Ethics Heba ion

8/4/2019 Ethics Heba ion

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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


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,


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


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.



(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.



(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


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


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



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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


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.


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.


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.




5. Schedule II prescriptions may not be refilled.

7. How frequently may a prescription in Schedule III be refilled?





5. Schedule II prescriptions may not be refilled.


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

Ethics Heba ion

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