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