United States General Accounting Office

GAO Report to the Ranking Minority Member,

Committee on Commerce, House of

Representatives

August 1995 NONPRESCRIPTION

DRUGS

Value of a PharmacistControlled Class Has

Yet to Be

Demonstrated

GAO/PEMD-95-12

GAO United States

General Accounting Office

Washington, D.C. 20548

Program Evaluation and

Methodology Division

B-252141 

August 24, 1995

The Honorable John D. Dingell

Ranking Minority Member

Committee on Commerce

House of Representatives

Dear Mr. Dingell:

In response to your request, we are pleased to submit this report assessing the evidence for

creating an additional class of drugs in the United States that would not be for sale outside

pharmacies but would be available without a physician’s prescription. As you requested, to

determine if there are significant benefits or costs from such a class, we review the drug

distribution systems in ten countries and the European Union. The report also reviews the

practice of pharmacy, focusing on pharmacists counseling of patients on the use of

nonprescription drugs.

We are sending copies of this report to interested congressional committees and government

agencies, and we will make copies available to others upon request. If you have any questions

or would like additional information, please call me at (202) 512-3092. Major contributors to this

report are listed in appendix VIII.

Sincerely yours,

Kwai-Cheung Chan

Director for Program Evaluation

 in Physical Systems Areas
Executive Summary

Purpose The classification of drugs in the United States into one of two classes,

prescription or nonprescription, is unique. Other countries have a class of

drugs that is available without a prescription but can be obtained only in a

pharmacy and sometimes can be dispensed only by a pharmacist. To

determine whether the United States would benefit from adding such a

drug class, the Ranking Minority Member of the House Committee on

Commerce asked GAO to examine the drug distribution systems in 10

countries. Because their health care systems differ, their experiences may

not be completely applicable in the United States; however, they can help

inform the debate. Accordingly, this report answers the following

questions: (1) What conclusions can be drawn from studies or reports on

the development, operation, and consequences of different drug

distribution systems? (2) What are the drug distribution systems for the 10

countries? (3) What drug distribution system will be implemented in the

European Union? (4) How does access to nonprescription drugs vary

between the study countries and the United States? (5) How do

pharmacists ensure the proper use of nonprescription drugs? (6) What is

the U.S. experience with dispensing drugs without a physician’s

prescription but only by pharmacists?

Background The United States has very few restrictions on where nonprescription

drugs can be sold. It has been argued that the United States would benefit

from the creation of a pharmacy- or pharmacist-class of drugs.1

 Of two

general views on such a class, the first sees it as a fixed class into which

drugs could be placed permanently with no expectation that they would

eventually be moved into a different class. The second (and the one

generally advocated by proponents of an intermediate class at this time)

sees it as a transition class from prescription to nonprescription: a drug

would spend a period of time in the transition class, during which its

suitability for sale outside pharmacies could be assessed.

Supporters of an additional class of nonprescription drugs argue that,

because pharmacists would be more involved in patients’ selection and

use of nonprescription drugs, such a class would (1) increase the number

of drugs available to consumers without a prescription, (2) reduce drug

misuse, and (3) lower health care costs by reducing the number of visits to

physicians for ailments that could be treated with the wider range of drugs

1

A pharmacy class of drugs is defined as a category of nonprescription drugs that may be sold only in

pharmacies. There are no restrictions on who may sell the product. A pharmacist class of

nonprescription drugs may also be sold only in pharmacies, but unlike the pharmacy class, the

pharmacist must be involved in the sale. In this report, intermediate class refers to either a pharmacy

or pharmacist class.

Page 2 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Executive Summary

that would be available without a prescription. To assess the merits of

these arguments, GAO reviewed the pertinent literature and interviewed or

requested information from national and state government health officials,

representatives of professional and consumer associations, academics,

and pharmacists in the United States, the European Union, Australia,

Canada, Denmark, France, Germany, Italy, the Netherlands, Sweden,

Switzerland, and the United Kingdom.

Results in Brief Little evidence supports the establishment of a pharmacy or pharmacist

class of drugs in the United States at this time, as either a fixed or a

transition class. The evidence that is available tends to undermine the

contention that major benefits are being obtained in the countries that

have such a class. This conclusion is substantiated by six points.

(1) Reliable and valid studies that examine the effect of different drug

distribution systems on overall health and health care system costs do not

exist. (2) While a pharmacy or pharmacist class exists in all 10 countries, it

is not used with any frequency in any of them to facilitate the movement of

drugs to sale outside specialized drug outlets. (3) The European Union has

decided not to impose any particular drug distribution system on its

member countries because it has found no evidence of the superiority of

one system over another. (4) There is no clear pattern of increased or

decreased access to drugs as nonprescription products where a

pharmacist or pharmacy class exists. (5) While a pharmacy or pharmacist

class is assumed by some to improve safeguards against drug misuse and

abuse, in the 10 countries these safeguards are easily circumvented, and

studies show that pharmacist counseling is infrequent and incomplete.

(6) Experience in Florida with a class of drugs similar to a pharmacist

class has not been successful; pharmacists have not regularly prescribed

these drugs, and recordkeeping requirements have not been followed.

GAO’s Analysis

Extant Studies No systematic evidence supports the superiority of one drug distribution

system over another. Studies have not attempted to link different systems

with differences between countries in health care costs, adverse drug

reactions, and quality of care. No studies show that problems or benefits

arise from either restricting the sale of nonprescription drugs to

pharmacies or allowing them to be sold outside pharmacies.

Page 3 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Executive Summary

Drug Distribution Systems All 10 countries restrict the sale of some or all nonprescription products.

France, Italy, and the Netherlands restrict the sale of all nonprescription

drugs to specialized drug outlets, while the 7 other countries allow the sale

of only some nonprescription drugs outside these outlets. No country

limits nonprescription drugs to sale by pharmacists or in pharmacies in

order to assess their suitability for sale outside pharmacies. Instead, drugs

are placed in the pharmacy or pharmacist class with no assurances that

they will eventually be assessed for more general sale.

The European Union has set criteria for distinguishing prescription from

nonprescription products. However, since EU officials could find no

evidence showing the superiority of a particular drug distribution system,

each country will decide the nature and number of its own drug

distribution classes.

Access to Nonprescription

Drugs

There is no consistent pattern across the 10 countries and the United

States on the accessibility of 14 selected drugs. The United States allows

the sale of some of the drugs without a prescription that most of the other

countries restrict to prescription sale. Conversely, the United States

restricts some drugs to prescription sale that most of the other countries

allow to be sold in a pharmacist or pharmacy class.

The United States has fewer community pharmacies per capita than 6 of

the 10 countries, so that restricting the sale of some nonprescription drugs

to community pharmacies in the United States would appear to be

somewhat of a greater inconvenience. However, this could be partially or

completely offset if other outlets such as managed-care and mail-order

pharmacies also sold these products or if new pharmacies opened.

Access could be reduced in the United States if consumers had to request

these drugs from a pharmacist or an employee, as is generally the case in

the other countries. However, even if self-selection were not allowed, if

the intermediate class were used to move drugs out of prescription status

that would not otherwise have been reclassified, access to the drugs

would increase since a prescription would no longer be needed.

The Role of Pharmacists Only in Australia (and only for some drugs in some states) do

requirements that pharmacists counsel customers on nonprescription drug

use explicitly state what information should be discussed. In 3 countries,

pharmacists are expected to provide sufficient information for the proper

Page 4 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Executive Summary

use of nonprescription drugs, but there are no detailed counseling

requirements. Other countries typically require that a pharmacist be aware

of sales, be on the premises when a sale is made, or promote proper drug

use. However, counseling and other pharmacist interventions with

customers often do not occur. Although counseling by pharmacists on the

use of nonprescription drugs has improved, it is often infrequent and

incomplete.

Only in some states in Australia and only for some drugs are pharmacists

required to maintain records on nonprescription drug use. In none of the

countries are pharmacists required to report adverse drug reactions. In

Italy and the United Kingdom, such reports from pharmacists are not

accepted, while in the others pharmacists rarely report these reactions.

Pharmacist associations in the United States and other countries advocate

“pharmaceutical care,” a concept that seeks to expand pharmacy practice

from only dispensing drugs to being more involved in monitoring drug

therapy (for instance, checking for adverse drug reactions).

Pharmaceutical care is being implemented in some community

pharmacies, but even if its value there can be documented, there will still

be reason for debate on the need for an intermediate class.

The U.S. Experience The Florida Pharmacist Self-Care Consultant Law allows pharmacists to

prescribe specific medications without the supervision of a physician.

However, they rarely use this authority and, when they do, seldom follow

the law’s recordkeeping requirements. As in the 10 countries, Florida

pharmacists often gather incomplete information and spend little time in

assessing and responding to their patients’ medical complaints.

Recommendations GAO is making no recommendations in this report.

Agency Comments Officials from the Food and Drug Administration reviewed a draft of this

report and provided written comments (see appendix VI). Their comments

were brief and stated that the report does not address all the changes that

would be necessary for the United States to adopt an intermediate class of

drugs. A comprehensive assessment of all such changes was beyond the

scope of GAO’s work.

Page 5 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Contents

Executive Summary 2

Chapter 1 

Introduction

10

Arguments for and Against an Intermediate Class of Drugs 14

Objectives, Scope, and Methodology 17

Study Strengths and Limitations 20

Agency Comments 21

Report Organization 21

Chapter 2 

Drug Distribution

Systems

22

Studies on the Consequences of Different Drug Distribution

Systems

22

The Number and Type of Drug Classes in the Study Countries 23

Criteria for Classifying Drugs 25

An Intermediate Class as a Transition Class 26

Preventing Abuse 27

The Economics of an Intermediate Class of Drugs 29

Drug Distribution in the European Union 32

Summary 34

Chapter 3 

Access to

Nonprescription

Drugs

36

The Access to Pharmacies and Drugstores 37

The Self-Selection of Drugs 40

The Effect of an Intermediate Class on Drug Classification 42

Summary 43

Chapter 4 

The Practice of

Pharmacy

45

Counseling Requirements on Nonprescription Drugs 45

The Enforcement of Counseling Requirements 48

Studies of Pharmacist Counseling on Nonprescription Drugs 50

Activities of Pharmacists 57

Recent Developments in Pharmacy Practice 60

Summary 65

Chapter 5 

The U.S. Experience

66

Schedule V Controlled Substances and Insulin 66

The Florida Pharmacist Self-Care Consultant Law 68

Pharmacists as Dependent Prescribers 72

Summary 74

Page 6 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Contents

Chapter 6 

Summary and

Conclusions

75

Extant Studies 75

Drug Distribution Systems 75

The European Union 77

Access to Pharmaceuticals 77

Pharmacy Practice 79

The Florida Experience 79

Conclusions 79

Appendixes Appendix I: History of the Intermediate-Drug Class Issue in the

United States

82

Appendix II: Description of Drug Classification Systems in Ten

Countries, Ontario, and the United States

85

Appendix III: Classification of 14 Drugs in Ten Countries,

Ontario, and the United States

104

Appendix IV: Descriptions of Drugs Examined in This Study 110

Appendix V: The Florida Pharmacist Self-Care Consultant Law 116

Appendix VI: Comments From the Food and Drug Administration 122

Appendix VII: Reviewers of This Report 123

Appendix VIII: Major Contributors to This Report 124

Bibliography 125

Glossary 133

Related GAO Products 136

Tables Table 1.1: Arguments for and Against an Intermediate Class of

Drugs

14

Table 2.1: Drug Classes in Ten Countries, Ontario, and the United

States

24

Table 3.1: Number of Community Pharmacies and Drugstores in

Ten Countries, Ontario, and the United States in 1993-94

39

Table 3.2: Self-Service for Nonprescription Drugs in Ten

Countries, Ontario, and the United States

41

Table 4.1: Pharmacist Counseling Responsibilities for

Nonprescription Drugs in Ten Countries and Ontario

47

Table 4.2: Description of Studies of Pharmacist Counseling on

Nonprescription Products in Five Countries and the United

States

51

Page 7 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Contents

Table III.1: Classification of 14 Drugs in Ten Countries, Ontario,

and the United States

104

Figure Figure 1.1: Possible Uses of an Intermediate Drug Class in the

United States

13

Abbreviations

AMA American Medical Association

APhA American Pharmaceutical Association

DIN Drug identification number

EU European Union

FDA Food and Drug Administration

GAO General Accounting Office

GP General public

IHS Indian Health Service

NARD National Association of Retail Druggists

NDMA Nonprescription Drug Manufacturers Association

OTC Over the counter

VA Department of Veterans Affairs

Page 8 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Page 9 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Chapter 1 

Introduction

In the United States, there are essentially two categories of drugs for

distribution: prescription and nonprescription. Nonprescription drugs are

often referred to as over-the-counter (OTC) medications (the terms are

used interchangeably in this report). The term “prescription” has several

meanings but generally refers to the order of a physician to a pharmacist

for the delivery of certain medications to a patient. A prescription drug

may be dispensed to a patient only on the basis of such an order.

Nonprescription drugs are available for general sale without a prescription

by self-service in pharmacies and in nonpharmacy outlets such as grocery

stores, mass merchandisers, gas stations, and restaurants.1

 The principal

factors used to determine the prescription or nonprescription status of

drugs are the margin of safety, method of use and collateral measures

necessary to use, benefit-to-risk ratio, and adequacy of labeling for

self-medication. Nonprescription drug sales were over $13 billion in 1992

and may reach $18 billion by the end of 1995 or 1996 (Covington, 1993, p.

xxv). The importance of these medicines is growing, partly as a result of

the reclassification of some commonly used drugs from prescription to

nonprescription status.2

The two-tier system in the United States is unusual. Other countries

typically have either more or different categories. There can be limitations

on where and by whom a nonprescription drug can be sold. In some

countries, the sale of some or all nonprescription drugs is restricted to

pharmacies. Additionally, in some countries, certain nonprescription

products have to be dispensed personally by a pharmacist.

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

Cosmetic Act of 1938 provided the statutory basis for the two-tier drug

classification system in the United States. Since that time, there have been

a number of proposals to introduce a third category of drugs in the United

1

There are several exceptions to the two-class system. First, in some states selected schedule V

controlled substances are available without a prescription but must be dispensed by a pharmacist.

(Controlled substances are psychoactive drugs regulated under the Controlled Substances Act on the

basis of their abuse potential, medical acceptance, and ability to produce dependence.) Second, insulin

is a nonprescription product in some states but can be dispensed only by a pharmacist. Third, in

Florida pharmacists can prescribe a limited number of prescription drugs without a prescription

having been written by another health professional. Fourth, in some states pharmacists have

“dependent” prescribing authority in which typically they can prescribe drugs under protocols

established by supervisory physicians. These exceptions are discussed in chapter 5.

2

This is commonly referred to as switching. Between 1976 and July 1995, FDA switched 55 drug

products. The pace of drug switches has increased in the past 10 to 15 years and the current pace is

expected to continue. When a drug becomes available without a prescription, it is sometimes sold for

different ailments and at different strengths than it was as a prescription product. For example,

ibuprofen was prescribed for chronic arthritis in 400 mg and larger doses. As an OTC product, it is

marketed as a general pain reliever and is available only in doses of 200 mg or less. In these situations,

the prescription product remains available as well.

Page 10 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Chapter 1 

Introduction

States. These proposals have been called by a number of names, including

pharmacist-legend, pharmacist-only, third class of drugs, and transition

class. Although there is some variation between them, the basic idea is the

same: a class of drugs would be established that would be available only in

pharmacies but no prescription would be needed. One variation is that the

pharmacist would have to be personally involved in the sale of a drug in

this class; a sales clerk could not sell the drug without the permission of

the pharmacist. (For additional information on the history of this issue in

the United States, see appendix I.)

There are two general views on how an additional class of drugs would be

used in the United States. The first, and the one advocated in the past by

various pharmacist organizations such as the American Pharmaceutical

Association (APhA) and the California Pharmacists Association, sees it as a

permanent class. It would be similar to the current classes in that drugs

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

eventually be moved to the prescription or nonprescription class. Drugs in

the new class would be thought not to be appropriate for use without

some supervision by a health professional but a physician’s oversight

would not be necessary. Drugs in this middle class could come from either

the prescription or nonprescription classes, although it is generally

believed that they should come from the prescription class. Opponents of

this proposal have included the Nonprescription Drug Manufacturers

Association (NDMA) and the American Medical Association (AMA).

The second, advocated first in 1982 by the National Association of Retail

Druggists (NARD) and currently supported by such groups as APhA and the

National Consumers League, sees the intermediate class as a transition

class. A drug that was being switched from prescription to nonprescription

status would spend a period of time in the transition class, during which

the suitability of the drug for general sale could be assessed.3

 The

assessment could be based not only on experiences with the drug as a

prescription product (as is currently done) but also on experiences with

the drug in the transition class, where it would not be limited to

prescription sale. The argument is that this would give a better picture of

how the drug would be used if it were available for general sale (that is,

without a prescription and outside of pharmacies). 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 the end of a

3

The length of time a drug would spend in the transition class has not been specified, although Penna

(1985) gives 5 years as a possibility.

Page 11 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Chapter 1 

Introduction

specified period, the Food and Drug Administration (FDA) would decide to

switch the drug to the general sale class, return the drug to prescription

status, or keep the drug in the transition class for further study.4

 This

proposal has also been opposed by, among others, NDMA and AMA.

The effect of an intermediate class of drugs in the United States would

depend on whether the drugs in it would come from the prescription or

general sale class. Figure 1.1 illustrates the several ways an intermediate

drug class might function in the United States.

4

This report uses the following definitions:

—Fixed, intermediate class = a class of nonprescription drugs into which pharmaceuticals would be

permanently placed. The sale of these drugs would be restricted to sale either in pharmacies or by

pharmacists.

—Transition class = a class of nonprescription drugs into which a drug could be temporarily placed

while its suitability for less restrictive sale was being assessed. As proposed in the United States, drugs

in the transition class would be available for sale without a prescription but only from a pharmacist.

The class would be used for assessing the appropriateness of selling a drug in any retail outlet.

—Intermediate class = a general term encompassing both a fixed, intermediate class and a transition

class.

—Pharmacist class = a class of nonprescription drugs that can be sold only in pharmacies and if the

pharmacist is personally involved in the sale.

—Pharmacy class = a class of nonprescription drugs that can be sold only in pharmacies, but the

pharmacist does not have to be personally involved in the sale. The distinction between a pharmacy

class and a pharmacist class is relevant for both a fixed, intermediate class and a transition class.

—General sale class = a class of nonprescription drugs available for sale outside pharmacies and

drugstores.

Page 12 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Chapter 1 

Introduction

Figure 1.1: Possible Uses of an

Intermediate Drug Class in the United

States

Intermrdiate

class

Prescription

class Nonprescription

General Sale

C

A B

C

Transition Class

Fixed Class

Intermediate

class

Note:

A = If the intermediate class were viewed as a fixed class, it would primarily be used to switch

prescription drugs into it rather than into the unrestricted sale category. The intermediate class

would increase access by removing the need for a prescription in order to purchase the product

but sales would be restricted to pharmacies or by a pharmacist.

B = If it were determined that a nonprescription drug available for general sale should be more

restricted, it could be moved to the intermediate class rather than to the prescription class. The

intermediate class would be used to decrease access to the drug by providing safeguards (for

instance, sale only in pharmacies) that are not available if there are no restrictions on the sale of

the drug.

C = If the intermediate class were viewed as a transition class, a prescription drug would be

switched into it for a period of time and then reassessed to determine if sale should be allowed

outside pharmacies. The intermediate class would be used to allow nonprescription access to

drugs but would include the safeguard of pharmacist counseling and the assessment of safety for

future switching to the general sale class.

Page 13 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Chapter 1 

Introduction

Arguments for and

Against an

Intermediate Class of

Drugs

Arguments for and against an intermediate class of drugs fall into two

general (but sometimes related) categories: health and economic. Table

1.1 lists some of the arguments that have been put forth in support of and

opposition to an intermediate class of drugs. Most of the arguments are

relevant for both a fixed and a transition class. The principal difference

between a fixed and a transition class is not the benefits and costs that

would ensue but their goals. The goal of a transition class in the United

States would be to facilitate the movement of drugs into the general sale

category. The goal of a fixed class would be to place drugs permanently in

the class.

Table 1.1: Arguments for and Against an Intermediate Class of Drugs

For Against

With the establishment of a transition class, consumers would have

access to more pharmaceuticals without a prescription.

Medications formerly available only by prescription would become

available earlier without a physician’s prescription but with

pharmacists’ counseling (National Consumers League, 1991).a This

argument, made specifically in support of a transition class, could

also be made for a fixed class. Advocates of a transition class

further state that drugs would be moved only from prescription

status into the intermediate class; current OTCs would not be

moved into it. (Fixed- class proposals did not address this issue)

The NDMA president (Cope, 1984) has argued that access to

nonprescription products would decrease because the

intermediate class would be limited to sale in pharmacies: there

are approximately 54,000 U.S. community pharmacies but over

750,000 stores that sell nonprescription products.b NDMA has not

uniquely addressed the transition class proposal. Instead, it has

grouped it with the proposals calling for a fixed class and stated

that both will restrict access to some nonprescription drugs.

NDMA argues that current OTCs could be moved into the

intermediate class under any of these proposals

APhA has stated that customers could use the expertise of

pharmacists, well trained in pharmacology, as an added resource

on nonprescription drug use, drug interactions, and other factors.

This is relevant for both a fixed and a transition class

Industry officials have noted that pharmacists’ counseling is

infrequent and sometimes incorrect and this would not change

with an additional drug class; in addition, a new class of drugs is

not needed for pharmacists to give counseling. This is relevant for

both a fixed and a transition class

APhA officials have stated that because of their training,

pharmacists can a play a useful role in helping customers assess

their medical needs and determining whether a physician’s visit is

necessary. Through this advice, visits to physicians for minor

ailments would decrease and physicians would have more time for

patients with serious illnesses. In addition, patients would not have

to go to the doctor for a medication previously available only by

prescription, so the cost of the physician’s visit would be saved.

This is relevant for both a fixed and a transition class

NDMA has stated that only physicians possess the skills

necessary for diagnosing and treating illnesses; pharmacists

could not replace physicians.c A visit to the physician can be not

merely to receive a drug but also to be diagnosed. Improper

diagnosis can lead to symptoms being treated and the patient

feeling better but, because of the lack of a physician’s diagnosis,

what was treated might not be the true underlying cause.

Improper treatment could have serious and expensive

consequences, thereby negating the savings from not visiting a

physician. For example, an antiulcer medication might make the

patient feel better but the underlying cause might be not an ulcer

but stomach cancer. This is relevant for both a fixed and a

transition class

National Consumers League officials have stated that an

intermediate class facilitates the giving of advice to individuals who

cannot read drug labels or have difficulties understanding them.a

This is relevant for both a fixed and a transition class

Consumers practice self-medication responsibly. NDMA has

stated that consumers read and understand drug labels, which

contain all the information they need. This is relevant for both a

fixed and a transition class

(continued)

Page 14 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Chapter 1 

Introduction

For Against

Proponents state that until consumers learn how to properly use

recently switched drugs, pharmacists should be particularly

accessible for them because of their high potential for toxicity and

abuse. While this argument holds for both a fixed and a transition

class, it is most relevant for the latter because of the implication that

once there is more experience with these drugs as nonprescription

products, pharmacists will not have to be involved in their sale

NDMA has stated that drugs unsafe for unsupervised use by

consumers on the basis of their labeling directions should be

prescription products; they should not be available for

nonprescription sale even with pharmacist counseling.d

Opponents have also argued that there have been no problems

with already switched drugs; they have not been abused or

caused widespread toxicity. This is relevant for both a fixed and a

transition class

Penna writes that pharmacists could provide FDA postmarketing

surveillance information on misuse, adverse reactions, and the

extent of the use of a drug as a nonprescription product.e This

would be useful information for both a fixed and a transition class; it

is most relevant for the latter because of the use of the class to

facilitate and better assess the appropriateness of switching drugs.

This information could be used to determine whether to allow sales

in any retail outlet, keep the drug in the intermediate class, or return

it to prescription status

NDMA president Cope writes that the current two-tier system

works well; an additional class is not necessary to ensure safety.b

If they wish, consumers can go to pharmacies for advice but are

not compelled to do so (NDMA, 1992). This is relevant for both a

fixed and transition class

Proponents argue that when necessary, recalls of nonprescription

products would be facilitated since there would be fewer outlets

from which to recall intermediate-class drugs. APhA officials have

stated that pharmacists have a commendable record in facilitating

drug recalls. This is relevant for both a fixed and a transition class

Opponents argue that FDA and the pharmaceutical industry have

an excellent record in recalling products from both pharmacy and

nonpharmacy outlets. Thus, an intermediate class is not needed

for this purpose. This is relevant for both a fixed and a transition

class

Proponents have argued that abuse of nonprescription drugs would

be reduced because a pharmacist would check if the drug and

quantity being purchased were appropriate. Pharmacists could

educate consumers on proper drug use. This is relevant for both a

fixed and a transition class

Opponents argue that an intermediate class would not be

effective in preventing abuse since it would not address the

underlying problem and would represent only a small

inconvenience in obtaining the product. In addition, they argue

that the abuse of OTCs is often localized and generally sporadic

and subsides after a short period. Consumer education at the

local level is the best approach to solving these problems. This is

relevant for both a fixed and transition class

More drugs would be available without a prescription because of

the safeguard of restricting sale to pharmacies or by a pharmacist;

proponents argue that health care costs would decrease because

the nonprescription version of a drug is generally less expensive

than the prescription version. This is relevant for both a fixed and

transition class

Opponents argue that because of restricted competition and

pharmacists’ wanting to be compensated for counseling, the price

of intermediate-class drugs would be higher than if they had been

made nonprescription in the current two-tier system, without any

corresponding benefit to consumers or the health care systemc

aNational Consumers League, Taking Your Medicine: Providing Consumer Safeguards

(Washington, D.C.: September 1991).

bJ. D. Cope, “A Third Class of Drugs Would Release a New Flood of Problems,” Pharmaceutical

Executive, September 1984, pp. 42-43.

cNonprescription Drug Manufacturers Association, National Consumers League Symposium on

Transition [Third Class] of Drugs: An NDMA Response (Washington, D.C.: 1992).

dNonprescription Drug Manufacturers Association, Self-Medications’ Role in U.S. Health Care: A

Briefing Book (Washington, D.C.: 1993).

eR. P. Penna, “A Transition Category: How APhA’s Policy Would Work,” American Pharmacy,

NS25 (1985), 46-47.

Page 15 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Chapter 1 

Introduction

Many of the arguments for an intermediate class of drugs suggest that the

quality of health care would improve if pharmacists’ involvement were

greater. Proponents such as APhA argue that pharmacists are well trained in

pharmacology and that their expertise is underused. They could play an

important role in improving drug use. It is argued further that making use

of this expertise is especially important for recently switched drugs whose

potential for widespread abuse and toxicity is great. In the case of a

transition class, Penna (1985) writes that pharmacists would be in a

position to aid FDA in its switch decisions by maintaining records of the

medications they dispense and by providing access to them to researchers

assessing the safety and efficacy of these drugs. They might also be

encouraged or required to report adverse drug reactions and be involved

in postmarketing evaluation studies. Currently, FDA derives this

information only from the use of drugs as prescription products.

