Transcript Figure 4.4 (continued)

The Pharmacy Technician
FOUNDATIONS AND PRACTICES
Chapter 4
Pharmacy Law and Ethics
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Constitutional Law
• Outlines the organization of the federal
•
•
government
All states must comply with constitutional
law
Overrides all other laws—if a state law is
ruled "not legal" under the constitution
(whether federal or state), it is not legal
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Constitutional Law (cont.)
• U.S. Constitution contains the Bill of
Rights
– Freedom of speech and religion
– Right to a jury trial
– Protection against unreasonable searches
and seizures
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Statutes and Regulations
• Statutes: laws passed by federal, state, or
•
local legislatures
Regulations: clarify and explain statutes
– Must be consistent with statute
– Have the same power or authority as the
statute
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
State Law and Regulations
• State constitutions establish the
•
•
organization of state government
Must be consistent with federal statutes
and regulations
State statutes and regulations may provide
additional rights
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
State Law and Regulations (cont.)
• States may not guarantee rights that are
•
explicitly not constitutionally legal (e.g.,
drug possession)
States may not take away rights that are
provided by federal law
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Legislative Intent
• The "meaning" of a law is based on its
•
intent
Legal interpretation is based on:
– Words such as "may" and "shall" ("may"
means optional, "shall" means required)
– Punctuation (a comma may imply connected
intent; a semicolon may imply a separate
intent)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Legislative Intent (cont.)
• Commonly influenced by "case law," as
intent may be determined or refined when
a law is challenged in court
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Criminal Laws
• Deal with homicide, illegal drugs, theft,
•
•
•
and other antisocial behavior
Enforced by state agents against specific
persons or corporations
Crimes are considered harmful actions
against society, rather than an individual
Criminal cases are thus titled State v. John
Smith
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Civil Laws
• Involve personal injuries, business
•
•
•
disputes, land deals, libel and slander, and
various other commercial interests
Plaintiff (injured party) brings charges
against defendant (alleged wrongdoer)
Parties in a civil case may be individuals,
corporations, or the state itself
Medical malpractice is a civil law action—
harm is caused to an individual, not
society
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Administrative Law
• Federal government uses administrative
agencies to enforce laws
– Internal Revenue Service (IRS)
– Occupational Safety and Health
Administration (OSHA)
– Centers for Medicare and Medicaid Services
(CMS)
– Social Security Administration (SSA)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Administrative Law (cont.)
• Exceptions: Defense Department and law
•
enforcement agencies
States may also operate through
administrative agencies that have no
federal counterpart
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Administrative Agencies and
Regulations
• Administrative agencies refine laws with
•
regulations
Some laws unambiguously state an
agency’s role; others are deliberately
nonspecific
– Americans with Disabilities Act (not much
room for interpretation)
– Creation of state boards of pharmacy (wide
room for interpretation)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Administrative Agencies and
Regulations (cont.)
• Once the regulations are established, they
have the force of law
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Violations of the Law
• Any action that harms or threatens society
is referred to as a crime
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Violations of the Law (cont.)
• Crimes are classified by the punishment
allowed or mandated upon conviction
– Misdemeanor: considered less serious in
nature, punishable by community service,
parole, a fine, or imprisonment for 12 months
or less
– Felony: determined to be more serious;
punishable by at least one year of
imprisonment
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Regulatory Agencies
• Centers for Medicare and Medicaid
•
•
•
•
•
Services (CMS)
Drug Enforcement Administration (DEA)
Food and Drug Administration (FDA)
Joint Commission on Accreditation of
Healthcare Organization (JCAHO)
Occupational Safety and Health
Administration (OSHA)
State Board of Pharmacy
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Centers for Medicare and Medicaid
Services (CMS)
• Formerly known as the Health Care
Financing Administration (HCFA)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Centers for Medicare and Medicaid
Services (CMS) (cont.)
• Regulates the administration of federal
healthcare programs and laws
– Medicare
– Medicaid
– State Children’s Health Insurance Program
(SCHIP)
– Health Insurance Portability and
Accountability Act (HIPAA)
– Clinical Laboratory Improvement
Amendments (CLIA)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Centers for Medicare and Medicaid
Services (CMS) (cont.)
