Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to
Be Demonstrated (Chapter Report, 08/24/95, GAO/PEMD-95-12).
The drug classification system in the United States, under which drug
are classified as eight prescription or nonprescription, is unique.
Other countries have a class of drugs that is available without a
prescription but can be obtained only at a pharmacy and sometimes can be
dispensed only by a pharmacist. This report reviews the drug
distribution systems in 10 countries and the European Union. GAO also
reviews the practice of pharmacy focusing on pharmacists counseling of
patients on the use of non prescription drugs. GAO found that little
evidence exists to support the establishment of a pharmacy or a
pharmacist class of drugs in the United States at this time, either as a
fixed or a transition class. Available evidence tends to undermine the
argument that countries with such a class obtain major benefits. This
report discusses in detail the facts supporting this conclusion.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: PEMD-95-12
TITLE: Nonprescription Drugs: Value of a Pharmacist-Controlled
Class Has Yet to Be Demonstrated
DATE: 08/24/95
SUBJECT: Pharmaceutical industry
Drugs
Sales
Controlled substances
Comparative analysis
Medical records
Foreign governments
Cost analysis
Information dissemination operations
IDENTIFIER: European Union
Australia
Canada
Denmark
France
Germany
Italy
Netherlands
Sweden
Switzerland
United Kingdom
Medicaid Program
Florida
California
Mississippi
Missouri
Nevada
New Mexico
North Dakota
South Dakota
Oregon
Washington
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Cover
================================================================ COVER
Report to the Ranking Minority Member, Committee on Commerce, House
of Representatives
August 1995
NONPRESCRIPTION DRUGS - VALUE OF A
PHARMACIST- CONTROLLED CLASS HAS
YET TO BE DEMONSTRATED
GAO/PEMD-95-12
Pharmacist-Controlled Nonprescription Drugs
(973392)
Abbreviations
=============================================================== ABBREV
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
Letter
=============================================================== LETTER
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
============================================================ Chapter 0
PURPOSE
---------------------------------------------------------- Chapter 0:1
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
---------------------------------------------------------- Chapter 0:2
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 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.
--------------------
\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.
RESULTS IN BRIEF
---------------------------------------------------------- Chapter 0:3
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
---------------------------------------------------------- Chapter 0:4
EXTANT STUDIES
-------------------------------------------------------- Chapter 0:4.1
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.
DRUG DISTRIBUTION SYSTEMS
-------------------------------------------------------- Chapter 0:4.2
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
-------------------------------------------------------- Chapter 0:4.3
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
-------------------------------------------------------- Chapter 0:4.4
Only in Australia (and only for some drugs in some states) do
requirements that pharmacists counsel customers on nonprescription
drug use explicitly state what information should be discussed. In 3
countries, pharmacists are expected to provide sufficient information
for the proper use of nonprescription drugs, but there are no
detailed counseling requirements. Other countries typically require
that a pharmacist be aware of sales, be on the premises when a sale
is made, or promote proper drug use. However, counseling and other
pharmacist interventions with customers often do not occur. Although
counseling by pharmacists on the use of nonprescription drugs has
improved, it is often infrequent and incomplete.
Only in some states in Australia and only for some drugs are
pharmacists required to maintain records on nonprescription drug use.
In none of the countries are pharmacists required to report adverse
drug reactions. In Italy and the United Kingdom, such reports from
pharmacists are not accepted, while in the others pharmacists rarely
report these reactions.
Pharmacist associations in the United States and other countries
advocate "pharmaceutical care," a concept that seeks to expand
pharmacy practice from only dispensing drugs to being more involved
in monitoring drug therapy (for instance, checking for adverse drug
reactions). Pharmaceutical care is being implemented in some
community pharmacies, but even if its value there can be documented,
there will still be reason for debate on the need for an intermediate
class.
THE U.S. EXPERIENCE
-------------------------------------------------------- Chapter 0:4.5
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
---------------------------------------------------------- Chapter 0:5
GAO is making no recommendations in this report.
AGENCY COMMENTS
---------------------------------------------------------- Chapter 0:6
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.
INTRODUCTION
============================================================ Chapter 1
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 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 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.
Figure 1.1: Possible Uses of
an Intermediate Drug Class in
the United States
(See figure in printed
edition.)
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.
(See figure in printed
edition.)
--------------------
\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.
\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.
\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.