Some arguments against an intermediate class of drugs come from

industry officials who have argued that while pharmacists have useful

information to pass on to consumers, an intermediate class is not

necessary for tapping into it. If customers are interested in getting advice

from pharmacists, they can go to a pharmacy and ask for it but are not

forced to do so. They also note some difficulties with an increased role for

pharmacists. Counseling for nonprescription products is infrequent and

sometimes inappropriate, and they argue that this would not change with

the establishment of an intermediate class of drugs. In addition,

consumers use nonprescription drugs responsibly. They read and

understand drug labels. There is nothing for the pharmacist to add. NDMA

agrees that pharmacists are well-trained in pharmaceuticals but believes

that they are not trained in other roles—in particular, diagnosing illnesses

(NDMA, 1992). Only physicians have this training and should be performing

this role. Improper diagnosis could lead to treating symptoms rather than

the underlying cause of an illness. Finally, opponents argue that the

current two-tier system works well (NDMA, 1992). It is simple and effective.

Either a drug is safe enough to be taken without medical supervision or it

is not. There is no need for an intermediate class of drugs.

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Introduction

Objectives, Scope,

and Methodology

Objectives To find out whether there would be significant advantages to creating an

additional class of drugs, the Ranking Minority Member of the House

Committee on Commerce asked us to examine the operation of drug

distribution systems in 10 countries that have a pharmacist or pharmacy

class of drugs and to compare these systems with that in the United States.

To respond to this request, we posed specific evaluation questions:

1. What conclusions can be drawn from studies or reports on the

development, operation, and consequences of different

multiple-classification drug distribution systems?

2. What are the drug distribution systems for the 10 countries?

3. What drug distribution will be implemented in the European Union?

4. How does access to nonprescription drugs vary between the study

countries and the United States?

5. How do pharmacists ensure the proper use of nonprescription drugs?

6. What is the U.S. experience with dispensing drugs without a physician’s

prescription but only by pharmacists?

Our purpose was to learn generally about factors that affect drug

distribution in other countries and, in particular, about the perceived costs

and benefits of a pharmacist or pharmacy class of drugs. This can raise

important issues about the desirability or usefulness of such a class of

drugs in the United States. By studying other countries, it is possible to

bring empirical data to the debate.

Scope We examined the drug distribution systems in Australia, Canada,

Denmark, France, Germany, Italy, the Netherlands, Sweden, Switzerland,

and the United Kingdom. (See appendix II.) As requested, we also studied

the harmonized system for the members of the European Union (EU).5

 We

5

The 15 members of the European Union are Austria, Belgium, Denmark, Finland, France, Germany,

Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United

Kingdom.

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Introduction

examined the classification of the following 14 drugs: aspirin, cimetidine,

codeine, diclofenac, diflunisal, ibuprofen, indomethacin, naproxen,

phenylpropanolamine, promethazine, ranitidine, sulindac, terfenadine, and

theophylline. (See appendix III and IV.) We chose these drugs because

they either are past switches or have been suggested as candidates for

switching in the United States or another country.

We focused on an intermediate class of drugs as it has generally been

discussed in the United States and practiced in other countries—that is, a

class of nonprescription drugs available only in pharmacies or from a

pharmacist. We did not assess the more general notion of pharmaceutical

care, although we discuss it briefly in chapters 4 and 5.6

 An intermediate

class of drugs might be considered one form of pharmaceutical care. While

some arguments and evidence regarding pharmaceutical care are therefore

relevant for an intermediate class of drugs, a complete evaluation of

pharmaceutical care was beyond our scope.

Methodology To determine what is known about the operation of drug distribution

systems that include a pharmacist or pharmacy class of drugs, we

examined extant information and gathered expert opinion on six general

issues. (1) The findings of studies on the health and economic effects of a

pharmacist or pharmacy class. (2) The experiences of other countries and

the European Union with a pharmacist or pharmacy class, including its

use to move a drug to a general sale class, its usefulness in preventing drug

abuse, and its effect on drug expenditures. (3) The effect on consumers’

access to nonprescription drugs of restricting their sale to pharmacies or

personal sale by pharmacists. (4) The role of pharmacists in the study

countries and the United States and the findings of studies on pharmacist

counseling for nonprescription drugs. (5) The limited experience in the

United States of pharmacists prescribing drugs without a physician’s

involvement and of restricting some nonprescription drugs to sale only by

pharmacists.

We gathered information from a number of sources and used several data

collection methods. We did not do independent analyses of data bases.

Literature Review We conducted computerized literature searches on the following topics:

(1) drug distribution systems in the study countries, (2) the behavior of

6

Pharmaceutical care involves pharmacists “designing, implementing, and monitoring a therapeutic

plan, in cooperation with the patient and other health professionals, that will produce specific

therapeutic outcomes” (Klein-Schwartz and Hoopes, 1993, p. 11).

Page 18 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
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Introduction

pharmacists, (3) the classification of the 14 drugs, (4) the advantages and

disadvantages of an intermediate class of drugs, and (5) assessments of

the health and economic effects of different drug distribution systems.

Interviews With U.S.

Experts and Officials

We conducted interviews with officials of FDA involved in the regulation of

prescription and nonprescription drugs, pharmacy associations, drug

manufacturers, consumer groups, and drug manufacturer associations. We

also interviewed academics who have written on this subject. In addition,

we met with officials and academics in Florida to discuss their

experiences with the Florida Pharmacist Self-Care Consultant Law (see

appendix V).

Country Studies We requested information from government and pharmacy association

officials in the 10 study countries. Because Canada’s individual provinces

have a great deal of power over drug distribution, we also requested

information from officials in Ontario.7

 We sought to gather descriptive

information on the drug distribution system in each country, including

criteria for drug classification, the classification of the 14 drugs,

requirements for pharmacist counseling, and liability issues.

To obtain more in-depth information about the systems and experiences of

particular countries, we traveled to Australia, Canada, Germany, the

Netherlands, Switzerland, and the United Kingdom. We chose these

countries because each allows the sale of some drugs outside pharmacies.

The extensiveness of this general sale class varies greatly between

countries; however, it was important to assess the experiences of

countries where at least some drugs are available in the same manner as in

the United States. We met with government officials, industry and

pharmacy representatives, and other individuals knowledgeable about

drug distribution in each country. The trips also allowed us to gather the

views of a wider range of people than we contacted by mail, such as

consumer groups, physicians’ associations, drug manufacturers, and

academics. We also visited officials in Brussels, Belgium, to understand

the rationale behind the decisions of the European Union regarding drug

distribution in the member countries.

We conducted our evaluation between February 1993 and December 1994

in accordance with generally accepted government auditing standards.

7

We chose Ontario because it is the most populous Canadian province and the distribution system

there is typical of (although not exactly the same as) the systems in other provinces.

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Introduction

Study Strengths and

Limitations

Although studies have examined individual drug distribution systems, we

found that little effort has been made to systematically compare systems.

Our study brings together information about the drug distribution systems

in 11 countries (including the United States), Ontario, Canada, and the

European Union. In addition to describing the systems, we examine the

accessibility of nonprescription drugs in the study countries and the

United States, describe the role of pharmacists in the countries, and assess

evidence for implementing a class of nonprescription drugs available only

from pharmacies (or personally from a pharmacist) in the United States.

This information allows the assessment of the operation of a pharmacist

or pharmacy class of drugs in the study countries as well as raises issues

that would have to be addressed if such a class of drugs were considered

in the United States.

One important difference between the United States and the other

countries limits the lessons that can be learned. In all the countries other

than the United States, there is some government provision of health care

to the general public or universal health insurance through the private

sector but regulated by the government. Thus, the context in which drugs

are acquired, sold, and paid for can be quite different in these countries

from that in the United States. If the barriers to obtaining a prescription

drug in these countries are smaller than in the United States because

individuals do not directly pay for physician visits and drugs prescribed in

them, there may be less incentive there to purchase nonprescription

products.

Another limitation is that the available data did not allow us to directly

assess the effect of a pharmacy or pharmacist class on adverse drug

effects, quality of care, and cost of drugs to the consumer and health care

system. Instead, we had to rely on the assessments of government

officials, association representatives, and other experts in each country.

We also did not examine in great detail the individual drug classification

decisions made in each country. That is, we did not examine the

documentation that supports particular classification decisions to assess

how decisionmaking varies between countries. Additionally, because of

cost and resource limitations, we did not visit every country included in

the study. (We did not travel to Denmark, France, Italy, and Sweden.)

Finally, because our focus is on the experiences of other countries and

what can be learned from them, we did not assess the principal reason FDA

has given for not establishing an intermediate class of drugs—namely, that

a public health need for such a class in the United States has not been

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Introduction

demonstrated. Consequently, we did not address issues such as the

frequency of adverse effects for nonprescription drugs in general and,

more specifically, for recently switched drugs in the United States.

Agency Comments Officials from FDA reviewed a draft of this report and provided written

comments (see appendix VI). They stated that the report does not consider

certain additional requirements establishing an intermediate class of drugs

would impose upon FDA, drug manufacturers, or pharmacists such as new

FDA labeling requirements and additional training of pharmacists. The

report discusses other potential additional requirements for pharmacists in

chapters 2, 3, and 5. However, we did not attempt to address all additional

requirements because a comprehensive assessment was beyond the scope

and objectives of our report. An assessment of the additional requirements

for FDA and drug manufacturers was also beyond our scope.

Report Organization The following chapters address each of the five evaluation questions.

Chapter 2 summarizes studies that have assessed the effects of different

drug distribution systems and describes the drug distribution systems in

the 10 countries as well as officials’ views on the operation of their

systems. It also describes the system in the European Union. Chapter 3

presents information on access to nonprescription drugs in the study

countries, including the classification of the 14 drugs. Chapter 4

summarizes the role of pharmacists in each country and examines studies

of pharmacists’ behavior in the study countries and the United States.

Chapter 5 examines the U.S. experience, focusing on Florida with its

Pharmacist Self-Care Consultant Law. Chapter 6 summarizes our findings

and presents conclusions.

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Drug Distribution Systems

Drug distribution systems differ from country to country. In this chapter,

we summarize information from studies on the consequences of the

different systems. To show how the United States differs, we describe the

drug distribution systems for the 10 countries and the European Union.

Our purpose is to identify the countries that have a pharmacist or

pharmacy class of drugs and examine possible benefits that the United

States does not receive because they have such a class and the United

States does not. Specifically, we answer the following questions:

1. What conclusions can be drawn from studies or reports on the

development, operation, and consequences of different drug distribution

systems?

2. What is the structure of the drug distribution system in each country?

3. What are the criteria for the initial classification, and subsequent

classification changes, of a given drug product in each country?

4. To what extent is the pharmacist or pharmacy drug class used as a

transition class for drugs being moved from prescription to general sale?

5. How effective is a pharmacist or pharmacy class in preventing the abuse

of drugs?

6. What is the effect on expenditures on a drug when the drug is switched

from prescription to nonprescription status?

7. What drug distribution system will be implemented in the European

Union?1

Studies on the

Consequences of

Different Drug

Distribution Systems

Little or no analysis has been done to show the advantages and

disadvantages of different drug distribution systems. For example, as of

March 1995, researchers had not attempted to determine how differences

in drug distribution systems may affect health care costs. A number of

studies have found significant differences in prescription drug prices

across countries, both at the retail and manufacturers’ level. However, as

the costs of production and distribution make up only a small share of the

total cost of any prescription drug, it is unlikely that differences in

distribution systems are major sources of country-by-country differences

1

A major argument made in favor of a pharmacist or pharmacy class of drugs—the counseling role of

pharmacists—is addressed in chapter 4.

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Drug Distribution Systems

in drugs prices (GAO, 1994a, p. 29). The effect of different drug distribution

systems on nonprescription drug prices has not been assessed.2

Similarly, no studies have attempted to link the type of drug distribution

system in a country to the frequency of adverse drug reactions or have

attempted to relate different drug distribution systems to the quality of

health care.

The studies that have been done focus on the experiences of a single

country when switching specific drugs and do not attempt to assess the

merits of alternative drug distribution systems (Andersen and Schou, 1993;

Bytzer, Hansen, and Schaffalitzky de Muckadell, 1991; Halpern,

Fitzpatrick, and Volans, 1993; Hansen, Bytzer, and Schaffalitzky de

Muckadell, 1991; Hopf, 1989; Perry, Streete, and Volans, 1987; Ryan and

Yule, 1990; and Temin, 1992). While some researchers have found health

and economic benefits to switching specific drugs in a particular country,

no attempt has been made to determine what the effects would have been

under a different drug classification system. For instance, would cough

and cold remedies have been switched earlier in the United States if an

intermediate-drug class had been available? If so, what would the benefits

have been? If not, are there costs (for instance, adverse drug reactions)

that would have been avoided if they had been switched into an

intermediate class? There are also no studies that explicitly attempt to link

the drug distribution system with the switching of specific drugs. In sum, it

is necessary to examine other data to assess how a new class of drugs in

the United States might operate.

The Number and Type

of Drug Classes in the

Study Countries

Table 2.1 summarizes the drug classes in the 10 countries, Ontario, and the

United States. Note that in the Netherlands and Switzerland, a distinction

is made between pharmacies and drugstores. Pharmacies are run by

professionals with university degrees in pharmacy. All nonprescription

drugs can be sold in pharmacies and prescriptions can be dispensed.

Conversely, in drugstores, the principal “drug expert” is the druggist.

Although some training is required to become a druggist, it is not

university-based and is not as extensive as that for a pharmacist. In

2

The only comparative information we identified on nonprescription drugs costs, drawn from OTC

News, indicated that of 6 countries examined, the United States had the lowest percentage markup

(33 percent) from manufacturers’ price to retail price (“Editorial,” 1993, p. 391). The figures do not

indicate why the differences existed and whether there was a difference in the average markup for

drugs restricted to sale in pharmacies and those available for general sale (in countries that have both

distribution classes). Moreover, these results do not necessarily mean that the United States has the

lowest nonprescription drug prices, since manufacturers’ prices may vary between countries. The 6

countries were France, Germany, Italy, the Netherlands, the United Kingdom, and the United States.

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Drug Distribution Systems

contrast to pharmacies, prescription drugs cannot be dispensed in

drugstores, nor can all nonprescription drugs be sold there.

Table 2.1: Drug Classes in Ten Countries, Ontario, and the United States

Country Prescriptiona Pharmacistb Pharmacyc Drugstored General salee

Australia x x x x

Canadaf x x x

Ontario x x x x

Denmark x x x

France x x

Germany x xg x

Italy x x

Netherlands x xg x

Sweden x x x

Switzerland x x x x

United Kingdom x xg x

United States x x

aPrescription = class of drugs available only with a prescription. Some countries have multiple

classes of prescription drugs. For instance, in some countries, refillable prescriptions are not

allowed for certain prescription drugs. For our purposes, it is sufficient to combine these

categories into a single prescription class.

bPharmacist = class of drugs available without a prescription but the pharmacist must be involved

in a sale. Involvement may be defined as loosely as being on the premises when the sale is

made.

cPharmacy = class of drugs available without a prescription but only in pharmacies. The

pharmacist does not have to be involved in a sale.

dDrugstore = class of drugs available without a prescription but only in pharmacies or drugstores.

In some countries, pharmacies and drugstores are distinguishable drug outlets. A pharmacist

does not have to be employed at a drugstore. Instead, it is sufficient for someone with less

training to be the “drug expert.” Fewer drugs are available in drugstores than in pharmacies.

eGeneral sale = class of drugs available without a prescription and outside pharmacies and

drugstores.

f

The federal government classifies a drug as either prescription or nonprescription. Each province

determines where the drug can be sold in that province. However, the federal government does

recommend whether the drug should be available outside pharmacies. Because of this, we list

three drug classes at the national level in Canada.

gThe name of this class is “pharmacy restricted” in Germany, “pharmacy-only products” in the

Netherlands, and “pharmacy medicines” in the United Kingdom. We list these classes here under

pharmacist class because the requirements to sell drugs in these classes fit our definition of

pharmacist class rather than pharmacy class.

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Drug Distribution Systems

In Australia, Canada, and Switzerland, some of or all the power for

classifying drugs for distribution rests with the states, provinces, or

cantons rather than the national government. For our purposes, it is

sufficient to note that drug classification is rather uniform throughout

Australia and Switzerland and, therefore, we categorize these systems as

being national rather than local. In Canada, since the number of drug

classes and classification decisions varies greatly between provinces, we

present information on Ontario as well as the national government.3

As table 2.1 shows, the two-tier system in the United States is unique. All

the other countries restrict the sale of at least some nonprescription drugs

to pharmacies. France, Italy, and the Netherlands do not allow the sale of

any drugs outside pharmacies or drugstores. Although some drugs are

available for sale outside pharmacies in Denmark, Germany, Sweden, and

Switzerland, this general sale class is quite small.4

 In Australia, Canada

(including Ontario), and the United Kingdom, the general sale class is

larger than in these 4 countries but smaller than in the United States.

The general rationale for restricting the sale of nonprescription drugs is

the same in all the countries. Drugs are not typical consumer products.

The dangerous aspects to them means they should be treated accordingly.

A pharmacist can help provide guidance to patients on the proper use of

the drugs and, thereby, reduce the possibility of adverse effects.5

Criteria for

Classifying Drugs

All 10 countries and the United States generally use a drug’s safety,

efficacy, and quality for approving it. Each country then uses related

criteria for determining the drug’s distribution class. For instance, among

the criteria the United Kingdom uses when switching a drug from

prescription to pharmacist class is that the medicine has an acceptable

margin of safety during unsupervised use, including safety in overdose or

following accidental misdiagnosis. Officials in the United Kingdom also

3

There is currently an effort in Canada to harmonize the drug distribution regulations among the

provinces. The proposal calls for four classes: prescription, pharmacist, pharmacy, and general sale.

4

For instance, in Denmark this class is limited to such items as vitamins, certain medicines for animals,

and anthelmintics (that is, medicines for killing or ejecting intestinal worms).

5

The origins of restricting drugs to sale in pharmacies dates back hundreds of years. For instance, in

Germany between the 14th and 18th centuries pharmacists were given exclusive rights to market drugs

and other products such as sugar, spices, liquors, wine, tobacco, coffee, and chocolate in order to

ensure a livelihood to pharmacists. Over time, the exclusive rights to sell products became

increasingly limited to medicines. However, the rationale for these restrictions remained the same: to

protect the pharmacies on behalf of the public welfare. In the 17th century, apothecaries were given

exclusive right to sell medicines in Britain. (See Sonnedecker, 1976.) More information on current drug

classification systems is in appendix III.

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Drug Distribution Systems

told us that when making classification decisions, they take into account

the role that pharmacists are expected to play. Among the criteria

Denmark uses is that the drug should be available by prescription for 2

years without problems before it is switched. (A detailed comparison of

the specific classification criteria was beyond our scope.)

An Intermediate Class

as a Transition Class

Over the last 15 years, the number of drugs switched from prescription to

nonprescription status has increased in the United States. In fact, this is a

worldwide trend. Despite arguments for a transition class in the United

States, an intermediate class is not frequently used as a transition class in

the study countries. It is operative only in Australia (and there was some

support for it by government officials in Ontario and by Canadian national

pharmacy association officials). In the Australian state of Victoria, after a

drug is switched from prescription class to pharmacist class, officials

watch for reports of adverse drug effects (they do not actively track users

of the drug). If reports do not materialize, they consider switching the drug

from pharmacist to pharmacy class. It is important to emphasize that even

when the class is considered a transition class, the goal is not to allow the

drug to be sold outside pharmacies. One Australian official told us that she

could remember only paracetemol (acetaminophen in the United States)

being moved into the general sale category.6

In Canada, although some government and pharmacy officials told us they

support the general idea of a transition class, the intermediate class is not

generally used in this manner. Some manufacturers’ officials were

concerned that drugs could get “stuck” in a transition class. They said that

ibuprofen was switched in the provinces in 1989 out of prescription class

into pharmacist class, where it was supposed to remain for only a short

time, but it still remains there today, 6 years later. More generally, a

Canadian official questioned the idea of whether a transition class would

allow drugs to be switched from prescription status faster if the data

package for switching remained the same. Only by altering the package

could the process be made faster: either fewer or shorter tests would be

required or drugs would have to be switched before the tests were

completed. The same official raised the issue of the usefulness of the data

that might be gathered through a transition class. There would be no

controls in the studies. The official thought that because of the lack of

controls, the studies would provide little useful information. A U.S.

6

Since this conversation, aspirin in 500 mg packages of 16 pills or less (single ingredient only) has been

switched to general sale in Australia. The movement of drugs to general sale is also very rare in the

United Kingdom. However, U.K. officials did speculate that cost considerations might increase

movement in the future.

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Drug Distribution Systems

manufacturer echoed this idea and stated that FDA responds to

randomized, double-blind studies in which the experimental drugs are

compared to placebos. (In a double-blind medical experiment, neither the

patients nor the persons administering the treatment and recording the

results know which subjects are receiving the drug and which are

receiving the placebo.) This allows the effectiveness and adverse effects to

be accurately assessed. A transition class would not provide this type of

study. An official in the United Kingdom stated that, theoretically, new

adverse reactions could be found when a drug is switched to a pharmacist

or pharmacy class but that, as a practical matter, the adverse-effect profile

for a drug is established by the time a drug is switched.

In the other countries we visited, the intermediate classes were not

transition but permanent. There was no certainty that the drugs would be

assessed for reclassification after a period of time. Thus, little helpful

information is available from other countries as to whether or how a

transition class might speed the switching of drugs.

If a transition class is to play a role in speeding approval of a change from

prescription to nonprescription status, it must regularly employ a system

to track adverse effects. Without this information, the class could not aid

FDA in assessing a drug for general sale. Tracking studies would help link

drug use (or at least purchases) to adverse effects. They could also give

some indication of the pattern of use in the population. Two difficulties

with such a recordkeeping requirement are the time burden it places on

pharmacists and the likelihood of increased costs.

Preventing Abuse Proponents for an intermediate class of nonprescription drugs argue that

limiting the availability of certain drugs to pharmacies would impede

abuse. For example, the pharmacist would be expected to intervene if a

customer wanted to purchase inordinate amounts of a drug (either at one

time or over a period of time) or if the customer appeared to have no

medical need for it. The class could be used in two ways. First, for drugs

being switched from prescription to nonprescription status, abuse could

be studied and a decision made at a later time on appropriate

classification. Second, nonprescription products that were being abused

could be moved back to the intermediate class for some safeguards.7

7

For example, this issue has been raised in regard to phenylpropanolamine, an appetite suppressant

and an ingredient in some weight-reduction products. Various officials raised the issue of young

women taking large amounts of these products in attempts to lose weight. Associations between the

drug and bulimia and anorexia have been suggested.

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The advantage of moving a drug from general sale to an intermediate class

is that it would still be available to customers for legitimate uses. Although

access would be restricted to pharmacies, the added impediment of a

prescription would not be required. Currently, if access is to be restricted,

the drug must be moved to prescription class.8

The usefulness of an intermediate class to prevent drug abuse has not

been demonstrated. We identified no studies that addressed the general

issue of using an intermediate class to deter drug abuse. Few government

and pharmacy officials whom we spoke with in the United States and

abroad thought that an intermediate class would be completely successful

in doing so. They agreed that it would be quite easy for an individual who

wanted a large amount of a drug simply to visit several pharmacies and

buy what appears to be a reasonable amount in each one, thereby avoiding

potential surveillance. Having to deal with a pharmacist might be an

impediment, as would the necessity of visiting several pharmacies;

however, it would not be overly difficult to get around the system.

The difficulties in using a pharmacist class to prevent abuse can be

illustrated by experience in New South Wales, where Australian truck

drivers were taking ephedrine to try to stay awake. At the time, the drug

was restricted to sale by pharmacists. New South Wales officials decided

to move the drug back to prescription status, and eventually the other

Australian states followed their lead. In this case, since restricting the sale

of ephedrine to pharmacists did not prevent abuse, officials thought it

necessary to put tighter controls on the product.

Similarly, a study in Germany indicated the difficulty of preventing the sale

of nonprescription drugs even when they are restricted to pharmacies

(Product Testing Foundation, 1991). Children between the ages of 10 and

14 were sent to pharmacies to see how easily they could purchase

nonprescription medications containing alcohol. In all 54 pharmacies the

children visited, they were allowed to purchase the drugs. In only one case

was the purchaser questioned intensively. The consumer association that

did the study criticized the pharmacists, and the pharmacy association

called the results “lamentable.”

8

This recently occurred in Oregon when the state switched ephedrine (which is used, among other

uses, as a nasal decongestant in the treatment of asthma) from nonprescription to prescription status.

Oregon investigators had found that large amounts of ephedrine tablets were being sold weekly by a

few retailers. The drug was being used in the illegal production of methamphetamine. To deal with the

problem, Oregon officials restricted ephedrine to prescription sale. An intermediate class of drugs

would have allowed the drug to remain a nonprescription product but sale would have been limited to

pharmacies or pharmacists.

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The Economics of an

Intermediate Class of

Drugs

Much of the discussion about the proposed roles for an intermediate drug

class has centered on public health issues. For example, a primary

concern has been the effect of an intermediate class on consumers’ ability

to use pharmaceuticals safely and effectively. In addition, an intermediate

class of drugs would also have an economic effect. Establishing a

pharmacy or pharmacist class could affect the price and availability of

drugs to consumers and might also alter the revenues or profits of both

manufacturers and retailers.

Drug Expenditures Pharmacy experts in the United States told us that drugs cost less as

nonprescription than prescription medicines, although initially the

nonprescription cost may be higher than was the prescription price.

Ibuprofen is an example. However, the experiences of other countries do

not clarify what the economic effect of establishing an intermediate class

of drugs would be in the United States. The few studies that have been

done focus on the switching of particular drugs in particular countries.

The studies do not generalize beyond the study country and do not

attempt to determine the effect of the presence or absence of a pharmacist

or pharmacy class.

Ryan and Yule (1990), examining the economic benefits of switching

loperamide (an antidiarrheal) and topical hydrocortisone from

“prescription only medicines” to “pharmacy medicines” in the United

Kingdom, found that the costs of obtaining each drug decreased after the

products were switched. However, in the United Kingdom (and all the

study countries), prescription drug prices are controlled in some manner

by the government.9

 Nonprescription drug prices generally are not,

although some are controlled if the drugs are purchased with a

prescription. Therefore, a comparison of drug prices before and after a

switch is not a comparison of two free markets. Because there is no U.S.

government price control, a comparison of drug prices in the study

countries before and after switching would not yield useful insights for the

United States. (Thus, the Ryan and Yule findings do not necessarily

indicate what would occur in the United States if a drug were switched to

an intermediate class.)

9

For example, in France the government regulates both new product prices and price increases. In

Germany and Sweden, the government sets an upper limit on the amount the insurer can pay for

groups of identical or equivalent drugs. In the United Kingdom, the government determines how much

profit a company is allowed to make from selling medicines to the National Health Service. (See GAO,

1994b.)

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When Temin (1992) studied the costs and benefits of switching

cough-and-cold medicines in the United States, he found that visits to

doctors for common colds fell by 110,000 per year (from 4.4 million) from

1976 to 1989, coinciding with the switching of the medicines.10 After ruling

out other possibilities, he concluded that the decrease in physicians’ visits

was attributable to the switching of these drugs.11 He estimated this to be a

saving of $70 million per year.

Although there is thus some evidence of cost savings from switching

drugs, the effect of an intermediate class of drugs has not been assessed.

Ryan and Yule did not assess what the savings would have been if

loperamide and topical hydrocortisone had been sold outside pharmacies.

