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Chapter 2
Regulations
Objectives
 Define key terms.
 Describe the roles of OSHA, FDA, and
DEA in patient safety.
 Discuss how drugs are developed.
 Distinguish between brand, generic, and
trade names.
 Know the slang street names for illegal
drugs.
Objectives
 Discuss why some drugs are more tightly
controlled than others.
 Give an example of a drug from each
controlled substances schedule and state
why it is classified that way.
 Discuss the role of allied health
professionals in recognizing and reporting
impaired patients and professionals.
Regulatory Authorities
 OSHA
 FDA
 DEA
OSHA
 Occupational Safety and Health
Administration
 Part of Department of Labor
 Oversees safety for workforce
 Includes medical workforce
FDA
 Food and Drug Administration
 Approves drugs
 Monitors drugs for adverse reactions
 Removes drugs from the market if unsafe
Critical Thinking
 Mr. Dupee is upset that he cannot get a
drug he has read about. He knows a
website in Mexico where he can order this
drug. What are the potential dangers if he
orders a drug from another country? How
might you discuss this with him?
DEA
 Drug Enforcement Agency
 Part of Department of Justice
 Controls certain substances that are
addictive and abused
 Criminal penalties
Drug Development
Clinical trials
 Phase 1 Safety
 Phase 2 Efficacy
 Phase 3 Dosage
 Phase 4 Continuing Evaluation—
MedWatch
Critical Thinking
 Not all people who volunteer for clinical
trials qualify for the research. What do you
think might eliminate a patient from clinical
trials?
Availability of Medications
 World wide web has increased access of
Americans to drugs from other countries.
 These drugs are not approved by FDA.
 These drugs are in experimental stages in
United States.
 These drugs may not be made under safe
conditions.
 These drugs may not be genuine.
Critical Thinking
 Canadians are protected by the Health
Protection Branch (HPB) of the
Department of Health and Welfare. Why
might it be important for countries to
cooperate in drug research?
Names of Drugs
 Chemical
 Brand
 Generic—official
 Street
Critical Thinking
 Drug names sometimes reflect what the
drug does. Without looking them up,
guess for what purpose the following
drugs are used. Then check them in your
drug reference book:
Controlled Substances
 Control based on
 Addictive qualities
 Abuse potential
 Criminal prosecution for illegal possession
DEA Schedules
Schedule Abuse Potential
Example
I
High
Heroin
II
High
OxyContin
III
Moderate
Steroids, codeine
IV
Low
Valieum
V
Limited
Cough medicine with
codeine
Managing Controlled Substances
 Keep track of inventory.
 Watch for drug seekers.
 Report theft or loss.
 Carefully dispose of unused medications.
Substance Abuse
 Maladaptive pattern of behavior
 Legal and illegal chemical agents
 Addiction
 Tolerance
 Habituation
 Pain treatment
 Withdrawal
 Impairment
Critical Thinking
 A patient calls frequently and begs for
more pain medication. The doctor and
staff are frustrated with the repeated
requests, which they attribute to drugseeking behavior. How would you handle
this situation?
Impaired Providers
 Impaired healthcare providers are a
danger to patients.
 Impaired providers must be reported.
 Notify the Boards of Medicine and
Nursing.
Critical Thinking
 What are the phone numbers and
addresses for the Board of Medicine and
the Board of Nursing in your state?
Summary
 What new piece of information in this
chapter were you most interested to
learn?
 What questions do you still have about the
information in this chapter?
 Return to Objectives to determine extent
of learning.
Credits
Publisher: Margaret Biblis
Acquisitions Editor: Andy McPhee
Developmental Editor: Yvonne N. Gillam
Production Manager: Samuel A. Rondinelli
Manager, Electronic Development: Kirk Pedrick
Technical Project Manager, EP: Frank Musick
Design Associate, EP: Sandra Glennie
The publisher is not responsible for errors or omission or for consequences from application of
information in this presentation, and makes no warranty, expressed or implied, in regards to its
content. Any practice described in this presentation should be applied by the reader in accordance
with professional standards of care used with regard to the unique circumstances that may apply in
each situation.