ARGUMENTS FOR AND AGAINST AN
INTERMEDIATE CLASS OF DRUGS
---------------------------------------------------------- Chapter 1:1
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 The NDMA president (Cope, 1984) has
class, consumers would have access to argued that access to nonprescription
more pharmaceuticals without a products would decrease because the
prescription. Medications formerly intermediate class would be limited to
available only by prescription would sale in pharmacies: there are
become available earlier without a approximately 54,000 U.S. community
physician's prescription but with pharmacies but over 750,000 stores that
pharmacists' counseling (National sell nonprescription products.\b NDMA
Consumers League, 1991).\a This has not uniquely addressed the
argument, made specifically in support transition class proposal. Instead, it
of a transition class, could also be has grouped it with the proposals
made for a fixed class. Advocates of a calling for a fixed class and stated
transition class further state that that both will restrict access to some
drugs would be moved only from nonprescription drugs. NDMA argues that
prescription status into the current OTCs could be moved into the
intermediate class; current OTCs would intermediate class under any of these
not be moved into it. (Fixed-class proposals
proposals did not address this issue)
APhA has stated that customers could Industry officials have noted that
use the expertise of pharmacists, well pharmacists' counseling is infrequent
trained in pharmacology, as an added and sometimes incorrect and this would
resource on nonprescription drug use, not change with an additional drug
drug interactions, and other factors. class; in addition, a new class of
This is relevant for both a fixed and a drugs is not needed for pharmacists to
transition class give counseling. This is relevant for
both a fixed and a transition class
APhA officials have stated that because NDMA has stated that only physicians
of their training, pharmacists can a possess the skills necessary for
play a useful role in helping customers diagnosing and treating illnesses;
assess their medical needs and pharmacists could not replace
determining whether a physician's visit physicians.\c A visit to the physician
is necessary. Through this advice, can be not merely to receive a drug but
visits to physicians for minor ailments also to be diagnosed. Improper
would decrease and physicians would diagnosis can lead to symptoms being
have more time for patients with treated and the patient feeling better
serious illnesses. In addition, but, because of the lack of a
patients would not have to go to the physician's diagnosis, what was treated
doctor for a medication previously might not be the true underlying cause.
available only by prescription, so the Improper treatment could have serious
cost of the physician's visit would be and expensive consequences, thereby
saved. This is relevant for both a negating the savings from not visiting
fixed and a transition class 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 Consumers practice self-medication
have stated that an intermediate class responsibly. NDMA has stated that
facilitates the giving of advice to consumers read and understand drug
individuals who cannot read drug labels labels, which contain all the
or have difficulties understanding information they need. This is relevant
them.\a This is relevant for both a for both a fixed and a transition class
fixed and a transition class
Proponents state that until consumers NDMA has stated that drugs unsafe for
learn how to properly use recently unsupervised use by consumers on the
switched drugs, pharmacists should be basis of their labeling directions
particularly accessible for them should be prescription products; they
because of their high potential for should not be available for
toxicity and abuse. While this argument nonprescription sale even with
holds for both a fixed and a transition pharmacist counseling.\d Opponents have
class, it is most relevant for the also argued that there have been no
latter because of the implication that problems with already switched drugs;
once there is more experience with they have not been abused or caused
these drugs as nonprescription widespread toxicity. This is relevant
products, pharmacists will not have to for both a fixed and a transition class
be involved in their sale
Penna writes that pharmacists could NDMA president Cope writes that the
provide FDA postmarketing surveillance current two-tier system works well; an
information on misuse, adverse additional class is not necessary to
reactions, and the extent of the use of ensure safety.\b If they wish,
a drug as a nonprescription product.\e consumers can go to pharmacies for
This would be useful information for advice but are not compelled to do so
both a fixed and a transition class; it (NDMA, 1992). This is relevant for both
is most relevant for the latter because a fixed and transition class
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
Proponents argue that when necessary, Opponents argue that FDA and the
recalls of nonprescription products pharmaceutical industry have an
would be facilitated since there would excellent record in recalling products
be fewer outlets from which to recall from both pharmacy and nonpharmacy
intermediate-class drugs. APhA outlets. Thus, an intermediate class is
officials have stated that pharmacists not needed for this purpose. This is
have a commendable record in relevant for both a fixed and a
facilitating drug recalls. This is transition class
relevant for both a fixed and a
transition class
Proponents have argued that abuse of Opponents argue that an intermediate
nonprescription drugs would be reduced class would not be effective in
because a pharmacist would check if the preventing abuse since it would not
drug and quantity being purchased were address the underlying problem and
appropriate. Pharmacists could educate would represent only a small
consumers on proper drug use. This is inconvenience in obtaining the product.
relevant for both a fixed and a In addition, they argue that the abuse
transition class 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 Opponents argue that because of
prescription because of the safeguard restricted competition and pharmacists'
of restricting sale to pharmacies or by wanting to be compensated for
a pharmacist; proponents argue that counseling, the price of intermediate-
health care costs would decrease class drugs would be higher than if
because the nonprescription version of they had been made nonprescription in
a drug is generally less expensive than the current two-tier system, without
the prescription version. This is any corresponding benefit to consumers
relevant for both a fixed and or the health care system\c
transition class
--------------------------------------------------------------------------------
\a National Consumers League, Taking Your Medicine: Providing
Consumer Safeguards (Washington, D.C.: September 1991).
\b J. D. Cope, "A Third Class of Drugs Would Release a New Flood of
Problems," Pharmaceutical Executive, September 1984, pp. 42-43.
