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Pharmacy Law & Ethics
1. The Basis of Pharmacy Law
The law is both a body of information and a system within which that
information is used to resolve conflicts and preserve order within society.
Pharmacy law is a body of information about drugs, drug distribution, and
drug therapy. The information is used by legislatures, administrative agencies,
and courts of law, to assure that all parties to whom responsibilities have been
assigned by society meet those responsibilities.
When things have not gone well in drug therapy, legal authorities are likely to
ask who was in a position of responsibility prior to the problem having
developed, and then to ask that the responsible person (or persons) account
for actions taken.
A requirement that this explanation of actions be provided is known as
accountability. If the responsible person or persons providing the accounting
fail to furnish an acceptable explanation for the conduct, then liability will be
imposed.
Liability is legal recognition that an acceptable accounting was not providedby a party who was in a position of responsibility when a problem occurred.
The law defines a set of responsibilities for pharmacists and for others who
are formally involved with medication use.
The law also provides a mechanism through which adverse outcomes are
reviewed by affording responsible persons an opportunity to account for their
actions and avoid liability through a satisfactory accounting.
1. The Purpose of Pharmacy Law
Pharmacy law protects patients from harm that might occur if medications
were used in ways that unreasonably increase the risk of their causing harm.
Some pharmacy laws relate to all drugs and the hazards of using them for
therapeutic reasons. Other laws relate to a subset of drugs that have the
potential for abuse, and these laws seek to restrict inappropriate use while not
interfering with legitimate use.
In studying pharmacy law, the primary goal is to address the question:
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How far should government go to protect people who use medications
from the consequences of their own choices in drug therapy?
This is both an empirical question and a normative question, because it asks
both what the rules are and what the rules ought to be.To fully appreciate pharmacy laws, it is important to understand what is
required and why, as well as understand that pharmacy law is dynamic and
can be changed to protect the public in ways that extend beyond the status
quo.
Most laws exist for a reason, and pharmacy laws are no exception to this
general rule. Restrictions on the use of chemicals as drugs and restrictions on
individual practice of pharmacy exist because the open market would fail to
protect the public if any old chemical could be used as a drug and if anyone
could practice pharmacy.
The public would be unnecessarily exposed to risks of harm from dangerous
chemicals and dangerous dispensers of them.
This prospect of harm is a reason to regulate, and it justifies legal restrictions
on drug distribution.
2. The Structure of Pharmacy Law
Pharmacy is regulated at the federal and state levels. Federal rules primarily
relate to the drug product, while state rules primarily relate to the people who
practice pharmacy and the practice sites withing which they perform their
professional duties.
As a general rule, pharmacists are required to comply with the most restrictive
law, if both state and federal law address a specific issue and if they conflict
on that issue.
For example, if under federal law a particular drug is not restricted to
prescription-only sale, but under state law there is such a restriction,
pharmacists may not sell the drug without a prescription, because state law
would be more strict. It is important, however, to assure that apparently
conflicting laws really do relate to the same issue.
At both the federal and state levels there are administrative agencies,
legislatures, and courts that decide whether and how pharmacists must
comply with particular rules. Administrative agencies such as the board of
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pharmacy, at the state level, and the Food and Drug Administration (FDA) or
the Drug Enforcement Administration
Copyright 2000, David B. Brushwood 2 (DEA), at the federal level, make rules
for pharmacists and they enforce their own rules as well as rules made by thestate and federal legislatures. State legislatures and the United States
Congress establish a general framework of rules and enforcement processes,
by enacting laws such as the state pharmacy act and the federal Food Drug &
Cosmetic Act (FDCA). It is important to remember that the answer to a
question of pharmacy law may be found in either the administrative rules or
the relevant legislation, and that a legal question has not been thoroughly
researched until both sources have been consulted.
3. The History of Pharmacy Law
Pharmacy is an old profession that traces its history back at least 4,000 years
ago, when people who prepared medications were different from those who
decided what medications people needed to use. Even in the early years of
the pharmacy profession, the distinction between medication prescibers and
medications preparers was noted in the law, due to the need to avoid conflicts
of interest. As American pharmacy began to formally develop in the early 19thCentury, the need to regulate the profession became evident, and by the end
of that century most states had enacted pharmacy practice acts with boards of
pharmacy empowered to make and enforce rules for the profession. The
selfregulation approach, through a board of pharmacy, persists today, even
though there have been frequent calls for more public oversight in the
regulation of pharmacy and of the other health care professions.
Federal regulation of drugs began only in 1906 with passage of the Pure Food
and Drug Act. This legislation was a classic example of indirect regulation,
because it merely provided that labeling on medications be truthful and not
adulterated, allowing consumers to make decisions for themselves. It did not
prevent the marketing of dangerous chemicals as drugs. In 1938, the Food,
Drug & Cosmetic Act (FDCA) was passed. This act, as amended, forms the
basis of drug regulation today. The 1938 law required that new drugs be
shown to be safe prior to their marketing.
