Introduction & Drug Evaluation (Pharmaco)

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GODDY M. MANZANO JR.,MAN, R.N.

Instructor
LEARNING OBJECTIVES
✔ Define the word pharmacology,
pharmacognosy, pharmacy,
pharmacotherapeutics, toxicology, pharmacy
and chemotherapy.
✔ Know the history of pharmacology.
✔ What will need to know about drugs,
✔ Outline the steps involved in developing and
approving a new drug
PHARMACOLOGY
Etymologically, it is the science of drugs.
Pharmacology is derived from Greek words:
Pharmacon = Drug
Logos = Discourse in / study
✔ It is the study of how chemical agents affect
living processes.
✔ It studies the effects of drugs and how they
exert their effects to the body.
PHARMACOLOGY
Pharmacology is the branch of biology
concerned with the study of drug
action.

It deals with interaction of exogenously


administered drugs with living
systems.
PHARMACOTHERAPEUTICS
✔ Otherwise known as clinical
pharmacology, the branch of
pharmacology that uses drugs to
treat, prevent, and diagnose disease.
✔ Addresses two key concerns: the
drug’s effects on the body and the
body’s response to the drug.
PHARMACOGNOSY
• branch of pharmacology
dealing with natural
drugs & their
constituents.
• deals with the sources,
procurement & chemistry
of natural products.
PHARMATHERAPEUTICS
⚫treatment of
diseases with
medicines.
TOXICOLOGY
⚫study of
poisons
CHEMOTHERAPY
⚫ The use of
chemicals for the
treatment of any
disease.
⚫ May also be
synonymous to
cancer treatment.
PHARMACY
⚫ The science of
identification,
compounding and
dispensing of drugs.
⚫ It also includes collection,
isolation, purification,
synthesis and
standardization of medical
substances.
PHARMACOLOGY HISTORY
⚫ MATERIA MEDICA Latin
(medical material)
• Body of collected knowledge
about the therapeutic
properties of any substance
used for healing.• Derived
from work of ancient Greek
physician DIOSCORIDES in
1st century AD
PHARMACOLOGY HISTORY
⚫ The term material
medica was used from
the Roman Empire until
the 20th century but
now has been replaced
in medical education
contexts by the term
P H A R M A C O L O G Y.
PHARMACOLOGY HISTORY
⚫ 1st extensive PHARMACOPEIA
commentary on 600 plants along
with therapeutically useful animal
and mineral products.
⚫ De Materia Medica included
about a thousand natural product
drugs (mostly plant-based), 4,740
medicinal usages for drugs, and
360 medical properties
(antiseptic, anti-inflammatory
etc.)
PHARMACOLOGY HISTORY
ANCIENT EGYPT
⚫ The EBERS PAPYRUS is
an Egyprtian Medical
Papyrus of herbal
knowledge..
⚫ A scroll, some 60 feet long
and a foot wide, contains
700 magical formula and
folk medicines.
PHARMACOLOGY HISTORY
ANCIENT EGYPT
⚫ The EBERS PAPYRUS
is meant to cure
afflictions ranging
from crocodile bite to
toe nail pain and to
get rid of the pest
such as flies, rats, and
scorpions.
PHARMACOLOGY HISTORY
ANCIENT EGYPT
⚫ The EBERS PAPYRUS also
includes an accurate
description of the
circulatory system, noting
the existence of blood
vessels throughout the
body and the hearths
function as center of the
blood supply.
PHARMACOLOGY HISTORY
ANCIENT EGYPT
⚫ The EBERS PAPYRUS is an
ancient recipe book dated
to approximately 1552 BC.
It contains a mixture of
magic and medicine with
invocations to banish
disease and a catalogue of
useful plants, minerals,
magic amulets and spells.
PHARMACOLOGY HISTORY
⚫The most famous
Egyptian
physician was
IMHOTEP who
lived in Memphis
around 2500 B.C.
PHARMACOLOGY HISTORY
ANCIENT INDIA –
AYURVEDIC MEDICINE
⚫In India, the Ayurveda is
traditional medicine that
emphasizes plant-based
treatments, hygiene, and
balance in the body’s
state of being.
PHARMACOLOGY HISTORY
ANCIENT INDIA –
AYURVEDIC MEDICINE
⚫ Indian materia medica
included knowledge of
plants, where they grow in all
season, methods for storage
and shelf life of harvested
materials. It also included
directions for making juice
from vegetables, dried
powders from herb, cold
infusions and extracts.
PHARMACOLOGY HISTORY
ANCIENT CHINA MEDICINE
⚫ Compendium of Materia
Medica (also known by
the romanizations Bencao
Gangmu or Pen-tsao
Kang-mu) is a Chinese
herbology volume written
by Li Shizhen during the
Ming dynasty; its first
draft was completed in
1578.
PHARMACOLOGY HISTORY
ANCIENT CHINA MEDICINE
⚫It is a work epitomizing the
materia medica known at the
time.
⚫The Compendium of Materia
Medica is regarded as the most
complete and comprehensive
medical book ever written in
the history of traditional
Chinese medicine.
PHARMACOLOGY HISTORY
ANCIENT CHINA MEDICINE
⚫It lists all the plants, animals,
minerals, and other items that were
believed to have medicinal
properties.
⚫The text consists of 1,892 entries,
each entry with its own name called
a gang. The mu in the title refers to
the synonyms of each name.
PHARMACOLOGY HISTORY
⚫ HIPPOCRATES – Father of
Medicine
⚫ He founded a school of
medicine that focused on
treating the causes of disease
rather than its symptoms.
⚫ Disease was dictated by
natural laws and therefore
could be treated through
close observation of
symptoms.
DRUG
✔ According to WHO, “Any
substance or product which is
used or intended to be used to
modify or explore physiological
systems or pathological states for
the benefit of the recipient”.
DRUG
✔ It is a chemical
substance used in the
treatment, cure,
prevention or
diagnosis of disease or
used to otherwise
enhance physical or
mental wellbeing.
DRUG NOMENCLATURE
⚫ Every DRUG has three
(3) of Names
1. Chemical Name
2. Non-proprietary Name
(Generic Name)
3. Proprietary Name (
Trade/Brand Name)
DRUG NOMENCLATURE
⚫ Chemical Name – These are given according to the
chemical constitution of drug.
⚫ Non-proprietary Name– (Official name) It is assigned
by the United States Adopted name (USAN) council. It
is uniform all over the world.
Generic Name – Typically derived from chemical
name. Usually shorter.
⚫ Proprietary Name– It is given by the pharmaceutical
manufacturer.
Trade/Brand Name – Name registered by the
manufacturer; only be used by the single
manufacturer; The first letter of the name is
CHEMICAL NON TRADE NAME
NAME PROPRIETARY

