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FUNDAMENTAL CONCEPTS OF
PHARMACOLOGY

Part 1: Understanding the Fundamental

Concepts of Pharmacology

Pharmacology- the branch of medicine

concerned with the uses, effects, and modes of
action of drugs.

Paracelsus- is the Father of Pharmacology.

Branch of Pharmacology

• Pharmacodynamics- What the drug

does to body
• Pharmacokinetics- What the body does
to drug
• Pharmacotherapeutics- The study of the
use of drugs
• Pharmacy-Preparing suitable dosage
forms
• Posology-The study of drug dosage
• Toxicology-The study of nature, effects
and detection of poisons

Dose- Refers to the quantity of drug

administered at one time (ex: 500mg
PARACETAMOL)

Dosage-Refers to the amount of drug that

should be given over time (ex: 500mg
PARACETAMOL three times a day for 3 days)

Drugs- Dutch droog, meaning dry; are chemical

substances that have an effect on living
organisms.

Medicines- therapeutic drugs used in the

treatment of diseases.

Nice to know Story:

Naming Drugs in 3 Ways (Drug
Nomenclature)

1. Chemical Name- are the scientific names

based on the molecular structure of the drug.

The exact formula of the drug. Describes the

drug’s chemical structure. Includes chemical
constitution of the drugs.

2. Trade Names a commercial name granted by

a naming authority for use in marketing
a drug/device product in a particular jurisdiction.

or,

Brand Names- the brand name is developed by Drug Information

the company requesting approval for the drug
and identifies it as the exclusive property of that
company. When a drug is under patent
protection, the company markets it under its
brand name. Also known as proprietary name, is
chosen by the drug company and is usually a
registered trademark owned by that specific
manufacturer.
4. Generic Name- means the name of a genus.
This term is usually used to name a class or
category of products or services. Common or
general name assigned to the drug; Is the official
or non-proprietary name for the drug.
• Indications: A list of medical
conditions or diseases for which the
drug is meant to be used.
• Action: A description of the cellular
changes that occur as a result of the
drug.
• Contraindication: A list of
conditions for which the drug should
not be given.
• Cautions: A list of conditions or
types of patients that warrant closer
observation for a specific side
effects when given the drug.
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• Side Effects and Adverse
Reactions: A list of possible
unpleasant or dangerous secondary
effects, other than the desired
effects. (listing is quite extensive)
• Interactions: A list of other drugs or
food that may alter the
effect of the drug and usually
should not be given during the
same course of therapy.
SOURCES OF DRUG INFORMATION
1. Drug Handbook
2. Physician Desk Reference (PDR)
3. Packet Insert
4. Nursing Journal
5. Medical Let
6. MIMS (Monthly Index of Medical
Specialties)
Drug Standards and Legislations
Drug Standards
• Are rules set to assure consumers
that they get what they pay for.
• The law says that all preparations
called by the same drug name must
be of uniform strength, quality and
purity.
1906 Pure Food And Drug Act
• First government attempt to
establish consumer protection in the
manufacture of drugs and foods.
• Required all drugs marketed to
meet minimal standards of strength,
purity and quality. (US)
Federal Legislations
• The primary purpose of this
legislation is to ensure
safety. America’s 1st law to
regulate drugs was the Federal
Pure Food and Drug Act of 1906,
which did not include drug
effectiveness and drug safety.
Food and Drug Administration (FDA)
• Concerned with general safety
standards in the production of
drugs, foods, and cosmetics.
• Responsible for approval and
removal of products on the market.
1938 Food, Drug and Cosmetic Act
• Establish to prevent adulteration of
and tampering with drugs, food and
cosmetics:
• All labels must be accurate and
must include the generic names.
• All new products must be approved
by the FDA before public release.
• “Warning” labels must be present on
certain preparations, for example,
“may cause drowsiness”, may
cause “nervousness”, and “may be
habit forming”.
1952: Durham-Humphrey Amendment to the
1938 Act
• The Durham-Humphrey
Amendment to the Food, Drug and
Cosmetic Act of 1938 distinguished
between drugs that can be sold with
or without prescription and those
that should not be refilled without a
new prescription, such as narcotics,
hypnotics, or tranquilizer must be so
labelled.
1962: Kefauver-Harris Amendment to the
1938 Act
• The Kefauver-Harris
amendment to the Food, Drug and
Cosmetic Act of 1938 resulted from
the widely publicized thalidomide
tragedy of the 1950s in which
pregnant European woman who
took thalidomide the sedative-
hypnotic thalidomide during the first
trimester of pregnancy gave birth to
infants with extreme limb
deformities.
• The Kefauver-Harris amendment
tightened controls on drug safety,
especially experimental drugs, and
required that adverse reactions and
contraindications must be labelled
and included in the literature.
1970: The Controlled Substances Act
• In 1970 The Controlled Substances
Act (CSA) of the Comprehensive
Drug Abuse Drug Abuse Prevention
and Control Act, Title II, was passed
by Congress.
• This act, designed to remedy the
escalating problem of drug abuse,
included several provisions:
1. The promotion of drug
education and research
into the prevention and
treatment of drug
dependence;
2. The strengthening of
enforcement authority;
3. The establishment of
treatment and
rehabilitation facilities;
4. The designation of
schedules, or
categories, for
controlled substances
according to abuse
liability.
1978: Drug Regulation Reform Act
• This reform act shortened the time
in which new drugs could be
developed and marketed.
1992: Drug Relation Act
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• The regulation were changed to • Malfeasance. Giving the correct

increase the approval rate of drugs drug but by the wrong route that
used to treat AIDS and cancer. The results in the client’s death.
pharmaceutical companies pay a
user fee at the time they file the
application for the new drug. The
fee is for the FDA drug approval
process.

1997: The Food and Drug Administration

Modernization Act

There are five provisions in this act, which

include the following:

1. review and use of new drugs is

accelerated;
2. drugs can be tested in children before
marketing;
3. clinical trial data is necessary for
experimental drug use for serious or life-
threatening health conditions;
4. drug companies are required to give
information on “off-label” drugs (non-
FDA approved drugs) and their uses
and costs; and
5. drug companies that plan to discontinue
drugs must inform health professionals
and clients at least 6 months before
stopping drug production.

Nurse Practice Act

• Every state has its own laws

regarding drug administration by
nurses.
• Generally, nurses cannot prescribe
or administer drugs without a health
care provider’s order, but state laws
vary. A practicing nurse should
request a copy of the nurse practice
act in the state in which she or he is
licensed.
• In some states, a nurse who
administers a drug without a
physician’s order is in violation of
the nurse practice act and could
have her or his license revoked.
• In a civil court, the nurse can be
prosecuted for giving the wrong
drug or dosage, omitting a drug
dose, or giving the drug by the
wrong route

Nursing Practice Act

• Offenses related to wrong

administration of drugs
• RA 9173- An act providing for a
more responsive nursing profession,
repealing for the purpose of RA no.
7164, otherwise known as "The
Philippine Nursing Act of 1991

The legal terms for these offenses are the

following:

• Misfeasance. Negligence; giving

the wrong drug or drug dose that
results in the client’s death
• Nonfeasance. Omission; omitting a
drug dose that results in the client’s
death