Temin did not study how the savings would have been different if

cough-and-cold medications had been restricted to sale by pharmacists.12

Therefore, while the studies do indicate potential savings from switching

drugs, we cannot use them to assess empirically the relative savings from

different drug distribution systems.

Our interviews with officials in the study countries indicated that the cost

savings from fewer physicians’ visits may not be as great as expected.

They said that many patients do not pay the full price for a prescribed

drug. For instance, an insured patient might have only a $5.00 copayment

for a prescription drug while having to pay the full price for a

nonprescription product. Patients might thus have an incentive to go to

doctors for a prescription. It could be for either a different but

therapeutically equivalent product or the original drug if insurance covers

it. The latter has occurred in Denmark with antiulcer medications that

were switched in 1989. Bytzer, Hansen, and Schaffalitzky de Muckadell

(1991) estimated that only 3 percent of the sales of cimetidine and

ranitidine were made without some medical assessment or control. In

Germany, approximately half of nonprescription drug sales are prescribed

and reimbursed.

10In 1983, Temin estimated the potential costs and benefits of switching topical hydrocortisone,

thiazide diuretics, and oral penicillin. He based his estimates not on empirical data but on a theoretical

exploration of switching. He concluded that there would be clear benefits to switching hydrocortisone

and penicillin but that the net benefit from switching thiazide diuretics would be small.

11The factors he considered and rejected as possible explanations were different definitions of the

common cold, decreased incidence of the common cold, decreased number of potential patients, a

general decrease in visits to physicians, and a relative increase in the cost of visits to physicians.

12It should be clear that neither study was meant to assess the effect of an intermediate drug class;

each followed the norm in the country where it was conducted. In the United Kingdom, drugs are

normally switched from “prescription only medicines” to “pharmacy medicines.” Few drugs have been

switched to the “general sale list.” In the United States, Temin studied the only possible switch to make

a drug available for less-restrictive sale, from prescription to general sale.

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A somewhat similar situation exists in the Netherlands with respect to

acetaminophen. This drug can be purchased without a prescription as a

general pain reliever; however, it is also commonly used as a pain killer for

cancer patients and, in fact, is the most prescribed drug in the country.

When it is prescribed, it is reimbursable. An official told us that this results

in consumers being able to get their headache remedy free of charge.

Economic Factors The economic effects of an intermediate class of drugs depend on several

different factors and the current literature does not provide a

comprehensive analysis of them. A complete treatment of economic issues

was outside our scope. In the remainder of this section, however, we

briefly illustrate some of the unresolved economic issues in assessing

proposals for an intermediate class of drugs.

The economic effect of an intermediate class of drugs would largely

depend on how this class were structured and used—that is, whether it

was a transition or a permanent class and, if the latter, whether the drugs

in this class were coming largely from the prescription or the

nonprescription category. For example, if drugs were moved to pharmacy

or pharmacist class from prescription status, then the drug choices

available to consumers without a prescription would increase. However, if

drugs were largely moved to the intermediate class from the general sale

category, then these drugs would be less widely available to consumers

because fewer retail outlets could sell them (although they would still be

available without a prescription).

A major unresolved question is how the availability of a pharmacist or

pharmacy class would affect pharmaceutical prices. Depending on the

structure of the new class, several factors might strengthen or soften its

effect. The following four examples provide an illustrative, but not

comprehensive, list of scenarios that could play out if the United States

adopted an intermediate class of drugs.

• The availability of an intermediate class of drugs might prompt a change in

manufacturers’ pricing patterns. For example, if the introduction of an

intermediate class permitted a drug to be switched from prescription

status, the price might decline.

• If drugs were switched from general sale to the intermediate class, they

would be available in fewer retail outlets. It is possible that the decrease in

the number of retailers selling these drugs could adversely affect retail

competition and, as a result, drive up prices. However, the availability of

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mail-order pharmacies and other outlets (provided they sold the drugs in

the intermediate class), and the likelihood of new pharmacies opening,

could mitigate or eliminate this effect.

• If drugs were moved to the intermediate class from the general sale

category, the greater role of pharmacists might lead to higher prices if a

counseling fee were implemented.

• The effect of an intermediate class of drugs on consumers’ out-of-pocket

drug expenses would depend on the behavior of third-party payers such as

health insurers, which often pay all or most of the cost of prescription

drugs but generally do not pay for over-the-counter products. If insurers

elected not to reimburse consumers for drugs that were moved from

prescription status to an intermediate class, consumers’ out-of-pocket

expenditures would increase. However, if fewer drugs were reimbursed,

health insurance costs might decrease and partially or fully offset

consumers’ greater out-of-pocket drug expenditures.

An intermediate class of drugs could also produce savings in other health

care costs. The cost of obtaining a prescription drug includes not only the

cost of the drug itself but also the cost of the visit to a physician. Patients

would be saved the cost of the visit to the physician for a pharmacy- or

pharmacist-class drug.13 While this is potentially true for new

prescriptions, cost savings for refilling prescriptions is less clear, since

refills are often ordered on the telephone.

Drug Distribution in

the European Union

The 15 member countries of the European Union are moving toward the

creation of a single international market, without barriers to the free

movement of goods, services, persons, or capital. One aspect of this is the

harmonization of requirements governing the manufacturing and

marketing of pharmaceuticals.Regulatory authority rests with Directorate

General III “Industry.” Section III-E-3 deals with pharmaceutical products.

Decisions of the European Union must be approved by a vote of the

member countries.

EU directives for pharmaceuticals establish the same requirements

throughout the European Union, including requirements for advertising,

labeling, and wholesale distribution. A 1992 directive “concerning the

classification for the supply of medicinal products for human use”

13However, we saw in the previous section that savings from reduced physicians’ visits may not be as

large as anticipated.

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establishes criteria for determining whether a drug will be a prescription

or nonprescription product.14 Article 3 states that

“Medicinal products shall be subject to medical prescription where they:

—are likely to present a danger either directly or indirectly, even when used correctly, if

utilized without medical supervision, or

—are frequently and to a very wide extent used incorrectly, and as a result are likely to

present a direct or indirect danger to human health, or

—contain substances or preparations thereof the activity and/or side effects of which

require further investigation, or

—are normally prescribed by a doctor to be established parenterally.”

The directive goes on to state that “Medicinal products not subject to

prescription shall be those which do not meet the criteria established in

Article 3.”

Despite this directive, the member countries will retain the authority for

classifying drugs into prescription and nonprescription classes. This

power will not be transferred to the European Union. Nonetheless, the

expectation is that because of the EU classification criteria, drugs will be

increasingly classified as prescription or nonprescription throughout the

union. It is expected that classification into prescription and

nonprescription classes will become harmonized throughout the European

Union in the next 15 to 20 years.

However, the European Union has decided not to impose a particular drug

distribution system on the member countries. It will be up to each country

to determine the number and nature of nonprescription drug classes in it.

If a country decides that it wants to restrict the sale of nonprescription

drugs to pharmacies, this will be allowed. Similarly, if a country wants to

allow the sale of some or all nonprescription drugs outside pharmacies, it

may do so. Thus, despite the European Union’s developing criteria to

distinguish prescription from nonprescription products, member countries

can have more than two drug distribution classes.

An EU official with major responsibilities for and involvement in the

directive told us that the reason the European Union decided not to

14Directive 92/26/EEC. See Official Journal of the European Communities, April 30, 1992.

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require a particular drug distribution system was that sufficient evidence

did not exist to recommend one system over another. EU officials were not

convinced that restricting drug sales to pharmacies was a commercial

barrier to trade. Conversely, they were not convinced that allowing the

sale of drugs outside pharmacies would increase health concerns. We

were told that as long as a country’s requirements are the same for both

domestic and foreign entities, the European Union will accept its drug

distribution system.

Drug distribution systems are seen, in part, as a function of tradition.

Member countries were unwilling to give up their current systems. In

general, the northern European countries are less restrictive on the sale of

medications than are the southern countries. The northern countries did

not want to restrict the sale of all nonprescription drugs to pharmacies,

while the southern countries did not want to allow their sale outside

pharmacies. In the absence of sound evidence to support one system as

superior to the other, the European Union decided to allow the countries

to determine their own individual systems.

While there will be no required changes in the number and type of drug

classes in a country, officials in the Netherlands told us that they are

planning to adapt to EU guidelines by moving from a three-tier to a two-tier

system. Their plan is to combine the pharmacist and drugstore classes into

one class and allow the drugs to be sold in both locations. It was noted

that some nonprescription drugs currently restricted to sale by

pharmacists will be moved back to prescription status. Officials of the

Netherlands indicated that they perceived no major, consistent benefit

from requiring that a large category of nonprescription drugs be available

only from pharmacists.

Summary Proponents of an intermediate class of drugs, as either a fixed or transition

class, in the United States argue that it would create certain benefits.

Evidence supporting this contention is small. No studies have assessed the

relative merits of alternative drug distribution systems. All 10 of our study

countries had a pharmacist or pharmacy class of drugs or both, but it was

not used as a transition class to facilitate the movement of drugs to

general sale. We also found no evidence that such a class of drugs is

successful in preventing abuse. At most, it is an impediment. No studies

have assessed whether an intermediate class deters drug abuse and

anecdotal evidence suggests that drug abuse is not easily deterred with

such a class. An additional class would not necessarily reduce drug

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expenditures. Physicians’ visits might not be reduced as greatly as

expected if the drug costs remained reimbursable with a prescription or if

a reimbursable prescription product could be substituted. Finally, the

European Union has not found evidence to support the superiority of one

drug distribution system over another and, thus, is not requiring the

establishment of a particular drug distribution system in its member

countries.

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Access to Nonprescription Drugs

Proponents of an intermediate drug class argue that access to

pharmaceuticals would increase in the United States if an additional

nonprescription drug class, either fixed or transition, were established.

Opponents argue that access would decrease. The actual change in access

would depend on how the intermediate class were used.

In general, access would decrease if (1) drugs that are currently available

without a prescription were to be moved into the intermediate class or

(2) drugs that would have been switched to general sale were instead

placed into the intermediate class.

However, access would increase if (1) drugs that would have been moved

back to prescription status were placed in the intermediate category or

(2) the effect of an intermediate class were to allow drugs to move into it

that could not be moved into the general sale class. While the number of

outlets (54,000 pharmacies) selling the product would not change,

accessibility would increase because a prescription would not be

necessary.

Beyond these general observations, it is unclear exactly how access would

change. No studies have assessed this issue and, moreover, it would be

very difficult to do so. A complete understanding of how access would be

affected would require assessing a number of factors, including the

number of drug outlets that would sell the drugs, how the class would be

used, and the number and nature of drugs that would be placed in it. None

of these can be precisely predicted.

In this chapter, we report our comparison of access to nonprescription

drugs in the United States with that in the study countries. Making this

comparison helped us understand what the effects of an intermediate class

might be in the United States regardless of whether a fixed or transition

class were established. We focused on the following three aspects of

access: the number of community pharmacies and drugstores in each

country, the availability of nonprescription drugs by self-selection, and,

more generally, the classification of particular drugs as either prescription

or nonprescription products. In particular, we answer the following

questions:

1. How many pharmacies and drugstores are there in each of the study

countries and the United States?

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2. In the study countries, can consumers select nonprescription drugs

themselves, or must they request such drugs from a pharmacist?

3. How does the classification of the 14 drugs we selected vary between

the study countries and the United States?

The drugs include a number of pain relievers, antiulcer medications, and

allergy medicines (see appendix IV). Their classification varies from

country to country, and all have been either switched or mentioned as

candidates for switching in the United States or another country. Private

sector officials in the United States indicated that the 14 are a good list for

getting a general indication of the access to nonprescription drugs in a

country.1

 However, it is not possible to generalize from this list about drug

classification in a country—that is, the classification of these drugs does

not necessarily indicate the overall availability of nonprescription drugs in

a country. Instead, the drugs should be viewed as examples of differences

between countries.

The Access to

Pharmacies and

Drugstores

Number of Pharmacies and

Drugstores

The number of community pharmacies can give some indication of how

available intermediate-class drugs would be in the United States. However,

there are a number of other drug outlets that could increase the

availability of these products, including government, managed care, and

mail-order pharmacies.2

 If these outlets were to sell intermediate class

drugs, consumers would not have to go to a community pharmacy to

purchase them. However, we cannot be certain that all or any of these

potential outlets would choose to sell the drugs. Thus, any analysis of how

accessible intermediate class drugs would be is limited by uncertainty over

the number of outlets.

1

As our work progressed, we encountered some criticism of the list based on the belief that it should

have included a more diverse array of drugs such as antibiotics and muscle relaxants.

2

Government pharmacies include those operated by the Department of Defense, the Department of

Veterans Affairs, and the Public Health Service (including the Indian Health Service). The importance

of noncommunity pharmacies is illustrated by the fact that one fourth of all prescriptions are

dispensed in these outlets.

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Similarly, any comparison between countries of the number of drug

outlets must note that in some countries physicians are permitted to

dispense drugs where there is no convenient pharmacy. For example, in

France and Italy physicians are allowed to dispense nonprescription drugs

in rural areas where no pharmacy is available. The effect is to increase the

number of drug outlets for nonprescription drugs and, hence, their

accessibility. For countries that have more specialized drug outlets than

the United States, physicians’ dispensing would increase the difference

between the countries while narrowing the difference for countries that

have fewer pharmacies than the United States. If the United States were to

allow physicians to dispense intermediate-class drugs where no pharmacy

was available, this would also reduce inconvenience but negate one

rationale (not having to visit a physician to receive the drug) for such a

class of drugs.

To get some indication of how many U.S. outlets would be able to sell

these drugs and how similar this is to other countries, we compared the

number of community pharmacies per capita in the United States with a

comparable measure in other countries. We found that the United States

has considerably fewer community pharmacies or drugstores per capita

than 6 of the countries.3

 (See table 3.1.) However, only Denmark, with one

pharmacy for every 17,500 residents, and Sweden, with one for every

10,200 residents, have substantially fewer pharmacies per capita than the

United States, which has one for every 4,800 residents. The United

Kingdom, Canada, and Ontario have a similar number per capita to the

United States. This gives some indication that restricting nonprescription

drugs to sale in pharmacies might be more of an inconvenience in the

United States than it is in 6 of the countries we studied.

3

While the Netherlands has fewer pharmacies per capita than the United States and Switzerland has

approximately the same, there are also drugstores in these countries that can sell some but not all

nonprescription drugs. Taking the pharmacies and drugstores together, there are proportionately more

of these drug outlets in these countries than pharmacies in the United States.

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Table 3.1: Number of Community

Pharmacies and Drugstores in Ten

Countries, Ontario, and the United

States in 1993-94

Country Pharmacies Drugstores

Pharmacies and

drugstores per capita

Australia 5,000 a 1:3,600

Canada 6,121 a 1:4,500

Ontario 2,400 a 1:4,200

Denmark 297 a 1:17,500

France 22,377 a 1:2,600

Germany 20,648 a 1:3,900

Italy 15,633 a 1:3,700

Netherlands 1,500 3,000 1:3,400

Sweden 857 a 1:10,200

Switzerland 1,500 900 1:2,900

United Kingdom 12,025 a 1:4,800

United States 53,841b a 1:4,800

aNot applicable.

bIncludes drug chain, independent, food store, and mass merchant pharmacies. (See Drug Store

News for Pharmacists, April 11, 1994.)

Accessibility of

Community Pharmacies in

the United States

If drugs in the intermediate class were to come from the general sale

rather than prescription class, change in access to these products would

depend on not only the number of community pharmacies but also their

distribution. In some parts of the country, the nearest pharmacy can be

100 or more miles away. Even within a city, the number of pharmacies

varies between neighborhoods, and nonpharmacy drug outlets generally

sell fewer products than do pharmacies. Therefore, people with a nearby

pharmacy already have an advantage in the number of nonprescription

products readily available to them. Moving drugs from the general sale

class to an intermediate class could make this difference somewhat larger.

The number of outlets selling the drugs would decrease, and individuals

with easy access to pharmacies would find these drugs readily available to

them while those without accessible pharmacies would not.

However, moving drugs from the prescription class to an intermediate

class would not change the number of outlets (that is, pharmacies) selling

them (assuming noncommunity pharmacies chose to sell the products),

and, therefore, the difference in access for individuals with readily

available pharmacies and those without would remain the same. It would

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still be necessary to go to a pharmacy to purchase the drug. The difference

would be that a prescription would not be required.

Moreover, introducing an intermediate class of drugs in the United States

would constitute a large change in nonprescription drug distribution since

the more than 690,000 nonpharmacy drug outlets would not be allowed to

sell these products. Consumers would have to learn that not all

nonprescription drugs could be sold in all retail outlets. Individuals who

wanted to purchase a drug in the intermediate class would need to know

that it was necessary to purchase the drug at a pharmacy. This would

affect all residents, regardless of location.

The Self-Selection of

Drugs

In the United States, nonprescription products (except for controlled

substances available without a prescription and insulin) are generally

available by self-service—that is, consumers can select their

nonprescription products from the shelves personally. Consumers have

the power to choose their own nonprescription drug regimen by

comparing different products on such items as dosing, side-effects, and

price. Of course, if they are in a pharmacy, they can always ask the

pharmacist for information or advice. In other countries, self-selection of

pharmaceuticals is limited to certain drug classes or not allowed at all.

Table 3.2 summarizes the direct availability of nonprescription drugs to

consumers.

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Table 3.2: Self-Service for

Nonprescription Drugs in Ten

Countries, Ontario, and the United

Statesa

Country Pharmacist Pharmacy Drugstore General sale

Australia No Varies by

state

Yes

Canadab Noc Varies by

product

Yes

Ontario No Yes Yes

Denmark No

France No

Germany No Yes

Italy No

Netherlands No No

Sweden Varies by

product

Yes

Switzerland No No Yes

United Kingdom No Yes

United States Nod Yes

aThe table reports on actual availability of drugs by self-service rather than by what the law

allows. In some countries, self-service is legally allowed but pharmacy association policy (which

is followed) forbids self-selection. A blank cell indicates the country does not have the indicated

drug class.

bAccess to pharmaceuticals is a provincial responsibility in Canada. The federal government

indicates whether it believes products should be restricted to sale only in pharmacies or be

available for general sale. Some provinces do not allow self-selection for some nonprescription

drugs sold only in pharmacies.

cThis category exists only for controlled substances.

dThis category exists only for controlled substances and insulin in some states.

The table shows that the ability to choose one’s own drugs is limited,

except for drugs available outside pharmacies (in countries where this is

allowed). Only in Australia, Canada (as determined by the individual

provinces such as Ontario), and Sweden is self-service allowed for some

or all pharmacist or pharmacy drugs.

If the United States were to follow the general pattern in other countries of

not permitting self-service for pharmacist- or pharmacy-class products (as

is done for controlled substances available without a prescription and

insulin in some states), purchasing these products would be much

different from purchasing other nonprescription drugs. Consumers would

not only be unable to buy the products in outlets such as convenience

stores and gas stations but would also find it more difficult to compare

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products if they could not select pharmacist- or pharmacy-class drugs

directly from the shelf.4

The Effect of an

Intermediate Class on

Drug Classification

One of the principal benefits cited by proponents of an intermediate class

is that the number of products available without a prescription would

increase because FDA would have the option of putting drugs in a class that

provides for consumer counseling (National Consumers League, 1991). To

see if there is a pattern of greater nonprescription availability in countries

that have a pharmacist or pharmacy class, we examined the classification

of 14 drugs in the study countries and the United States. (See appendixes

III and IV.) These drugs have either been switched or mentioned as

candidates for switching in the United States or in another country, but

they are only examples meant to illustrate differences between the

countries. It is not possible to generalize from them to the entire drug

classification system in a country. Our analysis shows only that the

presence or absence of a pharmacist or pharmacy class has no consistent

effect on drug classification. It is unclear what effect establishing an

intermediate class in the United States would have on the classification of

drugs as prescription or nonprescription products.

Specific examples illustrate how classification varies between countries.

Ibuprofen is available for general sale in the United States but, although it

is a nonprescription product in 10 other countries, its distribution is

limited to specialized drug outlets in all of them. Naproxen is also

available for general sale in the United States but as a nonprescription

product in only 2 of the 10 countries. For these two drugs, the United

States clearly has the most open system and the lack of an intermediate

class has not prevented their being switched here. In fact, the United

States was among the first to classify ibuprofen (1984) and naproxen

(1994) as nonprescription products.

However, for other drugs the United States is more restrictive. For the 10

countries studied, only France, Italy, and Sweden, like the United States,

do not allow nonprescription sale of the antihistamine terfenadine.

Similarly, only Germany, Sweden, and the United States do not allow the

4

While some control over the sale of intermediate-class drugs would be necessary if the theoretical

benefits of such a class were to be achieved, this would not necessitate prohibiting self-selection for

these drugs. Instead, the requirement could be that the pharmacist would have to consult with

consumers when the purchase was made. This would allow customers to select their own drugs and

compare one with another.

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nonprescription sale of promethazine, another antihistamine.5 In the seven

countries, these drugs are available in either a pharmacist or pharmacy

class; the U.S. system is less open than theirs are. It is unclear whether the

theoretical safeguards associated with a pharmacist or pharmacy class

would be sufficient for regulators to switch these drugs from prescription

to nonprescription.

It is thus unclear whether establishing an intermediate class of drugs in the

United States would allow more drugs to be switched, since the United

States already classifies some drugs as nonprescription that other

countries that have a pharmacist or pharmacy class still restrict to

prescription class. What is clear is that other factors in addition to or

instead of the existence of a pharmacist or pharmacy class account for

differences in drug classification between the study countries.

An assessment of the relative openness of the current drug distribution

system in the United States compared to the other countries studied

depends on one’s definition of “access.” If access is defined by the

availability of drugs for general sale, the United States appears to have the

most open system, since more of the 14 drugs are available for sale outside

pharmacies than in any of the other countries. However, if access is

defined by the availability of drugs for nonprescription sale regardless of

where they can be sold, the United States falls somewhere in the middle.

Some countries have more of the 14 drugs available without a prescription

than the United States does, but others have fewer.

Summary There is no simple answer to the general question of how access to

nonprescription drugs would be affected by creating an intermediate class

of drugs in the United States. It would depend partly on where drugs in the

class came from. If they were switched from prescription class (as both

fixed- and transition-class proposals emphasize), access could increase,

since the drugs would be available without a prescription. But if they were

switched from general sale (which advocates of a transition class argue

would not occur), access could decrease, since their sale would be limited

to pharmacies.

5

In the 1980’s, FDA approved promethazine as a nonprescription product. However, in response to

comments and a citizens’ petition, FDA withdrew its approval. There were allegations that the drug

was connected with Sudden Infant Death Syndrome (often referred to as SIDS). At the time, the

manufacturer volunteered to withdraw the drug as a nonprescription product. FDA has not approved

an application to switch terfenadine to nonprescription status because of concern about drug

interactions as well as complications for patients with heart or liver disease.

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Restricting the sale of some nonprescription drugs to pharmacies could be

somewhat more inconvenient in the United States than in the 6 study

countries that have substantially more community pharmacies and

drugstores per capita than the United States. In addition, the accessibility

of pharmacies varies greatly between areas in the United States. People

without ready access to a community pharmacy would be at a

disadvantage if they wanted to purchase drugs in the intermediate class.

However, this could be partially offset if outlets such as mail-order

pharmacies chose to sell these products. The larger change might be that

people would have to adjust to not being able to buy some nonprescription

medicines outside pharmacies.

All 10 study countries have some restrictions on self-selection of

nonprescription drugs. Only the United States allows self-service for all

nonprescription products (except for controlled substances available

without a prescription and insulin). Other countries restrict consumer

access to some or all nonprescription products. Thus, on this dimension,

consumers in the United States have greater access to nonprescription

drugs than do consumers in the other countries. The establishment of an

intermediate class could change this. Because the benefits of such a class

would be difficult to achieve without some control on the distribution of

these drugs in pharmacies, self-selection might not be allowed for them.

No clear picture of the effect of a pharmacist or pharmacy class on drug

classification decisions emerges from our analysis of 14 drugs. There is no

consistent pattern of greater or lesser nonprescription drug availability as

a result of the existence of a pharmacist or pharmacy class. The United

States allows the sale of some drugs without a prescription that many

other countries do not, while the opposite is also true. Whether the

establishment of such a class in the United States would allow more drugs

to be moved out of the prescription class is unknown.

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Many of the theoretical benefits associated with a pharmacist or pharmacy

class of drugs (whether a fixed or transition class) involve improving drug

use or, conversely, reducing misuse. The assumption is that pharmacists

will pass on to consumers the information they need to take a drug

properly. Critics of an intermediate class in the United States do not

question the potential value of pharmacists’ relaying information to

consumers but do not believe that it is necessary to have an additional

drug class to do this.

In this chapter, we describe the role pharmacists play in monitoring the

use of pharmacist- and pharmacy-class drugs in the study countries. We

focus on pharmacist practices that would have to be engaged in for a fixed

or transition class to be effective. We also report on selected aspects of

pharmacy practice in the United States, including counseling on

nonprescription drugs. Specifically, we answer the following questions:

1. Are pharmacists in the 10 countries required by law to counsel

consumers on the proper use of nonprescription drugs?

2. What are the legal sanctions for failing to provide counseling?

3. What studies show whether pharmacists in the study countries and the

United States counsel purchasers of nonprescription drugs, and what is

the quality of that counseling?

4. What are the requirements and practices of pharmacists in monitoring

adverse drug reactions and maintaining patient profiles?

5. How might recent developments in the practice of pharmacy affect the

counseling behavior of pharmacists in the United States?

Counseling

Requirements on

Nonprescription

Drugs

One reason proponents commonly give for limiting nonprescription drugs

to sale in pharmacies (even if no counseling is required) is that it allows

customers to ask for advice if they want it. Table 4.1 summarizes the

counseling requirements for nonprescription drugs in the 10 study

countries and Ontario. Only in Australia, Denmark, Germany, and Italy are

pharmacists required to provide information to patients on the use of

nonprescription drugs. In Australia, these requirements vary by state:

some states require counseling on pharmacist class drugs but others do

not. For instance, in Victoria, the pharmacist is required to speak with the

patient every time a pharmacist-class drug is sold. In Denmark, Germany,

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and Italy, the pharmacist is required to provide information to patients on

their medications; however, there are no specific counseling requirements.

In Ontario and the United Kingdom, nothing is required beyond the

pharmacists’ supervision of sales. In France, the Netherlands, and

Switzerland, pharmacists need merely be physically present on the

premises of the pharmacy. In Sweden, while the pharmacist is expected to

promote proper drug usage, there is no requirement that a pharmacist be

present when a nonprescription drug is sold. There are no national

counseling requirements in Canada.

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Table 4.1: Pharmacist Counseling

Responsibilities for Nonprescription

Drugs in Ten Countries and Ontario

Country Pharmacist responsibility

Australia Counseling requirements are set by the states. There are no counseling

requirements for pharmacy-class drugs. Some states have counseling

requirements for pharmacist-class drugs. For instance, in Victoria

pharmacists must “give appropriate and adequate advice in respect of

dosage, frequency of administration, general toxicity, adverse effects,

contra-indications or precautions to be observed in the usage of that

potent substance”

Canada There are no national counseling requirements

Ontario Pharmacists must “make [the] decision to” sell a pharmacist-class drug.

