CHAPTER 1

Pharmacy
From Greek word pharmakon (drug)
2 meanings
o General sense
Place or shop where
drugs or medicines are
sold
o Professional sense
The profession, the
members of which deal
with drugs
Art and science of preparing and
dispensing
medications
and
the
provision of drug and related information
to the public
Study of the science of drugs
Pharmacist
One who is educated and licensed to
prepare and dispense drugs and to
provide drug and related information to
the public
Expert on drugs
Dosage Forms
Pharmaceuticals
Preparation devised to make possible
the administration of medications in
measured or prescribed amount
Drug
Any agent intended for use in the
diagnosis, mitigation, treatment, cure,
prevention of disease of man or in
animal as well
Substances/articles that have to be
recognized in official drug standards
(USP, NF, HPUS)
A substance that acts on the living body
to alter the physiological process and
are used for the prevention, diagnosis
and treatment of diseases
Medicine
Any drug which has a definite form and
dose and are therapeutically used for
the treatment of diseases of living
subjects
Pharmaceutical Preparations
Forms in which drugs are prepared by
the pharmacist for administration in the
treatment of the sick
Dosage
Giving of medicine or other therapeutic
agent in prescribed amount
Shelf life

Refers to the length of time that a drug

produced may remain on the pharmacist
shelf in the original packages and under
usual environmental conditions and
retain an acceptable level of its potency
and overall quality
Stability
Maintenance of the original physical,
chemical and therapeutic properties
over extended period of time or until the
expiry date assigned
Drugs
Agent intended for use in the diagnosis,
mitigation, treatment, cure, or prevention
of disease in human or in other animals
Examples:
o Mydriatic dilate the pupil
o Miotic constrict or diminish
papillary size
o Emetic induce vomiting
o Antiemetic prevents vomiting
o Diuretic increases the flow of
urine
o Expectorant

increase
respiratory tract fluid
o Cathartic/Laxative evacuate
bowel
o Antidotes work against the
poisoning effects of other drugs
o Antineoplastic

attack
cancerous processes
o Radioactive pharmaceuticals
used in diagnosis
New Drug may be derived from
o Plant of animal source
o By products of microbial growth
o Chemical synthesis
o Molecular Modification
o Biotechnology
Pharmaceutical ingredients
Non-therapeutic ingredient
Fillers, thickeners, solvents, suspending
agents, tablet coatings, disintegrants,
penetration
enhancers,
stabilizing
agents, antimicrobial preservatives,
flavors, colorants, and sweeteners
THE HERITAGE OF PHARMACY
Diseases
Caused by entrance of demons or evil
spirits into the body

OUTLINE BY ARIANNE ANGELI F. BALUYUT 1

Methods of removing spirits

o Spiritual incantations
o Application of noisome materials
o Administration of herbs
THE FIRST APOTHECARY
The wise man/woman of the tribe
Has knowledge about the healing
qualities of plants
Gathered information through:
o Experience
o Handed down by word
Called to attend to the sick/wounded
and prepare the remedy
Pharmakon
Connotes charm/drug that can be used
for good and evil
Failure
Impotent/inappropriate medicine
Underdosage
Overdosage
Poisoning
Success
Attribute to experience
Coincidence
of
appropriate
drug
selection
Natural healing
Placebo Effects
o Treatment due to psychologic
rather than therapeutic effects
o Used until today to treat patients
and in clinical evaluations of
new drug
EARLY DRUGS
Ebers papyrus
Continuous scroll 60 ft x 1 ft
Discovered by Georg Ebers
800 formulas/prescriptions
700 drugs mentioned
INTRODUCTION
OF
THE
SCIENTIFIC
VIEWPOINT
Hippocrates (Greek physician)
Introduction of scientific pharmacy and
medicine
Rationalized medicine
Systematized medical knowledge
Put the practice of medicine on a high
ethical plane
o Hippocratic oath of ethical
behavior
Pharmakon
o Purifying remedy for good only
Father of Medicine