Acetyl Salycylic ASPIRIN DISPRIN (India)


Acid Bayer’s Asprin
(USA)
Ecospirin
(India)
CHARACTERISTICS
OF IDEAL DRUG
✔ It should be biocompatible and
biodegradable.
✔ No side effects.
✔ Shows the selectivity in its action.
WISHLIST FOR A
PERFECT DRUG
✔ Reversible
✔ Predictable
✔ NO adverse effects
✔ NO interaction
✔ Cheap and simple
GOALS OF
PHARMACOLOGY
✔Maximum
benefit for the
patient.
✔Minimum harm
to the patient.
NURSING RESPONSIBILITIES
IN DRUG THERAPY
✔ Administering drugs.
✔ Assessing drug effects.
✔ Intervening to make the drug regimen
more tolerable.
✔ Providing patient teaching about drugs
and the drug regimen.
✔ Monitoring the overall patient care plan
to prevent medication errors.
SOURCES OF
DRUGS
PLANT SOURCES
✔ Is the oldest source of drugs.
✔ Almost all parts of the plants
are used i.e. leaves, stem,
bark, fruits and roots.
✔ Ex: Morphine, Digoxin, Quinine, Reserpine
etc.
ALKALOIDS
✔ Diverse group of bitter
tasting, organic, basic
substances found in plants
with examples such as
caffeine, morphine and
atropine.
✔ Digitalis
purpurea are
the source of
Digitoxin and
Digoxin, which
are cardiac
glycosides.
✔ Leaves of
Eucalyptus
give oil of
Eucalyptus,
which is
important
component of
cough syrup.
Tobacco leaves give nicotine.
Poppy
papaver
somniferum
gives
morphine
(opoid)
ANIMAL SOURCES
✔ Drugs obtained from animals
sources are whole animals,
glandular products
(thyroid organ), insulin,
heparin, liver extract,
polypeptide venoms,
non-peptide toxins and
Urine of
pregnant
women gives
hCG used for
the treatment
of infertility.
Thyroid of
sheep is a
source of
thyroxine,
used in
hypothyroidism
Cod liver is
used as a
source of
vitamin A
and D.
INORGANIC COMPOUNDS
SYNTHETIC SOURCES
✔ Drugs that are produced
upon alteration of chemical
compositions of exisiting
plants and animals when
proven to have therapeutic
activity.
SYNTHETIC SOURCES
Advantage:
1.Quality can be controlled.
2.Process is easier and cheaper.
3.More potent and safer.
4.Large scale production.
MINERAL SOURCES and EARTH
SOURCES
DRUG
EVALUATION
PHASES
PRE-CLINICAL TRIALS
✔ A study to test a drug, a procedure,
or another medical treatment in
animals. The aim of
a preclinical study is to collect data in
support of the safety of the new
treatment.
✔ Preclinical studies are required
before clinical trials in humans can
be started
PRE-CLINICAL TRIALS
✔ In this stage, chemicals that may
have therapeutic value are tested
on laboratory animals for two main
purposes:
▪ To determine whether they have the
presumed effects in living tissue.
▪ To evaluate any adverse effects.
PRE-CLINICAL TRIALS
✔ At the end of the preclinical trials,
some chemicals are discarded for the
following reasons:
▪ The chemical lacks therapeutic
activity when used with living animals.
▪ The chemical is too toxic to living
animals to be worth the risk of
developing into a drug.
PRE-CLINICAL TRIALS
✔ The chemical is highly
teratogenic (causing adverse
effects to the fetus).
✔ The safety margins are so
small that the chemical would
not be useful in the clinical
setting.
NOTE:
✔ Some chemicals, however, are
found to have therapeutic effects
and reasonable safety margins.
✔ This means that the chemicals are
therapeutic at doses that are
reasonably different from doses
that cause toxic effects.
PHASE 1 STUDIES
✔ Uses human volunteers to test the
drugs.
✔ More tightly controlled than preclinical
trials and are performed by specially
trained clinical investigators.
✔ The volunteers are fully informed of
possible risks and may be paid for their
participation.
PHASE 1 STUDIES
✔ Usually, the volunteers are
healthy, young men.
✔ Women are not good candidates
because the chemicals may exert