This is defined as the pharmacist “must be aware of the sale.” No

counseling requirements state what specific information must be given to

the consumer

Denmark The pharmacist must provide information about pharmaceuticals. The

pharmacist is required to be on duty when a pharmaceutical is sold. No

counseling requirements state what specific information must be given to

the consumer

France The pharmacist must be on duty when a drug is sold. No counseling

requirements state what specific information must be given to the

consumer

Germany The pharmacist must render the information necessary for proper

administration of nonprescription drugs to the consumer. No counseling

requirements state what specific information must be given to the

consumer

Italy The pharmacist is expected to provide the consumer with sufficient

information for the proper use of the drug. The pharmacist must be on

the premises when nonprescription drugs are sold and must identify the

packaging as well as the expiration date of the product. No counseling

requirements state what specific information must be given to the

consumer

Netherlands The pharmacist must be on the premises when nonprescription drugs

are sold. No counseling requirements state what specific information

must be given to the consumer

Sweden The agreement between the government and Apoteksbolaget (the

corporation of Swedish pharmacies) states that “the company shall

promote the development of good information in the drug field.”

However, there are no counseling requirements. There is no requirement

that a pharmacist be present when a nonprescription drug is sold

Switzerland Pharmacists must be on the premises when nonprescription drugs are

sold. They must be available to give advice on pharmacist-class drugs.

No counseling requirements state what specific information must be

given to the consumer

United

Kingdom

Pharmacy-only medicines must be sold under the supervision of a

pharmacist. No counseling requirements state what specific information

must be given to the consumer

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The Enforcement of

Counseling

Requirements

In the 6 countries we visited—Australia, Canada, Germany, the

Netherlands, Switzerland, and the United Kingdom—and Ontario, there is

some enforcement of the requirements for pharmacists selling

nonprescription drugs, but it is somewhat limited. Enforcement is

sometimes by a professional association and is sometimes focused on

physical aspects of the pharmacy rather than the counseling of patients.

The number of inspectors is sometimes small and nonprescription drugs

can be less emphasized than prescription products.

Counseling requirements are set by the states in Australia. Officials in the

state of Victoria told us that enforcement is done primarily through three

pharmacy inspectors of the Pharmacy Board of Victoria on the basis of

professional standards. One reason for the board’s enforcing the law

rather than the state is that the board’s standard of proof is less stringent,

thereby making it easier to discipline recalcitrant pharmacists. The state

standard of proof, “beyond a reasonable doubt,” has been replaced by the

less strict “balance of probabilities.” The pharmacy board brings its case

before pharmacy representatives who may impose penalties ranging from

letters of admonition and fines to temporary suspension or permanent

cancellation of a pharmacist’s registration. There are three or four

suspensions or cancellations per year. We were told that generally there is

not a great deal of enforcement in Australia unless there are complaints or

drug abuse concerns.

Enforcement of pharmacist requirements is done at the state and regional

level in Germany and focuses on the physical aspect of the pharmacy

rather than the behavior of pharmacists. Inspectors check such items as

cleanliness of the pharmacy, proper storage of medicines, size of the

laboratory, availability of instruments, and orderliness of records.

In the Netherlands, the State Public Health Inspectorate supervises all

matters relating to the sale of drugs. Pharmacists must give access at any

time to inspectors to examine the pharmacy and everything in it. If

inspectors find that the pharmacy is not operating in accordance with the

law, they inform the pharmacist and stipulate a time within which the

problem must be corrected. We were unable to determine the amount of

effort put forth in identifying violations of counseling requirements for

nonprescription products.

In Switzerland, each canton has a pharmacist organization that conducts

inspections. Inspectors examine the shop and laboratory to determine if

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they are in accordance with regulations. They also check to see if the

pharmacist is present when the pharmacy is open, as required by law.

In the United Kingdom, pharmacy medicines are to be sold only under the

supervision of a pharmacist. This is normally defined as being present,

aware of the transaction, and in a position to intervene. Enforcement of

the law is not by the government but by the Royal Pharmaceutical Society

of Great Britain. The society has 18 pharmacy inspectors and 2 inspectors

for nonpharmacy drug outlets. This works out to about 650 to 700

pharmacies per inspector.

We were told that a large number of cases are brought to the attention of

the Royal Pharmaceutical Society every year by competitors and

consumers. After the society visits the pharmacy to meet with the

pharmacist, it decides whether to handle the case informally or to take

formal evidence. Often it sends only a warning letter. Approximately 15

cases a year are prosecuted. Additional cases (6 in 1993) are dealt with

through the pharmacy code of ethics. However, we were told that the

society is unlikely to base action on the sale of pharmacy-class drugs (for

instance, selling a pharmacy medicine without appropriate counseling).

Overall, Royal Pharmaceutical Society officials thought that a great deal of

effort was put into identifying violations of laws and regulations

concerning purchases of nonprescription drugs. Government officials told

us that enforcement of pharmacy practice requirements is successful

mainly as a deterrent. Pharmacists are aware of the law and try to stay

within it.

In Ontario, pharmacists (or an intern) must make the “decision to sell” a

pharmacist-class drug. This is generally defined as the pharmacist’s being

“aware of the sale.” There is no requirement that pharmacists actually

speak with the patients. Enforcement is done by the Ontario College of

Pharmacists, a professional and regulatory association. Officials told us

that compliance with the law is minimal. There is no method for

monitoring pharmacist interventions other than through consumer

complaints to the college, which are then investigated.

We asked pharmacy officials in the countries we did not visit how much

effort is put forth in enforcing nonprescription drug counseling

requirements. Officials in France and Denmark told us that “moderate”

effort is put into enforcing counseling requirements in those countries;

Swedish officials said that there is “some” effort. In Italy, there are no

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sanctions against pharmacists who do not counsel patients on the use of

nonprescription drugs.

Officials noted that the enforcement of counseling requirements can be

problematic. It is difficult to determine what is or is not appropriate

counseling behavior. Appropriateness needs to be assessed case by case.

What appears to be a lack of counseling might reflect a legitimate

judgment by the pharmacist, such as that a particular customer regularly

uses the drug and does not need counseling on it. This makes enforcement

of counseling requirements quite difficult.

Studies of Pharmacist

Counseling on

Nonprescription

Drugs

Various academics, consumer groups, and pharmacy associations have

conducted studies of the behavior of pharmacists when they sell

nonprescription drugs. Typically, participants in a study go to a pharmacy

and attempt to purchase a particular nonprescription product or describe

their symptoms (or those of the person for whom they are buying the

product), seeking advice from the pharmacist on what drug to purchase.

Each shopper has been trained by the investigators to act in accordance

with a script developed for the study. The pharmacist’s advice is recorded

and compared to what the pharmacist should have done according to

criteria determined by a group of experts. We refer to these investigations

as trained shopper studies. Other common study designs are investigators’

observation of pharmacists’ behavior and pharmacists’ completion of a

questionnaire on their counseling activities.

Table 4.2 lists the pharmacist counseling studies, their methodologies, and

what they assessed. Studies have not been conducted in all the countries.

While the studies vary considerably in design and objective, a number of

common themes are evident. Despite differences in the law and

regulations across countries, counseling is generally incomplete and

infrequent.

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Table 4.2: Description of Studies of Pharmacist Counseling on Nonprescription Products in Five Countries and the United

States

Country, author, and datea Methodology Sample selection

Aspect of

counseling

assessedb

Australia

Feehan (1981) 2 trained shoppers 2 random samples of 43 pharmacies

each in Victoria

Quality, quantity

Harris et al. (1985) 1 trained shopper Random sample of 40 pharmacies in

Perth

Quality

Ortiz, Walker, and Thomas (1989) Observation Random sample of 50 pharmacies in

Sydney; 28 agreed to participate

Quantity

Ortiz et al. (1984a, b) Mail survey of pharmacists Commercial mailing list covering 98.1%

of pharmacies in the Australian Capital

Territory and New South Wales

Quantity

Stewart, Garde, and Benrimoj (1985) Observation Sample of 10 pharmacies in Brisbane

chosen using specific criteria

Frequency, quantity

Canada

Poston, Kennedy, and Waruszynski

(1994)

Survey of pharmacists Random sample of 681 pharmacies

stratified by province

Quantity

Taylor and Suveges (1992a) Observation and consumer

questionnaire

Random sample of 11 pharmacies in

Saskatoon

Frequency, quantity

Taylor and Suveges (1992b) Observation 4 pharmacies in Saskatoon; selection

method not given

Frequency, quantity

Willison and Muzzin (1992) 8 trained shoppers Random sample of 37 pharmacies in

Ontario; 30 agreed to participate

Quality

Germany

Glaeske (1989) 30 trained shoppers 222 pharmacies in 27 cities; selection

method not given

Quality

Product Testing Foundation (1984) 944 trained shoppers Random sample of 1,530 pharmacies Frequency, quality

Product Testing Foundation (1991) “Several hundred” trained

shoppers

Selection method for pharmacies not

given

Frequency, quality

Sweden

Marklund, Karlsson, and Bengtsson

(1990)

Observation by pharmacy

personnel

4 pharmacies in 4 towns; in 3 of the

towns, there was only 1 pharmacy; in the

other town, 1 of the 2 pharmacies was

studied; selection method not given

Frequency

United Kingdom

Consumers Association (1985) 6 trained shoppers Over 200 pharmacies in 3 areas;

selection method not given

Quality, quantity

Consumers Association (1991) 8 trained shoppers 240 pharmacies; selection method not

given

Quality, quantity

Consumers Association (1994) Trained shoppers; number

not given

30 pharmacies in 4 cities; selection

method not given

Frequency, quality

(continued)

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Country, author, and datea Methodology Sample selection

Aspect of

counseling

assessedb

Goodburn et al. (1991) Interviews with pharmacists,

1 trained shopper

Random sample of 20 pharmacies in

Newcastle upon Tyne; random sample

of 10 pharmacies for trained shopper

part of project

Quality

Hardisty (1982) Observation Nonrandom sample of 225 pharmacies

in England, Scotland, and Wales

Quality, quantity

“Most Pharmacists ‘Give Good Advice’”

(1984)

Observation, 4 trained

shoppers

Observation of 6 pharmacies in

Birmingham, selection method not given;

for trained shoppers component, 123

visits to a random sample of 85

pharmacies, location not given

Frequency, quality,

quantity

“Over-the-Counter Advice” (1988) 7 trained shoppers Random sample of over 200 pharmacies

in 3 cities

Frequency, quality,

quantity

Phelan and Jepson (1980) Mail survey of pharmacies Random sample of 417 pharmacies in

England

Frequency

Smith, Salkind, and Jolly (1990) Observation Random sample of 64 (5%) of

pharmacies in London

Quality

Taylor et al. (1987) Pharmacist recording of

activities

313 pharmacies throughout Britain;

selection method not given

Frequency

United States

Barnett, Nykamp, and Hopkins (1992) 6 trained shoppers; 2

scenarios

84 randomly selected pharmacies in

Atlanta; 72 visited for both scenarios

Quality

Carroll and Gagnon (1983) Mail survey of households Random sample of 300 households in

Raleigh, N.C.

Quantity

Jang, Knapp, and Knapp (1975) 6 trained shoppers Random sample of 48 pharmacies in 1

city

Quality

Knapp et al. (1969) Trained shoppers asking

questions on the telephone;

number not given

Random sample of 36 pharmacies in 1

city

Quality

Linn and Davis (1973) 2 trained shoppers;

pharmacist questionnaire

Random sample of 133 pharmacies in

Los Angeles for trained shopper method

(164 visits were made, with 31

pharmacies visited twice to interact with

a different pharmacist); the same 164

pharmacists were later sent

questionnaires

Quality

Market Facts (1994) Telephone interviews with

adults who had a

prescription filled in the

past 6 months

Sample of 1,302 adults chosen to

represent all U.S. households

Quantity

Meade (1992) Telephone interviews with

pharmacists

200 randomly selected pharmacists Quantity

Vanderveen, Adams, and Sanborn

(1978)

Trained shoppers either

visited or telephoned

pharmacies; number not

given

72 pharmacies in Michigan; selection

method not given

Quality

(continued)

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Country, author, and datea Methodology Sample selection

Aspect of

counseling

assessedb

Vanderveen and Jirak (1990) Trained shoppers; number

not given

46 pharmacies in Michigan; selection

based on location

Quality

Wertheimer, Shefter, and Cooper (1973) 1 trained shopper for each

of 3 scenarios

86, 50, and 31 pharmacies for each of

the respective scenarios; selection

method not given for two scenarios,

random selection for the other

Quality

aComplete citations are in the bibliography.

bQuality = appropriateness of counseling, such as the recommendation of the correct drug,

discussion of possible side effects, and completeness of advice. Quantity = time spent

counseling, number of counseling events per day, or availability of pharmacist for counseling.

Frequency = percentage of patients receiving counseling.

Estimates of the frequency of pharmacists’ counseling on nonprescription

products (that is, the percentage of patients receiving advice) ranged from

11.1 percent in Sweden (Marklund, Karlsson, and Bengtsson, 1990) and

12.3 percent in Canada (Taylor and Suveges, 1992a) to 93.75 percent in

Germany (Product Testing Foundation, 1991).1

 Germany’s was by far the

highest estimate.2

 The second highest, based on self-reports of

pharmacists, was 37.6 percent in the United Kingdom for single proprietor

pharmacies (Phelan and Jepson, 1980). (The lowest estimate for the

United Kingdom was 21 percent for chain pharmacies, also found by

Phelan and Jepson.) However, even in Germany, the researchers generally

thought that too little counseling was being done. In one third of the cases

in Germany, only one piece of information was being passed to the

consumer.

An Australian study found that the vast majority of pharmacists thought

that they should counsel for both prescription and nonprescription

medications (Ortiz et al., 1984b). However, pharmacists gave a number of

reasons for not counseling. The three most important were

• lack of adequate medical histories,

• lack of feedback from the person counseled, and

• the belief that counseling may not be necessary.

1

The Swedish estimate was based on reports by pharmacy personnel, the Canadian estimate on

observation of pharmacists, and the German estimate on a trained shopper study.

2

This estimate is somewhat misleading since an unspecified proportion of the shoppers actively

requested advice from the pharmacist while the others requested a product but relied on the

pharmacist to provide information without the shopper’s requesting it. Thus 93.75 percent is an

estimate of pharmacist counseling based on active and passive shoppers. It is unclear from the study

what proportion of shoppers received information without requesting it.

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Another reason counseling may not occur is that customers may not want

it. In Canada, Taylor and Suveges (1992a) found that 195 of 207 customers

who did not receive advice on a nonprescription product indicated that

they did not want counseling. The main reasons they gave were that they

had “used [the] medicine before with good results” and “had already

received advice elsewhere on what to buy.”

Regarding the quantity of counseling (that is, the availability of

pharmacists to counsel, the number of counseling events per day, and the

time spent counseling), a Canadian study found that pharmacists

responded to requests from patients for advice on nonprescription drugs

an average of 2.8 times a day (Poston, Kennedy, and Waruszynski, 1994).

The range between pharmacies was from 0.07 to 38.64 counseling events

per day. A study in Australia found that 23 percent of pharmacist

counseling activities involved OTC medications (Ortiz, Thomas, and

Walker, 1989). (This was the second most frequent counseling activity

behind giving advice on prescribed medications.) Patients initiated the

counseling in 259 of 438 cases. In 394 of the cases, counseling took 2

minutes or less.

The quality of counseling was somewhat mixed. Recommended products

and advice (when given) were generally found to be appropriate. Willison

and Muzzin (1992) found that in Canada the quality of advice varied by

ailment, with patients receiving better advice on less complex problems.

For three of four scenarios in which the use of a prescription medication

was not involved, the percentage of patients receiving totally safe and

appropriate advice ranged from 62 to 77 percent. For the fourth scenario,

only 17 percent received such advice. In Germany, the Product Testing

Foundation (1991) found that pharmacists’ explanations tended to be

accurate for preparations requiring special explanations (for instance,

appetite suppressants and iron preparations) and that performance had

improved since 1984. There are also examples of inappropriate advice

being given. For instance, Goodburn et al. (1991) found that pharmacists

in the United Kingdom gave inappropriate advice for the treatment of

childhood diarrhea 70 percent of the time. In Germany, Glaeske

(1989) found that 61 percent of all nonprescription products sold were

ineffective or presented dangers to the uninformed user.

In all the countries where studies have been conducted, researchers found

that information-gathering and advice were often incomplete (that is, the

information given was appropriate but not everything that should have

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been covered was discussed). In Australia, Feehan (1981) found a lack of

information-gathering on patients’ characteristics. For instance, 25 of 43

pharmacists were prepared to sell a weight-reduction product without

checking on the patient’s health or to see whether she was taking other

medications. Glaeske (1989) reported that in Germany no pharmacist

asked all the questions considered to be essential. For instance, not one

trained shopper who was a woman was asked if she was pregnant or

lactating. Consultation on side effects was unsatisfactory—for example,

such simplistic statements as “every medication has side effects” and

“there are no side effects” were sometimes made. In a 1991 study, the

Consumers Association (1991) of the United Kingdom found that

customers were not adequately questioned. Only 10 percent of

pharmacists asked the trained shoppers what other medications they were

taking.

Studies in Australia (Harris et al., 1985), Canada (Willison and Muzzin,

1992), and the United Kingdom (Smith, Salkind, and Jolly, 1990) found a

wide range of skills and performance between pharmacists. Feehan

(1981) in Australia and Willison and Muzzin (1992) in Canada thought that

this could indicate a shortcoming in pharmacists’ education for dealing

with patients and that there is a need to strengthen their clinical

interviewing skills. Interestingly, Smith, Salkind, and Jolly (1990) in the

United Kingdom found that pharmacists’ counseling was either very good

or very poor. Few pharmacists were in the middle.

The studies generally found that pharmacy practice has improved as more

and better counseling has been given. This is so when the same

organization collected the same data at different times (Product Testing

Foundation, 1984 and 1991) as well as when the results of different studies

over time were compared (Willison and Muzzin, 1992).

The results of studies in the United States of pharmacist counseling on

nonprescription drug use are quite similar to the findings in other

countries. However, no studies in the United States have assessed the

frequency of pharmacy counseling on these products.

Three studies assessed some aspect of the quantity of counseling. In a mail

survey, Carroll and Gagnon (1983) found that 96 percent of households

said the pharmacist was available to answer questions about

nonprescription medications half the time or more. Meade (1992),

reporting on a study conducted for APhA, noted that 69 percent of

pharmacists said they counsel patients 10 or more times per day on

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nonprescription products, well within the range reported in Canadian

pharmacies. Another survey conducted for APhA (Market Facts,

1994) indicates that pharmacist counseling for nonprescription drugs is

increasing. The 1993 National Prescription Buyers Survey found that the

percentage of respondents who had ever asked a pharmacist for advice

about a nonprescription drug had increased from 37 percent in 1979 to

64 percent in 1993. (There was evidence that interactions with pharmacists

for prescription advice had increased as well.)

The other U.S. studies in table 4.2 examined the quality of counseling. In

the 1960’s and early 1970’s, two studies examined pharmacists’ counseling

regarding nonprescription drugs in U.S. pharmacies (Knapp et al., 1969,

and Wertheimer, Shefter, and Cooper, 1973). The conclusions of both

studies were generally negative. Insufficient inquiries of patients were

made, counseling was infrequent, and inappropriate drugs were sold.3

Jang, Knapp, and Knapp (1975), while finding some positive aspects of

pharmacists’ counseling, also had criticisms, including poor performance

on drug monitoring and controlling OTC drug use.

The Wertheimer, Shefter, and Cooper (1973) study was replicated by

Vanderveen and colleagues (Vanderveen, Adams, and Sanborn, 1978;

Vanderveen and Jirak, 1990). In the 1978 study, the authors concluded that

the pharmacy “profession has not made any great strides in the area of OTC

product counseling.” The only question asked by more than one fourth of

the pharmacists was the age of the child for whom the medicine was being

purchased. The 1990 study found some improvement, with a majority of

pharmacists asking about both the age of the child and the duration of the

illness. However, no other issue was raised by more than half the

pharmacists. The general conclusion was that while pharmacists’

counseling had improved, it could still be better.

Barnett, Nykamp, and Hopkins (1992) found that the majority of

pharmacists questioned customers before making OTC recommendations

and gave directions on their use. For one scenario, an average of 2.81 out

of 5 pertinent questions were asked; for a second, an average of 1.58

questions out of 5 were asked. Combining results from the two scenarios,

they found that 68.2 percent of product recommendations by pharmacists

younger than 30 were appropriate while 42.4 percent by pharmacists 30

3

Linn and Davis (1973) also studied nonprescription drug counseling in the United States but had a

different focus. They found some support for the hypothesis that “business oriented” pharmacists were

more likely to recommend medications than were “professional oriented” pharmacists.

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and older were appropriate. Overall, the authors concluded in 1992 that

pharmacists had made strides in OTC counseling since the earlier studies.

In a study of pharmacist counseling for prescription drugs in Wisconsin,

where there is a requirement that pharmacists provide appropriate

consultation for a prescription, Pitting and Hammel (1983) sent trained

shoppers to 84 pharmacies. (The number of trained shoppers and the

selection method for the pharmacies was not given.) They found that

61.5 percent of pharmacists did not consult with the patient when a

prefabricated drug was dispensed, although 87.5 percent did consult on

compounded products. Thus, even when pharmacists were legally

required to counsel patients, not all pharmacists did so. 4

The results of the studies in the United States are rather similar to those in

countries where the sale of at least some nonprescription drugs is

restricted to pharmacies. In general, the theory of pharmacy practice

diverges from the reality. The advice of pharmacists is often appropriate

but not universally given. In addition, it is often incomplete, with little

information being given to customers on such items as possible side

effects. In other words, what information is given is accurate, but not

enough was passed on to consumers. Researchers consistently found a

lack of information-gathering on the part of pharmacists. For instance,

information is often not gathered on symptoms and other medications.

More positively, within a range of pharmacists’ behavior, many

pharmacists do a good job. In addition pharmacists’ performance, while

still often deficient, has improved over time.

Activities of

Pharmacists

Reporting Adverse Drug

Reactions

One argument for an intermediate class of drugs is that pharmacists would

be in a position to monitor patients for adverse drug reactions to

medications in this class. In the case of a transition class, this information

could be passed on to FDA and aid in its decision whether to allow the sale

of a drug outside pharmacies. However, in Italy and the United Kingdom,

4

The authors speculated that their overall estimates of counseling might be high because (1) the

prescription mix was dominated by prefabricated dosage forms for which a low rate of appropriate

consultation was observed, (2) the prescriptions in the study were all new prescriptions and the

consultation rate is probably lower for renewals (counseling is required for both new prescriptions

and renewals), and (3) most prescriptions contain more specific instructions to the patient than those

in this study and specific instructions would seem less likely to stimulate the pharmacist to consult.

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adverse drug reaction reports from pharmacists are not accepted. In the

other countries, reports from pharmacists are accepted but not required.

This is the same as in the United States. Government, pharmacy, and

manufacturers’ officials stated that pharmacists rarely submit adverse

drug reaction reports. Thus, the experiences of the 10 other countries do

not allow us to assess the benefits from or costs of requiring pharmacists

to report adverse drug reactions.

However, there is some limited information from the United States that

suggests that community pharmacists can, at least in some situations,

successfully monitor patients for adverse drug reactions. Meade (1994a

and b) gives examples of pharmacists who have successfully done this.

She reported on a pharmacist in Minnesota who, through consultation

with a patient, detected that a prescription drug was causing the patient

dizziness, chest pain, and swelling and tingling in the hands. When the

prescribing physician took the patient off the drug, the symptoms

disappeared. Meade also reported on a pharmacist in Tennessee who

discovered from a patient’s reaction to a prescribed drug that the patient

had diabetes.

Maintaining Patient

Profiles

One potential role for pharmacists is to record prescription and

nonprescription drug sales in patient profiles. This information could help

link drug use with adverse drug reactions and other complications. Other

uses for profiles would be prospective. For instance, a patient profile

could alert a pharmacist to medical conditions that might be affected by a

prescribed drug’s side effects. The pharmacist could alert the physician to

the problem and, if it were appropriate, the physician or pharmacist could

select a different drug without these side effects. Similarly, a profile could

alert the pharmacist to possible adverse interactions with other drugs that

a patient was currently taking.

It is not possible to judge the usefulness of such a procedure for

nonprescription products. Only in Australia are pharmacists ever required

to include nonprescription drug use in patient profiles.5

 These

requirements are determined by the individual Australian states and exist

only in certain states and for particular pharmacist-class drugs. The drugs

for which sales must be recorded vary from state to state. There are no

requirements in any of the states for recording sales of pharmacy-class

drugs or drugs available outside pharmacies. Officials in Victoria told us

5

As we show in chapter 5, a similar recordkeeping requirement exists for some prescription drugs that

pharmacists themselves can prescribe in Florida. The experience has been that patients’ profiles are

not adequately maintained.

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that there has been some difficulty in getting pharmacists to comply with

recording requirements. They attributed this to the requirements’ covering

too many drugs and, consequently, they have reduced the list of

nonprescription drugs for which the sale must be recorded to those for

which they believe recording is most important.

The situation in Victoria is similar to one in the state of Washington in the

United States for prescription drugs. Washington has mandatory

regulations governing pharmacy practice that include a requirement that

pharmacists maintain and use patient profiles. In a trained shopper study,

Campbell et al. (1989) found that 67 percent maintained these profiles.

While this was an increase from 54 percent in 1974 (when the law was

enacted), it was considerably below the law’s 100 percent. The authors

speculated that it was doubtful that maintaining and using patient profiles

was significantly greater in Washington than it was in states that did not

have the same requirements.

In 1987, the National Association of Retail Druggists surveyed pharmacists

through the NARD Newsletter (The NARD Survey, 1988). More than 1,300

pharmacists responded.6

 While 92 percent of the pharmacists reported that

they maintain patient profiles, only 15 percent said that they record OTC

drug sales in them.

Officials’ Views The views of many of the government officials in the countries we visited

(Australia, Canada, Germany, the Netherlands, Switzerland, and the United

Kingdom) were consistent with the results of the studies discussed above.

There was agreement that pharmacists have done a rather poor job of

passing their knowledge on to consumers. Many officials questioned the

frequency of pharmacists’ counseling and thought that not enough

counseling was being done. Pharmacists were selling drugs and providing

little or no advice on their use. Officials gave several possible explanations

for this, including time constraints and a lack of counseling skills.

Nonetheless, the officials thought that pharmacists had the potential to

improve drug use if they passed their knowledge on to patients. There was

general agreement that pharmacists are knowledgeable and have a great

deal to offer patients on the proper use of medications. This position was

held even by those who opposed or questioned the usefulness of

6

The number of pharmacists who were sent the survey was not reported. It is possible that there is a

selection bias problem in this study—that is, the pharmacists who responded to the survey might not

be representative of all pharmacists. Those who responded could be among the more or less active

pharmacists.

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restricting the sale of some nonprescription drugs to pharmacies.

Pharmacists could ask key questions about other drugs a patient is

currently taking and about underlying medical conditions and could

monitor compliance and report adverse drug reactions.

Professional pharmacist associations in these countries are taking

criticisms seriously, and many have initiated various programs to address

them. They have instituted continuing education courses to give

pharmacists the skills necessary to better perform their counseling role. A

number of officials noted that pharmacy education has changed a great

deal in the past 10 or so years. There is currently more of an emphasis on

clinical pharmacy with its focus on patient service. Pharmacists who

received their training before this change are often described as not having

the “people skills” to be good counselors.

