MODULE 1- BASIC CONCEPTS IN PHARMACOLOGY

Presentor
Joyce Acena, RN, MAN
GOAL: Understand foundational concepts relevant to
pharmacology

recall significant events in history leading to what

pharmacology is today

define the common terms used in drug administration

identify the phases of clinical trials

categorize drugs based on its regulated classification

ANCIENT Herbal Trading of
Elderly plants and Migration herbs and
TIMES animals animals
De Materia
Medica

Pharmacopeia
Source: Wiggins, J.M. and Albanese, J.A. (2019), A Brief History of Pharmacopeias: A Global
Perspective, Pharmacopeia Compliance Series
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 (EO No. 302,

Series 2004)
COMMON TERMINOLOGIES USED

Drug Pharmacology Pharmacokinetics

• A substance which has • The study of the • The process of drug
a physiological effect biological effects of movement to achieve
when ingested or chemicals on living drug action. The four
otherwise introduced organisms (Karch, processes that completes
into the body (Oxford 2016). pharmacokinetics include:
Dictionary) ADME-absorption,
distribution, metabolism
and excretion
(McCuistion, et al, 2018)
COMMON TERMINOLOGIES USED

Pharmacotherapeutics Drug Classifications Mechanism of Action

• Also known as clinical • Various categorization • This explains how the

pharmacology is the of drugs which include drug provides a
science which deals classification of drugs therapeutic effect
with use of drugs in according to: a) body including the effects
treatment, prevention systems; b) regulation that happen when the
and diagnosis of of substance abuse c) drug combines with
diseases (Karch 2016). therapeutic use , and cellular drug receptors
d) physiologic or (Woods,Vaughn, et.al,
chemical actions. 2020)
 COMMON TERMINOLOGIES USED
Therapeutic Indication
• The disease/s to be treated
by the given medicine and
the individuals for which it is
intended (EUPATI, 2020)
Contraindication
• The conditions and
circumstances which the
drug is undesirable to use
and caution must be given
(Woods,Vaughn, et.al, 2020)
Side effects
• Are secondary effects of
drugs which may be
predictable resulting to
either desirable or
undesirable effects. This
reaction may be different
from one patient to another
(McCuistion, et al, 2018).
 COMMON TERMINOLOGIES USED
Adverse drug reactions
(ADRs)
• Are drug effects which is • Occurs when drug
unintentional and/or
unexpected after
administration of drug in
normal dosage
(McCuistion, et al, 2018).
Drug toxicity
• The use of nursing
exceeds the therapeutic
drug level which may be
caused by improper
prescription and
administration and/or
due to genetics, age,
disease process
including co-morbidities.
Nursing responsibilities
process in drug
administration using
appropriate assessment,
diagnosis, plan of care,
intervention and
evaluation (ADPIE).
Phase Phase Phase Phase

1 2 3 4
Companies,
organizations and
individuals who
wish to introduce
new medications in
any country should
undergo clinical
trial under the
supervision,
monitoring, review
and approval of a
regulatory
commission of the
country where it is
to be used.

PHASES OF CLINICAL TRIAL

 FDA’s main function:
To protect and promote the right to health
DRUG of the Filipino people and to establish and
REGULATION maintain an effective health products
regulatory system responsive to the
country’s health needs and problems
Some other functions of the FDA
1. Establishes safety or efficacy standards and quality measures for foods, drugs and
cosmetics
2. Analyzes and inspects health products
3. Helps the public get the accurate, science-based information needed to use medicines
and foods to maintain and improve their health
4. Helps to speed innovations that make medicines more effective, safer, and more
affordable
5. Issues certificates of compliance, cease and desist orders
6. Conducts, supervises, monitors and audits research studies on health and safety issues of
health products
7. Prescribes standards, guidelines and regulations with respect to information,
advertisement and marketing
 DRUG CLASSIFICATIONS
Other
1 Classifications
THERAPEUTIC According to
THERAPEUTIC USE
CLASS According to
REGULATION OF
1-2-3 2 According to SUBSTANCE ABUSE
CHEMICAL AND
PHYSIOLOGIC ACTION
PHARMACOLOGIC According to

CLASS 3 According to
PREGNANCY
CATEGORY
1+2+3 BODY SYSTEMS
DRUG CLASSIFICATIONS
Classification EXAMPLES
According to BODY SYSTEMS CNS drugs, Cardiovascular drugs,
Respiratory drugs, Kidney drugs

According to THERAPEUTIC USE Antacids, Antibiotics, Antihypertensive,

diuretics, or laxatives
According to CHEMICAL and Anticholinergics, Beta-adrenergic
PHYSIOLOGIC ACTIONS blockers, Calcium channel blockers,
Cholinergics.
 Pregnancy Category
CATEGORY DESCRIPTION
Adequate studies in pregnant women have not demonstrated a risk to
the fetus in the first trimester of pregnancy, and no evidence of risk in
Category A
late trimester. Example include multivitamins

Animal studies have not demonstrated a risk to the fetus but there are no
Pregnancy adequate studies in pregnant human, OR;
Category B
Animal studies have shown an adverse effect, but adequate studies in
pregnant humans have not demonstrated a risk to the fetus in the first
trimester of pregnancy, and no evidence of risk in late trimester
Examples include certain antibiotics such Amoxicillin and Penicillin
 Pregnancy Category
CATEGORY DESCRIPTION
Pregnancy Animal studies have shown an adverse effect on the fetus but there are
Category C no adequate studies in humans; the benefits from the use of the drug in
pregnant women maybe acceptable despite its potential risks
Examples include Aspirin, Fluoroquinoles, Gentamicin

Pregnancy There is evidence of human fetal risk, but the potential benefits from the
Category D use of the drug in pregnant women may be acceptable despite its
potential risks
Examples include Tetracyclines, Chemotherapy drugs, ACE inhibitors
 Pregnancy Category
CATEGORY DESCRIPTION
Pregnancy Teratogenic. Evidence of fetal harm is established. May cause congenital
Category X disease or death of the fetus.
Example includes contraceptive drugs
 Substance Abuse Category
CATEGORY DESCRIPTION
Classification I Drugs or substances that have a high potential for abuse; no
Schedule 1 (S1) currently accepted medical use and have a lack of accepted safety
for use under medical supervision. (heroin, marijuana)

Classification II Drugs or substances that have a high potential for abuse; currently
Schedule 2 (S2) : have an accepted medical use in treatment but with severe
(Yellow prescription restrictions; abuse may lead to severe psychological or physical
drugs) dependence. (narcotics, amphetamines, barbiturates). purchaser
must be at least 18 years old, and all transactions must be recorded
by the dispensing pharmacist.
 Substance Abuse Category
CATEGORY DESCRIPTION

Classification III Drugs or substances that have a potential for abuse less than
Schedule 3 (S3) : Schedule I or II; currently have an accepted medical use; abuse may
lead to moderate or low physical and high psychological dependence.
(some sedatives, anti-anxiety and non-narcotic analgesics)
Classification IV Drugs or substances that have a low potential for abuse relative to
Schedule 4 (S4) : those listed in Schedule III; currently have an accepted medical use;
abuse may lead to limited physical or psychological dependence those
in schedule III.
Classification V Drugs or substances that have a low potential for abuse relative to
Schedule 5 (S5): Schedule IV; may not need prescription by a doctor (Over-the-Counter
or OTC drugs).