Transcript Drug Discovery and Creation

Understanding Pharmacology
For Health Professionals
Edition
For theFourth
Dental
Hygienist
2
CHAPTER
Drug Design, Testing,
Manufacturing, and
Marketing
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Learning Objectives
• Name several ways in which drugs are
discovered or created.
• Describe how computers facilitate drug
design.
• Differentiate between the chemical,
generic, and trade/brand names of a drug.
• List at least five things that the trade
names of drugs might tell you about those
drugs.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Learning Objectives
• Describe the three phases of the human
testing of new drugs.
• Define the phrases in vitro, in vivo, clinical
trials, control group, drug patent, isomer,
and placebo.
• Describe how inert ingredients might affect
the bioavailability of a drug.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Learning Objectives
• Describe how direct marketing of
prescription drugs has affected consumers
and drug costs.
• Give four reasons why a drug might be
withdrawn from the market or recalled.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Introduction
• The development, testing, manufacturing,
and eventual marketing of any drug is a
time-consuming and expensive process.
• A drug company may evaluate thousands
of different chemicals before finding one
that moves successfully through all
phases of testing and is finally approved
by the FDA for release and marketing.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Introduction
• This chapter traces the steps from a newly
discovered or designed chemical to final
FDA approval and clinical use of a drug.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• Drugs are discovered or created in several
ways
– Ancient sources
– A totally new chemical can be discovered in
the environment, from plants, animals, the
ocean, or the soil
– A totally new chemical can be derived from
molecular manipulation of a drug that is
already in use
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• Drugs are discovered or created in several
ways
– a totally new chemical can be created through
genetic manipulation
– stem cell therapy
– gene therapy
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 2-1 Derivative chemical structure. In 1957, the first benzodiazepine antianxiety drug was
synthesized: chlordiazepoxide (Librium). Its chemical structure is shown on the left. Working with that
molecule, the same researcher then derived diazepam (Valium). Its chemical structure is shown on the
right. Both drugs are still in use today to treat anxiety and neurosis.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• Ancient sources
– many drugs still in use today were originally
derived from plant, animal, or mineral sources
hundreds or even thousands of years ago.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• A totally new chemical can be discovered
in the environment, from plants, animals,
the ocean, or the soil
– chemotherapy drug Taxol – needles of Pacific
yew tree.
– antituberculosis drug streptomycin – stomach
of sick chickens
– fungus from which cephalosporin antibiotic
drugs were derived
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• A totally new chemical can be derived
from molecular manipulation of a drug that
is already in use.
– isomer
 dextrorotary
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• In the past
– designing a new drug by changing molecular
structure of an existing drug was a slow
process of trial and error
– using intuition and molecular models made
from wood and wire.
– example
 Penicillin G
 terfenadine (Seldane) = fexofenadine (Allegra)
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• Computers
– display the molecular structure of any drug
– With very slight molecular changes, the
original drug may be significantly changed
 absorption
 metabolism
 half-life
 therapeutic effect
 side effects
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 2-2 Creating new drugs with computer-aided design (CAD). With computers, researchers
can study any molecule, rotating it in three dimensions on the computer screen. By analyzing the
molecules, researchers can tell if that particular arrangement of atoms is the “key” that will open the
“lock”—that is, activate a particular receptor on the cell membrane. When a researcher wants to know
why different-looking drugs seem to produce a similar effect on the same receptor, he/she can have
the computer superimpose all of the drugs on the screen to see how their atoms match up. Jacob
Halaska © Photolibrary.com.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• Computers
– identify unsuccessful chemicals before time
and money are invested in extensive testing.