\c Nonprescription Drug Manufacturers Association, National Consumers
League Symposium on Transition [Third Class] of Drugs: An NDMA
Response (Washington, D.C.: 1992).
\d Nonprescription Drug Manufacturers Association, Self-Medications'
Role in U.S. Health Care: A Briefing Book (Washington, D.C.:
1993).
\e R. P. Penna, "A Transition Category: How APhA's Policy Would
Work," American Pharmacy, NS25 (1985), 46-47.
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.
OBJECTIVES, SCOPE, AND
METHODOLOGY
---------------------------------------------------------- Chapter 1:2
OBJECTIVES
-------------------------------------------------------- Chapter 1:2.1
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
-------------------------------------------------------- Chapter 1:2.2
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 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.
--------------------
\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.
\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).
METHODOLOGY
-------------------------------------------------------- Chapter 1:2.3
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
-------------------------------------------------------- Chapter 1:2.4
We conducted computerized literature searches on the following
topics: (1) drug distribution systems in the study countries, (2)
the behavior of pharmacists, (3) the classification of the 14 drugs,
(4) the advantages and disadvantages of an intermediate class of
drugs, and (5) assessments of the health and economic effects of
different drug distribution systems.
INTERVIEWS WITH U.S.
EXPERTS AND OFFICIALS
-------------------------------------------------------- Chapter 1:2.5
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
-------------------------------------------------------- Chapter 1:2.6
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.
STUDY STRENGTHS AND LIMITATIONS
---------------------------------------------------------- Chapter 1:3
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 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
---------------------------------------------------------- Chapter 1:4
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
---------------------------------------------------------- Chapter 1:5
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.
DRUG DISTRIBUTION SYSTEMS
============================================================ Chapter 2
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
--------------------
\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.
STUDIES ON THE CONSEQUENCES OF
DIFFERENT DRUG DISTRIBUTION
SYSTEMS
---------------------------------------------------------- Chapter 2:1
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 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.
--------------------
\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.
THE NUMBER AND TYPE OF DRUG
CLASSES IN THE STUDY COUNTRIES
---------------------------------------------------------- Chapter 2:2
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 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
Prescripti Pharmacist Drugstore\ General
Country on\a \b Pharmacy\c d sale\e
-------------------- ---------- ---------- ---------- ---------- ----------
Australia x x x x
Canada\f x x x
Ontario x x x x
Denmark x x x
France x x
Germany x x\g x
Italy x x
Netherlands x x\g x
Sweden x x x
Switzerland x x x x
United Kingdom x x\g x
United States x x
--------------------------------------------------------------------------------
\a Prescription = 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.
\b Pharmacist = 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.
\c Pharmacy = class of drugs available without a prescription but
only in pharmacies. The pharmacist does not have to be involved in a
sale.
\d Drugstore = 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.
\e General 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.
\g The 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.
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
--------------------
\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.
CRITERIA FOR CLASSIFYING DRUGS
---------------------------------------------------------- Chapter 2:3
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 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
---------------------------------------------------------- Chapter 2:4
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. 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.
--------------------
\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.
PREVENTING ABUSE
---------------------------------------------------------- Chapter 2:5
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
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."
--------------------
\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.
\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.
THE ECONOMICS OF AN
INTERMEDIATE CLASS OF DRUGS
---------------------------------------------------------- Chapter 2:6
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
-------------------------------------------------------- Chapter 2:6.1
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.)
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.
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.
--------------------
\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.)
\10 In 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.
\11 The 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.
\12 It 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.
ECONOMIC FACTORS
-------------------------------------------------------- Chapter 2:6.2
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
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.
--------------------
\13 However, we saw in the previous section that savings from reduced
physicians' visits may not be as large as anticipated.
DRUG DISTRIBUTION IN THE
EUROPEAN UNION
---------------------------------------------------------- Chapter 2:7
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" 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
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.
--------------------
\14 Directive 92/26/EEC. See Official Journal of the European
Communities, April 30, 1992.
SUMMARY
---------------------------------------------------------- Chapter 2:8
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 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.
ACCESS TO NONPRESCRIPTION DRUGS
============================================================ Chapter 3
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?
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.
--------------------
\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.
THE ACCESS TO PHARMACIES AND
DRUGSTORES
---------------------------------------------------------- Chapter 3:1
NUMBER OF PHARMACIES AND
DRUGSTORES
-------------------------------------------------------- Chapter 3:1.1
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.
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.
Table 3.1
Number of Community Pharmacies and
Drugstores in Ten Countries, Ontario,
and the United States in 1993-94
Pharmacies and
Pharmaci Drugstor drugstores per
Country es es 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 53,841\b \a 1:4,800
----------------------------------------------------------------------
\a Not applicable.
\b Includes drug chain, independent, food store, and mass merchant
pharmacies. (See Drug Store News for Pharmacists, April 11, 1994.)
--------------------
\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.
\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.
ACCESSIBILITY OF COMMUNITY
PHARMACIES IN THE UNITED
STATES
-------------------------------------------------------- Chapter 3:1.2
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 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
---------------------------------------------------------- Chapter 3:2
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.
