pharmacy practice, policy and regulations
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| show | amount of a drug that will produce an effect in 50% of animals tested
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| LD 50 | show 🗑
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| show | voluntary reporting of ADEs, product quality concerns etc. for health care professionals. and ok to disclose PHI for public health purposes
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| Medwatch form FDA 3500A | show 🗑
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| show | like 3500 but specifically for consumer reporting.
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| show | PHARMACEUTICAL COMPOUNDING FOR NONSTERILE PREPARATIONS
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| USP 797 | show 🗑
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| CSPs | show 🗑
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| beyond use dating | show 🗑
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| show | the assigned beyond use date based on the maximum chemical stability as listed in valid references.
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| show | room temperature = 48 hours
fridge = 14 days
freezer = 45 days
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| show | room temperature = 30 hours
fridge = 7 days
freezer = 45 days
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| beyond use dating for high risk compounded sterile products without sterility testing. room temp/refrigeration/freezer | show 🗑
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| show | Low-risk: using sterile transfer of sterile liquids from manufacturer-sealed containers to sterile devices or other sterile packages. It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution.
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| medium risk according to USP 797 | show 🗑
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| show | non-sterile ingredients/devices. Exposing sterile items below ISO Class 5. prolonged storage of opened or partially-used products that lack antimicrobial preservatives. solution that will be terminally sterilized from non-sterile bulk drug or device.
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| when should the investigational new drug application be submitted to the FDA | show 🗑
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| show | lab and animal studies assessing safety and biological activity. establishes ED50 and LD 50 and toxicology and preggers category B, C and some D.
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| show | first study in human subjects. must have INDA approved by FDA prior to starting. starts with healthy volunteers. PK and PD properties are established
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| show | controlled studies in a small (several hundred) group of subjects that evaluates effectiveness for specific indication in pts with the disease under investigation. determines short term ADEs and risks
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| WHat constitutes a phase III trial | show 🗑
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| show | post marketing studies. verifies effectiveness or focus treatment on special populations. the FDA can require this of manufacturers to help identify additional risks not identified in Phase III trials
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| what is 45 Code of Federal Regulations part 46 | show 🗑
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| show | HIPAA
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| Hatch Watchman Act 1984 | show 🗑
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| show | drugs must demonstrate efficacy AND safety. requires informed consent of study subjects. authorizes FDA to regulate drug advertising and establish good manufacturing practices
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| show | amendment to the food and drug act to differentiate between prescription and non prescription drugs
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| show | clinical trials.gov. exclusive provisions for pediatric drugs. streamlines research on drugs and devies
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| PDUFA prescription drug user fee act of 1992 | show 🗑
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| show | cost minimization analysis, cost benefit analysis, cost effectiveness analysis, cost utility analysis
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| partial economic evaluations | show 🗑
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| direct health care costs | show 🗑
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| indirect health care costs | show 🗑
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| show | pain, suffering, inconvenience, grief. not usually formally quantified. may use QALYs to measure.
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| show | looking at two clinical outcomes, evaluate the value of the difference in cost
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| cost benefit analysis | show 🗑
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| cost utility analysis | show 🗑
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| cost of illness | show 🗑
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| show | cost per treatment alternative. determines least costly alternative. compares two or more treatment alternatives with demonstrated equivalence in therapeutic outcomes.
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