Adams ch01 lecture

PHARMACOLOGY FOR NURSESPHARMACOLOGY FOR NURSES
A Pathophysiological ApproachA Pathophysiological Approach
FOURTH EDITIONFOURTH EDITION
Copyright © 2014, © 2011, © 2008 by Pearson Education, Inc.
All Rights Reserved
CHAPTER
Introduction to
Pharmacology
1

Pharmacology for Nursing: A Pathophysiology Approach, Fourth Edition
Michael Patrick Adams | Leland N. Holland | Carol Urban
History of PharmacologyHistory of Pharmacology
• Records exist in every culture dating to
antiquity.
• Records describe use of plants (herbs)
to relieve symptoms.
• Dark Ages show few records; still using
herbs.

Pharmacologia seu Manuductio adPharmacologia seu Manuductio ad
Materiam MedicamMateriam Medicam
• Written by Samuel Dale in 1693
• First recorded reference to
pharmacology

Modern Pharmacology Began inModern Pharmacology Began in
Early 1800sEarly 1800s
• Chemists isolated pharmacological
substances from natural substances.
• Effects on animals were studied.
• Early researchers used themselves as
test subjects.

Pharmacology Recognized asPharmacology Recognized as
Distinct DisciplineDistinct Discipline
• First department of pharmacology
established at Estonia in 1847

John Jacob AbelJohn Jacob Abel
• Father of American pharmacology
• Founded first pharmacology
department in United States at
University of Michigan in 1890

20th Century to Present20th Century to Present
• Drugs synthesized in laboratory
• Drugs tested for relatively short time
• Increased understanding of how drugs
produce their effects
• Focus is on improvements in quality of
life.

PharmacologyPharmacology
• Simply defined, from the Greek, as the
study of medicine
• Pharmacology is an expansive subject
encompassing:
– How drugs are administered
– Where drugs travel in the body
– Responses that drugs produce

Interrelated Subject AreasInterrelated Subject Areas
• Anatomy and physiology
• Chemistry
• Microbiology
• Pathophysiology

Pharmacology Is Challenging andPharmacology Is Challenging and
Always ChangingAlways Changing
• 10,000 drugs currently available
• Each drug has its own characteristics:
– Therapeutic applications
– Interactions
– Side effects
– Mechanisms of action

Pharmacology Is Challenging andPharmacology Is Challenging and
Always ChangingAlways Changing
• Many drugs prescribed for more than
one disease
• Drugs elicit different responses
depending on individual factors:
– Age
– Sex
– Body mass
– Health status
– Genetics

Nursing and PharmocologyNursing and Pharmocology
• Knowledge of pharmacology is essential
to the nursing profession.
• Nurses are health care providers most
often directly involved in patient care.
– Applies to nurses in all settings, from
hospital to home care
• Study of pharmacology is a long,
challenging, and continual process.

Therapeutics and PharmacologyTherapeutics and Pharmacology
Are Closely ConnectedAre Closely Connected
• Therapeutics is concerned with
– Prevention of disease
– Treatment of suffering
• Pharmacotherapy is the application of
drugs for
– Disease prevention
– Treatment of suffering

Traditional Drugs Are ChemicalTraditional Drugs Are Chemical
AgentsAgents
• Synthesized in a laboratory
• Produce biological responses in the
body
– If desirable response—therapeutic
– If undesirable response—adverse
• After a drug is administered, it is called
a medication.

BiologicsBiologics
• Biologics are agents naturally produced
in animal cells, by microorganisms, or
by the body itself.

Examples of BiologicsExamples of Biologics
• Hormones
• Monoclonal antibodies
• Natural blood products and components
• Interferon
• Vaccines

Complementary and AlternativeComplementary and Alternative
TherapiesTherapies
• Natural plant extracts, herbs, vitamins,
minerals, dietary supplements
• Acupuncture, hypnosis, biofeedback,
massage

Prescription Drugs and Over thePrescription Drugs and Over the
Counter (OTC) DrugsCounter (OTC) Drugs
• Prescription drugs require that the
recipient obtain a written order from a
person with the legal authority to write
such a prescription.

