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BCPS study guide

pharmacy practice, policy and regulations

QuestionAnswer
ED50 amount of a drug that will produce an effect in 50% of animals tested
LD 50 amount of a drug that will cause death in 50% of animals tested
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
Medwatch form FDA 3500A like 3500 but specifically for industry following new drug or biologic regulations. and for hospitals and nursing homes
Medwatch Form FDA 3500B like 3500 but specifically for consumer reporting.
USP 795 PHARMACEUTICAL COMPOUNDING FOR NONSTERILE PREPARATIONS
USP 797 pharmaceutical compounding for sterile preparations
CSPs compounded sterile products
beyond use dating allows pharmacies to assign expiration for drugs that have not undergone sterility testing. based upon low medium and high risk preparations.
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.
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
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
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
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.
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.
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.
when should the investigational new drug application be submitted to the FDA prior to Phase I trials but AFTER preclinical studies
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.
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
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
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
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
what is 45 Code of Federal Regulations part 46 protection of human subjects
what is 45 code of federal regulations part 160 and subparts A and E of 164 HIPAA
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)
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
Durham-Humphery Amendment of 1951 amendment to the food and drug act to differentiate between prescription and non prescription drugs
FDA modernization act of 1997 clinical trials.gov. exclusive provisions for pediatric drugs. streamlines research on drugs and devies
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.
full economic evaluations cost minimization analysis, cost benefit analysis, cost effectiveness analysis, cost utility analysis
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.
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.
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.
intangible health care costs pain, suffering, inconvenience, grief. not usually formally quantified. may use QALYs to measure.
cost effectiveness analysis looking at two clinical outcomes, evaluate the value of the difference in cost
cost benefit analysis cost to benefit ratio. compare treatment alternatives when determining how to allocate costs
cost utility analysis expressed in QALYs gained or other patient perspective measure.
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
cost minimization analysis cost per treatment alternative. determines least costly alternative. compares two or more treatment alternatives with demonstrated equivalence in therapeutic outcomes.
Created by: mjuhlin