from prescription to OTC represents a large

change in the distribution of the drug, from requiring a prescription to 

requiring no medical intervention at all. Proponents argue that

pharmacists could help bridge this gap if there were a BTC drug class. By 

providing a new avenue for switches from prescription to nonprescription, 

Arguments Made 

Supporting and 

Opposing a BTC Drug 

Class Reflect 

Disagreement on Its 

Impact on Health 

Care and Health Care 

Costs 

Some Proponents of a BTC 

Drug Class Argue It Will 

Improve Public Health 

 12Academics, pharmacy association officials, manufacturer representatives, and others 

presented many arguments supporting and opposing a BTC drug class at FDA’s November

2007 public meeting. See FDA, Behind the Counter Availability of Certain Drugs. 

Page 10 GAO-09-245 Behind-the-Counter Drug Class
 

a BTC drug class would give consumers access to more drugs that could 

benefit their health. Pharmacists could counsel consumers on BTC 

medications and, consequently, some drugs that were unsuitable for OTC 

availability could be made available as BTC drugs. Proponents argue that

this would be particularly important for underserved populations, such as 

the uninsured, underinsured, or those with limited access to a primary 

care provider and, thus, to prescription drugs. Moreover, an FDA official 

told us that many of the drugs that could be switched to OTC under the 

current two-tier drug classification system have already been reclassified

and that a BTC drug class might allow additional drugs to be switched out 

of prescription status.. The convenience of acquiring BTC drugs at a 

pharmacy could improve consumer adherence to drug regimens by 

eliminating the need for a visit to a physician to obtain refill prescriptions. 

Additionally, FDA has noted that people are now taking a larger role in 

managing their health. Experts have stated that increased access to drugs 

through a BTC class could give them even more tools to do so, thus 

potentially improving their health. 

Other arguments in favor of a BTC drug class focus on the expanded role 

of pharmacists under such a class, suggesting that greater use of 

pharmacist expertise would improve health outcomes. Proponents of a 

BTC drug class note that pharmacists are successfully engaging in 

activities beyond their traditional role of dispensing drugs, such as 

prescribing drugs under certain circumstances13 or reviewing individuals’ 

drug regimens if they participate as providers of medication therapy 

management (MTM) in programs where they are authorized to perform 

 13VA and IHS allow some specially trained VA and IHS pharmacists to prescribe drugs.

Additionally, according to the American College of Clinical Pharmacy, 44 states now allow

some form of collaborative drug therapy management, in which pharmacists enter into

collaborative practice agreements with physicians and other prescribers. Under these 

agreements, pharmacists can be authorized to select appropriate drug therapies and 

regimens for patients who have a confirmed diagnosis by a physician and adjust them on

the basis of patients’ responses. 

Page 11 GAO-09-245 Behind-the-Counter Drug Class
 

such reviews.14 Proponents also point out that pharmacists are well trained

in medication therapy, and a BTC drug class would make better use of 

pharmacists’ knowledge of drug use, drug interactions, and other factors. 

Additionally, pharmacy schools are becoming more patient focused, 

integrating training on counseling, physical assessments of patients, and 

interpretation of lab results into their curricula. Because pharmacists 

might be more accessible than physicians, better health outcomes could 

result from the greater consumer interaction with pharmacists brought on 

by a BTC drug class. During such interactions, pharmacists might also 

refer individuals with potentially serious medical conditions to a 

physician; these individuals might not have otherwise entered the health 

care system. Moreover, proponents of a BTC class note that numerous 

studies have demonstrated that expanded pharmacist roles in individuals’ 

care can result in health improvements. They note that the pharmacy 

practice literature generally supports the ability of community 

pharmacists15 to reduce adverse reactions and improve clinical outcomes 

 14Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA), for example, drug plan sponsors participating in Medicare Part D—a voluntary 

insurance program for outpatient prescription drug benefits—must offer MTM programs to

improve prescription drug use and outcomes among individuals with multiple chronic 

diseases and taking multiple drugs covered under Part D. (Individuals targeted for MTM 

programs must also be identified as likely to incur annual costs for covered Part D drugs

that exceed a level specified by the Secretary of Health and Human Services.) See Pub. L. 

No. 108-173, § 101(a), 117 Stat. 2066, 2085-87 (2003). MTM services are designed to optimize 

therapeutic outcomes through improved drug use and to reduce the risk of adverse events. 

Examples of MTM services might include performing assessments of the individual’s health

status; initiating, modifying, or administering drug therapy; monitoring and evaluating the

response to therapy; and providing verbal education and training designed to enhance

individuals’ appropriate use of their drugs.

15Community pharmacy settings include independent, chain, mass merchandiser, and 

supermarket pharmacies. This term excludes pharmacists who practice in hospitals and

other institutional settings. 

Page 12 GAO-09-245 Behind-the-Counter Drug Class
 

for conditions such as asthma, diabetes, hypertension, and high 

cholesterol.16

Proponents also argue that a BTC drug class would improve public health

by permitting additional data to be obtained that would better indicate 

when a drug would be appropriate for OTC availability. For example, BTC 

availability might allow consumer–pharmacist interactions to be studied to

determine if consumers really need the pharmacist’s input. Additionally, 

information might be collected from pharmacists about whether 

consumers could understand product information and appropriately 

assess their suitability for a medication without pharmacist prompting. 

This could affect the labeling if the drug were switched to OTC availability. 

Depending on a drug’s safety and usage profile in a BTC class, a drug 

could either remain permanently in the BTC class or subsequently 

transition to OTC. 

Some Opponents of a BTC 

Drug Class Raise Concerns 

about Potential Harm to 

Public Health 

Opponents of a BTC drug class, including some academics and 

representatives of drug manufacturers, raise concerns that such a class 

could harm public health by decreasing the availability of nonprescription 

drugs. Overall, opponents believe that the current two-tier drug 

classification system works well and provides consumers with an 

appropriate level of drug availability.17 Opponents of a BTC drug class 

argue that such a class could become the default option for drugs being 

switched from prescription status due to the cautious approach of 

regulators. Prescription drugs that could have switched to OTC might 

instead be placed into a BTC drug class, resulting in decreased consumer 

 16For example, see B. A. Bunting and C. W. Cranor, “The Asheville Project: Long-Term 

Clinical, Humanistic, and Economic Outcomes of a Community-Based Medication Therapy 

Management Program for Asthma,” Journal of the American Pharmacists Association, 

vol. 46, no. 2 (2006); T. Fera, et al., “The Diabetes Ten City Challenge: Interim Clinical and 

Humanistic Outcomes of a Multisite Community Pharmacy Diabetes Care Program,” 

Journal of the American Pharmacists Association, vol. 48, no. 2 (2008); D. G. Garrett and 

B. M. Bluml, “Patient Self-Management Program for Diabetes: First-Year Clinical, 

Humanistic, and Economic Outcomes,” Journal of the American Pharmacists 

Association, vol. 45, no. 2 (2005); B. J. Isetts, et al., “Clinical and Economic Outcomes of

Medication Therapy Management Services: The Minnesota Experience,” Journal of the 

American Pharmacists Association, vol. 48, no. 2 (2008); and B. A. Bunting, et al., “The

Asheville Project: Clinical and Economic Outcomes of a Community-based Long-term 

Medication Therapy Management Program for Hypertension and Dyslipidemia,” Journal of 

the American Pharmacists Association, vol. 48, no. 1 (2008). 

17Opponents argue that if a drug is not suitable for OTC use, it should be available only by

prescription. Consequently, they believe that a BTC class is inappropriate. 

Page 13 GAO-09-245 Behind-the-Counter Drug Class
 

access compared to OTC availability. Drugs might also remain in a BTC 

drug class even if suitable for OTC use. Concerns have also been raised 

that current OTC products could be moved into a BTC class, thereby 

reducing availability. Additionally, depending on how well information is 

communicated to consumers about a BTC drug class, both in public 

campaigns and within pharmacies, consumers could be unaware of 

available BTC drugs. Underserved and rural communities with few or no 

pharmacies might also experience barriers to accessing BTC drugs, which 

would only be available through pharmacies. 

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. Physician association representatives and others 

have stated that pharmacists lack adequate clinical training to properly 

diagnose and treat illnesses, skills which might be required when 

dispensing BTC drugs.18 Opponents also raise the concern that pharmacists 

are very busy and might not have enough time to provide individualized 

counseling to consumers regarding BTC drugs. Additionally, pharmacists 

might not have access to relevant information (e.g., a complete medical 

record, laboratory results, and a complete list of medications taken by the 

individual) necessary to make an optimal and safe BTC drug 

recommendation. Opponents also argue that, currently, pharmacists 

counsel infrequently and sometimes incorrectly. Beyond concerns over 

inadequate service, opponents suggest that a lack of private confidential 

areas in pharmacies for consumer–pharmacist interactions could 

discourage individuals from seeking care for sensitive matters. 

Some opponents of a BTC drug class assert that adverse health outcomes 

could result from improper use of BTC drugs. Individuals who use BTC 

drugs without consulting a physician might treat symptoms but not the 

 18Although some pharmacists are engaging in expanded roles, such as providing MTM 

services or participating in collaborative practice agreements, some experts we

interviewed do not consider these experiences adequate preparation for the role 

pharmacists would be expected to assume for a BTC drug class. Whereas physicians and 

prescription drug plans can initiate the provision of MTM services, BTC counseling would 

be initiated by a pharmacist. Additionally, MTM programs primarily focus on managing 

consumers’ current drug therapy, not initiating new therapy, as pharmacists would for BTC 

drugs. Collaborative practice agreements involve physicians delegating some

responsibilities to pharmacists, whereas a BTC drug class would give pharmacists 

independent decision-making authority. Physician–pharmacist interaction is also 

formalized through collaborative practice agreements, but physician involvement would 

likely not be a requirement of a BTC drug class. 

Page 14 GAO-09-245 Behind-the-Counter Drug Class
 

underlying cause of the illness, thus delaying appropriate therapy. Readily 

available BTC drugs could also encourage individuals with chronic 

conditions to seek pharmaceutical remedies instead of lifestyle changes 

that could alleviate the conditions. Additionally, an individual’s personal 

physician might not be aware when a person begins a pharmacistrecommended BTC drug regimen and thus might not be able to monitor 

the individual appropriately. Experts told us this uncoordinated care could 

further fragment the provision of health care. 