Table 3.2
Self-Service for Nonprescription Drugs
in Ten Countries, Ontario, and the
United States\a
Pharmaci Drugstor General
Country st Pharmacy e sale
------------------------------ -------- -------- -------- --------
Australia No Varies Yes
by state
Canada\b No\c Varies Yes
by
product
Ontario No Yes Yes
Denmark No
France No
Germany No Yes
Italy No
Netherlands No No
Sweden Varies Yes
by
product
Switzerland No No Yes
United Kingdom No Yes
United States No\d Yes
----------------------------------------------------------------------
\a The 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.
\b Access 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.
\c This category exists only for controlled substances.
\d This 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 products if
they could not select pharmacist- or pharmacy-class drugs directly
from the shelf.\4
--------------------
\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.
THE EFFECT OF AN INTERMEDIATE
CLASS ON DRUG CLASSIFICATION
---------------------------------------------------------- Chapter 3:3
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 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.
--------------------
\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.
SUMMARY
---------------------------------------------------------- Chapter 3:4
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.
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.
THE PRACTICE OF PHARMACY
============================================================ Chapter 4
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
---------------------------------------------------------- Chapter 4:1
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, 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.
Table 4.1
Pharmacist Counseling Responsibilities
for Nonprescription Drugs in Ten
Countries and Ontario
Country Pharmacist responsibility
-------- ------------------------------------------------------------
Australi Counseling requirements are set by the states. There are no
a 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
Netherla The pharmacist must be on the premises when nonprescription
nds 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
Switzerl Pharmacists must be on the premises when nonprescription
and 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 Pharmacy-only medicines must be sold under the supervision
Kingdom\ of a pharmacist. No counseling requirements state what
specific information must be given to the consumer
----------------------------------------------------------------------
THE ENFORCEMENT OF COUNSELING
REQUIREMENTS
---------------------------------------------------------- Chapter 4:2
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 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 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
---------------------------------------------------------- Chapter 4:3
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.
Table 4.2
Description of Studies of Pharmacist
Counseling on Nonprescription Products
in Five Countries and the United States
Aspect of
Country, author, and counseling
date\a Methodology Sample selection assessed\b
---------------------- ------------------ ---------------------- ------------
Australia
Feehan (1981) 2 trained shoppers 2 random samples of 43 Quality,
pharmacies each in quantity
Victoria
Harris et al. (1985) 1 trained shopper Random sample of 40 Quality
pharmacies in Perth
Ortiz, Walker, and Observation Random sample of 50 Quantity
Thomas (1989) pharmacies in Sydney;
28 agreed to
participate
Ortiz et al. (1984a, Mail survey of Commercial mailing Quantity
b) pharmacists list covering 98.1% of
pharmacies in the
Australian Capital
Territory and New
South Wales
Stewart, Garde, and Observation Sample of 10 Frequency,
Benrimoj (1985) pharmacies in Brisbane quantity
chosen using specific
criteria
Canada
Poston, Kennedy, and Survey of Random sample of 681 Quantity
Waruszynski (1994) pharmacists pharmacies stratified
by province
Taylor and Suveges Observation and Random sample of 11 Frequency,
(1992a) consumer pharmacies in quantity
questionnaire Saskatoon
Taylor and Suveges Observation 4 pharmacies in Frequency,
(1992b) Saskatoon; selection quantity
method not given
Willison and Muzzin 8 trained shoppers Random sample of 37 Quality
(1992) pharmacies in Ontario;
30 agreed to
participate
Germany
Glaeske (1989) 30 trained 222 pharmacies in 27 Quality
shoppers cities; selection
method not given
Product Testing 944 trained Random sample of 1,530 Frequency,
Foundation (1984) shoppers pharmacies quality
Product Testing "Several hundred" Selection method for Frequency,
Foundation (1991) trained shoppers pharmacies not given quality
Sweden
Marklund, Karlsson, Observation by 4 pharmacies in 4 Frequency
and Bengtsson (1990) pharmacy personnel 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
United Kingdom
Consumers Association 6 trained shoppers Over 200 pharmacies in Quality,
(1985) 3 areas; selection quantity
method not given
Consumers Association 8 trained shoppers 240 pharmacies; Quality,
(1991) selection method not quantity
given
Consumers Association Trained shoppers; 30 pharmacies in 4 Frequency,
(1994) number not given cities; selection quality
method not given
Goodburn et al. (1991) Interviews with Random sample of 20 Quality
pharmacists, 1 pharmacies in
trained shopper Newcastle upon Tyne;
random sample of 10
pharmacies for trained
shopper part of
project
Hardisty (1982) Observation Nonrandom sample of Quality,
225 pharmacies in quantity
England, Scotland, and
Wales
"Most Pharmacists Observation, 4 Observation of 6 Frequency,
`Give Good Advice'" trained shoppers pharmacies in quality,
(1984) Birmingham, selection quantity
method not given; for
trained shoppers
component, 123 visits
to a random sample of
85 pharmacies,
location not given
"Over-the-Counter 7 trained shoppers Random sample of over Frequency,
Advice" (1988) 200 pharmacies in 3 quality,
cities quantity
Phelan and Jepson Mail survey of Random sample of 417 Frequency
(1980) pharmacies pharmacies in England
Smith, Salkind, and Observation Random sample of 64 Quality
Jolly (1990) (5%) of pharmacies in
London
Taylor et al. (1987) Pharmacist 313 pharmacies Frequency
recording of throughout Britain;
activities selection method not
given
United States
Barnett, Nykamp, and 6 trained 84 randomly selected Quality
Hopkins (1992) shoppers; 2 pharmacies in Atlanta;
scenarios 72 visited for both
scenarios
Carroll and Gagnon Mail survey of Random sample of 300 Quantity
(1983) households households in Raleigh,
N.C.
