Dr. G's Lec 1
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
Help!
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| Act | a law passed by the legislature
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| administer | direct application (by injection, inhalation, ingestion, etc) of a drug to the body of a pt by a practitioner or his authorized agent or by the pt at the direction of the practitioner
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| adjudication | a formal determination or judgment
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| bioequivalent | term describing products which are pharmaceutical equivalents or alternatives that display comparable bioavailability; the parameters evaluated regarding bioavailability are the rate and extent of absorption
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| CI-CV | denotes a controlled substance in Class I, Class II, etc., as determined in the CSA
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| CE | continuing education
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| CFR | code of federal regulations
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| CGMP | current good manufacturing practices; the standard established by the FDA and applied to all drug manufacturers
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| closed system | as applied to the CSA; refers to the distribution of CS among registrants only
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| common law | refers to law developed from decisions of the courts
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| compounding | preparation, mixing, assembling, packaging, or labeling of a drug/device by a pharmacist or by a practitioner in the course of professional practice.
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| CSA | controlled substances act; federal CSA is enforced by the DEA
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| DEA | drug enforcement administration; under the jurdisdiction of the Dept. of Justice; concerned w/ CS only
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| DEA 222 forms | Drug Enforcement Administration Form 222 for the ordering of CI and CII CS btw registrants
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| Direct supervision of a pharmacist | (in AZ) pharmacist is present
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| dispense | deliver med to an ultimate user on the lawful order of a practitioner
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| distribute | deliver, other than by administering (directly to a pt by the practitioner) or dispensing (on the order/Rx of the practitioner)
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| drug | articles, recognized in the official compendium, intended for the use in the dx, tx, mitigation, cure or prevention of disease; also articles other than food intended to affect the structure or fxn of the body
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| DUE | drug use evaluation
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| DUE process | law in its regular course of administration through the courts; fundamental fairness
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| DUR | drug utilization review/drug use review
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| Ex post facto | after the fact
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| Ex post facto law | law passed after the occurrence of an act which retroactively changes the legal consequences of the act
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| FDA | Federal Food and Drug Administration
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| FDCA (Federal Food, Drug and Cosmetic Act) | (1938)catalyst = sulfanilamide. Reg. drug development, manuf. & marketing (focuse on quality). Only safe and properly labeled drugs may be intro. into interstate commerce. Defined label/labeling (labels must contain adequate SIG); estab. FDA
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| Generic equivalent | contains identical amt. of the same AI in the same dosage form and, if administered in the same amt., will provide comparable therapeutic effects
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| GMP | good manufacturing practices; mandated by the FDCA, with standards for manuf. promulgated in reg. by the FDA
🗑
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| internship | the practical, experiential, hands-on training of a pharmacy intern under the supervision of a preceptor
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| jurisdiction | (a) the power to decide a matter; (b) the geographic area over which someone has authority
🗑
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| label | written, printed, or graphic matter immediately attached to the container for sale
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| labeling | includes the label and any accompanying material to the container for sale (may be inside the container, like a package insert)
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| legend drug | a drug which is available by RX or medication order only
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| NDA | new drug application: filed with the FDA to get approval for marketing in interstate commerce in the US; drug must be proven safe and effective to be approved.
🗑
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| NDC # | national drug code; 9-11 #s specifying the manuf. (1st 4/5#), product (name, strength, dosage form)(next 4#), the package size (last 2#); requested by the FDA to be on the label; not required; widely used when submitting info for dispensing reimbursement
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| new drug | drug not generally recognized by qualified experts as safe and effective for use
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| OBRA '90 | federal Omnibus Budget Reconciliation Act of 1990; mandates that pharmacists (a) provide DUR of Rx orders; (b) offer to counsel pt; and, (c) maintain a written pt hx in order for the state to receive federal funds for Medicaid programs; 1st effective pt c
🗑
|
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| off-label use | use an approvd drug for other than the approved indication
🗑
|
||||
| Act | a law passed by the legislature
🗑
|
||||
| administer | direct application (by injection, inhalation, ingestion, etc) of a drug to the body of a pt by a practitioner or his authorized agent or by the pt at the direction of the practitioner
🗑
|
||||
| adjudication | a formal determination or judgment
🗑
|
||||
| bioequivalent | term describing products which are pharmaceutical equivalents or alternatives that display comparable bioavailability; the parameters evaluated regarding bioavailability are the rate and extent of absorption
🗑
|
||||
| CI-CV | denotes a controlled substance in Class I, Class II, etc., as determined in the CSA
🗑
|
||||
| CE | continuing education
🗑
|
||||
| CFR | code of federal regulations
🗑
|
||||
| CGMP | current good manufacturing practices; the standard established by the FDA and applied to all drug manufacturers
🗑
|
||||
| closed system | as applied to the CSA; refers to the distribution of CS among registrants only
🗑
|
||||
| common law | refers to law developed from decisions of the courts
🗑
|
||||
| compounding | preparation, mixing, assembling, packaging, or labeling of a drug/device by a pharmacist or by a practitioner in the course of professional practice.