• Conducts inspections to ensure
compliance with guidelines
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Enforcement Administration
(DEA)
• Regulates legal trade in narcotic and
•
•
•
dangerous drugs
Manages national narcotics intelligence
system
Works with other agencies to support drug
traffic prevention
Shares jurisdiction over drug offenses with
Federal Bureau of Investigation (FBI)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Enforcement Administration
(DEA) (cont.)
• Agents of the two organizations work
•
together on drug law enforcement
Administrator of the DEA reports to the
director of the FBI
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Food and Drug Administration (FDA)
• Reviews/approves new drugs, generic
equivalents, and therapeutic indications for
existing medications
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Food and Drug Administration (FDA)
(cont.)
• Responsible for protecting public health
• Assures safety, efficacy, and security of:
–
–
–
–
–
Drugs
Biological products
Medical devices
Food
Cosmetics
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Joint Commission on Accreditation of Healthcare
Organizations (JCAHO)
• Evaluates and accredits nearly 15,000
•
healthcare organizations and programs
Establishes and enforces standards that
improve quality and safety of healthcare
organizations
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) (cont.)
• Evaluates and accredits:
–
–
–
–
–
–
Hospitals
Hospice facilities
Nursing homes
Long term care facilities
Rehabilitation centers
Other healthcare organizations
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Occupational Safety and Health
Administration (OSHA)
• Division of the U.S. Department of Labor
• Assures the safety and health of American
•
•
workers by setting and enforcing
protective standards
Enforces occupational safety standards in
all 50 states
Provides technical assistance and
consultation programs
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
State Board of Pharmacy (SBOP)
• State agency that registers and regulates:
– Pharmacy facilities
– Pharmacists
– Pharmacy technicians
• Responsible for the actual practice of
•
pharmacy within state domain
Granted the authority to monitor,
reprimand, and revoke licensures
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Pure Food and Drug Act of 1906
• Provided for federal inspection of meat
•
products
Forbade the manufacture, sale, or
transport of adulterated food products or
poisonous patent medicines
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Pure Food and Drug Act of 1906 (cont.)
• Ultimately proved to be inadequate
because it did not:
–
–
–
–
Cover cosmetics
Provide the authority to ban unsafe drugs
Prohibit false statements about drugs
Require labeling to identify product contents
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Food, Drug, and Cosmetic Act of 1938
• Prompted by the sulfanilamide disaster of
•
•
•
•
1937
Limited interstate commerce in drugs to
those that are safe and effective
Established the Food and Drug
Administration (FDA)
Regulated labeling of drugs
Regulated who could prescribe legend
(prescription-only) drugs
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Durham-Humphrey Amendment of
1951
• Also known as the Prescription Drug
•
•
Amendment
Required prescription drugs to bear the
legend, "Caution: Federal law prohibits
dispensing without a prescription."
Later amendments approved a substitute
legend that reads "RX only."
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Kefauver-Harris Amendment of 1962
• Prompted by the thalidomide disaster of
•
•
1962
Also known as the Drug Efficacy
Amendments
Focused on accountability from drug
manufacturers for the effectiveness of
drugs
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Kefauver-Harris Amendment of 1962
(cont.)
• Manufacturers required to supply proof of
•
•
effectiveness and safety
Advertising of prescription drugs placed
under the supervision of the FDA
Established procedures for new drug
applications
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Comprehensive Drug Abuse Prevention
and Control Act of 1970
• Also known as the Controlled Substances
•
•
•
Act of 1970
Combined all federal laws dealing with
narcotics, stimulants, depressants, and
abused designer drugs
Established the Drug Enforcement
Administration (DEA)
Established five "classes" or schedules for
controlled substances
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Occupational Safety and Health Act of
1970
• Ensures worker and workplace safety
• Requires employers to provide a
workplace free from hazards such as:
–
–
–
–
–
Exposure to toxic chemicals
Excessive noise levels
Mechanical dangers
Heat or cold stress
Unsanitary conditions
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Occupational Safety and Health Act of
1970 (cont.)
