pharmacy practice, policy and regulations
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| ED50 | amount of a drug that will produce an effect in 50% of animals tested
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| LD 50 | amount of a drug that will cause death in 50% of animals tested
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| Medwatch Form FDA 3500 | 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 | like 3500 but specifically for industry following new drug or biologic regulations. and for hospitals and nursing homes
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| Medwatch Form FDA 3500B | like 3500 but specifically for consumer reporting.
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| USP 795 | PHARMACEUTICAL COMPOUNDING FOR NONSTERILE PREPARATIONS
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| USP 797 | pharmaceutical compounding for sterile preparations
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| CSPs | compounded sterile products
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| beyond use dating | allows pharmacies to assign expiration for drugs that have not undergone sterility testing. based upon low medium and high risk preparations.
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| according to USP 797, if sterility testing has been performed on a drug, what can the pharmacy use as its expiration date | the assigned beyond use date based on the maximum chemical stability as listed in valid references.
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| beyond use dating for low risk compounded sterile products without sterility testing. room temp/refrigeration/freezer | room temperature = 48 hours
fridge = 14 days
freezer = 45 days
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| beyond use dating for medium risk compounded sterile products without sterility testing. room temp/refrigeration/freezer | 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 | room temperature = 24hours
fridge = 3 days
freezer = 45 days
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| low risk according to USP 797 | 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 | mult doses of sterile prods for multiple patients or to be given on multiple occasions and process involves more than single volume transfer or using a compounder.
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| high risk according to USP 797 | 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 | prior to Phase I trials but AFTER preclinical studies
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| what constitutes a preclinical study | 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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| what constitutes a Phase I trial | 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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| what constitutes a phase II trial | 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 | involves administration to many subjects (several hundred-thousand) in different clinical settings to confirm safety, efficacy and appropriate dosage. establishes risk benefit of drug then submission of new drug application to FDA
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| what constitutes a phase IV trial | 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 | protection of human subjects
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| what is 45 code of federal regulations part 160 and subparts A and E of 164 | HIPAA
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| Hatch Watchman Act 1984 | generic drugs must establish bioequivalence. ADA drug price competition and patent term restoration act of 1984. created an abbreviated regulatory pathway for generic drugs. (ANDA - abbreviated new drug application)
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| Kefauver Harris Amendments of 1992 | 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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| Durham-Humphery Amendment of 1951 | amendment to the food and drug act to differentiate between prescription and non prescription drugs
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| FDA modernization act of 1997 | 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 | manufacturers have to pay fees for product applications supplement sand other services for drugs biologics and medical devises.
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| full economic evaluations | cost minimization analysis, cost benefit analysis, cost effectiveness analysis, cost utility analysis
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| partial economic evaluations | only look at part of the picture. looking at only consequences or costs of a programs service or treatment. full would look at both.
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| direct health care costs | direct medical costs examples would be hospitalizations, drugs, medical supplies, equipment, lab and diagnostic testing. direct nonmedical costs examples would be transportation, extra trips to ED, care expenses, diets clothes.
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| indirect health care costs | morbidity costs such as missed work, loss of productivity. mortality costs measured as the cost associated with loss of earnings for that individual.
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| intangible health care costs | pain, suffering, inconvenience, grief. not usually formally quantified. may use QALYs to measure.
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| cost effectiveness analysis | looking at two clinical outcomes, evaluate the value of the difference in cost
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| cost benefit analysis | cost to benefit ratio. compare treatment alternatives when determining how to allocate costs
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| cost utility analysis | expressed in QALYs gained or other patient perspective measure.
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| cost of illness | cost of a disease compared to cost of implementing prevention or treatment strategy identified direct and indirect costs of a given disease
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| cost minimization analysis | cost per treatment alternative. determines least costly alternative. compares two or more treatment alternatives with demonstrated equivalence in therapeutic outcomes.
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