PHARMACOLOGY

TRANSCRIBED BY: MARTH JASMINE M. ALLEJOS, SN

skill and understanding of the

I. Fundamental Concepts of administration of medications in all
Pharmacology settings.
 To help each nurse observe and
Drug Definitions and Classification understand the therapeutic effects
and adverse effects of these drugs
on each patient.
PHARMACOLOGY
 The word Pharmacology is derived
from Greek – pharmacon means
drug and logos means study.
 Pharmacology is the science that IMPORTANCE OF PHARMACOLOGY
deals with the study of drugs and IN NURSING
their interaction with the living
systems.  Pharmacology plays a critical role
in the field of nursing. An in-depth
understanding of the subject assists
nurses in safe medication
administration. Safe medication
administration reduces medication
errors and promotes better patient
 Pharmacology is the scientific outcomes.
study of the effects of drugs and  Nurses use their knowledge of
chemicals on living organisms where pharmacology to manage patient
a drug can be broadly defined as care appropriately. This includes:
any chemical substance, natural or  monitoring medication
synthetic, which affects a biological  managing side effects
system.  evaluating drug effectiveness
 patient and family education
regarding medication
 collaboration with the
PHARMACOLOGY IN NURSING: AN interdisciplinary team.
OVERVIEW
DRUG
 The study of pharmacology focuses
on the use of drugs and their role in  In pharmacology, a drug is a
preventing and treating diseases. chemical substance, typically of
 The effects on the body, such as: known structure, which, when
 side effects administered to a living organism,
 drug interactions produces a biological effect.
 adverse reactions - are all  A pharmaceutical drug, also
components of pharmacology called a medication or medicine,
studies. is a chemical substance used to
treat, cure, prevent, or diagnose a
MAIN GOAL OF NURSING disease or to promote well-being.
PHARMACOLOGY  The importance of drugs: Some
drugs replace missing substances or
 To help clients return to optimal correct low levels of natural body
health by increasing the level of chemicals such as some hormones

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or vitamins. Medicines can even

affect parts of the nervous system
that control a body process. Nearly
everyone has taken an antibiotic
this type of medicine fights bacterial
infections.
 The word Drug, taken from French
word Drogue which means Dry
Herb, strongly suggests that FOOD AND DRUG ADMINISTRATION
earliest drugs were taken out from
plant sources. Earliest people used FDA came from;
to treat diseases by some  Silver Spring, Maryland, U.S.
unconventional methods, using  The FDA's primary focus is
plants, animal products and enforcement of the federal food,
minerals, of them plants were given drug, and cosmetic act (FD&C).
priority. However, the agency also enforces
 A drug is any chemical substance other laws, notably section 361 of
other than a nutrient or an essential the public health service act as well
dietary ingredient, which, when as associated regulations.
administered to a living organism,  Beginning as the Division of
produces a biological effect. Chemistry and then (after July
 Drugs are substances that change a 1901) the Bureau of Chemistry,
person's mental or physical state. the modern era of the FDA dates to
They can affect the way your brain 1906 with the passage of the
works, how you feel and behave, Federal Food and Drugs Act; this
your understanding and your added regulatory functions to the
senses. This makes them agency's scientific mission.
unpredictable and dangerous,  The federal regulation of food,
especially for young people. The drugs, cosmetics, biologics,
effects of drugs are different for medical products and tobacco is
each person and drug. legally mandated by acts of the
United States Congress. Since
BASIC CONCEPT OF DRUG the early-20th century, the laws that
establish FDA's regulatory authority
 A drug is a substance that can be have been modified to cover new
taken into the human body and, product areas, expand enforcement
once taken, alters some processes powers, provide for new funding
within the body. sources, modernize surveillance,
 Drugs can be used in the diagnosis, inspection and investigative
prevention, or treatment of a methods and enhance public
disease. Some drugs are used to kill education efforts.
bacteria and help the body recover  The Food and Drug
from infections. Administration (FDA) is
responsible for protecting the public
health by assuring the safety,
efficacy, and security of human and
veterinary drugs, biological
products, medical devices, our
nation's food supply, cosmetics, and
products that emit radiation.