• Created a national research institution
devoted to occupational safety
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Listing Act of 1972
• Amended the Federal Food, Drug, and
•
•
•
Cosmetic Act of 1938
Required drug establishments to register
their products with the FDA
Includes establishments that repackage
any drug products
Assigns a unique and permanent product
code known as the National Drug Code
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Medical Device Amendment of 1976
• Requires life-sustaining and life-supporting
devices to have premarket approval from
the FDA
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Orphan Drug Act of 1983
• Intended to stimulate the development of
drugs for rare diseases
– Rare disease: affects 200,000 people or
fewer
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Orphan Drug Act of 1983 (cont.)
• Provides three primary incentives:
– Seven-year market exclusivity to sponsors of
approved orphan products
– Tax credit of 50 percent of the cost of
conducting human clinical trials
– Federal research grants for clinical testing of
new therapies to treat and/or diagnose rare
diseases
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Orphan Drug Act of 1983 (cont.)
• Congress created an additional incentive
in 1997
– Companies developing orphan products
receive an exemption from the usual drug
application or user fees charged by the FDA
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Price Competition and Patent
Term Restoration Act of 1984
• Also known as the Hatch-Waxman Act
• Established modern system of generic
•
drugs
Manufacturers of generic drugs can seek
FDA approval for generic versions of
drugs whose patent protection is set to
expire
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Prescription Drug Marketing Act of
1987
• Enacted to address certain prescription
drug marketing practices
– Distribution of free samples
– Use of coupons redeemable for drugs at no
cost or low cost
– Sale of deeply discounted drugs to hospitals
and healthcare entities
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Prescription Drug Marketing Act of
1987 (cont.)
• These marketing practices helped create a
•
secondary grey market
grey market—an unofficial or unregulated
market
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Anabolic Steroid Control Act of 1990
• Placed anabolic steroids into Schedule III
•
of the Controlled Substances Act (CSA)
CSA defines anabolic steroid as:
– "any drug or hormonal substance chemically
and pharmacologically related to testosterone
(other than estrogens, progestins, and
corticosteroids) that promotes muscle growth"
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Omnibus Budget Reconciliation Act of
1990 (OBRA ’90)
• Focused on federal funding of Medicare
•
•
and Medicaid
Increased the necessity for pharmacy
technicians
Mandated that pharmacists perform drug
utilization reviews (DURs) and offer
counseling to patients
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Dietary Supplement Health and
Education Act of 1994
• Defined dietary supplement and dietary
•
•
•
ingredient
Established a framework for assuring
safety
Outlined guidelines for literature displayed
where supplements are sold
Provided for use of claims and nutritional
support statements
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Dietary Supplement Health and
Education Act of 1994 (cont.)
• Required ingredient and nutrition labeling
• Granted the FDA authority to establish
good manufacturing practice (GMP)
regulations
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Health Insurance Portability and Accountability
Act of 1996 (HIPAA)
• Enacted to ensure patient confidentiality
•
•
and privacy
Gave patients the right to review their
medical records
Established the requirement of patient
consent for the transfer of medical records
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Health Insurance Portability and Accountability
Act of 1996 (HIPAA) (cont.)
• Defines protected health information (PHI)
as:
– Any information created or received by the
pharmacy
– Information relating to a patient’s health—
mental or physical; past, present, or future
– Information that may identify a patient
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Combat Methamphetamine Epidemic
Act of 2005 (CMEA)
• Regulates retail over-the-counter sales of
ephedrine, pseudoephedrine, and
phenylpropanolamine products, including:
– Daily sales limits
– 30-day purchase limits
– Placement of product out of direct customer
access
– Sales logbooks
– Customer ID verification
– Employee training
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Monographs
• Commonly known as package inserts
• A necessary component of drug labeling
• Provides all the clinical information
required by the FDA
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 4.4
Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 4.4 (continued)
Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 4.4 (continued)
Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 4.4 (continued)
Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Components of a Monograph
• Description
• Clinical Pharmacology
• Indications and Usage
• Contraindications
• Warnings
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Components of a Monograph (cont.)
