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Introduction to
Pharmacology
Practicum of Health Science
Technology 2009 - 2010
What is Pharmacology?
• Pharmaceutical derived from the
Greek word for poison
• A science that studies drug effects
within a living system
• Deals with all drugs used in society
today, legal or illegal, including
street, prescription, and nonprescription or over –the-counter
medications
Drug
• A drug is defined as any
substance used in the diagnosis,
cure, treatment, or prevention of
a disease or condition
Drug Names
• Chemical Name
• Generic Name
• Trade Name
Chemical Name
• Describes its molecular structure
and distinguishes it from other
drugs
Generic name
• Determined by the
pharmaceutical company along
with a special organization
known as the U.S. Adopted
Names Council (USAN)
Trade Name
• Or brand name- the
manufacturer selects alone…can
become a registered trademark.
They are the only one who can
advertise and market the drug
under that name
How is the Trade Name Chosen?
• The particular spelling of a brand
name drug is proposed by a
manufacturer for one of several
reasons.
1. To indicate the disease
process being treated
• Azmacort- treats asthma
• Rythmol- treats cardiac
arrhythmias
2. To simplify the generic
name
• Pseudoephedrine to Sudefed
• Haloperidol to Haldol
• Ciprofloxacin to Cipro
3. To indicate the duration
• Slow-K slow release
potassium supplement
Prescription Drugs
• Or legend drugs
• Means in order to obtain drug, you
must have a legal prescription
Non-Prescription Drugs
• Or Over-the-Counter (OTC) drugs
• Drug that may be purchased without
a prescription
Sources of Drugs
Drugs and biological products have
been identified or derived from four
main sources:
• Plants
• Animals and Humans
• Minerals and Mineral Products
• Synthetic or Chemical Substances
Made in the Laboratory
Active Constituents of Plant
Drugs
• The leaves, roots, seeds, and other
parts of plants may be dried or
otherwise processed for use as a
medicine and , as such, are known as
Crude drugs.
• Their therapeutic effect is produced
by the chemical substances they
contain.
Active Constituents of Plant
Drugs
• When the pharmacologically active
parts are separated from the crude
preparation, the resulting substances
are more potent and usually produce
effects more reliably than the crude
drug.
Active Constituents of Plant
Drugs
• Some of the types of
pharmacologically active compounds
found in plants, grouped according to
their physical and chemical
properties, are alkaloids, glycosides,
gums and oils
Alkaloids
• Organic compounds that are alkaline
in nature and are chemically
combined with acids in the
laboratory to form water – soluble
salts
• Example – Morphine Sulfate
Glycosides
• Active plant substances that, on
hydrolysis, yield sugar plus one or
more additional active substances
• The sugar is believed to increase the
solubility, absorption, permeability,
and cellular distribution of the
glycoside
• Example - Digoxin
Gums
• Plant exudates
• When water is added, some of them will swell and
form gelatinous masses
• Others remain unchanged in the GI tract, where
they act as hydrophilic colloids
• They absorb water, form watery bulk, and exert a
laxative effect
• Are also used to soothe irritated skin and mucous
membranes
• Example – Psyllium seeds are a natural laxative
gum
• Example – Carboxymethylcellulose are synthetic
colloids
Oils
•
Highly viscous liquids and are
generally of two kinds
1. Volatile
2. Fixed
Volatile Oil
• Imparts an aroma to a plant
• Because of their pleasant odor and
taste, these oils are frequently used as
flavoring agents
• Evaporate easily
• Typically non-greasy
• Example – Peppermint
Fixed Oil
• Generally greasy and do not
evaporate easily
• Example – Castor Oil
Drug Classification
•
Can be approached from two
perspectives
1. Clinical Indication
Example – Bronchodilator Drugs
2. Body System
Example – Drugs Affecting the
Nervous System
Controlled Substances
• Drugs which are classified according to
their use and abuse potential
• Term originated in 1970 as a result of the
Controlled Substances Act which was
developed to provide increased research
into, and prevention of, drug abuse and
drug dependence; to provide treatment
and rehabilitation of drug abusers and
drug dependent persons; and to improve
the administration and regulation of the
manufacturing, distributing, and
dispensing of controlled substances
Schedule of Controlled
Substances
• Classifies drugs solely according to
their use and abuse potential
• Drugs are classified into numbered
levels, or schedules, from Schedule I
to Schedule V
• Drugs with the highest abuse
potential are placed in Schedule I;