– manipulate chemicals at the molecular level
 design new drugs
 involves molecular pharmacology
 Example: molecular pharmacology
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• A totally new chemical can be created
through genetic manipulation
– recombinant DNA technology (RDNA)
 gene splicing
 genetic engineering
 enzymes in test tubes (in vitro)
 gene cloning
 human insulin (Humulin)
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• Stem cell therapy
– use of stem cells to repair or replace
damaged body cells
– in 2001 first embryonic stem cell manipulated
– ignited controversy
– umbilical cord blood
– harvesting of adult stem cells
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• Gene therapy
– missing specific or have abnormal gene
– normal version linked to harmless virus
– vector
– Human Genome Project
– Connectivity Map database
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Discovery and Creation
• Human genome
– pharmacogenetics
– pharmacogenomics
– new area of research: the proteome
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Names
• Every drug has a chemical name
– International Union of Pure and Applied
Chemistry (IUPAC) describes molecular
structure
• Generic name
– United States Adopted Names (USAN)
determines a drug’s generic name
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Names
• Trade name or Brand name
– created by drug company after FDA approval
– designed to
 be easy for physicians and patients to remember
 suggest how the drug is used
• Accurate spelling of drug name critical
• No linguistic standards
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 2-3 Molecular structure and chemical name. The chemical name of this drug actually
describes its molecular structure: 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7- sulfonamide 1,1dioxide. The generic name of this drug is hydrochlorothiazide, a diuretic drug. It is also available as the
trade names HydroDIURIL (from the Merck drug company) and Microzide (from the Watson drug
company), among others.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
The accurate spelling of drug names is critical. Some trade
name drugs are difficult to spell because drug
manufacturers are not held to any linguistic standards. For
example, the trade name drug Rythmol is used to
normalize the rhythm of the heart, and yet the h found in
rhythm is not in the drug name. The trade name drug
Levothroid is a thyroid hormone replacement, and yet the y
found in thyroid is not in the drug name. Throughout this
textbook, there are tips to assist you in the accurate
spelling of generic and trade name drugs contained in that
chapter.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 1 The spellings of generic drugs
belonging to same category often reflect
chemical structure
• beta blocker class
–
–
–
–
–
–
–
acebutolol
atenolol
betaxolol
metoprolol
nadolol
pindolol
propanolol
• Benzodiazepine class
–
–
–
–
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
clonazepam
diazepam
lorazepam
oxazepam
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 1 The spellings of generic drugs
belonging to same category often reflect
chemical structure
• penicillin class
–
–
–
–
–
ampicillin
amoxicillin
nafcillin
oxacillin
penicillin
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 2 The drug manufacturer selects a trade
name that indicates what disease condition
or symptom the drug is being used to treat.
• Azmacort – asthma
• Habitrol – nicorette decreases the craving for
nicotine in smokers
• Mucinex – remove mucus
• Pepcid – peptic ulcers
• Rythmol – irregular heart rhythm
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 3 The drug manufacturer selects a trade
name that indicates what part of the body is
being treated.
•
•
•
•
Boniva – strengthen bones
Bronkaid – dilate bronchi
Dermatop – skin lotion
Nasalcrom – nasal allergies
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 4 The drug manufacturer selects a trade
name that simplifies the generic name while
retaining its phonetic sound
•
•
•
•
•
Cipro – ciprofloxacin
Haldol – haloperidol
Humulin – human recombinant DNA insulin
Levothroid – thyroid replacement hormone
Sudafed - pseudoephedrine
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 5 The drug manufacturer selects a trade
name that indicates the ingredients or
source of the drug
•
•
•
•
Fer-In-Sol – iron (Fe) in solution
Kay Ciel –potassium (K) chloride (Cl)
Premarin – pregnant mares’ urine
cetuximab – monoclonal antibody
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 6 The drug manufacturer selects a trade
name that indicates the action of the drug.
•
•
•
•
Elimite – eliminates mites (scabies)
Glucotrol – controls the level of glucose
Lipitor – decreases level of blood lipids
Restoril – restores rest/sleep to treat
insomnia
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 7 The drug manufacturer selects a trade
name that indicates how often the drug is to
be taken.
• Lithobid – lithium drug given twice a day
• Nitro-Bid – nitroglycerin drug given twice a day
• b.i.d. is a Latin abbreviation that means twice
a day
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 8 The drug manufacturer selects a trade
name that indicates the duration of the
drug's therapeutic effect.
• Cardizem LA – long-acting drug for
hypertension
• Pronestyl-SR – sustained release drug for
heart arrhythmia
• Zyflo CR controlled release – slow-release
potassium (K) supplement
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 9 The drug manufacturer selects a trade
name that indicates the strength of the drug.
• Bactrim DS – double-strength dose of
antibiotic drug
• Cortizone-5 – 0.5% hydrocortisone antiinflammatory ointment
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 10 The drug manufacturer selects a
trade name that indicates the route of
administration.
