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28 Cards in this Set

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Schedule II
high potential for abuse, may lead to severe psychological or physiological dependence.

Ex. morphine, methadone, secobarbital (seconal - short acting, lipid soluble, barbiturate), amphetamines

What schedule?
Prescription for schedule II
What schedule?

May be for 30 day supply (max)

MAY NOT BE REFILLED. In an emergency or "managed care" setting, prescriptions may be RENEWED by telephone, but a written prescription must follow within 72 hours. This is NOT A REFILL but is an entirely new order - REORDER
REFILL
REORDER
MAY NOT BE REFILLED. In an emergency or "managed care" setting, prescriptions may be RENEWED by telephone, but a written prescription must follow within 72 hours. This is NOT A ________ but is an entirely new order - A _______
Schedule III
abuse potential medium - i.e. less than I and II but more than IV

What schedule?
Schedule III
What schedule?

moderate to low physical dependence

perhaps high psychological dependence

ex. many of the barbiturates (especially longer acting), drugs combined with codeine or other narcotics (higher concentration than in cough syrup)
III and IV
Must renew ("rewrite") prescriptions for schedule ___ and ___ medications after 6 months or 5 refills.

What schedule?
Prescription for schedule III
What schedule?

May be renewed by telephone (if pharmacist writes down immediately) or FAX (i.e. a "reorder").

Physicians use a regular prescription form for the FAX so the word "void" does not appear, but must write in the required information and licenses on the on the form to it legal.
Schedule IV
What schedule?

lower potential for abuse

may lead to limited physical or psychological dependece

ex. some tranquilizers, meprobamate, chlordiazepoxide (Librium), diazepam (valium), Ambien, Advan
I to V
Because controlled substances require prescriptions, what schedules need to have the legend written on them?
Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
Say the legend.
Food and Drug Administration
What division of gov't does this?

supervises and controls RESEARCH AND MANUFACTURE of ALL drugs, i.e. researcherers must apply to ______ before studying new drug in humans.
FDA
_____ must approve studies before drug can be marketed.

Quality control in the MANUFACTURING PROCESS also.

Certain BIOLOGICS like serums and vaccines, but no longer insulin and antibiotics (changed 1997) must be certified batch by batch.
usefullness verses potential for abuse
How are the schedule II to IV distinguished?
HHS
FDA and PHS (public health service are both under what category? (hint: formerly HEW)
DEA (Drug Enforcement Administration)
What Administration is runned by the Department of Justice?
Drug Enforcement Administration
established in 1973 by Executive Order (takes over for Department of Tresury)-controls DISTRIBUTION AND SALE OF ALL drugs
Drug Enforcement Administration
i.e. nation's sole legal drug enforcement agency
Drug Enforcement Administration
This division of drug manufacture and control is important and a big improvement since is separates drug enforcement from approval of new drugs.
Department of Commerce
Federal Trade Commission is under control by what part of the government?
Federal Trade Commission
controls misleading advertising for over the counter drugs.
FDA
Who controls advertising for prescription products?
investingational new drug
Drug company uses animal trial data to apply to the FDA for ______________ _____ ______ approval. Once liscense obtained may begin human trials.
Phase I
What phase?

Healthy volunteers. Record all data in areas such as purity, bioavailavailability, potency, efficacy, safety, toxicity.
Phase II
What phase?

Test on relatively few individuals who need the drug therapeutically. Continue monitoring safety and toxicity. Add info on potency and efficacy.
Phase III
What phase?

Expanded clinical trials. Provides information about more rare adverse effects.

use of
randomization
blinding
Phase III
After what phase does the FDA reevaluate. If favorable, company may file a NEW DRUG APPLICATION (NDA)
NEW DRUG APPLICATION (NDA)
After phase III, FDA reevaluates. If favorable, company may file a ___ ____ ___________.
Phase IV
What phase?

Voluntary monitoring of drug though the first years of its use. Company collects and monitors data on the product. (open ended)