those with the lowest potential for
abuse are in Schedule V
Investigational Drugs
• The multibillion dollar
pharmaceutical industry is constantly
screening substances with potential to
market as new drugs
• Prospective drugs take anywhere
from 5 – 10+ years and huge amounts
of money to progress through the
Food and Drug Administration
required testing sequence
Drug Design
• New drugs are discovered in one of
two ways
1. Totally new chemical substance
2. Derived from molecular
manipulation of a current drug
Drug Design
• Until recently,designing a new
drug by changing the
molecular structure of an
existing drug was a very slow
process of trial and error
Recombinant DNA technology
Gene splicing or genetic engineering
• Aided by computer design and use of
enzymes, researchers are able to
remove DNA chemically from one
organism and transplant into other
Testing
• In vitro- in glass
• In vivo- in living
• Many guidelines set by FDA
Animal Phase
• Precedes human testing
• Watching for toxic effects,side
effects, addictions, cancerous
tumors or fetal deformities
Animal Phase
• Calculating the Therapeutic
Index (TI) …. The difference
between the dosage that
produces a Therapeutic Effect
and the dosage that produces a
Toxic Effect
Animal Phase
• NOT always a reliable
indicator of how well a drug
will perform in humans.
Animal Phase
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Modes of Absorption
Distribution
Metabolism
Excretion
Human Testing
• Occurs in three phases
• All participants must be given
informed consent
Informed Consent
• Written consent to an experimental
procedure by an individual after he
or she has been given a careful
explanation of the purpose of the
study, procedure to be used, the
expected effects, and the risks
involved
Nuremberg Code
• Developed under the guidance of
American physicians as a result of
the post World War II trials at
Nuremberg of Nazi physicians who
had conducted experiments on
political prisoners without their
consent
The Code states:
• Truly voluntary consent of the
human subject is critical
• The experiment must be proved to be
valid or made possible only through
the use of human subjects
• The results and risks are justified by
the study
The Nuremberg Code
• Unnecessary suffering, death, or
disability will be avoided
• The experiment will be conducted in
a careful and professional manner by
scientifically qualified persons
• The subject or the investigator may
terminate the experiment at any
point that it is felt unendurable or
impossible
Human Testing: Phase I
• Healthy volunteers used to study
absorption, distribution, metabolism,
and routes of elimination or excretion
• Safe dose range, evaluate side effects
and establish a correct dosage for
therapeutic effect.
• Blood tests, urine analysis, vital signs,
and specific monitoring tests are
performed during this phase
Human Testing: Phase II
• Drug is administered at gradually
increasing dosages to selected
individuals with the targeted disease
• During this phase individuals are
closely monitored for drug
effectiveness and for side effects
• If no serious side effects occur, the
study will progress to Phase III
Human Testing: Phase III
•
•
Drug is ready for testing at various
different centers in larger numbers
than previous phases
Standard protocols have been
established to be followed at each
center
Human Testing: Phase III
• Objectives for this phase are:
- Determination of clinical
effectiveness
- Drug Safety determination
- Establishment of tolerated dosage
or dosage range
Human Testing: Phase III
• Group A
• all patients with the disorder
receive the new drug being
studied
• results compared to next two
groups for side effects and ability
to treat disorder
Human Testing: Phase III
• Group B
• all patients have disorder meant
to be treated by new drug
• all patients receive a placebo and
results are compared to other 2
groups
Human Testing: Phase III
• Group C
• all patients have disorder meant
to be treated by new drug
• patients will be treated by
another drug currently being
used to treat disorder
FDA Approval
• After reviewing all
documentation on the safety
and effectiveness of the new
drug
• May be protected by a patent
for up to 17 years
Pregnancy Safe Categories
• Before using any drug during pregnancy,
the expected benefits should be considered
against the possible risks to the fetus
• The FDA has established a scale to indicate
drugs that may have documented
problems in animals and/or humans
during pregnancy
• For many drugs, this information is
unknown
Category A
• Adequate and well – controlled
studies indicate no risk to the fetus in
the first trimester of pregnancy, and
there is no evidence of risk in later
trimesters.
