Antibiotic resistance 2 Flashcards
What are some effects of antibiotics?
antibiotic resistance
adverse drug event
- hypersensitivity/allergy
- drug side effects
- Clostridium difficile infections
- antibiotic associated diarrhea/colitis
increased health-care
What are the 6 goals for antibiotic recognition?
- reduce antibiotic consumption and inappropriate use
- reduce Clostridium difficile infections
- improve patient outcomes
- increase adherence/utilization of treatment guidelines
- reduce adverse drug events
- decrease or limit antibiotic resistance
What are the 9 factors to consider when selecting antimicrobial?
- spectrum of coverage
- patterns of resistance
- evidence or track record for specified infection
- achievable serum, tissue, or body fluid concentration
- allergy
- toxicity
- formulation (IV vs PO)
- adherence/convenience
- cost
What are the empiric therapy principles to antibiotic therapy?
- infection not well defined (best guess)
- broad spectrum
- multiple drugs
- evidence usually only 2 randomized controlled trials
- more adverse reactions
- more expensive
What are the principles of directed therapy for antibiotics?
- infection well defined
- narrow spectrum
- 1, seldom 2 drugs
- evidence usually stronger
- less adverse reactions
- less expensive
Why is so much empiric therapy used?
need for prompt therapy with certain infections
cultures difficult to do to provide microbiologic definition
negative cultures
provider beliefs
What are the 3 reasons for the failure of the antimicrobial market?
scientific
economic
regulatory
Describe the scientific failure of antimicrobials
all the drugs that are easily developed have already been developed
this means it will cost considerably more to develop
How is the development field limited to anti-biotics?
numerous drugs but only a few targets
What are the economics for antibiotics?
poor ROI due to short course therapy
constricted market share
costs the company $50 million
little incentive
Describe the Telithromycin (Ketex) effect
- phase IV noticed many mortalities
- FDA issued PHA to ban indications
- used to treat pneumonia, warns mortality
FDA now required that applicants needed to show that patients were no more likely to die of any cause w/in 28 days of treatment with a new drug
Discentive to the antimicrobial drug development
T/F FDA approves antibiotics based on indication
true,
should be based on microbe present
What is the GAIN act of 10/1/12?
added exclusivity for antibiotics to include longer term for patent rights
earmarks antibiotics for priority review
develop drugs for MDR pathogens based on the bugs they kill - regardless of site of infection
can prove efficacy with smaller numbers of trials