• Precautions
• Drug Abuse and Dependence
• Adverse Reactions
• Dosage
• How Supplied
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethics
• Derived from the Greek word ethos,
•
•
referring to one’s character
Discipline of evaluating the merits, risks,
and social concerns
Commonly defined as considered
reflection or systematic analysis when
required actions are unclear
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethics (cont.)
• Based on certain universal principles such
•
as justice, doing no harm, etc.
Ethics are not morals, but can be
influenced by personal morals
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Decisions
• Not clear-cut, either/or, correct or incorrect
•
•
(binary) decisions
Require a balance between a professional
code of ethics and personal morals
Are not emotional reactions, but courses
of conduct that have been weighed and
measured carefully
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Moral Philosophy
• An individualized set of values or value
•
•
•
system
The reasoning process that defines the
subjective rightness or wrongness of
conduct
The reasoning process that defines good
or evil conduct
Often based in spiritual or religious
practice and thought
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Practicing Ethical and/or Moral
Behavior
• Beneficence—bringing about good
• Fidelity—keeping a promise
• Veracity—telling the truth
• Justice—acting with fairness or equity
•
within the law
Autonomy—acting with self-reliance
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 1
• Consequentialism—all actions should
bring about the greatest good to the
greatest number of people
– The actions are justified by the outcome
– The best decisions benefit the greatest
number of people, regardless of whether the
decisions are "right" or "wrong"
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 1 (cont.)
• Nonconsequentialism—some actions
cannot be justified because they are
inherently wrong, regardless of the
outcome
– Some actions can never be condoned,
regardless of the outcome
– The best decision adheres to all ethical and
moral principles, regardless of whether
someone benefits from it or not
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 2
• Social contracts—explicit or assumed
expectations of people in a given situation
– Pharmacists are expected to provide
medication in a prompt manner; patients are
expected to keep their medications current
and pay a fair price
– The best decision satisfies everyone’s social
expectations
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 2 (cont.)
• Ethics of care—requires caregivers (such
as healthcare professionals) to focus on
moral skills
– Kindness, sensitivity, attentiveness, tact,
patience, and reliability are emphasized
– The best decisions are moral in nature
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 3
• Rights-based ethics—based on a belief in
democratic human rights
– Individuals in a democratic society should be
allowed to do what they want without
interference from outside agencies
– The best decisions satisfy an individual’s
desires
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 3 (cont.)
• Principle-based ethics—based on a belief
in universal guides to action
– A personal approach; the individual’s moral
beliefs guide action
– The best decisions satisfy the decisionmaker’s personal beliefs
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 3 (cont.)
• Virtues-based ethics—based on specific,
idealized morals or virtues
– An ideal-world approach; everyone agrees on
what is correct or virtuous
– The best decisions satisfy the community’s
sense of virtuous behavior
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 4
• Law—a formalized, enforceable system of
rules
– An either/or system of conformity—something
is legal or it is not
– May not reflect moral issues—behavior may
be legal but immoral, or illegal yet moral
– The best decisions have already been
determined; only those actions within the
scope of the legal system are acceptable
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Ethical Theories, Part 4 (cont.)
• Professional code of ethics—a
predetermined system of ethical guidelines
for a specific group, created by members
of that group
– An example of virtues-based ethics
– The best decisions are guided by the
profession’s idea of ethical behavior
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Pharmacy Technician Code of Ethics,
Part 1
• Health and safety
– Ensure the health and safety of the patient
– Never assist in dispensing or distributing
medications or devices that are not of good
quality or do not meet the standards required
by law
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Pharmacy Technician Code of Ethics,
Part 1 (cont.)
• Respect and integrity
– Support and promote honesty and integrity in
the profession
– Respect and value the abilities of other
healthcare professionals
– Respect and support the patient’s
individuality, dignity, and confidentiality
– Respect the confidentiality of the patient’s
records
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Pharmacy Technician Code of Ethics,
Part 2
• Professional development
– Use knowledge and skills to serve others
– Maintain competency and continually
enhance professional expertise
– Do not engage in any activity that will
discredit the profession
– Associate with organizations that promote the
profession of pharmacy
The Pharmacy Technician: Foundations and Practices
Mike Johnston, Karen Davis, and Jeff Gricar
Copyright ©2009 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.