Advantages and DisadvantagesAdvantages and Disadvantages
of Prescription Drugsof Prescription Drugs
• Advantages
– Health care provider examines the
patient and orders the proper drug.
 Amount and frequency of drug is
controlled.
 Instructions on use and side effects of
drug are discussed.

of Prescription Drugsof Prescription Drugs
• Disadvantages
– Require a prescription to obtain
– Need for health care provider
appointment

of OTC Drugsof OTC Drugs
• Advantages
– No health care provider appointment
required
– Often less expensive than prescription
drugs

of OTC Drugsof OTC Drugs
• Disadvantages
– Patient may choose wrong drug.
– Patient may not know reactions or
interactions.
– Ineffective treatment may result in
progression of disease.

Prior to 19th CenturyPrior to 19th Century
• Few standards or guidelines to protect
the public
– Some drugs contained hazardous levels
of
 Dangerous substances
 Addictive substances

Early Drug ReferencesEarly Drug References
• The first standard commonly used by
pharmacists was the formulary, or list
of drugs and drug recipes.
• A pharmacopeia is a medical reference
summarizing standards of drug purity,
strength, and directions for synthesis.

United States PharmacopeiaUnited States Pharmacopeia
(USP)(USP), 1820, 1820
• First comprehensive publication of drug
standards
• Summarized standards of drug:
– Purity
– Strength
– Directions for synthesis

American PharmaceuticalAmerican Pharmaceutical
Organization (APhA)Organization (APhA)
• National professional society of
pharmacists, established 1852
• Maintained the national compendia of
drug standards, the National Formulary
(NF)
• National Formulary competed with
other compendia, U.S. Pharmacopeia
(USP).

USP and NF Merged in 1975USP and NF Merged in 1975
• Formed United States Pharmacopeia–
National Formulary (USP-NF)
• Official monographs and interim
announcements published regularly
• Full bound version printed every five
years

United States Develops and EnforcesUnited States Develops and Enforces
Tougher Drug Laws, 1900sTougher Drug Laws, 1900s
• Biologics Control Act, 1902
– Standardized serum and blood-related
products
• Pure Food and Drug Act, 1906
– Government controls labeling of
medicines.
• Sherley Amendment, 1912
– Prohibited drugs labeled with false
therapeutic claims

United States Develops and EnforcesUnited States Develops and Enforces
Tougher Drug Laws, 1900sTougher Drug Laws, 1900s
• Food, Drug, and Cosmetic Act (1938)
and amendments
– Thorough testing of drug
– Proof of safety and efficacy of drug
• Dietary Supplement Health and
Education Act, 1994
– Controls misleading industry claims

Figure 1.1 Medication with the USP label (left)
Source: Practice Label “for educational purposes only.”
continued on next slide

Figure 1.1 (continued) Medication without USP label (right)
Source: Practice Label “for educational purposes only.”

Food and Drug AdministrationFood and Drug Administration
(FDA)(FDA)
• Officially established in 1988
• Agency of U.S. Department of Health
and Human Services in 1988

Figure 1.2 A historical time line of regulatory acts, standards, and organizations
continued on next slide

Figure 1.2 (continued) A historical time line of regulatory acts, standards, and organizations

Center for Drug Evaluation andCenter for Drug Evaluation and
ResearchResearch
• Branch of FDA
• Determines safety and efficacy of drugs
• Pharmaceutical laboratories must solicit
approval from FDA before marketing a
drug.

Center for Biologics Evaluation andCenter for Biologics Evaluation and
Research (CBER)Research (CBER)
• Branch of FDA
• Regulates use of biologics (serums,
vaccines, and blood products)
• 1986 Childhood Vaccine Act result of
CBER work

Center for Food Safety andCenter for Food Safety and
Applied Nutrition (CFSAN)Applied Nutrition (CFSAN)
• Branch of FDA
• Oversees herbal and dietary products

Center for Food Safety andCenter for Food Safety and
Applied Nutrition (CFSAN)Applied Nutrition (CFSAN)
• Enforces 1994 Dietary and
Supplemental Health and Education Act
– Regulation not as close as Food, Drug,
and Cosmetic Act
– Herbal and dietary supplements can be
marketed without prior approval from
FDA.