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Thus, this was a first step toward direct regulation, because it made
decisions for consumers. Several subsequent amendments have added
requirements to the FDCA. In 1952, the prescription-only requirement became
effective, creating two classes of drugs: those available without a prescriptionand those available only with a prescription. In 1961, an amendment required
proof of efficacy, in addition to safety, prior to marketing of a new drug. The
1984 amendment made is easier to market generic equivalents of drugs, but
granted patent term extension to the innovators of new drugs, under certain
conditions. The FDA Modernization Act of 1997 is the most recent
amendment to clarify pharmacist responsibilities in drug distribution.
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II. The Federal Food, Drug & Cosmetic ActPassed by the United States Congress in 1938, and amended many times
since then, the FDCA serves as the basis for
drug regulation in the United States. The FDCA is both simple and complex at
the same time. The simplicity is that it specifies
only three basic illegal acts; adulteration, misbranding, and the placing into
interstate commerce of an unapproved new drug.
The complexity is that many activities are included under the umbrella of
these three basis illegal acts. If you are ever
challenged to explain why something you know to be illegal is illegal under the
FDCA, a safe explanation would be to assert that
the activity is either adulteration, misbranding, or the placing into interstate
commerce of an unapproved new drug.
Definitions
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(a) If its labeling is false or misleading in any particular. Health care economic
information provided to a formulary committee, or other similar entity, in the
course of the committee or the entity carrying out its responsibilities for the
selection of drugs for managed care or other similar organizations, shall notbe considered to be false or misleading under this paragraph if the health
care economic information directly relates to an indication approved under
section 505 [21 USCS 355] or under section 351(a) of the Public Health
Service Act [42 USCS 262(a)] for such drug and is based on competent and
reliable scientific evidence. . . . In this paragraph, the term "health care
economic information" means any analysis that identifies, measures, or
compares the economic consequences, including the costs of the
represented health outcomes, of the use of a drug to the use of another drug,
to another
health care intervention, or to no intervention.
(b) If in package form unless it bears a label containing:
(1) the name and place of business of the manufacturer, packer, or
distributor;
(2) an accurate statement of the quantity of the contents in terms of weight,
measure, or numerical count: Provided, That under clause (2) of this
paragraph reasonable variations shall be permitted.
(c) If any word, statement, or other information required by or under authority
of this Act to appear on the label or labeling is not prominently placed thereon
with such conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to render it likely to
be read and understood by the ordinary individual under customary conditions
of purchase and use.
(f) Unless its labeling bears (1) adequate directions for use; and (2) such
adequate warnings against use in those pathological conditions or by children
where its use may be dangerous to health, or against unsafe dosage or
methods or duration of administration or application, in such manner and
form, as are necessary for the protection of users, except that where any
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requirement of clause (1) of this paragraph, as applied to any drug or device,
is not necessary for the protection of the public health, the Secretary shall
promulgate regulations exempting such drug or device from such
requirement.(g) If it purports to be a drug the name of which is recognized in an official
compendium, unless it is packaged and
labeled as prescribed therein. . . .
(h) If it has been found by the Secretary to be a drug liable to deterioration,
unless it is packaged in such form and manner, and its label bears a
statement of such precautions, as the Secretary shall by regulations require
as necessary for the protection of the public health. . . .
(i) If it is a drug and its container is so made, formed, or filled as to be
misleading, or (2) if it is an imitation of another drug; or (3) if it is offered for
sale under the name of another drug.
(j) If it is dangerous to health when used in the dosage, or manner or with the
frequency or duration prescribed, recommended, or suggested in the labeling
thereof.
(n) In the case of any prescription drug distributed or offered for sale in any
State, unless the manufacturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect to that drug a
true statement of (1) the established name as defined in section 502(e)
[subsec. (e) of this section], printed prominently and in type at least half as
large as that used for any trade or brand name thereof, (2) the formula
showing quantitatively each ingredient of such drug to the extent required for
labels under section 502(e) [subsec. (e) of this section], and (3) such other
information in brief summary relating to side effects, contraindications, and
effectiveness as shall be required in regulations which shall be issued by the
Secretary.
Note that the general purpose of the misbranding provisions is to assure that
accurate and complete information accompanies every drug product. This
requirement applies to advertisements as well as to other product-related
materials.