Food and Drug Administration

stands for Philippines

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 As a regulatory agency under the The Five(5) Drug Development

Department of Health, the Food and Phases
Drug Administration, created under
Republic Act No. 3720, series of 1. Discovery and Development
1963, as amended by Executive 2. Preclinical Research
Order 175, series of 1987, 3. Clinical Research
otherwise known as the “Food, 4. FDA Review
Drugs and Devices, and 5. FDA post-market safety
Cosmetics Act”, and subsequently monitoring
Republic Act No. 9711 otherwise
known as “The Food and Drug PROCESS OF DRUG DISCOVERY
Administration Act of 2009”, is AND MANUFACTURING TAKES 10-12
mandated to ensure the safety, YEAR
efficacy or quality of health products
as defined by RA No. 97111, which
include means food, drugs,
cosmetics, devices, biologicals,
vaccines, in-vitro diagnostic
reagents, radiation-emitting devices
or equipment, and household/urban
hazardous substances, including
pesticides and toys, or consumer
products that may have an effect on
health which require regulations as
determined by the FDA.

Approval of New Drugs by the US

Food and Drug Administration

 Approval of new drugs has been

steady since the early 2000s,
reaching an all-time high in 2014
with the approval of 44 new drugs.
 To facilitate this increase, in 2004
the FDA established its Critical Path
Initiative, a national strategy : to
driven innovation in the scientific
process through which medical
products are developed, evaluated,
and manufactured.
 One focus of this initiative is on “
improving the prevention, diagnosis,
and treatment of rare and neglected
disorders”.
 Initiative successes include:
 Developing biomarkers and other
scientific tools
 Streamlining clinical trials
 Ensuring product safety

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Drug Standard and Drug

Information

DRUG STANDARD

 A drug reference standard or

pharmaceutical reference
standard is a highly characterized
material suitable to test the identity,
strength, quality and purity of
substances for pharmaceutical use
and medicinal products.

DRUG INFORMATION

 It is called drug information,

medication information, or drug
informatics. It's really the
discovery, use, and management of
information in the use of
medications. Drug information
covers the gamut from
identification, cost, and
pharmacokinetics to dosage and
adverse effects.
How to classify Drug or
Medications?

 Drugs can be classified based upon

their similar chemical structures,
how they work, or which
diseases and disorders they
treat. associated vocabulary and
differ- entiate between brand and
generic drugs.

Drug Classification

Drugs can be categorized by the way

Three(3) Drug Types of name
in which they affect our bodies:
 In the majority of
DEPRESSANTS
circumstances, drugs have 3
 slow down the function of the
types of names:
central nervous system.

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CHEMICAL NAMES effect and the dose needed to elicit

therapeutic effects.
 the most important of which is  The therapeutic index (TI; also
the IUPAC name referred to as therapeutic ratio) is a
quantitative measurement of the
GENERIC/NON-PROPRIETARY relative safety of a drug. It is a
NAMES comparison of the amount of a
therapeutic agent that causes
 the most important of which are toxicity to the amount that causes
International Nonproprietary the therapeutic effect.
Names (INNs)  The therapeutic index of a drug is
the ratio of the dose that exerts
TRADE NAMES/PROPRIETARY toxicity in 50% of the population
NAMES (TD50) to the dose that exerts a
therapeutic or effective response
 which are brand names. (ED50) in 50% of the population
(TI=TD50 / ED50).
 Therapeutic index can also be
derived from the ratio of the lethal,
instead of toxic, dose in 50% of the
population (LD50) that is measured
in animal studies. The term
represents the safety margin of a
particular drug for clinical use, as
high therapeutic index values
indicate a wide margin between
effective and toxic doses.
PHARMACODYNAMICS
INDEX OF SAFETY OF A DRUG

PHARMACODYNAMICS  The therapeutic index of a drug is a

key parameter in pharmacology that
 It comes from the Greek words quantifies the relative safety of a
"pharmakon," meaning "drug," drug by calculating the ratio
and "dynamikos," meaning between the dose that causes
"power.“ toxicity in half the population (50%)
to the dose that proves to be
 It is the study of a drug's effective for half the population
molecular, biochemical, and (50%).
physiologic effects or actions of
drugs. The effects can include WHY HIGH THERAPETIC INDEX
those manifested within animals, GOOD?
microorganisms, or combinations of
organisms.  The larger the therapeutic index
(TI), the safer the drug is.
C.1 THERAPEUTIC INDEX AND  If the TI is small (the difference
DRUG SAFETY between the two concentrations is
very small), the drug must be dosed
THERAPEUTIC INDEX carefully and the person receiving
the drug should be monitored
 is a ratio that expresses the closely for any signs of drug toxicity.
relationship between the dose
expected to elicit some adverse WHEN A DRUG HAS A LOW

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THERAPEUTIC INDEX? safety of a drug. It is the ratio of the

dose that produces toxicity to the
 Narrow therapeutic index (NTI) dose needed to produce the desired
drugs are drugs where small therapeutic response.
differences in dose or blood
concentration may lead to serious POTENTIAL PHARMACOVIGILANCE
therapeutic failures and/or adverse STRATEGIES FOR BIOSIMILARS
drug reactions that are life-
threatening or result in persistent or
significant disability or incapacity.