Some Proponents of a BTC 

Drug Class Argue that It 

Would Reduce Costs 

Proponents of a BTC class have argued that establishment of such a class 

would likely reduce costs. In the past, the price of a drug has decreased 

when it was switched from prescription to OTC. Consequently, if a BTC 

drug class permits increased switching of drugs and pricing follows this 

pattern, it could reduce costs to consumers and to the overall health care

system. Cost savings could also result from a decrease in the number of 

physicians’ visits. The availability of BTC drugs that previously had 

prescription status could result in fewer physician office visits for patients 

seeking prescriptions and, accordingly, fewer co-payments and third-party 

reimbursements to physicians. This would reduce costs for both 

consumers and insurers, as well as overall health care system 

expenditures. The pharmacy practice literature also supports the ability of 

community pharmacists to provide cost-effective interventions and reduce 

the cost of drug therapy.19

Additionally, because third-party payers do not typically reimburse 

consumers for nonprescription drugs and thus might not provide coverage 

for BTC drugs, drug expenditures for third-party payers could decrease if

prescription drugs were switched to a BTC class. Cost reductions for 

 19For example, pharmacists participating in a diabetes care program in Asheville, North 

Carolina helped individuals set and monitor treatment goals, performed physical 

assessments, and provided physician referrals, as needed. Pharmacists also provided

individuals with diabetes education training, home glucose monitor training, and 

information about adherence to their treatment regimens. Individuals in the study 

maintained clinically meaningful improvements in their levels of glycosylated 

hemoglobin—a diabetes-related indicator—over time, and third-party payers experienced

an overall decline in mean total direct medical costs during each year of follow-up. 

Pharmacists were reimbursed for their services by employers’ health plans. Based on the

clinical improvements and financial savings associated with this diabetes management 

program, the participating employers made the program a permanent component of their

health plan benefit. See C. W. Cranor, et al., “The Asheville Project: Long-Term Clinical and 

Economic Outcomes of a Community Pharmacy Diabetes Care Program,” Journal of the 

American Pharmaceutical Association, vol. 43, no. 2 (2003). 

Page 15 GAO-09-245 Behind-the-Counter Drug Class
 

insurers could also be realized in the area of compensation for 

professional services. Although pharmacist associations maintain that 

pharmacists would need to be compensated for health care services 

provided under a BTC paradigm, health services provided by pharmacists 

are less expensive than those provided by physicians—pharmacists are 

reimbursed at approximately 80 percent of physician rates for similar timebased services.20

Some Opponents of a BTC 

Drug Class Cite the 

Potential for Increased 

Costs 

Many arguments against a BTC drug class are based on the potential 

increased costs to individuals, third-party payers, and the overall health 

care system that such a class might cause. 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.21

Opponents of a BTC drug class have argued also that costs could increase 

as the result of the pharmacy services required for establishing such a 

class. Compensation for pharmacists providing BTC services could result 

in greater costs for consumers and third-party payers than if the drugs had 

been made OTC in the current two-tier system. Furthermore, restricted 

competition could also increase costs. It has been noted that there would 

be fewer outlets for BTC drugs than for OTC products because BTC 

products could not be sold at retail outlets other than pharmacies. This 

reduced availability could adversely affect retail competition and, as a 

result, drive up prices. 

Additionally, improper use of BTC drugs and the absence of physician 

consultations in the BTC process could result in expensive adverse health 

outcomes. For example, without a physician’s diagnosis, a pharmacist 

might recommend a BTC drug to treat stomach pain. However, potentially

serious gastrointestinal problems might underlie this symptom, and delays 

 20Under MMA, plans offering Part D prescription drug coverage must include a MTM 

program for certain plan enrollees which may be provided by a pharmacist and may

include elements to promote the appropriate use of medications by enrollees and 

adherence with prescription medication regimens. Pharmacists are eligible to be

compensated for the services they provide under such plans. Pub. L. No. 108-173, 117 

Stat. 2086-7 (2003). Although MMA does not specify a payment schedule, the rate often 

used by CMS to pay for pharmacists’ services under the Medicare program is 80 percent of 

the physician rate. 

21Additionally, lack of third-party payment for BTC drugs may result in a shift by consumers

to alternative and more costly prescription drugs, which could, in turn, result in additional 

expenditures. 

Page 16 GAO-09-245 Behind-the-Counter Drug Class
 

in obtaining appropriate treatment could have serious and expensive 

consequences to the consumer and the health care system as a whole. 

All five study countries have increased nonprescription drug availability 

since 1995; however, the impact of restricted nonprescription drug classes 

on availability is unclear. The five study countries increased drug 

availability in two ways: by changing nonprescription drug classes or by 

switching some drugs into less restrictive classes. 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. When we 

compared the classification of 86 selected drugs in the five study 

countries, we found that the impact of restricted nonprescription drug 

classes on availability is unclear. 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.

Consumers in all five study countries have experienced an increase in 

nonprescription drug availability compared to 1995 due to changes in drug 

classes or reclassification of drugs into less restrictive classes. Two 

countries changed their drug classes. The Netherlands added an OTC class 

in 2007; previously, all nonprescription drugs in the Netherlands were 

restricted to pharmacy or drugstore sales.22 As a result, the Netherlands 

now has three nonprescription drug classes: pharmacy, drugstore, and 

OTC. Italy also relaxed nonprescription drug sale restrictions in 2006 by 

making all nonprescription drugs available in nonpharmacy outlets; 

previously, nonprescription drugs could be sold only in pharmacies. Italy 

requires that a pharmacist be on the premises in any outlet that sells 

nonprescription drugs. As a result, Italy’s single nonprescription drug class 

has changed from a pharmacy class to an OTC/pharmacist class. The 

All Study Countries 

Have Increased 

Nonprescription Drug 

Availability, but the 

Impact of Restricted 

Nonprescription Drug 

Classes on Availability 

Is Unclear 

All the Study Countries 

Have Increased 

Nonprescription Drug 

Availability Since 1995 by 

Changing Drug Classes or 

Switching Drugs 

 22In the Netherlands, a distinction is made between pharmacies (run by pharmacists and 

able to sell all prescription and nonprescription medicines) and drugstores (run by

druggists with less training than pharmacists and able to sell only some nonprescription

drugs). Although the Netherlands has both pharmacy and drugstore classes for

nonprescription drugs, contact with the pharmacist or druggist is not required. Therefore,

the Netherlands does not have a BTC drug class.

Page 17 GAO-09-245 Behind-the-Counter Drug Class
 

presence of a pharmacist is not a requirement for the OTC class in any of 

the other countries we examined. Due to the changes made by Italy and 

the Netherlands, all five of the study countries now have some form of 

OTC availability of drugs. The other three study countries made no 

changes to their drug distribution categories since 1995. Australia has 

three nonprescription drug classes: BTC, pharmacy, and OTC.23 The United 

Kingdom has two nonprescription classes: BTC and OTC.24 The United 

States has one nonprescription class: OTC. (Table 1 summarizes the drug 

classes in use in the study countries in 2008. Appendix II provides more 

details on the drug classification systems in each of the study countries.) 

 23Although Australia has not changed its drug classification system since 1995, research is

currently being undertaken to determine whether there is benefit in retaining separate BTC

and pharmacy drug classes. These studies were prompted by the Galbally Review, which 

made a number of recommendations related to achieving uniformity of regulations

between Australian states, territories, and the national government through legislative 

reforms. The review noted that the goals of the BTC and pharmacy drug classes 

(e.g., ensuring that consumers have sufficient information for the safe and appropriate use 

of drugs) were valid but concluded that use of these restricted classes resulted in reduced

competition and higher costs to consumers, industry, and the government. As a result, the 

review recommended that standards be developed to facilitate a risk-based approach to

pharmacist intervention in the supply of drugs to individual consumers and that research

be conducted to determine the benefits obtained from such pharmacist intervention. See 

Galbally, Rhonda, National Competition Review of Drugs, Poisons and Controlled

Substances Legislation, Final Report Part A, a special report prepared at the request of 

the State, Territory, and Commonwealth governments of Australia, December 2000. A

report on the results of this research will be presented in 2011; the BTC and pharmacy drug 

classes will be retained if the report provides evidence to support doing so. 

24The BTC drug class in the United Kingdom (called pharmacy medicines) has some 

characteristics of both the BTC and pharmacy classes as defined in figure 1. The United 

Kingdom makes these drugs available only in pharmacies under the supervision of a

pharmacist and requires that they be stored behind the counter. The pharmacist establishes

procedures so that all staff involved in the supply of these drugs should know when to refer 

a customer to the pharmacist. Although direct pharmacist–consumer contact is necessary 

for only some of these drugs, the requirement that pharmacists supervise the sale of all 

drugs in this class and store them behind the counter makes this class most similar to a 

BTC class. 

Page 18 GAO-09-245 Behind-the-Counter Drug Class
 

Table 1: Drug Classes Used in the Study Countries, 2008 

Drug class Australia Italy Netherlands

United 

Kingdom 

United 

States 

Prescription drugs X X X X X

Nonprescription drugs 

Subclasses:

BTC X X

Pharmacy X X

Drugstore X

OTC/pharmacist X

OTC X X X X

Source: GAO analysis of agency data from the 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.25 For example, the United States switched 31 

drugs—including nonsedating antihistamines, orlistat (a weight-loss aid), 

and levonorgestrel (an emergency contraceptive switched for consumers 

aged 18 and above)—from prescription to nonprescription status during 

this period; there were no switches from nonprescription to prescription 

status. Australia approved more than six times as many drug switches as 

the United States—193—to less restrictive classes in the same period. 

Australia does not require drugs to switch in a stepwise manner; for 

example, 28 percent of switches approved from 1995 to 2008—54 out of 

193 switches—bypassed an intermediate class in favor of a less restrictive 

class (e.g., bypassing BTC when switching from prescription to pharmacy 

status). During this same period, an additional 67 drug switches resulted in 

more restrictive classification (e.g., from pharmacy to prescription). 

The United Kingdom also switched drugs from more restrictive to less 

restrictive classes, approving more than 50 switches from prescription to 

BTC or BTC to OTC between 1995 and 2008. Among the switches 

approved were two that were the first of their kind for any country: the 

2004 switch of a cholesterol-lowering statin—simvastatin—from 

prescription to BTC status and the 2008 switch of an antibiotic—

 25In some cases, a switch in one country may have involved a drug that was not approved

for use in one of the other countries or was not subject to regulation as a drug in another 

country. 

Page 19 GAO-09-245 Behind-the-Counter Drug Class
 

azithromycin for treatment of chlamydia—to BTC status.26 In 2002, the 

United Kingdom began exploring ways to increase the number of drugs 

available without a prescription. As part of this process, the United 

Kingdom has changed its approach to nonprescription switches from a 

focus on switching drugs for short-term conditions to include drugs for 

chronic conditions. The United Kingdom uses a stepwise process in which 

drugs leaving prescription status are given BTC status for several years 

before they are considered for OTC sale. Thus the BTC drug class in the 

United Kingdom can serve as a transition class. 

The Impact of Restricted 

Nonprescription Drug 

Classes on Drug 

Availability Is Unclear 

It is unclear whether the presence of restricted nonprescription drug 

classes increases drug availability. The United States required a 

prescription for more of the drugs we examined than did the two study 

countries—Australia and the United Kingdom—using a BTC drug class in

addition to other nonprescription drug classes. When we compared the 

classification status of 86 selected drugs in the five study countries, the 

United States required a prescription for 42 drugs while Australia and the 

United Kingdom each required a prescription for 23 of the drugs (see table 

2). The United States had slightly more of the selected drugs available 

without a prescription than the two study countries—Italy and the 

Netherlands—that did not use a BTC drug class. (See app. III for further 

details on classification of these 86 drugs in the study countries.) 