Recent Developments

in Pharmacy Practice

In this section, we briefly describe some recent developments in the

practice of pharmacy that are relevant to our assessment of an

intermediate class of drugs. Our purpose is not to evaluate these changes

but to make the reader aware of them.

Pharmaceutical Care The idea of pharmaceutical care constitutes a major change in the practice

of pharmacy. It moves pharmacists away from their traditional role of

dispensing drug products and involves them more in selecting and

monitoring drug therapies. The idea has been advocated in the United

States by academics in university-based pharmacy schools and pharmacy

organizations and has spread to other countries (the initiatives mentioned

above have often been undertaken under the name of pharmaceutical

care). Hepler defined pharmaceutical care as “the responsible provision of

drug therapy for the purpose of achieving definite outcomes that increase

a patient’s quality of life” (1991, pp. 141-42). It involves “designing,

implementing, and monitoring a therapeutic plan, in cooperation with the

patient and other health professionals, that will produce specific

therapeutic outcomes” (Klein-Schwartz and Hoopes, 1993, p. 11).

The proponents of pharmaceutical care point to various studies (most of

them in institutional settings where complete patient information exists)

that show the benefits that pharmacists can have on health care. For

instance, one hospital study showed shorter length of stay, smaller total

cost per admission, and smaller pharmacy cost per admission for patients

who received either of two programs involving pharmaceutical care

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(Clapham et al., 1988).6 In another study, elderly apartment residents were

instructed in drug use and given access to drug counseling by pharmacists

(Hammarlund, Ostrom, and Kethley, 1985). After 1 year, the residents who

initially had the greatest number of medication problems (and were

available for follow-up interviews) were found to have had an 11-percent

decrease in the number of prescriptions taken and a 39-percent decrease

in the number of medication problems.

There is some evidence of the value of pharmaceutical care in community

pharmacies. McKenney et al. (1973) examined the effect of a clinical

pharmacist’s counseling hypertensive patients in three community

pharmacies. Throughout the study, the pharmacist maintained close

contact with the patients’ physicians. The patients who received the

counseling were more likely than those who did not receive it to show an

increased knowledge of hypertension and its treatment, comply more

often with their prescribed therapy, and maintain their blood pressure

within the normal range. In a later study, pharmacists in six community

pharmacies in Virginia were trained to provide similar services (McKenney

et al., 1978). Results showed improved compliance and better blood

pressure control in patients receiving counseling than in those not

receiving it. Pharmacists also detected 38 instances of adverse drug

reactions.

Rupp (1992) estimated the value of community pharmacists intervening to

correct prescribing errors. Of 33,011 prescriptions that were examined,

623 (1.9 percent) were found to be problematic. The estimated value of

these interventions was $76,615.7

 Nichols et al. (1992) examined the effect

of counseling on nonprescription drug purchasing decisions. They found

that 25.4 percent of patients purchased a different product than they had

intended after receiving counseling, 13.4 percent did not purchase a drug,

and 1.3 percent were referred to their physician. However, the study did

not measure the importance of these decisions (for instance, how much of

an improvement was brought by changing medications).

More research is being conducted on the effect of pharmaceutical care in

community pharmacies. Studies are focusing on the effect of drug use

reviews by pharmacists, the use of protocols by pharmacists in managing

and monitoring diseases, and a pharmaceutical care program for pediatric

6

The two programs were (1) pharmacist monitoring of drug therapy in the patient-care area and

(2) centralized pharmacist monitoring of computerized patient profiles.

7

These projected savings include only the estimated direct costs of medical care that was avoided

because of the pharmacists’ intervention. Such items as losses in patient productivity, pain and

suffering cost, and the value of possible litigation were not estimated.

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and adolescent patients with asthma. In addition, there appears to be at

least some movement among community pharmacists to implement

pharmaceutical care. Training courses are offered on how to implement

pharmaceutical care (Martin, 1994) and articles have been written on

pharmacies where it has been established (Meade, 1994a and b).

For our purposes, it is important to note that the methods and goals of

pharmaceutical care are consistent with those of an intermediate drug

class. The general idea of both is that pharmacists would be more involved

in a patient’s drug therapy by such actions as consulting with patients. The

evaluation of pharmaceutical care in community pharmacies would give

some indication of the potential value of a greater role for pharmacists

and, consequently, would provide some information on the value of an

intermediate class of drugs. However, even if a positive value were

established, or at least indicated, a number of the difficulties we have

identified in this report would still have to be addressed. For

nonprescription drugs, pharmacists would need to counsel patients,

monitor and report adverse drug reactions, refer patients to physicians

when necessary, and perform many other activities. This has not been the

norm.

Other issues would also need to be addressed. For instance,

pharmaceutical care can take a great deal of time. Pharmacists would

probably have to delegate more responsibility to technicians. The

appropriate role for technicians would have to be determined.

Pharmacists’ compensation for pharmaceutical care activities may be

especially important. Many pharmacies now charge a fee for

pharmaceutical care services. (Some pharmacies have different fees

depending on the level of services offered.) However, some insurance

companies have been reluctant to pay for the services (Martin, 1994).

It should be clear that pharmaceutical care regarding nonprescription

drugs can be given without an intermediate class of drugs. When and if

pharmaceutical care is established in community pharmacies, the need for

an intermediate class will still need to be established. It will still be unclear

what benefits would accrue from establishing such a class of drugs.

Arguments such as we hear now will still be heard (for instance, more

drugs would be switched and health care costs would be reduced). The

difference would be that, at least in some areas, pharmacists would be

doing what is necessary for an intermediate-drug class to be successful.

How much, if anything, would be gained by establishing an intermediate

class of drugs, even under these circumstances, is unclear.

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Omnibus Budget

Reconciliation Act of 1990

Within the Omnibus Budget Reconciliation Act of 1990 are new

requirements for the practice of pharmacy that went into effect on

January 1, 1993, and that mandate prospective drug use reviews,

counseling of patients, and maintenance of patient profiles for Medicaid

recipients. Although these requirements cover only Medicaid beneficiaries,

most (44) state boards of pharmacy have extended them to cover other

patients receiving prescriptions. The goal, of course, is to improve health

care through helping patients understand and follow medication directions

better. Success is being evaluated by several studies funded by the Health

Care Financing Administration.

The applicable regulations require prospective drug use reviews before

each Medicaid prescription is filled. Prescriptions are to be screened for

potential problems from therapeutic duplication, drug-disease

interactions, drug-drug interactions, incorrect dosage or duration of

treatment, drug-allergy interactions, and clinical abuse or misuse. The

pharmacist is to intervene, if necessary, before the prescription is

dispensed.

Additionally, in drug use reviews pharmacists must offer to counsel

patients about their prescription medications. Exact counseling

requirements are defined by each state. Information that might be passed

on includes the name and description of the medication, the dosage,

special directions and precautions, common severe side or adverse effects,

interactions, therapeutic contraindications, and proper storage.

Pharmacists must also make a “reasonable effort” to obtain, record, and

maintain at least the following information:

• the patient’s name, address, telephone number, date of birth or age, and

gender;

• the patient’s individual history, where significant, including disease states,

known allergies and drug reactions, and a comprehensive list of

medications and relevant devices;

• the pharmacist’s comments relevant to the patient’s drug therapy.

The reaction of practicing pharmacists to the new requirements has been

mixed. Some see it as an opportunity while others are wary. While the law

requires pharmacists to perform additional duties, it does not stipulate

that they should be compensated for them, despite some pharmacies’

having had to hire new employees and buy new computer software.

Pharmacists are also concerned that lawsuits against them will increase.

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A 1994 survey conducted for the National Association of Boards of

Pharmacy found that only 38 percent of all customers stated that someone

in the pharmacy offered to have a pharmacist discuss their prescription

medications with them. The president of the association stated that the

results “clearly indicate that too few patients and caregivers are being

counseled on their prescription medications.” However, the same study

found that pharmacist counseling is perceived positively by the public.

Seventy-one percent of offers to counsel were accepted, and the same

percentage of patients thought that counseling was very important. The

counseling that was done also appears to have been of a high quality, with

99 percent of respondents believing that the pharmacist had clearly

presented the information and with pharmacists telling patients how and

how often to use their medications at least 93 percent of the time. A large

majority of patients were also told the dosage amount, the name (along

with a description) of the medication, how long it should be taken, special

directions or precautions, and any side effects. However, less than half of

the pharmacists told patients how to monitor the effects of their

medications and what they should do in the event of a missed dose.

Liability Pharmacists’ liability is becoming a concern throughout the United States.8

Data from the Chicago Insurance Company show that claims against

pharmacists rose 22 percent from 1987 to 1990. Recent court rulings have

expanded a pharmacist’s liability under some circumstances. Pharmacists

in some states may now be held liable if they fail to instruct a patient

about the maximum safe dosage or fail to identify a potential adverse drug

interaction for a prescribed drug. (Chapter 5 discusses pharmacists’

liability in prescribing drugs in Florida.)

A 1994 ruling by an Arizona appellate court also indicates that

pharmacists’ liability might be increasing. According to one source, a

majority of court decisions involving pharmacy liability between 1986 and

1994 had concluded that pharmacists generally did not have a

responsibility to warn patients of potential adverse effects of their drug

regimen. However, in Lasley v. Shrake (880 P.2d 1129 (1994)), the

appellate court ruled that pharmacists have a general duty of “reasonable

care” that could include a duty to warn. The case was sent back to the trial

court to determine what constitutes reasonable care.

8

Liability was not a concern to officials in other countries where there is a general lack of litigiousness

compared to the United States.

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In addition, some pharmacists have speculated that requirements of the

Omnibus Budget Reconciliation Act of 1990 will also increase pharmacists’

potential liability, as could pharmaceutical care.

Summary The success of an intermediate class of drugs, whether a fixed or

transition class, depends in part on the role of pharmacists in the drug

distribution system. The theory of pharmacy practice diverges from the

reality. In all 10 study countries, pharmacists are expected to play a role

(although the role varies between countries) in ensuring the proper use of

drugs in a pharmacist or pharmacy class. Despite these requirements,

pharmacists’ counseling of patients, although increasing, is not as frequent

and complete as it should be. Our findings for the United States are

similar.

Pharmacists in the study countries are not required (or not allowed) to

report adverse drug reactions. In only one instance are they required to

record the sale of nonprescription drugs in patient profiles. Thus, in these

countries, nonprescription drug sales are limited to pharmacists or

pharmacies in order to restrict distribution or promote counseling, not to

increase surveillance of nonprescription drug use.

Our findings indicate the difficulty of successfully establishing an

intermediate class of drugs. Active pharmacist involvement is necessary

for an intermediate class to serve its purpose of improving drug use.

However, pharmacists will not necessarily counsel patients simply

because it is expected or required, and enforcing such requirements is

quite difficult. Also, it is unclear whether requiring pharmacists to

maintain patient profiles and monitor adverse drug effects would succeed.

There is little international experience in these matters.

Recent developments in pharmacy practice in the United States indicate

that the role of community pharmacists may be changing. The

implementation of pharmaceutical care and the counseling requirements

of the Omnibus Budget Reconciliation Act of 1990 are beginning to move

pharmacists from their traditional role of dispensing medications to one of

monitoring their patients’ drug therapies. The activities involved are

similar to those that would be required for the theoretical benefits of an

intermediate class to be achieved. However, even if pharmacists begin to

regularly perform these activities, there will still be reason to determine

the need for establishing such a class of drugs.

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While the United States has essentially only two classes of drugs

(prescription and general sale, the latter commonly referred to as OTCs),

there are situations in which a pharmacist may supply a prescription drug

to a patient without a physician’s prescription and instances in which

nonprescription drugs are not available for general sale. These include

dispensing a small number of controlled substances (for instance,

particular amounts of codeine) regulated under the Controlled Substances

Act (Public Law 91-513, title II) and insulin. Similarly, in Florida

pharmacists have been given the independent authority to dispense a

limited number of prescription drugs without a doctor’s prescription.

Federal law requires that prescriptions be dispensed by “practitioners” but

allows individual states to determine who is a “practitioner.” In Florida,

this group includes pharmacists. Finally, in some states pharmacists have

been given dependent prescribing authority—that is, they may prescribe

under the supervision of a physician. In this chapter, we describe these

situations. The lessons that can be learned from them are relevant for both

a fixed and transition class since, as with an intermediate class,

pharmacists are expected to do more than simply dispense medications.

Schedule V Controlled

Substances and

Insulin

Under the Controlled Substances Act of 1970, the manufacturing,

distribution, and dispensing of controlled substances (that is, psychoactive

drugs) is regulated. The act’s purpose, among other things, is to prevent

drug abuse and dependence and strengthen law enforcement authority in

the field of drug abuse. These drugs are placed into one of five categories

(referred to as schedules) based on three criteria: currently accepted

medical use, abuse potential, and human safety. Schedule V drugs have the

fewest restrictions and may be made available by FDA without a

prescription. They are defined as drugs having a low abuse potential

relative to drugs or other substances in schedule IV, having a currently

accepted medical use in treatment in the United States, and leading to

limited physical or psychological dependence when abused relative to

drugs or other substances in schedule IV.

Schedule V drugs are classified as prescription or nonprescription

products as determined under the Durham-Humphrey Amendment to the

Federal Food, Drug, and Cosmetic Act of 1938. Some schedule V drugs

classified as nonprescription under this act are available without a

prescription in some states but not all. However, even when a prescription

is not required, schedule V drugs are still available only from a pharmacist.

Schedule V products are few. They are the narcotic buprenorphine, the

stimulant pyrovalerone, and products containing specific amounts of the

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narcotics codeine, dihydrocodeine, ethylmorphine, diphenoxylate with

atropine sulfate, opium, or difenoxin with atropine sulfate. Larger doses of

these products (when available) are in a more restricted schedule.

Sellers of schedule V products must follow federal and state requirements.

For instance, in Connecticut the seller must keep a record containing “the

full name and address of the person purchasing the medicinal preparation,

in the handwriting of the purchaser, the name and quantity of the

preparation sold and the time and date of sale.” Federal regulations state

more generally that the purchaser must be 18 years old or older and

furnish suitable identification and that all transactions must be recorded

by the dispensing pharmacist.

While one purpose of the Controlled Substances Act is to improve public

health, the requirements for selling a product differ from what is typically

discussed for an intermediate class of drugs. Under the act, the focus is on

recordkeeping; in an intermediate class of drugs, activities such as

counseling and monitoring patients would be stressed. Nonetheless, the

two are somewhat similar in that the pharmacist is involved in the sale and

that reducing drug abuse is a goal. Any information on how successful the

establishment of schedule V has been in reducing drug abuse would be

helpful in evaluating the potential value of an intermediate class of drugs.

However, we were unable to locate any studies evaluating the usefulness

of schedule V in preventing abuse or monitoring the use of the products.1

Therefore, while it would be useful to know how successful schedule V

has been, we have no data with which to find out.

Insulin is also available without a prescription but restricted to dispensing

by pharmacists in most states.2

 However, a physician must first determine

the patient’s insulin needs and provide instructions for controlling

diabetes. As with schedule V products, we located no studies that

evaluated the effect of this restriction.

1

In an earlier study, we reported on state prescription drug monitoring programs. While 11 states had

programs, schedule V drugs were not covered in any of them (GAO, 1992).

2

In the other states, insulin either is restricted to prescription sale or may be sold without a

prescription by any retailer.

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The Florida

Pharmacist Self-Care

Consultant Law

The Florida Pharmacist Self-Care Consultant Law (sometimes referred to

as the Florida Pharmacist Prescribing Law), which went into effect on

October 1, 1985, is unique in the United States. It allows pharmacists to

independently prescribe specific categories of medications that under

federal law may be dispensed only upon the prescription of a licensed

practitioner; in Florida, this includes pharmacists. Perhaps the most

important point about the law is that pharmacists are able to

independently prescribe medicines—that is, they are not operating under

the supervision of a physician.3

Despite this independence, the law does limit what pharmacists can do.

Pharmacists are not allowed to order injectable products, treat a pregnant

patient or nursing mother, order more than a 34-day supply of the drug,

prescribe refills unless specifically authorized to do so in the formulary, or

order and dispense anyplace but in a pharmacy.4

 Pharmacists

recommending a drug must advise patients to see a physician if their

condition does not improve at the end of the drug regimen.

When the law went into effect, there were 35 drugs in the formulary. Since

then, 7 drugs have been added, bringing the total to 42. Responsibility for

the original list, as well as for adding and deleting drugs, rests with a

seven-member committee.5

 The law states that any drug sold as an OTC

product under federal law may not be included in the formulary. Among

the categories of drugs in the formulary are oral analgesics, antinausea

preparations, and antihistamines and decongestants.

Under the law, pharmacists are not required to perform the prescribing

role. However, if they choose to do so, a number of requirements pertain,

including the labeling of products, creating prescriptions, and maintaining

patients’ profiles. (More detail on the products in the formulary and the

requirements for pharmacists is in appendix V.)

Evaluation In 1990, a group of researchers from the College of Pharmacy at the

University of Florida reported on the effect of Florida’s Pharmacist

3

In some states, other health professionals (physicians’ assistants, nurse practitioners, and

pharmacists) may prescribe medications but only under protocols established by supervisory

physicians. (These situations for pharmacists are described later in this chapter.)

4

The formulary is the list of drugs pharmacists are allowed to prescribe and the conditions under

which they may be prescribed.

5

The committee consists of two members of the Board of Medicine, one member of the Board of

Osteopathic Medicine, three members of the Board of Pharmacy, and one additional person with a

background in health care or pharmacology.

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Self-Care Consultant Law during its second and third years of operation

(Eng et al., 1990). Four methods were used in the study: a survey of

pharmacists, pharmacy audits, shopper visits, and a survey of consumers.

The following four subsections summarize the results that are most

relevant to our report.

Survey of Pharmacists In a mail survey of pharmacists, Eng and colleagues found that

pharmacists infrequently prescribed drugs from the formulary.

Thirty-three percent of community pharmacists had prescribed a drug at

least once. Of this group, 60 percent had prescribed less than one drug per

month. The principal reasons given for not prescribing were that drugs in

the formulary offered no advantages over nonprescription drugs,

prescribing increased the risk of liability, and time was too short.

Conversely, the main reasons for prescribing were that it helped the

patient maximize self-care, used the pharmacist’s knowledge, and saved

the patient money.

No differences were found between the prescribers and nonprescribers

with respect to gender, professional degree, position (for instance,

prescription department manager and pharmacy owner), and prescription

volume. The study authors did find that pharmacists with fewer years of

practice were more likely to prescribe than those with more years of

practice, and independent community pharmacists were more likely to

prescribe than chain pharmacists.

Pharmacy Audits The law requires that if a pharmacist prescribes a drug, the pharmacy must

maintain a profile of the patient. Of 19 pharmacies that reported that their

pharmacists prescribed drugs, only 9 maintained the required profiles. The

audits showed that pharmacists’ prescriptions made up a small proportion

of the total number of prescriptions: less than 0.25 percent of all the

medications that were prescribed in the 9 pharmacies. These prescriptions

were primarily limited to topical pediculicides (lindane shampoo), oral

analgesics, and otic (ear) analgesics. These categories constituted

82 percent of all pharmacists’ prescriptions.

Shoppers’ Visits Trained shoppers found that the quality of the pharmacists’ performance

in 21 community pharmacies was high in two areas: (1) following the law’s

labeling and quantity limitation requirements and (2) practicing the art of

communication. In more than 70 percent of the cases, the shoppers found

that the pharmacist was friendly, provided some privacy, and appeared to

be interested.

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However, the pharmacists spent very little time in assessing and

responding to medical complaints presented by patients. Less than

17 percent of the 62 pharmacists asked about chronic medical conditions,

medication allergies, and current prescription and nonprescription drugs

that the patients were taking. Only 5 percent of the pharmacists asked

about the onset, duration, and frequency of the medical problem while

13 percent asked if they had tried other medications. In less than

40 percent of the visits, pharmacists provided information on topics such

as the number of doses to be taken per day, the duration of the treatment,

and side effects. The authors noted that when counseling was provided,

the information was generally accurate but incomplete.

The performance of the 21 pharmacists in three scenarios was mixed. In a

scenario leading to the recommendation of an OTC product, all 21

pharmacists recommended the correct product. However, for a scenario

that should have led to referral to a physician, only 1 pharmacist made the

referral. In a scenario leading to the pharmacist’s prescribing a product,

the patient asked for a specific shampoo that was in the formulary; only 5

pharmacists prescribed it. The four reasons given for not prescribing were

that liability insurance did not cover the pharmacist’s prescribing, it is

against company policy to prescribe, a prescription is needed, and the

particular pharmacist does not prescribe.

Consumer Survey Consumers in the pharmacies were surveyed to determine their attitudes

toward receiving advice from pharmacists.6

 Three principal reasons were

given for seeking advice from pharmacists: confidence in their abilities,

convenience, and the problem’s not being serious enough to consult a

physician. All 149 of the patients who answered the question on how

pleased they were with the pharmacist’s actions indicated that they were

satisfied. Ninety percent of consumers said that they would follow the

pharmacists’ advice regarding seeing their physician or taking a

recommended OTC product or pharmacist prescribed drug. A small

majority (52.3 percent) also indicated a willingness to pay a fee for a

pharmacist’s services if a drug were prescribed by the pharmacist but not

if the pharmacist only provided advice, recommended a nonprescription

product, or referred the patient to a doctor. Of those willing to pay a

separate fee, one third were willing to pay more than $5.00.

6

The pharmacists selected the customers to be surveyed. Of 362 surveys distributed by the

pharmacists, 163 were returned.

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Officials’ Assessment of

the Effect of the Law

Officials we met with in Florida invariably thought that the effect of the

law had been minimal because few pharmacists were using their

prescribing authority. One official who had previously done pharmacy

inspections in Florida estimated that 1 in 50 pharmacists actually

prescribed drugs.

The officials’ reasons for the lack of prescribing mirrored those given by

the pharmacists themselves. The first involved the drugs in the formulary.

There is a belief that the drug categories available to the pharmacists and

the specific drugs in them are not very useful because some OTC products

work just as well. Therefore, there is no incentive for a pharmacist to use

one of the drugs in the formulary to treat patients.7

The second explanation involved the liability issue. Individual pharmacists

were concerned that they would increase their liability risk if they

prescribed. Insurance companies did not want to insure individuals who

prescribed drugs. The policies of some pharmacists who prescribed were

canceled while others had riders attached. At one point, there was an

insurance surcharge if a pharmacist wanted to prescribe.

The third common reason given for pharmacists’ not prescribing was the

presence of time constraints. As shown in appendix V, a number of

recordkeeping requirements are associated with prescribing a drug. They

take time (one official estimated 10 minutes per prescription). One official

tied the recordkeeping requirements to the liability issue, noting that the

paperwork involved with prescribing brings pharmacists into the spotlight

and makes them more fearful of liability.

Comparisons With Studies

in Other Countries

In chapter 4, we discussed the practice of pharmacy in the study countries,

including reports on pharmacists’ counseling on nonprescription drugs.

The experiences in Florida are generally similar to those in the other

countries. For example, Florida is similar to Australia—the one country

where pharmacists are ever required to maintain patient profiles on

nonprescription drug use—in that pharmacists often did not maintain the

required profiles. Recordkeeping requirements were seen in both places as

being excessive. In Florida, this was attributed to the requirements taking

7

In addition, a number of the drugs were switched to nonprescription status at the national level soon

after the development of the Florida formulary, thereby limiting pharmacists’ prescription authority

(since no drug sold OTC under federal law may be included in the formulary). Moreover, some of the

products were available at lower doses without a prescription, which could lessen the incentive for

pharmacists to prescribe. Thirteen of the drugs fell into one of these categories within 3 years of the

law’s going into effect.

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Chapter 5 

The U.S. Experience

too much time, while in Australia the requirements were viewed as

covering too many drugs.

Similarly, in counseling their patients, pharmacists in other countries and

Florida did not gather sufficient information from them on such items as

medical conditions and other medications being taken. In many cases,

counseling was more incomplete than inappropriate.

Consumers’ views toward pharmacist counseling were also quite similar.

Customers in Florida were generally positive toward pharmacists’

counseling, but they were less willing to pay for advice from pharmacists if

only a nonprescription drug was involved. A study in Canada also found

that most customers did not want advice on nonprescription drugs.

Pharmacists as

Dependent

Prescribers

While pharmacists in Florida have been given independent (although

limited) prescribing authority, some pharmacists elsewhere in the United

States have been given dependent prescribing authority. Typically, the

pharmacists are constrained by protocols established by supervisory

physicians. Dependent prescribing has not normally been discussed in

terms of an intermediate class of drugs, but it does indicate roles that

pharmacists have played in addition to the traditional one of dispensing

medications. Because these activities are outside the scope of this report,

we do not evaluate them here. Instead, we only describe alternative roles

that pharmacists sometime have in the United States.

Pharmacists in the Indian

Health Service and the

Veterans Administration

The Indian Health Service (IHS), part of the U.S. Public Health Service in

the Department of Health and Human Services, provides health services to

American Indians and Alaskan Natives, including hospital and ambulatory

medical care. IHS pharmacists are authorized to provide certain

prescription drugs directly to patients without a physician’s authorization.

At the outset of the program, the pharmacists could modify doses, dosage

forms, and quantities of medicines and make therapeutic substitution of

medicines. Later, their responsibilities were expanded to include treating

minor acute illness and monitoring patients receiving chronic drug therapy

between physician visits. The activities of pharmacists are defined by

approved protocols that indicate their functions, responsibilities, and

prescribing privileges. The protocols are organized by disease and include

such elements as the criteria for inclusion in pharmacy-based care,

specific definitions of the role of the referring physician or nurse and the

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Chapter 5 

The U.S. Experience

pharmacist, criteria for periodic visits by physicians to review a patient’s

status and the quality of care the pharmacist delivers, and drug therapy.

In March 1995, the Department of Veterans Affairs (VA) issued a directive

establishing medication prescribing authority for, among others, clinical

pharmacy specialists.8

 The directive defines inpatient and outpatient

prescribing authority for clinical pharmacy specialists and other

professionals, it lists the requirements for pharmacists to be given

prescription authority, and it notes that each professional given the

prescription authority will be limited by “a locally-determined scope of

practice” that indicates his or her authority. Prescriptions written within

the scope of practice do not require a physician’s signature, but those

outside the scope of practice do.

Dependent Prescribing

Authority in the States

Nine states have established dependent prescribing privileges for

pharmacists.9

 In California, Nevada, and North Dakota, pharmacists are

allowed to prescribe only in institutional settings; there are no such

restrictions in the six other states. Only in New Mexico is special training

required for pharmacists to prescribe.

In these nine states, prescribing is done by a protocol that involves a

voluntary agreement between the pharmacist and the physician. The

pharmacist is responsible for initiating, monitoring, and modifying drug

therapy while the physician supervises the process and overall patient

care. For example, in Washington, all practicing pharmacists are eligible to

initiate and modify drug therapy by protocol, but a written agreement

must be developed between the pharmacist and an authorized prescriber.

The agreement must be sent to the Washington State Board of Pharmacy

for review. It must include, among other items, the type of prescribing

authority to be exercised (including types of medical conditions and drugs

or drug categories), documentation of prescriptive activities to be

performed, and a mechanism for communicating with the authorizing

practitioner.

