John Paul Joson MSN CNS 1 Objectives Role of the FDA Phases of Approval Controlled Substances Drug Schedules and Teratogenic Risks 2 FDA US Food and Drug Administration 1997 Black Box Warnings ID: 734301
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Drug Approval and Regulation
John Paul Joson MSN CNS
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Objectives
Role of the F.D.A.
Phases of Approval
Controlled Substances, Drug Schedules, and Teratogenic Risks
2Slide3
F.D.A.
U.S. Food and Drug Administration
1997 Black Box Warnings
Drugs with “special problems”
Adverse Effects aka Undesirable
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Black Box Warning
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Phases of Approval
1. Preclinical investigation
2. Clinical investigation
3. Review of the New Drug Application
4. Post marketing surveillance
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Preclinical Investigation
Laboratory research
Animal studies/ studies on human cells
Prediction
Inconclusive
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Clinical Investigation
Longest part of drug approval process
Good let’s go!!!!
Show’s promise but precautions slow down.
Safe for humans
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New Drug Application Review
Drug’s name is finalized
FDA review = 6 months
All good go to Post marketing surveillance
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Post marketing Surveillance
Survey for harmful drug effects
FDA can withdraw med
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Prototype approach to drug classification
“Prototype” drug is one drug from a class of drugs that is well understood and serves as model
Predicts the action and adverse effects of other drugs in that class
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U.S. controlled substances act of 1970
Drugs placed into 5 schedules
Under law, hospitals/pharmacies must maintain complete records of all controlled substances purchased and soldDrug Enforcement Administration (DEA) –regulates Controlled Substance Act
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Controlled substance
Drugs frequently abused or have a high potential for addiction or dependence
Addiction –overwhelming feeling that drives repeated drug useDependence –physical or psychological need for substance
Restricted for use in medical necessity
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Scheduled drugs
Drugs that have a significant potential for abuse
Placed in 5 categories called “schedules”Classified according to potential for abuse
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U.S. Drug schedules
Drug Schedule
Abuse Potential
Physical Dependency
Psychologic
Dependency
Examples
Therapeutic use
I
Highest
High
High
Heroin, LSD, MJ
Limited or none
II
High
High
High
Morphine,
PCP, Cocaine
Used therapeutically with prescription
III
Moderate
Moderate
High
Steroids,
Vicodin
, T#3
Used therapeutically with prescription
IV
Lower
Lower
Lower
Darvon
/
Darvocet
, Valium
Used therapeutically with prescription
V
Lowest
Lowest
Lowest
OTC
cough meds w/ codeine
Used therapeutically
without prescription
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U.S. Drug schedules
Schedule II -IV:Require special order form to obtain
Must be written and signed by health care providerTelephone orders to pharmacies/refills not permittedPatients must visit health care provider first
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Teratogenic Risks
Category A
Category B
Category C
Category D
Category X
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Chronic pain patient in the emergency room
http://www.youtube.com/watch?v=FcFhxA102s8&feature=related
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