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Angelyka Cabalo 2A PH (2016-2017)

PharDose Chapter 1
Introduction to Drugs and Pharmacy

agent intended for use in the diagnosis,

mitigation, treatment, cure or prevention of
disease (FDCA 1938)
diverse actions and effects on the body
selective use (stimulate, decrease, reduce pain,
combat disease, assist, treat, protect, diagnose,
replenish, sustain etc.)

mydriatic drugs dilate pupil of the eye

miotics constrict or diminish pupillary size

emetic induce vomiting

diuretic increase flow of urine

expectorant increase respiratory tract fluid

cathartics/laxatives evacuate the bowel

plant or animal source
process of discovery and development is complex
its difference with poison is the dose
physically and chemically compatible
Basic Pharmacology
nature and mechanism of action of the drug on
the biologic system
To be determined :

short and long term effects

adverse effects

effective routes (oral, rectal,


dosages (neonates, adult, elderly)

dosage forms

pharmaceutical ingredients (fillers, thickeners,

solvents, flavors, colorants)
a vital member of the health care team
intimate knowledge of drug actions,
pharmacotherapeutics, drug information sources
entrusted with legal responsibility for the
procurement, storage, control and distribution ;
compounding and prescription filling ; patient
Disease caused by the entrance of demons or evil spirits
into the body

wise man or woman of the tribe

knows healing qualities of plants through

experience and word of mouth

prepares the remedy art of the apothecary

Drug with magical associations
Tribal apothecary
one to be feared, respected, trusted (mistrusted),
worshipped and revered
Knowledge of drugs and their application to disease =
Pharmakon (greek)
where pharmacy was derived
connotes a charm or a drug that can be used for
good or for evil
Placebo effects psychological treatment/healing
Priest-physician healer of the body & soul
Pharmacy & Medicine = combined function
Ebers Papyrus

continuous scroll some 60 ft long and a foot wide

University of Leipzig

German Egyptologist Georg Ebers


More than 800 drug formulas or presriptions

More than 700 drugs mentioned

Drugs = botanical

Animal excrements
Vehicles : beer, wine, milk and honey

pharmaceutical formulas employed 2 dozen

medicinal agents

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
Galens Cerate cold cream

Pharmacy & medicine separated 1240 AD

(Emperor Frederick II of Germany ; Two

Pharmacists obligated by oath to prepare

reliable drugs of uniform quality

Pharmacy & chemistry = united

Aureolus Theophrastus Bombastus von Hohenheim (14931541 ad)
Swiss physician and chemist
a.k.a Paracelsus
pharmacy from botanical science chemical
Karl Wilhelm Scheele (1742-1786)
Most famous of all pharmacists
Lactic acid, citric acid, oxalic acid, tartaric acid &
arsenic acid
Identified glycerin
New methods to prepare calomel & benzoic acid
Discovered oxygen before Priestley
Friedrich Serturner (1783-1841)
isolation of morphine from opium
German pharmacist
Joseph Caventou & Joseph Pelletier
isolated quinine and cinchonine from cinchona
and strychnine
isolated brucine from nux vomica
Pelletier & Pierre Robiquet
isolated caffeine
Pierre Robiquet
separated codeine from opium
Drugs isolated from a natural source :

Taxol (paclitaxel)

agent with antitumor activity

from Pacific yew tree (Taxus baccata)

treatment of metastatic carcinoma of the ovary

antineoplastic drug


from Vinca rosea

cardiac glycoside
Digitalis lanata

Philadelphia College of Pharmacay nations

1st school of pharmacy


United States Pharmacopeia (USP) aid in

establishing standards for drugs
Pharmacopeias/fomularies organized set of monographs
or books of these standards
United States Pharmacopeia and the National Formulary
pharmacopeia pharmakon & poiein (make)
[term 1st used in 1580]
1864 British Pharmacopeia
Dec. 15, 1820 1st USP published (English and
Latin) ; 217 drugs
1st American pharmacopeia [ Lititz Pharmacopeia
1778 Lititz, Pennsylvannia ; for military hospital
of the us army ; 84 internal & 16 external drugs &
preparations ]
1808 Massachusetts Medical Societ 272 page
pharmacopeia 536 monographs
Jan. 6 1817 Lyman Spalding (NYC physician)
submitted a plan for the creation of a national
pharmacopeia ; Father of the USP
Jan 1, 1820 USP Convention in Washington DC ;
USP revised every 10 years
1940 USP revised every 5 years
1872 synthesis of salicylic acid (phenol)
analgesic compounds [acetylsalicylic acid /
barbiturates sleep-producing derivatives
1910 arsphenamine syphilis [chemotherapy]
Paul Ehrlich
German bacteriologist
Sahachiro Hata
Discovered arsphenamine

