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vocabulary Flashcards

1
Q

act

A

a law passed by the legislature

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2
Q

adminster

A

direct application (by injection, inhalation, ingestion, etc) of a drug to the body of a patient by a practitioner or his authorized agent of by the patient at the direction of the practitioner

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3
Q

adjudication

A

a formal determination or judgment

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4
Q

bioequivalent

A

term describing products which are pharmaceutical equivalents or pharmaceutical alternatives that display comparable bioavailability; the parameters evaluated regarding bioavailability are the rate and extent of absorption.

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5
Q

Biosimilar

A

biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product

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6
Q

Biosimilar,
interchangeable

A

interchangeable
An interchangeable biological product is biosimilar to an FDA-approved reference product and meets additional standards for interchangeability. An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product (The following terminology may also be used: interchangeable biosimilar).

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7
Q

CI - CV:

A

denotes a controlled substance in Class I, Class II, etc., as determined in the CSA

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8
Q

CARA

A

Comprehensive Addiction and Recovery Act (2016)

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9
Q

CFR:

A

Code of Federal Regulations

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10
Q

CGMP

A

current good manufacturing practices; the standard established by the FDA and applied to all drug manufacturers

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11
Q

closed system

A

as applied to the CSA; refers to the distribution of controlled substances among registrants only

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12
Q

common law

A

refers to law developed from decisions of the courts

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13
Q

compounding

A

Preparation, mixing, assembling, packaging, or labeling of a drug/device by a pharmacist or by a practitioner in the course of professional practice. Compounding includes the preparation of drugs/devices as the result of a practitioner order or initiative, as well as in anticipation of prescriptions of medication orders based on routine prescribing patterns.

Compounding does not include the preparation of
commercially available products from bulk compounds, or the preparation of
drugs/devices for sale to pharmacies, practitioners or any other agent for the
purpose of dispensing or distribution.

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14
Q

compounding quality act

A

Title 1 of DQSA (Drug Quality and Security Act)

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15
Q

csa

A

Controlled Substances Act; federal CSA is enforced by the DEA

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16
Q

DEA

A

Drug Enforcement Administration is under the jurisdiction of the Department of
Justice; concerned with controlled substances only

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17
Q

DEA Form 222

A

Drug Enforcement Administration Form 222 for the ordering of CI and CII controlled substances between registrants

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18
Q

Direct
supervision of a
pharmacist

A

(in Arizona) pharmacist is present

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19
Q

Dispense

A

deliver medication to an ultimate user on the lawful order of a practitioner

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20
Q

Distribute

A

deliver, other than by administering (directly to a patient by the practitioner) or dispensing (on the order/prescription of the practitioner)

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21
Q

DQSA

A

Drug Quality and Security Act. The Act has 2 titles. Title 1: Compounding Quality Act Title 2: The Drug Supply Chain Security Act

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22
Q

Drug

A

articles, recognized in the official compendium, intended for the use in the diagnosis, treatment, mitigation, cure, or prevention of disease; also articles other than food intended to affect the structure or function of the body

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23
Q

DSCSA

A

Drug Supply Chain Security Act (Title 2 of DQSA; Drug Quality and Security Act)