unknown and harmful effects on
a woman’s ova.
PHASE 1 STUDIES
✔ Many chemicals are dropped from the
process for the following reasons:
▪ They lack therapeutic effect in
humans.
▪ They cause unacceptable adverse
effects.
▪ They are highly teratogenic.
▪ They are too toxic.
NOTE:
✔ Some chemicals move to the next stage of
testing despite undesirable effects.
✔ For example, the antihypertensive drug
minoxidil (Loniten) was found to effectively
treat malignant hypertension, but it caused
unusual hair growth on the palms and other
body areas.
✔ Now, its hair-growing effect has been
channeled for therapeutic use into various
hair-growth preparations such as Rogaine.
PHASE 2 STUDIES
✔ Allows clinical investigators to try out the
drug in patients who have the disease that
the drug is designed to treat to evaluate the
drug’s effects.
✔ Usually, phase II studies are performed at
various sites across the country—in
hospitals, clinics, and doctors’ offices—and
are monitored by representatives of the
pharmaceutical company studying the drug.
PHASE 2 STUDIES
✔ Drug may be removed from further
investigation for the following
reasons:
▪ It is less effective than anticipated.
▪ It is too toxic when used with
patients.
▪ It produces unacceptable adverse
effects.
PHASE 2 STUDIES
▪ It has a low benefit-to-risk ratio,
meaning that the therapeutic
benefit it provides does not
outweigh the risk of potential
adverse effects that it causes.
▪ It is no more effective than other
drugs already on the market.
PHASE 3 STUDIES
✔ Involves use of the drug in a vast
clinical market.
✔ Prescribers are informed of all the
known reactions to the drug and
precautions required for its safe use.
✔ Prescribers observe patients very
closely, monitoring them for any
adverse effects.
PHASE 3 STUDIES
✔ Prescribers ask patients to keep
journals and record any
symptoms they experience.
✔ Prescribers then evaluate the
reported effects to determine
whether they are caused by the
disease or by the drug.
PHASE 3 STUDIES
✔ A drug that produces unacceptable
adverse effects is usually removed
from further study by the drug
company.
✔ In some cases, the FDA may have
to request that a drug be removed
from the market.
FDA APPROVAL
✔ Drugs that finish phase III studies
are evaluated by the Food and
Drug Administration, which relies
on committees of experts familiar
with the specialty area in which
the drugs will be used before
marketing in the public.
FDA APPROVAL
✔ An approved drug will be
given generic name, brand
name, and chemical name.
PHASE 4 STUDIES
✔ Stage of continual evaluation.
✔ Prescribers are obligated to
report to the FDA any
untoward or unexpected
adverse effects associated with
drugs.
PHASE 4 STUDIES
✔ Some drugs cause unexpected
effects that are not seen until
wide distribution occurs.
✔ Sometimes, those effects are
therapeutic.
PHASE 4 STUDIES
✔ For example, patients taking the
antiparkinsonism drug amantadine
(Symmetrel) were found to have
fewer cases of influenza than other
patients, leading to the discovery
that amantadine is an effective
antiviral agent.
PHASE 4 STUDIES
✔ In other instances, the unexpected
effects are dangerous.
✔ The diet drug dexfenfluramine
(Redux) may develop serious heart
problems.
✔ NSAID Rofecoxib (Vioxx) show an
increase in cardiovascular
mortality.
SUMMARY
✔ To be approved for marketing, a
drug must pass through animal
testing, testing on healthy
humans, selected testing on
people with the disease being
treated, and then broad testing on
people with the disease being
treated.
ACTIVITY
✔ Using an appropriate
graphic organizer, outline
the steps involved in
developing and approving a
new drug.

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