-
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?
-
6 periods/steps of drug approval process (Marsh)
- 1. Preclinical
- 2. Phase I
- 3. Phase II
- 4. Phase III
- 5. FDA
- 6. Phase IV
-
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
-
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.)
-
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
-
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
-
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!)
-
products approved (Marsh)
- 1990: 30
- 1995: 28
- 2000: 15.6 (what happened here? war?)
- 2005: 30
- 2008: 24
-
definition: simply a list of medications/treatments that one wishes to use (Marsh)
formulary (I fricken missed this on the bonus ... boo!)
-
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
-
formulary construction is based upon 4 components (Marsh)
- 1. evidence-based medicine (EBM)
- 2. protocols
- 3. treatment guidelines
- 4. pricing factors
-
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
-
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)
-
Two types of informatics barriers
- 1. technological
- 2. non-technological
-
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.
-
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?
|
|