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24
Q

DUE

A

drug use evaluation

25
Due process
law in its regular course of administration through the courts; fundamental fairness
26
DUR
drug utilization review/drug use review
27
Ex post facto
after the fact
28
Ex post facto law
law passed after the occurrence of an act which retroactively changes the legal consequences of the act
29
FDCA
Federal Food, Drug and Cosmetic Act; enacted to protect public health; enforced b the FDA
30
Generic equivalent
contains an identical amount of the same active chemical ingredients in the same dosage form and which, if administered in the same amounts, will provide comparable therapeutic effects; this does not include any drug that is listed by the FDA as having unresolved bioequivalence concerns; see all therapeutic equivalent and pharmaceutical equivalent
31
GMP
good manufacturing practices; mandated by the FDCA, with standards for manufacturers promulgated in regulations by the FDA
32
Label
written, printed, or graphic matter immediately attached to the container for sale
33
Labeling
includes the label and any accompanying material to the container for sale (may be inside the container, like a package insert)
34
Legend drug
a drug which is available by prescription or medication order only
35
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.
36
NDC #
National Drug Code; a unique identifier number placed on the label of drugs, containing 9 - 11 digits arranged to specify the manufacturer, the product, the package size and dosage form; is required as part of the manufacturer prescription label with the passage of the Food Drug Administration Amendments Act 2007 (Public Law 110-85)
37
OBRA '90
federal Omnibus Budget Reconciliation Act of 1990; mandates that pharmacists (a) provide DUR of prescription orders; (b) offer to counsel patients; and © maintain a written patient history in order for the state to receive federal funds for Medicaid programs; first effective patient counseling rule
38
off-label use
use of an approved drug for other than the approved indication
39
Official compendium
the United States Pharmacopeia and the National Formulary (USP/NF); official listing of recognized drugs in the US; and Homeopathic Pharmacopoeia of the United States; official compendia for homeopathic products in the US
40
Orphan drug
safe & effective drug; but the number of patients requiring the drug is so small as to not provide a reasonable return on investment to a manufacturer, thus the FDA provides incentives to companies that will market the drug
41
Original state of licensure
any state from which the license is obtained by examination and not by reciprocity
42
Orange book
the "Approved Drug Products with Therapeutic Equivalence Evaluations", published by the federal Department of Health and Human Services (DHHS); lists all approved drugs in the US as well as therapeutic equivalence information; it has an orange cover -- hence it's nickname
43
OTC
over-the-counter; medications/devices not requiring a prescription for sale
44
PDMA
Prescription Drug Marketing Act
45
PDMP/PMP
Prescription Drug Monitoring Program/Prescription Monitoring Program
46
Pharmaceutical equivalent
drug products that contain the same active ingredient(s), same dosage form, same route of administration, and are identical in strength or concentration; they may have different shape, coloring, flavoring, or release mechanisms
47
Pharmaceutical alternative
drug products which contain the same therapeutic moiety but are different salts, esters, complexes, dosage forms or strengths
48
PPPA
Poison Prevention Packaging Act; enacted to decrease accidental poisonings of children; the guidelines supersede any state legislation for packaging; administered by the US Consumer Product Safety Commission
49
Prescription (or prescription order)
an order for medication or vaccine which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (i.e. an order to dispense a drug to a patient in the hospital for immediate administration is a medication order; not a prescription order). See ARS 32-1901 (77) for complete definitions.
50
Promulgate
to announce officially; to make a law known; to put a law into action or force
51
Purple Book
The “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations” published by CDER/FDA and has a “purple cover”, hence it’s name.
52
Regulation
official guidelines promulgated by agencies of the executive branch (e.g. State Board of Pharmacy) which interpret and define statutes; although not laws, thy hold the strength of statutes
53
Retroactive
applying to the time prior to enactment
54
Statute
a law; promulgated by elected officials (the legislature)
55
The act
usually referring to the Food, Drug, and Cosmetic Act (FDCA)
56
Therapeutic alternate:
drug product containing different therapeutic moieties but which are of the same pharmacological and/or therapeutic class that can be expected to have similar therapeutic effects when administered to patients in therapeutically equivalent doses
57
Therapeutic equivalent
drugs which are pharmaceutical equivalents AND which can be expected to have the same clinical effect and safety profile when administered under the conditions specified in the labeling AND which are bioequivalent; all generic equivalents are therapeutic equivalents; when used by the FDA, therapeutic equivalent does not mean different therapeutic moieties used for the same condition
58
Therapeutic moiety
the portion or part of a drug that produces or causes a therapeutic effect or action.
59
USP
the United States Pharmacopeia; one of the two official compendium

az- mpje (2 decks)

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