1852 American Pharmaceutical Association

(APhA) USP only allows drugs with established
therapeutic merit
1888 National Formulary of Unofficial
June 30, 1906 National Formulary Pres.
Roosevelt Pure Food and Drug Act
1975 USP Inc purchased NF
USP-NF = continuously revised annually
USP [monographs drugs subs, supplements,
dosage froms and compounded preparations]
NF [monographs pharmaceutical excipients
2006 Spanish USP-NF
USP used in more than 140 countries
Products manufactured drugs
Preparations compounded drugs
NF Monographs
provide suitable tests and assay procedures
every statement must be of a high degree of
clarity and specificity
a drug recognized in the USP-NF must comply with
compendial standards :

of identity or be deemed aduleterated,

misbranded or both

for strength, quality or purity

for packaging and labeling

the individual components in these products are
decsribed in monographs & in supplements to the

compendia or in drug applications for marketing

approved by the US FDA
Organic Medicinal Agents

official title (generic name)

graphic/structural formula ; empirical formula

molecular weight

established chem names

the drugs Chemical Abstracts Service (CAS)

registry number (identifies each compound

chemical purity ; toxic nature of the agent

packaging & storage recommendations

chem and physical tests

Other Pharmacopeias
Homeopathic Pharmacopeia of the US (HPUS)

law enforcement agencies

homeopathy Samuel Hahnemann [homoios :

similar ; pathos : disease] like cures like

1. Testing of the drug 2. Use of only minute

doses (dilutions) 3. Administration 4.
Treatment of the entire symptom
International Pharmacopeia (IP)

World Health Organization (WHO) of the

United Nations

Recommendation to national pharmacopeial

revision committees to modify accdg to
international standards

1951 1st volume

MERCOSUR Pharmacopeia

Argentina, Brazil, Paraguay & Uruguay

FDA Approved New Drug
subsequently developed standards are adopted as
new monographs by the USP-NF
International Organization for Standardization (ISO)
international consortium of representative bodies
to develop & promote uniform or harmonized
international standards
American National Standards Institute
Standards pertaining to :

development production

quality assurance

quality control

detection of defective products

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
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

1938 sulfanilamide (wonder drug ; not

soluble in most common pharmaceutical
solvents ; elixir ; solvent is diethylene glycol
antifreeze solutions) people died of
diethylene glycol poisoning

testing of thorough pharmacologic and

toxicologic testing
prohibits the distribution & use of any new drug or
drug product w/o prior filling of a New Drug
Application (NDA) & approval of the FDA
responsibility of FDA grant/deny permission to
manufacture & distribute a new product

requires manufactured pharmaceutical products

safe for human use
Durham Humphrey Amendment of 1951
legal distinction between OTC and Rx drugs
Rx drugs w/ Rx only or Caution : Federal Law
Prohibits Dispensing W/o Prescription
Prescriptions for legend drugs = may not be
refilled without consent of the prescriber

Drug Abuse Control Amendments of 1965

Comprehensive Drug Abuse Prevention and

Control Act of 1970
Kefauver Harris Amendments of 1962

thalidomide as sedative & tranquilizer ; lack

toxicity even at extreme dosage levels ;
replace the barbiturates ; produced birth
defects (phocomelia)

fever, painful skin lesions, erythema nodosum

leprosum, myeloma, Kaposi sarcoma
Oct 10, 1962
To ensure greater degree of safety for approved
Sponsor of a new drug is required to file
investigational new drug (IND) application
FDA issue good manufacturing practice (GMP)
Comprehensive Drug Abuse Prevention and Control Act of
Controlled Substances Act (CSA)
To consolidate & codify control authority over
drugs of abuse into single statute
+ the Harrison Narcotic Act of 1914

Schedule I no accepted medical use + high

potential for abuse (heroin, LSD, mescaline,
peyote, methaqualone, marijuana)

Sched II w/ accepted medical use + high

potential for abuse + if abused
psychological/physical dependence
(morphine, cocaine, methamphetamine,

Sched III - w/ accepted medical use +

potential for abuse + if abused moderate
psychological/physical dependence (codeine,

Sched IV - w/ accepted medical use + low

potential for abuse + if abused limited
psychological/physical dependence
(difenoxin, diazepam, oxazepam)

