Chapter 2

Chapter 2Chapter 2

Regulations

ObjectivesObjectivesDefine 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.

ObjectivesObjectivesDiscuss 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 AuthoritiesOSHAFDADEA

OSHAOSHAOccupational Safety and Health

AdministrationPart of Department of LaborOversees safety for workforce Includes medical workforce

FDAFDAFood and Drug AdministrationApproves drugsMonitors drugs for adverse reactionsRemoves drugs from the market if unsafe

Critical ThinkingCritical ThinkingMr. 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?

DEADEADrug 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 ThinkingNot 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 MedicationsWorld 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 ThinkingCanadians 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 DrugsChemicalBrandGeneric—officialStreet

Critical ThinkingCritical ThinkingDrug 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 SubstancesControl 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 SubstancesKeep track of inventory.Watch for drug seekers.Report theft or loss.Carefully dispose of unused medications.

Substance AbuseSubstance AbuseMaladaptive pattern of behaviorLegal and illegal chemical agentsAddictionToleranceHabituationPain treatmentWithdrawal Impairment

Critical ThinkingCritical ThinkingA 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 ThinkingWhat are the phone numbers and

addresses for the Board of Medicine and the Board of Nursing in your state?

SummarySummaryWhat 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.

CreditsCreditsPublisher: Margaret BiblisAcquisitions Editor: Andy McPheeDevelopmental Editor: Yvonne N. GillamProduction Manager: Samuel A. RondinelliManager, Electronic Development: Kirk PedrickTechnical Project Manager, EP: Frank MusickDesign 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.