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Pharmacy Law & Ethics
Lesson I: Introduction to Law and Ethics
Note: In this lesson, italics is used for language quoted verbatim from the law. The source of the cited law has been
provided when appropriate. A series of dots (. . .) within an italicized quote signifies that language has been editorially
deleted because it is deemed not sufficiently relevant to the objectives of this chapter. Because the language of the law
as quoted in this chapter is taken out of context, and has been edited for purposes of educational clarity, the chapter
should not be used as a reference by one who is seeking a complete understanding of all laws. For specific legal advice,
pharmacists and pharmacy students should refer to the complete law at a library, or seek competent legal counsel.
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. To understand the law, one must both know the information that forms the basis of the law, and
also appreciate how that information supports particular social interests such as public health or individual freedom. 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 provided by 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: “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
pharmacy, at the state level, and the Food and Drug Administration (FDA) or the Drug Enforcement Administration
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(DEA), at the federal level, make rules for pharmacists and they enforce their own rules as well as rules made by the
state 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 19th
Century, 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.
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 prescription and 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.
II.
The Federal Food, Drug & Cosmetic Act
Passed 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.
1.
Definitions
Important to a thorough understanding of the FDCA is a knowledge of how the FDCA defines the terms to
which it frequently refers. Whether an activity falls outside or inside a definition under the act may well determine
whether the activity is lawful or unlawful. Some of the most important definitions follow. The language is quoted
directly from the FDCA. Numerations refer to subsections of Section 321, Title 21, of the United States Code.
(g) (1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official
Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of
them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man
or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of
man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or
(C). A food or dietary supplement for which a claim. . . . is made in accordance with the requirements of section
403(r) [21 USCS § 343(r)] is not a drug solely because t he label or the labeling contains such a claim. A food,
dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance
with section 403(r)(6) [21 USCS § 343(r)(6)] is not a drug under clause (C) solely because the label or the
labeling contains such a statement.
Note that the definition of “drug” is in dependent on the intended use of the article, not on the actual use of it. And
the relevant intent is that of the provider of the article, not the user of the article. A single article may be a drug in one
context, and not be a drug in another context, because the intent of the provider changes between the two contexts.
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Note also that subsections (B) and (C) differ significantly, because in (B) an article can be a drug due to its intended
use in therapeutics, while in (C) and article can be a drug merely due to its intended use in affecting the structure or
function of the body.
(h) The term "device" . . . means an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including any component, part, or accessory, which is-(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve
its primary intended purposes through chemical action within or on the body of man or other animals and which is
not dependent upon being metabolized for the achievement of its primary intended purposes.
Note that the principle distinction between drugs and devices is that drugs achieve their intended purpose through
chemical action while devices do not. Sometimes the distinction between drugs and devices is blurry, and it is
important to ask in what way the article achieves its intended purpose. The terms “drug” and “device” are mutually
exclusive. A single article cannot be both.
(i) The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into,
or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term
shall not include soap.
The FDCA definition of “cosmetic” is relatively consistent with the lay usage of that term. The terms “cosmetic” and
“drug” are not mutually exclusive. A single article can be both.
(j) The term "official compendium" means the official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.
Official Compendia set standards with which those who are responsible for drug formulation and distribution must
comply. Many of the requirements for drugs are not explicitly stated within the FDCA because the act defers to an
official compendium and merely requires compliance with compendial standards. This does not mean that there are no
legally mandated standards; only that the standards are contained within a compendium that is adopted by reference
within the act.
(k) The term "label" means a display of written, printed, or graphic matter upon the immediate container of any
article.
(m) The term "labeling" means all labels and other written, printed, or graphic matters (1) upon any article or any
of its containers or wrappers, or (2) accompanying such article.
Note that “labeling” includes the “label.” It is to the labeling that attention usually turns when decisions are made
about the intend of a provider of an article. It is the labeling that will frequently make the difference between an act
being legal or illegal. Because the FDCA is oriented toward the product, rather than the prescibers and dispensers of
the product, the labeling is considered part of the product.
