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Focus on
PHARMACOLOGY
ESSENTIALS FOR HEALTH PROFESSIONALS
CHAPTER
2
Law and Ethics of
Medications
Introduction
• All health-care workers who work with
medications should understand the
legal and ethical requirements of their
jobs.
• Controlled substances are those drugs
that are prone to abuse and fall under
the 5 drug schedules established by the
Controlled Substances Act.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
The Need for Drug Control
• In the 19th century, there was virtually
no regulation of the sale of drugs in the
United States.
• Many people became addicted to
opiates or relied on false claims of
manufacturers of drugs and other
substances, resulting in passage of the
first Pure Food and Drug Act in 1906.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Federal Drug Control
• Pure Food and Drug Act (1906): first
law to regulate standards of drug
strength and purity, and proper labeling
• Sherley Amendment (1912): prohibits
fraudulent therapeutic claims
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Federal Drug Control
• Federal Food, Drug, and Cosmetic Act
(1938): ensures that drugs comply with
standards of safety and efficacy;
authorized FDA to approve new drug
applications
– This act was prompted in part by the
sulfanilamide disaster of 1937, which
caused many birth defects
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Pearson Education / PH College
Figure 2-1 During the nineteenth century in the United States, over-the-counter opium
could be purchased at pharmacies and grocery stores. As a result, addiction became a
problem, leading to programs such as the one advertised in this poster. However, in
1906, the Pure Food and Drug Act put an end to the sale of unsafe and untested drugs,
such as opium.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Pearson Education / PH College
Figure 2-2
Amphetamines, Schedule II drugs, have a high abuse potential and are sold
illegally under many street names.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Drugs and Birth Defects
• Drinking alcohol while pregnant can
cause fetal alcohol syndrome,
characterized by abnormalities of the
face and head, growth disturbances,
and mental deficiency.
• Smoking during pregnancy is linked to
smaller birth-weight babies and
abnormal infant reflexes.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Federal Laws
• Durham-Humphrey Amendment
(1951): prohibits dispensing of legend
drugs without a prescription; allows
nonlegend (OTC) drugs to be sold
without a prescription
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Federal Laws
• Kefauver-Harris Amendment (1962):
passed in response to thalidomide
disaster; requires adverse effects to be
reported to FDA and proof of safety
and efficacy
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Federal Laws: Drug Abuse
• Drug Abuse Control Amendment (1965)
– Allowed only certain authorized registrants
to manufacture stimulant drugs
– Contained first guidelines for determining
classifications of drugs subject to abuse
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Keeping Medications Safe
in the Hospital
• All restricted substances must be
stored in locked storage facilities.
• This prevents access by unauthorized
persons.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Controlled
Substances Act (1970)
• Gave sole drug control to the DEA
• Classified drugs according to abuse
potential
• Provided research into drug abuse and
dependence and drug abuse treatment
and rehabilitation
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Table 2-1
Drug Schedules
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Table 2-1 (continued)
Drug Schedules
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Additional Control of Drug Abuse
• Anabolic Steroids Control Act (1990):
placed anabolic steroids under CSA’s
regulatory provisions
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
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Ensuring Specificity of Orders
• An order or prescription must clearly
state the specific circumstances and
conditions under which the drug must
be given.
• Do not accept nonspecific orders, such
as “if needed,” “if indicated,” or “as
warranted.”
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Ensuring Clarity of Orders
• Ensure that orders and prescriptions
clearly include in writing the drug’s:
– Name
– Dosage
– Route
– Frequency of administration
• Ensure that prescriber signed the order
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Orphan Drug Act of 1983
• Orphan drugs: used to treat diseases
that affect fewer than 200,000 people
• Orphan Drug Act: offers financial
incentives to nonprofit and commercial
organizations to develop and market
new orphan drugs in the United States
– Provides a 7-year monopoly on orphan
drug sales and tax breaks to new drug
developers
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Prescription Drug Marketing Act
• Prohibits the reimportation of a drug
into the United States by anyone but
the manufacturer; adopted in 1987
• Prohibits the trading or sale of drug
samples and controls their distribution
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Safe Medical Devices Act (1990)
• Requires reporting of serious injury,
illness, or death caused by medical
devices, including:
– Dialyzers and ventilators
– Electronic equipment and monitors
– Implants, syringes, thermometers, and
catheters
– Restraints
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Safe Medical Devices Act (1990)
• Requires reporting of serious injury,
illness, or death caused by medical
devices, including:
– In vitro equipment
– Disposables
– Parts, components, accessories, related
software
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Anabolic Steroids Control
Act of 1990
• Anabolic steroids are hormonal
substances related to estrogen,
progestins, testosterone, and
corticosteroids.