DRUG SAFETY

 Drug safety (also known as

pharmacovigilance) is the science of
detection, assessment,
understanding, and prevention of
side effects, which allows us to
understand more about the risks
and benefits of a medicine (WHO,
2002). From: clinical case studies on
medication safety, 2023.

MEDICATION SAFETY

 is defined as the freedom from

accidental injury due to medical
care or. medical errors during the
medication-use. process, deserves
the same prioritization, given the
scope of medication use in patient
care and the frequency and severity
of potential harm.

PURPOSE OF DRUG SAFETY

 Drug safety is the science of

detection, assessment,
understanding and prevention of
side effects which allows us to
understand more about the risks
and benefits of a medicine.

HOW DO YOU DETERMINE THE

SAFETY OF A DRUG

 The Therapeutic Index (TI) is used to

compare the therapeutically
effective dose to the toxic dose of a
pharmaceutical agent.
 The TI is a statement of relative

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response end-points which are seen

when dose is increased.

THERAPEUTIC RESPONSE

 A therapeutic response is a
consequence of a medical treatment
of any kind, the results of which are
judged to be desirable and
C.2 GRADED DOSE RESPONSE beneficial. This is true whether the
RELATIONSHIP AND THERAPEUTIC result was expected, unexpected, or
RESPONSE even an unintended consequence of
the treatment.
GRADED DOSE-RESPONSE  THERAPEUTIC RESPONSE METHOD
RELATIONSHIP - this method is based on observing
the clinical response to a drug
 describes a drug effect which formulation given to patients
increases in proportion to increasing suffering from disease for which it is
drug dose. intended to be used.
 A graded response to a drug is seen
in an individual, and increases with THERAPEUTIC RESPONSE TO
dose. MEDICATION
 Dose-response relationships may be
graded or quantal.  The therapeutic effects of a drug are
defined as the specific, desired
effects of drug administration.
 For example, a physician may
prescribe a narcotic to relive pain;
the relief of pain is the therapeutic
effect.
QUANTAL DOSE-RESPONSE  Therapeutic responses in nursing
RELATIONSHIPS are actionable items in which the
nurse listens, responds, or acts
 A quantal dose-response appropriately in a way that may
relationship describes a drug effect provide comfort to the patient.
which is binary (either present or  Nurses may therapeutically respond
absent). by: offering patient-specific
 A quantal response to a drug is suggestions to the medical team.
observed in a population, and is
either present or absent in any
single individual.
 Quantal dose-response graphs plot
the rate of an outcome occurrence
in a population against the drug C.3 POTENCY AND EFFICACY
dose.
 A drug's effect can be evaluated in
ORDERED DOSE-RESPONSE terms of potency and efficacy.
RELATIONSHIPS
POTENCY EFFICACY
 An ordered dose-response Strength Refers to the
relationship is a sequence of quantal refers to the relative ability of
dose-response relationships amount of drug a drug-receptor
which represent several quantal (usually complex to

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expressed in produce a sequence of biochemical events is

milligrams)neede maximum usually initiated.
d to produce a functional  Receptors may be located on the
given effect. response. cell membrane, in the cytosol or in
Potency is the the nucleus.
intensity of effect  Drug-receptor interactions are
produced for a characterized by affinity, potency
given drug dose. and efficacy.
 There are four main classes of
receptors:
Potency is the Efficacy is getting 1. G-protein-coupled receptors;
intensity of effect things done. It is 2. ligand-gated ion channels
produced for a the ability to 3. intracellular receptors
given drug dose. produce a desired 4. tyrosine kinase-coupled receptors.
Two drugs can be amount of the
equiefficacious desired effect, or  Drugs may act outside the cell, at
(i.e., produce the success in the cell membrane, or inside the
same maximal achieving a given cell. Regardless of cell localization,
response) but goal. the drug action may be mediated by
vary in potency receptors or can be independent of
(dose required to receptors.
produce the  Drug action of similar importance is
response). information about the drug's action
or effect. Data submitted to the FDA
Drug potency is a drug's should show known and predictable
depends on the capacity to pharmacodynamics of the drug with
affinity of a drug produce an effect its intended target (primary
for the receptor such as lowering pharmacodynamics) but also that if
(i.e., tendency for blood pressure. the drug has off-target binding or
the drug to bind efficacy (i.e., interaction that could lead to
to the receptor) ability to produce unanticipated or deleterious effects.
an effect). The majority of these studies can be
conducted in vitro.
Example, relief of For example, a
pain or reduction drug may have DRUG ACTION
of blood pressure. high efficacy in
lowering blood  initial consequence of drug–
pressure but may receptor combination.
have low
effectiveness DRUG EFFECT
because it causes
so many adverse  biochemical and physiological
effects that changes that occur as a
patients stop consequence of drug action.
taking it.
C.5 Types of Drug Receptor
C.4 CELLULAR RECEPTORS AND Interactions
DRUG ACTION
 Drug–receptor interactions involve
 Many drugs interact with specific all known types of bond:
cellular proteins known as receptors.  Ionic interaction – between atoms
 As a result of this interaction, with opposite charges, stronger than
activation or inhibition of a hydrogen, weaker than covalent

