Chapter 2
Law and Ethics of Pharmacy
Copyright © 2004 by Elsevier Inc. All rights reserved.
Introduction
• Practice of pharmacy–governed by
series of laws, regulations, and rules
enforced by federal, state, local
government; institutions and
pharmacy management
• Technician–needs to understand
these laws for passing the PTCB
Certification Exam and for
employment
Copyright © 2004 by Elsevier Inc. All rights reserved.
1906 Federal Food and Drug Act
• Enacted to stop the sale of
inaccurately labeled drugs
• Manufacturers were required to put
truthful information on the label
before selling the drug
• Manufacturers had to prove their
drug’s effectiveness
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1914 Harrison Narcotic Act
• Enacted because of the excessive
number of opium addicts in the
United States
• People could no longer obtain
opium without a prescription
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1938 Food, Drug, and
Cosmetic Act
• Enacted because the earlier Food
and Drug Act was not worded strictly
enough and did not include cosmetics
• Required drug companies to include
directions to the consumer regarding
use and package inserts on drugs
• All narcotics were required to be
labeled “Warning: May be habitforming”
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1938 Food, Drug, and
Cosmetic Act
• Defined the exact labeling for
products and defined misbranding
and adulteration as being illegal
• Proves the legal status for the Food
and Drug Administration (FDA)
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1951 Durham-Humphrey
Amendment
• Required the labeling ”Caution:
Federal law prohibits dispensing
without a prescription”
• Made certain drugs require a doctor’s
order and supervision
• Made the initial distinction between
legend drugs (by prescription only)
and over-the-counter (OTC)
medications
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1962 Kefauver-Harris
Amendment
• Enacted in an attempt to ensure the
safety and effectiveness of all new
drugs on the market
• Burden put on manufacturing companies
to have good manufacturing practices
(GMP)
• Prevented the sale of thalidomide in the
United States because children were born
with birth defects after usage in pregnancy
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1970 Comprehensive Drug Abuse
Prevention and Control Act
• The Drug Enforcement Agency (DEA)
was formed to enforce the laws
concerning narcotics and their
distribution
• Created a stair-step schedule of
controlled substances
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Orphan Drug Act of 1983
• Allowed drug companies to bypass
the lengthy time requirements of
testing a new drug and the cost that
accompanied them to provide a
medication to persons who had rare
disease(s) (disease that affected 1 in
every 200,000 people)
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1987 Prescription Drug
Marketing Act
• Controlled the use of drugs in animals
• Required the labeling “Caution: Federal
law restricts this drug to use by or in
order of a licensed veterinarian”
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1990 Anabolic Steroids
Control Act
• Helped stiffen regulation on the
abuse problems of anabolic steroids
and their misuse by athletes
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1990 Omnibus Budget
Reconciliation Act (OBRA 90)
• Deals specifically with practicing
pharmacists
• Enacted because of reimbursement
regulations for people who are covered
under Medicaid or Medicare Insurance
• States that a pharmacist must counsel
(at the time of purchase) all patients
who receive new prescriptions
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1990 Omnibus Budget
Reconciliation Act
• All patients must be given information
on the drug that they are taking, its
name, when to take it, how long to
take it, and any side effects or
possible interactions
• Many states adopted OBRA to apply
to all new prescriptions. Federal law
deals only with Medicare and Medicaid
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Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
• Has been only partially implemented
• Deals with patient’s right to continuance
of health insurance even when changing
employers
• Changes for pharmacy: Technician
has direct knowledge of patient’s medical
information on a daily basis –consent
form to access this information will have
to be signed by the patient
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FDA/DEA
• Important with respect to pharmacy
• FDA was created under the department
of Health and Human Services
• Main function–to enforce guidelines for
manufacturers to ensure the safety and
effectiveness of medications
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FDA/DEA
• DEA–created under the Department
of Justice
• Its function is to prevent the illegal
distribution and misuse of narcotics
• DEA–issues licenses to practitioners,
pharmacies, and manufacturers of
controlled substances
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FDA Reporting Process and
Adverse Reactions
• Toll free number (1-800-FDA-1088)
for reporting any defect found in OTC
medications and any other drug problems
• Any medication reaction that may cause
disability, hospitalization,
or death should be reported
• Patient’s identity must be kept confidential
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FDA Reporting Process and
Adverse Reactions
• MedWatch–program under the FDA
that allows consumers and health
care professionals to report any
discrepancies in medication or
adverse reactions to medications
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Controlled Substances
• Commonly known as narcotics and are
addictive
• Narcotics are derived from opium or
opium-like substances
• Opium comes from the poppy seed
plant and has analgesic effects and
also effects mood and behavior
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Controlled Substances
• Opiates, such as codeine and
morphine, are substances created
from opium
• Opioids are narcotics that are produced
synthetically in the laboratory
• Each type of narcotic is assigned a rating
that depends on its addiction potential
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Registration Required
for Maintaining Narcotics
• DEA–three main registration forms
• Form 224–needed by pharmacy to
dispense controlled substances
• Form 225–to manufacture or distribute
controlled substances
• Form 363–to run a narcotic treatment
program or compound narcotics
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Ordering Controlled Substances
• Pharmacy obtains C-II substances
from a distributor
• Form 222 must be filled out by the
receiving pharmacy in pen, typewriter,
or indelible pencil
• Top copy and middle copy with carbon
paper are sent to the supplier or
manufacturer
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Ordering Controlled Substances
• Second Copy with carbon paper–
returned to distributor or wholesaler
• Third copy–sent by distributor or
wholesaler to the DEA
• Errors–forms become invalid; cannot
be erased or thrown away
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Ordering Controlled Substances
• C-III, C-IV, C-V–ordered on normal
invoice forms but must be filed and
retained for DEA or BOP inspection
• Should be kept separate from other
nonscheduled drugs
• Forms kept for 2 years
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Ordering Controlled Substances
• Receipt of controlled substances–
pharmacist compares copy of Form
222 to invoice
• Both copies signed for accuracy
• Documents stapled together and
retained for 7 years
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Record Keeping
Three Methods of Filing Controlled
Substances and Legend Drugs
System
1
Drawer 1
C-II
separate
Drawer II
C-III
through C-V
2
C-II
separate
C-III–C-V* and
all legend drugs
3
C-II
through C-V*
All other
prescriptions
Drawer III
All other
prescriptions
*If any C-III, C-IV, or C-V controlled drugs are kept with non-controlled drugs (System 2) or mixed with C-II drugs
(System 3), they must be stamped with a red “C” for easy identification. All records must be kept on site for no
less than 2 years. Many states, however, have longer requirements for keeping records; remember the strictest
law is the one that must be followed. When taking inventory it is necessary to have exact counts of C-II
controlled substances at all times. The final count can only be inventoried by a licensed pharmacist.