 26Chlamydia is a sexually transmitted disease that can damage a woman’s reproductive 

organs. BTC azithromycin will be available only after a consumer purchases a chlamydia 

test kit from a pharmacy, sends a urine sample to an approved laboratory, and receives a 

positive result. The consumer can then visit a pharmacy where the test results will be 

confirmed via computer and azithromycin will be dispensed to the consumer and his or her 

partners. 

Page 20 GAO-09-245 Behind-the-Counter Drug Class
 

Table 2: Number of 86 Selected Drugs Assigned to Each Drug Class in the Study 

Countries

Number of drugs assigned to each drug class 

Drug class Australia Italy Netherlands

United 

Kingdom

United 

States

Prescription drugs 23 43 45 23 42

Nonprescription drugs 63 43 41 63 44

Subcategories:

BTC 11 NAaNAa34 NAa

Pharmacy 29 NAa2 NAa1b

Drugstore NAaNAa26 NAaNAa

OTC/pharmacist NAa43 NAaNAaNAa

OTC 23 NAa13 29 43

Total (prescription +

nonprescription) 86 86 86 86 86

Source: GAO analysis of agency data from the study countries. 

a

Class does not exist in this country. 

b

In the United States, levonorgestrel (an emergency contraceptive) may only be sold in pharmacies—

as a nonprescription drug for those 18 and over, and by prescription for those under 18. 

However, the United States had more of the 86 selected drugs classified as

OTC—the option that provides greatest availability of these drugs for 

consumers—than all other study countries. With the exception of 

levonorgestrel (an emergency contraceptive), all nonprescription drugs 

(43 drugs, or 98 percent) were OTC in the United States without any 

restrictions. In contrast, 54 to 100 percent of nonprescription drugs in the 

other four study countries had conditions placed on their sale that 

restricted their availability. These restrictions included limiting sale to 

pharmacies and requiring pharmacist involvement in the sale (Australia 

and the United Kingdom), limiting sales to pharmacies and drugstores (the 

Netherlands), or requiring a pharmacist to be on the premises at any retail 

outlet selling nonprescription drugs (Italy). 

Therefore, an assessment of the restrictiveness of the drug distribution 

system in the United States compared to the other countries studied 

depends on the definition of availability. If availability is defined by the 

number of drugs available for OTC sale, the United States appears to have

the least restrictive system, because more of the 86 drugs are available for 

OTC sale than in any of the other countries. However, if availability is 

defined by the number of drugs for nonprescription sale regardless of any 

other restriction on their sale, the United States is more restrictive than 

Page 21 GAO-09-245 Behind-the-Counter Drug Class
 

Australia and the United Kingdom but slightly less restrictive than Italy 

and the Netherlands. 

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. It is unclear whether 

establishing a BTC drug class in the United States would allow more drugs 

to be switched out of the prescription class. We did not find a consistent 

association between the classification of particular drugs in our sample by 

a given country and the drug classification system in that country. For 

example, the United States gave less restrictive classification to some 

drugs and more restrictive classification to other drugs when compared to 

the other four study countries. Twelve drugs (14 percent) in the sample 

had OTC status in the United States but a more restrictive status in all of 

the other study countries, including two drugs with OTC status in the 

United States but prescription status in all of the other study countries 

(see table 3). 

Table 3: Drugs with OTC Status in the United States but a More Restrictive Status in

All Other Study Countries

Drug Australia Italy Netherlands

United 

Kingdom 

United 

States 

Bacitracin (topical) Rx OTC/P Rx Rx OTC 

Dextromethorphan P OTC/P P BTC OTC

Insulin Rx Rx Rx Rx OTC

Ketoprofen BTC OTC/P D BTC OTC 

Ketotifen BTC Rx Rx Rx OTC 

Miconazole (vaginal) BTC OTC/P Rx BTC OTC 

Naproxen P OTC/P D BTC OTC

Nizatidine P Rx Rx BTC OTC

Omeprazole Rx Rx D BTC OTC

Orlistat BTC RxaP RxbOTC 

Polymyxin B (topical) Rx OTC/P Rx Rx OTC 

Tetracycline Rx Rx Rx Rx OTCb

Legend: Rx = prescription; BTC = behind-the-counter; P = pharmacy; D = drugstore; OTC/P = overthe-counter (pharmacist required); OTC = over-the-counter. 

Source: GAO analysis of agency data from the study countries. 

Note: This table indicates the least restrictive class to which each drug was assigned regardless of 

pack size, dosage, or combination ingredients. Other formulations of a drug may only be available 

under a more restrictive class. For example, in the United States some types of insulin are available 

as prescription drugs and other insulin products are available OTC. 

Page 22 GAO-09-245 Behind-the-Counter Drug Class
 

a

On January 21, 2009, the European Commission approved orlistat (60 mg) for nonprescription use in

the EU. At the time of this report, nonprescription orlistat was not yet available to consumers. 

b

In the United States, the topical dosage form of tetracycline is OTC. 

Conversely, we found that seven drugs (8 percent) in the sample had 

prescription status in the United States and nonprescription status in all 

other study countries (see table 4). 

Table 4: Drugs with Prescription Status in the United States but Nonprescription 

Status in All Other Study Countries

Drug Australia Italy Netherlands

United 

Kingdom 

United 

States 

Aciclovir (topical) OTC OTC/P OTC OTC Rx 

Diclofenac P OTC/P D OTC Rx 

Econazole OTC OTC/P D BTC Rx 

Hyoscine (Scopolamine) P OTC/P D BTC Rx

Lactulose OTC OTC/P D BTC Rx 

Nicotine (oral inhaler) P OTC/P D OTC Rx 

Penciclovir P OTC/P OTC BTC Rx 

Legend: Rx = prescription; BTC = behind-the-counter; P = pharmacy; D = drugstore; OTC/P = overthe-counter (pharmacist required); OTC = over-the-counter. 

Source: GAO analysis of agency data from the study countries. 

Note: This table indicates the least restrictive class to which each drug was assigned regardless of 

pack size, dosage, or combination ingredients. Other formulations of a drug may only be available 

under a more restrictive class. 

Additionally, we found that seven drugs (8 percent) in the sample had 

prescription status in the United States, Italy, and the Netherlands but had 

nonprescription status in Australia and the United Kingdom, the two 

countries with a BTC drug class (see table 5). Study countries without a 

BTC drug class, therefore, had reduced availability of a small percentage 

of drugs when compared with the study countries using a BTC drug class. 

Page 23 GAO-09-245 Behind-the-Counter Drug Class
 

Table 5: Drugs with Prescription Status in Countries without a BTC Drug Class but 

Nonprescription Status in Countries with a BTC Drug Class 

Drug Australia Italy Netherlands

United 

Kingdom 

United 

States 

Beclometasone (nasal) P Rx Rx OTC Rx 

Budesonide (nasal) P Rx Rx BTC Rx 

Cyproheptadine BTC Rx Rx BTC Rx 

Fluticasone P Rx Rx BTC Rx 

Nitroglycerin P Rx Rx BTC Rx 

Nystatin P Rx Rx BTC Rx 

Theophylline BTC Rx Rx BTC Rx 

Legend: Rx = prescription; BTC = behind-the-counter; P = pharmacy; D = drugstore; OTC/P = overthe-counter (pharmacist required); OTC = over-the-counter. 

Source: GAO analysis of agency data from the study countries. 

Note: This table indicates the least restrictive class to which each drug was assigned regardless of 

pack size, dosage, or combination ingredients. Other formulations of a drug may only be available 

under a more restrictive class. 

Pharmacist-, infrastructure-, and cost-related issues would have to be

addressed before a BTC drug class could be established in the United 

States. Several issues involved with implementing a BTC drug class pertain 

to the roles and responsibilities of pharmacists, such as defining their BTC 

dispensing responsibilities and training needs. Infrastructure issues, such 

as establishing systems for the transfer of patient information and private 

consultation areas, would also be important if a BTC drug class were 

established. In addition, cost-related issues, such as the availability of 

third-party coverage for BTC drugs and counseling, would also be 

important considerations.27

Pharmacist-, 

Infrastructure-, and 

Cost-Related Issues 

Would Be Important 

Considerations if a 

BTC Drug Class Were 

Established 

 27In addition to these issues, it would also have to be determined whether a BTC drug class

could be established administratively by FDA or whether legislation would be necessary; 

however, this issue is beyond the scope of this report. 

Page 24 GAO-09-245 Behind-the-Counter Drug Class
 

If the United States were to establish a BTC drug class, it would be 

important to establish pharmacists’ responsibilities for dispensing BTC 

drugs. According to FDA, pharmacists’ responsibilities for dispensing BTC 

drugs could include but are not limited to reviewing or conducting an 

initial screening for clinical laboratory results, contraindications, or drug 

interactions; advising consumers on safe drug use; and monitoring for 

continued safe or effective use. Additionally, a pharmacist could be 

required to document interventions with consumers when dispensing BTC 

drugs. Experts told us that dispensing procedures could vary depending on

the product and disease. Determining whether a standard set of BTC 

dispensing requirements would apply to all pharmacies and pharmacists 

across the country would also be important. Determining whether BTC 

drugs could be sold through mail-order and Internet pharmacies—where 

physical observation of the consumer would not be possible—would be 

important, as well as determining whether pharmacists in these settings 

would need to fulfill additional dispensing requirements, such as using 

screening questions designed for remote counseling to ensure appropriate 

drug use. 

Issues Related to 

Pharmacists’ Roles and 

Responsibilities Would Be 

Important to Consider if a 

BTC Drug Class Were 

Established 

Ensuring that pharmacists meet their responsibilities for dispensing BTC 

drugs, including providing necessary counseling, would be an important 

issue to resolve. One potential purpose of classifying drugs as BTC is for 

pharmacists to ensure that consumers meet specified criteria for using 

these drugs and then to provide education on the proper use of these 

drugs. Failure to ensure that such counseling occurs would diminish the 

value of a BTC drug class. In Australia, one of our study countries with a 

BTC drug class, a 2000 government-sponsored review of the drug 

classification system found that pharmacist counseling did not occur to 

the intended extent and called for an enhancement of professional 

standards for pharmacists. Australian agency officials told us that since 

the time of this report, pharmacists’ provision of counseling for BTC drugs 

has improved with the development of counseling standards and 

clarification of legislative controls which regulate these professional 

standards. Professional associations have also played a role in monitoring 

the quality of pharmacist counseling in Australia. A study examining the 

Quality Care Pharmacy Support Centre’s “mystery shopper” visits—used 

to monitor and provide feedback on Australian pharmacies’ performance 

Page 25 GAO-09-245 Behind-the-Counter Drug Class
 

since 2002—found that repeated mystery shopper visits led to notable 

improvement in pharmacists’ handling of nonprescription drugs.28

FDA officials told us that, if a BTC drug class were created in the United 

States, FDA would need to work with the states to determine the 

mechanisms through which oversight would be provided. An official from 

the National Association of Boards of Pharmacy told us that, if a BTC drug 

class were created, the state boards of pharmacy would need to establish 

national standards for a number of issues, including the types of data 

systems, consumer interactions, documentation, and expertise required 

for a BTC practice. This official noted that it could be challenging for the 

state boards of pharmacy to provide oversight for a BTC drug class 

because of resource constraints. Pharmacy practice experts and others 

have also raised concerns that BTC verbal counseling requirements would 

need to be more stringent than the counseling requirements associated 

with the Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90).29 Under 

OBRA ‘90, consumers are allowed to waive their right to speak with a 

pharmacist, and according to pharmacy practice experts and others, many 

consumers do so. These experts told us that verbal counseling for a BTC 

drug class should be mandatory. 