Jang, Knapp, and Knapp 6 trained shoppers Random sample of 48 Quality
(1975) pharmacies in 1 city
Knapp et al. (1969) Trained shoppers Random sample of 36 Quality
asking questions pharmacies in 1 city
on the telephone;
number not given
Linn and Davis (1973) 2 trained Random sample of 133 Quality
shoppers; pharmacies in Los
pharmacist Angeles for trained
questionnaire 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
Market Facts (1994) Telephone Sample of 1,302 adults Quantity
interviews with chosen to represent
adults who had a all U.S. households
prescription
filled in the past
6 months
Meade (1992) Telephone 200 randomly selected Quantity
interviews with pharmacists
pharmacists
Vanderveen, Adams, and Trained shoppers 72 pharmacies in Quality
Sanborn (1978) either visited or Michigan; selection
telephoned method not given
pharmacies; number
not given
Vanderveen and Jirak Trained shoppers; 46 pharmacies in Quality
(1990) number not given Michigan; selection
based on location
Wertheimer, Shefter, 1 trained shopper 86, 50, and 31 Quality
and Cooper (1973) for each of 3 pharmacies for each of
scenarios the respective
scenarios; selection
method not given for
two scenarios, random
selection for the
other
--------------------------------------------------------------------------------
\a Complete citations are in the bibliography.
\b Quality = 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.
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 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 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 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.
--------------------
\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.
\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.
\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.
ACTIVITIES OF PHARMACISTS
---------------------------------------------------------- Chapter 4:4
REPORTING ADVERSE DRUG
REACTIONS
-------------------------------------------------------- Chapter 4:4.1
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, 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
-------------------------------------------------------- Chapter 4:4.2
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 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.
--------------------
\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.
\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.
OFFICIALS' VIEWS
-------------------------------------------------------- Chapter 4:4.3
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 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
---------------------------------------------------------- Chapter 4:5
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
-------------------------------------------------------- Chapter 4:5.1
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 (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 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.
--------------------
\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.
OMNIBUS BUDGET
RECONCILIATION ACT OF 1990
-------------------------------------------------------- Chapter 4:5.2
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.
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
-------------------------------------------------------- Chapter 4:5.3
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.
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.
--------------------
\8 Liability was not a concern to officials in other countries where
there is a general lack of litigiousness compared to the United
States.
SUMMARY
---------------------------------------------------------- Chapter 4:6
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.
THE U.S. EXPERIENCE
============================================================ Chapter 5
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
---------------------------------------------------------- Chapter 5:1
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 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.
THE FLORIDA PHARMACIST
SELF-CARE CONSULTANT LAW
---------------------------------------------------------- Chapter 5:2
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.)
--------------------
\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.
EVALUATION
-------------------------------------------------------- Chapter 5:2.1
In 1990, a group of researchers from the College of Pharmacy at the
University of Florida reported on the effect of Florida's Pharmacist
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
------------------------------------------------------ Chapter 5:2.1.1
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
------------------------------------------------------ Chapter 5:2.1.2
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
------------------------------------------------------ Chapter 5:2.1.3
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.
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
------------------------------------------------------ Chapter 5:2.1.4
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.
OFFICIALS' ASSESSMENT OF THE
EFFECT OF THE LAW
-------------------------------------------------------- Chapter 5:2.2
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.
--------------------
\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.
COMPARISONS WITH STUDIES IN
OTHER COUNTRIES
-------------------------------------------------------- Chapter 5:2.3
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 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
---------------------------------------------------------- Chapter 5:3
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
-------------------------------------------------------- Chapter 5:3.1
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 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.
--------------------
\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."
DEPENDENT PRESCRIBING
AUTHORITY IN THE STATES
-------------------------------------------------------- Chapter 5:3.2
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.
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.
--------------------
\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).
SUMMARY
---------------------------------------------------------- Chapter 5:4
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.
SUMMARY AND CONCLUSIONS
============================================================ Chapter 6
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
---------------------------------------------------------- Chapter 6:1
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
---------------------------------------------------------- Chapter 6:2
THE BENEFITS OF A TRANSITION
CLASS
-------------------------------------------------------- Chapter 6:2.1
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.