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4. New Drug Approval
One of the most controversial aspects of the FDCA is the restrictive provision
regarding the approval of new drugs. The Food and Drug Administration
(FDA) is criticized by some because it is too lenient in its interpretation of theFDCA and permits new drugs to be marketed without adequate studies for
safety and efficacy, while others criticize the agency for
being too strict and preventing the use of perfectly safe and effective
remedies that are needed by people who are ill and near
death. In response to these criticisms, the agency has attempted to speed up
approval of those new drugs that represent a
significant advance in therapy, while continuing to maintain a healthy
skepticism regarding new drugs that are not as likely to
advance therapy and have the potential to cause significant harm. The
language of the act follows. Numerations refer to
subsections of Section 355, Title 21, of the United States Code.
(a) No person shall introduce or deliver for introduction into interstate
commerce any new drug, unless an approval
of an application filed pursuant to subsection (b) or (j) is effective with respect
to such drug.
(b) (1) Any person may file with the Secretary an application with respect to
any drug subject to the provisions of
Copyright 2000, David B. Brushwood 6
subsection (a). Such person shall submit to the Secretary as a part of the
application (A) full reports of
investigations which have been made to show whether or not such drug is
safe for use and whether such drug is
effective in use; (B) a full list of the articles used as components of such drug;
(C) a full statement of the composition
of such drug; (D) a full description of the methods used in, and the facilities
and controls used for, the manufacture,
processing, and packing of such drug; (E) such samples of such drug and of
the articles used as components thereof
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as the Secretary may require; and (F) specimens of the labeling proposed to
be used for such drug.
The information that must be included in an NDA is quite specific, and the
brief list cited above is misleading in itssimplicity. In fact, an NDA includes massive amounts of information beyond
what is described here, because often
FDA reviewers require additional information to maintain a comfort zone
regarding product safety and efficacy. In
addition to safety and efficacy information, product sponsors must include
information about the patent status of the
product they sponsor.
5. Prescription Exemption
Some medications are so potentially hazardous to health that the law
recognizes they are not capable of being
labeled for safe and effective use without medical supervision. For these
drugs, a prescription is required before a
pharmacist may dispense them to a patient. These drugs must bear the
federal legend on the label affixed to each
stock bottle provided to pharmacists. When dispensed to patients, these
drugs must be labeled with specific
information required by the FDCA, but under such circumstances the drug is
exempt from most requirements of the
misbranding provisions. Other drugs are of such a character that they can be
labeled for safe and effective use without
medical supervision, thus they are available without a prescription. The FDCA
specifies the conditions and
characteristics that will cause a drug to be classified as Rx or otc. The
language of the act follows. Numerations refer
to subsections of Section 353, Title 21, of the United States Code.
(b)(1) A drug intended for use by man which--
(A) because of its toxicity or other potentiality for harmful effect, or the method
of its use, or the collateral
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measures necessary to its use, is not safe for use except under the
supervision of a practitioner licensed by law to
administer such drug; or
(B) is limited by an approved application under section 505 [21 USCS 355]to use under the professional
supervision of a practitioner licensed by law to administer such drug,
shall be dispensed only (i) upon a written prescription of a practitioner
licensed by law to administer such drug,
or (ii) upon an oral prescription of such practitioner which is reduced promptly
to writing and filed by the
pharmacist, or (iii) by refilling any such written or oral prescription if such
refilling is authorized by the prescriber
either in the original prescription or by oral order which is reduced promptly to
writing and filed by the pharmacist.
The act of dispensing a drug contrary to the provisions of this paragraph shall
be deemed to be an act which results
in the drug being misbranded while held for sale.
Note the two ways for a product to be classified as prescription-only: (1) lack
of safety if used without medical
supervision, and (2) the sponsors request for prescription-only classification
in the products NDA. Note also the
three ways in which a prescription may be authorized by a prescriber; (1) in
writing, (2) verbal authorization, and (3)
refilling a written or verbal order. Finally, note that the dispensing of a
prescription drug without a prescription is a
misbranding violation, because the law says so; regardless of the truthfulness
and non-misleading nature of the drug
labeling.
(2) Any drug dispensed by filling or refilling a written or oral prescription of a
practitioner licensed by law to
administer such drug shall be exempt from the requirements of section 502
[21 USCS 352], except paragraphs (a),
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(i)(2) and (3), (k), and (l) [21 USCS 352(a), (i)(2), (3), (k), (l)], and the
packaging requirements of paragraphs
(g), (h) and (p) [21 USCS 352(g), (h), (p)], if the drug bears a label
containing t he name and address of thedispenser, the serial number and date of the prescription or of its filling, the
name of the prescriber, and, if stated in
the prescription, the name of the patient, and the directions for use and
cautionary statements, if any, contained in
such prescription. This exemption shall not apply to any drug dispensed in the
course of the conduct of a business of
dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in
violation of paragraph (1) of this
subsection.
