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BCPS study guide
pharmacy practice, policy and regulations
| Question | Answer |
|---|---|
| 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
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