Another consideration in the establishment of a BTC drug class would be 

determining if additional training would be needed for pharmacists and 

pharmacy staff and assessing whether all pharmacists and pharmacy staff 

would need to undergo this training. In pharmacist education today, more 

emphasis is being placed on patient care and assessment than was the 

case in earlier years. To fulfill degree requirements, pharmacy students 

must now earn a Doctor of Pharmacy degree, for which they are required 

to complete a minimum of 4 academic years, with at least 30 percent of the

program spent in clinical training in settings such as community 

 28Australia’s Quality Care Pharmacy Support Centre, a joint effort of the Pharmacy Guild of

Australia and the University of Sydney, has monitored the application of practice standards

in community pharmacies since 2002. Mystery shopping involves researchers acting as 

consumers or potential consumers in order to monitor the quality of service delivery. 

29See Pub. L. No. 101-508, § 4401(a)(3), 104 Stat. 1388, 1388-143 to 1388-161 (1990). As a

result of OBRA ‘90, states participating in the Medicaid program must require pharmacists 

to offer to counsel Medicaid beneficiaries on matters which the pharmacist, in his or her 

professional judgment, deems significant, including special directions for preparation and 

administration, common severe side effects that may occur, and techniques for selfmonitoring drug therapy. In addition, 45 states extended these counseling requirements to

cover all individuals receiving prescriptions. J. C. Vivian and J. L. Fink III, “OBRA ‘90 at 

Sweet Sixteen: A Retrospective Review,” U.S. Pharmacist, vol. 33, no. 3 (2008). 

Page 26 GAO-09-245 Behind-the-Counter Drug Class
 

pharmacy, hospital pharmacy, ambulatory care, and acute care general 

medicine to develop advanced professional practice skills.30 However, one

study found significant variation in courses used to teach patient 

assessment skills—which have been mentioned as potentially important 

for pharmacists providing BTC counseling.31 Further, pharmacists who 

received their education prior to the current shift toward patient care and

assessment might not have the same skills and abilities as recent 

graduates. Consequently, several experts told us that additional training 

would be necessary for at least some pharmacists in order for them to 

appropriately dispense BTC drugs. At VA and IHS, where some

pharmacists have expanded dispensing responsibilities and have been 

authorized to prescribe drugs, credentialing programs are used to assess 

pharmacists’ competencies before they are granted expanded privileges. 

Pharmacy associations have indicated that they could design and 

administer training for a BTC drug class. It would also be necessary to 

determine whether all pharmacists and pharmacy staff would be required 

to be trained in BTC-related skills. For example, one retail chain we spoke 

with suggested that each pharmacy should have the discretion to designate 

certain pharmacies or pharmacists who would be responsible for 

dispensing BTC drugs. However, if BTC drugs were only dispensed at 

certain pharmacies or by BTC-accredited pharmacists, confusion about 

how to access BTC drugs could result. 

To implement a BTC drug class, it would be important to evaluate whether 

a sufficient pharmacist workforce would be available to make such a 

program viable. Pharmacy practice experts told us that there is currently a

pharmacist shortage that will continue for some time.32 The Health 

Resources and Services Administration found that pharmacists have 

 30The Accreditation Council for Pharmacy Education adopted the Doctor of Pharmacy 

degree as the sole professional practice degree offered by schools of pharmacy in the

United States in 1997. The deadline for implementing the new standards for entering 

professional classes was in academic year 2000-2001, and the last student graduated from 

an accredited baccalaureate in pharmacy program in the academic year 2004-2005. 

31J. W. Spray and S. A. Parnapy, “Teaching Patient Assessment Skills to Doctor of Pharmacy 

Students: The TOPAS Study,” American Journal of Pharmaceutical Education, vol. 71, 

no. 4 (2007). 

32The duration of the pharmacist shortage is uncertain. The supply of pharmacists is

affected by factors such as the number of new graduates entering the workforce, the 

creation of new schools of pharmacy, annual hours of employment, and losses through

death and retirement. K. K. Knapp and J. M. Cultice, “New Pharmacist Supply Projections: 

Lower Separation Rates and Increased Graduates Boost Supply Estimates,” Journal of the 

American Pharmacists Association, vol. 47, no. 4 (2007). 

Page 27 GAO-09-245 Behind-the-Counter Drug Class
 

experienced increasing demand for their time in part because of an 

increase in prescription volume and in part because of the increased 

amount of time needed to address insurance coverage problems for 

prescriptions. In addition, experts we interviewed raised the possibility 

that some pharmacists might not want to take on the additional duties 

associated with dispensing BTC drugs, which could further reduce the 

number of pharmacists available to participate. In other countries, 

pharmacists have been unwilling at times to dispense BTC products. For 

example, a survey of 1,156 community pharmacists regarding their views 

and early experiences with BTC simvastatin (a cholesterol-lowering drug) 

in Great Britain revealed that pharmacists had a number of concerns and 

infrequently sold simvastatin.33 Despite feeling well prepared to counsel on 

BTC simvastatin, pharmacists were still reluctant to dispense the drug 

without cholesterol or blood pressure testing—which was not required by 

the drug’s protocol—and therefore infrequently sold it. 

Another example of this can be seen in Florida, which in 1985 authorized 

pharmacists to independently prescribe certain drugs.34 Experts have 

stated that despite having this authority, pharmacists in Florida have

rarely done so. Florida pharmacists’ rare use of their prescribing authority 

is primarily attributable to drugs being available without a prescription 

that are just as effective as those they are allowed to prescribe. 

Pharmacists were also concerned that they would increase their liability 

risk if they prescribed and they considered the recordkeeping

requirements associated with prescribing a drug to be excessively time 

consuming. Having an inadequate number of pharmacists willing to carry 

out BTC functions could reduce the value of such a class. 

Communicating pharmacists’ new role to the public could influence 

demand for products and services and would be an important issue for the 

implementation and viability of a BTC drug class. Experts have stated that 

consumers would need to understand protocols for obtaining BTC drugs, 

such as the necessity of consulting with a pharmacist before obtaining a 

BTC drug. Consumers would also need to be aware that, after a 

consultation, the pharmacist could decide that a BTC drug is not 

appropriate for the consumer or that a physician visit is necessary. If a 

BTC drug class were established in the United States, consumers might 

 33BTC simvastatin is indicated to reduce the risk of a first major coronary event in 

individuals who are likely to be at moderate risk of such events. 

34See 1985 Fla. Laws ch. 85-35. 

Page 28 GAO-09-245 Behind-the-Counter Drug Class
 

need time to adjust to pharmacists’ new role under such a class. For 

example, in the United Kingdom, which has had a BTC drug class since 

1968, pharmacists have expressed concerns that consumers have a poor 

understanding of the pharmacist’s role. Researchers have suggested that 

marketing pharmacists’ professional services could help to create a 

demand for these services. Officials with the United Kingdom Department 

of Health consider increasing the public’s awareness of pharmacist 

services to be a goal. According to these officials, while some consumers 

are comfortable obtaining health advice through a pharmacy, very few use 

a pharmacy’s full range of services.35

In implementing a BTC drug class, it would be important to determine 

whether restrictions on the size of a BTC drug class are necessary. Experts 

raised concerns that if a BTC drug class were too large or if whole 

categories of drugs switched to BTC at once, it could overwhelm 

pharmacies because of the time burden involved in dispensing these drugs 

and the need to train pharmacists and pharmacy staff on new procedures 

associated with BTC drugs. As a consequence, this situation could create

unintended gaps in care by disrupting pharmacies’ regular prescription 

dispensing duties or interfering with their ability to provide BTC drugs. 

For instance, pharmacists in the United Kingdom found following different 

dispensing procedures for multiple drugs to be burdensome. Their ability 

to make appropriate recommendations was hampered by the time 

involved in following these procedures. However, some pharmacy officials 

we spoke with told us that restricting the size of a BTC drug class would 

not be necessary because pharmacists are accustomed to managing a large 

number of drugs for various individuals. 

Infrastructure Issues 

Would Be Important 

Considerations in the 

Establishment of a BTC 

Drug Class 

An assessment of infrastructure needs would be important to the 

establishment of a BTC drug class in the United States. Implementing a 

BTC drug class could entail infrastructure changes for pharmacies so that

pharmacists could have better patient information on which to base 

dispensing decisions. For example, data infrastructure enhancements 

would be necessary for some pharmacies to meet the possible recordkeeping requirements of a BTC drug class and to facilitate communication 

between pharmacists and physicians. Other countries consider 

 35United Kingdom Department of Health, Pharmacy in England: Building on Strengths—

Delivering the Future (Norwich, 2008). Also available online at http://www.officialdocuments.gov.uk/document/cm73/7341/7341.asp (accessed Oct. 8, 2008). 

Page 29 GAO-09-245 Behind-the-Counter Drug Class
 

information-sharing systems important for supporting physician–

pharmacist communication. For example, in the Netherlands, physicians 

and pharmacists communicate regularly through electronic prescribing 

systems, and health officials are developing a system that physicians and

pharmacists can use to share patient-specific drug data. Electronic patient 

health information, such as laboratory results and diagnoses, could also

help U.S. pharmacists make better decisions when dispensing BTC drugs. 

Although commentators note that most state regulations require that a 

patient drug profile be maintained at the pharmacy and reviewed prior to 

dispensing a drug, pharmacies currently have limited access to electronic 

patient health information.36 For example, a study of Nebraska 

pharmacists found that 6 percent of surveyed pharmacists had access to 

electronic patient health information from other providers. Additionally, a 

2003 survey of community pharmacies from across the United States 

found that 54 percent of the respondent pharmacies were using a paper 

documentation system.37 Researchers have found several challenges 

associated with a paper system, all of which could impact implementation 

of a BTC drug class; these challenges include documentation time, 

retrieval of patient data, tracking consumer outcomes, and storage. 