Note the information that is required to appear on the label of a drug
prescribed for a patient, when the drug is
dispensed to the patient. Some pieces of information are mandatory for every
prescription, other pieces of information
need be included on the label only when they are contained in the
prescription. The very important effect of this
Copyright 2000, David B. Brushwood 7
section is to exempt from most important misbranding provisions those drugs
that are dispensed pursuant to a
prescription and are properly labeled. This is the reason why requirements
such as the adequate directions for use
requirement need not be met by pharmacists dispensing properly labeled
drugs pursuant to a prescription; the drug is
exempt from that requirement.
(3) The Administrator may by regulation remove drugs subject to section 505
[21 USCS 355] from the
requirements of paragraph (1) of this subsection when such requirements are
not necessary for the protection of the
public health.
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(4) (A) A drug that is subject to paragraph (1) shall be deemed to be
misbranded if at any time prior to dispensing
the label of the drug fails to bear, at a minimum, the symbol "Rx only".
(B) A drug to which paragraph (1) does not apply shall be deemed to bemisbranded if at any time prior to
dispensing the label of the drug bears the symbol described in subparagraph
(A).
Note that drugs may be switched from prescription to non-prescription status.
They must contain the federal legend,
which is now Rx Only, but used to be Caution: Federal law prohibits
dispensing without a prescription. If the label
of a non-prescription drug contains this federal legend, then the drug is
misbranded.
6. Prohibited Acts
It would be nice to think that all parties involved in drug development,
marketing, and distribution could be
trusted to voluntarily comply with requirements of the FDCA, and that there
would be no need to actually enforce the law
through penalties. Actually, voluntary compliance with the act is quite
prevalent, but occasionally there are those who test the
waters by going out on a limb and conducting themselves in ways that the
law simply cannot allow. Very rarely there are
others who simply have no respect for the law or for the public health, and
they conduct themselves in ways that cannot be
tolerated. In either event, the FDCA contains within it provisions to penalize
those who fail to voluntarily comply with the law.
These penalties vary in severity, and can be used as necessary to protect the
public health. The language of the act follows.
Numerations refer to subsections of Section 331, Title 21, of the United States
Code.
The following acts and the causing thereof are hereby prohibited:
(a) The introduction or delivery for introduction into interstate commerce of
any food, drug, device, or cosmetic that
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is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or cosmetic in
interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device, or cosmeticthat is adulterated or misbranded, and
the delivery or proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate commerce of
any article in violation of section 404
or 505 [21 USCS 344 or 355].
Note that the bad stuff that cannot be done relates primarily to adulteration,
misbranding, and the placing into
interstate commerce of an unapproved new drug. When these violations
occur, the FDA may initiate injunction
proceedings to prevent further distribution of a drug, it may seize the drug,
and it may criminally prosecute those
responsible for the violation. The act also allows the FDA to issue a warning
letter to alert violators of possible
problems and to permit voluntary compliance. The product recalls that are
often publicized are theoretically voluntary,
because there is no statutory authority to require them. However, the FDA can
enforce the statute strongly against
those who do not voluntarily withdraw their product when asked to do so.
FDA does classify voluntary recalls. A
Class I recall applies when there is a reasonable probability that the product
will cause serious adverse health
consequences or death. A Class II recall applies when the product may cause
temporary or medically reversible
adverse health consequences, but the probability of serious adverse
consequences is remote. A Class III recall applies
when a product is not likely to cause adverse health consequences.
III. The Federal Controlled Substances Act
A significant component of the federal Comprehensive Drug Abuse
Prevention and Control Act of 1970, the federal
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Controlled Substances Act (CSA) establishes rules that empower the Drug
Enforcement Administration (DEA) to assure that
drugs intended for medical use are not diverted to nonmedical uses.
Pharmacists, as custodians of the nations medicinal drugsupply find themselves significantly involved in police activities in which they
have little interest and no training. However,
Copyright 2000, David B. Brushwood 8
there is no escaping the reality that the law requires pharmacists to do their
best to assure that the drugs pharmacists control do
not end up in the wrong hands. The basic structure of the CSA is to place all
potentially abused drugs in one of five schedules.
People and places that are authorized to possess these drugs are then
required to be registered with the DEA. Specific records
must be kept so that the whereabouts of any controlled substance can be
followed from cradle to grave. Of particular interest to
pharmacists are rules relating to dispensing of controlled substances pursuant
to a prescription. The failure to keep controlled
substances within authorized medical channels exposes to discipline the
person or persons responsible for diversion outside
authorized medical channels.
A. Definitions
The CSA uses specific words and phrases in ways that might not be
anticipated from their ordinary day-today
meaning. To fully appreciate the functioning of the CSA, one must understand
how the act uses these words and
phrases. Some of the most important definitions follow. The language is
quoted directly from the CSA. Numerations
refer to subsections of Section 802, Title 21, of the United States Code.