Four Stages of Approval forFour Stages of Approval for
Therapeutic and Biologic DrugsTherapeutic and Biologic Drugs
• Four stages:
– Preclinical investigation
– Clinical investigation
– Review of new drug application (NDA)
– Postmarketing surveillance
• Amount of time for approval varies.

Figure 1.3 A new drug development time line with the four phases of drug approval

Preclinical InvestigationPreclinical Investigation
• Involves laboratory research
• Tests done on cells and animals
• Determines drug-dose range
• Examines adverse effects
• Results considered inconclusive

FDA Critical Path InitiativeFDA Critical Path Initiative
• In 1997, FDA restated its concern that
a number of innovative and critical
medical products had decreased since
the 1990s.
– Critical Path Initiative was initiated to
modernize the sciences to enhance the
use of bioinformation to improve the
“safety, effectiveness, and
manufacturability of candidate medical
products.”

Clinical InvestigationClinical Investigation
• Takes place in three different stages
termed clinical phase trials
• Longest part of approval process
• Evaluates human benefits
• Tests on healthy humans first, then on
those with the target ailment

Review of New Drug ApplicationReview of New Drug Application
(NDA)(NDA)
• If results of clinical investigation are
positive, even if precautions are noted,
a New Drug Application is the next
step.
• NDA is the third step of the drug
approval process.
• Average review time 17–24 months
• Drug approved: process continues
• Drug rejected: process suspended

Investigational New DrugInvestigational New Drug
Application (IND)Application (IND)
• May be submitted for Phase I clinical
trials when it is determined there are
significant therapeutic benefits, and the
product is reasonably safe for initial use
in humans

Postmarketing SurveillancePostmarketing Surveillance
• New drug placed on market
• Surveyed for harmful effects in larger
population
– Diabetes drug troglitazone (Rezulin) is
an example of a drug that did not
exhibit harmful effects until the year
after release.

Postmarketing SurveillancePostmarketing Surveillance
• FDA holds annual public meetings.
– Will withdraw a drug if serious problem
found

The Lengthy FDAThe Lengthy FDA
Drug-Approval ProcessDrug-Approval Process
• NDAs can be massively long and FDA
review can take several years.
• Pharmaceutical manufacturer expenses
for creating and marketing a new drug
can be in the millions of dollars.
• Core FDA goal is to make sure drugs
are safe for the public.

The Lengthy FDAThe Lengthy FDA
Drug-Approval ProcessDrug-Approval Process
• In 1990s, delays in process determined
– Outdated guidelines
– Insufficient staff
– Poor communication

Prescription DrugPrescription Drug
User Fee Act, 1992User Fee Act, 1992
• Established on five-year trial basis
• Drug and biologic manufacturers
provide drug-user fee.
• FDA hired more employees.
• FDA restructured its organization.

Results SuccessfulResults Successful
• Doubled the number of drugs approved
• Some review times cut by half

FDA Modernization Act, 1997FDA Modernization Act, 1997
• Reauthorized Prescription Drug User
Fee Act
• FDA Amendments Act expanded the
reforms in 2007.

Research ShowsResearch Shows
• Researchers recently completed a
review of all adverse drug events
reported to the FDA since 2006.
– Clinicians found 10 potentially fatal
drugs.
• Nurses should constantly review the
literature for drugs that have been
recalled or reported dangerous.

Nurses and the Drug ApprovalNurses and the Drug Approval
ProcessProcess
• Nurses participate most in the drug
approval process during the
postmarketing surveillance period of
Phase IV.
• All nurses administering medications
monitor for therapeutic effects and
adverse reactions from the drugs.
• Responsible for reporting adverse
reactions

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