Introduction to Drugs and Pharmacy

Heritage of Pharmacy

Drug

The First Apothecary

agent used for diagnosis, mitigation, treatment,

cure, prevention of disease in humans or other
animals
(1)USP, Official Homeopathic Pharmacopeia, NF
(2) articles intended for use in the diagnosis,
cure, mitigation, treatment

Categories
1.
2.
3.
4.
5.
6.
7.
8.
9.

Mydriatric/ Miotic
Emetic / Antiemetic
Diuretic
Expectorant
Cathartics and Laxatives
Antineoplastic drugs
Analgesics
Antipyretics
Anesthetic

New Drug Sources:

plants
animals
by-products of microbial growth
chemical synthesis
molecular modification or biotechnology

Why is the process of drug discovery complex?

entails collective contributions of many

scientific specialists (16-18years)
definitive chemical and physical
characterization
pharmacokinetic and pharmacodynamics
studies
determination of the effective route of
administration and guidelines for dosage
recommendation
each particular pharmaceutical product is
unique
establishment of product stability profile or
expiry date
proper administration of pharmaceutical
products

healing qualities of plants acquired through

experience and handed down by the word of
mouth
art of apothecary has always been associated
with mysterious, and its practitioners were
believed to have connection with the world of
spirits
Pharmacy came from the Greek word
pharmakon
connotes a charm or a drug that can be
used for good or for evil

Early Drugs
Summerian Clay tablet worlds oldest written
prescription
Ebers Papyrus 60 feet long and a foot wide
- 800 formulas or prescriptions described and
700 drugs mentioned
- drugs are chiefly botanical
Introduction of Scientific Viewpoint
Hippocrates
-

Greek physician
rationalized medicine, systematized medical
knowledge and put practice of medicine on high
ethical plate
Hippocratic oath
pharmakon - purifying remedy for good only

Dioscorides
-

Greek physician and botanist

author of De Materia Medica (milestone in
development of pharmaceutical botany
nowadays called Pharmacognosy or natural
product chemistry)
opium, ergot and hyoscyamus were some
plants mentioned in his work that continue to
have use in medicine today

Cladius Galen
-

Greek pharmacist-physician
medical writings include descriptions of
numerous drugs of natural origin with a
profusion of drug formulas and methods of
compounding
Galenic Pharmacy preparations of vegetable
drugs by mixing or melting the individual
ingredients

Aureolus Theophrastus Bombastus von Hohenheim

-

Swiss physician and chemist (Paracelsus)

believed it was possible to prepare a specific
medicinal agent to combat each specific disease
introduced a host of chemical substances to
internal therapy

*Methodically, one chemical after another was isolated

from plant drugs and identified as an agent responsible
for plants medicinal activity.
*Contemporary examples of drugs isolated from a
natural source include:

paclitaxel (Taxol) agent with antitumor activity

derived from Pacific yew tree (Taxus baccata)
and employed in treatment of meastatic
carcinoma of the ovary
vincaleukoblastine antineoplastic drug from
Vinca rosea
(Digoxin) Lanoxin cardiac glycoside from
Digitalis lanata

Drug Standards
Pharmacopeias or formularies

Early Research
Karl Wilhelm Scheele
-

discovered lactic acid, citric acid, oxalic acid,

tartaric acid and arsenic acid
identified glycerin
invented new methods of preparing calomel
and benzoic acid
discovered oxygen

monographs and reference books containing

such standards to be used by those involved in
the production of drugs and pharmaceutical
products

The United States Pharmacopeia and the National

Formula
pharmacopeia Greek pharmakon (drug)
poiein (make(

Friedrich Serturner
-

German pharmacist
isolated morphine from opium

combination indicates any recipe or formula or

other standards required to make a drug

Lilitz Pharmacopeia first American pharmacopeia

Joseph Caventou and Joseph Pelletier
-

isolated quinine and cinchonine from cinchona

and strychnine
isolated brucine from nux vomica

Lyman Spalding Father for USP (January 6, 1817)

USP and NF Monographs
-

Joseph Pelletier and Pierre Robiquet

-

isolated caffeine

Pierre Robiquet
-

separated codeine from opium

adopt standards for drug substances,

pharmaceutical ingredients, and dosage froms
reflecting the best in the current practices of
medicine and pharmacy
initial part of the monograph consists of:
official title
graphic or structural formula
empirical formula
molecular weight
established chemical names

 CAS (Chemical Abstract Service) registry

number

The Federal Food, Drug and Cosmetic Act of 1938

Other Pharmacopeias
Homeopathic Pharmacopeia of the United States
(HPUS)
-

used by pharmacists and law enforcement

agencies that must ensure the quality of
homeopathic drugs

homeopathy Gr. homoios (similar)

pathos (disease)
like cures like (law of similar)
embodied in the homeopathic approach:
a) the testing of a drug on healthy persons
to find the drugs effects
b) the use of only minute doses of drugs in
therapy
c) the administration of more than one
drug at a time
d) the treatment of the entire symptom
complex of the patient

Durham-Humphrey Amendment of 1951

Pharmacopeia Internationalis (IP)

-

published by WHO of the UN

intended as a recommendation to the national
pharmacopeial revision committees to modify
their pharmacopeias