Category B
• Animal reproduction studies indicate
no risk to the fetus and there are no
well – controlled studies in pregnant
women
Category C
• Animal reproduction studies have
reported adverse effects on the fetus;
and there are no well – controlled
studies in humans, but potential
benefits may indicate use of the drug
in pregnant women despite potential
risks
Category D
• Positive human fetal risk has been
reported in data from investigational
or marketing experience, or human
studies
• Considering potential benefit versus
risk may, in selected cases, warrant
the use of these drugs in pregnant
women
Category X
• Fetal abnormalities reported and
positive evidence of fetal risk in
humans is available from animal
and/or human studies
• The risks involved outweigh the
potential benefits
• These drugs should NOT be used in
pregnant women
Medication Orders
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Verbal Order
Telephone Order
Incomplete Order
Incorrect or Inappropriate Order
Invalid Order
Orders for Unfamiliar Drugs
Medication Order
Should Include:
• Name of patient medication is to be
administered
• Medication name
• Dosage
• Route
• Time of administration
• Signature of prescriber
Verbal Order
• Given or received verbally
• All orders must be written prior to
administration
Telephone Order
• An order given over the telephone
• Prescriber must sign order within
48h of administration
• Person receiving the orders should
listen to the order, write it down, then
repeat it back to the prescriber
completely for verification prior to
ending the call
Incomplete Order
• Orders that are not complete in
patient name, medication name, dose,
route, time, or signature must be
clarified and corrected BEFORE
administration
Incorrect or Inappropriate
Order
• May be judged by the administrator as
being incorrect, or inappropriate for the
client it is ordered
• It is the administrator’s RIGHT and
RESPONSIBILITY to question ANY order
or action that is potentially harmful to the
patient
• To carry out an order that one knows to
be incorrect constitutes negligence
• To change an order by modifying any part
of it without the consultation with the
prescriber is ILLEGAL
Incorrect or Inappropriate
Order
• Validate the order by consulting an
authoritative reference source such as a
drug reference book
• If the order is apparently incorrect,
objectively report the conflicting facts and
discuss it with the prescriber
• If the prescriber still wants the medication
given as ordered after the objections have
been stated the immediate supervisors, or
managers should be sought
Incorrect or Inappropriate
Order
• If the prescriber decides to
administer the medication themselves
make sure the documentation reflects
the objections and actions that have
taken place
Invalid Order
• Orders signed by medical students,
unlicensed interns and medical
residents; and physicians who do not
have prescriptive authority at your
institution should not be
administered until the order is
verified and clarification is made
Order for Unfamiliar Drug
• Prior to administration of an unfamiliar
medication, the administrator should
“Look It Up” or “Ask the Pharmacists”!
• Administration of an unfamiliar
medication while remaining in ignorance
of its actions, its intended effects and side
effects, and its adverse reactions is
considered negligence if it results in harm
to the patient
5 Rights of Drug Administration
1.
2.
3.
4.
5.
Right Medication
Right Patient
Right Dosage
Right Route
Right Time
Medical Terminology
Instructions
Define the following terms in your
interactive note book. Utilize KIM
technique with the K = Key word/
key term; I = Information/
Definition; and M = Memory Cue –
something that will help you to
remember the term. Maybe a
picture, word, or phrase.
Terms
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Pharmacology
Pharmacopeia
Drug
Chemical Name
Generic Name
Trade Name
Prescription Drug
Non-prescription
Drug
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Alkaloid
Glycoside
Gums
Hydrophilic
Water – soluble
Volatile oil
Fixed oil
Terms
• Controlled
Substance
• Therapeutic Index
• Therapeutic effect
• Informed Consent
• Crude drugs
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Toxic effect
Alkaline
Hydrolysis
Distribution
Metabolism
Excretion
Medical Abbreviations
• USAN – United States Adopted Name
Council
• OTC – Over – the – Counter
• PDR – Physician’s Desk Reference
• FDA – Food and Drug Administration
• DEA – Drug Enforcement Administration
• TI – Therapeutic Index
• VO – Verbal order
• TO – Telephone order
VIP of the Week
Alexander Fleming
Instructions: Research this person and write
the following in your interactive notebook.
• Who is he? Describe him as a person.
• What significance did he have to medicine,
science, or health care?
• How can you utilize his contribution in
your profession?
• How did his contribution affect the world?