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Chapter 2Chapter 2
Regulations
ObjectivesObjectives
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.
ObjectivesObjectives
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 AuthoritiesRegulatory Authorities
OSHAFDADEA
OSHAOSHA
Occupational Safety and Health Administration
Part of Department of LaborOversees safety for workforce Includes medical workforce
FDAFDA
Food and Drug AdministrationApproves drugsMonitors drugs for adverse reactionsRemoves drugs from the market if unsafe
Critical ThinkingCritical 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?
DEADEA
Drug Enforcement AgencyPart of Department of JusticeControls certain substances that are
addictive and abusedCriminal penalties
Drug DevelopmentDrug Development
Clinical trialsPhase 1 SafetyPhase 2 EfficacyPhase 3 DosagePhase 4 Continuing Evaluation—
MedWatch
Critical ThinkingCritical 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 MedicationsAvailability 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 ThinkingCritical 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 DrugsNames of Drugs
ChemicalBrandGeneric—officialStreet
Critical ThinkingCritical 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 SubstancesControlled Substances
Control based on Addictive qualities Abuse potential Criminal prosecution for illegal possession
Schedule Abuse Potential Example
I High Heroin
II High OxyContin
III Moderate Steroids, codeine
IV Low Valieum
V Limited Cough medicine with codeine
DEA SchedulesDEA Schedules
Managing Controlled SubstancesManaging Controlled Substances
Keep track of inventory.Watch for drug seekers.Report theft or loss.Carefully dispose of unused medications.
Substance AbuseSubstance Abuse
Maladaptive pattern of behaviorLegal and illegal chemical agentsAddictionToleranceHabituationPain treatmentWithdrawal Impairment
Critical ThinkingCritical 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 drug-seeking behavior. How would you handle this situation?
Impaired ProvidersImpaired Providers
Impaired healthcare providers are a danger to patients.
Impaired providers must be reported.Notify the Boards of Medicine and
Nursing.
Critical ThinkingCritical Thinking
What are the phone numbers and addresses for the Board of Medicine and the Board of Nursing in your state?
SummarySummary
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.
CreditsCredits
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.