(p) The term "new drug" means-(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the
composition of which is such that such drug is not generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the
condition prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized
shall not be deemed to be a "new drug" if at any time prior to the enactment of this Act [enacted June 25, 1938] it
was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the
same representations concerning the conditions of its use; or (2) Any drug (except a new animal drug or an
animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of
investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but
which has not, otherwise than in such investigations, been used to a material extent or for a material time under
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such conditions.
Note that whether a drug is “new” or “not new” (most people who are familiar with pharmacy law use the phrase “not
new” drug rather than “old” drug), depends on its general recognition as safe and effective under the conditions
suggested in the labeling. As the labeling changes, perceptions of newness may change. Only new drugs must be
shown to be safe and effective prior to their being place into interstate commerce. “Not new” drugs must meet all other
relevant requirements for drugs (i.e., adulteration and misbranding provisions), but not those applicable to new drugs,
because they are not new.
2.
Adulteration
A drug may be adulterated either because it is actually adulterated or because it is deemed to be adulterated
due to some requirement for proper storage or handling not having been met. The FDCA adopts a take-no-chances
approach. It also recognizes the practical difficulties of proving that an article actually is adulterated. Thus, the act
creates circumstances under which the assumption is made that an article must be adulterated. These assumptions are
virtually impossible to rebut. The language of the act follows. Numerations refer to subsections of Section 351, Title
21, of the United States Code.
A drug or device shall be deemed to be adulterated-(a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been
prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or
whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities
or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or
administered in conformity with current good manufacturing practice to assure that such drug meets the
requirements of this Act as to safety and has the identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to possess; . . .
(b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its
strength differs from, or its quality or purity falls below, the standard set forth in such compendium. . . .
(c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or
quality falls below, that which it purports or is represented to possess.
Note that a drug may be adulterated either because it is actually adulterated in some way (contamination by a foreign
substance, for example), or because it has been deemed to be adulterated due to the possibility of its being adulterated
(by being held under unsanitary conditions, for example).
C.
Misbranding
The FDCA requires that any information a manufacturer places on the label of a drug be truthful and not
misleading. In addition, the act imposes certain mandatory disclosure requirements. So a provider of drugs cannot get
cute and omit information that is mandated, else the provider will violate the disclosure requirement. And the provider
cannot disclose in a misleading way or the provider will violate the basic requirement of truth. This is essentially a
“Catch 22" situation, in which the only way out is full and truthful (not misleading) disclosure. The language of the act
follows. Numerations refer to subsections of Section 352, Title 21, of the United States Code.
A drug or device shall be deemed to be misbranded-(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 not be 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.
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(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer,
packer, or distributor; and (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, and
exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
(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 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.
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 the FDCA
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
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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
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 its
simplicity. 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
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 o ral 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 sponsor’s 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),
(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 the
dispenser, 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
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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.
(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 be misbranded if at any time prior t o
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
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 cosmetic that 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
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 nation’s medicinal drug
supply find themselves significantly involved in police activities in which they have little interest and no training. However,
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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
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
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 United States 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 t he two-year period beginning one year
Copyright 2000, David B. Brushwood
8
after the date of enactment of this title [enacted Oct. 27, 1970] and shall be updated and republished on an annual
basis thereafter.
(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 of
an 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.
(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 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 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.
(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 a
registration 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
9
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.
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 be recorded. 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
commonplace, specific rules have been developed to guide appropriateness of it. These rules are intended to assure
that all prescriptions filled by pharmacists for controlled substances have been issued for a medical purpose, and will
not result in diversion to nonmedical use. The DEA issues regulations that expand on the CSA requirements, to assure
that prescriptions are in such a form as to make it likely that they have been issued for a medical purpose. The
language below is quoted directly from the CSA. Numerations refer to subsections of Section 829, Title 21, of the
United States Code.
(a) Schedule II substances. Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate
user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food,
Drug, and Cosmetic Act [21 USCS §§ 301 et seq.], may be dispensed without the written prescription of a
practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation
with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of
that Act [21 USCS § 353(b)]. Prescriptions shall be retained in conformity with the requirements of section 307 of
this title [21 USCS § 827]. No prescription for a controlled substance in schedule II may be refilled.