Dioscorides (Greek physician and botanist)

first to deal with botany as an applied
science of pharmacy
De Materia Medica
o Milestone in the development of
pharmacognosy
Pharmakon (drug)
Gnosis (knowledge)
Described opium, ergot, hyoscyamus
Claudius Galen (Greek pharmacist-physician)
Aimed to create a perfect system of
physiology, pathology and treatment
Descriptions of numerous drugs of
natural origin
Galenic Pharmacy
o Mixing or Melting vegetables
Cold cream (Galens Cerate)
o Most famous formula
Emperor Frederick II (Germany)
Pharmacy was officially separated from
medicine (1240)
Regulated pharmacy practice within the
part of his kingdom, Two Sicilies
Aureolus Theophrastus Bombastus von
Hohenheim (Paracelsus) (Swiss physician and
chemist)
Influenced the transformation from
botanical sciences to chemical
sciences
Karl Wilhelm Scheele (Swiss)
Lactic acid, Citric Acid, Oxalic Acid,
Tartaric Acid, Arsenic Acid
Invented new methods of preparing
calomel and benzoic acid
Discovered oxygen before Priestley
Friedrich Serturner (German)
Isolation of morphine from opium
Joseph Caventou & Joseph Pelletier (French)
Isolated quinine and cinchocine from
cinchona
Isolated strychnine and brucine from
nux vomica
Joseph Pelletier & Pierre Robiquet

Isolated caffeine
Pierre Robiquet
Isolated codeine from opium
DRUG STANDARDS
Pharmacopeia
Pharmakon (drug)
Poiein (make)

2 OUTLINE BY ARIANNE ANGELI F. BALUYUT

First used in 1580 in connection with a

local book of drug standards in Bergano,
Italy
British Pharmacopoeia (BP)
Three city pharmacopeias combined
o London
o Edinburgh
o Dublin
United States Pharmacopeia
Lititz Pharmacopeia
o First American pharmacopeia
o Published in 1778 at Lititz,
Pennsylvania
o For Military Hospital of US Army
Massachusetts Medical Society
o Published
a
272-paged
pharmacopeia in 1808
Lyman Spalding
o Jan. 6, 1817
o Submitted plan for the creation
of a national pharmacopeia
o Father of the United States
Pharmacopeia
January 1, 1820, Washington , DC
o First
United
States
Pharmacopeial Convention
December 15, 1820
o First USP was published in
English and Latin (international
language of medicine)
o Revised every 10 years
In 1850
o Pharmacists were awarded full
membership in the convention
American
Pharmaceutical
Association (APhA)
o Restricted
to
drugs
of
established therapeutic merit
o Many of those already accepted
were removed
In 1870
o USP nearly in the hands of
pharmacist
In 1900
o Allowed to issue supplements
In 1940
o USP is revised every 5 years
In 1975
o USP Convention Inc. bought the
National Formulary
USP XX and NF XV
o First combined compendium

July 1, 1980
USP Section
Active drug substance
o NF Section
Pharmaceutical agents
USP 23-National Formulary 18
o First to drop roman numerals
o Official in 1995
In 2002
o USP-NF became an annual
publication
o Started with USP 25-NF 20
USP 31-NF 26 (2003 edition)
o Contains 4240 drug monograph
o 220 general tests and assays
o in print and in CD-ROM
USP Drug Research and Testing
Laboratory
o Provide
direct
laboratory
assistance to the USP and NF
National Formulary
First published as National Formulary
or Unofficial Preparations in 1888 as a
form of protest against APhA
President Theodore Roosevelt
o June 30, 1906
o Signed the first Federal Pure
Food
and
Drug
Act,
establishing legal standards for
medicinal and pharmaceutical
substances
In 1975
o Bought by USP Convention Inc.
USP Pharmacist Pharmacopeia
First edition was published in 2005
Second edition in 2008
Address the needs of pharmacist
practitioners
Homeopathic Pharmacopeia of the United
States
Ensures quality of homeopathic drug
Coined by Samuel Hahnemann
o Homoios (similar)
o Pathos (disease)
Basis is the law of similars
o A drug that produces symptoms
of the illness in healthy persons
will also be capable of treating
those same symptoms and
curing the disease
International Pharmacopeia
Published in 1951
o
o

