NCM106: PHARMACOLOGY

Chapter I: Introduction to Drugs

PHARMACOLOGY
• study of the biological effects of chemicals.
• Nurses deal with pharmacotherapeutics, or
clinical pharmacology.
• Some drug effects are therapeutic, or helpful, but
others are undesirable or potentially dangerous
(adverse effects) SOURCES OF DRUGS #2
• Natural Sources (cont.)
DRUGS • Animal products
• are medicines or other substances used to modify • Used to replace human chemicals
or improve physiologic or pathologic that are not produced because of disease or
effect/condition when ingested or otherwise genetic problems
introduced into the body. • Genetic engineering
• Many of these preparations are
Nurse’s Responsibility now created synthetically
1. Administering
- administering drug SOURCES OF DRUGS #3
2. Assessing • Natural Sources (cont.)
- assessing drug effects • Inorganic compounds
3. Intervening • Salts of various elements can have
-intervening to make the drug regimen therapeutic effects in the human body
more tolerable • Synthetic Sources
4. Providing • Genetic engineering alter bacteria
-providing patient teachings about drugs to produce chemicals that are therapeutic
and the drug regimen and effective
5. Monitoring • Original prototypes
- monitoring the overall patient care plan
to prevent medication errors.

QUESTION #1 : TRUE/FALSE
• Tell whether the following statement is true or
false

Pharmacotherapeutics is the branch of

pharmacology that uses drugs to treat, prevent,
and diagnose disease.
Answer: True
RATIONALE: Pharmacotherapeutics uses drugs
to treat, prevent, and diagnose disease.

Sources of Drugs #1 QUESTION #2

• Natural Sources
• Plants
• Synthetic version of the active
chemical found in a plant
• Main component of the growing
alternative therapy movement
Tell whether the following statement is true or
false.
Groups of similar drugs, all of which are derived
from an original prototype, are available today
because of technological advances that make a
particular drug more desirable in a specific
situation.
Answer: True
Rationale: These technological advances have led
to the development of groups of similar drugs, all
of which are derived from an original prototype,
but each of which has slightly different properties,
making a particular drug more desirable in a
specific situation.
DRUG STANDARDS AND LEGISLATION
 Drug standards
United States Pharmacopeia National
Formulary (USP-NF)
a. met high standards for therapeutic use
b. patient safety
c. quality
d. purity
e. strength
f. Packaging safety
g. dosage form
 The Philippine Pharmacopeia (PP) 1st
edition April 2004 and any supplement
thereto, is hereby declared and adopted as
the official book of the standards and
references for the determination of the
identity, purity, and quality of
pharmaceutical products and crude plant
drugs in the Philippines.
DRUG STANDARDS AND LEGISLATION
1997: The Food and Drug Administration
Modernization Act
5 provisions:
1) review and use of new drugs is accelerated
2) drugs can be tested in children before
marketing
3) clinical trial data are necessary for experimental
drug use for serious or life- threatening health
conditions.
4) drug companies are required to give
information on “off label drugs” and their uses
and costs (e.g. Vancomycin (most antibiotics –
Surgical prophylaxis off-label)
5) drug companies that plan to discontinue drugs
must inform health professionals and patients at
least 6 months before stopping drug production
DRUG EVALUATION
• Preclinical Trials Chemicals tested on laboratory
animals
• Phase I Studies Chemicals tested on human
volunteers
• Phase II Studies Drug tried on informed patients
with the disease
• Phase III Studies (COVID19 VACCINES) Drug
used in vast clinical market passed safety data
milestone for EMERGENCY USE
AUTHORIZATION (EUA)
• Phase IV Studies
• Continual evaluation of the drug (for
more side & adverse effects not discovered
in previous trials)
1938: Food, Drug, and Cosmetic Act
-empowered the FDA to ensure drug safety
by monitoring and regulating the
manufacture and marketing of drugs.
a )Tested for harmful effects
b) Labels with accurate information
c) Enclosed detailed literature (druglit) in
the packaging that explains adverse
effects.
1978: Drug Regulation Reform Act
shortened the time in which new drugs
could be developed and marketed. It
protects patients’ rights and investigational
process and promote research.
DRUG NAMES
 Chemical names
- describes the drug chemical structure.
 Generic names 
-is the official nonproprietary name for the
drug; universally accepted. 
 Brand or Trade names
-known as proprietary name, is chosen by
the drug company and is usually a
registered trademark owned by that
specific company.
GENERIC DRUGS
• Chemicals that are produced by companies
involved solely in the manufacturing of drugs
• Bioavailability of the drug
• “Dispensed as written” (DAW)
• Important in drugs that have narrow
safety margins
OVER-THE-COUNTER DRUGS #1
• Products that are available without prescription
for self- treatment of a variety of complaints.
• Some of these agents were approved as
prescription drugs.
• Later were found to be very safe and useful for
patients
• example: loratadine (Claritin) •
Many of these drugs were “grandfathered” (drugs
originally marketed before 1938 w/o approved
NDAs).
OVER-THE-COUNTER DRUGS #2
• Nurses should consider several problems related
to OTC drug use:
• Taking these drugs could mask the signs and
symptoms of underlying disease, making
diagnosis difficult.
• Taking these drugs with prescription
medications could result in drug interactions and
interfere with drug therapy.
• Not taking these drugs as directed could result in
serious overdoses.
ORPHAN DRUGS #1
• Drugs that have been discovered, but are not
financially viable and therefore have not been
“adopted” by any drug company
• The Orphan Drug Act of 1983
• Designed to promote the development and
manufacture of orphan drugs, for the treatment of
rare diseases. (ALS – Lou Gehrig’s Disease – Ice
Bucket Challenge)
ORPHAN DRUGS ACT #2
3 primary incentives:
a) federal funding of grants and contracts to
perform clinical trials of orphan products
b) 50% tax credits for cost of clinical testing
c) exclusive (PATENT) right to market the drug
for 7 years from marketing approval date.
CONTROLLED SUBSTANCES #1
• The Controlled Substances Act of 1970
• Control over the coding of drugs and the
enforcement of these codes to the FDA
and the Drug Enforcement Agency (DEA),
a part of the U.S. Department of Justice.
• Prescription, distribution, storage, and
use of these drugs are closely monitored.
• Local policies and procedures might be
even more rigorous.
CONTROLLED SUBSTANCES #2
Provisions:
a) promotion of drug education and research into
the prevention and treatment of drug dependence
b) Strengthening of enforcement authority
c) Establishment of treatment and rehabilitation
facilities.
E.g.TRC our current affiliation agency for
PSYCHIA
d) Designation of schedules or categories for
controlled substances according to abuse liability.
SOURCES OF DRUG INFORMATION #1
• Drug Label
• Drug labels have specific information
that identifies a specific drug
• Understanding how to read a drug label
is essential
• Package Insert
• Prepared by the manufacturer
• Contains all the chemical and study
information that led to the drug’s approval
• Difficult to understand and read
SOURCES OF DRUG INFORMATION #2
• Reference Books
• Physician’s Drug Reference (PDR)
• Drug Facts and Comparisons
• AMA Drug Evaluations
• Lippincott’s Nursing Drug Guide
(LNDG)
• Journals
• Internet
QUESTION #3
Drug labels are a source of information. What
information might a drug label provide?
A. The manufactured date
B. The expiration date
C. When the patent expires
D. The binding properties of the drug

Answer: B
Rationale: Drug labels have specific information
that identifies a specific drug. For example, a drug
label identifies the brand and generic names for
the drug, the drug dosage, expiration date, and
special drug warnings. Some labels also indicate
the route and dosage for administration.