Improving pharmacists’ access to patient information has been shown to 

improve decision-making. One study found that pharmacists performing 

drug utilization reviews made better decisions when they had access to 

more complete patient information on which to base decisions.38

The need for private pharmacy consultation areas is another important 

infrastructure issue that would require consideration if a BTC drug class 

were implemented. Several groups have identified a need to establish 

 36D.B. Christensen and K.B. Farris, “Pharmaceutical Care in Community Pharmacies: 

Practice and Research in the US,” The Annals of Pharmacotherapy, vol. 40, no. 7 (2006). 

Pharmacists may also have difficulty transferring patient information to physicians 

electronically. In a national survey, 4 percent of physicians reported having an extensive, 

fully functioning electronic health records system—13 percent of physicians reported 

having a basic system. See C. M. DesRoches, et al., “Electronic Health Records in 

Ambulatory Care—A National Survey of Physicians,” New England Journal of Medicine,

vol. 359, no.1 (2008). 

37This is the most recent survey that we identified of community pharmacies that examined

pharmacies’ use of paper and electronic documentation systems. It is likely that the

percentage of pharmacies using electronic documentation systems has increased since 

2003. 

38T. Warholak-Juarez, et al., “Effect of Patient Information on the Quality of Pharmacists’ 

Drug Use Review Decisions,” Journal of the American Pharmacists Association, vol. 40, 

no. 4, 2000. 

Page 30 GAO-09-245 Behind-the-Counter Drug Class
 

private counseling areas in pharmacies to ensure consumer privacy. 

Consumers might be reluctant to receive counseling from pharmacists if 

they have concerns about privacy. A study of Dutch pharmacies indicated

that if individuals are aware that a pharmacy has a separate consultation 

room, they might be more likely to seek a private consultation with a 

pharmacist.39 Similarly, researchers have found that enclosed counseling 

areas in Australian pharmacies increase the likelihood that screening 

activities and other enhanced pharmacy services occur.40 One pharmacy 

practice expert told us that the majority of Australian pharmacies are 

including private consultation areas when updating their infrastructure.41 If 

private consultation rooms were required as part of a BTC drug class, U.S.

pharmacies could incur costs to remodel their facilities. Although the 

National Association of Boards of Pharmacy currently recommends that

U.S. pharmacies have a private area for confidential conversations, states

have varied in requiring these areas.42

Cost-Related Issues for 

Drugs, Pharmacists’ 

Services, and Drug 

Switches Would Be 

Important Considerations 

in Establishing a BTC Drug 

Class 

Several cost-related issues would be important for the establishment of a 

BTC drug class. One consideration would be the availability of third-party 

coverage of BTC drugs. Pharmacy association and consumer group 

officials we spoke with told us that the effect of a BTC drug class on 

consumers’ out-of-pocket drug expenses would depend on the 

reimbursement decisions of third-party payers such as health insurers, 

who often pay all or most of the cost of prescription drugs but generally

do not pay for OTC products. A 1999 review of insurance plan benefits 

reported that less than one-third of plans covered selected OTC products 

 39M. P. Mobach, “The Counter and Consultation Room Work Explored in the Netherlands,” 

Pharmacy World & Science, vol. 30 (2008). 

40C. G. Berbatis, et al., “Enhanced Pharmacy Services, Barriers and Facilitators in 

Australia’s Community Pharmacies: Australia’s National Pharmacy Database Project,” 

International Journal of Pharmacy Practice, vol. 15 (2007); and Andrew Joyce, et al., 

“Analysis of Primary Prevention Service for Cardiovascular Disease in Australia’s

Community Pharmacies,” Australian and New Zealand Journal of Public Health, vol. 31, 

no. 6 (2007). 

41Australia’s Quality Care Pharmacy Program Standards require that community 

pharmacies maintain a Professional Services Area that, among other requirements, is easily 

identifiable by consumers as the area of the pharmacy from which therapeutic products are 

available and that will accommodate privacy and confidentiality requirements. 

42Regulations implementing title II of the Health Insurance Portability and Accountability 

Act of 1996, Pub. L. No. 104-191, 110 Stat. 1936, require most health providers, including

pharmacists, to have in place appropriate physical safeguards to protect the privacy of 

health information. See 45 C.F.R. §164.530(c)(2008). 

Page 31 GAO-09-245 Behind-the-Counter Drug Class
 

and that less than one-third of plans continued to cover products switched 

from prescription to OTC status.43 A 2003 study found that although 39 of 

43 state Medicaid programs reporting in 2003 covered some OTC drugs 

when ordered by a prescriber, only 12 provided coverage for OTC drugs 

that switched from prescription to OTC.44 HHS officials told us that 

legislative changes might be necessary to allow for Medicare Part D 

coverage of BTC drugs. A similar consideration concerns drugs now 

covered under the Medicaid program. If third-party payers do not 

reimburse consumers for drugs that were switched from prescription to 

BTC, consumers’ out-of-pocket expenditures could increase.

The cost of nonreimbursable BTC drugs could also affect the extent to

which consumers use BTC drugs. Evidence from other countries suggests 

that drug costs can be prohibitive to consumers. In the view of 

pharmacists in Great Britain, the high cost of BTC drugs such as 

omeprazole, especially relative to prescription or OTC alternatives, might

deter consumers from using the drug.

45 Another expensive BTC drug in the 

United Kingdom is simvastatin, which is intended for use by individuals 

who do not qualify for National Health Service coverage of statin 

treatment. However, according to pharmacists, the high cost of the drug 

could discourage some consumers from using it. Officials with the 

Medicines Evaluation Board of the Netherlands told us that consumers 

often oppose switches of drugs from prescription to pharmacy status 

because they lose insurance coverage when a drug becomes 

nonprescription. Therefore, in the Netherlands, prescription drugs that are 

not already covered by insurance are more likely to be considered viable

switch candidates for pharmacy class status. A survey of individuals with 

indigestion or hypertension found that about half of all Italian

respondents—regardless of their ability to pay for drugs—had obtained 

prescriptions for drugs that were available OTC in order to obtain 

 43Novartis Pharmaceuticals Corporation, “Novartis Pharmacy Benefit Report, Facts & 

Figures, 2001 ed.,” (East Hanover, N.J., 2001). 

44J. S. Crowley, et al., “Medicaid Outpatient Prescription Drug Benefits: Findings from a 

National Survey, 2003,” Kaiser Commission on Medicaid and the Uninsured (Washington,

D.C., 2003). 

45Great Britain includes England, Scotland, and Wales, while the United Kingdom includes

Great Britain and Northern Ireland. 

Page 32 GAO-09-245 Behind-the-Counter Drug Class
 

insurance coverage because they considered the OTC products too 

expensive.46

The availability of third-party coverage for BTC counseling could influence 

pharmacists’ involvement in a BTC drug class and the quality of 

pharmacists’ services, and third-party coverage for BTC counseling could 

also increase drug prices. Officials from the American Pharmacists 

Association have raised concerns about whether it would be financially 

feasible for pharmacies to carry BTC drugs unless pharmacists were able 

to bill and be fully paid for the clinical services that might be required for a 

BTC drug class. In addition to influencing pharmacists’ willingness to 

participate in a BTC drug class, whether or not pharmacists are 

compensated might also affect their performance. One study of the factors 

that increase the prevalence of patient care services in community 

pharmacies found that paying pharmacists increased their detection of 

drug-related problems.47 Another study found that providing pharmacists 

with a financial incentive was associated with significantly higher 

documentation levels and higher advanced service levels.48 A counseling 

fee could lead to higher drug prices if pharmacist compensation were 

included in the price of BTC drugs. However, consumers might be willing 

to pay more for BTC drugs if they consider pharmacist services valuable. A 

survey of 2,500 adults in the United States found that the majority of 

respondents were willing to pay an out-of-pocket fee for pharmaceutical 

care services, even if they were not currently receiving such services.49

Third-party payers might also be willing to cover pharmacist services. In 

one diabetes management study, self-insured employers reimbursed 

pharmacists for consultation services, and based on the clinical 

 46V. Atella, et al., “Affordability of Medicines and Patients’ Cost-Reducing Behaviour: 

Empirical Evidence Based on SUR Estimates from Italy and the UK,” Applied Health 

Economics and Health Policy, vol. 4, no. 1 (2005). 

47D. B. Christensen and R. W. Hansen, “Characteristics of Pharmacies and Pharmacists

Associated with the Provision of Cognitive Services in the Community Setting,” Journal of

the American Pharmaceutical Association, vol. 39, no. 5 (1999). 

48D. B. Christensen, et al., “Frequency and Characteristics of Cognitive Services Provided in

Response to a Financial Incentive,” Journal of the American Pharmaceutical Association,

vol. 40, no. 5 (2000). 

49Pharmaceutical care services were described in the survey as pharmacists consistently 

providing detailed counseling, monitoring outcomes, determining the appropriateness of 

drugs based on individual medical history, and consulting with physicians on prescriptions. 

See R. A. Larson, “Patients’ Willingness to Pay for Pharmaceutical Care,” Journal of the 

American Pharmaceutical Association, vol. 40, no. 5 (2000). 

Page 33 GAO-09-245 Behind-the-Counter Drug Class
 

improvements and financial savings associated with the diabetes 

management program, decided to retain the program as a permanent 

component of their health plan benefit.50

Compensation for BTC services might be necessary to offset increased 

liability. Additional liability could be incurred by pharmacists and 

pharmacies as a result of their participation in BTC counseling. Pharmacy 

officials raised the possibility that pharmacists participating in the 

implementation of a BTC drug class could have a greater exposure to 

liability because they would dispense drugs without a physician’s order. 

Concerns about liability might deter pharmacists from dispensing BTC 

drugs. For instance, such concerns were cited by pharmacists in Florida 

who were hesitant to use their prescribing authority. 

Costs might also be affected by new incentives necessary to encourage 

drug manufacturers to invest funds in a two-stage switch process (from 

prescription to BTC and then from BTC to OTC). Clinical trials, including 

actual use studies, are often conducted to help determine whether a drug 

could be switched from prescription to OTC, and an FDA official indicated 

that these trials may also be needed to determine if a product could be 

switched from prescription to BTC and from BTC to OTC. Currently, drug 

manufacturers may receive 3 additional years of exclusive marketing 

rights for drugs switched from prescription to OTC status if the switch 

requires additional clinical trials.51 Some FDA officials and manufacturers 

we spoke with believe it might be necessary to provide manufacturers 

with exclusive marketing rights for drugs switching from prescription to 

BTC status and also for BTC-to-OTC switches. It is unclear what period of

exclusivity would make drug manufacturers’ investment in clinical studies 

for prescription-to-BTC and BTC-to-OTC switches worthwhile. However, 

FDA noted that granting this additional period of market exclusivity could 

reduce competition. 

 50C. W. Cranor, et al., “The Asheville Project: Long-Term Clinical and Economic Outcomes 

of a Community Pharmacy Diabetes Care Program,” Journal of the American 

Pharmaceutical Association, vol. 43, no. 2 (2003). 