As used in this title:
(1) The term "addict" means any individual who habitually uses any narcotic
drug so as to endanger the public
morals, health, safety, or welfare, or who is so far addicted to the use of
narcotic drugs as to have lost the power of
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self-control with reference to his addiction.
Note that a patient who is using controlled substances to treat a medical
condition, and who becomes habituated to the
controlled substances, is not an addict under the CSA.(2) The term "administer" refers to the direct application of a controlled
substance to the body of a patient or
research subject by--
(A) a practitioner (or, in his presence, by his authorized agent), or
(B) the patient or research subject at the direction and in the presence of the
practitioner,
whether such application be by injection, inhalation, ingestion, or any other
means.
(6) The term "controlled substance" means a drug or other substance, or
immediate precursor, included in
schedule I, II, III, IV, or V of part B of this title [21 USCS 812]. The term
does not include distilled spirits, wine,
malt beverages, or tobacco, as those terms are defined or used in subtitle E
of the Internal Revenue Code of 1954 [26
USCS 5001 et seq.].
(8) The terms "deliver" or "delivery" mean the actual, constructive, or
attempted transfer of a controlled substance
or a listed chemical, whether or not there exists an agency relationship.
(10) The term "dispense" means to deliver a controlled substance to an
ultimate user or research subject by, or
pursuant to the lawful order of, a practitioner, including the prescribing and
administering of a controlled
substance and the packaging, labeling, or compounding necessary to prepare
the substance for such delivery. The
term "dispenser" means a practitioner
who so delivers a controlled substance to an ultimate user or research
subject.
(12) The term "drug" has the meaning given that term by section 201(g)(1) of
the Federal Food, Drug, and
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Cosmetic Act [21 USCS 321(g)(1)].
(21) The term "practitioner" means a physician, dentist, veterinarian, scientific
investigator, pharmacy, hospital,
or other person licensed, registered, or otherwise permitted, by the UnitedStates or the jurisdiction in which he
practices or does research, to distribute, dispense, conduct research with
respect to, administer, or use in teaching
or chemical analysis, a controlled substance in the course of professional
practice or research.
2. Controlled Substance Schedules
Under the CSA, the DEA is given responsibility to schedule controlled
substances in five categories knows
as Schedules I through V. The restrictions on controlled substances vary
according the schedule in which the
controlled substance has been placed. Controlled substances in Schedule I
are the most restrictively controlled, and
controlled substances in Schedule V are the least restrictively controlled. Of
course, there are many medicinal agents
that are not controlled at all because they have no abuse potential, and these
drugs are the least restricted because
they fall into no schedule. The language below is quoted directly from the
CSA. Numerations refer to subsections of
Section 812, Title 21, of the United States Code.
a) Establishment. There are established five schedules of controlled
substances, to be known as schedules I, II, III, IV,
and V. Such schedules shall initially consist of the substances listed in this
section. The schedules established by this
section shall be updated and republished on a semiannual basis during the
two-year period beginning one year
Copyright 2000, David B. Brushwood 9
after the date of enactment of this title [enacted Oct. 27, 1970] and shall be
updated and republished on an annual
basis thereafter.
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(b) Placement on schedules; findings required. Except where control is
required by United States obligations under
an international treaty, convention, or protocol, in effect on the effective date
of this part, and except in the case ofan immediate precursor, a drug or other substance may not be placed in any
schedule unless the findings required
for such schedule are made with respect to such drug or other substance.
The findings required for each of the
schedules are as follows:
(1) SCHEDULE I.
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in
treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other substance
under medical supervision.
(2) SCHEDULE II.
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use in
treatment in the United States or a
currently accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe psychological
or physical dependence.
(3) SCHEDULE III.
(A) The drug or other substance has a potential for abuse less than the drugs
or other substances in schedules I
and II.
(B) The drug or other substance has a currently accepted medical use in
treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or low
physical dependence or high
psychological dependence.
(4) SCHEDULE IV.
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(A) The drug or other substance has a low potential for abuse relative to the
drugs or other substances in
schedule III.
(B) The drug or other substance has a currently accepted medical use intreatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical
dependence or psychological dependence
relative to the drugs or other substances in schedule III.
(5) SCHEDULE V.
(A) The drug or other substance has a low potential for abuse relative to the
drugs or other substances in
schedule IV.
(B) The drug or other substance has a currently accepted medical use in
treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical
dependence or psychological dependence
relative to the drugs or other substances in schedule IV.
Note that the schedules of controlled substances are based on the potential
for abuse, the recognition of a medical use,
and the possibility of physical or psychological dependence.
C. Registration
Under the CSA, only certain parties are permitted to possess controlled
substances legally. These parties
must be registered with the DEA, or they must be exempt from registration.