8

See VHA Directive 10-95-019, “General Guidelines for Establishing Medication Prescribing Authority

for Clinical Nurse Specialists, Nurse Practitioners, Clinical Pharmacy Specialists and Physician

Assistants.”

9

The nine states are California, Mississippi, Missouri, Nevada, New Mexico, North Dakota, Oregon,

South Dakota, and Washington. A number of evaluations of pharmacist prescribing have been done.

For instance, in California they have been conducted in a hospital (Chenella et al., 1983), nursing

facility (Thompson et al, 1984), and health maintenance organization (McGhan et al., 1983).

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The U.S. Experience

North Dakota recently gave pharmacists the right to prescribe but only in

institutional settings (a hospital, skilled nursing facility, or swing bed

facility) in which a patient’s medical records are readily available to the

physician. Following diagnosis and initial patient assessment by a licensed

physician, pharmacists in these settings (under the supervision of the

same licensed physician) can initiate or modify drug therapy.

Summary We found no data to evaluate the experience of pharmacists in the United

States dispensing schedule V controlled substances or insulin. However,

the data on Florida show that the experience there of pharmacists

prescribing drugs, whether a fixed or transition class, has been quite

similar to that in 10 countries we studied. A number of lessons for the

success of an intermediate class of drugs, whether a fixed or transition

class, in the United States can be learned from Florida. First, the drugs in

an intermediate class must be seen as worth the effort of dispensing. If

not, the drugs will not be used and the benefits of the class will not be

realized. Second, the liability and insurance issues have to be addressed.

Third, recordkeeping requirements can be burdensome. Pharmacists are

busy and, if the recordkeeping requirements are too extensive, they will

either not maintain the records or not dispense the drugs. A method of

collecting the data would have to be developed that does not impose too

great a burden on pharmacists. This would be especially important for a

transition class of drugs, for which recordkeeping would be a necessity if

FDA were to gather data on the suitability of a drug for sale outside

pharmacies.

Calls for an intermediate class of drugs do not focus on pharmacists’

dependent prescribing authority, but it gives some indication of roles

pharmacists may play other than the traditional one of dispensing

medications. An evaluation of these roles would have to study the

counseling of patients, monitoring adverse drug reactions, any reductions

in cost, and the setting in which the prescribing takes place. Pharmacists

in institutional settings (including IHS and VA) have access to patients’

records that indicate their health status and drug regimen while

pharmacists in community pharmacies (from where intermediate-class

drugs would be dispersed) might not have this information. Prescribing

under these two circumstances is quite different. The results of evaluating

one may not be applicable to the other.

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Summary and Conclusions

The purpose of this report was to examine the structure and operation of

drug distribution systems in other countries in order to better understand

the potential advantages and disadvantages of establishing an intermediate

class of drugs in the United States. The assumption is that while the

experiences of other countries might not be models for the United States,

they might provide a useful starting point for discussion. This chapter

summarizes our findings and presents our conclusions.

Extant Studies The two-tier U.S. drug distribution system with its prescription and

general sale classes is unique among the 10 countries we studied. These

countries restrict the sale of at least some nonprescription drugs to

pharmacies or personal sale by a pharmacist. However, their drug

distribution systems differ, and no efforts have been made to study

systematically the consequences of the different systems. We found no

systematic evidence to support the superiority of one drug distribution

system over another.

Drug Distribution

Systems

The Benefits of a

Transition Class

It is unclear how some of the benefits of a transition class would be

realized in the United States. The experiences of other countries cannot be

used to assess its usefulness because their intermediate classes are not

used in this manner. Instead, they are generally viewed as fixed classes

into which drugs are placed permanently. The intermediate classes are

used solely to restrict access to drugs, not to facilitate their movement to

general sale.

It is unclear whether a transition class could be effective in monitoring

adverse drug reactions while a drug is being considered for general sale.

Several officials, questioning the usefulness of the data that would be

collected, argued that toxicity profiles are well established through clinical

research and experience with drugs as prescription products. Additionally,

the data that would be collected when a drug was in the transition class

would not be from well-controlled studies. The conclusions that could be

drawn from the data would not be as well supported as conclusions from

other types of studies.

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Summary and Conclusions

If an intermediate class were used to increase knowledge to better assess

drugs for switching, pharmacists would have to keep records on patients’

drug purchases. This would allow the purchase of a drug to be linked with

adverse outcomes. Pharmacists would have to record symptoms, other

medical conditions, the practitioners who recommended the product, and

the amount purchased. They would also have to follow up, recording

experiences with a product such as efficacy, side effects, and interactions

with food, drugs, and medical conditions. These recordkeeping

requirements would take time and add costs; much less demanding

recordkeeping requirements deter pharmacists in Florida from prescribing

such drugs. Similarly, in the Australian state of Victoria, we found that

pharmacists often did not maintain records of patients’ use of

pharmacist-class drugs, despite being required to do so.

The Use of an Intermediate

Class to Prevent Abuse

Officials in the United States and abroad thought that an intermediate

class, whether fixed or transition, would do little to prevent drug abuse.

While having to buy drugs in pharmacies rather than in other outlets

would be a deterrent (for instance, a consumer would have to talk to the

pharmacist or would be able to buy only a small amount of the drug), this

safeguard would be relatively easy to circumvent. Consumers could visit

the same pharmacy on numerous occasions or go to several pharmacies to

purchase the drug. Experiences in Australia and Germany in which

pharmacist-controlled nonprescription drugs were either used or

purchased improperly are consistent with these conclusions.

Drug Expenditures All 10 countries control the prices of prescription drugs but not

necessarily nonprescription products. Consequently, we could not draw

useful lessons for the United States (where neither prescription nor

nonprescription prices are controlled) on how prices change when a drug

is switched.

We did find some evidence from the United States and the United

Kingdom that the price of a drug decreases when it is switched from

prescription to nonprescription status. However, the effect on price of the

presence or absence of an intermediate drug class has not been assessed.

We also found that moving a drug to nonprescription status did not

necessarily reduce health care costs. An incentive is created to obtain a

drug with a prescription when such drugs remain reimbursable if they are

prescribed but not if bought without a prescription. This can occur if

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Summary and Conclusions

patients have less out-of-pocket costs (for instance, because of a small

copayment) for a prescription drug than for a nonprescription product,

even if the nonprescription product is less expensive.

The European Union The European Union has decided not to require that the member countries

establish a particular drug distribution system. The European Union was

not convinced of the superiority of any particular system. Each member

country will be allowed to establish whatever drug distribution it wants,

provided the requirements for domestic producers and importers are the

same. The European Union has established criteria for distinguishing

prescription from nonprescription drugs in the hope that drugs in these

categories will become consistent from country to country.

Access to

Pharmaceuticals

Number of Pharmacies and

Drugstores

There are approximately 54,000 community pharmacies in the United

States. This is substantially less per capita than 6 of the countries studied

(if drugstores are included), while 2 other countries and the Canadian

province of Ontario have approximately the same number as the United

States. Only Denmark and Sweden have many fewer community

pharmacies per capita than the United States. This suggests that limiting

the sale of some nonprescription drugs to pharmacies in the United States

would create somewhat greater access problems than in 6 of the countries.

However, this is complicated by the number of other outlets such as

mail-order and managed care pharmacies that might choose to sell these

drugs. If such outlets chose to sell these products, the reduced access to

these drugs from limiting them to sale in pharmacies could be offset.

While the number of pharmacies gives some indication of access, the

distance to a pharmacy is also very important. The distance that people

live from pharmacies varies greatly in the United States. The nearest

pharmacy can be 100 or more miles away. Restricting the sale of some

nonprescription drugs to pharmacies would give individuals who have

ready access to a pharmacy a greater number of nonprescription drugs

from which to choose. However, if the drugs were to come from the

prescription class, relative access between customers with and without

ready access to a pharmacy would remain the same. The drugs would still

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Summary and Conclusions

be available for sale only in pharmacies; the difference would be that a

prescription would not be required.

Self-Selection of Drugs Of the countries studied, only the United States allows self-selection of all

nonprescription drugs. Denmark, France, and Italy do not allow

self-service for any drugs, while the remaining countries allow it for some

but not all nonprescription products. If the United States were to establish

an intermediate class of drugs (whether fixed or transition), it might not

allow the self-selection of these products, since the theoretical benefits

associated with the class would be difficult to achieve without some

control on their distribution in pharmacies. This could change the way

nonprescription drug purchases are made, since comparisons between

products would be more difficult for consumers to make, not being able to

select intermediate-class products from the shelf personally.

Classification of Drugs Our examination of the classification of 14 selected drugs in the study

countries indicated no clear pattern of increased nonprescription drug

availability because of the existence of a pharmacist or pharmacy class. It

appears that other factors in addition to or instead of the existence of a

pharmacist or pharmacy class account for differences in drug

classification between the countries. Despite the absence of an

intermediate class, the United States allows the sale of some of the 14

drugs without a prescription that many other countries restrict to

prescription sale. Conversely, the United States restricts to prescription

sale some drugs that other countries allow to be sold without a

prescription but only in a pharmacist or pharmacy class.

It also appears that access in one country relative to another depends in

part on how access is defined. More of the 14 drugs were available for sale

outside pharmacies in the United States than in any of the other countries.

However, the United States restricts the sale of more of these drugs to

prescription status than do 5 of the countries. These drugs, while available

for sale without a prescription, are restricted to a pharmacist class. Thus,

if the criterion used for defining access is the number of drugs available

for general sale, the United States has the most accessible system.

However, if the criterion is the number of drugs available without a

prescription, the United States is somewhere in the middle in terms of

accessibility.

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Summary and Conclusions

Pharmacy Practice Officials in the countries we visited and the literature on pharmacist

counseling generally agree that the theory of pharmacy practice diverges

from the reality. The theory of pharmacy practice involves (and the

success of a fixed-intermediate or transition class requires), for example,

the complete and appropriate counseling of patients on such issues as

dosing instructions and potential adverse drug reactions, as well as

maintaining patient profiles. However, pharmacists have often not

performed these roles (especially for nonprescription drugs), either in the

United States or abroad, even when doing so is expected and, in some

cases, required. Pharmacist counseling, as practiced, is less frequent and

less thorough than desired, although it has improved over time. In efforts

in the United States and elsewhere to increase the role of pharmacists,

professional associations and academics are advocating the idea of

“pharmaceutical care,” with its emphasis on monitoring a patient’s drug

therapy rather than on dispensing the drugs. There is evidence that in

institutional settings such as hospitals, there are benefits from

pharmaceutical care. However, pharmaceutical care is only now being

implemented in community pharmacies and its value has yet to be

established.

Improved drug use is often cited as a justification for an intermediate drug

class, and evidence for it gives support for expanding the role of

pharmacists in general. Such an expansion does not necessitate creating

an additional drug class. Indeed, the current system would benefit from an

improvement in pharmacist counseling.

The Florida

Experience

The Florida Pharmacist Self-Care Consultant Law has had very little effect

on the practice of pharmacy. Pharmacists rarely prescribe drugs in the

formulary. This is attributed to (1) drugs being available without a

prescription that are just as effective as the ones in the formulary, (2) the

perception of increased liability, and (3) burdensome recordkeeping

requirements.

Conclusions Other countries’ and Florida’s experiences do not support a fundamental

change in the drug distribution system of the United States such as

creating an intermediate class of drugs, whether fixed or transition, at this

time. Its benefits are unclear. No evidence at this time shows the overall

superiority of a drug distribution system that restricts the sale of at least

some nonprescription drugs to pharmacies. However, it should also be

clear that there is no evidence that systems that do this are necessarily

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Summary and Conclusions

inferior to drug distribution systems that allow some or all

nonprescription drugs to be sold outside pharmacies.

The evidence that does exist tends to undermine the contention that major

benefits are being obtained in countries with a pharmacist or pharmacy

class. Such a class is not being used to facilitate the movement of drugs to

sale outside pharmacies. Also, pharmacist counseling as it is currently

practiced does not support the goals of either a fixed or a transition class.

Pharmacists are not regularly counseling patients, maintaining patient

profiles, or monitoring for adverse drug effects. Thus, there is no evidence

to show that the role that U.S. pharmacists would have to play to support

the appropriate use of an intermediate class of drugs (either fixed or

transition) would be fulfilled reliably and effectively. The evidence

indicates that at this time major improvements in nonprescription drug use

are unlikely to result from restricting the sale of some OTCs to pharmacies

or by pharmacists, nor are the safeguards for pharmacy- or

pharmacist-class drugs that would have otherwise remained in the

prescription class likely to be sufficient.

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Page 81 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix I 

History of the Intermediate-Drug Class Issue

in the United States

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

Cosmetic Act of 1938 provided the statutory basis for two classes of drugs

in the United States: (1) those restricted to sale by prescription and

(2) those that can be sold without prescription. The latter are available

without any medical intervention and can be sold in both pharmacy and

nonpharmacy outlets. A little over a decade after the passage of this

amendment, various organizations began to call for an additional class or

classes of drugs. In 1964, the APhA House of Delegates sought the

establishment of the following four drug classes:

1. prescription-only, renewable only with the prescriber’s authorization;

2. prescription-only, renewable at the pharmacist’s discretion;

3. nonprescription, dispensed by a pharmacist only at a patient’s request;

and

4. nonprescription, available directly to the public without professional

direction or control.

Each year from 1967 to 1970, the APhA House of Delegates reaffirmed its

support for four classes of drugs, but FDA took no action.

In 1974, FDA wrote that there have been “comments by pharmacy

organizations that a so-called ‘third class of drugs,’ under the control of

pharmacists be created,” but

“no controlled studies or other adequate research data have been supplied to support the

position that any class of OTC drugs must be dispensed only by pharmacists in order to

assure their safe use . . . . There is at this time no public health concern that would justify

the creation of a third class of drugs to be dispensed only by a pharmacist or in a

pharmacy. The ‘third class of drug’ issue is at this time solely an economic issue. The

Commissioner therefore categorically rejects the establishment of a third class of drugs at

this time” (39 Fed. Reg. 19881 (June 4, 1974)).

This response drew on a 1974 letter from the Department of Justice to the

Department of Health, Education, and Welfare that dealt with proposals

for a new class of drugs. The letter stated that “these proposals would

severely restrain competition in the distribution and sale of OTC drug

products and inconvenience the consuming public.”

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History of the Intermediate-Drug Class Issue

in the United States

In 1982, NARD passed a resolution calling for a “pharmacist legend” class of

drugs—drugs moving from prescription to nonprescription status that

could be dispensed only under a pharmacist’s supervision. Drugs would

remain in this class only until consumer understanding was demonstrated

and a drug’s safety as a nonprescription medicine had been evaluated.

This resolution formed the basis for a 1984 petition from NARD to FDA

asking it to restrict the right to sell ibuprofen (which FDA was considering

moving from prescription to nonprescription status) to pharmacists. In the

petition, NARD also sought that all drugs being switched initially be

considered for the “pharmacist legend” category. Later in 1984, the APhA

House of Delegates passed a resolution favoring the idea of a category of

drugs that supported the movement of drugs from prescription to

nonprescription status.

In response to the NARD petition, FDA stated that “the agency has continued

to conclude that limiting certain drugs to sale-by-pharmacist only is

unnecessary because a public health need for such a limitation has not

been demonstrated” (FDC Reports, 46:50 (December 10, 1984), 12). FDA

went on to question whether it has the authority to establish an additional

class of drugs, the implication being that legislation would be needed.

Also in 1984, AMA adopted a resolution against a third class of drugs:

“Resolved, that the Association oppose the establishment of a third class

of drugs” (American Medical Association, 1984, p. 432). It stated that AMA

supported the present classification into prescription and OTC drugs.

Seeing no reason to change the classification system, FDA took no action

and the two-tier system remained in place.

Florida established a class of drugs quite similar to a fixed, intermediate

class of drugs in 1986. Pharmacists were given the power to prescribe

approximately 30 prescription drugs. In other words, the state (which has

the power to grant prescribing authority) gave pharmacists the right to

dispense particular prescription drugs. (The Florida experience is

discussed in detail in chapter 5.)

In 1987, APhA reaffirmed its 1984 position and also supported the use of the

term “transition class of drugs” for this drug category.

In 1992, in response to a petition from the Pharmacists Planning Service (a

pharmacy advocacy group based in California) that an intermediate class

of drugs be created, FDA reiterated its position on the lack of empirical

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Appendix I 

History of the Intermediate-Drug Class Issue

in the United States

support for one and its lack of authority to establish such a class. In a 1994

letter to the Consumers for World Trade, FDA made the same points.

In addition to these national efforts, there have been attempts at the state

level to establish an intermediate class of drugs. For instance, in 1959 a bill

was proposed in Minnesota that a pharmacy board be allowed to restrict

certain nonprescription products to pharmacy sale. In 1985, a bill was

introduced in the Illinois state legislature that called for pharmacist-only

sale of switched drugs. More recently, a 1993 Oregon bill proposed

establishing a transition class of drugs. Except for the Florida law

discussed above, none of these, or other similar bills, have passed.1

 In

1992, the California legislature passed a resolution calling for the Congress

and FDA to investigate a transitional class of drugs. The resolution was

forwarded to the president, the Congress, and FDA.

Throughout this period, the Nonprescription Drug Manufacturers

Association (formerly called the Proprietary Association), an industry

trade association, has been a principal opponent of an additional class of

drugs. Among other activities, it has opposed bills considered in state

legislatures that would have restricted to pharmacists the sale of switched

drugs. Other current opponents of a transition class of drugs include AMA,

the Food Marketing Institute, the National Coalition of Hispanic Health

and Human Services Organizations, the National Council on Aging, and the

National Grange.

Current supporters of a transition class include APhA, the American College

of Apothecaries, the Consumers Federation of America, the National

Association of Retail Druggists, the National Consumers League, the

National Council of Senior Citizens, and the Public Citizen Health

Research Group.

1

As discussed in chapter 5, drugs have been made available for sale under certain circumstances

without a prescription but only from pharmacists and in nine states pharmacists have been given

dependent prescribing authority. However, these situations are not what has typically been discussed

when an intermediate class of drugs has been considered.

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Appendix II 

Description of Drug Classification Systems

in Ten Countries, Ontario, and the United

States

Australia

Regulatory Authority The Therapeutic Goods Administration of the Ministry of Health is

responsible for the quality, safety, and efficacy of drugs in Australia. After

the administration completes its assessment, the scheduling (distribution

class) of drugs is determined. The National Health and Medical Research

Council, acting upon the advice of its Drugs and Poisons Scheduling

Committee, recommends to the states and territories what drugs should be

in what class. The drug classes are enforced by state or territory

legislation. The states and territories do not have to accept the

recommendation of the national committee. In practice, there is only slight

variation in the scheduling of drugs from one state or territory to another.

Drug Classes Drugs are classified into one of the following poisons schedules.

“Schedule 1: Poisons of plant origin of such danger to health as to warrant their being

available only from medical practitioners, pharmacists or veterinary surgeons.

“Schedule 2: Poisons for therapeutic use that should be available to the public only from

pharmacies; or where there is no pharmacy service available, from persons licensed to sell

Schedule 2 poisons.

“Schedule 3: Poisons for therapeutic use that are dangerous or are so liable to abuse as to

warrant their availability to the public being restricted to supply by pharmacists or medical,

dental, or veterinary practitioners.

“Schedule 4: Poisons that should, in the public interest, be restricted to medical, dental or

veterinary prescription or supply, together with substances or preparations intended for

therapeutic use, the safety or efficacy of which requires further evaluation.

“Schedule 5: Poisons of a hazardous nature that must be readily available to the public but

require caution in handling, storage, and use.

“Schedule 6: Poisons that must be available to the public but are of a more hazardous or

poisonous nature than those in Schedule 5.

“Schedule 7: Poisons which require special precautions in manufacture, handling, storage

or use, or special individual regulations regarding labelling or availability.

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Description of Drug Classification Systems

in Ten Countries, Ontario, and the United

States

“Schedule 8: Poisons to which the restrictions recommended for drugs of dependence by

the 1980 Australian Royal Commission of Inquiry into Drugs should apply.

“Schedule 9: Poisons which are drugs of abuse, the manufacture, possession, sale or use of

which should be prohibited by law except for amounts which may be necessary for medical

or scientific research conducted with the approval of Commonwealth and/or State or

Territory Health Authorities.”

Pharmacists deal primarily with drugs in schedules 2, 3, 4, and 8. Drugs in

schedule 2 are available in pharmacies or from a licensed dealer where

there is no pharmacy within a certain distance. Schedule 2 drugs are

considered to be dangerous to human life if misused or carelessly handled.

Schedule 3 drugs are available from a pharmacist but a prescription is not

required. The general criterion for schedule 3 is that professional

supervision over the supply of a drug is needed but the prescription of a

physician is not necessarily required. These drugs are not accessible to the

public. Schedule 4 drugs are available only on the prescription of a

medical practitioner, dentist, or veterinarian. Addictive substances, such

as morphine and other narcotics, are listed in schedule 8. Storage and

recording provisions for schedule 8 poisons are very strict.

Additionally, an “unscheduled” group of drugs is available for sale in retail

outlets other than pharmacies.

When the System Began The current classification system was developed in response to a 1954

request of the Public Health Committee. Originally, there were eight

schedules. In 1985, a ninth schedule was formed at the national level.

Schedule 8 was divided into two parts and named schedule 8 and schedule

9. All the states and territories still have eight schedules except

Queensland, which has nine.

Switch Decisions Drugs are switched between distribution classes based on the

recommendations of the National Health and Medical Research Council.

Manufacturers can petition that drugs be switched. Drugs can also be

switched by the states and territories based on their processes. The

following are the principal types of data required for a switch:

“—Full details of investigations made with respect to the safety of the substance, including

tests carried out by universities and/or research institutions, and clinical trials,

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Description of Drug Classification Systems

in Ten Countries, Ontario, and the United

States

—Known side effects,

—Occurrence of sensitivity tolerance or idiosyncrasy in response to the substance,

—Metabolism, rate, extent and mode of elimination of the substance,

—Any tendency towards accumulation in the body,

—Any special incompatibility,

—Any recognised standard such as pharmacopoeial monograph,

—Complete bibliography relating to pharmacological and therapeutic actions,

—Summary of animal studies,

—Adverse drug reactions from Australia and overseas,

—Occurrence of unusual or alarming reactions,

—Occurrence of abuse or habituation,

—Any epidemiological data that may be available,

—Details of scheduling status of the product in other countries,

—A copy of any data submitted to any overseas regulatory bodies in support of a

scheduling change,

—If that application was unsuccessful, the rationale for refusal by the regulatory authority,

—Indications for which claims are to be made if proposal is for a Schedule 3 product,

—Strength, dose and frequency proposed,

—Full details of proposed labelling and packaging,

—Warning statements and limitations proposed for the label,

—Whether an insert is proposed and, if so, the text,

—What aspects the applicant expects the pharmacist to advise on during Schedule 3 supply,

—Any other data the Company feels is relevant to the submission,

—Risk/benefit analysis data.”

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The guidelines do not lay out the criteria by which this information is

assessed.

Canada

Regulatory Authority Regulatory authority for pharmaceuticals is divided between the federal

and provincial governments. Generally, federal law determines what may

be sold as a drug and what may be said about it. Provincial law regulates

how and where drug products may be sold.

At the federal level, the regulation of drugs rests with the Drugs

Directorate of the Health Protection Branch, Health Canada. Within the

directorate, there are the bureaus of Human Prescription Drugs and of

Nonprescription Drugs. The principal federal drug law is the Food and

Drugs Act.

Authorities in each province also have control over some aspects of drug

regulation. The authority in Ontario is described later in this appendix.

Drug Classes At the federal level, there are two classes of drugs: prescription and

nonprescription. Nonprescription drugs are further divided into

proprietary medicines (GP, or general public) and products assigned a drug

identification number (DIN). GP products are “drugs intended for the

symptomatic treatment of minor self-limiting illnesses that do not require

the advice or intervention of a health professional.” GP numbers are

assigned to products available for sale outside pharmacies. DINs are

normally assigned to prescription and nonprescription drugs restricted to

pharmacies. This allows the federal government to indicate its preference

for place of sale.

However, provincial authorities make the final determination on place of

sale. They may allow the sale outside pharmacies of any drug classified as

a nonprescription product by the federal government, whether it has a GP

number or a DIN. Provinces may make federal regulations more but not

less strict. For instance, a province could require that a drug classified

nonprescription be sold only with a prescription in that province. Five

provinces (British Columbia, New Brunswick, Nova Scotia, Ontario, and

Saskatchewan) require that some nonprescription drugs be kept in a “no

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public access” area. Others may be stored on shelves accessible to the

public.

A provincial effort is under way to harmonize the number and types of

drug classes throughout the country. The proposal calls for four drug

classes: prescription, pharmacist, pharmacy, and general sale.

When the System Began Regulations of the Food and Drugs Act were amended in 1975 to include

drugs intended for sale without a prescription and outside pharmacies.

(These drugs had been covered by the Proprietary or Patent Medicines

Act.) In 1976, British Columbia became the first province to establish a

class of nonprescription drugs to which the public did not have direct

access.

Switch Decisions Switch decisions are made by the Bureau of Nonprescription Drugs. The

Health Protection Branch has published the following guidelines on the

information needed for a switch decision:

“1. Efficacy data will be required if the indication of use or dosage differ from those

approved for prescription use . . . .

“2. A summary of all animal and human clinical safety data, including data that may have

been part of an original New Drug Submission, as well as data which have accumulated

since the product’s introduction.

“3. A summary of all known and foreign adverse reaction reports since the introduction of

the medicinal ingredient on the market, and a summary of adverse effects, their frequency

and the dose at which they occurred. Any adverse effects that could require patient

monitoring by a physician should be clearly described. Any potential for misuse or abuse

and actual occurrences thereof should also be discussed.

“4. All proposed nonprescription labelling and promotional material demonstrating that the

safe and effective use of the product can be assured by nonprescription labelling, rather

than depending upon the professional judgement of a physician. The appropriate cautions

and contraindications must be expressed in lay terms.

“5. . . . Chemistry and manufacturing data will be required where they differ from the

prescription product.

“6. Date of introduction of the prescription drug onto the Canadian market and a summary

of the sales data . . . . A summary of international market status, i.e. countries where

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requests for authorization to sell (either prescription or nonprescription) have been made

and the status (approved, pending, rejected) of those authorizations. If an authorization has

been refused, the reason for refusal, for both the prescription and nonprescription

products. If an authorization has been approved for nonprescription sale, the date of

introduction onto the market and confirmation that the product is currently marketed.”

Switch decisions may be changed by the individual province to further

restrict access to the drug by specifying place of sale.

Ontario

Regulatory Authority The Ontario Ministry of Health is responsible for the classification of drugs

for distribution. It is advised by the Ontario College of Pharmacists, which

makes scheduling recommendations. The ministry rarely disagrees with

the recommendation of the college. Statutory authority is contained in the

Health Disciplines Act.

Drug Classes Drug distribution classes are divided into prescription and two

nonprescription classes—namely, products available only from

pharmacists and products that can be sold in both pharmacies and other

retail outlets.1

 The former category of nonprescription drugs is referred to

as schedule C. A further refinement on schedule C drugs is that they must

be kept in areas to which the public does not have access. This “no public

access” rule is not by statute but is College of Pharmacists policy.

When the System Began We were unable to determine when the drug classification system was

established.

Switch Decisions Switch decisions are made by the Ontario Ministry of Health with the

advice of the Ontario College of Pharmacists.