• This act was established to control
illegal use of anabolic steroids to
increase physical performance (mostly
by athletes).
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Anabolic Steroids Control
Act of 1990
• Abuse of anabolic steroids may lead to
heart, liver, immune function, and
mood-related conditions that may
become fatal.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Omnibus Budget Reconciliation
Act of 1990
• Requires pharmacists to offer to discuss
prescription information with Medicaid
and Medicare patients
• Limits Medicare/Medicaid
reimbursement to drugs approved as
safe and effective
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
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Reasonable Standards of Care
• Always maintain reasonable standards
of patient care regarding medication
management duties.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
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Occupational Safety
and Health Act of 1970
• Administered by Occupational Safety
and Health Administration (OSHA)
• Revised in 1992: requires medical
facilities to comply and prove
compliance with the Bloodborne
Pathogens Standard
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Michal Heron / Pearson Education / PH College
Figure 2-3 In 1992, the Occupational Safety and Health Administration’s Final Ruling
on Bloodborne Pathogens became law. Safety measures, such as sharps containers for
the disposal of needles and syringes, were implemented to stem the spread of HIV/AIDS
and other bloodborne diseases.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Health Insurance Portability and
Accountability Act of 1996
• Also known as HIPAA; has four parts:
– Electronic health transaction standards
– Unique identifiers
– Security and electronic signature standards
– Privacy and confidentiality standards
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Mike Gallitelli / Pearson Education / PH College
Figure 2-4
The electronic transmission and storage of medical records is protected by
the Health Insurance Portability And Accountability Act.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
FDA Modernization Act of 1997
• This act focused on safe pharmacy
compounding, user fees, food safety,
and medical devices.
• It gave patients increased access to
experimental drugs and devices.
• It also gave extension to manufacturers
developing new pediatric drugs.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Medicare Modernization
Act of 2003
• This act created new “Advantage” plans
providing better patient care.
• It partially privatized Medicare.
• Medicare Part D was established to
cover FDA-approved drugs, and is a
voluntary program with varied plans
and co-payment amounts.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Combat Methamphetamine
Epidemic Act of 2005
• This act was designed to stop illegal
use of methamphetamine and
regulated trafficking of this drug and
others, when these activities are used
to finance terrorism.
• Ingredients used to manufacture
methamphetamine are now limited for
sale, and buyers must be registered
with the U.S. Attorney General.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Federal Agencies
• Food and Drug Administration (FDA):
part of U.S. Department of Health and
Human Services; controls all drugs for
legal use
• Drug Enforcement Administration
(DEA): part of the Federal Bureau of
Investigation (FBI); enforces controlled
substance laws
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Federal Agencies
• Centers for Disease Control and
Prevention (CDC): ensures infection
control regulations and provides
statistics and information to health
professionals about disease treatment
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
State Law
• The states are the main regulators of
laws governing pharmacy practice.
• No one may practice pharmacy without
a state license except those exempted
by state legislation.
• Certificates of registration are granted
for 1 or 2 years in most states.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Ethics and Pharmacology
• Ethics: standards of behavior that
encompass the concepts of right and
wrong beyond a given situation’s legal
considerations
• Confidentiality: health professionals
must maintain strict confidentiality
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Ethics and Pharmacology
• Health-care workers must know laws of
state in which they work, including
rules that apply to phoning
prescriptions to pharmacists.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini
Michal Heron / Pearson Education / PH College
Figure 2-5
Pharmaceutical company representatives provide drug samples to physician
offices. These samples may not be sold.
Focus on Pharmacology: Essentials for Health Professionals, Second Edition
Jahangir Moini