For example, a pharmacist who meets the
licensure requirements of the state where the pharmacist is practicing, may
possess controlled substances to patients
as long as the pharmacist practices in a pharmacy that is registered with the
DEA. The pharmacist need not personally
be registered with the DEA. The language below is quoted directly from the
CSA. Numerations refer to subsections of
Section 822, Title 21, of the United States Code.
(a) Annual registration.
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(1) Every person who manufactures or distributes any controlled substance or
list I chemical, or who proposes to
engage in the manufacture or distribution of any controlled substance or list I
chemical, shall obtain annually aregistration issued by the Attorney General in accordance with the rules and
regulations promulgated by him.
(2) Every person who dispenses, or who proposes to dispense, any controlled
substance, shall obtain from the
Attorney General a registration issued in accordance with the rules and
regulations promulgated by him. The
Attorney General shall, by regulation, determine the period of such
registrations. In no event, however, shall such
registrations be issued for less than one year nor for more than three years.
(b) Authorized activities. Persons registered by the Attorney General under
this title to manufacture, distribute, or
Copyright 2000, David B. Brushwood 10
dispense controlled substances or list I chemicals are authorized to possess,
manufacture, distribute, or dispense
such substances or chemicals (including any such activity in the conduct of
research) to the extent authorized by
their registration and in conformity with the other provisions of this title.
(d) Waiver. The Attorney General may, by regulation, waive the requirement
for registration of certain
manufacturers, distributors, or dispensers if he finds it consistent with the
public health and safety.
(e) Separate registration. A separate registration shall be required at each
principal place of business or
professional practice where the applicant manufactures, distributes, or
dispenses controlled substances or list I
chemicals.
(f) Inspection. The Attorney General is authorized to inspect the
establishment of a registrant or applicant for
registration in accordance with the rules and regulations promulgated by him.
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Note that the registration for dispensers is currently effective for a period of
three years.
4. Records
Every transaction in which controlled substances change hands must berecorded. This means generally that
the receipt of controlled substances must be recorded as must the dispersal
of controlled substances. In addition,
there are requirements for the periodic inventory of controlled substances.
Based on records kept of controlled
substances, it should be possible to discern, for any registrant, what
controlled substances are on hand, where they
came from, and where controlled substances have gone to. The language
below is quoted directly from the CSA.
Numerations refer to subsections of Section 827, Title 21, of the United States
Code.
(b) Availability of records. Every inventory or other record required under this
section (1) shall be in accordance
with, and contain such relevant information as may be required by,
regulations of the Attorney General, (2) shall (A)
be maintained separately from all other records of the registrant, or (B)
alternatively, in the case of nonnarcotic
controlled substances, be in such form that information required by the
Attorney General is readily retrievable from
the ordinary business records of the registrant, and (3) shall be kept and be
available, for at least two years, for
inspection and copying by officers or employees of the United States
authorized by the Attorney General.
E. Prescriptions
The most frequent method through which controlled substances are dispersed
by a pharmacy is through a
prescription, issued by a licensed prescriber and filled for a patient. Because
this method of dispersion is so
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Federal Food, Drug, and Cosmetic Act [21 USCS 301 et seq.], may be
dispensed without a written or oral
prescription in conformity with section 503(b) of that Act [21 USCS 353(b)].
Such prescriptions may not be filledor refilled more than six months after the date thereof or be refilled more than
five times after the date of the
Copyright 2000, David B. Brushwood 11
prescription unless renewed by the practitioner.
This is the five times in six months rule under which Schedule III and IV
prescriptions may be refilled if authorized by
the prescriber, during the six months following the issuance of the
prescription.
(c) Schedule V substances. No controlled substance in schedule V which is a
drug may be distributed or dispensed
other than for a medical purpose.
Note that for prescriptions issued for Schedule V controlled substances there
is no hard and fast time limit on refills,
but there is the basic requirement of a medical purpose.
IV. Introduction to Pharmacy Ethics
Pharmacy ethics is a branch of medical ethics that provides a framework for
pharmacists to use in resolving questions
about what ought to be done in pharmacy practice. To conduct an ethical
exercise requires that one ask normative questions
about what should be done, rather than that one ask only legal questions
about what must be done, or empirical questions
about why something is done. To address a question from an ethical
perspective requires that one reflect on the morality of a
situation; that one ask what will be the impact on others of ones own action
and whether one can justify ones action to a
higher authority.