5121 U.S.C. § 355(c)(3)(E)(iv). 

Page 34 GAO-09-245 Behind-the-Counter Drug Class
 

HHS provided comments on a draft of this report. The comments are 

reproduced in appendix IV. In its comments HHS agreed that cost-related

issues would have to be addressed before implementing a BTC drug class. 

HHS recommended that GAO add a discussion regarding the statutory 

authority to provide reimbursement under Medicare Part D for drugs that 

would be included in a BTC drug class if it were to be created. Such 

discussion is beyond the scope of this report, but we noted in the report 

that the ramifications for Medicare, as well as Medicaid, would need to be

considered before establishment of a BTC drug class. 

HHS also suggested that a footnote in the report could mislead the reader 

to believe that the Medicare Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) requires pharmacists to review 

Medicare beneficiaries’ prescription drug regimens as a component of 

MTM under Medicare Part D. While pharmacists are required to participate 

in the development of such programs, we added text to the main body of

the report to clarify that MMA does not require that pharmacists furnish 

the services provided in MTM programs but also does not prohibit them 

from doing so. 

HHS stated that while MMA required Part D sponsors to implement MTM 

programs, the Part D program does not establish any payment schedules 

for either physicians or pharmacists performing MTM. HHS was concerned 

that a footnote in the report might be read to mean that MMA specified 

such a payment schedule. We have revised the text to clarify that MMA 

does not specify a payment schedule but that CMS often uses a rate that is 

80 percent of the physician rate to determine their payments under 

Medicare. 

In addition, HHS and VA provided technical comments on the report draft, 

which we have incorporated as appropriate. 

As agreed with your offices, unless you publicly announce the contents of

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the Secretary of Health 

and Human Services, the Commissioner of the Food and Drug 

Administration, committees, and others. The report also will be available 

at no charge on the GAO’s Web site at http://www.gao.gov. 

Agency Comments 

and Our Evaluation 

Page 35 GAO-09-245 Behind-the-Counter Drug Class
 

If you or your staff have questions about this report, please contact me at

(202) 512-7114 or crossem@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page 

of this report. GAO staff who made major contributions to this report are 

Marcia Crosse 

listed in appendix V. 

Director, Health Care 

Page 36 GAO-09-245 Behind-the-Counter Drug Class
Appendix I: 

Methodology 

Objectives, Scope, and 

Page 37 GAO-09-245

Appendix I: Objectives, Scope, and 

Methodology 

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,1

 we are updating information we first presented in 

our 1995 report.2

 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 

countries3 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. 

To describe the arguments that have been made supporting and opposing 

a BTC drug class in the United States, we reviewed published literature, 

reports, and meeting minutes of FDA hearings on prescription-to-over-thecounter (OTC) switches, and the transcript of and docket submissions for 

the November 2007 FDA meeting on BTC drug availability.4

 We

interviewed officials at FDA, pharmacy associations, drug manufacturers, 

consumer groups, and industry associations in the United States. We also 

interviewed academics and other officials knowledgeable about 

pharmaceutical practice.

Objectives 

Scope and 

Methodology 

To determine the impact of restricted nonprescription drug classes on 

drug availability, we interviewed experts to ask them to help us identify 

countries that had evaluated drug classification in their countries since 

our 1995 report. Based on this information, we selected 5 of the 11 

 1

While our study defined BTC drugs as those that require the intervention of a pharmacist, 

FDA noted that there may be other models for providing access to these drugs. They stated 

that these may include other health care personnel (e.g., nurse practitioners or physician 

assistants) providing access to BTC drugs in various professional settings. 

2

GAO, Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be 

Demonstrated, GAO/PEMD-95-12 (Washington, D.C.: Aug. 24, 1995), 

www.gao.gov/archive/1995/pe95012.pdf. 

3

In addition to the United States, the study countries are Australia, Italy, the Netherlands, 

and the United Kingdom. We also describe drug classification in the European Union (EU). 

4

One issue that has been raised, but is beyond the scope of this report, is whether FDA has

the regulatory authority to create such a class without a legislative change. 

Behind-the-Counter Drug Class
Appendix I: Objectives, Scope, and 

Methodology 

countries covered in our previous report.5 We also examined drug 

classification in the European Union (EU) because these factors affect 

drug availability in three of our study countries. We reviewed published 

literature, reports, and agency documents on drug classification and 

prescription-to-nonprescription switches. We also interviewed agency 

officials, industry representatives, and others knowledgeable about 

pharmaceutical practices and the relevant laws and regulations in our 

study countries.6

 Although some countries—including the United States—

place additional restrictions on certain prescription drugs, a complete 

analysis of prescription drug classification was beyond the scope of this 

report.7

 For our analysis, all prescription drugs were placed in the same 

class. We examined changes since 1995 in the drug classification systems 

in two study countries (Italy and the Netherlands) that changed the 

number or type of nonprescription drug classes in use. We also 

determined the number of drugs switched from one drug class to another 

(e.g., prescription to BTC) between 1995 and 2008 for the three study 

countries—Australia, the United Kingdom, and the United States—that 

maintained the same number and type of nonprescription drug classes 

during that time. We examined relevant documents and interviewed 

knowledgeable officials in those countries. We counted the first switch of 

a particular drug (e.g., ibuprofen) from one drug class to another that 

occurred after January 1, 1995, but did not count subsequent switches of 

additional products containing the same drug between the same two drug 

classes (except in the case of different nicotine dosage forms such as gum 

and patches) in order to achieve consistency with the World SelfMedication Industry (WSMI) data discussed below.8

 We also did not count 

switches that changed only the allowable dosage, pack size, or indications 

for a drug that had previously been switched. In some cases, a switch in 

one country may have involved a drug that was not approved for use in 

 5

In addition to the United States, in our previous report we examined the drug 

classification systems in Australia, Canada, Denmark, France, Germany, Italy, the

Netherlands, Sweden, Switzerland, the United Kingdom, and the EU (GAO/PEMD-95-12, 

85-103). In this report, the study countries are Australia, Italy, the Netherlands, the United

Kingdom, and the United States. 

6

We did not perform the legal analysis of any laws and regulations of foreign jurisdictions, 

but relied on summaries provided by those jurisdictions. 

7

For example, some prescription drugs classified in the United States as controlled 

substances cannot be refilled and have stricter documentation requirements than ordinary

prescription drugs. 

8

WSMI is a federation of more than 50 member associations representing manufacturers

and distributors of nonprescription medicines. 

Page 38 GAO-09-245 Behind-the-Counter Drug Class
Appendix I: Objectives, Scope, and 

Methodology 

one of the other countries or was not subject to regulation as a drug in 

another country. 

Additionally, we determined the classification of selected drugs in the 

United States and the other study countries. We selected a sample of drugs 

using the WSMI databases that describe the classification status—

prescription or nonprescription—of more than 200 drugs in 36 countries.9

We used the February 1, 2007, tables; these were the most recent tables 

available at the time we were conducting our study. We excluded from the 

list any drugs listed as “not registered” or with a blank entry for Australia, 

the Netherlands, the United Kingdom, or the United States; a sample of 110 

drugs resulted. We examined the survey format used to collect information 

on drug classification and response rates from the most recent survey, and 

determined that the data were sufficiently reliable for our purposes. After 

drawing the initial sample from the WSMI tables, we added Italy to our 

scope. We then determined the classification status of the sample drugs in 

each of the study countries using agency information including

information from knowledgeable agency officials and an examination of 

the Standard for the Uniform Scheduling of Drugs and Poisons No. 22 

(Australia); the Prontuario Farmaceutico Nazionale and the Elenco 

indicativo dei farmaci SOP e OTC in commercio con prezzo in vigore al 

31/12/2006 ai sensi del comma 802 dell’art. 1 Legge 27 dicembre 2006, n. 

296 (Italy); the Medicines Evaluation Board Database Human Medicines 

(Netherlands); List A: Consolidated list of substances which are present in

prescription only medicines (POM), with exemptions for pharmacy sale or

supply (P), List B: Consolidated list of substances which are present in 

authorised medicines for general sale, and List C: Consolidated list of 

substances which are present in authorised products which have been 

reclassified since 1 April 2002 (United Kingdom); the list of Approved Drug 

Products with Therapeutic Equivalence Evaluations, 28th Edition (i.e., the 

Orange Book) (United States); and other agency documents. The data in

these reference documents are standard data sources published by each 

country’s regulatory authority and were sufficiently reliable for our 

purposes. We found that 24 of the 110 drugs in our initial sample were not 

approved in one or more of the five study countries and eliminated these 

drugs from our sample, resulting in a final sample of 86 drugs. We then 

compared the classification of these drugs across the five study countries

 9

Methodology adapted from A. Gilbert, D. Rao, and N. Quintrell, “A Review of

Pharmaceutical Scheduling Processes in Six Countries and the Effect on Consumer Access 

to Medicines,” International Journal of Pharmacy Practice, vol. 14, no. 2 (2006). 

Page 39 GAO-09-245 Behind-the-Counter Drug Class
Appendix I: Objectives, Scope, and 

Methodology 

in order to determine the least restrictive class to which each drug was 

assigned regardless of pack size, dosage, or combination ingredients. 

To identify issues that would be important to the establishment of a BTC 

drug class in the United States, we interviewed officials at FDA, the 

Centers for Medicare & Medicaid Services (CMS), the Department of 

Veterans Affairs (VA), the Indian Health Service (IHS), pharmacist 

associations, drug manufacturers, consumer groups, and industry 

associations. We interviewed academics and other experts knowledgeable 

about pharmacists’ prescribing authority, including individuals who have 

testified to FDA on the possible creation of a BTC drug class in the United

States. We also interviewed agency officials, industry representatives, 

pharmacist association representatives, and others knowledgeable about 

pharmacy practices in our other study countries. We reviewed reports and 

the transcript of and docket submissions for the November 2007 FDA 

meeting on BTC drugs. We also reviewed published, peer-reviewed 

pharmacy practice literature, focusing on articles published since our 1995 

report and relating to the United States or our other study countries. For 

this literature review, we searched 67 databases, including International 

Pharmaceutical Abstracts, EMBASE, Pharmaceutical News Index, Gale 

Group Health & Wellness Database, Pharm-Line, Science Citation Index, 

and MEDLINE. Key search terms used were pharmacy practice, 

pharmacist counseling, pharmacist intervention, pharmacist prescribing 

authority, pharmaceutical care, collaborative practice, medication therapy 

management, drug classification, and drug reclassification. We also 

reviewed literature cited in these studies and studies recommended to us

by those we interviewed.

We conducted our work from March 2008 through February 2009 in 

accordance with all sections of GAO’s quality assurance framework that 

are relevant to our objectives. The framework requires that we plan and 

perform the engagement to obtain sufficient and appropriate evidence to 

meet our stated objectives and to discuss any limitations in our work. We 

believe that the information and data obtained, and the analysis 

conducted, provide a reasonable basis for any findings and conclusions. 

