Shared Flashcard Set

Details

Pharmacology
Unit 1
20
Nursing
Undergraduate 2
01/21/2010

Additional Nursing Flashcards

 


 

Cards

Term
Which drug law states the drugs must be "strong and pure" and prohibits mislabeling and adulteration?
Definition
Pure Food and Drug Act
Term

Which drug law regulated importation, manufacture, sale, and use of opium?

 

Which law repealed and superseded it?

Definition

Harrison Narcotic Act

 

 

Controlled Substance Act

Term
Which law forced registration of all parties involved in making and selling drugs? (Also required drugs to be safe)
Definition
Food, Drug and Cosmetic Act
Term
Which drug law separated drugs into legend and nonlegend
Definition
Durham-Humphrey Amendments
Term
What is a legend drug versus non-legend drug?
Definition
Legend is a prescription and non legend is an OTC drug.
Term
What phrase must all legend drugs contain on their label?
Definition
"Caution: Federal law prohibits dispensing without a prescription."
Term
Which drug law required a drug to be both safe and effective, set guidelines for clinical trials, and established the Drug Efficacy Study Implementation (DESI)?
Definition
Kefauver-Harris Amendments
Term
Which drug law established rehab programs, control (registration) and enforcement (DEA), and regulated export/import of controlled substances?
Definition

Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act)

This is a huge set of law that are always in flux

Term
Which drug law introduced special packaging for drug to make it difficult for children under 5 to open?
Definition
Poison Prevention Packaging Act
Term

Child-resistant containers are applied to which drugs?

Which drugs are in non-complying containers?

Definition

All control drugs, aspirin (and aspirin containing preparations), iron containing drugs, dietary supplements, all legend drugs except

 

sublingual nitroglycerin, oral contraceptives, effervescent tablets (aspirin containing)

Term
Which drug law required proof of safety and efficacy of medical devices and established standards for existing devices?
Definition
Medical Devices Act
Term
Which drug act allows for patents to be extended for 5 years (but not to exceed 14 years), and established Abbreviated New Drug Application (ANDA) procedure for making generic drugs? 
Definition
Drug Price Competition and Patent Restoration Act
Term
Which drug law attempted to curb drug diversion by prohibiting purchase, sale, or trade of drug samples?
Definition
Prescription Drug Marketing Act
Term
Which drug law amended the 1965 Medicaid law and developed drug utilization review (DUR), patient counseling and participation of states in federal Medicaid program?
Definition

Omnibus Budget Reconciliation Act

*Always being amended; ensures education of the patient; DUR meets at the hospital and looks at all the drugs that the hospital uses - they get rid of the drugs they don't use very often.

Term
How many different classifications (schedules) are there for drugs?
Definition

Five

Schedule I - V

Term
Describe a schedule I drug.
Definition

High abuse potential

No accepted medical use in U.S.

Investigational drugs, opitates (heroin), hallucinogens (LSD, mescaline, peyote), marijuana, methaqualone (Quaalude) 

Term
The Food and Drug Administration Modernization Act of 1997 (FDAMA) did what?
Definition
Allowed for fast tracking of drugs for serious illnesses, drug manufacturers have to give patients 6 months notice before discontinuing a drug, companies can inform patient of off-label uses
Term
What drug laws promoted drug studies in children and set the stage for for pediatric drug trials?
Definition
The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Term

TRUE OR FALSE:

A study drug is considered a schedule I drug.

Definition
TRUE
Term
Describe a schedule II drug.
Definition
Acceptable medical use, high abuse potential (resulting in severe physical/psychological dependence) 
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