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 Hydrogen binding - stronger

 Van der waals – weak forces AGONIST
 Covalent – essentially irreversible
 Drugs with short duration of action  A chemical substance that binds to
generally have weaker bonds; long- and activates certain receptors on
duration or irreversible drug– cells, causing a biological response.
receptor interactions may have  Examples of Opioid Receptor
stronger bonds such as covalent. Agonists:
 Oxycodone, Morphine, Heroin,
 Drugs interact with receptors by Fentanyl, Methadone, and
means of chemical bonds. The three Endorphins
major types of drug-receptor bonds
are: ANTAGONIST
 Covalent
 Electrostatic  A chemical substance that binds to
 Hydrophobic and blocks the activation of certain
receptors on cells, preventing a
THREE(3) MAJOR TYPES OF DRUG- biological response. A substance
RECEPTOR BONDS that stops the action or effect of
another substance.
1. Covalent drugs block protein  For example, a drug that blocks the
function by forming a specific bond stimulating effect of estrogen
between the ligand and target on a tumor cell is called an estrogen
protein. receptor antagonist.
A covalent mechanism of action can
provide many pharmacological
advantages over a reversible
mechanism of action  these
advantages include: Four(4) Main Types of Receptors
> enhanced potency
> selectivity  Nuclear receptors
> prolonged duration of  Enzyme-linked receptors
action.  G-protein coupled receptors
Examples of covalent bonds  Ligand-gated ion channels.
include: water, carbon dioxide,
ammonia, ozone, glucose, carbon
monoxide, methane, phosphorus PHARMACOKINETICS
trichloride, fructose, and chlorine
gas.
PHARMACOKINETICS
2. Most drug-receptor interactions occur
through electrostatic interactions, Pharmacokinetics is the discipline
ranging from strong ionic linkages to within clinical pharmacology that
weaker hydrogen bonds and van der broadly describes the changes in the
waals forces. quantity of drug and/or drug metabolite
in various body compartments over
3. The hydrophobic effect occurs when time.
lipophilic drugs interact with  These changes can be described by
hydrophobic pockets within receptors, four processes:
excluding surrounding water molecules. 1. absorption
2. distribution
EXAMPLE OF A DRUG THAT BINDS 3. metabolism
TO A RECEPTOR 4. excretion.
 Pharmacokinetics, as a

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field, attempts to summarize the drug.

movement of drugs throughout the  Whether any other drugs have been
body and the actions of the body on taken around the same time.
the drug. By using the above terms,  A person's mood or the environment
theories, and equations, they are in.
practitioners can better estimate the
locations and concentrations of a FACTORS INFLUENCING RESPONSE
drug in different areas of the body. TO DRUG IN HUMANS
 Pharmacokinetics, sometimes
abbreviated as PK, is a branch of  Overview of Response to Drugs
pharmacology dedicated to  Genetic makeup.
describing how the body affects a  Age.
specific substance after  Body size.
administration. The substances of  Use of other drugs and dietary
interest include any chemical supplements (such as medicinal
xenobiotic such as pharmaceutical herbs)
drugs, pesticides, food additives,  Consumption of food (including
cosmetics, etc. beverages)
 Presence of diseases (such as
kidney or liver disease)
 Storage of the drug (whether the
drug was stored too long or in the
wrong environment)