Page 40 GAO-09-245 Behind-the-Counter Drug Class
Appendix II: De

Classificatio

Countries a

scription of Drug 

n Systems in the Five Study 

nd the European Union 

Page 41 GAO-09-245

Appendix II: Description of Drug 

Classification Systems in the Five Study 

Countries and the European Union 

In this appendix, we describe the drug classification systems in our five 

study countries—Australia, Italy, the Netherlands, the United Kingdom, 

and the United States. We also describe drug classification in the EU 

because it affects drug availability in three of our study countries. 

Although the terms used for different drug classes are included for each 

country, a standardized set of terminology is also used to facilitate 

comparisons (see fig. 2).

Figure 2: Definitions and Relative Levels of Restriction for Drug Classes Used in

This Report 

Source: GAO analysis of agency documents from the study countries.

Term used in the report

Prescription drugs

 Prescription

Nonprescription drugs

 BTC

 Pharmacy

 Drugstore

 OTC/pharmacist

 OTC

Definition

Available only from a pharmacist 

or other licensed dispenser upon 

submission of a prescription

Available only in pharmacies; 

contact with pharmacist required

Available only in pharmacies; 

contact with pharmacist not required

Available only in pharmacies or 

drugstores; contact with pharmacist 

not requireda

Available for self-selection in pharmacies and other retail outlets, but 

a pharmacist must be present

Available for self-selection in pharmacies and other retail outlets, including 

those without pharmacists or druggists

Levels of restriction

Most restrictive

Least restrictive

a

In the Netherlands, a distinction is made between pharmacies (run by pharmacists and able to sell all 

prescription and nonprescription drugs) and drugstores (run by druggists with less training than 

pharmacists and able to sell only some nonprescription drugs). 

Australia The Therapeutic Goods Administration within the Department of Health 

and Ageing is responsible for the evaluation and approval of new drugs in 

Australia. The National Drugs and Poisons Schedule Committee makes 

recommendations on the appropriate classification of drugs and is also 

Behind-the-Counter Drug Class
Appendix II: Description of Drug 

Classification Systems in the Five Study 

Countries and the European Union 

responsible for all decisions to switch a drug from one class to another.1

Generally, the committee requires that a drug be marketed for 2 years 

before it will consider allowing it to move to a less restrictive 

classification; applications that do not meet this requirement may be 

considered when sufficient evidence is presented. While each state or 

territory has the authority to determine drug classification independently, 

all states and territories agreed in 2005 to adopt the national scheduling

committee’s decisions in full in order to reduce barriers to commerce in 

Australia.2

Australia has a complex, multilevel classification system for drugs that 

includes 

• Schedule 2 (equivalent to pharmacy), 

• Schedule 3 (equivalent to BTC), 

• Schedule 4 (equivalent to prescription), 

• Schedules 5 and 6 (certain essential oils for human therapeutic use, as well

as household and agricultural chemicals); available without a prescription 

at nonpharmacy outlets, and 

• Schedule 8 (controlled substances for which restrictions on availability are 

necessary to reduce abuse, misuse, or dependence; e.g., opioids and 

amphetamines). 

Additionally, if a substance does not appear in a schedule, it is referred to 

as unscheduled; unscheduled drugs can be supplied to the public from any 

retail outlet (i.e., these are OTC drugs).3

 Schedule 1 (formerly containing a 

number of toxic volatile oils) is not currently in use; Schedule 7 contains 

dangerous agricultural and industrial poisons; and Schedule 9 contains 

 1

The National Drugs and Poisons Schedule Committee also determines the classification of 

agricultural, veterinary, and household chemicals.

2

Rhonda Galbally, National Competition Review of Drugs, Poisons and Controlled

Substances Legislation, Final Report Part A, a special report prepared at the request of 

the State, Territory, and Commonwealth governments of Australia, December 2000, 27. 

3

Except in Queensland and South Australia, where an unscheduled new drug or poison is

deemed to be a prescription drug until the classification is determined by the National 

Drugs and Poisons Schedule Committee. 

Page 42 GAO-09-245 Behind-the-Counter Drug Class
Appendix II: Description of Drug 

Classification Systems in the Five Study 

Countries and the European Union 

substances whose manufacture, possession, sale, or use is prohibited 

except under specific circumstances (e.g., heroin and cannabis).4

The Italian Pharmaceutical Agency (l’Agenzia Italiana del farmaco), an 

autonomous agency under the oversight of the Ministry of Health, 

authorizes the marketing of drugs in Italy. The agency is assisted by the 

Scientific and Technical Committee which evaluates and issues opinions 

on marketing applications. Italy currently has the following drug classes: 

• prescription, and 

• nonprescription.5

All nonprescription drugs in Italy are available for sale in nonpharmacy 

outlets such as supermarkets as long as a pharmacist is on the premises. 

The requirement that a pharmacist be present wherever nonprescription 

drugs are sold means that nonprescription drugs in Italy are in an 

OTC/pharmacist class. However, Italian officials are evaluating the 

possibility of making small packs of some drugs available in nonpharmacy 

outlets without the presence of a pharmacist. 

The agency is also responsible for the decision to switch drugs from one 

classification to another. Switches from prescription to nonprescription 

status are generally initiated by the manufacturer; switches from 

nonprescription to prescription status are much less frequent. Drugs can 

also be switched from prescription to more restrictive classification on 

rare occasions for safety reasons. 

The Medicines Evaluation Board (College ter Beoordeling van

Geneesmiddelen) is responsible for drug approval and classification in the 

Netherlands. The Medicines Evaluation Board is also responsible for 

approving requests to switch a drug; requests for OTC classification must 

be initiated by the company holding the marketing authorization. 

Italy 

Netherlands 

 4

The specific circumstances are when use of the substance is required for medical and 

scientific research, or for analytical, teaching, or training purposes with the approval of the 

Australian government and/or state or territory health authorities. 

5

Italy subdivides its nonprescription drugs into two categories based on whether they can

be advertised to the public; there is no other difference between the two categories. 

Page 43 GAO-09-245 Behind-the-Counter Drug Class
Appendix II: Description of Drug 

Classification Systems in the Five Study 

Countries and the European Union 

The drug classification system in the Netherlands includes four categories: 

• prescription, 

• pharmacy only (equivalent to pharmacy), 

• pharmacy and drugstore (equivalent to drugstore), and 

• general sale (equivalent to OTC). 

The last three categories are all nonprescription and differ primarily in the 

locations at which the drugs are available for sale. OTC classification in 

the Netherlands is based, in part, on a determination of public benefit and 

the risk–benefit profile of the drug. The drugstore class is the default class 

for all nonprescription drugs that do not meet the criteria for pharmacy or 

OTC sale. In the Netherlands, the distinction between drugstore and OTC 

classification is often based on the dosage or pack size; large pack sizes or 

higher dosages of a drug might be restricted to pharmacies and drugstores 

even when smaller pack sizes or lower dosages are available for OTC sale. 

The pharmacy class in the Netherlands is reserved for drugs requiring 

interaction with pharmacy staff although not necessarily a pharmacist; 

agency officials told us that they do not expect to place many drugs into 

this class. At the time of our analysis, six drugs were assigned to the 

pharmacy class: domperidone (to suppress nausea), orlistat (weight loss 

aid), aliskiren (treatment of hypertension), clotrimazole (antifungal agent), 

hexamidine, and dextromethorphan (cough suppressant). 

The Medicines and Healthcare products Regulatory Agency (MHRA) 

within the Department of Health is responsible for drug approval and

classification in the United Kingdom. The United Kingdom continues to 

use the three-tier drug classification system that was in place in 1995. This

system includes 

United Kingdom 

• prescription only (equivalent to prescription), 

Page 44 GAO-09-245 Behind-the-Counter Drug Class
Appendix II: Description of Drug 

Classification Systems in the Five Study 

Countries and the European Union 

• pharmacy (equivalent to BTC),6 and 

• general sale list (equivalent to OTC). 

The presumption under law is that all drugs are restricted to the BTC drug 

class unless they meet the criteria for prescription or OTC status.7

MHRA encourages wider availability of drugs as soon as there is adequate 

evidence of safety in use. Manufacturers or other interested parties can 

initiate switches, which proceed in a stepwise manner (prescription to 

BTC, then BTC to OTC). Experience gained at one level is used to inform 

the decision to switch the drug to the next level. For example, MHRA 

guidelines indicate that substances suitable for OTC classification will 

have been in widespread use in BTC products for many years. Switching to

more restrictive classes can also occur when warranted; this was done for 

large pack sizes of paracetamol in 1998 in an attempt to reduce adverse 

events associated with this drug. 

In the United States, FDA has authority to approve drugs before they are 

marketed, to ensure that they are safe and effective, and to determine 

whether they will be available only by prescription. The United States uses 

a two-class drug system—prescription and nonprescription—established 

by the 1951 Durham-Humphrey Amendments to the Federal Food, Drug, 

and Cosmetic Act.8

 Prescription drugs can be dispensed only with written 

or oral orders (i.e., a prescription) from a licensed prescriber—such as a 

doctor, nurse practitioner, or physician’s assistant—to a pharmacist or 

other licensed dispenser, while nonprescription drugs do not require a 

prescription. Although most nonprescription drugs in the United States are 

publicly available without any restrictions, a few are stored behind the 

United States 

 6

The BTC drug class in the United Kingdom (called pharmacy medicines) has some 

characteristics of both the BTC and pharmacy classes as defined in figure 2. The United 

Kingdom makes these drugs available only in pharmacies under the supervision of a

pharmacist and requires that they be stored behind the counter. The pharmacist establishes

procedures so that all staff involved in the supply of these drugs should know when to refer 

a customer to the pharmacist. Although direct pharmacist–consumer contact is necessary 

for only some of these drugs, the requirement that pharmacists supervise the sale of all 

drugs in this class and store them behind the counter makes this class most similar to a 

BTC class. 

7

The Medicines Act 1968 and EU Directive 2001/83/EC. 

8

Pub. L. No. 82-215, 65 Stat. 648 (1951). 

Page 45 GAO-09-245 Behind-the-Counter Drug Class
Appendix II: Description of Drug 

Classification Systems in the Five Study 

Countries and the European Union 

counter due to refrigeration requirements (e.g., insulin), to monitor 

quantity of purchase (e.g., pseudoephedrine), or are restricted to 

pharmacy sale in order to monitor consumer age (e.g., levonorgestrel). 

Nonprescription drugs are often referred to in the United States as OTC 

drugs. 

