Chapter 6

Drug Therapy in the 21st Century

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Changes in Health Care in the 21st Century
• Access to medical and pharmacologic information is
available from many sources
• Consumers are taking steps to demand specific
treatments and considerations
• Alternative therapies are being offered and
advertised
• Financial pressures are leading to early discharge
• Patient teaching and home care provisions are vital

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Federal Guidelines—Drug Advertising

• When the advertisement states the indication,

it must also include:

– Contraindications

– Adverse effects

– Precautions

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Internet Sources for Drug Information

• Pharmaceutical company information sites

• Chat rooms with other people who are taking
the drug
• Online pharmacies
• Lists of government regulations
• Research reports about the drug and its
effectiveness

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 Internet Site Evaluation
• Navigation
– Is the site easy to access and navigate or confusing?
• Contributor
– Who prepared the site and what are his qualifications?
Is it reviewed, or is it purely commercial?
• Dates
– Is the site updated frequently?
• Accuracy/reliability
– Is the information supported by other sites, accurate,
and in agreement with other sources you have
reviewed? Are other links listed?
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Problems Associated With OTC Medications

• Can mask the signs and symptoms of disease

• Can interact with prescription drugs

• Can be taken in greater than the recommended

dose, leading to toxicity

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 Over-the-Counter Drugs

• Drugs that were “grandfathered” in

• Former prescription drugs that have been tested

and found to be safe for the general public if
used as directed

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 Alternative Therapy Drawbacks

• The active ingredient has not been tested by the

FDA

• Incidental ingredients are unknown

• Patients do not always mention these therapies to

their health care providers

• Drug–alternative therapy interactions may occur

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 Controls for Alternative Therapy

• Herbal medications and alternative therapies are

not controlled or tested by the FDA

• Advertisement for these drugs is not restricted

because they are considered dietary supplements

• No regulation by any industry

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Dietary Supplement Health & Education
Act of 1994

• Herbal products, vitamins & minerals,

and amino acids are classified as
dietary supplements and are not
required to go premarketing testing.
• The advertising that is permitted for
these products does not allow direct
claims to cure treat, diagnose, or
prevent a specific disease but does
allow for nondisease claims such as
“for hot flashes, or “for memory loss”
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• Herbal therapies
can produce
unexpected effects
and toxic reactions,
can interact with
prescription drugs,
and can contain
various unknown
ingredients that
alter theirs
effectiveness and
toxicity
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SAW PALMETTO

•Herb that has

been used
successfully to
alleviate the
symptoms of
BPH

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St. John’s Wort

• for
depression,
anxiety,
and/or
sleep
disorders.

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 Off-Label Medications
• Definition

– The use of a drug for an indication that is not

approved by the FDA

• Occurrence

– Commonly takes place in groups of patients for

whom there is little premarketing testing

– Used with pediatric and geriatric populations

Copyright © 2008 Lippincott Williams & Wilkins.

Off-Label Medications
• is the practice of prescribing pharmaceuticals for an
unapproved indication or in an unapproved age group,
unapproved dose or unapproved form of administration.
• In the US, the Food and Drug Administration Center for
Drug Evaluation and Research (CDER) reviews a
company's New Drug Application (NDA) for data
from clinical trials to see if the results support the drug
for a specific use or indication.
• If satisfied that the drug is safe and effective, the drug's
manufacturer and the FDA agree on specific language
describing dosage, route of administration, and other
information to be included on the drug's label. More
detail is included in the drug's package insert.

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 Health Care in Crisis

• Skyrocketing cost of medical care and drugs

• Huge research and equipment requirements

to meet consumer demands

• Rising cost of health insurance

• Earlier discharge from hospitals

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Emergency Preparedness
• Biological weapons- so-
called germ war fare
real seen in the anthrax.
(mail scares in
Washington DC)

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 Measures to Protect the Public
From Bioterrorism

• Emergency preparedness at all levels of the

government

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 Treatments for Exposure to
Biological/Chemical Weapons
• Insert table 6.3

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