A. Ethical Theories
Modern medical ethics has its roots in two classical theories known as
deontology and utilitarianism. It is a
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would do more harm than good. So, while the two theories might lead to the
same conclusion about the unethical
nature of the research, the theoretical basis of the conclusion would differ
significantly.B. Ethical Principles
Principle-based ethics has at times been criticized as too methodic and not
sufficiently sensitive to the
individual differences of ethical cases, but the study of pharmacy ethics would
be incomplete without a description of
the four basic ethical principles that apply in pharmacy ethics. The purpose of
ethical principles is to determine the
right of patients under the principles, and to then permit a decision about
pharmacist duties that correlate with those
rights. The primary objective of the principle-based approach is to enable a
pharmacist to justify to himself or herself,
and to others, the action taken in a given situation.
The principle of autonomy (respect for persons) requires that individuals be
permitted to make their own
evaluations and choices when their own interests are at stake. If individuals
are viewed as moral agents with their own
unique approach to life (their own values, interests, attitudes and beliefs), then
it would be disrespectful of individuals
to reject their considered judgments or to deny them the liberty to act on those
judgements. Autonomous individuals
are at liberty to perform whatever actions they wish, as long as another
autonomous individuals actions are not
infringed, even if the actions appear to be foolish or unwise based upon
conventional and generally accepted wisdom.
For example, under the principle of autonomy, a person who is a competent
decision-maker is free to use a medication
in a way that is less than optimally safe and effective, if the generally
recognized right way to use the drug interferes
Copyright 2000, David B. Brushwood 12
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with the persons lifestyle.
The principle of nonmaleficence (doing no harm) requires that pharmacists
refrain from acting in ways that will
cause harm or injury to others. A pharmacist who fails to counsel patients, forfear that the patients will discontinue
using a drug if information about the drug is disclosed, is adhering to the
principle of nonmaleficence, because it is
through acts of commission that this principle is violated. Nonmaleficence
prohibits both deliberate harmful action
(substituting one generic drug product for another without authorization and
without evidence of bioequivalence) and
unintentional harm (inadvertently using the sig code for take one tablet four
times daily for the label of a digoxin
prescription that has directed the patient to take only one tablet daily.
The principle of beneficence (doing good) requires positive action to (1)
prevent what is bad, (2) remove bad
or evil, and (3) do or promote good. It is through acts of omission that this
principle is violated. For example, the
pharmacist described above who neglects to counsel patients is violating the
principle of beneficence, because
information about medications generally helps patients use their medications
the correct way. Health care providers,
including pharmacists, have at times used the principle of beneficence as
justification for doing for patients what, in the
care providers view, is best for the patient even if the patient prefers that it
not be done. Beneficence of this type is
sometimes referred to as paternalism. A paternalistic act toward a patient is
an act that is done benevolently, either
contrary to the patients expressed wishes, or without considering the patients
wishes.
The principle of justice (fairness) requires that all benefits and burdens be
distributed equally. It requires that
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people be given that to which they are entitled. Distributive justice requires
that resources be allocated in a fair way.
Corrective justice requires that one who has harmed another place the
harmed person back in a position the personwould have been in had the harm not occurred (as well as this can be done
with resources available). Justice is a
principle that is difficult to apply in a practice setting, but it greatly facilitates
the decisions made by policy makers.
C. Ethical Problem-Solving
Ethical principles are useful to one who ponders the value of the pharmacy
profession and the relationship of
pharmacists with their patients. Yet, without a framework for decision-making,
ethical principles are of little use.
Because pharmacists, and other health care professionals, need a method for
solving ethical problems, ethicists have
suggested an approach that seeks first to define the ethical dilemma and then
to suggest the best potential resolution
of the dilemma.
The first step in ethical problem-solving is to clarify facts. Sometimes
disagreements can be traced to
misunderstandings of fact rather than to differences of opinion. Once the facts
are clarified, the dispute may evaporate,
because the disagreement does not exist. Alternatively, the parties to a
disagreement may realize that they simply must
agree to disagree, because a difference in factual interpretation is
unavoidable. In either event, there is no point in
proceeding to treat the problem as if it were conceptual instead of factual. It
may be the case that one party to a
disagreement is mistaken about a fact. It is far easier to clarify a mistaken fact
than it is to reach agreement on ethical
principles, so the potential to solve a problem through clarification of facts is
temp ting when faced with the possibility
of an arduous discussion of esoteric principles.
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The second step is to clarify concepts. For example, there are concepts such
as the right to health care, or
unacceptable risk, that may seem to be the basis of a disagreement, when
clarification of these concepts will resolvethe controversy. Perhaps the disagreeing parties were really talking about the
same thing but did not realize it.
Step three is to clarify principles. This is the time to apply the concepts of
autonomy, beneficence,
nonmaleficence and justice to a specific fact situation. By asking what result
each of the four major principles would
produce to solve the problem, those who are involved with ethical analysis
can determine the patients rights and the
correlative pharmacist duties. Usually this exercise will require some sort of
decision regarding the weight to afford a
specific principle in balancing that principle against another. The problem-
solving that can result from this approach is
not as scientifically objective as is the clinical drug trial, but it is useful in
helping gather information and consider
alternatives.