OUTLINE BY ARIANNE ANGELI F. BALUYUT 3

Intended as a recommendation to
national
pharmacopeial
revision
committees
to
modify
their
pharmacopeias
according
to
international standards
International
organization
for
Standardization (ISO)
o To develop and promote uniform
or harmonized international
standards

DRUG REGULATION AND CONTROL

Food and Drug Act of 1906
Required drugs marketed interstate to
comply with their claimed standards for
strength, purity, and quality
The Federal Food, Drug, and Cosmetic Act of
1938
Prohibits the distribution and use of any
new drug or drug product without the
prior filling of a New Drug Application
(NDA) and approval of the FDA
Durham-Humphrey Amendment of 1952
Prescriptions for legend drugs (Rx
drug) may not be refilled without the
express consent of the prescriber
Kefauver-Harris Amendments of 1962
The sponsor of a new drug is required to
file an Investigational New Drug
Application (INDA) with the FDA before
the drug may be clinically tested on
human subjects
Comprehensive Drug Abuse Prevention and
control Act of 1970
Served to consolidate and codify control
authority over drugs of abuse into a
single statute
Schedule I
o No accepted medical use
o High potential for abuse
Schedule II
o With accepted medical use
o High potential for abuse or may
lead to severe psychological or
physical dependence
Schedule III
o With accepted medical use
o Potential for abuse less than
those listed in schedules I and II
o If abused may lead to moderate
psychological
or
physical
dependence

Schedule IV
o With accepted medical uses
o Low Potential for abuse relative
to schedule III
o May lead to limited psychologic
or physical dependence
Schedule V
o With accepted medical uses
o Low potential for abuse relative
to those in schedule IV
FDA Pregnancy Categories
Category A
o Failed to demonstrate a risk to
the fetus
Category B
o Animal reproduction studies
failed to demonstrate a risk to
the fetus
o No adequate and well-controlled
studies in pregnant women
Category C
o Animal reproduction studies
have shown an adverse effect
on the fetus
o No adequate and well-controlled
studies in humans
o Potential benefits may warrant
use of drug
Category D
o Positive evidence of human fetal
risk
o Potential benefits may warrant
use of the drug
Category X
o Studies in animal or human
have
demonstrated
fetal
abnormalities
o Positive evidence of human fetal
risk
o Risks involved clearly outweigh
potential benefits
o Contraindicated
Two important factors to consider
o Stage of pregnancy
o Amount of medication taken
Pregnant or breast-feeding patient
o Must be counseled about
potential adverse effects
Black Box Warnings (BBWs)
Strongest labeling requirements for
high-risk medicines
Manufacturers should add black box
warning to the health professional

4 OUTLINE BY ARIANNE ANGELI F. BALUYUT

labeling
of
all
antidepressant
medications
Advertisements are not allowed
Drug Listing Act of 1972
Provide the FDA with the legislative
authority to compile a list of marketed
drugs to assist in the enforcement of
federal laws requiring that drugs be safe
and effective and not adulterated or
misbranded
Drug Price Competition and Patent Term
Restoration Act of 1984
Changes to speed FDA approval of
generic drugs and the extension of
patent life for innovative new drugs
Prescription Drug Marketing Act of 1987
Intended to reduce the risks of
adulterated, misbranded, repackaged, or
mislabeled drugs entering the legitimate
marketplace
through
secondary
sources
Reimportation
o Prohibits reimportation of drugs
manufactured in the US except
by the manufacturer of the
product
Sales Restrictions
o Prohibits selling or purchasing
of a drug sample
o Prohibits resale by health care
institutions of pharmaceuticals
o Charitable
institutions
that
receive drugs at reduced prices
or no cost should not resell
Distribution of samples
o Samples may be distributed to
practitioners
licensed
to
prescribe such drugs
o And to pharmacies or other
health care institutions at the
written request of practitioner
Wholesale distributors
o Manufacturers are required to
maintain a list of authorized
distributors
Dietary Supplement Health and Education
Act of 1994
Forbids manufacturers or distributors of
these products to make any advertising
or labeling claims that indicate that the
use of the product can prevent or cure a
specific disease