🗑
|
||||
| CSA | controlled substances act; federal CSA is enforced by the DEA
🗑
|
||||
| DEA | drug enforcement administration; under the jurdisdiction of the Dept. of Justice; concerned w/ CS only
🗑
|
||||
| DEA 222 forms | Drug Enforcement Administration Form 222 for the ordering of CI and CII CS btw registrants
🗑
|
||||
| Direct supervision of a pharmacist | (in AZ) pharmacist is present
🗑
|
||||
| dispense | deliver med to an ultimate user on the lawful order of a practitioner
🗑
|
||||
| distribute | deliver, other than by administering (directly to a pt by the practitioner) or dispensing (on the order/Rx of the practitioner)
🗑
|
||||
| drug | articles, recognized in the official compendium, intended for the use in the dx, tx, mitigation, cure or prevention of disease; also articles other than food intended to affect the structure or fxn of the body
🗑
|
||||
| DUE | drug use evaluation
🗑
|
||||
| DUE process | law in its regular course of administration through the courts; fundamental fairness
🗑
|
||||
| DUR | drug utilization review/drug use review
🗑
|
||||
| Ex post facto | after the fact
🗑
|
||||
| Ex post facto law | law passed after the occurrence of an act which retroactively changes the legal consequences of the act
🗑
|
||||
| FDA | Federal Food and Drug Administration
🗑
|
||||
| FDCA (Federal Food, Drug and Cosmetic Act) | (1938)catalyst = sulfanilamide. Reg. drug development, manuf. & marketing (focuse on quality). Only safe and properly labeled drugs may be intro. into interstate commerce. Defined label/labeling (labels must contain adequate SIG); estab. FDA
🗑
|
||||
| Generic equivalent | contains identical amt. of the same AI in the same dosage form and, if administered in the same amt., will provide comparable therapeutic effects
🗑
|
||||
| GMP | good manufacturing practices; mandated by the FDCA, with standards for manuf. promulgated in reg. by the FDA
🗑
|
||||
| internship | the practical, experiential, hands-on training of a pharmacy intern under the supervision of a preceptor
🗑
|
||||
| jurisdiction | (a) the power to decide a matter; (b) the geographic area over which someone has authority
🗑
|
||||
| label | written, printed, or graphic matter immediately attached to the container for sale
🗑
|
||||
| labeling | includes the label and any accompanying material to the container for sale (may be inside the container, like a package insert)
🗑
|
||||
| legend drug | a drug which is available by RX or medication order only
🗑
|
||||
| NDA | new drug application: filed with the FDA to get approval for marketing in interstate commerce in the US; drug must be proven safe and effective to be approved.
🗑
|
||||
| NDC # | national drug code; 9-11 #s specifying the manuf. (1st 4/5#), product (name, strength, dosage form)(next 4#), the package size (last 2#); requested by the FDA to be on the label; not required; widely used when submitting info for dispensing reimbursement
🗑
|
||||
| new drug | drug not generally recognized by qualified experts as safe and effective for use
🗑
|
||||
| OBRA '90 | federal Omnibus Budget Reconciliation Act of 1990; mandates that pharmacists (a) provide DUR of Rx orders; (b) offer to counsel pt; and, (c) maintain a written pt hx in order for the state to receive federal funds for Medicaid programs; 1st effective pt c
🗑
|
||||
| off-label use | use an approvd drug for other than the approved indication
🗑
|
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Created by:
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