D. The APhA Code of Ethics
The American Pharmaceutical Association has adopted a Code of Ethics that
is intended to present to the
public the principles on which the pharmacy profession bases its professional
duties. This code is not as useful in
practice as one might wish it to be. Seldom will a practitioner of pharmacy find
an unequivocal answer to a questions
Copyright 2000, David B. Brushwood 13
of rights and wrongs in practice by simply looking up the answer in the APhA
Code of Ethics. But the code serves
the profession well as a general statement of ideals.
Code of Ethics for Pharmacists
PREAMBLE
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encouraging patients to participate in decisions about their health. A
pharmacist communicates with
patients in terms that are understandable. In all cases, a pharmacist respects
personal and culturaldifferences among patients.
IV. A pharmacist acts with honesty and integrity in professional relationships.
A pharmacist has a duty to tell the truth and to act with conviction of
conscience. A pharmacist avoids
discriminatory practices, behavior or work conditions that impair professional
judgment, and actions
that compromise dedication to the best interests of patients.
V. A pharmacist maintains professional competence.
A pharmacist has a duty to maintain knowledge and abilities as new
medications, devices, and
technologies become available and as health information advances.
VI. A pharmacist respects the values and abilities of colleagues and other
health
professionals.
When appropriate, a pharmacist asks for the consultation of colleagues or
other health professionals or
refers the patient. A pharmacist acknowledges that colleagues and other
health professionals may
differ in the beliefs and values they apply to the care of the patient.
Copyright 2000, David B. Brushwood 14
VII. A pharmacist serves individual, community, and societal needs.
The primary obligation of a pharmacist is to individual patients. However, the
obligations of a
pharmacist may at times extend beyond the individual to the community and
society. In these
situations, the pharmacist recognizes the responsibilities that accompany
these obligations and acts
accordingly.
VIII. A pharmacist seeks justice in the distribution of health resources.
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When health resources are allocated, a pharmacist is fair and equitable,
balancing the needs of patients
and society.
* adopted by the membership of the American Pharmaceutical AssociationOctober 27, 1994.
Copyright 2000, David B. Brushwood 15
Problem Set #1
Instructions: Answer each of the ten questions in this problem set. Select the
ONE BEST answer for each question.
1. Which of the following agencies regulates primarily at the state level?
1. The board of pharmacy.
2. The DEA.
3. The FDA.
4. Both the DEA and the FDA.
5. Both the board of pharmacy and the FDA.
2. Which of the following factors is most likely to determine classification as a
drug under the FDCA?
A. Actual use by the patient.
2. Intended purpose of the patient.
3. Adverse effects to the patient.
4. Intended purpose of the provider.
5. Research done by the provider.
3. Which of the following factors is most likely to be considered in determining
classification of an article as a new drug
under the FDCA?
1. The article is generally recognized as safe.
2. The article is generally recognized as effective.
3. The article is not generally recognized as safe and effective.
4. The article is known to cause adverse effects to patients.
5. Extensive research on the article has been conducted by the provider.
4. A prescription only drug is deemed misbranded if an any time prior to
dispensing it fails to bear a label with what
symbol?
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1. Rx
2. Rx only
3. Not OTC
4. Not for OTC sale5. Rx required
5. Into which of the following schedules would a drug with no accepted
medical use be placed?
1. Schedule I.
2. Schedule II.
3. Schedule III.
4. Schedule IV.
5. Schedule V.
6. How frequently may a prescription in Schedule II be refilled?
1. 5 times in 6 months.
2. 6 times in 5 months.
3. 6 times in 12 months.
4. 12 times in 6 months.
5. Schedule II prescriptions may not be refilled.
7. How frequently may a prescription in Schedule III be refilled?
1. 5 times in 6 months.
2. 6 times in 5 months.
3. 6 times in 12 months.
4. 12 times in 6 months.
5. Schedule II prescriptions may not be refilled.
Copyright 2000, David B. Brushwood 16
8. According to the APhA Code of Ethics, what is the nature of the relationship
between pharmacists and patients?
A. A constitutional relationship.
B. A consistent relationship.
C. A covenental relationship.
D. A contractual relationship.
E. A convenient relationship.
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9. Benevolent action taken by a pharmacist toward a patient, without
consideration of the patients desires, or contrary to
the patients desires, is known by what name?
A. Radical.B. Paternalistic.
C. Maternalistic.
D. Gracious.
E. Caring.
10. Which of the following is generally considered to be a consequentialist
ethical theory?
A. Deontology.
B. Idealism.
C. Beneficence.
D. Justice.
E. Utilitarianism
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