Abx Resistance Pharm Perspective Flashcards
1
Q
3 problems with abx use
A
- abx resistance
- adverse drug events (hypersensitivity, diarrhea/colitis, Clostridium difficile infection)
- inc health care costs
2
Q
Abx account for ___% of adverse drug events
A
19.3% (rate relates to how frequently they are used)
3
Q
9 factors to consider when selecting abx:
A
- spectrum of coverage
- patterns of resistance
- track record of a drug against that bug
- breakpoint (achievable conc in serum or tissue)
- allergy
- toxicity (risk-benefit analysis, will this inf kill the pt?)
- route of delivery/formulation (IV vs oral)
- pt adherence
- cost (public perception is that it should be cheap)
4
Q
Describe an empiric therapy of abx administration
A
broad spectrum
** more
5
Q
Describe the directed therapy of abx administration
A
narrow spectrum
** more
6
Q
Why is empiric therapy more widely used? (4 reasons)
A
- need for prompt therapy
- difficult to culture (to ID pathogen)
- negative culture results
- provider beliefs (fear of error, sick = need more abx, etc)
7
Q
Why are fewer abx being developed?
A
- scientific (many drugs w/ few targets, “low-hanging fruits” already plucked)
- regulatory: (telithromycin effect)
- economics: poor return on investment (short treatment, low value in society, small market share) (abx drug = MINUS $50 mill
8
Q
Telithromycin effect (what happened and what problems did it cause)
A
- NDA twice rejected before being approved
- sever toxicities seen –> health advisory w/ addnl labeling
- applicants needed to show patients were no more likely to die of any cause (w/in 28 days of treatment w/in a new drug)
- proved antimicrobial agents are very difficult to get approved –> MUST GET SEPARATE approval for each indication not just for the microbe the drug kills
9
Q
GAIN Act (what did it do and why was it significant)
A
- added exclusivity–> inc 20 year patent to get return on investment
- priority review
- approval for BUG the drugs kill, not an indication
* provides additional incentives to develop new abx