Note that Schedule II prescriptions must be in writing, except in the case of particular narrowly circumscribed situations
in which oral prescriptions are permitted. Schedule II prescriptions may never be refilled. Never! End of story!!
(b) Schedule III and IV substances. Except when dispensed directly by a practitioner, other than a pharmacist, to an
ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the
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 filled
or 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
10
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 one’s own action and whether one can justify one’s 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
gross oversimplification to say that the deontological view is idealistic, while the utilitarian view is consequentialist,
but that is an effective way of beginning to think of these two differing approaches to ethical theory. The deontologist
is generally considered to be means and ends oriented, while the utilitarian is usually considered to be ends oriented
only. In other words, for the deontologist the process matters more than the result, while for the utilitarian it is the
result that matters most.
Consider the hypothetical situation of a clinical investigator who believes that a new drug to treat cancer will
produce uncomfortable but temporary side effects. To persuade subjects to volunteer for clinical trials, the researcher
is tempted to not disclose information about the side effects, reasoning that the overall good of proving the drug
effective will benefit a large number of future patients, and will override the harm resulting from the side effects
experienced by the small number of subjects in the clinical trial. This approach will likely be deemed invalid and
inappropriate by both those who adhere to the idealistic, deontological view, and those who are adherents of the
consequentialist, utilitarian view. But the criticisms these two theories offer of the plan will be different. Under the
deontological view, one would likely argue that it is morally wrong ever to lie or to use a subject merely as a means to
an end. The deontologist will be critical of the process that violates the principles of truth telling and respect for
persons. On the other hand, the utilitarian would likely assert that if the deception is ever disclosed, future research
would be impaired because prospective subjects would be distrustful of researchers and would not volunteer. The
result of decreased participation in research would be unacceptable to the utilitarian. The withholding of information
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 individual’s 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
11
with the person’s 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, for fear 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 provider’s 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 patient’s expressed wishes, or without considering the patient’s wishes.
The principle of justice (fairness) requires that all benefits and burdens be distributed equally. It requires that
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 person
would 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.
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 resolve
the 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 patient’s 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
12
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
Pharmacists are health professionals who assist individuals in making the best use of medications. This
Code, prepared and supported by pharmacists, is intended to state publicly the principles that form the
fundamental basis of the roles and responsibilities of pharmacists. These principles, based on moral
obligations and virtues, are established to guide pharmacists in relationships with patients, health
professionals, and society.
I. A pharmacist respects the covenantal relationship between the patient and pharmacist.
Considering the patient-pharmacist relationship as a covenant means that a pharmacist has moral
obligations in response to the gift of trust received from society. In return for this gift, a pharmacist
promises to help individuals achieve optimum benefit from their medications, to be committed to their
welfare, and to maintain their trust.
II. A pharmacist promotes the good of every patient in a caring, compassionate, and
confidential manner.
A pharmacist places concern for the well-being of the patient at the center of professional practice. In
doing so, a pharmacist considers needs stated by the patient as well as those defined by health
science. A pharmacist is dedicated to protecting the dignity of the patient. With a caring attitude and a
compassionate spirit, a pharmacist focuses on serving the patient in a private and confidential manner.
III. A pharmacist respects the autonomy and dignity of each patient.
A pharmacist promotes the right of self-determination and recognizes individual self-worth by
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 cultural
differences 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.
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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.
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 Association October 27, 1994.
Copyright 2000, David B. Brushwood
14
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.
2.
3.
4.
5.
The board of pharmacy.
The DEA.
The FDA.
Both the DEA and the FDA.
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?
1.
“Rx”
2.
“Rx only”
3.
“Not OTC”
4.
“Not for OTC sale”
5.
“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
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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.
9.
Benevolent action taken by a pharmacist toward a patient, without consideration of the patient’s desires, or contrary to
the patient’s 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
Copyright 2000, David B. Brushwood
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