All drugs are poisons – what matters is the dose.

PARCELSUS (1493–1541)

UNIT I: Fundamental Concepts of Pharmacology

A. Drug Definitions and Classification
By: Krizelle Xyra T. Paguirigan, RPh
1. Pharmacology- from the
Greek pharmakon, meaning “drugs,”
and logos, meaning “science”
• is the study of substances that interact with
living systems through chemical processes,
especially by binding to regulatory molecules
and activating or inhibiting normal body
processes.
2. Toxicology- the branch of pharmacology that deals
with the undesirable effects of chemicals on living
systems, from individual cells to humans to complex
ecosystems
3. Pharmacotherapeutics- or Clinical Pharmacology
• is the branch of pharmacology that uses
drugs to treat, prevent and diagnose disease.
 DRUG DEFINITION
As defined by the FDA:
a. A substance recognized by an official pharmacopoeia or
national formulary (USP NF).
b. A substance intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease.
c. A substance (other than food) intended to affect the
structure or any function of the body.
d. A substance intended for use as component of a medicine
but not a device or a component, part or accessory of a
device.
e. Biological products are included within this definition and is
generally covered by the same laws and regulations, but
differences exist regarding their manufacturing processes
(chemical processes vs biological processes).
 Drug Nomenclature
1. Chemical Name- contains the chemical composition and molecular
structure of the drug.
• For example, Eg.// N-acetyl-p-amino-phenol
2. Generic name- also know as the Common Name or Non-Proprietary Name.
• It usually contains the active ingredients of drugs.
• Eg.// acetaminophen/paracetamol
3. Brand Name- also known as Proprietary Name or Trademark Name. It is
usually followed by the letter ®.
• Eg.// Tylenol®
 I.B. Drug Classification
1. Number of Active Ingredients
a. Single ingredient eg. Paracetamol (Biogesic®)
b. Fixed- dose combination of 2 or more ingredient
eg. Aluminum hydroxide/Magnesium hydroxide (Maalox®)
2. Available scientific Evidence and Experience on drug use
a. Investigational New drug (IND): a new drug or biological drug that is used in a clinical investigation. The term
also includes a biological product that is used in vitro for diagnostic purposes.
b. New drug: refers to new chemical or structural modification of a tried and tested or established drug proposed
to be used for a specific therapeutic indication.
c. Tried and tested drug: A drug which has been used for at least 5 years in the market and involves at least
5,000 patients.
d. Established drug: safety and efficacy has been demonstrated through long years of general use. It is
recognized by the USP-NF and other internationally recognized pharmacopoeias.
e. Pharmaceutical or Therapeutic innovation of a trial and tested or Established drug
• An innovation involving use for new indications
• An innovation involving a new mode of administration
• An innovation involving new dosage from
• An innovation involving a new fixed dose combination of two or more active ingredients
Clinical Trial
• A research study in which one or more human subjects are prospectively
assigned to one or more interventions to evaluate the effects of those
interventions on health-related biomedical or behavioral outcomes.”
• Clinical trials are important in determining which medical approaches work
best for certain types of illnesses or specific groups of people.
 Clinical Trials
PHASE I Trial Clinical trials using healthy individuals are conducted to determine the drug’s basic properties
and safety profile in humans. Typically the drug remains in this stage for one to two
years. Usually 20 to 80 people.
Approximately 70% of drugs move to the next phase
PHASE II Trial Uses more people (100 to 300). This emphasis in Phase II is on effectiveness. This phase aims
to obtain preliminary data on whether the drug works in people who have a certaain disease or
condition. These trials also continue to study safety, including short-terms side effects.
Length of Study: Several months to 2 years
Approximately 33% of drugs move to the next phase
PHASE III Trial The experimental drug or treatment being studied is given to large groups of people.
Researchers will use these trials to confirm the drug’s efficacy, monitor side effects, compare it
to other commonly used treatments or to a placebo, and collect information to ensure safe use
of the drug or treatment. Study Participants: 300 to 3,000 volunteers who have the disease or
condition. Length of Study: 1 to 4 years
Approximately 25-30% of drugs move to the next phase
PHASE IV Trial Studies done at this stage are designed to evaluate the long-term risks and benefits of a
medication. This phase can also determine more about the side effects, interactions with other
drugs, and how well it works when it’s more widely used.
Study Participants: Several thousand volunteers who have the disease/condition
NDA Classification