Sched V - w/ accepted medical use + low

potential for abuse + if abused limited
psychological/physical dependence
(dihydrocodein, diphenoxylate)
FDA Pregnancy Categories
1979 US FDA classification of fetal risks due to

Category A X risk to the 1st trimester until

later trimesters

Category B X risk to fetus, X well controlled

studies in pregnant women

Category C adverse effect of fetus

Category D - + evidence of human fetal risk

Category X fetal abnormalities

every woman 3-5% risk of having a child w/ birth
defects or mental retardation infant mortality
Black Box Warnings
used to call attention
there is an adverse reaction so serious in
proportion to the potential benefit
risk of a serious adverse reaction can be
prevented or reduced in severity
FDA approved drug w/ restrictions to

Drug Listing Act of 1972

provide FDA w/ legislative authority to compile a
list of marketed drugs to assist in the enforcement
of federal laws
National Drug Code (NDC) permanent
registration number

first 4 no labelers code

last 6 no drug formulation (product code)

and trade package & size (package code)

appears on all manufacturers drug labeling

(imprint directly on dosage unit)
Orphan Drug Act of 1983
treatment if rare diseases or conditions (more
than or less than 200,000 people are affected)
the company is unlikely to recover its research &
development costs
Drug Price Competition and Patent Term Restoration Act of
applications for generic copies of an originally
approved new drug
generic version is equivalent to the originally
approved drug ( chemistry, manufacturing,
control, bioavailability)
patent life = time required for FDA review + half
of the time spent testing phase (5-20 years)
Prescription Drug Marketing Act of 1987 & Prescription
Drug Amendments of 1992
reduce the risks of adulterated, misbranded,
repackaged or mislabeled drugs


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
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
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
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
Imported in the US :
80% - active ingredients
40% - finished dosage forms
150 countries
Drug Product Recall

FDA or manufacturer finds a marketed product

with a possible threat to consumer safety
sought for return
Product defects & adulteration, container leakage,
improper labeling, unexpected adverse reactions

Class I will cause serious adverse health

consequences or death

Class II may cause temporary or medically

reversible adverse health consequences

Class III not likely to cause adverse health

Drug Products Removed or Withdrawn

Adenosine phosphate

Adrenal cortex




Bromfenac sodium

Butamben (parenteral)

Camphorated Oil

Carbetapentane citrate (oral gel)

Casein, iodinated

Chlorhexidine gluconate (tinctures)

Chlormadinone acetate



Dexfenfluramine HCl

Diamthazole diHCl


Diethylstilbestrol (oral & parenteral 25mg)

Dihydrostretomycin sulfate


Encainide HCl

Fenfluramine HCl


Gelatin (IV)

Glycerol, iodinated

Gonadotropin, chorionic (animal origin)

Mepazine (HCl or acetate)


Methamphetamine HCl (parenteral)



Miberfradil diHCl


Nomifensine maleate

Oxyphenisatin (& acetate)


Phenformin HCl


K arsenite

KCl (solid oral 100mg)

Povidone (IV)

Reserpine (oral more than 1mg)

Sparteine sulfate




Sweet spirits of nitre

Temafloxacin HCl



Tetracycline (liquid oral-pediatric-25mg/ml)



Trichloroethane (aerosol)


Vinyl Cl (aerosol)

Zirconium (aerosol)

Zomepirac sodium
Pharmacists Contemporary Role
RPh (Registered Pharmacist) professional
DPh (Doctor of Pharmacy) licensure designation
Active role in the pts use of Rx and Non-Rx
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

general management & administration

processing the prescription

pt care functions

educ of health care professionals and patients

Omnibus Budget Reconciliation Act of 1990
Jan 1, 1993
Requirement for each state to develop and
mandate DUR programs to improve the quality of
pharmaceutical care
To ensure that prescriptions are appropriate,
medically necessary and not likely to result in
adverse medical effects
Patient Protection and Affordable Care Act of 2010
to decrease the number of medically uninsured
Code of Ethics APhA

respects covenatal relationship between pt &


promotes the good caring, compassionate &

confidential manner

respects autonomy & dignity of pt

acts with honesty & integrity

maintains professional competence

respects the values & abilities of colleagues

serves individual, community & societal needs

Code of Ethics AAPS

adheres to highest principles of scientific


concern for proper use of animals involved

avoid scientific misconduct

recognize difference of scientific opinion

disclose sources of financial support

report results accurately

respect the known ownership rights of others