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Dr. G's Lec 1

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Question
Answer
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  
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: nluong on 2010-09-30



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