• The NDA classification code

system was developed to enable
identification and grouping of
product applications received by
the FDA.
• This classification is based on
characteristics of the product in
the application and their
relationships to products already
approved or marketed in the
United States (Table 1).
• This code was previously referred
to as a Chemistry Classification
Code.
 3. Their Therapeutic use or clinical indications (e.g., antacids, antibiotics,
antihypertensives, diuretics, laxatives) as aspecified by the PH National
Formulary
4. Their Physiologic or chemical action (e.g., anticholinergics, beta-
adrenergic blockers, calcium channel blockers, cholinergics.
5. The family or active ingredient they have.
• An active ingredient is any component that provides pharmacological activity or
other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of
disease, or to affect the structure or any function of the body of man or animals.

Drug classifications by family Drug classification by Drug classification by

(or active ingredient) physiological effect therapeutic effect
Barbiturates Selective serotonin-reuptake Antidepressants
inhibitors (SSRIs)
Penicillin Antibiotics Antimicrobial
Heparin (and mimetics) Anti-coagulants Antithrombotics
ACE inhibitors Diuretics Antihypertensives
 6. ATC Classification
System:
• It was first published in 1976
Controlled by the World Health Organization
Collaborating Centre for Drug Statistics Methodology
(WHOCC).
Level 1: Describes the organ system the drug treats
Level 2: Describes the drug’s therapeutic effect
Level 3: Describes the mechanism of action
Level 4: Describes the general chemical properties of the drug
Level 5: Describes the chemical components that make up the drug
LEVEL 1: The system has fourteen main anatomical or pharmacological groups
7. USP Drug Classification
This tool has the potential to provide guidance towards the design
and comparison of balanced formularies.
• Category 1: Therapeutic use
• Category 2: Mechanism of action/ Pharmacologic Class
• Category 3: Formulary classification

Therapeutic Category Pharmacologic Class Formulary Key Drug Types

Amino Derivative Penicillins, Extended Spectrum
Antibacterials Beta-lactam, Penicillins
Penicillins
Blood Glucose Protease Inhibitors
Coagulants
Regulators
Calcium Channel Blocking Calcium Channel Blocking Agents (Non-
Cardiovascular Agents
Agents dihydropyridines)
Respiratory Tract Antihistamines Histamine1 (H1) Blocking Agents, Mildly/Non-
Agents sedating
Reading Assignment: 49 Drug categories of the USP Drug Classification
8. Prescribing and Dispensing Regulations

1. Prescription drugs requires a doctor's authorization to purchase. Contains the symbol Rx.
2. Non-prescription or Over-the-counter (OTC) drugs are safe and effective drugs used
by the general public without a doctor's prescription. No Rx symbol on the label.
3. Non-controlled drugs: Most prescriptions for infections or chronic conditions for example,
blood pressure and cholesterol medications, diabetes medications.
4. Controlled drugs: require additional care in their prescription and administration, as these
drugs have the capability to either cause significant harm to patients if taken incorrectly, or
have the potential to be abused. Harm can be characterized as physiological damage,
mental harm, or causing psychological and physiological dependence.
• Illegal Drugs- which are sometimes referred to as Recreational Drugs, are drugs or
chemical substances used for non-therapeutic purposes. These substances are
obtained illegally or have not received approval for use by the FDA.
9. By the potential risk they pose when administered
during pregnancy.
• Some drugs, such as
diethylstilboestrol
(thalidomide), have the
potential to cause congenital
malformation (teratogenesis)
when administered in the first
trimester.
10. By Lactation Risk Categories
 Implications of Drug
Classification Systems for
Nurses
Nurses need to fully understand the way
medications are named as confusion between
names can lead to medication errors and thus
affect patient safety as some product names are
very similar.
• “SALAD” Sound Alike Look Alike Drugs/
“LASA” Look Alike Sound Alike
Classification systems enable us to readily
identify the similarities and differences among a
large number of medications within and outside of
a particular classification
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II. Drug Standards and
Drug Information
To determine if the drugs you are
administering are safe, you must first
check the integrity of the packaging,
the label and the package insert or
drug literature/ information. The
following information should be
indicated as prescribed by the law.
A. Drug Standards