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
-------------------------------------------------------- Chapter 6:2.2
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
-------------------------------------------------------- Chapter 6:2.3
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 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
---------------------------------------------------------- Chapter 6:3
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
---------------------------------------------------------- Chapter 6:4
NUMBER OF PHARMACIES AND
DRUGSTORES
-------------------------------------------------------- Chapter 6:4.1
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 be available for sale only in
pharmacies; the difference would be that a prescription would not be
required.
SELF-SELECTION OF DRUGS
-------------------------------------------------------- Chapter 6:4.2
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
-------------------------------------------------------- Chapter 6:4.3
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.
PHARMACY PRACTICE
---------------------------------------------------------- Chapter 6:5
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
---------------------------------------------------------- Chapter 6:6
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
---------------------------------------------------------- Chapter 6:7
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 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.
HISTORY OF THE INTERMEDIATE-DRUG
CLASS ISSUE IN THE UNITED STATES
=========================================================== Appendix I
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."
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 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.
DESCRIPTION OF DRUG CLASSIFICATION
SYSTEMS IN TEN COUNTRIES, ONTARIO,
AND THE UNITED STATES
========================================================== Appendix II
AUSTRALIA
-------------------------------------------------------- Appendix II:1
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:1.1
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
------------------------------------------------------ Appendix II:1.2
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.
"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
------------------------------------------------------ Appendix II:1.3
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
------------------------------------------------------ Appendix II:1.4
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,
--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."
The guidelines do not lay out the criteria by which this information
is assessed.
CANADA
-------------------------------------------------------- Appendix II:2
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:2.1
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
------------------------------------------------------ Appendix II:2.2
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 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
------------------------------------------------------ Appendix II:2.3
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
------------------------------------------------------ Appendix II:2.4
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
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
-------------------------------------------------------- Appendix II:3
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:3.1
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
------------------------------------------------------ Appendix II:3.2
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.
--------------------
\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.
WHEN THE SYSTEM BEGAN
------------------------------------------------------ Appendix II:3.3
We were unable to determine when the drug classification system was
established.
SWITCH DECISIONS
------------------------------------------------------ Appendix II:3.4
Switch decisions are made by the Ontario Ministry of Health with the
advice of the Ontario College of Pharmacists.
DENMARK
-------------------------------------------------------- Appendix II:4
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:4.1
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
------------------------------------------------------ Appendix II:4.2
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
------------------------------------------------------ Appendix II:4.3
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
------------------------------------------------------ Appendix II:4.4
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,
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
-------------------------------------------------------- Appendix II:5
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:5.1
The regulatory authority for drugs rests with the National Drug
Administration (Agencie du medicament) in the Ministry of Health.
DRUG CLASSES
------------------------------------------------------ Appendix II:5.2
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
------------------------------------------------------ Appendix II:5.3
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).
SWITCH DECISIONS
------------------------------------------------------ Appendix II:5.4
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
-------------------------------------------------------- Appendix II:6
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:6.1
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
------------------------------------------------------ Appendix II:6.2
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
------------------------------------------------------ Appendix II:6.3
The drug classification system was adopted in 1961.
SWITCH DECISIONS
------------------------------------------------------ Appendix II:6.4
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?
-- 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
-------------------------------------------------------- Appendix II:7
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:7.1
Regulatory authority for classifying drugs into distribution classes
rests with the United Commission for Drugs (Commissione Unica per il
Farmaca).
DRUG CLASSES
------------------------------------------------------ Appendix II:7.2
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
------------------------------------------------------ Appendix II:7.3
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
------------------------------------------------------ Appendix II:7.4
Authority to switch drugs resides in the Ministry of Health.
NETHERLANDS
-------------------------------------------------------- Appendix II:8
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:8.1
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 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
------------------------------------------------------ Appendix II:8.2
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
------------------------------------------------------ Appendix II:8.3
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
------------------------------------------------------ Appendix II:8.4
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.
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
-------------------------------------------------------- Appendix II:9
REGULATORY AUTHORITY
------------------------------------------------------ Appendix II:9.1
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
------------------------------------------------------ Appendix II:9.2
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
------------------------------------------------------ Appendix II:9.3
The prescription and nonprescription categories were established in
1934. We were unable to determine when the free medicines and herbal
medicines classes were established.
SWITCH DECISIONS
------------------------------------------------------ Appendix II:9.4
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
------------------------------------------------------- Appendix II:10
REGULATORY AUTHORITY
----------------------------------------------------- Appendix II:10.1
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
----------------------------------------------------- Appendix II:10.2
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.
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.
--------------------
\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.
WHEN THE SYSTEM BEGAN
----------------------------------------------------- Appendix II:10.3
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
----------------------------------------------------- Appendix II:10.4
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,
-- 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
------------------------------------------------------- Appendix II:11
REGULATORY AUTHORITY
----------------------------------------------------- Appendix II:11.1
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.