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Ratings of Scheduled
(Controlled) Substances
• Letter “C,” meaning controlled substances,
is used in addition to Roman numerals to
indicate the addictiveness or abuse potential
of narcotics
• Five levels based on potential
for abuse
• C-I–strongest potential for abuse; no
medicinal use in the USA–LSD, Heroin
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Ratings of Schedules
(Controlled) Substances
• C-II, C-III, C-IV, C-V–all medicinal narcotic
drugs
• C-V–kept OTC in some states because of
low potential abuse
• C-II–must be locked up because of high
potential abuse
• Attorney General decides which schedule
to place a drug under
• Refer to Table 2.2
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Refilling Controlled Substances
• Strict guidelines
• C-II or C-IV–can be refilled a maximum
of 5 times or within 6 months from the
original order, whichever comes first
• Record must be kept with pharmacist’s
initials and date it was dispensed
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Monographs/Package Inserts
• Contained in the Physicians’ Desk
Reference (PDR) in doctor’s office and
Facts and Comparisons in pharmacy
• Contains the following: Adverse
reactions, Clinical pharmacology,
Contraindications, Description,
Dosage, Drug abuse and dependence,
How supplied, Indications and usage,
Precautions, and Warnings
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Prescription Regulations
• Who can prescribe? FDA and DEA
have no authority in determining
prescribers
• Prescribers are licensed by their
governing bodies
• Standard practitioners in all 50 states
are: physicians, surgeons, doctors of
osteopathy, dentists, podiatrists,
veterinarians, and optometrists
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Who Can Receive a Prescription?
• Pharmacy Technicians–takes in
prescriptions, interprets them, and
fills them
• Technicians cannot take phone orders
• Pharmacists–give the final check, take
verbal telephone orders, and transfer
prescriptions to another pharmacy
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Receiving Prescriptions for
Controlled Drugs
• Pharmacists can receive an oral
prescription for a controlled drug
over the phone by reducing it to
written form
• C-II has strict guidelines–refer to
guidelines on page 21
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Prescription Label
• The information on a prescription
label differs from a prescription order
• Two necessary components: pharmacy
information and patient information
• Refer to list on page 21
• Special labeling–sometimes required
because of possibility of teratogenicity
on an unborn fetus
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DEA Verification
• All prescribers must be registered with
the DEA to write prescriptions for
controlled substances
• Prescribers are given a nine character
identification code, which is different
for each prescriber
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DEA Verification
• First two characters are letters–A or B
followed by first letter of prescriber’s
last name
• Next seven digits are composed of
numbers added together
• Refer to Box 2.3 for DEA Verification
Process
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Childproof Caps
• The Poison Prevention Act addresses
the issue of accidental poisoning of
children
• Childproof caps were created
• Adults–can require no childproof
caps by requesting it
• Pharmacy–keeps information on
patient’s record and may require
a signed release form
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Mailing Prescription Drugs
• Online and mail-order pharmacies
provide an option to patients to
receive their prescription via the mail
• U.S. Postal Service will not allow
narcotics to be sent by mail unless
it’s a veteran through the Veterans’
Administration
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Mailing Prescription Drugs
• For mailed prescriptions–envelope
must be unmarked as to contents
• Pharmacy must be registered with
the DEA
• Manufacturer to patient–must be sent
registered mail with a return receipt
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Recalled Drugs
• Manufacturers must recall items that
have been found to be either defective
or somehow tainted
• Three classes of recalls
• Refer to list on page 23 for levels
of recall
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Records and Labeling
Requirements
• Repackaging–done from bulk to unit
dose by technicians
• Following information is needed on
each label: Drug name, strength,
dosage form, manufacturer, lot
number, and expiration date
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State Laws
• Each state has their own set of laws
that must be followed by all employees
in the pharmacy
• States have laws that differ from
federal law
• The strictest law is the one you follow
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Liabilities
• Tort–causing injury to a person
intentionally or because of negligence
• Negligence–an action taken without
the forethought that should have
been taken by a reasonable person;
a mistake
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Liabilities
• Intentional mistake–penalty ranges
from criminal charges to awarding
of damages
• Negligent mistake–affect employment
and can result in punitive damages
• Be aware of rights and responsibilities
• Refer to list on page 25
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Morals Versus Ethics
in the Workplace
• The pharmacy technician has a clear
responsibility to the patient on many
levels
• Ethics are morals in the workplace
and in the public domain
• Work ethics will guide your behavior
• Working within pharmacy guidelines
will ensure that patients are getting
the best service possible
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