501 hawtness Final

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Author:
VASUpharm14
ID:
54492
Filename:
501 hawtness Final
Updated:
2010-12-08 23:03:16
Tags:
im too cool
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Description:
just because you are hot doesn't mean you don't study. now go ace it hotstuff
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  1. context: Accelerated Approval Process (Marsh)
    5 questions must be passed to achieve approval as FAST TRACK drug
    • 1. is some aspect of the condition serious or life-threatening?
    • 2. does the drug show potential to treat a serious aspect of the condition?
    • 3. is the drug development program designed to determine whether the drug will effect a serious aspect of the condition?
    • 4. is there any approved treatment for the serious or life-threatening aspect of the condition being studied? ("NO" will be OK here! pass go and get $200 ... booyah!)
    • 5. is a medical need unmet by available treatments being studied?
  2. 6 periods/steps of drug approval process (Marsh)
    • 1. Preclinical
    • 2. Phase I
    • 3. Phase II
    • 4. Phase III
    • 5. FDA
    • 6. Phase IV
  3. context: 6 periods/steps of drug approval process (Marsh)
    Preclinical
    • Years: 6.5
    • Test Population: lab and animal studies
    • Purpose: assess safety and biological activity
    • Success Rate: 5,000 compounds evaluated
  4. context: 6 periods/steps of drug approval process (Marsh)
    Phase I
    • Years: 1.5
    • Test Population: 20 to 80 healthy volunteers
    • Purpose: determine safety and dosage
    • Success Rate: 5 enter trials (only 5??? I expected better, but then again I'm not working on it am I.)
  5. context: 6 periods/steps of drug approval process (Marsh)
    Phase II
    • Years: 2
    • Test Population: 100-300 patient volunteers
    • Purpose: evaluate effectiveness, look for side effects
    • Success Rate: 5 enter trials
  6. context: 6 periods/steps of drug approval process (Marsh)
    Phase III
    • Years: 3.5
    • Test Population: 1,000-3,000 patient volunteers
    • Purpose: confirm effectiveness, monitor adverse reactions from long-term use
    • Success Rate: 5 enter trials
  7. context: 6 periods/steps of drug approval process (Marsh)
    FDA
    • Years: 1.5
    • Test Population: review process/approval
    • Purpose: review process/approval
    • Success Rate: 1 approved (YOU must get to this point, you are a WINNER!)
  8. products approved (Marsh)
    • 1990: 30
    • 1995: 28
    • 2000: 15.6 (what happened here? war?)
    • 2005: 30
    • 2008: 24
  9. definition: simply a list of medications/treatments that one wishes to use (Marsh)
    formulary (I fricken missed this on the bonus ... boo!)
  10. 4 purposes of a formulary (Marsh)
    • 1. save money
    • -allow one to negotiate for discounts based upon placement on formulary or volume
    • 2. ensure only proven therapies used
    • 3. reduce stock needed
    • 4. can reduce medication errors
  11. formulary construction is based upon 4 components (Marsh)
    • 1. evidence-based medicine (EBM)
    • 2. protocols
    • 3. treatment guidelines
    • 4. pricing factors
  12. 7 formulary policies (Marsh)
    • 1. open or voluntary
    • 2. closed, mandatory
    • 3. restrictions
    • 4. therapeutic interchange
    • 5. generics first
    • 6. access to non-formulary products through prior-authorization
    • 7. co-pay structures
  13. context: 7 formulary policies (Marsh)
    2 parts of copayment structures
    • 1. incentives, incentives, incentives (you should know it has something to do with incentives ... but what?)
    • -changes to copays drives consumer behavior
    • 2. usual structures
    • -two tier system
    • -three tier system:
    • ex- drug copays where health providers are beginning to offer three-tier co-pay systems for prescription drugs. Aetna's plan for 30-day supply with first tier at $10 (generic), second tier at $15 (preferred), third tier at $30 (nonpreferred)
  14. Two types of informatics barriers
    • 1. technological
    • 2. non-technological
  15. context: two types of informatics barriers (Green)
    3 technological barriers
    • 1. lack of standards
    • -electronic access
    • -different programs
    • -depth of experience/training
    • 2. cost
    • -training, equipment, standards, maintenance, etc.
    • 3. security concerns
    • -HIPAA
    • -coworkers, insurance companies, maintenance. etc.
  16. context: two types of informatics barriers (Green)
    3 non-technological barriers
    • 1. time consuming
    • -training, accessing/entering info properly
    • 2. knowledge
    • -not included in most professional training programs
    • 3. change and complacency
    • -new technology and fear of change
    • -interruption of work flow
    • -how will this impact my practice?

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