Drug products made by different manufacturers or in

different batches by the same manufacturer must be
uniformly pure, potent, and effective.
1. Potency: (strength) refers to the amount of drug
(usually expressed in milligrams) needed to produce
an effect.
2. Purity: is a drug's capacity to produce an effect.
3. Effectiveness: takes into account how well a drug
works in real-world use.
 Sources of Drug Standards
1. Pharmacopoeia: a legally binding collection of standards
and quality specifications for medicines used in a country
or region.
• The word “pharmacopoeia” translates from the
ancient Greek as “drug-making”
• The International Pharmacopoeia (Ph. Int.): is issued
by WHO as a recommendation with the aim of
providing international standards.
• Examples: USP (United States Pharmacopoeia), The
European Pharmacopoeia (EP),The British
Pharmacopoeia (BP), and the Japanese
Pharmacopoeia (JP)
2. National Formulary: a manual containing clinically
oriented summaries of pharmacological information about
selected drugs. The manual may also include
administrative and regulatory information pertaining to the
prescribing and dispensing of drugs.
• Example: Philippine National Drug Formulary (PNDF),
British National Formulary,
3. Drup Monographs
• A publication that specifies for a drug
(or class of related drugs) the kinds
and amount of ingredients it may
contain, the conditions and limitations
for which it may be offeresd,
directions for use, warnings and other
information its labeling must ontain.
• It also contains important information
concerning the interactions with other
drugs.
II. Drug Information
1. Package Inserts and Labels:
• Labels and inserts are
important markers that
describe and explain who,
what, where, when, why and
how of the drug.
• How the drug is prescribed for,
What is the drug, Where is the
drug administered, When to
administer the drug, Why is the
drug used, How to administer
the drug.
2. Nursing Journals

• articles about drug therapy as it relates to a specific field

of interest (Journal of Nursing Education and Practice, ).
• Nursing journals such as Advances in Nursing Science,
The International Journal of Nursing Studies
(IJNS) provide drug updates and articles that discuss
nursing considerations related to drug therapy and drugs.
• The Philippine Journal of Nursing, is the official
publication of the Philippines Nurses Association
published biannually.
• It considers original articles written for, but not
limited to, Filipino nurses at all levels of health
care organizations and in various settings.
3. Electronic Databases
[Link] is a cumulative index of nursing and allied health literature.
• It is the largest and most well-known specialist international
database of literature in nursing.
2. Medline is the largest and most well-known bibliographic database of
health care literature.
3. UpToDate, Lexi-Comp, and ePocrates are three vendors with several
different packages of regularly updated information
• Lexi-Comp has a particularly strong database, because the
American Hospital Formulary Service is available through its portal.
4. Journals@Ovid. This database helps researchers, librarians, clinicians,
and other healthcare professionals find important medical information so that
they can make critical decisions to improve patient care, enhance ongoing
research, and fuel new discoveries.
5. The DailyMed system makes available to health care providers and the
public a standard, comprehensive, up-to-date resource about medicines.
 Medications have great power both to help and to
harm patients. Having an understanding of the basics
of pharmacology will allow clinicians and healthcare
providers to better serve their patients.