1

The prescription and nonprescription classes are divided into a number of subclasses, each with

particular requirements. For our purposes, the three-tier division of one prescription and two

nonprescription classes is sufficient.

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Denmark

Regulatory Authority The National Board of Health (Sundhedsstyrelsen) under the Minister of

the Interior gives final approval to recommendations on classification by

the Licensing Committee.

Drug Classes Denmark has seven pharmaceutical distribution classes.

1. Group A Narcotics: prescription only, no refills.

2. Group A: prescription only, no refills.

3. Group B: prescription only, refills allowed.

4. Group BEGR: prescription only, dispensing only to hospitals.

5. Group NB-S: prescription only, dispensing only to hospitals or after

prescription by specialists defined by the National Board of Health.

6. Group H: nonprescription, sale in pharmacies only.

7. Nonprescription: a few medicinal products that can be sold outside

pharmacies (for example, certain pharmaceutical specialties for animals,

vitamins, and anthelmintics—that is, medicines for killing or ejecting

intestinal worms).

When the System Began The drug classification system was revised in the Medicines Act of 1975. At

that time, a small class of drugs available for sale outside pharmacies was

established. Further revisions to this system were made in 1993 as part of

the implementation of European Union directive 92/26/EEC. (See chapter

2 for a discussion of this directive.)

Switch Decisions There is no formal procedure for switches. Switch decisions are made by

the National Board of Health. Six principles are used to guide switch

decisions:

1. OTC products should be safe in ordinary use,

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2. risks of overdose reactions should be minimal,

3. the drug should not possess an abuse potential,

4. the drug should be indicated for minor diseases and symptoms easily

diagnosed by lay persons,

5. the drug should not need professional supervision, and

6. the regulatory authorities should have great experience with the drugs

in question.

France

Regulatory Authority The regulatory authority for drugs rests with the National Drug

Administration (Agencie du medicament) in the Ministry of Health.

Drug Classes France has four drug classes:

1. Prescription, list A: nonrefillable prescriptions.

2. Prescription, list B: controlled narcotics and certain psychotropics.

3. Prescription, list C: refillable prescriptions.

4. Nonprescription.

All drugs may be sold only in pharmacies. In rural areas where there is no

pharmacy, physicians may be authorized to dispense drugs.

When the System Began We were unable to determine when the current drug classification system

was established. However, the distribution of drugs has been limited to

pharmacies since the Royal Declaration in 1777 (and even earlier).

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Switch Decisions Safety, efficacy, and quality are the factors considered when a drug

approval decision is made. We were unable to gather specific information

on the criteria used for reclassifying drugs.

Germany

Regulatory Authority The registration of pharmaceuticals and market approval are regulated by

the Drug Institute Federal Health Office (Institut fur Arzneimittel des

Bundesgesundheitsamts). Its authority rests in the drug law,

Arzneimittelgesetz.

Drug Classes Pharmaceuticals are categorized into one of three classes for distribution.

1. Prescription. These products are available only with a prescription and

only in pharmacies.

2. Pharmacy restricted. These are nonprescription products sold only in

pharmacies.

3. Free-to-sell. These drugs are nonprescription but their sale is not

restricted to pharmacies. However, the retailer has received some special

education.

When the System Began The drug classification system was adopted in 1961.

Switch Decisions Switch decisions are made by the Federal Health Office. Dr. Walter

Alhterr, a member of the German Parliament and Deputy Chairman of the

Committee for Health, cited the following factors as being particularly

important when assessing a switch candidate:

• Is the drug sufficiently effective?

• Can the application and the indications of the drug be assessed by the

self-medicating consumer?

• Is the margin of safety large enough?

• What about the safety profile at high dose?

• Is there a specific toxic risk?

• What about the adverse reaction profile?

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• What about interactions?

• Has the drug been used for a sufficiently long time under prescription

rules?

• What is the marketing experience?

• Do we already have OTC experience?

Italy

Regulatory Authority Regulatory authority for classifying drugs into distribution classes rests

with the United Commission for Drugs (Commissione Unica per il

Farmaca).

Drug Classes Italy has the following three drug classes:

1. Prescription only.

2. Free sale (nonprescription, sale in pharmacies only).

3. Hospital use only (for use in hospitals and other health centers).

Further distinctions are made between drugs that are reimbursable by the

government and those that are not.

When the System Began The current classification was adopted in 1992. At that time, a subcategory

of the free sale class was established for switch products. Unlike other

nonprescription medications, these drugs cannot be advertised to the

general public.

Switch Decisions Authority to switch drugs resides in the Ministry of Health.

Netherlands

Regulatory Authority The responsibility for drug approval resides in the Ministry of Welfare,

Health, and Cultural Affairs (Ministerie van Welzijn, Volksgezondheid en

Cultuur). Within the ministry is the Committee for the Evaluation of

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Medicines, which judges the efficacy and safety of drugs. The committee

consists of 18 experts on pharmacy, clinical pharmacology, toxicology,

and related disciplines. The committee is assisted in its work by the

National Institute for Drug Analysis and Control, which performs drug

analyses and evaluates chemical and pharmaceutical data, and the

National Institute for Public Health and the Environment, which assesses

pharmacological and toxicological data. The drug approval process

includes the classifying of drugs into classes for sale.

Drug Classes In the Netherlands, drugs are classified into one of three schedules for

sale.

1. Prescription-only medicines. Drugs in this class can be sold only in

pharmacies and only with a prescription from a physician. In rural areas,

physicians may dispense drugs.

2. Pharmacy-only products. This class of nonprescription products is

available without a prescription but only in pharmacies. (Despite drugs in

this class being legally available for sale without a prescription, most

pharmacists will not sell them without a prescription.)

3. Over-the-counter. These drugs are available without a prescription in

both pharmacies and druggist shops. In the pharmacy, the leading

professional is the pharmacist, who is licensed to dispense all drugs

registered by the Medicines Evaluation Board. The leading professional in

a druggist shop is the druggist, who is licensed to dispense only drugs that

are neither prescription-only medicines nor pharmacy only.

The Dutch government plans to move to a two-class system consisting of

their current prescription and over-the-counter classes.

When the System Began The legal structure for the supply of medicines and, therefore, the drug

classification system are based on the Direct Supply Act of 1958, which

became effective in 1963.

Switch Decisions Decisions to change the classification of a drug are made by the Ministry

of Welfare, Health, and Cultural Affairs, acting on the advice of the

Committee for the Evaluation of Medicines.

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The criteria for classifying a drug as a pharmacy-class product are

• the diagnosis of the disease can be made by the patient with the help of

the pharmacist,

• taking the drug according to the dosage instructions in the leaflet does not

result in severe side effects,

• there are no dangerous interactions with other drugs, and

• a dosage two to three times the recommended dose has no severe toxic

effects.

Sweden

Regulatory Authority The regulatory authority responsible for the classification of drugs is the

Medical Products Agency (Lakemedelsverket) of the Ministry of Health

and Social Affairs.

The exclusive right to market pharmaceuticals at the retail level in Sweden

belongs to the National Corporation of Swedish Pharmacies

(Apoteksbolaget). Only the corporation may sell pharmaceuticals directly

to patients and customers in the outpatient-care sector and to hospitals in

the inpatient-care sector. The corporation is owned two thirds by the state

and one third by Apoteksbolaget’s Pension Foundation. Because of its

exclusive right to the retail sale of pharmaceuticals, all pharmacists who

dispense medication at the retail level are employees of the state. The

current agreement with the government expires December 31, 1995. There

has been some discussion of allowing the sale of some nonprescription

drugs outside pharmacies.

Drug Classes There are four drug classes in Sweden: prescription, nonprescription

(which can be sold only in pharmacies), free medicines, and herbal

medicines. Some antiseptic solutions and liniments are classified as free

medicines and can be sold outside pharmacies. Herbal medicines can also

be sold in general stores.

When the System Began The prescription and nonprescription categories were established in 1934.

We were unable to determine when the free medicines and herbal

medicines classes were established.

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Switch Decisions Authority to switch drugs rests with the Medical Products Agency. Among

the criteria for assessing the reclassification of a drug to nonprescription

status are pack size, toxicity, adverse reactions, interactions, drug

dependence, years of prescription use, suitability for self-medication, and

worldwide experience.

Switzerland

Regulatory Authority Marketing approval for drugs is the responsibility of the cantons, not the

central government. However, five cantons concluded in 1900 that it was

not feasible for each of them to regulate pharmaceuticals individually.

They formed the Intercantonal Office for the Control of Medicaments

(Interkantonale Kontrollstelle fur Heilmittel) “to investigate and assess the

secret medicines and medical specialties sent to it by the participating

Cantons as to harmfulness, appropriate composition, misleading character

of advertisements, labels and inserts, and the relationship of price to

value.” By 1934, all 25 cantons were parties to the agreement. This

agreement has been revised on several occasions. The 1971 agreement

gave four principal purposes for the office:

1. the quality control of marketed drugs,

2. the quality control of manufacturing,

3. the licensing of new drugs, and

4. continuous review. Licenses are issued for only 5 years, so the office is

continually reviewing products that are already on the market.

Proposals have been made to give the federal government more power,

but none has been accepted.

Drug Classes Pharmaceuticals are categorized into one of five distribution classes in

Switzerland.

1. Class A: nonrefillable prescription. These drugs are available only with a

prescription, in pharmacies, and the prescription cannot be refilled. This

class includes restricted pharmaceuticals such as narcotics.

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2. Class B: prescription only. Like class A products, drugs in class B are

available only with a prescription and in pharmacies. However, unlike

class A, the prescription can be refilled.

3. Class C: nonprescription, pharmacies only. Drugs in this class are

available without a prescription but only from a pharmacy.

4. Class D: nonprescription, pharmacies and drugstores. Class D drugs are

available without a prescription but only in pharmacies and drugstores.2

Drugstores specialize in the sale of certain nonprescription products such

as herbal medicines, cosmetics, health foods, household items, and

chemicals.

5. Class E: nonprescription, all stores. These products are sold without a

prescription and are available outside pharmacies and drugstores. Items in

this category are limited to such health products as herbal cough candy,

bandaids, dietetics, and baby products.

The decisions of the Intercantonal Office for the Control of Medicaments

are binding for prescription drugs, but the cantons have some freedom on

the classification of nonprescription products. In practice, there is little

variation between cantons.

When the System Began Classes A, B, and C were established in 1927. Class D dates from 1948. We

were unable to determine when class E was established.

Switch Decisions Switch decisions are made by the Intercantonal Office for the Control of

Medicaments. A medication switched from prescription to nonprescription

status is placed in class C (pharmacy only). In recent years, a number of

drugs have been switched from class C to class D (nonprescription,

pharmacies and drugstores).

The factors examined when a drug is considered for switching include

• need for diagnosis by a physician,

• adequate labeling for nonprescription use,

• consistency in the expected benefits of the drug,

• efficacy,

2

Pharmacies are managed by university-trained and licensed pharmacists, while drugstores are

managed by druggists who undergo a 4-year nonacademic apprenticeship and a specialty examination.

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• consistency in expected side effects,

• side effects of long-term use,

• side effects of short-term use,

• toxicity (acute and chronic),

• potential for interaction with other drugs,

• potential for interaction with foods,

• masking symptoms of another disease,

• habit-forming or abuse potential,

• history of use,

• method of use,

• indications amenable to self-treatment,

• risk-benefit relationship.

United Kingdom

Regulatory Authority Marketing authorizations for all drug products are granted by the

Licensing Authority, which consists of the health and agriculture

ministers. The regulatory authority for human drugs is contained in the

Department of Health. (The Department of Agriculture is responsible for

animal drugs.) Within the Department of Health, the Medicines Control

Agency is responsible for the approval (licensing) of human drugs. It is

advised by the Medicines Commission. The commission gives general

advice on the administration of the Medicines Act of 1968 and on any

matter relating to medicinal products. It must have at least eight members,

who together cover the following areas of expertise: (1) the practice of

medicine, (2) the practice of veterinary medicine, (3) the practice of

pharmacy, (4) chemistry other than pharmaceutical chemistry, and (5) the

pharmaceutical industry. The commission may recommend the

establishment of expert committees. Among the committees established

are the Committee on the Safety of Medicines and the Committee on the

Review of Medicines. The Committee on the Safety of Medicines is

responsible for advising on the efficacy, safety, and quality of new

medicines for human use. The Committee on the Review of Medicines

advises on the efficacy, safety, and quality of products already on the

market that have not previously been reviewed by the regulatory

authorities.

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Drug Classes For the purpose of retail sale or supply, drugs for human use are divided

into three classes.

1. Prescription-only medicines. Drugs in this category may be sold or

supplied only from a registered pharmacy and in accordance with a

prescription issued by an authorized practitioner.

2. Pharmacy medicines. These products may be sold or supplied only from

a registered pharmacy or under the supervision of a pharmacist. A

prescription is not required. If the pharmacist is not present or on the

premises, the staff may not sell the drug.

3. General sale list. General sale medicines can be sold without the

supervision of a pharmacist. Sales must be made from places that can be

closed to the public. This prohibits sales from market stalls, street

markets, or vehicles. Some of these medicines may be sold by means of

automatic machines.

When the System Began The classification system was established under the Medicines Act of 1968.

Switch Decisions The responsibility for switching drugs between classes rests with the

Licensing Authority, which amends the product license if a switch is

approved. The Department of Health receives requests to change the

classification of drugs. The Medicines Control Agency, advised by the

Committee on the Safety of Medicines and the Medicines Commission,

recommends approval or disapproval of a switch. The criteria for

switching a drug from prescription-only medicine to pharmacy class are

“Indications suitable for self-medication including self-diagnosis (may be recurrent attack

of condition requiring physician aided diagnosis on first attack);

“Medicine has acceptable margin of safety during unsupervised use including safety in

overdose or following accidental misdiagnosis;

“Medicine is not a new drug substance for which further postmarketing evidence of safety

is required;

“Medicine does not present a hazard to the community (indirect danger) from unsupervised

use as might occur with development of resistant flora to antibiotics;

“Medicine has no major abuse or dependence potential; and

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States

“Medicine is not for parenteral use.”

Reclassification of a drug from pharmacy only to general sale may be

requested formally through either a variation in the product license or an

abridged application for a product license, requesting general sale status

for the product. The Licensing Authority makes the decision on whether to

allow general sale list status. The request may also occur informally

through a submission to the Department of Health that asks that the

switch be considered. The evidence may then be referred to the

Committee on the Safety of Medicines. Very few switches of drugs have

been made from pharmacy class to general sale.

Generally, the product license-holder applies for a change in the product

license. The authorities or a third party may also initiate a switch.

However, if the manufacturer does not want a product switched to a less

restricted distribution class, it will not normally be reclassified.

United States

Regulatory Authority FDA has regulatory authority for classifying drugs for distribution. Each

individual state has the power to determine who has prescribing authority

in it.

Drug Classes There are two drug classes in the United States: prescription and

nonprescription. Nonprescription drugs may be sold in any retail outlet.

Prescription drugs may be dispensed pursuant to a “practitioner’s” order,

usually a doctor’s prescription. There are several exceptions to this. First,

in Florida, some prescription drugs may be dispensed by pharmacists, who

are considered “practitioners” under Florida law. (See appendix V.)

Second, insulin is available in some states without a prescription but only

from pharmacists. Third, in some states some controlled substances may

be dispensed by a pharmacist without a prescription if there is low abuse

potential. Fourth, there are some situations in which pharmacists have

dependent prescribing authority. Typically, in this situation, pharmacists

may prescribe drugs but only under protocols established by supervisory

physicians. (See chapter 5 for more discussion on these four cases.)

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When the System Began The two-tier classification was enacted into law by the 1951

Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic

Act of 1938.

Switch Decisions Switch decisions are made by FDA with the advice of advisory committees.

The Durham-Humphrey Amendment specified three classes of drugs that

were required to be limited to prescription use:

• certain habit-forming drugs listed by name in the Federal Food, Drug, and

Cosmetic Act;

• drugs not safe for use except under the supervision of a licensed

practitioner because of toxicity or other potentiality for harmful effect, the

method of use, or the collateral measures necessary for use; and

• drugs limited to prescription under an approved new drug application.

For purposes of switching, the second criterion is the most important. A

former director of the Center for Drug Evaluation and Research discussed

13 issues that should be considered when making switch decisions. These

build on the second criterion.

1. Does the switch candidate’s frequency of dosing affect its safe use?

2. Is the minimally effective dose for the proposed OTC indication known?

3. Has the candidate been used for sufficiently long time on the

prescription market to allow a full characterization of its safety profile?

4. Does the candidate have a large margin of safety?

5. Has the candidate’s safety profile been defined at high dose?

6. Does the candidate have a special toxicity in its class?

7. Have possible drug interactions for the candidate been characterized?

8. Is there a full understanding of the pharmacodynamics of the switch

candidate?

9. Has a vigorous risk analysis been performed?

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10. Has the efficacy literature been reviewed in a way that would support

the expected usage and labeling of the candidate?

11. What do “use data” (from National Prescription Audit, National

Drug/Disease, and other sources) show?

12. What foreign countries market the candidate OTC? What is its

experience in those countries?

13. What is the worldwide marketing experience of the candidate?

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Appendix III 

Classification of 14 Drugs in Ten Countries,

Ontario, and the United States

Table III.1 displays the current classification of each of the 14 drugs in 8 of

the study countries (we were unable to obtain complete classification

information for France and Italy). In some of the countries, particular

drugs appear in more than one distribution class because classification

can depend on dosage, intended use, pack size, and other factors. For

instance, naproxen is both a pharmacy-class and prescription-class drug in

Australia. It is a pharmacy-class drug when it is “the only therapeutically

active substance in packs of 12 or less dosage units, for treatment of

spasmodic dysmenorrhoea.” In all others cases, naproxen is a prescription

drug. Therefore, in table III.1, Australia is indicated as classifying

naproxen as both a prescription- and pharmacy-class product.

Table III.1: Classification of 14 Drugs in Ten Countries, Ontario, and the United Statesa

Country Not available Prescription Pharmacist Pharmacy Drugstore General sale

Australia Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen,

PPAb (both as a

decongestant and

in weight-reduction

products),

Promethazine,

Ranitidine,

Sulindac,

Terfenadine,

Theophylline

Codeine,

Ibuprofen,

Indomethacin,

PPAb (as a

decongestant),

Promethazine,

Terfenadine,

Theophylline

Aspirin,

Codeine,

Naproxen,

Promethazine

Aspirin

Canada PPAb (in weightreduction products)Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen,

Ranitidine,

Sulindac,

Theophylline

Codeinec Ibuprofen,

Promethazine,

Terfenadine

Aspirin, 

PPAb (as a

decongestant)

(continued)

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Classification of 14 Drugs in Ten Countries,

Ontario, and the United States

Country Not available Prescription Pharmacist Pharmacy Drugstore General sale

Ontario PPAb (in weightreduction products)Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen,

PPAb (as a

decongestant),

Ranitidine,

Sulindac,

Theophylline

Aspirin,

Codeine,

Ibuprofen,

Promethazine,

Terfenadine

Aspirin,

PPAb (as a

decongestant)

Denmark PPAb (both as a

decongestant and

in weight-reduction

products)

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen,

Promethazine,

Sulindac,

Theophylline

Aspirin,

Cimetidine,

Codeine,

Ibuprofen,

Promethazine,

Ranitidine,

Terfenadine

Germany Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen,

Promethazine,

Ranitidine,

Sulindac,

Theophylline

Aspirin,

Ibuprofen,

PPAb (both as a

decongestant and

in weight-reduction

products),

Terfenadine

Netherlands Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Indomethacin,

Promethazine,

Ranitidine

Aspirin,

Cimetidine,

Ibuprofen,

Naproxen,

PPAb (both as a

decongestant and

in weight-reduction

products),

Promethazine,

Ranitidine,

Sulindac,

Terfenadine,

Theophyllined

Aspirin,

Ibuprofen

(continued)

Page 105 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix III 

Classification of 14 Drugs in Ten Countries,

Ontario, and the United States

Country Not available Prescription Pharmacist Pharmacy Drugstore General sale

Sweden PPAb (in weightreduction products)Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen,

PPAb (as a

decongestant),

Promethazine,

Ranitidine,

Sulindac,

Terfenadine,

Theophylline

Aspirin,

Ibuprofen

Switzerland Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen,

PPAb (as a

decongestant),

Promethazine,

Ranitidine,

Sulindac,

Terfenadine,

Theophylline

Codeine,

Diclofenac,

Ibuprofen,

Indomethacin,

PPAb (both as a

decongestant and

in weight-reduction

products),

Promethazine,

Terfenadine

Aspirin

United

Kingdom

Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen, 

PPAb (both as a

decongestant and

in weight-reduction

products),

Ranitidine,

Sulindac,

Terfenadine

Aspirin,

Cimetidine,

Codeine,

Diclofenac,

Ibuprofen,

PPAb (both as a

decongestant and

in weight-reduction

products),

Promethazine,

Ranitidine,

Terfenadine,

Theophylline

Aspirin

(continued)

Page 106 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix III 

Classification of 14 Drugs in Ten Countries,

Ontario, and the United States

Country Not available Prescription Pharmacist Pharmacy Drugstore General sale

United States Cimetidine,

Codeine,

Diclofenac,

Diflunisal,

Ibuprofen,

Indomethacin,

Naproxen,

Promethazine,

Ranitidine,

Sulindac,

Terfenadine,

Theophylline

Codeinee Aspirin,

Cimetidine,

Ibuprofen,

Naproxen,

PPAb (both as a

decongestant

and in 

weightreduction

products),

Theophylline

aIn France, cimetidine, diclofenac, diflunisal, indomethacin, naproxen, ranitidine, and terfenadine

are limited to prescription sale. Aspirin, ibuprofen, PPA as a decongestant, promethazine, and

theophylline are pharmacist class; we were unable to determine if these drugs are ever restricted

to prescription sale as they sometimes are in other countries. PPA as a weight-control product is

not available. We were unable to obtain information on codeine and sulindac. In Italy, naproxen,

ranitidine, and terfenadine are limited to prescription sale. Aspirin, cimetidine, diclofenac,

diflunisal, ibuprofen, indomethacin, PPA as a decongestant, and promethazine are in the

pharmacist class in at least some cases. We were unable to determine if these drugs are ever

restricted to prescription sale. Theophylline is not available. We were unable to obtain information

on codeine, PPA in weight-control products, and sulindac.

bPhenylpropanolamine.

cCodeine is regulated under the Narcotics Control Act in Canada. Some codeine products are

available from pharmacists without a prescription.

dAlthough all these drugs are legally available without a prescription in the Netherlands, most

pharmacists will not dispense them without a prescription.

eSome codeine products are available from pharmacists without a prescription in some states.

All the U.S. nonprescription medications are restricted either to

prescription sale or to nonprescription sale in pharmacies or drugstores in

most of the study countries. The United States allows the sale of 7

(counting both indications of phenylpropanolamine as 1 drug) of the 14

drugs without a prescription. This includes ibuprofen and naproxen, for

which only doses of 200 mg have been switched, and cimetidine, which

has been switched only in doses of 100 mg. Larger doses of these products

remain available only by prescription. It also includes codeine, which is

available in low doses in some states without a prescription, and

theophylline, which is available without a prescription only in combination

products. Thus, 6 of the drugs are available outside pharmacies. It is clear

from the table that none of the other countries allow the sale of as many of

Page 107 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix III 

Classification of 14 Drugs in Ten Countries,

Ontario, and the United States

these drugs outside pharmacies as does the United States.1 However, 5 of

the countries (Australia, Italy, the Netherlands, Switzerland, and the

United Kingdom) allow more of the drugs to be sold without a prescription

than the United States. (Denmark allows the same number to be sold while

Canada, France, Germany and Sweden allow fewer.)

Of the 7 drugs available without a prescription in the United States, only

aspirin and phenylpropanolamine (as a decongestant) are available for

sale outside pharmacies in any of the study countries. All but aspirin and

the 200 mg dose of ibuprofen are restricted to prescription sale in at least 1

country. Thus, for these 7 drugs, the United States has the most open

system.2

All 7 drugs available only by prescription in the United States are available

in at least 1 of the study countries without a prescription. In addition,

ibuprofen is available in larger doses in the United Kingdom as a

nonprescription product than it is in the United States, while cimetidine

may be sold without a prescription in larger doses in Denmark and the

Netherlands.3

Two of these drugs (promethazine and terfenadine) are allowed for

nonprescription sale in 3 or more of the countries. Each of these has been

considered for nonprescription status in the United States.4

1

This observation holds even if France and Italy are included, since these countries limit the sale of all

drugs to pharmacies. Codeine, when it is available as a nonprescription drug in the United States, is

available only from pharmacists. Thus, 5 of the drugs are sold outside of pharmacies in the United

States.

2

When codeine is available without a prescription in the United States, it must be dispensed by a

pharmacist. Thus, for codeine, the United States is more restrictive than Australia, where pharmacist

involvement is not required, and equally restrictive as Canada, Ontario, Denmark, Switzerland, and the

United Kingdom.

3

We were unable to determine what doses of cimetidine are available without a prescription in Italy.

4

In addition, cimetidine was just recently switched after a long process. In 1993, FDA’s

Nonprescription Drugs and Gastrointestinal Drugs Advisory committees considered evidence for

switching cimetidine. The dose under consideration (200 mg or less), which is smaller than the

prescription dose, was for the treatment of heartburn. (Larger doses of cimetidine are used in the

treatment of ulcers. These were not considered for switching.) The committees decided that the

effectiveness of cimetidine at the lower dosage had not been demonstrated. The same committees

reassessed cimetidine in 1994. They concluded that, based on additional analyses and a new dosing

regimen, the lower dose of cimetidine was effective. However, they still recommended against

switching the drug because of concerns about drug-drug interactions. They said that the drug could be

approved for nonprescription sale if the results of new drug interaction tests are sufficient for approval

and committee recommendations for labeling are implemented. At the joint meeting of the

Nonprescription Drugs and Gastrointestinal Drugs Advisory committees in March 1995, it was

recommended that cimetidine be approved for nonprescription use. The drug, in doses of 100 mg, was

switched in June 1995. (Dosing is 200 mg up to twice daily.)

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Appendix III 

Classification of 14 Drugs in Ten Countries,

Ontario, and the United States

In the 1980’s, FDA approved promethazine as a nonprescription product.

However, in response to comments and a citizens’ petition, FDA withdrew

its approval. There were allegations that the drug was connected with

Sudden Infant Death Syndrome (often referred to as SIDS). At the time,

the manufacturer volunteered to withdraw the drug as a nonprescription

product.

FDA has not approved an application to switch terfenadine to

nonprescription status because of concern about drug interactions as well

as complications for patients with heart or liver disease. Terfenadine had

been sold without pharmacists’ intervention in Canada. However, because

of concerns about drug interactions, the Canadian federal government

suggested to the provinces that they restrict it to sale only by pharmacists.

There are competing explanations for why these drugs are allowed for sale

without a prescription in some countries but not here. Certainly, at least

these two drugs have been considered for nonprescription status in the

United States but have been denied for what appear to be appropriate

reasons. Whether they would be nonprescription products now if an

intermediate drug class were available is not possible to know.

Moreover, 9 of the study countries (all but Sweden) have used their

pharmacist or pharmacy class to allow nonprescription sale of some drugs

restricted to prescription sale in the United States. None of these drugs

can be sold outside pharmacies in any of the countries. It is unclear

whether these drugs would be more or less restricted if these countries

had a two-tier system like the one in the United States. However, it is clear

that officials in these countries see a role for their pharmacist or pharmacy

class as they have restricted the sale of these drugs to pharmacies or by

pharmacists. However, some FDA officials told us that they were unclear

about the purpose of an intermediate drug class and how it would be used

in the United States.