• Bactrim IV – intravenous (IV) antibiotic drug
• Transderm-Scop – transdermal skin patch
for motion sickness
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 11 The drug manufacturer selects a
trade name that indicates the amount of a
particular active ingredient
• Tylenol w/Codeine No. 2 – contains 15 mg of
codeine
• Tylenol w/Codeine No. 3 – contains 30 mg of
codeine
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Clinical Applications
Tip 12 The drug manufacturer selects a
trade name that reflects the manufacturer’s
identity.
• ED Tuss HC cough syrup – manufactured by
Edwards drug company
• Wytensin for hypertension – manufactured by
Wyeth-Ayerst drug company
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drugs
• All drugs must be thoroughly tested
• Tested by the company before marketing
according to FDA guidelines
• Testing to determine:
– drug’s effectiveness
– drug’s safety
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drugs
• in vitro testing
– in vitro is Latin for in glass
– chemical analysis
– laboratory test tubes
• in vivo testing
– in vivo is Latin for in living
– animal testing
– human testing
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drugs
• Animal testing
– precedes testing on humans
– drug evaluated and noted for:
 side effects
 toxic effects
 addictions
 cancerous tumors
 fetal deformities
 pharmacodynamics
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drugs
• Pharmacodynamics
– frequency distribution curve
– half-life
– median effect dose (ED50)
– median toxicity dose (TD50)
– therapeutic index (TI)
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
“This drug was tested on 2000 white mice, and they had a ball.”
David W. Harbaugh.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drugs
• After completion of animal studies
– company submits an IND (Investigational
New Drug) Application
 contains information about animal trials
 shows drug not a risk to humans
 includes information
• chemistry of drug
• manufacturing process
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drug
• Phases of Human Testing (clinical trials)
– Phase I
 10-100 healthy volunteers
 Informed consent mandatory
 evaluate side effects
 establish final, correct dosage
 pharmacokinetics studied
 generally takes 1½ years
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 2-4 Newpaper advertisement. A typical newspaper ad seeking volunteers to participate in
clinical trials to test a new drug.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drug
• Phases of Human Testing (clinical trials)
– Phase II
 50-500 patients who have disease drug intended
to treat
 drug given on experimental basis
 determines therapeutic effect
 usually takes 2 years
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Alert!
A placebo is a drug form that exerts no
pharmacologic effect, no therapeutic effect, and
has no side effects when administered. The word
placebo means I will please in Latin. Placebos are
used in double-blind research studies in which
neither the researcher nor the patient knows
whether the drug given was the drug being tested
or was a placebo. Placebos are commonly sugar
pills or injections of sterile normal saline solution.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Alert!
Interestingly, while it is physiologically impossible
for a placebo to exert any pharmacologic effect,
patients often report a decrease in certain types of
symptoms and can even experience ”side effects”
when given a placebo. These effects are quite real
and demonstrate that, in some situations, the
power of suggestion can produce changes within
the body that closely mimic the pharmacologic
action of an actual drug.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drug
• Phases of Human Testing (clinical trials)
– Phase III
 several hundred or several thousand ill patients
 Administered same way that it will be used on the
market
 performance compared with other drugs that are
currently on the market
 double-blind studies with placebo performed
 usually lasts 3 years
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drug
• Phases of Human Testing (clinical trials)
– Phase III
 testing on children
• standardizes pediatric doses
• manufacturer receives 6 month extension on standard 17
year patent
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drug
• Completion of Phase III
– drug company submits all documentation to
FDA in a New Drug Application (NDA)
– waits for final FDA decision
 approval
 denial
– only 20% NDA’s receive final FDA approval
for marketing
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Did You Know?
The data collected for just one patient in just one
clinical drug trial can exceed 100 pages of
documentation, and the total documentation for all
aspects of the drug testing can exceed 100,000
pages.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Did You Know?