SIX(6) FACTORS THAT INFLUENCE

DRUG ACTION

 Route of administration
FACTORS INFLUENCING RESPONSES  Rate and degree of absorption
TO DRUGS  Rate of elimination
 Effect of other drugs
 Tolerance
INCLUDES;  Idiosyncrasy and allergy
 Route Of Drug Administration  Disease
 Dosing Frequency
 Biological Factors Including Renal Drug Legislation Controlled
And Hepatic Function Substances,
 Drug–drug, Drug–food, And Drug– Generic Drugs, Orphan Drugs,
hormone Interactions and Over the Counter Drugs
 Therapeutic Regimen Compliance
 Genetic Variation
 Drug response or adverse effect is Drug Legislation Controlled
the net effect of multiple factors: Substances
age, organ function, concomitant
therapy, drug interactions, and  Prior to the generics act of 1988,
disease. the following general guidelines on
prescribing have been operative. In
How a drug affects an individual is order to have an integrated
dependent on: implementation of all relevant
guidelines on prescribing, these
 Body size. guidelines based on prior laws are
 General health. restated
 The amount and strength of the  The imposition of the above

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sanctions does not preclude the law for conduct relating to the
institution of appropriate criminal development or approval, including
proceedings pursuant to section 12 the process for development or
of R.A. 6675 known as the approval, of any Abbreviated Drug
“generics act of 1988”, R.A. Application (ADA) be debarred from
3720 known as “food, drug and submitting, or assisting in the
devices and cosmetics act” as submission of, any ADA.
amended, and R.A. 5921 known as
“pharmacy law” as amended, Top 10 Most Common Generic
R.A. 382 or the veterinary Medications
practice act, R.A. 6425 known
as the “dangerous drugs act of 1. Albuterol (Accuneb, Ventolin, Proair,
1972” as amended, R.A. 1556 Proventil)
known as the “livestock and 2. Levothyroxine (Synthroid, Unithroid,
poultry feed act”, R.A. 1071, RA. Levoxyl, Levo-t,
3101, and other relevant laws, upon 3. Euthyrox)
receipt of complaints or reports of 4. Amlodipine (Norvasc, Amvaz)
violations. 5. Gabapentin (Neurontin)
 A drug or other substance that is 6. Omeprazole (Prilosec)
tightly controlled by the government 7. Metformin (Glucophage)
because it may be abused or cause 8. Losartan (Cozaar) Drug Class: Arb's.
addiction. The control applies to the 9. Metoprolol (Toprol, Lopressor)
way the substance is made, used,
handled, stored, and distributed. ORPHAN DRUGS
 Controlled substances include:
 Opioids  The Orphan Drug Act (ODA) [1], first
 Stimulants enacted in the United States in
 Depressants 1983, was set up to encourage the
 Hallucinogens development of drugs for rare
 Anabolic steroids. diseases. At that time, drug
therapies for such diseases were
GENERIC DRUGS rarely developed.

 Generics act of 1988 (Republic  The Orphan Drug Act of 1983 is a

Act no. 6675) law passed in the united states to
 An act to promote, require and facilitate development of orphan
ensure the production of an drugs—drugs for rare diseases such
adequate supply, distribution, use as Huntington's disease, Myoclonus,
and acceptance of drugs and ALS, Tourette syndrome or muscular
medicines identified by their generic dystrophy which affect small
names. To promote drug safety by numbers of individuals residing in
minimizing duplication in the united states.
medications and/or use of drugs  The FDA has authority to grant
with potentially adverse drug orphan drug designation to a drug or
interactions. biological product to prevent,
diagnose or treat a rare disease or
 Generic Drug Enforcement Act condition. Orphan drug designation
of 1992 qualifies sponsors for incentives
 Amends the Federal Food, Drug, and including: tax credits for qualified
Cosmetic Act to require that any clinical trials. Exemption from user
person, other than an individual, fees.
convicted after the enactment of
this Act of a felony under Federal Examples of orphan drugs include:

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ALGLUCERASE

 a treatment for Gaucher disease,

which causes pain and damage to
tissue in the liver, spleen, lungs and
bone marrow.

IVACAFTOR

 a therapy to treat cystic fibrosis, a

genetic disorder that causes
problems with breathing and
digestion and affects about 30,000
Americans.

OVER THE COUNTER DRUGS

 Over-the-counter (OTC) medicines

are those that can be sold directly to
people without a prescription.

 OTC medicines treat a variety of

illnesses and their symptoms
including pain, coughs and colds,
diarrhea, constipation, acne, and
others.

10 most common over-the-counter

medicines used worldwide include:

1. Acetaminophen.
2. Ibuprofen.
3. Fexofenadine.
4. Loratadine.
5. Hydrocortisone Creams.
6. Dextromethorphan.
7. Pseudoephedrine.
8. Bismuth Subsalicylate.

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