Chapter 2 Regulations. Objectives Define key terms. Describe the roles of OSHA, FDA, and DEA in patient safety. Discuss how drugs are developed.

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.