The ulcer drug cimetidine (Tagamet) is a case in
point. After four years of testing, the SmithKline
company had accumulated a stack of documents
17 feet high that had to be taken to the FDA in a
truck. Denise Grady, “Bottleneck at the FDA,”
Discover (November 1981), p. 56.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Testing of New Drug
• Once FDA approves
– ingredients, dosage, manufacturing process,
labeling, and packaging cannot change
– can conduct further clinical trials
 expand the drug’s use
 example:
• Propranolol (Inderal)
• Indomethacin (Indocin)
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Manufacturing
• In the past pharmacists mixed drugs
• Today the manufacturing process is strictly
regulated
– drug quality
– sanitation
– packaging
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Manufacturing
• Generic drugs and trade name drugs,
regardless of who manufactures must:
– have same dose strength
– contain same active ingredient
– be administered in the same way
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Manufacturing
• Generic drugs and trade name drugs,
regardless of who manufactures, does not
apply to:
– bioavailability
– inert ingredients
– preservatives
– antioxidants
– buffers
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Manufacturing
• Process includes securing drugs in
appropriate containers
– adding a packet of desiccant
– tightly sealing the top to prevent tampering
– placing drugs in individual blister packs
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
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Figure 2-5 Protective packaging. Blister paks protect the integrity of the drug while allowing he
drug form to be seen through a protective plastic window. Access is through a peel-off backing.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Marketing
• Advertising of over-the-counter drugs
– regulated by the FTC (Federal Trade
Commission)
• Advertising of precsription drugs
– regulated by the FDA
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Marketing
• Previously, drug companies promoted
prescription drugs by
– direct to physicians by sales reps
– free samples
– literature and videos
• Still the most prevalent form of prescription
drug advertising
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Marketing
• Now, direct-to-consumer (DTC) marketing
– magazine ads
 men’s Magazines: erectile dysfunction, enlarged
prostate
 women’s Magazines: birth control, infertility,
menopause, osteoporosis
– television
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Marketing
• “Ask your doctor if [this drug] is right for
you”
– created consumer-driven shift
– proactively ask for certain prescription drugs
– may not need particular medicine
– pressures physicians to prescribe
 unnecessary medications
 more expensive medications
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
DTC Marketing Milestones
• 1981 The first direct-to-consumers (DTC)
print advertisement appears for an
analgesic drug.
• 1985 FDA rules that drug ads marketed to
consumers must include risk information.
• 1997 FDA allows drug manufacturers to
direct market their ads to consumers via
TV.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
DTC Marketing Milestones
• 2001 More than 100 prescription drugs
are regularly marketed directly to
consumers. Advertising slogans like “the
little purple pill” (for Nexium) become well
known.
• 2004 Cialis, a drug for erectile dysfunction
in men, advertised during TV broadcasts
of the 2004 Super Bowl.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Patents
• Trade name of drug registered with U.S.
Patent Office as a registered trademark ™
• Under patent, right to advertise and
market
• Protected by 17-year patent
– includes testing period before approval
– 1984 law gives back 5 years
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Patents
• After expiration, competitors can enter the
market
• Drug’s original trade name can only be
used by the original company
• If generic is manufactured, listed under
different trade names
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Table 2-2 Example of generic name and related trade names
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Patents
• All drug companies must provide a
complete list of all drugs on the market to
the FDA
• Each drug has a unique identifier
– National Drug Code (NDC)
– multi-digit number (given in three segments)
 first segment: identifies drug company
 second segment: identifies drug’s strength/dose
 third segment: package code
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Figure 2-6 National Drug Code. Each prescription drug has a National Drug Code or NDC. The
NDC identifies the drug manufacturer (Eon Labs), drug strength/dose (amiodarone 200 mg), and
package size and type. The NDC may also appear on the label on the prescription bottle or on other
printed labels generated by the pharmacy.
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Withdrawals and Recalls
• Drug approval is no guarantee it will stay
on the market
• Post-marketing surveillance
– drug companies and FDA continue to monitor
the drug after approval
– some adverse effects become apparent
– health professional reports
– MedWatch
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Withdrawals and Recalls
• Continually evaluates current reports
– especially those involving death
– example: antidepressant drugs changed their
warnings to include risk of suicide in 18-24
year olds
– unexpected adverse effects
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Withdrawals and Recalls
• A drug recall can be done for:
– drug does not contain the correct amount of
active ingredient
– drug does not remain stable until its expiration
date
– drug is contaminated with particulate matter
from manufacturing process
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.
Drug Withdrawals and Recalls
• Responsibility of drug manufacturer to
notify physicians, hospitals, and
pharmacies of a drug recall
Understanding Pharmacology for Health Professionals, Fourth Edition
Susan M. Turley
Copyright ©2010 by Pearson Education, Inc.
Upper Saddle River, New Jersey 07458
All rights reserved.