This product is not intended to

diagnose, treat, cure, or prevent any
disease
FDA Modernization Act of 1997
FDA Mission
o To protect the public health
against risks associated with the
production, distribution, and sale
of food and food additives,
human drugs and biologicals,
radiologic and medical devices,
animal drugs and feeds, and
cosmetics
Enacted to streamline FDA policies and
to codify many of the agencys newer
regulations
Expanded
patient
access
to
investigational treatments for AIDS,
cancer, Alzheimer disease, and other
serious of life-threatening illnesses
Provided incentives for investigations of
drugs for children
Drug product Recall
If the FDA or a manufacturer finds that a
marketed product presents a threat of a
potential threat to consumer safety, that
product may be recalled of sought for
return to the manufacturer from its depth
of distribution
o Product
defects,
product
adulteration, container leakage,
improper labeling, unexpected
adverse reactions, etc.
Drug product recall may be initiated by
the FDA or by the manufacturer
(voluntary recall)
Class I
o Will cause adverse health
consequences or death
Class II
o May cause temporary or
medically reversible adverse
health consequences
o Probabily of serious adverse
health consequences is remote
Class III
o Not likely to cause adverse
health consequences
Depth of recall
o Level of market removal or
correction
o Depends on the nature of
product, urgency of situation,
depth to which it was distributed

OUTLINE BY ARIANNE ANGELI F. BALUYUT 5

Lot number on packages and

Control
Numbers
on
containers or labels
Help identify the product
to be recalled

THE
PHARMACISTS
ROLE

CONTEMPORARY

BS Pharmacy (BS)
Doctor of Pharmacy (PharmD now DPh)
Registered Pharmacist (RPh)
Roles:
Community Pharmacies
Patient care institutions
Managed Care
Home Health Care
Military and Government Service
Academic Settings
Professional associations
Pharmaceutical research
Manufacturing Industry
THE MISSION OF PHARMACY
To serve society as the profession
responsible for the appropriate use of
medications, devices, and services to
achieve optimal therapeutic outcomes
PHARMACEUTICAL CARE
Component of pharmacy practice which
entails the direct interaction of the
pharmacist with the patient for the
purpose of caring for that patients drugrelated needs
Patient-centered,
outcomes-oriented
pharmacy practice that requires the
pharmacist to work in concert with the
patient
and
the patients other
healthcare providers to promote health
Goal is to optimize the patients healthrelated quality of life and achieve
positive clinical outcomes, within
realistic economic expenditures

PHARMACY PRACTICE STANDARDS

General
management
and
administration of the pharmacy
o Selects and supervises
o Establishes pricing structure
o Administers budgets
o Develops and maintains a
purchasing
and
inventory
system
Processing the prescription
o Verifies for legality
o Checks patients record before
dispensing
o Measures quantities needed
o Performs final check
o Dispenses prescription
Patient care functions
o Clarifies patients understanding
of dosage
o Integrates drug with patient
information
o Advises of potential drug-related
conditions
o Refers patient to other health
care resources
o Monitors
and
evaluates
therapeutic response of patient
o Reviews and seeks additional
drug-related information
Education of health care professionals
o Organizes,
maintains
and
provides drug information to
other health care professionals
o Organizes/participates in inpharmacy education programs
for other pharmacists
o Makes
recommendations
regarding drug therapy to
physician or patient
o Develops and maintains system
for drug distributions and quality
control

6 OUTLINE BY ARIANNE ANGELI F. BALUYUT