Professional Documents
Culture Documents
PharDose Chapter 1
PharDose Chapter 1
PharDose Chapter 1
Introduction to Drugs and Pharmacy
DRUG
-
adverse effects
dosage forms
University of Leipzig
Hieroglyphics
Drugs = botanical
Animal excrements
Vehicles : beer, wine, milk and honey
Polypharmacy
type of preparation
Hippocrates (ca. 460-377 bc)
greek physician
rationalized medicine, systemized medical
knowledge and put practice of medicine on high
ethical plane
Hippocratic oath of ethical behavior for the
healing professions
Pharmakon : purifying remedy for the good only
Works : descriptions of hundreds of drugs
Father of Medicine
Dioscorides (1st century ad)
greek physician and botanist
botany as an applied science of pharmacy
De Materia Medica pharmaceutical botany /
natural products chemistry / pharmacognosy
(pharmakon & gnosis : knowledge)
Opium, ergot, hyoscyamus
Claudius Galen (ca. 130-200 ad)
greek pharmacist physician
Roman citizen
Create a perfect system of physiology, pathology
and treatment
Formulated doctrines (1500 yrs)
500 treaties on medicine, 250 others on philo, law
& grammar
Galenic pharmacy (field of pharmaceutical
preparations)
Galens Cerate cold cream
Taxol (paclitaxel)
Vincaleukoblastine
antineoplastic drug
1821
Digoxin
cardiac glycoside
Digitalis lanata
1820
molecular weight
development production
quality assurance
quality control
quality management
compliance w/ the standards is voluntary
ISO certified through a rigorous evaluation and
accreditation process
Food and Drug Act of 1906
1st federal law
to regulate drug products manufactured
domestically
to comply with their claimed standards for
strength, purity and quality
Sherley Amendment
prohibits false claims of therapeutic effects
declaring such products misbranded
Federal Food, Drug and Cosmetic Act of 1938
reimportation
sales restrictions
distribution of samples
wholesale distributors
Prescription Drug User Fee Act of 1992
allows the FDA to accept user fees, in return for
committing to review new drug & biologic
applications
more rapid review process
speedier approval
Dietary Supplement Health and Education Act of 1994 &
Dietary Supplement and Nonprescription Drug Consumer
Protection Act of 2006
growing interest in the various use of herbs
(alternatives) and dietary supplements
forbids indication of the product that can
prevent or cure a specific disease
National Institutes of Health (NIH) assess the
therapeutic usefulness
Dietary Supplement Verification program
FDA
established 1938
administer & enforce FDCA
to protect the public health against risks
associated w/ the production, distribution & sale
of food and additives, drugs, devices and
cosmetics
set policies, monitors, establish requirements,
governments gatekeepers
agency of DOH and Human Services
FDA Modernization Act of 1997
to streamline FDA policies
provided for faster new drug approvals by using
sponsors fees
Globalization
Imported in the US :
80% - active ingredients
40% - finished dosage forms
150 countries
Drug Product Recall
Adenosine phosphate
Adrenal cortex
Azarbine
Benoxaprofen
Bithionol
Bromfenac sodium
Butamben (parenteral)
Camphorated Oil
Casein, iodinated
Chlormadinone acetate
Chloroform
Cobalt
Dexfenfluramine HCl
Diamthazole diHCl
Dibromsalan
Dihydrostretomycin sulfate
Dipyrone
Encainide HCl
Fenfluramine HCl
Flosequinan
Gelatin (IV)
Glycerol, iodinated
Metabromsalan
Methapyrilene
Methopholine
Miberfradil diHCl
Nitrofurazone
Nomifensine maleate
Phenacetin
Phenformin HCl
Pipamazine
K arsenite
Povidone (IV)
Sparteine sulfate
Sulfadimethoxine
Sulfathiazole
Suprofen
Temafloxacin HCl
Terfenadine
3,3,4,5-tetrachlorosalicylanilide
Ticrynafen
Tribromsalan
Trichloroethane (aerosol)
Urethane
Vinyl Cl (aerosol)
Zirconium (aerosol)
Zomepirac sodium
Pharmacists Contemporary Role
RPh (Registered Pharmacist) professional
designation
DPh (Doctor of Pharmacy) licensure designation
Active role in the pts use of Rx and Non-Rx
medication
Maintains individual pts medication profile,
compounds drug preparations, dispenses drug
products, provide information, counsel patients
Board of Pharmaceutical Specialties Jan 5 1976
establish standards for certification &
recertification of pharmacists
Nuclear ph, nutrition support ph,
pharmacotherapy, psychiatric ph, ambulatory
care & oncology ph
Pharmacy residency directed postgraduate
training program
Fellowship develop skill in research
Pharmaceutical Care
1975 Mikeal care that a given pt requires and
receives which assures rational drug usage
direct interaction of the Ph with the Pt
is patient-centered
optimize the pts health-related quality of life &
achieve + clinical outcomes
pharmacy graduate = problem solver, able to
achieve health outcomes, able to collaborate, a
committed lifelong learner
Pharmacy Practice Standards
pt care functions