DRUG CLASSES
----------------------------------------------------- Appendix II:11.2
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
----------------------------------------------------- Appendix II:11.3
The classification system was established under the Medicines Act of
1968.
SWITCH DECISIONS
----------------------------------------------------- Appendix II:11.4
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
"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
------------------------------------------------------- Appendix II:12
REGULATORY AUTHORITY
----------------------------------------------------- Appendix II:12.1
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
----------------------------------------------------- Appendix II:12.2
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.)
WHEN THE SYSTEM BEGAN
----------------------------------------------------- Appendix II:12.3
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
----------------------------------------------------- Appendix II:12.4
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?
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?
CLASSIFICATION OF 14 DRUGS IN TEN
COUNTRIES, ONTARIO, AND THE UNITED
STATES
========================================================= Appendix III
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
States\a
Not Prescripti Drugsto
Country available on Pharmacist Pharmacy re General sale
-------- ---------- ---------- ---------- ---------- ------- -------------
Australi Cimetidine Codeine, Aspirin, Aspirin
a , Codeine, Ibuprofen, Codeine,
Diclofenac Indomethac Naproxen,
, in, PPA\b Promethazi
Diflunisal (as a ne
, decongesta
Ibuprofen, nt),
Indomethac Promethazi
in, ne,
Naproxen, Terfenadin
PPA\b e,
(both as a Theophylli
decongesta ne
nt and in
weight-
reduction
products),
Promethazi
ne,
Ranitidine
,
Sulindac,
Terfenadin
e,
Theophylli
ne
Canada PPA\b (in Cimetidine Codeine\c Ibuprofen, Aspirin,
weight- , Codeine, Promethazi PPA\b (as a
reduction Diclofenac ne, decongestant)
products) , Terfenadin
Diflunisal e
,
Ibuprofen,
Indomethac
in,
Naproxen,
Ranitidine
,
Sulindac,
Theophylli
ne
Ontario PPA\b (in Cimetidine Aspirin, Aspirin,
weight- , Codeine, Codeine, PPA\b (as a
reduction Diclofenac Ibuprofen, decongestant)
products) , Promethazi
Diflunisal ne,
, Terfenadin
Ibuprofen, e
Indomethac
in,
Naproxen,
PPA\b (as
a
decongesta
nt),
Ranitidine
,
Sulindac,
Theophylli
ne
Denmark PPA\b Codeine, Aspirin,
(both as a Diclofenac Cimetidine
decongesta , ,
nt and in Diflunisal Codeine,
weight- , Ibuprofen,
reduction Ibuprofen, Promethazi
products) Indomethac ne,
in, Ranitidine
Naproxen, ,
Promethazi Terfenadin
ne, e
Sulindac,
Theophylli
ne
Germany Cimetidine Aspirin,
, Codeine,
Diclofenac Ibuprofen,
, PPA\b
Diflunisal (both as a
, decongesta
Ibuprofen, nt and in
Indomethac weight-
in, reduction
Naproxen, products),
Promethazi Terfenadin
ne, e
Ranitidine
,
Sulindac,
Theophylli
ne
Netherla Cimetidine Aspirin, Aspirin
nds , Codeine, Cimetidine ,
Diclofenac , Ibuprof
, Ibuprofen, en
Diflunisal Naproxen,
, PPA\b
Indomethac (both as a
in, decongesta
Promethazi nt and in
ne, weight-
Ranitidine reduction
products),
Promethazi
ne,
Ranitidine
,
Sulindac,
Terfenadin
e,
Theophylli
ne\d
Sweden PPA\b (in Cimetidine Aspirin,
weight- , Codeine, Ibuprofen
reduction Diclofenac
products) ,
Diflunisal
,
Ibuprofen,
Indomethac
in,
Naproxen,
PPA\b (as
a
decongesta
nt),
Promethazi
ne,
Ranitidine
,
Sulindac,
Terfenadin
e,
Theophylli
ne
Switzerl Cimetidine Codeine, Aspirin
and , Codeine, Diclofenac
Diclofenac ,
, Ibuprofen,
Diflunisal Indomethac
, in, PPA\b
Ibuprofen, (both as a
Indomethac decongesta
in, nt and in
Naproxen, weight-
PPA\b (as reduction
a products),
decongesta Promethazi
nt), ne,
Promethazi Terfenadin
ne, e
Ranitidine
,
Sulindac,
Terfenadin
e,
Theophylli
ne
United Cimetidine Aspirin, Aspirin
Kingdom , Codeine, Cimetidine
Diclofenac ,
, Codeine,
Diflunisal Diclofenac
, ,
Ibuprofen, Ibuprofen,
Indomethac PPA\b
in, (both as a
Naproxen, decongesta
PPA\b nt and in
(both as a weight-
decongesta reduction
nt and in products),
weight- Promethazi
reduction ne,
products), Ranitidine
Ranitidine ,
, Terfenadin
Sulindac, e,
Terfenadin Theophylli
e ne
United Cimetidine Codeine\e Aspirin,
States , Codeine, Cimetidine,
Diclofenac Ibuprofen,
, Naproxen,
Diflunisal PPA\b (both
, as a
Ibuprofen, decongestant
Indomethac and in
in, weight-
Naproxen, reduction
Promethazi products),
ne, Theophylline
Ranitidine
,
Sulindac,
Terfenadin
e,
Theophylli
ne
--------------------------------------------------------------------------------
\a In 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.
