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 Tell whether the following statement is true or
• Plants false.
• Synthetic version of the active
chemical found in a plant Groups of similar drugs, all of which are derived
• Main component of the growing from an original prototype, are available today
alternative therapy movement 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 DRUG EVALUATION
c. quality • Preclinical Trials Chemicals tested on laboratory
d. purity animals
e. strength • Phase I Studies Chemicals tested on human
f. Packaging safety volunteers
g. dosage form • Phase II Studies Drug tried on informed patients
with the disease
 The Philippine Pharmacopeia (PP) 1st • Phase III Studies (COVID19 VACCINES) Drug
edition April 2004 and any supplement used in vast clinical market passed safety data
thereto, is hereby declared and adopted as milestone for EMERGENCY USE
the official book of the standards and AUTHORIZATION (EUA)
references for the determination of the • Phase IV Studies
identity, purity, and quality of • Continual evaluation of the drug (for
pharmaceutical products and crude plant more side & adverse effects not discovered
drugs in the Philippines. 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
DRUG STANDARDS AND LEGISLATION shortened the time in which new drugs
1997: The Food and Drug Administration could be developed and marketed. It
Modernization Act protects patients’ rights and investigational
5 provisions: process and promote research.
1) review and use of new drugs is accelerated
2) drugs can be tested in children before DRUG NAMES
marketing  Chemical names
3) clinical trial data are necessary for experimental - describes the drug chemical structure.
drug use for serious or life- threatening health  Generic names 
conditions. -is the official nonproprietary name for the
4) drug companies are required to give drug; universally accepted. 
information on “off label drugs” and their uses  Brand or Trade names
and costs (e.g. Vancomycin (most antibiotics – -known as proprietary name, is chosen by
Surgical prophylaxis off-label) the drug company and is usually a
5) drug companies that plan to discontinue drugs registered trademark owned by that
must inform health professionals and patients at specific company.
least 6 months before stopping drug production
GENERIC DRUGS and the Drug Enforcement Agency (DEA),
• Chemicals that are produced by companies a part of the U.S. Department of Justice.
involved solely in the manufacturing of drugs • Prescription, distribution, storage, and
• Bioavailability of the drug use of these drugs are closely monitored.
• “Dispensed as written” (DAW) • Local policies and procedures might be
• Important in drugs that have narrow even more rigorous.
safety margins
CONTROLLED SUBSTANCES #2
OVER-THE-COUNTER DRUGS #1 Provisions:
• Products that are available without prescription a) promotion of drug education and research into
for self- treatment of a variety of complaints. the prevention and treatment of drug dependence
• Some of these agents were approved as b) Strengthening of enforcement authority
prescription drugs. c) Establishment of treatment and rehabilitation
• Later were found to be very safe and useful for facilities.
patients E.g.TRC our current affiliation agency for
• example: loratadine (Claritin) • PSYCHIA
Many of these drugs were “grandfathered” (drugs d) Designation of schedules or categories for
originally marketed before 1938 w/o approved controlled substances according to abuse liability.
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. SOURCES OF DRUG INFORMATION #1
• Drug Label
ORPHAN DRUGS #1 • Drug labels have specific information
• Drugs that have been discovered, but are not that identifies a specific drug
financially viable and therefore have not been • Understanding how to read a drug label
“adopted” by any drug company is essential
• The Orphan Drug Act of 1983 • Package Insert
• Designed to promote the development and • Prepared by the manufacturer
manufacture of orphan drugs, for the treatment of • Contains all the chemical and study
rare diseases. (ALS – Lou Gehrig’s Disease – Ice information that led to the drug’s approval
Bucket Challenge) • Difficult to understand and read

ORPHAN DRUGS ACT #2 SOURCES OF DRUG INFORMATION #2

3 primary incentives: • Reference Books
a) federal funding of grants and contracts to • Physician’s Drug Reference (PDR)
perform clinical trials of orphan products • Drug Facts and Comparisons
b) 50% tax credits for cost of clinical testing • AMA Drug Evaluations
c) exclusive (PATENT) right to market the drug • Lippincott’s Nursing Drug Guide
for 7 years from marketing approval date. (LNDG)
• Journals
CONTROLLED SUBSTANCES #1 • Internet
• The Controlled Substances Act of 1970
• Control over the coding of drugs and the
enforcement of these codes to the FDA
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.