International Organization for Standardization

-

an international consortium of representative

bodies constituted to develop and promote
uniform international standard
ISO 9000 and ISO 9004
1. includes standards pertaining to
development, production, quality
assurance (QA), quality control (QC),
detection of defective products, quality
management (QM) and other issues
such as safety and liability

Food and Drug Act of 1906

-

standards for strength, purity, and quality

sulphanilamide not soluble in most common

pharmaceutical solvents
distributed as an elixir using diethylene glycol
as its solvent a higly toxic agent used in
antifreeze solutions
100 people died of diethylene glycol poisoning
the necessity for proper product formulation
and thorough pharmacologic and toxicologic
testing of the therapeutic agent,
pharmaceutical ingredients, and the completed
product was painfully recognized

drugs approved for marketing by the FDA are

categorized according to the manner in which
they may be legally obtained by the patient
prescription drugs must bear the symbol Rx
only or the legend Caution: Federal Law
Prohibits Dispensing Without Prescription
prescriptions for legend drugs may not be
refilled without the express consent of the
prescriber

Kefauver-Harris Amendments of 1962

thalidomide, recommended as a sedative and

tranquilizer, was being sold OTC in Europe
benzodiazipine former name of thalidomide
thalidomide given to women during pregnancy
produced birth defects (phocomelia arrested
development of the limbs of the affected
newborn)
purpose: to ensure a greater degree of safety
for approved drugs, and manufacturers were
now required to prove a drug both safe and
effective

Comprehensive Drug Abuse Prevention and Control

Act of 1970
-

served to consolidate and codify control

authority over drugs of abuse into a single
statute

established five schedules for the

classification and control of drug substances
that are subject to abuse

Drug Listing Act of 1972 (US only)

-

FDA-assigned Pregnancy Categories:

Category A no risk in animals and humans

based on studies
Category B no risk in animals based on studies
and no studies on humans
Category C adverse effect on animals based
on studies and no studies in humans
- potential benefits may warrant use of
the drug in humans despite risks
Category D positive fetal risk on humans but
may warrant use of the drug in humans despite
risks
Category X risks clearly outweigh potential
benefits

Medication Exposures During Pregnancy and Lactation

-

birth defects are the leading cause of infant

mortality
factors to consider when assessing the
teratogenic potential:
1. stage of pregnancy at which exposure
occurred
2. amount of medication taken

Drug Price Competition and Patent Term Restoration

Act of 1984
-

most serious warning placed in the labelling of a

prescription medication
NO reminder ads
FDAs strongest labelling requirements for high
risk medicines
*no black box in PH, only high risk meds
situations requiring a black box warning:
a) there is an adverse reaction so serious
in proportion to the potential benefit
b) the risk of a serious adverse reaction
can be prevented or reduced in severity
by careful use of the drug
c) the FDA has approved the drug with
restrictions to distribution

applications for generic copies of an originally

approved new drug can be filed thru an
abbreviated new drug application (ANDA)
the legislation provides an extension of patent
life equal to the time required for FDA review of
the NDA + half the time spent in testing phase
(5-20 years)

Prescription Drug Marketing Act of 1987 and

Prescription Drug Amendments of 1992
-

safeguards on the integrity of the nations

supply of prescription drugs

Dietary Supplement Health and Education Act of 1994

and the Dietary Supplement and Non-prescription
Drug Consumer Protection Act of 2006
-

Black Box Warning

-

enacted to provide the FDA with the legislative

authority to compile a list of marketed drugs to
assist the enforcement of federal laws requiring
that drugs be safe and effective and not
adulterated or misbranded

none in PH
addressed the need to regulate the labelling
claims made for dietary supplements
forbids manufacturers to make any advertising
of the products use in preventing or curing a
specific disease

Drug Product Recall

-

if the FDA or the manufacturer finds that a

marketed product presents a threat, that
product may be recalled or sought for return to
the manufacturer from its depth of distribution
numerical classification indicating the degree of
hazard associated with the product being
recalled:
Class I: the product has a reasonable
probability of causing serious adverse
health consequence or death

 Class II: the product may cause

temporary or medically reversible
adverse health consequences with a
remote probability
Class III: the product is not likely to
cause adverse health consequences

The Pharmacists Contemporary Role

Most pharmacists practice within an ambulatory care or
community pharmacy setting. In either setting, the
pharmacist plays an active role in:

patients use of prescription and nonprescription medication, diagnostic agents,

durable medical equipment and devices, and
other health products
develops and maintains individual patient
medication profiles
compounds drug preparations,
dispenses drug products,
issues patient information leaflets (PILs),
counsels patients on their health status, and
provides information on the use of drug and
nondrug measures

In an institutional setting:

manage drug distribution and control systems

and provide a variety of clinical services:
drug utilization reviews (DURs),
drug use evaluations,
therapeutic drug monitoring (TDM),
intravenous admixture programs,
pharmacokinetic consulting services,
investigational drug supplies, and
poison control and drug information

Pharmaceutical Care is a patient-centered, outcomesoriented pharmacy practice that requires the

pharmacist to work in concert with the patient and
patients other healthcare providers to promote health,
to prevent disease, and to assess, monitor, initiate, and
modify medication use to assure that the drug therapy
regimens are safe and effective.

Goal: to optimize the patients health-related quality of

life and achieve positive clinical outcomes, within
realistic economic expenditures.