\b Phenylpropanolamine.
\c Codeine is regulated under the Narcotics Control Act in Canada.
Some codeine products are available from pharmacists without a
prescription.
\d Although all these drugs are legally available without a
prescription in the Netherlands, most pharmacists will not dispense
them without a prescription.
\e Some 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 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
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.
--------------------
\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.)
DESCRIPTIONS OF DRUGS EXAMINED IN
THIS STUDY
========================================================== Appendix IV
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
-------------------------------------------------------- Appendix IV:1
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
-------------------------------------------------------- Appendix IV:2
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),
leading to an increased risk of adverse effects. It can increase the
effect of anticoagulant drugs and the blood levels of anticonvulsant
drugs.
CODEINE
-------------------------------------------------------- Appendix IV:3
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.
--------------------
\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.
DICLOFENAC
-------------------------------------------------------- Appendix IV:4
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
-------------------------------------------------------- Appendix IV:5
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 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
-------------------------------------------------------- Appendix IV:6
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
-------------------------------------------------------- Appendix IV:7
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.
NAPROXEN
-------------------------------------------------------- Appendix IV:8
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
-------------------------------------------------------- Appendix IV:9
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
------------------------------------------------------- Appendix IV:10
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.
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
------------------------------------------------------- Appendix IV:11
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
------------------------------------------------------- Appendix IV:12
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
------------------------------------------------------- Appendix IV:13
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 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.
--------------------
\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.
THEOPHYLLINE
------------------------------------------------------- Appendix IV:14
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.
THE FLORIDA PHARMACIST SELF-CARE
CONSULTANT LAW
=========================================================== Appendix V
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 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
"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 . . . .
"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."
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.
(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."
(See figure in printed edition.)Appendix VI
COMMENTS FROM THE FOOD AND DRUG
ADMINISTRATION
=========================================================== Appendix V
REVIEWERS OF THIS REPORT
========================================================= Appendix VII
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
MAJOR CONTRIBUTORS TO THIS REPORT
======================================================== Appendix VIII
PROGRAM EVALUATION AND
METHODOLOGY DIVISION
------------------------------------------------------ Appendix VIII:1
Winslow T. Wheeler, Project Director
Robert M. Copeland, Project Manager
Penny Pickett, Communications Analyst
Venkareddy Chennareddy, Referencer
ACKNOWLEDGMENTS
------------------------------------------------------ Appendix VIII:2
In addition to the persons named above, Gerald L. Dillingham, who
served as the initial project director, made an important
contribution to this report.
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============================================================ Chapter 1
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GLOSSARY
============================================================ Chapter 2
DRUGGIST
-------------------------------------------------------- Chapter 2:0.1
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
-------------------------------------------------------- Chapter 2:0.2
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
-------------------------------------------------------- Chapter 2:0.3
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
-------------------------------------------------------- Chapter 2:0.4
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
-------------------------------------------------------- Chapter 2:0.5
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
-------------------------------------------------------- Chapter 2:0.6
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
-------------------------------------------------------- Chapter 2:0.7
The ailment a drug is meant to treat.
INTERMEDIATE CLASS
-------------------------------------------------------- Chapter 2:0.8
A general term encompassing both a fixed, intermediate class and a
transition class.
NONPRESCRIPTION DRUG
-------------------------------------------------------- Chapter 2:0.9
A drug available without a prescription. Also referred to as
over-the-counter drug or OTC.
OVER-THE-COUNTER DRUG
------------------------------------------------------- Chapter 2:0.10
A drug available without a prescription. Also referred to as a
nonprescription drug or OTC.
PHARMACIST CLASS
------------------------------------------------------- Chapter 2:0.11
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
------------------------------------------------------- Chapter 2:0.12
A drug outlet where prescriptions can be dispensed and all
nonprescription drugs can be sold.
PHARMACY CLASS
------------------------------------------------------- Chapter 2:0.13
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
------------------------------------------------------- Chapter 2:0.14
Generally, an order from a physician to a pharmacist to dispense a
particular drug.
SWITCHING
------------------------------------------------------- Chapter 2:0.15
The reclassification of drugs from one class to another. Generally,
switching reduces restrictions on the sale of a drug.
THIRD CLASS OF DRUGS
------------------------------------------------------- Chapter 2:0.16
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
------------------------------------------------------- Chapter 2:0.17
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.
RELATED GAO PRODUCTS
============================================================ Chapter 3
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).
*** End of document. ***