Between 1995 and 2007, FDA assigned 99.7 percent (1233 out of 1237) of 

newly approved drugs to the prescription class, with four new drugs—a 

topical herpes simplex treatment, a sunscreen product, a nicotine lozenge, 

and a product to block contact with poison ivy—classified as 

nonprescription. Drugs can be switched from prescription to OTC status in 

a number of ways, including through rulemaking or submission of a 

supplemental new drug application to FDA by the sponsor. In making 

switch decisions, FDA may seek advice from the Nonprescription Drugs 

Advisory Committee, often in conjunction with an appropriate specialty

committee (e.g., the Pediatric Advisory Committee or the Gastrointestinal 

Drugs Advisory Committee). Although not bound by the advisory 

committee’s advice, FDA follows the committee’s recommendation most 

of the time. 

The Pharmaceuticals Unit of the European Commission Directorate 

General for Enterprise and Industry is responsible for approving new 

drugs submitted for marketing throughout the EU, and the European 

Medicines Agency makes a recommendation on whether the new drug 

should receive prescription or nonprescription status. The EU leaves to 

each member state the decision on whether to use subcategories within 

the prescription and nonprescription classes. Pharmacy experts told us 

that European countries have a long tradition of restricting drug sales to 

pharmacies and that about 60 percent of EU countries do not have an OTC 

drug class. 

There are four primary methods to receive marketing approval for a drug 

in the EU. These include national authorization procedures that allow a 

drug to be marketed in a specific country based on an individual 

application and for which the classification decision is made by the 

appropriate national authority, plus three methods that are handled at the 

EU level: 

European Union 

• The centralized approval procedure allows applicants to market an 

approved product throughout the EU with a single application. 

Page 46 GAO-09-245 Behind-the-Counter Drug Class
Appendix II: Description of Drug 

Classification Systems in the Five Study 

Countries and the European Union 

• The mutual recognition procedure can be used to request that a drug 

approval from one EU country be recognized as valid in one or more other 

EU countries. 

• The decentralized procedure allows a company to apply for simultaneous 

approval in multiple EU countries for a drug that is not yet approved in 

any EU country. 

Centralized approval is required for certain categories of drugs, including 

all drugs developed through biotechnology; drugs for the treatment of 

certain diseases, including acquired immunodeficiency syndrome (AIDS), 

cancer, neurodegenerative diseases, diabetes, and autoimmune diseases; 

and orphan drugs.9

 Although most drugs currently on the market in the EU

were originally approved through national authorization procedures prior 

to the development of a centralized approval process, about 95 percent of 

new drugs brought to market are now approved through the centralized 

procedures. The first-ever application for the centralized switch of a drug 

(orlistat) from prescription to nonprescription status, which will make 

orlistat available without a prescription in all EU countries, was recently 

approved.10 Orlistat was granted centralized approval as a prescription 

drug in 1998. 

 9

In the EU, orphan drugs are defined as those intended for the diagnosis, prevention, or

treatment of life-threatening or chronically debilitating conditions that affect no more than

5 in 10,000 people in the EU, or are drugs which, for economic reasons, would be unlikely 

to be developed without incentives. 

10On January 21, 2009, the European Commission approved orlistat (60 mg) for 

nonprescription use in the EU. At the time of this report, nonprescription orlistat was not 

yet available to consumers. 

Page 47 GAO-09-245 Behind-the-Counter Drug Class
Appendix III: Classification of 86 Drugs in 

Australia, Italy, the Netherlands, the United 

Kingdom, and the United States

Ingredient Australia Italy Netherlands United Kingdom United States 

Acetylcysteine OTC OTC/P OTC Rx Rx 

Acetylsalicylic acid OTC OTC/P D OTC OTC

Aciclovir (topical) OTC OTC/P OTC OTC Rx 

Adenosine Rx Rx Rx BTC Rx 

Azelastine P Rx OTC BTC Rx 

Bacitracin (topical) Rx OTC/P Rx Rx OTC 

Beclometasone (nasal) P Rx Rx OTC Rx 

Benzoyl peroxide OTC OTC/P D OTC OTC

Bisacodyl OTC OTC/P D OTC OTC 

Budesonide (nasal) P Rx Rx BTC Rx 

Calcium carbonate OTC OTC/P D OTC OTC 

Cetirizine P OTC/P OTC OTC OTC 

Chloramphenicol Rx Rx Rx BTC Rx 

Cimetidine BTC OTC/P Rx BTC OTC

Clindamycin Rx Rx Rx Rx Rx 

Clotrimazole (topical) OTC OTC/P D OTC OTC 

Clotrimazole (vaginal) BTC OTC/P Rx OTC OTC 

Colestyramine Rx Rx Rx Rx Rx 

Cromoglicic acid P Rx OTC BTC OTC

Cyproheptadine BTC Rx Rx BTC Rx 

Dextromethorphan P OTC/P P BTC OTC

Diclofenac P OTC/P D OTC Rx 

Dimeticone OTC OTC/P Rx OTC OTC 

Econazole OTC OTC/P D BTC Rx 

Epinephrine (not for asthma) (adrenaline) OTC Rx Rx BTC OTC 

Erythromycin (topical) Rx Rx Rx Rx Rx 

Famotidine P Rx D OTC OTC

Fexofenadine P Rx Rx Rx Rx 

Flunisolide (nasal) Rx Rx Rx BTC Rx 

Fluoride (sodium) OTC OTC/P D OTC OTC

Flurbiprofen (lozenges) P OTC/P Rx BTC Rx 

Fluticasone P Rx Rx BTC Rx 

Hydrocortisone (topical) P OTC/P Rx OTC OTC

Hydroxyzine Rx Rx Rx BTC Rx 

Hyoscine (scopolamine) P OTC/P D BTC Rx 

Appendix III: Classification of 86 Drugs in 

Australia, Italy, the Netherlands, the United 

Kingdom, and the United States 

Page 48 GAO-09-245 Behind-the-Counter Drug Class
Appendix III: Classification of 86 Drugs in 

Australia, Italy, the Netherlands, the United 

Kingdom, and the United States

Ingredient Australia Italy Netherlands United Kingdom United States 

Ibuprofen (oral) OTC OTC/P D OTC OTC 

Insulin Rx Rx Rx Rx OTC

Itraconazole Rx Rx Rx Rx Rx 

Ketoconazole (topical) OTC OTC/P Rx OTC OTC 

Ketoprofen BTC OTC/P D BTC OTC 

Ketotifen BTC Rx Rx Rx OTC 

Lactulose OTC OTC/P D BTC Rx 

Levonorgestrel BTC Rx D BTC Pa

Lidocaine (topical/oral topical) OTC OTC/P OTC OTC OTC 

Loperamide P OTC/P OTC OTC OTC 

Loratadine P OTC/P OTC OTC OTC 

Mebendazole P Rx D BTC Rx 

Metoclopramide BTC Rx Rx Rx Rx 

Miconazole (topical) OTC OTC/P D BTC OTC 

Miconazole (vaginal) BTC OTC/P Rx BTC OTC 

Minoxidil (topical) P OTC/P D OTC OTC 

Mometasone (nasal) P Rx Rx Rx Rx

Mupirocin (topical) Rx Rx Rx Rx Rx 

Naproxen P OTC/P D BTC OTC

Nicotine (gum) OTC OTC/P OTC OTC OTC 

Nicotine (oral inhaler) P OTC/P D OTC Rx 

Nicotine (patch) OTC OTC/P D OTC OTC 

Nitroglycerin P Rx Rx BTC Rx 

Nizatidine P Rx Rx BTC OTC

Nystatin P Rx Rx BTC Rx 

Omeprazole Rx Rx D BTC OTC

Orlistat BTC RxbP RxbOTC 

Orphenadrine Rx Rx Rx Rx Rx 

Oxymetazoline P OTC/P D OTC OTC 

Pantoprazole Rx Rx Rx Rx Rx 

Paracetamol OTC OTC/P OTC OTC OTC 

Penciclovir P OTC/P OTC BTC Rx 

Phenylephrine OTC OTC/P Rx OTC OTC

Polymyxin B (topical) Rx OTC/P Rx Rx OTC 

Povidone iodine OTC OTC/P OTC OTC OTC

Pravastatin Rx Rx Rx Rx Rx 

Prednisolone Rx Rx Rx Rx Rx 

Page 49 GAO-09-245 Behind-the-Counter Drug Class
Appendix III: Classification of 86 Drugs in 

Australia, Italy, the Netherlands, the United 

Kingdom, and the United States

Ingredient Australia Italy Netherlands United Kingdom United States 

Prilocaine P Rx D BTC Rx 

Promethazine P OTC/P Rx BTC Rx

Ranitidine P Rx D OTC OTC

Salbutamol BTC Rx Rx Rx Rx 

Selenium sulfide OTC OTC/P D BTC OTC

Silver sulfadiazine 1% Rx OTC/P Rx Rx Rx 

Simvastatin Rx Rx Rx BTC Rx 

Sumatriptan Rx Rx Rx BTC Rx 

Terbinafine OTC Rx OTC BTC OTC

Tetracycline Rx Rx Rx Rx OTCc

Theophylline BTC Rx Rx BTC Rx 

Tretinoin Rx Rx Rx Rx Rx 

Xylometazoline (nasal) P OTC/P D OTC OTC 

Zolmitriptan Rx Rx Rx Rx Rx 

Legend: Rx = prescription; BTC = behind-the-counter; P = pharmacy; D = drugstore; OTC/P = overthe-counter (pharmacist required); OTC = over-the-counter. 

Source: GAO analysis of agency data. 

Note: This table indicates the least restrictive class to which each drug was assigned regardless of 

pack size, dosage, or combination ingredients. Other formulations of a drug may only be available 

under a more restrictive class. For example, in the United States some types of insulin are available 

as prescription drugs and other insulin products are available OTC. 

a

In the United States, levonorgestrel (an emergency contraceptive) may only be sold in pharmacies—

as a nonprescription drug for those 18 and over, and by prescription for those under 18. 

b

On January 21, 2009, the European Commission approved orlistat (60 mg) for nonprescription use in

the EU. At the time of this report, nonprescription orlistat was not yet available to consumers. 

c

In the United States, the topical dosage form of tetracycline is OTC. 

Page 50 GAO-09-245 Behind-the-Counter Drug Class
Appendix IV: Comments from the Department Appendix IV of Health and Human Services : Comments from the 

Department of Health and Human Services 

Page 51 GAO-09-245 Behind-the-Counter Drug Class
Appendix IV: Comments from the Department 

of Health and Human Services 

Page 52 GAO-09-245 Behind-the-Counter Drug Class
Appendix IV: Comments from the Department 

of Health and Human Services 

Page 53 GAO-09-245 Behind-the-Counter Drug Class
Appendix V: 

A

GAO Contact and Staff 

cknowledgments 

Page 54 GAO-09-245

Appendix V: GAO Contact and Staff 

Acknowledgments 

GAO Contact Marcia Crosse, (202) 512-7114 or crossem@gao.gov

In addition to the contact above, Thomas Conahan, Assistant Director; 

Robert Copeland; Cathy Hamann; Karen Howard; Kristen Jones; Marisa 

Lee; and Julian Klazkin made key contributions to this report. 

Behind-the-Counter Drug Class

Acknowledgments 

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