Page 109 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix IV 

Descriptions of Drugs Examined in This

Study

This appendix briefly describes the 14 drugs whose classification in the

study countries we examined. We include common brand names, the

purpose of the drug, adverse effects, and interactions with other

pharmaceuticals. The information presented comes primarily from two

publications by the American Medical Association and from The Essential

Guide to Prescription Drugs by James W. Long, M.D., and The Complete

Drug Reference by the U.S. Pharmacopeia (American Medical Association,

1993; Clayman, 1988; Long, 1992; U.S. Pharmacopeia, 1992).

Aspirin Aspirin is known chemically as acetylsalicylic acid, or ASA. It has been

commonly used since 1899. It is a nonnarcotic analgesic that relieves pain,

reduces fever, and alleviates the symptoms of arthritis. In small doses, it

helps prevent blood clots. Common adverse effects are indigestion,

nausea, and vomiting. Aspirin has a tendency to irritate the stomach and

even cause bleeding. Taken in large doses, it can aggravate ulcers, kidney

disease, and liver disease. It has been linked to Reye’s syndrome, a rare

brain and liver disorder occurring usually in children.

Aspirin can increase the effect of anticoagulants, leading to an increased

risk of abnormal bleeding. Nonsteroidal antiinflammatory drugs can

increase the likelihood of stomach irritation when taken with aspirin.

Corticosteroids taken with aspirin can also increase the likelihood of

stomach irritation. Aspirin may reduce the effect of drugs for gout and

increase the effect of oral antidiabetic drugs.

Cimetidine Cimetidine was introduced in 1976. It is marketed under the brand name

Tagamet. Cimetidine is used in the treatment of peptic ulcer disease. It

works by inhibiting the secretion of stomach acid and, thus, creating a

more favorable environment for the healing of peptic ulcers of the

duodenum, esophagus, and stomach. The overall incidence of adverse

reactions to cimetidine is low. As cimetidine promotes healing of the

stomach lining, there is a risk that it may mask stomach cancer. It is

therefore usually prescribed only when the possibility of stomach cancer

has been ruled out. Lower doses are used to treat heartburn, acid

indigestion, and sour stomach.

Antacids may reduce absorption of cimetidine. Cimetidine can cause an

increase in the blood level of some benzodiazepine drugs (a family of

psychoactive compounds with a common molecular configuration),

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Appendix IV 

Descriptions of Drugs Examined in This

Study

leading to an increased risk of adverse effects. It can increase the effect of

anticoagulant drugs and the blood levels of anticonvulsant drugs.

Codeine Codeine is an analgesic narcotic that was introduced in 1886. It is used

primarily to relieve mild to moderate pain and control cough. It is often

used in combination with milder analgesics, such as aspirin and

acetaminophen, to enhance their effectiveness. It is frequently added to

cough mixtures containing antihistamines, decongestants, and

expectorants to make these preparations more effective in reducing the

frequency and severity of cough. It is an ingredient in many prescription

cold medicines and coughs. All drugs that have a sedative effect on the

central nervous system are likely to increase sedation with codeine.

Codeine may interact with monoamine oxidase inhibitors to cause a

dangerous rise in blood pressure.1

Serious adverse effects are rare. The most common is constipation. In fact,

codeine has been used to control diarrhea. Codeine can be habit-forming if

taken for extended periods, especially if higher-than-average doses are

taken. It is normally used only for short-term relief of symptoms.

Diclofenac Diclofenac is a nonsteroidal antiinflammatory drug that was introduced in

1976. It is marketed under the brand name Voltaren. Its principal uses are

to relieve the symptoms associated with major types of arthritis, menstrual

cramps, and bursitis, tendinitis, and related conditions. The most common

side effects are gastrointestinal disturbances, particularly abdominal pain,

indigestion, nausea, and either diarrhea or constipation. Fluid retention is

the only expected side effect.

In combination with a number of drugs, diclofenac can increase the risk of

bleeding. It may also increase the toxicity of a number of other drugs.

Diflunisal Diflunisal, introduced in 1982, is a nonsteroidal antiinflammatory drug

with a prolonged duration of action. It is marketed under the brand name

Dolobid. It reduces mild to moderate pain and inflammation. It is used to

relieve discomfort in osteoarthritis and rheumatoid arthritis, although it

does not cure the underlying disease. It is also effective for pain relief after

1

Monoamines play an important part in the metabolism of the brain. An excessive accumulation of

monoamine can induce a dangerous reaction characterized by high blood pressure, palpitations,

sweating, and a feeling of suffocation. Monoamine oxidase is a naturally occurring enzyme involved in

the breakdown of monoamines.

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Appendix IV 

Descriptions of Drugs Examined in This

Study

minor operations and dental work and may also be given to treat sprains,

strains, and some types of back pain. Serious adverse effects are rare, even

with prolonged use. Common adverse effects are nausea and diarrhea,

heartburn and indigestion, abdominal pain, and rash.

Diflunisal can interact with a wide range of drugs to increase the risk of

bleeding or peptic ulcers. The beneficial effects of antihypertensive drugs

and diuretics may be decreased by diflunisal.

Ibuprofen Ibuprofen is a nonsteroidal antiinflammatory drug that was introduced in

1967. Among the common brand names are Advil, Medipren, Motrin,

Nuprin, PediaProfen, and Rufen. It is an effective treatment for the

symptoms of rheumatoid arthritis, osteoarthritis, and gout. It also relieves

mild to moderate discomfort of headache, menstrual pain, soft tissue

injury, and pain following an operation. Ibuprofen has fewer side effects

than many of the other nonsteroidal antiinflammatory drugs. The most

common adverse effects are diarrhea or constipation and nausea or

vomiting.

Ibuprofen can interact with a wide range of drugs to increase the risk of

bleeding and peptic ulcers. Ibuprofen can reduce the beneficial effects of

antihypertensives and diuretics. It can also increase the

blood-sugar-lowering effect of oral antidiabetic drugs.

Indomethacin Indomethacin was introduced in 1963. Common brand names are

Indameth, Indocin, and Indocin SR. It is a nonsteroidal antiinflammatory

drug that reduces pain, stiffness, and inflammation. It is used in the

treatment of many arthritic conditions, acute attacks of gout, bursitis, and

tendinitis. It has several potentially serious adverse effects, including

gastrointestinal disorders, severe headache, and dizziness, and it may

mask the symptoms of infections. It is generally not given to people with

poor kidney function.

Indomethacin can interact with a wide range of drugs to increase the risk

of bleeding and peptic ulcers. Indomethacin can reduce the beneficial

effects of antihypertensive drugs and diuretics. It may increase the

blood-sugar-lowering effects of oral antidiabetic drugs.

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Descriptions of Drugs Examined in This

Study

Naproxen Naproxen is a nonsteroidal antiinflammatory drug that was introduced in

1970. Common brand names include Aleve, Anaprox, and Naprosyn. It

reduces pain, stiffness, and inflammation. It is used primarily to relieve

mild to moderately severe pain associated with musculoskeletal injuries,

acute and chronic gout, adult and juvenile rheumatoid arthritis,

osteoarthritis, menstrual cramps, and dental, obstetrical, and orthopedic

surgery. Gastrointestinal side effects are fairly common, and there is an

increased risk of bleeding.

Naproxen can interact with a wide range of drugs to increase the risk of

bleeding and peptic ulcers. The beneficial effects of antihypertensive

drugs and diuretics may be reduced by naproxen.

Phenylpropanolamine Phenylpropanolamine, commonly known as PPA, has two principal uses.

It works as a decongestant by reducing the inflammation and swelling of

blood vessels in the nose, thus relieving stuffiness and nasal congestion in

colds, hay fever, and sinusitis. Phenylpropanolamine is also used in

weight-reduction products. It acts as an appetite suppressant. Among the

common brand names are Acutrim, Dexatrim, Prolamine, Propagest, and

Rhindecon. Overall, adverse effects are rare. However, concern has been

raised about the drug as a cause of dangerously high blood pressure,

kidney disease, heart muscle damage, heart rhythm abnormalities, and

seizures.

Other sympathomimetic drugs (those producing an effect comparable to

that produced by stimulation of the sympathetic nervous system) can

increase the risk of adverse effects if taken concurrently with

phenylpropanolamine. Phenylpropanolamine can reduce the

blood-pressure-lowering effect of antihypertensive drugs. Monoamine

oxidase inhibitors dangerously increase the risk of high blood pressure

when taken with phenylpropanolamine.

Promethazine Promethazine is an antihistamine that was introduced in 1945. Common

brand names include Anergan, Phenazine, Phenergan, Prorex, and

Prothazine. Its principal use is as a single drug product to provide

symptomatic relief in allergic disorders, to control nausea and vomiting,

and to produce mild sedation. Common side effects are drowsiness and

lethargy, dry mouth, and blurred vision.

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Descriptions of Drugs Examined in This

Study

Promethazine is used in combination with analgesics, such as aspirin and

codeine, to enhance their pain-relieving actions by producing mild

sedation. It is also used in cough mixtures for its drying effect. All drugs

that have a sedative effect are likely to increase the sedative properties of

promethazine. Antacids can reduce the absorption of promethazine from

the stomach, thus reducing its effect.

Ranitidine Ranitidine is an antiulcer medication that was introduced in 1981. It is

marketed under the brand name Zantac. Ranitidine is used primarily in the

treatment of peptic ulcer disease. It works by inhibiting the secretion of

stomach acid and thus creating a more favorable environment for the

healing of peptic ulcers. Ranitidine also reduces discomfort and

inflammation from reflux esophagitis. Headache is the most common

adverse effect. As ranitidine promotes healing of the stomach lining, there

is a risk that it may mask stomach cancer. It is therefore usually

prescribed only when the possibility of stomach cancer has been ruled

out.

There are no known interactions with other drugs. This means that

ranitidine can be taken with other medications without reducing its

effectiveness or that of the other drug.

Sulindac Sulindac is a nonsteroidal antiinflammatory drug that was introduced in

1976. It is marketed under the brand name Clinoril. Sulindac is used

primarily to relieve mild to moderately severe pain and inflammation

associated with rheumatoid arthritis and osteoarthritis, acute and chronic

gout, and bursitis, tendinitis, and related disorders. It has not been

completely established how the drug works. Indigestion, nausea and

vomiting, diarrhea, and constipation are fairly common adverse effects.

There is also a risk of stomach bleeding or peptic ulcer.

Sulindac can interact with a wide range of drugs to increase the risk of

bleeding and peptic ulcers. The beneficial effects of antihypertensive and

diuretic drugs may be reduced by sulindac. Concurrent use of sulindac

with oral antidiabetic drugs can increase the blood-sugar-lowering effect

of these drugs.

Terfenadine Terfenadine is an antihistamine that was introduced in 1977. It is marketed

under the brand name Seldane. Its main use is in the treatment of allergic

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Appendix IV 

Descriptions of Drugs Examined in This

Study

rhinitis, particularly hay fever. Allergic skin conditions may also be helped

by terfenadine. It works by reducing the intensity of the allergic response

by blocking the action of histamine after it has been released from

sensitized tissue cells in the eye, nose, and skin.2

 Terfenadine differs from

older antihistamines in that it has little or no sedative effect on the central

nervous system. Nausea and loss of appetite occur occasionally with

terfenadine. There are concerns about persons with heart or liver disease

using the drug. Other side effects are very rare.

Terfenadine can increase the sedative effects on the central nervous

system of anti-anxiety drugs, sleeping drugs, antidepressants, and

antipsychotic drugs. The anticholinergic effects (lowered blood pressure

and increased motion of the alimentary canal and other hollow organs) of

terfenadine are likely to be increased by all drugs that also have these

effects. There is a risk of a dangerous rise in blood pressure if terfenadine

is taken within 14 days of monoamine oxidase inhibitors.

Theophylline Theophylline is a bronchodilator that was introduced in 1929. Some

commonly used brand names are Slo-Bid, Slo-Phyllin, Theo-24, and

Theo-Dur. It has two main actions. First, theophylline relaxes and dilates

the airways in the lungs. Second, it stimulates breathing and the heart rate.

Theophylline is used primarily in the treatment of asthma. It is also helpful

in heart failure. It is sometimes given to premature infants who are prone

to attacks of apnea (stopped breathing). Treatment with theophylline must

be monitored because the effective dose is very close to the toxic dose.

Common adverse effects are agitation, dizziness, and nausea and vomiting.

Some drugs increase the level of theophylline in the blood while others

decrease it.

2

Histamine is a stimulant of gastric juice, a constrictor of smooth muscle including that of the bronchi,

and a dilator of arterioles and capillaries.

Page 115 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix V 

The Florida Pharmacist Self-Care

Consultant Law

The Florida Pharmacist Self-Care Consultant Law went into effect on

October 1, 1985. It gives pharmacists the authority to prescribe specific

medications without the approval of a physician. It is stated in Florida law

(Fla. Stat. Ann. S. 465.186) that the formulary (that is, the list of drugs a

pharmacist can prescribe) may include products falling within the

following categories:

• any medicinal drug of single or multiple active ingredients in any strengths

when such active ingredients have been approved individually or in

combination for OTC sale by FDA,

• any medicinal drug recommended by the FDA Advisory Panel for transfer

to OTC status pending approval by FDA,

• any medicinal drug containing any antihistamine or decongestant as a

single active ingredient or in combination,

• any medicinal drug containing fluoride in any strength, and

• any medicinal drug containing lindane in any strength.

Any drug that is sold as an OTC product may not be included in the

formulary.

Florida Board of Pharmacy rules 21S-27.220 and 21S-27.230 state that

“A Pharmacist may order and dispense from the following formulary, subject to the stated

conditions:

(1) Oral analgesics for mild to moderate pain: magnesium salicylate/phenyltoloxamine

citrate, acetylsalicylic acid (Zero order release, long acting tablets), choline salicylate and

magnesium salicylate, IBUPROFEN (no more than 400 mg per dosage unit for minor pain

and menstrual cramps limited to a six (6) day supply for one treatment). When appropriate,

such prescription shall be labeled to be taken with food or milk.

(2) Urinary analgesics; phenazopyridine, not exceeding a two (2) day supply. Such

prescriptions shall be labeled as to the tendency to discolor urine and when appropriate

shall be labeled to be taken after meals.

(3) Otic analgesics; antipyrine 5.4%, benzocaine 1.4%, glycerin, which shall be labeled for

use in the ear only.

(4) Hemorrhoid medications; 0.5% hydrocortisone acetate and 0.5% dibucaine ointments

and creams, limited to a seven (7) day supply.

(5) Leg cramps; quinine sulfate tablets, except to patients with cardiac arrhythmias, and

Page 116 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix V 

The Florida Pharmacist Self-Care

Consultant Law

not to patients currently using anticoagulant or digitalis containing drugs. When

appropriate, such prescriptions shall be labeled to be taken with or after meals.

(6) Anti-nausea preparations; Meclizine up to 25 mg except for a patient currently using a

central nervous system (CNS) depressant. The prescription shall be labeled to advise the

patient of drowsiness and to caution against concomitant use with alcohol or other

depressants. Scopolamine not exceeding 1.5 mg per dermal patch. Patient to be warned ‘if

eye pain develops, seek appropriate medical attention.’

(7) Antihistamines and decongestants. The following, including their salts, either as a single

ingredient product or in combination, including nasal decongestants, may be ordered for

patients above six (6) years of age:

(a) Diphenhydramine

(b) Carbinoxamine

(c) Clemastine—1.34 mg

(d) Pyrilamine

(e) Chlorpheniramine

(f) Dexchlorpheniramine

(g) Brompheniramine

(h) Tripolidine

(i) Terfenadine

“The patient should be warned that antihistamines should not be used by patients with

bronchial asthma or other lower respiratory symptoms, glaucoma, cardiovascular

disorders, hypertension, prostate conditions and urinary retention. Antihistamines shall be

labeled to advise the patient of drowsiness and caution against the concomitant use with

alcohol or other depressants.

(j) Pseudoephedrine

(k) Phenylpropanolamine

(l) Ephedrine

(m) Phenylephrine

(n) Phenyltoloxamine

(o) Azatadine

(p) Diphenylpyraline

Page 117 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix V 

The Florida Pharmacist Self-Care

Consultant Law

“Oral decongestants shall not be ordered for use by patients with coronary artery disease,

angina, hyperthyroidism, diabetes, glaucoma, prostate conditions, hypertension, or patients

currently using monoamine oxidase inhibitors.

(8) Anthelmintic: Pyrantel pamoate. The drug product may only be ordered for use by

patients over 2 years of age.

(9) Topical antifungal/antibacterials; Iodochlorhydroxyquin with 0.5% Hydrocortisone (not

exceeding 20 grams), Haloprogin 1%, Clotrimazole topical cream and lotion. Nystatin

topical cream, ointment, lotion or powder, miconazole nitrate topical cream. The patient

shall be warned that all of the above products should not be used near deep or puncture

wounds, and Iodochlorhydroxyquin preparations shall be labeled as to the staining

potential.

(10) Topical anti-inflammatory; preparations containing hydrocortisone not exceeding

0.5%. The patient shall be warned that hydrocortisone should not be used on bacterial or

fungal infections or by patients with impaired circulation. Such prescriptions shall be

labeled to avoid contact with eyes and broken skin.

(11) Otic antifungal/antibacterial; acetic acid 2% in aluminum acetate solution which shall

be labeled for use in ears only.

(12) Keratolytics; salicylic acid 16.7% and lactic acid 16.7% in flexible collodion, to be

applied to warts, except for patients under two (2) years of age, and those with diabetes or

impaired circulation. Prescriptions shall be labeled to avoid contact with normal skin, eyes

and mucous membranes.

(13) Vitamins with fluoride. (This does not include vitamins with folic acid in excess of 0.9

mg.)

(14) Medicinal drug shampoos containing Lindane may be ordered pursuant to the

following conditions:

(a) The pharmacist shall limit the order to the treatment of head lice only and provide the

patient with the appropriate instructions and precautions for use.

(b) The amount allowed per person shall be four ounces.

(15) Antidiarrheal: Loperamide 2 mg per dosage unit. No more than a two day supply may

be dispensed.

(16) Smoking cessation products: Nicotine polacrilex not exceeding 2 mg per dose. Before

prescribing, the pharmacist:

(a) Must receive written authorization from the patient’s physician allowing participation in

a smoking cessation program.

(b) Must ensure patient involvement in a behavior modification program.

(17) Opthalmics: Naphazoline 1% opthalmic solution . . . .

Page 118 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix V 

The Florida Pharmacist Self-Care

Consultant Law

“Oral medicinal drug products containing fluoride may be ordered by pharmacists for their

patients who do not have fluoride supplement in their drinking water, pursuant to the

following limitations:

(1) The fluoride content of drinking water does not exceed 0.5 ppm.

(2) Once a fluoride treatment has been initiated with one specific fluoride medicinal drug

product it should not be interchanged with a product of a different manufacturer for the

course of the treatment.

(3) If the fluoride content is less than 0.5 ppm then the following dosage schedule for oral

usage shall be followed:

(a) 1. For ages 0-2 years

a. less than 0.2 ppm in water—supplement with 0.25 mg F/day

b. 0.2-0.5 ppm in water—no supplementation

c. 0.5 ppm in water—no supplementation

2. For ages 2-3 years

a. less than 0.2 ppm in water—supplement with 0.5 mg F/day

b. 0.2-0.5 ppm in water—supplement with 0.25 mg F/day

c. 0.5 ppm in water—no supplementation

3. For ages 3-13 years

a. less than 0.2 ppm in water—supplement with 1.00 mg F/day

b. 0.2-0.5 ppm in water—supplement with 0.5 mg F/day

c. 0.5 ppm in water—no supplementation

(b) No more than 264 mg of sodium fluoride may be dispensed at any one time to a patient

(c) . . . a pharmacist may continue a course of therapy with fluoride products until

appropriate referral to another health care practitioner is indicated or in no event shall the

course of therapy be more than one (1) year.”

Page 119 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix V 

The Florida Pharmacist Self-Care

Consultant Law

Pharmacists are not required to perform the prescribing role. However, if

they choose to, there are a number of requirements. The first, concerning

product labeling, is given in section 465.186 of the pharmacy statutes.

“Affixed to the container containing a medicinal drug dispensed pursuant to this section

shall be a label bearing the following information:

(a) The name of the pharmacist ordering the medication.

(b) The name and address of the pharmacy from which the medication was dispensed.

(c) The date of dispensing.

(d) The order number or other identification adequate to readily identify the order.

(e) The name of the patient for whom the medicinal drug was ordered.

(f) The directions for use of the medicinal drug ordered.

(g) A clear, concise statement that the order may not be refilled.”

The second set of requirements is laid out in section 21S-27.210 of the

pharmacy regulations.

“Pharmacists may order the medicinal drug products . . . subject to the following terms and

limitations:

(1) Injectable products shall not be ordered by the pharmacist.

(2) No oral medicinal drugs shall be ordered by a pharmacist for a pregnant patient or

nursing mother.

(3) In any case of dispensing hereunder, the amount or quantity of drug dispensed shall not

exceed a 34-day supply or standard course of treatment unless subject to the specific

limitations in this rule. Patients shall be advised that they should seek the advice of an

appropriate health care provider if their present condition, symptom, or complaint does not

improve upon the completion of the drug regimen.

(4) The directions for use of all prescribed medicinal drugs shall not exceed the

manufacturer’s recommended dosage.

Page 120 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix V 

The Florida Pharmacist Self-Care

Consultant Law

(5) The pharmacist may only perform the acts of ordering and dispensing in a pharmacy

which has been issued a permit by the Board of Pharmacy.

(6) The pharmacist shall create a prescription when ordering and dispensing medicinal

drug products which shall be maintained in the prescription files of the pharmacy. The

pharmacist shall place the trade or generic name and the quantity dispensed on the

prescription label, in addition to all other label requirements.

(7) The pharmacist shall maintain patient profiles, separate from the prescription order, for

all patients for whom the pharmacist orders and dispenses medicinal drug products and

shall initial and date each profile entry. Such profiles shall be maintained at the pharmacy

wherein the ordering and dispensing originated for a period of seven (7) years.

(8) In the patient profiles, the pharmacist shall record as a minimum the following

information if a medicinal drug product is ordered and dispensed.

(a) Patient’s chief complaint or condition in the patient’s own words.

(b) A statement regarding the patient’s medical history.

(c) A statement regarding the patient’s current complaint which may include onset,

duration, and frequency of the problem.

(d) The medicinal drug product ordered and dispensed.

(e) The pharmacist ordering and dispensing the medicinal drug product shall initial the

profile.

(f) The prescription number shall be recorded in the patient’s profile.

(9) A medicinal drug product may be ordered and dispensed only by the pharmacist so

ordering.

(10) Only legend medicinal drug may be prescribed by a pharmacist. Over-the-counter

drugs are exempt from the requirement of this rule and shall be recommended as

over-the-counter products.

(11) Pharmacy interns and supportive personnel may not be involved in the ordering of the

medicinal drugs permitted in this Rule.”

Page 121 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix VI 

Comments From the Food and Drug

Administration

Page 122 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix VII 

Reviewers of This Report

The following experts and organizations reviewed the report; however,

they do not necessarily endorse the positions we have taken in it.

David Brushwood, J.D.

Professor, Pharmacy Health Care Administration

College of Pharmacy

University of Florida

Henry A. Palmer, Ph.D.

Associate Dean for Professional Affairs

School of Pharmacy

University of Connecticut

Albert I. Wertheimer, Ph.D.

First Health Services Corporation

Glen Allen, Virginia

American Medical Association

American Pharmaceutical Association

National Association of Retail Druggists

National Consumers League

Nonprescription Drug Manufacturers Association

Page 123 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Appendix VIII 

Major Contributors to This Report

Program Evaluation

and Methodology

Division

Winslow T. Wheeler, Project Director

Robert M. Copeland, Project Manager

Penny Pickett, Communications Analyst

Venkareddy Chennareddy, Referencer

Acknowledgments In addition to the persons named above, Gerald L. Dillingham, who served

as the initial project director, made an important contribution to this

report.

Page 124 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
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Glossary

Druggist In the Netherlands and Switzerland, druggists, as distinguished from

pharmacists, are health professionals. Some training is required to become

a druggist but it is not as extensive as that for a pharmacist. The training is

not university-based.

Drugstore Drugstores, as distinguished from pharmacies, in the Netherlands and

Switzerland are run by druggists. Prescriptions cannot be dispensed in

drugstores and not all nonprescription drugs can be sold.

Durham-Humphrey

Amendment of 1951

An amendment to the Federal Food, Drug, and Cosmetic Act of 1938 that

established the statutory basis for the present two-tier (prescription and

nonprescription) drug distribution system in the United States.

Fixed, Intermediate Class A class of nonprescription drugs into which pharmaceuticals would be

permanently placed. These drugs would be restricted to sale either in

pharmacies or by pharmacists.

Formulary A collection of recipes, formulas, and prescriptions. In Florida, the

formulary lists the drugs a pharmacist may prescribe and the conditions

under which they may be prescribed.

General Sale Class A class of nonprescription drugs available for sale outside pharmacies

(and also drugstores in Switzerland). The nonprescription class in the

United States is a general sale class.

Indication The ailment a drug is meant to treat.

Intermediate Class A general term encompassing both a fixed, intermediate class and a

transition class.

Nonprescription Drug A drug available without a prescription. Also referred to as

over-the-counter drug or OTC.

Page 133 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Glossary

Over-the-Counter Drug A drug available without a prescription. Also referred to as a

nonprescription drug or OTC.

Pharmacist Class A class of nonprescription drugs that can be sold only in pharmacies and if

the pharmacist is personally involved in the sale. The distinction between

a pharmacist class and a pharmacy class is relevant for both a fixed,

intermediate class and a transition class.

Pharmacy A drug outlet where prescriptions can be dispensed and all

nonprescription drugs can be sold.

Pharmacy Class A class of nonprescription drugs that can be sold only in pharmacies, but

the pharmacist does not have to be personally involved in the sale. The

distinction between a pharmacy class and a pharmacist class is relevant

for both a fixed, intermediate class and a transition class.

Prescription Generally, an order from a physician to a pharmacist to dispense a

particular drug.

Switching The reclassification of drugs from one class to another. Generally,

switching reduces restrictions on the sale of a drug.

Third Class of Drugs In the United States, a proposed class of nonprescription drugs that would

be available for sale only in pharmacies. One variation would be to allow

the drugs to be sold only by pharmacists.

Transition Class A class of nonprescription drugs into which a drug could be temporarily

placed while its suitability for less restrictive sale was being assessed. In

the United States, drugs in the transition class would be available for sale

without a prescription but only from a pharmacist. The class would be

used for assessing the appropriateness of selling the drug in any retail

outlet.

Page 134 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Glossary

Page 135 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
Related GAO Products

Nonprescription Drugs: Over the Counter and Underemphasized

(GAO/PEMD-92-9, Jan. 1992)

FDA’s Approach to Reviewing Over-the-Counter Drugs Is Reasonable But

Progress Is Slow (GAO/HRD-82-41, Apr. 1982).

(973392) Page 136 GAO/PEMD-95-12 Pharmacist-Controlled Nonprescription Drugs
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